32 CFR Part 199 — Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)

PART 199—CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED SERVICES (CHAMPUS) Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55. Source: 51 FR 24008, July 1, 1986, unless otherwise noted. § 199.1 General provisions. (a) Purpose. (b) Applicability Geographic. (2) Agency. (c) Authority and responsibility Legislative authority Joint regulations. (ii) Administration. (2) Organizational delegations and assignments Assistant Secretary of Defense (Health Affairs) (ASD(HA)). 1 2 1 2 (ii) Department of Health and Human Services. (iii) Department of Transportation. (iv) Office of CHAMPUS (OCHAMPUS). (A) Supervise and administer the programs and missions to: ( 1 ( 2 ( 3 ( 4 ( i ( ii ( iii ( 5 ( 6 ( 7 ( 8 ( 9 ( 10 (B) Direct and control of the office, activities, and functions of OCHAMPUS Europe (OCHAMPUSEUR). Note: The Director, OCHAMPUS, may also establish similar offices for OCHAMPUS Southern Hemisphere (OCHAMPUSSO) and OCHAMPUS Pacific (OCHAMPUSPAC). (C) Develop for issuance, subject to approval by the ASD(HA), such policies or regulations as required to administer and manage CHAMPUS effectively. (v) Evidence of eligibility. (d) Medical benefits program. (e) Program funds. (f) Claims adjudication and processing. (1) The United States Contracting out. (ii) In-house. (2) Outside the United States Special subsidiary office or contracting out. (ii) Support agreements. (g) Recommendations for change to part. (h) CHAMPUS, claims forms. (i) The CHAMPUS handbook. (j) Program integrity. (k) Role of CHAMPUS Health Benefits Advisor (HBA). (l) Cooperation and exchange of information with other Federal programs. (1) Investigation for fraud. (2) Unnecessary services. (m) Disclosure of information to the public. 3 4 5 3 4 5 (n) Discretionary authority. (o) Demonstration projects Authority. (2) Procedures. (3) Definition. (p) Military-Civilian Health Services Partnership Program. (1) Partnership agreements. (i) External partnership agreements. (ii) Internal partnership agreements. (2) Beneficiary cost-sharing. (3) Reimbursement. (4) Beneficiary eligibility and authorized providers. (5) Range of benefits. (q) Equality of benefits. (r) TRICARE program. [51 FR 24008, July 1, 1986, as amended at 52 FR 38754, Oct. 19, 1987; 53 FR 27961, July 26, 1988; 55 FR 43338, Oct. 29, 1990; 60 FR 52094, Oct. 5, 1995] § 199.2 Definitions. (a) General. (b) Specific definitions. Abortion. Absent treatment. Note: Technically, “Absent Treatment” is an obsolete term. The current Christian Science terminology is “treatment through prayer and spiritual means,” which is employed by an authorized Christian Science practitioner either with the beneficiary being present or absent. However, to be considered for coverage under CHAMPUS, the beneficiary must be present physically when a Christian Science service is rendered, regardless of the terminology used. Abuse. Note: Unless a specific action is deemed gross and flagrant, a pattern of inappropriate practice will normally be required to find that abuse has occurred. Also, any practice or action that constitutes fraud, as defined by this part, would also be abuse. Abused dependent. or Accidental injury. Active duty. Active duty member. Activities of daily living. Acupuncture. Note: Acupuncture is not covered by CHAMPUS. Adequate Medical Documentation, Medical Treatment Records. Adequate medical documentation, mental health records. e.g., Adjunctive dental care. Admission. Adopted child. Note: There is no CHAMPUS benefit entitlement during any interim waiting period. All-inclusive per diem rate. Allowable charge. Allowable cost. Ambulance. Ambulatory Payment Classifications Ambulatory Surgery Center (ASC). e.g., 1 ii iii Amount in dispute. Anesthesia services. Appealable issue. Appealing party. Appropriate medical care. (ii) The authorized individual professional provider rendering the medical care is qualified to perform such medical services by reason of his or her training and education and is licensed or certified by the state where the service is rendered or appropriate national organization or otherwise meets CHAMPUS standards; and (iii) The services are furnished economically. For purposes of this part, “economically” means that the services are furnished in the least expensive level of care or medical environment adequate to provide the required medical care regardless of whether or not that level of care is covered by CHAMPUS. Approved teaching programs. Assistant Secretary of Defense (Health Affairs). Assistive technology devices. e.g., e.g., Attending physician. Augmentative communication device (ACD). Authorized provider. Automobile liability insurance. (1) Circumstances in which liability benefits are paid to an injured party only when the insured party's tortious acts are the cause of the injuries; and (2) Uninsured and underinsured coverage, in which there is a third-party tortfeasor who caused the injuries (i.e., benefits are not paid on a no-fault basis), but the insured party is not the tortfeasor. Backup hospital. Balance billing. Bariatric Surgery. Basic program. Beneficiary. Beneficiary liability. Biotelemetry. Birthing center. Birthing room. Brace. CAHs. Cancer hospital. Capped rate. Case management. Case-mix index. Certified nurse-midwife. Certified psychiatric nurse specialist. CHAMPUS DRG-Based Payment System. CHAMPUS fiscal intermediary. CHAMPUS Health Benefits Advisors (HBAs). Chemotherapy. Child. Children's hospital. Chiropractor. Note: Services of chiropractors are not covered by CHAMPUS. Christian science nurse. (i) Graduate Christian Science nurse. (ii) Practical Christian Science nurse. Christian Science practitioner. Christian Science sanatorium. Chronic medical condition. Chronic renal disease (CRD). Clinical psychologist. Clinical social worker. Clinically meaningful endpoints. reliable evidence Collateral visits. Combined daily charge. Complications of pregnancy. (i) Caesarean delivery; hysterectomy. (ii) Pregnancy terminating before expiration of 26 weeks, except a voluntary abortion. (iii) False labor or threatened miscarriage. (iv) Nephritis or pyelitis of pregnancy. (v) Hyperemesis gravidarum. (vi) Toxemia. (vii) Aggravation of a heart condition or diabetes. (viii) Premature rupture of membrane. (ix) Ectopic pregnancy. (x) Hemorrhage. (xi) Other conditions as may be determined by the Director, OCHAMPUS, or a designee. Confinement. Conflict of interest. Congenital anomaly. Note: Also refer to § 199.4(e)(7) of this part. Consultation. Note: Staff consultations required by rules and regulations of the medical staff of a hospital or other institutional provider do not qualify as consultation. Consultation appointment. Consulting physician or dentist. Conviction. nolo contendere Coordination of benefits. Corporate services provider. Cosmetic, reconstructive, or plastic surgery. Cost-share. Custodial care. (1) Can be rendered safely and reasonably by a person who is not medically skilled; or (2) Is or are designed mainly to help the patient with the activities of daily living. Days. Deceased member. Deceased reservist. Deceased retiree. Deductible. Deductible certificate. Defense Enrollment Eligibility Reporting System (DEERS). (1) Enrolling members, former members and their dependents, and (2) Verifying members', former members' and their dependents' eligibility for health care benefits in the direct care facilities and for CHAMPUS. Dental care. Dentist. Dependent. Deserter or desertion status. Diagnosis-Related Groups (DRGs). Diagnostic admission. Director. Director, OCHAMPUS. Director, TRICARE Management Activity. Doctor of Dental Medicine (D.M.D.). Doctor of Medicine (M.D.). Doctor of Osteopathy (D.O.). Domiciliary care. (1) Providing support for the activities of daily living in the home is not available or is unsuitable; or (2) Members of the patient's family are unwilling to provide the care. Donor. Double coverage. Double coverage plan. (i) Medicaid. (ii) Coverage specifically designed to supplement CHAMPUS benefits. (iii) Entitlement to receive care from the Uniformed Services medical facilities; (iv) Entitlement to receive care from Veterans Administration medical care facilities; or (v) Part C of the Individuals with Disabilities Education Act for services and items provided in accordance with Part C of the IDEA that are medically or psychologically necessary in accordance with the Individual Family Service Plan and that are otherwise allowable under the CHAMPUS Basic Program or the Extended Care Health Option (ECHO). Dual compensation. Duplicate equipment. Durable equipment. (1) Is a medically necessary item, which can withstand repeated use; (2) Is primarily and customarily used to serve a medical purpose; and (3) Is generally not useful to an individual in the absence of an illness or injury. It includes durable medical equipment as defined in § 199.2, wheelchairs, iron lungs, and hospital beds. It does not include equipment (including wheelchairs) used or designed primarily for use in sports or recreational activities. Durable medical equipment. (1) Improve, restore, or maintain the function of a malformed, diseased, or injured body part or can otherwise minimize or prevent the deterioration of the beneficiary's function or condition; or (2) Maximize the beneficiary's function consistent with the beneficiary's physiological or medical needs. Economic interest. (2) A referral relationship exists when a CHAMPUS beneficiary is sent, directed, assigned or influenced to use a specific CHAMPUS-authorized provider, or a specific individual or entity eligible to be a CHAMPUS-authorized provider. (3) An accreditation relationship exists when a CHAMPUS-authorized accreditation organization evaluates for accreditation an entity that is an applicant for, or recipient of CHAMPUS-authorized provider status. Emergency inpatient admission. Entity. Essential Access Community Hospital (EACH). Extended Care Health Option (ECHO). External Partnership Agreement. External Resource Sharing Agreement. Extramedical individual providers of care. Extraordinary physical or psychological condition. Facility charge. i.e. i.e. Former member. Former spouse. Fraud. and Freestanding. Full-time course of higher education. General staff nursing service. Good faith payments. Habilitation. Handicap. High-risk pregnancy. Homebound. Home health discipline. Home health market basket index. Hospice care. Hospital, acute care (general and special). Hospital, psychiatric. Illegitimate child. Immediate family. Independent laboratory. Infirmaries. Initial determination. In-out surgery. Inpatient. Inpatient Rehabilitation Facility (IRF). Institution-affiliated. Institution-based. Institutional provider. Intensive care unit (ICU). Intensive outpatient program (IOP). Intern. Internal Partnership Agreement. Internal Resource Sharing Agreement. Item, Service, or Supply. Laboratory and pathological services. Legitimized child. Licensed practical nurse (L.P.N.). Licensed vocational nurse (L.V.N.) Life threatening conditions. Long Term Care Hospital (LTCH). Low-risk pregnancy. Major life activity. Marriage and family therapist, certified. Maternity care. Medicaid. Medical. Medical emergency. Medically or psychologically necessary preauthorization. Medical supplies and dressings (consumables). Medically or psychologically necessary. Medicare. Medication assisted treatment (MAT). Member. Mental disorder, to include substance use disorder. Mental health therapeutic absence. Missing in action (MIA). Note: Claims for eligible CHAMPUS beneficiaries whose sponsor is classified as MIA are processed as dependents of an active duty service member. Morbid obesity. 2 2 Note: Body mass index is equal to weight in kilograms divided by height in meters squared. Most-favored rate. National Institutes of Health (NIH)-approved clinical trial. i.e., Natural childbirth. Naturopath. Note: Services of a naturopath are not covered by CHAMPUS. NAVCARE clinics. NIH-sponsored clinical trial. i.e., No-fault insurance. Nonavailability statement. Nonparticipating provider. North Atlantic Treaty Organization (NATO) member. Not-for-profit entity. Occupational therapist. Off-label use of a drug or device. Office-based opioid treatment. Official formularies. U.S. Pharmacopeia. Opioid Treatment Program. Optometrist (Doctor of Optometry). Oral surgeon (D.D.S. or D.M.D.). Orthopedic shoes. Other allied health professionals. Other special institutional providers. Outpatient. Ownership or control interest. (1) Has directly or indirectly a 5 percent or more ownership interest in the entity; or (2) Is the owner of a whole or part interest in any mortgage, deed of trust, note, or other obligation secured (in whole or in part) by the entity or any of the property or assets thereof, which whole or part interest is equal to or exceeds 5 percent of the total property and assets of the entity; or (3) Is an officer or director of the entity if the entity is organized as a corporation; or (4) Is a partner in the entity if the entity is organized as a partnership. Partial hospitalization. Participating provider. Part-time or intermittent home health aide and skilled nursing services. Party to a hearing. Party to the initial determination. Pastoral counselor. Pharmaceutical Agent. Pharmacist. Physical medicine services or physiatry services. Physical therapist. Physician. Physician in training. Podiatrist (Doctor of Podiatry or Surgical Chiropody). Preauthorization. Prescription drugs and medicines. Note: The fact that the U.S. Food and Drug Administration has approved a drug for testing on humans would not qualify it within this definition. Preventive care. Primary caregiver. Primary payer. PRIMUS clinics. Private room. Profound hearing loss (adults). (1) 40 dB HL or greater in one or both ears when tested at 500, 1,000, 1,500, 2,000, 3,000, or 4,000Hz; or (2) 26 dB HL or greater in one or both ears at any three or more of those frequencies; or (3) A speech recognition score less than 94 percent. Profound hearing loss (children). Program year. e.g., e.g., Progress notes. Prosthetic device (prosthesis). Prosthetic or Prosthetic device (prosthesis). Prosthetic supplies. Provider. Provider exclusion and suspension. Provider termination. Psychiatric emergency. Public facility. Public facility adequacy. Public facility availability. Qualified accreditation organization. (1) Develops process standards and outcome standards for health care delivery programs, or knowledge standards and skill standards for health care professional certification testing, using experts both from within and outside of the health care program area or individual specialty to which the standards are to be applied; (2) Creates measurable criteria that demonstrate compliance with each standard; (3) Publishes the organization's standards, criteria and evaluation processes so that they are available to the general public; (4) Performs on-site evaluations of health care delivery programs, or provides testing of individuals, to measure the extent of compliance with each standard; (5) Provides on-site evaluation or individual testing on a national or international basis; (6) Provides to evaluated programs and tested individuals time-limited written certification of compliance with the organization's standards; (7) Excludes certification of any program operated by an organization which has an economic interest, as defined in this section, in the accreditation organization or in which the accreditation organization has an economic interest; (8) Publishes promptly the certification outcomes of each program evaluation or individual test so that it is available to the general public; and (9) Has been found by the Director, OCHAMPUS, or designee, to apply standards, criteria, and certification processes which reinforce CHAMPUS provider authorization requirements and promote efficient delivery of CHAMPUS benefits. Qualified mental health provider. Radiation therapy services. Rare diseases. Referral. Registered nurse. Rehabilitation. Rehabilitative therapy. Reliable evidence. (i) Well controlled studies of clinically meaningful endpoints, published in refereed medical literature. (ii) Published formal technology assessments. (iii) The published reports of national professional medical associations. (iv) Published national medical policy organization positions; and (v) The published reports of national expert opinion organizations. (2) The hierarchy of reliable evidence of proven medical effectiveness, established by (1) through (5) of this paragraph, is the order of the relative weight to be given to any particular source. With respect to clinical studies, only those reports and articles containing scientifically valid data and published in the refereed medical and scientific literature shall be considered as meeting the requirements of reliable evidence. Specifically not included in the meaning of reliable evidence are reports, articles, or statements by providers or groups of providers containing only abstracts, anecdotal evidence or personal professional opinions. Also not included in the meaning of reliable evidence is the fact that a provider or a number of providers have elected to adopt a drug, device, or medical treatment or procedure as their personal treatment or procedure of choice or standard of practice. Representative. Reservist. Resident (medical). Residential treatment center (RTC). Respite care. Retired category. Retiree. Routine eye examinations. Sanction. Secondary payer. Semiprivate room. Serious physical disability. Severely debilitating conditions. Skilled nursing facility. Skilled nursing services. Sole community hospital Spectacles, eyeglasses, and lenses. Speech generating device (SGD). Sponsor. Spouse. State. State victims of crime compensation programs. Student status. Substance use disorder rehabilitation facility (SUDRF). Supervised mental health counselor. Supplemental insurance plan. (1) An indemnity supplemental insurance plan must meet all of the following criteria: (i) It provides insurance coverage, regulated by state insurance agencies, which is available only to beneficiaries of CHAMPUS. (ii) It is premium based and all premiums relate only to the CHAMPUS supplemental coverage. (iii) Its benefits for all covered CHAMPUS beneficiaries are predominantly limited to non-covered services, to the deductible and cost-shared portions of the pre-determined allowable charges, and/or to amounts exceeding the allowable charges for covered services. (iv) It provides insurance reimbursement by making payment directly to the CHAMPUS beneficiary or to the participating provider. (v) It does not operate in a manner which results in lower deductibles or cost-shares than those imposed by law, or that waives the legally imposed deductibles or cost-shares. (2) A supplemental insurance plan offered by a Health Maintenance Organization (HMO) must meet all of the following criteria: (i) The HMO must be authorized and must operate under relevant provisions of state law. (ii) The HMO supplemental plan must be premium based and all premiums must relate only to CHAMPUS supplemental coverage. (iii) The HMO's benefits, above those which are directly reimbursed by CHAMPUS, must be limited predominantly to services not covered by CHAMPUS and CHAMPUS deductible and cost-share amounts. (iv) The HMO must provide services directly to CHAMPUS beneficiaries through its affiliated providers who, in turn, are reimbursed by CHAMPUS. (v) The HMO's premium structure must be designed so that no overall reduction in the amount of the beneficiary deductibles or cost-shares will result. Suppliers of portable X-ray services. Surgery. Surgical assistant. Suspension of claims processing. Teaching physician. Telephonic consultations: Telephonic office visits. Third-party billing agent. Third-party payer. Note: TRICARE is secondary payer to all third-party payers. Under limited circumstances described in § 199.8(c)(2) of this part, TRICARE payment may be authorized to be paid in advance of adjudication of the claim by certain third-party payers. TRICARE advance payments will not be made when a third-party provider is determined to be a primary medical insurer under § 199.8(c)(3) of this part.” Timely filing. Transitional Assistance Management Program (TAMP). Treatment plan. TRICARE certified mental health counselor. TRICARE Extra. TRICARE for Life. TRICARE Hospital Outpatient Prospective Payment System TRICARE Prime. TRICARE program. TRICARE Reserve Select. TRICARE Retired Reserve. TRICARE Select. TRICARE Standard. TRICARE Young Adult. Uniform HMO benefit. Uniformed Services. Veteran. Note: Unless the veteran is eligible for “retired pay,” “retirement pay,” or “retainer pay,” which refers to payments of a continuing nature and are payable at fixed intervals from the government for military service neither the veteran nor his or her dependents are eligible for benefits under CHAMPUS. Waiver of benefit limits. Well-child care. Widow or Widower. Worker's compensation benefits. X-ray services. [51 FR 24008, July 1, 1986] Editorial Note: For Federal Register www.govinfo.gov. § 199.3 Eligibility. (a) General. (b) CHAMPUS eligibles Retiree. (2) Dependent. (i) Spouse. and 1 2 (A) Must be unremarried; and (B) Must not be covered by an employer-sponsored health plan; and (C) Must have been married to a member or former member who performed at least 20 years of service which can be credited in determining the member's or former member's eligibility for retired or retainer pay; and (D) Must not be eligible for Part A of Title XVIII of the Social Security Act (Medicare) except as provided in paragraphs (b)(3), (f)(3)(vii), (f)(3)(viii), and (f)(3)(ix) of this section; and (E) Must not be the dependent of a NATO member; and (F) Must meet the requirements of paragraph (b)(2)(i)(F)( 1 2 ( 1 ( i ( ii ( 2 ( i ( ii ( iii (ii) Child. 2 (A) A legitimate child; or (B) An adopted child whose adoption has been legally completed on or before the child's twenty-first (21st) birthday; or (C) A legitimate stepchild; or (D) An illegitimate child of a member or former member has been (E) An illegitimate child of a member or former member has not been (F) An illegitimate child of a spouse of a member (G) An illegitimate child of a spouse of a former member (H) An individual who falls into one of the following classes: ( 1 A student. Note: Courses of education offered by institutions listed in the “Education Directory,” “Higher Education” or “Accredited Higher Institutions” issued periodically by the Department of Education meet the criteria approved by the Administering Secretary or the Secretary of Education. For determination of approval of courses offered by a foreign institution, by an institution not listed in either of the above directories, or by an institution not approved by a state agency pursuant to 38 U.S.C. chapters 34 and 35, a statement may be obtained from the Department of Education, Washington, D.C. 20202. ( 2 An incapacitated child. ( i ( ii 2 iii ( iii 2 ii Note: An institution of higher learning is a college, university, or similar institution, including a technical or business school, offering post-secondary level academic instruction that leads to an associate or higher degree, if the school is empowered by the appropriate State education authority under State law to grant an associate, or higher, degree. When there is no State law to authorize the granting of a degree, the school may be recognized as an institution of higher learning if it is accredited for degree programs by a recognized accrediting agency. The term also shall include a hospital offering educational programs at the post-secondary level regardless of whether the hospital grants a post-secondary degree. The term also shall include an educational institution that is not located in a State, that offers a course leading to a standard college degree, or the equivalent, and that is recognized as such by the Secretary of Education (or comparable official) of the country, or other jurisdiction, in which the institution is located (38 U.S.C. chapter 34, section 1661, and chapter 35, section 1701. Courses of education offered by institutions listed in the “Education Directory,” “Higher Education” or “Accredited Higher Institutions” issued periodically by the Department of Education meet the criteria approved by the Administering Secretary or the Secretary of Education. For determination of approval of courses offered by a foreign institution, by an institution not listed in either of the above directories, or by an institution not approved by a state agency pursuant to chapters 34 and 35 of 38 U.S.C., a statement may be obtained from the Department of Education, Washington, D.C. 20202. ( 3 A child of a deceased reservist. ( 4 An unmarried person. 1 2 (iii) Abused dependents Categories of abused dependents. ( 1 ( 2 (B) Requirements for categories of abused dependents 1 Abused spouse. ( i 1 ( ii 2 ( A ( B ( C ( 2 Abused child. ( i 1 ( ii 2 ( A ( B ( C ( D ( E ( F ( 3 TAMP eligibles. (iv) An unmarried person who is placed in the legal custody of a member or former member by a court of competent jurisdiction in the United States (or possession of the United States) for a period of at least 12 consecutive months. The unmarried person shall be considered a dependent of the member or former member under this section provided he or she otherwise meets the following qualifications: (A) Has not reached the age of 21 unless he or she otherwise meets the requirements of a student set out in paragraph (b)(2)(ii)(H)( 1 2 (B) Is dependent on the member or former member for over one-half of the person's support; (C) Resides with the member or former member unless separated by the necessity of military service or to receive institutional care as a result of disability or incapacitation or under such other authorized circumstances; and, (D) Is not a dependent of a member or former member under any other provision of law or regulation. (3) Eligibility under TRICARE Senior Pharmacy Program. (i) Medicare eligible, who is: (A) 65 years of age or older; and (B) Entitled to Medicare Part A; and (C) Enrolled in Medicare Part B, except for a person who attained age 65 prior to April 1, 2001, is not required to enroll in Part B; and (ii) Otherwise qualified under one of the following categories: (A) A retired uniformed service member who is entitled to retired or retainer pay, or equivalent pay including survivors who are annuitants; or (B) A dependent of a member of the uniformed services described in one of the following: ( 1 ( 2 ( i ( ii Note to paragraph ( b ii Dependent under Section 711 of the National Defense Authorization Act for Fiscal Year 2001 includes spouse, unremarried widow/widower, child, parent/parent-in-law, unremarried former spouse, and unmarried person in the legal custody of a member or former member, as those terms of dependency are defined and periods of eligibility are set forth in 10 U.S.C. 1072(2). (4) Medal of Honor recipients. (ii) Immediate dependents. 4 (iii) Effective date. (5) Reserve Component Members issued delayed-effective-date orders Member. (ii) Dependents. (iii) Effective date. (A) The date of issuance of the order referred to in paragraph (b)(5)(i) of this section; or (B) 180 days before the date on which the period of active duty is to begin. (iv) Termination date. (c) Beginning dates of eligibility. (2) Beginning dates of eligibility for each class of spouse ( excluding spouses who are victims of abuse and eligible spouses of certain deceased reservists (i) A spouse of a member for: (A) Medical benefits authorized by the Dependents' Medical Care Act of 1956, December 7, 1956; (B) Outpatient medical benefits under the Basic Program, October 1, 1966; (C) Inpatient medical benefits under the Basic Program and (ii) A spouse of a former member: (A) For medical benefits under the Basic Program, January 1, 1967. (B) Ineligible for benefits under the Extended Care Health Option. (iii) A former spouse: (A) For medical benefits under the Basic Program, dates of beginning eligibility are as indicated for each category of eligible former spouse identified within paragraph (b)(2)(i) of this section. (B) Ineligible for benefits under the Extended Care Health Option. (3) Beginning dates of eligibility for spouses who are victims of abuse ( excluding spouses who are victims of abuse of certain deceased reservists (i) An abused spouse meeting the requirements of paragraph (b)(2)(iii)(A)( 1 (A) For medical and dental care for problems associated with the physical or emotional abuse under the Basic Program for a period of up to one year (12 months) following the person's separation from the Uniformed Service, November 14, 1986. (B) For all medical and dental benefits under the Basic Program for the period that the spouse is in receipt of transitional compensation under section 1059 of title 10 U.S.C., October 17, 1998. (C) For medical and dental care for problems associated with the physical or emotional abuse under the Extended Care Health Option for a period up to one year (12 months) following the person's separation from the Uniformed Service, November 14, 1986. (D) For all medical and dental benefits described in section 199.5 for the period that the spouse is in receipt of transitional compensation under section 1059 of title 10 U.S.C., October 17, 1998. (ii) An abused spouse meeting the requirements of paragraphs (b)(2)(iii)(A)( 2 (A) For all benefits under the CHAMPUS Basic Program, October 23, 1992. (B) Ineligible for benefits under the Extended Care Health Option. (4) Beginning dates of eligibility for spouses of certain deceased reservists, including spouses who are victims of abuse of certain deceased reservists, (i) A spouse meeting the requirements of paragraph (b)(2)(i) of this section, including an eligible former spouse: (A) For benefits under the Basic Program, November 14, 1986. (B) Ineligible for benefits under the Extended Care Health Option. (ii) An abused spouse of certain deceased reservists, meeting the requirements of paragraphs (b)(2)(iii) of this section, including an eligible former spouse, for the limited benefits and period of eligibility (A) For benefits under the Basic Program, November 14, 1986. (B) For benefits under the Extended Care Health Option, November 14, 1986. (iii) An abused spouse of certain deceased reservists, including an eligible former spouse, meeting the requirements of paragraphs (b)(2)(iii) of this section: (A) For benefits under the Basic Program, October 23, 1992. (B) Ineligible for benefits under the Extended Care Health Option. (5) Beginning dates of eligibility for each class of dependent children, ( excluding dependent children of certain deceased reservists, abused children and incapacitated children whose incapacity occurred between the ages of 21 and 23 while enrolled in a full-time course of study in an institution of higher learning (i) Legitimate child, adopted child, or legitimate stepchild of a member, (A) Medical benefits authorized by the Dependents' Medical Care Act of 1956, December 7, 1956; (B) Outpatient medical benefits under the Basic Program, October 1, 1966; (C) Inpatient medical benefits under the Basic Program and (ii) Legitimate child, adopted child or legitimate stepchild of former members (A) For medical benefits under the Basic Program, January 1, 1967. (B) Ineligible for benefits under the Extended Care Health Option. (iii) Illegitimate child of a male or female member or former member (A) All benefits for which otherwise entitled, August 31, 1972. (B) Extended Care Health Option benefits limited to dependent children of members (iv) Illegitimate child of: (A) A male member or former member whose paternity has not been (B) A female member or former member who resides with, or in a home provided by the member or former member, or who was residing in a home provided by the member or former member at the time of the member's or former member's death, and who is or continues to be dependent on the member for over one-half of his or her support, or was so dependent on the member or former member at the time of death; (C) A spouse of a member or former member who resides with or in a home provided by the member or former member, or the parent who is the spouse of the member or former member or was the spouse of a member or former member at the time of death, and who is and continues to be dependent upon the member or former member for over one-half of his or her support, or was so dependent on the member or former member at the time of death; for: ( 1 ( 2 members (6) Beginning dates of eligibility for children of certain deceased reservists who meet the requirements of paragraph (b)(2)(ii)(H)( 3 excluding incapacitated children 2 (i) Benefits under the Basic program, November 14, 1986. (ii) Not eligible for benefits under the Extended Care Health Option. (7) Beginning dates of eligibility for children who are victims of abuse, including incapacitated children 2 (i) An abused child meeting the requirements of paragraph (b)( 2 1 (A) Medical and dental care for problems associated with the physical or emotional abuse under the Basic Program for a period of up to one year (12 months) following the person's separation from the Uniformed Service, November 14, 1986. (B) For all medical and dental benefits under the Basic Program for the period that the child is in receipt of transitional compensation under section 1059 of title 10 U.S.C., October 17, 1998. (C) Medical and dental care for problems associated with the physical or emotional abuse under the Extended Care Health Option for a period up to one year (12 months) following the person's separation from the Uniformed Service, November 14, 1986. (D) For all medical and dental benefits described in section 199.5 for the period that the child is in receipt of transitional compensation under section 1059 of title 10 U.S.C., October 17, 1998. (ii) An abused child meeting the requirements of paragraphs (b)(2)(iii)(A)( 2 (A) For all benefits under the CHAMPUS Basic Program, October 23, 1992. (B) Ineligible for benefits under the Extended Care Health Option. (8) Beginning dates of eligibility for incapacitated children who meet the requirements of paragraph (b)(2)(ii)(H)( 2 (i) All benefits for which otherwise entitled, October 23, 1992. (ii) Extended Care Health Option benefits limited to children of members (9) Beginning dates of eligibility for a child who meets the requirements of paragraph (b)(2)(ii)(H)( 4 (i) Has been placed in custody by a court: (A) All benefits for which entitled, July 1, 1994. (B) Extended Care Health Option benefits limited to children of members (ii) Has been placed in custody by a recognized adoption agency: (A) All benefits for which entitled, October 5, 1994. (B) Extended Care Health Option benefits limited to children of members (iii) Has been placed in the home of a member by a placement agency or by any other source authorized by State or local law to provide adoption placement, in anticipation of the legal adoption of the member: (A) All benefits for which entitled, January 6, 2006. (B) Extended Care Health Option benefits limited to children of members only, January 6, 2006. (10) Beginning dates of eligibility for a retiree for: (i) Medical benefits under the Basic Program January 1, 1967. (ii) Retirees and their dependents are not eligible for benefits under the Extended Care Health Option. (d) Dual eligibility. Note: No CHAMPUS eligibility arises as the result of the marriage of two active duty members. (e) Eligibility under the Transitional Assistance Management Program (TAMP). (i) A member who is involuntarily separated from active duty. (ii) A member of a Reserve component who is separated from active duty to which called or ordered in support of a contingency operation if the active duty is active duty for a period of more than 30 consecutive days. (iii) A member who is separated from active duty for which the member is involuntarily retained under 10 U.S.C. 12305 in support of a contingency operation; or (iv) A member who is separated from active duty served pursuant to a voluntary agreement of the member to remain on active duty for a period of less than 1 year in support of a contingency operation. (v) A member who receives a sole survivorship discharge (as defined in section 1174(i) of this title). (vi) A member who is separated from Active Duty who agrees to become a member of the Selected Reserve of the Ready Reserve of a reserve component. (2) A spouse (as described in paragraph (b)(2)(i) of this section except former spouses) and child (as described in paragraph (b)(2)(ii) of this section) of a member described in paragraph (e)(1) of this section is also eligible for TAMP benefits under TRICARE. (3) TAMP benefits under TRICARE begin on the day after the member is separated from active duty, and, if such separation occurred on or after November 6, 2003, end 180 days after such date. TRICARE benefits available to both the member and eligible family members are generally those available to family members of members of the uniformed services under this Part. However, during TAMP eligibility, a member of a Reserve Component as described in paragraph (e)(1)(ii) of this section, is entitled to dental care to which a member of the uniformed services on active duty for more than 30 days is entitled. Each branch of service will determine eligibility for its members and eligible family members and provide data to DEERS. (f) Changes in status which result in termination of CHAMPUS eligibility. (1) Changes in the status of a member. (ii) When an active duty member is placed on desertion status (eligibility is reinstated when the active duty member is removed from desertion status and returned to military control). Note: A member serving a sentence of confinement in conjunction with a sentence of punitive discharge is still considered on active duty until such time as the discharge is executed. (2) Changes in the status of a retiree. 2 (ii) A retiree also loses eligibility when no longer entitled to retired, retainer, or equivalent pay. Note: A retiree who waives his or her retired, retainer or equivalent pay is still considered a retiree for the purposes of CHAMPUS eligibility. (iii) Attainment of entitlement to hospital insurance benefits (Part A) under Medicare except as provided in paragraphs (b)(3), (f)(3)(vii), (f)(3)(viii) and (f)(3)(ix) of this section. (3) Changes in the status of a dependent. own Note: An unadopted stepchild loses eligibility as of 12:01 a.m. of the day following the day the divorce becomes final. (ii) Annulment, except for certain classes of former spouse as provided in paragraph (b)(2)(i) of this section and the member or former member's own Note: An unadopted stepchild loses eligibility as of 12:01 a.m. of the day following the day the annulment becomes final. (iii) Adoption, except for adoptions occurring after the death of a member or former member. (iv) Marriage of a child, except when the marriage is terminated by death, divorce, or annulment before the child is 21 or 23 if an incapacitated child as provided in paragraph (b)(2)(ii)(H)( 2 (v) Marriage of a widow or widower, except for the child of the widow or widower who was the stepchild of the deceased member or former member at the time of death. The stepchild continues CHAMPUS eligibility as other classes of dependent children. (vi) Attainment of entitlement to hospital insurance benefits (Part A) under Medicare except as provided in paragraphs (b)(3), (f)(3)(vii), (f)(3)(viii), and (f)(3)(ix) of this section. (This also applies to individuals living outside the United States where Medicare benefits are not available.) (vii) Attainment of age 65, except for dependents of active duty members, beneficiaries not entitled to part A of Medicare, beneficiaries entitled to Part A of Medicare who have enrolled in Part B of Medicare, and as provided in paragraph (b)(3) of this section. For those who do not retain CHAMPUS, CHAMPUS eligibility is lost at 12:01 a.m. on the first day of the month in which the beneficiary becomes entitled to Medicare. Note: If the person is not eligible for Part A of Medicare, he or she must file a Social Security Administration, “Notice of Disallowance” certifying to that fact with the Uniformed Service responsible for the issuance of his or her identification card so a new card showing CHAMPUS eligibility can be issued. Individuals entitled only to supplementary medical insurance (Part B) of Medicare, but not Part A, or Part A through the Premium HI provisions (provided for under the 1972 Amendments to the Social Security Act) retain eligibility under CHAMPUS (refer to § 199.8 for additional information when a double coverage situation is involved). (viii) End stage renal disease. All beneficiaries, except dependents of active duty members, lose their CHAMPUS eligibility when Medicare coverage becomes available to a person because of chronic renal disease unless the following conditions have been met. CHAMPUS eligibility will continue if: (A) The individual is under 65 years old; (B) The individual became eligible for Medicare under the provisions of 42 U.S.C. 426-1(a); (C) The individual is enrolled in Part B of Medicare; and (D) The individual has applied and qualified for continued CHAMPUS eligibility through the Defense Enrollment Eligibility Reporting System (DEERS). (ix) Individuals with certain disabilities. Each case relating to Medicare eligibility resulting from being disabled requires individual investigation. All beneficiaries except dependents of active duty members lose their CHAMPUS eligibility when Medicare coverage becomes available to a disabled person unless the following conditions have been met. CHAMPUS eligibility will continue if: (A) The individual is under 65 years old; (B) The individual became eligible for Medicare under the provisions of 42 U.S.C. 426(b)(2); (C) The individual is enrolled in Part B of Medicare except that in the case of a retroactive determination of entitlement to Medicare Part A hospital insurance benefits for a person under 65 years of age there is no requirement to enroll in Medicare Part B from the Medicare Part A entitlement date until the issuance of such retroactive determination; and (D) The individual has applied and qualified for continued CHAMPUS eligibility through the Defense Enrollment Eligibility Reporting System (DEERS). (x) Disabled students, that is children age 21 or 22, who are pursuing a full-time course of higher education and who, either during the school year or between semesters, suffer a disabling illness or injury with resultant inability to resume attendance at the institution remain eligible for CHAMPUS medical benefits for 6 months after the disability is removed or until the student passes his or her 23rd birthday, whichever occurs first. However, if recovery occurs before the 23rd birthday and there is resumption of a full-time course of higher education, CHAMPUS benefits can be continued until the 23rd birthday. The normal vacation periods during an established school year do not change the eligibility status of a dependent child 21 or 22 years old in a full time student status. Unless an incapacitating condition existed before, and at the time of, a dependent child's 21st birthday, a dependent child 21 or 22 years old in student status does not may not 2 (g) Reinstatement of CHAMPUS eligibility. (1) End Stage renal disease. (2) Disability. (3) Enrollment in Medicare Part B. (h) Determination of eligibility status. (i) Procedures for determination of eligibility. (j) CHAMPUS procedures for verification of eligibility. (2) Ineligibility for CHAMPUS benefits may be presumed in the absence of prescribed eligibility evidence in the DEERS file. (3) The Director, OCHAMPUS, shall issue guidelines as necessary to implement the provisions of this section. [64 FR 46135, Aug. 24, 1999, as amended at 66 FR 9654, Feb. 9, 2001; 66 FR 16400, Mar. 26, 2001; 66 FR 40606, Aug. 3, 2001; 67 FR 15725, Apr. 3, 2002; 68 FR 23032, Apr. 30, 2003; 68 FR 32361, May 30, 2003; 69 FR 51564, Aug. 20, 2004; 69 FR 60554, Oct. 12, 2004; 70 FR 12802, Mar. 16, 2005; 72 FR 2447, Jan. 19, 2007; 75 FR 50883, Aug. 18, 2010; 76 FR 81367, Dec. 28, 2011; 77 FR 38176, June 27, 2012; 80 FR 55254, Sept. 15, 2015] § 199.4 Basic program benefits. (a) General. (1)(i) Scope of benefits. (ii) Impact of TRICARE program. (2) Persons eligible for Basic Program benefits. (3) Authority to act for CHAMPUS. (4) Status of patient controlling for purposes of cost-sharing. (5) Right to information. (i) Disclosure of such information is authorized specifically by the beneficiary; (ii) Disclosure is necessary to permit authorized governmental officials to investigate and prosecute criminal actions, or (iii) Disclosure is authorized or required specifically under the terms of the Privacy Act or Freedom of Information Act (refer to § 199.1(m) of this part). For the purposes of determining the applicability of and implementing the provisions of §§ 199.8, 199.11, and 199.12, or any provision of similar purpose of any other medical benefits coverage or entitlement, OCHAMPUS or CHAMPUS fiscal intermediaries may release, without consent or notice to any beneficiary or sponsor, to any person, organization, government agency, provider, or other entity any information with respect to any beneficiary when such release constitutes a routine use published in the Federal Register (6) Physical examinations. (7) Claims filing deadline. (8) Double coverage and third party recoveries. (9) Nonavailability Statements within a 40-mile catchment area. (i) With the exception of maternity services, the ASD(HA) may require an NAS prior to TRICARE cost-sharing for additional services from civilian sources if such services are to be provided to a beneficiary who lives within a 40-mile catchment area of an MTF where such services are available and the ASD(HA): (A) Demonstrates that significant costs would be avoided by performing specific procedures at the affected MTF or MTFs; or (B) Determines that a specific procedure must be provided at the affected MTF or MTFs to ensure the proficiency levels of the practitioners at the MTF or MTFs; or (C) Determines that the lack of NAS data would significantly interfere with TRICARE contract administration; and (D) Provides notification of the ASD(HA)'s intent to require an NAS under this authority to covered beneficiaries who receive care at the MTF or MTFs that will be affected by the decision to require an NAS under this authority; and (E) Provides at least 60-day notification to the Committees on Armed Services of the House of Representatives and the Senate of the ASD(HA)'s intent to require an NAS under this authority, the reason for the NAS requirement, and the date that an NAS will be required. (ii) Rules in effect at the time civilian medical care is provided apply. The applicable rules and regulations regarding Nonavailability Statements in effect at the time the civilian care is rendered apply in determining whether a NAS is required. (iii) The Director, TMA is responsible for issuing the procedural rules and regulations regarding Nonavailability Statements. Such rules and regulations should address: (A) When and for what services a NAS is required. However, a NAS may not be required for services otherwise available at an MTF located within a 40-mile radius of the beneficiary's residence when another insurance plan or program provides the beneficiary's primary coverage for the services. This requirement for an NAS does not apply to beneficiaries enrolled in TRICARE Prime, even when those beneficiaries use the point-of-service option under § 199.17(n)(3) of this part; and (B) When and how notifications will be made to a beneficiary who is not enrolled in TRICARE Prime as to whether or not he or she resides in a geographic area that requires obtaining a NAS; and (C) What information relating to claims submissions, including the documentation, if any, that is required to document that a valid NAS was issued. However, when documentation of a NAS is required, then that documentation shall be valid for the adjudication of CHAMPUS claims for all related care otherwise authorized by this part which is received from a civilian source while the beneficiary resided within the Uniformed Service facility catchment area which issued the NAS. (iv) In the case of any service subject to a NAS requirement under this paragraph (a)(9) and also subject to a preadmission (or other pre-service) authorization requirement under § 199.4 or § 199.15 of this part, the administrative processes for the NAS and pre-service authorization may be combined. (10) [Reserved] (11) Quality and Utilization Review Peer Review Organization program. All benefits under the CHAMPUS program are subject to review under the CHAMPUS Quality and Utilization Review Peer Review Organization program pursuant to Sec 199.15. (12) [Reserved] (13) Implementing instructions. (14 ) Confidentiality of substance use disorder treatment. (b) Institutional benefits General. (i) Billing practices. (ii) Successive inpatient admissions. (iii) Related services and supplies. (iv) Inpatient, appropriate level required. (v) General or special education not covered. (vi) Substance use disorder treatment exclusions. (B) Domiciliary settings. (2) Covered hospital services and supplies Room and board. (ii) General staff nursing services. (iii) ICU. (iv) Operating room, recovery room. (v) Drugs and medicines. (vi) Durable medical equipment, medical supplies, and dressings. Note: If durable medical equipment is to be used on an outpatient basis or continued in outpatient status after use as an inpatient, benefits will be provided as set forth in paragraph (d) of this section and cost-sharing will be on an outpatient basis (refer to paragraph (a)(4) of this section). (vii) Diagnostic services. (viii) Anesthesia. (ix) Blood. (x) Radiation therapy. (xi) Physical therapy. (xii) Oxygen. (xiii) Intravenous injections. (xiv) Shock therapy. (xv) Chemotherapy. (xvi) Renal and peritoneal dialysis. (xvii) Psychological evaluation tests. (xviii) Other medical services. (xix) Medication assisted treatment. (xx) Withdrawal management (detoxification). (3) Covered services and supplies provided by special medical treatment institutions or facilities, other than hospitals or RTCs— Room and board. (ii) General staff nursing services. (iii) Drugs and medicines. (iv) Durable medical equipment, medical supplies, and dressings. Note: If the durable medical equipment is to be used on an outpatient basis or continued in outpatient status after use as an inpatient, benefits will be provided as set forth in paragraph (d) of this section, and cost-sharing will be on an outpatient basis (refer to paragraph (a)(4) of this section). (v) Diagnostic services. (vi) Blood. (vii) Physical therapy. (viii) Oxygen. (ix) Intravenous injections. (x) Shock therapy. (xi) Chemotherapy. (xii) Psychological evaluation tests. (xiii) Renal and peritoneal dialysis. (xiv) Skilled nursing facility (SNF) services. (A) Nursing care provided by or under the supervision of a registered professional nurse; (B) Bed and board in connection with the furnishing of such nursing care; (C) Physical or occupational therapy or speech-language pathology services furnished by the SNF or by others under arrangements with them by the facility; (D) Medical social services; (E) Such drugs, biological, supplies, appliances, and equipment, furnished for use in the SNF, as are ordinarily furnished for the care and treatment of inpatients; (F) Medical services provided by an intern or resident-in-training of a hospital with which the facility has such an agreement in effect; and (G) Such other services necessary to the health of the patients as are generally provided by SNFs, or by others under arrangements with them made by the facility. (xv) Other medical services. (xvi) Medication assisted treatment. (xvii) Withdrawal management (detoxification). (4) Services and supplies provided by RTCs Room and board. (ii) Patient assessment. (iii) Diagnostic services. (iv) Psychological evaluation tests. (v) Treatment of mental disorders. (vi) Other necessary medical care. (vii) Criteria for determining medical or psychological necessity. all (A) Patient has a diagnosable psychiatric disorder. (B) Patient exhibits patterns of disruptive behavior with evidence of disturbances in family functioning or social relationships and persistent psychological and/or emotional disturbances. (C) RTC services involve active clinical treatment under an individualized treatment plan that provides for: ( 1 ( 2 ( 3 ( 4 (D) Unless therapeutically contraindicated, the family and/or guardian must actively participate in the continuing care of the patient either through direct involvement at the facility or geographically distant family therapy. (In the latter case, the treatment center must document that there has been collaboration with the family and/or guardian in all reviews.) (5) Extent of institutional benefits Inpatient room accommodations Semiprivate. (B) Private. ( 1 ( 2 ( 3 ( 4 (C) Duration of private room stay. (D) Hospital (except an acute care hospital, general or special) or other authorized institutional provider without semiprivate accommodations. 