42 C.F.R. Subpart N—Medicare Contract Determinations and Appeals
Title 42 - Public Health
This subpart establishes the procedures for reviewing the following contract determinations: (a) A determination that an entity is not qualified to enter into a contract with CMS under Part D of title XVIII of the Act. (b) A determination not to authorize a renewal of a contract with a PDP sponsor in accordance with §423.507(b). (c) A determination to terminate a contract with a PDP sponsor in accordance with §423.509. (d) Fallback entities are governed under subpart Q of this part, and are not subject to this subpart, except to the extent a fallback prescription drug plan contract is terminated by CMS. (a) When CMS makes a contract determination under §423.641, it gives the PDP sponsor written notice. (b) The notice specifies the— (1) Reasons for the determination; and (2) PDP sponsor's right to request reconsideration. (c) For CMS-initiated terminations, CMS mails notice 90 days before the anticipated effective date of the termination. For terminations based on initial determinations described at §423.509(a)(4) or (a)(5), CMS immediately notifies the PDP sponsor of its decision to terminate the organization's PDP contract. (d) When CMS determines that it is not going to authorize a contract renewal, CMS mails the notice to the PDP sponsor by May 1 of the current contract year. The contract determination is final and binding unless— (a) The determination is reconsidered in accordance with §423.644 through §423.649; (b) A timely request for a hearing is filed under §423.651; or (c) The reconsideration decision is revised as a result of a reopening under §423.668. (a) Reconsideration is the first step for appealing a contract determination specified in §423.641. (b) CMS reconsiders the specified determinations if the contract applicant or the PDP sponsor files a written request in accordance with §423.645. (a) Method and place for filing a request. A request for reconsideration must be made in writing and filed with any CMS office. (b) Time for filing a request. The request for reconsideration must be filed within 15 days from the date of the notice of the initial determination. (c) Proper party to file a request. Only an authorized official of the contract applicant or PDP sponsor that was the subject of a contract determination may file the request for reconsideration. (d) Withdrawal of a request. The PDP sponsor or contract applicant who filed the request for a reconsideration may withdraw it at any time before the notice of the reconsidered determination is mailed. The request for withdrawal must be in writing and filed with CMS. CMS provides the PDP sponsor or contract applicant and the CMS official or officials who made the contract determination reasonable opportunity, not to exceed the timeframe in which a PDP sponsor chooses to request a hearing as described at §423.651, to present as evidence any documents or written statements that are relevant and material to the matters at issue. A reconsidered determination is a new determination that— (a) Is based on a review of the contract determination, the evidence and findings upon which that was based, and any other written evidence submitted before notice of the reconsidered determination is mailed, including facts relating to the status of the PDP sponsor subsequent to the contract determination; and (b) Affirms, reverses, or modifies the initial determination. (c) Any favorable redetermination, including those resulting from a hearing or Administrator review, must be made by July 15 for the contract in question to be effective on January of the following year. (a) CMS gives the PDP sponsor or contract applicant written notice of the reconsidered determination. (b) The notice— (1) Contains findings for the contract applicant's qualifications to enter into, or the PDP sponsor's qualifications to remain under, a contract with CMS under Part D of the Act; (2) States the specific reasons for the reconsidered determination; and (3) Informs the PDP sponsor or contract applicant of its right to a hearing if it is dissatisfied with the determination. A reconsidered determination is final and binding unless a request for a hearing is filed in accordance with §423.651 or it is revised in accordance with §423.668. The following parties are entitled to a hearing: (a) A contract applicant that is determined in a reconsidered determination to be unqualified to enter into a contract with CMS under Part D of title XVIII of the Act. (b) A PDP sponsor whose contract with CMS is terminated or is not renewed as a result of a contract determination as provided in §423.641. (a) Method and place for filing a request. A request for a hearing must be made in writing and filed by an authorized official of the contract applicant or PDP sponsor that was the party to the determination under appeal. The request for a hearing must be filed with any CMS office. (b) Time for filing a request. A request for a hearing must be filed within 15 days after the date of the reconsidered determination. (c) Parties to a hearing. The parties to a hearing must be— (1) The parties described in §423.650; (2) At the discretion of the hearing officer, any interested parties who make a showing that their rights may be prejudiced by the decision to be rendered at the hearing; and (3) CMS. (a) CMS postpones the proposed effective date of the contract determination to terminate a contract with a PDP sponsor until a hearing decision is reached and affirmed by the Administrator following review under §423.666 in instances where a PDP sponsor requests review by the Administrator; and (b) CMS extends the current contract at the end of the contract period (in the case of a determination not to renew) only— (1) If CMS finds that an extension of the contract is consistent with the purpose of this part; and (2) For the period as CMS and the PDP sponsor agree. (c) Exception: A contract terminated in accordance with §423.509(a)(4) or (a)(5) is immediately terminated and is not postponed if a hearing is requested. CMS designates a hearing officer to conduct the hearing. The hearing officer need not be an ALJ. (a) A hearing officer may not conduct a hearing in a case in which he or she is prejudiced or partial to any party or has any interest in the matter pending for decision. (b) A party to the hearing who objects to the designated hearing officer must notify that officer in writing at the earliest opportunity. (c) The hearing officer must consider the objections, and may, at his or her discretion, either proceed with the hearing or withdraw. (1) If the hearing officer withdraws, CMS designates another hearing officer to conduct the hearing. (2) If the hearing officer does not withdraw, the objecting party may, after the hearing, present objections and request that the officer's decision be revised or a new hearing be held before another hearing