§ 423.568 Standard timeframe and notice requirements for coverage determinations. ( a ) *Method and place for filing a request.* An enrollee must ask for a standard coverage determination by making a request with the Part D plan sponsor in accordance with the following: ( 1 ) Except as specified in paragraph (a)(2) of this section, the request may be made orally or in writing.
( 2 ) Requests for payment must be made in writing (unless the Part D plan sponsor has implemented a voluntary policy of accepting oral payment requests).
( 3 ) The Part D plan sponsor must establish and maintain a method of documenting all oral requests and retain the documentation in the case file.
( b ) *Timeframe for requests for drug benefits.* When a party makes a request for a drug benefit, the Part D plan sponsor must notify the enrollee (and the prescribing physician or other prescriber involved, as appropriate) of its determination as expeditiously as the enrollee's health condition requires, but no later than 72 hours after receipt of the request. For an exceptions request, the Part D plan sponsor must notify the enrollee (and the prescribing physician or other prescriber involved, as appropriate) of its determination as expeditiously as the enrollee's health condition requires, but no later than 72 hours after receipt of the physician's or other prescriber's supporting statement. If a supporting statement is not received by the end of 14 calendar days from receipt of the exceptions request, the Part D plan sponsor must notify the enrollee (and the prescribing physician or other prescriber involved, as appropriate) of its determination as expeditiously as the enrollee's health condition requires, but no later than 72 hours from the end of 14 calendar days from receipt of the exceptions request.
( c ) *Timeframe for requests for payment.* When a party makes a request for payment, the Part D plan sponsor must notify the enrollee of its determination and make payment (when applicable) no later than 14 calendar days after receipt of the request.
( d ) *Written notice for favorable decisions by a Part D plan sponsor.* If a Part D plan sponsor makes a completely favorable decision under paragraph (b) of this section, it must give the enrollee written notice of the determination. The initial notice may be provided orally, so long as a written follow-up notice is sent within 3 calendar days of the oral notification.
( e ) *Form and content of the approval notice.* The notice of any approval under paragraph (d) of this section must explain the conditions of the approval in a readable and understandable form.
( f ) *Written notice for denials by a Part D plan sponsor.* If a Part D plan sponsor decides to deny a drug benefit, in whole or in part, it must give the enrollee written notice of the determination. The initial notice may be provided orally, so long as a written follow-up notice is mailed to the enrollee within 3 calendar days of the oral notification.
( g ) *Form and content of the denial notice.* The notice of any denial under paragraph (f) of this section must meet the following requirements: ( 1 ) Use approved notice language in a readable and understandable form.
( 2 ) State the specific reasons for the denial. ( i ) For drug coverage denials, describe both the standard and expedited redetermination processes, including the enrollee's right to, and conditions for, obtaining an expedited redetermination and the rest of the appeals process.
( ii ) For payment denials, describe the standard redetermination process and the rest of the appeals process.
( 3 ) Inform the enrollee of his or her right to a redetermination.
( 4 ) Comply with any other notice requirements specified by CMS.
( h ) *Effect of failure to meet the adjudicatory timeframes.* If the Part D plan sponsor fails to notify the enrollee of its determination in the appropriate timeframe under paragraphs (b) or (c) of this section, the failure constitutes an adverse coverage determination, and the plan sponsor must forward the enrollee's request to the IRE within 24 hours of the expiration of the adjudication timeframe.
( i ) *Dismissing a request.* The Part D plan sponsor dismisses a coverage determination request, either entirely or as to any stated issue, under any of the following circumstances: ( 1 ) When the individual making the request is not permitted to request a coverage determination under § 423.566(c).
( 2 ) When the Part D plan sponsor determines the party failed to make out a valid request for a coverage determination that substantially complies with paragraph (a) of this section.
( 3 ) When an enrollee or the enrollee's representative files a request for a coverage determination, but the enrollee dies while the request is pending, and both of the following criteria apply: ( i ) The enrollee's surviving spouse or estate has no remaining financial interest in the case.
( ii ) The enrollee's representative, if any, does not wish to pursue the request for coverage.
( 4 ) When a party filing the coverage determination request submits a timely request for withdrawal of the request for a coverage determination with the Part D plan sponsor.
( j ) *Notice of dismissal.* The Part D plan must mail or otherwise transmit a written notice of the dismissal of the coverage determination request to the parties. The notice must state all of the following: ( 1 ) The reason for the dismissal.
( 2 ) The right to request that the Part D plan sponsor vacate the dismissal action.
( 3 ) The right to request redetermination of the dismissal.
( k ) *Vacating a dismissal.* If good cause is established, the Part D plan sponsor may vacate its dismissal of a request for coverage determination within 6 months from the date of the notice of dismissal.
( l ) *Effect of dismissal.* The Part D plan sponsor's dismissal is binding unless it is modified or reversed by the Part D plan sponsor or vacated under paragraph (k) of this section.
( m ) *Withdrawing a request.* A party that requests a coverage determination may withdraw its request at any time before the decision is issued by filing a request with the Part D plan sponsor.
[75 FR 19823, Apr. 15, 2010, as amended at 76 FR 21576, Apr. 15, 2011; 84 FR 15843, Apr. 16, 2019; 86 FR 6119, Jan. 19, 2021; 86 FR 29528, June 2, 2021]