1 2 (ii) General staff nursing services. (iii) ICU. (iv) Treatment rooms. (v) Drugs and medicines. (A) They represent a cost to the facility rendering treatment; (B) They are furnished to a patient receiving treatment, and are related directly to that treatment; and (C) They are ordinarily furnished by the facility for the care and treatment of inpatients. (vi) Durable medical equipment, medical supplies, and dressings. (A) If ordinarily furnished by the facility for the care and treatment of patients; and (B) If specifically related to, and in connection with, the condition for which the patient is being treated; and (C) If ordinarily furnished to a patient for use in the hospital or other authorized institution (except in the case of a temporary or disposable item); and (D) Use of durable medical equipment is limited to those items provided while the patient is an inpatient. If such equipment is provided for use on an outpatient basis, the provisions of paragraph (d) of this section apply. (vii) Transitional use items. (viii) Anesthetics and oxygen. (6) Inpatient mental health services. (i) Criteria for determining medical or psychological necessity. (A) Patient poses a serious risk of harm to self and/or others. (B) Patient is in need of high dosage, intensive medication or somatic and/or psychological treatment, with potentially serious side effects. (C) Patient has acute disturbances of mood, behavior, or thinking. (ii) Emergency admissions. (A) The patient must be at immediate risk of serious harm to self and or others based on a psychiatric evaluation performed by a physician (or other qualified mental health professional with hospital admission authority); and (B) The patient requires immediate continuous skilled observation and treatment at the acute psychiatric level of care. (iii)-(iv)[Reserved] (7) Emergency inpatient hospital services. (i) Existence of medical emergency. (ii) Immediate admission required. (iii) Closest hospital utilized. (8) Residential treatment for substance use disorder In general. (ii) Criteria for determining medical or psychological necessity of residential treatment for substance use disorder. (A) The patient has been diagnosed with a substance use disorder. (B) The patient is experiencing withdrawal symptoms or potential symptoms severe enough to require inpatient care and physician management, or who have less severe symptoms that require 24-hour inpatient monitoring or the patient's addiction-related symptoms, or concomitant physical and emotional/behavioral problems reflect persistent dysfunction in several major life areas. (iii) Services and supplies. (A) Room and board. (B) Patient assessment. (C) Psychological testing. (D) Treatment services. (iv) Case management required. (v) Professional mental health benefits. (vi) Non-mental health related medical services. (9) Psychiatric and substance use disorder partial hospitalization services In general. (ii) Criteria for determining medical or psychological necessity of psychiatric and SUD partial hospitalization services. (A) The patient is suffering significant impairment from a mental disorder (as defined in § 199.2) which interferes with age appropriate functioning or the patient is in need of rehabilitative services for the management of withdrawal symptoms from alcohol, sedative-hypnotics, opioids, or stimulants that require medically-monitored ambulatory detoxification, with direct access to medical services and clinically intensive programming of rehabilitative care based on individual treatment plans. (B) The patient is unable to maintain himself or herself in the community, with appropriate support, at a sufficient level of functioning to permit an adequate course of therapy exclusively on an outpatient basis, to include outpatient treatment program, outpatient office visits, or intensive outpatient services (but is able, with appropriate support, to maintain a basic level of functioning to permit partial hospitalization services and presents no substantial imminent risk of harm to self or others). These patients require medical support; however, they do not require a 24-hour medical environment. (C) The patient is in need of crisis stabilization, acute symptom reduction, treatment of partially stabilized mental health disorders, or services as a transition from an inpatient program. (D) The admission into the partial hospitalization program is based on the development of an individualized diagnosis and treatment plan expected to be effective for that patient and permit treatment at a less intensive level. (iii) Services and supplies. (A) Board. (B) Patient assessment. (C) Psychological testing. Treatment services. (iv) Case management required. (v) Educational services required. (vi) Family therapy required. (vii) Professional mental health benefits. (viii) Non-mental health related medical services. (10) Intensive psychiatric and substance use disorder outpatient services In general. (ii) Criteria for determining medical or psychological necessity of intensive outpatient services. (A) The patient is suffering significant impairment from a mental disorder, to include a substance use disorder (as defined in § 199.2), which interferes with age appropriate functioning. Patients receiving a higher intensity of treatment may be experiencing moderate to severe instability, exacerbation of severe/persistent disorder, or dangerousness with some risk of confinement. Patients receiving a lower intensity of treatment may be experiencing mild instability with limited dangerousness and low risk for confinement. (B) The patient is unable to maintain himself or herself in the community, with appropriate support, at a sufficient level of functioning to permit an adequate course of therapy exclusively in an outpatient treatment program or an outpatient office basis (but is able, with appropriate support, to maintain a basic level of functioning to permit a level of intensive outpatient treatment and presents no substantial imminent risk of harm to self or others). (C) The patient is in need of stabilization, symptom reduction, and prevention of relapse for chronic mental illness. The goal of maintenance of his or her functioning within the community cannot be met by outpatient office visits, but requires active treatment in a stable, staff-supported environment; (D) The admission into the intensive outpatient program is based on the development of an individualized diagnosis and treatment plan expected to be effective for that patient and permit treatment at a less intensive level. (iii) Services and supplies. (A) Patient assessment. (B) Treatment services. (iv) Case management. (v) Professional mental health benefits. (vi) Non-mental health related medical services. (11) Opioid treatment programs In general. (ii) Criteria for determining medical or psychological necessity of an opioid treatment program are set forth in 42 CFR part 8. (iii) Services and supplies. (A) Patient assessment. (B) Treatment services. (iv) Case management. (c) Professional services benefit General. (i) Billing practices. (ii) Services must be related. (iii) Telehealth services. (2) Covered services of physicians and other authorized profession providers. (i) Surgery. Bronchoscopy Laryngoscopy Thoracoscopy Catheterization of the heart Arteriograph thoracic lumbar Esophagoscopy Gastroscopy Proctoscopy Sigmoidoscopy Peritoneoscopy Cystoscopy Colonscopy Upper G.I. panendoscopy Encephalograph Myelography Discography Visualization of intracranial aneurysm by intracarotid injection of dye, with exposure of carotid artery, unilateral Ventriculography Insufflation of uterus and fallopian tubes for determination of tubal patency (Rubin's test of injection of radiopaque medium or for dilation) Introduction of opaque media into the cranial arterial system, preliminary to cerebral arteriography, or into vertebral and subclavian systems Intraspinal introduction of air preliminary to pneumoencephalography Intraspinal introduction of opaque media preliminary to myelography Intraventricular introduction of air preliminary to ventriculography Note: The Director, OCHAMPUS, or a designee, shall determine such additional procedures that may fall within the intent of this definition of “surgery.” (ii) Surgical assistance. (iii) Inpatient medical services. (iv) Outpatient medical services. (v) Psychiatric services. (vi) Consultation services. (vii) Anesthesia services. (viii) Radiation therapy services. (ix) X-ray services. (x) Laboratory and pathological services. (xi) Physical medicine services or physiatry services. (xii) Maternity care. (xiii) Well-child care. (xiv) Other medical care. Note: A separate professional charge for the oral administration of approved antineoplastic drugs is not covered. (xv) [Reserved] (xvi) Routine eye examinations. (3) Extent of professional benefits (i) Multiple Surgery. (A) One hundred (100) percent of the CHAMPUS-determined allowable charge for the major surgical procedure (the procedure for which the greatest amount is payable under the applicable reimbursement method); and (B) Fifty (50) percent of the CHAMPUS-determined allowable charge for each of the other surgical procedures; (C) Except that: ( 1 ( 2 (ii) Different types of inpatient care, concurrent. Note: This provision is not meant to imply that when extra time and special effort are required due to postsurgical or postdelivery complications, the attending physician may not request special consideration for a higher than usual charge. (iii) Need for surgical assistance. (A) If the surgical assistance occurred in a hospital that has a residency program in a specialty appropriate to the surgery; (B) If the surgery was performed by a team of surgeons; (C) If there were multiple surgical assistants; or (D) If the surgical assistant was a partner of or from the same group of practicing physicians as the attending surgeon. (iv) Aftercare following surgery. (v) Cast and sutures, removal. (vi) Inpatient care, concurrent. (vii) Consultants who become the attending surgeon. (viii) Anesthesia administered by the attending physician. (ix) Treatment of mental disorders, to include substance use disorder. (A) Covered diagnostic and therapeutic services. ( 1 Individual psychotherapy, adult or child. ( 2 Group psychotherapy. ( 3 Family or conjoint psychotherapy. ( 4 Psychoanalysis. ( 5 Psychological testing and assessment. ( 6 Administration of psychotropic drugs. ( 7 Electroconvulsive treatment. ( 8 Collateral visits. ( 9 Medication assisted treatment. (B) Therapeutic settings 1 Outpatient psychotherapy. ( 2 Inpatient psychotherapy. (C) Covered ancillary therapies. (D) Review of claims for treatment of mental disorder. (x) Physical and occupational therapy. (A) The services are prescribed and monitored by a physician, certified physician assistant, certified nurse practitioner or Doctor of Podiatric Medicine (Podiatrist) acting within the scope of their license. (B) The purpose of the prescription is to reduce the disabling effects of an illness, injury, or neuromuscular disorder; and (C) The prescribed treatment increases, stabilizes, or slows the deterioration of the beneficiary's ability to perform specified purposeful activity in the manner, or within the range considered normal, for a human being. (xi) Well-child care. (A) The following services are covered when required as a part of the specific well-child care program and when rendered by the attending pediatrician, family physician, certified nurse practitioner, or certified physician assistant. ( 1 ( 2 ( i ( ii ( iii ( iv ( v ( vi ( vii ( viii ( ix ( x (B) Additional services or visits required because of specific findings or because the particular circumstances of the individual case are covered if medically necessary and otherwise authorized for benefits under CHAMPUS. (C) The Deputy Assistant Secretary of Defense, Health Services Financing, will determine when such services are separately reimbursable apart from the health supervision visit. (xii) [Reserved] (xiii) Physicians in a teaching setting. (A) Teaching physicians. ( 1 General. ( i ( ii ( iiii ( iv ( v ( vi ( 2 Direct supervision by an attending physician of care provided by physicians in training. ( 3 Individual, personal services. ( 4 Who may bill. (B) Physicians in training. ( 1 ( 2 (d) Other benefits (2) Billing practices. (3) Other covered services and supplies Blood. (ii) Durable equipment 1 ( i ( ii ( 2 ( i ( ii Wheelchairs. e.g., 3 ( iii ( iv ( v ( 3 ( i ( ii ( iii (B) Cardiorespiratory monitor exception. 1 ( i ( ii ( iii ( iv ( v ( 2 ( i ( ii ( iii ( iv (C) Exclusions. ( 1 ( 2 (D) Basis for reimbursement. 1 i.e., ( 2 (iii) Medical supplies and dressings (consumables) In general. Note 1 to paragraph ( d iii Generally, the allowable charge of a medical supply item will be under $100. Any item over this amount must be reviewed to determine whether it would qualify as a DME item. If it is, in fact, a medical supply item and does not represent an excessive charge, it can be considered for benefits under paragraph (d)(3)(iii) of this section. (B) Medically necessary food and medical equipment and supplies necessary to administer such food (other than durable medical equipment and supplies) when prescribed for dietary management of a covered disease or condition. 1 ( i ( ii ( iii ( iv ( v ( 2 ( i ( ii ( iii ( iv ( 3 ( i ( ii ( iii ( iv ( v (iv) Oxygen. (v) Ambulance. Note: The inpatient cost-sharing provisions for ambulance transfers only apply to otherwise covered transfers between hospitals, i.e., acute care, general, and special hospitals; psychiatric hospitals; and long-term hospitals. (A) Ambulance service cannot be used instead of taxi service and is not payable when the patient's condition would have permitted use of regular private transportation; nor is it payable when transport or transfer of a patient is primarily for the purpose of having the patient nearer to home, family, friends, or personal physician. Except as described in paragraph (d)(3)(v)(C)( 1 (B) Vehicles such as medicabs or ambicabs function primarily as public passenger conveyances transporting patients to and from their medical appointments. No actual medical care is provided to the patients in transit. These types of vehicles do not qualify for benefits for the purpose of CHAMPUS payment. (C) Except as described in paragraph (d)(3)(v)(C)(1)( 1 ( 1 ( 2 (vi) Drugs and medicines. (A) Drugs administered by a physician or other authorized individual professional provider as an integral part of a procedure covered under paragraph (b) or (c) of this section (such as chemotherapy) are not covered under this subparagraph inasmuch as the benefit for the institutional services or the professional services in connection with the procedure itself also includes the drug used. (B) CHAMPUS benefits may not be extended for drugs not approved by the U.S. Food and Drug Administration for commercial marketing. Drugs grandfathered by the Federal Food, Drug and Cosmetic Act of 1938 may be covered under CHAMPUS as if FDA approved. (C) Over-the-counter (OTC) drugs (drugs that by United States law do not require a prescription), in general, are not covered. However, insulin is covered for a known diabetic even in states that do not require a prescription for its purchase. In addition, OTC drugs used for smoking cessation are covered when all requirements under the TRICARE smoking cessation program are met as provided in paragraph (e)(30) of this section. (D) Medically necessary vitamins used for the management of a covered disease or condition pursuant to a prescription, order, or recommendation of a TRICARE authorized provider acting within the provider's scope of license/certificate of practice. For purposes of this paragraph (d)(3)(vi)(D), the term “covered disease or condition” means: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 (vii) Prosthetics, prosthetic devices, and prosthetic supplies, as determined by the Secretary of Defense to be necessary because of significant conditions resulting from trauma, congenital anomalies, or disease. Additionally, the following are covered: (A) Any accessory or item of supply that is used in conjunction with the device for the purpose of achieving therapeutic benefit and proper functioning; (B) Services necessary to train the recipient of the device in the use of the device; (C) Repair of the device for normal wear and tear or damage; (D) Replacement of the device if the device is lost or irreparably damaged or the cost of repair would exceed 60 percent of the cost of replacement. (viii) Orthopedic braces and appliances. (ix) Diabetes Self-Management Training (DSMT). Coverage limitations on the provision of this benefit will be as determined by the Director, TRICARE Management Activity, or designee. (e) Special benefit information General. (2) Abortion. Note: Covered abortion services are limited to medical services or supplies only for the single circumstance outlined above and do not include abortion counseling or referral fees. Payment is not allowed for any services involving preparation for, or normal followup to, a noncovered abortion. The Director, OCHAMPUS, or a designee, shall issue guidelines describing the policy on abortion. (3) Family planning. (i) Birth control (such as contraception) Benefits provided. ( 1 ( 2 ( 3 ( 4 (B) Exclusions. ( 1 ( 2 ( 3 ( 4 (ii) Genetic testing. (A) Benefits provided. ( 1 ( 2 ( 3 ( 4 ( 5 (B) Exclusions. ( 1 ( 2 (4) [Reserved] (5) Transplants. Organ transplants. (A) General. 1 ( i ( ii ( iii ( iv ( v ( vi ( vii ( viii ( ix ( 2 ( 3 ( i ( ii ( iii ( iv ( 4 ( 5 (B) [Reserved] (ii) Stem cell transplants. (6) Eyeglasses, spectacles, contact lenses, or other optical devices. (i) Exception to general exclusion. (A) Eyeglasses or lenses that perform the function of the human lens, lost as a result of intraocular surgery or ocular injury or congenital absence. Note: Notwithstanding the general requirement for U.S. Food and Drug Administration approval of any surgical implant set forth in paragraph (d)(3)(vii) of this section, intraocular lenses are authorized under CHAMPUS if they are either approved for marketing by FDA or are subject to an investigational device exemption. (B) “Pinhole” glasses prescribed for use after surgery for detached retina. (C) Lenses prescribed as “treatment” instead of surgery for the following conditions: ( 1 ( 2 ( 3 ( 4 (ii) Limitations. (7) [Reserved] (8) Cosmetic, reconstructive, or plastic surgery. Note: If a surgical procedure primarily restores function, whether or not there is also a concomitant improvement in physical appearance, the surgical procedure does not fall within the provisions set forth in this paragraph (e)(8). (i) Limited benefits under CHAMPUS. (A) Correction of a congenital anomaly; or (B) Restoration of body form following an accidental injury; or (C) Revision of disfiguring and extensive scars resulting from neoplastic surgery. (D) Reconstructive breast surgery following a medically necessary mastectomy performed for the treatment of carcinoma, severe fibrocystic disease, other nonmalignant tumors or traumatic injuries. (E) Penile implants and testicular prostheses for conditions resulting from organic origins (i.e., trauma, radical surgery, disease process, for correction of congenital anomaly, etc.). Also, penile implants for organic impotency. Note: Organic impotence is defined as that which can be reasonably expected to occur following certain diseases, surgical procedures, trauma, injury, or congenital malformation. Impotence does not become organic because of psychological or psychiatric reasons. (F) Generally, benefits are limited to those cosmetic, reconstructive, or plastic surgery procedures performed no later than December 31 of the year following the year in which the related accidental injury or surgical trauma occurred, except for authorized postmastectomy breast reconstruction for which there is no time limitation between mastectomy and reconstruction. Also, special consideration for exception will be given to cases involving children who may require a growth period. (ii) General exclusions. (B) Cosmetic, reconstructive, or plastic surgery procedures performed primarily for psychological reasons or as a result of the aging process also are excluded. (C) Procedures performed for elective correction of minor dermatological blemishes and marks or minor anatomical anomalies also are excluded. (D) Any procedures related to sex gender changes, except as provided in paragraph (g)(29) of this section, are excluded. (iii) Noncovered surgery, all related services and supplies excluded. (iv) Example of noncovered cosmetic, reconstructive, or plastic surgery procedures. (A) Any procedure performed for personal reasons to improve the appearance of an obvious feature or part of the body that would be considered by an average observer to be normal and acceptable for the patient's age or ethnic or racial background. (B) Cosmetic, reconstructive, or plastic surgical procedures that are justified primarily on the basis of a psychological or psychiatric need. (C) Augmentation mammoplasties. (D) Face lifts and other procedures related to the aging process. (E) Reduction mammoplasties. (F) Panniculectomy; body sculpture procedures. (G) Repair of sagging eyelids (without demonstrated and medically documented significant impairment of vision). (H) Rhinoplasties (without evidence of accidental injury occurring within the previous 6 months that resulted in significant obstruction of breathing). (I) Chemical peeling for facial wrinkles. (J) Dermabrasion of the face. (K) Elective correction of minor dermatological blemishes and marks or minor anatomical anomalies. (L) Revision of scars resulting from surgery or a disease process, except disfiguring and extensive scars resulting from neoplastic surgery. (M) Removal of tattoos. (N) Hair transplants. (O) Electrolysis. (P) [Reserved] (Q)) Penile implant procedure for psychological impotency or as related to sex gender changes, as prohibited by section 1079 of title 10, United States Code. (R) Insertion of prosthetic testicles as related to sex gender changes, as prohibited by section 1079 of title 10, United States Code. (9) Care related to non-covered initial surgery or treatment. (ii) Benefits are available for otherwise covered services and supplies required in the treatment of complications (unfortunate sequelae) and any necessary follow-on care resulting from a non-covered incident of treatment provided in an MTF, when the initial non-covered service has been authorized by the MTF Commander and the MTF is unable to provide the necessary treatment of the complications or required follow-on care, according to the guidelines adopted by the Director, DHA, or a designee. (iii) Benefits are available for otherwise covered services and supplies required in the treatment of complications (unfortunate sequelae) and any necessary follow-on care resulting from a non-covered incident of treatment provided in the private sector pursuant to a properly granted waiver under § 199.16(f). The Director, DHA, or designee, shall issue guidelines for implementing this provision. (10) Dental. (i) Adjunctive dental care: Limited. (A) Dental care which is medically necessary in the treatment of an otherwise covered medical (not dental) condition, is an integral part of the treatment of such medical condition and is essential to the control of the primary medical condition. The following is a list of conditions for which CHAMPUS benefits are payable under this provision: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( 8 Note: The test of whether dental trauma is covered is whether the trauma is solely dental trauma. Dental trauma, in order to be covered, must be related to, and an integral part of medical trauma; or a result of medically necessary treatment of an injury or disease. (B) Dental care required in preparation for medical treatment of a disease or disorder or required as the result of dental trauma caused by the medically necessary treatment of an injury or disease (iatrogenic). ( 1 ( 2 (C) Dental care is limited to the above and similar conditions specifically prescribed by the Director, OCHAMPUS, as meeting the requirements for coverage under the provisions of this section. (ii) General exclusions. (B) The adding or modifying of bridgework and dentures. (C) Orthodontia, except when directly related to and an integral part of the medical or surgical correction of a cleft palate or when required in preparation for, or as a result of, trauma to the teeth and supporting structures caused by medically necessary treatment of an injury or disease. (iii) Preauthorization required. (iv) Covered oral surgery. (A) Excision of tumors and cysts of the jaws, cheeks, lips, tongue, and roof and floor of the mouth, when such conditions require a pathological (histological) examination. (B) Surgical procedures required to correct accidental injuries of the jaws, cheeks, lips, tongue, and roof and floor of the mouth. (C) Treatment of oral or facial cancer. (D) Treatment of fractures of facial bones. (E) External (extra-oral) incision and drainage of cellulitis. (F) Surgery of accessory sinuses, salivary glands, or ducts. (G) Reduction of dislocations and the excision of the temporomandibular joints, when surgery is a necessary part of the reduction. (H) Any oral surgical procedure that falls within the cosmetic, reconstructive, or plastic surgery definition is subject to the limitations and requirements set forth in paragraph (e)(8) of this section. Note: Extraction of unerupted or partially erupted, malposed or impacted teeth, with or without the attached follicular or development tissues, is not a covered oral surgery procedure except when the care is indicated in preparation for medical treatment of a disease or disorder or required as a result of dental trauma caused by the necessary medical treatment of an injury or illness. Surgical preparation of the mouth for dentures is not covered by CHAMPUS. (v) Inpatient hospital stay in connection with non-adjunctive, noncovered dental care. (vi) Anesthesia and institutional costs for dental care for children and certain other patients. (11) Drug abuse. (i) Limitations on who can prescribe drugs. (ii) [Reserved] (iii) Kinds of prescription drugs that are monitored carefully by CHAMPUS for possible abuse situations Narcotics. (B) Nonnarcotic analgesics. (C) Tranquilizers. (D) Barbiturates. (E) Nonbarbituate hypnotics. (F) Stimulants. (iv) CHAMPUS fiscal intermediary responsibilities. (A) When a possible drug abuse situation is identified, all claims for drugs for that specific beneficiary or provider will be suspended pending the results of a review. (B) If the review determines that a drug abuse situation does in fact exist, all drug claims held in suspense will be denied. (C) If the record indicates previously paid drug benefits, the prior claims for that beneficiary or provider will be reopened and the circumstances involved reviewed to determine whether or not drug abuse also existed at the time the earlier claims were adjudicated. If drug abuse is later ascertained, benefit payments made previously will be considered to have been extended in error and the amounts so paid recouped. (D) Inpatient stays primarily for the purpose of obtaining drugs and any other services and supplies related to drug abuse also are excluded. (v) Unethical or illegal provider practices related to drugs. (vi) Detoxification. (12) [Reserved] (13) Domiciliary care. (i) Examples of domiciliary care situations. (A) Home care is not available. (B) Home care is not suitable. (C) Family unwilling to care for a person in the home. (ii) Benefits available in connection with a domiciliary care case. (iii) General exclusion. (14) CT scanning Approved CT scan services. (A) The patient is referred for the diagnostic procedure by a physician. (B) The CT scan procedure is consistent with the preliminary diagnosis or symptoms. (C) Other noninvasive and less costly means of diagnosis have been attempted or are not appropriate. (D) The CT scan equipment is licensed or registered by the appropriate state agency responsible for licensing or registering medical equipment that emits ionizing radiation. (E) The CT scan equipment is operated under the general supervision and direction of a physician. (F) The results of the CT scan diagnostic procedure are interpreted by a physician. (ii) Review guidelines and criteria. (15) Morbid obesity. reliable evidence (i) Conditions for coverage. (B) Covered bariatric surgical procedures are payable only when the patient has completed growth (18 years of age or documentation of completion of bone growth) and has met one of the following selection criteria: ( 1 2 ( 2 2 Note: The Director, TMA, shall issue guidelines for review of the specific high-risk co-morbid conditions, exacerbated or caused by obesity based on the Reliable Evidence Standard as defined in § 199.2 of this part. (ii) Treatment of complications. (B) Payment is authorized for otherwise covered medical services and supplies directly related to complications of obesity when such services and supplies are an integral and necessary part of the course of treatment that was aggravated by the obesity. (iii) Exclusions. (16) Maternity care. Benefit. (ii) Cost-share. (A) Inpatient cost-share formula applies to maternity care ending in childbirth in, or on the way to, a hospital inpatient childbirth unit, and for maternity care ending in a non-birth outcome not otherwise excluded by this part. (B) Ambulatory surgery cost-share formula applies to maternity care ending in childbirth in, or on the way to, a birthing center to which the beneficiary is admitted and from which the beneficiary has received prenatal care, or a hospital-based outpatient birthing room. (C) Outpatient cost-share formula applies to maternity care which terminates in a planned childbirth at home. (D) Otherwise covered medical services and supplies directly related to “Complications of pregnancy,” as defined in § 199.2 of this part, will be cost-shared on the same basis as the related maternity care for a period not to exceed 42 days following termination of the pregnancy and thereafter cost-shared on the basis of the inpatient or outpatient status of the beneficiary when medically necessary services and supplies are received. (17) Biofeedback Therapy. (i) Benefits Provided. (A) Adjunctive treatment for Raynaud's Syndrome. (B) Adjunctive treatment for muscle re-education of specific muscle groups or for treating pathological muscle abnormalities of spasticity, or incapacitating muscle spasm or weakness. (ii) Limitations. (iii) Exclusions. (iv) Provider Requirements. (v) Implementation Guidelines. (18) Cardiac rehabilitation. (i) Benefits Provided. (A) Myocardial Infarction. (B) Coronary Artery Bypass Graft. (C) Coronary Angioplasty. (D) Percutaneous Transluminal Coronary Angioplasty (E) Chronic Stable Angina (see limitations below). (F) Heart valve surgery. (G) Heart or Heart-lung Transplantation. (ii) Limitations. (iii) Exclusions. (iv) Providers. (v) Payment. (vi) Implementation Guidelines. (19) Hospice care. (i) Benefit coverage. (A) Physician services. (B) Nursing care provided by or under the supervision of a registered professional nurse. (C) Medical social services provided by a social worker who has at least a bachelor's degree from a school accredited or approved by the Council on Social Work Education, and who is working under the direction of a physician. Medical social services include, but are not limited to the following: ( 1 ( 2 ( 3 ( 4 (D) Counseling services provided to the terminally ill individual and the family member or other persons caring for the individual at home. Counseling, including dietary counseling, may be provided both for the purpose of training the individual's family or other care-giver to provide care, and for the purpose of helping the individual and those caring for him or her to adjust to the individual's approaching death. Bereavement counseling, which consists of counseling services provided to the individual's family after the individual's death, is a required hospice service but it is not reimbursable. (E) Home health aide services furnished by qualified aides and homemaker services. Home health aides may provide personal care services. Aides also may perform household services to maintain a safe and sanitary environment in areas of the home used by the patient. Examples of such services are changing the bed or light cleaning and laundering essential to the comfort and cleanliness of the patient. Aide services must be provided under the general supervision of a registered nurse. Homemaker services may include assistance in personal care, maintenance of a safe and healthy environment, and services to enable the individual to carry out the plan of care. Qualifications for home health aides can be found in 42 CFR 484.36. (F) Medical appliances and supplies, including drugs and biologicals. Only drugs that are used primarily for the relief of pain and symptom control related to the individual's terminal illness are covered. Appliances may include covered durable medical equipment, as well as other self-help and personal comfort items related to the palliation or management of the patient's condition while he or she is under hospice care. Equipment is provided by the hospice for use in the beneficiary's home while he or she is under hospice care. Medical supplies include those that are part of the written plan of care. Medical appliances and supplies are included within the hospice all-inclusive rates. (G) Physical therapy, occupational therapy and speech-language pathology services provided for purposes of symptom control or to enable the individual to maintain activities of daily living and basic functional skills. (H) Short-term inpatient care provided in a Medicare participating hospice inpatient unit, or a Medicare participating hospital, skilled nursing facility (SNF) or, in the case of respite care, a Medicaid-certified nursing facility that additionally meets the special hospice standards regarding staffing and patient areas. Services provided in an inpatient setting must conform to the written plan of care. Inpatient care may be required for procedures necessary for pain control or acute or chronic symptom management. Inpatient care may also be furnished to provide respite for the individual's family or other persons caring for the individual at home. Respite care is the only type of inpatient care that may be provided in a Medicaid-certified nursing facility. The limitations on custodial care and personal comfort items applicable to other CHAMPUS services are not applicable to hospice care. (ii) Core services. (iii) Non-core services. (iv) Availability of services. (v) Periods of care. (vi) Conditions for coverage. (A) There must be written certification in the medical record that the CHAMPUS beneficiary is terminally ill with a life expectancy of six months or less if the terminal illness runs its normal course. ( 1 Timing of certification. ( i Basic requirement. 1 ii ( ii Exception. ( 2 Sources of certification. ( i i)(ii ( A ( B ( ii 2)(i B (B) The terminally ill beneficiary must elect to receive hospice care for each specified period of time; i.e., the two 90-day periods, a subsequent 30-day period, and a final period of unlimited duration. If the individual is found to be mentally incompetent, his or her representative may file the election statement. Representative means an individual who has been authorized under State law to terminate medical care or to elect or revoke the election of hospice care on behalf of a terminally ill individual who is found to be mentally incompetent. ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( i ( ii ( 7 ( i ( ii ( iii ( iv ( v ( 8 (C) The beneficiary must waive all rights to other CHAMPUS payments for the duration of the election period for: ( 1 ( 2 ( i ( ii ( iii ( 3 (D) A written plan of care must be established by a member of the basic interdisciplinary group assessing the patient's needs. This group must have at least one physician, one registered professional nurse, one social worker, and one pastoral or other counselor. ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( 8 (E) Complete medical records and all supporting documentation must be submitted to the CHAMPUS contractor within 30 days of the date of its request. If records are not received within the designated time frame, authorization of the hospice benefit will be denied and any prior payments made will be recouped. A denial issued for this reason is not an initial determination under § 199.10, and is not appealable. (vii) Appeal rights under hospice benefit. (20) [Reserved] (21) Home health services. (i) Benefit coverage. (A) Part-time or intermittent skilled nursing care furnished by a registered nurse or a licensed practical (vocational) nurse under the supervision of a registered nurse; (B) Physical therapy, speech-language pathology, and occupational therapy; (C) Medical social services under the direction of a physician; (D) Part-time or intermittent services of a home health aide who has successfully completed a state-established or other training program that meets the requirements of 42 CFR Part 484; (E) Medical supplies, a covered osteoporosis drug (as defined in the Social Security Act 1861(kk), but excluding other drugs and biologicals) and durable medical equipment; (F) Medical services provided by an interim or resident-in-training of a hospital, under an approved teaching program of the hospital in the case of an HHA that is affiliated or under common control of a hospital; and (G) Services at hospitals, SNFs or rehabilitation centers when they involve equipment too cumbersome to bring to the home but not including transportation of the individual in connection with any such item or service. (ii) Conditions for Coverage. (A) The person for whom the services are provided is an eligible TRICARE beneficiary. (B) The HHA that is providing the services to the beneficiary has in effect a valid agreement to participate in the TRICARE program. (C) Physician certifies the need for home health services because the beneficiary is homebound. (D) The services are provided under a plan of care established and approved by a physician. ( 1 ( 2 (E) The beneficiary must need skilled nursing care on an intermittent basis or physical therapy or speech-language pathology services, or have continued need for occupational therapy after the need for skilled nursing care, physical therapy, or speech-language pathology services has ceased. (F) The beneficiary must receive, and an HHA must provide, a patient-specific, comprehensive assessment that: ( 1 ( 2 ( 3 (G) TRICARE is the appropriate payer. (H) The services for which payment is claimed are not otherwise excluded from payment. (I) Any other conditions of coverage/participation that may be required under Medicare's HHA benefit; i.e. (22) Pulmonary rehabilitation. (23) A speech generating device (SGD) as defined in § 199.2 of this part is covered as a voice prosthesis. The prosthesis provisions found in paragraph (d)(3)(vii) of this section apply. (24) A hearing aid, but only for a dependent of a member of the uniformed services on active duty and only if the dependent has a profound hearing loss as defined in § 199.2 of this part. Medically necessary and appropriate services and supplies, including hearing examinations, required in connection with this hearing aid benefit are covered. (25) Rehabilitation therapy as defined in § 199.2 of this part to improve, restore, or maintain function, or to minimize or prevent deterioration of function, of a patient when prescribed by a physician. The rehabilitation therapy must be medically necessary and appropriate medical care, rendered by an authorized provider, necessary to the establishment of a safe and effective maintenance program in connection with a specific medical condition, and must not be custodial care or otherwise excluded from coverage. (26) National Institutes of Health clinical trials. (i) Demonstration waiver. (ii) Continuous waiver General. (B) National Cancer Institute (NCI) sponsored or approved cancer prevention, screening, and early detection clinical trials. ( 1 ( i ( ii ( iii ( iv ( 2 ( 3 ( 4 (C) NIH-sponsored and approved clinical trials for severely debilitating diseases, life-threatening diseases, and rare diseases. ( 1 ( i ( ii ( iii ( iv ( 2 ( 3 ( 4 (iii) Public health emergency or national emergency waiver General. (B) Infectious disease health emergencies. ( 1 ( i ( ii ( iii ( 2 ( 3 ( 4 ( 5 Note: A waiver has been authorized for CHAMPUS cost-sharing for those eligible beneficiaries selected to participate in NIH-sponsored or approved Phase I, II, III, and IV studies examining the treatment or prevention of Coronavirus Disease 2019 and its associated sequelae. (27) TRICARE will cost share forensic examinations following a sexual assault or domestic violence. The forensic examination includes a history of the event and a complete physical and collection of forensic evidence, and medical and psychological follow-up care. The examination for sexual assault also includes, but is not limited to, a test kit to retrieve forensic evidence, testing for pregnancy, testing for sexually transmitted disease and HIV, and medical services and supplies for prevention of sexually transmitted diseases, HIV, pregnancy, and counseling services. (28) Preventive care. (i) Cervical, breast, colon and prostate cancer screenings according to standards issued by the Director, TRICARE Management Activity, based on guidelines from the U.S. Department of Health and Human Services. The standards may establish a specific schedule that includes frequency, age specifications, and gender of the beneficiary, as appropriate. (ii) Immunizations as recommended by the Centers for Disease Control and Prevention (CDC). (iii) Well-child visits for children under 6 years of age as described in paragraph (c)(3)(xi) of this section. (iv) Health promotion and disease prevention visits (which may include all of the services provided pursuant to § 199.17(f)(2)) for beneficiaries 6 years of age or older may be provided in connection with immunizations and cancer screening examinations authorized by paragraphs (e)(28)(i) and (ii) of this section). (v) Breastfeeding support, supplies (including breast pumps and associated equipment), and counseling. (29) Physical examinations. (i) Physical examinations for dependents of Active Duty military personnel who are traveling outside the United States. The examination must be required because of an Active Duty member's assignment and the travel is being performed under orders issued by a Uniformed Service. Any immunizations required for a dependent of an Active Duty member to travel outside of the United States is covered as a preventive service under paragraph (e)(28) of this section. (ii) Physical examinations for beneficiaries ages 5-11 that are required for school enrollment and that are provided on or after October 30, 2000. (iii) Other types of physical examinations not listed above are excluded including routine, annual, or employment-requested physical examinations and routine screening procedures that are not part of medically necessary care or treatment or otherwise specifically authorized by statute. (30) Smoking cessation program. (i) Availability. Federal Register. (ii) Benefits. (A) Pharmaceutical agents. (B) Face-to-face smoking cessation counseling. (C) Toll-free quit line. Federal Register. (D) Web-based resources. (f) Beneficiary or sponsor liability General. (2) Dependents of members of the Uniformed Services. (i) Annual calendar year deductible for outpatient services and supplies. (A) For care rendered all eligible beneficiaries prior to April 1, 1991, or when the active duty sponsor's pay grade is E-4 or below, regardless of the date of care: ( 1 Individual Deductible: ( 2 Family Deductible: (B) For care rendered on or after April 1, 1991, for all CHAMPUS beneficiaries except dependents of active duty sponsors in pay grades E-4 or below. ( 1) Individual Deductible: ( 2) Family Deductible: (C) CHAMPUS- approved Ambulatory Surgical Centers or Birthing Centers. (D) Allowable Amount does not exceed Deductible Amount. 2 1 (E) For any family the outpatient deductible amounts will be applied sequentially as the CHAMPUS claims are processed. (F) If the calendar year outpatient deductible under either paragraphs (f)(2)(i)(A) or (f)(2)(i)(B) of this section has been met by a beneficiary or a family through the submission of a claim or claims to a CHAMPUS fiscal intermediary in another geographic location from the location where a current claim is being submitted, the beneficiary or sponsor must obtain a deductible certificate from the CHAMPUS fiscal intermediary where the applicable beneficiary or family calendar year deductible was met. Such deductible certificate must be attached to the current claim being submitted for benefits. Failure to obtain a deductible certificate under such circumstances will result in a second beneficiary or family calendar year deductible being applied. However, this second deductible may be reimbursed once appropriate documentation, as described in paragraph (f)(2)(i)(F) of this section, is supplied to the CHAMPUS fiscal intermediary applying the second deductible. (G) Notwithstanding the dates specified in paragraphs (f)(2)(i)(A) and (f)(B)(2)(i) of this section in the case of dependents of active duty members of rank E-5 or above with Persian Gulf Conflict service, dependents of service members who were killed in the Gulf, or who died subsequent to Gulf service, and of members who retired prior to October 1, 1991, after having served in the Gulf War, the deductible shall be the amount specified in paragraph (f)(2)(i)(A) of this section for care rendered prior to October 1, 1991, and the amount specified in paragraph (f)(2)(i)(B) of this section for care rendered on or after October 1, 1991. (H) The Director, TRICARE Management Activity, may waive the annual individual or family calendar year deductible for dependents of a Reserve Component member who is called or ordered to active duty for a period of more than 30 days or a National Guard member who is called or ordered to fulltime federal National Guard duty for a period of more than 30 days in support of a contingency operation (as defined in 10 U.S.C. 101(a)(13)). For purposes of this paragraph, a dependent is a lawful husband or wife of the member and a child is defined in paragraphs (b)(2)(ii)(A) through (F) and (b)(2)(ii)(H)(1), (2), and (4) of § 199.3. (ii) Inpatient cost-sharing. Note: (A) Inpatient cost-sharing payable with each separate inpatient admission. (B) Multiple family inpatient admissions. (C) Newborn patient in his or her own right. (iii) Outpatient cost-sharing. (iv) Ambulatory surgery. (v) [Reserved] (vi) Transitional Assistance Management Program (TAMP). (3) Former members and dependents of former members. (i) Annual calendar year deductible for outpatient services or supplies. (ii) Inpatient cost-sharing. (iii) Outpatient cost-sharing. (4) Former spouses. (i) Annual calendar year deductible for outpatient services or supplies. (ii) Inpatient cost-sharing. (iii) Outpatient cost-sharing. (5) Cost-Sharing under the Military-Civilian Health Services Partnership Program. (i) External Partnership Agreement. (ii) Internal Partnership Agreement. (6)-(7) [Reserved] (8) Cost-sharing for services provided under special discount arrangements General rule. (ii) Specific applications. (A) In the case of services provided by individual health care professionals and other noninstitutional providers, the cost-share shall be the usual percentage of the CHAMPUS allowable charge determined under § 199.14(e). (B) In the case of services provided by institutional providers normally paid on the basis of a pre-set amount (such as DRG-based amount under § 199.14(a)(1) or per-diem amount under § 199.14(a)(2)), if the discount rate is lower than the pre-set rate, the cost-share amount that would apply for a beneficiary other than an active duty dependent pursuant to the normal pre-set rate would be reduced by the same percentage by which the pre-set rate was reduced in setting the discount rate. (9) Waiver of deductible amounts or cost-sharing not allowed General rule. (ii) Exception for bad debts. (iii) Remedies for noncompliance. (A) A claim for services regarding which the provider has waived the beneficiary's liability may be disallowed in full, or, alternatively, the amount payable for such a claim may be reduced by the amount of the beneficiary liability waived. (B) Repeated noncompliance with this requirement is a basis for exclusion of a provider. (10) Catastrophic loss protection for basic program benefits. (i) Dependents of active duty members. (ii) All other beneficiaries. (iii) Payment after cap is met. Note to paragraph ( f Under the Defense Authorization Act for Fiscal Year 2001, the cap for beneficiaries other than dependents of active duty members was reduced from $7,500 to $3,000 effective October 30, 2000. Prior to this, the Defense Authorization Act for Fiscal Year 1993 reduced this cap from $10,000 to $7,500 on October 1, 1992. The cap remains at $1,000 for dependents of active duty members. (11) Beneficiary or sponsor liability under the Pharmacy Benefits Program. (12) Elimination of cost-sharing for certain preventive services. (i) Effective for dates of service on or after October 14, 2008, beneficiaries, subject to the limitation in paragraph (f)(12)(iii) of this section, shall not pay any cost-share for preventive services listed in paragraph (e)(28)(i) through (iv) of this section. The beneficiary shall not be required to pay any portion of the cost of these preventive services even if the beneficiary has not satisfied the deductible for that year. (ii) Beneficiaries who paid a cost-share for preventive services listed in paragraph (e)(28)(i) through (iv) of this section on or after October 14, 2008, may request reimbursement until January 28, 2013 according to procedures established by the Director, TRICARE Management Activity. (iii) This elimination of cost-sharing for preventive services does not apply to any beneficiary who is a Medicare-eligible beneficiary. For purposes of this section, the term “Medicare-eligible” beneficiary is defined in 10 U.S.C. 1111(b) and refers to a person eligible for Medicare Part A. (iv) Appropriate copayments and deductibles will apply for all services not listed in paragraph (e)(28) of this section, whether considered preventive in nature or not. (13) Special transition rule for the last quarter of calendar year 2017. (g) Exclusions and limitations. (1) Not medically or psychologically necessary. (2) Unnecessary diagnostic tests. (3) Institutional level of care. (4) Diagnostic admission. Note: If it is determined that the diagnostic x-ray, laboratory, and pathological services and machine tests performed during such admission were medically necessary and would have been covered if performed on an outpatient basis, CHAMPUS benefits may be extended for such diagnostic procedures only, but cost-sharing will be computed as if performed on an outpatient basis. (5) Unnecessary postpartum inpatient stay, mother or newborn. (6) Therapeutic absences. (7) Custodial care. (8) Domiciliary care. (9) Rest or rest cures. (10) Amounts above allowable costs or charges. (11) No legal obligation to pay, no charge would be made. (12) Furnished without charge. (13) Furnished by local, state, or Federal Government. (14) Study, grant, or research programs. (15) Unproven drugs, devices, and medical treatments or procedures. (i) A drug, device, or medical treatment or procedure is unproven: (A) If the drug or device cannot be lawfully marketed without the approval or clearance of the United States Food and Drug Administration (FDA) and approval or clearance for marketing has not been given at the time the drug or device is furnished to the patient. Note to paragraph ( g i Although the use of drugs and medicines not approved by the FDA for commercial marketing, that is for use by humans, (even though permitted for testing on humans) is excluded from coverage as unproven, drugs grandfathered by the Federal Food, Drug and Cosmetic Act of 1938 may be covered by CHAMPUS as if FDA approved. Certain cancer drugs, designated as Group C drugs (approved and distributed by the National Cancer Institute), and investigational drugs authorized by the FDA for treatment use under expanded access programs are not covered under TRICARE because they are not approved for marketing by the FDA. However, medical care related to the use of Group C drugs and investigational drugs authorized for treatment use under FDA expanded access programs can be cost-shared under TRICARE when the patient's medical condition warrants their administration, and the care is provided in accordance with generally accepted standards of medical practice. CHAMPUS will consider coverage of off-label uses of drugs and devices that meet the definition of Off-Label Use of a Drug or Device in § 199.2(b). Approval for reimbursement of off-label uses requires review for medical necessity and also requires demonstrations from medical literature, national organizations, or technology assessment bodies that the off-label use of the drug or device is safe, effective, and in accordance with nationally accepted standards of practice in the medical community. (B) If a medical device (as defined by 21 U.S.C. 321(h)) with an Investigational Device Exemption (IDE) approved by the Food and Drug Administration is categorized by the FDA as experimental/investigational (FDA Category A). Note: CHAMPUS will consider for coverage a device with an FDA-approved IDE categorized by the FDA as non-experimental/investigational (FDA Category B) for CHAMPUS beneficiaries participating in FDA approved clinical trials. Coverage of any such Category B device is dependent on its meeting all other requirements of the laws and rules governing CHAMPUS and upon the beneficiary involved meeting the FDA-approved IDE study protocols. (C) Unless reliable evidence shows that any medical treatment or procedure has been the subject of well-controlled studies of clinically meaningful endpoints, which have determined its maximum tolerated dose, its toxicity, its safety, and its efficacy as compared with standard means of treatment or diagnosis. (See the definition of reliable evidence (D) If reliable evidence shows that the consensus among experts regarding the medical treatment or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated doses, its toxicity, its safety, or its effectiveness as compared with the standard means of treatment or diagnosis (see the definition of reliable evidence in § 199.2 for the procedures used in determining if a medical treatment or procedure is unproven). (ii) CHAMPUS benefits for rare diseases are reviewed on a case-by-case basis by the Director, Office of CHAMPUS, or a designee. In reviewing the case, the Director, or a designee, may consult with any or all of the following sources to determine if the proposed therapy is considered safe and effective: (A) Trials published in refereed medical literature. (B) Formal technology assessments. (C) National medical policy organization positions. (D) National professional associations. (E) National expert opinion organizations. (iii) Care excluded. (A) Treatment that is not related to the unproven drug, device or medical treatment or procedure; e.g., medically necessary in the absence of the unproven treatment. (B) Treatment which is necessary follow-up to the unproven drug, device or medical treatment or procedure but which might have been necessary in the absence of the unproven treatment. (16) Immediate family, household. (17) Double coverage. (18) Nonavailability Statement required. (19) Preauthorization required. (20) Psychoanalysis or psychotherapy, part of education. (21) Runaways. (22) Services or supplies ordered by a court or other government agency. (23) Work-related (occupational) disease or injury. (24) Cosmetic, reconstructive, or plastic surgery. (25) Surgery, psychological reasons. (26) Electrolysis. (27) Dental care. (28) Obesity, weight reduction. (29) Sex gender changes. (30) Therapy or counseling for sexual dysfunctions or sexual inadequacies. (31) Corns, calluses, and toenails. (32) Dyslexia. (33) Surgical sterilization, reversal. (34) Noncoital reproductive procedures including artifical insemination, in-vitro fertilization, gamete intrafallopian transfer and all other such reproductive technologies. (35) Nonprescription contraceptives. (36) Tests to determine paternity or sex of a child. (37) Preventive care. (38) Chiropractors and naturopaths. (39) Counseling. (i) Services provided by a certified marriage and family therapist, pastoral or mental health counselor in the treatment of a mental disorder as specifically