On September 15, the Centers for Medicare and Medicaid Services (CMS) issued a new set of questions and answers for (Programs of All-Inclusive Care for the Elderly) PACE organizations. CMS provided answers to questions in three areas: overnight care in a PACE center, COVID-19 case reporting requirements, and waivers from PACE regulations.

This document follows CMS guidance documents from March and April, both of which are still in effect today. Summaries of both of these are available from LeadingAge (here and here). This article is meant to summarize the new September 2020 document.

Overnight Care in a PACE Center

CMS provided some clarity on whether PACE organizations are able to provide overnight care in their PACE centers. The short answer: probably, but with some items to consider. Further details are below, and whether the PACE participant needs skilled nursing facility (SNF) care or just overnight care will play a role.

• SNF Care: If the IDT determines that a PACE participant needs skilled nursing facility (SNF) care, the PACE organization may be able to provide that in the PACE center but are required to follow all conditions for being a SNF provider. If the PACE organization is able to meet this threshold, then they should be able to provide SNF care in-house. CMS notes that the agency has issued some flexibility during the COVID-19 pandemic and “will waive certain conditions of participation and certification requirements for opening a nursing facility if the state determines there is a need to quickly stand up a temporary COVID-19 isolation and treatment location.”
• Non-SNF Care: PACE organizations have more flexibility if the IDT determines that a PACE participant needs overnight care to “improve or maintain” their overall health status, but does not need SNF services. If so, overnight care in the PACE center would be allowed if state and local law/licensing standards allow it. CMS recommends that PACE organizations looking to provide overnight care to consult with their state(s) to determine whether this would be allowed.

Waiver from PACE Regulations

CMS declines to waive PACE regulatory requirements or issue blanket waivers for all PACE organizations (as the agency did for some Medicare services). Instead, the agency is relying on its “enforcement discretion” introduced in March 2020 to give flexibility to PACE organizations operating during the pandemic. While no PACE blanket waivers are available, CMS does point out that existing regulation (42 CFR § 460.26) allows for individual PACE organizations to request waivers “in response to their particular needs.”

The regulatory language disallows waivers that would violate the following principles:

1. A focus on frail elderly qualifying individuals who require the level of care provided in a nursing facility.
2. The delivery of comprehensive, integrated acute and long-term care services.
3. An interdisciplinary team approach to care management and service delivery.
4. Capitated, integrated financing that allows the provider to pool payments received from public and private programs and individuals.
5. The assumption by the provider of full financial risk.

PACE organizations seeking such waivers would need to work with their state agencies to do so, as the regulation requires waiver requests to come to CMS from the states.

In the September 2020 document, CMS specifically says they will not waive or lax enforcement on personnel regulations, specifically those required in 42 CFR 460.64 (personnel qualifications) and 460.68a (criminal convictions/exclusion from Medicare or Medicaid). CMS also directs PACE organizations to check with their state agencies/licensing boards on any licensure questions at the state level.

Reporting Positive Cases

CMS directs PACE organizations to follow the Quality Monitoring and Reporting Guidance from April 2018 for the purposes of reporting COVID-19 cases. According to the September document, PACE organizations “are required to report any infectious disease outbreak that meets the following criteria:

1. Has resulted in death, or
2. All incidents that are reportable to the respective state or county public health authority, have three or more cases and are linked to the same infectious agent within the same time frame.

POs must enter this information under the Infectious Disease Outbreak category in HPMS [the Health Plan Management System], and complete the required information, for example, number of participants affected, number hospitalized, and participants’ current status.” The document then reminds organizations of the timelines for reporting quality data: July 15 for 2020 quarter 1, and October 1 for 2020 quarter 2.

If the COVID-19 case needs to be reported to HPMS, the PACE organization must also complete a root cause analysis as part of the data submission.

Finally, PACE organizations must “report positive COVID-19 cases immediately to their local health department and are encouraged to alert their CMS PACE account manager.”

PACE organization members with questions may contact Brendan Flinn of the LeadingAge staff.