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Winter 2020 - Integrated Care

CMS Finalizes Rule for Programs of All-Inclusive Care for the Elderly

The Centers for Medicare and Medicaid Services (CMS) has finalized a rule to update and modernize the Programs of All-Inclusive Care for the Elderly (PACE) that reflects updates based upon best practices in caring for frail and elderly individuals. PACE provides comprehensive medical and social services to certain frail, elderly individuals who qualify for nursing home care but, at the time of enrollment, can still live safely in the community.

The final rule provides administrative flexibility and regulatory relief for PACE organizations. Previously, team members could serve in only one role on the team. Now, one individual can fill two separate roles on the team under certain circumstances to better meet participants’ needs and participate in more aspects of participants’ care. It will allow certain nonphysician primary care providers to provide some services in place of primary care physicians.

The rule also strengthens protections and improves care for PACE participants. It clarifies that PACE organizations offering qualified prescription drug coverage must comply with Medicare Part D prescription drug program requirements unless the requirement has been waived; implements changes related to PACE enforcement actions, including sanctions and civil money penalties, to strengthen CMS’s ability to hold PACE organizations accountable for providing quality care and protecting PACE participants from harm; and adds language to help ensure individuals with a conviction for a criminal offense relating to physical, sexual or drug or alcohol abuse or use will not be employed by a PACE organization in any capacity where their contact with patients would pose a potential risk.

In addition, the rule provides greater operational flexibility, removes redundancies and outdated information, and codifies existing practice of relying on automated review systems for processing initial applications to become a PACE organization and expansion applications for existing PACE organizations. And, it modifies the PACE regulations to eliminate the need for PACE organizations to request waivers for a number of the most commonly waived provisions. Finally, it includes important clarifications to enrollment policies, quality improvement and other requirements for PACE organizations, resulting in more consistent, transparent and comprehensible regulations and guidance.


Programs of All-Inclusive Care for the Elderly (PACE) Final Rule (CMS-4168-F). Centers for Medicare and Medicaid Services press release, May 28, 2019. Accessed at

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.