provided in paragraph (c)(3)(ix) of this section and in § 199.6. (ii) Diabetes self-management training (DSMT) as specifically provided in paragraph (d)(3)(ix) of this section. (iii) Smoking cessation counseling and education as specifically provided in paragraph (e)(30) of this section. (iv) Services provided by alcoholism rehabilitation counselors only when rendered in a CHAMPUS-authorized treatment setting and only when the cost of those services is included in the facility's CHAMPUS-determined allowable cost rate. (v) Medical nutritional therapy (also referred to as medical nutritional counseling) required in the administration of the medically necessary foods, services and supplies authorized in paragraph (d)(3)(iii)(B) of this section, medically necessary vitamins authorized in paragraph (d)(3)(vi)(D) of this section, or when medically necessary for other authorized covered services. (40) Acupuncture. (41) Hair transplants, wigs/hair pieces/cranial prosthesis. Note: In accordance with section 744 of the DoD Appropriation Act for 1981 (Pub. L. 96-527), CHAMPUS coverage for wigs or hairpieces is permitted effective December 15, 1980, under the conditions listed below. Continued availability of benefits will depend on the language of the annual DoD Appropriation Acts. (i) Benefits provided. (ii) Exclusions. (A) Alopecia resulting from conditions other than treatment of malignant disease. (B) Maintenance, wig or hairpiece supplies, or replacement of the wig or hairpiece. (C) Hair transplants or any other surgical procedure involving the attachment of hair or a wig or hairpiece to the scalp. (D) Any diagnostic or therapeutic method or supply intended to encourage hair regrowth. (42) Education or training. (43) Exercise/relaxation/comfort/sporting items or sporting devices (44) Exercise. (45) [Reserved] (46) Vision care. (47) Eye and hearing examinations. (48) Prosthetic devices. (49) Orthopedic shoes. (50) Eyeglasses. (51) Hearing aids. (52) Telephone services. (i) Medically necessary and appropriate Telephonic office visits are covered as authorized in paragraph (c)(1)(iii) of this section. (ii) A diagnostic or monitoring procedure which incorporates electronic transmission of data or remote detection and measurement of a condition, activity, or function (biotelemetry) is not excluded when: (A) The procedure without electronic transmission of data or biotelemetry is otherwise an explicit or derived benefit of this section; (B) The addition of electronic transmission of data or biotelemetry to the procedure is found by the Director, CHAMPUS, or designee, to be medically necessary and appropriate medical care which usually improves the efficiency of the management of a clinical condition in defined circumstances; and (C) The each data transmission or biotelemetry devices incorporated into a procedure that is otherwise an explicit or derived benefit of this section, has been classified by the U.S. Food and Drug Administration, either separately or as a part of a system, for consistent use with the defined circumstances in paragraph (g)(52)(ii) of this section. (53) Air conditioners, humidifiers, dehumidifiers, and purifiers. (54) Elevators or chair lifts. (55) Alterations. (56) Clothing. (57) Food, food substitutes. (58) Enuretic. (59) Duplicate equipment. (60) Autopsy and postmortem. (61) Camping. (62) Housekeeper, companion. (63) Non-covered condition/treatment, unauthorized provider. (64) Comfort or convenience. (65) [Reserved] (66) Megavitamin psychiatric therapy, orthomolecular psychiatric therapy. (67) Transportation. (68) Travel. (69) Institutions. Note: In order to be approved under CHAMPUS, an institution must, in addition to meeting CHAMPUS standards, provide a level of care for which CHAMPUS benefits are payable. (70)-(71) [Reserved] (72) [Reserved] (73) Economic interest in connection with mental health admissions. (74) Not specifically listed. Note: The fact that a physician may prescribe, order, recommend, or approve a service or supply does not, of itself, make it medically necessary or make the charge an allowable expense, even though it is not listed specifically as an exclusion. (h) Payment and liability for certain potentially excludable services under the Peer Review Organization program Applicability. (2) Payment for certain potentially excludable expenses. (3) Liability for certain excludable services. (i) The beneficiary did not know and could not reasonably have been expected to know that the services were excludable by reason of being not medically necessary; and (ii) The provider knew or could reasonably have been expected to know that the items or services were excludable by reason of being not medically necessary. (4) Criteria for determining that beneficiary knew or could reasonably have been expected to have known that services were excludable. (5) Criteria for determining that provider knew or could reasonably have been expected to have known that services were excludable. (i) The PRO or fiscal intermediary had informed the provider that the services provided were excludable or that similar or reasonably comparable services were excludable. (ii) The utilization review group or committee for an institutional provider or the beneficiary's attending physician had informed the provider that the services provided were excludable. (iii) The provider had informed the beneficiary that the services were excludable. (iv) The provider had received written materials, including notices, manual issuances, bulletins, guides, directives or other materials, providing notification of PRO screening criteria specific to the condition of the beneficiary. Attending physicians who are members of the medical staff of an institutional provider will be found to have also received written materials provided to the institutional provider. (v) The services that are at issue are the subject of what are generally considered acceptable standards of practice by the local medical community. (vi) Preadmission authorization was available but not requested, or concurrent review requirements were not followed. [51 FR 24008, July 1, 1986] Editorial Note: For Federal Register www.govinfo.gov. § 199.5 TRICARE Extended Care Health Option (ECHO). (a) General. (2) The purpose of the ECHO is to provide an additional financial resource for an integrated set of services and supplies designed to assist in the reduction of the disabling effects of the ECHO-eligible dependent's qualifying condition. Services include those necessary to maintain, minimize or prevent deterioration of function of an ECHO-eligible dependent. (3) The Government's cost-share for ECHO or ECHO home health benefits during any program year is limited as stated in this section. In order to transition the program year from a fiscal year to a calendar year basis, the Government's annual cost-share limitation specified in paragraph (f) of this section shall be prorated for the last quarter of calendar year 2018 as authorized by 10 U.S.C. 1079(f)(2)(A). (b) Eligibility. (i) A spouse, child, or unmarried person (as described in § 199.3(b)(2)(i), (b)(2)(ii), or (b)(2)(iv)) of a member of the Uniformed Services on active duty for a period of more than 30 days. (ii) An abused dependent as described in § 199.3(b)(2)(iii). (iii) A spouse, child, or unmarried person (as described in § 199.3(b)(2)(i), (b)(2)(ii), or (b)(2)(iv)), of a member of the Uniformed Services who dies while on active duty for a period of more than 30 days and whose death occurs on or after October 7, 2001. In such case, an eligible surviving spouse remains eligible for benefits under the ECHO for a period of 3 years from the date the active duty sponsor dies. Any other eligible surviving dependent remains eligible for benefits under the ECHO for a period of three years from the date the active duty sponsor dies or until the surviving eligible dependent: (A) Attains 21 years of age, or (B) Attains 23 years of age or ceases to pursue a full-time course of study prior to attaining 23 years of age, if, at 21 years of age, the eligible surviving dependent is enrolled in a full-time course of study in a secondary school or in a full-time course of study in an institution of higher education approved by Secretary of Defense and was, at the time of the sponsor's death, in fact dependent on the member for over one-half of such dependent's support. (iv) A spouse, child, or unmarried person (as defined in paragraphs § 199.3(b)(2)(i), (b)(2)(ii), or (b)(2)(iv)) of a deceased member of the Uniformed Services who, at the time of the member's death was receiving benefits under ECHO, and the member at the time of death was eligible for receipt of hostile-fire pay, or died as a result of a disease or injury incurred while eligible for such pay. In such a case, the surviving dependent remains eligible for benefits under ECHO through midnight of the dependent's twenty-first birthday. (2) Qualifying condition. (i) Mental retardation. (ii) Serious physical disability. (iii) Extraordinary physical or psychological condition. (iv) Infant/toddler. (v) Multiple disabilities. (3) Loss of ECHO eligibility. (i) The sponsor ceases to be an active duty member for any reason other than death; or (ii) Eligibility based upon the abused dependent provisions of paragraph (b)(1)(ii) of this section expires; or (iii) Eligibility based upon the deceased sponsor provisions of paragraphs (b)(1)(iii) or (iv) of this section expires; or (iv) Eligibility based upon a beneficiary's participation in the Transitional Assistance Management Program ends; or (v) The Director, TRICARE Management Activity or designee determines that the beneficiary no longer has a qualifying condition. (c) ECHO benefit. (1) Diagnostic procedures to establish a qualifying condition or to measure the extent of functional loss resulting from a qualifying condition. (2) Medical, habilitative, rehabilitative services and supplies, durable equipment and assistive technology (AT) devices that assist in the reduction of the disabling effects of a qualifying condition. Benefits shall be provided in the beneficiary's home or another environment, as appropriate. An AT device may be covered only if it is recommended in a beneficiary's Individual Educational Program (IEP) or, if the beneficiary is not eligible for an IEP, the AT device is an item or educational learning device normally included in an IEP and is preauthorized under ECHO as an integral component of the beneficiary's individual comprehensive health care services plan (including rehabilitation) as prescribed by a TRICARE authorized provider. (i) An AT device may be covered under ECHO only if it is not otherwise covered by TRICARE as durable equipment, a prosthetic, augmentation communication device, or other benefits under § 199.4. (ii) An AT device may include an educational learning device directly related to the beneficiary's qualifying condition when recommended by an IEP and not otherwise provided by State or local government programs. If an individual is not eligible for an IEP, an educational learning device normally included in the IEP may be authorized as if directly related to the beneficiary's qualifying condition and prescribed by a TRICARE authorized provider as part of the beneficiary's individual comprehensive health care services plan. (iii) Electronic learning devices may include the hardware and software as appropriate. The Director, DHA, shall determine the types and (or) platforms of electronic devices and the replacement lifecycle of the hardware and its supporting software. All upgrades or replacements shall require a recommendation from the individual's IEP or the individual's comprehensive health care services plan. (iv) Duplicative or redundant hardware platforms are not authorized. Note to paragraph ( c iv When one or more electronic platforms such as a desktop computer, laptop, notebook or tablet can perform the same functions in relation to the teaching or educational objective directly related to the qualifying condition, it is the intent of this provision to allow only one electronic platform that may be chosen by the beneficiary. Duplicative or redundant platforms are not allowed; however, a second platform may be obtained, if the individual's IEP recommends one platform such as a computer for the majority of the learning objectives, but there exists another objective, which cannot be performed on that platform. In these limited circumstances, the beneficiary may submit a request with the above justification to the Director, TMA, who may authorize a second device. (v) AT devices damaged through improper use of the device may not be replaced until the device would next be eligible for a lifecycle replacement. (vi) AT devices do not include equipment or devices whose primary purpose is to assist the individual to engage in sports or recreational activities. (3) Training that teaches the use of assistive technology devices or to acquire skills that are necessary for the management of the qualifying condition. Such training is also authorized for the beneficiary's immediate family. Vocational training, in the beneficiary's home or a facility providing such, is also allowed. (4) Special education as provided by the Individuals with Disabilities Education Act and defined at 34 CFR 300.26 and that is specifically designed to accommodate the disabling effects of the qualifying condition. (5) Institutional care within a state, as defined in § 199.2, in private nonprofit, public, and state institutions and facilities, when the severity of the qualifying condition requires protective custody or training in a residential environment. For the purpose of this section protective custody means residential care that is necessary when the severity of the qualifying condition is such that the safety and well-being of the beneficiary or those who come into contact with the beneficiary may be in jeopardy without such care. (6) Transportation of an ECHO beneficiary receiving benefits under paragraph (c)(5), and a medical attendant when necessary to assure the beneficiary's safety, to or from a facility or institution to receive authorized ECHO services or items. (7) Respite care. (i) TRICARE-authorized home health agencies must provide and bill for all authorized ECHO respite care services through established TRICARE claims' mechanisms. No special billing arrangements will be authorized in conjunction with coverage that may be provided by Medicaid or other federal, state, community or private programs. (ii) For authorized ECHO respite care, TRICARE will reimburse the allowable charges or negotiated rates. (iii) The Government's cost-share incurred for these services accrues to the program year benefit limit of $36,000. (8) Other services. Assistive services. (ii) Equipment adaptation. (iii) Equipment maintenance. (d) ECHO Exclusions Basic Program. (2) Inpatient care. (3) Structural alterations. (4) Homemaker services. (5) Dental care or orthodontic treatment. (6) Deluxe travel or accommodations. (7) Equipment. (i) The beneficiary is a patient in an institution or facility that ordinarily provides the same type of equipment or AT devices to its patients at no additional charge in the usual course of providing services; or (ii) The item is available to the beneficiary from a Uniformed Services Medical Treatment Facility; or (iii) The item has deluxe, luxury, immaterial or nonessential features that increase the cost to the Department relative to a similar item without those features; or (iv) The item is a duplicate DE or an AT device, as defined in § 199.2. (v) The item (or charge for access to such items through health club membership or other activities) is exercise equipment including an item primarily and customarily designed for use in sports or recreational activities, spa, whirlpool, hot tub, swimming pool, an electronic device used to locate or monitor the location of the beneficiary, or other similar items or charges. (8) Maintenance agreements. (9) No obligation to pay. (10) Public facility or Federal government. (11) Study, grant, or research programs. (12) Unproven status. (13) Immediate family or household. (14) Court or agency ordered care. (15) Excursions. (16) Drugs and medicines. (17) Therapeutic absences. (18) Custodial care. (19) Domiciliary care. (20) Respite care. (e) ECHO Home Health Care (EHHC). (1) Home health care. (2) Respite care. (3) EHHC eligibility. (i) Physically reside within the 50 United States, the District of Columbia, Puerto Rico, the Virgin Islands, or Guam; and (ii) Are homebound, as defined in § 199.2; and (iii) Require medically necessary skilled services that exceed the level of coverage provided under the Basic Program's home health care benefit; and/or (iv) Require frequent interventions by the primary caregiver(s) such that respite care services are necessary to allow primary caregiver(s) the opportunity to rest; and (v) Are case managed to include a reassessment at least every 90 days, and receive services as outlined in a written plan of care; and (vi) Receive all home health care services from a TRICARE-authorized home health agency, as described in § 199.6(b)(4)(xv), in the beneficiary's primary residence. (4) EHHC plan of care. (5) EHHC exclusions General. (ii) Respite care. (f) Cost-share liability No deductible. (2) Sponsor cost-share liability. Table 1—Monthly Cost-Share by Member's Pay Grade E-1 through E-5 $25 E-6 30 E-7 and O-1 35 E-8 and O-2 40 E-9, W-1, W-2 and O-3 45 W-3, W-4 and O-4 50 W-5 and O-5 65 O-6 75 O-7 100 O-8 150 O-9 200 O-10 250 (ii) The Sponsor's cost-share shown in Table 1 in paragraph (f)(2)(i) of this section will be applied to the first allowed ECHO charges in any given month. The Government's share will be paid, up to the maximum amount specified in paragraph (f)(3) of this section, for allowed charges after the sponsor's cost-share has been applied. (iii) The provisions of § 199.18(d)(1) and (e)(1) regarding elimination of copayments for active duty family members enrolled in TRICARE Prime do not eliminate, reduce, or otherwise affect the sponsor's cost-share shown in Table 1 in paragraph (f)(2)(i) of this section. (iv) The sponsor's cost-share shown in Table 1 in paragraph (f)(2)(i) of this section does not accrue to the Basic Program's Catastrophic Loss Protection under 10 U.S.C. 1079(b)(5) as shown at §§ 199.4(f)(10) and 199.18(f). (3) Government cost-share liability ECHO. (ii) ECHO home health care. (B) When a beneficiary moves to a different locality within the 50 United States, the District of Columbia, Puerto Rico, the Virgin Islands, or Guam, the annual program year cap will be recalculated to reflect the maximum established under paragraph (f)(3)(ii)(A) of this section for the beneficiary's new location and will apply to the EHHC benefit for the remaining portion of that program year. (g) Benefit payment Transportation. (2) Equipment. (ii) Cost-share. A cost-share, as provided by paragraph (f)(2) of this section, is required for each month in which equipment or an AT device is purchased under this section. However, in no month shall a sponsor be required to pay more than one cost-share regardless of the number of benefits the sponsor's dependents received under this section. (3) For-profit institutional care provider. (i) Is contracted for by a public facility as a part of a publicly funded long-term inpatient care program; and (ii) Is provided based upon the ECHO beneficiary's being eligible for the publicly funded program which has contracted for the care; and (iii) Is authorized by the public facility as a part of a publicly funded program; and (iv) Would cause a cost-share liability in the absence of TRICARE eligibility; and (v) Produces an ECHO beneficiary cost-share liability that does not exceed the maximum charge by the provider to the public facility for the contracted level of care. (4) ECHO home health care and EHHC respite care. (ii) For authorized ECHO home health care and respite care, TRICARE will reimburse the allowable charges or negotiated rates. (iii) The maximum monthly Government reimbursement for EHHC, including EHHC respite care, will be based on the actual number of hours of EHHC services rendered in the month, but in no case will it exceed one-twelfth of the annual maximum Government cost-share as determined in this section and adjusted according to the actual number of days in the month the services were provided. (h) Other Requirements Applicable part. (2) Registration. (3) Benefit authorization. (i) Documentation. (ii) Format. (iii) Valid period. (iv) Authorization waiver. (v) Public facility use. (B) The domicile of the beneficiary shall be the basis for the determination of public facility availability when the sponsor and beneficiary are separately domiciled due to the sponsor's move to a new permanent duty station or due to legal custody requirements. (C) Written certification, in accordance with information requirements, formats, and procedures established by the director, TRICARE Management Activity or designee that requested ECHO services or items cannot be obtained from public facilities because the services or items are not available and adequate, is a prerequisite for ECHO benefit payment for training, rehabilitation, special education, assistive technology, and institutional care in private nonprofit, public, and state institutions and facilities, and if appropriate, transportation to and from such institutions and facilities. ( 1 ( 2 ( i ( ii (4) Repair or maintenance of DE owned by the beneficiary or an AT device is exempt from the public facility-use certification requirements. (5) The requirements of this paragraph (h)(3)(v)(A) notwithstanding, no public facility use certification is required for services and items that are provided under Part C of the Individuals with Disabilities Education Act in accordance with the Individualized Family Services Plan and that are otherwise allowable under the ECHO. (i) Implementing instructions. (j) Effective date. [69 FR 51564, Aug. 20, 2004, as amended at 71 FR 47092, Aug. 16, 2006; 72 FR 2447, Jan. 19, 2007; 75 FR 47711, Aug. 9, 2010; 79 FR 78713, Dec. 31, 2014; 81 FR 27329, May 6, 2016; 82 FR 45447, Sept. 29, 2017; 86 FR 36217, July 9, 2021] § 199.6 TRICARE—authorized providers. (a) General. (1) Listing of provider does not guarantee payment of benefits. (2) Outside the United States or emergency situations within the United States. Note: Only the Secretary of Defense, the Secretary of Health and Human Services, or the Secretary of Transportation, or their designees, may authorize (in emergency situations) payment to civilian facilities in the United States that are not in compliance with title VI of the Civil Rights Act of 1964. For the purpose of the Civil Rights Act only, the United States includes the 50 states, the District of Columbia, Puerto Rico, Virgin Islands, American Samoa, Guam, Wake Island, Canal Zone, and the territories and possessions of the United States. (3) Dual compensation/Conflict of interest. (4) [Reserved] (5) Utilization review and quality assurance. (6) Exclusion of beneficiary liability. (7) Provider required. (8) Participating providers. (i) Mandatory participation. (B) A SNF or a HHA, in order to be an authorized provider under TRICARE, must enter into a participation agreement with TRICARE for all claims. (C) Corporate services providers authorized as CHAMPUS providers under the provisions of paragraph (f) of this section must enter into a participation agreement as provided by the Director, OCHAMPUS, or designee. (ii) Voluntary participation Total claims participation: The participating provider program. (B) Claim-specific participation. (iii) Claim-by-claim participation. (9) Limitation to authorized institutional provider designation. (10) Authorized provider. (11) Balance billing limits In general. (ii) Waiver. (iii) Compliance. (12) Medical records. (i) The cognizant state licensing authority; (ii) The Joint Commission on Accreditation of Healthcare Organizations, or the appropriate Qualified Accreditation Organization as defined in § 199.2; (iii) Standards of practice established by national medical organizations; and (iv) This part. (13) Participation agreements. (i) Not charge a beneficiary for the following: (A) Services for which the provider is entitled to payment from CHAMPUS; (B) Services for which the beneficiary would be entitled to have CHAMPUS payment made had the provider complied with certain procedural requirements. (C) Services not medically necessary and appropriate for the clinical management of the presenting illness, injury, disorder or maternity; (D) Services for which a beneficiary would be entitled to payment but for a reduction or denial in payment as a result of quality review; and (E) Services rendered during a period in which the provider was not in compliance with one or more conditions of authorization; (ii) Comply with the applicable provisions of this part and related CHAMPUS administrative policy; (iii) Accept the CHAMPUS determined allowable payment combined with the cost-share, deductible, and other health insurance amounts payable by, or on behalf of, the beneficiary, as full payment for CHAMPUS allowed services; (iv) Collect from the CHAMPUS beneficiary those amounts that the beneficiary has a liability to pay for the CHAMPUS deductible and cost-share; (v) Permit access by the Director, OCHAMPUS, or designee, to the clinical record of any CHAMPUS beneficiary, to the financial and organizational records of the provider, and to reports of evaluations and inspections conducted by state, private agencies or organizations; (vi) Provide the Director, OCHAMPUS, or designee, prompt written notification of the provider's employment of an individual who, at any time during the twelve months preceding such employment, was employed in a managerial, accounting, auditing, or similar capacity by an agency or organization which is responsible, directly or indirectly for decisions regarding Department of Defense payments to the provider; (vii) Cooperate fully with a designated utilization and clinical quality management organization which has a contract with the Department of Defense for the geographic area in which the provider renders services; (viii) Obtain written authorization before rendering designated services or items for which CHAMPUS cost-share may be expected; (ix) Maintain clinical and other records related to individuals for whom CHAMPUS payment was made for services rendered by the provider, or otherwise under arrangement, for a period of 60 months from the date of service; (x) Maintain contemporaneous clinical records that substantiate the clinical rationale for each course of treatment, periodic evaluation of the efficacy of treatment, and the outcome at completion or discontinuation of treatment; (xi) Refer CHAMPUS beneficiaries only to providers with which the referring provider does not have an economic interest, as defined in § 199.2; and (xii) Limit services furnished under arrangement to those for which receipt of payment by the CHAMPUS authorized provider discharges the payment liability of the beneficiary. (14) Implementing instructions. (15) Exclusion. (b) Institutional providers General. (i) Preauthorization. (ii) Billing practices. (A) Each institutional billing, including those institutions subject to the CHAMPUS DRG-based reimbursement method or a CHAMPUS-determined all-inclusive rate reimbursement method, must be itemized fully and sufficiently descriptive for the CHAMPUS to make a determination of benefits. (B) Institutional claims subject to the CHAMPUS DRG-based reimbursement method or a CHAMPUS-determined all-inclusive rate reimbursement method, may be submitted only after the beneficiary has been discharged or transferred from the institutional provider's facility or program. (C) Institutional claims for Residential Treatment Centers and all other institutional providers, except those listed in (B) above, should be submitted to the appropriate CHAMPUS fiscal intermediary at least every 30 days. (2) Nondiscrimination policy. (i) Emergency care. (ii) Care rendered before finding of a violation. (iii) Other facility not available. (3) Procedures for qualifying as a CHAMPUS-approved institutional provider. (i) JCAH accreditation status. (ii) Required to comply with criteria. (iii) Notice of peer review rights. (iv) Surveying of facilities. (v) Institutions not in compliance with CHAMPUS standards. (vi) Participation agreements required for some hospitals which are not Medicare-participating. (4) Categories of institutional providers. (i) Hospitals, acute care, general and special. (A) Is engaged primarily in providing to inpatients, by or under the supervision of physicians, diagnostic and therapeutic services for the medical or surgical diagnosis and treatment of illness, injury, or bodily malfunction (including maternity). (B) Maintains clinical records on all inpatients (and outpatients if the facility operates an outpatient department or emergency room). (C) Has bylaws in effect with respect to its operations and medical staff. (D) Has a requirement that every patient be under the care of a physician. (E) Provides 24-hour nursing service rendered or supervised by a registered professional nurse, and has a licensed practical nurse or registered professional nurse on duty at all times. (F) Has in effect a hospital utilization review plan that is operational and functioning. (G) In the case of an institution in a state in which state or applicable local law provides for the licensing of hospitals, the hospital: ( 1 ( 2 (H) Has in effect an operating plan and budget. (I) Is accredited by the JCAH or meets such other requirements as the Secretary of Health and Human Services, the Secretary of Transportation, or the Secretary of Defense finds necessary in the interest of the health and safety of patients who are admitted to and furnished services in the institution. (ii) Organ transplant centers. (iii) Organ transplant consortia. (iv) Hospitals, psychiatric. (A) There are two major categories of psychiatric hospitals: ( 1 ( 2 (B) In order for the services of a psychiatric hospital to be covered, the hospital shall comply with the provisions outlined in paragraph (b)(4)(i) of this section. All psychiatric hospitals shall be accredited under an accrediting organization approved by the Director, in order for their services to be cost-shared under CHAMPUS. In the case of those psychiatric hospitals that are not accredited because they have not been in operation a sufficient period of time to be eligible to request an accreditation survey, the Director, or a designee, may grant temporary approval if the hospital is certified and participating under Title XVIII of the Social Security Act (Medicare, Part A). This temporary approval expires 12 months from the date on which the psychiatric hospital first becomes eligible to request an accreditation survey by an accrediting organization approved by the Director. (C) Factors to be considered in determining whether CHAMPUS will cost-share care provided in a psychiatric hospital include, but are not limited to, the following considerations: ( 1 ( 2 ( 3 ( 4 (D) Although psychiatric hospitals are accredited under an accrediting organization approved by Director, their medical records must be maintained in accordance with accrediting organization's current standards manual, along with the requirements set forth in § 199.7(b)(3). The hospital is responsible for assuring that patient services and all treatment are accurately documented and completed in a timely manner. (v) Long Term Care Hospital (LTCH). (A) In order for the services of LTCHs to be covered, the hospitals must comply with the provisions outlined in paragraph (b)(4)(i) of this section. In addition, in order for services provided by such hospitals to be covered by TRICARE, they must be primarily for the treatment of the presenting illness. (B) Custodial or domiciliary care is not coverable under TRICARE, even if rendered in an otherwise authorized LTCH. (C) The controlling factor in determining whether a beneficiary's stay in a LTCH is coverable by TRICARE is the level of professional care, supervision, and skilled nursing care that the beneficiary requires, in addition to the diagnosis, type of condition, or degree of functional limitations. The type and level of medical services required or rendered is controlling for purposes of extending TRICARE benefits; not the type of provider or condition of the beneficiary. (vi) Skilled nursing facility. (A) Has policies that are developed with the advice of (and with provisions for review on a periodic basis by) a group of professionals, including one or more physicians and one or more registered nurses, to govern the skilled nursing care and related medical services it provides. (B) Has a physician, a registered nurse, or a medical staff responsible for the execution of such policies. (C) Has a requirement that the medical care of each patient must be under the supervision of a physician, and provides for having a physician available to furnish necessary medical care in case of an emergency. (D) Maintains clinical records on all patients. (E) Provides 24-hour skilled nursing service that is sufficient to meet nursing needs in accordance with the policies developed as provided in paragraph (b)(4)(iv)(A) of this section, and has at least one registered professional nurse employed full-time. (F) Provides appropriate methods and procedures for the dispensing and administering of drugs and biologicals. (G) Has in effect a utilization review plan that is operational and functioning. (H) In the case of an institution in a state in which state or applicable local law provides for the licensing of this type facility, the institution: ( 1 ( 2 (I) Has in effect an operating plan and budget. (J) Meets such provisions of the most current edition of the Life Safety Code 8 8 (K) Is an authorized provider under the Medicare program, and meets the requirements of Title 18 of the social Security Act, sections 1819(a), (b), (c), and (d) (42 U.S.C. 1395i-3(a)-(d)). Note: If a pediatric SNF is certified by Medicaid, it will be considered to meet the Medicare certification requirement in order to be an authorized provider under TRICARE. (vii) Residential treatment centers. (A) Organization and administration 1 Definition. ( i ( ii ( iii ( iv ( v ( vi ( 2 Eligibility. i ( ii ( iii ( iv (B) Participation agreement requirements. In addition to other requirements set forth in this paragraph (b)(4)(vii), for the services of an RTC to be authorized, the RTC shall have entered into a Participation Agreement with OCHAMPUS. The period of a participation agreement shall be specified in the agreement, and will generally be for not more than five years. In addition to review of a facility's application and supporting documentation, an on-site inspection by OCHAMPUS authorized personnel may be required prior to signing a Participation Agreement. Retroactive approval is not given. In addition, the Participation Agreement shall include provisions that the RTC shall, at a minimum: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( i ( ii ( 8 ( 9 ( 10 ( 11 ( i ( ii ( iii ( iv ( v (C) Other requirements applicable to RTCs. 1 ( 2 ( 3 (viii) Christian Science sanatoriums. (ix) Infirmaries. Note: An infirmary in a boarding school also may qualify under this provision, subject to review and approval by the Director, OCHAMPUS or a designee. (x) Other special institution providers. General. 1 ( i ( ii ( iii ( iv ( v ( vi ( 2 ( i ( ii ( iii ( iv ( v ( vi ( 3 ( i ( ii (B) Types of providers. ( 1 Ambulatory surgical centers ASC). ( i ( ii 1 i ( iii e.g., 1 ii ( 2 (xi) Birthing centers. (A) Certification requirements. ( 1 ( 2 ( 3 ( 4 ( 5 ( i ( ii ( iii ( iv ( v ( 6 (B) CHAMPUS birthing center standards. 1 Environment: ( 2 Policies and procedures: ( 3 Informed consent: ( 4 Beneficiary care: ( 5 Medical direction: ( 6 Admission and emergency care criteria and procedures. 5 ( 7 Emergency treatment. ( 8 Emergency medical transportation. 7 ( 9 Professional staff. ( 10 Medical records. 3 ( 11 Quality assurance. ( 12 Governance and administration. (xii) Psychiatric and substance use disorder partial hospitalization programs. (A) Organization and administration 1 Definition. ( 2 Eligibility. i ( ii ( iii ( iv (B) Participation agreement requirements. ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( i ( ii ( 8 ( 9 ( 10 ( 11 ( i ( ii ( iii ( iv ( v (C) Other requirements applicable to PHPs. 1 ( 2 ( 3 (xiii) Hospice programs. (A) Is primarily engaged in providing the care and services described under § 199.4(e)(19) and makes such services available on a 24-hour basis. (B) Provides bereavement counseling for the immediate family or terminally ill individuals. (C) Provides for such care and services in individuals' homes, on an outpatient basis, and on a short-term inpatient basis, directly or under arrangements made by the hospice program, except that the agency or organization must: ( 1 ( 2 ( 3 ( 4 ( i ( ii ( iii ( iv ( 5 ( 6 ( 7 ( 8 ( i ( ii ( 9 (xiv) Substance use disorder rehabilitation facilities. (A) Organization and administration 1 Definition. ( i ( ii ( iii ( iv ( v ( vi ( 2 Eligibility. i ( ii ( iii ( iv (B) Participation agreement requirements. ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( i ( ii ( iii ( 8 ( 9 ( 10 ( 11 ( i ( ii ( iii ( iv ( v (C) Other requirements applicable to substance use disorder rehabilitation facilities. ( 1 ( 2 ( 3 (xv) Home health agencies (HHAs). (A) Engaged in providing skilled nursing services and other therapeutic services, such as physical therapy, speech-language pathology services, or occupational therapy, medical services, and home health aide services. ( 1 ( 2 (B) Policies established by a professional group associated with the agency or organization (including at least one physician and one registered nurse) to govern the services and provides for supervision of such services by a physician or a registered nurse. (C) Maintains clinical records for all patients. (D) Licensed in accordance with State and local law or is approved by the State or local licensing agency as meeting the licensing standards, where applicable. (E) Enters into an agreement with TRICARE in order to participate and to be eligible for payment under the program. In this agreement the HHA and TRICARE agree that the HHA will: ( 1 ( 2 (F) Abide by the following consolidated billing requirements: ( 1 ( 2 ( 3 ( i ( ii ( iii ( iv ( v ( vi ( vii ( viii (G) Meet such other requirements as the Secretary of Health and Human Services and/or Secretary of Defense may find necessary in the interest of the health and safety of the individuals who are provided care and services by such agency or organization. (xvi) Critical Access Hospitals (CAHs). (xvii) Sole community hospitals (SCHs). (xviii) Intensive outpatient programs. (A) Organization and administration 1 Definition. ( 2 Eligibility. i ( ii ( iii ( iv (B) Participation agreement requirements. ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( i ( ii ( iii ( 8 ( 9 ( 10 ( 11 ( i ( ii ( iii ( iv ( v (C) Other requirements applicable to Intensive Outpatient Programs (IOP). 1 ( 2 ( 3 (xix) Opioid Treatment Programs (OTPs). (A) Organization and administration. 1 Definition. ( 2 Eligibility. i ( ii ( iii (B) Participation agreement requirements. In addition to other requirements set forth in this paragraph (b)(4)(xix), in order for the services of OTPs to be authorized, OTPs shall have entered into a Participation Agreement with TRICARE. A single consolidated participation agreement is acceptable for all units of a TRICARE authorized facility. The period of a Participation Agreement shall be specified in the agreement, and will generally be for not more than five years. In addition to review of a facility's application and supporting documentation, an on-site inspection by DHA authorized personnel may be required prior to signing a participation agreement. The Participation Agreement shall include at least the following requirements: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( i ( ii ( 8 ( 9 ( 10 ( 11 ( i ( ii ( iii (C) Other requirements applicable to OTPs. 1 ( 2 ( 3 (xx) Inpatient Rehabilitation Facility (IRF). (A) In order for the services of inpatient rehabilitation facilities to be covered, the facility must comply with the provisions outlined in paragraph (b)(4)(i) of this section. In addition, in order for services provided by these facilities to be covered by TRICARE, they must be primarily for the treatment of the presenting illness. (B) Custodial or domiciliary care is not coverable under TRICARE, even if rendered in an otherwise authorized inpatient rehabilitation facility. (C) The controlling factor in determining whether a beneficiary's stay in an inpatient rehabilitation facility is coverable by TRICARE is the level of professional care, supervision, and skilled nursing care that the beneficiary requires, in addition to the diagnosis, type of condition, or degree of functional limitations. The type and level of medical services required or rendered is controlling for purposes of extending TRICARE benefits; not the type of provider or condition of the beneficiary. (xxi) Freestanding End Stage Renal Disease (ESRD) facilities. (c) Individual professional providers of care General Purpose. (ii) Professional corporation affiliation or association membership permitted. (iii) Scope of practice limitation. (iv) Employee status exclusion. (v) Training status exclusion. (2) Conditions of authorization Professional license requirement. (ii) Professional certification requirement. (iii) Education, training and experience requirement. (iv) Physician referral and supervision. (v) Subject to section 1079(a) of title 10, U.S.C., chapter 55, a physician or other health care practitioner who is eligible to receive reimbursement for services provided under Medicare (as defined in section 1086(d)(3)(C) of title 10 U.S.C., chapter 55) shall be considered approved to provide medical care authorized under section 1079 and section 1086 of title 10, U.S.C., chapter 55 unless the administering Secretaries have information indicating Medicare, TRICARE, or other Federal health care program integrity violations by the physician or other health care practitioner. Approval is limited to those classes of provider currently considered TRICARE authorized providers as outlined in 32 CFR 199.6. Services and supplies rendered by those providers who are not currently considered authorized providers shall be denied. (3) Types of providers. (i) Physicians. (B) Doctors of Osteopathy (D.O.). (ii) Dentists. (A) Doctors of Dental Medicine (D.M.D.). (B) Doctors of Dental Surgery (D.D.S.). (iii) Other allied health professionals. (A) Clinical psychologist. ( 1 ( 2 ( 3 1 2 (B) Doctors of Optometry. (C) Doctors of Podiatric Medicine or Podiatrists. (D) Certified nurse midwives. ( 1 ( i ( ii ( 2 (E) Certified nurse practitioner. ( 1 ( 2 ( 3 (F) Certified Clinical Social Worker. ( 1 ( 2 ( 3 Note: Patients' organic medical problems must receive appropriate concurrent management by a physician. (G) Certified psychiatric nurse specialist. ( 1 ( 2 ( 3 ( 4 (H) Certified physician assistant. ( 1 ( 2 ( i ( ii ( iii ( 3 2 (I) Anesthesiologist Assistant. ( 1 ( i ( ii ( iii ( iv ( v ( vi ( vii ( viii ( 2 ( 3 ( i ( ii ( 4 (J) Certified Registered Nurse Anesthetist (CRNA). ( 1 ( 2 (K) Other individual paramedical providers. 1 ( i ( ii ( 2 ( i ( ii ( 3 (L) Nutritionist. (M) Registered dietician. (N) TRICARE certified mental health counselor. 1 2 ( 1 ( i ( ii ( iii ( iv ( 2 ( i ( ii ( iii ( iv ( 3 (iv) Extramedical individual providers. (A) Certified marriage and family therapists. ( 1 ( 2 ( i ( ii ( iii ( iv ( 3 ( 4 ( 5 ( 6 (B) Pastoral counselors. ( 1 ( 2 ( i ( ii ( iii ( iv ( 3 ( 4 ( i ( ii ( iii ( 5 Note: No dual status will be recognized by the Office of CHAMPUS. Pastoral counselors must elect to become one of the categories of extramedical CHAMPUS provides specified above. Once authorized as either a pastoral counselor, or a certified marriage and family therapist, claims review and reimbursement will be in accordance with the criteria established for the elected provider category. (C) Supervised mental health counselor. ( 1 ( 2 ( 3 ( 4 ( i ( ii ( iii (D) The following additional information applies to each of the above categories of extramedical individual providers: ( 1 ( 2 (E) Christian Science practitioners and Christian Science nurses. 1 1 (d) Other providers. (1) Independent laboratory. (2) Suppliers of portable x-ray services. (3) Pharmacies. (4) Ambulance companies. (5) Medical equipment firms, medical supply firms, and Durable Medical Equipment, Prosthetic, Orthotic, Supplies providers/suppliers. (6) Mammography suppliers. (e) Extended Care Health Option Providers General. (ii) A Program for Persons with Disabilities (PFPWD) provider with TRICARE-authorized status on the effective date for the Extended Care Health Option (ECHO) Program shall be deemed to be a TRICARE-authorized provider until the expiration of all outstanding PFPWD benefit authorizations for services or items being rendered by the provider. (2) ECHO provider categories ECHO inpatient care provider. (A) A not-for-profit entity or a public facility; and (B) Located within a state; and (C) Be certified as eligible for Medicaid payment in accordance with a state plan for medical assistance under Title XIX of the Social Security Act (Medicaid) as a Medicaid Nursing Facility, or Intermediate Care Facility for the Mentally Retarded, or be a TRICARE-authorized institutional provider as defined in paragraph (b) of this section, or be approved by a state educational agency as a training institution. (ii) ECHO outpatient care provider. (A) A TRICARE-authorized provider of services as defined in this section; or (B) An individual, corporation, foundation, or public entity that predominantly renders services of a type uniquely allowable as an ECHO benefit and not otherwise allowable as a benefit of § 199.4, that meets all applicable licensing or other regulatory requirements of the state, county, municipality, or other political jurisdiction in which the ECHO service is rendered, or in the absence of such licensing or regulatory requirements, as determined by the Director, TRICARE Management Activity or designee. (iii) ECHO vendor. (3) ECHO provider exclusion or suspension. (f) Corporate services providers General. (ii) Payment for otherwise allowable services may be made to a CHAMPUS-authorized corporate services provider subject to the applicable requirements, exclusions and limitations of this part. (iii) The Director, OCHAMPUS, or designee, may create discrete types within any allowable category of provider established by this paragraph (f) to improve the efficiency of CHAMPUS management. (iv) The Director, OCHAMPUS, or designee, may require, as a condition of authorization, that a specific category or type of provider established by this paragraph (f): (A) Maintain certain accreditation in addition to or in lieu of the requirement of paragraph (f)(2)(v) of this section; (B) Cooperate fully with a designated utilization and clinical quality management organization which has a contract with the Department of Defense for the geographic area in which the provider does business; (C) Render services for which direct or indirect payment is expected to be made by CHAMPUS only after obtaining CHAMPUS written authorization; and (D) Maintain Medicare approval for payment when the Director, OCHAMPUS, or designee, determines that a category, or type, of provider established by this paragraph (f) is substantially comparable to a provider or supplier for which Medicare has regulatory conditions of participation or conditions of coverage. (v) Otherwise allowable services may be rendered at the authorized corporate services provider's place of business, or in the beneficiary's home under such circumstances as the Director, OCHAMPUS, or designee, determines to be necessary for the efficient delivery of such in-home services. (vi) The Director, OCHAMPUS, or designee, may limit the term of a participation agreement for any category or type of provider established by this paragraph (f). (vii) Corporate services providers shall be assigned to only one of the following allowable categories based upon the predominate type of procedure rendered by the organization; (A) Medical treatment procedures; (B) Surgical treatment procedures; (C) Maternity management procedures; (D) Rehabilitation and/or habilitation procedures; or (E) Diagnostic technical procedures. (viii) The Director, OCHAMPUS, or designee, shall determine the appropriate procedural category of a qualified organization and may change the category based upon the provider's CHAMPUS claim characteristics. The category determination of the Director, OCHAMPUS, designee, is conclusive and may not be appealed. (2) Conditions of authorization. (i) Be a corporation or a foundation, but not a professional corporation or professional association; and (ii) Be institution-affiliated or freestanding as defined in § 199.2; and (iii) Provide: (A) Services and related supplies of a type rendered by CHAMPUS individual professional providers or diagnostic technical services and related supplies of a type which requires direct patient contact and a technologist who is licensed by the state in which the procedure is rendered or who is certified by a Qualified Accreditation Organization as defined in § 199.2; and (B) A level of care which does not necessitate that the beneficiary be provided with on-site sleeping accommodations and food in conjunction with the delivery of services; and (iv) Complies with all applicable organizational and individual licensing or certification requirements that are extant in the state, county, municipality, or other political jurisdiction in which the provider renders services; and (v) Be approved for Medicare payment when determined to be substantially comparable under the provisions of paragraph (f)(1)(iv)(D) of this section or, when Medicare approved status is not required, be accredited by a qualified accreditation organization, as defined in § 199.2; and (vi) Has entered into a participation agreement approved by the Director, OCHAMPUS, or designee, which at least complies with the minimum participation agreement requirements of this section. (3) Transfer of participation agreement. (i) The merger of the provider corporation or foundation into another corporation or foundation, or the consolidation of two or more corporations or foundations resulting in the creation of a new corporation or foundation, constitutes a change of ownership. (ii) Transfer of corporate stock or the merger of another corporation or foundation into the provider corporation or foundation does not constitute change of ownership. (iii) The surviving corporation or foundation shall notify the Director, OCHAMPUS, or designee, in writing of the change of ownership promptly after the effective date of the transfer or change in ownership. (4) Pricing and payment methodology: (5) Termination of participation agreement. [51 FR 24008, July 1, 1986] Editorial Note: For Federal Register www.govinfo.gov. § 199.7 Claims submission, review, and payment. (a) General. (1) CHAMPUS identification card required. (2) Claim required. (3) Responsibility for perfecting claim. (4) Obtaining appropriate claim form. (5) Prepayment not required. (6) Deductible certificate. (7) Nonavailability Statement (DD Form 1251). (i) Rules applicable to issuance of Nonavailability Statement. (ii) Beneficiary responsibility. (iii) Rules in effect at time civilian care is provided apply. (iv) Nonavailability Statement must be filed with applicable claim. (b) Information required to adjudicate a CHAMPUS claim. (1) Patient's identification information. (i) Patient's full name. (ii) Patient's residence address. (iii) Patient's date of birth. (iv) Patient's relationship to sponsor. Note: If name of patient is different from sponsor, explain (for example, stepchild or illegitimate child). (v) Patient's identification number (from DD Form 1173). (vi) Patient's identification card effective date and expiration date (from DD Form 1173). (vii) Sponsor's full name. (viii) Sponsor's service or social security number. (ix) Sponsor's grade. (x) Sponsor's organization and duty station. (xi) Sponsor's branch of service or deceased or retiree's former branch of service. (xii) Sponsor's current status. (2) Patient treatment information. (i) Diagnosis. (ii) Source of care. (iii) Full address of source of care. (iv) Attending physician. (v) Referring physician. (vi) Status of patient. (vii) Dates of service. (viii) Inpatient stay. (ix) Physicians or other authorized individual professional providers. (A) Date each service was rendered. (B) Procedure code or narrative description of each procedure or service for each date of service. (C) Individual charge for each item of service or each supply for each date. (D) Detailed description of any unusual complicating circumstances related to the medical care provided that the physician or other individual professional provider may choose to submit separately. (x) Hospitals or other authorized institutional providers. (A) An itemized billing showing each item of service or supply provided for each day covered by the claim. Note: The Director, OCHAMPUS, or a designee, may approve, in writing, an alternative billing procedure for RTCs or other special institutions, in which case the itemized billing requirement may be waived. The particular facility will be aware of such approved alternate billing procedure. (B) Any absences from a hospital or other authorized institution during a period for which inpatient benefits are being claimed must be identified specifically as to date or dates and provide details on the purpose of the absence. Failure to provide such information will result in denial of benefits and, in an ongoing case, termination of benefits for the inpatient stay at least back to the date of the absence. (C) For hospitals subject to the CHAMPUS DRG-based payment system (see paragraph (a)(1)(ii)(D) of § 199.14), the following information is also required: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 (D) Claims submitted by hospitals (or other authorized institutional providers) must include the name of the individual actually rendering the care, along with the individual's professional status (e.g., M.D., Ph.D., R.N., etc.). (xi) Prescription drugs and medicines (and insulin). (A) Name of drug. Note: When the physician or pharmacist so requests, the name of the drugs may be submitted to the CHAMPUS fiscal intermediary directly by the physician or pharmacist. (B) Strength of drug. (C) Name and address of pharmacy where drug was purchased. (D) Prescription number of drug being claimed. (xii) Other authorized providers. (xiii) Nonparticipating providers. (3) Medical records/medical documentation. (i) All care rendered and billed must be appropriately documented in writing. Failure to document the care billed will result in the claim or specific services