On August 11, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (CMS-4168-P) to revise and update regulations from the 2006 Final rule for Programs of All-Inclusive Care for the Elderly (PACE). CMS states that the changes in the proposed rule will strengthen protections for beneficiaries and provide administrative flexibility and regulatory relief for PACE organizations. The proposed rule will also remove redundancies, outdated information, and codify existing practice. The proposed rule was published at the Office of the Federal Register on August 16, 2016, and public comments are due on Monday, October 17, 2016, after a 60-day comment period. LeadingAge National is in the process of reviewing the proposed rule and preparing comments.
The proposed rule addresses several program elements including:
Administrative flexibility and regulatory relief for PACE organizations
- CMS is proposing to modify the PACE Program Agreement. The changes would permit more frequent updates of information crucial to PACE organizations while streamlining and making more efficient the development of Program Agreements.
- CMS is proposing a more flexible approach to the composition of the interdisciplinary team in order to allow the team to better meet beneficiaries’ needs. Team members would be able to participate in more aspects of a participant’s care than is currently the case, which would strengthen the ability of PACE organizations to provide more seamless care and better tailor care to individual participants. Currently, team members can fulfill only one role on the care team.
- CMS is proposing to remove “recreational therapist or activity coordinator” from the list of the interdisciplinary team members that must participate in the semiannual reassessment.
- CMS is proposing to allow non-physician primary care practitioners to provide some services in the place of primary care physicians. This change would give PACE organizations flexibility and improve efficiency, while ensuring that PACE organizations continue to meet the needs and preferences of participants.
Additional beneficiary protections
- Clarifying that PACE organizations offering qualified prescription drug coverage must adopt two key elements of the Part D compliance program in the PACE regulations. Specifically, CMS would require each PACE organization (PO) to develop compliance oversight requirements that would be responsible for monitoring and auditing their organization for compliance with our regulations. Additionally, CMS would require POs to have measures that prevent, detect and correct non-compliance with CMS’s program requirements as well as measures that prevent, detect, and correct fraud, waste, and abuse.
- Proposing changes to sanctions, enforcement actions, and terminations to strengthen CMS’ ability to hold PACE organizations accountable and decrease the risk of harm to PACE participants.
- Adding language to ensure that individuals with convictions for physical, sexual, drug or alcohol abuse are not employed in any capacity where their contact would pose a potential risk to beneficiaries in the PACE program.
- CMS is proposing amendments to specifically prohibit POs from using non-employed agents/brokers, including contracted entities, to market PACE programs.
Oversight
- CMS is proposing to use technology to enhance efficiencies in monitoring by remotely reviewing PACE organization documents, which they have to date reviewed primarily through site visits. CMS would reduce the number of onsite visits after the 3-year trial period by utilizing a risk assessment to select which PACE organization will be audited each year. This risk assessment would rely largely on an organization’s past performance and ongoing compliance with CMS and state requirements.
- The proposed rule would allow CMS the discretion to take alternative actions in the form of sanctions or Civil Monetary Penalties when they are authorized to terminate a PACE program agreement. This new provision aligns the PACE enforcement structure with the enforcement structure that applies to Medicare Advantage.
