Editorial Note on Part 460
Editorial Note: Nomenclature changes to part 460 appear at 67 FR 61504, Oct. 1, 2002.

§ 460.122 PACE organization's appeals process. For purposes of this section, an appeal is a participant's action taken with respect to the PACE organization's noncoverage of, or nonpayment for, a service including denials, reductions, or termination of services. A request to initiate, modify or continue a service must first be processed as a service determination request under § 460.121 before the PACE organization can process an appeal under this section. ( a ) *PACE organization's written appeals process.* The PACE organization must have a formal written appeals process, with specified timeframes for response, to address noncoverage or nonpayment of a service.
( b ) *Notification of participants.* Upon enrollment, at least annually thereafter, and whenever the interdisciplinary team denies a service determination request or request for payment, the PACE organization must give a participant written information on the appeals process.
( c ) *Minimum requirements.* At a minimum, the PACE organization's appeals process must include written procedures for the following: ( 1 ) Timely preparation and processing of a written denial of coverage or payment as provided in §§ 460.121(i) and (m).
( 2 ) How a participant or their designated representative files an appeal, including procedures for accepting oral and written appeal requests.
( 3 ) Documentation of a participant's appeal.
( 4 ) Review of an appeal by an appropriate third party reviewer or committee. An appropriate third party reviewer or member of a review committee must be an individual who meets all of the following: ( i ) Appropriately credentialed in the field(s) or discipline(s) related to the appeal.
( ii ) An impartial third party who meets both of the following: ( A ) Was not involved in the original action.
( B ) Does not have a stake in the outcome of the appeal.
( 5 ) The distribution of written or electronic materials to the third party reviewer or committee that, at a minimum, explain all of the following: ( i ) Services must be provided in a manner consistent with the requirements in §§ 460.92 and 460.98.
( ii ) The need to make decisions in a manner consistent with how determinations under section 1862(a)(1)(A) of the Act are made.
( iii ) The rules in § 460.90(a) that specify that certain limitations and conditions applicable to Medicare or Medicaid or both benefits do not apply.
( 6 ) Responses to, and resolution of, appeals as expeditiously as the participant's health condition requires, but no later than 30 calendar days after the organization receives an appeal.
( 7 ) Maintenance of confidentiality of appeals.
( d ) *Opportunity to submit evidence.* A PACE organization must give all parties involved in the appeal a reasonable opportunity to present evidence related to the dispute, in person, as well as in writing.
( e ) *Services furnished during appeals process.* During the appeals process, the PACE organization must meet the following requirements: ( 1 ) For a Medicaid participant, continue to furnish the disputed services until issuance of the final determination if the following conditions are met: ( i ) The PACE organization is proposing to terminate or reduce services currently being furnished to the participant.
( ii ) The participant requests continuation with the understanding that he or she may be liable for the costs of the contested services if the determination is not made in his or her favor.
( 2 ) Continue to furnish to the participant all other required services, as specified in subpart F of this part.
( f ) *Expedited appeals process.* ( 1 ) A PACE organization must have an expedited appeals process for situations in which the participant believes that his or her life, health, or ability to regain or maintain maximum function could be seriously jeopardized, absent provision of the service in dispute.
( 2 ) Except as provided in paragraph (f)(3) of this section, the PACE organization must respond to the appeal as expeditiously as the participant's health condition requires, but no later than 72 hours after it receives the appeal.
( 3 ) The PACE organization may extend the 72-hour timeframe by up to 14 calendar days for either of the following reasons: ( i ) The participant requests the extension.
( ii ) The organization justifies to the State administering agency the need for additional information and how the delay is in the interest of the participant.
( g ) *Notification.* A PACE organization must give all parties involved in the appeal appropriate written notification of the decision to approve or deny the appeal. ( 1 ) *Notice of a favorable decision.* Notice of any favorable decision must explain the conditions of the approval in understandable language.
( 2 ) *Notice of partially or fully adverse decisions.* ( i ) Notice of any denial must— ( A ) State the specific reason(s) for the denial;
( B ) Explain the reason(s) why the service would not improve or maintain the participant's overall health status;
( C ) Inform the participant of his or her right to appeal the decision; and
( D ) Describe the external appeal rights under § 460.124.
( ii ) At the same time the decision is made, the PACE organization must also notify the following: ( A ) CMS.
( B ) The State administering agency.
( h ) *Actions following a favorable decision.* A PACE organization must furnish the disputed service as expeditiously as the participant's health condition requires if a determination is made in favor of the participant on appeal.
( i ) *Analyzing appeals information.* A PACE organization must maintain, aggregate, and analyze information on appeal proceedings and use this information in the organization's internal quality improvement program.
[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71336, Dec. 8, 2006; 84 FR 25675, June 3, 2019; 86 FR 6134, Jan. 19, 2021]