on the claim being denied CHAMPUS cost-sharing. (ii) A pattern of failure to adequately document medical care will result in episodes of care being denied CHAMPUS cost-sharing. (iii) Cursory notes of a generalized nature that do not identify the specific treatment and the patient's response to the treatment are not acceptable. (iv) The documentation of medical records must be legible and prepared as soon as possible after the care is rendered. Entries should be made when the treatment described is given or the observations to be documented are made. The following are documentation requirements and specific time frames for entry into the medical records: (A) General requirements for acute medical/surgical services: ( 1 ( 2 ( 3 ( 4 (B) Requirements specific to mental health services: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( 8 ( 9 ( 10 ( 11 Note: A pattern of failure to meet the above criteria may result in provider sanctions prescribed under § 199.9. (4) Double coverage information. (i) Name of other coverage. (ii) Source of double coverage. (iii) Employer information. (iv) Identification number. (5) Right to additional information. (A) Disclosure of such information is authorized specifically by the beneficiary; (B) Disclosure is necessary to permit authorized governmental officials to investigate and prosecute criminal actions; or (C) Disclosure is authorized or required specifically under the terms of DoD Directive 5400.7 and 5400.11, the Freedom of Information Act, and the Privacy Act (refer to paragraph (m) of § 199.1 of this part). (ii) For the purposes of determining the applicability of and implementing the provisions of §§ 199.8 and 199.9, or any provision of similar purpose of any other medical benefits coverage or entitlement, OCHAMPUS or CHAMPUS fiscal intermediaries, without consent or notice to any beneficiary or sponsor, may release to or obtain from any insurance company or other organization, governmental agency, provider, or person, any information with respect to any beneficiary when such release constitutes a routine use duly published in the Federal Register (iii) Before a beneficiary's claim of benefits is adjudicated, the beneficiary or the provider(s) must furnish to CHAMPUS that information which is necessary to make the benefit determination. Failure to provide the requested information will result in denial of the claim. A beneficiary, by submitting a CHAMPUS claim(s) (either a participating or nonparticipating claim), is deemed to have given consent to the release of any and all medical records or documentation pertaining to the claims and the episode of care. (c) Signature on CHAMPUS Claim Form Beneficiary signature. (i) Certification of identity. (ii) Certification of medical care provided. (iii) Authorization to obtain or release information. Note: If the care was rendered to a minor and a custodial parent or legal guardian requests information prior to the minor turning 18 years of age, medical records may still be released pursuant to the signature of the parent or guardian, and claims information may still be released to the parent or guardian in response to the request, even though the beneficiary has turned 18 between the time of the request and the response. However, any follow-up request or subsequent request from the parent or guardian, after the beneficiary turns 18 years of age, will necessitate the authorization of the beneficiary (or the beneficiary's legal guardian as appointed by a cognizant court), before records and information can be released to the parent or guardian. (iv) Certification of accuracy and authorization to release double coverage information. (v) Exceptions to beneficiary signature requirement. (B) When the institutional provider obtains the signature of the beneficiary (or the signature of the parent or guardian when the beneficiary is under 18 years) on a CHAMPUS claim form at admission, the following participating claims may be submitted without the beneficiary's signature. ( 1 ( 2 (C) Claims filed by providers using CHAMPUS-approved signature-on-file and claims submission procedures. (2) Provider's signature. (i) Certification. (A) Certifies that the specific medical care listed on the claim form was, in fact, rendered to the specific beneficiary for which benefits are being claimed, on the specific date or dates indicated, at the level indicated and by the provider signing the claim unless the claim otherwise indicates another individual provided the care. For example, if the claim is signed by a psychiatrist and the care billed was rendered by a psychologist or licensed social worker, the claim must indicate both the name and profession of the individual who rendered the care. (B) Certifies that the provider has agreed to participate (providing this agreement has been indicated on the claim form) and that the CHAMPUS-determined allowable charge or cost will constitute the full charge or cost for the medical care listed on the specific claim form; and further agrees to accept the amount paid by CHAMPUS or the CHAMPUS payment combined with the cost-shared amount paid by, or on behalf of the beneficiary, as full payment for the covered medical services or supplies. ( 1 ( 2 (ii) Physician or other authorized individual professional provider. (iii) Hospital or other authorized institutional provider. (d) Claims filing deadline. (1) Claims returned for additional information. (i) One year after the services are provided; or (ii) 90 days from the date the claim was returned to the provider or beneficiary. (2) Exception to claims filing deadline. (i) Types of exception. Retroactive eligibility. (B) Administrative error. (C) Mental incompetency. (D) Delays by other health insurance. (E) Other waiver authority. (ii) Request for exception to claims filing deadline. (A) Such requests for an exception must include a complete explanation of the circumstances of the late filing, together with all available documentation supporting the request, and the specific claim denied for late filing. (B) Each request for an exception to the claims filing deadline is reviewed individually and considered on its own merits. (e) Other claims filing requirements. (1) Continuing care. (2) [Reserved] (3) Claims involving the services of marriage and family counselors, pastoral counselors, and supervised mental health counselors. CHAMPUS requires that marriage and family counselors, pastoral counselors, and supervised mental health counselors make a written report to the referring physician concerning the CHAMPUS beneficiary's progress. Therefore, each claim for reimbursement for services of marriage and family counselors, pastoral counselors, and supervised mental health counselors must include certification to the effect that a written communication has been made or will be made to the referring physician at the end of treatment, or more frequently, as required by the referring physician. (f) Preauthorization. (1) Preauthorization must be granted before benefits can be extended. (i) Specifically preauthorized services. (ii) Time limit on preauthorization. (2) Treatment plan. (3) Claims for services and supplies that have been preauthorized. (4) Advance payment prohibited. (g) Claims review. (h) Benefit payments. (1) Benefit payments made to beneficiary or sponsor. (2) Benefit payments made to participating provider. (3) CEOB. (i) Name and address of beneficiary. (ii) Name and address of provider. (iii) Services or supplies covered by claim for which CEOB applies. (iv) Dates services or supplies provided. (v) Amount billed; CHAMPUS-determined allowable charge or cost; and amount of CHAMPUS payment. (vi) To whom payment, if any, was made. (vii) Reasons for any denial. (viii) Recourse available to beneficiary for review of claim decision (refer to § 199.10 of this part). Note: The Director, OCHAMPUS, or a designee, may authorize a CHAMPUS fiscal intermediary to waive a CEOB to protect the privacy of a CHAMPUS beneficiary. (4) Benefit under $1. (i) Extension of the Active Duty Dependents Dental Plan to areas outside the United States. (j) General assignment of benefits not recognized. [51 FR 24008, July 1, 1986] Editorial Note: For Federal Register www.govinfo.gov. § 199.8 Double coverage. (a) Introduction. et seq. (2) The provision in paragraph (a)(1) of this section is made applicable specifically to retired members, dependents, and survivors by 10 U.S.C. 1086(g). The underlying intent, in addition to preventing waste of Federal resources, is to ensure that TRICARE beneficiaries receive maximum benefits while ensuring that the combined payments of TRICARE and other health and insurance plans do not exceed the total charges. (b) Double coverage plan. (1) Insurance plan. (2) Medical service or health plan. (3) Third-party payer. (4) Exceptions. (i) Plans administered under title XIX of the Social Security Act (Medicaid); (ii) Coverage specifically designed to supplement CHAMPUS benefits (a health insurance policy or other health benefit plan that meets the definition and criteria under supplemental insurance plan as set forth in § 199.2(b)); (iii) Entitlement to receive care from Uniformed Services medical care facilities; (iv) Certain Federal Government programs, as prescribed by the Director, OCHAMPUS, that are designed to provide benefits to a distinct beneficiary population and for which entitlement does not derive from either premium payment of monetary contribution (for example, the Indian Health Service); or (v) State Victims of Crime Compensation Programs. (c) Application of double coverage provisions. (1) TRICARE last pay. except (2) TRICARE advance payment. (i) The claim is submitted for health care services furnished to a covered beneficiary; and, (ii) The claim is identified as involving services for which a third-party payer, other than a primary medical insurer, may be liable. (3) Primary medical insurer. (4) Waiver of benefits. (5) Lack of payment by double coverage plan. (d) Special considerations CHAMPUS and Medicare General rule. (ii) Payment limit. (iii) Application of general rule. (A) For items or services or portions or segments of items or services for which payment may be made under Medicare, the CHAMPUS payment will be the amount of the beneficiary's actual out of pocket liability, minus the amount payable by Medicare, also minus amount payable by other third party payers, subject to the limit under paragraph (d)(1)(ii) of this section. (B) For items or services or segments of items or services for which no payment may be made under Medicare, the CHAMPUS payment will be the same as it would be for a CHAMPUS eligible retiree, dependent, or survivor beneficiary who is not Medicare eligible. (C) For Medicare beneficiaries who enroll in Medicare Part D, the Part D plan is primary and TRICARE is secondary payer. TRICARE will pay the beneficiary's out-of-pocket costs for Medicare and TRICARE covered medications, including the initial deductible and Medicare Part D cost-sharing amounts up to the initial coverage limit of the Medicare Part D plan. The Medicare Part D plan, although the primary plan, pays nothing during any coverage gap period. When the beneficiary becomes responsible for 100 percent of the drug costs under a Part D coverage gap period, the beneficiary may use the TRICARE pharmacy benefit as the secondary payer. TRICARE will cost share during the coverage gap to the same extent as it does under Section 199.21 for beneficiaries not enrolled in Medicare Part D plan. The beneficiary is responsible for the applicable TRICARE pharmacy cost-sharing amounts (and deductible if using a retail non-network pharmacy). Part D plan sponsors may offer a defined standard benefit, or an actuarially equivalent standard benefit. Part D plan sponsors may also offer alternative prescription drug coverage, which may consist of basic alternative coverage or enhanced alternative coverage. Therefore depending on the Part D plan that a beneficiary chooses, monthly premiums, coinsurances, co-pays, deductibles and benefit design may vary from plan to plan. TRICARE payment of the beneficiary's initial deductible, if any, along with payment of any beneficiary cost share count towards total spending on drugs, and may have the effect of moving the beneficiary more quickly through the initial phase of coverage to the coverage gap. Irrespective of the phase of the benefit in which a beneficiary may be, if a beneficiary is accessing a pharmacy under contract with his or her Part D plan, the provider will bill the Part D plan first, then TRICARE. If the beneficiary chooses to use his or her TRICARE pharmacy benefit during a coverage gap under Part D, the beneficiary may do so, but the beneficiary is responsible for the TRICARE cost-shares. (iv) Examples of applications of general rule. (A) In the case of a Medicare-eligible beneficiary receiving typical physician office visit services, Medicare payment generally will be made. CHAMPUS payment will be determined consistent with paragraph (d)(1)(iii)(A) of this section. (B) In the case of a Medicare-eligible beneficiary residing and receiving medical care overseas, Medicare payment generally may not be made. CHAMPUS payment will be determined consistent with paragraph (d)(1)(iii)(B) of this section. (C) In the case of a Medicare-eligible beneficiary receiving skilled nursing facility services a portion of which is payable by Medicare (such as during the first 100 days) and a portion of which is not payable by Medicare (such as after 100 days), CHAMPUS payment for the first portion will be determined consistent with paragraph (d)(1)(iii)(A) of this section and for the second portion consistent with paragraph (d)(1)(iii)(B) of this section. (v) Application of catastrophic cap. (vi) Retroactive determinations of disability. (vii) Effect on enrollment in Medicare Advantage Prescription Drug (MA-PD) plan. (viii) Effect of other double coverage plans, including medigap plans. (ix) Effect of employer-provided insurance. (2) CHAMPUS and Medicaid. (3) TRICARE and Workers' Compensation. (4) Extended Care Health Option (ECHO). (5) Primary payer. (6) Prohibition against financial and other incentives not to enroll in a group health plan General rule. (ii) Application of general rule. (A) The beneficiary has primary coverage other than TRICARE; or (B) The benefit is offered under a cafeteria plan under section 125 of the Internal Revenue Code and is offered to all similarly situated employees, including non-TRICARE eligible employees; or (C) The benefit is offered under a cafeteria plan under section 125 of the Internal Revenue Code and, although offered only to TRICARE-eligible employees, the employer does not provide any payment for the benefit nor receive any direct or indirect consideration or compensation for offering the benefit; the employer's only involvement is providing the administrative support for the benefits under the cafeteria plan, and the employee's participation in the plan is completely voluntary. (iii) Documentation. (iv) Remedies and penalties. et seq. (B) Penalties for violation of this paragraph (d)(6) include a civil monetary penalty of up to $5,000 for each violation. The provisions of section 1128A of the Social Security Act, 42 U.S.C. 1320a-7a, (other than subsections (a) and (b)) apply to the civil monetary penalty in the same manner as the provisions apply to a penalty or proceeding under section 1128A. (v) Definitions. (A) The term “employer” includes any State or unit of local government and any employer that employs at least 20 employees. (B) The term “group health plan” means a group health plan as that term is defined in section 5000(b)(1) of the Internal Revenue Code of 1986 without regard to section 5000(d) of the Internal Revenue Code of 1986. (C) The term “similarly situated” means sharing common attributes, such as part-time employees, or other bona fide employment-based classifications consistent with the employer's usual business practice. (Internal Revenue Service regulations at 26 CFR 54.9802-1(d) may be used as a reference for this purpose). However, in no event shall eligibility for or entitlement to TRICARE (or ineligibility or non-entitlement to TRICARE) be considered a bona fide employment-based classification. (D) The term “TRICARE-eligible employee” means a covered beneficiary under section 1086 of title 10, United States Code, Chapter 55, entitled to health care benefits under the TRICARE program. (vi) Procedures. (e) Implementing instructions. [51 FR 24008, July 1, 1986, as amended at 62 FR 35097, June 30, 1997; 62 FR 54384, Oct. 20, 1997; 63 FR 59232, Nov. 3, 1998; 64 FR 46141, Aug. 24, 1999; 66 FR 40607, Aug. 3, 2001; 67 FR 18827, Apr. 17, 2002; 68 FR 6618, Feb. 10, 2003; 68 FR 23032, Apr. 30, 2003; 68 FR 32361, May 30, 2003; 69 FR 51569, Aug. 20, 2004; 74 FR 55775, Oct. 29, 2009; 75 FR 18054, Apr. 9, 2010; 77 FR 38176, June 27, 2012; 82 FR 45447, Sept. 29, 2017; 85 FR 26355, May 4, 2020] § 199.9 Administrative remedies for fraud, abuse, and conflict of interest. (a) General. (2) This section also sets forth provisions for invoking administrative remedies in situations requiring administrative action to enforce provisions of law, regulation, and policy in the administration of CHAMPUS and to ensure quality of care for CHAMPUS beneficiaries. Examples of such situations may include a case in which it is discovered that a provider fails to meet requirements under this part to be an authorized CHAMPUS provider; a case in which the provider ceases to be qualified as a CHAMPUS provider because of suspension or revocation of the provider's license by a local licensing authority; or a case in which a provider meets the minimum requirements under this part but, nonetheless, it is determined that it is in the best interest of the CHAMPUS or CHAMPUS beneficiaries that the provider should not be an authorized CHAMPUS provider. (3) The administrative remedies set forth in this section are in addition to, and not in lieu of, any other remedies or sanctions authorized by law or regulation. For example, administrative action under this section may be taken in a particular case even if the same case will be or has been processed under the administrative procedures established by the Department of Defense to implement the Program Fraud Civil Remedies Act. (4) Providers seeking payment from the Federal Government through programs such as CHAMPUS have a duty to familiarize themselves with, and comply with, the program requirements. (5) CHAMPUS contractors and peer review organizations have a responsibility to apply provisions of this regulation in the discharge of their duties, and to report all known situations involving fraud, abuse, or conflict of interest. Failure to report known situations involving fraud, abuse, or conflict of interest will result in the withholding of administrative payments or other contractual remedies as determined by the Director, OCHAMPUS, or a designee. (b) Abuse. (1) A pattern of waiver of beneficiary (patient) cost-share or deductible. Note: In a case of a legitimate bad debt write-off of patient cost-share or deductible, the provider's record should include documentation as to what efforts were made to collect the debt, when the debt was written off, why the debt was written off, and the amount of the debt written off. (2) Improper billing practices. Examples include, charging CHAMPUS beneficiaries rates for services and supplies that are in excess of those charges routinely charged by the provider to the general public, commercial health insurance carriers, or other federal health benefit entitlement programs for the same or similar services. (This includes dual fee schedules—one for CHAMPUS beneficiaries and one for other patients or third-party payers. This also includes billing other third-party payers the same as CHAMPUS is billed but accepting less than the billed amount as reimbursement. However, a formal discount arrangement such as through a preferred provider organization, may not necessarily constitute an improper billing practice.) (3) A pattern of claims for services which are not medically necessary or, if medically necessary, not to the extent rendered. For example, a battery of diagnostic tests are given when, based on the diagnosis, fewer tests were needed. (4) Care of inferior quality. For example, consistently furnishing medical or mental health services that do not meet accepted standards of care. (5) Failure to maintain adequate medical or financial records. (6) Refusal to furnish or allow the Government (for example, OCHAMPUS) or Government contractors access to records related to CHAMPUS claims. (7) Billing substantially in excess of customary or reasonable charges unless it is determined by OCHAMPUS that the excess charges are justified by unusual circumstances or medical complications requiring additional time, effort, or expense in localities when it is accepted medical practice to make an extra charge in such cases. (8) Unauthorized use of the term “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)” in private business. While the use of the term “CHAMPUS” is not prohibited by federal statute, misrepresentation or deception by use of the term “CHAMPUS” to imply an official connection with the Government or to defraud CHAMPUS beneficiaries may be a violation of federal statute. Regardless of whether the actual use of the term “CHAMPUS” may be actionable under federal statute, the unauthorized or deceptive use of the term “CHAMPUS” in private business will be considered abuse for purposes of this Section. (c) Fraud. (1) Submitting CHAMPUS claims (including billings by providers when the claim is submitted by the beneficiary) for services, supplies, or equipment not furnished to, or used by, CHAMPUS beneficiaries. For example, billing or claiming services when the provider was on call (other than an authorized standby charge) and did not provide any specific medical care to the beneficiary; providing services to an ineligible person and billing or submitting a claim for the services in the name of an eligible CHAMPUS beneficiary; billing or submitting a CHAMPUS claim for an office visit for a missed appointment; or billing or submitting a CHAMPUS claim for individual psychotherapy when a medical visit was the only service provided. (2) Billing or submitting a CHAMPUS claim for costs for noncovered or nonchargeable services, supplies, or equipment disguised as covered items. Some examples are: (i) Billings or CHAMPUS claims for services which would be covered except for the frequency or duration of the services, such as billing or submitting a claim for two one-hour psychotherapy sessions furnished on separate days when the actual service furnished was a two-hour therapy session on a single day, (ii) spreading the billing or claims for services over a time period that reduces the apparent frequency to a level that may be cost-shared by CHAMPUS, (iii) charging to CHAMPUS, directly or indirectly, costs not incurred or not reasonably allowable to the services billed or claimed under CHAMPUS, for example, costs attributable to nonprogram activities, other enterprises, or the personal expenses of principals, or (iv) billing or submitting claim on a fee-for-service basis when in fact a personal service to a specific patient was not performed and the service rendered is part of the overall management of, for example, the laboratory or x-ray department. (3) Breach of a provider participation agreement which results in the beneficiary (including parent, guardian, or other representative) being billed for amounts which exceed the CHAMPUS-determined allowable charge or cost. (4) Billings or CHAMPUS claims for supplies or equipment which are clearly unsuitable for the patient's needs or are so lacking in quality or sufficiency for the purpose as to be virtually worthless. (5) Billings or CHAMPUS claims which involve flagrant and persistent overutilization of services without proper regard for results, the patient's ailments, condition, medical needs, or the physician's orders. (6) Misrepresentations of dates, frequency, duration, or description of services rendered, or of the identity of the recipient of the services or the individual who rendered the services. (7) Submitting falsified or altered CHAMPUS claims or medical or mental health patient records which misrepresent the type, frequency, or duration of services or supplies or misrepresent the name(s) of the individual(s) who provided the services or supplies. (8) Duplicate billings or CHAMPUS claims. This includes billing or submitting CHAMPUS claims more than once for the same services, billing or submitting claims both to CHAMPUS and the beneficiary for the same services, or billing or submitting claims both to CHAMPUS and other third-parties (such as other health insurance or government agencies) for the same services, without making full disclosure of material facts or immediate, voluntary repayment or notification to CHAMPUS upon receipt of payments which combined exceed the CHAMPUS-determined allowable charge of the services involved. (9) Misrepresentation by a provider of his or her credentials or concealing information or business practices which bear on the provider's qualifications for authorized CHAMPUS provider status. For example, a provider representing that he or she has a qualifying doctorate in clinical psychology when the degree is not from a regionally accredited university. (10) Reciprocal billing. Billing or claiming services which were furnished by another provider or furnished by the billing provider in a capacity other than as billed or claimed. For example, practices such as the following: (i) One provider performing services for another provider and the latter bills as though he had actually performed the services (e.g., a weekend fill-in); (ii) providing service as an institutional employee and billing as a professional provider for the services; (iii) billing for professional services when the services were provided by another individual who was an institutional employee; (iv) billing for professional services at a higher provider profile than would be paid for the person actually furnishing the services, (for example, bills reflecting that an M.D. or Ph.D. performed the services when services were actually furnished by a licensed social worker, psychiatric nurse, or marriage and family counselor); or (v) an authorized provider billing for services which were actually furnished by an unauthorized or sanctioned provider. (11) Submitting CHAMPUS claims at a rate higher than a rate established between CHAMPUS and the provider, if such a rate has been established. For example, billing or claiming a rate in excess of the provider's most favored rate limitation specified in a residential treatment center agreement. (12) Arrangements by providers with employees, independent contractors, suppliers, or others which appear to be designed primarily to overcharge the CHAMPUS through various means (such as commissions, fee-splitting, and kickbacks) used to divert or conceal improper or unnecessary costs or profits. (13) Agreements or arrangements between the supplier and recipient (recipient could be either a provider or beneficiary, including the parent, guardian, or other representative of the beneficiary) that result in billings or claims which include unnecessary costs or charges to CHAMPUS. (d) Conflict of Interest. (2) CHAMPUS cost-sharing shall be denied on any claim where a conflict of interest situation is found to exist. This denial of cost-sharing applies whether the claim is submitted by the individual who provided the care, the institutional provider in which the care was furnished, or the beneficiary. (e) Dual Compensation. (2) CHAMPUS cost-sharing of a claim shall be denied where the services or supplies were provided by an active duty member of the Uniformed Services or a civilian employee of the Government. This denial of CHAMPUS payment applies whether the claim for reimbursement is filed by the individual who provided the care, the institutional provider in which the care was furnished, or by the beneficiary. Note: Physicians of the National Health Service Corps (NHSC) may be assigned to areas where there is a shortage of medical providers. Although these physicians would be prohibited from accepting CHAMPUS payments as individuals if they are employees of the United States Government, the private organizations to which they may be assigned may be eligible for payment, as determined by the Director, OCHAMPUS, or a designee. (3) The prohibition against dual compensation does not apply to individuals under contract to the Uniformed Services or the Government. (f) Administrative Remedies. (1) Provider exclusion or suspension. (i) Criminal conviction or civil judgment involving fraud by a provider Criminal conviction involving CHAMPUS fraud. Note: Under the above paragraph (f)(1)(i)(A) of this section, an entity may be excluded or suspended from CHAMPUS whenever the entity is found to have a person, convicted of a crime involving CHAMPUS fraud, who has a direct or indirect ownership or control interest (see § 199.2) of 5 percent or more in the entity, or is an officer, director, agent or managing employee of the entity. The entity will have an opportunity to provide evidence to show that the ownership or control relationship has ceased. While an entity will not be excluded or suspended from CHAMPUS for employing a provider who has been sanctioned under this Section, the entity will be denied CHAMPUS payment for any services furnished by the sanctioned employee. As an authorized CHAMPUS provider, the entity is responsible for ensuring that all CHAMPUS claims involve services furnished to CHAMPUS beneficiaries by employees who meet all requirements under CHAMPUS for provider status. (B) Criminal conviction involving fraud of other Federal programs. (C) Criminal conviction involving fraud of non-Federal programs. (D) Civil fraud involving CHAMPUS. (E) Civil fraud involving other programs. (ii) Administrative determination of fraud or abuse under CHAMPUS. (iii) Administrative determination that the provider has been excluded or suspended by another agency of the Federal Government, a state, or local licensing authority. (iv) Administrative determination that the provider has participated in a conflict of interest situation. provided (v) Administrative determination that it is in the best interests of the CHAMPUS or CHAMPUS beneficiaries to exclude or suspend a provider Unethical or improper practices or unprofessional conduct. 1 ( 2 (B) In any other case in which the Director, OCHAMPUS (or designee), determines that exclusion or suspension of a provider is in the best interests of CHAMPUS or CHAMPUS beneficiaries. (2) Provider termination. (i) Effective date of termination. (A) The retroactive effective date of termination shall not be limited due to the passage of time, erroneous payment of claims, or any other events which may be cited as a basis for CHAMPUS recognition of the provider notwithstanding the fact that the provider does not meet program qualifications. Unless specific provision is made in this part to “grandfather” or authorize a provider who does not otherwise meet the qualifications established by this part, all unqualified providers shall be terminated. (B) Any claims cost-shared or paid under CHAMPUS for services or supplies furnished by the provider on or after the effective date of termination, even when the effective date is retroactive, shall be deemed an erroneous payment unless specific exception is provided in this part. All erroneous payments are subject to collection under § 199.11 of this part. (C) If an institution is terminated as an authorized CHAMPUS provider, the institution shall immediately give written notice of the termination to any CHAMPUS beneficiary (or their parent, guardian, or other representative) admitted to, or receiving care at, the institution on or after the effective date of the termination. In addition, when an institution is terminated with an effective date of termination after the date of the initial determination terminating the provider, any beneficiary admitted to the institution prior to the effective date of termination (or their parent, guardian, or other representative) shall be notified by the Director, OCHAMPUS, or a designee, by certified mail of the termination, and that CHAMPUS cost-sharing of the beneficiary's care in the institution will cease as of the effective date of the termination. However, any beneficiary admitted to the institution prior to any grace period extended to the institution under paragraph (f)(2)(ii)(A) of this section shall be advised that, if the beneficiary's care otherwise qualifies for CHAMPUS coverage, CHAMPUS cost-sharing of the care in the institution will continue in order to provide a reasonable period of transition of care; however the transitional period of CHAMPUS cost-sharing shall not exceed the last day of the month following the month in which the institution's status as a CHAMPUS provider is terminated. (This authorized CHAMPUS cost-sharing of the inpatient care received during the transition period is an exception to the general rule that CHAMPUS payment for care furnished after the effective date of termination of the provider's status shall be deemed to be an erroneous payment.) If a major violation under paragraph (f)(2)(ii)(B) of this section is involved, in order to ensure immediate action is taken to transfer beneficiaries to an approved provider, CHAMPUS cost-sharing shall not be authorized after the effective date of termination of the provider's status. (ii) Institutions not in compliance with CHAMPUS standards. (A) Minor violations. ( 1 ( 2 ( 3 and ( 4 or, (B) Major violations. (3) Beneficiary sanctions. (ii) Pursuant to § 199.11 of this part, the Director, OCHAMPUS, or a designee, may recover erroneous payments on claims involving fraud or false or misleading statements. Remedies for recovery of the erroneous payments include the use of offset against future CHAMPUS payments. (iii) Under policies adopted by the Director, OCHAMPUS, or a designee, individuals who, based on reliable information, have previously submitted fraudulent or false CHAMPUS claims, may be required to comply with any procedures (e.g., partial or total pre-payment audit or review, restriction to a designated primary care provider, etc.) which the Director, OCHAMPUS, or a designee, deems appropriate to ensure that their future medical care and CHAMPUS claims (including the medical care and CHAMPUS claims submitted by or for members of their family) are valid. (g) Period of exclusion, suspension, or termination Exclusions or suspensions. (i) Exclusion or suspension of a provider based on the provider's exclusion or suspension by another agency of the Federal Government, a state, or a local licensing authority. solely solely (ii) Factors to be considered in determining the period of exclusion or suspension of providers under CHAMPUS. (A) When the case concerns all or any part of the same issues which have been the subject of criminal conviction or civil judgment involving fraud by a provider: ( 1 ( 2 ( i ( ii ( iii ( iv ( v ( 3 ( i ( ii (B) The Director, OCHAMPUS, or a designee, may consider the following factors in determining a reasonable period of exclusion or suspension of a provider under CHAMPUS: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( 8 ( 9 ( 10 ( 11 (2) Terminations. (i) Termination of the provider under CHAMPUS shall continue even if the provider obtains a license to practice in a second jurisdiction during the period of suspension or revocation of the provider's license by the original licensing jurisdiction. A provider who has licenses to practice in two or more jurisdictions and has one or more license(s) suspended or revoked will also be terminated as a CHAMPUS provider. (A) Professional providers shall remain terminated from the CHAMPUS until the jurisdiction(s) suspending or revoking the provider's license(s) to practice restores it or removes the impediment to restoration. (B) Institutional providers shall remain terminated under CHAMPUS until their license is restored. In the event the facility is sold, transferred, or reorganized as a new legal entity, and a license issued under a new name or to a different legal entity, the new entity must submit an application to be an authorized CHAMPUS provider. (ii) If the CHAMPUS provider status is terminated due to the loss of the provider's license, the effective date shall be retroactive to the date the provider lost the license; however, in the case of a professional provider who has licenses in two or more jurisdictions and submitted claims from a jurisdiction from which he/she had a valid license, the effective date of the termination will be 15 calendar days from the date of the written initial determination of termination for purposes of claims from the jurisdiction in which the provider still has a valid license. (h) Procedures for initiating and implementing the administrative remedies Temporary suspension of claims processing. unless (ii) When adequate evidence exists to determine that a provider or beneficiary is submitting fraudulent or false claims or claims involving practices that may be fraud or abuse as defined by this part, the Director, OCHAMPUS, or a designee, may suspend CHAMPUS claims processing (in whole or in part) for claims submitted by the beneficiary or any CHAMPUS claims involving care furnished by the provider. The temporary suspension of claims processing for care furnished by a provider may be invoked against all such claims, whether or not the claims are submitted by the beneficiary or by the provider as a participating CHAMPUS provider. In cases involving a provider, notice of the suspension of claims processing may also be given to the beneficiary community either directly or indirectly through notice to appropriate military facilities, health benefit advisors, and the information or news media. (A) Adequate evidence is any information sufficient to support the reasonable belief that a particular act or omission has occurred. (B) Indictment or any other initiation of criminal charges, filing of a complaint for civil fraud, issuance of an administrative complaint under the Program Fraud Civil Remedies Act, or issuance of an initial determination under this part for submitting fraudulent or false claims or claims involving practices that may be fraud or abuse as defined by this part, shall constitute adequate evidence for invoking temporary suspension of claims processing. (iii) The Director, OCHAMPUS, or a designee, may suspend CHAMPUS claims processing without first notifying the provider or beneficiary of the intent to suspend payments. Following a decision to invoke a temporary suspension, however, the Director, OCHAMPUS, or a designee, shall issue written notice advising the provider or beneficiary that: (A) A temporary suspension of claims processing has been ordered and a statement of the basis of the decision to suspend payment. Unless the suspension is based on any of the actions set forth in paragraph (h)(1)(ii)(B) of this section, the notice shall describe the suspected acts or omissions in terms sufficient to place the provider or beneficiary on notice without disclosing the Government's evidence. (B) Within 30 days (or, upon written request received by OCHAMPUS during the 30 days and for good cause shown, within 60 days) from the date of the notice, the provider or beneficiary may: ( 1 ( 2 (C) Additional proceedings to determine disputed material facts may be conducted unless: ( 1 ( 2 (iv) If the beneficiary or provider submits, either in writing or in person, additional information or argument in opposition to the suspension, the Director, OCHAMPUS, or a designee, shall issue a suspending official's decision which modifies, terminates, or leaves in force the suspension of claims processing. However, a decision to terminate or modify the suspension shall be without prejudice to the subsequent imposition of suspension of claims processing, imposition of sanctions under this § 199.9, the recovery of erroneous payments under § 199.11 of this part, or any other administrative or legal action authorized by law or regulation. The suspending official's decision shall be in writing as follows: (A) A written decision based on all the information in the administrative record, including any submission by the beneficiary or provider, shall be final in a case: ( 1 ( 2 ( 3 (B) In a case in which additional proceedings are necessary as to disputed material facts, the suspending official's decision shall advise the beneficiary or provider that the case has been referred for handling as a hearing under § 199.10 of this part. (v) A suspension of claims processing may be modified or terminated for reasons such as: (A) Newly discovered evidence; (B) Elimination of any of the causes for which the suspension was invoked; or (C) Other reasons the Director, OCHAMPUS, or a designee, deems appropriate. (vi) A suspension of claims processing shall be for a temporary period pending the completion of investigation and any ensuing legal or administrative proceedings, unless sooner terminated by the Director, OCHAMPUS, or a designee, or as provided in this subparagraph. (A) If legal or administrative proceedings are not initiated within 12 months after the date of the suspension notice, the suspension shall be terminated unless the Government official responsible for initiation of the legal or administrative action requests its extension, in which case it may be extended for an additional 6 months. In no event may a suspension extend beyond 18 months, unless legal or administrative proceedings have been initiated during that period. (B) The Director, OCHAMPUS, or a designee, shall notify the Government official responsible for initiation of the legal or administrative action of the proposed termination of the suspension, at least 30 days before the 12-month period expires, to give the official an opportunity to request an extension. (2) Notice of proposed administrative sanction. (A) The notice shall state which sanction will be taken and the effective date of that sanction as determined in accordance with the provisions of this part. (B) The notice shall inform the provider of the situation(s), circumstance(s), or action(s) which form the basis for the proposed sanction and reference the paragraph of this part under which the administrative action is being taken. (C) The notice will be sent to the provider's last known business or office address (or home address if there is no known business address.) (D) The notice shall offer the provider an opportunity to respond within 30 days (or, upon written request received by OCHAMPUS during the 30 days and for good cause shown, within 60 days) from the date on the notice with either: ( 1 ( 2 (3) Initial determination. (ii) The initial determination shall include: (A) A statement of the sanction being invoked; (B) A statement of the effective date of the sanction; (C) A statement of the facts, circumstances, or actions which form the basis for the sanction and a discussion of any information submitted by the provider relevant to the sanction; (D) A statement of the factors considered in determining the period of sanction; (E) The earliest date on which a request for reinstatement under CHAMPUS will be accepted; (F) The requirements and procedures for reinstatement; and, (G) Notice of the available hearing upon request of the sanctioned provider. (4) Reinstatement procedures Restitution. (B) If the Government has made erroneous payments to a provider because of claims involving fraud, abuse, or conflicts of interest, restitution of the erroneous payments shall be made before a request for reinstatement as a CHAMPUS authorized provider will be considered. Without restitution or resolution of the debt under § 199.11 of this part, a provider shall not be reinstated as an authorized CHAMPUS provider. This is not an appealable issue under § 199.10 of this part. (C) For purposes of authorization as a CHAMPUS provider, a provider who is excluded or suspended under this § 199.9 and who submits participating claims for services furnished on or after the effective date of the exclusion or suspension is considered to have forfeited or waived any right or entitlement to bill the beneficiary for the care involved in the claims. Similarly, because a provider is expected to know the CHAMPUS requirements for qualification as an authorized provider, any participating provider who fails to meet the qualification requirements for CHAMPUS is considered to have forfeited or waived any right or entitlement to bill the beneficiary for the care involved in the CHAMPUS claims. If, in either situation, the provider bills the beneficiary, restitution to the beneficiary may be required by the Director, OCHAMPUS, or a designee, as a condition for consideration of reinstatement as a CHAMPUS authorized provider. (ii) Terminated providers. (iii) Providers (other than entities) excluded or suspended under CHAMPUS. ( 1 ( 2 (B) A provider entity excluded from CHAMPUS under § 199.9(f)(1)(i) may seek reinstatement by submitting a written request to the Director, OCHAMPUS, or a designee, with documentation sufficient to establish the provider's qualifications under this part to be a CHAMPUS authorized provider and either: ( 1 or ( 2 ( i ( ii ( iii Note: Under paragraph (h)(4)(iii)(B)( 2 (iv) Action on request for reinstatement. (A) The provider meets all requirements under this part to be an authorized CHAMPUS provider; (B) No additional criminal, civil, or administrative action has been taken or is being considered which could subject the provider to exclusion, suspension, or termination under this section; (C) In the case of a provider entity, verification has been made of the divestiture or termination of the owner, controlling party, officer, director, agent or managing employee whose conviction led to the entity's exclusion, or (v) Notice of action on request for reinstatement Notice of approval of request. ( 1 ( 2 (B) Notice of denial of request. (5) Reversed or vacated convictions or civil judgments involving CHAMPUS fraud. solely (ii) If an exclusion is voided under paragraph (h)(5)(i) of this section, CHAMPUS will make payment, either to the provider or the beneficiary (if the claim was not a participating claim) for otherwise authorized services under CHAMPUS that are furnished or performed during the period of exclusion. (iii) CHAMPUS will also void the exclusion of any entity that was excluded under § 199.9(f)(1)(i) based solely (iv) When CHAMPUS voids the exclusion of a provider or an entity, notice will be given to the agencies and others that were originally notified, in accordance with § 199.9(k). (i) Evidence required for determinations to invoke administrative remedies General. (2) Types of evidence. (i) Results of audits conducted by or on behalf of the Government. Such audits can include the results of 100 percent review of claims and related records or a statistically valid sample audit of the claims or records. A statistical sampling shall constitute prima facie (ii) Reports, including sanction reports, from various sources including a peer review organization (PRO) for the area served by the provider; state or local licensing or certification authorities; peer or medical review consultants of the Government, including consultants for Government contractors; state or local professional societies; or other sources deemed appropriate by the Director, OCHAMPUS, or a designee. (iii) Orders or documents issued by Federal, state, foreign, or other courts of competent jurisdiction which issue findings and/or criminal convictions or civil judgments involving the provider, and administrative rulings, findings, or determinations by any agency of the Federal Government, a state, or local licensing or certification authority regarding the provider's status with that agency or authority. (j) Suspending Administrative Action. (2) The normal OCHAMPUS procedure is to suspend action on the administrative process pending an investigation by the Department of Defense—Inspector General or final disposition by the Department of Justice. (3) Though OCHAMPUS administrative action is taken independently of any action by the Department of Defense-Inspector General or by the Department of Justice, once a case is forwarded to the Department of Defense-Inspector General or the Department of Justice for legal action (criminal or civil), administrative action may be held in abeyance. (4) In some instances there may be dual jurisdiction between agencies; as in, for example, the joint regulations issued by the Department of Justice and the Government Accounting Office regarding debt collection. (k) Notice to Other Agencies. (2) If CHAMPUS has temporarily suspended claims processing, notice of such action normally will be given to the affected provider and Uniformed Services Medical Treatment Facilities, Health Benefits Advisors, beneficiaries, and sponsors. Notice may also be given to any information or news media and any other individual, professional provider, or institutional provider, as deemed appropriate. However, since a “temporary suspension of claims processing” is by definition not a final or formal agency action, the basis for the action generally will not be disclosed. It is noted that the basis for the action can be a result of questions arising from routine audits to investigation of possible criminal violations. (l) Compromise, Settlement, and Resolution Authority. (2) When it is in the best interest of CHAMPUS, the Director, OCHAMPUS, has the discretionary authority to waive an action or enter into compromise or settlement of administrative actions taken under this § 199.9. (m) Government-wide effect of exclusion or suspension from CHAMPUS. (n) Third-party billing agents as defined in § 199.2(b) of this part, while not considered providers, are subject to the provisions of this section to the same extent as such provisions apply to providers. [54 FR 25246, June 14, 1989, as amended at 63 FR 48445, Sept. 10, 1998; 78 FR 12954, Feb. 26, 2013; 85 FR 60705, Sept. 28, 2020] § 199.10 Appeal and hearing procedures. (a) General. (1) Initial determination Notice of initial determination and right to appeal. (B) CHAMPUS contractors and OCHAMPUSEUR shall notify a provider of an initial determination on a claim only if the provider participated in the claim. (See § 199.7 of this part.) (C) CHAMPUS peer review organizations shall notify providers and fiscal intermediaries of a denial determination on a claim. (D) Notice of an initial determination on a claim processed by a CHAMPUS contractor or OCHAMPUSEUR normally will be made on a CHAMPUS Explanation of Benefits (CEOB) form. (E) Each notice of an initial determination on a request for benefit authorization, a request by a provider for approval as an authorized CHAMPUS provider, or a decision to disqualify or exclude a provider as an authorized provider under CHAMPUS shall state the reason for the determination and the underlying facts supporting the determination. (F) In any case when the initial determination is adverse to the beneficiary or participating provider, or to the provider seeking approval as an authorized CHAMPUS provider, the notice shall include a statement of the beneficiary's or provider's right to appeal the determination. The procedure for filing the appeal also shall be explained. (ii) Effect of initial determination. (B) An initial determination involving a CHAMPUS beneficiary entitled to Medicare Part A, who is enrolled in Medicare Part B, may be appealed by the beneficiary or their provider under this section of this Part only when the claimed services or supplies are payable by CHAMPUS and are not payable under Medicare. Both Medicare and CHAMPUS offer an appeal process when a claim for healthcare services or supplies is denied and most healthcare services and supplies are a benefit payable under both Medicare and CHAMPUS. In order to avoid confusion on the part of beneficiaries and providers and to expedite the appeal process, services and supplies denied payment by Medicare will not be considered for coverage by CHAMPUS if the Medicare denial of payment is appealable under Medicare. Because such claims are not considered for payment by CHAMPUS, there can be no CHAMPUS appeal. If, however, a Medicare claim or appeal results in some payment by Medicare, the services and supplies paid by Medicare will be considered for payment by CHAMPUS. In that situation, any decision to deny CHAMPUS payment will be appealable under this section. The following examples of CHAMPUS appealable issues involving Medicare-eligible CHAMPUS beneficiaries are illustrative; they are not all-inclusive. ( 1 ( 2 ( 3 (2) Participation in an appeal. (i) Parties to the initial determination. (A) A provider disqualified or excluded as an authorized provider under CHAMPUS based on a determination of abuse or fraudulent practices or procedures under another Federal or federally funded program is not a party to the CHAMPUS action and may not appeal under this section. (B) A beneficiary who has an interest in receiving care or has received care from a particular provider cannot be an appealing party regarding the exclusion, suspension, or termination of the provider under § 199.9 of this part. (C) A sponsor or parent of a beneficiary under 18 years of age or guardian or an incompetent beneficiary is not a party to the initial determination and may not serve as the appealing party, although such persons may represent the appealing party in an appeal. (D) A third party, such as an insurance company, is not a party to the initial determination and is not entitled to appeal even though it may have an indirect interest in the initial determination. (E) A nonparticipating provider is not a party to the initial determination and may not appeal. (ii) Representative. (A) The representative shall have the same authority as the party to the appeal and notice given to the representative shall constitute notice required to be given to the party under this part. (B) To avoid possible conflicts of interest, an officer or employee of the United States, such as an employee or member of a Uniformed Service, including an employee or staff member of a Uniformed Service legal office, or a CHAMPUS advisor, subject to the exceptions in 18 U.S.C. 205, is not eligible to serve as a representative. An exception usually is made for an employee or member of a Uniformed Service who represents an immediate family member. In addition, the Director, OCHAMPUS, or designee, may appoint an officer or employee of the United States as the CHAMPUS representative at a hearing. (3) Burden of proof. prima facie prima facie (4) Evidence in appeal and hearing cases. (5) Late filing. (6) Appealable issue. (i) A dispute regarding a requirement of the law or regulation. (ii) The amount of the CHAMPUS-determined allowable cost or charge, since the methodology for determining allowable costs or charges is established