CMS Announces Proposed Stark and Anti-Kickback Rule Revisions

On October 9, 2019, the Centers for Medicare & Medicaid Services announced two major proposed rule changes affecting both the Stark and Anti-Kickback Statutes. The first is “Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations” and the second, “Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements.” The intended purpose of the revisions is the elimination of some of the burdens of compliance, additional incentives for coordinated care, and incentives for certain types of technology sharing to encourage cybersecurity and EHR implementation.

Revisions to Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulation

The first of the two proposed rule changes attempts to address “undue regulatory impact and burden” of the physician self-referral law. The proposed rule proposes exceptions to the self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It would also create a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; create a new exception for donations of cybersecurity technology and related services; and amend the existing exception for electronic health records (EHR) items and services. This proposed rule also provides “critically necessary” guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.

The full text of the proposed rule change can be found here.

Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

The Safe Harbor Revisions rule change proposes to add additional 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 would also add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for electronic health records (EHR) arrangements, warranties, local transportation, and personal services and management contracts. Further, the proposed rule would add a new safe harbor pursuant to a statutory change set forth in the Bipartisan Budget Act of 2018 (Budget Act of 2018) related to beneficiary incentives under the Medicare Shared Savings Program and a new CMP exception for certain telehealth technologies offered to patients receiving in-home dialysis, also pursuant to the Budget Act of 2018.

The full text of the proposed rule change can be found here.


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NOTE: This post is provided for general information purposes and is not, by itself, intended to create an attorney-client relationship or provide legal, accounting, or other professional advice.

Bush Health Law PLLC is law firm that offers legal counsel to clinicians, researchers, and organizations to support the mission of quality, innovative healthcare. With offices in Gainesville, Florida, the firm serves healthcare clients throughout Florida. Copyright © 2019 Bush Health Law PLLC. All rights reserved.

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