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HHS/OIG | RIN: 0936-AA10 | Publication ID: Fall 2019 |
Title: Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement | |
Abstract:
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. |
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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 |
EO 13771 Designation: Fully or Partially Exempt | |
CFR Citation: 42 CFR 1001.952 42 CFR 1003.110 | |
Legal Authority: 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 |
Legal Deadline:
None |
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Statement of Need: 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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Summary of the Legal Basis:
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Alternatives: 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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Anticipated Costs and Benefits: 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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Risks: 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. |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: Yes | |
RIN Data Printed in the FR: No | |
Agency Contact: Meredith Williams Senior Counsel Department of Health and Human Services Office of the Inspector General 330 Independence Avenue SW, Washington, DC 20201 Phone:202 619-2580 Email: meredith.williams@oig.hhs.gov |