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HHS/CMS RIN: 0938-AR60 Publication ID: Fall 2015 
Title: Programs of All-Inclusive Care for the Elderly (PACE) Update (CMS-4168-P) 

This proposed rule would update the PACE regulations published on December 8, 2006. The rule would improve the quality of the existing regulations, provide operational flexibility and modifications, and remove redundancies and outdated information. These updates are intended to ensure the health and safety of PACE participants.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 460   
Legal Authority: 42 U.S.C. 1302    42 U.S.C. 1395    42 U.S.C. 1395eee(f)    42 U.S.C. 1396u-4(f)   
Legal Deadline:  None

Statement of Need:

We are proposing to revise and update policies to reflect subsequent changes in the practice of caring for PACE participants and changes in technology based on our experience implementing and overseeing the PACE program. PACE has proven successful in keeping frail elderly individuals, some of whom are eligible for both Medicare and Medicaid benefits (dual eligibles), in the community. However, we believe that we should revise certain regulatory provisions to afford more flexibility as a means to encourage the expansion of the PACE program to more states, increasing access for participants, and further enhancing the program's effectiveness at providing care while reducing costs.

Summary of the Legal Basis:

Sections 1894(f)(2) and 1934(f)(2) of the Act state that the Secretary shall incorporate the requirements applied to PACE demonstration waiver programs under the PACE Protocol when issuing interim final or final regulations, to the extent consistent with the provisions of sections 1894 and 1934 of the Act, but allow the Secretary to modify or waive these provisions under certain circumstances. Sections 1894(a)(6) and 1934(a)(6) of the Act define the PACE Protocol as the Protocol for PACE as published by On Lok, Inc., as of April 14, 1995, or any successor protocol that may be agreed upon between the Secretary and On Lok, Inc. We issued the 1999 and 2002 interim final rules and the 2006 final rule under this authority.


The requirements for the PACE program have not been comprehensively updated in many years, but the effective and efficient delivery of health care services has changed substantially in that time. We could choose not to make any regulatory changes; however, we believe the changes we are proposing are necessary to ensure the requirements are consistent with current standards of practice and continue to meet statutory obligations. They will ensure that participants receive care that maintains or enhances quality of life and enable them to remain in the community.

Anticipated Costs and Benefits:

As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.


None. The proposals in this rule would update the existing requirements to reflect current standards of practice. In addition, proposed changes would provide added flexibility to providers, improve efficiency and effectiveness, and enhance participant quality of care and life.

Action Date FR Cite
NPRM  02/00/2016 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, State 
Small Entities Affected: Organizations  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Martha Hennessy
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Centers for Medicare, MS: C4-21-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-0575