This Commentary is part of a series of nine Commentaries on the newly finalized Stark Law and Anti-Kickback Statute exceptions and safe harbors seeking to remove regulatory barriers to care coordination.
In Short
The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or fair market value compensation exceptions because, for example, the arrangements were not reduced to writing before services were rendered.
The Action: The Centers for Medicare & Medicaid Services ( CMS ) issued a final rule, effective January 19, 2021, expressly excluding from protection under the isolated transactions exception those arrangements whereby a single payment is made for repeated services already performed. To provide protection to certain lower risk arrangements that may have otherwise relied on the isolated transactions exception for repeated perio
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Two new healthcare fraud and abuse final rules, effective Jan. 19, 2021, may increase flexibility for private equity firms exploring opportunities in the healthcare space as well as private equity-backed healthcare platforms as they consider transactions, investment/alignment opportunities, patient engagement approaches and other business opportunities.
As discussed in a previous alert, the new final rules released by the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services Office of Inspector General (OIG) significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law, with the intent to “provide greater flexibility for healthcare providers to participate in value-based arrangements” and “ease unnecessary compliance burden for healthcare providers and other stakeholders.”
Wednesday, January 6, 2021
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules) will become effective.[1] This alert is a part of the Dinsmore Health Care practice group’s ongoing summary of the Final Rules.
The CMS Final Rule implements changes to the Stark Law and offers several clarifying provisions related to key Stark Law terms and concepts. Included in the changes are definitions and special rules related to: (1) commercial reasonableness, (2) the volume or value standard and other business generated standard, and (3) fair market value and general market value.
Published: 26 December 2020 26 December 2020
Dallas, Texas - Texas Heart Hospital of the Southwest LLP, a partially physician-owned hospital in Plano, Texas, and its wholly owned subsidiary, THHBP Management Company, LLC (collectively, the “Heart Hospital”) have agreed to pay the United States $48 million to resolve claims that the Heart Hospital violated the False Claims Act by knowingly submitting claims to the Medicare program that resulted from violations of the Physician Self-Referral Law and the Anti‑Kickback Statute, the Justice Department announced.
The Physician Self‑Referral Law, commonly known as the Stark Law, prohibits a hospital from billing Medicare for certain services referred by physicians with whom the hospital has a financial relationship, unless that relationship satisfies one of the law’s statutory or regulatory exceptions. The Anti‑Kickback Statute prohibits offering or paying remuneration to induce the referral of items or services covered b
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Previously, Sheppard Mullin released its “Critical Analysis and Practical Implications of CMS’ Changes to the Stark Law’s Implementing Regulations” discussing the Stark Law Final Rule and the significant changes the Stark Law Final Rule made to the Stark Law exceptions and other provisions included in the Stark Law regulations at 42 C.F.R. 411.351 et seq.
As linked to this article, Sheppard Mullin presents its, “Analysis of OIG’s New and Revised Regulatory Safe Harbors to the Federal Health Care Program Anti-Kickback Statute and Beneficiary Inducement Prohibition” (the “AKS Analysis”). The AKS Analysis includes a deep-dive into the AKS Final Rule including the addition of new AKS safe harbors for remuneration exchanged under various value-based arrangements, a new safe harbor applicable to financial arrangements designed to benefit program beneficiaries, and the revision of other AKS safe harbors to add