PART 476—QUALITY IMPROVEMENT ORGANIZATION REVIEW Authority: 42 U.S.C. 1302 and 1395hh. Source: 44 FR 32081, June 4, 1979, unless otherwise noted. Redesignated at 64 FR 66279, Nov. 24, 1999. Subpart A—General Provisions § 476.1 Definitions. As used in this part, unless the context indicates otherwise: Admission review Appointed representative Authorized representative Beneficiary complaint Beneficiary complaint review Beneficiary representative Continued stay review Criteria Diagnosis related group (DRG) DRG validation Elective, Five percent or more owner (1) Has an ownership interest of 5 percent or more; (2) Has an indirect ownership interest equal to 5 percent or more; (3) Has a combination of direct and indirect ownership interests (the possession of equity in the capital, the stock, or the profits of an entity) equal to five percent or more; or (4) Is the owner of an interest of five percent or more in any obligation secured by an entity, if the interest equals at least five percent of the value of the property or assets of the entity. General quality of care review Gross and flagrant violation Health care facility facility Health care practitioners other than physicians Hospital Immediate advocacy Initial denial determination Major clinical area Major procedure Non-facility organization Norm Norms Outliers Peer review Physician (1) A doctor or medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatry, a doctor of optometry, or a chiropractor, as described in section 1861(r) of the Act; (2) An intern, resident, or Federal Government employee authorized under State or Federal law to practice as a doctor as described in paragraph (1) of this definition; and (3) An individual licensed to practice as a doctor as described in paragraph (1) of this definition in any Territory or Commonwealth of the United States of America. Practitioner Preadmission certification Preadmission review Preprocedure review Provider QIO review Quality improvement initiative Quality of care concern Quality of care review Profile Profile analysis Quality review study Regional norms, criteria, and standards Retrospective review Review responsibility Significant quality of care concern Skilled nursing facility (SNF) Standards Subcontractor Substantial violation in a substantial number of cases Working day [44 FR 32081, June 4, 1979, as amended at 45 FR 67545, Oct. 10, 1980; 46 FR 48569, Oct. 1, 1981. Redesignated and amended at 50 FR 15328, 15329, Apr. 17, 1985; 51 FR 43197, Dec. 1, 1986. Redesignated at 64 FR 66279, Nov. 24, 1999, as amended at 64 FR 67052, Nov. 30, 1999; 77 FR 53682, Aug. 31, 2012; 77 FR 68559, Nov. 15, 2012; 78 FR 75199, Dec. 10, 2013] Subpart B [Reserved] Subpart C—Review Responsibilities of Quality Improvement Organizations (QIOs) Source: 50 FR 15330, Apr. 17, 1985, unless otherwise noted. Redesignated at 64 FR 66279, Nov. 24, 1999. General Provisions § 476.70 Statutory bases and applicability. (a) Statutory bases. (b) Applicability. [77 FR 68560, Nov. 15, 2012] § 476.71 QIO review requirements. (a) Scope of QIO review. (1) Whether the services are or were reasonable and medically necessary for the diagnosis and treatment of illness or injury or to improve functioning of a malformed body member, or (with respect to pneumococcal vaccine) for prevention of illness or (in the case of hospice care) for the palliation and management of terminal illness; (2) Whether the quality of the services meets professionally recognized standards of health care, as determined through the resolution of oral beneficiary complaints as specified in § 476.110, written beneficiary complaints as specified in § 476.120, or the completion of general quality of care reviews as specified in § 476.160. (3) Whether those services furnished or proposed to be furnished on an inpatient basis could, consistent with the provisions of appropriate medical care, be effectively furnished more economically on an outpatient basis or in an inpatient health care facility of a different type; (4) Through DRG validation, the validity of diagnostic and procedural information supplied by the hospital; (5) The completeness, adequacy and quality of hospital care provided; (6) The medical necessity, reasonableness and appropriateness of hospital admissions and discharges; (7) The medical necessity, reasonableness and appropriateness of inpatient hospital care for which additional payment is sought under the outlier provisions of §§ 412.82 and 412.84 of this chapter; and (8) Whether a hospital has misrepresented admission or discharge information or has taken an action that results in— (i) The unnecessary admission of an individual entitled to benefits under part A; (ii) Unnecessary multiple admissions of an individual; or (iii) Other inappropriate medical or other practices with respect to beneficiaries or billing for services furnished to beneficiaries. (9) Hospital reclassification of a beneficiary's inpatient admission status to that of an outpatient receiving observation services when a beneficiary meets the eligibility criteria at §§ 405.1210 through 405.1212 of this chapter. Appeals of determinations are available as specified in § 405.1212 of this chapter. (b) Payment determinations. (c) Other duties and functions. (2) As directed by CMS, the QIO must review changes in DRG and LTC-DRG assignments made by the intermediary under the provisions of §§ 412.60(d) and 412.513(c) of this chapter that result in the assignment of a higher-weighted DRG or a different LTC-DRG. The QIO's review must verify that the diagnostic and procedural information supplied by the hospital is substantiated by the information in the medical record. (d) Coordination of sanction activities. [52 FR 37457, Oct. 7, 1987; 52 FR 47003, Dec. 11, 1987, as amended at 59 FR 45402, Sept. 1, 1994. Redesignated at 64 FR 66279, Nov. 24, 1999; 67 FR 56056, Aug. 30, 2002; 77 FR 68560, Nov. 15, 2012; 89 FR 83294, Oct. 15, 2024] § 476.73 Notification of QIO designation and implementation of review. (a) Notice