42 CFR Part 424 — Conditions for Medicare Payment

PART 424—CONDITIONS FOR MEDICARE PAYMENT Authority: 42 U.S.C. 1302 and 1395hh. Source: 53 FR 6634, Mar. 2, 1988, unless otherwise noted. Subpart A—General Provisions § 424.1 Basis and scope. (a) Statutory basis. 1814—Basic conditions for, and limitations on, Medicare payments for Part A services. 1815—Payment to providers for Part A services. 1820—Conditions for designating certain hospitals as critical assess hospitals. 1833(e)—Requirement to furnish information to determine payment. 1834(a)—Payment for durable medical equipment. 1834(j)—Requirements for suppliers of medical equipment and supplies. 1835—Procedures for payment to providers for Part B services. 1842(b)(3)(B)(ii)—Assignment of Part B Medicare claims. 1842(b)(6)—Payment to entities other than the supplier. 1848—Payment for physician services. 1870(e) and (f)—Settlement of claims after death of the beneficiary. (2) Section 424.444(c) is also based on section 216(j) of the Act. (b) Scope. (1) The requirement that the need for services be certified and that a physician establish a plan of treatment (subpart B); (2) The procedures and time limits for filing claims (subpart C); (3) The individuals or entities to whom payment may be made (subparts D and E); (4) The limitations on assignment and reassignment of claims (subpart F); (5) Special requirements that apply to services furnished by nonparticipating U.S. hospitals and foreign hospitals (subparts G and H); and (6) The replacement and reclamation of Medicare payment checks (subpart M). (c) Other applicable rules. [53 FR 6634, Mar. 2, 1988, as amended at 60 FR 38271, July 26, 1995; 60 FR 50442, Sept. 29, 1995; 62 FR 46035, Aug. 29, 1997; 71 FR 20775, Apr. 21, 2006; 71 FR 48409, Aug. 18, 2006] § 424.3 Definitions. As used in this part, unless the context indicates otherwise— HCPCS ICD-9-CM means International Classification of Diseases, Ninth Revision, Clinical Modification. Nonparticipating hospital Participating hospital [53 FR 6634, Mar. 2, 1988, as amended at 59 FR 10299, Mar. 4, 1994; 63 FR 26311, May 12, 1998; 70 FR 45055, Aug. 4, 2005] § 424.5 Basic conditions. (a) As a basis for Medicare payment, the following conditions must be met: (1) Types of services. (i) Covered services, as specified in part 409 or part 410 of this chapter; or (ii) Services excluded from coverage as custodial care or services not reasonable and necessary, but reimbursable in accordance with §§ 405.332 through 405.334 of this chapter, pertaining to limitation of liability. (2) Sources of services. (3) Beneficiary of services. (4) Certification of need for services. (5) Claim for payment. (6) Sufficient information. (b) Additional conditions applicable in certain circumstances or to certain services are set forth in other sections of this part. [53 FR 6635, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988; 60 FR 38271, July 26, 1995] § 424.7 General limitations. (a) Utilization review finding on medical necessity. (1) Hospitals subject to PPS. (2) Hospitals not subject to PPS and SNFs Basic rule. (ii) Exception. (b) Failure to make timely utilization review. [53 FR 6635, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988] Subpart B—Certification and Plan Requirements § 424.10 Purpose and scope. (a) Purpose. Section 1814(a)(2) of the Act also permits nurse practitioners, clinical nurse specialists, or physician assistants to certify and recertify the need for post-hospital extended care services. (b) Scope. [60 FR 38271, July 26, 1995, as amended at 78 FR 47968, Aug. 6, 2013] § 424.11 General procedures. (a) Responsibility of the provider. (1) Obtain the required certification and recertification statements; (2) Keep them on file for verification by the intermediary, if necessary; and (3) Certify, on the appropriate billing form, that the statements have been obtained and are on file. (b) Obtaining the certification and recertification statements. (c) Required information. (d) Timeliness. (2) A hospital or SNF may provide for obtaining a certification or recertification earlier than required by these regulations or vary the timeframe (within the prescribed outer limits) for different diagnostic or clinical categories. (3) Delayed certification and recertification statements are acceptable when there is a legitimate reason for delay. (For instance, the patient was unaware of his or her entitlement when he or she was treated.) Delayed certification and recertification statements must include an explanation of the reasons for the delay. (4) A delayed certification may be included with one or more recertifications on a single signed statement. (5) For all inpatient hospital services, including inpatient psychiatric facility services, a delayed certification may not extend past discharge. (e) Limitation on authorization to sign statements. (1) A physician who is a doctor of medicine or osteopathy. (2) A dentist in the circumstances specified in § 424.13(d). (3) A doctor of podiatric medicine if his or her certification is consistent with the functions he or she is authorized to perform under State law. (4) A nurse practitioner or clinical nurse specialist as defined in paragraph (e)(5) or (e)(6) of this section, or a physician assistant as defined in section 1861(aa)(5)(A) of the Act, in the circumstances specified in § 424.20(e). (5) For purposes of this section, to qualify as a nurse practitioner, an individual must— (i) Be a registered professional nurse who is currently licensed to practice nursing in the State where he or she practices; be authorized to perform the services of a nurse practitioner in accordance with State law; and have a master's degree in nursing; (ii) Be certified as a nurse practitioner by a professional association recognized by CMS that has, at a minimum, eligibility requirements that meet the standards in paragraph (e)(5)(i) of this section; or (iii) Meet the requirements for a nurse practitioner set forth in paragraph (e)(5)(i) of this section, except for the master's degree requirement, and have received before August 25, 1998 a certificate of completion from a formal advanced practice program that prepares registered nurses to perform an expanded role in the delivery of primary care. (6) For purposes of this section, to qualify as a clinical nurse specialist, an individual must— (i) Be a registered professional nurse who is currently licensed to practice nursing in the State where he or she practices; be authorized to perform the services of a clinical nurse specialist in accordance with State law; and have a master's degree in a defined clinical area of nursing; (ii) Be certified as a clinical nurse specialist by a professional association recognized by CMS that has at a minimum, eligibility requirements that meet the standards in paragraph (e)(6)(i) of this section; or (iii) Meet the requirements for a clinical nurse specialist set forth in paragraph (e)(6)(i) of this section, except for the master's degree requirement, and have received before August 25, 1998 a certificate of completion from a formal advanced practice program that prepares registered nurses to perform an expanded role in the delivery of primary care. [53 FR 6634, Mar. 2, 1988, as amended at 56 FR 8845, Mar. 1, 1991; 60 FR 38272, July 26, 1995; 78 FR 47968, Aug. 6, 2013; 78 FR 50969, Aug. 19, 2013; 79 FR 50359, Aug. 22, 2014; 83 FR 41706, Aug. 17, 2018] § 424.13 Requirements for inpatient services of hospitals other than inpatient psychiatric facilities. (a) Content of certification and recertification. (1) The reasons for either— (i) Continued hospitalization of the patient for medical treatment or medically required diagnostic study; or (ii) Special or unusual services for cost outlier cases (under the prospective payment system set forth in subpart F of part 412 of this chapter). (2) The estimated time the patient will need to remain in the hospital. (3) The plans for posthospital care, if appropriate. (b) Timing of certification. (c) Certification of need for hospitalization when a SNF bed is not available. (2) If this is the basis for the physician's certification or recertification, the required statement must so indicate; and the certifying physician is expected to continue efforts to place the patient in a participating SNF as soon as a bed becomes available. (d) Signatures Basic rule. (2) Exception. (e) Timing of certifications and recertifications: Outlier cases not subject to the prospective payment system (PPS). (2) The first recertification is required no later than as of the 18th day of hospitalization. (3) Subsequent recertifications are required at intervals established by the UR committee (on a case-by-case basis if it so chooses), but no less frequently than every 30 days. (f) Timing of certification and recertification: Outlier cases subject to PPS. (1) For day outlier cases, certification is required no later than 1 day after the hospital reasonably assumes that the case meets the outlier criteria, established in accordance with § 412.80(a)(1)(i) of this chapter, or no later than 20 days into the hospital stay, whichever is earlier. The first and subsequent recertifications are required at intervals established by the UR committee (on a case-by-case basis if it so chooses) but not less frequently than every 30 days. (2) For cost outlier cases, certification is required no later than the date on which the hospital requests cost outlier payment or 20 days into the hospital stay, whichever is earlier. If possible, certification must be made before the hospital incurs costs for which it will seek cost outlier payment. In cost outlier cases, the first and subsequent recertifications are required at intervals established by the UR committee (on a case-by-case basis if it so chooses). (g) Recertification requirement fulfilled by utilization review. (2) A utilization review that is used to fulfill the recertification requirement is considered timely if performed no later than the seventh day after the day the recertification would have been required. The next recertification would need to be made no later than the 30th day following such review; if review by the UR committee took the place of this recertification, the review could be performed as late as the seventh day following the 30th day. (h) Description of procedures. [78 FR 50969, Aug. 19, 2013, as amended at 79 FR 67033, Nov. 10, 2014] § 424.14 Requirements for inpatient services of inpatient psychiatric facilities. (a) Requirements for certification and recertification: General considerations. (b) Content of certification. (1) That inpatient psychiatric services were required for treatment that could reasonably be expected to improve the patient's condition, or for diagnostic study. (2) That the inpatient psychiatric services were provided in accordance with § 412.3 of this chapter. (c) Content of recertification. (i) For treatment that could reasonably be expected to improve the patient's condition; or (ii) For diagnostic study; and (2) The hospital records show that the services furnished were— (i) Intensive treatment services; (ii) Admission and related services necessary for diagnostic study; or (iii) Equivalent services. (3) The patient continues to need, on a daily basis, active treatment furnished directly by or requiring the supervision of inpatient psychiatric facility personnel. (d) Timing of certification and recertification. (2) The first recertification is required as of the 12th day of hospitalization. Subsequent recertifications are required at intervals established by the UR committee (on a case-by-case basis if it so chooses), but no less frequently than every 30 days. (e) Other requirements. [53 FR 6634, Mar. 2, 1988, as amended at 71 FR 27087, May 9, 2006; 71 FR 37504, June 30, 2006; 78 FR 50970, Aug. 19, 2013] § 424.15 Requirements for inpatient CAH services. (a) Medicare Part A pays for inpatient CAH services only if a physician certifies that the individual may reasonably be expected to be discharged or transferred to a hospital within 96 hours after admission to the CAH, and that the services are provided in accordance with § 412.3 of this chapter. (b) Certification begins with the order for inpatient admission. All certification requirements must be completed, signed, and documented in the medical record no later than 1 day before the date on which the claim for payment for the inpatient CAH service is submitted. [78 FR 50970, Aug. 19, 2013, as amended at 79 FR 50359, Aug. 22, 2014] § 424.16 Timing of certification for individual admitted to a hospital before entitlement to Medicare benefits. (a) Basic rule. (b) Example. (Hospital that is not a psychiatric hospital and is not subject to PPS). (1) The certification is required no later than September 12; (2) The first recertification is required no later than September 18; and (3) Subsequent recertifications are required at least every 30 days after September 18. [53 FR 6635, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988, as amended at 78 FR 50970, Aug. 19, 2013] § 424.20 Requirements for posthospital SNF care. Medicare Part A pays for posthospital SNF care furnished by an SNF, or a hospital or CAH with a swing-bed approval, only if the certification and recertification for services are consistent with the content of paragraph (a) or (c) of this section, as appropriate. (a) Content of certification General requirements. (i) The individual needs or needed on a daily basis skilled nursing care (furnished directly by or requiring the supervision of skilled nursing personnel) or other skilled rehabilitation services that, as a practical matter, can only be provided in an SNF or a swing-bed hospital on an inpatient basis, and the SNF care is or was needed for a condition for which the individual received inpatient care in a participating hospital or a qualified hospital, as defined in § 409.3 of this chapter, or for a new condition that arose while the individual was receiving care in the SNF or swing-bed hospital for a condition for which he or she received inpatient care in a participating or qualified hospital; or (ii) The individual has been correctly assigned one of the case-mix classifiers that CMS designates as representing the required level of care, as provided in § 409.30 of this chapter. (2) Special requirement for certifications performed prior to July 1, 2002: A swing-bed hospital with more than 49 beds (but fewer than 100) that does not transfer a swing-bed patient to a SNF within 5 days of the availability date. (b) Timing of certification General rule. (2) Special rules for certain swing-bed hospitals. (c) Content of recertifications. (2) The estimated time the individual will need to remain in the SNF; (3) Plans for home care, if any; and (4) If appropriate, the fact that continued services are needed for a condition that arose after admission to the SNF and while the individual was still under treatment for the condition for which he or she had received inpatient hospital services. (d) Timing of recertifications. (2) Subsequent recertifications are required at least every 30 days after the first recertification. (e) Signature. (1) The physician responsible for the case or, with his or her authorization, by a physician on the SNF staff or a physician who is available in case of an emergency and has knowledge of the case; or (2) A physician extender (that is, a nurse practitioner, a clinical nurse specialist, or a physician assistant as those terms are defined in section 1861(aa)(5) of the Act) who does not have a direct or indirect employment relationship with the facility but who is working in collaboration with a physician. For purposes of this section— (i) Collaboration. (B) The services are delivered within the scope of the physician extender's professional expertise, with medical direction and appropriate supervision as provided for in guidelines jointly developed by the physician extender and the physician or other mechanisms defined by Federal regulations and the law of the State in which the services are performed. (ii) Types of employment relationships. Direct employment relationship. (B) Indirect employment relationship. 1 ( 2 (f) Recertification requirement fulfilled by utilization review. (g) Description of procedures. [53 FR 6634, Mar. 2, 1988, as amended at 54 FR 37275, Sept. 7, 1989; 58 FR 30671, May 26, 1993; 60 FR 38272, July 26, 1995; 62 FR 46037, Aug. 29, 1997; 63 FR 26311, May 12, 1998; 63 FR 53307, Oct. 5, 1998; 66 FR 39600, July 31, 2001; 70 FR 45055, Aug. 4, 2005; 75 FR 73626, Nov. 29, 2010; 82 FR 36635, Aug. 4, 2017; 83 FR 39290, Aug. 8, 2018] § 424.22 Requirements for home health services. Medicare Part A or Part B pays for home health services only if a physician or allowed practitioner as defined at § 484.2 of this chapter certifies and recertifies the content specified in paragraphs (a)(1) and (b)(2) of this section, as appropriate. (a) Certification Content of certification. (i) The individual needs or needed intermittent skilled nursing care, or physical therapy or speech-language pathology services as defined in § 409.42(c) of this chapter. If a patient's underlying condition or complication requires a registered nurse to ensure that essential non-skilled care is achieving its purpose, and necessitates a registered nurse be involved in the development, management, and evaluation of a patient's care plan, the physician or allowed practitioner will include a brief narrative describing the clinical justification of this need. If the narrative is part of the certification form, then the narrative must be located immediately prior to the physician or allowed practitioner's signature signature. If the narrative exists as an addendum to the certification form, in addition to the physician or allowed practitioner's signature signature on the certification form, the physician or allowed practitioner must sign immediately following the narrative in the addendum. (ii) Home health services are or were required because the individual is or was confined to the home, as defined in sections 1835(a) and 1814(a) of the Act, except when receiving outpatient services. (iii) A plan for furnishing the services has been established and will be or was periodically reviewed by a physician or allowed practitioner and who is not precluded from performing this function under paragraph (d) of this section. (iv) The services will be or were furnished while the individual was under the care of a physician or allowed practitioner. (v) A face-to-face patient encounter, which is related to the primary reason the patient requires home health services, occurred no more than 90 days prior to the home health start of care date or within 30 days of the start of the home health care and was performed by physician or non-physician practitioner defined in paragraph (a)(1)(v)(A) of this section. The certifying physician or certifying allowed practitioner must also document the date of the encounter as part of the certification. (A) The face-to-face encounter must be performed by one of the following: ( 1 ( 2 ( 3 ( 4 ( 5 (B) The face-to-face patient encounter may occur through telehealth, in compliance with section 1834(m) of the Act and subject to the list of payable Medicare telehealth services established by the applicable physician fee schedule regulation. (2) Timing and signature. (b) Recertification Timing and signature of recertification. (i) Beneficiary elected transfer; or (ii) Discharge with goals met and/or no expectation of a return to home health care. (2) Content and basis of recertification. (i) Need for occupational therapy may be the basis for continuing services that were initiated because the individual needed skilled nursing care or physical therapy or speech therapy. (ii) If a patient's underlying condition or complication requires a registered nurse to ensure that essential non-skilled care is achieving its purpose, and necessitates a registered nurse be involved in the development, management, and evaluation of a patient's care plan, the physician or allowed practitioner must include a brief narrative describing the clinical justification of this need. If the narrative— (A) Is part of the recertification form, then the narrative must be located immediately prior to the physician or allowed practitioner's signature. (B) Exists as an addendum to the recertification form, in addition to the physician or allowed practitioner's signature on the recertification form, the physician or allowed practitioner must sign immediately following the narrative in the addendum. (c) Determining patient eligibility for Medicare home health services. (i) The documentation from the HHA can be corroborated by other medical record entries in the certifying physician or allowed practitioner's medical record for the patient or the acute/post-acute care facility's medical record for the patient or both, thereby creating a clinically consistent picture that the patient is eligible for Medicare home health services. (ii)(A) The certifying physician or allowed practitioner signs and dates the HHA documentation demonstrating that the documentation from the HHA was considered when certifying patient eligibility for Medicare home health services. (B) HHA documentation can include, but is not limited to, the patient's plan of care required under § 409.43 of this chapter, or the initial or comprehensive assessment of the patient required under § 484.55 of this chapter. (2) The documentation must be provided upon request to review entities or CMS or both. If the documentation used as the basis for the certification of eligibility is not sufficient to demonstrate that the patient is or was eligible to receive services under the Medicare home health benefit, payment is not rendered for home health services provided. (d) Limitation of the performance of physician or allowed practitioner's certification and plan of care functions. (1) If a physician or allowed practitioner has a financial relationship as defined in § 411.354 of this chapter, with an HHA, the physician or allowed practitioner may not certify or recertify need for home health services provided by that HHA, establish or review a plan of treatment for such services, or conduct the face-to-face encounter required under sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act unless the financial relationship meets one of the exceptions set forth in § 411.355 through § 411.357 of this chapter. (2) A Nonphysician practitioner may not perform the face-to-face encounter required under sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act if such encounter would be prohibited under paragraph (d)(1) if the nonphysician practitioner were a physician. [53 FR 6638, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988; 56 FR 8845, Mar. 1, 1991, as amended at 65 FR 41211, July 3, 2000; 66 FR 962, Jan. 4, 2001; 70 FR 70334, Nov. 21, 2005; 72 FR 51098, Sept. 5, 2007; 74 FR 58133, Nov. 10, 2009; 75 FR 70463, Nov. 17, 2010; 76 FR 9503, Feb. 18, 2011; 76 FR 68606, Nov. 4, 2011; 77 FR 67163, Nov. 8, 2012; 79 FR 66116, Nov. 6, 2014; 80 FR 68717, Nov. 5, 2015; 83 FR 56627, Nov. 13, 2018; 85 FR 27624, May 8, 2020; 90 FR 55607, Dec. 2, 2025] § 424.24 Requirements for medical and other health services furnished by providers under Medicare Part B. (a) Exempted services. (1) Hospital services and supplies incident to physicians' services furnished to outpatients. The exemption applies to drugs and biologicals that cannot be self-administered, but not to partial hospitalization services, as set forth in paragraph (e) of this section. (2) Outpatient hospital diagnostic services, including necessary drugs and biologicals, ordinarily furnished or arranged for by a hospital for the purpose of diagnostic study. (b) General rule. (c) Outpatient physical therapy, occupational therapy, and speech-language pathology services Content of certification. (ii) The services were furnished while the individual was under the care of a physician, nurse practitioner, clinical nurse specialist, or physician assistant. (iii) The services were furnished under a plan of treatment that meets the requirements of § 410.61 of this chapter. (2) Timing. (3) Signature. (ii) If the plan of treatment is established by a physical therapist, occupational therapist, or speech-language pathologist, the certification must be signed by a physician or by a nurse practitioner, clinical nurse specialist, or physician assistant who has knowledge of the case, except as specified in paragraph (c)(5) of this section. (4) Recertification Timing. (ii) Content. (iii) Signature. (5) Treatment plan. (d) Intensive outpatient services: Content of certification and plan of treatment requirements (1) Content of certification. (ii) The services are or were furnished while the individual was under the care of a physician. (iii) The services were furnished under a written plan of treatment that meets the requirements of paragraph (d)(2) of this section. (2) Plan of treatment requirements. (A) The physician's diagnosis; (B) The type, amount, duration, and frequency of the services; and (C) The treatment goals under the plan. (ii) The physician determines the frequency and duration of the services taking into account accepted norms of medical practice and a reasonable expectation of improvement in the patient's condition. (3) Recertification requirements Signature. (ii) Timing. (iii) Content. (A) The patient's response to the therapeutic interventions provided by the intensive outpatient program. (B) The patient's psychiatric symptoms that continue to place the patient at risk of relapse or hospitalization. (C) Treatment goals for coordination of services to facilitate discharge from the intensive outpatient program. (e) Partial hospitalization services: Content of certification and plan of treatment requirements Content of certification. (ii) The services are or were furnished while the individual was under the care of a physician. (iii) The services were furnished under a written plan of treatment that meets the requirements of paragraph (e)(2) of this section. (2) Plan of treatment requirements. (A) The physician's diagnosis; (B) The type, amount, duration, and frequency of the services; and (C) The treatment goals under the plan. (ii) The physician determines the frequency and duration of the services taking into account accepted norms of medical practice and a reasonable expectation of improvement in the patient's condition. (3) Recertification requirements Signature. (ii) Timing. (iii) Content. (A) The patient's response to the therapeutic interventions provided by the partial hospitalization program. (B) The patient's psychiatric symptoms that continue to place the patient at risk of hospitalization. (C) Treatment goals for coordination of services to facilitate discharge from the partial hospitalization program. (f) Blood glucose testing. (g) All other covered medical and other health services furnished by providers Content of certification. (2) Signature. (3) Timing. (4) Recertification. [53 FR 6638, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988, as amended at 56 FR 8845, 8853, Mar. 1, 1991; 63 FR 58912, Nov. 2, 1998; 65 FR 18548, Apr. 7, 2000; 71 FR 69788, Dec. 1, 2006; 72 FR 66405, Nov. 27, 2007; 88 FR 82182, Nov. 22, 2023; 89 FR 98565, Dec. 9, 2024] § 424.27 Requirements for comprehensive outpatient rehabilitation facility (CORF) services. Medicare Part B pays for CORF services only if a physician certifies, and the facility physician recertifies, the content specified in paragraphs (a) and (b)(2) of this section, as appropriate. (a) Certification: Content. (2) The services were furnished while the individual was under the care of a physician; and (3) A written plan of treatment has been established and is reviewed periodically by a physician. (b) Recertification Timing. (2) Content. (ii) The patient is making progress in attaining the rehabilitation goals; and, (iii) The treatment is not having any harmful effect on the patient. [53 FR 6634, Mar. 2, 1988, as amended at 72 FR 66405, Nov. 27, 2007] Subpart C—Claims for Payment § 424.30 Scope. This subpart sets forth the requirements, procedures, and time limits for claiming Medicare payments. Claims must be filed in all cases except when services are furnished on a prepaid capitation basis by an MA organization, or through cost settlement with either a health maintenance organization (HMO), a competitive medical plan (CMP), or a health care prepayment plan (HCPP), or as part of a demonstration. Therefore, claims must be filed by hospitals seeking IME payment under § 412.105(g) of this chapter, and/or direct GME payment under § 413.76(c) of this chapter, and/or nursing or allied health education payment under § 413.87 of this chapter associated with inpatient services furnished on a prepaid capitation basis by an MA organization. Hospitals that must report patient data for purposes of the DSH payment adjustment under § 412.106 of this chapter for inpatient services furnished on a prepaid capitation basis by an MA organization, or through cost settlement with an HMO/CMP, or as part of a demonstration, are required to file claims by submitting no pay bills for such inpatients. Special procedures for claiming payment after the beneficiary has died and for certain bills paid by organizations are set forth in subpart E of this part. [77 FR 53682, Aug. 31, 2012] § 424.32 Basic requirements for all claims. (a) A claim must meet the following requirements: (1) A claim must be filed with the appropriate intermediary or carrier on a form prescribed by CMS in accordance with CMS instructions. (2) A claim for physician services, clinical psychologist services, or clinical social worker services must include appropriate diagnostic coding for those services using ICD-9-CM. (3) A claim must be signed by the beneficiary or on behalf of the beneficiary (in accordance with § 424.36). (4) A claim must be filed within the time limits specified in § 424.44. (5) All Part B claims for services furnished to SNF residents (whether filed by the SNF or by another entity) must include the SNF's Medicare provider number and appropriate HCPCS coding. (b) The prescribed forms for claims are the following: CMS-1450—Uniform Institutional Provider Bill. (This form is for institutional provider billing for Medicare inpatient, outpatient and home health services.) CMS-1490S—Request for Medicare payment. (For use by a patient to request payment for medical expenses.) CMS-1500—Health Insurance Claim Form. (For use by physicians and other suppliers to request payment for medical services.) CMS-1660—Request for Information-Medicare Payment for Services to a Patient now Deceased. (For use in requesting amounts payable under title XVIII to a deceased beneficiary.) (c) Where claims forms are available. (d) Submission of electronic claims Definitions. (i) Claim (ii) Electronic claim (iii) Direct data entry (iv) Electronic media (v) Initial Medicare claim (vi) Physician, practitioner, facility, or supplier (vii) Provider of services (viii) Small provider of services or small supplier (A) A provider of services with fewer than 25 full-time equivalent employees; or (B) A physician, practitioner, facility, or supplier with fewer than 10 full-time equivalent employees. (2) Submission of electronic claims required. (3) Exceptions to requirement to submit electronic claims. (i) There is no method available for the submission of an electronic claim. This exception includes claims submitted by Medicare beneficiaries and situations in which the standard adopted by the Secretary at 45 FR 162.1102 does not support all of the information necessary for payment of the claim. The Secretary may identify situations coming within this exception in guidance. (ii) The entity submitting the claim is a small provider of services or small supplier. (4) Unusual cases. (i) The submission of dental claims. (ii) There is a service interruption in the mode of submitting the electronic claim that is outside the control of the entity submitting the claim, for the period of the interruption. (iii) The entity submitting the claim submits fewer than 10 claims to Medicare per month, on average. (iv) The entity submitting the claim only furnishes services outside of the U.S. territory. (v) On demonstration, satisfactory to the Secretary, of other extraordinary circumstances precluding submission of electronic claims. (5) Effective date. [53 FR 6639, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988, as amended at 59 FR 10299, Mar. 4, 1994; 63 FR 26311, May 12, 1998; 63 FR 53307, Oct. 5, 1998; 66 FR 39601, July 31, 2001; 68 FR 48813, Aug. 15, 2003; 70 FR 71020, Nov. 25, 2005; 71 FR 48143, Aug. 18, 2006; 72 FR 66405, Nov. 27, 2007] § 424.33 Additional requirements: Claims for services of providers and claims by suppliers and nonparticipating hospitals. All claims for services of providers and all claims by suppliers and nonparticipating hospitals must be— (a) Filed by the provider, supplier, or hospital; and (b) Signed by the provider, supplier, or hospital unless CMS instructions waive this requirement. § 424.34 Additional requirements: Beneficiary's claim for direct payment. (a) Basic rule. (b) Itemized bill from the hospital or supplier. (1) The name and address of— (i) The beneficiary; (ii) The supplier or nonparticipating hospital that furnished the services; and (iii) The physician who prescribed the services if they were furnished by a supplier other than the physician. (2) The place where each service was furnished, e.g., home, office, independent laboratory, hospital. (3) The date each service was furnished. (4) A listing of the services in sufficient detail to permit determination of payment under the fee schedule for physicians' services; for itemized bills from physicians, appropriate diagnostic coding using ICD-9-CM must be used. (5) The charges for each service. (c) Report of services furnished by a supplier. [53 FR 6634, Mar. 2, 1988, as amended at 59 FR 10299, Mar. 4, 1994; 59 FR 26740, May 24, 1994] § 424.36 Signature requirements. (a) General rule. (b) Who may sign when the beneficiary is incapable. (1) The beneficiary's legal guardian. (2) A relative or other person who receives social security or other governmental benefits on the beneficiary's behalf. (3) A relative or other person who arranges for the beneficiary's treatment or exercises other responsibility for his or her affairs. (4) A representative of an agency or institution that did not furnish the services for which payment is claimed but furnished other care, services, or assistance to the beneficiary. (5) A representative