PART 478—RECONSIDERATIONS AND APPEALS Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart A [Reserved] Subpart B—Utilization and Quality Control Quality Improvement Organization (QIO) Reconsiderations and Appeals Source: 50 FR 15372, Apr. 17, 1985, unless otherwise noted. Redesignated at 64 FR 66279, Nov. 24, 1999. § 478.10 Scope. This subpart establishes the requirements and procedures for— (a) Reconsiderations conducted by a Utilization and Quality Control Quality Improvement Organization (QIO) or its subcontractor of initial denial determinations concerning services furnished or proposed to be furnished under Medicare; (b) Hearings and judicial review of reconsidered determinations; and (c) QIO review of a change in diagnostic and procedural coding information. [50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999] § 478.12 Statutory basis. (a) Under section 1154 of the Act, a QIO may make an initial determination that services furnished or proposed to be furnished are not reasonable, necessary, or delivered in the most appropriate setting. (b) Under section 1155 of the Act, the following rules apply: (1) A Medicare beneficiary, a provider, or an attending practitioner who is dissatisfied with an initial denial determination under paragraph (a) of this section is entitled to a reconsideration by the QIO that made that determination. (2) The beneficiary is also entitled to the following: (i) A hearing by an administrative law judge if $200 or more is still in controversy after a reconsidered determination. (ii) Judicial review if $2000 or more is still in controversy after a final determination by the Department. (c) Under section 1866(a)(1)(F) of the Act, a hospital that is reimbursed by the Medicare program must maintain an agreement with a QIO under which the QIO reviews the validity of diagnostic information furnished by the hospital. [50 FR 15372, Apr. 17, 1985, as amended at 60 FR 50442, Sept. 29, 1995. Redesignated at 64 FR 66279, Nov. 24, 1999] § 478.14 Applicability. (a) Basic provision. (1) Reasonableness of services. (2) Medical necessity of services. (3) Appropriateness of the inpatient setting in which services were furnished or are proposed to be furnished. (b) Concurrent appeal. (c) Nonapplicability of rules to related determinations. (2) Limitation of liability determinations on excluded coverage of certain services are made under section 1879 of the Act. Initial determinations under section 1879 and further appeals are governed by the reconsideration and appeal procedures in part 405, subpart I of this chapter for determinations under Medicare Part A and Part B. References in those subparts to initial and reconsidered determinations made by an intermediary, carrier or CMS should be read to mean initial and reconsidered determinations made by a QIO. [50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999; 82 FR 5139, Jan. 17, 2017] § 478.15 QIO review of changes resulting from DRG validation. (a) General rules. (i) The change caused an assignment of a different DRG; and (ii) Resulted in a lower payment. (2) A beneficiary may obtain a review of a QIO DRG coding change only if that change results in noncoverage of a furnished service. (3) The individual who reviews changes in DRG procedural or diagnostic information must be a physician, and the individual who reviews changes in DRG coding must be qualified through training and experience with ICD-9-CM coding. (b) Procedures. (c) Finality of review. [50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999; 77 FR 68563, Nov. 15, 2012] § 478.16 Right to reconsideration. A beneficiary, provider or practitioner who is dissatisfied with a QIO initial denial determination on one of the issues specified in § 478.14 has a right to a reconsideration of that determination by the QIO that made the initial denial determination. [50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68563, Nov. 15, 2012] § 478.18 Location for submitting requests for reconsideration. (a) Beneficiaries. (1) The QIO or the QIO subcontractor that made the initial determination. (2) An SSA District Office. (3) A Railroad Retirement Board Office, if the beneficiary is a railroad retiree. (b) Others. (c) Expedited reconsideration. § 478.20 Time limits for requesting reconsideration. (a) Basic rules. (2) The date of receipt of the notice of the initial determination is presumed to be five days after the date on the notice, unless there is a reasonable showing to the contrary. (3) A request is considered filed on the date it is postmarked. (b) Late filing of request. (c) Request for expedited reconsideration. [50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68563, Nov. 15, 2012] § 478.22 Good cause for late filing of a request for a reconsideration or hearing. (a) General Rule. (1) What circumstances kept the party from making the request on time. (2) Whether an action by the QIO misled the party. (3) Whether the party understood the requirements of the Act as affected by amendments to the Act, other legislation, or court decisions. (b) Examples. (1) A party was seriously ill and was prevented from requesting a reconsideration in person, through another person, or in writing. (2) There was a death or serious illness in a party's immediate family. (3) Important records were accidentally destroyed or damaged by fire or other cause. (4) A party made a diligent effort but could not find or obtain