by this part. (iii) The establishment of diagnosis-related groups (DRGs), or the methodology for the classification of inpatient discharges within the DRGs, or the weighting factors that reflect the relative hospital resources used with respect to discharges within each DRG, since each of these is established by this part. (iv) Certain other issues on the basis that the authority for the initial determination is not vested in CHAMPUS. Such issues include but are not limited to the following examples: (A) Determination of a person's eligibility as a CHAMPUS beneficiary is the responsibility of the appropriate Uniformed Service. Although OCHAMPUS, OCHAMPUSEUR, and CHAMPUS contractors must make determinations concerning a beneficiary's eligibility in order to ensure proper disbursement of appropriated funds on each CHAMPUS claim processed, ultimate responsibility for resolving a beneficiary's eligibility rests with the Uniformed Services. Accordingly, disputed question of fact concerning a beneficiary's eligibility will not be considered an appealable issue under the provisions of this section, but shall be resolved in accordance with § 199.3 of this part. (B) Similarly, decisions relating to the issuance of a Nonavailability Statement (DD Form 1251) in each case are made by the Uniformed Services. Disputes over the need for a Nonavailability Statement or a refusal to issue a Nonavailability Statement are not appealable under this section. The one exception is when a dispute arises over whether the facts of the case demonstrate a medical emergency for which a Nonavailability Statement is not required. Denial of payment in this one situation is an appealable issue. (C) Any sanction, including the period of the sanction, imposed under § 199.9 of this part which is based solely on a provider's exclusion or suspension by another agency of the Federal Government, a state, or a local licensing authority is not appealable under this section. The provider must exhaust administrative appeal rights offered by the other agency that made the initial determination to exclude or suspend the provider. Similarly, any sanction imposed under § 199.9 which is based solely on a criminal conviction or civil judgment against the provider is not appealable under this section. If the sanction imposed under § 199.9 is not based solely on the provider's criminal conviction or civil judgment or on the provider's exclusion or suspension by another agency of the Federal Government, a state, or a local licensing authority, that portion of the CHAMPUS administrative determination which is in addition to the criminal conviction/civil judgment or exclusion/suspension by the other agency may be appealed under this section. (v) A decision by the Director, OCHAMPUS, or a designee, as a suspending official when the decision is final under the provisions of § 199.9(h)(1)(iv)(A). (7) Amount in dispute. (i) The amount in dispute is calculated as the amount of money CHAMPUS would pay if the services and supplies involved in dispute were determined to be authorized CHAMPUS benefits. Examples of amounts of money that are excluded by the Regulation from CHAMPUS payments for authorized benefits include, but are not limited to: (A) Amounts in excess of the CHAMPUS-determined allowable charge or cost. (B) The beneficiary's CHAMPUS deductible and cost-share amounts. (C) Amounts that the CHAMPUS beneficiary, or parent, guardian, or other responsible person has no legal obligation to pay. (D) Amounts excluded under the provisions of § 199.8 of this part. (ii) The amount of dispute for appeals involving a denial of a request for authorization in advance of obtaining care shall be the estimated allowable charge or cost for the services requested. (iii) There is no requirement for an amount in dispute when the appealable issue involves a denial of a provider's request for approval as an authorized CHAMPUS provider or the determination to exclude, suspend, or terminate a provider's authorized CHAMPUS provider status. (iv) Individual claims may be combined to meet the required amount in dispute if all of the following exist: (A) The claims involve the same beneficiary. (B) The claims involve the same issue. (C) At least one of the claims so combined has had a reconsideration decision issued by OCHAMPUSEUR, a CHAMPUS contractor, or a CHAMPUS peer review organization. Note: A request for administrative review under this appeal process which involves a dispute regarding a requirement of law or regulation (paragraph (a)(6)(i) of this section) or does not involve a sufficient amount in dispute (paragraph (a)(7) of this section) may not be rejected at the reconsideration level of appeal. However, an appeal shall involve an appealable issue and sufficient amount in dispute under these paragraphs to be granted a formal review or hearing. (8) Levels of appeal. (i) Appeal levels for initial determination made by OCHAMPUSEUR, CHAMPUS contractor, or CHAMPUS peer review organization. (B) Formal review by OCHAMPUS (except for CHAMPUS peer review organization reconsiderations). (C) Hearing. (ii) Appeal levels for initial determination made by OCHAMPUS. (B) Formal review by OCHAMPUS except 1 2 (C) Hearing. (9) Appeal decision. (b) Reconsideration. (1) Requesting a reconsideration Written request required. (ii) Where to file. (iii) Allowed time to file. (iv) Official filing date. (2) The reconsideration process. (3) Timeliness of reconsideration determination. (4) Notice of reconsideration determination. (i) A statement of the issues or issue under appeal. (ii) The provisions of law, regulation, policies, and guidelines that apply to the issue or issues under appeal. (iii) A discussion of the original and additional information that is relevant to the issue or issues under appeal. (iv) Whether the reconsideration upholds the initial determination or reverses it, in whole or in part, and the rationale for the action. (v) A statement of the right to appeal further in any case when the reconsideration determination is less than fully favorable to the appealing party and the amount in dispute is $50 or more. (5) Effect of reconsideration determination. (i) The amount in dispute is less than $50. (ii) Appeal rights have been offered, but a request for formal review is not received by OCHAMPUS within 60 days of the date of the notice of the reconsideration determination. (c) Formal review. (1) Requesting a formal review. Written request required. (ii) Where to file. (iii) Allowed time to file. (iv) Official filing date. (2) The formal review process. (3) Timeliness of formal review determination. (4) Notice of formal review determination. (i) A statement of the issue or issues under appeal. (ii) The provisions of law, regulation, policies, and guidelines that apply to the issue or issues under appeal. (iii) A discussion of the original and additional information that is relevant to the issue or issues under appeal. (iv) Whether the formal review upholds the prior determination or determinations or reverses the prior determination or determinations in whole or in part and the rationale for the action. (v) A statement of the right to request a hearing in any case when the formal review determination is less than fully favorable, the issue is appealable, and the amount in dispute is $300 or more. (5) Effect of formal review determination. (i) The issue is not appealable. (See paragraph (a)(6) of this section.) (ii) The amount in dispute is less than $300. (See paragraph (a)(7) of this section.) (iii) Appeal rights have been offered but a request for hearing is not received by OCHAMPUS within 60 days of the date of the notice of the formal review determination. (d) Hearing. or (1) Requesting a hearing Written request required. (ii) Where to file. (iii) Allowed time to file. (iv) Official filing date. (2) Hearing process. (3) Timeliness of hearing. (ii) The hearing officer, except as otherwise provided in this Section, normally shall have 60 days from the date of written notice of assignment to review the file, schedule and hold the hearing, and issue a recommended decision to the Director, OCHAMPUS, or designee. (iii) The Director, OCHAMPUS, or designee, may delay the case assignment to the hearing officer if additional information is needed that cannot be obtained and included in the record within the time period specified above. The appealing party will be notified in writing of the delay resulting from the request for additional information. The Director, OCHAMPUS, or a designee, in such circumstances, will assign the case to a hearing officer within 30 days of receipt of all such additional information, or within 60 days of receipt of the request for hearing, whichever shall occur last. (iv) The hearing officer may delay submitting the recommended decision if, at the close of the hearing, any party to the hearing requests that the record remain open for submission of additional information. In such circumstances, the hearing officer will have 30 days following receipt of all such additional information including comments from the other parties to the hearing concerning the additional information to submit the recommended decision to the Director, OCHAMPUS, or a designee. (4) Representation at a hearing. (5) Consolidation of proceedings. (6) Authority of the hearing officer. (7) Disqualification of hearing officer. (8) Notice and scheduling of hearing. (9) Dismissal of request for hearing. By application of appealing party. (ii) By stipulation of the parties to the hearing. (iii) By abandonment. (A) An appealing party shall be deemed to have abandoned a request for hearing, other than when personal appearance is waived in accordance with § 199.10(d)(11)(xii), if neither the appealing party nor an appointed representative appears at the time and place fixed for the hearing and if, within 10 days after the mailing of a notice by certified mail to the appealing party by the hearing officer to show cause, such party does not show good and sufficient cause for such failure to appear and failure to notify the hearing officer before the time fixed for hearing that an appearance could not be made. (B) An appealing party shall be deemed to have abandoned a request for hearing if, before assignment of the case to the hearing officer, OCHAMPUS is unable to locate either the appealing party or an appointed representative. (C) An appealing party shall be deemed to have abandoned a request for hearing if the appealing party fails to prosecute the appeal. Failure to prosecute the appeal includes, but is not limited to, an appealing party's failure to provide information reasonably requested by OCHAMPUS or the hearing officer for consideration in the appeal. (D) If the Director, OCHAMPUS, or a designee, dismisses the request for hearing because of abandonment, the formal review determination in the case shall be deemed to be final, unless the dismissal is vacated in accordance with paragraph (d)(9)(v) of this section. (iv) For cause. (A) When the appealing party requesting the hearing is not a proper party under paragraph (a)(2)(i) of this section, or does not otherwise have a right to participate in a hearing. (B) When the appealing party who filed the hearing request dies, and there is no information before the Director, OCHAMPUS, or a designee, showing that a party to the initial determination who is not an appealing party may be prejudiced by the formal review determination. (C) When the issue is not appealable (see § 199.10(a)(6)). (D) When the amount in dispute is less than $300 (see § 199.10(a)(7)). (E) When all appealable issues have been resolved in favor of the appealing party. (v) Vacation of dismissal. (10) Preparation for hearing. Prehearing statement of contentions. (ii) Discovery. (iii) Witnesses and evidence. (11) Conduct of hearing. Right to open hearing. (ii) Right to examine parties to the hearing and their witnesses. (iii) Taking of evidence. (iv) Questioning and admission of evidence. (v) Relevant evidence. (vi) CHAMPUS determination first. (vii) Testimony. (viii) Oral argument and briefs. (ix) Continuance of hearing. (x) Continuance for additional evidence. (A) Continue hearing. (B) Closed hearing. (xi) Transcript of hearing. (xii) Waiver of right to appear and present evidence. (12) Recommended decision. (i) Statement of findings. (ii) Statement of reasons. (e) Final decision Director, OCHAMPUS. (i) Final action. (ii) Referral for review by ASD(HA). (2) ASD(HA). [51 FR 24008, July 1, 1986, as amended at 52 FR 33007, Sept. 1, 1987; 54 FR 25255, June 14, 1989; 55 FR 43341, Nov. 16, 1990; 56 FR 59880, Nov. 26, 1991; 66 FR 40607, Aug. 3, 2001; 68 FR 11973, Mar. 13, 2003; 68 FR 23033, Apr. 30, 2003; 68 FR 32362, May 30, 2003; 69 FR 6920, Feb. 12, 2004] § 199.11 Overpayments recovery. (a) General. (b) Authority Federal statutory authority. et seq., 1 1 http://www.dtic.mil/whs/directives/. (2) Other authority. (i) State worker's compensation laws. (ii) State hospital lien laws. (iii) State no-fault automobile statutes. (iv) Contract rights under terms of insurance policies. (c) Policy. (d) Appealability. (e) Delegation. (f) Recoupment of erroneous payments. See (2) Scope General. (ii) Debtor defined. (iii) Delinquency defined. (3) Claims arising from erroneous TRICARE payments in situations where the beneficiary has entitlement to an insurance, medical service, health and medical plan, including any plan offered by a third party payer as defined in 10 U.S.C. 1095(h)(1) or other government program, except in the case of a plan administered under Title XIX of the Social Security Act (42 U.S.C. 1396, et seq. (4) Claim denials due to clarification or change. (5) Good faith payment. (ii) When it is determined that a person was not a TRICARE beneficiary, the TRICARE contractor and the civilian source of medical care are expected to make all reasonable efforts to obtain payment or to recoup the amount of the good faith payment from the person who erroneously claimed to be the TRICARE beneficiary. Recoupment of good faith payments initiated by the TRICARE contractor will be processed pursuant to the provisions of paragraph (f) of this section. (6) Recoupment procedures. Initial action. (ii) Demand for payment. (A) The basis for and amount of the debt and the consequences of failing to cooperate to resolve the debt; (B) The right to inspect and copy TRICARE records pertaining to the debt; (C) The opportunity to request an administrative review by the TRICARE contractor; and that such a request must be received by the TRICARE contractor within 90 days from the date of the initial demand letter; (D) That payment of the debt is due within 30 days from the date of the initial demand notification; (E) That interest will be assessed on the debt at the Treasury Current Value of Funds rate, pursuant to 31 U.S.C. 3717, and will begin to accrue on the date of the initial demand letter; and that interest will be waived on the debt, or any portion thereof, which is paid within 30 days from the date of the initial demand notification letter; (F) That administrative costs and penalties will be charged pursuant to 31 CFR 901.9; (G) That collection by offset against current or subsequent claims or other amounts payable from the government may be taken; (H) The opportunity to enter into a written agreement to repay the debt; (I) The name, address, and phone number of a contact person or office that the debtor may contact regarding the debt. (iii) A minimum of one demand letter is required. However, the specific content, timing and number of demand letters may be tailored to the type and amount of the debt, and the debtor's response, if any. Contractors' demand letters must be mailed or hand-delivered on the same date they are dated. (iv) The initial or subsequent demand letters may also inform the debtor of the requirement to report delinquent debts to credit reporting agencies and to collection agencies, the requirement to refer debts to the Treasury Offset Program for offset from Federal income tax refunds and other amounts payable by the Government, offset from state payments, the requirement to refer debts to Treasury for collection and TRICARE policies concerning the referral of delinquent debts to the Department of Justice for enforced collection action. The initial or subsequent demand letter may also inform the debtor of TRICARE policies concerning waiver. When necessary to protect the Government's interest (for example to prevent the running of a statute of limitations), written demand may be preceded by other appropriate actions under this regulation, including referral to the Department of Justice for litigation. There should be no undue delay in responding to any communication received from the debtor. Responses to communications from debtors should be made within 30 days of receipt whenever feasible. If prior to the initiation of the demand process or at any time during or after completion of the demand process, the Director, TMA, or a designee, determines to pursue or is required to pursue offset, the procedures applicable to administrative offset, found at paragraph (f)(6)(v) of this section, must be followed. If it appears that initial collection efforts are not productive or if immediate legal action on the claim appears necessary, the claim shall be referred promptly by the contractor to the Office of General Counsel, TMA. (v) Collection by administrative offset. (A) Referral for centralized administrative offset. (B) Referral for non-centralized administrative offset. ad hoc (vi) Collection by transfer of debts to Treasury or a Treasury-designated debt collection center for collection through cross servicing. (B) The requirement of paragraph (f)(1) of this section does not apply to any debt that: ( 1 ( 2 ( 3 ( 4 ( 5 (vii) Collection by salary offset. (A) For collections by salary offset the Director, TMA, or designee, will issue written notification, as required by 5 CFR 550.1104(d) at least 30 days before any offsets are taken. In addition, the notification will advise the employee that if he or she retires, resigns or his or her employment ends before collection of the debt is completed, collection may be made from subsequent payments of any nature due from the United States (e.g., final salary payment, lump-sum leave under 31 U.S.C. 3716 due the employee as of date of separation.) A debtor's involuntary payment of all or part of a debt being collected will not be construed as a waiver of any rights the debtor may have under 5 U.S.C. 5514 or any other provision of contract or law, unless there are statutory or contractual provisions to the contrary or the employee's paying agency is directed by an administrative or judicial order to refund amounts deducted from his or her current pay. No interest will be paid on amounts waived or determined not to be owed unless there are statutory or contractual provisions to the contrary. (B) Petition for hearing. (C) Extreme financial hardship. ( 1 ( 2 ( 3 ( 4 ( 5 (D) Form and content of hearings. (E) Costs for attendance at oral hearings. (F) Hearing official's decision. (viii) [Reserved] (ix) Collection of installments. (x) Interest, penalties, and administrative costs. (A) Waiver of interest consistent with 31 CFR 903.2(c)(2) in connection with a suspension of collection when a TRICARE appeal is pending under § 199.10 of this part where there is a substantial issue of fact in dispute. (B) Waiver of interest where the original debt arose through no fault or lack of good faith on the part of the debtor and the collection of interest would impose a financial hardship or burden on the debtor. Some examples in which such a waiver would be appropriate include: A debt arising when a TRICARE beneficiary in good faith files and is paid for a claim for medical services or supplies, which are later determined not to be covered benefits, or a debt arising when a TRICARE beneficiary is overpaid as the result of a calculation error on the part of the TRICARE contractor or TMA. (C) Waiver of interest where there has been an agreement to repay a debt in installments, there is no indication of fault or lack of good faith on the part of the debtor, and the amount of interest is so large in relation to the size of the installments that the debtor can reasonably afford to pay, that it is likely the debt will never be repaid in full. When a debt is paid in installments, the installment payments first will be applied to the payment of outstanding penalty and administrative cost charges, second, to accrued interest and then to principal. Administrative costs incurred as the result of a debt becoming delinquent (as defined in paragraph (f)(2)(iii) of this section) shall be assessed against a debtor. These administrative costs represent the additional costs incurred in processing and handling the debt because it became delinquent. The calculation of administrative costs should be based upon cost analysis establishing an average of actual additional costs incurred in processing and handling claims against other debtors in similar stages of delinquency. A penalty charge, not exceeding six percent a year, shall be assessed on the amount due on a debt that is delinquent for more than 90 days. This charge, which need not be calculated until the 91st day of delinquency, shall accrue from the date that the debt became delinquent. (xi) Referral to private collection agencies. (xii) Reporting delinquent debts to credit reporting agencies. (xiii) Use and disclosure of mailing addresses. (g) Compromise, suspension or termination of collection actions arising under the Federal Claims Collection Act Basic considerations. (2) Authority. (3) Basis for compromise. (i) The debtor or the estate of a debtor does not have the present or prospective ability to pay the full amount within a reasonable time; (ii) The cost of collecting the claim does not justify enforced collection of the full amount; or (iii) The government is unable to enforce collection of the full amount within a reasonable time by enforced collection proceedings; or (iv) There is significant doubt concerning the Government's ability to prove its case in court for the full amount claimed; or (v) The cost of collecting the claim does not justify enforced collection of the full amount. (4) Basis for suspension. (i) The debtor cannot be located; or (ii) The debtor's financial condition is expected to improve; or (iii) The debtor is unable to make payments on the government's claim or effect a compromise at the time, but the debtor's future prospects justify retention of the claim for periodic review and action and; (A) The applicable statute of limitations has been tolled or started running anew; or (B) Future collections can be effected by administrative offset, notwithstanding the expiration of the applicable statute of limitations for litigation of claims with due regard to the 10-year limitation for administrative offset under 31 U.S.C. 3716(e)(1); or (C) The debtor agrees to pay interest on the amount of the debt on which collection action will be temporarily suspended and such temporary suspension is likely to enhance the debtor's ability fully to pay the principal amount of the debt with interest at a later date. (iv) Consideration may be given by the Director, TMA, or designee to suspend collection action pending action on a request for a review of the government's claim against the debtor or pending an administrative review under § 199.10 of this part of any TRICARE claim or claims directly involved in the government's claim against the debtor. Suspension under this paragraph will be made on a case-by-case basis as to whether: (A) There is a reasonable possibility that the debt (in whole or in part) will be found not owing from the debtor; (B) The government's interest would be protected if suspension were granted by reasonable assurance that the debt would be recovered if the debtor does not prevail; and (C) Collection of the debt will cause undue hardship. (5) Collection action may be terminated for one or more of the following reasons: (i) TMA cannot collect or enforce collection of any substantial amount through its own efforts or the efforts of others, including consideration of the judicial remedies available to the government, the debtor's future financial prospects, and the exemptions available to the debtor under state and federal law; (ii) The debtor cannot be located, and either; (iii) The costs of collection are anticipated to exceed the amount recoverable; or (iv) It is determined that the debt is legally without merit or enforcement of the debt is barred by any applicable statute of limitations; or (v) The debt cannot be substantiated; or (vi) The debt against the debtor has been discharged in bankruptcy. Collection activity may be continued subject to the provisions of the Bankruptcy Code, such as collection of any payments provided under a plan of reorganization or in cases when TMA did not receive notice of the bankruptcy proceedings. (6) In determining whether the debt should be compromised, suspended or terminated, the responsible TMA collection authority will consider the following factors: (i) Age and health of the debtor; present and potential income; inheritance prospects; the possibility that assets have been concealed or improperly transferred by the debtor; and the availability of assets or income which may be realized by enforced collection proceedings; (ii) Applicability of exemptions available to a debtor under state or federal law; (iii) Uncertainty as to the price which collateral or other property may bring at a forced sale; (iv) The probability of proving the claim in court because of legal issues involved or because of a bona fide dispute of the facts; the probability of full or partial recovery; the availability of necessary evidence and related pragmatic considerations. Debtors may be required to provide a completed Department of Justice Financial Statement of Debtor form (OBD-500 or such other form that DOJ shall prescribe) or other financial information that will permit TMA to verify debtors' representations. TMA may obtain credit reports or other financial information to enable it independently to verify debtors' representations. (7) Payment of compromised claims. (i) Time and manner. (ii) Failure to pay the compromised amount. (iii) Effect of compromise, waiver, suspension or termination of collection action. Pursuant to the Internal Revenue Code, 26 U.S.C. 6050P, compromises and terminations of undisputed debts totaling $600 or more for the year will be reported to the Internal Revenue Service in the manner prescribed. Amounts, other than those discharged in bankruptcy, will be included in the debtor's gross income for that year. Any action taken under paragraph (g) of this section regarding the compromise of a federal claim, or waiver or suspension or termination of collection action on a federal claim is not an initial determination for the purposes of the appeal procedures in § 199.10. (h) Referrals for collection Prompt referral. (2) Preservation of evidence. (i) Claims involving indication of fraud, filing of false claims or misrepresentation. (ii) [Reserved] [73 FR 71547, Nov. 25, 2008, as amended at 77 FR 38176, June 27, 2012; 82 FR 45447, Sept. 29, 2017] § 199.12 Third party recoveries. (a) General. Authority Third-party payers. (2) Federal Medical Care Recovery Act In general. et. seq. (ii) Cases involving tort liability. (c) Appealability. (d) Statutory obligation of third-party payer to pay Basic Rule. (2) Application of cost shares. (3) Claim from the United States exclusive. (4) Assignment of benefits not necessary. (e) Exclusions impermissible Statutory requirement. (2) Regulatory application. (f) Records available. (g) Remedies. (1) This includes the authority under 10 U.S.C. 1095(e)(1) for the United States to institute and prosecute legal proceedings against a third-party payer to enforce a right of the United States under 10 U.S.C. 1095b and this section. (2) This also includes the authority under 10 U.S.C. 1095(e)(2) for an authorized representative of the United States to compromise, settle or waive a claim of the United States under 10 U.S.C. 1095b and this section. (3) The authorities provided by the Federal Claims Collection Act of 1966, as amended (31 U.S.C. 3701 et. seq. (h) Obligations of beneficiaries. (1) To provide information regarding coverage by a third-party payer plan and/or the circumstances surrounding an injury to the patient as a conditional precedent of the processing of a TRICARE claim involving possible third-party payer coverage. (2) To furnish such additional information as may be requested concerning the circumstances giving rise to the injury or disease for which care and treatment are being given and concerning any action instituted or to be instituted by or against a third person; and, (3) To cooperate in the prosecution of all claims and actions by the United States against such third person. (i) Responsibility for recovery. (1) Identification and referral. (2) Processing TRICARE claims. (3) Ascertaining total potential liability. (j) Reporting requirements. (1) TRICARE contractors. (2) Uniformed Services. (3) Implementation of the reporting requirements. [68 FR 6619, Feb. 10, 2003] § 199.13 TRICARE Dental Program. (a) General provisions Purpose. (2) Applicability Geographic scope. (B) Extension of the TDP to areas outside the CONUS service area. In accordance with the authority cited in 10 U.S.C. 1076a(h), the Assistant Secretary of Defense (Health Affairs) (ASD(HA)) may extend the TDP to areas other than those areas specified in paragraph (a)(2)(i)(A) of this section for the eligible members and eligible dependents of members of the Uniformed Services. These areas are collectively referred to as the “OCONUS (or outside the Continental United States) service area”. In extending the TDP outside the CONUS service area, the ASD(HA), or designee, is authorized to establish program elements, methods of administration and payment rates and procedures to providers that are different from those in effect for the CONUS service area to the extent the ASD(HA), or designee, determines necessary for the effective and efficient operation of the TDP. This includes provisions for preauthorization of care if the needed services are not available in a Uniformed Service overseas dental treatment facility and payment by the Department of certain cost-shares (or co-payments) and other portions of a provider's billed charges for certain beneficiary categories. Other differences may occur based on limitations in the availability and capabilities of the Uniformed Service overseas dental treatment facility and a particular nation's civilian sector providers in certain areas. These differences include varying licensure and certification requirements of OCONUS providers, Uniformed Service provider selection criteria and local results of provider selection, referral, beneficiary pre-authorization and marketing procedures, and care for beneficiaries residing in distant areas. The Director, Office of Civilian Health and Medical Program of the Uniformed Services (OCHAMPUS) shall issue guidance, as necessary, to implement the provisions of paragraph (a)(2)(i)(B). Beneficiaries will be eligible for the same TDP benefits in the OCONUS service area although services may not be available or accessible in all OCONUS countries. (ii) Agency. (iii) Exclusion of benefit services performed in military dental care facilities. (iv) Exception to the exclusion of services performed in military dental care facilities. (A) Dependents who are 12 years of age or younger and are covered by a dental plan established under this section may be treated by postgraduate dental residents in a dental treatment facility of the uniformed services under a graduate dental education program accredited by the American Dental Association if ( 1 ( 2 (B) The total number of dependents treated in all facilities of the uniformed services under paragraph (a)(2)(iv) in a fiscal year may not exceed 2,000. (3) Authority and responsibility Legislative authority Joint regulations. (B) Administration. (ii) Organizational delegations and assignments Assistant Secretary of Defense (Health Affairs) (ASD(HA)). (B) Evidence of eligibility. (4) Preemption of State and local laws. (ii) Based on the determination set forth in paragraph (a)(4)(i) of this section, any State or local law relating to health or dental insurance, prepaid health or dental plans, or other health or dental care delivery or financing methods is preempted and does not apply in connection with the TDP contract. Any such law, or regulation pursuant to such law, is without any force or effect, and State or local governments have no legal authority to enforce them in relation to the TDP contract. (However, DoD may, by contract, establish legal obligations on the part of the dental plan contractor to conform with requirements similar or identical to requirements of State or local laws or regulations.) (iii) The preemption of State and local laws set forth in paragraph (a)(4)(ii) of this section includes State and local laws imposing premium taxes on health or dental insurance carriers or underwriters or other plan managers, or similar taxes on such entities. Such laws are laws relating to health insurance, prepaid health plans, or other health care delivery or financing methods, within the meaning of the statutes identified in paragraph (a)(4)(i) of this section. Preemption, however, does not apply to taxes, fees, or other payments on net income or profit realized by such entities in the conduct of business relating to DoD health services contracts, if those taxes, fees, or other payments are applicable to a broad range of business activity. For purposes of assessing the effect of Federal preemption of State and local taxes and fees in connection with DoD health and dental services contracts, interpretations shall be consistent with those applicable to the Federal Employees Health Benefits Program under 5 U.S.C. 8909(f). (5) Plan funds Funding sources. (ii) Disposition of funds. (iii) Plan. (iv) Contracting out. (A) Development, publication, and enforcement of benefit policy, exclusions, and limitations in compliance with the law, regulation, and the contract provisions; (B) Adjudicating and processing claims; and conducting related supporting activities, such as enrollment, disenrollment, collection of premiums, eligibility verification, provider relations, and beneficiary communications. (6) Role of Health Benefits Advisor (HBA). (7) Right to information. (i) Disclosure of such information is necessary to the determination by a provider or the dental plan contractor of beneficiary enrollment or eligibility for coverage of specific services; (ii) Disclosure of such information is authorized specifically by the beneficiary; (iii) Disclosure is necessary to permit authorized Government officials to investigate and prosecute criminal actions; (iv) Disclosure constitutes a routine use of a routine use of a record which is compatible with the purpose for which it was collected. This includes a standard and acceptable business practice commonly used among dental insurers which is consistent with the principle of preserving confidentiality of personal information and detailed clinical data. For example, the release of utilization information for the purpose of determining eligibility for certain services, such as the number of dental prophylaxis procedures performed for a beneficiary, is authorized; (v) Disclosure is pursuant to an order from a court of competent jurisdiction; or (vi) Disclosure by the Director, OCHAMPUS, or designee, is for the purpose of determining the applicability of, and implementing the provisions of, other dental benefits coverage or entitlement. (8) Utilization review and quality assurance. (b) Definitions. (1) Assignment of benefits. (2) Authorized provider. (3) Beneficiary. (4) Beneficiary liability. (5) By report. (6) Contingency operation. (7) Cost-share. (8) Defense Enrollment Eligibility Reporting System (DEERS). (i) Enrolling all active duty, Reserve and retired service members, their dependents, and the dependents of deceased service members; and (ii) Verifying their eligibility for health care benefits in the direct care facilities and through the TDP. (9) Dental hygienist. (10) Dentist. (11) Diagnostic services. (i) Clinical oral examinations; (ii) Radiographic examinations; and (iii) Diagnostic laboratory tests and examinations provided in connection with other dental procedures authorized as benefits of the TDP and further defined in paragraph (e) of the section. (12) Endodontics. (13) Initial determination. (14) Nonparticipating provider. (15) Oral and maxillofacial surgery. (16) Orthodontics. (17) Participating provider. (18) Party to the initial determination. (19) Periodontics. (20) Preventive services. (21) Prosthodontics. (22) Provider. (23) Restorative services. (c) Eligibility and enrollment General. (2) Eligibility Persons eligible. (A) A person who bears one of the following relationships to an active duty member (under a call or order that does not specify a period of thirty (30) days or less) or a member of the Selected Reserve (as specified in 10 U.S.C. 10143) or Individual Ready Reserve (as specified in 10 U.S.C. 10144): ( 1 Spouse. ( 2 Child. (B) A member of the Selected Reserve of the Ready Reserve (as specified in 10 U.S.C. 10143). (C) A member of the Individual Ready Reserve of the Ready Reserve (as specified in 10 U.S.C. 10144(b)) who is subject to being ordered to active duty involuntarily in accordance with 10 U.S.C. 12304. (D) All other members of the Individual Ready Reserve of the Ready Reserve (as specified in 10 U.S.C. 10144(a)). (ii) Determination of eligibility status and evidence of eligibility Eligibility determination responsibility of the Uniformed Services. (B) Procedures for determination of eligibility. (C) Evidence of eligibility required. (3) Enrollment Previous plans Basic Active Duty Dependents Dental Benefit Plan. (B) Expanded Active Duty Dependents Dental Benefit Plan. (ii) TRICARE Dental Program (TDP) Election of coverage. 1 ( 2 (B) Premiums 1 ( i ( ii ( 2 Exceptions. i ( ii ( iii (C) Enrollment period 1 General. ( 2 Special enrollment period for Reserve component members ordered to active duty in support of contingency operations. ( 3 Continuation of enrollment from Expanded Active Duty Dependents Dental Benefit Plan. ( 4 Continuation of enrollment from TRICARE Selected Reserve Dental Program. (D) Beginning dates of eligibility. (E) Changes in and termination of enrollment 1 Changes in status of active duty, Selected Reserve or Individual Ready Reserve member. ( i Reserve component members separated from active duty in support of a contingency operation. ( ii Dependents of members separated from active duty in support of a contingency operation. ( iii Members separated from active duty and not covered by 10 U.S.C. 1145(a)(2)(B). ( iv ( 2 Survivor eligibility. i.e., ( i ( ii ( iii ( 3 Changes in status of dependent i Divorce. ( ii Annulment. ( iii Adoption. ( iv Marriage of child. ( v Disabling illness or injury of child age 21 or 22 who has eligibility based on his or her student status. 2 ( 4 Other i Disenrollment because of no eligible beneficiaries. ( ii Option to disenroll as a result of a change in active duty station. ( iii Option to disenroll due to transfer to OCONUS service area. ( iv Option to disenroll after an initial one (1) year enrollment. ( 5 (d) Premium sharing General. (i) Members required to pay a portion of the premium cost. (ii) Members required to pay the full premium cost. (2) Proportion of premium share. (3) Provision for increases in active duty, Selected Reserve and Individual Ready Reserve member's premium share. (A) The percent by which the rates of basic pay of members of the Uniformed Services are increased on such date; or (B) The sum of one-half percent and the percent computed under 5 U.S.C. 5303(a) for the increase in rates of basic pay for statutory pay systems for pay periods beginning on or after such date. (ii) Under the legislation authorizing an increase in the monthly premium cap, the methodology for determining the active duty, Selected Reserve and Individual Ready Reserve member's TDP premium pursuant to paragraph (d)(1)(i) of this section will be applied as if the methodology had been in continuous use since December 31, 1993. (4) Reduction of premium share for enlisted members. (5) Reduction of cost-shares for enlisted members. (6) Premium payment method. (7) Annual notification of premium rates. (e) Plan benefits General Scope of benefits. (ii) Authority to act for the plan. (iii) Dental benefits brochure Content. (B) Distribution. (iv) Alternative course of treatment policy. (A) The service, procedure, or course of treatment must be consistent with sound professional standards of dental practice for the dental condition concerned. (B) The service, procedure, or course of treatment must be a generally accepted alternative for a service or procedure covered by the TDP for the dental condition. (C) Payment for the alternative service or procedure may not exceed the lower of the prevailing limits for the alternative procedure, the prevailing limits or dental plan contractor's scheduled allowance for the otherwise authorized benefit procedure for which the alternative is substituted, or the actual charge for the alternative procedure. (2) Benefits. (i) Diagnostic and preventive services. Benefits may be extended for those dental services described as oral examination, diagnostic, and preventive services when performed directly by dentists and dental hygienists as authorized under paragraph (f) of this section. These include the following categories of service: (A) Diagnostic services. ( 1 ( 2 ( 3 (B) Preventive services. ( 1 ( 2 ( 3 ( 4 ( 5 (ii) General services and services “by report (A) Unclassified treatment. (B) Anesthesia. (C) Professional consultation. (D) Professional visits. (E) Drugs. (F) Miscellaneous services. (iii) Restorative services. (A) Amalgam restorations. (B) Resin restorations. (C) Inlay and onlay restorations. (D) Crowns. (E) Other restorative services. (iv) Endodontic services. (A) Pulp capping. (B) Pulpotomy and pulpectomy. (C) Endodontic therapy. (D) Apexification and recalcification procedures. (E) Apicoectomy and periradicular services. (F) Other endodontic procedures. (v) Periodontic services. (A) Surgical services. (B) Periodontal services. (C) Other periodontal services. (vi) Prosthodontic services. (A) Prosthodontics (removable). ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 (B) Prosthodontics (fixed). ( 1 ( 2 ( 3 (vii) Orthodontic services. (A) Limited orthodontic treatment. (B) Minor treatment to control harmful habits. (C) Interceptive orthodontic treatment. (D) Comprehensive orthodontic treatment. (E) Other orthodontic services. (viii) Oral and maxillofacial surgery services. (A) Extractions. (B) Surgical extractions. (C) Other surgical procedures. (D) Alveoloplasty—surgical preparation of ridge for denture. (E) Surgical incision. (F) Repair of traumatic wounds. (G) Complicated suturing. (H) Other repair procedures. (ix) Exclusion of adjunctive dental care. Adjunctive dental care benefits are excluded under the TDP. For further information on adjunctive dental care benefits under TRICARE/CHAMPUS, see § 199.4(e)(10). (x) Benefit limitations and exclusions. (xi) Limitation on reduction of benefits. (3) Cost-shares, liability and maximum coverage Cost-shares. [In percent] Covered services Cost-share for pay grades E-1, E-2, E-3 and E-4 Cost-share for all other pay grades Diagnostic 0 0 Preventive, except Sealants 0 0 Emergency Services 0 0 Professional Consultations 20 20 Professional Visits 20 20 Post Surgical Services 20 20 Basic Restorative (example: amalgams, resins, stainless steel crowns) 20 20 Endodontic 30 40 Periodontic 30 40 Oral and Maxillofacial Surgery 30 40 General Anesthesia 40 40 Intravenous Sedation 50 50 Other Restorative (example: crowns, onlays, casts) 50 50 Prosthodontics 50 50 Medications 50 50 Orthodontic 50 50 Miscellaneous 50 50 (ii) Dental plan contractor liability. (iii) Maximum coverage amounts. (f) Authorized providers General. (2) Authorized provider status does not guarantee payment of benefits. (3) Utilization review and quality assurance. (4) Provider required. (5) Participating provider. (6) Nonparticipating provider. (i) Assignment of benefits. (ii) No assignment of benefits. (7) Alternative delivery system General. (ii) Defined. (iii) Elective or exclusive arrangement. (iv) Provider election of participation. (v) Limitation on authorized providers. (vi) Charge agreements. (g) Benefit payment General. (2) Benefit payment. (i) Nonparticipating providers (or the Beneficiaries or active duty, Selected Reserve or Individual Ready Reserve members for unassigned claims) shall be reimbursed at the lesser of the provider's actual charge: Or the network maximum allowable charge for similar services for that same locality (region) or state, whichever is lower, subject to the exception listed in paragraph (e)(3)(ii) of this section, less any cost-share amount due for authorized services. The network maximum allowable charge is the maximum negotiated fee between the dental contractor and any TDP participating provider for similar services covered by the dental plan in that same locality (region) or state. (ii) Participating providers shall be reimbursed in accordance with the contractor's network agreements, less any cost-share amount due for authorized services. (3) Fraud, abuse, and conflict of interest. (h) Appeal and hearing procedures. (1) General. (i) Initial determination Notice of initial determination and right to appeal. (B) Effect of initial determination. (ii) Participation in an appeal. (A) Parties to the initial determination. (B) Representative. (iii) Burden of proof. (iv) Evidence in appeal and hearing cases. (v) Late filing. (vi) Appealable issue. (A) The amount of the dental plan contractor-determined allowable charge since the methodology constitutes a limitation on benefits under the provisions of this section. (B) Certain other issues on the basis that the authority for the initial determination is not vested in OCHAMPUS. Such issues include but are not limited to the following examples: ( 1 ( 2 ( 3 (vii) Amount in dispute General. (B) Calculated amount. ( 1 ( 2 ( 3 ( 4 (viii) Levels of appeal. (ix) Appeal decision. (2) Reconsideration. (3) Formal review. (4) Hearing General. (ii) Authority of the hearing officer. (5) Final decision. (i) Implementing Instructions. [66 FR 12860, Mar. 1, 2001; 66 FR 16400, Mar. 26, 2001, as amended at 68 FR 65174, Nov. 19, 2003; 69 FR 55359, Sept. 14, 2004; 70 FR 55252, Sept. 21, 2005; 71 FR 1696, Jan. 11, 2006; 71 FR 66872, Nov. 17, 2006; 72 FR 53685, Sept. 20, 2007; 76 FR 57643, Sept. 16, 2011; 76 FR 81367, Dec. 28, 2011; 80 FR 55254, Sept. 15, 2015; 81 FR 11667, Mar. 7, 2016] § 199.14 Provider reimbursement methods. (a) Hospitals. (1) CHAMPUS Diagnosis Related Group (DRG)-based payment system. (i) General DRGs used. (B) Assignment of discharges to DRGs. 1 ( 2 (C) Basis of payment 1 Hospital billing. ( 2 Payment on a per discharge basis. ( 3 Pricing of claims. ( 4 Payment in full. 5 1 i A ( 5 Inpatient operating costs. ( i ( ii ( iii ( iv ( 6 Discharges and transfers i Discharges. ( A 6 ii ( B ( C ( ii Transfers. 6 i ( A ( B ( C ( D ( iii Payment in full to the discharging hospital. ( iv Payment to a hospital transferring an inpatient to another hospital. ( v Additional payments to transferring hospitals. (D) DRG system updates. (ii) Applicability of the DRG system Areas affected. (B) Services subject to the DRG-based payment system. (C) Services exempt from the DRG-based payment system. 1 4 7 9 5 6 ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( 8 ( 9 ( 10 (D) Hospitals subject to the CHAMPUS DRG-based payment system. ( 1 Psychiatric hospitals. ( 2 Inpatient Rehabilitation Facilities (IRF). ( 3 Psychiatric and rehabilitation units (distinct parts). ( 4 Long Term Care Hospitals. ( 5 Hospitals within hospitals. ( 6 Sole community hospitals (SCHs). ( 7 Christian Science sanitoriums. ( 8 Cancer hospitals. ( 9 Hospitals outside the 50 states, the District of Columbia, and Puerto Rico. ( 10 CAHs. (E) Hospitals which do not participate in Medicare. (F) Substance Use Disorder Rehabilitation facilities. (iii) Determination of payment amounts. (A) Calculation of DRG weights 1 Grouping of charges. ( 2 ( 3 Indirect medical education standardization. ( 4 Wage level standardization. ( 5 Elimination of statistical outliers. ( 6 Calculation of DRG average charge. ( 7 Calculation of national average charge per discharge. ( 8 DRG relative weights. (B) Empty and low-volume DRGs. (C) Updating DRG weights. ( 1 ( 2 ( 3 (D) Calculation of the adjusted standardized amounts. 1 ( 2 Indirect medical education standardization. ( 3 Wage level standardization. ( 4 Apply the cost to charge ratio. ( 5 ( 6 Update for inflation. ( 7 ( 8 Labor and nonlabor portions of the adjusted standardized amounts. (E) Adjustments to the DRG-based payments amounts. ( 1 Outliers. ( i Length-of-stay outliers. ( A Short-stay outliers. ( B Long-stay outliers. ( ii Cost outliers. ( A 4 ( B 4 ( C Cost outliers for burn cases. 1 ii A 1 ii B ( 2 Wage adjustment. ( 3 Indirect medical education adjustment. ( 4 Children's hospital differential. ( i Qualifying children's hospitals. ( ii Calculation of differential. ( A ( B ( C ( D ( iii Transition rule. ( iv Hold harmless provision. ( v No update for inflation. ( vi Administrative corrections. 4 iii (F) Updating the adjusted standardized amounts. (G) Annual cost pass-throughs 1 Capital costs. ( i Costs included as capital costs. ( ii Services, facilities, or supplies provided by supplying organizations. ( A ( B ( C ( 2 Direct medical education costs. ( 3 ( i ( ii ( iii ( iv ( v ( vi ( vii ( viii ( ix ( x ( A ( B ( xi ( xii ( xiii ( xiv 3 vi vii viii ix x (iv) Special Programs and Incentive Payments. Additional payment for new medical services and technologies. 1 11 ( 1 Adoption of Medicare NTAPs. ( 2 Pediatric cases. ( 3 TRICARE designated NTAP adjustments. 4 11 ( 4 Eligibility requirements and reimbursement methodology for TRICARE designated NTAP adjustments. ( 5 Criteria for improvement. ( i ( ii) ( iii ( iv ( 6 Evidence. ( 7 Prevalence. ( 8 Subpopulation. ( 9 Newness criteria. ( 10 Payment methodology. 4 9 11 ( i ( ii ( 11 Publication and timing. 4 9 (B) Hospital Value Based Purchasing. (C) Additional payment for new COVID-19 Treatments. (2) CHAMPUS mental health per diem payment system. (i) Applicability of the mental health per diem payment system Hospitals and units covered. (B) Services covered. (ii) Hospital-specific per diems for higher volume hospitals and units. (A)( 1 Per diem amount. ( 2 (B) Cap 1 ( 2 (C) Review of per diem. (iii) Regional per diems for lower volume hospitals and units. (A) Per diem amounts. (B) Review of per diem amount. (C) Adjustments to regional per diems. ( 1 Area wage index. 2 ( 2 Indirect medical education. 3 (D) Annual cost pass-through for direct medical education. (iv) Base period and update factors Base period. (B) Alternative hospital-specific data base. (C) Update factors 1 ( 2 3 ( 3 2 2 ( 4 (v) Higher volume hospitals. (A) In general. (B) Hospitals that subsequently become higher volume hospitals. (C) Special retrospective payment provision for new hospitals. (D) Review of classification. (vi) Payment for hospital based professional services. (vii) Leave days. (viii) Exemptions from the CHAMPUS mental health per diem payment system. (A) Non-specialty providers. (B) DRG 424. (C) Non-mental health services. (D) Sole community hospitals (SCHs). (E) Hospitals outside the U.S. (ix) Payment for psychiatric and substance use disorder rehabilitation partial hospitalization services, intensive outpatient psychiatric and substance use disorder services and opioid treatment services Per diem payments. 