of the provider or of the nonparticipating hospital claiming payment for services it has furnished if the provider or nonparticipating hospital is unable to have the claim signed in accordance with paragraph (b)(1), (2), (3), or (4) of this section after making reasonable efforts to locate and obtain the signature of one of the individuals specified in paragraph (b)(1), (2), (3), or (4) of this section. (6) An ambulance provider or supplier with respect to emergency or nonemergency ambulance transport services, if the following conditions and documentation requirements are met. (i) None of the individuals listed in paragraph (b)(1), (2), (3), or (4) of this section was available or willing to sign the claim on behalf of the beneficiary at the time the service was provided; (ii) The ambulance provider or supplier maintains in its files the following information and documentation for a period of at least four years from the date of service: (A) A contemporaneous statement, signed by an ambulance employee present during the trip to the receiving facility, that, at the time the service was provided, the beneficiary was physically or mentally incapable of signing the claim and that none of the individuals listed in paragraph (b)(1), (2), (3), or (4) of this section were available or willing to sign the claim on behalf of the beneficiary, and (B) Documentation with the date and time the beneficiary was transported, and the name and location of the facility that received the beneficiary, and (C) Either of the following: ( 1 ( 2 ( i ( ii ( iii ( iv ( v (c) Who may sign if the beneficiary was not present for the service. (d) Claims by entities that provide coverage complementary to Medicare. (e) Acceptance of other signatures for good cause. [53 FR 6640, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988, as amended at 53 FR 28388, July 28, 1988; 72 FR 66406, Nov. 27, 2007; 73 FR 2432, Jan. 15, 2008; 73 FR 66938, Nov. 19, 2008] § 424.37 Evidence of authority to sign on behalf of the beneficiary. (a) Beneficiary incapable. (1) Describes his or her relationship to the beneficiary; and (2) Explains the circumstances that make it impractical for the beneficiary to sign the claim or statement. (b) Beneficiary not present for services. [53 FR 6640, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988] § 424.40 Request for payment effective for more than one claim. (a) Basic procedure. (b) Claims filed by a provider or nonparticipating hospital Inpatient services. (2) Home health services and outpatient physical therapy or speech pathology services. (c) Signed statement in the provider record Services to inpatients. (i) By the hospital or SNF; (ii) By physicians, if their services are billed by the hospital or SNF in its name; or (iii) By physicians who bill separately, if the services were furnished in the hospital or SNF. (2) Services to outpatients: Providers and renal dialysis facilities. (i) By the provider or facility; (ii) By physicians whose services are billed by the provider or facility in its name; or (iii) By physicians who bill separately, if the services were furnished in the provider or facility. (3) Services to outpatients: Independent rural health clinics and Federally qualified health centers. (d) Signed statement in the supplier's record. (1) This policy does not apply to unassigned claims for rental of durable medical equipment (DME). (2) With respect to assigned claims for rental or purchase of DME, a new statement is required if another item of equipment is rented or purchased. [53 FR 6634, Mar. 2, 1988, as amended at 57 FR 24982, June 12, 1992] § 424.44 Time limits for filing claims. (a) Time limits. (2) Except as provided in paragraphs (b) and (e) of this section and except for services furnished during the last 3 months of 2009, for services furnished before January 1, 2010, the claim must be filed— (i) On or before December 31 of the following year for services that were furnished during the first 9 months of a calendar year; and (ii) On or before December 31st of the second following year for services that were furnished during the last 3 months of the calendar year. (3) For services furnished during the last 3 months of CY 2009 all claims must be filed no later than December 31, 2010. (b) Exceptions to time limits. (1) The time for filing a claim will be extended if CMS or one of its contractors determines that a failure to meet the deadline in paragraph (a) of this section was caused by error or misrepresentation of an employee, Medicare contractor (including Medicare Administrative Contractor, intermediary, or carrier), or agent of HHS that was performing Medicare functions and acting within the scope of its authority. (2) The time for filing a claim will be extended if CMS or one of its contractors determines that a failure to meet the deadline in paragraph (a) of this section is caused by all of the following conditions: (i) At the time the service was furnished the beneficiary was not entitled to Medicare. (ii) The beneficiary subsequently received notification of Medicare entitlement effective retroactively to or before the date of the furnished service. (3) The time for filing a claim will be extended if CMS or one of its contractors determines that a failure to meet the deadline in paragraph (a) of this section is caused by all of the following conditions: (i) At the time the service was furnished the beneficiary was not entitled to Medicare. (ii) The beneficiary subsequently received notification of Medicare entitlement effective retroactively to or before the date of the furnished service. (iii) A State Medicaid agency recovered the Medicaid payment for the furnished service from a provider or supplier 6 months or more after the service was furnished. (4) The time for filing a claim will be extended if CMS or one of its contractors determines that a failure to meet the deadline in paragraph (a) of this section is caused by all of the following conditions: (i) At the time the service was furnished the beneficiary was enrolled in a Medicare Advantage plan or Program of All-inclusive Care for the Elderly (PACE) provider organization. (ii) The beneficiary was subsequently disenrolled from the Medicare Advantage plan or Program of All-inclusive Care for the Elderly (PACE) provider organization effective retroactively to or before the date of the furnished service. (iii) The Medicare Advantage plan or Program of All-inclusive Care for the Elderly (PACE) provider organization recovered its payment for the furnished service from a provider or supplier 6 months or more after the service was furnished. (5) Extension of time. (ii) If CMS or one of its contractors determines that both of the conditions are met in paragraph (b)(2) of this section but that all of the conditions in paragraph (b)(3) are not satisfied, the time to file a claim will be extended through the last day of the sixth calendar month following the month in which either the beneficiary or the provider or supplier received notification of Medicare entitlement effective retroactively to or before the date of the furnished service. (iii) If CMS or one of its contractors determines that all of the conditions are met in paragraph (b)(3) of this section, the time to file a claim will be extended through the last day of the sixth calendar month following the month in which the State Medicaid agency recovered the Medicaid payment for the furnished service from the provider or supplier. (iv) If CMS or one of its contractors determines that all of the conditions are met in paragraph (b)(4) of this section, the time to file a claim will be extended through the last day of the sixth calendar month following the month in which the Medicare Advantage plan or Program of All-inclusive Care for the Elderly (PACE) provider organization recovered its payment for the furnished service from the provider or supplier. (c) Extension of period ending on a nonworkday. (d) Outpatient diabetes self-management training. (e) As specified in §§ 424.520 and 424.521 of this subpart, there are restrictions on the ability of the following newly-enrolled suppliers to submit claims for items or services furnished prior to the effective date of their Medicare billing privileges: (1) Physician or nonphysician practitioner organizations. (2) Physicians. (3) Nonphysician practitioners. (4) Independent diagnostic testing facilities. [53 FR 6634, Mar. 2, 1988, as amended at 65 FR 83153, Dec. 29, 2000; 73 FR 69939, Nov. 19, 2008; 75 FR 73627, Nov. 29, 2010] Subpart D—To Whom Payment Is Ordinarily Made § 424.50 Scope. (a) This subpart specifies to whom Medicare payment is ordinarily made for different kinds of services. (b) Subpart E of this part sets forth provisions applicable in special situations. (c) Subpart F of this part specifies the exceptional circumstances under which payment may be made to an assignee or reassignee. § 424.51 Payment to the provider. (a) Basic rule. (b) Exception. § 424.52 Payment to a nonparticipating hospital. Medicare pays a nonparticipating hospital for the following services, if covered, in the specified circumstances: (a) Emergency inpatient and outpatient services furnished by a U.S. hospital, if the hospital has in effect an election to claim payment in accordance with subpart G of this part. (b) Certain medical and other health services covered under Medicare Part B and furnished by a U.S. hospital, if the hospital meets the requirements of § 424.55 for payment as a supplier. (c) Emergency or nonemergency inpatient services furnished by a foreign hospital if the hospital has in effect an election to claim payment in accordance with subpart G of this part. § 424.53 Payment to the beneficiary. Medicare pays the beneficiary for the following services, if covered, in the specified circumstances: (a) Emergency inpatient and outpatient services furnished by a nonparticipating U.S. hospital that has not elected to claim payment in accordance with subpart G of this part. (b) Certain medical and other health services covered under Medicare Part B and furnished by a nonparticipating U.S. hospital, if the hospital does not receive assigned payment as a supplier under § 424.55. (c) Emergency or nonemergency services furnished by a foreign hospital if the hospital does not have in effect an election to claim payment in accordance with subpart H of this part. (d) Physician and ambulance services furnished outside the United States. (e) Services furnished by a supplier if the claim has not been assigned to the supplier. § 424.54 Payment to the beneficiary's legal guardian or representative payee. Medicare may pay amounts due a beneficiary to the beneficiary's legal guardian or representative payee. § 424.55 Payment to the supplier. (a) Medicare pays the supplier for covered services if the beneficiary (or the person authorized to request payment on the beneficiary's behalf) assigns the claim to the supplier and the supplier accepts assignment. (b) In accepting assignment, the supplier agrees to the following: (1) To accept, as full charge for the service, the amount approved by the carrier as the basis for determining the Medicare Part B payment (the reasonable charge or the lesser of the fee schedule amount and the actual charge). (2) To limit charges to the beneficiary or any other source as follows: (i) To collect nothing for those services for which Medicare pays 100 percent of the Medicare approved amount. (ii) To collect only the difference between the Medicare approved amount and the Medicare Part B payment (for example, the amount of any reduction in incurred expenses under § 410.155(c), any applicable deductible amount, and any applicable coinsurance amount) for services for which Medicare pays less than 100 percent of the approved amount. (3) Not to charge the beneficiary when Medicare paid for services determined to be “not reasonable or necessary” if— (i) The beneficiary was without fault in the overpayment; and (ii) The determination that the payment was incorrect was made by the carrier after the third year following the year in which the carrier sent notice to the beneficiary that it approved the payment. (c) Exception. (d) For purposes of claims for services submitted by an MDPP supplier (as defined at § 410.79(b) of this chapter), Medicare deems such claims to have been assigned by the beneficiary (or the person authorized to request payment on the beneficiary's behalf) and the assignment accepted by the MDPP supplier. [53 FR 6634, Mar. 2, 1988, as amended at 63 FR 20130, Apr. 23, 1998; 69 FR 66426, Nov. 15, 2004; 82 FR 53364, Nov. 15, 2017] § 424.56 Payment to a beneficiary and to a supplier. (a) Conditions for split payment. (b) Payment to the supplier. (1) The reasonable charge minus the amount the beneficiary had already paid to the supplier; or (2) The full Part B benefit due for the services furnished. (c) Payment to the beneficiary. (d) Examples. Example 1. An assigned bill of $300 on which partial payment of $100 has been made is submitted to the carrier. The carrier determines that $300 is the reasonable charge for the service furnished. Total payment due is 80 percent of $300 or $240. Of this amount, $200 (the difference between the $100 partial payment and the $300 reasonable charge) is paid to the supplier. The remaining $40 is paid to the beneficiary. Example 2. An assigned bill of $325 on which partial payment of $275 has been made is submitted to the carrier. The carrier determines that $275 is the reasonable charge for the services. Total payment due is 80 percent of $275 or $220. The $220 is paid to the beneficiary, since any payment to the supplier, when added to the $275 partial payment would exceed the reasonable charge for the services furnished. [53 FR 6641, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988] § 424.57 Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges. (a) Definitions. Accredited DMEPOS suppliers Affiliate Assessment Attended facility-based polysomnogram Authorized surety Civil money penalty (CMP) CMS approved accreditation organization Continuous positive airway pressure (CPAP) device DMEPOS DMEPOS supplier Final adverse action (i) A Medicare-imposed revocation of any Medicare billing privileges. (ii) Suspension or revocation of a license to provide health care by any State licensing authority. (iii) Revocation for failure to meet DMEPOS quality standards. (iv) A conviction of a Federal or State felony offense (as defined in § 424.535(a)(3)(i) within the last 10 years preceding enrollment, revalidation, or re-enrollment. (v) An exclusion or debarment from participation in a Federal or State health care program. Government-operated supplier Independent accreditation organization Medicare covered items Penal sum Rider Sleep test Sufficient evidence Surety bond Unpaid claim unpaid claim (b) General rule. (1) The supplier has submitted a completed application to CMS to furnish Medicare-covered items including required enrollment forms. (The supplier must enroll separate physical locations it uses to furnish Medicare-covered DMEPOS, with the exception of locations that it uses solely as warehouses or repair facilities.) (2) The item was furnished on or after the date CMS issued to the supplier a DMEPOS supplier number conveying billing privileges. (CMS issues only one supplier number for each location.) This requirement does not apply to items furnished incident to a physician's service. (3) CMS has not revoked or excluded the DMEPOS supplier's privileges during the period which the item was furnished has not been revoked or excluded. (4) A supplier that furnishes a drug used as a Medicare-covered supply with durable medical equipment or prosthetic devices must be licensed by the State to dispense drugs (A supplier of drugs must bill and receive payment for the drug in its own name. A physician, who is enrolled as a DMEPOS supplier, may dispense, and bill for, drugs under this standard if authorized by the State as part of the physician's license.) (5) The supplier has furnished to CMS all information or documentation required to process the claim. (6) The supplier is in compliance with all conditions of payment in paragraph (b) of this section, as well as with paragraph (c)(1)(ii)(A) of this section, at the time the item or service is furnished. (c) Application certification standards. (1) Operates its business and furnishes Medicare-covered items in compliance with the following applicable laws: (i) Federal regulatory requirements that specify requirements for the provision of DMEPOS and ensure accessibility for the disabled. (ii) State licensure and regulatory requirements. (A) Must be licensed to provide the item or service; and (B) May contract with a licensed individual or other entity to provide the licensed services unless expressly prohibited by State law. (2) Has not made, or caused to be made, any false statement or misrepresentation of a material fact on its application for billing privileges. (The supplier must provide complete and accurate information in response to questions on its application for billing privileges. The supplier must report to CMS any changes in information supplied on the application within 30 days of the change.); (3) Must have the application for billing privileges signed by an individual whose signature binds a supplier; (4) Fills orders, frabicates, or fits items from its own inventory or by contracting with other companies for the purchase of items necessary to fill the order. If it does, it must provide, upon request, copies of contracts or other documentation showing compliance with this standard. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs, or from any other Federal Government Executive Branch procurement or nonprocurement program or activity; (5) Advises beneficiaries that they may either rent or purchase inexpensive or routinely purchased durable medical equipment, and of the purchase option for capped rental durable medical equipment, as defined in § 414.220(a) of this subchapter. (The supplier must provide, upon request, documentation that it has provided beneficiaries with this information, in the form of copies of letters, logs, or signed notices.); (6) Honors all warranties expressed and implied under applicable State law. A supplier must not charge the beneficiary or the Medicare program for the repair or replacement of Medicare covered items or for services covered under warranty. This standard applies to all purchased and rented items, including capped rental items, as described in § 414.229 of this subchapter. The supplier must provide, upon request, documentation that it has provided beneficiaries with information about Medicare covered items covered under warranty, in the form of copies of letters, logs, or signed notices; (7) Maintains a physical facility on an appropriate site. An appropriate site must meet all of the following: (i) Must meet the following criteria: (A)( 1 2 ( i ( ii ( iii ( 2 1 ( i ( ii (B) Is in a location that is accessible to the public, Medicare beneficiaries, CMS, NSC, and its agents. (The location must not be in a gated community or other area where access is restricted.) (C) Is accessible and staffed during posted hours of operation. (D) Maintains a permanent visible sign in plain view and posts hours of operation. If the supplier's place of business is located within a building complex, the sign must be visible at the main entrance of the building or the hours can be posted at the entrance of the supplier. (E) Except for business records that are stored in centralized location as described in paragraph (c)(7)(ii) of this section, is in a location that contains space for storing business records (including the supplier's delivery, maintenance, and beneficiary communication records). (F) Is in a location that contains space for retaining the necessary ordering and referring documentation specified in § 424.516(f). (ii) May be the centralized location for all of the business records and the ordering and referring documentation of a multisite supplier. (iii) May be a “closed door” business, such as a pharmacy or supplier providing services only to beneficiaries residing in a nursing home, that complies with all applicable Federal, State, and local laws and regulations. “Closed door” businesses must comply with all the requirements in this paragraph. (8) Permits CMS, the NSC, or agents of CMS or the NSC to conduct on-site inspections to ascertain supplier compliance with the requirements of this section. (9) Maintains a primary business telephone that is operating at the appropriate site listed under the name of the business locally or toll-free for beneficiaries. (i) Cellular phones, beepers, or pagers must not be used as the primary business telephone. (ii) Calls must not be exclusively forwarded from the primary business telephone listed under the name of the business to a cellular phone, beeper, or pager. (iii) Answering machines, answering services, facsimile machines or combination of these options must not be used exclusively as the primary business telephone during posted operating hours. (10) Has a comprehensive liability insurance policy in the amount of at least $300,000 that covers both the supplier's place of business and all customers and employees of the supplier. (i) In the case of a supplier that manufactures its own items, this insurance must also cover product liability and completed operations. (ii) Failure to maintain required insurance at all times results in revocation of the supplier's billing privileges retroactive to the date the insurance lapsed. (iii) An authorized official of the supplier (as that term is defined in § 424.502) must sign the liability insurance policy. (11) Must agree not to contact a beneficiary by telephone when supplying a Medicare-covered item unless one of the following applies: (i) The individual has given written permission to the supplier to contact them by telephone concerning the furnishing of a Medicare-covered item that is to be rented or purchased. (ii) The supplier has furnished a Medicare-covered item to the individual and the supplier is contacting the individual to coordinate the delivery of the item. (iii) If the contact concerns the furnishing of a Medicare-covered item other than a covered item already furnished to the individual, the supplier has furnished at least one covered item to the individual during the 15-month period preceding the date on which the supplier makes such contact. (12) Must be responsible for the delivery of Medicare covered items to beneficiaries and maintain proof of delivery. (The supplier must document that it or another qualified party has at an appropriate time, provided beneficiaries with necessary information and instructions on how to use Medicare-covered items safely and effectively); (13) Must answer questions and respond to complaints a beneficiary has about the Medicare-covered item that was sold or rented. A supplier must refer beneficiaries with Medicare questions to the appropriate carrier. A supplier must maintain documentation of contacts with beneficiaries regarding complaints or questions; (14) Must maintain and replace at no charge or repair directly, or through a service contract with another company, Medicare-covered items it has rented to beneficiaries. The item must function as required and intended after being repaired or replaced; (15) Must accept returns from beneficiaries of substandard (less than full quality for the particular item or unsuitable items, inappropriate for the beneficiary at the time it was fitted and rented or sold); (16) Must disclose these supplier standards to each beneficiary to whom it supplies a Medicare-covered item; (17) Must comply with the disclosure provisions in § 420.206 of this subchapter; (18) Must not convey or reassign a supplier number; (19) Must have a complaint resolution protocol to address beneficiary complaints that relate to supplier standards in paragraph (c) of this section and keep written complaints, related correspondence and any notes of actions taken in response to written and oral complaints. Failure to maintain such information may be considered evidence that supplier standards have not been met. (This information must be kept at its physical facility and made available to CMS, upon request.); (20) Must maintain the following information on all written and oral beneficiary complaints, including telephone complaints, it receives: (i) The name, address, telephone number, and health insurance claim number of the beneficiary. (ii) A summary of the complaint; the date it was received; the name of the person receiving the complaint, and a summary of actions taken to resolve the complaint. (iii) If an investigation was not conducted, the name of the person making the decision and the reason for the decision. (21) Provides to CMS, upon request, any information required by the Medicare statute and implementing regulations. (22)(i) All suppliers of DMEPOS and other items and services, and all of their locations whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited to enroll in and bill Medicare. (ii) The accreditation must indicate the specific products and services for which the DMEPOS supplier is accredited in order for the supplier to receive payment for those specific products and services. (iii) An accredited DMEPOS supplier may be denied enrollment, or its enrollment may be revoked, if CMS determines that it is not compliant with the DMEPOS quality standards. (23) All DMEPOS suppliers must notify their DMEPOS accrediting organization when a new DMEPOS location is opened. (24) All accredited DMEPOS suppliers must be surveyed and reaccredited at least once every 12 months. (25) All DMEPOS suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation. If a new product line is added after enrollment, the DMEPOS supplier will be responsible for notifying the accrediting body of the new product so that the DMEPOS supplier can be re-surveyed and accredited for these new products. (26) Must meet the surety bond requirements specified in paragraph (d) of this section. (27) Must obtain oxygen from a State-licensed oxygen supplier (applicable only to those suppliers in States that require oxygen licensure.) (28) Is required to maintain ordering and referring documentation consistent with the provisions found in § 424.516(f) (29)(i) Except as specified in paragraph (c)(29)(ii) of this section, is prohibited from sharing a practice location with any other Medicare supplier or provider. (ii) The prohibition specified in paragraph (c)(29)(i) of this section is not applicable at a practice location that meets one of the following: (A) Where a physician whose services are defined in section 1848(j)(3) of the Act or a nonphysician practitioner, as described in section 1842(b)(18)(C) of the Act, furnishes items to his or her own patient as part of his or her professional service. (B) Where a physical or occupational therapist whose services are defined in sections 1861(p) and 1861(g) of the Act, furnishes items to his or her own patient as part of his or her professional service. (C) Where a DMEPOS supplier is co-located with and owned by an enrolled Medicare provider (as described in § 489.2(b) of this chapter). The DMEPOS supplier— ( 1 ( 2 (30)(i) Except as specified in paragraph (c)(30)(ii) of this section, is open to the public a minimum of 30 hours per week. (ii) The provision of paragraph (c)(30)(i) of this section is not applicable at a practice location where a— (A) Physician whose services are defined in section 1848(j)(3) of the Act furnishes items to his or her own patient(s) as part of his or her professional service; (B) A physical or occupational therapist whose services are defined in sections 1861(p) and 1861(g) of the Act furnishes items to his or her own patient(s) as part of his or her professional service; or (C) DMEPOS supplier is working with custom made orthotics and prosthetics. (d) Surety bonds requirements Effective date of surety bond requirements DMEPOS suppliers seeking enrollment or with a change in ownership. (ii) Existing DMEPOS suppliers. (2) Minimum requirements for a DMEPOS supplier. (ii) A supplier that seeks to become an enrolled DMEPOS supplier through a purchase or transfer of assets or ownership interest must submit to the CMS contractor surety bond from an authorized surety of $50,000 and, if required by the CMS contractor, an elevated bond amount as described in paragraph (d)(3) of this section that is effective from the date of the purchase or transfer in order to exercise billing privileges as of that date. If the bond is effective at a later date, the effective date of the new DMEPOS supplier billing privileges is the effective date of the surety bond as validated by the CMS contractor. (iii) A DMEPOS supplier enrolling a new practice location must submit to the CMS contractor a new surety bond from an authorized surety or an amendment or rider to the existing bond, showing that the new practice location is covered by an additional base surety bond of $50,000 or, as necessary, an elevated surety bond amount as described in paragraph (d)(3) of this section. (3) Elevated surety bond amounts. (ii) The CMS contractor prescribes an elevated surety bond amount of $50,000 per occurrence of an adverse legal action within the 10 years preceding enrollment, revalidation, or reenrollment, as defined in paragraph (a) of this section. (4) Type and terms of the surety bond Type of bond. (ii) Minimum requirements of liability coverage. (B) CMS requires a DMEPOS supplier to submit a bond that on its face reflects the requirements of this section. CMS revokes or denies a DMEPOS supplier's billing privileges based upon the submission of a bond that does not reflect the requirements of paragraph (d) of this section. (5) Specific surety bond requirements. (A) The amount of any unpaid claim, plus accrued interest, for which the DMEPOS supplier is responsible. (B) The amount of any unpaid claims, CMPs, or assessments imposed by CMS or OIG on the DMEPOS supplier, plus accrued interest. (ii) The bond must provide the following: The surety is liable for unpaid claims, CMPs, or assessments that occur during the term of the bond. (iii) If the DMEPOS supplier fails to furnish a bond meeting the requirements of paragraph (d) of this section, fails to submit a rider when required, or if the DMEPOS supplier's billing privileges are revoked, the last bond or rider submitted by the DMEPOS supplier remains in effect until the last day of the surety bond coverage period and the surety remains liable for unpaid claims, CMPs, or assessments that— (A) CMS or the OIG imposes or asserts against the DMEPOS supplier based on overpayments or other events that took place during the term of the bond or rider; and (B) Were imposed or assessed by CMS or the OIG during the 2 years following the date that the DMEPOS supplier failed to submit a bond or required rider, or the date the DMEPOS supplier's billing privileges were terminated, whichever is later. (6) Cancellation of a bond and lapse of surety bond coverage. (ii) Cancellation of a surety bond is grounds for revocation of the DMEPOS supplier's Medicare billing privileges unless the DMEPOS supplier provides a new bond before the effective date of the cancellation. The liability of the surety continues through the termination effective date. (iii) If CMS receives notification of a lapse in bond coverage from the surety, the DMEPOS supplier's billing privileges are revoked. During this lapse, Medicare does not pay for items or services furnished during the gap in coverage, and the DMEPOS supplier is held liable for the items or services (that is, the DMEPOS supplier would not be permitted to charge the beneficiary for the items or services). (iv) The surety must immediately notify the CMS contractor if there is a lapse in the surety's coverage of the DMEPOS supplier's coverage. (7) Actions under the surety bond. (8) Required surety information on the surety bond. (9) Change of surety. (10) Parties to the surety bond. (11) Effect of DMEPOS supplier's failure to obtain, maintain, and timely file a surety bond. (i) CMS revokes the DMEPOS supplier's billing privileges if an enrolled DMEPOS supplier fails to obtain, file timely, or maintain a surety bond as specified in this subpart and CMS instructions. Notwithstanding paragraph (e) of this section, the revocation is effective the date the bond lapsed and any payments for items furnished on or after that date must be repaid to CMS by the DMEPOS supplier. (ii) CMS denies billing privileges to a DMEPOS supplier if the supplier seeking to become an enrolled DMEPOS supplier fails to obtain and file timely a surety bond as specified with this subpart and CMS instructions. (12) Evidence of DMEPOS supplier's compliance. (13) Effect of subsequent DMEPOS supplier payment. (14) Effect of review reversing determination. (15) Exception to the surety bond requirement Qualifying entities and requirements. (B) State-licensed orthotic and prosthetic personnel in private practice making custom made orthotics and prosthetics are provided an exception to the surety bond requirement if— ( 1 ( 2 (C) Physicians and nonphysician practitioners as defined in section 1842(b)(18) of the Act are provided an exception to the surety bond requirement when items are furnished only to the physician or nonphysician practitioner's own patients as part of his or her physician service. (D) Physical and occupational therapists in private practice are provided an exception to the surety bond requirement if— ( 1 ( 2 ( 3 (ii) Loss of a DMEPOS supplier exception. (e) Failure to meet standards Revocation. (2) Overpayments associated with final adverse actions. (f) Payment prohibition. (g) Revalidation of billing privileges. (h) Change in majority ownership. [65 FR 60377, Oct. 11, 2000, as amended at 71 FR 48409, Aug. 18, 2006; 73 FR 69939, Nov. 19, 2008; 75 FR 52648, Aug. 27, 2010; 76 FR 5962, Feb. 2, 2011; 77 FR 14994, Mar. 14, 2012; 79 FR 69773, Nov. 24, 2014; 87 FR 70231, Nov. 18, 2022; 90 FR 55607, Dec. 2, 2025] § 424.58 Accreditation. (a) Scope and purpose. (b) Definitions. Complaint Immediate family member (i) A husband or wife. (ii) Birth or adoptive parent, child, or sibling. (iii) Stepparent, stepchild, stepbrother, or stepsister. (iv) Father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law. (v) Grandparent or grandchild. (vi) Spouse of a grandparent or grandchild. Immediate jeopardy Reasonable assurance (i) Its DMEPOS accreditation program requirements meet or exceed the Medicare program requirements. (ii) The DMEPOS suppliers that