necessary relevent information within the appropriate time period. (5) A party requested additional information to further explain the determination within the time limit, and requested reconsideration within 60 days of receiving the explanation (or within 30 days for a Departmental Appeals Board hearing). (6) The QIO gave the party incorrect or incomplete information about when and how to request a reconsideration or hearing. (7) A party sent the request to another Government agency in good faith within the time limit, but the request did not reach an office authorized to receive the request until after the time period had expired. (8) Other unusual or unavoidable circumstances exist that— (i) Show that a party could not have known of the need to file timely; or (ii) Prevented a party from filing timely. [50 FR 15372, Apr. 17, 1985, as amended at 61 FR 32349, June 24, 1996. Redesignated at 64 FR 66279, Nov. 24, 1999] § 478.24 Opportunity for a party to obtain and submit information. (a) Subject to the rules concerning disclosure of QIO information in section 1160 of the Act, at the request of a provider, practitioner or beneficiary, the QIO must provide an opportunity for examination of the material upon which the initial denial determination was based. The QIO may not furnish a provider, practitioner or beneficiary with— (1) A record of the QIO deliberation; or (2) The identity of the QIO review coordinators, physician advisors, or consultants who assisted in the initial denial determination without their consent. (b) The QIO may require the requester to pay a reasonable fee for the reproduction of the material requested. (c) The QIO must provide a party with an opportunity to submit new evidence before the reconsidered determination is made. § 478.26 Delegation of the reconsideration function. A QIO may delegate the authority to reconsider an initial determination to a nonfacility subcontractor, including the organization that made the initial determination as a QIO subcontractor. § 478.28 Qualifications of a reconsideration reviewer. A reconsideration reviewer must be someone who is— (a) Qualified under § 476.98 of this chapter to make an initial determination. (b) Not the individual who made the initial denial determination. (c) A specialist in the type of services under review, except where meeting this requirement would compromise the effectiveness or efficiency of QIO review. [50 FR 15330, Apr. 17, 1985, as amended at 77 FR 68563, Nov. 15, 2012] § 478.30 Evidence to be considered by the reconsideration reviewer. A reconsidered determination must be based on— (a) The information that led to the initial determination; (b) New information found in the medical records; or (c) Additional evidence submitted by a party. § 478.32 Time limits for issuance of the reconsidered determination. (a) Beneficiaries. (1) Within three working days after the QIO receives the request for reconsideration if— (i) The beneficiary is still an inpatient in a hospital for the stay in question when the QIO receives the request for reconsideration; or (ii) The initial determination relates to institutional services for which admission to the institution is sought, the initial determination was made before the patient was admitted to the institution; and a request was submitted timely for an expedited reconsideration. (2) Within 10 working days after the QIO receives the request for reconsideration if the beneficiary is still an inpatient in a SNF for the stay in question when the QIO receives the request for reconsideration. (3) Within 30 working days after the QIO receives the request for reconsideration if— (i) The initial determination concerns ambulatory or noninstitutional services; (ii) The beneficiary is no longer an inpatient in a hospital or SNF for the stay in question; or (iii) The beneficiary does not submit a request for expedited reconsideration timely. (b) Providers or practitioners. § 478.34 Notice of a reconsidered determination. (a) Notice to parties. (1) The basis for the reconsidered determination. (2) A detailed rationale for the reconsidered determination. (3) A statement explaining the Medicare payment consequences of the reconsidered determination. (4) A statement informing the parties of their appeal rights, including the information concerning what must be included in the request for hearing, the amount in controversy, locations for submitting a request for an administrative hearing and the time period for filing a request. (b) Notice to payers. (2) This notice must contain adequate information to allow the intermediary or carrier to locate the claim file. This must include the name of the beneficiary, the Health Insurance Claim Number, the name of the provider, date of admission, and dates or services for which Medicare payment will not be made. § 478.36 Record of reconsideration. (a) QIO requirements. (1) Four years after the date on the notice of the QIO's reconsidered determination. (2) Completion of litigation and the passage of the time period for filing all appeals. (b) Contents of the record. (1) The initial determination. (2) The basis for the initial determination. (3) Documentation of the date of the receipt of the request for reconsideration. (4) The detailed basis for the reconsidered determination. (5) Evidence submitted by the parties. (6) A copy of the notice of the reconsidered determination that was provided to the