1 3 3 ii e.g., ( 1 Partial hospitalization programs. ( 2 Intensive outpatient programs. ( 3 Opioid treatment programs. ( i Weekly all-inclusive per diem rate. i.e., ( ii Exceptions to per diem reimbursement. i.e., ( iii Discretionary authority. e.g., (B) Services which may be billed separately. (3) Reimbursement for inpatient services provided by a CAH. i.e., (ii) The percentage amount stated in paragraph (a)(3)(i) of this section is subject to possible upward adjustment based on a inpatient GTMCPA for TRICARE network hospitals deemed essential for military readiness and support during contingency operations under paragraph (a)(8) of this section. (4) The allowable cost for authorized care in all hospitals not subject to the TRICARE DRG-based payment system, the TRICARE mental health per-diem system, the TRICARE reasonable cost method for CAHs, the TRICARE reimbursement rules for SCHs, the TRICARE LTCH-PPS, or the TRICARE IRF PPS shall be determined on the basis of billed charges or set rates. (i) The actual charge for such service made to the general public; or (ii) The allowed charge applicable to the policyholders or subscribers of the CHAMPUS fiscal intermediary for comparable services under comparable circumstances, when extended to CHAMPUS beneficiaries by consent or agreement; or (iii) The allowed charge applicable to the citizens of the community or state as established by local or state regulatory authority, excluding title XIX of the Social Security Act or other welfare program, when extended to CHAMPUS beneficiaries by consent or agreement. (5) CHAMPUS discount rates. (6) Hospital outpatient services. (i) Outpatient Services Not Subject to Hospital Outpatient Prospective Payment System (OPPS). (A) Laboratory services. (B) Rehabilitation therapy services. (C) Venipuncture. (D) Radiology services. (E) Diagnostic services. (F) Ambulance services. (G) Durable medical equipment (DME) and supplies. (H) Oxygen and related supplies. (I) Drugs administered other than by oral method. (J) Professional provider services. (K) Facility charges. (L) Ambulatory surgery services. (ii) Outpatient services subject to OPPS General. (B) Under the above governing provisions, TRICARE will recognize to the extent practicable, in accordance with 10 U.S.C. 1089(j)(2), Medicare's OPPS reimbursement methodology to include specific coding requirements, ambulatory payment classifications (APCs), nationally established APC amounts and associated adjustments ( e.g., (C) While TRICARE intends to remain as true as possible to Medicare's basic OPPS methodology, there will be some deviations required to accommodate TRICARE's unique benefit structure and beneficiary population as authorized under the provisions of 10 U.S.C. 1079(j)(2). (D) TRICARE is also authorized to deviate from Medicare's basic OPPS methodology to establish special reimbursement methods, amounts, and procedures to encourage use of high-value products and discourage use of low-value products with respect to pharmaceutical agents provided as part of medical services from authorized providers. Therefore, drugs administered other than oral method provided on an outpatient basis by hospitals are paid on the same basis as drugs administered other than oral method covered by the allowable charge method under paragraph (j)(1) of this section. (E) Temporary transitional payment adjustments (TTPAs). ( 1 For network hospitals. ( 2 For non-network hospitals. ( 3 3 i iii ( i ( ii ( iii ( 4 For cancer and children's hospitals. (iii) Outpatient Services Subject to CAH Reasonable Cost Method. (iv) CAH Ambulance Services. (7) Reimbursement for inpatient services provided by an SCH. (ii) The first step referred to in paragraph (a)(7)(i) of this section will be to calculate the TRICARE allowable cost by multiplying the applicable TRICARE percentage by the billed charge amount on each institutional inpatient claim. The applicable TRICARE percentage is the greater of: the SCH's most recently available cost-to-charge ratio (CCR) from the Centers for Medicare and Medicaid Services' (CMS') inpatient Provider Specific File (after the ratio has been converted to a percentage), or the TRICARE allowed-to-billed ratio, defined as the ratio of the TRICARE allowed amounts (including discounts) to the amount of billed charges for TRICARE inpatient admissions at the SCH in FY 2012 (after it has been converted to a percentage). The TRICARE allowed-to-billed ratio in FY 2012 shall be reduced as follows (after the ratio has been converted to a percentage): (A) In the first year of implementation, 10 percentage points for network SCHs and 15 percentage points for non-network SCHs. (B) In the second year of implementation, 20 percentage points for network SCHs and 30 percentage points for non-network SCHs. (C) In the third year of implementation, 30 percentage points for network SCHs and 45 percentage points for non-network SCHs. (D) In the fourth year of implementation, 40 percentage points for network SCHs and 60 percentage points for non-network SCHs. (E) In the fifth year of implementation, 50 percentage points for network SCHs and 75 percentage points for non-network SCHs. (F) In the sixth year of implementation, 60 percentage points for network SCHs and 90 percentage points for non-network SCHs. (G) In the seventh year of implementation, 70 percentage points for network SCHs and 100 percentage points for non-network SCHs. (H) In the eighth year of implementation, 80 percentage points for network SCHs and 100 percentage points for non-network SCHs. (I) In the ninth year of implementation, 90 percentage points for network SCHs and 100 percentage points for non-network SCHs. (J) In the tenth year of implementation, 100 percentage points for network SCHs and 100 percentage points for non-network SCHs. (iii) The second step referred to in paragraph (a)(7)(i) of this section is a year-end adjustment. The year-end adjustment will compare the aggregate allowable costs over a 12-month period under paragraph (a)(7)(ii) of this section to the aggregate amount that would have been allowed for the same care using the TRICARE DRG-method (under paragraph (a)(1) of this section). In the event that the DRG method amount is the greater, the year-end adjustment will be the amount by which it exceeds the aggregate allowable costs. In addition, the year-end adjustment also may incorporate a possible upward adjustment for inpatient services based on a GTMCPA for TRICARE network hospitals under paragraph (a)(8) of this section. (iv) At the end of an SCH's transition period, when the SCH reaches its Medicare CCR, a special allowable cost shall be applicable for discharges that group to inpatient nursery and labor/delivery DRGs. For these discharges, instead of using the percentage of the SCH's Medicare cost-to-charge ratio (as described in paragraph (a)(7)(ii) of this section), the percentage will be 130 percent of the Medicare CCR. (v) The SCH reimbursement provisions of paragraphs (a)(7)(i) through (iv) of this section do not apply to any costs of physician services or other professional services provided to SCH inpatients (which are subject to individual provider payment provisions of this section), inpatient services provided in psychiatric distinct part units (which are subject to the CHAMPUS mental health per-diem payment system), or inpatient services provided in rehabilitation distinct part units (which are reimbursed on the basis of billed charges or set rates). (vi) The SCH payment system under this paragraph (a)(7) applies to hospitals classified by CMS as Essential Access Community Hospitals (EACHs). (vii) The SCH payment system under this paragraph (a)(7) does not apply to hospitals in States that are paid by Medicare and TRICARE under a cost containment waiver. (8) General temporary military contingency payment adjustment for SCHs and CAHs. (A) The hospital serves a disproportionate share of ADSMs and ADDs; (B) The hospital is a TRICARE network hospital; (C) The hospital's actual costs for inpatient services exceed TRICARE payments or other extraordinary economic circumstance exists; and, (D) Without the GTMCPA, DoD's ability to meet military contingency mission requirements will be significantly compromised. (ii) Policy and procedural instructions implementing the GTMCPA will be issued as deemed appropriate by the Director, TMA, or a designee. As with other discretionary authority under this Part, a decision to allow or deny a GTMCPA to a hospital is not subject to the appeal and hearing procedures of § 199.10. (9) Reimbursement for inpatient services provided by a Long Term Care Hospital (LTCH). (ii) Implementation of the TRICARE LTCH PPS will include a gradual transition to full implementation of the Medicare LTCH PPS rates as follows: (A) For the first 12 months following implementation, the TRICARE LTCH PPS allowable cost will be 135 percent of Medicare LTCH PPS amounts. (B) For the second 12 months of implementation, TRICARE LTCH PPS allowable cost will be 115 percent of the Medicare LTCH PPS amounts. (C) For the third 12 months of implementation, and subsequent years, TRICARE LTCH PPS allowable cost will be 100 percent of the Medicare LTCH PPS amounts. (iii) Exemption. (10) Reimbursement for inpatient services provided by Inpatient Rehabilitation Facilities (IRF). (ii) Implementation of the TRICARE IRF PPS will include a gradual transition to full implementation of the Medicare IRF PPS rates as follows: (A) For the first 12 months of implementation, the TRICARE IRF PPS allowable cost will be 135 percent of Medicare IRF PPS amounts. (B) For the second 12 months of implementation, the TRICARE IRF PPS allowable cost will be 115 percent of the Medicare IRF PPS amounts. (C) For the third 12 months of implementation, and subsequent years, the TRICARE IRF PPS allowable cost will be 100 percent of the Medicare IRF PPS amounts. (iii) The IRF PPS allowable cost in paragraph (a)(10)(ii) of this section may be supplemented by an inpatient general temporary military contingency payment adjustment (GTMCPA) for TRICARE authorized IRFs. (A) This is a year-end discretionary, temporary adjustment that the Director, DHA (or designee) may approve based on the following criteria: ( 1 ( 2 ( 3 ( 4 (B) Policy and procedural instructions implementing the GTMCPA will be issued as deemed appropriate by the Director, DHA (or designee). As with other discretionary authority under this part, a decision to allow or deny a GTMCPA to an IRF is not subject to the appeal and hearing procedures of § 199.10. (iv) Exemption. (b) Skilled nursing facilities (SNFs) Use of Medicare prospective payment system and rates. (2) Payment in full. (3) Education costs. 2 (4) Resident assessment data. (c) Reimbursement of Freestanding End Stage Renal Disease (ESRD) facilities. (i) Services included in the flat per-session rate must be furnished by an authorized TRICARE ESRD institutional provider: (A) Institutional charges (e.g., charges for facility use, use or treatment rooms, and general nursing services); (B) Routine laboratory services related to the dialysis session; (C) Pharmaceuticals and supplies related to the dialysis; (D) Home dialysis support services identified at 42 CFR 494.100; (E) Purchase and delivery of all necessary home dialysis supplies; and (F) Dialysis training for days 1-120. (ii) Services which may be billed separately: (A) Evaluation and management services provided by authorized individual professional providers. These services will continue to be reimbursed using existing reimbursement systems (e.g., CMAC). (B) Drugs, supplies, and devices listed by Medicare as eligible for Transitional Drug Add-on Payment Adjustment and Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies under the Medicare ESRD PPS. These services will continue to be reimbursed using existing reimbursement systems (e.g., CMAC). (C) Professional services, supplies, and pharmaceuticals unrelated to dialysis care (e.g., if a flu shot is administered at the same time as dialysis treatment). These services will continue to be reimbursed using existing reimbursement systems (e.g., CMAC). (iii) Establishment of the flat rate: (A) Per session rate for treatment days 1-120. (B) Per session rate for treatment day 121 and beyond. (C) Wage adjustment. (D) Annual updates. www.health.mil. (E) Dialysis training. (2) The reimbursement methods established in paragraph (c)(1) of this section applies to freestanding ESRD facilities meeting the requirements established for TRICARE authorized freestanding ESRD facilities in § 199.6. For purposes of cost-sharing and copayments, treatment provided by freestanding ESRD facilities are considered outpatient specialty visits. The applicable copayments and cost-shares described in §§ 199.4 and 199.17(k)(2)(iii) shall apply. Hospital-based ESRD facilities are not subject to the provisions of this paragraph, and will continue to be reimbursed utilizing other applicable reimbursement systems (e.g., the Outpatient Prospective Payment System). (d) Payment of institutional facility costs for ambulatory surgery. (e) Reimbursement of Birthing Centers. (2) The all-inclusive rate shall include the following to the extent that they are usually associated with a normal pregnancy and childbirth: Laboratory studies, prenatal management, labor management, delivery, post-partum management, newborn care, birth assistant, certified nurse-midwife professional services, physician professional services, and the use of the facility. (3) The CHAMPUS established all-inclusive rate is equal to the sum of the CHAMPUS area prevailing professional charge for total obstetrical care for a normal pregnancy and delivery and the sum of the average CHAMPUS allowable institutional charges for supplies, laboratory, and delivery room for a hospital inpatient normal delivery. The CHAMPUS established all-inclusive rate areas will coincide with those established for prevailing professional charges and will be updated concurrently with the CHAMPUS area prevailing professional charge database. (4) Extraordinary maternity care services, when otherwise authorized, may be reimbursed at the lesser of the billed charge or the CHAMPUS allowable charge. (5) Reimbursement for an incomplete course of care will be limited to claims for professional services and tests where the beneficiary has been screened but rejected for admission into the birthing center program, or where the woman has been admitted but is discharged from the birthing center program prior to delivery, adjudicated as individual professional services and items. (6) The beneficiary's share of the total reimbursement to a birthing center is limited to the cost-share amount plus the amount billed for non-covered services and supplies. (f) Reimbursement of Residential Treatment Centers. (1) The all-inclusive per diem rate for RTCs operating or participating in CHAMPUS during the base period of July 1, 1987, through June 30, 1988, will be the lowest of the following conditions: (i) The CHAMPUS rate paid to the RTC for all-inclusive services as of June 30, 1988, adjusted by the Consumer Price Index—Urban (CPI-U) for medical care as determined applicable by the Director, OCHAMPUS, or designee; or (ii) The per diem rate accepted by the RTC from any other agency or organization (public or private) that is high enough to cover one-third of the total patient days during the 12-month period ending June 30, 1988, adjusted by the CPI-U; or Note: The per diem rate accepted by the RTC from any other agency or organization includes the rates accepted from entities such as Government contractors in CHAMPUS demonstration projects. (iii) An OCHAMPUS determined capped per diem amount not to exceed the 80th percentile of all established CHAMPUS RTC rates nationally, weighted by total CHAMPUS days provided at each rate during the base period discussed in paragraph (f)(1) of this section. (2) The all-inclusive per diem rates for RTCs which began operation after June 30, 1988, or began operation before July 1, 1988, but had less than 6 months of operation by June 30, 1988, will be calculated based on the lower of the per diem rate accepted by the RTC that is high enough to cover one-third of the total patient days during its first 6 to 12 consecutive months of operation, or the CHAMPUS determined capped amount. Rates for RTCs beginning operation prior to July 1, 1988, will be adjusted by an appropriate CPI-U inflation factor for the period ending June 30, 1988. A period of less than 12 months will be used only when the RTC has been in operation for less than 12 months. Once a full 12 months is available, the rate will be recalculated. (3) For care on or after April 6, 1995, the per diem amount may not exceed a cap of the 70th percentile of all established Federal fiscal year 1994 RTC rates nationally, weighted by total CHAMPUS days provided at each rate during the first half of Federal fiscal year 1994, and updated to FY95. For Federal fiscal years 1996 and 1997, the cap shall remain unchanged. For Federal fiscal years after fiscal year 1997, the cap shall be adjusted by the Medicare update factor for hospitals and units exempt from the Medicare prospective payment system. (4) All educational costs, whether they include routine education or special education costs, are excluded from reimbursement except when appropriate education is not available from, or not payable by, a cognizant public entity. (i) The RTC shall exclude educational costs from its daily costs. (ii) The RTC's accounting system must be adequate to assure CHAMPUS is not billed for educational costs. (iii) The RTC may request payment of educational costs on an individual case basis from the Director, OCHAMPUS, or designee, when appropriate education is not available from, or not payable by, a cognizant public entity. To qualify for reimbursement of educational costs in individual cases, the RTC shall comply with the application procedures established by the Director, OCHAMPUS, or designee, including, but not limited to, the following: (A) As part of its admission procedures, the RTC must counsel and assist the beneficiary and the beneficiary's family in the necessary procedures for assuring their rights to a free and appropriate public education. (B) The RTC must document any reasons why an individual beneficiary cannot attend public educational facilities and, in such a case, why alternative educational arrangements have not been provided by the cognizant public entity. (C) If reimbursement of educational costs is approved for an individual beneficiary by the Director, OCHAMPUS, or designee, such educational costs shall be shown separately from the RTC's daily costs on the CHAMPUS claim. The amount paid shall not exceed the RTC's most-favorable rate to any other patient, agency, or organization for special or general educational services whichever is appropriate. (D) If the RTC fails to request CHAMPUS approval of the educational costs on an individual case, the RTC agrees not to bill the beneficiary or the beneficiary's family for any amounts disallowed by CHAMPUS. Requests for payment of educational costs must be referred to the Director, OCHAMPUS, or designee for review and a determination of the applicability of CHAMPUS benefits. (5) Subject to the applicable RTC cap, adjustments to the RTC rates may be made annually. (i) For Federal fiscal years through 1995, the adjustment shall be based on the Consumer Price Index-Urban (CPI-U) for medical care as determined applicable by the Director, OCHAMPUS. (ii) For purposes of rates for Federal fiscal years 1996 and 1997: (A) For any RTC whose 1995 rate was at or above the thirtieth percentile of all established Federal fiscal year 1995 RTC rates normally, weighted by total CHAMPUS days provided at each rate during the first half of Federal fiscal year 1994, that rate shall remain in effect, with no additional update, throughout fiscal years 1996 and 1997; and (B) For any RTC whose 1995 rate was below the 30th percentile level determined under paragraph (f)(5)(ii)(A) of this section, the rate shall be adjusted by the lesser of: the CPI-U for medical care, or the amount that brings the rate up to that 30th percentile level. (iii) For subsequent Federal fiscal years after fiscal year 1997, RTC rates shall be updated by the Medicare update factor for hospitals and units exempt from the Medicare prospective payment system. (6) For care provided on or after July 1, 1995, CHAMPUS will not pay for days in which the patient is absent on leave from the RTC. The RTC must identify these days when claiming reimbursement. (g) Reimbursement of hospice programs. (1) National hospice rates. (i) Routine home care. (ii) Continuous home care. (A) A minimum of 8 hours of care must be provided within a 24-hour day starting and ending at midnight. (B) More than half of the total actual hours being billed for each 24-hour period must be provided by either a registered or licensed practical nurse. (C) Homemaker and home health aide services may be provided to supplement the nursing care to enable the beneficiary to remain at home. (D) For every hour or part of an hour of continuous care furnished, the hourly rate will be reimbursed to the hospice up to 24 hours a day. (iii) Inpatient respite care. (A) Payment for respite care may be made for a maximum of 5 days at a time, including the date of admission but not counting the date of discharge. The necessity and frequency of respite care will be determined by the hospice interdisciplinary group with input from the patient's attending physician and the hospice's medical director. (B) Payment for the sixth and any subsequent days is to be made at the routine home care rate. (iv) General inpatient care. (v) Date of discharge. (2) Use of Medicare rates. (3) Physician reimbursement. (i) Physicians employed by, or contracted with, the hospice. (B) Direct patient care services are paid in addition to the adjusted national payment rate. ( 1 ( 2 (ii) Independent attending physician. (A) Attending physician may bill in his/her own right. (B) Services will be subject to the appropriate allowable charge methodology. (C) Reimbursement is not counted toward the hospice cap limitation. (D) Services provided by an independent attending physician must be coordinated with any direct care services provided by hospice physicians. (E) The hospice must notify the CHAMPUS contractor of the name of the physician whenever the attending physician is not a hospice employee. (iii) Voluntary physician services. (4) Unrelated medical treatment. (5) Cap amount. (i) The cap amount will be adjusted annually by the percent of increase or decrease in the medical expenditure category of the Consumer Price Index for all urban consumers (CPI-U). (ii) The aggregate cap amount (i.e., the statutory cap amount times the number of CHAMPUS beneficiaries electing hospice care during the cap period) will be compared with total actual CHAMPUS payments made during the same cap period. (iii) Payments in excess of the cap amount must be refunded by the hospice program. The adjusted cap amount will be obtained from the Health Care Financing Administration (HCFA) prior to the end of each cap period. (iv) Calculation of the cap amount for a hospice which has not participated in the program for an entire cap year (November 1 through October 31) will be based on a period of at least 12 months but no more than 23 months. For example, the first cap period for a hospice entering the program on October 1, 1994, would run from October 1, 1994 through October 31, 1995. Similarly, the first cap period for hospice providers entering the program after November 1, 1993 but before November 1, 1994 would end October 31, 1995. (6) Inpatient limitation. (i) If the number of days of inpatient care furnished to CHAMPUS beneficiaries exceeds 20 percent of the total days of hospice care to CHAMPUS beneficiaries, the total payment for inpatient care is determined follows: (A) Calculate the ratio of the maximum number of allowable inpatient days of the actual number of inpatient care days furnished by the hospice to Medicare patients. (B) Multiply this ratio by the total reimbursement for inpatient care made by the CHAMPUS contractor. (C) Multiply the number of actual inpatient days in excess of the limitation by the routine home care rate. (D) Add the amounts calculated in paragraphs (g)(6)(i) (B) and (C) of this section. (ii) Compare the total payment for inpatient care calculated in paragraph (g)(6)(i)(D) of this section to actual payments made to the hospice for inpatient care during the cap period. (iii) Payments in excess of the inpatient limitation must be refunded by the hospice program. (7) Hospice reporting responsibilities. (i) Total reimbursement received and receivable for services furnished CHAMPUS beneficiaries during the cap period, including physician's services not of an administrative or general supervisory nature. (ii) Total reimbursement received and receivable for general inpatient care and inpatient respite care furnished to CHAMPUS beneficiaries during the cap period. (iii) Total number of inpatient days furnished to CHAMPUS hospice patients (both general inpatient and inpatient respite days) during the cap period. (iv) Total number of CHAMPUS hospice days (both inpatient and home care) during the cap period. (v) Total number of beneficiaries electing hospice care. The following rules must be adhered to by the hospice in determining the number of CHAMPUS beneficiaries who have elected hospice care during the period: (A) The beneficiary must not have been counted previously in either another hospice's cap or another reporting year. (B) The beneficiary must file an initial election statement during the period beginning September 28 of the previous cap year through September 27 of the current cap year in order to be counted as an electing CHAMPUS beneficiary during the current cap year. (C) Once a beneficiary has been included in the calculation of a hospice cap amount, he or she may not be included in the cap for that hospice again, even if the number of covered days in a subsequent reporting period exceeds that of the period where the beneficiary was included. (D) There will be proportional application of the cap amount when a beneficiary elects to receive hospice benefits from two or more different CHAMPUS-certified hospices. A calculation must be made to determine the percentage of the patient's length of stay in each hospice relative to the total length of hospice stay. (8) Reconsideration of cap amount and inpatient limit. (9) Beneficiary cost-sharing. may be (i) The patient is responsible for 5 percent of the cost of outpatient drugs or $5 toward each prescription, whichever is less. Additionally, the cost of prescription drugs (drugs or biologicals) may not exceed that which a prudent buyer would pay in similar circumstances; that is, a buyer who refuses to pay more than the going price for an item or service and also seeks to economize by minimizing costs. (ii) For inpatient respite care, the cost-share for each respite care day is equal to 5 percent of the amount CHAMPUS has estimated to be the cost of respite care, after adjusting the national rate for local wage differences. (iii) The amount of the individual cost-share liability for respite care during a hospice cost-share period may not exceed the Medicare inpatient hospital deductible applicable for the year in which the hospice cost-share period began. The individual hospice cost-share period begins on the first day an election is in effect for the beneficiary and ends with the close of the first period of 14 consecutive days on each of which an election is not in effect for the beneficiary. (h) Reimbursement of Home Health Agencies (HHAs). (1) Split percentage payments. (2) Low-utilization payment. (3) Partial episode payment (PEP). (4) Significant change in condition (SCIC). (i) The first part of the SCIC payment adjustment reflects the adjustment to the level of payment prior to the significant change in the patient's condition during the 60-day episode. (ii) The second part of the SCIC payment adjustment reflects the adjustment to the level of payment after the significant change in the patient's condition occurs during the 60-day episode. (5) Outlier payment. (i) TRICARE makes an outlier payment for an episode whose estimated cost exceeds a threshold amount for each case-mix group. (ii) The outlier threshold for each case-mix group is the episode payment amount for that group, the PEP adjustment amount for the episode or the total significant change in condition adjustment amount for the episode plus a fixed dollar loss amount that is the same for all case-mix groups. (iii) The outlier payment is a proportion of the amount of estimated cost beyond the threshold. (iv) TRICARE imputes the cost for each episode by multiplying the national per-visit amount of each discipline by the number of visits in the discipline and computing the total imputed cost for all disciplines. (v) The fixed dollar loss amount and the loss sharing proportion are chosen so that the estimated total outlier payment is no more than the predetermined percentage of total payment under the home health PPS as set by the Centers for Medicare & Medicaid Services (CMS). (6) Services paid outside the HHA prospective payment system. (i) Durable medical equipment (DME). (ii) Osteoporosis drugs. (7) Accelerated payments. (i) Approval of payment. (ii) Amount of payment. (iii) Recovery of payment. (8) Assessment data. (9) Administrative review. (i) Establishment of the payment unit, including the national 60-day prospective episode payment rate, adjustments and outlier payment. (ii) Establishment of transition period, definition and application of the unit of payment. (iii) Computation of the initial standard prospective payment amounts. (iv) Establishment of case-mix and area wage adjustment factors. (i) Changes in Federal Law affecting Medicare. (j) Reimbursement of individual health care professionals and other non-institutional, non-professional providers. The CHAMPUS-determined reasonable charge (the amount allowed by CHAMPUS) for the service of an individual health care professional or other non-institutional, non-professional provider (even if employed by or under contract to an institutional provider) shall be determined by one of the following methodologies, that is, whichever is in effect in the specific geographic location at the time covered services and supplies are provided to a CHAMPUS beneficiary. (1) Allowable charge method Introduction In general. (B) CHAMPUS Maximum Allowable Charge. (C) Limits on balance billing by nonparticipating providers. (D) Special rule for TRICARE Prime Enrollees. (E) Special rule for certain TRICARE Standard Beneficiaries. (ii) Prevailing charge level. (B) The national prevailing charge level referred to in paragraph (j)(1)(ii)(A) of this section is the level that does not exceed the amount equivalent to the 80th percentile of billed charges made for similar services during the base period. The 80th percentile of charges shall be determined on the basis of statistical data and methodology acceptable to the Director, OCHAMPUS (or a designee). (C) For purposes of paragraph (j)(1)(ii)(B) of this section, the base period shall be a period of 12 calendar months and shall be adjusted once a year, unless the Director, OCHAMPUS, determines that a different period for adjustment is appropriate and publishes a notice to that effect in the Federal Register. (iii) Appropriate charge level. (A) Step 1: Procedures classified. ( 1 Overpriced procedures. ( 2 Other procedures. ( 3 Underpriced procedures. (B) Step 2: Calculating appropriate charge levels. ( 1 ( 2 ( 3 (C) Special rule for cases in which the CHAMPUS appropriate charge was prematurely reduced. (D) Special rule for cases in which the national CMAC is less than the Medicare rate. Note: This paragraph will be implemented when CMAC rates are published. In any case in which the national CMAC calculated in accordance with paragraphs (j)(1)(i) through (iii) of this section is less than the Medicare rate, the Director, TSO, may determine that the use of the Medicare Economic Index under paragraph (j)(1)(iii)(B) of this section will result in a CMAC rate below the level necessary to assure that beneficiaries will retain adequate access to health care services. Upon making such a determination, the Director, TSO, may increase the national CMAC to a level not greater than the Medicare rate. (iv) Calculating CHAMPUS Maximum Allowable Charge levels for localities In general. (B) Special locality-based phase-in provision 1 In general. ( 2 Exception. 1 (C) Special locality-based waivers of reductions to assure adequate access to care. 1 ( 1 Waiver based on balanced billing rates. 2 ( 2 Exception. 1 3 ( 3 Waiver based on other evidence that adequate access to care would be impaired. (D) Special locality-based exception to applicable CMACs to assure adequate beneficiary access to care. ( 1) Procedure. ( 2) Establishing the higher payment rate(s). ( i ( ii ( 3) Application of higher payment rates. (E) Special locality-based exception to applicable CMACs to ensure an adequate TRICARE Prime preferred network. ( 1 ( i ( ii ( iii ( iv ( v ( 2 (v) Special rules for 1991. (B) Appropriate charge levels will be established for each locality for which an appropriate charge level was in effect immediately prior to October 7, 1991. For each procedure, the appropriate charge level shall be the prevailing charge level in effect immediately prior to October 7, 1991, adjusted as provided in (j)(1)(v)(B) ( 1 3 ( 1 ( 2 ( 3 (C) For purposes of this paragraph (j)(i)(v), “appropriate charge levels” in effect at any time prior to October 7, 1991 shall mean the lesser of: ( 1 ( 2 (vi) Special transition rule for 1992. (B) The adjustment to calendar year 1991 of the product of paragraph (j)(1)(vi)(A) of this section shall be as follows: ( 1 2 ( 2 2 (vii) Adjustments and procedural rules. (B) The Director, OCHAMPUS will issue procedural instructions for administration of the allowable charge method. (viii) Clinical laboratory services. (A) The calculation of national prevailing charge levels, national appropriate charge levels and national CMACs for laboratory service shall begin in calendar year 1993. For purposes of the 1993 calculation, the prior year's national appropriate charge level or national prevailing charge level shall be the level that does not exceed the amount equivalent to the 80th percentile of billed charges made for similar services during the period July 1, 1991, through June 30, 1992 (referred to in this paragraph (j)(1)(viii) of this section as the “base period”). (B) For purposes of comparison to Medicare allowable payment amounts pursuant to paragraph (j)(1)(iii) of this section, the Medicare national laboratory payment limitation amounts shall be used. (C) For purposes of establishing laboratory service local CMACs pursuant to paragraph (j)(1)(iv) of this section, the adjustment factor shall equal the ratio of the local average charge (standardized for the distribution of clinical laboratory services) to the national average charge for all clinical laboratory services during the base period. (D) For purposes of a special locality-based phase-in provision similar to that established by paragraph (j)(1)(iv)(B) of this section, the CMAC in a locality will not be less than 85 percent of the maximum charge level in effect for that locality during the base period. (ix) The allowable charge for physician assistant services other than assistant-at-surgery shall be at the same percentage, used by Medicare, of the allowable charge for a comparable service rendered by a physician performing the service in a similar location. For cases in which the physician assistant and the physician perform component services of a procedure other than assistant-at-surgery (e.g., home, office, or hospital visit), the combined allowable charge for the procedure may not exceed the allowable charge for the procedure rendered by a physician alone. The allowable charge for physician assistant services performed as an assistant-at-surgery shall be at the same percentage, used by Medicare, of the allowable charge for a physician serving as an assistant surgeon when authorized as CHAMPUS benefits in accordance with the provisions of § 199.4(c)(3)(iii). Physician assistant services must be billed through the employing physician who must be an authorized CHAMPUS provider. (x) A charge that exceeds the CHAMPUS Maximum Allowable Charge can be determined to be allowable only when unusual circumstances or medical complications justify the higher charge. The allowable charge may not exceed the billed charge under any circumstances. (xi) Pharmaceutical agents utilized as part of medically necessary medical services. (2) Bonus payments in medically underserved areas. (3) All-inclusive rate. (4) Alternative method. (k) Reimbursement of Durable Medical Equipment, Prosthetics, orthotics and Supplies 9DMEPOS). (l) Reimbursement Under the Military-Civilian Health Services Partnership Program. (1) Reimbursement of institutional health care providers. (2) Reimbursement of individual health-care professionals and other non-institutional health care providers. (m) Accommodation of Discounts Under Provider Reimbursement Methods General rule. (2) Special applications. (i) In the case and individual health care professionals and other non-institutional providers, if the discounted fee is below the provider's normal billed charge and the prevailing charge level (see paragraph (g) of this section), the discounted fee shall be the provider's actual billed charge and the CHAMPUS allowable charge. (ii) In the case of institutional providers normally paid on the basis of a pre-set amount (such as DRG-based amount under paragraph (a)(1) of this section or per-diem amount under paragraph (a)(2) of this section), if the discount rate is lower than the pre-set rate, the discounted rate shall be the CHAMPUS-determined allowable cost. This is an exception to the usual rule that the pre-set rate is paid regardless of the institutional provider's billed charges or other factors. (3) Procedures. (ii) The Director of OCHAMPUS may establish uniform terms, conditions and limitations for this payment method in order to avoid administrative complexity. (n) Outside the United States. (o) Implementing Instructions. [55 FR 13266, Apr. 10, 1990] Editorial Note: For Federal Register www.govinfo.gov. § 199.15 Quality and utilization review peer review organization program. (a) General Purpose. (2) Applicability of program. (3) Contractor implementation. (4) Medical issues affected. (5) Provider responsibilities. (6) Medicare rules used as model. (b) Objectives and general requirements of review system In general. (2) Payment exclusion for services provided contrary to utilization and quality standards. (ii) In any case in which payment is excluded pursuant to paragraph (b)(2)(i) of this section, the patient (or the patient's family) may not be billed for the excluded services. (iii) Limited exceptions and other special provisions pertaining to the requirements established in paragraphs (b)(2) (i) and (ii) of this section, are set forth in § 199.4(h). (3) Review of services covered by DRG-based payment system. (4) Preauthorization and other utilization review procedures In general. (A) The procedures for this review may be prospective (before the care is provided), concurrent (while the care is in process), or retrospective (after the care has been provided). Regardless of the procedures of this utilization review, the same generally accepted standards, norms and criteria for evaluating the medical necessity, appropriateness and reasonableness of the care involved shall apply. The Director, TRICARE Management Activity, or a designee, shall establish procedures for conducting reviews, including types of health care services for which preauthorization or concurrent review shall be required. Preauthorization or concurrent review may be required for categories of health care services. Except where required by law, the categories of health care services for which preauthorization or concurrent review is required may vary in different geographical locations or for different types of providers. (B) For healthcare services provided under TRICARE contracts entered into by the Department of Defense after October 30, 2000, medical necessity preauthorization will not be required for referrals for specialty consultation appointment services requested by primary care providers or specialty providers when referring TRICARE Prime beneficiaries for specialty consultation appointment services within the TRICARE contractor's network. However, the lack of medical necessity preauthorization requirements for consultative appointment services does not mean that non-emergent admissions or invasive diagnostic or therapeutic procedures which in and of themselves constitute categories of health care services related to, but beyond the level of the consultation appointment service, are not subject to medical necessity prior authorization. In fact many such health care services may continue to require medical necessity prior authorization as determined by the Director, TRICARE Management Activity, or a designee. TRICARE Prime beneficiaries are also required to obtain preauthorization before seeking health care services from a non-network provider. (ii) Preauthorization procedures. (A) The requirement for preauthorization shall be widely publicized to beneficiaries and providers. (B) All requests for preauthorization shall be responded to in writing. Notification of approval or denial shall be sent to the beneficiary. Approvals shall specify the health care services and supplies approved and identify any special limits or further requirements applicable to the particular case. (C) An approved preauthorization shall state the number of days, appropriate for the type of care involved, for which it is valid. In general, preauthorizations will be valid for 30 days. If the services or supplies are not obtained within the number of days specified, a new preauthorization request is required. For organ and stem cell transplants, the preauthorization shall remain in effect as long as the beneficiary continues to meet the specific transplant criteria set forth in the TRICARE/CHAMPUS Policy Manual, or until the approved transplant occurs. (D) For healthcare services provided under TRICARE contracts entered into by the Department of Defense after October 30, 2000, medical necessity preauthorization for specialty consultation appointment services within the TRICARE contractor's network will not be required. However, the Director, TRICARE Management Activity, or designee, may continue to require or waive medical necessity prior (or pre) authorization for other categories of other health care services based on best business practice. (iii) Payment reduction for noncompliance with required utilization review procedures. ( 1 ( 2 ( 3 In such a case, reimbursement will be reduced, unless such reduction is waived based on special circumstances. (B) In a case described in paragraph (b)(4)(iii)(A) of this section, reimbursement will be reduced, unless such reduction is waived based on special circumstances. The amount of this reduction shall be at least ten percent of the amount otherwise allowable for services for which preauthorization (including preauthorization for continued stays in connection with concurrent review requirements) approval should have been obtained, but was not obtained. (C) The payment reduction set forth in paragraph (b)(4)(iii)(B) of this section may be waived by the Director, OCHAMPUS when the provider could not reasonably have been expected to know of the preauthorization requirement or some other special circumstance justifies the waiver. (D) Services for which payment is disallowed under paragraph (b)(4)(iii) of this section may not be billed to the patient (or the patient's family). (c) Hospital cooperation. (1) Documentation that the beneficiary has received the required information about the CHAMPUS PRO program must be maintained in the same manner as is the notice required for the Medicare program by 42 CFR 466.78(b). (2) The physician acknowledgment required for Medicare under 42 CFR 412.46 is also required for CHAMPUS as a condition for payment and may be satisfied by the same statement as required for Medicare, with substitution or addition of “CHAMPUS” when the word “Medicare” is used. (3) Participating hospitals must execute a memorandum of understanding with the PRO providing appropriate procedures for implementation of the PRO program. (4) Participating hospitals may not charge a CHAMPUS beneficiary for inpatient hospital services excluded on the basis of § 199.4(g)(1) (not medically necessary), § 199.4(g)(3) (inappropriate level), or § 199.4(g)(7) (custodial care) unless all of the conditions established by 42 CFR 412.42(c) with respect to Medicare beneficiaries have been met with respect to the CHAMPUS beneficiary. In such cases in which the patient requests a PRO review while the patient is still an inpatient in the hospital, the hospital shall provide to the PRO the records required for the review by the close of business of the day the patient requests review, if such request was made before noon. If the hospital fails to provide the records by the close of business, that day and any subsequent working day during which the hospital continues to fail to provide the records shall not be counted for purposes of the two-day period of 42 CFR 412.42(c)(3)(ii). (d) Areas of review Admissions. (i) Transfers of CHAMPUS beneficiaries from a hospital or hospital unit subject to the CHAMPUS DRG-based payment system to another hospital or hospital unit. (ii) CHAMPUS admissions to a hospital or hospital unit subject to the CHAMPUS DRG-based payment system which occur within a certain period (specified by OCHAMPUS) of discharge from a hospital or hospital unit subject to the CHAMPUS DRG-based payment system. (iii) A random sample of other CHAMPUS admissions for each hospital subject to the CHAMPUS DRG-based payment system. (iv) CHAMPUS admissions in any DRGs which have been specifically identified by OCHAMPUS for review or which are under review for any other reason. (2) DRG validation. (i) Perform DRG validation reviews of each case under review. (ii) Review of claim adjustments submitted by hospitals which result in the assignment of a higher weighted DRG. (iii) Review for physician's acknowledgement of annual receipt of the penalty statement as contained in the Medicare regulation at 42 CFR 412.46. (iv) Review of a sample of claims for each hospital reimbursed under the CHAMPUS DRG-based payment system. Sample size shall be determined based upon the volume of claims submitted. (3) Outlier review. (4) Procedure review. (5) Other review. (e) Actions as a result of review Findings related to individual claims. (i) Deny payment for or recoup (in whole or in part) any amount claimed or paid for the inpatient hospital and professional services related to such determination. (ii) Require the hospital to take other corrective action necessary to prevent or correct the inappropriate practice. (iii) Advise the provider and beneficiary of appeal rights, as required by § 199.10 of this part. (iv) Notify OCHAMPUS of all such actions. (2) Findings related to a pattern of inappropriate practices. (3) Revision of coding relating to DRG validation. (i) If the diagnostic and procedural information in the patient's medical record is found to be inconsistent with the hospital's coding or DRG assignment, the hospital's coding on the CHAMPUS claim will be appropriately changed and payments recalculated on the basis of the appropriate DRG assignment. (ii) If the information stipulated under paragraph (d)(2) of this section is found not to be correct, the PRO will change the coding and assign the appropriate DRG on the basis of the changed coding. (f) Special procedures in connection with certain types of health care services or certain types of review activities In general. (2) Services not covered by the DRG-based payment system. (3) Peer review activities by contractors also performing other administration or management functions Sole-function PRO versus multi-function PRO. (ii) Special rules and procedures. (A) A reconsidered determination that would be final in cases involving sole-function PROs under paragraph (i)(2) of this section will not be final in connection with multi-function PROs. Rather, in such cases (other than any case which is appealable under paragraph (i)(3) of this section), an opportunity for a second reconsideration shall be provided. The second reconsideration will be provided by OCHAMPUS or another contractor independent of the multi-function PRO that performed the review. The second reconsideration may not be further appealed by the provider. (B) Procedures established by paragraphs (g) through (m) of this section shall not apply to any action of a multi-function PRO (or employee or other person or entity affiliated with the PRO) carried out in performance of functions other than functions under this section. (g) Procedures regarding initial determinations. (h) Procedures regarding reconsiderations. (i) Appeals and hearings. (2) Except as provided in paragraph (i)(3), a PRO reconsidered determination may not be further appealed by a provider. (3) A provider may appeal a PRO reconsideration determination to OCHAMPUS and obtain a hearing on such appeal to the extent allowed under the procedures set forth in § 199.10(d) if it is a determination pursuant to § 199.4(h) that the provider knew or could reasonably have been expected to know that the services were excludable. (4) For purposes of the hearing process, a PRO reconsidered determination shall be considered as the procedural equivalent of a formal review determination under § 199.10, unless revised at the initiative of the Director, OCHAMPUS prior to a hearing on the appeal, in which case the revised determination shall be considered as the procedural equivalent of a formal review determination under § 199.10. (5) The provisions of § 199.10(e) concerning final action shall apply to hearings cases. (j) Acquisition, protection and disclosure of peer review information. (k) Limited immunity from liability for participants in PRO program. (l) Additional provision regarding confidentiality of records General rule. (2) Specific applications. (ii) Initial denial determinations by PROs pursuant to paragraph (g) of this section (concerning medical necessity determinations, DRG validation actions, etc.) and subsequent decisions regarding those determinations are not nondisclosable quality assurance records under 10 U.S.C. 1102. (iii) Information the subject of mandatory PRO disclosure under 42 CFR part 476 is not a nondisclosable quality assurance record under 10 U.S.C. 1102. (m) Obligations, sanctions and procedures. (2) The provisions of 42 U.S.C. section 1395ww(f)(2) concerning circumvention by any hospital of the applicable payment methods for inpatient services shall apply to CHAMPUS payment methods as they do to Medicare payment methods. (3) The Director, or a designee, of CHAMPUS shall determine whether to impose a sanction pursuant to paragraphs (m)(1) and (m)(2) of this section. Providers may appeal adverse sanctions decisions under the procedures set forth in § 199.10(d). (n) Authority to integrate CHAMPUS PRO and military medical treatment facility utilization review activities. (2) In any case in which such a contractor has comparable responsibility and authority regarding utilization review in both an MTF (or MTFs) and CHAMPUS, determinations as to medical necessity in connection with services from an MTF or CHAMPUS-authorized provider may be consolidated. (3) In any case in which an MTF reserves authority to separate an MTF determination on medical necessity from a CHAMPUS PRO program determination on medical necessity, the MTF determination is not binding on CHAMPUS. [55 FR 625, Jan. 8, 1990, as amended at 58 FR 58961, Nov. 5, 1993; 60 FR 52095, Oct. 5, 1995; 63 FR 48447, Sept. 10, 1998; 66 FR 40608, Aug. 3, 2001; 67 FR 42721, June 25, 2002; 68 FR 23033, Apr. 30, 2003; 68 FR 32363, May 30, 2003; 68 FR 44881, July 31, 2003; 70 FR 19266, Apr. 13, 2005; 81 FR 61098, Sept. 2, 2016] § 199.16 Supplemental Health Care Program for active duty members. (a) Purpose and applicability. (2) This section applies to the program, known as the supplemental care program, which provides for the payment by the uniformed services to private sector health care providers for health care services provided to active duty members of the uniformed services. Although not part of CHAMPUS, the supplemental care program is similar to CHAMPUS in that it is a program for the uniformed services to purchase civilian health care services for active duty members. For this reason, the Director, OCHAMPUS assists the uniformed services in the administration of the supplemental care program. (3) This section applies to all health care services covered by the CHAMPUS. For purposes of this section, health care services ordered by a military treatment facility (MTF) provider for an MTF patient (who is not an active duty member) for whom the MTF provider maintains responsibility are also covered by the supplemental care program and subject to the requirements of this section. (b) Obligation of providers concerning payment for supplemental health care for active duty members Hospitals covered by DRG-based payment system. (2) Other participating providers. (c) General rule for payment and administration. (d) Special rules and procedure. (1) There is no patient cost sharing under the supplemental care program. All amounts due to be paid to the provider shall be paid by the program. (2) Preauthorization by the Uniformed Services of each service is required for the supplemental care program except for services in cases of medical emergency (for which the definition in Sec. 199.2 shall apply) or in cases governed by the TRICARE Prime Remote program for active duty service members set forth in paragraph (e) of this section. It is the responsibility of the active duty members to obtain preauthorization for each service. With respect to each emergency inpatient admission, after such time as the emergency condition is addressed, authorization for any proposed continued stay must be obtained within two working days of admission. (3) With respect to the filing of claims and similar administrative matters for which this part refers to activities of the CHAMPUS fiscal intermediaries, for purposes of the supplemental care program, responsibilities for claims processing, payment and some other administrative matters may be assigned by the Director, OCHAMPUS to the same fiscal intermediaries, other contractor, or to the nearest military medical treatment facility or medical claims office. (4) The annual cost pass-throughs for capital and direct medical education costs that are available under the CHAMPUS DRG-based payment system are also available, upon request, under the supplemental care program. To obtain payment include the number of active duty bed days as a separate line item on the annual request to the CHAMPUS fiscal intermediaries. (5) For providers other than participating providers, the Director, OCHAMPUS may authorize payment in excess of CHAMPUS allowable amounts. No provider may bill an active duty member any amount in excess of the CHAMPUS allowable amount. (e) TRICARE Prime Remote for Active Duty Members General. (2) Eligibility. (i) Has a permanent duty assignment that is greater than fifty miles or approximately one hour drive from a military treatment facility or military clinic designated as adequate to provide the needed primary care services to the active duty service member; and (ii) Pursuant to the assignment of such duty, resides at a location that is greater than fifty miles or approximately one hour from a military medical treatment facility or military clinic designated as adequate to provide the needed primary care services to the active duty service member. (3) Enrollment. (4) Preauthorization. (f) Waiver authority. (g) Authorities. (2) The Assistant Secretary of Defense for Health Affairs is responsible for the overall policy direction of the supplemental care program and the administration of this part. (3) The Director, OCHAMPUS shall issue procedural requirements for the implementation of this section, including requirement for claims submission similar to those established by § 199.7. [56 FR 23801, May 24, 1991, as amended at 58 FR 58963, Nov. 5, 1993; 67 FR 5479, Feb. 6, 2002; 71 FR 50348, Aug. 25, 2006] § 199.17 TRICARE program. (a) Establishment. (1) Purpose. (2) Statutory authority. (3) Scope of the program. (4) Rules and procedures affected. (5) Implementation based on local action. (6) Major features of the TRICARE program. (i) Beneficiary categories. (A) Active duty members, who are covered by 10 U.S.C. 1074(a). (B) Active duty family members, who are beneficiaries covered by 10 U.S.C. 1079 (also referred to in this section as “active duty family category”). (C) Retirees and their family members (also referred to in this section as “retired category”), who are beneficiaries covered by 10 U.S.C. 1086(c) other than those beneficiaries eligible for Medicare Part A. (D) Medicare eligible retirees and Medicare eligible retiree family members who are beneficiaries covered by 10 U.S.C. 1086(d) as each become individually eligible for Medicare Part A and enroll in Medicare Part B. (E) Military treatment facility (MTF) only beneficiaries are beneficiaries eligible for health care services in military treatment facilities, but not eligible for a TRICARE plan covering non-MTF care. (ii) Health plans available. (A) TRICARE Prime. (B) TRICARE Select. (C) TRICARE for Life. (D) TRICARE Standard. (iii) Comprehensive enrollment system. (7) Preemption of State laws. (ii) Based on the determination set forth in paragraph (a)(7)(i) of this section, any State or local law relating to health insurance, prepaid health plans, or other health care delivery or financing methods is preempted and does not apply in connection with