the DMEPOS accrediting organization accredits meet or exceed Medicare program requirements. (iii) The DMEPOS accrediting organization is compliant with all provisions of this section. Unannounced survey (i) A survey that is conducted without any prior notice of any type (through any means of communication or forum) to the DMEPOS supplier to be surveyed such that the supplier does not expect the survey until the surveyors arrive. (ii) The DMEPOS accrediting organization schedules its surveys so that DMEPOS suppliers cannot predict when they will be performed. (c) Initial application procedures Required information. (i) A list of the types of DMEPOS supplies, products, and services for which the organization is requesting approval. (ii) A detailed comparison of the organization's accreditation requirements and standards with the applicable DMEPOS quality standards, such as a crosswalk. (iii) A detailed description of the organization's operational, survey, and other accreditation processes to confirm that the DMEPOS suppliers it accredits meet or exceed the DMEPOS quality standards and Medicare program requirements. This must include all of the following: (A) Procedures for performing unannounced surveys. (B) Frequency of the surveys performed. (C) Copies of the organization's survey forms. (D) Guidelines and instructions to surveyors. (E) Quality review processes for deficiencies identified with accreditation requirements. (F) Dispute resolution processes and policies when there is a negative survey finding or decision. (G) If the DMEPOS accrediting organization has the discretion to perform a survey in certain instances, how it determines whether to perform one. This must include a suggested methodology for sampling locations for surveys under a single tax identification number or organization. (iv) Procedures used to notify DMEPOS suppliers of compliance or noncompliance with the accreditation requirements. (v) Procedures used to monitor the correction of deficiencies found during an accreditation survey. (vi) Procedures for coordinating surveys with another DMEPOS accrediting organization if the organization does not accredit all supplies, products, and services the DMEPOS supplier provides. (vii) Detailed professional information about the individuals who perform surveys for the DMEPOS accrediting organization, including the size and composition of accreditation survey teams for each type of DMEPOS supplier accredited, and the education and experience requirements that surveyors must meet. The information must also include the following: (A) The content and frequency of the continuing education training provided to survey personnel. (B) The evaluation systems used to monitor the performance of individual surveyors and survey teams. (C) Policies and procedures for a surveyor or institutional affiliate of the DMEPOS accrediting organization that participates in a survey or accreditation decision regarding a DMEPOS supplier with which that individual or institution is professionally or financially affiliated. (D) The organization's policies and procedures to avoid conflicts of interest and the appearance thereof involving individuals who conduct surveys or participate in accreditation decisions. This must include the organization's policies and procedures for all of the following: ( 1 ( 2 ( 3 ( i ( ii ( iii ( iv ( v ( vi ( vii ( viii ( ix 3 i viii ( x ( 4 ( 5 (E) The organization's policies and procedures for ensuring it has an adequate number of surveyors at all times. (viii) Its processes for identifying and correcting deficiencies within its DMEPOS accreditation program. (ix) A description of the organization's data management, analysis and reporting system for its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system. This must also include a detailed description of how the organization uses its data to ensure the compliance of its DMEPOS accreditation program with Medicare program requirements. (x) Procedures for responding to, investigating, and (as applicable) closing out complaints against accredited facilities, including policies and procedures regarding coordination of these activities with appropriate licensing bodies, ombudsman programs, the applicable National Provider Enrollment contractor, and CMS. This must also include a detailed outline of all of the following: (A) The steps and research the DMEPOS accrediting organization will undertake in its initial review of the complaint as described in paragraph (e)(3) of this section. (B) How the DMEPOS accrediting organization determines whether, in accordance with a complaint, non-compliance with a DMEPOS quality standard or other applicable CMS requirement exists, including the information it considers in its review and when and how it would take action against the DMEPOS supplier. (xi) The organization's policies and procedures for notifying CMS of DMEPOS suppliers that fail to meet the DMEPOS accrediting organization's requirements. (xii) A description of all types, categories, and durations of accreditations offered by the organization. (xiii) A list of the following: (A) All currently accredited DMEPOS suppliers. (B) The types, categories, and product codes of accreditation currently held by each DMEPOS supplier. (C) The effective and expiration dates of each DMEPOS supplier's current accreditation. (D) The upcoming survey cycles for all DMEPOS suppliers' accreditation surveys scheduled to be performed by the organization. (xiv) A written presentation that demonstrates the organization's ability to furnish CMS with electronic data in ASCII comparable code. (xv) A resource analysis that demonstrates that the organization's staffing, funding, and other resources are adequate to perform fully the required surveys and related activities. (xvi) Information that demonstrates the DMEPOS accrediting organization's knowledge, expertise, and experience in DMEPOS. (xvii) Information about the DMEPOS accrediting organization's ability to conduct timely reviews of DMEPOS supplier accreditation applications. (xviii) A description of the organization's accreditation decision-making process. This includes its policies and procedures for approving, denying, or terminating accreditation status for DMEPOS suppliers that fail to meet the DMEPOS accrediting organization's standards or requirements. This must include an explanation of the reasons for which it will deny or terminate a supplier's accreditation. (xix) Policies and procedures for both of the following: (A) Determining whether and when a survey is performed (for example, the DMEPOS supplier is providing a new item type). This includes the circumstances under which the DMEPOS accrediting organization will impose a corrective action plan (CAP) in lieu of performing a follow-up survey for an identified DMEPOS supplier deficiency. (B) Ensuring that all onsite surveys are unannounced, including procedures that protect against unannounced surveys becoming known to the DMEPOS supplier before the visit. (xx) Policies and procedures regarding when the DMEPOS accrediting organization will apply a CAP to a DMEPOS supplier. This must include the following: (A) The specific circumstances under which the DMEPOS accrediting organization will apply a CAP as opposed to, as applicable, denying or terminating accreditation and the rationale for why the accrediting organization believes a CAP in these situations is more appropriate. (B) How a CAP is developed, implemented, and enforced, including the following: ( 1 ( 2 ( 3 ( 4 (xxi) An explanation of the following: (A) What the DMEPOS accrediting organization considers to be a DMEPOS supplier deficiency and how it defines the term deficiency. (B) Whether the DMEPOS accrediting organization has different levels of DMEPOS supplier deficiencies. (xxii) In performing the functions described in this section, its processes for both of the following: (A) Detecting and addressing potential fraud, waste, and abuse by DMEPOS suppliers (including identifying the accrediting organization's definitions of the terms fraud, waste, and abuse). (B) Reporting this activity to CMS and, as applicable, law enforcement. (xxiii) A statement on the DMEPOS accrediting organization's letterhead that is signed and dated by the accrediting organization's chief executive officer (or similar official with authority to commit the organization to adhere to Medicare laws and regulations) acknowledging that, as a condition for CMS approval or continued approval of a DMEPOS accrediting organization's accreditation program, the organization agrees to all of the following: (A) Provide CMS, within 3 business days of CMS's request, both of the following: ( 1 ( 2 (B) Provide CMS written notification when an accreditation survey or complaint investigation identifies an immediate jeopardy situation (as that term is defined in paragraph (b) of this section). Consistent with paragraph (e)(1)(iii) of this section, this notice must be provided within 2 business days of the finding. (C) Provide written notification to CMS of any proposed changes to the DMEPOS accrediting organization's accreditation program and that it will not implement the proposed changes without prior written notice of continued program approval from CMS consistent with paragraph (e)(2) of this section. (D) Notify CMS in writing of any decision to terminate, revoke, withdraw, or amend the accreditation status of a specific DMEPOS supplier within 3 business days of the date the organization took such action. (E) Notify CMS of any decision to apply a CAP to a specific DMEPOS supplier within 10 calendar days of the decision. This notification must include the following: ( 1 ( 2 ( 3 (F) Submit timely, accurate, and complete data to support CMS's evaluation of the DMEPOS accrediting organization's performance. ( 1 ( 2 (G) In response to a written notice from CMS to the organization of a change in the CMS quality standards, survey process, or other requirement, provide CMS with proposed corresponding changes in the organization's requirements for its DMEPOS accreditation program to ensure continued comparability with the CMS quality standards, survey process, and requirements. This includes compliance with the following requirements: ( 1 ( 2 ( 3 (H) Apply and adhere to in its accreditation activities any CMS-established— ( 1 ( 2 (I) The DMEPOS accrediting organization will permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings. (J) If CMS permits the DMEPOS accrediting organization to perform surveys via a sampling process, the accrediting organization: ( 1 ( 2 (K) Will not include the following as patient medical records in its DMEPOS supplier surveys: ( 1 ( 2 ( 3 ( 4 ( 5 (L) Have a binding written agreement with each DMEPOS supplier the DMEPOS accrediting organization accredits regarding whether the accrediting organization, the supplier in question, or both will assume the costs of a survey that CMS directs the accrediting organization to perform in accordance with paragraph (e)(8)(ii) of this section. (M) Submit all required information to CMS both before and after approval of its DMEPOS accreditation program in a truthful, accurate, and complete manner. (N) Adhere to all of the requirements of this section at all times, including the policies, procedures, practices, and agreements it outlined in paragraph (c) of this section as part of its initial or reapproval application and any CMS-approved changes thereto under paragraph (e)(2) or (7) of this section. (2) Additional information needed. (3) Withdrawing an application. (4) Reasons for denial. (i) The DMEPOS accrediting organization has failed to comply with all application, data, and agreement submission requirements outlined in this paragraph (c). (ii) The DMEPOS accrediting organization has failed to provide reasonable assurance (as defined in paragraph (b) of this section). (iii) The current number of CMS-approved DMEPOS accreditation programs is sufficient to ensure the continued administration of CMS' DMEPOS accreditation program. (iv) The DMEPOS accrediting organization's DMEPOS accreditation program was previously terminated, suspended, or placed on probation by CMS under, respectively, paragraph (h), (i), or (j) of this section. (v) The DMEPOS accrediting organization, or any owner (as defined in § 424.502), managing employee (as defined in § 424.502), governing body member, W-2 or contracted surveyor, or W-2 or contracted health care or administrative or management services personnel thereof— (A) Is excluded by the Office of Inspector General (OIG) from Medicare, Medicaid, and any other Federal health care program; (B) Is debarred, suspended, or otherwise excluded from participating in any Federal procurement or non-procurement activity in accordance with section 2455 of the Federal Acquisition Streamlining Act (FASA); (C) Within the preceding 10 years— ( 1 ( 2 ( 3 ( 4 (vi) The DMEPOS accrediting organization has submitted false or misleading information on its application in order to gain CMS approval or reapproval as a DMEPOS accrediting organization. (vii) The AO is non-compliant with any provision in this section. (viii) CMS otherwise determines that approval of the applicant as a DMEPOS AO would not be in the best interests of the Medicare program and its beneficiaries. (5) Notice of approval or denial of application. (i) The basis for the decision. (ii) If applicable, the effective date of approval. (iii) If applicable, the term of the approval (not to exceed 6 years). (6) Decision announcement. (i) This announcement is posted within 210 calendar days from the date that CMS determines that the DMEPOS accrediting organization's application was complete. (ii) If the application is approved, the posting states the approval's effective date (no later than the announcement's posting date) and length (6 years or less). (7) Term of approval. (d) Reapproval process General requirement Timeline for submission. (ii) Discretion to request reapproval applications. (2) Submission of information and statements. (3) Withdrawing an application. (4) Denial reasons. (5) Notice of approval or denial of application. (i) The basis for the decision. (ii) If applicable, the effective date of reapproval. (iii) If applicable, the term of the reapproval (not to exceed 6 years). (6) Decision announcement. (i) This announcement is posted within 210 calendar days from the date that CMS determines that the DMEPOS accrediting organization's reapproval application was complete. (ii) If the reapproval application is approved, the posting states the reapproval's effective date (no later than the announcement's posting date) and length (6 years or less). (7) Term of approval. (e) Ongoing responsibilities of a CMS-approved DMEPOS

accrediting organization. (1) Submission of information. (A) Copies of all accreditation survey results and reports, together with any survey related information that CMS may require. This includes both of the following: ( 1 ( 2 (B) Notice of all accreditation decisions. (C) Notice of all resolved deficiencies. (D) Information about any supplier of DMEPOS and other items and services against which the CMS-approved DMEPOS accrediting organization has taken remedial or adverse action, including termination of the supplier's accreditation. (ii) CMS may at any time request the DMEPOS accrediting organization to submit any of the information described in paragraph (e)(1)(i) of this section or any other data CMS deems necessary to facilitate its oversight of the accrediting organization's DMEPOS accreditation program. This information must be furnished to CMS within 3 business days of the request. (iii) Within 2 business days of identifying an immediate jeopardy deficiency of a DMEPOS supplier, provide CMS with written notice of the deficiency and any adverse action implemented by the DMEPOS accrediting organization. (2) Standard or requirement changes. (i) The notice must be submitted to CMS no less than 60 calendar days before the proposal's planned effective date. It must include the following: (A) A detailed description of the changes and the rationale for them. (B) A detailed crosswalk (in table format) that states the exact language of the organization's revised accreditation requirements and the applicable Medicare requirements for each. (ii) CMS communicates to the DMEPOS accrediting organization in writing its approval or disapproval of the proposal within 30 calendar days of the proposed change's effective date. (iii) CMS approval is required before the DMEPOS accrediting organization can implement the change. If the organization implements the changes before or without CMS' approval, CMS may terminate its approval of the accrediting organization. (3) Addressing complaints. (A) Notify CMS in writing of the complaint no later than 5 calendar days after receipt; (B) Using the DMEPOS accrediting organization's policies and procedures described in paragraph (c)(1)(x) of this section, perform an initial review of the complaint to determine whether, based on the complaint and any other information, the DMEPOS supplier may be non-compliant with one or more DMEPOS quality standards or other applicable CMS requirement; and (C) Perform a survey of the DMEPOS supplier if the DMEPOS accrediting organization's initial review concludes that such non-compliance may exist. This survey must be performed no later than 21 calendar days after the accrediting organization received the initial complaint. (ii) No later than 10 calendar days after completing the action in, as applicable, paragraph (e)(3)(i)(B) or (C) of this section, notify CMS in writing of the result of the initial review or, as applicable, the survey. The notice must include information regarding any action the DMEPOS accrediting organization took or plans to take with respect to the DMEPOS supplier, such as a termination of accreditation or a CAP. (4) CAPs. (i) The reason for the decision. (ii) A detailed explanation and justification as to why the DMEPOS accrediting organization applied a CAP instead of, as applicable, denying or terminating the DMEPOS supplier's accreditation. (iii) The details of the DMEPOS supplier's CAP (for example, deadline for compliance, the DMEPOS accrediting organization's plans for enforcement and ensuring compliance). (5) Denials and terminations. (ii)(A) Notwithstanding any other provision in this section, the DMEPOS accrediting organization must deny accreditation to (or terminate the accreditation of) a DMEPOS supplier if— ( 1 ( 2 ( 3 ( 4 ( 5 (B) If paragraph (e)(5)(ii)(A)( 5 ( 1 ( 2 (6) Provide an annual summary of data related to accreditation. (7) Notification of change from CMS. (A) An acknowledgment of CMS's notification of the change. (B) A revised cross walk reflecting the new requirements. (C) An explanation of how the DMEPOS accrediting organization plans to alter its standards to conform to CMS's new requirements, within the timeframes specified in the notification it received from CMS. (ii) The DMEPOS accrediting organization must not implement its proposed corresponding changes without prior CMS approval. (8) Performance of surveys. (A) Perform a survey of all DMEPOS supplier locations for which the supplier seeks accreditation or reaccreditation with the DMEPOS accrediting organization. This includes, but is not limited to, accreditations for a new item type the supplier has not previously furnished or as required under § 424.551; (B) Perform all surveys as unannounced surveys; and (C) Not accredit the DMEPOS supplier before the survey is performed and the DMEPOS accrediting organization determines that the supplier is compliant with the quality standards. (ii) CMS may, at any time, direct the DMEPOS accrediting organization to perform a survey of an accredited DMEPOS supplier or a group thereof. Existence of an actual or suspected supplier deficiency is not a requirement for CMS to direct the performance of a survey of a supplier. (iii) When performing a survey, the DMEPOS accrediting organization must also confirm that the DMEPOS supplier meets the licensure requirements in § 424.57(c). (9) Surveyor witnesses. (10) Data entry. (11) Relationships. (i) A current exclusion by the OIG from Medicare, Medicaid, and any other Federal health care program. (ii) A current debarment, suspension, or exclusion from participating in any other Federal procurement or non-procurement activity in accordance with section 2455 of the Federal Acquisition Streamlining Act (FASA). (iii) Within the preceding 10 years— (A) A conviction of a Federal or State felony offense that CMS determines is detrimental to the best interests of the Medicare program and its beneficiaries; (B) A Medicare enrollment revocation under § 424.535; (C) A suspension or revocation of a license to provide health care by any State licensing authority; or (D) A suspension or termination from participating in a Federal or State health care program. (f) Continuing federal oversight of approved DMEPOS accrediting organizations. (1) Equivalency review. (2) Validation survey of DMEPOS supplier Survey scope. (ii) Authorization. (A) Authorize the validation survey to take place; and (B) Permit the CMS survey team to monitor the correction of any deficiencies found during the validation survey. (iii) Failure to authorize. (iv) Non-compliance. (3) Deficiencies. (A) Define the term deficiency. (B) Establish levels and categories of deficiencies. (C) Revise the quality standards. (ii) In its DMEPOS accreditation activities, the DMEPOS accrediting organization must apply and adhere to all of the following: (A) Any CMS-established definition of deficiency. (B) All CMS-established levels and categories of deficiencies. (C) All CMS-established quality standards. (4) Review of DMEPOS accrediting organization. ( 1 ( 2 (B) The scope, length, and timing of the review are within CMS' discretion. Evidence of the DMEPOS accrediting organization's potential non-compliance with any element addressed in paragraph (f)(4)(i)(A) of this section is not a prerequisite for performing a review. (ii) Types of CMS reviews include, but are not limited, the following, and may be performed collectively or individually: (A) Equivalency reviews under paragraph (f)(1) of this section. (B) Conducting surveys of accredited DMEPOS suppliers under paragraph (f)(2) of this section. (C) Examining the results of a DMEPOS accrediting organization's surveys of DMEPOS suppliers. (D) Observing a DMEPOS accrediting organization's onsite surveys and other audits of DMEPOS suppliers. (E) Conducting onsite inspections of the DMEPOS accrediting organization's operations and offices. (F) Requesting and reviewing documents. (G) Interviewing DMEPOS accrediting organization staff. (H) Observing an accreditation organization's internal meetings concerning the accreditation process. (g) Voluntary termination of CMS-approved DMEPOS accreditation program Timing. (i) Notify CMS of its decision to voluntarily terminate its approved DMEPOS accreditation program at least 120 calendar days in advance of the effective date of the termination. (ii) Provide written notice at least 90 days in advance of the effective date of the termination to each of its accredited DMEPOS suppliers but not before notifying CMS of its decision in accordance with paragraph (g)(1)(i) of this section. The notice to each supplier must do the following: (A) Describe the provisions in paragraph (g)(2) of this section regarding the expiration dates of the DMEPOS supplier's accreditation with the terminating DMEPOS accrediting organization. (B) Inform the DMEPOS supplier that any lapse in its accreditation (including between the date its existing accreditation with the terminating DMEPOS accrediting organization expires and the effective date of its accreditation with a different accrediting organization) may result in the revocation of its enrollment under § 424.535. (2) Supplier continuation of accreditation. (i) The expiration of its current term of accreditation with the terminating DMEPOS accrediting organization. (ii) The effective date of its accreditation with a different CMS-approved DMEPOS accrediting organization. (h) Involuntary termination Reasons for termination. (A) CMS determines that the DMEPOS accrediting organization no longer demonstrates reasonable assurance (as defined in paragraph (b) of this section). (B) CMS determines that the continued approval of a CMS-approved DMEPOS accreditation program of any DMEPOS accrediting organization poses an immediate jeopardy to the patients of the entities accredited under that program, or the continued approval otherwise constitutes a hazard to the public health. (C) CMS determines that the DMEPOS accrediting organization is non-compliant with any provision of this section. This includes, but is not limited to, situations where the accrediting organization has failed to do either of the following: ( 1 ( 2 (D) There is a pattern or practice of the DMEPOS accrediting organization's accredited DMEPOS suppliers being revoked under § 424.535(a) for failing to comply with the quality standards. (ii) CMS may terminate the DMEPOS accrediting organization's DMEPOS accreditation program effective the date of the letter described in paragraph (h)(2) of this section or any date thereafter. (2) Notification to DMEPOS accrediting organization. (i) The reason for the termination. (ii) The effective date of the termination. (3) Announcement. (4) Notification to DMEPOS suppliers. (i) Describe the provisions in paragraph (h)(6) of this section regarding the expiration dates of the DMEPOS supplier's accreditation with the terminated DMEPOS accrediting organization. (ii) Inform the DMEPOS supplier that any lapse in its accreditation (including between the date its existing accreditation with the terminated DMEPOS accrediting organization expires and the effective date of its accreditation with a different DMEPOS accrediting organization) results in the revocation of its enrollment under § 424.535. (5) Collaboration. (6) Continued accreditation. (A) The expiration of its current term of accreditation with the terminated DMEPOS accrediting organization. (B) The effective date of its accreditation with a different CMS-approved DMEPOS accrediting organization. (C) A date specified by CMS based on the circumstances of the termination of the DMEPOS accrediting organization's approval. (ii) In the event paragraph (h)(6)(i)(C) of this section is applicable, CMS notifies the affected DMEPOS supplier in writing of the deadline by which the supplier must be reaccredited. (7) Refunds. (i) As part of the DMEPOS supplier's request for accreditation or reaccreditation; and (ii) Prior to the organization's notification to the DMEPOS supplier of its final decision regarding the supplier's request. (i) Suspension Reasons for suspension. (i) CMS determines that the DMEPOS accrediting organization no longer demonstrates reasonable assurance (as defined in paragraph (b) of this section). (ii) CMS determines that the DMEPOS accrediting organization is non-compliant with any provision of this section. This can include, but is not limited to, situations where the DMEPOS accrediting organization has failed to do either of the following: (A) Comply with a term or condition of a statement or agreement in paragraph (c)(1)(xxiii) of this section. (B) Adhere to a policy, procedure, or practice it outlined under paragraph (c) of this section as part of its initial application or reapproval application or a CMS-approved change thereto under paragraph (e)(2) or (7) of this section. (iii) There is a pattern or practice of the DMEPOS accrediting organization's accredited DMEPOS suppliers being revoked under § 424.535 for failing to comply with the DMEPOS quality standards. (2) Components of a suspension. (ii) CMS determines the length of the suspension, which lasts no longer than 1 year. Upon the expiration of the suspension period, CMS either lifts the suspension or terminates the organization's approval in accordance with paragraph (h) of this section. (iii) CMS may suspend the DMEPOS accrediting organization's DMEPOS accreditation program effective the date of the letter described in paragraph (i)(3) of this section or any date thereafter. (3) Notification to DMEPOS accrediting organization. (A) The reason(s) for the suspension. (B) The effective date and length of the suspension. (C) The terms of the suspension. (D) The steps the DMEPOS accrediting organization must take to have the suspension lifted. (ii) No later than 3 calendar days after the date it receives the notice of suspension, the DMEPOS accrediting organization must notify CMS in writing its acknowledgment of receipt of such notice. (iii) No later than 3 calendar days after receipt of such acknowledgment, CMS publishes on its website a notice of its decision to suspend its approval of the organization's DMEPOS accreditation program. (4) Status of DMEPOS suppliers. (A) The DMEPOS supplier's current term of accreditation with the suspended DMEPOS accrediting organization expires during the suspension; (B) The DMEPOS supplier is otherwise determined to be non-compliant with the quality standards or other requirement for accreditation; or (C) CMS specifies a different accreditation termination date based on the circumstances of the suspension of the DMEPOS accrediting organization's DMEPOS accreditation program. (ii)(A) If paragraph (i)(4)(i)(A) of this section applies, the DMEPOS supplier must be reaccredited by— ( 1 ( 2 (B) If paragraph (i)(4)(i)(C) of this section applies, CMS notifies the affected DMEPOS supplier in writing of the deadline by which the supplier must be reaccredited. (iii) Any lapse in the DMEPOS supplier's accreditation (including between the date its existing accreditation with the suspended DMEPOS accrediting organization expires and the effective date of its accreditation with a different accrediting organization) may result in the revocation of its enrollment under § 424.535(a). (5) Lifting of suspension. (A) The reasons for the suspension no longer exist. (B) The DMEPOS accrediting organization demonstrates reasonable assurance (as defined in paragraph (b) of this section). (C) The DMEPOS accrediting organization is in compliance with all provisions of this section. (ii) If the suspension is lifted: (A) CMS notifies the DMEPOS accrediting organization thereof in writing. (B) No later than 3 calendar days after the date it receives the notice described in paragraph (i)(5)(i)(A) of this section, the DMEPOS accrediting organization must notify CMS in writing its acknowledgment of receipt of such notice. (C) No later than 3 calendar days after receipt of such acknowledgment, CMS publishes on its website a notice of the lifting of the suspension. (6) Refunds. (i) As part of the DMEPOS supplier's request for accreditation or reaccreditation; and (ii) Prior to the organization's notification to the DMEPOS supplier of its final decision regarding the supplier's request. (7) Multiple suspensions. (j) Probation Placement on probation. (i) The DMEPOS accrediting organization no longer demonstrates reasonable assurance (as defined in paragraph (b) of this section). (ii) The DMEPOS accrediting organization is non-compliant with any provision of this section. This can include, but is not limited to, situations where the accrediting organization has failed to— (A) Comply with a term or condition of a statement or agreement in paragraph (c)(1)(xxiii) of this section; or (B) Adhere to a policy, procedure, or practice it outlined under paragraph (c) of this section as part of its— ( 1 ( 2 (iii) There is a pattern or practice of the DMEPOS accrediting organization's accredited DMEPOS suppliers being revoked under § 424.535(a) for failing to comply with the quality standards. (iv) The DMEPOS organization's period of suspension under paragraph (i) of this section has expired and CMS determines that a subsequent probationary period and CAP are warranted. (2) Notification to accrediting organization. (A) The reason(s) for CMS' decision. (B) The length of the probationary period, which must not exceed 1 year. (C) The terms of the CAP. (D) The requirements and deadline for achieving compliance. (E) A description of how CMS will monitor the DMEPOS accrediting organization's efforts to resume compliance (for example, requests for information, surveys). (ii) Except as otherwise prescribed in the CAP, the DMEPOS accrediting organization may continue its accreditation activities as normal. (3) Conclusion of period. (A) Whether the DMEPOS accrediting organization is compliant with all requirements of this section. (B) The reason for the determination in paragraph (j)(3)(i)(A) of this section. (C) The consequences of the determination (for example, termination or suspension of accreditation, successful completion of and cessation of the probationary period and CAP). (ii) If CMS determines that the DMEPOS accrediting organization has resumed compliance with all requirements of this section, CMS may do all of the following: (A) Send the notice described in paragraph (j)(3)(i) of this section. (B) Terminate the probationary period. (C) End the CAP before the conclusion of the assigned probationary period. (k) Noncompliance actions. (2) CMS may terminate— (i) A probation period (either before or in accordance with the probationary period's original expiration date) and impose a suspension or termination if grounds for either action exist. (ii) A suspension (either before or in accordance with the suspension's original expiration date) and impose a termination if a basis for doing so exists. (l) Reconsiderations and rebuttals Reconsiderations. (A) Denial of the DMEPOS accrediting organization's application for initial approval of its DMEPOS accreditation program under paragraph (c)(4) of this section. (B) Denial of the DMEPOS accrediting organization's application for reapproval of its DMEPOS accreditation program under paragraph (d)(4) of this section. (C) Termination of the DMEPOS accrediting organization's approval of its DMEPOS accreditation program under paragraph (h)(1) of this section. (2) Rebuttals. (B) CMS may, at its discretion, extend the 15-day time-period referenced in paragraph (l)(2)(i)(A) of this section. (ii) A rebuttal submitted under this section must— (A) Be in writing; (B) Specify the facts or issues about which the DMEPOS accrediting organization disagrees with CMS' determination, as well as the reasons for disagreement; (C) Submit all documentation the DMEPOS accrediting organization wants CMS to consider in its review of its determination; and (D) Be submitted in the form of a letter that is signed and