0936-AA10 201910 The Regulatory Plan and the 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 proposed 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 proposes to 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 proposed rule also proposes modifications to some existing safe harbors and codification of new statutory safe harbors and CMP exceptions.

]]> Other Significant Previously Published in The Unified Agenda Proposed 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 sec. 102 of the Social Security Act Yes

The Department has identified the broad reach of the Federal anti-kickback statute and beneficiary inducements CMP as potentially inhibiting beneficial arrangements that would advance the ability of providers, suppliers, and others to transition more effectively and efficiently to value-based care and to better coordinate care among providers, suppliers, and others in both the Federal health care programs and commercial sectors.  To the extent providers are discouraged from entering into innovative arrangements, patient care may not be provided as efficiently as possible.  In addition, the potential consequences of noncompliance with these statutes may impede the ability of providers, suppliers, and others, including small providers and suppliers or those serving rural or medically underserved populations, to raise capital to invest in the transition to value-based care or to obtain infrastructure necessary to coordinate patient care, including technology.  This proposed rule attempts to address these concerns by removing unnecessary impediments to the transformation of the healthcare system into one that better pays for and delivers value.

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  • Section 1128B of the Act, the anti-kickback statue;
  • Section 205 of HIPAA established section 1128D of the Act (42 U.S.C. 1320a-7d), which includes criteria for modifying and establishing safe harbors under the anti-kickback statute;
  • Section 1128A(a)(5) of the Act sets forth civil monetary penalties for prohibited beneficiary inducements and section 1128A(i)(6) defines "remuneration";
  • We proposed to amend the definition of "remuneration"in the CMP rules at 42 CFR 1003.110.

 

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We considered both more restrictive and less restrictive proposals. We considered whether we could achieve the same results by modifying existing safe harbors rather than establishing a new framework for coordinated and value-based arrangements. We also considered not using the value-based framework for several of the proposed safe harbors, but we concluded that the fraud and abuse risks of protecting arrangements without the guardrails created by the value-based framework were too high.

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There are no significant costs associated with the proposed regulatory revisions that would impose any mandates on State, local or Tribal Governments or on the private sector.

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It is a challenge to predict the effects of this regulatory action in a rapidly evolving and diverse healthcare ecosystem of substantial innovation, experimentation, and deployment of technology and digital data. Our goal is to finalize safe harbors that protect arrangements that foster beneficial arrangements and promote value, while also protecting programs and beneficiaries against harms caused by fraud and abuse.

]]> 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 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