CMS Proposes Changes for Programs of All-Inclusive Care for the Elderly (PACE)

The Centers for Medicare & Medicaid Services (CMS) recently proposed a rule that would change how organizations that participate in Programs of All-Inclusive Care for the Elderly (PACE) respond to complaints and address PACE participants' requests for services, while modifying CMS’ monitoring of PACE organizations' corrective actions in contract year 2025.

Proposed Rule Details

First, the Proposed Rule would codify an existing expectation from CMS that PACE organizations respond to complaints in the Complaints Tracking Module (CTM), CMS' central repository for complaints received from sources such as the Medicare Ombudsman, CMS contractors and CMS websites. Currently, CMS requires Medicare Advantage organizations and Part D sponsors (including PACE organizations that provide Part D coverage) to address and resolve complaints received by CMS regarding their services in the CTM. However, the Proposed Rule would impose requirements on PACE organizations for all complaints received in CTM (not just Part D complaints) and would use definitions of "urgent complaint" and "immediate need complaint" that, with respect to PACE organizations, are broader than the definitions in existing guidance. Under the Proposed Rule, all PACE organizations would now be required to:

• resolve "immediate need complaints" within two calendar days of the date on which CMS assigns the complaint to the organization in the CTM (assignment date)
• resolve "urgent complaints" within seven calendar days of the assignment date
• resolve all other complaints within 30 days of the assignment date
• contact the individual who filed the complaint within three calendar days of the assignment date, regardless of the type of complaint received

The Proposed Rule states that an "immediate need complaint" involves a situation that prevents beneficiaries from accessing care or a service for which they have an immediate need, including when the beneficiaries are seeking access to drugs or supplies and only has enough for two or fewer days. Similarly, an "urgent complaint" involves a situation that prevents beneficiaries from accessing care or a service for which they do not have an immediate need, including when beneficiaries are seeking access to drugs or supplies and only has enough to last for three to 14 days.

Notably, in contrast to existing guidance, the Proposed Rule would expand the scope of immediate need and urgent complaints to include situations that involve a beneficiary with a limited supply of non-Part D drugs or supplies, such as drugs covered under Medicare Part B.

However, the CTM obligations from the Proposed Rule would not change a PACE organization's responsibility to resolve grievances or appeals currently addressed in other PACE regulations. To the extent that CMS receives a CTM complaint that would also be considered a grievance or appeal in the current PACE regulations, the Proposed Rule states that the PACE organization must also meet the regulatory requirements, notices and/or deadlines set forth in the applicable PACE regulations pertaining to grievances and appeals.

Second, the Proposed Rule would modify how a PACE organization’s interdisciplinary team (IDT) addresses service determination requests made by a PACE participant prior to the finalization of the participant's initial plan of care. Current regulations require PACE organizations to follow specific processes to review and resolve so-called "service determination requests," a participant's request to initiate, modify or continue coverage of a service.

Under a regulation finalized in January 2021, requests that occur before the development of a PACE participant's initial plan of care are not "service determination requests" and are not subject to the review processes in the PACE regulations. Although CMS believed this change would allow the PACE participant and the IDT to discuss these kinds of requests during the care planning process, it has found that these discussions have not been occurring. Consequently, the Proposed Rule would now require the IDT to address service requests made prior to developing the participant's initial plan of care by documenting them, discussing them, and either 1) approving and incorporating them into the participant's initial plan of care or 2) denying them and documenting the rationale for doing so.

Lastly, the Proposed Rule appears to ease some of the oversight on PACE organizations by giving discretion to CMS and the state agency responsible for administering the PACE program over whether to monitor a PACE organization's corrective actions. Under current regulations, CMS and the state agency administering the PACE program must monitor the effectiveness of every corrective action that a PACE organization is required to take when it fails to substantially comply with PACE program requirements.

Conclusion and Next Steps

CMS has concluded that this level of monitoring is a heavy burden (especially as the PACE program continues to grow) and that it is not always "necessary or worthwhile" to conduct this monitoring. Consequently, the Proposed Rule would modify existing regulations so that CMS or the state agency may monitor corrective actions at their discretion. Notably, the Proposed Rule states that this modification would not change the expectation that PACE organizations "expeditiously and fully correct any identified deficiencies."

CMS is accepting comments about the Proposed Rule. Comments must be received before 5 p.m. ET on Jan. 5, 2024, to be considered.

For more information on the Proposed Rule or PACE in general, please contact the authors or any member of Holland & Knight's Healthcare Regulatory Compliance Team.

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