Editorial Note on Part 422
Editorial Note: Nomenclature changes to part 422 appear at 70 FR 4741, Jan. 28, 2005.

§ 422.568 Standard timeframes and notice requirements for organization determinations. ( a ) *Method and place for filing a request.* An enrollee must ask for a standard organization determination by making a request with the MA organization or, if applicable, to the entity responsible for making the determination (as directed by the MA organization), in accordance with the following: ( 1 ) The request may be made orally or in writing, except as provided in paragraph (a)(2) of this section.
( 2 ) Requests for payment must be made in writing (unless the MA organization or entity responsible for making the determination has implemented a voluntary policy of accepting verbal payment requests).
( b ) *Timeframes* — ( 1 ) *Requests for service or item.* Except as provided in paragraph (b)(2) of this section, when a party has made a request for an item or service, the MA organization must notify the enrollee of its determination as expeditiously as the enrollee's health condition requires but no later than either of the following: ( i ) For a service or item not subject to the prior authorization rules in § 422.122, 14 calendar days after receiving the request for the standard organization determination.
( ii ) Beginning on or after January 1, 2026, for a service or item subject to the prior authorization rules in § 422.122, 7 calendar days after receiving the request for the standard organization determination.
( 2 ) *Extensions; requests for service or item* — ( i ) *Extension of timeframe on a request for service or item.* The MA organization may extend the timeframe by up to 14 calendar days under any of the following circumstances: ( A ) The enrollee requests the extension.
( B ) The extension is justified and in the enrollee's interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization's decision to deny an item or service.
( C ) The extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee's interest.
( ii ) *Notice of extension.* ( A ) When the MA organization extends the timeframe, it must— ( 1 ) Notify the enrollee in writing of the reasons for the delay; and
( 2 ) Inform the enrollee of the right to file an expedited grievance if the enrollee disagrees with the MA organization's decision to grant an extension.
( B ) The MA organization must notify the enrollee of its determination as expeditiously as the enrollee's health condition requires, but no later than upon expiration of the extension.
( 3 ) *Requests for a Part B drug.* An MA organization 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. This 72-hour period may not be extended under the provisions in paragraph (b)(2) of this section.
( c ) *Timeframe for requests for payment.* The MA organization must process requests for payment according to the “prompt payment” provisions set forth in § 422.520.
( d ) *Written notice for MA organization denials.* The MA organization must give the enrollee a written notice if— ( 1 ) An MA organization decides to deny a service or an item, Part B drug, or payment in whole or in part, or reduce or prematurely discontinue the level of care for a previously authorized ongoing course of treatment.
( 2 ) An enrollee requests an MA organization to provide an explanation of a practitioner's denial of an item, service or Part B drug, in whole or in part.
( e ) *Form and content of the MA organization notice.* The notice of any denial under paragraph (d) of this section must— ( 1 ) Use approved notice language in a readable and understandable form;
( 2 ) State the specific reasons for the denial;
( 3 ) Inform the enrollee of his or her right to a reconsideration;
( 4 ) ( i ) For service, item, and Part B drug denials, describe both the standard and expedited reconsideration processes, including the enrollee's right to, and conditions for, obtaining an expedited reconsideration and the rest of the appeal process; and
( ii ) For payment denials, describe the standard reconsideration process and the rest of the appeal process; and
( 5 ) Comply with any other notice requirements specified by CMS.
( f ) *Effect of failure to provide timely notice.* If the MA organization fails to provide the enrollee with timely notice of an organization determination as specified in this section, this failure itself constitutes an adverse organization determination and may be appealed.
( g ) *Dismissing a request.* The MA organization dismisses an organization determination request, either entirely or as to any stated issue, under any of the following circumstances: ( 1 ) The individual or entity making the request is not permitted to request an organization determination under § 422.566(c).
( 2 ) The MA organization determines the party failed to make out a valid request for an organization determination that substantially complies with paragraph (a) of this section.
( 3 ) An enrollee or the enrollee's representative files a request for an organization determination, but the enrollee dies while the request is pending, and both of the following apply: ( i ) The enrollee's surviving spouse or estate has no remaining financial interest in the case.
( ii ) No other individual or entity with a financial interest in the case wishes to pursue the organization determination.
( 4 ) A party filing the organization determination request submits a timely request for withdrawal of their request for an organization determination with the MA organization.
( h ) *Notice of dismissal.* The MA organization must mail or otherwise transmit a written notice of the dismissal of the organization 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 MA organization vacate the dismissal action.
( 3 ) The right to request reconsideration of the dismissal.
( i ) *Vacating a dismissal.* If good cause is established, the MA organization may vacate its dismissal of a request for an organization determination within 6 months from the date of the notice of dismissal.
( j ) *Effect of dismissal.* The dismissal of a request for an organization determination is binding unless it is modified or reversed by the MA organization upon reconsideration or vacated under paragraph (i) of this section.
( k ) *Withdrawing a request.* A party that requests an organization determination may withdraw its request at any time before the decision is issued by filing a request with the MA organization.
[65 FR 40329, June 29, 2000, as amended at 70 FR 4739, Jan. 28, 2005; 70 FR 52027, Sept. 1, 2005; 75 FR 19812, Apr. 15, 2010; 75 FR 32859, June 10, 2010; 80 FR 7961, Feb. 12, 2015; 84 FR 23880, May 23, 2019; 86 FR 6101, Jan. 19, 2021; 89 FR 8976, Feb. 8, 2024]