0936-AA10 202004 Unified Agenda of Federal Regulatory and Deregulatory Actions 0936 Office of the Inspector General OIG 0900 Department of Health and Human Services HHS Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement

This rule is being issued by the Office of Inspector General (OIG) in conjunction with the Department of Health and Human Services’ Regulatory Sprint to Coordinated Care.  It will add safe harbor protections under the Federal anti-kickback statute for certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions.  It also would add protections under the anti-kickback statute and civil monetary penalty (CMP) law that prohibits inducements offered to patients for certain patient engagement and support arrangements to improve quality of care, health outcomes, and efficiency of care delivery that squarely meet all safe harbor conditions. The rule also modifies some existing safe harbors and the codification of new statutory safe harbors and CMP exception.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No Fully or Partially Exempt 42 CFR 1001.952 42 CFR 1003.110 Bipartisan Budget Act of 2018 (BBA, Pub. L. No. 115-123), secs. 50341 and 50412 sec. 1128D(b) of the Social Security Act and section 102 of the Social Security Act Yes Request for Information 08/27/2018 83 FR 43607 Request for Information Comment Period End 10/26/2018 NPRM 10/17/2019 84 FR 55694 NPRM Comment Period End 12/31/2019 Final Action 08/00/2020 No No None No No No Meredith Williams Senior Counsel 0936 Office of the Inspector General OIG 202 619-2580 meredith.williams@oig.hhs.gov 330 Independence Avenue SW, Washington DC 20201