dated by the DMEPOS accrediting organization's CEO (or similar official with authority to commit the organization to adhere to Medicare laws and regulations) or a legal representative (as defined in § 498.10 of this chapter). ( 1 ( 2 (iii) The DMEPOS accrediting organization's failure to submit a rebuttal that is both timely under paragraph (l)(2)(i) of this section and fully compliant with all of the requirements of paragraph (l)(2)(ii) of this section constitutes a waiver of all rebuttal rights under this section. (iv) Upon receipt of a timely and compliant rebuttal, CMS reviews the rebuttal to determine whether the imposition of the suspension or probation is correct. (v) CMS is not required to delay the imposition of the suspension or probation pending the completion of the CMS review described in paragraph (l)(2)(iv) of this section. (vi) A determination made under paragraph (i) or (j) of this section is not an initial determination under § 498.3(b) of this chapter and therefore not appealable. (m) Restrictions on consulting Definition. consulting consulting services (2) Prohibitions. (i) To any new DMEPOS supplier before the initial accreditation survey has been completed. (A) For purposes of this paragraph (m)(2)(i), the term initial survey (B) If a supplier is voluntarily or involuntarily terminated from the services of a DMEPOS accrediting organization and later retains the services of the same or a new DMEPOS accrediting organization, the first accreditation survey performed by the same or new DMEPOS accrediting organization of that supplier would be considered an initial accreditation survey. (ii) To a DMEPOS supplier that the DMEPOS accrediting organization accredits within 6 months prior to the next scheduled re-accreditation survey of that supplier. For purposes of this paragraph (m)(2)(ii), the term re-accreditation survey (iii) To a DMEPOS supplier to which the DMEPOS accrediting organization provides accreditation services, in response to a complaint received by the accrediting organization regarding that supplier. (3) Circumstances permitting consulting. (i) During the 6-month period after an initial or re-accreditation survey is performed. (ii) To address complaints received and investigated by CMS or its contractor regarding a DMEPOS accrediting organization's accredited DMEPOS supplier in which one or more immediate jeopardy deficiencies or grounds for revocation of enrollment under § 424.535 are identified. Such consulting by an accrediting organization may occur only after CMS or the CMS contractor investigation is completed and must only address those issues identified in the investigation. (iii) Consulting services provided to DMEPOS suppliers that the DMEPOS accrediting organization does not accredit at the time the consulting services are furnished. (iv) General education provided by the DMEPOS accrediting organization about its DMEPOS accreditation program. (4) Submission of report. (i) Whether the DMEPOS accrediting organization or an associated consulting division or company established by the accrediting organization provides consulting services. (ii) The names, National Provider Identifiers, and addresses of all DMEPOS suppliers to which the DMEPOS accrediting organization or its associated consulting division or company has provided consulting services during the previous 6-month period. (iii) The dates the consulting services were provided to each DMEPOS supplier. (iv) Whether the DMEPOS accrediting organization has ever provided, or is currently providing, accreditation services to any DMEPOS supplier listed in this report. (v) For each DMEPOS supplier listed in this report, the date— (A) Of the most recent accreditation survey performed; and (B) That the next re-accreditation survey is due to be performed. (vi) A description of the consulting services provided to each DMEPOS supplier listed in this report. (5) Consulting firewall policies and procedures. (A) The DMEPOS accrediting organization's consulting services must be provided by a separate division of the accrediting organization or separate business entity, such as a company or corporation, that is separate from the accrediting organization's accreditation division. (B) A DMEPOS accrediting organization's consulting division or separate business entity must maintain separate staff from that of the accrediting organization's accreditation divisions to ensure that the consulting division staff do not perform the accrediting organization's accreditation division functions and that the accrediting organization's accreditation division staff do not perform consulting division functions. (C) A DMEPOS accrediting organization's accreditation staff and surveyors are prohibited from marketing the accrediting organization's consulting services to the accrediting organization's accreditation clients. (ii) A DMEPOS accrediting organization that provides consulting services must submit its written consulting firewall policies and procedures to CMS by a date specified by CMS and with each application submitted seeking initial CMS approval or reapproval of their DMEPOS accreditation programs. (n) Conflicts of interest General prohibition regarding relationships. (A) Participate in the survey of that DMEPOS supplier. (B) Have input into the results of the survey and accreditation for that DMEPOS supplier. (C) Have involvement with the pre-or post-survey activities for that DMEPOS supplier. (D) Have contact with or access to the records for the survey and accreditation of that DMEPOS supplier. (ii) For purposes of this paragraph (n)(1), the term immediate family member (iii) CMS may request at any time outside of the initial approval and reapproval processes that the DMEPOS accrediting organization furnish any and all information required under paragraph (c)(1)(vii)(D) of this section. (2) CMS Contractor. (o) Change of ownership. [71 FR 48409, Aug. 18, 2006, as amended at 90 FR 55607, Dec. 2, 2025] Subpart E—To Whom Payment is Made in Special Situations § 424.60 Scope. (a) This subpart sets forth provisions applicable to payment after the beneficiary's death and payment to entities that provide coverage complementary to Medicare Part B. (b) The provisions applicable to payment for services excluded as custodial care or services not reasonable and necessary are set forth in §§ 405.332 through 405.336 of this chapter. [53 FR 6634, Mar. 2, 1988, as amended at 53 FR 28388, July 28, 1988] § 424.62 Payment after beneficiary's death: Bill has been paid. (a) Scope. (b) Situation. (2) The beneficiary died without receiving Medicare payment. (3) The bill has been paid. (c) Persons whom Medicare pays. (1) The person or persons who, without a legal obligation to do so, paid for the services with their own funds, before or after the beneficiary's death. (2) The legal representative of the beneficiary's estate if the services were paid for by the beneficiary before he or she died, or with funds from the estate. (3) If the deceased beneficiary or his or her estate paid for the services and no legal representative of the estate has been appointed, the survivors, in the following order of priority: (i) The person found by SSA to be the surviving spouse, if he or she was either living in the same household with the deceased at the time of death, or was, for the month of death, entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased beneficiary; (ii) The child or children, who were, for the month of death, entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased (and, if there is more than one child, in equal parts to each child); (iii) The parent or parents, who were, for the month of death, entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased (and, if there is more than one parent, in equal parts to each parent); (iv) The person found by SSA to be the surviving spouse who was not living in the same household with the deceased at the time of death and was not, for the month of death, entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased beneficiary; (v) The child or children who were not entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased (and, if there is more than one child, in equal parts to each child); (vi) The parent or parents who were not entitled to monthly social security or railroad retirement benefits on the basis of the same earnings record as the deceased (and, if there is more than one parent, in equal parts to each parent). (4) If none of the listed relatives survive, no payment is made. (5) If the services were paid for by a person other than the deceased beneficiary, and that person died before payment was completed, Medicare does not pay that person's estate. Medicare pays a surviving relative of the deceased beneficiary in accordance with the priorities in paragraph (c)(3) of this section. If none of those relatives survive. Medicare pays the legal representative of the deceased beneficiary's estate. If there is no legal representative of the estate, no payment is made. (d) Amount of payment. (e) Conditions for payment. (1) The person who claims payment must meet the following requirements: (i) Submit a claim on a CMS-prescribed form and an itemized bill in accordance with the requirements of this subpart. (See paragraph (g) of this section for an exception.) (ii) Provide evidence that the services were furnished if the intermediary or carrier requests it. (iii) Provide evidence of payment of the bill and of the identity of the person who paid it. (2) If a person claims payment as the legal representative of the deceased beneficiary's estate, he or she must also submit a copy of the papers showing appointment as legal representative. (3) If a person claims payment as a survivor of the beneficiary, he or she must also submit evidence, if the intermediary or carrier requests it, that he or she is highest on the priority list of paragraph (c)(3) of this section. (f) Evidence of payment. (1) A receipted bill, or a properly completed “Report of Services” section of a claim form, showing who paid the bill; (2) A cancelled check; (3) A written statement from the provider or supplier or an authorized staff member; or (4) Other probative evidence. (g) Exception: Claim submitted before beneficiary died. § 424.64 Payment after beneficiary's death: Bill has not been paid. (a) Scope. (b) Situation. (2) The beneficiary died without making an assignment to the physician or other supplier or receiving Medicare payment. (3) The bill has not been paid. (c) To whom payment is made. (1) Payment to the supplier. (i) Files a claim on a CMS-prescribed form in accordance with the applicable requirements of this subpart; (ii) Upon request from the carrier, provides evidence that the services for which it claims payment were, in fact, furnished; and (iii) Agrees in writing to accept the reasonable charge as the full charge for the services. (2) Payment to a person who assumes legal obligation to pay for the services. (i) A statement indicating that he or she has assumed legal obligation to pay for the services. (ii) A claim on a CMS-prescribed form in accordance with the requirements of this subpart. (If a claim had been submitted by or on behalf of the beneficiary before he or she died, submission of another claim form is not required; a written request by the person seeking payment meets the requirement for a claim.) (iii) An itemized bill that identifies the claimant as the person to whom the physician or other supplier holds responsible for payment. (If such an itemized bill had been submitted by or on behalf of the beneficiary before he or she died, submission of another itemized bill is not required.) (iv) If the intermediary or carrier requests it, evidence that the services were actually furnished. [53 FR 6634, Mar. 2, 1988, as amended at 53 FR 28388, July 28, 1988] § 424.66 Payment to entities that provide coverage complementary to Medicare Part B. (a) Conditions for payment. (1) Provides coverage of the service under a complementary health benefit plan (this is, the coverage that the plan provides is complementary to Medicare benefits and covers only the amount by which the Part B payment falls short of the approved charge for the service under the plan). (2) Has paid the person who provided the service an amount (including the amount payable under the Medicare program) that the person accepts as full payment. (3) Has the written authorization of the beneficiary (or of a person authorized to sign claims on his behalf under § 424.36) to receive the Part B payment for the services for which the entity pays. (4) Relieves the beneficiary of liability for payment for the service and will not seek any reimbursement from the beneficiary, his or her survivors or estate. (5) Submits any information CMS or the carrier may request, including an itemized physician or supplier bill, in order to apply the requirements under the Medicare program. (6) Identifies and excludes from its requests for payment all services for which Medicare is the secondary payer. (b) Services paid for by the entity. [53 FR 28388, July 28, 1988; 53 FR 40231, Oct. 14, 1988] § 424.67 Enrollment requirements for opioid treatment programs (OTP). (a) General enrollment requirement. (b) Specific requirements and standards for enrollment. (1) Fully complete and submit, as applicable, the Form CMS-855A or Form CMS-855B application (or their successor applications) and any applicable supplement or attachment thereto to its applicable Medicare contractor. This includes, but is not limited to, the following: (i) Maintain and submit to CMS (via the applicable supplement or attachment) a list of all physicians, other eligible professionals, and pharmacists (regardless of whether the individual is a W-2 employee of the OTP) who are legally authorized to prescribe, order, or dispense controlled substances on behalf of the OTP. The list must include the physician's, other eligible professional's, or pharmacist's: (A) First and last name, and middle initial. (B) Social Security Number. (C) National Provider Identifier. (D) License number (if applicable). (ii) Certifying via the Form CMS-855A or Form CMS-855B (as applicable) and/or the applicable supplement or attachment thereto that the OTP meets and will continue to meet the specific requirements and standards for enrollment described in paragraphs (b) and (e) of this section. (2) Comply with the application fee requirements in § 424.514. (This includes OTPs enrolling under the circumstances described in paragraph (c)(2) of this section.) (3)(i) Except as stated in paragraph (b)(3)(ii) of this section, successfully complete the assigned categorical risk level screening required under, as applicable, § 424.518(b) and (c). (ii) For currently enrolled OTPs that are changing their OTP enrollment from a Form CMS-855B enrollment to a Form CMS-855A enrollment, or vice versa, successfully complete the limited level of categorical screening under § 424.518(a) if the OTP has already completed, as applicable, the moderate or high level of categorical screening under § 424.518(b) or (c), respectively. (4)(i) Have a current, valid certification by SAMHSA for an opioid treatment program consistent with the provisions and requirements of § 8.11 of this title. (ii) A provisional certification under § 8.11(e) of this title does not meet the requirements of paragraph (b)(4)(i) of this section. (5) Report on the Form CMS-855A or Form CMS-855B (as applicable) and/or any applicable supplement all OTP staff who meet the definition of “managing employee” in § 424.502. Such individuals include, but are not limited to, the following: (i) Medical director (as described in § 8.2 of this title). (ii) Program sponsor (as described in § 8.2 of this title). (6)(i)(A) Must not employ or contract with a prescribing or ordering physician or eligible professional or with any individual legally authorized to dispense narcotics who, within the preceding 10 years, has been convicted (as that term is defined in 42 CFR 1001.2) of a Federal or State felony that CMS deems detrimental to the best interests of the Medicare program and its beneficiaries based on the same categories of detrimental felonies, as well as case by case detrimental determinations, found at § 424.535(a)(3). (B) Paragraph (b)(6)(i)(A) of this section applies regardless of whether the individual in question is: ( 1 ( 2 (ii) Must not employ or contract with any personnel (regardless of whether the individual is a W-2 employee of the OTP) who is revoked from Medicare under § 424.535 or any other applicable section in Title 42, or who is on the preclusion list under § 422.222 or § 423.120(c)(6) of this chapter. (iii) Must not employ or contract with any personnel (regardless of whether the individual is a W-2 employee of the OTP) who has a prior adverse action by a State oversight board, including, but not limited to, a reprimand, fine, or restriction, for a case or situation involving patient harm that CMS deems detrimental to the best interests of the Medicare program and its beneficiaries. CMS will consider the factors enumerated at § 424.535(a)(22) in each case of patient harm that potentially applies to this paragraph. (7)(i) Sign (and adhere to the term of) a provider agreement in accordance with the provisions of part 489 of this chapter. (ii) An OTP's appeals under part 498 of a Medicare revocation (under § 424.535) and a provider agreement termination (under § 489.53 of this chapter) must be filed jointly and, as applicable, considered jointly by CMS under part 498 of this chapter. (8) Comply with all other applicable requirements for enrollment specified in this section and in subpart P of this part. (c) Clarification of required enrollment forms. (2) If a currently enrolled OTP is changing its OTP enrollment from a Form CMS-855B enrollment to a Form CMS-855A enrollment, or vice versa, the effective date of billing that was established for the OTP's prior enrollment under §§ 424.520(d) and 424.521(a) is applied to the OTP's new enrollment. (d) Denial of enrollment. (1)(i) The provider does not have a current, valid certification by SAMHSA as required under paragraph (b)(4)(i) of this section or fails to meet any other applicable requirement in this section. (ii) Any of the denial reasons in § 424.530 applies. (2) An OTP may appeal the denial of its enrollment application under part 498 of this chapter. (e) Continued compliance, standards, and reasons for revocation. (i) Must remain validly certified by SAMHSA as required under § 8.11 of this title. (ii) Remains subject to, and must remain in full compliance with, the provisions of this section and of subpart P of this part. This includes, but is not limited to, the provisions of paragraph (b)(6) of this section, the revalidation provisions in § 424.515, and the deactivation and reactivation provisions in § 424.540. (iii) Upon revalidation, successfully complete the moderate categorical risk level screening required under § 424.518(b). (2) CMS may revoke an OTP's enrollment on any of the following grounds: (i) The provider does not have a current, valid certification by SAMHSA as required under paragraph (b)(4)(i) of this section or fails to meet any other applicable requirement or standard in this section, including, but not limited to, the OTP standards in paragraphs (b)(6) and (e)(1) of this section. (ii) Any of the revocation reasons in § 424.535 applies. (3) An OTP may appeal the revocation of its enrollment under part 498 of this title. (f) Claim payment. (1) The prescribing or medication ordering physician's or other eligible professional's National Provider Identifier must be listed on Field 17 of the Form CMS-1500; and (2) All other applicable requirements of this section, this part, and part 8 of this title must be met. (g) Relation to part 8 of this title. (1) Supplanting any of the provisions in part 8 of this title; or (2) Eliminating an OTP's obligation to maintain compliance with all applicable provisions in part 8 of this title. [84 FR 63202, Nov. 15, 2019, as amended at 85 FR 85038, Dec. 28, 2020] § 424.68 Enrollment requirements for home infusion therapy suppliers. (a) Definition. (1) Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs. (2) Ensures the safe and effective provision and administration of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis. (3) Is accredited by an organization designated by the Secretary in accordance with section 1834(u)(5) of the Act. (4) Is enrolled in Medicare as a home infusion therapy supplier consistent with the provisions of this section and subpart P of this part. (b) General requirement. (c) Specific requirements for enrollment. (1)(i) Fully complete and submit the Form CMS-855B application (or its electronic or successor application) to its applicable Medicare contractor. (ii) Certify via the Form CMS-855B that the home infusion therapy supplier meets and will continue to meet the specific requirements and standards for enrollment described in this section and in subpart P of this part. (2) Comply with the application fee requirements in § 424.514. (3) Be currently and validly accredited as a home infusion therapy supplier by a CMS-recognized home infusion therapy supplier accreditation organization. (4) Comply with § 414.1515 of this chapter and all provisions of part 486, subpart I of this chapter. (5) Successfully complete the limited categorical risk level of screening under § 424.518. (d) Denial of enrollment. (i) The supplier does not meet all of the requirements for enrollment outlined in § 424.68 and in subpart P of this part. (ii) Any of the applicable denial reasons in § 424.530. (2) Appeal of an enrollment denial. A supplier may appeal the denial of its enrollment application as a home infusion therapy supplier under part 498 of this chapter. (e) Continued compliance, standards, and reasons for revocation. (i) Must remain currently and validly accredited as described in paragraph (c)(3) of this section. (ii) Remains subject to, and must remain in full compliance with, all of the provisions of— (A) This section; (B) Subpart P of this part; (C) Section 414.1515 of this chapter; and (D) Part 486, subpart I of this chapter. (2) CMS may revoke a home infusion therapy supplier's enrollment on any of the following grounds: (i) The supplier does not meet the accreditation requirements as described in paragraph (c)(3) of this section. (ii) The supplier does not comply with all of the provisions of— (A) This section; (B) Subpart P of this part; (C) Section 414.1515 of this chapter; and (D) Part 486, subpart I of this chapter; or (iii) Any of the revocation reasons in § 424.535 applies. (3) A home infusion therapy supplier may appeal the revocation of its enrollment under part 498 of this chapter. [85 FR 70355, Nov. 4, 2020] Subpart F—Limitations on Assignment and Reassignment of Claims § 424.70 Basis and scope. (a) Statutory basis. (b) Scope. (1) Prohibits the assignment, reassignment, or other transfer of the right to Medicare payments except under specified conditions; (2) Sets forth the sanctions that CMS may impose on a provider or supplier that violates this prohibition, or on a supplier that violates the conditions to which it agreed in accepting assignment from the individual; and (3) Specifies the conditions for payment under court-ordered assignments or reassignments. § 424.71 Definitions. As used in this subpart, unless the context indicates otherwise— Court of competent jurisdiction Facility Entity Power of attorney (1) Receive, in the agent's name, any payments due the principal; (2) Negotiate checks payable to the principal; or (3) Receive, in any other manner, direct payment of amounts due the principal. [53 FR 6634, Mar. 2, 1988, as amended at 69 FR 66426, Nov. 15, 2004] § 424.73 Prohibition of assignment of claims by providers. (a) Basic prohibition. (b) Exceptions to the prohibition Payment to a government agency or entity. (2) Payment under assignment established by court order. (3) Payment to an agent. (i) The agent receives the payment under an agency agreement with the provider; (ii) The agent's compensation is not related in any way to the dollar amounts billed or collected; (iii) The agent's compensation is not dependent upon the actual collection of payment; (iv) The agent acts under payment disposition instructions that the provider may modify or revoke at any time; and (v) The agent, in receiving the payment, acts only on behalf of the provider. Payment to an agent will always be made in the name of the provider. § 424.74 Termination of provider agreement. CMS may terminate a provider agreement, in accordance with § 489.53(a)(1) of this chapter, if the provider— (a) Executes or continues a power of attorney, or enters into or continues any other arrangement, that authorizes or permits payment contrary to the provisions of this subpart; or (b) Fails to furnish, upon request by CMS or the intermediary, evidence necessary to establish compliance with the requirements of this subpart. § 424.80 Prohibition of reassignment of claims by suppliers. (a) Basic prohibition. (b) Exceptions to the basic rule Payment to employer. (2) Payment to an entity under a contractual arrangement. (3) Payment to a government agency or entity. (4) Payment under a reassignment established by court order. (5) Payment to an agent. (c) Rules applicable to an employer or entity. (d) Reassignment to an entity under an employer-employee relationship or under a contractual arrangement: Conditions and limitations Liability of the parties. (2) Access to records. (3) Reassignment of the technical or professional component of a diagnostic test. [53 FR 6634, Mar. 2, 1988, as amended at 54 FR 4027, Jan. 27, 1989; 69 FR 66426, Nov. 15, 2004; 70 FR 16722, Apr. 1, 2005; 71 FR 69788, Dec. 1, 2006; 72 FR 66406, Nov. 27, 2007] § 424.82 Revocation of right to receive assigned benefits. (a) Scope. (b) Definition. other party (c) Basis for revocation. (1) Violates the terms of assignment in § 424.55(b). (2) Continues collection efforts or fails to refund moneys incorrectly collected, in violation of the terms of assignment in § 424.55(b). (3) Executes or continues in effect a reassignment or power of attorney or any other arrangement that seeks to obtain payment contrary to the provisions of § 424.80; or (4) Fails to furnish evidence necessary to establish its compliance with the requirements of § 424.80. (d) Proposed revocation: Notice and opportunity for review. (1) States the reasons for the proposed revocation; and (2) Provides an opportunity for the supplier or other party to submit written argument and evidence against the proposed revocation. CMS usually allows 15 days from the date on the notice, but may extend or reduce the time as circumstances require. (e) Actual revocation: Timing, notice, and opportunity for hearing Timing. (2) Notice and opportunity for hearing. (i) The reasons for the revocation; (ii) That the revocation is effective as of the date on the notice; (iii) That the supplier or other party may, within 60 days from the date on the notice (or a longer period if the notice so specifies), request an administrative hearing and may be represented by counsel or other qualified representative. (iv) That the carrier will withhold payment on any claims submitted by the supplier or other party until the period for requesting a hearing expires or, if a hearing is requested, until the hearing officer issues a decision; (v) That if the hearing decision reverses the revocation, the carrier will pay the supplier's or other party's claims; and (vi) That if a hearing is not requested or the hearing decision upholds the revocation, payment will be made to the beneficiary or to another person or agency authorized to receive payment on his or her behalf. [53 FR 6644, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988] § 424.83 Hearings on revocation of right to receive assigned benefits. If the supplier or other party requests a hearing under § 424.82(e)(2)— (a) The hearing is conducted— (1) By a CMS hearing official who was not involved in the decision to revoke; and (2) In accordance with the procedures set forth in §§ 405.824 through 405.833 (but excepting § 405.832(d)) and 405.860 through 405.872 of this chapter. In applying those procedures, “CMS” is substituted for “carrier”; and “hearing official”, for “hearing officer”. (b) As soon as practicable after the close of the hearing, the official who conducted it issues a hearing decision that— (1) Is based on all the evidence presented at the hearing and included in the hearing record; and (2) Contains findings of fact and a statement of reasons. § 424.84 Final determination on revocation of right to receive assigned benefits. (a) Basis of final determination Final determination without a hearing. (2) Final determination following a hearing. (b) Notice of final determination. (c) Application of the final determination (2) A final determination to revoke remains in effect until CMS finds that the reason for the revocation has been removed and that there is reasonable assurance that it will not recur. (d) Effect of revocation when supplier or other party has a financial interest in another entity. [53 FR 6644, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988] § 424.86 Prohibition of assignment of claims by beneficiaries. (a) Basic prohibition. (b) Exceptions Payment to a government agency or entity. (2) Payment under an assignment established by court order. § 424.90 Court ordered assignments: Conditions and limitations. (a) Conditions for acceptance. (1) Someone files a certified copy of the court order and of the executed assignment or reassignment (if it was necessary to execute one) with the intermediary or carrier responsible for processing the claim; and (2) The assignment or reassignment— (i) Applies to all Medicare benefits payable to a particular person or entity during a specified or indefinite time period; or (ii) Specifies a particular amount of money, payable to a particular person or entity by a particular intermediary or carrier. (b) Retention of authority to reduce interim payments to providers. (c) Liability of the parties. Subpart G—Special Conditions: Emergency Services Furnished by a Nonparticipating Hospital § 424.100 Scope. This subpart sets forth procedures and criteria that are followed in determining whether Medicare will pay for emergency services furnished by a hospital that is located in the United States and does not have in effect a provider agreement, that is, an agreement to participate in Medicare. § 424.101 Definitions. As used in this subpart, unless the context indicates otherwise— Emergency services Hospital (1) Is primarily engaged in providing, by or under the supervision of doctors of medicine or osteopathy, inpatient services for the diagnosis, treatment, and care or rehabilitation of persons who are sick, injured, or disabled; (2) Is not primarily engaged in providing skilled nursing care and related services for patients who require medical or nursing care, as described in section 1861(j)(1)(A) of the Act; (3) Provides 24-hour nursing service in accordance with section 1861(e)(5) of the Act; and (4) Is licensed, or is approved as meeting the standards for licensing, by the State or local licensing agency. Reasonable charges § 424.102 Situations that do not constitute an emergency. Without additional evidence of a threat to life or health, the following situations do not in themselves indicate a need for emergency services: (a) Lack of care at home. (b) Lack of transportation to a participating hospital. (c) Death of the patient in the hospital. § 424.103 Conditions for payment for emergency services. Medicare pays for emergency services furnished to a beneficiary by a nonparticipating hospital or under arrangements made by such a hospital if the conditions of this section are met. (a) General requirements. (2) The hospital has in effect an election to claim payment for all emergency services furnished in a calendar year in accordance with § 424.104. (3) The need for emergency services arose while the beneficiary was not an inpatient in a hospital. (4) In the case of inpatient hospital services, the services are furnished during a period in which the beneficiary could not be safely discharged or transferred to a participating hospital or other institution. (5) The determination that the hospital was the most accessible hospital available and equipped to furnish the services is made in accordance with § 424.106. (b) Medical information requirements. (1) Describes the nature of the emergency and specifies why it required that the beneficiary be treated in the most accessible hospital; (2) Establishes that all the conditions in paragraph (a) of this section are met; and (3) Indicates when the emergency ended, which, for inpatient hospital services, is the earliest date on which the beneficiary could be safely discharged or transferred to a participating hospital or other institution. § 424.104 Election to claim payment for emergency services furnished during a calendar year. (a) Terms of the election. (1) To comply with the provisions of subpart C of part 489 of this chapter relating to charges for items and services the hospital may make to the beneficiary, or any other person on his or her behalf. (2) To comply with the provisions of subpart D of part 489 of this chapter relating to proper disposition of monies incorrectly collected from, or on behalf of a beneficiary. (3) To request payment under the Medicare program based on amounts specified in § 413.74 of this chapter. (b) Filing of election statement. (c) Acceptance and effective date of election. (d) Appeal by hospital. (e) Conditions for reinstatement after notice of failure to continue to qualify. (1) The reason for its failure to qualify has been removed; and (2) There is reasonable assurance that it will not recur. § 424.106 Criteria for determining whether the hospital was the most accessible. (a) Basic requirement. (2) CMS determines accessibility based on the factors specified in paragraphs (b) and (c) of this section and the conditions set forth in paragraph (d) of this section. (b) Factors that are considered. (1) The relative distances of participating and nonparticipating hospitals in the area. (2) The transportation facilities available to these hospitals. (3) The quality of the roads to each hospital. (4) The availability of beds at each hospital. (5) Any other factors that bear on whether or not the services could be provided sooner in the nonparticipating hospitals than in a participating hospital in the general area. In urban and suburban areas where both