of CMS's decision. (b) Notification to health care facilities and the public. (1) Provide, to each health care facility scheduled to come under review, a timely written notice that specifies the date and manner in which the QIO proposes to implement review, and the information to be furnished by the facility to each Medicare beneficiary upon admission as specified in § 476.78(b)(3) of this part. (2) Publish, in at least one local newspaper of general circulation in the QIO area, a notice that states the date the QIO will assume review responsibilities and lists each area health care facility to be under review. The QIO must indicate that its plan for the review of health care services as approved in its contract with CMS is available for public inspection in the QIO's business office and give the address, telephone number and usual hours of business. [50 FR 15330, Apr. 17, 1985. Redesignated at 52 FR 37457, Oct. 7, 1987, and further redesignated at 64 FR 66279, Nov. 24, 1999; 77 FR 68560, Nov. 15, 2012] § 476.74 General requirements for the assumption of review. (a) A QIO must assume review responsibility in accordance with the schedule, functions and negotiated objectives specified in its contract with CMS. (b) A QIO must notify the appropriate Medicare administrative contractor, fiscal intermediary, or carrier of its assumption of review in specific health care facilities no later than five working days after the day that review is assumed in the facility. (c) A QIO must maintain and make available for public inspection at its principal business office— (1) A copy of each agreement with Medicare administrative contractors, fiscal intermediaries, and carriers; (2) A copy of its currently approved review plan that includes the QIO's method for implementing review; and (3) Copies of all subcontracts for the conduct of review. (d) A QIO must not subcontract with a facility to conduct any review activities except for the review of the quality of care. The QIO may subcontract with a non-facility organization to conduct review in a facility. (e) If required by CMS, a QIO is responsible for compiling statistics based on the criteria contained in § 411.402 of this chapter and making limitation of liability determinations on excluded coverage of certain services that are made under section 1879 of the Act. If required by CMS, QIOs must also notify a provider of these determinations. These determinations and further appeals are governed by the reconsideration and appeals procedures in part 405, subpart G of this chapter for Medicare Part A related determinations and part 405, subpart H of this chapter for Medicare Part B related determinations. (f) A QIO must make its responsibilities under its contract with CMS, primary to all other interests and activities that the QIO undertakes. [50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68560, Nov. 15, 2012] § 476.76 Cooperation with health care facilities. Before implementation of review, a QIO must make a good faith effort to discuss the QIO's administrative and review procedures with each involved health care facility. § 476.78 Responsibilities of providers and practitioners. (a) Every hospital seeking payment for services furnished to Medicare beneficiaries must maintain a written agreement with a QIO operating in the area in which the hospital is located. These agreements must provide for the QIO review specified in § 476.71. (b) Cooperation with QIOs. (1) Providers must allocate adequate space to the QIO for its conduct of review at the times the QIO is conducting review. (2) Providers and practitioners must provide patient care data and other pertinent data to the QIO at the time the QIO is collecting review information that is required for the QIO to make its determinations. When the QIO does postadmission, preprocedure review, the provider must provide the necessary information before the procedure is performed, unless it must be performed on an emergency basis. Providers and practitioners must— (i) Except as provided under §§ 476.130(b) and 476.160(b), relating to beneficiary complaint reviews and general quality of care reviews, deliver to the QIO all required information within 14 calendar days of a request. A QIO is authorized to require the receipt of the medical information earlier than the 14-day timeframe if the QIO makes a preliminary determination that the review involves a potential gross and flagrant or substantial violation as specified in part 1004 of this title and circumstances warrant earlier receipt of the medical information. A practitioner's or provider's failure to comply with the request for medical information within the established timeframe may result in the QIO taking action in accordance with § 476.90. (ii) Except if granted a waiver as described in paragraph (d) of this section, send secure transmission of an electronic version of each requested patient record to the QIO. (A) Providers and practitioners must deliver electronic versions of patient records within 14 calendar days of the request. (B) A QIO is authorized to require the receipt of the patient records earlier than the 14-day timeframe if the QIO makes a preliminary determination that the review involves a potential gross and flagrant or substantial violation as specified in part 1004 of this title and circumstances warrant earlier receipt of the patient records. (C) A practitioner's or provider's failure to comply with the request for patient records within the established timeframe may result in the QIO taking action in accordance with § 476.90. (3) Providers must inform Medicare beneficiaries at the time of admission, in writing, that the care for which Medicare payment is sought will be subject to QIO review and indicate the potential outcomes of that review. Furnishing this information to the patient does not constitute notice, under § 411.402(a) of this chapter, that can support a finding that the beneficiary knew the services were not covered. (4) When the