officer. The objections must be submitted in writing to CMS. (a) The hearing officer fixes a time and place for the hearing, which is not to exceed 30 days from the receipt of the request for the hearing, and sends written notice to the parties. The notice also informs the parties of the general and specific issues to be resolved and information about the hearing procedure. (b) The hearing officer may, on his or her own motion, or at the request of a party, change the time and place for the hearing. The hearing officer may adjourn or postpone the hearing. (c) The hearing officer gives the parties reasonable notice of any change in time or place of hearing, or of adjournment or postponement. A party may appoint as its representative at the hearing anyone not disqualified or suspended from acting as a representative before the Secretary or otherwise prohibited by law. (a) A representative appointed and qualified in accordance with §423.656, on behalf of the represented party— (1) Gives or accepts any notice or request pertinent to the proceedings set forth in this subpart; (2) Presents evidence and allegations as to facts and law in any proceedings affecting that party; and (3) Obtains information to the same extent as the party. (b) A notice or request sent to the representative has the same force and effect as if it is sent to the party. (a) The hearing is open to the parties and to the public. (b) The hearing officer inquires fully into all the matters at issue and receives in evidence the testimony of witnesses and any documents that are relevant and material. (c) The hearing officer provides the parties an opportunity to enter any objection to the inclusion of any document. (d) The hearing officer decides the order in which the evidence and the arguments of the parties are presented and the conduct of the hearing. The hearing officer rules on the admissibility of evidence and may admit evidence that is inadmissible under rules applicable to court procedures. (a) The hearing officer may examine the witnesses. (b) The parties or their representatives are permitted to examine their witnesses and cross-examine witnesses of other parties. (a) Prehearing discovery is permitted upon timely request of a party. (b) A request is timely if it is made before the beginning of the hearing. (c) A reasonable time for inspection and reproduction of documents is provided by order of the hearing officer. (d) The hearing officer's order on all discovery matters is final. The hearing officer may schedule a prehearing conference if he or she believes that a conference may more clearly define the issues. (a) A complete record of the proceedings at the hearing is made and transcribed and made available to all parties upon request. (b) The record may not be closed until a hearing decision is issued. In exercising his or her authority, the hearing officer must comply with the provisions of title XVIII and related provisions of the Act, the regulations issued by the Secretary, and general instructions issued by CMS in implementing the Act. (a) As soon as practical after the close of the hearing, the hearing officer issues a written decision that— (1) Is based upon the evidence of record; and (2) Contains separately numbered findings of fact and conclusions of law. (b) The hearing officer provides a copy of the hearing decision to each party. (c) The hearing decision is final and binding unless it is reversed or modified by the Administrator following review under §423.666, or reopened and revised in accordance with §423.668. (a) Request for review by the Administrator. A PDP sponsor that receives a hearing decision upholding a contract termination determination may request review by the Administrator within 15 days of receiving the hearing decision as provided under §423.665(b). (b) Review by the Administrator. The Administrator must review the hearing officer's decision, and determine, based upon this decision, the hearing record, and any written arguments submitted by the PDP sponsor, whether the termination decision must be upheld, reversed, or modified. (c) Decision by the Administrator. The Administrator issues a written decision, and furnishes the decision to the PDP sponsor requesting review. A decision by the Administrator under section §423.666(c) is final and binding unless it is reopened and revised in accordance with §423.668. (a) Initial or reconsidered determination. CMS may reopen and revise an initial or reconsidered determination upon its own motion within 1 year of the date of the notice of determination. (b) Decision of hearing officer. A decision of a hearing officer that is unfavorable to any party and is otherwise final may be reopened and revised by the hearing officer upon the officer's own motion within 1 year of the notice of the hearing decision. Another hearing officer designated by CMS may reopen and revise the decision if the hearing officer who issued the decision is unavailable. (c) Decision of Administrator. A decision by the Administrator that is otherwise final may be reopened and revised by the Administrator upon the Administrator's own motion within 1 year of the notice of the Administrator's decision. (d) Notices. (1) The notice of reopening and of any revisions following the reopening is mailed to the parties. (2) The notice of revision specifies the reasons for revisions. The revision of a contract or reconsidered determination is binding unless a party files a written request for hearing of the revised determination in accordance with §423.651.
Title 42: Public Health
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart N—Medicare Contract Determinations and Appeals
§ 423.641 Contract determinations.
§ 423.642 Notice of contract determination.
§ 423.643 Effect of contract determination.
§ 423.644 Reconsideration: Applicability.
§ 423.645 Request for reconsideration.
§ 423.646 Opportunity to submit evidence.
§ 423.647 Reconsidered determination.
§ 423.648 Notice of reconsidered determination.
§ 423.649 Effect of reconsidered determination.
§ 423.650 Right to a hearing.
§ 423.651 Request for hearing.
§ 423.652 Postponement of effective date of a contract determination when a request for a hearing for a contract determination is filed timely.
§ 423.653 Designation of hearing officer.
§ 423.654 Disqualification of hearing officer.
§ 423.655 Time and place of hearing.
§ 423.656 Appointment of representatives.
§ 423.657 Authority of representatives.
§ 423.658 Conduct of hearing.
§ 423.659 Evidence.
§ 423.660 Witnesses.
§ 423.661 Discovery.
§ 423.662 Prehearing.
§ 423.663 Record of hearing.
§ 423.664 Authority of hearing officer.
§ 423.665 Notice and effect of hearing decision.
§ 423.666 Review by the Administrator.
§ 423.667 Effect of Administrator's decision.
§ 423.668 Reopening of contract or reconsidered determination or decision of a hearing officer or the Administrator.
§ 423.669 Effect of revised determination.