participating and nonparticipating hospitals are similarly available, CMS presumes that the services could have been provided in a participating hospital unless clear and convincing evidence shows that there was a medical or practical need to use the nonparticipating hospital. (c) Factors that are not considered. (1) The personal preference of the beneficiary, the physician, or members of the family. (2) The fact that the attending physician did not have staff privileges in a participating hospital which was available and the most accessible to the beneficiary. (3) The location of previous medical records. (d) Conditions under which the accessibility requirement is met. (1) It was the nearest hospital to the point where the emergency occurred, it was medically equipped to handle the type of emergency, and it was the most accessible, on the basis of the factors specified in paragraph (b) of this section; or (2) There was a closer participating hospital equipped to handle the emergency, but the participating hospital did not have a bed available or would not accept the individual. § 424.108 Payment to a hospital. (a) Conditions for payment. (1) Has in effect a statement of election to claim payment for all covered emergency services furnished during a calendar year, in accordance with § 424.104; (2) Claims payment in accordance with § 424.32; and (3) Submits evidence requested by CMS to establish that the services meet the requirements of this subpart. (b) Subsequent claims. (1) Contain sufficient information to clearly establish that, when the additional services were furnished, the emergency still existed; and (2) Indicate when the emergency ended, which, for inpatient hospital services, is the earliest date on which the beneficiary could be safely discharged or transferred to a participating hospital or other institution. § 424.109 Payment to the beneficiary. Medicare pays the beneficiary for emergency services if the following conditions are met: (a) The hospital does not have in effect an election to claim payment. (b) The beneficiary, or someone on his or her behalf, submits— (1) A claim that meets the requirements of § 424.32; (2) An itemized hospital bill; and (3) Evidence requested by CMS to establish that the services meet the requirements of this subpart. Subpart H—Special Conditions: Services Furnished in a Foreign Country § 424.120 Scope. This subpart sets forth the conditions for payment for services furnished in a foreign country. § 424.121 Scope of payments. Subject to the conditions set forth in this subpart— (a) Medicare Part A pays, in the amounts specified in § 413.74 of this chapter, for emergency and nonemergency inpatient hospital services furnished by a foreign hospital. (b) Medicare Part B pays for certain physicians' services and ambulance services furnished in connection with covered inpatient care in a foreign hospital, as specified in § 424.124. (c) All other services furnished outside the United States are excluded from Medicare coverage, as specified in § 411.9 of this chapter. [53 FR 6634, Mar. 2, 1988, as amended at 71 FR 48143, Aug. 18, 2006] § 424.122 Conditions for payment for emergency inpatient hospital services. Medicare Part A pays for emergency inpatient hospital services furnished by a foreign hospital if the following conditions are met: (a) At the time of the emergency that required the inpatient hospital services, the beneficiary was— (1) In the United States; or (2) In Canada traveling between Alaska and another State without unreasonable delay and by the most direct route. (b) The foreign hospital was closer to, or more accessible from, the site of the emergency than the nearest United States hospital equipped to deal with, and available to treat, the individual's illness or injury. (c) The conditions for payment for emergency services set forth in § 424.103 are met. (d) The hospital is a hospital as defined in § 424.101, and is licensed, or approved as meeting the conditions for licensing, by the appropriate agency of the country in which it is located. (e) The determination of whether the hospital was more accessible is made in accordance with § 424.106. § 424.123 Conditions for payment for nonemergency inpatient services furnished by a hospital closer to the individual's residence. Medicare Part A pays for inpatient hospital services furnished by a foreign hospital if the following conditions are met: (a) The beneficiary is a resident of the United States. (b) The foreign hospital is closer or more accessible to the beneficiary's residence than the nearest United States hospital equipped to deal with, and available to treat, the individual's illness or injury. (c) The foreign hospital is— (1) A hospital as defined in § 424.101 and, it is licensed, or approved as meeting the conditions for licensing, by the appropriate agency of the country in which it is located; and (2) Accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or accredited or approved by a program of the country where it is located under standards the CMS finds to be essentially equivalent to those of the JCAHO. (d) The services are covered services that Medicare would pay for if they were furnished by a participating hospital. [53 FR 6634, Mar. 2, 1988, as amended at 71 FR 48143, Aug. 18, 2006] § 424.124 Conditions for payment for physician services and ambulance services. (a) Basic rules. (1) They are furnished— (i) To an individual who is entitled to Part B benefits; and (ii) In connection with covered inpatient hospital services; and (2) They meet the conditions set forth in paragraphs (b) and (c) of this section. (b) Physician services. (i) In the hospital, during a period of covered inpatient services; or (ii) Outside the hospital, on the day of admission and for the same condition that required inpatient admission; and (2) The physician is legally authorized to practice in the country where he or she furnishes the services. (c) Ambulance services. (1) Necessary because the use of other means of transportation is contraindicated by the beneficiary's condition; and (2) Furnished by an ambulance that meets the definition in § 410.41 of this chapter. [53 FR 6646, Mar. 2, 1988; 53 FR 12945, Apr. 20, 1988; 64 FR 3649, Jan. 25, 1999] § 424.126 Payment to the hospital. (a) Conditions for payment. (1) Has in effect an election that— (i) Meets the requirements set forth in § 424.104; and (ii) Reflects the hospital's intent to claim for all covered services furnished during a calendar year. (2) Claims payment in accordance with §§ 424.32 and 413.74 of this chapter; and (3) Submits evidence requested by CMS to establish that the services meet the requirements of this subpart. (b) Amount of payment. § 424.127 Payment to the beneficiary. (a) Conditions for payment of inpatient hospital services. (1) The hospital does not have in effect an election to claim payment; and (2) The beneficiary, or someone on his or her behalf, submits— (i) A claim in accordance with § 424.32; (ii) An itemized hospital bill; and (iii) Evidence requested by CMS to establish that the services meet the requirements of this subpart. (b) Amount payable for inpatient hospital services. (c) Conditions for payment for Part B services. (d) The amount payable to the beneficiary is determined in accordance with § 410.152 of this chapter. Subpart I—Requirements for Medicare Diabetes Prevention Program Suppliers and Beneficiary Engagement Incentives Under the Medicare Diabetes Prevention Program Expanded Model Source: 82 FR 53364, Nov. 15, 2017, unless otherwise noted. § 424.200 Scope. This subpart specifies the requirements for Medicare Diabetes Prevention Program suppliers and beneficiary engagement incentives under the Medicare Diabetes Prevention Program expanded model. § 424.205 Requirements for Medicare Diabetes Prevention Program suppliers. (a) Definitions. Administrative location Coach Coach eligibility end date Coach eligibility start date, Community setting Eligible coach Ineligible coach (b) Conditions for MDPP supplier enrollment. (1) Has either preliminary, full, full plus CDC DPRP recognition. (2) Maintains an active and valid TIN and NPI at the organizational level. (3) Has passed screening requirements as follows: (i) Upon initial enrollment, at a “high” categorical risk in accordance with § 424.518(c)(2); and (ii) Upon revalidation, at a “moderate” categorical risk in accordance with § 424.518(b)(2). (4) Maintains, and submits to CMS through the CMS-approved enrollment application, a roster of all coaches who will be furnishing MDPP services on the entity's behalf that includes each coach's first and last names, middle initial (if applicable), date of birth, Social Security Number (SSN), active and valid NPI, coach eligibility start date, and coach eligibility end date (if applicable). This roster must be updated in accordance with paragraph (c)(5) of this section. (5) The Medicare provider enrollment application fee does not apply to all Medicare Diabetes Prevention Program (MDPP) suppliers that submit an enrollment application on or after January 1, 2022. (6) Meets and certifies in its CMS-approved enrollment application that it meets and will continue to meet the supplier enrollment standards described in paragraph (c) of this section. (7) Revalidates its Medicare enrollment every 5 years after the effective date of enrollment. (c) Medicare Diabetes Prevention Program supplier standards. (1) The MDPP supplier must have and maintain preliminary, full, or full plus CDC DPRP recognition. (2) The MDPP supplier must not currently have its billing privileges terminated for-cause or be excluded by a State Medicaid agency. (3) The MDPP supplier must not include on the roster of coaches, described in paragraph (b)(4) of this section and updated in accordance with paragraph (c)(5) of this section, nor permit MDPP services to be furnished by, any individual coach who meets any of ineligibility criteria outlined in paragraph (d)(1) of this section. (4) The MDPP supplier must maintain at least one administrative location. All administrative locations maintained by the MDPP supplier must be located at an appropriate site and be reported on the CMS-approved enrollment application. An appropriate site for such an administrative location would include all of the following characteristics: (i) Signage posted on the exterior of the building or suite, in a building directory, or on materials located inside of the building. Such signage may include, for example, the MDPP supplier's legal business name or DBA, as well as hours of operation. (ii) Open for business during stated operational hours. (iii) Employees, staff, or volunteers present during operational hours; and (iv) Not a private residence. (5) The MDPP supplier must update its enrollment application within 30 days of any changes of ownership, changes to the coach roster (including due to coach ineligibility or because the coach is no longer an employee, contractor, or volunteer of the MDPP supplier), and final adverse action history, and report all other changes, including but not limited to changes in the MDPP supplier's administrative location(s), to CMS within 90 days of the reportable event. (6) The MDPP supplier must maintain a primary business telephone that operates either at administrative locations described in paragraph (c)(4) of this section or directly where services are furnished, if services are furnished in community settings. The associated telephone number must be listed with either the legal or doing business as name of the supplier in public view, including on Web sites, flyers, and materials. (7) The MDPP supplier must not knowingly sell to or allow another individual or entity to use its supplier billing number. (8) Subject to paragraph (c)(8)(i) of this section, the MDPP supplier must not deny an MDPP beneficiary access to MDPP services during the MDPP services period described in § 410.79(c)(2) of this chapter, including on the basis of the beneficiary's weight, health status, or achievement of performance goals. (i) Suppliers may deny an MDPP beneficiary access to MDPP services during the MDPP services period only under one of the following conditions: (A) The MDPP beneficiary no longer meets the eligibility criteria for MDPP services under § 410.79(c)(1) of this chapter. (B) The MDPP supplier lacks the self-determined publicly-posted capacity to furnish MDPP services to a given MDPP beneficiary. (C) The MDPP supplier determines that the MDPP beneficiary significantly disrupts the session for other MDPP beneficiaries or becomes abusive. (ii) MDPP suppliers must maintain a record of the number of MDPP beneficiaries for whom it declined access away for the reasons outlined in paragraphs (c)(8)(i)(B) and (C) of this section, to include the date each such beneficiary was declined access. For beneficiaries who were declined access for the reasons described in paragraph (c)(8)(i)(C) of this section, the MDPP supplier must document details of the occurrence(s), including date(s) of the behavior, any remediation efforts taken by the MDPP supplier, and final action (for example, dismissal from an MDPP session or denial from future sessions) in the beneficiary's MDPP records. (9) The MDPP supplier and other individuals or entities performing functions or services related to MDPP services on the MDPP supplier's behalf must not unduly coerce an MDPP beneficiary's decision to change or not to change to a different MDPP supplier, including through the use of pressure, intimidation, or bribery. (10) Except as allowed under paragraph (c)(8) of this section, the MDPP supplier must offer an MDPP beneficiary no fewer than all of the following: (i) 16 in-person, distance learning, or Online core sessions no more frequently than weekly for the first 6 months of the MDPP services period, which begins on the date of attendance at the first core session. (ii) One in-person, distance learning, or Online core maintenance session each month during months 7 through 12 (6 months total) of the MDPP services period. (11) Before the initial core session is furnished, the MDPP supplier must disclose detailed information about the set of MDPP services to each MDPP beneficiary to whom it wishes to begin furnishing MDPP services. Such information must include all of the following: (i) Eligibility requirements under § 410.79(c)(1) of this chapter, including the once-per-lifetime nature of MDPP services. (ii) Minimum coverage requirements under § 410.79(c)(2). (iii) The MDPP supplier standards as specified in paragraph (c) of this section. (12) The MDPP supplier must answer MDPP beneficiaries' questions about MDPP services and respond to MDPP-related complaints within a reasonable timeframe. An MDPP supplier must implement a complaint resolution protocol and maintain documentation of all beneficiary contact regarding such complaints, including the name and Medicare Beneficiary Identifier of the beneficiary, a summary of the complaint, related correspondences, notes of actions taken, and the names and/or NPIs of individuals who took such actions on behalf of the MDPP supplier. Failure to maintain a complaint resolution protocol or to retain information regarding MDPP related complaints in accordance with paragraph (f) of this section may be considered evidence that the MPPP supplier standards have not been met. This information must be kept at each administrative location and made available to CMS or its contractors upon request. (13) The MDPP supplier must maintain a crosswalk file which indicates how beneficiary identifications for the purposes of CDC performance data requirements correspond to corresponding beneficiary health insurance claims numbers or Medicare Beneficiary Identifiers for each MDPP beneficiary receiving MDPP services from the MDPP supplier. The MDPP supplier must submit the crosswalk file to CMS or its contractor. (14) The MDPP supplier must submit performance data for MDPP beneficiaries who ever attended ongoing maintenance sessions with data elements consistent with the CDC's DPRP standards for data elements required for the core services period. (15) The MDPP supplier must allow CMS or its agents to conduct onsite inspections or recordkeeping reviews in order to ascertain the MDPP supplier's compliance with these standards, and must adhere to the documentation requirements as outlined in paragraph (f) of this section. (d) Coach eligibility Criteria. (i) Currently have Medicare billing privileges revoked and be currently subject to the reenrollment bar. (ii) Currently have its Medicaid billing privileges terminated for-cause or be excluded by a State Medicaid agency. (iii) Currently be excluded from any other Federal health care program, as defined in 42 CFR 1001.2, in accordance with section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act. (iv) Currently be debarred, suspended, or otherwise excluded from participating in any other Federal procurement or nonprocurement program or activity in accordance with the Federal Acquisition Streamlining Act implementing regulations and the Department of Health and Human Services nonprocurement common rule at 45 CFR part 76. (v) Have, in the previous 10 years, one of the following State or Federal felony convictions: (A) Crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion. (B) Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion. (C) Any felony that placed Medicare or its beneficiaries at immediate risk, such as a malpractice suit that results in the individual being convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion of criminal neglect or misconduct. (D) Any felonies for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion that would result in mandatory exclusion under section 1128(a) of the Act. (2) CMS determination of coach eligibility. (e) Effective date for billing privileges. (i) The later of— (A) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; (B) The date of filing of a corrective action plan that was subsequently approved by a Medicare contractor; or (C) The date that the supplier first began furnishing services at a new administrative location that resulted in a new enrollment record or Provider Transaction Access Number. (ii) Under no circumstances should the effective date of billing privileges for any MDPP supplier be prior to April 1, 2018. (2) For any newly established administrative locations that do not result in a new enrollment record or Provider Transaction Access Number, the existing billing privilege effective date for their Provider Transaction Access Number will apply, but not earlier than April 1, 2018. (f) Documentation retention and provision requirements. (1) The documentation for the first core session must be established contemporaneous with the furnishing of MDPP services and must include at least all of the following: (i) Organizational information, including MDPP supplier name, CDC DPRP number, and NPI. (ii) Basic beneficiary information for each MDPP beneficiary in attendance, including but not limited to beneficiary name, MBI, and age. (iii) Evidence that each such beneficiary satisfied the eligibility requirements under § 410.79(c) of this chapter at the time of service. (2) The documentation for each MDPP session attended by an MDPP must be established contemporaneous with the furnishing of MDPP services and must include at least all of the following: (i) Documentation of the type of session (in-person, distance learning, or Online). (ii) Identification of which CDC-approved DPRP curriculum was associated with the session. (iii) The NPI of the coach who furnished the session. (iv) The date and place of service of the session. (v) Each MDPP's beneficiary's weight and date weight taken, in a form and manner as specified by CMS. (3) If an MDPP supplier chooses to offer in-kind beneficiary engagement incentives to MDPP beneficiaries as permitted under § 424.210, the records maintained by the MDPP supplier in accordance with this section must also include the information required by § 424.210(e). (4) An MDPP supplier is required to maintain and handle any beneficiary information related to MDPP, including Personally Identifiable Information (PII) and Protected Health Information (PHI), as would be required under HIPAA, other applicable state and federal privacy laws, and CMS standards. (5) The MDPP supplier's records must include an attestation from the MDPP supplier that, as applicable, the MDPP beneficiary for which it is submitting a claim— (i) Has achieved required minimum weight loss as measured in accordance with § 410.79(e)(3)(iii) of this chapter during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(1) of this chapter. (ii) Has achieved required minimum weight loss as measured in accordance with § 410.79(c)(ii) during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(1) of this chapter. (iii) Has achieved at least a 9-percent weight loss percentage as measured in accordance with § 410.79(e)(3)(iii) of this chapter during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(2) of this chapter. (iv) Has achieved at least a 9-percent weight loss percentage as measured in in accordance with § 410.79(c)(ii) during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(2) of this chapter. (6) The MDPP supplier must maintain all records required under this section for a period of 10 years from the last day of the MDPP beneficiary's receipt of MDPP services provided by the MDPP supplier or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless either of the following apply: (i) CMS determines that there is a special need to retain a particular record or group of records for a longer period and notifies the MDPP supplier at least 30 calendar days before the normal disposition rate; or (ii) There has been a dispute or allegation of fraud or similar fault against the MDPP supplier, in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the dispute or allegation of fraud or similar fault, as defined at § 405.902 of this chapter. (g) Denial or revocation of MDPP supplier enrollment. (i) Failure to meet enrollment requirements. (A) An enrollment denial under this paragraph (g)(1)(i) is considered an enrollment denial under § 424.530(a)(1) or (18). (B) A revocation under this paragraph (h)(1)(i) is considered a revocation under § 424.535(a)(1) or (23). (C) An MDPP supplier that does not satisfy the requirements in paragraph (b)(1) of this section may become eligible to bill for MDPP services again if it successfully achieves preliminary, full, or full plus CDC DPRP recognition, and successfully enrolls again in Medicare as an MDPP supplier after any applicable reenrollment bar has expired. (ii) Failure to meet MDPP supplier standards. (A) An enrollment denial under this paragraph (g)(1)(ii) is considered an enrollment denial under § 424.530(a)(1) or (18). (B) A revocation under this paragraph (g)(1)(ii) is considered a revocation under § 424.535(a)(1) or (23). (iii) Application of existing enrollment denial reasons. (iv) Application of existing revocation reasons. (v) Use of an ineligible coach. (B) Revocation under this paragraph (g)(1)(v) is subject to the following requirements: ( 1 ( 2 ( 3 (2) An MDPP supplier may appeal an enrollment denial or revocation decision in accordance with the procedures specified in part 498 of this chapter. References to suppliers in that section apply to MDPP suppliers. [82 FR 53364, Nov. 15, 2017,as amended at 86 FR 65682, Nov. 19, 2021; 88 FR 79540, Nov. 16, 2023; 89 FR 98565, Dec. 9, 2024; 90 FR 50014, Nov. 5, 2025; 90 FR 55617, Dec. 2, 2025] § 424.210 Beneficiary engagement incentives under the Medicare Diabetes Prevention Program expanded model. (a) Definitions. Engagement incentive period (i) The MDPP beneficiary's MDPP services period ends as described in § 410.79(c)(3) of this chapter. (ii) The MDPP supplier knows the MDPP beneficiary will no longer be receiving MDPP services from the MDPP supplier. (iii) The MDPP supplier has not had direct contact, either in-person, by telephone, or via other telecommunications technology, with the MDPP beneficiary for more than 90 consecutive calendar days during the MDPP services period. (b) General. (1) The item or service must be furnished directly to an MDPP beneficiary by an MDPP supplier or by an agent of the MDPP supplier, such as a coach, under the MDPP supplier's direction and control. (2) The item or service must be reasonably connected to the CDC-approved National Diabetes Prevention Program curriculum furnished to the MDPP beneficiary during a core session or core maintenance session furnished by the MDPP supplier. (3) The item or service must be a preventive care item or service or an item or service that advances a clinical goal, as specified in paragraph (d) of this section, for an MDPP beneficiary by engaging him or her in better managing his or her own health. (4) The item or service must not be tied to the receipt of items or services outside of the MDPP services. (5) The item or service must not be tied to the receipt of items or services from a particular provider, supplier, or coach. (6) The availability of the item or service must not be advertised or promoted as an in-kind beneficiary engagement incentive available to an MDPP beneficiary receiving MDPP services from the MDPP supplier except that an MDPP beneficiary may be made aware of the availability of the item or service at the time the MDPP beneficiary could reasonably benefit from it during the engagement incentive period. (7) The cost of the item or service must not be shifted to another Federal health care program, as defined at section 1128B(f) of the Act. (8) The cost of the item or service must not be shifted to an MDPP beneficiary. (c) Technology furnished to an MDPP beneficiary. (1) Items or services involving technology may not, in the aggregate, exceed $1,000 in retail value for any one MDPP beneficiary. (2) Items or services involving technology must be the minimum necessary to advance a clinical goal, as specified in paragraph (d) of this section, for an MDPP beneficiary. (3) Items involving technology exceeding $100 in retail value must— (i) Remain the property of the MDPP supplier; and (ii) Be retrieved from the MDPP beneficiary at the end of the engagement incentive period. The MDPP supplier must document all retrieval attempts, including the ultimate date of retrieval, in accordance with paragraph (e)(3) of this section. Documented diligent, good faith attempts to retrieve items of technology will be deemed to meet the retrieval requirement. (d) Clinical goals of the MDPP expanded model. (1) Attendance at core sessions or core maintenance sessions. (2) Weight loss. (3) Long-term dietary change. (4) Adherence to long-term health behavior changes. (e) Documentation of beneficiary engagement incentives. (1) The documentation must be established contemporaneous with the furnishing of the in-kind items and services and must include at least the following: (i) The date the item or service is furnished. (ii) The identity of the MDPP beneficiary to whom the item or service is furnished. (iii) The agent of the MDPP supplier that furnished the item or service, if applicable. (iv) A description of the item or service. (v) The retail value of the item or service. (vi) Documentation establishing that the item or service was furnished to the MDPP beneficiary during the engagement incentive period. (2) Documentation regarding items or services that are furnished to the MDPP beneficiary for use on an ongoing basis during the engagement incentive period, including items involving technology exceeding $100 in retail value, must also include contemporaneous documentation establishing that the MDPP beneficiary is in the engagement incentive period throughout the time period that the MDPP beneficiary possesses or has access to the item or service furnished by the MDPP supplier. (3) The documentation regarding items involving technology exceeding $100 in retail value must also include contemporaneous documentation of any attempt to retrieve the item as required by paragraph (c)(3)(ii) of this section. (4) The MDPP supplier must retain and provide access to the documentation required in this section in accordance with § 424.205(g). [82 FR 53364, Nov. 15, 2017, as amended at 88 FR 79540, Nov. 16, 2023] Subparts J-L [Reserved] Subpart M—Replacement and Reclamation of Medicare Payments § 424.350 Replacement of checks that are lost, stolen, defaced, mutilated, destroyed, or paid on forged endorsements. (a) U.S. Government checks Responsibility. (2) Action by CMS. (3) Action by the Treasury Department. (b) Intermediary and carrier benefit checks. [58 FR 65129, Dec. 13, 1993] § 424.352 Intermediary and carrier checks that are lost, stolen, defaced, mutilated, destroyed or paid on forged endorsements. (a) When an intermediary or carrier is notified by a payee that a check has been lost, stolen, defaced, mutilated, destroyed, or paid on forged endorsement, the intermediary or carrier contacts the commercial bank on whose paper the check was drawn and determines whether the check has been negotiated. (b) If the check has been negotiated— (1) The intermediary or carrier provides the payee with a copy of the check and other pertinent information (such as a claim form, affidavit or questionnaire to be completed by the payee) required to pursue his or her claim in accordance with State law and commercial banking regulations. (2) To pursue the claim, the payee must examine the check and certify (by completing the claim form, questionnaire or affidavit) that the endorsement is not the payee's. (3) The claim form and other pertinent information is sent to the intermediary or carrier for review and processing of the claim. (4) The intermediary or carrier reviews the payee's claim. If the intermediary or carrier determines that the claim appears to be valid, it forwards the claim and a copy of the check to the issuing bank. The intermediary or carrier takes further action to recover the proceeds of the check in accordance with the State law and regulations. (5) Once the intermediary or carrier recovers the proceeds of the initial check, the intermediary or carrier issues a replacement check to the payee. (6) If the bank of first deposit refuses to settle on the check for good cause, the payee must pursue the claim on his or her own and the intermediary or carrier will not reissue the check to the payee. (c) If the check has not been negotiated— (1) The intermediary or carrier arranges with the bank to stop payment on the check; and (2) Except as provided in paragraph (d), the intermediary or carrier reissues the check to the payee. (d) No check may be reissued under (c)(2) unless the claim for a replacement check is received by the intermediary or carrier no later than 1 year from the date of issuance of the original check, unless State law (including any applicable Federal banking laws or regulations that may affect the relevant State proceeding) provides a longer period which will control. [58 FR 65130, Dec. 13, 1993] Subparts N-O [Reserved] Subpart P—Requirements for Establishing and Maintaining Medicare Billing Privileges Source: 71 FR 20776, Apr. 21, 2006, unless otherwise noted. § 424.500 Scope. The provisions of this subpart contain the requirements for enrollment, periodic resubmission and certification of enrollment information for revalidation, and timely reporting of updates and changes to enrollment information. These requirements apply to all providers and suppliers except for physicians and practitioners who have entered into a private contract with a beneficiary as described in part 405, subpart D of this chapter. Providers and suppliers must meet and maintain these enrollment requirements to bill either the Medicare program or its beneficiaries for Medicare covered services or supplies. § 424.502 Definitions. As used in this subpart, unless the context indicates otherwise— Additional disclosable party (1)(i) Exercises operational, financial, or managerial control over the facility or a part thereof; (ii) Provides policies or procedures for any of the operations of the facility; or (iii) Provides financial or cash management services to the facility. (2)(i) Leases or subleases real property to the facility; or (ii) Owns a whole or part interest equal to or exceeding 5 percent of the total value of such real property. (3) Provides— (i) Management or administrative services; (ii) Management or clinical consulting services; or (iii) Accounting or financial services to the facility. Affiliation (1) A 5 percent or greater direct or indirect ownership interest that an individual or entity has in another organization. (2) A general or limited partnership interest (regardless of the percentage) that an individual or entity has in another organization. (3) An interest in which an individual or entity exercises operational or managerial control over, or directly or indirectly conducts, the day-to-day operations of another organization (including, for purposes of this paragraph (3), sole proprietorships), either under contract or through some other arrangement, regardless of whether or not the managing individual or entity is a W-2 employee of the organization. (4) An interest in which an individual is acting as an officer or director of a corporation. (5) Any reassignment relationship under § 424.80. Approve/Approval Authorized official Change in majority ownership Deactivate Delegated official Deny/Denial Director Disclosable event (1) Currently has an uncollected debt to Medicare, Medicaid, or CHIP, regardless of— (i) The amount of the debt; (ii) Whether the debt is currently being repaid (for example, as part of a repayment plan); or (iii) Whether the debt is currently being appealed; (2) Has been or is subject to a payment suspension under a federal health care program (as that latter term is defined in section 1128B(f) of the Act), regardless of when the payment suspension occurred or was imposed; (3) Has been or is excluded by the OIG from participation in Medicare, Medicaid, or CHIP, regardless of whether the exclusion is currently being appealed or when the exclusion occurred or was imposed; or (4) Has had its Medicare, Medicaid, or CHIP enrollment denied, revoked, or terminated, regardless of— (i) The reason for the denial, revocation, or termination; (ii) Whether the denial, revocation, or termination is currently being appealed; or (iii) When the denial, revocation, or termination occurred or was imposed. Enroll/Enrollment (1) Identification of a provider or supplier; (2) Except for those suppliers that complete the CMS-855O form, CMS-identified equivalent, successor form or