provider has issued a written determination in accordance with § 412.42(c)(3) of this chapter that a beneficiary no longer requires inpatient hospital care, it must submit a copy of its determination to the QIO within 3 working days. (5) Providers must assure, in accordance with the provisions of their agreements with the QIO, that each case subject to preadmission review has been reviewed and approved by the QIO before admission to the hospital or a timely request has been made for QIO review. (6)(i) Providers must agree to accept financial liability for any admission subject to preadmission review that was not reviewed by the QIO and is subsequently determined to be inappropriate or not medically necessary. (ii) The provisions of paragraph (b)(6)(i) of this section do not apply if a provider, in accordance with its agreement with a QIO, makes a timely request for preadmission review and the QIO does not review the case timely. Cases of this type are subject to retrospective prepayment review under paragraph (b)(7) of this section. (7) Hospitals must agree that, if the hospital admits a case subject to preadmission review without certification, the case must receive retrospective prepayment review, according to the review priority established by the QIO. (c) Submission of patient records in electronic format. (d) Waiver from the requirement to submit patient records in an electronic format. (i) For providers that are required to execute a written agreement with the QIO, a request for a waiver must be made during execution of the written agreement with the QIO. (ii) Providers that are required to execute a written agreement with the QIO must request a waiver by notifying the QIO that they lack the capability to submit patient records in electronic format, if their lack of capability arises after the written agreement is executed. (iii) Upon approval of the waiver, the waiver becomes part of the written agreement with the QIO. (iv) A provider with an approved waiver may submit patient records by facsimile or by photocopying and mailing to the QIO. (v) A provider with an approved waiver may be reimbursed by the QIO for patient records submitted by facsimile or by photocopying and mailing in accordance with paragraph (e)(2) of this section. (vi) A QIO may not reimburse for any patient record submitted to the QIO by facsimile or by photocopying and mailing if the provider does not have an approved waiver. (2) Providers and practitioners that are not required to execute a written agreement with the QIO may request a waiver to be exempted from submitting patient records in an electronic format. (i) Such providers and practitioners may request a waiver by notifying the QIO that they lack the capability to submit patient records in electronic format. (ii) Upon approval of the waiver, a provider or practitioner may submit patient records by facsimile or by photocopying and mailing to the QIO. (iii) Providers and practitioners with approved waivers may be reimbursed by the QIO for patient records submitted by facsimile or by photocopying and mailing in accordance with paragraph (e)(2) of this section. (iv) A QIO may not reimburse for any patient records submitted to the QIO by facsimile or by photocopying and mailing, if the provider or practitioner does not have an approved waiver. (e) Reimbursement for submitting patient records to the QIO. patient record (2) A QIO may reimburse a provider or practitioner for requested patient records submitted in an electronic format, at the rate of $3.00 per patient record. (3) For a provider or practitioner that has an approved waiver under paragraph (d) of this section, a QIO may reimburse the provider or practitioner for requested records submitted by— (i) Facsimile at the rate of $0.15 per page; or (ii) Photocopying and mailing at the rate of $0.15 per page, plus the cost of first class postage. (4) A QIO may only reimburse a provider or practitioner once for each patient record submitted, per request, even if a patient record is submitted using multiple formats, in fragments, or more than once in response to a single request by the QIO. (f) Appeals. (c) Submission of patient records in electronic format. (d) Waiver from the requirement to submit patient records in an electronic format. (i) For providers that are required to execute a written agreement with the QIO, a request for a waiver must be made during execution of the written agreement with the QIO. (ii) Providers that are required to execute a written agreement with the QIO must request a waiver by notifying the QIO that they lack the capability to submit patient records in electronic format, if their lack of capability arises after the written agreement is executed. (iii) Upon approval of the waiver, the waiver becomes part of the written agreement with the QIO. (iv) A provider with an approved waiver may submit patient records by facsimile or by photocopying and mailing to the QIO. (v) A provider with an approved waiver may be reimbursed by the QIO for patient records submitted by facsimile or by photocopying and mailing in accordance with paragraph (e)(2) of this section. (vi) A QIO may not reimburse for any patient record submitted to the QIO by facsimile or by photocopying and mailing if the provider does not have an approved waiver. (2) Providers and practitioners that are not required to execute a written agreement with the QIO may request a waiver to be exempted from submitting patient records in an electronic format. (i) Such providers and practitioners may request a waiver by notifying the QIO that they lack the capability to submit patient records in electronic format. (ii) Upon approval of the waiver, a provider or practitioner may submit patient records by facsimile or by photocopying and mailing to the QIO. (iii) Providers and practitioners with approved waivers may be reimbursed by the QIO for patient records submitted by facsimile or by photocopying and mailing in accordance with paragraph (e)(2) of this