On March 29, 2023, the Department of Justice’s (DOJ) Office for the Eastern District of Michigan announced a notable set of three settlements (collectively, the Settlement) in excess of $69 million dollars total with a regional hospital system (Hospital) and two individual physicians, respectively.
On October 18, 2022, the Department of Justice (DOJ) announced two settlements with CHC Holdings, LLC, an Oklahoma limited liability company doing business as Carter Healthcare (Carter), and two former senior corporate officers, resolving alleged violations of the federal False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (commonly referred to as the “Stark Law”). One case settled claims that Carter had made improper payments to referring physicians in Oklahoma and Texas, while the other case settled claims that Carter had made false billing claims in Florida. Both matters were initiated by qui tam whistleblower complaints filed under the FCA. Carter agreed to pay more than $30 million to resolve the allegations.…
In June 2021, the Centers for Medicare and Medicaid Services (CMS) issued a notable interpretation of the Physician Self-Referral Law (aka the Stark Law) in Advisory Opinion No. CMS-AO-2021-01 (Advisory Opinion) regarding whether a physician practice can furnish designated health services (DHS) through a wholly-owned subsidiary and still qualify as a group practice (as defined under the Physician Self-Referral Law) for purposes of compliance with various Physician Self-Referral Law exceptions.
Continue Reading CMS Issues Advisory Opinion Clarifying Physician Self-Referral Law Group Practice Structure
On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited and highly anticipated final rule updating regulations promulgated under the Physician Self-Referral or “Stark” law (the OIG simultaneously published updates to the Anti-Kickback Statute regulations). Among other things, CMS introduced new Stark exceptions for certain “value-based arrangements,” the donation…
On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations. The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.
The full text of each rule is available below.
- Final Physician Self-Referral Law Rule, Centers for Medicare & Medicaid Services (CMS): https://public-inspection.federalregister.gov/2020-26140.pdf
- Final AKS Rule and Beneficiary Inducements CMP Regulations, Office of Inspector General (OIG): https://public-inspection.federalregister.gov/2020-26072.pdf
- Final Rule on Rebate/Point-of-Sale Price Reductions Safe Harbor, OIG: https://public-inspection.federalregister.gov/2020-25841.pdf?utm_campaign=pi+subscription+mailing+list&utm_source=federalregister.gov&utm_medium=email
Excerpt of a contributed article published in Medical Economics on November 3, 2020.
These waivers could lead to lasting flexibilities for physicians — if a few bad apples don’t spoil the bunch
On October 19, 2020, the Administrator of the Centers for Medicare & Medicaid Services (CMS) highlighted recent actions taken by the federal government…
On August 24, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an “extension of the timeline” for publication of a final rule addressing changes to the Physician Self-Referral Law (or Stark Law) regulations. In its announcement, CMS set a new deadline of August 31, 2021 for publication of a final rule.
Continue Reading CMS Extends Timeline for Finalizing Changes to Physician Self-Referral (Stark) Law Regulations to August 2021
Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services (CMS) published “Explanatory Guidance” (Guidance) of the applicability of the blanket waivers of the federal Physician Self-Referral Law (PSR Law) CMS previously issued on March 30, 2020. See our analysis of the PSR Law blanket waivers here.
Continue Reading CMS Issues Explanatory Guidance of Blanket Physician Self-Referral (Stark) Law Waivers for COVID-19 in Response to Industry Feedback
On April 3, 2020 the Office of Inspector General (OIG) issued a Policy Statement to notify health care providers and other parties subject to the Anti-Kickback Statute (AKS) that the OIG will not impose administrative sanctions for potential AKS violations for COVID-19-related arrangements that are covered by some – but not all – of the Blanket Waivers of the Physician Self-Referral (Stark) Law issued on March 30 (see here for our analysis of the Blanket Waivers).
Continue Reading OIG Will Not Impose Administrative Sanctions for AKS Violations for Conduct Covered by Certain Blanket Waivers of the Stark Law
On March 30th, the Centers for Medicare and Medicaid Services (CMS) issued blanket waivers (Blanket Waivers) of sanctions under the federal physician self-referral law (Stark Law) to relax regulatory requirements related to health care providers’ response to the COVID-19 pandemic. The Blanket Waivers were issued under the Department of Health and Human Services Secretary’s authority in Section 1135 of the Social Security Act to ensure that (i) sufficient health care items and services are available to federal health care program beneficiaries, and (ii) health care providers are reimbursed for providing such health care items and services while addressing the COVID-19 crisis. The Blanket Waivers apply to remuneration that is between an entity (as defined under the Stark Law) and (1) a physician, (2) the physician organization in whose shoes the physician stands (under 42 C.F.R. 411.354(c)) or (3) the physician’s immediate family member.
Continue Reading CMS Issues Blanket Waivers of Physician Self Referral (Stark) Law Penalties to Support COVID-19 Response Efforts