process for the sole purpose of obtaining eligibility to order or certify Medicare-covered items and services, validating the provider or supplier's eligibility to provide items or services to Medicare beneficiaries; (3) Identification and confirmation of the provider or supplier's practice location(s) and owner(s); and (4) Except for those suppliers that complete the CMS-855O form, CMS-identified equivalent, successor form or process for the sole purpose of obtaining eligibility to order or certify Medicare-covered items and services, granting the Medicare provider or supplier Medicare billing privileges. Enrollment application Final adverse action (1) A Medicare-imposed revocation of any Medicare billing privileges; (2) Suspension or revocation of a license to provide health care by any State licensing authority; (3) Revocation or suspension by an accreditation organization; (4) A conviction of a Federal or State felony offense (as defined in § 424.535(a)(3)(i)) within the last 10 years preceding enrollment, revalidation, or re-enrollment; or (5) An exclusion or debarment from participation in a Federal or State health care program. Indirect ownership interest (1)(i) Any ownership interest in an entity that has an ownership interest in the enrolling or enrolled provider or supplier. (ii) Any ownership interest in an indirect owner of the enrolling or enrolled provider or supplier. (2) The amount of indirect ownership interest is determined by multiplying the percentages of ownership in each entity. For example, if A owns 10 percent of the stock in a corporation that owns 80 percent of the provider or supplier, A's interest equates to an 8 percent indirect ownership interest in the provider or supplier and must be reported on the enrollment application. Conversely, if B owns 80 percent of the stock of a corporation that owns 5 percent of the stock of the provider or supplier, B's interest equates to a 4 percent indirect ownership interest in the provider or supplier and need not be reported. Institutional provider Managing employee (1) A general manager, business manager, administrator, director, or other individual that exercises operational or managerial control over, or who directly or indirectly conducts, the day-to-day operation of the provider or supplier, either under contract or through some other arrangement, whether or not the individual is a W-2 employee of the provider or supplier. For purposes of this definition, this includes, but is not limited to, a hospice or skilled nursing facility administrator and a hospice or skilled nursing facility medical director. (2) With respect to the additional requirements at § 424.516(g) for a skilled nursing facility defined at section 1819(a) of the Act, an individual, including a general manager, business manager, administrator, director, or consultant, who directly or indirectly manages, advises, or supervises any element of the practices, finances, or operations of the facility. Managing organization NPI Officer Operational Organizational structure (1) A corporation. (2) A limited liability company. (3) A general partnership. (4) A limited partnership. (5) A trust. (6) An individual. Owner PECOS Physician or nonphysician practitioner organization Private equity company Real estate investment trust Reject/Rejected Revoke/Revocation State oversight board Supplier (1) The individuals and entities that qualify as suppliers under § 400.202. (2) Physical therapists in private practice. (3) Occupational therapists in private practice. (4) Speech-language pathologists. Voluntary termination [71 FR 20776, Apr. 21, 2006, as amended at 73 FR 69939, Nov. 19, 2008; 75 FR 70464, Nov. 17, 2010; 75 FR 73628, Nov. 29, 2010; 76 FR 5962, Feb. 2, 2011; 79 FR 72531, Dec. 5, 2014; 82 FR 53368, Nov. 15, 2017; 84 FR 47852, Sept. 10, 2019; 84 FR 63203, Nov. 15, 2019; 86 FR 65682, Nov. 19, 2021; 87 FR 70231, Nov. 18, 2022; 88 FR 77877, Nov. 13, 2023; 88 FR 79540, Nov. 16, 2023; 88 FR 80168, Nov. 17, 2023; 90 FR 55617, Dec. 2, 2025] § 424.505 Basic enrollment requirement. To receive payment for covered Medicare items or services from either Medicare (in the case of an assigned claim) or a Medicare beneficiary (in the case of an unassigned claim), a provider or supplier must be enrolled in the Medicare program. Except for those suppliers that complete the CMS-855O form or CMS-identified equivalent, successor form or process for the sole purpose of obtaining eligibility to order or certify Medicare-covered items and services; once enrolled the provider or supplier receives billing privileges and is issued a valid billing number effective for the date a claim was submitted for an item that was furnished or a service that was rendered. (See 45 CFR part 162 for information on the National Provider Identifier and its use as the Medicare billing number.) [71 FR 20776, Apr. 21, 2006, as amended at 79 FR 72531, Dec. 5, 2014] § 424.506 National Provider Identifier (NPI) on all enrollment applications and claims. (a) Definition. Eligible professional (b) Enrollment requirements. (i) Report its NPI on its Medicare enrollment application. (ii) If the provider or supplier was in the Medicare program before obtaining an NPI and the provider's or the supplier's NPI is not in the provider's or supplier's Medicare enrollment record, the provider or supplier must update its Medicare enrollment record by submitting its NPI using either of the following: (A) The applicable paper CMS-855 form. (B) Internet-based PECOS. (2) A physician or eligible professional who has validly opted-out of the Medicare program is not required to submit a Medicare enrollment application for any reason, including to order or certify. (c) Claims reporting requirements. (2) A Medicare beneficiary who submits a claim for service to Medicare— (i) Must include the legal name of any provider or supplier who is required to be identified in that claim; and (ii) May, if known to the beneficiary, include the National Provider Identifier (NPI) of any provider or supplier who is required to be identified in that claim. (3) A Medicare contractor will reject a claim from a provider or a supplier if the required NPI(s) is not reported. [75 FR 24448, May 5, 2010, as amended at 77 FR 25317, Apr. 27, 2012] § 424.507 Ordering covered items and services for Medicare beneficiaries. (a) Conditions for payment of claims for ordered covered imaging and clinical laboratory services and items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Ordered covered imaging, clinical laboratory services, and DMEPOS item claims. (i) The ordered covered imaging, clinical laboratory services, and DMEPOS items (excluding home health services described in paragraph (b) of this section, and Part B drugs) must have been ordered by a physician or, when permitted, an eligible professional (as defined in § 424.506(a) of this part). (ii) The claim from the provider or supplier must contain the legal name and the National Provider Identifier (NPI) of the physician or the eligible professional (as defined in § 424.506(a) of this part) who ordered the item or service. (iii) The physician or, when permitted, other eligible professional, as defined in § 424.506(a), who ordered the item or service must— (A) Be identified by his or her legal name; (B) Be identified by his or her NPI; and (C)( 1 ( 2 (iv) If the item or service is ordered by— (A) An unlicensed resident (as defined in § 413.75), or by a non-enrolled licensed resident (as defined in § 413.75), the claim must identify a teaching physician, who must be enrolled in Medicare in an approved status, as follows: ( 1 ( 2 ( 3 (B) A licensed resident (as defined in § 413.75), he or she must have a provisional license or be otherwise permitted by State law, where the resident is enrolled in an approved graduate medical education program, to practice or order such items and services, the claim must identify by legal name and NPI the— ( 1 ( 2 (2) Part B beneficiary claims. (i) The physician or, when permitted, other eligible professional (as defined § 424.506(a)) who ordered the item or service must— (A) Be identified by his or her legal name; and (B)( 1 ( 2 (ii) If the item or service is ordered by— (A) An unlicensed resident (as defined in § 413.75) or a non-enrolled licensed resident, (as defined in § 413.75) the claim must identify a teaching physician, who must be enrolled in Medicare in an approved status as follows: ( 1 ( 2 (B) A licensed resident (as defined in § 413.75), he or she must have a provisional license or are otherwise permitted by State law, where the resident is enrolled in an approved graduate medical education program, to practice or to order such items and services, the claim must identify by legal name the— ( 1 ( 2 (b) Conditions for payment of claims for covered home health and hospice services. (1) The ordering/certifying physician for hospice or home health services, or, for home health services, the ordering/certifying physician assistant, nurse practitioner, or clinical nurse specialist working in accordance with State law, must meet all of the following requirements: (i) Be identified by his or her legal name. (ii) Be identified by his or her NPI. (iii)(A) Be enrolled in Medicare in an approved status; or (B) Have validly opted-out of the Medicare program. (2) If the services were ordered/certified by— (i) An unlicensed resident, as defined in § 413.75, or by a non-enrolled licensed resident, as defined in § 413.75, the claim must identify a teaching physician who must be enrolled in Medicare in an approved status— (A) As the ordering/certifying supplier; (B) By his or her legal name; and (C) By his or her NPI. (ii) A licensed resident (as defined in § 413.75), he or she must have a provisional license or are otherwise permitted by State law, where the resident is enrolled in an approved graduate medical education program, to practice or to order/certify such items and services, the claim must identify by legal name and NPI the— (A) Resident, who is enrolled in Medicare in an approved status to order; or (B) Teaching physician, who is enrolled in Medicare in an approved status. (3) For claims for hospice services, the requirements of this paragraph (b) apply with respect to any physician described in § 418.22(c) of this chapter who made the applicable certification described in § 418.22(c) of this chapter. (c) Denial of provider- or supplier-submitted claims. (d) Denial of beneficiary-submitted claims. [77 FR 25317, Apr. 27, 2012, as amended at 85 FR 27625, May 8, 2020; 88 FR 51199, Aug. 2, 2023] § 424.510 Requirements for enrolling in the Medicare program. (a)(1) Providers and suppliers must submit enrollment information on the applicable enrollment application. Once the provider or supplier successfully completes the enrollment process, including, if applicable, a State survey and certification or accreditation process, CMS enrolls the provider or supplier into the Medicare program. (2) To be enrolled to furnish Medicare-covered items and services, a provider or supplier must meet the requirements specified in paragraphs (d) and (e) of this section. (3) To be enrolled solely to order and certify Medicare items or services, a physician or non-physician practitioner must meet the requirements specified in paragraph (d) of this section except for paragraphs (d)(2)(iii)(B), (d)(2)(iv), (d)(3)(ii), and (d)(5), (6), and (9) of this section. (b) The effective dates for reimbursement are specified in § 489.13 of this chapter for providers and suppliers requiring State survey or certification or accreditation, § 424.5 and § 424.44 for non-surveyed or certified/accredited suppliers, and § 424.57 and section 1834(j)(1)(A) of the Act for DMEPOS suppliers. (c) The effective date for reimbursement for providers and suppliers seeking accreditation from a CMS-approved accreditation organization as specified in § 489.13. (d) Providers and suppliers must meet the following enrollment requirements: (1) Submittal of the enrollment application. (2) Content of the enrollment application. (i) Complete, accurate, and truthful responses to all information requested within each section as applicable to the provider or supplier type. (ii) Submission of all documentation required by CMS under this or other statutory or regulatory authority, or under the Paperwork Reduction Act of 1995, to uniquely identify the provider or supplier. This documentation may include, but is not limited to, proof of the legal business name, practice location, social security number (SSN), tax identification number (TIN), National Provider Identifier (NPI), if issued, and owners of the business. (iii) Submission of all documentation, including the following: (A) All applicable Federal and State licenses, certifications including, but not limited to Federal Aviation Administration. (B) Documentation associated with regulatory and statutory requirements necessary to establish a provider's or supplier's eligibility to furnish Medicare covered items or services to beneficiaries in the Medicare program. (C) Any other documentation needed to verify and confirm the information furnished on the enrollment application. This includes, but is not limited to, documentation regarding the provider's or supplier's ownership or management. (iv) At the time of enrollment, an enrollment change request, revalidation or change of Medicare contractors where the provider or supplier was already receiving payments via EFT, providers and suppliers must agree to receive Medicare payments via EFT, if not already receiving payment through EFT. In order to receive Medicare payments via EFT, providers and suppliers must submit the CMS-588 form. (3) Signature(s) required on the enrollment application. (i) Requirements. (A) An individual practitioner, the applying practitioner. (B) A sole proprietorship, the applying sole proprietor. (C) A corporation, partnership, group, limited liability company, or other organization (hereafter referred to collectively in this section as an organization), an authorized official, as defined in § 424.502. When an authorized official signs the certification statement on behalf of an organization, the signed statement is considered legally binding upon the organization. (ii) Delegation of authority. (A) Be assigned by the authorized official currently on file with CMS; (B) Be submitted to CMS using the appropriate enrollment application or CMS established electronic enrollment process; (C) Include the title and SSN of each person delegated authority to update or change the organization's enrollment information; (D) Be an individual that has an ownership or control interest in the organization or is a W-2 managing employee as defined in section 1126(b) of the Act; and (E) Be signed by the authorized official and the delegated official(s) of the organization. (4) Verification of information. (5) Completion of any applicable State surveys, certifications, and provider agreements. (6) Ability to furnish Medicare covered items or services. (7) Additional requirements. (8) On-site review. (i) Medicare Part A providers. (ii) Medicare Part B suppliers. (9) In order to obtain enrollment and to maintain enrollment for the first three months after Medicare billing privileges are conveyed, a home health agency must satisfy the home health “initial reserve operating funds” requirement as set forth in § 489.28 of this chapter. (10) Legal responsibility. (e) Providers and suppliers must— (1) Agree to receive Medicare payment via electronic funds transfer (EFT) at the time of enrollment, revalidation, change of Medicare contractors where the provider or supplier was already receiving payments via EFT or submission of an enrollment change request; and (2) Submit the CMS-588 form to receive Medicare payment via electronic funds transfer. [71 FR 20776, Apr. 21, 2006, as amended at 73 FR 36461, June 27, 2008; 75 FR 50418, Aug. 16, 2010; 75 FR 70464, Nov. 17, 2010; 75 FR 73628, Nov. 29, 2010; 77 FR 29030, July 16, 2012; 79 FR 72531, Dec. 5, 2014; 90 FR 55617, Dec. 2, 2025] § 424.514 Application fee. (a) Application fee requirements for prospective institutional providers. (1) The applicable application fee. (2) A request for a hardship exception to the application fee at the time of filing a Medicare enrollment application. (b) Application fee requirements for revalidating institutional providers. (1) The applicable application fee. (2) A request for a hardship exception to the application fee at the time of filing a Medicare enrollment application. (c) Hardship exception for disaster areas. (d) Application fee. (1) For 2010, $500.00. (2) For 2011 and subsequent years— (i) Is adjusted by the percentage change in the consumer price index for all urban consumers (all items; United States city average) for the 12-month period ending with June of the previous year; (ii) Is effective from January 1 to December 31 of a calendar year; (iii) Is based on the submission of an initial application, application to establish a new practice location or the submission of an application in response to a CMS revalidation request; (iv) Must be in the amount calculated by CMS in effect for the year during which the application for enrollment is being submitted; (v) Is nonrefundable, except if submitted with one of the following: (A) A request for hardship exception that is subsequently approved; (B) An application that is rejected prior to initiation of screening processes; (C) An application that is subsequently denied as a result of the imposition of a temporary moratorium; (e) Denial or revocation based on application fee. (f) Information needed for submission of a hardship exception request. (g) Failure to submit application fee or hardship exception request. (1) Reject an enrollment application from a newly-enrolling institutional provider that, with the exceptions described in § 424.514(b), is not accompanied by the application fee or by a letter requesting a hardship exception from the application fee. (2) Revoke the billing privileges of a currently enrolled institutional provider that, with the exceptions described in § 424.514(b), is not accompanied by the application fee or by a letter requesting a hardship exception from the application fee. (3)(i) Notwithstanding the foregoing, the contractor must first inform the provider that the application fee was not submitted in accordance with this section. (ii) Within 30 days after the date of the notification, the contractor may reject the application of the newly-enrolling institutional provider or revoke the billing privileges of the currently enrolled institutional provider that has not submitted the fee. (h) Consideration of hardship exception request. (1) A Medicare contractor does not— (i) Begin processing an enrollment application that is accompanied by a hardship exception request until CMS has made a decision to approve or disapprove the hardship exception request; and (ii) Deny an enrollment application that is accompanied by a hardship exception request unless the hardship exception request is denied by CMS and the provider or supplier fails to submit the required application fee within 30 days of being notified that the request for a hardship exception was denied. (2) A hardship exception determination made by CMS is appealable using § 405.874 of this chapter. [76 FR 5962, Feb. 2, 2011] § 424.515 Requirements for reporting changes and updates to, and the periodic revalidation of Medicare enrollment information. To maintain Medicare billing privileges, a provider or supplier (other than a DMEPOS supplier) must resubmit and recertify the accuracy of its enrollment information every 5 years. All providers and suppliers currently billing the Medicare program or initially enrolling in the Medicare program are required to complete the applicable enrollment application. The provider or supplier then enters a 5-year revalidation cycle once a completed enrollment application is submitted and validated. (Ambulance service providers must continue to resubmit enrollment information in accordance with § 410.41(c)(2) of this chapter and DMEPOS suppliers must continue to renew enrollment in accordance with § 424.57(g)). The requirements for the resubmission, recertification and reverification of enrollment information include the following: (a) Submission of the enrollment application and supporting documentation. (1) CMS contacts each provider or supplier directly when it is time to revalidate their enrollment information. (2) A provider or supplier must submit to CMS the applicable enrollment application with complete and accurate information and applicable supporting documentation within 60 calendar days of our notification to resubmit and certify to the accuracy of its enrollment information. (b) Completion of any applicable State surveys, certifications and provider agreements. (c) On-site inspections. (1) Medicare Part A providers. (2) Medicare Part B suppliers. (d) Off Cycle revalidations. (2) CMS reserve the right to adjust the routine 5-year revalidation schedule if we determine that revalidation should occur on a more frequent basis due to complaints or evidence we receive indicating noncompliance with the statute or regulations by specific provider or supplier types. The schedule may also be on a less frequent basis if we determine that the integrity of and compliance with the statute and regulations by specific provider or supplier types indicates that less frequent validation is justified. If a change occurs, CMS notifies all affected providers and suppliers at least 90 days in advance of implementing the change. (3) CMS revalidates enrollment information for ambulance service suppliers in accordance with § 410.41(c)(2) of this chapter (Requirements for ambulance suppliers), and DMEPOS suppliers renews enrollment in accordance with § 424.57(g) (Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing numbers). (e) Additional off-cycle revalidation. (1) CMS will contact providers or suppliers to revalidate their enrollment for off-cycle revalidation. (2) As with all revalidations, revalidations described in this paragraph are conducted in accordance with the screening procedures specified at § 424.518. [71 FR 20776, Apr. 21, 2006, as amended at 76 FR 5963, Feb. 2, 2011; 79 FR 69775, Nov. 24, 2014] § 424.516 Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program. (a) Certifying compliance. (1) Compliance with title XVIII of the Act and applicable Medicare regulations. (2) Compliance with Federal and State licensure, certification, and regulatory requirements, as required, based on the type of services or supplies the provider or supplier type will furnish and bill Medicare. (3) Not employing or contracting with individuals or entities that meet either of the following conditions: (i) Excluded from participation in any Federal health care programs, for the provision of items and services covered under the programs, in violation of section 1128A(a)(6) of the Act. (ii) Debarred by the General Services Administration (GSA) from any other Executive Branch procurement or nonprocurement programs or activities, in accordance with the Federal Acquisition and Streamlining Act of 1994, and with the HHS Common Rule at 45 CFR part 76. (b) Reporting requirements Independent Diagnostic Testing Facilities (IDTFs). (c) Reporting requirements DMEPOS suppliers. (d) Reporting requirements for physicians, nonphysician practitioners, and physician and nonphysician practitioner organizations. (1) Within 30 days— (i) A change of ownership; (ii) Any adverse legal action; or (iii) A change, addition, or deletion of a practice location. (2) All other changes in enrollment must be reported within 90 days. (e) Reporting requirements for all other providers and suppliers. (1) Within 30 days for a change of ownership or control (including changes in authorized official(s) or delegated official(s)), an adverse legal action, or a change, addition, or deletion of a practice location. (2) All other changes to enrollment must be reported within 90 days. (3) Within 30 days of any revocation or suspension of a Federal or State license or certification including Federal Aviation Administration certifications, an air ambulance supplier must report a revocation or suspension of its license or certification to the applicable Medicare contractor. The following FAA certifications must be reported: (i) Specific pilot certifications including but not limited to instrument and medical certifications. (ii) Airworthiness certification. (f) Maintaining and providing access to documentation. (A) Maintain documentation (as described in paragraph (f)(1)(ii) of this section) for 7 years from the date of service; and (B) Upon the request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(1)(ii) of this section). (ii) The documentation includes written and electronic documents (including the NPI of the physician or, when permitted, other eligible professional who ordered, certified, referred, or prescribed the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions, and requests for payments for Part A or B services, items or drugs. (2)(i) A physician or, when permitted, an eligible professional who orders, certifies, refers, or prescribes Part A or B services, items or drugs is required to— (A) Maintain documentation (as described in paragraph (f)(2)(ii) of this section) for 7 years from the date of the service; and (B) Upon request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(2)(ii) of this section). (ii) The documentation includes written and electronic documents (including the NPI of the physician or, when permitted, other eligible professional who ordered, certified, referred, or prescribed the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions or requests for payments for Part A or B services, items, or drugs. (g) Skilled nursing facilities. (i) Each member of the governing body of the facility, including the name, title, and period of service for each such member. (ii) Each person or entity who is an officer, director, member, partner, trustee, or managing employee (as defined in § 424.502) of the facility, including the name, title, and period of service of each such person or entity. (iii) Each person or entity who is an additional disclosable party of the facility (as defined in § 424.502). (iv) The organizational structure (as defined in § 424.502) of each additional disclosable party of the facility and a description of the relationship of each such additional disclosable party to the facility and to one another. (2) The skilled nursing facility need not disclose the same information described in paragraph (g)(1) of this section more than once on the same enrollment application submission. (3) The skilled nursing facility must report any change to any of the information described in paragraph (g)(1) of this section consistent with the applicable timeframes in paragraph (e) of this section. [73 FR 69939, Nov. 19, 2008; 73 FR 80304, Dec. 31, 2008, as amended at 75 FR 24449, May 5, 2010; 75 FR 73628, Nov. 29, 2010; 77 FR 25318, Apr. 27, 2012; 82 FR 53368, Nov. 15, 2017; 84 FR 47852, Sept. 10, 2019; 88 FR 79541, Nov. 16, 2023; 88 FR 80168, Nov. 17, 2023; 90 FR 55617, Dec. 2, 2025] § 424.517 Onsite review. (a) CMS reserves the right, when deemed necessary, to perform onsite review of a provider or supplier to verify that the enrollment information submitted to CMS or its agents is accurate and to determine compliance with Medicare enrollment requirements. Site visits for enrollment purposes do not affect those site visits performed for establishing compliance with conditions of participation. Based upon the results of CMS's onsite review, the provider may be subject to denial or revocation of Medicare billing privileges as specified in § 424.530 or § 424.535 of this part. (1) Medicare Part A providers. (i) Is unable to furnish Medicare-covered items or services. (ii) Has failed to satisfy any of the Medicare enrollment requirements. (2) Medicare Part B providers. (i) Is unable to furnish Medicare-covered items or services. (ii) Has failed to satisfy any or all of the Medicare enrollment requirements. (iii) Has failed to furnish Medicare covered items or services as required by the statute or regulations. (b) [Reserved] [73 FR 66940, Nov. 19, 2008] § 424.518 Screening levels for Medicare providers and suppliers. A Medicare contractor is required to screen all initial applications, revalidation applications, change of ownership applications pursuant to 42 CFR 489.18, applications to add a new practice location, and applications to report any new owner (regardless of ownership percentage) pursuant to a change of information or other enrollment transaction under title 42, based on a CMS assessment of risk and assignment to a level of “limited,” “moderate,” or “high.” (a) Limited categorical risk Limited categorical risk: Provider and supplier categories. (i) Physician or nonphysician practitioners (including nurse practitioners, CRNAs, occupational therapists, speech/language pathologists, and audiologists) and medical groups or clinics. (ii) Ambulatory surgical centers. (iii) Competitive Acquisition Program/Part B Vendors. (iv) End-stage renal disease facilities. (v) Federally qualified health centers. (vi) Histocompatibility laboratories. (vii) Home infusion therapy suppliers. (viii) Hospitals, including critical access hospitals, rural emergency hospitals, Department of Veterans Affairs hospitals, and other federally owned hospital facilities. (ix) Health programs operated by an Indian Health Program (as defined in section 4(12) of the Indian Health Care Improvement Act) or an urban Indian organization (as defined in section 4(29) of the Indian Health Care Improvement Act) that receives funding from the Indian Health Service pursuant to Title V of the Indian Health Care Improvement Act. (x) Mammography screening centers. (xi) Mass immunization roster billers (xii) Opioid treatment programs (if § 424.67(b)(3)(ii) applies). (xiii) Organ procurement organizations. (xiv) Pharmacies newly enrolling or revalidating via the CMS-855B application. (xv) Radiation therapy centers. (xvi) Religious non-medical health care institutions. (xvii) Rural health clinics. (2) Limited screening level: Screening requirements. (i) Verifies that a provider or supplier meets all applicable Federal regulations and State requirements for the provider or supplier type prior to making an enrollment determination. (ii) Conducts license verifications, including licensure verifications across State lines for physicians or nonphysician practitioners and providers and suppliers that obtain or maintain Medicare billing privileges as a result of State licensure, including State licensure in States other than where the provider or supplier is enrolling. (iii) Conducts database checks on a pre- and post-enrollment basis to ensure that providers and suppliers continue to meet the enrollment criteria for their provider/supplier type. (b) Moderate categorical risk Moderate categorical risk: Provider and supplier categories. (i) Ambulance service suppliers. (ii) Community mental health centers. (iii) Comprehensive outpatient rehabilitation facilities. (iv) Independent clinical laboratories. (v) Independent diagnostic testing facilities. (vi) Physical therapists enrolling as individuals or as group practices. (vii) Portable x-ray suppliers. (viii) Prospective (newly enrolling) and revalidating opioid treatment programs that have been fully and continuously certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) since October 23, 2018. (ix) Revalidating opioid treatment programs that have not been fully and continuously certified by SAMHSA since October 23, 2018, revalidating DMEPOS suppliers, revalidating MDPP suppliers, revalidating HHAs, revalidating SNFs, and revalidating hospices to which CMS applied the fingerprinting requirements outlined in paragraph (c)(2)(ii) of this section upon the provider's or supplier's— (A) New/initial enrollment; or (B) Revalidation after CMS waived the fingerprinting requirements, under the circumstances described in paragraph (c)(1)(viii) of this section, when the provider or supplier initially enrolled in Medicare. (2) Moderate screening level: Screening requirements. (i) Performs the “limited” screening requirements described in paragraph (a)(2) of this section. (ii) Conducts an on-site visit. (c) High categorical risk High categorical risk: Provider and supplier categories. (i) Prospective (newly enrolling) home health agencies. (ii) Prospective (newly enrolling) DMEPOS suppliers. (iii) Prospective (newly enrolling) MDPP suppliers (iv) Prospective (newly enrolling) opioid treatment programs that have not been fully and continuously certified by SAMHSA since October 23, 2018. (v) Prospective (newly enrolling) (SNFs). (vi) Prospective (newly enrolling) hospices. (vii) Enrolled opioid treatment programs that have not been fully and continuously certified by SAMHSA since October 23, 2018, DMEPOS suppliers, MDPP suppliers, HHAs, SNFs, and hospices that are submitting a change of ownership application pursuant to 42 CFR 489.18 or reporting any new owner (regardless of ownership percentage) pursuant to a change of information or other enrollment transaction under title 42. (viii) Except as stated in paragraph (b)(1)(ix) of this section, revalidating opioid treatment programs that have not been fully and continuously certified by SAMHSA since October 23, 2018, revalidating DMEPOS suppliers, revalidating MDPP suppliers, revalidating HHAs, revalidating SNFs, and revalidating hospices for which, upon their new/initial enrollment, CMS waived the fingerprinting requirements outlined in paragraph (c)(2)(ii) of this section in accordance with applicable legal authority due to a national, state, or local emergency declared under existing law. (2) High screening level: Screening requirements. (i) Performs the “limited” and “moderate” screening requirements described in paragraphs (a)(2) and (b)(2) of this section. (ii)(A) Requires the submission of a set of fingerprints for a national background check from all individuals who maintain a 5 percent or greater direct or indirect ownership interest in the provider or supplier; and (B) Conducts a fingerprint-based criminal history record check of the Federal Bureau of Investigation's Integrated Automated Fingerprint Identification System on all individuals who maintain a 5 percent or greater direct or indirect ownership interest in the provider or supplier. (3) Adjustment in the categorical risk. (i) CMS imposes a payment suspension on a provider or supplier at any time