section. (iv) A QIO may not reimburse for any patient records submitted to the QIO by facsimile or by photocopying and mailing, if the provider or practitioner does not have an approved waiver. (e) Reimbursement for submitting patient records to the QIO. patient record (2) A QIO may reimburse a provider or practitioner for requested patient records submitted in an electronic format, at the rate of $3.00 per patient record. (3) For a provider or practitioner that has an approved waiver under paragraph (d) of this section, a QIO may reimburse the provider or practitioner for requested records submitted by— (i) Facsimile at the rate of $0.15 per page; or (ii) Photocopying and mailing at the rate of $0.15 per page, plus the cost of first class postage. (4) A QIO may only reimburse a provider or practitioner once for each patient record submitted, per request, even if a patient record is submitted using multiple formats, in fragments, or more than once in response to a single request by the QIO. (f) Appeals. [50 FR 15330, Apr. 17, 1985, as amended at 57 FR 47787, Oct. 20, 1992; 59 FR 45402, Sept. 1, 1994. Redesignated at 64 FR 66279, Nov. 24, 1999, as amended at 68 FR 67960, Dec. 5, 2003; 76 FR 51784, Aug. 18, 2011; 77 FR 53682, Aug. 31, 2012; 77 FR 68560, Nov. 15, 2012; 85 FR 59025, Sept. 18, 2020] § 476.80 Coordination with Medicare administrative contractors, fiscal intermediaries, and carriers (a) Procedures for agreements. (1) The QIO and the Medicare administrative contractor, fiscal intermediary, or carrier must negotiate in good faith in an effort to reach written agreement. If they cannot reach agreement, CMS will assist them in resolving matters in dispute. (2) The QIO must incorporate its administrative procedures into an agreement with the Medicare administrative contractor, fiscal intermediary, or carrier and obtain approval from CMS, before it makes conclusive determinations for the Medicare program, unless CMS finds that the Medicare administrative contractor, fiscal intermediary, or carrier has— (i) Refused to negotiate in good faith or in a timely manner, or (ii) Insisted on including in the agreement, provisions that are outside the scope of its authority under the Act. (b) Content of agreement. (1) Informing the appropriate Medicare administrative contractors, fiscal intermediaries, and carriers of— (i) Changes as a result of DRG validations and revisions as a result of the review of these changes; and (ii) Initial denial determinations and revisions of these determinations as a result of reconsideration, or reopening all approvals and denials with respect to cases subject to preadmission review, and outlier claims in hospitals under a prospective payment system for health care services and items; (2) Exchanging data or information; (3) Modifying the procedures when additional review responsibility is authorized by CMS; and (4) Any other matters that are necessary for the coordination of functions. (c) Action by CMS. (2) If CMS approves the agreement or the administrative procedures (after a finding by CMS as specified in paragraph (a)(2) of this section), the QIO may begin to make determinations under its contract with CMS. (3) If CMS disapproves the agreement or procedures, it will— (i) Notify the QIO and the appropriate fiscal agents in writing, stating the reasons for disapproval; and (ii) Require the QIO and Medicare administrative contractor, fiscal intermediary, or carrier to revise its agreements or procedures. (d) Modification of agreements. (1) Through a revised agreement with the Medicare administrative contractor, fiscal intermediary, or carrier, or (2) In the case of procedures, by the QIO, after providing opportunity for comment by the Medicare administrative contractor, fiscal intermediary, or carrier. (e) Role of the Medicare administrative contractor or fiscal intermediary. (2) A QIO's determination that an admission is medically necessary is not a guarantee of payment by the Medicare administrative contractor or fiscal intermediary. Medicare coverage requirements must also be applied. [50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999; 77 FR 68560, Nov. 15, 2012] § 476.82 Continuation of functions not assumed by QIOs. Any of the duties and functions under Part B of Title XI of the Act for which a QIO has not assumed responsibility under its contract with CMS must be performed in the manner and to the extent otherwise provided for under the Act or in regulations. QIO Review Functions § 476.83 Initial denial determinations. A determination by a QIO that the health care services furnished or proposed to be furnished to a patient are not medically necessary, are not reasonable, or are not at the appropriate level of care, is an initial denial determination and is appealable under part 473 of this chapter. § 476.84 Changes as a result of DRG validation. A provider or practitioner may obtain a review by a QIO under part 473 of this chapter for changes in diagnostic and procedural coding that resulted in a change in DRG assignment as a result of QIO validation activities. § 476.85 Conclusive effect of QIO initial denial determinations and changes as a result of DRG validations. A QIO initial denial determination or change as a result of DRG validation is final and binding unless, in accordance with the procedures in part 473— (a) The initial denial determination is reconsidered and revised; or (b) The change as a result of DRG validation is reviewed and revised. § 476.86 Correlation of Title XI functions with Title XVIII functions. (a) Payment determinations. (i) Whether inpatient care furnished in a psychiatric hospital meets the requirements of § 424.14 of this chapter. (ii) Whether payment for inpatient hospital or SNF care beyond 20 consecutive days is precluded under § 489.50 of this chapter because of failure to perform review of long-stay cases. (iii) Whether the care furnished was custodial care or care not reasonable and necessary and, as such, excluded under § 411.15(g) or § 411.15(k) of this chapter. (iv) Whether the care was appropriately furnished in the inpatient or outpatient setting. (2) Reviews with respect to determinations listed in paragraph (a)(1) of this section must not be conducted, for purposes of payment, by Medicare administrative contractors, fiscal intermediaries, and carriers except as outlined in paragraph (c) of this section. (3) QIOs make determinations as to the appropriateness of the location in which procedures are performed. A procedure may be medically necessary but denied if the QIO determines that it could, consistent with the provision of appropriate medical care, be effectively provided more economically on an outpatient basis or in an inpatient health care facility of a different type. (4) QIO determinations as to whether the provider and the beneficiary knew or could reasonably be expected to have known that the services described in paragraph (a)(1) of this section were excluded are also conclusive for payment purposes. (b) Utilization review activities. (c) Coverage. (1) In the case of items or services not reviewed by a QIO, whether they meet coverage requirements of Title XVIII relating to medical necessity, reasonableness, or appropriateness of placement at an acute level of patient care. However, if a coverage determination pertains to medical necessity, reasonableness, or appropriateness of placement at an acute level of patient care, the Medicare administrative contractor, fiscal intermediary, or carrier must use a QIO to make a determination on those issues if a QIO is conducting review in the area and must abide by the QIO's determination. (2) Whether any claim meets coverage requirements of Title XVIII relating to issues other than medical necessity, reasonableness or appropriateness of placement at an acute level of patient care. (d) Payment. (e) Survey, compliance and assistance activities. (f) Appeals. [50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985, as amended at 53 FR 6648, Mar. 2, 1988. Redesignated at 64 FR 66279, Nov. 24, 1999; 77 FR 68561, Nov. 15, 2012] § 476.88 Examination of the operations and records of health care facilities and practitioners. (a) Authorization to examine records. (1) Perform review functions including, but not limited to— (i) DRG validation; (ii) Outlier review in facilities under a prospective payment system; and (iii) Implementation of corrective action and fraud and abuse prevention activities; (2) Evaluate cases that have been identified as deviating from the QIO norms and criteria, or standards; and (3) Evaluate the capability of the facility to perform quality review functions under a subcontract with the QIO. (b) Limitations on access to records. (1) The records relate to review performed under a non-Medicare QIO contract and if authorized by those patients in accordance with State law; or (2) The QIO needs the records to perform its quality review responsibilities under the Act and receives authorization from the facility or practitioner. (c) Conditions of examination. (1) Examine only those operations and records (including information on charges) required to fulfill the purposes of paragraph (a) of this section; (2) Cooperate with agencies responsible for other examination functions under Federal or Federally assisted programs in order to minimize duplication of effort; (3) Conduct the examinations during reasonable hours; and (4) Maintain in its principal office written records of the results of the examination of the facility. § 476.90 Lack of cooperation by a provider or practitioner. (a) If a provider or practitioner refuses to allow a QIO to enter and perform the duties and functions required under its contract with CMS, the QIO may— (1) Determine that the provider or practitioner has failed to comply with the requirements of 42 CFR 1004.10(c) and report the matter to the HHS Inspector General; or (2) Issue initial denial determinations for those claims it is unable to review, make the determination that financial liability will be assigned to the provider or practitioner, and may report the matter to the HHS Inspector General. (b) If a QIO gives a provider or practitioner sufficient notice and a reasonable amount of time to respond to a request for information about a claim, and if the provider or practitioner does not respond in a timely manner, the QIO will deny the claim. A provider or practitioner may request that the QIO reconsider its decision to deny the claim. No further appeal rights are available. [77 FR 53683, Aug. 31, 2012] § 476.93 Opportunity to discuss proposed initial denial determination and changes as a result of a DRG validation. Before a QIO reaches an initial denial determination or makes a change as a result of a DRG validation, it must— (a) Promptly notify the provider or supplier and the patient's attending physician (or other attending health care practitioner) of the proposed determination or DRG change; and (b) Afford an opportunity for the provider or supplier and the physician (or other attending health care practitioner) to discuss the matter with the QIO physician advisor and to explain the nature of the patient's need for health care services, including all factors which preclude treatment of the patient as an outpatient or in an alternative level of inpatient care. § 476.94 Notice of QIO initial denial determination and changes as a result of a DRG validation. (a) Notice of initial denial determination Parties to be notified. (i) The patient, or if the patient is expected to be unable to comprehend the notice, the patient's next of kin, guardian or other representative or sponsor; (ii) The attending physician, or other attending health care practitioner; (iii) The facility; and (iv) The Medicare administrative contractor, fiscal intermediary, or carrier. (2) Timing of the notice. (i) For admission, on the first working day after the initial denial determination; (ii) For continued stay (e.g., outliers in facilities under a prospective