TRICARE regional contracts. Any such law, or regulation pursuant to such law, is without any force or effect, and State or local governments have no legal authority to enforce them in relation to the TRICARE regional contracts. (However, the Department of Defense may by contract establish legal obligations of the part of TRICARE contractors to conform with requirements similar or identical to requirements of State or local laws or regulations). (iii) The preemption of State and local laws set forth in paragraph (a)(7)(ii) of this section includes State and local laws imposing premium taxes on health or dental insurance carriers or underwriters or other plan managers, or similar taxes on such entities. Such laws are laws relating to health insurance, prepaid health plans, or other health care delivery or financing methods, within the meaning of the statutes identified in paragraph (a)(7)(i) of this section. Preemption, however, does not apply to taxes, fees, or other payments on net income or profit realized by such entities in the conduct of business relating to DoD health services contracts, if those taxes, fees or other payments are applicable to a broad range of business activity. For purposes of assessing the effect of Federal preemption of State and local taxes and fees in connection with DoD health and dental services contracts, interpretations shall be consistent with those applicable to the Federal Employees Health Benefits Program under 5 U.S.C. 8909(f). (b) TRICARE Prime and TRICARE Select health plans in general. (1) TRICARE Prime. (2) TRICARE Select. (c) Eligibility for enrollment in TRICARE Prime and TRICARE Select. (1) Active duty members. (2) Dependents of active duty members. (3) Survivors of deceased members. (ii) A dependent child or unmarried person (as described in § 199.3(b)(2)(ii) or (iv)) of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001, is eligible to enroll in Prime (where offered) or Select and is subject to the same rules and provisions of dependents of active duty members for a period of three years from the date the active duty sponsor dies or until the surviving eligible dependent: (A) Attains 21 years of age; or (B) Attains 23 years of age or ceases to pursue a full-time course of study prior to attaining 23 years of age, if, at 21 years of age, the eligible surviving dependent is enrolled in a full-time course of study in a secondary school or in a full-time course of study in an institution of higher education approved by the Secretary of Defense and was, at the time of the sponsor's death, in fact dependent on the member for over one-half of such dependent's support. (4) Retirees, dependents of retirees, and survivors (other than survivors of deceased members covered under paragraph (c)(3) of this section). (d) Health benefits under TRICARE Prime Military treatment facility (MTF) care In general. (A) Active duty service members; (B) Active duty service members' dependents and survivors of service members who died on active duty, who are enrolled in TRICARE Prime; (C) Retirees, their dependents and survivors, who are enrolled in TRICARE Prime; (D) Active duty service members' dependents and survivors of deceased members, who are not enrolled in TRICARE Prime; and (E) Retirees, their dependents and survivors who are not enrolled in TRICARE Prime. For purposes of this paragraph (d)(1), survivors of members who died while on active duty are considered as among dependents of active duty service members. (ii) Special provisions. (2) Non-MTF care for active duty members. (3) Civilian sector Prime benefits. (e) Health benefits under the TRICARE Select plan Civilian sector care. (2) Military treatment facility (MTF) care. (f) Benefits under TRICARE Prime and TRICARE Select In general. (2) Preventive care services. (i) Laboratory and imaging tests, including blood lead, rubella, cholesterol, fecal occult blood testing, and mammography; (ii) Cancer screenings (including cervical, breast, lung, prostate, and colon cancer screenings); (iii) Immunizations; (iv) Periodic health promotion and disease prevention exams; (v) Blood pressure screening; (vi) Hearing exams; (vii) Sigmoidoscopy or colonoscopy; (viii) Serologic screening; and (ix) Appropriate education and counseling services. The exact services offered shall be established under uniform standards established by the Director. (3) Treatment of obesity. (4) High value services. (5) Other services. (g) TRICARE Prime Remote for Active Duty Family Members In general. (2) Active duty family member. (i) Spouse, child, or unmarried person, as defined in § 199.3(b)(2)(i), (ii), or (iv); (ii) For a 3-year period, the surviving spouse of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001; and (iii) The surviving dependent child or unmarried person, as defined in § 199.3(b)(2)(ii) or (iv), of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001. Active duty family member status is for a period of 3 years from the date the active duty sponsor dies or until the surviving eligible dependent: (A) Attains 21 years of age; or (B) Attains 23 years of age or ceases to pursue a full-time course of study prior to attaining 23 years of age, if, at 21 years of age, the eligible surviving dependent is enrolled in a full-time course of study in a secondary school or in a full-time course of study in an institution of higher education approved by the Secretary of Defense and was, at the time of the sponsor's death, in fact dependent on the member for over one-half of such dependent's support. (3) Eligibility. (A) The family member's active duty sponsor has been assigned permanent duty as a recruiter; as an instructor at an educational institution, an administrator of a program, or to provide administrative services in support of a program of instruction for the Reserve Officers' Training Corps; as a full-time adviser to a unit of a reserve component; or any other permanent duty designated by the Director that the Director determines is more than 50 miles, or approximately one hour driving time, from the nearest military treatment facility that is adequate to provide care. (B) The family members and active duty sponsor, pursuant to the assignment of duty described in paragraph (g)(3)(i)(A) of this section, reside at a location designated by the Director, that the Director determines is more than 50 miles, or approximately one hour driving time, from the nearest military medical treatment facility adequate to provide care. (C) The family member, having resided together with the active duty sponsor while the sponsor served in an assignment described in paragraph (g)(3)(i)(A) of this section, continues to reside at the same location after the sponsor relocates without the family member pursuant to orders for a permanent change of duty station, and the orders do not authorize dependents to accompany the sponsor to the new duty station at the expense of the United States. (D) For a 3 year period, the surviving spouse of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001. (E) The surviving dependent child or unmarried person as defined in § 199.3(b)(2)(ii) or (iv), of a member who dies while on active duty for a period of more than 30 days whose death occurred on or after October 7, 2001, for three years from the date the active duty sponsor dies or until the surviving eligible dependent: ( 1 ( 2 (ii) A family member who is a dependent of a reserve component member is eligible for TRICARE Prime Remote for Active Duty Family Members if he or she is eligible for CHAMPUS and meets all of the following additional criteria: (A) The reserve component member has been ordered to active duty for a period of more than 30 days. (B) The family member resides with the member. (C) The Director, determines the residence of the reserve component member is more than 50 miles, or approximately one hour driving time, from the nearest military medical treatment facility that is adequate to provide care. (D) “Resides with” is defined as the TRICARE Prime Remote residence address at which the family resides with the activated reservist upon activation. (4) Enrollment. (5) Health care management requirements under TRICARE Prime Remote for Active Duty Family Members. (6) Cost sharing. (h) Resource sharing agreements. (1) In connection with internal resource sharing agreements, beneficiary cost sharing requirements shall be the same as those applicable to health care services provided in facilities of the uniformed services. (2) Under internal resource sharing agreements, the double coverage requirements of § 199.8 shall be replaced by the Third Party Collection procedures of 32 CFR part 220, to the extent permissible under such part. In such a case, payments made to a resource sharing agreement provider through the TRICARE managed care support contractor shall be deemed to be payments by the MTF concerned. (3) Under internal or external resource sharing agreements, the commander of the MTF concerned may authorize the provision of services, pursuant to the agreement, to Medicare-eligible beneficiaries, if such services are not reimbursable by Medicare, and if the commander determines that this will promote the most cost-effective provision of services under the TRICARE program. (4) Under external resource sharing agreements, there is no cost sharing applicable to services provided by military facility personnel. Cost sharing for non-MTF institutional and related ancillary charges shall be as applicable to services provided under TRICARE Prime or TRICARE Select, as appropriate. (i) General quality assurance, utilization review, and preauthorization requirements under the TRICARE program. (j) Pharmacy services. (k) Design of cost sharing structures under TRICARE Prime and TRICARE Select In general. e.g., i.e., (2) Categories of health care services. (i) Preventive care visits. These are outpatient visits and related services described in paragraph (f)(2) of this section. There are no cost sharing requirements for preventive care listed under §§ 199.4(e)(28)(i) through (iv) and 199.17(f)(2). Beneficiaries shall not be required to pay any portion of the cost of these preventive services even if the beneficiary has not satisfied any applicable deductible for that year. (ii) Primary care outpatient visits. These are outpatient visits, not occurring in an ER or urgent care center, with the following provider specialties: (A) General Practice. (B) Family Practice. (C) Internal Medicine. (D) OB/GYN. (E) Pediatrics. (F) Physician's Assistant. (G) Nurse Practitioner. (H) Nurse Midwife. (iii) Specialty care outpatient visits. This category applies to outpatient care provided by provider specialties other than those listed under primary care outpatient visits under paragraph (k)(2)(ii) of this section and not specifically included in one of the other categories of care ( e.g., 3 i (iv) Emergency room visits. (v) Urgent care center visits. (vi) Ambulance services. This is for ground ambulance services. (vii) Ambulatory surgery. This is for facility-based outpatient ambulatory surgery services. (viii) Inpatient hospital admissions. (ix) Skilled nursing facility or rehabilitation facility admissions. This category includes a residential treatment center, or substance use disorder rehabilitation facility residential treatment program. (x) Durable medical equipment, prosthetic devices, and other authorized supplies. (xi) Outpatient prescription pharmaceuticals. These are addressed in § 199.21. (3) Beneficiary categories further subdivided. e.g., (i) Group A consists of Prime or Select enrollees whose sponsor originally enlisted or was appointed in a uniformed service before January 1, 2018. (ii) Group B consists of Prime or Select enrollees whose sponsor originally enlisted or was appointed in a uniformed service on or after January 1, 2018. (l) Enrollment fees and cost sharing (including deductibles and catastrophic cap) amounts. (1) Enrollment fee and cost sharing under TRICARE Prime. (A) There is no enrollment fee for the active duty family member category. (B) The retired category enrollment fee in calendar year 2018 is equal to the Prime enrollment fee for fiscal year 2017, indexed to calendar year 2018 and thereafter in accordance with 10 U.S.C. 1097. The Assistant Secretary of Defense (Health Affairs) may exempt survivors of active duty deceased sponsors and medically retired Uniformed Services members and their dependents from future increases in enrollment fees. The Assistant Secretary of Defense (Health Affairs) may also waive the enrollment fee requirements for Medicare-eligible beneficiaries. (C) The cost sharing amounts are established annually in connection with the open season enrollment period. An amount is established for each category of care identified in paragraph (k)(2) of this section, taking into account all applicable statutory provisions, including 10 U.S.C. chapter 55. The amount for each category of care may not exceed the amount for Group B as set forth in 10 U.S.C. 1075a. (D) The catastrophic cap is $1,000 for active duty families and $3,000 for retired category families. (ii) For Group B TRICARE Prime enrollees, the enrollment fee, catastrophic cap, and cost sharing amounts are as set forth in 10 U.S.C. 1075a. The cost sharing requirements applicable to services not specifically addressed in the table set forth in 10 U.S.C. 1075a(b)(1) shall be determined by the Director, DHA. (iii) For both Group A and Group B, for health care services obtained by a Prime enrollee but not obtained in accordance with the rules and procedures of Prime ( e.g. (2) Enrollment fee and cost sharing under TRICARE Select. (A) The enrollment fee in calendar years 2018 through 2020 is zero and the catastrophic cap is as provided in 10 U.S.C. 1079 or 1086. The enrollment fee and catastrophic cap in 2021 and thereafter for certain beneficiaries in the retired category is as provided in 10 U.S.C. 1075(e), except the enrollment fee and catastrophic cap adjustment shall not apply to survivors of active duty deceased sponsors and medically retired Uniformed Services members and their dependents. Payment of TRICARE premiums and enrollment fees will be withheld from the retired, retainer or equivalent pay of these beneficiaries in the retired category to the maximum extent practicable upon complete implementation of this rule and thereafter. Appropriate processes to require and manage these allotments, to include frequency and method, as well as alternatives when allotments are not practicable, shall be determined by the Director, DHA. An exception may be made for certain survivors of active duty deceased sponsors and medically retired Uniformed Services members and their dependents, for which the enrollment fee and catastrophic cap adjustments shall not apply. (B) The cost sharing amounts for network care for Group A enrollees are calculated for each category of care described in paragraph (k)(2) of this section by taking into account all applicable statutory provisions, including 10 U.S.C. chapter 55, as if TRICARE Extra and Standard programs were still being implemented. When determined practicable, including efficiency and effectiveness in administration, the amounts established are converted to fixed dollar amounts for each category of care for which a fixed dollar amount is established by 10 U.S.C. 1075. When determined not to be practicable, as in the categories of care including ambulatory surgery, inpatient admissions, and inpatient skilled nursing/rehabilitation admissions, the calculated cost-sharing amounts are not converted to fixed dollar amounts. The fixed dollar amount for each category is set prospectively for each calendar year as the amount (rounded down to the nearest dollar amount) equal to 15% for enrollees in the active duty family beneficiary category or 20% for enrollees in the retired beneficiary category of the projected average allowable payment amount for each category of care during the year, as estimated by the Director. The projected average allowable payment amount for primary care (including urgent care) and specialty care outpatient appointments include payments for ancillary services ( e.g., (C) The cost share for care received from non-network providers is as provided in § 199.4. (D) The annual deductible amount is as provided in 10 U.S.C. 1079 or 1086. (ii) For Group B TRICARE Select enrollees, the enrollment fee, annual deductible for services received while in an outpatient status, catastrophic cap., and cost sharing amounts are as provided in 10 U.S.C. 1075 and as consistent with this section. The cost sharing requirements applicable to services not specifically addressed in 10 U.S.C. 1075 shall be determined by the Director, DHA. (3) Special cost-sharing rules. (ii) Cost-sharing for maternity care services shall be determined in accordance with § 199.4(e)(16). (4) Special transition rule for the last quarter of calendar year 2017. (A) A Prime enrollee's enrollment fee for the quarter is one-fourth of the enrollment fee for fiscal year 2017. (B) The deductible amount and the catastrophic cap amount for fiscal year 2017 will be applicable to the 15-month period of October 1, 2016 through December 31, 2017. (m) Limit on out-of-pocket costs under TRICARE Prime and TRICARE Select. (n) Additional health care management requirements under TRICARE Prime. (1) Primary care manager. (2) Referral and preauthorization requirements. (A) For the purpose of this paragraph (n)(2), referral addresses the issue of who will provide authorized health care services. In many cases, Prime beneficiaries will be referred by a primary care manager to a medical department of an MTF if the type of care needed is available at the MTF. In such a case, failure to adhere to that referral will result in the care being subject to point-of-service charges. In other cases, a referral may be to the civilian provider network, and again, point-of-service charges would apply to a failure to follow the referral. (B) In contrast to referral, preauthorization addresses the issue of whether particular services may be covered by TRICARE, including whether they appear necessary and appropriate in the context of the patient's diagnosis and circumstances. A major purpose of preauthorization is to prevent surprises about coverage determinations, which are sometimes dependent on particular details regarding the patient's condition and circumstances. While TRICARE Prime has referral requirements that do not exist for TRICARE Select, TRICARE Select has some preauthorization requirements that do not exist for TRICARE Prime. (ii) Except as otherwise provided in this paragraph (n)(2), a beneficiary enrolled in TRICARE Prime is required to obtain a referral for care through a designated primary care manager (or other authorized care coordinator) prior to obtaining care under the TRICARE program. (iii) There is no referral requirement under paragraph (n)(2)(i) of this section in the following circumstances: (A) In emergencies; (B) For urgent care services for a certain number of visits per year (zero to unlimited), with the number specified by the Director and notice provided in connection with the open season enrollment period preceding the plan year; and (C) In any other special circumstances identified by the Director, generally with notice provided in connection with the open season enrollment period for the plan year. (iv) A primary care manager who believes a referral to a specialty care provider is medically necessary and appropriate need not obtain pre-authorization from the managed care support contractor before referring a patient to a network specialty care provider. Such preauthorization is only required with respect to a primary care manager's referral for: (A) Inpatient hospitalization; (B) Inpatient care at a skilled nursing facility; (C) Inpatient care at a rehabilitation facility; and (D) Inpatient care at a residential treatment facility. (v) The restrictions in paragraph (n)(2)(iv) of this section on preauthorization requirements do not apply to any preauthorization requirements that are generally applicable under TRICARE, independent of TRICARE Prime referrals, such as: (A) Under the Pharmacy Benefits Program under 10 U.S.C. 1074g and § 199.21. (B) For laboratory and other ancillary services. (C) Durable medical equipment. (vi) The cost-sharing requirement for a beneficiary enrolled in TRICARE Prime who does not obtain a referral for care when it is required, including care from a non-network provider, is as provided in paragraph (l)(1)(iii) of this section concerning point of service care. (vii) In the case of care for which preauthorization is not required under paragraph (n)(2)(iv) of this section, the Director may authorize a managed care support contractor to offer a voluntary pre-authorization program to enable beneficiaries and providers to confirm covered benefit status and/or medical necessity or to understand the criteria that will be used by the managed care support contractor to adjudicate the claim associated with the proposed care. A network provider may not be required to use such a program with respect to a referral. (3) Restrictions on the use of providers. (i) Prime enrollees must obtain all primary health care from the primary care manager or from another provider to which the enrollee is referred by the primary care manager or otherwise authorized. (ii) For any necessary specialty care and non-emergent inpatient care, the primary care manager or other authorized individual will assist in making an appropriate referral. (iii) Though referrals for specialty care are generally the responsibility of the primary care managers, subject to discretion exercised by the TRICARE Regional Directors, and established in regional policy or memoranda of understanding, specialist providers may be permitted to refer patients for additional specialty consultation appointment services within the TRICARE contractor's network without prior authorization by primary care managers. (iv) The following procedures will apply to health care referrals under TRICARE Prime: (A) The first priority for referral for specialty care or inpatient care will be to the local MTF (or to any other MTF in which catchment area the enrollee resides). (B) If the local MTF(s) are unavailable for the services needed, but there is another MTF at which the needed services can be provided, the enrollee may be required to obtain the services at that MTF. However, this requirement will only apply to the extent that the enrollee was informed at the time of (or prior to) enrollment that mandatory referrals might be made to the MTF involved for the service involved. (C) If the needed services are available within civilian preferred provider network serving the area, the enrollee may be required to obtain the services from a provider within the network. Subject to availability, the enrollee will have the freedom to choose a provider from among those in the network. (D) If the needed services are not available within the civilian preferred provider network serving the area, the enrollee may be required to obtain the services from a designated civilian provider outside the area. However, this requirement will only apply to the extent that the enrollee was informed at the time of (or prior to) enrollment that mandatory referrals might be made to the provider involved for the service involved (with the provider and service either identified specifically or in connection with some appropriate classification). (E) In cases in which the needed health care services cannot be provided pursuant to the procedures identified in paragraphs (n)(3)(iv)(A) through (D) of this section, the enrollee will receive authorization to obtain services from a TRICARE-authorized civilian provider(s) of the enrollee's choice not affiliated with the civilian preferred provider network. (iv) When Prime is operating in non-catchment areas, the requirements in paragraphs (n)(3)(iv)(B) through (E) of this section shall apply. (4) Point-of-service option. (5) Prime travel benefit. (o) TRICARE program enrollment procedures. (1) Annual open season enrollment. (ii) Open season enrollment procedures may include automatic re-enrollment in the same plan for the next plan year for enrollees or sponsors that will occur in the event the enrollee does not take other action during the open season period. (2) Exceptions to the calendar year enrollment process. (3) Installment payments of enrollment fee. Effect of failure to enroll. (5) Automatic enrollment for certain dependents. (6) Grace periods. (p) Civilian preferred provider networks. (1) Status of network providers. (2) Utilization management policies. (3) Quality assurance requirements. (4) Provider qualifications. (i) They must be TRICARE-authorized providers and TRICARE- participating providers. In addition, a network provider may not require payment from the beneficiary for any excluded or excludable services that the beneficiary received from the network provider ( i.e., (A) If the beneficiary did not inform the provider that he or she was a TRICARE beneficiary, the provider may bill the beneficiary for services provided. (B) If the beneficiary was informed in writing that the specific services were excluded or excludable from TRICARE coverage and the beneficiary agreed in writing, in advance of the services being provided, to pay for the services, the provider may bill the beneficiary. (ii) All physicians in the preferred provider network must have staff privileges in a hospital accredited by The Joint Commission (TJC) or other accrediting body determined by the Director. This requirement may be waived in any case in which a physician's practice does not include the need for admitting privileges in such a hospital, or in locations where no accredited facility exists. However, in any case in which the requirement is waived, the physician must comply with alternative qualification standards as are established by the Director. (iii) All preferred providers must agree to follow all quality assurance, utilization management, and patient referral procedures established pursuant to this section, to make available to designated DoD utilization management or quality monitoring contractors medical records and other pertinent records, and to authorize the release of information to MTF Commanders regarding such quality assurance and utilization management activities. (iv) All preferred network providers must be Medicare participating providers, unless this requirement is waived based on extraordinary circumstances. This requirement that a provider be a Medicare participating provider does not apply to providers who not eligible to be participating providers under Medicare. (v) The network provider must be available to all TRICARE beneficiaries. (vi) The provider must agree to accept the same payment rates negotiated for Prime enrollees for any person whose care is reimbursable by the Department of Defense, including, for example, Select participants, supplemental care cases, and beneficiaries from outside the area. (vii) All preferred providers must meet all other qualification requirements, and agree to comply with all other rules and procedures established for the preferred provider network. (viii) In locations where TRICARE Prime is not available, a TRICARE provider network will, to the extent practicable, be available for TRICARE Select enrollees. In these locations, the minimal requirements for network participation are those set forth in paragraph (p)(4)(i) of this section. Other requirements of this paragraph (p) will apply unless waived by the Director. (5) Access standards. (i) Under normal circumstances, enrollee travel time may not exceed 30 minutes from home to primary care delivery site unless a longer time is necessary because of the absence of providers (including providers not part of the network) in the area. (ii) The wait time for an appointment for a well-patient visit or a specialty care referral shall not exceed four weeks; for a routine visit, the wait time for an appointment shall not exceed one week; and for an urgent care visit the wait time for an appointment shall generally not exceed 24 hours. (iii) Emergency services shall be available and accessible to handle emergencies (and urgent care visits if not available from other primary care providers pursuant to paragraph (p)(5)(ii) of this section), within the service area 24 hours a day, seven days a week. (iv) The network shall include a sufficient number and mix of board certified specialists to meet reasonably the anticipated needs of enrollees. Travel time for specialty care shall not exceed one hour under normal circumstances, unless a longer time is necessary because of the absence of providers (including providers not part of the network) in the area. This requirement does not apply under the Specialized Treatment Services Program. (v) Office waiting times in nonemergency circumstances shall not exceed 30 minutes, except when emergency care is being provided to patients, and the normal schedule is disrupted. (6) Special reimbursement methods for network providers. (q) Preferred provider network establishment. (i) The provider must meet all applicable requirements in paragraph (p)(4) of this section. (ii) The provider must agree to follow all quality assurance and utilization management procedures established pursuant to this section. (iii) The provider must be a participating provider under TRICARE for all claims. (iv) The provider must meet all other qualification requirements, and agree to all other rules and procedures, that are established, publicly announced, and uniformly applies by the Director (or other authorized official). (v) The provider must sign a preferred provider network agreement covering all applicable requirements. Such agreements will be for a duration of one year, are renewable, and may be canceled by the provider or the Director (or other authorized official) upon appropriate notice to the other party. The Director shall establish an agreement model or other guidelines to promote uniformity in the agreements. (2) In addition to the above requirements, the Director, or designee, may establish additional categories of preferred providers of high quality/high value that require additional qualifications. (r) General fraud, abuse, and conflict of interest requirements under TRICARE program. (s) [Reserved] (t) Inclusion of Department of Veterans Affairs Medical Centers in TRICARE networks. (u) Care provided outside the United States. (1) TRICARE Prime. (2) TRICARE Select. (3) TRICARE for Life. (v) Administration of the TRICARE program in the state of Alaska. (w) Administrative procedures. [82 FR 45448, Sept. 29, 2017, as amended at 84 FR 4333, Feb. 15, 2019; 85 FR 27927, May 12, 2020; 87 FR 33014, June 1, 2022; 87 FR 46886, Aug. 1, 2022; 89 FR 45767, May 24, 2024] § 199.18 [Reserved] § 199.20 Continued Health Care Benefit Program (CHCBP). (a) Purpose. (b) General provisions. (c) Definitions. (d) Eligibility and enrollment. Eligibility, (i) Ceases to meet the requirements for eligibility under 10 U.S.C. chapter 55 or 10 U.S.C. 1145, and (ii) Who on the day before they cease to meet the eligibility requirements for such care they were covered under a health benefit plan under 10 U.S.C. chapter 55 or transitional healthcare under 10 U.S.C. 1145, and (iii) Who would otherwise not be eligible for any benefits under 10 U.S.C. chapter 55 or 10 U.S.C. 1145 except for CHCBP. (2) Exceptions. (i) Members of uniformed services, who are discharged or released from active duty either voluntarily or involuntarily under conditions that are adverse. (ii) Individuals who lost their eligibility or entitlement to care under 10 U.S.C. chapter 55 or 10 U.S.C. 1145 before October 1, 1994. (iii) Individuals who are locked out of other TRICARE programs per that program's requirements. (3) Effective date. (4) Notification of eligibility. (i) The Department of Defense and the other uniformed services (National Oceanic and Atmospheric Administration (NOAA), Public Health Service (PHS), and Coast Guard) will notify persons in the uniformed services eligible to receive health benefits under the CHCBP. In the case of a member who becomes (or will become) eligible for continued coverage, the Department of Defense shall notify the member of their rights for coverage as part of pre-separation counseling conducted under 10 U.S.C. 1142. (ii) In the case of a dependent of a member or former member who become eligible for continued coverage under paragraph (d)(1)(ii) of this section: (A) The member or former member may submit to the CHCBP contractor a notice with supporting documentation of the dependent's change in status (including the dependent's name, address, and such other information needed); and (B) The CHCBP contractor, within fourteen (14) days after receiving such information, will inform the dependent of the dependent's rights under 10 U.S.C. 1142. (iii) In the case of a former spouse of a member or former member who becomes eligible for continued coverage, the member, former member or former spouse may submit to the CHCBP contractor a notice of the former spouse's change in status. The CHCBP contractor within fourteen (14) days after receiving such information will notify the individual of their potential eligibility for CHCBP. (5) Election of coverage. (i) In the case of a member discharged or released from active duty or full-time National Guard duty (whether voluntarily or involuntarily), or a RC member formerly eligible for care under 10 U.S.C. chapter 55, the written election shall be submitted to the CHCBP contractor before the end of the 60-day period beginning on the later of: (A) The date of the discharge or release of the member; or (B) The date that the period of transitional health care applicable to the member under 10 U.S.C. 1145(a) ends; or (C) The date the member receives the notification required in paragraph (d)(3) of this section. (ii) In the case of a child who ceases to meet the requirements for being an unremarried dependent child of a member or former member under 10 U.S.C. 1072(2)(D) or an unmarried dependent of a member or former member of the uniformed services under 10 U.S.C. 1072(2)(I), the written election shall be submitted to the CHCBP contractor before the end of the 60-day period beginning on the later of: (A) The date that the dependent ceases to meet the definition of a dependent under 10 U.S.C. 1072(2)(D) or 10 U.S.C. 1072(2)(I); or (B) The date that the dependent receives the notification required in paragraph (d)(3) of this section, (iii) In the case of former spouse of a member or former member, the written election shall be submitted to the CHCBP contractor before the end of the 60-day period beginning on the date as of which the former spouse first ceases to meet the requirements for being considered a dependent under 10 U.S.C. 1072(2). (iv) In the case of an unmarried surviving spouse of a member or former member of the uniformed services who on the day before the death of the member or former member was covered under 10 U.S.C. chapter 55 or 10 U.S.C. 1145(a), the written election shall be submitted to the CHCBP contractor within 60 days of the date of the member or former member's death. (v) A member of the uniformed services who is eligible for enrollment under paragraph (d)(1) of this section may elect self-only or family coverage. Family members who may be included in such family coverage are the spouse and children of the member. (vi) All other categories eligible for enrollment under paragraph (d)(1) of this section must elect self-only coverage. (6) Enrollment. (7) Period of coverage. (i) Exceptions: (A) In the case of a child of a member or former member, the date which is 36 months after the date on which the person first ceases to meet the requirements for being considered an unmarried dependent child under 10 U.S.C. 1072(2)(D) or 10 U.S.C. 1072(2)(I). (B) In the case of an unremarried former spouse (as this term is defined in 10 U.S.C. 1072(2)(G) or (H)) of a member or former member, the date which is 36 months after the later of: ( 1 ( 2 (C) In the case of an unremarried surviving spouse (widow or widower) (under 10 U.S.C. 1072(2)(B) or (C)) of a member or former member of the uniformed services who is not otherwise eligible for care under 10 U.S.C. chapter 55, the date which is 36 months after the date the surviving spouse becomes ineligible under 10 U.S.C chapter 55 or 10 U.S.C. 1145(a). (D) In the case of a former spouse of a member or former member (other than the former spouse whose marriage was dissolved after the separation of the member from the service unless such separation was by retirement), the period of coverage under the CHCBP is unlimited, if former spouse: ( 1 ( 2 ( 3 ( 4 (E) For the beneficiary who becomes eligible for the CHCBP by ceasing to meet the requirements for being considered an unmarried dependent child of a member or former member, health care coverage may not extend beyond the date which is 36 months after the date the member becomes ineligible for medical and dental care under 10 U.S.C. 1074(a) and any transitional health care under 10 U.S.C. 1145(a). (e) CHCBP benefits In general. (2) Exceptions. (i) Section 199.4(a)(2) concerning eligibility. (ii) All provisions regarding requirements to use facilities of the uniformed services because CHCBP enrollees are not eligible to use those facilities. (3) Beneficiary liability. e.g., (f) Authorized providers. (g) Claims submission, review, and payment. (h) Double coverage. (i) Administrative remedies for fraud, abuse, and conflict of interest. (j) Appeal and hearing procedures. (k) Overpayments recovery. (l) Third party recoveries. (m) Provider reimbursement methods. (n) Quality and Utilization Review Peer Review Organization Program. (o) [Reserved] (p) Special programs not applicable In general. (2) Examples. (i) The Extended Care Health Option under § 199.5; (ii) The TRICARE Dental Program or Retiree Dental Program under § 199.13 and 199.22 respectively; (iii) The Supplemental Health Care Program under § 199.16; and (iv) The TRICARE Prime Program under § 199.17. (q) Premiums Rates. (2) Effects of failure to make premium payments. (r) Procedures. [76 FR 57639, Sept. 16, 2011, as amended at 82 FR 45457, Sept. 29, 2017] § 199.21 TRICARE Pharmacy Benefits Program. (a) General—(1) Statutory authority. (2) Pharmacy benefits program. Applicability. (ii) Applicability exception. (3) Uniform formulary. (i) The uniform formulary will assure the availability of pharmaceutical agents in the complete range of therapeutic classes authorized as basic program benefits. (ii) As required by 10 U.S.C. 1074g(a)(2) and implemented under the procedures established by paragraphs (e) and (f) of this section, pharmaceutical agents in each therapeutic class are selected for inclusion on the uniform formulary based upon the relative clinical effectiveness and cost effectiveness of the agents in such class. If a pharmaceutical agent in a therapeutic class is determined by the Department of Defense Pharmacy and Therapeutics Committee not to have a significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome over other pharmaceutical agents included on the uniform formulary, the Committee may recommend it be classified as a non-formulary agent. In addition, if the evaluation by the Pharmacy and Therapeutics Committee concludes that a pharmaceutical agent in a therapeutic class is not cost effective relative to other pharmaceutical agents in that therapeutic class, considering costs, safety, effectiveness, and clinical outcomes, the Committee may recommend it be classified as a non-formulary agent. (iii) Pharmaceutical agents which are used exclusively in medical treatments or procedures that are expressly excluded from the TRICARE benefit by statute or regulation will not be considered for inclusion on the uniform formulary. Excluded pharmaceutical agents shall not be available as non-formulary agents, nor will they be cost-shared under the TRICARE pharmacy benefits program. (b) Definitions. (1) Clinically necessary. (2) Therapeutic class. (3) Over-the-counter drug. (c) Department of Defense Pharmacy and Therapeutics Committee Purpose. (2) Composition. (3) Executive Council. (d) Uniform Formulary Beneficiary Advisory Panel. (e) Determinations regarding relative clinical and cost effectiveness for the selection of pharmaceutical agents for the uniform formulary Clinical effectiveness. (ii) Sources of information may include but are not limited to: (A) Medical and pharmaceutical textbooks and reference books; (B) Clinical literature; (C) U.S. Food and Drug Administration determinations and information; (D) Information from pharmaceutical companies; (E) Clinical practice guidelines, and (F) Expert opinion. (iii) The DoD Pharmacy and Therapeutics Committee will evaluate the relative clinical effectiveness of pharmaceutical agents within a therapeutic class by considering information about their safety, effectiveness, and clinical outcome. (iv) Information considered by the Committee may include but is not limited to: (A) U.S. Food and Drug Administration approved and other studied indications; (B) Pharmacology; (C) Pharmacokinetics; (D) Contraindications; (E) Warnings/precautions; (F) Incidence and severity of adverse effects; (G) Drug to drug, drug to food, and drug to disease interactions; (H) Availability, dosing, and method of administration; (I) Epidemiology and relevant risk factors for diseases/conditions in which the pharmaceutical agents are used; (J) Concomitant therapies; (K) Results of safety and efficacy studies; (L) Results of effectiveness/clinical outcomes studies, and (M) Results of meta-analyses. (2) Cost effectiveness. (i) In considering the relative cost effectiveness of pharmaceutical agents in a therapeutic class, the DoD Pharmacy and Therapeutics Committee shall evaluate the costs of the agents in relation to the safety, effectiveness, and clinical outcomes of the other agents in the class. (ii) Information considered by the Committee concerning the relative cost effectiveness of pharmaceutical agents may include but is not limited to: (A) Cost of the pharmaceutical agent to the Government; (B) Impact on overall medical resource utilization and costs; (C) Cost-efficacy studies; (D) Cost-effectiveness studies; (E) Cross-sectional or retrospective economic evaluations; (F) Pharmacoeconomic models; (G) Patent expiration dates; (H) Clinical practice guideline recommendations, and (I) Existence of existing or proposed blanket purchase agreements, incentive price agreements, or contracts. (3) Special rules for best clinical effectiveness. (ii) Actions under paragraph (e)(3)(i) of this section may include a complete or partial exclusion from the pharmacy benefits program of any pharmaceutical agent the Director determines provides very little or no clinical effectiveness relative to similar agents to covered beneficiaries and DoD. A partial exclusion under this paragraph may take the form (as one example) of a limitation on the clinical conditions, diagnoses, or indications for which the pharmaceutical agent may be prescribed. A partial exclusion may be implemented through any means recommended by the Pharmacy and Therapeutics Committee, including but not limited to preauthorization under paragraph (k) of this section. In the case of a partial exclusion, a pharmaceutical agent may be available on the non-formulary tier of the uniform formulary for limited purposes and for other purposes be excluded. (iii) Actions under paragraph (e)(3)(i) of this section may also include giving preferential status to any non-generic pharmaceutical agent of the uniform formulary by treating it for purposes of cost-sharing as a generic product. (f) Evaluation of pharmaceutical agents for determinations regarding inclusion on the uniform formulary. (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of existing pharmaceutical agents; (4) New information concerning the safety, effectiveness or clinical outcomes of existing pharmaceutical agents; (5) Price changes; (6) Shifts in market share; (7) Scheduled review of a therapeutic class; and (8) Requests from Pharmacy and Therapeutics Committee members, military treatment facilities, or other Military Health System officials. (g) Administrative procedures for establishing and maintaining the uniform formulary Pharmacy and Therapeutics Committee determinations. (2) Beneficiary Advisory Panel. (3) Uniform formulary final decisions. (4) Transition to the Uniform Formulary. (5) Administrative procedure for newly approved drugs. (h) Obtaining pharmacy services under the retail network pharmacy benefits program. Points of service. (i) Military Treatment Facilities (MTFs); (ii) Retail network pharmacies: Those are non-MTF pharmacies that are a part of the network established for TRICARE retail pharmacy services; (iii) Retail non-network pharmacies: Those are non-MTF pharmacies that are not part of the network established for TRICARE retail pharmacy services, and (iv) the TRICARE Mail Order Pharmacy (TMOP). (2) Availability of formulary pharmaceutical agents General. (ii) Availability of formulary pharmaceutical agents at military treatment facilities (MTF). (iii) Pharmaceutical agents prescribed for smoking cessation are not available for coverage when obtained through a retail pharmacy. This includes network and non-network retail pharmacies. (3) Availability of non-formulary pharmaceutical agents General. (ii) Availability of non-formulary pharmaceutical agents at military treatment facilities. (iii) Availability of clinically appropriate non-formulary pharmaceutical agents to members of the Uniformed Services. (iv) Availability of clinically appropriate pharmaceutical agents to other eligible beneficiaries at retail pharmacies or the TMOP. (4) Availability of vaccines/immunizations. (5) Availability of selected over-the-counter (OTC) drugs under the pharmacy benefits program. (i) An OTC drug may be included on the uniform formulary upon the recommendation of the Pharmacy and Therapeutics Committee and approval of the Director, DHA, based on a finding that it is cost-effective and clinically effective, as compared with other drugs in the same therapeutic class of pharmaceutical agents. Clinical need is judged by the criteria found in paragraph (e)(1)(i) and (ii) of this section. Cost effectiveness is determined based on criteria found in paragraph (e)(2) of this section. (ii) OTC drugs placed on the uniform formulary, in general, will be treated the same as generic drugs on the uniform formulary for purposes of availability in MTF pharmacies, retail pharmacies, and the mail order pharmacy program and other requirements. However, upon the recommendation of the Pharmacy and Therapeutics Committee and approval of the Director, DHA, the requirement for a prescription may be waived for a particular OTC drug for certain emergency care treatment situations. In addition, a special copayment may be established under paragraph (i)(2)(xii) of this section for OTC drugs specifically used in certain emergency care treatment situations. (i) Cost-sharing requirements under the pharmacy benefits program General. (2) Cost-sharing amounts. (i) For pharmaceutical agents obtained from a military treatment facility, there is no cost-sharing or annual deductible. (ii) For pharmaceutical agents obtained from a retail network pharmacy, the cost share will be as provided in 10 U.S.C. 1074g(a)(6), except that there is a $0 cost-share for vaccines/immunizations authorized as preventive care for eligible beneficiaries. (iii) For formulary and generic pharmaceutical agents obtained from a retail non-network pharmacy, except as provided in paragraph (i)(2)(vi) of this section, there is a 20 percent or $20.00 cost-share (whichever is greater) per prescription for up to a 30-day supply of the pharmaceutical agent. (iv) For pharmaceutical agents obtained under the TRICARE mail order program, the cost share will be as provided in 10 U.S.C. 1074g(a)(6), except that there is a $0 cost-share for smoking cessation pharmaceutical agents covered under the smoking cessation program. (v) [Reserved] (vi) For TRICARE Prime beneficiaries there is no annual deductible applicable for pharmaceutical agents obtained from retail network pharmacies or the TRICARE mail-order program. However, for TRICARE Prime beneficiaries who obtain formulary or generic pharmaceutical agents from retail non-network pharmacies, an enrollment year deductible of $300 per person and $600 per family must be met after which there is a beneficiary cost-share of 50 percent per prescription for up to a 30-day supply of the pharmaceutical agent. (vii) For TRICARE Select beneficiaries the annual deductible which must be met before the cost-sharing amounts for pharmaceutical agents in paragraph (i)(2) of this section are applicable is as provided for each category of TRICARE Select enrollee in § 199.17(l)(2). (viii) For TRICARE beneficiaries not otherwise qualified to enroll in TRICARE Prime or Select, the annual deductible which must be met before the cost-sharing amounts for pharmaceutical agents in paragraph (i)(2) of this section are applicable is as provided in § 199.4(f). (ix) The TRICARE catastrophic cap limits apply to pharmacy benefits program cost-sharing. (x) For any year after 2027, the cost-sharing amounts under this paragraph shall be equal to the cost-sharing amounts for the previous year adjusted by an amount, if any, determined by the Director to reflect changes in the costs of pharmaceutical agents and prescription dispensing, rounded to the nearest dollar. These cost changes, if any, will consider costs under the TRICARE pharmacy benefits program calculated separately for each of the following categories based on prescriptions filled in the most recent period for which TRICARE cost data are available, updated to the current year, if necessary, by appropriate industry data: (A) Generic drugs in the retail point of service; (B) Formulary drugs in the retail point of service; (C) Generic drugs in the mail order point of service; (D) Formulary drugs in the mail order point of service; (E) Non-formulary drugs. (xi) For a Medicare-eligible beneficiary, the cost-sharing requirements may not be in excess of the cost-sharing requirements applicable to all other beneficiaries covered by 10 U.S.C. 1086. (xii) Special copayment rule for OTC drugs in the retail pharmacy network. (3) Special cost-sharing rule when there is a clinical necessity for use of a non-formulary pharmaceutical agent. (ii) A clinical necessity for use of a non-formulary pharmaceutical agent is established when the beneficiary or their provider submits sufficient information to show that one or more of the following conditions exist: (A) The use of formualry pharmaceutical agents is contraindicated; (B) The patient experiences significant adverse effects from formulary pharmaceutical agents, or the provider shows that the patient is likely to experience significant adverse effects from formulary pharmaceutical agents; (C) Formulary pharmaceutical agents result in therapeutic failure, or the provider shows that the formulary pharmaceutical agent is likely to result in therapeutic failure; (D) The patient previously responded to a non-formulary pharmaceutical agent and changing to a formulary pharmaceutical agent would incur unacceptable clinical risk; or (E) There is no alternative pharmaceutical agent on the formulary. (iii) Information to establish clinical necessity for use of a non-formulary pharmaceutical agent should be provided to TRICARE for prescriptions submitted to a retail network pharmacy. (iv) Information to establish clinical necessity for use of a non-formulary pharmaceutical agent should be provided as part of the claims processes for non-formulary pharmaceutical agents obtained through non-network points of service, claims as a result of other health insurance, or any other situations requiring the submission of a manual claim. (v) Information to establish clinical necessity for use of a non-formulary pharmaceutical agent may be provided with the prescription submitted to the TMOP contractor. (vi) Information to establish clinical necessity for use of a non-formulary pharmaceutical agent may also be provided at a later date, but no later than sixty days from the dispensing date, as an appeal to reduce the non-formulary co-payment to the same co-payment as a formulary drug. (vii) The process of establishing clinical necessity will not unnecessarily delay the dispensing of a prescription. In situations where clinical necessity cannot be determined in a timely manner, the non-formulary pharmaceutical agent will be dispensed at the non-formulary co-payment and a refund provided to the beneficiary should clinical necessity be established. (viii) Peer review and appeal and hearing procedures. All levels of peer review, appeals, and grievances established by the Contractor for internal review shall be exhausted prior to forwarding to TRICARE Management Activity for a formal review. Procedures comparable to those established under §§ 199.15 and 199.10 of this part shall apply. If it is determined that the prescription is clinically necessary, the pharmaceutical agent will be provided to the beneficiary at the formulary cost-share. TRICARE may require that the time periods for peer review or for appeal and hearing be expedited under the pharmacy benefits program. For purposes of meeting the amount in dispute requirement of § 199.10(a)(7), the relevant amount is the difference between the cost shares of a formulary versus non-formulary drug. The amount for each of multiple prescriptions involving the same drug to treat the same medical condition and filled within a 12-month period may be combined to meet the required amount in dispute. (j) Use of generic drugs under the pharmacy benefits program. (2) The pharmacy benefits program generally requires mandatory substitution of generic drugs listed with an “A” rating in the current Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) published by the FDA and generic equivalents of grandfather or Drug Efficacy Study Implementation (DESI) category drugs for brand name drugs. In cases in which there is a clinical justification for a brand name drug in lieu of a generic equivalent, under the standards and procedures of paragraph (h)(3) of this section, the generic substitution policy is waived. (3) When a blanket purchase agreement, incentive price agreement, Government contract, or other circumstances results in a brand pharmaceutical agent being the most cost effective agent for purchase by the Government, the Pharmacy and Therapeutics Committee may also designate that the drug be cost-shared at the generic rate. (4) Upon the recommendation of the Pharmacy and Therapeutics Committee, a generic drug may be classified as non-formulary if it is less cost effective than non-generic formulary drugs in the same drug class. (5) The beneficiary copayment amount for any generic drug prescription may not exceed the total charge for that prescription. (k) Preauthorization