in the last 10 years. (ii) The provider or supplier— (A) Has been excluded from Medicare by the OIG; or (B) Had billing privileges revoked by a Medicare contractor within the previous 10 years and is attempting to establish additional Medicare billing privileges by— ( 1 ( 2 (C) Has been terminated or is otherwise precluded from billing Medicaid; (D) Has been excluded from any Federal health care program; or (E) Has been subject to any final adverse action, as defined at § 424.502, within the previous 10 years. (iii) CMS lifts a temporary moratorium for a particular provider or supplier type and a provider or supplier that was prevented from enrolling based on the moratorium, applies for enrollment as a Medicare provider or supplier at any time within 6 months from the date the moratorium was lifted. (4) Any screening level adjustment under paragraph (c)(3) of this section also applies to all other enrolled and prospective providers and suppliers that have the same legal business name and tax identification number as the provider or supplier for which the screening level under paragraph (c)(3) of this section was originally raised. (d) Fingerprinting requirements. (1) Must submit a set of fingerprints for a national background check. (i) Upon submission of a Medicare enrollment application; or (ii) Within 30 days of a Medicare contractor request. (2) In the event the individual(s) required to submit fingerprints under paragraph (c)(2) of this section fail to submit such fingerprints in accordance with paragraph (d)(1) of this section, the provider or supplier will have its billing privileges— (i) Denied under § 424.530(a)(1); or (ii) Revoked under § 424.535(a)(1). [76 FR 5963, Feb. 2, 2011, as amended at 82 FR 53368, Nov. 15, 2017; 84 FR 63203, Nov. 15, 2019; 85 FR 70355, Nov. 4, 2020; 85 FR 85038, Dec. 28, 2020; 87 FR 70231, Nov. 18, 2022; 87 FR 72293, Nov. 23, 2022; 88 FR 77877, Nov. 13, 2023] § 424.519 Disclosure of affiliations. (a) Definitions. (1) “Uncollected debt” only applies to the following: (i) Medicare, Medicaid, or CHIP overpayments for which CMS or the state has sent notice of the debt to the affiliated provider or supplier. (ii) Civil money penalties imposed under this title. (iii) Assessments imposed under this title. (2) “Revoked,” “Revocation,” “Terminated,” and “Termination” include situations where the affiliated provider or supplier voluntarily terminated its Medicare, Medicaid, or CHIP enrollment to avoid a potential revocation or termination. (b) General. (c) Information. (1) General identifying data about the affiliated provider or supplier. This includes the following: (i) Legal name as reported to the Internal Revenue Service or the Social Security Administration (if the affiliated provider or supplier is an individual). (ii) “Doing business as” name (if applicable). (iii) Tax identification number. (iv) NPI. (2) Reason for disclosing the affiliated provider or supplier. (3) Specific data regarding the affiliation relationship, including the following: (i) Length of the relationship. (ii) Type of relationship. (iii) Degree of affiliation. (4) If the affiliation has ended, the reason for the termination. (d) Mechanism. (e) Denial or revocation. (1) The denial of the provider's or supplier's initial enrollment application under § 424.530(a)(1) and, if applicable, § 424.530(a)(4). (2) The revocation of the provider's or supplier's Medicare enrollment under § 424.535(a)(1) and, if applicable, § 424.535(a)(4). (f) Undue risk. (1) The duration of the affiliation. (2) Whether the affiliation still exists and, if not, how long ago it ended. (3) The degree and extent of the affiliation. (4) If applicable, the reason for the termination of the affiliation. (5) Regarding the affiliated provider's or supplier's disclosable event under paragraph (b) of this section: (i) The type of disclosable event. (ii) When the disclosable event occurred or was imposed. (iii) Whether the affiliation existed when the disclosable event occurred or was imposed. (iv) If the disclosable event is an uncollected debt: (A) The amount of the debt. (B) Whether the affiliated provider or supplier is repaying the debt. (C) To whom the debt is owed. (v) If a denial, revocation, termination, exclusion, or payment suspension is involved, the reason for the disclosable event. (6) Any other evidence that CMS deems relevant to its determination. (g) Determination of undue risk. (h) Duplicate data. (i) Undisclosed affiliations. [84 FR 47853, Sept. 10, 2019] § 424.520 Effective date of Medicare billing privileges. (a) Surveyed, certified or accredited providers and suppliers. (b) Independent Diagnostic Testing Facilities. (c) DMEPOS suppliers. (d) Additional provider and supplier types. (i) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or (ii) The date that the provider or supplier first began furnishing services at a new practice location. (2) The provider and supplier types to which paragraph (d)(1) of this section applies are as follows: (i) Physicians. (ii) Non-physician practitioners. (iii) Physician organizations. (iv) Non-physician practitioner organizations. (v) Ambulance suppliers. (vi) Opioid treatment programs. (vii) Part B hospital departments. (viii) Clinical Laboratory Improvement Amendment labs. (ix) Intensive cardiac rehabilitation facilities. (x) Mammography centers. (xi) Mass immunizers/pharmacies. (xii) Radiation therapy centers. (xiii) Home infusion therapy suppliers. (xiv) Physical therapists. (xv) Occupational therapists. (xvi) Speech language pathologists. [73 FR 69940, Nov. 19, 2008, as amended at 75 FR 50418, Aug. 16, 2010; 79 FR 72531, Dec. 5, 2014; 84 FR 63203, Nov. 15, 2019; 85 FR 70355, Nov. 4, 2020; 86 FR 62419, Nov. 9, 2021] § 424.521 Request for payment by certain provider and supplier types. (a) Request for payment by certain provider and supplier types. (i) Thirty days prior to their effective date if circumstances precluded enrollment in advance of providing services to Medicare beneficiaries; or (ii) Ninety days prior to their effective date if a Presidentially-declared disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (Stafford Act) precluded enrollment in advance of providing services to Medicare beneficiaries. (2) The provider and supplier types to which paragraph (a)(1) of this section applies are as follows: (i) Physicians. (ii) Non-physician practitioners. (iii) Physician organizations. (iv) Non-physician practitioner organizations. (v) Ambulance suppliers. (vi) Opioid treatment programs. (vii) Part B hospital departments. (viii) Clinical Laboratory Improvement Amendment labs. (ix) Intensive cardiac rehabilitation facilities. (x) Mammography centers. (xi) Mass immunizers/pharmacies. (xii) Radiation therapy centers. (xiii) Home infusion therapy suppliers. (xiv) Physical therapists. (xv) Occupational therapists. (xvi) Speech language pathologists. (b) [Reserved] [79 FR 72531, Dec. 5, 2014, as amended at 84 FR 63203, Nov. 15, 2019; 85 FR 70355, Nov. 4, 2020; 86 FR 62419, Nov. 9, 2021] § 424.522 Additional effective dates. (a) Reassignments. (2) Retrospective billing in accordance with a reassignment of benefits and as described in § 424.521(a)(1) is permissible if the circumstances in § 424.521(a)(1) are applicable. (b) Form CMS-855O enrollment. [86 FR 62419, Nov. 9, 2021, as amended at 90 FR 55617, Dec. 2, 2025] § 424.525 Rejection of a provider's or supplier's application for Medicare enrollment. (a) Reasons for rejection. (1) The provider or supplier fails to furnish complete information on the provider/supplier enrollment application within 30 calendar days from the date of the Medicare contractor's request for the missing information. This includes the following situations: (i) The application is missing data required by CMS or the Medicare contractor to process the application (such as, but not limited to, names, Social Security Number, contact information, and practice location information). (ii) The application is unsigned or undated. (iii) The application contains a copied or stamped signature. (iv) The application is signed more than 120 days prior to the date on which the Medicare contractor received the application. (v) The application is signed by a person unauthorized to do so under this subpart. (vi) For paper applications, the required certification statement is missing. (vii) The paper application is completed in pencil. (viii) The application is submitted via fax or e-mail when the provider or supplier was not otherwise permitted to do so. (ix) The provider or supplier failed to submit all of the forms needed to process a Form CMS-855 reassignment package within 30 days of receipt. (x) The provider or supplier submitted the incorrect Form CMS-855 application. (2) The provider or supplier fails to furnish all required supporting documentation within 30 calendar days of submitting the enrollment application. (3) The Prospective institutional provider or supplier does not submit the application fee in the designated amount or a hardship waiver request with the Medicare enrollment application at the time of filing. (b) Extension of 30-day period. (c) Resubmission after rejection. (d) Additional review. (e) Applicability. (1) Form CMS-855 initial applications, change of information requests, changes of ownership, revalidations, and reactivations. (2) Form CMS-588 (Electronic Funds Transfer (EFT) Authorization Agreement) submissions. (3) Form CMS-20134 (Medicare Enrollment Application; Medicare Diabetes Prevention Program (MDPP) Suppliers) submissions. (4) Any electronic or successor versions of the forms identified in paragraphs (e)(1) through (3) of this section. [71 FR 20776, Apr. 21, 2006, as amended at 73 FR 36461, June 27, 2008; 76 FR 5964, Feb. 2, 2011; 86 FR 62419, Nov. 9, 2021] Editor's Note: At 86 FR 62419, Nov. 9, 2021, paragraph (a)(3) was amended by removing the phrase “prospective provider” and adding the word “provider” in its place; however, the phrase does not exist. § 424.526 Return of a provider's or supplier's enrollment application. (a) Reasons for return. (1) The provider or supplier sent its paper Form CMS-855, Form CMS-588, or Form CMS-20134 application to the incorrect Medicare contractor for processing. (2) The Medicare contractor received the application more than 60 days prior to the effective date listed on the application. (This paragraph (a)(2) does not apply to providers and suppliers submitting a Form CMS-855A application, ambulatory surgical centers, or portable x-ray suppliers.) (3) The seller or buyer in a change of ownership submitted its Form CMS-855A or Form CMS-855B application more than 90 days prior to the anticipated date of the sale. (4) The Medicare contractor received an initial application more than 180 days prior to the effective date listed on the application from a provider or supplier submitting a Form CMS-855A application, an ambulatory surgical center, or a portable x-ray supplier. (5) The Medicare contractor confirms that the provider or supplier submitted an initial enrollment application prior to the expiration of the time period in which it is entitled to appeal the denial of its previously submitted application. (6) The provider or supplier submitted an initial enrollment application prior to the expiration of their existing re-enrollment bar under § 424.535 or reapplication bar under § 424.530(f). (7) The application is not needed for (or is inapplicable to) the transaction in question. (8) The provider or supplier submitted a revalidation application more than 7 months prior to the provider's or supplier's revalidation due date. (9) A Medicare Diabetes Prevention Program supplier submitted an application with a coach start date more than 30 days in the future. (10) The provider or supplier requests that their application be withdrawn prior to or during the Medicare contractor's processing thereof. (11) The provider or supplier submits an application that is an exact duplicate of an application that has already been processed or is currently being processed or is pending processing. (12) The provider or supplier submits a paper Form CMS-855 or Form CMS-20134 enrollment application that is outdated or has been superseded by a revised version. (13) The provider or supplier submits a Form CMS-855A or Form CMS-855B initial application followed by a Form CMS-855A or Form CMS-855B change of ownership application. If the Medicare contractor— (i) Has not yet made a recommendation for approval concerning the initial application, both applications may be returned. (ii) Has made a recommendation for approval concerning the initial application, the Medicare contractor may return the change of ownership application. If, per the Medicare contractor's written request, the provider or supplier fails to submit a new initial Form CMS-855A or Form CMS-855B application containing the new owner's information within 30 days of the date of the letter, the Medicare contractor may return the originally submitted initial Form CMS-855A or Form CMS-855B application. (b) Appeals. (c) Applicability. (1) Form CMS-855 initial applications, change of information requests, changes of ownership, revalidations, and reactivations. (2) Form CMS-588 submissions. (3) Form CMS-20134 submissions. (4) Any electronic or successor versions of the forms identified in paragraphs (c)(1) through (3) of this section. [86 FR 62420, Nov. 9, 2021] § 424.527 Provisional period of enhanced oversight. (a) New provider or supplier. (1) A newly enrolling Medicare provider or supplier. (This includes providers that are required to enroll as a new provider in accordance with the change in majority ownership provisions in § 424.550(b).) (2) A certified provider or certified supplier undergoing a change of ownership consistent with the principles of 42 CFR 489.18. (This includes providers that qualify under § 424.550(b)(2) for an exception from the change in majority ownership requirements in § 424.550(b)(1) but which are undergoing a change of ownership under 42 CFR 489.18). (3) A provider or supplier (including an HHA or hospice) undergoing a 100 percent change of ownership via a change of information request under § 424.516. (4) A provider or supplier reactivating the provider's or supplier's Medicare enrollment and billing privileges in accordance with § 424.540(b). (b) Effective date. [88 FR 77877, Nov. 13, 2023, as amended at 89 FR 88485, Nov. 7, 2024] § 424.530 Denial of enrollment in the Medicare program. (a) Reasons for denial. (1) Noncompliance. (2) Provider or supplier conduct. (A) Excluded from the Medicare, Medicaid, and any other Federal health care program, as defined in § 1001.2 of this chapter, in accordance with section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act. (B) Debarred, suspended, or otherwise excluded from participating in any other Federal procurement or nonprocurement activity in accordance with section 2455 of the Federal Acquisition Streamlining Act (FASA). (ii) The individuals and organizations identified in paragraph (a)(2)(i) of this section include, but are not limited to, W-2 employees and contracted individuals and organizations of the provider or supplier. (3) Felonies. (i) Offenses include, but are not limited in scope or severity to— (A) Felony crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions. (B) Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions. (C) Any felony that placed the Medicare program or its beneficiaries at immediate risk, such as a malpractice suit that results in a conviction of criminal neglect or misconduct. (D) Any felonies that would result in mandatory exclusion under section 1128(a) of the Act. (ii) Denials based on felony convictions are for a period to be determined by the Secretary, but not less than 10 years from the date of conviction if the individual has been convicted on one previous occasion for one or more offenses. (iii) The individuals and organizations identified in paragraph (a)(3) of this section include, but are not limited to, W-2 employees and contracted individuals and organizations of the provider or supplier. (4) False or misleading information. (5) On-site review. (i) Is not operational to furnish Medicare-covered items or services; or (ii) Otherwise fails to satisfy any Medicare enrollment requirement. (6) Medicare debt. (ii) The enrolling provider, supplier, or owner (as defined in § 424.502) thereof was previously the owner (as defined in § 424.502) of a provider or supplier that had a Medicare debt that existed when the latter's enrollment was voluntarily terminated, involuntarily terminated, or revoked, and all of the following criteria are met: (A) The owner left the provider or supplier with the Medicare debt within 1 year before or after that provider or supplier's voluntary termination, involuntary termination or revocation. (B) The Medicare debt has not been fully repaid. (C) CMS determines that the uncollected debt poses an undue risk of fraud, waste, or abuse. In making this determination, CMS considers the following factors: ( 1 ( 2 ( 3 ( 4 ( 5 (iii) A denial of Medicare enrollment under this paragraph (a)(6) can be avoided if the enrolling provider, supplier or owner thereof does either of the following: (A)( 1 ( 2 (B) Repays the debt in full. (7) Payment suspension. (ii) CMS may apply the provision in this paragraph (a)(7) to the provider or supplier under any of the provider's, supplier's, or owning or managing employee's or organization's current or former names, numerical identifiers, or business identities or to any of its existing enrollments. (iii) In determining whether a denial is appropriate, CMS considers the following factors: (A) The specific behavior in question. (B) Whether the provider or supplier is the subject of other similar investigations. (C) Any other information that CMS deems relevant to its determination. (8) Initial Reserve Operating Funds. (ii) CMS may deny Medicare billing privileges upon an HHA applicant's failure to satisfy the initial reserve operating funds requirement found in 42 CFR 489.28(a). (9) Application fee/hardship exception. (10) Temporary moratorium. (11) Prescribing authority. (ii) The applicable licensing or administrative body for any State in which a physician or eligible professional practices has suspended or revoked the physician or eligible professional's ability to prescribe one or more drugs, and such suspension or revocation is in effect on the date the physician or eligible professional submits his or her enrollment application to the Medicare contractor. (12) Revoked under different name, numerical identifier or business identity. (i) Owning and managing employees and organizations (regardless of whether they have been disclosed on the Form CMS-855 application). (ii) Geographic location. (iii) Provider or supplier type. (iv) Business structure. (v) Any evidence indicating that the two parties are similar or that the provider or supplier was created to circumvent the revocation or reenrollment bar. (13) Affiliation that poses undue risk. (14) Other program termination or suspension. (A) The reason(s) for the termination, suspension, or revocation. (B) Whether, as applicable, the provider or supplier is currently terminated or suspended (or otherwise barred) from more than one program (for example, more than one State's Medicaid program), has been subject to any other sanctions during its participation in other programs or by any other State licensing boards or has had any other final adverse actions (as that term is defined in § 424.502) imposed against it. (C) Any other information that CMS deems relevant to its determination. (ii) CMS may apply paragraph (a)(14)(i) of this section to the provider or supplier under any of its current or former names, numerical identifiers or business identities, and regardless of whether any appeals are pending. (15) Patient harm. (A) The nature of the patient harm. (B) The nature of the physician's or other eligible professional's conduct. (C) The number and type(s) of sanctions or disciplinary actions that have been imposed against the physician or other eligible professional by a State oversight board, IRO, Federal or State health care program, or any other equivalent governmental body or program that oversees, regulates, or administers the provision of health care. Such actions include, but are not limited to in scope or degree: ( 1 ( 2 ( 3 ( 4 ( 5 (D) If applicable, the nature of the IRO determination(s). (E) The number of patients impacted by the physician's or other eligible professional's conduct and the degree of harm thereto or impact upon. (ii) Paragraph (a)(15)(i) of this section does not apply to actions or orders pertaining exclusively to either of the following: (A) Required participation in rehabilitation or mental/behavioral health programs; or (B) Required abstinence from drugs or alcohol and random drug testing. (16) [Reserved] (17) False Claims Act (FCA). (ii) In determining whether a denial under this paragraph is appropriate, CMS considers the following factors: (A) The number of provider or supplier actions that the judgment incorporates (for example, the number of false claims submitted). (B) The types of provider or supplier actions involved. (C) The monetary amount of the judgment. (D) When the judgment occurred. (E) Whether the provider or supplier has any history of final adverse actions (as that term is defined in § 424.502 of this chapter). (F) Any other information that CMS deems relevant to its determination. (18) Supplier standard or condition violation. (ii) The DMEPOS supplier is non-compliant with any provision in § 424.57(c). (iii) The opioid treatment program is non-compliant with any provision in § 424.67(b). (iv) The home infusion therapy supplier is non-compliant with any provision in § 424.68(c). (v) The Medicare diabetes prevention program is non-compliant with any provision in § 424.205(b) or (c). (b) Resubmission after denial. (1) Was not appealed, the provider or supplier may reapply after its appeal rights have lapsed. (2) Was appealed, the provider or supplier may reapply after notification that the determination was upheld. (c) Reversal of denial. (d) Additional review. (e) Effective date of denial. (f) Reapplication bar. (1) The reapplication bar applies to the prospective provider or supplier under any of its current, former, or future names, numerical identifiers or business identities. (2) CMS determines the bar's length by considering the following factors: (i) The materiality of the information in question. (ii) Whether there is evidence to suggest that the provider or supplier purposely furnished false or misleading information or deliberately withheld information. (iii) Whether the provider or supplier has any history of final adverse actions or Medicare or Medicaid payment suspensions. (iv) Any other information that CMS deems relevant to its determination. (3)(i) A provider or supplier that is currently subject to a reapplication bar under paragraph (f) of this section may not order, refer, certify, or prescribe Medicare-covered services, items, or drugs. (ii) Medicare does not pay for any otherwise covered service, item, or drug that is ordered, referred, certified, or prescribed by a provider or supplier that is currently under a reapplication bar. [71 FR 20776, Apr. 21, 2006, as amended at 73 FR 69940, Nov. 19, 2008; 75 FR 70464, Nov. 17, 2010; 76 FR 5964, Feb. 2, 2011; 79 FR 29968, May 23, 2014; 79 FR 72531, Dec. 5, 2014; 84 FR 47853, Sept. 10, 2019; 84 FR 63203, Nov. 15, 2019; 86 FR 65682, Nov. 19, 2021; 87 FR 70231, Nov. 18, 2022; 88 FR 77878, Nov. 13, 2023; 88 FR 79541, Nov. 16, 2023; 90 FR 55617, Dec. 2, 2025] § 424.535 Revocation of enrollment in the Medicare program. (a) Reasons for revocation. (1) Noncompliance. (i) CMS may request additional documentation from the provider or supplier to determine compliance if adverse information is received or otherwise found concerning the provider or supplier. (ii) Requested additional documentation must be submitted within 60 calendar days of request. (2) Provider or supplier conduct. (A) Excluded from the Medicare, Medicaid, and any other Federal health care program, as defined in § 1001.2 of this chapter, in accordance with section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act. (B) Debarred, suspended, or otherwise excluded from participating in any other Federal procurement or nonprocurement activity in accordance with the FASA implementing regulations and the Department of Health and Human Services nonprocurement common rule at 45 CFR part 76. (ii) The individuals and organizations identified in paragraph (a)(2)(i) of this section include, but are not limited to, W-2 employees and contracted individuals and organizations of the provider or supplier. (3) Felonies. (i) The provider, supplier, or any owner, managing employee, managing organization, officer, or director of the provider or supplier was, within the preceding 10 years, convicted (as that term is defined in 42 CFR 1001.2) of a Federal or State felony offense that CMS determines is detrimental to the best interests of the Medicare program and its beneficiaries. (ii) Offenses include, but are not limited in scope or severity to— (A) Felony crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions. (B) Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, including guilty pleas and adjudicated pretrial diversions. (C) Any felony that placed the Medicare program or its beneficiaries at immediate risk, such as a malpractice suit that results in a conviction of criminal neglect or misconduct. (D) Any felonies that would result in mandatory exclusion under section 1128(a) of the Act. (iii) Revocations based on felony convictions are for a period to be determined by the Secretary, but not less than 10 years from the date of conviction if the individual has been convicted on one previous occasion for one or more offenses. (iv) The individuals and organizations identified in paragraph (a)(3) of this section include, but are not limited to, W-2 employees and contracted individuals and organizations of the provider or supplier. (4) False or misleading information. (5) On-site review. (i) No longer operational to furnish Medicare-covered items or services. (ii) Otherwise fails to satisfy any Medicare enrollment requirement. (6) Grounds related to provider and supplier screening requirements. (B) The hardship exception is not granted and the institutional provider does not submit the applicable application form or application fee within 30 days of being notified that the hardship exception request was denied. (ii)(A) Either of the following occurs: ( 1 ( 2 (B) The provider or supplier lacks sufficient funds in the account at the banking institution whose name is imprinted on the check or other banking instrument to pay the application fee; or (C) There is any other reason why CMS or its Medicare contractor is unable to deposit the application fee into a government-owned account. (7) Misuse of billing number. (8) Abuse of billing privileges. (i) The provider or supplier submits a claim or claims for services that could not have been furnished to a specific individual on the date of service. These instances include but are not limited to the following situations: (A) Where the beneficiary is deceased. (B) The directing physician or beneficiary is not in the state or country when services were furnished. (C) When the equipment necessary for testing is not present where the testing is said to have occurred. (D) The beneficiary attests that the item(s) or service(s) identified on the provider's or supplier's claim or claims was not or were not rendered or furnished. (ii) CMS determines that the provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements. In making this determination, CMS considers, as appropriate or applicable, the following: (A) The percentage of submitted claims that were denied during the period under consideration. (B) Whether the provider or supplier has any history of final adverse actions and the nature of any such actions. (C) The type of billing non-compliance and the specific facts surrounding said non-compliance (to the extent this can be determined). (D) Any other information regarding the provider or supplier's specific circumstances that CMS deems relevant to its determination. (iii) The effective date of a revocation under this paragraph (a)(8) is— (A) For revocations under paragraph (a)(8)(i) of this section, the earliest date of service on the claim or claims that is or are triggering the revocation; and (B) For revocations under paragraph (a)(8)(ii), the last date of service on the claims in question. (9) Failure to report. (i) Whether the data in question was reported. (ii) If the data was reported, how belatedly. (iii) The materiality of the data in question. (iv) Any other information that CMS deems relevant to its determination. (10) Failure to document or provide CMS access to documentation. (ii) A provider or supplier that meets the revocation criteria specified in paragraph (a)(10)(i) of this section, is subject to revocation for a period of not more than 1 year for each act of noncompliance. (11) Initial reserve operating funds. (12) Other program termination. (A) The reason(s) for the termination or revocation. (B) Whether the provider or supplier is currently terminated, revoked or otherwise barred from more than one program (for example, more than one State's Medicaid program) or has been subject to any other sanctions during its participation in other programs. (C) Any other information that CMS deems relevant to its determination. (ii) Medicare may not revoke unless and until a provider or supplier has exhausted all applicable appeal rights or the timeframe for filing an appeal has expired without the provider or supplier filing an appeal. (iii) CMS may apply paragraph (a)(12)(i) of this section to the provider or supplier under any of its current or former names, numerical identifiers or business identities. (13) Prescribing authority. (ii) The applicable licensing or administrative body for any state in which the physician or eligible professional practices suspends or revokes the physician or eligible professional's ability to prescribe one or more drugs. (14) Improper prescribing practices. (i) The pattern or practice is abusive or represents a threat to the health and safety of Medicare beneficiaries or both. In making this determination, CMS considers the following factors: (A) Whether there are diagnoses to support the indications for which the drugs were prescribed. (B) Whether there are instances when the necessary evaluation of the patient for whom the drug was prescribed could not have occurred (for example, the patient was deceased or out of state at the time of the alleged office visit). (C) Whether the physician or eligible professional has prescribed controlled substances in excessive dosages that are linked to patient overdoses. (D) The number and type(s) of disciplinary actions taken against the physician or eligible professional by the licensing body or medical board for the State or States in which he or she practices, and the reason(s) for the action(s). (E) Whether the physician or eligible professional has any history of “final adverse actions” (as that term is defined in § 424.502). (F) The number and type(s) of malpractice suits that have been filed against the physician or eligible professional related to prescribing that have resulted in a final judgment against the physician or eligible professional or in which the physician or eligible professional has paid a settlement to the plaintiff(s) (to the extent this can be determined). (G) Whether any State Medicaid program or any other public or private health insurance program has restricted, suspended, revoked, or terminated the physician or eligible professional's ability to prescribe medications, and the reason(s) for any such restriction, suspension, revocation, or termination. (H) Any other relevant information provided to CMS. (ii) The pattern or practice of prescribing fails to meet Medicare requirements. In making this determination, CMS considers the following factors: (A) Whether the physician or eligible professional has a pattern or practice of prescribing without valid prescribing authority. (B) Whether the physician or eligible professional has a pattern or practice of prescribing for controlled substances outside the scope of the prescriber's DEA registration. (C) Whether the physician or eligible professional has a pattern or practice of prescribing drugs for indications that were not medically accepted—that is, for indications neither approved by the FDA nor medically accepted under section 1860D-2(e)(4) of the Act—and whether there is evidence that the physician or eligible professional acted in reckless disregard for the health and safety of the patient. (15) False Claims Act (FCA). (ii) In determining whether a revocation under this paragraph is appropriate, CMS considers the following factors: (A) The number of provider or supplier actions that the judgment incorporates (for example, the number of false claims submitted). (B) The types of provider or supplier actions involved. (C) The monetary amount of the judgment. (D) When the judgment occurred. (E) Whether the provider or supplier has any history of final adverse actions (as that term is defined in § 424.502). (F) Any other information that CMS deems relevant to its determination. (16) [Reserved] (17) Debt referred to the United States Department of Treasury. (A) The reason(s) for the failure to fully repay the debt (to the extent this can be determined). (B) Whether the provider or supplier has attempted to repay the debt (to the extent this can be determined). (C) Whether the provider or supplier has responded to CMS' requests for payment (to the extent this can be determined). (D) Whether the provider or supplier has any history of final adverse actions or Medicare or Medicaid payment suspensions. (E) The amount of the debt. (F) Any other evidence that CMS deems relevant to its determination. (ii) Paragraph (17)(i) of this paragraph does not apply to the following situations: (A) The provider's or supplier's Medicare debt has been discharged by a bankruptcy court; or (B) The administrative appeals process concerning the debt has not been exhausted or the timeframe for filing such an appeal (at the appropriate level of appeal) has not expired. (18) Revoked under different name, numerical identifier or business identity. (i) Owning and managing employees and organizations (regardless of whether they have been disclosed on the Form CMS-855 