Health and Human Services Department,
This final rule amends the safe harbors to the Federal anti- kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. This rule is issued in conjunction with the Department of Health and Human Services' (HHS's) Regulatory Sprint to Coordinated Care and focuses on care coordination and value-based care. This rule also amends the civil monetary penalty (CMP) rules by codifying a revision to the definition of "remuneration" added by the Bipartisan Budget Act of 2018 (Budget Act of 2018).
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Office of Inspector General 42 CFR Parts 1001 and 1003 RIN 0936-AA10 AGENCY: Office of Inspector General (OIG), Department of Health and Human Services (HHS). ACTION: Final rule. SUMMARY: This final rule amends the safe harbors to the Federal anti-kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. This rule is issued in conjunction with the Department of Health and Human Services' (HHS's) Regulatory Sprint to Coordinated Care and focuses on care coordination and value-based care. This rule also amends the civil monetary penalty (CMP) rules by codifying a revision to the definition of “remuneration” added by the Bipartisan Budget Act of 2018 (Budget Act of 2018). DATES: These regulations are effective January 19, 2021. FOR FURTHER INFORMATION CONTACT: Stewart Kameen or Samantha Flanzer, Office of Counsel to the Inspector General, (202) 619-0335. SUPPLEMENTARY INFORMATION: Social Security Act citation United States Code citation 1128B, 1128D, 1102, 1128A 42 U.S.C. 1320a-7b , 42 U.S.C. 1320a-7d , 42 U.S.C. 1302 , 42 U.S.C. 1320a-7a . I. Executive Summary A. Purpose of the Regulatory Action The Secretary of HHS (the Secretary) has identified transforming the U.S. health care system to one that pays for value as a top priority. Unlike the traditional fee-for-service (FFS) payment system, wh…
Citation: 85 FR 77684