payment system), by the first working day after the initial denial determination if the beneficiary is still in the facility, and within 3 working days if the beneficiary has been discharged; (iii) For preprocedure review, before the procedure is performed; (iv) For preadmission review, before admission; (v) If identification as a Medicare program patient has been delayed, within three working days of identification; (vi) For retrospective review, (excluding DRG validation and post procedure review), within 3 working days of the initial denial determination; and (vii) For post-procedure review, within 3 working days of the initial denial determination. (3) Preadmission review. (b) Notice of changes as a result of a DRG validation. (c) Content of the notice. (1) The reason for the initial denial determination or change as a result of the DRG validation; (2) For day outliers in hospitals, the date on which the stay or services in the facility will not be approved as being reasonable and medically necessary or appropriate to the patients' health care needs; (3) A statement informing each party or his or her representative of the right to request in accordance with the provisions of part 478, subpart B of this chapter— (i) Review of a change resulting from DRG validation; or (ii) Reconsideration of the initial denial determination; (4) The locations for filing a request for reconsideration or review and the time period within which a request must be filed; (5) A statement about who is liable for payment of the denied services under section 1879 of the Act; and (6) A statement concerning the duties and functions of the QIO under the Act. (d) Notice to payers. (e) Record of initial denial determination and changes as a result of a DRG validation. (2) The documentary record must include— (i) The detailed basis for the initial denial determination or changes as a result of a DRG validation; and (ii) A copy of the determination or change in DRG notices sent to all parties and identification of each party and the date on which the notice was mailed or delivered. [50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68561, Nov. 15, 2012] § 476.96 Review period and reopening of initial denial determinations and changes as a result of DRG validations. (a) General timeframe. (1) Within one year of the date of the claim containing the service in question, may review and deny payment; and (2) Within one year of the date of its decision, may reopen an initial denial determination or a change as a result of a DRG validation. (b) Extended timeframes. (2) A reopening of an initial denial determination or change as a result of a DRG validation may be made after one year but within four years of the date of the QIO's decision if— (i) Additional information is received on the patient's condition; (ii) Reviewer error occurred in interpretation or application of Medicare coverage policy or review criteria; (iii) There is an error apparent on the face of the evidence upon which the initial denial or DRG validation was based; or (iv) There is a clerical error in the statement of the initial denial determination or change as a result of a DRG validation. (c) Fraud and abuse. (2) An initial denial determination or change as a result of a DRG validation may be reopened and revised anytime there is a finding that it was obtained through fraud or a similar abusive practice that does not support a finding of fraud. § 476.98 Reviewer qualifications and participation. (a) Peer review by physician. (2) If a QIO determines that peers are not available to make initial denial determinations, a doctor of medicine or osteopathy may make denial determinations for services ordered or performed by a doctor in any of the three specialties. (3) For purposes of paragraph (a)(1) of this section, individuals authorized to practice medicine in American Samoa, the Northern Mariana Islands, and the Trust Territory of the Pacific Islands as “medical officers” may make determinations on care ordered or furnished by their peers but not on care ordered or furnished by licensed doctors of medicine or osteopathy. (b) Peer review by health care practitioners other than physicians. (c) DRG validation review. (d) Persons excluded from review. (i) Participated in developing or executing the beneficiary's treatment plan; (ii) Is a member of the beneficiary's family; or (iii) Is a governing body member, officer, partner, 5 percent or more owner, or managing employee in the health care facility where the services were or are to be furnished. (2) A member of a reviewer's family is a spouse (other than a spouse who is legally separated under a decree of divorce or separate maintenance), child (including a legally adopted child), grandchild, parent, or grandparent. [50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68561, Nov. 15, 2012] § 476.100 Use of norms and criteria. (a) Use of norms. (b) Use of criteria. (1) The necessity for facility admission and continued stay (in cases of day outliers in hospitals under prospective payment); (2) The necessity for surgery and other invasive diagnostic and therapeutic procedures; or (3) The appropriateness of providing services at a particular health care facility or at a particular level of care. The QIO must determine whether the beneficiary requires the level of care received or whether a lower and less costly level of care would be equally effective. (c) Establishment of criteria and standards. (1) Establish written criteria based upon typical patterns of practice in the QIO area, or use national criteria where appropriate; and (2) Establish written criteria and standards to be used in conducting quality review studies. (d) Variant criteria and standards. (1) The patterns of practice in those locations and facilities are substantially different from patterns in the remainder of the QIO area; and (2) There is a reasonable basis for the difference which makes the variation appropriate. § 476.102 Involvement of health care