of certain pharmaceutical agents. (2) The Pharmacy and Therapeutics Committee will assess the need to prior authorize a given agent by considering the relative clinical and cost effectiveness of pharmaceutical agents within a therapeutic class. Pharmaceutical agents that require prior authorization will be identified by a majority vote of the Pharmacy and Therapeutics Committee. The Pharmacy and Therapeutics Committee will establish the prior authorization criteria for the pharamaceutical agent. (3) Prescriptions for pharmaceutical agents for which prior authorization criteria are not met will not be cost-shared under the TRICARE pharmacy benefits program. (4) The Director, TRICARE Management Activity, may issue policies, procedures, instructions, guidelines, standards or criteria to implement this paragraph (k). (l) TRICARE Senior Pharmacy Program. (m) Effect of other health insurance. (n) Procedures. (o) Preemption of State laws. (2) Based on the determination set forth in paragraph (o)(1) of this section, any State or local law relating to health insurance, prepaid health plans, or other health care delivery or financing methods is preempted and does not apply in connection with TRICARE pharmacy contracts. Any such law, or regulation pursuant to such law, is without any force or effect, and State or local governments have no legal authority to enforce them in relation to the TRICARE pharmacy contracts. However, the Department of Defense may by contract establish legal obligations on the part of TRICARE contractors to conform with requirements similar or identical to requirements of State or local laws or regulations. (3) The preemption of State and local laws set forth in paragraph (o)(1) of this section includes State and local laws imposing premium taxes on health or dental insurance carriers or underwriters or other plan managers, or similar taxes on such entities. Such laws are laws relating to health insurance, prepaid health plans, or other health care delivery or financing methods, within the meaning of the statutes identified in paragraph (o)(1) of this section. Preemption, however, does not apply to taxes, fees, or other payments on net income or profit realized by such entities in the conduct of business relating to DoD pharmacy services contracts, if those taxes, fees or other payments are applicable to a broad range of business activity. For purposes of assessing the effect of Federal preemption of State and local taxes and fees in connection with DoD pharmacy services contracts, interpretations shall be consistent with those applicable to the Federal Employees Health Benefits Program under 5 U.S.C. 8909(f). (p) General fraud, abuse, and conflict of interest requirements under TRICARE pharmacy benefits program. (q) Pricing standards for retail pharmacy program Statutory requirement. (ii) Under paragraph (q)(1)(i) of this section, all covered drug TRICARE retail pharmacy network prescriptions are subject to Federal Ceiling Prices under 38 U.S.C. 8126. (2) Manufacturer written agreement. (A) Inclusion of that drug on the uniform formulary under this section; and (B) Availability of that drug through retail network pharmacies without preauthorization under paragraph (k) of this section. (ii) A covered drug not under an agreement under paragraph (q)(2)(i) of this section requires preauthorization under paragraph (k) of this section to be provided through a retail network pharmacy under the Pharmacy Benefits Program. This preauthorization requirement does not apply to other points of service under the Pharmacy Benefits Program. (iii) For purposes of this paragraph (q)(2), a covered drug is a drug that is a covered drug under 38 U.S.C. 8126, but does not include: (A) A drug that is not a covered drug under 38 U.S.C. 8126; (B) A drug provided under a prescription that is not covered by 10 U.S.C. 1074g(f); (C) A drug that is not provided through a retail network pharmacy under this section; (D) A drug provided under a prescription which the TRICARE Pharmacy Benefits Program is the second payer under paragraph (m) of this section; (E) A drug provided under a prescription and dispensed by a pharmacy under section 340B of the Public Health Service Act; or (F) Any other exception for a drug, consistent with law, established by the Director, TMA. (iv) The requirement of this paragraph (q)(2) may, upon the recommendation of the Pharmacy and Therapeutics Committee, be waived by the Director, TMA if necessary to ensure that at least one drug in the drug class is included on the Uniform Formulary. Any such waiver, however, does not waive the statutory requirement referred to in paragraph (q)(1) that all covered TRICARE retail network pharmacy prescriptions are subject to Federal Ceiling Prices under 38 U.S.C. 8126; it only waives the exclusion from the Uniform Formulary of drugs not covered by agreements under this paragraph (q)(2). (3) Refund procedures. (ii) The refund procedures referred to in paragraph (q)(3)(i) of this section shall, to the extent practicable, incorporate common industry practices for implementing pricing agreements between manufacturers and large pharmacy benefit plan sponsors. Such procedures shall provide the manufacturer at least 70 days from the date of the submission of the TRICARE pharmaceutical utilization data needed to calculate the refund before the refund payment is due. The basis of the refund will be the difference between the average non-federal price of the drug sold by the manufacturer to wholesalers, as represented by the most recent annual non-Federal average manufacturing prices (non-FAMP) (reported to the Department of Veterans Affairs (VA)) and the corresponding FCP or, in the discretion of the manufacturer, the difference between the FCP and direct commercial contract sales prices specifically attributable to the reported TRICARE paid pharmaceuticals, determined for each applicable NDC listing. The current annual FCP and the annual non-FAMP from which it was derived will be applicable to all prescriptions filled during the calendar year. (iii) A refund due under this paragraph (q) is subject to § 199.11 of this part and will be treated as an erroneous payment under that section. (A) A manufacturer may under section 199.11 of this part request waiver or compromise of a refund amount due under 10 U.S.C. 1074g(f) and this paragraph (q). (B) During the pendency of any request for waiver or compromise under paragraph (q)(3)(iii)(A) of this section, a manufacturer's written agreement under paragraph (q)(2) shall be deemed to exclude the matter that is the subject of the request for waiver or compromise. In such cases the agreement, if otherwise sufficient for the purpose of the condition referred to in paragraph (q)(2), will continue to be sufficient for that purpose. Further, during the pendency of any such request, the matter that is the subject of the request shall not be considered a failure of a manufacturer to honor a requirement or an agreement for purposes of paragraph (q)(4). (C) In addition to the criteria established in § 199.11, a request for waiver may also be premised on the voluntary removal by the manufacturer in writing of a drug from coverage in the TRICARE Pharmacy Benefit Program. (iv) In the case of disputes by the manufacturer of the accuracy of TMA's utilization data, a refund obligation as to the amount in dispute will be deferred pending good faith efforts to resolve the dispute in accordance with procedures established by the Director, TMA. If the dispute is not resolved within 60 days, the Director, TMA will issue an initial administrative decision and provide the manufacturer with opportunity to request reconsideration or appeal consistent with procedures under section 199.10 of this part. When the dispute is ultimately resolved, any refund owed relating to the amount in dispute will be subject to an interest charge from the date payment of the amount was initially due, consistent with section 199.11 of this part. (4) Remedies. (5) Beneficiary transition provisions. (r) Refills of maintenance medications for eligible covered beneficiaries through the mail order pharmacy program In general. (2) Medications covered. (i) It will be a medication prescribed for a chronic, long-term condition that is taken on a regular, recurring basis. (ii) It will be clinically appropriate to dispense the medication from the mail order pharmacy. (iii) It will be cost effective to dispense the medication from the mail order pharmacy. (iv) It will be available for an initial filling of a 30-day or less supply through retail pharmacies. (v) It will be generally available at military treatment facility pharmacies for initial fill and refills. (vi) It will be available for refill through the national mail-order pharmacy program. (3) Refills covered. (i) A subsequent filling of an original prescription under the same prescription number or other authorization as the original prescription; or (ii) A new original prescription issued at or near the end date of an earlier prescription for the same medication for the same patient. (4) Waiver of requirement. (i) There is a blanket waiver for prescription medications that are for acute care needs. (ii) There is a blanket waiver for prescriptions covered by other health insurance. (iii) There is a case-by-case waiver to permit prescription maintenance medication refills at a retail pharmacy when necessary due to personal need or hardship, emergency, or other special circumstance. This waiver is obtained through an administrative override request to the TRICARE pharmacy benefits manager under procedures established by the Director, DHA. (5) Procedures. (i) The Department will implement the program by utilizing best commercial practices to the extent practicable. (ii) An effective communication plan that includes efforts to educate beneficiaries in order to optimize participation and satisfaction will be implemented. (iii) Beneficiaries with active retail prescriptions for a medication on the maintenance medication list will be notified that their medication is included under the program. Beneficiaries will be advised that they may receive two 30 day fill at retail while they transition their prescription to the mail order program. (iv) Requests for a third fill at retail will result in 100% patient cost shares and will be blocked from any TRICARE payments and the beneficiary advised to call the pharmacy benefits manager (PBM) for assistance. (v) The PBM will provide a toll free number to assist beneficiaries in transferring their prescriptions from retail to the mail order program. With the beneficiary's permission, the PBM will contact the physician or other health care provider who prescribed the medication to assist in transferring the prescription to the mail order program. (vi) In any case in which a beneficiary required under paragraph (r) of this section to obtain a maintenance medication prescription refill from national mail order pharmacy program and attempts instead to refill such medications at a retail pharmacy, the PBM will also maintain the toll free number to assist the beneficiary. This assistance may include information on how to request a waiver, consistent with paragraph (r)(4)(iii) of this section, or in taking any other appropriate action to meet the beneficiary's needs and to implement the program. (vii) The PBM will ensure that a pharmacist is available at all times through the toll-free telephone number to answer beneficiary questions or provide other appropriate assistance. (6) This program will remain in effect indefinitely with any adjustments or modifications required by law. [69 FR 17048, Apr. 1, 2004, as amended at 74 FR 11292, Mar. 17, 2009; 74 FR 55776, Oct. 29, 2009; 74 FR 65438, Dec. 10, 2009; 75 FR 63397, Oct. 15, 2010; 76 FR 41065, July 13, 2011; 78 FR 13241, Feb. 27, 2013; 78 FR 75247, Dec. 11, 2013; 80 FR 46798, Aug. 6, 2015; 80 FR 44272, July 27, 2015; 81 FR 76310, Nov. 2, 2016; 82 FR 45458, Sept. 29, 2017; 83 FR 63577, Dec. 11, 2018] § 199.22 TRICARE Retiree Dental Program (TRDP). (a) Establishment. (1) The Director will, except as authorized in paragraph (a)(2) of this section, make available a premium based indemnity dental insurance plan for eligible TRDP beneficiaries specified in paragraph (d) of this section consistent with the provisions of this section. (2) The TRDP premium based indemnity dental insurance program under paragraph (a) of this section may be provided by allowing eligible beneficiaries specified in paragraph (d) of this section to enroll in an insurance plan under chapter 89A of title 5, United States Code that provides benefits similar to those benefits provided under paragraph (f) of this section. Such enrollment shall be authorized pursuant to an agreement entered into between the Department of Defense and the Office of Personnel Management which agreement, in the event of any inconsistency, shall take precedence over provisions in this section. (b) General provisions. (2) Premium costs for this coverage will be paid by the enrollee. (3) Geographic scope. (ii) The Assistant Secretary of Defense (Health Affairs) (ASD (HA)) may extend the TRDP to geographic areas other than those specified in paragraph (b)(3)(i) of this section. In extending the TRDP overseas, the ASD (HA) is authorized to establish program elements, methods of administration, and payment rates and procedures that are different from those in effect for the areas specified in paragraph (b)(3)(i) of this section to the extent the ASD (HA), or designee, determines necessary for the effective and efficient operation of the TRDP. These differences may include, but are not limited to, specific provisions for preauthorization of care, varying licensure and certification requirements for foreign providers, and other differences based on limitations in the availability and capabilities of the Uniformed Services overseas dental treatment facilities and a particular nation's civilian sector providers in certain areas. The Director, TRICARE Management Activity shall issue guidance, as necessary, to implement the provisions of this paragraph. TRDP enrollees residing in overseas locations will be eligible for the same benefits as enrollees residing in the continental United States, although dental services may not be available or accessible in all locations. (4) Except as otherwise provided in this section or by the Assistant Secretary of Defense (Health Affairs) or designee, the TRDP is administered in a manner similar to the TRICARE Dental Program under § 199.13 of this part. (5) The TRDP shall be administered through a contract. (c) Except as may be specifically provided in this section, to the extent terms defined in § 199.2 and § 199.13(b) are relevant to the administration of the TRICARE Retiree Dental Program, the definitions contained in § 199.2 and § 199.13(b) shall apply to the TRDP as they do to TRICARE/CHAMPUS and the TRICARE Dental Program. (d) Eligibility and enrollment Eligibility. (i) Members of the Uniformed Services who are entitled to retired pay, or former members of the armed forces who are Medal of Honor recipients and who are not otherwise entitled to dental benefits; (ii) Members of the Retired Reserve under the age of 60; (iii) Eligible dependents of a member described in paragraph (d)(1)(i) or paragraph (d)(1)(ii) of this section who are covered by the enrollment of the member; (iv) Eligible dependents of a member described in paragraph (d)(1)(i) or paragraph (d)(1)(ii) of this section when the member is not enrolled in the program and the member meets at least one of the conditions in paragraphs (d)(1)(iv)(A) through (C) of this section. Already enrolled members must satisfy any remaining enrollment commitment prior to enrollment of dependents becoming effective under this paragraph, at which time the dependent-only enrollment will continue on a voluntary basis as specified in paragraph (d)(4) of this section. Members must provide documentation to the TRDP contractor giving evidence of compliance with paragraphs (d)(1)(iv)(A), (B), or (C) of this section at the time of application for enrollment of their dependents under this paragraph. (A) The member is enrolled under Section 1705 of Title 38, United States Code, to receive ongoing, comprehensive dental care from the Department of Veterans Affairs pursuant to Section 1712 of Title 38, United States Code, and 38 CFR 17.93, 17.161, or 17.166. Authorization of such dental care must be confirmed in writing by the Department of Veterans Affairs. (B) The member is enrolled in a dental plan that is available to the member as a result of employment of the member that is separate from the Uniformed Service of the member, and the dental plan is not available to dependents of the member as a result of such separate employment by the member. Enrollment in this dental plan and the exclusion of dependents from enrollment in the plan must be confirmed by documentation from the member's employer or the dental plan's administrator. (C) The member is prevented by a current and enduring medical or dental condition from being able to obtain benefits under the TRDP. The specific medical or dental condition and reason for the inability to use the program's benefits over time, if not apparent based on the condition, must be documented by the member's physician or dentist. (v) The unremarried surviving spouse and eligible child dependents of a deceased member who died while in status described in paragraph (d)(1)(i) or paragraph (d)(1)(ii) of this section; the unremarried surviving spouse and eligible child dependents who receive a surviving spouse annuity; or the unremarried surviving spouse and eligible child dependents of a deceased member who died while on active duty for a period of more than 30 days and whose eligible dependents are not eligible or no longer for the TRICARE Dental Program. Note to paragraphs ( d iii d iv d v Eligible dependents of Medal of Honor recipients are described in § 199.3(b)(2)(i) (except for former spouses) and § 199.3(b)(2)(ii) (except for a child placed in legal custody of a Medal of Honor recipient under § 199.3(b)(2)(ii)(H)( 4 (2) Notification of eligibility. (3) Election of coverage. (4) Enrollment periods Enrollment period for basic benefits. (ii) Enrollment period for enhanced benefits. (5) Termination of coverage Involuntary termination. (ii) Voluntary termination. (A) Enrollment grace period. (B) Extenuating circumstances. ( 1 ( 2 ( 3 (C) Effective date of voluntary termination. (D) Appeal process for denied voluntary enrollment termination. (6) Continuation of dependents' enrollment upon death of enrollee. (e) Premium payments. (1) Premium payment method. (2) Effects of failure to make premium payments. (3) Member's payment of premiums. (f) Plan benefits. (1) The minimum TRDP benefit is basic dental care to include diagnostic services, preventive services, restorative services, endodontic services, periodontic services, oral surgery services, and other general services. The following is the minimum TRDP covered dental benefit: (i) Diagnostic services. (A) Clinical oral examinations. (B) Radiographs and diagnostic imaging. (C) Tests and laboratory examinations. (ii) Preventive services. (A) Dental prophylaxis. (B) Topical fluoride treatment (office procedure). (C) Sealants. (D) Other preventive services. (E) Space maintenance. (iii) Restorative services. (A) Amalgam restorations. (B) Resin-based composite restorations. (C) Other restorative services. (iv) Endodontic services. (A) Pulp capping. (B) Pulpotomy and pulpectomy. (C) Root canal therapy. (D) Apexification and recalcification procedures. (E) Apicoectomy and periradicular services. (F) Other endodontic procedures. (v) Periodontic Services. (A) Surgical services. (B) Periodontal services. (vi) Oral surgery. (A) Extractions. (B) Surgical extractions. (C) Alveoloplasty. (D) Biopsy. (E) Other surgical procedures. (vii) Other general services. (A) Palliative (emergenery) treatment of dental pain. (B) Therapeutic drug injection. (C) Other drugs and/or medicaments. (D) Treatment of postsurgical complications. (2) Enhanced benefits. (3) Alternative course of treatment policy. (i) The service, procedure, or course of treatment must be consistent with sound professional standards of generally accepted dental practice for the dental condition concerned. (ii) The service, procedure, or course of treatment must be a generally accepted alternative for a service or procedure covered by the TRDP for the dental condition. (iii) Payment for the alternative service or procedure may not exceed the lower of the prevailing limits for the alternative procedure, the prevailing limits or dental plan contractor's scheduled allowance for the otherwise authorized benefit procedure for which the alternative is substituted, or the actual charge for the alternative procedure. (g) Maximum coverage amounts. (h) Annual notification of rates. (i) Authorized providers. (j) Benefit payment. (1) Billed charges; or (2) Usual, Customary and Reasonable rates, in which the customary rate is calculated at the 50th percentile of billed charges in that geographic area, as measured in an undiscounted charge profile in 1995 or later for that geographic area (as defined by three-digit zip code). (k) Appeal procedures. (l) Preemption of State laws. (2) Based on the determination set forth in paragraph (l)(1) of this section, any State or local law or regulation pertaining to health or dental insurance, prepaid health or dental plans, or other health or dental care delivery, administration, and financing methods is preempted and does not apply in connection with the TRICARE Retiree Dental Program contract. Any such law, or regulation pursuant to such law, is without any force or effect, and State or local governments have no legal authority to enforce them in relation to the TRICARE Retiree Dental Program contract. (However, the Department of Defense may, by contract, establish legal obligations on the part of the TRICARE Retiree Dental Program contractor to conform with requirements similar to or identical to requirements of State or local laws or regulations). (3) The preemption of State and local laws set forth in paragraph (l)(2) of this section includes State and local laws imposing premium taxes on health or dental insurance carriers or underwriters or other plan managers, or similar taxes on such entities. Such laws are laws relating to health insurance, prepaid health plans, or other health care delivery or financing methods, within the meaning of section 1103. Preemption, however, does not apply to taxes, fees, or other payments on net income or profit realized by such entities in the conduct of business relating to DoD health services contracts, if those taxes, fees or other payments are applicable to a broad range of business activity. For the purposes of assessing the effect of Federal preemption of State and local taxes and fees in connection with DoD health and dental services contracts, interpretations shall be consistent with those applicable to the Federal Employees Health Benefits Program under 5 U.S.C. 8909(f). (m) Administration. [62 FR 66993, Dec. 23, 1997, as amended at 65 FR 48913, Aug. 10, 2000; 65 FR 49492, Aug. 14, 2000; 66 FR 9658, Feb. 9, 2001; 67 FR 4354, Jan. 30, 2002; 67 FR 15725, Apr. 3, 2002; 72 FR 54213, Sept. 24, 2007; 72 FR 64537, Nov. 16, 2007; 73 FR 59504, Oct. 9, 2008; 82 FR 45458, Sept. 29, 2017] § 199.23 Special Supplemental Food Program. (a) General provisions. (b) Definitions. (1) Applicant. (2) Breastfeeding women. (3) Certification. (4) Children. (5) Competent Professional Authority (CPA). (6) Contract brand. (7) Date-to-use. (8) Department. (9) Dependent. (A) Under 21 years of age; or (B) Incapable of self-support because of mental or physical incapacity and is in fact dependent on the member for more than 1/2 (C) Is under 23 years of age, is enrolled in a full-time course of study in an institution of higher education and is in fact dependent on the member for more than one-half of the child's support. (10) Drafts. (11) Economic unit. (12) Eligible civilian. (i) A dependent of a member of the armed forces residing with the member outside the United States, whether or not that dependent is command sponsored, or (ii) An employee of a military department who is a national of the United States and is residing outside the United States in connection with such individual's employment or a dependent of such individual residing with the employee outside the United States; or (iii) An employee of a Department of Defense contractor who is a national of the United States and is residing outside the United States in connection with such individual's employment or a dependent of such individual residing with the employee outside the United States. (13) Family. (14) Hematological test. (15) Income guidelines. (16) Infants. (17) National of the U.S. (i) Is a citizen of the U.S.; or (ii) Is not a citizen of the United States, but who owes permanent allegiance to the United States, as determined in accordance with the Immigration and Nationality Act. (18) NEXMART. (19) Nutrition education. (20) Nutritional risk. (ii) Other documented nutritionally related medical conditions, or (iii) Documented evidence of dietary deficiencies that impair or endanger health, or (iv) Conditions that directly affect the nutritional health of a person, such as alcoholism or drug abuse, or (v) Conditions that predispose persons to inadequate nutritional patterns, habits of poor nutritional choices or nutritionally related medical conditions. (21) Participants. (22) Postpartum Women. (23) Pregnant Women. (24) Rebate. (25) Regional Lead Agent. (26) Supplemental foods. (27) Verification. (c) Certification of eligibility. (i) Meet one of the participant type requirements: be a member of the armed forces on duty overseas; a family member/dependent of a member of the armed forces on duty overseas; a U.S. national employee of a military department serving overseas; a family member of a U.S. national employee of a DoD contractor serving overseas; a family member of a U.S. national employee of a DoD contractor serving overseas; (ii) Reside in the geographic area served by the WIC Overseas office; (iii) Meet the income criteria specified in this section; and (iv) Meet the nutrition risk criteria specified in this section. (2) In terms of income eligibility, the following apply: (i) The Department of Defense shall use the Alaska income poverty guidelines published by the DHHS for making determinations regarding income eligibility for the Program. (ii) Program income eligibility guidelines shall be adjusted annually to conform to annual adjustments made by the DHHS. (iii) For income eligibility, the Program may consider the income of the family during the past 12 months and the family's current rate of income to determine which indicator accurately reflects the family's status. (iv) A pregnant woman who is ineligible for participation in the Program because she does not meet income criteria shall be deemed eligible if the criteria would be met by increasing the number of individuals in her family (economic unit) by the number of children in utero. (v) The Program shall define income according to USDA regulations with regard to the USDA-administered WIC Program. In particular— (A) A basic allowance for housing is excluded from income as required by section 674 of the National Defense Authorization Act for Fiscal Year 2000. (B) The value of in-kind housing benefits is excluded from income as required under USDA regulations. (C) Cost of living allowances for duty outside the continental U.S. (OCONUS) is excluded from income as required under 7 CFR 246.7(d)(2)(iv)(A)( 2 (D) Public assistance and welfare payments are included in income. (3) Participants must be found to be at nutritional risk to be eligible for program benefits. (i) A Competent Professional Authority (CPA) shall determine if an applicant is at nutritional risk. (ii) At the request of the program, applicants shall provide, according to schedules set by the USDA in 7 CFR 246.7(e) (unless deemed impracticable), nutritional risk data as a condition of certification in the Program. Such data includes: (A) Anthropometric measurements, (B) The results of hematological tests, (C) Physical examination, (D) Dietary information, or (E) Developmental testing (iii) A pregnant woman who meets all other eligibility criteria and for whom a nutritional risk assessment cannot immediately be completed will be considered presumptively eligible to participate in the Program for a period up to 60 days. (iv) Infants under 6 months of age may be deemed to be at nutritional risk if the infant's mother was a Program participant during pregnancy or if medical records document that the mother was at nutritional risk during pregnancy. (v) Unless otherwise specified herein or in 7 CFR 246.7(e), required nutritional risk data shall be provided to, or obtained by, the WIC Overseas Program office within 90 days of enrollment. (4) In the event that it is impracticable for the WIC Overseas Program to adhere to the income and nutritional risk eligibility guidelines contained in USDA regulations, the Director, TRICARE Management Activity (TMA) may waive the Department's use of USDA WIC Program eligibility criteria by determining that it is impracticable to use these standards to certify participants in the WIC Overseas Program. (i) Such determination shall consider relevant practical, administrative, national security, financial factors and existing Department policies and their application to the population served by the WIC Overseas Program. (ii) Absent a written finding of impracticability described in section 199.23(c)(4), the eligibility criteria for the WIC program, contained in USDA regulations shall apply. (5) An applicant for the WIC Overseas Program who presents a valid WIC Program Verification of Certification card, which is issued to participants in the domestic WIC Program when they intend to move, shall be considered eligible for participation in the WIC Overseas Program for the duration of the individual's current domestic WIC certification period, as long as he/she is an eligible service/family member or eligible civilian/family member. (d) Program benefits. (i) Drafts shall at a minimum list the food items to be redeemed and the date-to-use. (ii) Food items listed on the draft must be approved for use under the Program. (iii) Drafts generally shall allow for a three-month supply of food items for each participant, unless the participant's nutritional status necessitates more frequent contacts with the WIC Overseas office. (iv) Participating commissaries and NEXMARTS shall accept the drafts in exchange for approved food items. (v) Commissary and NEXMART personnel shall be trained on verification and processing of drafts. (vi) Program guidelines shall provide for training of new participants in how to redeem drafts. (2) Supplemental Food. (i) The Director, TMA shall identify to the Defense Commissary Agency (DeCA) and NEXCOM a list of food items approved for the WIC Overseas Program. This list shall be developed in consultation with the USDA and shall include information regarding the appropriate package and/or container sizes and quantities available for participants, as well as the frequency with which food items can be acquired. Additions and/or deletions of food items from this list shall be communicated to the commissaries and NEXMARTS on an ongoing basis. (ii) A CPA shall prescribe appropriate foods from among the approved list to be included in food packages. (iii) A CPA shall coordinate documentation of medical need when such documentation is a prerequisite for prescribing certain food items. (iv) The Director, TMA may authorize changes regarding the supplemental foods to be made available in the WIC Overseas Program when local conditions preclude strict compliance or when such compliance is impracticable. (3) Nutrition Education. (i) The WIC Overseas nutrition education program shall be locally overseen by a CPA based on guidance and materials provided by TMA. (ii) Nutrition education and its means of delivery be tailored to the greatest extent practicable to the specific nutritional, cultural, practical, and other needs of the participant. Participant profiles created during certification may be used in designing appropriate nutrition education. A CPA may develop individual care plans, as necessary, consistent with USDA regulations. (iii) Nutrition education shall consist of sessions wherein individual participants or groups of participants meet with a CPA in an interactive setting such that participants can ask, and the CPA can answer, questions related to nutrition practices. In addition, nutrition education shall utilize prepared educational materials and/or Internet sites. Both the sessions and the information materials shall be designed to improve health status, achieve positive change in dietary habits, and emphasize relationships between nutrition and health. Individual and group sessions can be accomplished through, among other things, face-to-face meetings, remote tele-videoconferencing, real-time computer-based distance learning, or other means. (iv) Nutrition education services shall generally be provided to participants twice during each 6-month certification period, unless a different schedule is specified in USDA regulations. (v) The nutrition education program shall promote breastfeeding as the optimal method of infant nutrition, encourage pregnant participants to breastfeed unless contraindicated for health reasons, and educate all participating women about the harmful effects of substance abuse. (vi) Individual participants shall not be denied supplemental food due to the failure to attend scheduled nutrition education sessions. (e) Financial management. (i) Verification may utilize sampling techniques. (ii) Payment of drafts shall be made out of Defense Health Program funds. (f) Rebate agreements. (i) The agreement shall identify a contract brand of food item. (ii) Under the agreement, the manufacturer shall rebate to the Department an agreed portion of the amounts paid by DoD for the procurement of the contract brand. (2) The DoD shall use competitive procedures under title 10, chapter 137 to select the contract brand. (3) Amounts rebated shall be credited to the appropriation available for carrying out the program and shall be applied against expenditures for the program in the same period as the other sums in the appropriation. (g) Administrative appeals and civil rights. (2) Benefits shall not be provided while an appeal is pending when an applicant is denied benefits, a participant's certification has expired or a participant becomes categorically ineligible. (3) A request for appeal shall be submitted in writing within five working days. If the decision is an adverse one it shall include notice to the applicant of his further appeal rights as reflected in (iii) below, and that he/she has five working days to effect any such appeal. (4) Appeal reviews shall be conducted in the first instance by the CPA or team leader in charge of the local WIC Overseas office. (i) Written notice of a decision shall be provided to the applicant within five working days. (ii) If the appeal is upheld, retroactive benefits shall not be provided. (iii) At an applicant's request a denied appeal may be forwarded to the regional program manager for review, who will provide a decision on the appeal within 5 working days. (iv) If the regional program manager denies the appeal, there shall be no further right of appeal. (5) Complaints about discriminatory treatment shall be handled in accordance with procedures established at each local WIC Overseas site. (h) Operations and Administration. (2) Information and personnel security requirements shall be consistent with applicable laws and regulations. [69 FR 15678, Mar. 26, 2004, as amended at 90 FR 5632, Jan. 17, 2025] § 199.24 TRICARE Reserve Select. (a) Establishment. (1) Purpose. (2) Statutory Authority. (3) Scope of the Program. (4) Major Features of TRICARE Reserve Select. (i) TRICARE Select rules applicable. (B) Certain special programs established in 32 CFR part 199 are not available to members covered under TRICARE Reserve Select. These include the Extended Care Health Option (§ 199.5), the Special Supplemental Food Program (see § 199.23), and the Supplemental Health Care Program (§ 199.16), except when referred by a Military Treatment Facility (MTF) provider for incidental consults and the MTF provider maintains clinical control over the episode of care. The TRICARE Dental Program (§ 199.13) is independent of this program and is otherwise available to all members of the Selected Reserve and their eligible family members whether or not they purchase TRICARE Reserve Select coverage. The Continued Health Care Benefits Program (§ 199.20) is also independent of this program and is otherwise available to all members who qualify. (ii) Premiums. (iii) Procedures. (iv) Benefits. (b) Qualifications for TRICARE Reserve Select coverage Ready Reserve member. (i) Is a member of the Selected Reserve of the Ready Reserve of the Armed Forces, or a member of the Individual Ready Reserve of the Armed Forces who has volunteered to be ordered to active duty pursuant to the provisions of 10 U.S.C. 12304 in accordance with section 10 U.S.C. 10144(b); and (ii) Is not enrolled in, or eligible to enroll in, a health benefits plan under 5 U.S.C. chapter 89. That statute has been implemented under 5 CFR part 890 as the Federal Employees Health Benefits (FEHB) program. For purposes of the FEHB program, the terms “enrolled,” “enroll” and “enrollee” are defined in 5 CFR 890.101. Further, the member (or certain former member involuntarily separated) no longer qualifies for TRICARE Reserve Select when the member (or former member) has been eligible for coverage to be effective in a health benefits plan under the FEHB program for more than 60 days. (2) TRICARE Reserve Select survivor. (c) TRICARE Reserve Select premiums. (1) Annual establishment of rates. (2) Premium adjustments. (3) Survivor premiums. (d) Procedures. (1) Purchasing coverage. (i) Continuation coverage. (ii) Qualifying event. (iii) Enrollment. (iv) Survivor coverage under TRICARE Reserve Select. (2) Termination. (i) Coverage shall terminate when members or survivors no longer qualify for TRICARE Reserve Select as specified in paragraph (b) of this section, with one exception. If a member is involuntarily separated from the Selected Reserve under other than adverse conditions, as characterized by the Secretary concerned, and is covered by TRICARE Reserve Select on the last day of his or her membership in the Selected Reserve, then TRICARE Reserve Select coverage may terminate up to 180 days after the date on which the member was separated from the Selected Reserve. This applies regardless of type of coverage. This exception expires December 31, 2018. (ii) Coverage may terminate for members, former members, and survivors who gain coverage under another TRICARE program. (iii) In accordance with the provisions of § 199.17(o)(2) coverage terminates for members/survivors who fail to make premium payments in accordance with established procedures. (iv) Coverage may be terminated for members/survivors upon request at any time by submitting a completed request in the appropriate format in accordance with established procedures. (3) Re-enrollment following termination. (4) Processing. (5) Periodic revision. (e) Preemption of State laws. (2) Based on the determination set forth in paragraph (f)(1) of this section, any State or local law or regulation pertaining to health insurance, prepaid health plans, or other health care delivery, administration, and financing methods is preempted and does not apply in connection with TRICARE Reserve Select. Any such law, or regulation pursuant to such law, is without any force or effect, and State or local governments have no legal authority to enforce them in relation to TRICARE Reserve Select. (However, the Department of Defense may, by contract, establish legal obligations on the part of DoD contractors to conform with requirements similar to or identical to requirements of State or local laws or regulations with respect to TRICARE Reserve Select). (3) The preemption of State and local laws set forth in paragraph (f)(2) of this section includes State and local laws imposing premium taxes on health insurance carriers or underwriters or other plan managers, or similar taxes on such entities. Such laws are laws relating to health insurance, prepaid health plans, or other health care delivery or financing methods, within the meaning of 10 U.S.C. 1103. Preemption, however, does not apply to taxes, fees, or other payments on net income or profit realized by such entities in the conduct of business relating to DoD health services contracts, if those taxes, fees or other payments are applicable to a broad range of business activity. For the purposes of assessing the effect of Federal preemption of State and local taxes and fees in connection with DoD health services contracts, interpretations shall be consistent with those applicable to the Federal Employees Health Benefits Program under 5 U.S.C. 8909(f). (f) Administration. (g) Terminology. (1) Coverage. (2) Immediate family member. (3) Qualified member. (4) Qualified survivor. [72 FR 46383, Aug. 20, 2007, as amended at 76 FR 57641, Sept. 16, 2011; 80 FR 55254, Sept. 15, 2015; 82 FR 45458, Sept. 29, 2017; 86 FR 67862, Nov. 30, 2021] § 199.25 TRICARE Retired Reserve. (a) Establishment. (1) Purpose. (2) Statutory Authority. (3) Scope of the Program. (4) Major Features of TRICARE Retired Reserve. (i) TRICARE Select rules applicable. (B) Certain special programs established in 32 CFR part 199 are not available to members covered under TRICARE Retired Reserve. The Extended Health Care Option (ECHO) program (sec. 199.5) is not included. The Supplemental Health Care Program (sec. 199.16) is not included, except when a TRICARE Retired Reserve covered beneficiary is referred by a Military Treatment Facility (MTF) provider for incidental consults and the MTF provider maintains clinical control over the episode of care. The TRICARE Retiree Dental Program (sec. 199.13) is independent of this program and is otherwise available to all members who qualify for the TRICARE Retiree Dental Program whether or not they purchase TRICARE Retired Reserve coverage. The Continued Health Care Benefits Program (sec. 199.13) is also independent of this program and is otherwise available to all members who qualify for the Continued Health Care Benefits Program. (ii) Premiums. (iii) Procedures. (iv) Benefits. (b) Qualifications for TRICARE Retired Reserve coverage—(1) Retired Reserve Member. (i) Is a member of a Reserve component of the armed forces who is qualified for a non-regular retirement at age 60 under chapter 1223 of title 10, U.S.C., but who is not yet age 60 and (ii) Is not enrolled in, or eligible to enroll in, a health benefits plan under chapter 89 of title 5, U.S.C. That statute has been implemented under part 890 of title 5, CFR as the Federal Employee Health Benefits (FEHB) program. For purposes of the FEHB program, the terms “enrolled,” “enroll” and “enrollee” are defined in § 890.101 of title 5, CFR. (2) Retired Reserve Survivor. (c) TRICARE Retired Reserve premiums. (1) Annual establishment of rates. (ii) The appropriate actuarial basis used for calculating premium rates shall be one that most closely approximates the actual cost of providing care to the same demographic population as those enrolled in TRICARE Retired Reserve as determined by the ASD(HA). TRICARE Retired Reserve premiums shall be based on the actual costs of providing benefits to TRICARE Retired Reserve members and their dependents during the preceding years if the population of Retired Reserve members enrolled in TRICARE Retired Reserve is large enough during those preceding years to be considered actuarially appropriate. Until such time that actual costs from those preceding years becomes available, TRICARE Retired Reserve premiums shall be based on the actual costs during the preceding calendar years for providing benefits to the population of retired members and their dependents in the same age categories as the retired reserve population in order to make the underlying group actuarially appropriate. An adjustment may be applied to cover overhead costs for administration of the program by the government. (2) Premium adjustments. (3) Survivor Premiums. (d) Procedures. (1) Purchasing Coverage. (i) Continuation Coverage. (ii) Qualifying event. (iii) Enrollment. (iv) Survivor coverage under TRICARE Retired Reserve. (2) Termination. (i) Coverage shall terminate when members or survivors no longer qualify for TRICARE Retired Reserve as specified in paragraph (c) of this section. For purposes of this section, the member or their survivor no longer qualifies for TRICARE Retired Reserve when the member has been eligible for coverage in a health benefits plan under Chapter 89 of Title 5, U.S.C. for more than 60 days. Further, coverage shall terminate when the Retired Reserve member attains the age of 60 or, if survivor coverage is in effect, when the deceased Retired Reserve member would have attained the age of 60. (ii) Coverage may terminate for members, former members, and survivors who gain coverage under another TRICARE program. (iii) In accordance with the provisions of § 199.17(o)(2) coverage terminates for members/survivors who fail to make premium payments in accordance with established procedures. (iv) Coverage may be terminated for members/survivors upon request at any time by submitting a completed request in the appropriate format in accordance with established procedures. (3) Re-enrollment following termination. (4) Processing. (5) Periodic revision. (e) Preemption of State laws. (2) Based on the determination set forth in paragraph (f)(1) of this section, any State or local law or regulation pertaining to health insurance, prepaid health plans, or other health care delivery, administration, and financing methods is preempted and does not apply in connection with TRICARE Retired Reserve. Any such law, or regulation pursuant to such law, is without any force or effect, and State or local governments have no legal authority to enforce them in relation to TRICARE Retired Reserve. (However, the Department of Defense may, by contract, establish legal obligations on the part of DoD contractors to conform with requirements similar to or identical to requirements of State or local laws or regulations with respect to TRICARE Retired Reserve). (3) The preemption of State and local laws set forth in paragraph (f)(2) of this section includes State and local laws imposing premium taxes on health insurance carriers or underwriters or other plan managers, or similar taxes on such entities. Such laws are laws relating to health insurance, prepaid health plans, or other health care delivery or financing methods, within the meaning of 10 U.S.C. 1103. Preemption, however, does not apply to taxes, fees, or other payments on net income or profit realized by such entities in the conduct of business relating to DoD health services contracts, if those taxes, fees or other payments are applicable to a broad range of business activity. For the purposes of assessing the effect of Federal preemption of State and local taxes and fees in connection with DoD health services contracts, interpretations shall be consistent with those of the Federal Employees Health Benefits Program under 5 U.S.C. 8909(f). (f) Administration. (g) Terminology. (1) Coverage. (2) Immediate family member. (3) Qualified member. (4) Qualified survivor. [75 FR 47455, Aug. 6, 2010, as amended at 79 FR 78702, Dec. 31, 2014; 82 FR 45459, Sept. 29, 2017] § 199.26 TRICARE Young Adult. (a) Establishment. (1) Purpose. (2) Statutory authority. (3) Scope of the program. (4) Major features of TYA. TRICARE rules applicable. (A) Unless specified in this section or otherwise prescribed by the Assistant Secretary of Defense (Health Affairs) (ASD (HA)), provisions of this part apply to TYA. (B) The TRICARE Dental Program (§ 199.13) and the TRICARE Retiree Dental Program (§ 199.22) are not covered under TYA. (C) TRICARE Select is available to all TYA-eligible young adult dependents. (D) TRICARE Prime is available to TYA-eligible young adult dependents, provided that TRICARE Prime (including the Uniformed Services Family Health Plan) is available in the geographic location where the TYA enrollee resides. TYA-eligible young adults are: ( 1 ( 2 ( 3 (ii) Premiums. (iii) Procedures. (iv) Benefits. i.e., (b) Eligibility for TRICARE Young Adult coverage Young Adult Dependent. (i) Would be a dependent child under 10 U.S.C. 1072, but for exceeding the age limit under that section (abused dependents and NATO dependents are not eligible for TYA coverage); and (ii) Is a dependent under the age of 26; and (iii) Is not enrolled, or eligible to enroll, for medical coverage in an eligible employer-sponsored health plan as defined in section 5000A(f)(2) of the Internal Revenue Code of 1986; and (iv) Is not otherwise eligible under § 199.3; and (v) Is not a member of the uniformed services. (2) The dependents' sponsor is responsible for keeping the Defense Enrollment Eligibility Reporting System (DEERS) current with eligibility data through the sponsor's Service personnel office. Using information from the DEERS, the TRICARE regional contractors have the responsibility to validate a dependent's qualifications to purchase TYA coverage. (c) TRICARE Young Adult premiums. (1) Annual establishment of rates. (ii) The appropriate actuarial basis used for calculating premium rates shall be one that most closely approximates the actual cost of providing care to a similar demographic population (based on age and health plans) as those enrolled in TYA, as determined by the ASD(HA). TYA premiums shall be based on the actual costs of providing benefits to TYA dependents during the preceding years if the population of TYA enrollees is large enough during those preceding years to be considered actuarially appropriate. Until such time that actual costs from those preceding years become available, TYA premiums shall be based on the actual costs during the preceding calendar years for providing benefits to the population of similarly aged dependents to make the underlying group actuarially appropriate. An adjustment may be applied to cover overhead costs for administration of the program. (2) Premium adjustments. (d) Procedures. (1) Purchasing coverage. (i) Continuation coverage. (ii) Enrollment. (2) Termination. (i) Loss of eligibility or entitlement for coverage by the sponsor will result in termination of the dependent's TYA coverage unless otherwise specified. The effective date of the sponsor's loss of eligibility for care will also be the effective date of termination of benefits under the TYA program unless specified otherwise. (A) Active duty military sponsor. (B) Selected Reserve (Sel Res) Sponsor. (C) Retired Reserve Sponsor. (ii) Failure of a young adult dependent to maintain the eligibility qualifications in paragraph (b) of this section shall result in the termination of coverage under the TYA program. The effective date of termination shall be the date upon which the adult young dependent failed to meet any of the prerequisite qualifications. If a subsequent change in circumstances re-establishes eligibility (such as losing eligibility for an eligible employer-sponsored plan), the young adult dependent may re-enroll for coverage under the TYA program. (iii) Coverage may also be terminated due to a change in the sponsor's status, and the young adult dependent must re-qualify and reapply for TYA coverage within 30 days of termination to preclude a gap in coverage. (iv) Termination of coverage results in denial of claims for services with a date of service after the effective date of termination. (v) Coverage may be terminated for young adult dependents upon request at any time by submitting a completed request in the appropriate format in accordance with established procedures. (vi) In accordance with the provisions of § 199.17(o)(2), coverage terminates for young adult dependents who fail to make premium payments in accordance with established procedures. (vii) Absent a new qualifying event, young adults are not eligible to re-enroll in TYA until the next annual open season. (3) Eligibility for the Continued Health Care Benefit Program. (4) Changing coverage. (e) Preemption of State laws. (f) Administration. [78 FR 32119, May 29, 2013, as amended at 82 FR 45460, Sept. 29, 2017] Appendix A to Part 199—Acronyms AFR—Air Force Regulation AR—Army Regulation ASD (HA)—Assistant Secretary of Defense (Health Affairs) CCLR—Claims Collection Litigation Report CEOB—CHAMPUS Explanation of Benefits CFR—Code of Federal Regulations CHAMPUS—Civilian Health and Medical Program of the Uniformed Services CRD—Chronic Renal Disease CT—Computerized Tomography DASD (A)—Deputy Assistant Secretary of Defense (Administration) D.D.S.—Doctor of Dental Surgery DEERS—Defense Enrollment Eligibility Reporting System DHHS—Department of Health and Human Services D.M.D.—Doctor of Dental Medicine DME—Durable Medical Equipment D.O.—Doctor of Osteopathy DoD—Department of Defense DSM-III—Diagnostic and Statistical Manual of Mental Disorders (Third Edition) ECHO—Extended Care Health Option EEG—Electroencephalogram EST—Electroshock Therapy FAR—Federal Acquisition Regulation FEHBP—Federal Employees Health Benefits Program FMCRA—Federal Medical Care Recovery Act FR—Federal Register HBA—Health Benefits Advisor HL—Hearing Threshold Level Hz—Hertz ICD-9-CM—International Classification of Diseases, 9th Revision, Clinical Modification ICU—Intensive Care Unit IQ—Intelligence Quotient JCAH—Joint Commission on Accreditation of Hospitals L.P.N.—Licensed Practical Nurse L.V.N.—Licensed Vocational Nurse MBD—Minimal Brain Dysfunction MCO—Marine Corps Order M.D.—Doctor of Medicine MIA—Missing in Action NATO—North Atlantic Treaty Organization NAVMILPERSCOMINST—Navy Military Personnel Command Instruction NAVPERS—Navy Personnel NOAA—National Oceanic and Atmospheric Administration OCHAMPUS—Office of Civilian Health and Medical Program of the Uniformed Services OCHAMPUSEUR—Office of Civilian Health and Medical Program of the Uniformed Services for Europe OCHAMPUSPAC—Office of Civilian Health and Medical Program of the Uniformed Services for the Pacific Area OCHAMPUSSO—Office of Civilian Health and Medical Program of the Uniformed Services for the Southern Hemisphere OMB—Office of Management and Budget PKU—Phenylketonuria R.N.—Registered Nurse RTC—Residential Treatment Center SNF—Skilled Nursing Facility STF—Specialized Treatment Facility U.S.C.—United States Code USPHS—U.S. Public Health Service [51 FR 24008, July 1, 1986, as amended at 62 FR 35097, June 30, 1997; 63 FR 48448, Sept. 10, 1998; 69 FR 44952, July 28, 2004; 69 FR 51569, Aug. 20, 2004]

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