parties. (7) Documentation of the delivery or mailing and, if appropriate, the receipt of the notice of the reconsidered determination by the parties. (c) Confidentiality. § 478.38 Effect of a reconsidered determination. A QIO reconsidered determination is binding upon all parties to the reconsideration unless— (a) A hearing is requested in accordance with § 478.40 and a final decision rendered; or (b) The reconsidered determination is later reopened and revised in accordance with § 478.48. [50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985, as amended at 62 FR 25855, May 12, 1997; 62 FR 49938, Sept. 24, 1997. Redesignated at 64 FR 66279, Nov. 24, 1999; 77 FR 68563, Nov. 15, 2012] § 478.40 Beneficiary's right to a hearing. (a) Amount in controversy. (b) Subject matter. (1) Reasonableness of the services. (2) Medical necessity of the services. (3) Appropriateness of the setting in which the services were furnished. (c) Governing provisions. (2) The following part 405 regulations, and any references thereto, specifically do not apply under this subpart: (i) Section 405.950 (time frames for making a redetermination). (ii) Section 405.970 (time frames for making a reconsideration following a contractor redetermination, including the option to escalate an appeal to the OMHA level). (iii) Section 405.1016 (time frames for deciding an appeal of a QIC reconsideration, or escalated request for a QIC reconsideration, including the option to escalate an appeal to the Council). (iv) The option to request that an appeal be escalated from the OMHA level to the Council as provided in § 405.1100(b), and time frames for the Council to decide an appeal of an ALJ's or attorney adjudicator's decision or an appeal that is escalated from the OMHA level to the Council as provided in § 405.1100(c) and (d). (v) Section 405.1132 (request for escalation to Federal court). (vi) Sections 405.956(b)(8), 405.966(a)(2), 405.976(b)(5)(ii), 405.1018(c), 405.1028(a), and 405.1122(c), and any other reference to requiring a determination of good cause for the introduction of new evidence by a provider, supplier, or a beneficiary represented by a provider or supplier. [50 FR 15372, Apr. 17, 1985; 50 FR 41887, Oct. 16, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999; 82 FR 5139, Jan. 17, 2017] § 478.42 Submitting a request for a hearing. (a) Where to submit the written request. (b) Time limit for submitting a request for a hearing. (2) The date of receipt of the notice of the reconsidered determination is presumed to be 5 calendar days after the date on the notice, unless there is evidence to the contrary. (3) A request is considered filed on the date it is received by OMHA. [82 FR 5139, Jan. 17, 2017] § 478.44 Determining the amount in controversy for a hearing. (a) After an individual appellant has submitted a request for a hearing, the ALJ or attorney adjudicator determines the amount in controversy in accordance with § 405.1006(d) and (e) of this chapter. When two or more appellants submit a request for hearing, the ALJ or attorney adjudicator determines the amount in controversy in accordance with § 405.1006(d) and (e) of this chapter. (b) If the ALJ or attorney adjudicator determines that the amount in controversy is less than $200, the ALJ, without holding a hearing, or attorney adjudicator notifies the parties that the parties have 15 calendar days to submit additional evidence to prove that the amount in controversy is at least $200. (c) At the end of the 15-day period, if an ALJ determines that the amount in controversy is less than $200, the ALJ, without holding a hearing dismisses the request for a hearing without ruling on the substantive issues involved in the appeal and notifies the parties and the QIO that the QIO reconsidered determination is conclusive for Medicare payment purposes. [82 FR 5139, Jan. 17, 2017] § 478.46 Medicare Appeals Council and judicial review. (a) The circumstances under which the Medicare Appeals Council (Council) will review an ALJ's or attorney adjudicator's decision or dismissal are the same as those set forth at §§ 405.1102 (“Request for Council review when ALJ or attorney adjudicator issues decision or dismissal”) and 405.1110 (“Council reviews on its own motion”) of this chapter. (b) If $2,000 or more is in controversy, a party may obtain judicial review of a Council decision, or an ALJ's or attorney adjudicator's decision if a request for review by the Council was denied, by filing a civil action under the Federal Rules of Civil Procedure within 60 days after the date the party received notice of the Council decision or denial. [82 FR 5140, Jan. 17, 2017] § 478.48 Reopening and revision of a reconsidered determination or a decision. (a) QIO reopenings General rule. (2) Extension of time limit. (i) The QIO receives new material evidence; (ii) The QIO erred in interpretation or application of Medicare coverage policy; (iii) There is an error apparent on the face of the evidence upon which the reconsidered determination was based; or (iv) There is a clerical error in the statement of the reconsidered determination. (b) ALJ or attorney adjudicator and Council Reopening—Applicable procedures. (c) Fraud or similar abusive practice. [50 FR 15372, Apr. 17, 1985, as amended at 61 FR 32349, June 24, 1996; 62 FR 25855, May 12, 1997. Redesignated at 64 FR 66279, Nov. 24, 1999; 77 FR 68563, Nov. 15, 2012; 82 FR 5140, Jan. 17, 2017]