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

§ 422.631 Integrated organization determinations. ( a ) *General rule.* An applicable integrated plan must adopt and implement a process for enrollees to request that the plan make an integrated organization determination. The process for requesting that the applicable integrated plan make an integrated organization determination must be the same for all covered benefits. Timeframes and notice requirements for integrated organization determinations for Part B drugs are governed by the provisions for Part B drugs in §§ 422.568(b)(2), 422.570(d)(2), and 422.572(a)(2).
( b ) *Requests.* The enrollee, or a provider on behalf of an enrollee, may request an integrated organization determination orally or in writing, except for requests for payment, which must be in writing (unless the applicable integrated plan or entity responsible for making the determination has implemented a voluntary policy of accepting verbal payment requests).
( c ) *Expedited integrated organization determinations.* ( 1 ) An enrollee, or a provider on behalf of an enrollee, may request an expedited integrated organization determination.
( 2 ) The request can be oral or in writing.
( 3 ) The applicable integrated plan must complete an expedited integrated organization determination when the applicable integrated plan determines (based on a request from the enrollee or on its own) or the provider indicates (in making the request on the enrollee's behalf or supporting the enrollee's request) that taking the time for a standard resolution could seriously jeopardize the enrollee's life, physical or mental health, or ability to attain, maintain, or regain maximum function.
( d ) *Timeframes and notice* — ( 1 ) *Integrated organization determination notice.* ( i ) The applicable integrated plan must send an enrollee a written notice of any adverse decision on an integrated organization determination (including a determination to authorize a service or item in an amount, duration, or scope that is less than the amount previously requested or authorized for an ongoing course of treatment) within the timeframes set forth in this section.
( ii ) For an integrated organization determination not reached within the timeframes specified in this section (which constitutes a denial and is thus an adverse decision), the applicable integrated plan must send a notice on the date that the timeframes expire. Such notice must describe all applicable Medicare and Medicaid appeal rights.
( iii ) Integrated organization determination notices must be written in plain language, be available in a language and format that is accessible to the enrollee, and explain the following: ( A ) The applicable integrated plan's determination.
( B ) The date the determination was made.
( C ) The date the determination will take effect.
( D ) The reasons for the determination.
( E ) The enrollee's right to file an integrated reconsideration and the ability for someone else to file an appeal on the enrollee's behalf.
( F ) Procedures for exercising enrollee's rights to an integrated reconsideration.
( G ) Circumstances under which expedited resolution is available and how to request it.
( H ) If applicable, the enrollee's rights to have benefits continue pending the resolution of the integrated appeal process.
( 2 ) *Timing of notice* — ( i ) *Standard integrated organization determinations.* ( A ) The applicable integrated plan must send a notice of its integrated organization determination at least 10 days before the date of action (that is, before the date on which a termination, suspension, or reduction becomes effective), in cases where a previously approved service is being reduced, suspended, or terminated, except in circumstances where an exception is permitted under §§ 431.213 and 431.214 of this chapter.
( B ) Except as described in paragraph (d)(2)(i)(A) of this section, the applicable integrated plan must send a notice of its integrated organization determination as expeditiously as the enrollee's health condition requires but no later than either of the following: ( 1 ) 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 integrated organization determination.
( 2 ) 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 integrated organization determination.
( ii ) *Extensions.* The applicable integrated plan may extend the timeframe for a standard or expedited integrated organization determination by up to 14 calendar days if— ( A ) The enrollee or provider requests the extension; or
( B ) The applicable integrated plan can show that— ( 1 ) The extension is in the enrollee's interest; and
( 2 ) There is need for additional information and there is a reasonable likelihood that receipt of such information would lead to approval of the request, if received.
( iii ) *Notices in cases of extension.* ( A ) When the applicable integrated plan extends the timeframe, it must notify the enrollee in writing of the reasons for the delay as expeditiously as the enrollee's health condition requires but no later than upon expiration of the extension, and inform the enrollee of the right to file an expedited integrated grievance if he or she disagrees with the applicable integrated plan's decision to grant an extension.
( B ) If the applicable integrated plan extends the timeframe for making its integrated organization determination, it must send the notice of its determination as expeditiously as the enrollee's health condition requires and no later than the date the extension expires.
( iv ) *Expedited integrated organization determinations.* ( A ) The applicable integrated plan must provide notice of its expedited integrated organization determination as expeditiously as the enrollee's health condition requires, but no later than 72 hours after receiving the request.
( B ) If the applicable integrated plan denies the request for an expedited integrated organization determination, it must: ( 1 ) Automatically transfer a request to the standard timeframe and make the determination within the applicable timeframe established in paragraph (d)(2)(i)(B) of this section for a standard integrated organization determination. The timeframe begins the day the applicable integrated plan receives the request for expedited integrated organization determination.
( 2 ) Give the enrollee prompt oral notice of the denial and transfer and subsequently deliver, within 3 calendar days, a written letter that— ( i ) Explains that the applicable integrated plan will process the request using the timeframe for standard integrated organization determinations;
( ii ) Informs the enrollee of the right to file an expedited integrated grievance if he or she disagrees with the applicable integrated plan's decision not to expedite;
( iii ) Informs the enrollee of the right to resubmit a request for an expedited integrated organization determination with any physician's support; and
( iv ) Provides instructions about the integrated grievance process and its timeframes.
( C ) If the applicable integrated plan must receive medical information from noncontract providers, the applicable integrated plan must request the necessary information from the noncontract provider within 24 hours of the initial request for an expedited integrated organization determination. Noncontract providers must make reasonable and diligent efforts to expeditiously gather and forward all necessary information to assist the applicable integrated plan in meeting the required timeframe. Regardless of whether the applicable integrated plan must request information from noncontract providers, the applicable integrated plan is responsible for meeting the timeframe and notice requirements of this section.
( 3 ) *Timeframe for requests for payment.* The applicable integrated plan must process requests for payment according to the “prompt payment” provisions set forth in § 422.520.
( e ) *Dismissing a request.* The applicable integrated plan dismisses a standard or expedited integrated 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 integrated organization determination under § 422.629( l ).
( 2 ) The applicable integrated plan determines the party failed to make out a valid request for an integrated organization determination that substantially complies with paragraph (b) of this section.
( 3 ) An enrollee or the enrollee's representative files a request for an integrated 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 integrated organization determination.
( 4 ) A party filing the integrated organization determination request submits a timely request for withdrawal of their request for an integrated organization determination with the applicable integrated plan.
( f ) *Notice of dismissal.* The applicable integrated plan must mail or otherwise transmit a written notice of the dismissal of the integrated 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 applicable integrated plan vacate the dismissal action.
( 3 ) The right to request reconsideration of the dismissal.
( g ) *Vacating a dismissal.* If good cause is established, the applicable integrated plan may vacate its dismissal of a request for an integrated organization determination within 6 months from the date of the notice of dismissal.
( h ) *Effect of dismissal.* The dismissal of a request for an integrated organization determination is binding unless it is modified or reversed by the applicable integrated plan or vacated under paragraph (g) of this section.
( i ) *Withdrawing a request.* A party that requests an integrated organization determination may withdraw its request at any time before the decision is issued by filing a request with the applicable integrated plan.
[84 FR 15835, Apr. 16, 2019, as amended at 84 FR 23883, May 23, 2019; 86 FR 6102, Jan. 19, 2021; 87 FR 27897, May 9, 2022; 89 FR 8977, Feb. 8, 2024]