practitioners other than physicians. (a) Basic requirement. (1) Consult with the peers of the practitioners who furnish the services under review if the QIO reviews care and services delivered by health care practitioners other than physicians. (2) Assure that in determinations regarding medical necessity of services or the quality of the services they furnish, these practitioners are involved in— (i) Developing QIO criteria and standards; (ii) Selecting norms to be used; and (iii) Developing review mechanisms for care furnished by their peers. (3) Ensure that an initial denial determination or a change as a result of DRG validation of services provided by a health care practitioner other than a physician is made by a physician only after consultation with a peer of that practitioner. Initial denial determinations and changes as a result of DRG validations must be made only by a physician or dentist. (b) Exception. (1) The QIO has been unable to obtain a roster of peer practitioners available to perform review; or (2) The practitioners are precluded from performing review because they participated in the treatment of the patient, the patient is a relative, or the practitioners have a financial interest in the health care facility as described in § 466.98(d). (c) Peer involvement in quality review studies. (d) Consultation with practitioners other than physicians. [50 FR 15330, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999] § 476.104 Coordination of activities. In order to achieve efficient and economical review, a QIO must coordinate its activities (including information exchanges) with the activities of— (a) Medicare administrative contractors, fiscal intermediaries, and carriers. (b) Other QIOs; and (c) Other public or private review organizations as may be appropriate. [50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68561, Nov. 15, 2012] § 476.110 Use of immediate advocacy to resolve oral beneficiary complaints. (a) Immediate advocacy. (1) The complaint is received not later than 6 months from the date on which the care giving rise to the complaint occurred. (2) After initial screening of the complaint, the QIO makes a preliminary determination that— (i) The complaint is unrelated to the clinical quality of health care itself but relates to items or services that accompany or are incidental to the medical care and are provided by a practitioner and/or provider; or (ii) The complaint, while related to the clinical quality of health care received by the beneficiary, does not rise to the level of being a gross and flagrant, substantial, or significant quality of care concern. (3) The beneficiary agrees to the disclosure of his or her name to the involved provider and/or practitioner. (4) All parties orally consent to the use of immediate advocacy. (5) All parties agree to the limitations on redisclosure set forth in § 480.107 of this subchapter. (b) Discontinuation of immediate advocacy. (1) The QIO must inform the parties that immediate advocacy will be discontinued; and (2) The beneficiary must be informed of his or her right to submit a written complaint in accordance with the procedures in § 476.120. (c) Confidentiality requirements. (d) Abandoned complaints. (1) Inform the parties that immediate advocacy will be discontinued; and (2) Inform the Medicare beneficiary of his or her right to submit a written complaint in accordance with the procedures in § 476.120. [77 FR 68561, Nov. 15, 2012] § 476.120 Submission of written beneficiary complaints. (a) Timeframe for submission of written complaints. (1) A written complaint includes a complaint submitted electronically to the QIO. (2) In those instances where a Medicare beneficiary contacts the QIO regarding a complaint but declines to submit the complaint in writing and immediate advocacy has not been offered, the QIO may complete a general quality of care review in accordance with § 476.160 if the QIO makes a preliminary determination that the complaint involves a potential gross and flagrant, substantial or significant quality of care concern. (b) New concerns raised by a Medicare beneficiary. [77 FR 68561, Nov. 15, 2012] § 476.130 Beneficiary complaint review procedures. (a) Scope of the QIO review. (1) The QIO's review will focus on the episode of care from which the complaint arose and address the specific concerns identified by the beneficiary and any additional concerns identified by the QIO. The QIO may separate concerns into different complaints if the QIO determine that the concerns relate to different episodes of care. (2) The QIO will use evidence-based standards of care to the maximum extent practicable. If no standard of care exists, the QIO will use available norms, best practices and established guidelines to establish the standard that will be used in completing the review. The QIO's determination regarding the standard used is not subject to appeal. (b) Medical information requests. (2) In requesting medical information in response to a Medicare beneficiary complaint, the QIO must notify the practitioner and/or provider that the medical record is being requested in response to a beneficiary complaint, explain the practitioner's and/or provider's right to discuss the QIO's interim initial determination, and request the name of a contact person in order to ensure timely completion of the discussion. (c) Interim initial determination. (1) A practitioner and provider will be notified by telephone of the opportunity to discuss the QIO's interim initial determination with the QIO in those situations where the peer reviewer determines that the quality of services does not meet professionally recognized standards of care for any concern in the complaint. The discussion must be held no later than 7 calendar days from the date of the initial offer. (2) The interim initial determination becomes the final initial determination if the discussion is not completed timely as a result of the practitioner's and/or provider's failure to respond. (3) Written