Stark Law

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Stark Law & Mailing Physician-Dispensed Prescriptions: From COVID-19 Waivers to Federal Legislative Action

By Michele Munk on Posted in Legislation, Stark Law
In August 2024, a federal district court dismissed a lawsuit filed by the Community Oncology Alliance (“COA”), holding that the “in-office ancillary services” exception to the Stark Law does not permit physicians to dispense medications through the physician’s office and then mail prescriptions to the patient’s home.  COA v. Becerra, Case No. 23-cv-2168, Doc. 40, United … Continue Reading

CMS Blanket Stark Waivers will Terminate Upon End of COVID-19 Emergency

By Robert Nauman and John Wyand on Posted in Anti-kickback Statute, CMS, COVID-19, OIG, Section 1135 Waivers, Stark Law
Earlier this year, the U.S. Department of Health and Human Services (“HHS”) announced the expiration of the COVID-19 public health emergency declarations effective May 11, 2023.  As a result, many of the regulatory waivers and flexibilities available to health care providers, including the blanket waivers applicable to many Stark Law requirements (the “Stark Waivers”), will … Continue Reading

CMS Publishes Stark Law Final Rules-Updated

By Robert Nauman on Posted in CMS, Regulations, Stark Law
In follow up to our post last month, on Wednesday, December 2, The Centers for Medicare and Medicaid Services (CMS) published final rules implementing many of the Stark Law changes first proposed in October 2019 (the Final Rules). These changes have been adopted to address the shift to a value-based and coordinated healthcare environment. The … Continue Reading

CMS Releases Final Rules Implementing Stark Law Changes to Reflect Value-Based Healthcare Delivery and Payment Environment

By Robert Nauman on Posted in CMS, Regulations, Stark Law
On Friday, November 20, CMS released final rules implementing many Stark Law changes first proposed in October 2019 (the “Final Rules”). This release comes despite earlier suggestions that these Final Rules may be delayed until sometime in 2021. Developed as part of the Regulatory Sprint to Coordinated Care program, the Final Rules represent CMS’s recognition … Continue Reading

CMS Delays Publication of Final Rule Implementing Stark Law Changes to 2021.

By Robert Nauman on Posted in Anti-kickback Statute, Civil Monetary Penalties Law, CMS, OIG, Stark Law
As we reported last October, CMS and the OIG issued proposed rules aimed at updating the Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties Law as part of HHS’ Regulatory Sprint to Coordinated Care. In part, the proposed rules seek to address the current value-based and coordinated healthcare environment. While publication of final rules concerning … Continue Reading

CMS Issues Blanket Stark Law Waivers in Connection with COVID-19 Emergency

By Robert Nauman on Posted in CMS, COVID-19, Section 1135 Waivers, Stark Law
On March 30, in connection with the national COVID-19 emergency, the Centers for Medicare and Medicaid Services (“CMS”) issued waivers (the “Waivers”) for certain provisions of the federal physician self-referral law, commonly referred to as the “Stark Law.” To ensure there will be sufficient capacity to handle the unique challenges of the COVID-19 pandemic, CMS … Continue Reading

Proposed Changes to the Anti-Kickback Statute, Stark Law and Civil Monetary Penalties Law Address Value-Based Healthcare Environment

By Robert Nauman on Posted in Anti-kickback Statute, Civil Monetary Penalties Law, CMS, Department of Health and Human Services, Fraud and Abuse, OIG, Proposed Rule, Regulations, Stark Law, Uncategorized
On October 9, the Department of Health and Human Services (HHS) released proposed rules (the Proposed Rules) aiming to update the Anti-Kickback Statute (the AKS), Stark Law and Civil Monetary Penalties Law (CMPL) to address today’s value-based and coordinated healthcare environment. The proposals reflect a recognition on HHS’s part that the healthcare landscape of today … Continue Reading

CMS “Regulatory Sprint to Coordinate Care” Seeks Input to Lessen the Regulatory Burden of the Stark Law

By Robert Nauman on Posted in CMS, Fraud and Abuse, Stark Law
Late last month, the Centers for Medicare & Medicaid Services (“CMS”) issued a request for information (“RFI”) seeking input regarding the Medicare physician self-referral law and its implementing regulations (“Stark Law”) and how it may prevent or inhibit care coordination amongst healthcare providers. As part of CMS’s broader “Regulatory Sprint to Coordinated Care” initiative, the … Continue Reading

CMS to Review Stark Law in Connection with Payment Reform

By Robert Nauman on Posted in CMS, Fraud and Abuse, Stark Law
CMS has recently signaled its intention to review the Stark Law and its impact on providers. During a January, 2018 American Hospital Association webinar, CMS Administrator Seema Verma announced the development of an inter-agency group to review the Stark Law in light of provider complaints that the law acts as a barrier to their ability to … Continue Reading
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