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e-CFR data is current as of April 13, 2021

Amendment


42 CFR--PART 460

View Printed Federal Register page 86 FR 6132 in PDF format.

Amendment(s) published January 19, 2021, in 86 FR 6132

Effective Dates: Mar. 22, 2021

97. Section 460.121 is added to read as follows:

§460.121   Service determination process.

(a) Written procedures. Each PACE organization must have formal written procedures for identifying and processing service determination requests in accordance with the requirements of this Part.

(b) What is a service determination request—(1) Requests that constitute a service determination request. Except as provided in paragraph (b)(2) of this section, the following requests constitute service determination requests:

(i) A request to initiate a service.

(ii) A request to modify an existing service, including to increase, reduce, eliminate, or otherwise change a service.

(iii) A request to continue coverage of a service that the PACE organization is recommending be discontinued or reduced.

(2) Requests that do not constitute a service determination request. Requests to initiate, modify, or continue a service do not constitute a service determination request if the request is made prior to completing the development of the initial plan of care.

(c) Who can make a service determination request. Any of the following individuals can make a service determination request:

(1) The participant.

(2) The participant's designated representative.

(3) The participant's caregiver.

(d) Method for making a service determination request. An individual may make a service determination request as follows:

(1) Either orally or in writing.

(2) To any employee or contractor of the PACE organization that provides direct care to a participant in the participant's residence, the PACE center, or while transporting participants.

(e) Processing a service determination request. (1) Except as provided in paragraph (e)(2) of this section, the PACE organization must bring a service determination request to the interdisciplinary team as expeditiously as the participant's condition requires, but no later than 3 calendar days from the time the request is made.

(2) If a member of the interdisciplinary team is able to approve the service determination request in full at the time the request is made, the PACE organization—

(i) Must fulfill all of the following:

(A) Notice of the decision to approve a service determination request requirements specified in paragraph (j)(1) of this section.

(B) Effectuation requirements specified in paragraph (k) of this section.

(C) Recordkeeping requirements specified in paragraph (m) of this section.

(ii) Is not required to process the service determination request in accordance with paragraphs (f) through (i), (j)(2), and (l) of this section.

(f) Who must review a service determination request. The full interdisciplinary team must review and discuss each service determination request and decide to approve, deny, or partially deny the request based on that review.

(g) Interdisciplinary team decision making. The interdisciplinary team must consider all relevant information when evaluating a service determination request, including, but not limited to, the findings and results of any reassessments required in paragraph (h) of this section, as well as the criteria specified in §460.92(b).

(h) Reassessments in response to a service determination request. (1) If the interdisciplinary team expects to deny or partially deny a service determination request, the appropriate members of the interdisciplinary team, as identified by the interdisciplinary team, must conduct an in-person reassessment before the interdisciplinary team makes a final decision. The team members performing the reassessment must evaluate whether the requested service is necessary to meet the participant's medical, physical, emotional, and social needs.

(2) The interdisciplinary team may conduct a reassessment prior to approving a service determination request, either in-person or through the use of remote technology, if the team determines that a reassessment is necessary.

(i) Notification timeframe. Except as provided in paragraph (i)(1) of this section, when the interdisciplinary team receives a service determination request, it must make its decision and notify the participant or their designated representative of its decision as expeditiously as the participant's condition requires, but no later than 3 calendar days after the date the interdisciplinary team receives the request.

(1) Extensions. The interdisciplinary team may extend the timeframe for review and notification by up to 5 calendar days if either of the following occur:

(i) The participant or other requestor listed in paragraph (c)(2) or (3) of this section requests the extension.

(ii) The extension is in the participant's interest because the interdisciplinary team needs additional information from an individual not directly employed by the PACE organization that may change the interdisciplinary team's decision to deny a service. The interdisciplinary team must document the circumstances that led to the extension and demonstrate how the extension is in the participant's best interest.

(2) Notice of extension. When the interdisciplinary team extends the timeframe, it must notify the participant or their designated representative in writing. The notice must explain the reason(s) for the delay and must be issued as expeditiously as the participant's condition requires, but no later than 24 hours after the IDT decides to extend the timeframe.

(j) Notification requirements—(1) Notice of decisions to approve a service determination request. If the interdisciplinary team makes a determination to approve a service determination request, it must provide the participant or the designated representative either oral or written notice of the determination. Notice of any decision to approve a service determination request must explain the conditions of the approval in understandable language, including when the participant may expect to receive the approved service.

(2) Notice of decisions to deny a service determination request. If the interdisciplinary team decides to deny or partially deny a service, it must provide the participant or the designated representative both oral and written notice of the determination. Notice of any denial must—

(i) State the specific reason(s) for the denial, including why the service is not necessary to maintain or improve the participant's overall health status, taking into account the participant's medical, physical, emotional, and social needs, and the results of the reassessment(s) in understandable language.

(ii) Inform the participant or designated representative of his or her right to appeal the decision under §460.122.

(iii) Describe the standard and expedited appeals processes, including the right to, and conditions for, obtaining expedited consideration of an appeal of a denial of services as specified in §460.122.

(iv) For a Medicaid participant, inform the participant of both of the following, as specified in §460.122(e)(1):

(A) His or her right to continue receiving disputed services during the appeals process until issuance of the final determination.

(B) The conditions for continuing to receive disputed services.

(k) Effectuation requirements. If the interdisciplinary team approves a service determination request, in whole or in part, the PACE organization must provide the approved service as expeditiously as the participant's condition requires, taking into account the participant's medical, physical, emotional, and social needs. The interdisciplinary team must explain when the participant may expect to receive the service in accordance with paragraph (j)(1) of this section.

(l) Effect of failure to meet the processing timeframes. If the interdisciplinary team fails to provide the participant with timely notice of the resolution of the request or does not furnish the services required by the revised plan of care, this failure constitutes an adverse decision, and the participant's request must be automatically processed by the PACE organization as an appeal in accordance with §460.122.

(m) Recordkeeping. The PACE organization must establish and implement a process to document, track, and maintain records related to all processing requirements for service determination requests received both orally and in writing. These records must be available to the interdisciplinary team to ensure that all members remain alert to pertinent participant information.

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