statements in lieu of a discussion must be received no later than 7 calendar days from the date of the initial offer. (4) In rare circumstances, the QIO may grant additional time to complete the discussion or submission of a written statement in lieu of a discussion. (d) Final initial determination. (1) No later than 3 business days after completion of its review, or for cases in which the standard was not met, no later than 3 business days after the discussion or receipt of the provider's and/or practitioner's written statement, the QIO will notify (by telephone) the beneficiary and the provider/practitioner of its final initial determination and of the right to request a reconsideration of the QIO's final initial determination. (2) Written notice of the QIO's final initial determination will be forwarded to all parties within 5 calendar days after completion of its review, and must include: (i) A statement for each concern that care did or did not meet the standard of care; (ii) The standard identified by the QIO for each of the concerns; and (iii) A summary of the specific facts that the QIO determines are pertinent to its findings, including references to medical information and, if held, the discussion with the involved practitioner and/or provider. [77 FR 68561, Nov. 15, 2012] § 476.140 Beneficiary complaint reconsideration procedures. (a) Right to request a reconsideration. (1) The reconsideration request must be received by the QIO, in writing or by telephone, no later than 3 calendar days following initial notification of the QIO's determination. If the QIO is unable to accept a request, the request must be submitted by noon of the next day the QIO is available to accept a request. (2) The Medicare beneficiary, or his or her representative, and the practitioner and/or provider must be available to answer any questions or supply any information that the QIO requests in order to conduct its reconsideration. (3) The QIO must offer the Medicare beneficiary and the practitioner and/or provider an opportunity to provide further information. A Medicare beneficiary, a practitioner, and a provider may, but are not required to, submit evidence to be considered by the QIO in making its reconsideration decision. (b) Issuance of the QIO's final decision. (1) The QIO's initial notification may be done by telephone, followed by the mailing of a written notice by noon of the next calendar day that includes— (i) A statement for each concern that care did or did not meet the standard of care; (ii) The standard identified by the QIO for each of the concerns; (iii) A summary of the specific facts that the QIO determines are pertinent to its findings; and (iv) A statement that the letter represents the QIO's final determination and that there is no right to further appeal. (2) The QIO may provide information to the beneficiary, practitioner, and provider regarding opportunities for improving the care given to patients based on the specific findings of its review and the development of quality improvement initiatives. [77 FR 68561, Nov. 15, 2012] § 476.150 Abandoned complaints and reopening rights. (a) Abandoned complaints. (1) Inform the parties that its complaint review will be discontinued; and (2) Inform the beneficiary of his or her right to resubmit a written complaint in accordance with the procedures in § 476.120. (b) Reopening complaint reviews. [77 FR 68561, Nov. 15, 2012] § 476.160 General quality of care review procedures. (a) Scope of the QIO review. (1) A QIO may conduct general quality of care reviews based on— (i) Concerns identified during the course of other QIO review activities; (ii) Referrals from other sources, including but not limited to individuals, contractors, other Federal or State agencies; or (iii) Analysis of data. (2) The QIO's review will focus on all concerns identified by the QIO and/or identified by those who have referred or reported the concerns, with consideration being given to the episode of care related to the concerns. (3) The QIO will use evidence-based standards of care to the maximum extent practicable. If no standard of care exists, the QIO must use available norms, best practices, and established guidelines to establish the standard that will be used in completing the review. The QIO's determination regarding the standard used is not subject to appeal. (b) Medical information requests. (c) Initial determination. [77 FR 68561, Nov. 15, 2012] § 476.170 General quality of care reconsideration procedures. (a) Right to request a reconsideration. (1) The reconsideration request must be received by the QIO, in writing or by telephone, by no later than 3 calendar days following receipt of the QIO's initial determination. If the QIO is unable to accept the request, the request must be submitted by noon of the next day the QIO is available to accept a request. (2) The practitioner or provider must be available to answer any questions or supply any information that the QIO requests in order to conduct its reconsideration. (3) The QIO must offer the practitioner or provider an opportunity to provide further information. A practitioner or provider may, but is not required to, submit evidence to be considered by the QIO in making its reconsideration decision. (b) Issuance of the QIO's final decision. (1) The QIO's initial notification may be done by telephone, followed by the mailing of a written notice by noon the next calendar day that includes: (i) A statement for each concern that care did or did not meet the standard of care; (ii) The standard identified by the QIO for each of the concerns; (iii) A summary of the specific facts that the QIO determines are pertinent to its findings; and (iv) A statement that the letter represents the QIO's final determination and that there is no right to further appeal. (2) The QIO may provide information regarding opportunities for improving the care given to patients based on the specific findings of its review. [77 FR 68561, Nov. 15, 2012]