application). (ii) Geographic location. (iii) Provider or supplier type. (iv) Business structure. (v) Any evidence indicating that the two parties are similar or that the provider or supplier was created to circumvent the revocation or reenrollment bar. (19) Affiliation that poses an undue risk. (20) Billing from non-compliant location. (i) The reason(s) for and the specific facts behind the location's non-compliance. (ii) The number of additional locations involved. (iii) Whether the provider or supplier has any history of final adverse actions or Medicare or Medicaid payment suspensions. (iv) The degree of risk that the location's continuance poses to the Medicare Trust Funds. (v) The length of time that the non-compliant location was non-compliant. (vi) The amount that was billed for services performed at or items furnished from the non-compliant location. (vii) Any other evidence that CMS deems relevant to its determination. (21) Abusive ordering, certifying, referring, or prescribing of Part A or B services, items or drugs. (i) Whether the physician's or eligible professional's diagnoses support the orders, certifications, referrals or prescriptions in question. (ii) Whether there are instances where the necessary evaluation of the patient for whom the service, item or drug was ordered, certified, referred, or prescribed could not have occurred (for example, the patient was deceased or out of state at the time of the alleged office visit). (iii) The number and type(s) of disciplinary actions taken against the physician or eligible professional by the licensing body or medical board for the state or states in which he or she practices, and the reason(s) for the action(s). (iv) Whether the physician or eligible professional has any history of final adverse actions (as that term is defined in § 424.502). (v) The length of time over which the pattern or practice has continued. (vi) How long the physician or eligible professional has been enrolled in Medicare. (vii) The number and type(s) of malpractice suits that have been filed against the physician or eligible professional related to ordering, certifying, referring or prescribing that have resulted in a final judgment against the physician or eligible professional or in which the physician or eligible professional has paid a settlement to the plaintiff(s) (to the extent this can be determined). (viii) Whether any State Medicaid program or any other public or private health insurance program has restricted, suspended, revoked, or terminated the physician's or eligible professional's ability to practice medicine, and the reason(s) for any such restriction, suspension, revocation, or termination. (ix) Any other information that CMS deems relevant to its determination. (22) Patient harm. (A) The nature of the patient harm. (B) The nature of the physician's or other eligible professional's conduct. (C) The number and type(s) of sanctions or disciplinary actions that have been imposed against the physician or other eligible professional by the State oversight board, IRO, Federal or State health care program, or any other equivalent governmental body or program that oversees, regulates, or administers the provision of health care. Such actions include, but are not limited to in scope or degree: ( 1 ( 2 ( 3 ( 4 ( 5 (D) If applicable, the nature of the IRO determination(s). (E) The number of patients impacted by the physician's or other eligible professional's conduct and the degree of harm thereto or impact upon. (ii) Paragraph (a)(22)(i) of this section does not apply to actions or orders pertaining exclusively to either of the following: (A) Required participation in rehabilitation or mental/behavioral health programs; or (B) Required abstinence from drugs or alcohol and random drug testing. (23) Supplier standard or condition violation. (ii) The DMEPOS supplier is non-compliant with any provision in § 424.57(c). (iii) The opioid treatment program is non-compliant with any provision in § 424.67(b) or (e). (iv) The home infusion therapy supplier is non-compliant with any provision in § 424.68(c) or (e). (v) The Medicare diabetes prevention program is non-compliant with any provision in § 424.205(b) or (c). (b) Effect of revocation on provider agreements. (c) Reapplying after revocation. (i) Begins 30 days after CMS or its contractor mails notice of the revocation and lasts a minimum of 1 year, but not greater than 10 years (except for the situations described in paragraphs (c)(2) and (3) of this section), depending on the severity of the basis for revocation. (ii) Does not apply in the event a revocation of Medicare enrollment is imposed under paragraph (a)(1) of this section based upon a provider's or supplier's failure to respond timely to a revalidation request or other request for information. (2)(i) CMS may add up to 3 more years to the provider's or supplier's reenrollment bar (even if such period exceeds the 10-year period identified in paragraph (c)(1) of this section) if it determines that the provider or supplier is attempting to circumvent its existing reenrollment bar by enrolling in Medicare under a different name, numerical identifier or business identity. (ii) A provider's or supplier's appeal rights regarding paragraph (c)(2)(i) of this section— (A) Are governed by part 498 of this chapter; and (B) Do not extend to the imposition of the original reenrollment bar under paragraph (c)(1) of this section; and (C) Are limited to any additional years imposed under paragraph (c)(2)(i) of this section. (3) CMS may impose a reenrollment bar of up to 20 years on a provider or supplier if the provider or supplier is being revoked from Medicare for the second time. In determining the length of the reenrollment bar under this paragraph (c)(3), CMS considers the following factors: (i) The reasons for the revocations. (ii) The length of time between the revocations. (iii) Whether the provider or supplier has any history of final adverse actions (other than Medicare revocations) or Medicare or Medicaid payment suspensions. (iv) Any other information that CMS deems relevant to its determination. (4) A reenrollment bar applies to a provider or supplier under any of its current, former or future names, numerical identifiers or business identities. (d) Re-enrollment after revocation. (1) The provider or supplier must re-enroll in the Medicare program through the completion and submission of a new applicable enrollment application and applicable documentation, as a new provider or supplier, for validation by CMS. (2) Providers must be resurveyed and recertified by the State survey agency as a new provider and must establish a new provider agreement with CMS's Regional Office. (e) Reversal of revocation. (f) Additional review. (g) Effective date of revocation. (2) Except as described in paragraph (g)(3) of this section, the revocation effective dates in the situations identified in this paragraph (g)(2) are as follows: (i) For revocations based on a Federal exclusion or debarment, the date of the exclusion or debarment. (ii) For revocations based on a felony conviction, the date of the felony conviction. (iii) For revocations based on a State license suspension or revocation, the date of the license suspension or revocation. (iv) For revocations based on a CMS determination that the provider's or supplier's practice location is non-operational, the date on which the provider's or supplier's practice location was no longer operational (per CMS' or the CMS contractor's determination). (v) For revocations based on a State license surrender in lieu of further disciplinary action, the date of the license surrender. (vi) For revocations based on termination from a Federal health care program other than Medicare (for example, Medicaid), the date of the termination. (vii) For revocations based on termination of a provider agreement under part 489 of this chapter, and as applicable to the type of provider involved, the later of the following: (A) The date of the provider agreement termination; or (B) The date that CMS establishes under § 489.55. (viii) For revocations based on a lapse in the IDTF's comprehensive liability insurance under § 410.33(g)(6) of this chapter, the date the insurance lapsed. (ix) For revocations based on the provider's or supplier's submission of false or misleading information on the enrollment application, the date the application's certification statement was signed. (x) For revocations based on the provider's or supplier's failure to timely report a change of ownership or adverse legal action, or a change, addition, or deletion of a practice location, the day after the date by which the provider or supplier was required to report the change, addition, or deletion. (xi) For revocations based on the surrender of the provider's or supplier's provider's Drug Enforcement Administration certificate of registration in response to a show cause order, the date the certificate was surrendered. (xii) For revocations based on a State's suspension or revocation of the physician's or practitioner's ability to prescribe one or more drugs, the date of the suspension or revocation. (xiii) For revocations of any of the provider's or supplier's other enrollments under paragraph (i) of this section, the effective date of the revocation that triggered the revocation(s) of the other enrollment(s). (xiv) For revocations based on a DMEPOS supplier's non-compliance with a condition or standard in § 424.57(b) or (c), respectively, the date on which the non-compliance began. (xv) For revocations based on § 424.535(a)(23), the effective dates are as follows: (A) If the standard or condition violation involves the suspension, revocation, or termination (or surrender in lieu of further disciplinary action) of the provider's or supplier's Federal or State license, certification, accreditation, or MDPP recognition, the effective date is the date of the license, certification, accreditation, or MDPP recognition suspension, revocation, termination, or surrender. (B) If the standard or condition violation involves a non-operational practice location, the effective date is the date the non-operational status began. (C) If the standard violation involves a felony conviction of an individual or entity described in § 424.67(b)(6)(i), the effective date is the date of the felony conviction. (D) For all standard violations not addressed in this paragraph (g)(2), the effective date in paragraph (g)(1) of this section applies if the effective date in paragraph (g)(3) of this section does not. (3) If the action that resulted in the revocation occurred prior to the effective date of the provider's or supplier's enrollment, the effective date of the revocation is the same as the effective date of enrollment. (h) Submission of claims for services furnished before revocation. (ii) A revoked HHA must submit all claims for items and services within 60 days after the later of the following: (A) The effective date of the revocation. (B) The date that the HHA's last payable episode ends. (2) Nothing in this paragraph (h) impacts the requirements of § 424.44 regarding the timely filing of claims. (i) Extension of revocation. (2) In determining whether to revoke a provider's or supplier's other enrollments under this paragraph (i), CMS considers the following factors: (i) The reason for the revocation and the facts of the case. (ii) Whether any final adverse actions have been imposed against the provider or supplier regarding its other enrollments. (iii) The number and type(s) of other enrollments. (iv) Any other information that CMS deems relevant to its determination. (j) Voluntary termination. (i) Whether there is evidence to suggest that the provider knew or should have known that it was or would be out of compliance with Medicare requirements. (ii) Whether there is evidence to suggest that the provider knew or should have known that its Medicare enrollment would be revoked. (iii) Whether there is evidence to suggest that the provider voluntarily terminated its Medicare enrollment in order to circumvent such revocation. (iv) Any other evidence or information that CMS deems relevant to its determination. (2) A revocation under paragraph (j)(1) of this section is effective the day before the Medicare contractor receives the provider's or supplier's Form CMS-855 voluntary termination application. [71 FR 20776, Apr. 21, 2006, as amended at 72 FR 53648, Sept. 19, 2007; 73 FR 36461, June 27, 2008; 73 FR 69940, Nov. 19, 2008; 75 FR 24449, May 5, 2010; 75 FR 70465, Nov. 17, 2010; 76 FR 5964, Feb. 2, 2011; 77 FR 25318, Apr. 27, 2012; 77 FR 29030, May 16, 2012; 79 FR 29968, May 23, 2014; 79 FR 72532, Dec. 5, 2014; 84 FR 47854, Sept. 10, 2019; 84 FR 63204, Nov. 15, 2019; 86 FR 65682, Nov. 19, 2021; 87 FR 70232, Nov. 18, 2022; 88 FR 79541, Nov. 16, 2023; 90 FR 55618, Dec. 2, 2025] § 424.540 Deactivation of Medicare billing privileges. (a) Reasons for deactivation. (1) The provider or supplier does not submit any Medicare claims for 6 consecutive calendar months. The 6 month period will begin the 1st day of the 1st month without a claims submission through the last day of the 6th month without a submitted claim. (2) The provider or supplier does not report a change to the information supplied on the enrollment application within the applicable time period required under this title. (3) The provider or supplier does not furnish complete and accurate information and all supporting documentation within 90 calendar days of receipt of notification from CMS to submit an enrollment application and supporting documentation, or resubmit and certify to the accuracy of its enrollment information. (4) The provider or supplier is not in compliance with all enrollment requirements in this title. (5) The provider's or supplier's practice location is non-operational or otherwise invalid. (6) The provider or supplier is deceased. (7) The provider or supplier is voluntarily withdrawing from Medicare. (8) The provider is the seller in an HHA, hospice, or DMEPOS supplier change of ownership under § 424.550(b)(1). (b) Reactivation of billing privileges. (1) In order for a deactivated provider or supplier to reactivate its Medicare billing privileges, the provider or supplier must recertify that its enrollment information currently on file with Medicare is correct, furnish any missing information as appropriate, and be in compliance with all applicable enrollment requirements in this title. (2) Notwithstanding paragraph (b)(1) of this section, CMS may, for any reason, require a deactivated provider or supplier to, as a prerequisite for reactivating its billing privileges, submit a complete Form CMS-855 application. (3) Except as provided in paragraph (b)(3)(i) of this section, reactivation of Medicare billing privileges does not require a new certification of the provider or supplier by the State survey agency or the establishment of a new provider agreement. (i) An HHA whose Medicare billing privileges are deactivated under the provisions found at paragraph (a) of this section must obtain an initial State survey or accreditation by an approved accreditation organization before its Medicare billing privileges can be reactivated. (ii) [Reserved] (c) Effect of deactivation. (d) Effective dates. (ii) A retroactive deactivation effective date (based on the date that the provider's or supplier's action or non-compliance occurred or commenced (as applicable)) may be imposed in the following instances: (A) For the deactivation reasons in paragraphs (a)(2) through (4) of this section, the effective date is the date on which the provider or supplier became non-compliant. (B) For the deactivation reason in paragraph (a)(5) of this section, the effective date is the date on which the provider's or supplier's practice location became non-operational or otherwise invalid. (C) For the deactivation reason in paragraph (a)(6) of this section, the effective date is the date of death of the provider or supplier. (D) For the deactivation reason in paragraph (a)(7) of this section, the effective date is the date on which the provider or supplier voluntarily withdrew from Medicare. (E) For the deactivation reason in paragraph (a)(8) of this section, the effective date is the date of the sale. (2) The effective date of a reactivation of billing privileges under this section is the date on which the Medicare contractor received the provider's or supplier's reactivation submission that was processed to approval by the Medicare contractor. (e) Payment prohibition. [71 FR 20776, Apr. 21, 2006, as amended at 74 FR 58134, Nov. 10, 2009; 77 FR 29030, May 16, 2012; 84 FR 47856, Sept. 10, 2019; 86 FR 62420, Nov. 9, 2021; 88 FR 77878, Nov. 13, 2023; 90 FR 55618, Dec. 2, 2025] § 424.541 Stay of enrollment. (a)(1) CMS may stay an enrolled provider's or supplier's enrollment if the provider or supplier: (i) Is non-compliant with at least one enrollment requirement in this title. (This includes situations where its change of information or revalidation application was rejected under § 424.525(a)(1) or (2).) (ii) Can remedy the non-compliance via the submission of, as applicable to the situation, a Form CMS-855, Form CMS-20134, or Form CMS-588 change of information or revalidation application. (2) During the period of any stay imposed under this section, the following apply: (i) The provider or supplier remains enrolled in Medicare; (ii)(A) Except as stated in paragraph (a)(2)(ii)(B) of this section, claims submitted by the provider or supplier with dates of service within the stay period will be rejected. (B) Notwithstanding paragraph (a)(2)(ii)(A), claims submitted by the provider or supplier with dates of service within the stay period are eligible for payment (and may be resubmitted by the provider or supplier within applicable timeframes specified in Title 42) if: ( 1 ( 2 (3)(i) The effective date of a stay of enrollment is, as applicable— (A) The date on which the provider's or supplier's non-compliance began; or (B) The date on which the provider's or supplier's change of information or revalidation application was rejected under § 424.525. (ii) CMS may establish a stay of enrollment for any period up to a maximum of 60 days. (4) CMS notifies the affected provider or supplier in writing of the imposition of the stay. (5) A stay of enrollment ends on the date on which CMS or its contractor determines that the provider or supplier has resumed compliance with all Medicare enrollment requirements in this title or the day after the CMS-assigned stay period expires, whichever occurs first. (b)(1) If a provider or supplier receives written notice from CMS or its contractor that the provider or supplier is subject to a stay under this section, the provider or supplier has 15 calendar days from the date of the written notice to submit a rebuttal to the stay as described in paragraph (b) of this section. (2) CMS may, at its discretion, extend the 15-day time-period referenced in paragraph (b)(1) of this section. (3) Any rebuttal submitted pursuant to paragraph (b) of this section must: (i) Be in writing. (ii) Specify the facts or issues about which the provider or supplier disagrees with the stay's imposition and/or the effective date, and the reasons for disagreement. (iii) Submit all documentation the provider or supplier wants CMS to consider in its review of the stay. (iv) Be submitted in the form of a letter that is signed and dated by the individual supplier (if enrolled as an individual physician or nonphysician practitioner), the authorized official or delegated official (as those terms are defined in § 424.502), or a legal representative (as defined in 42 CFR 498.10). If the legal representative is an attorney, the attorney must include a statement that he or she has the authority to represent the provider or supplier; this statement is sufficient to constitute notice of such authority. If the legal representative is not an attorney, the provider or supplier must file with CMS written notice of the appointment of a representative; this notice of appointment must be signed and dated by, as applicable, the individual supplier, the authorized official or delegated official, or a legal representative. (4) The provider's or supplier's failure to submit a rebuttal that is both timely under paragraph (b)(1) of this section and fully compliant with all of the requirements of paragraph (b)(3) of this section constitutes a waiver of all rebuttal rights under this section. (5) Upon receipt of a timely and compliant stay rebuttal, CMS reviews the rebuttal to determine whether the imposition of the stay and/or the effective date thereof are correct. (6) A determination made under paragraph (b) of this section is not an initial determination under 42 CFR 498.3(b) and therefore not appealable. (7) Nothing in paragraph (b) of this section requires CMS to delay the imposition of a stay pending the completion of the review described in paragraph (b)(5) of this section. (8)(i) Nothing in paragraph (b) of this section requires CMS to delay the imposition of a deactivation or revocation, pending the completion of the review described in paragraph (b)(5) of this section. (ii)(A) If CMS deactivates the provider or supplier during the stay, any rebuttal to the stay that the provider or supplier submits that meets the requirements of paragraph (b) of this section is combined and considered with the provider's or supplier's rebuttal to the deactivation under § 424.546 if CMS has not yet made a determination on the stay rebuttal pursuant to this section. (B) In all cases other than that described in paragraph (b)(8)(ii)(A) of this section, a stay rebuttal that was submitted in compliance with the requirements of paragraph (b) of this section is considered separately and independently of any review of any other rebuttal or, for revocations, appeal under 42 CFR part 498. [88 FR 79542, Nov. 16, 2023, as amended at 89 FR 9784, Feb. 12, 2024; 90 FR 55618, Dec. 2, 2025] § 424.542 Prohibition on ordering, certifying, referring, or prescribing based on felony conviction. (a) General prohibition. (b) Payment. [88 FR 77878, Nov. 13, 2023] § 424.545 Provider and supplier appeal rights. (a) General. (1) Appeals resulting in the termination of a provider agreement. (ii) When a provider appeals the revocation of billing privileges and the termination of its provider agreement, there will be one appeals process which will address both matters. The appeal procedures for revocation of Medicare billing privileges will apply. (2) Payment of unpaid claims. (b) A provider or supplier whose billing privileges are deactivated may file a rebuttal in accordance with § 424.546 of this chapter. (c) The provider or supplier must be able to demonstrate that it meets the enrollment requirements and it must be able to make available any documents and records that support the provisions of this regulation and the Medicare enrollment application if requested by CMS or its agents. [71 FR 20776, Apr. 21, 2006, as amended at 73 FR 36461, June 27, 2008; 86 FR 65683, Nov. 19, 2021] § 424.546 Deactivation rebuttals. (a) Rebuttal submittal period (2) CMS may, at its discretion, extend the 15-day time-period referenced in paragraph (a)(1) of this section. (b) Rebuttal requirements (1) Be in writing. (2) Specify the facts or issues about which the provider or supplier disagrees with the deactivation's imposition and/or the effective date, and the reasons for disagreement. (3) Submit all documentation the provider or supplier wants CMS to consider in its review of the deactivation. (4) Be submitted in the form of a letter that is signed and dated by the individual supplier (if enrolled as an individual physician or nonphysician practitioner), the authorized official or delegated official (as those terms are defined in 42 CFR 424.502), or a legal representative (as defined in 42 CFR 498.10). If the legal representative is an attorney, the attorney must include a statement that he or she has the authority to represent the provider or supplier; this statement is sufficient to constitute notice of such authority. If the legal representative is not an attorney, the provider or supplier must file with CMS written notice of the appointment of a representative; this notice of appointment must be signed and dated by, as applicable, the individual supplier, the authorized official or delegated official, or a legal representative. (c) Waiver of rebuttal rights (d) CMS review (e) Imposition (f) Initial determination [86 FR 65683, Nov. 19, 2021] § 424.547 Deactivation based on ordering, certifying, or referring services and items. (a)(1) CMS may deactivate a physician's or practitioner's ability to order, certify, or refer the Medicare services and items identified in § 424.507(a) and (b) if the individual: (i) Is enrolled via the Form CMS-855O application solely to order, certify, or refer Medicare services or items; and (ii) Has not been listed as the ordering, certifying, or referring individual on a Medicare Part A or B claim received in the previous 12 consecutive months. (2) For purposes of this section only, the term deactivate (b)(1) For a deactivated physician or practitioner to reactivate an ability to order, certify, or refer Medicare services and items, the individual must recertify that the enrollment information currently on file with Medicare is correct, furnish any missing information as appropriate, and be in compliance with all applicable enrollment requirements in this title. (2) Notwithstanding paragraph (b)(1) of this section, CMS may, for any reason, require a deactivated physician or practitioner to, as a prerequisite for reactivating the ability to order, certify, or refer, submit a complete Form CMS-855O application. (c) The effective date of a reactivation of an ability to order, certify, or refer Medicare services and items under this section is the date on which the Medicare contractor received the individual's reactivation submission that was processed to approval. (d) A physician or practitioner may not order, certify, or refer the Medicare services or items described in § 424.507(a) and (b) while deactivated under this section. [90 FR 55618, Dec. 2, 2025] § 424.550 Prohibitions on the sale or transfer of billing privileges. (a) General rule. (b) Change of ownership. (1) Unless an exception in paragraph (b)(2) of this section applies, if there is a change in majority ownership of a home health agency (HHA) or hospice by sale (including asset sales, stock transfers, mergers, and consolidations) within 36 months after the effective date of the HHA's or hospice's initial enrollment in Medicare or within 36 months after the HHA's or hospice's most recent change in majority ownership, the provider agreement and Medicare billing privileges do not convey to the new owner. The prospective provider/owner of the HHA or hospice must instead do both of the following: (i) Enroll in the Medicare program as a new (initial) HHA or hospice under the provisions of § 424.510 of this subpart. (ii) Obtain a State survey or an accreditation from an approved accreditation organization. (2)(i) The HHA or hospice submitted 2 consecutive years of full cost reports since initial enrollment or the last change in majority ownership, whichever is later. For purposes of the exception in this paragraph (b)(2)(i), low utilization or no utilization cost reports do not qualify as full cost reports. (ii) An HHA's or hospice's parent company is undergoing an internal corporate restructuring, such as a merger or consolidation. (iii) The owners of an existing HHA or hospice are changing the HHA's or hospice's existing business structure (for example, from a corporation to a partnership (general or limited); from an LLC to a corporation; from a partnership (general or limited) to an LLC) and the owners remain the same. (iv) An individual owner of an HHA or hospice dies. (c) Suppliers not covered by part 489 of this chapter. [71 FR 20776, Apr. 21, 2006, as amended at 74 FR 58134, Nov. 10, 2009; 75 FR 70465, Nov. 17, 2010; 75 FR 76293, Dec. 8, 2010; 86 FR 62421, Nov. 9, 2021; 88 FR 77878, Nov. 13, 2023] § 424.551 DMEPOS supplier changes in majority ownership. (a) Definition. change in majority ownership (b) General principle. (1) Enroll in the Medicare program as a new DMEPOS supplier under the provisions of § 424.510. (2) Undergo a survey by, and obtain a new accreditation from, a CMS-approved DMEPOS accrediting organization in accordance with §§ 424.57 and 424.58. (c) Exceptions. (1) A DMEPOS supplier's parent company is undergoing an internal corporate restructuring, such as a merger or consolidation. (2) The owners of the existing DMEPOS supplier are changing the DMEPOS supplier's current business structure (for example, from a corporation to a partnership (general or limited); from a limited liability company (LLC) to a corporation; or from a general or limited to an LLC) and the owners remain the same. (3) An individual owner of the DMEPOS supplier dies. [90 FR 55618, Dec. 2, 2025] § 424.555 Payment liability. (a) No payment may be made for otherwise Medicare covered items or services furnished to a Medicare beneficiary by suppliers of durable medical equipment, prosthetics, orthotics, and other supplies unless the supplier obtains (and renews, as set forth in section 1834(j) of the Act) Medicare billing privileges. (b) No payment may be made for otherwise Medicare covered items or services furnished to a Medicare beneficiary by a provider or supplier if the billing privileges of the provider or supplier are deactivated, denied, or revoked, or if the provider or supplier is currently under a stay of enrollment (except as stated in § 424.541(a)(2)(ii)(B)). The Medicare beneficiary has no financial responsibility for expenses, and the provider or supplier must refund on a timely basis to the Medicare beneficiary any amounts collected from the Medicare beneficiary for these otherwise Medicare covered items or services. (c) If any provider or supplier furnishes an otherwise Medicare covered item or service for which payment may not be made by reason of paragraph (b) of this section, any expense incurred for such otherwise Medicare covered item or service shall be the responsibility of the provider or supplier. The provider or supplier may also be criminally liable for pursuing payments that may not be made by reason of paragraph (b) of this section, in accordance with section 1128B(a)(3) of the Act. [71 FR 20776, Apr. 21, 2006, as amended at 88 FR 79543, Nov. 16, 2023] § 424.565 Overpayment. A physician or nonphysician practitioner organization, physician or nonphysician practitioner that does not comply with the reporting requirements specified in § 424.516(d)(1)(ii) and (iii) of this subpart is assessed an overpayment back to the date of the final adverse action or change in practice location. Overpayments are processed in accordance with part 405 subpart C of this chapter. [73 FR 69941, Nov. 19, 2008] § 424.570 Moratoria on newly enrolling Medicare providers and suppliers. (a) Temporary moratoria General rules. (ii) CMS will announce the temporary enrollment moratorium in a Federal Register (iii) The temporary moratorium does not apply to any of the following: (A) Changes in practice location (except if the location is changing from a location outside the moratorium area to a location inside the moratorium area). (B) Changes in provider or supplier information, such as phone numbers. (C) Changes in ownership (except changes in ownership of home health agencies that would require an initial enrollment). (iv) A temporary moratorium does not apply to any enrollment application that has been received by the Medicare contractor prior to the date the moratorium is imposed. (2) Imposition of a temporary moratoria. (i) CMS determines that there is a significant potential for fraud, waste or abuse with respect to a particular provider or supplier type or particular geographic area or both. CMS's determination is based on its review of existing data, and without limitation, identifies a trend that appears to be associated with a high risk of fraud, waste or abuse, such as a— (A) Highly disproportionate number of providers or suppliers in a category relative to the number of beneficiaries; or (B) Rapid increase in enrollment applications within a category; (ii) A State Medicaid program has imposed a moratorium on a group of Medicaid providers or suppliers that are also eligible to enroll in the Medicare program; (iii) A State has imposed a moratorium on enrollment in a particular geographic area or on a particular provider or supplier type or both; or (iv) CMS, in consultation the HHS OIG or the Department of Justice or both and with the approval of the CMS Administrator identifies either or both of the following as having a significant potential for fraud, waste or abuse in the Medicare program: (A) A particular provider or supplier type. (B) Any particular geographic area. (b) Duration of moratoria. Federal Register (c) Denial of enrollment: Moratoria. (d) Lifting moratoria. Federal Register (1) The President declares an area a disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (Stafford Act). (2) Circumstances warranting the imposition of a moratorium have abated or CMS has implemented program safeguards to address the program vulnerability. (3) The Secretary has declared a public health emergency under section 319 of the Public Health Service Act in the area subject to a temporary moratorium. (4) In the judgment of the Secretary, the moratorium is no longer needed. [76 FR 5965, Feb. 2, 2011, as amended at 84 FR 47856, Sept. 10, 2019] § 424.575 Rural emergency hospitals. (a) A rural emergency hospital (as defined in § 485.502 of this chapter) must comply with all applicable provisions in this subpart in order to enroll and maintain enrollment in Medicare. (b) A provider that was enrolled in Medicare as of December 27, 2020, as a critical access hospital or a hospital (as defined in section 1886(d)(1)(B) of the Social Security Act) with not more than 50 beds located in a county (or equivalent unit of local government) in a rural area (as defined in section 1886(d)(2)(D) of the Social Security Act) (or treated as being located in a rural area pursuant to section 1886(d)(8)(E) of the Social Security Act) converts its existing enrollment to that of a rural emergency hospital (as defined in § 485.502 of this chapter) via a Form CMS-855A change of information application per § 424.516 rather than a Form CMS-855A initial enrollment application. [87 FR 72293, Nov. 23, 2022]

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