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CMS Again Settles Record Stark Self-Disclosures in 2023

The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2023 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark...more

Ounce of Prevention: Are Independent Contractor Agreements Signed?

Applicable Provider Types: All - Is Your Entity in Compliance? Financial relationships with an independent contractor in a position to make or influence referrals of federal healthcare program business can implicate...more

DOJ Settles Self-Reported Referral Incentives With Dermatology Practice Manager

On Sept. 13, 2023, the U.S. Attorney’s Office for the Northern District of Texas announced a settlement with Oliver Street Dermatology Management LLC. Oliver Street agreed to pay the United States $8.892 million to resolve...more

Regional Hospital System and Two Physicians Pay More Than $69 Million to Settle False Claims Act, Involving Allegations of...

On March 29, 2023, the U.S. District Court for the Eastern District of Michigan granted the parties’ joint stipulation for dismissal in U.S. ex. rel. Godsholl v. Covenant Healthcare, following three settlements of the...more

CMS Streamlines Stark Law Self-Disclosures

The Centers for Medicare & Medicaid Services recently announced updates to the voluntary self-referral disclosure protocol (SRDP), including revisions to streamline SRDP submissions. Providers and suppliers may report and...more

CMS Considers Streamlined Physician Group Stark Law Self-Disclosures

On June 9, 2022, the Centers for Medicare & Medicaid Services announced an opportunity for the public to comment through Aug. 8, 2022, on its voluntary self-referral disclosure protocol (SRDP). The voluntary SRDP is a way to...more

Transaction Considerations and Regulatory Updates for Hospital Executives: Five Key Takeaways

Hospitals and health systems continue to navigate an environment in flux, one consistently impacted by a significant amount of transactional and regulatory activity. During a Nov. 2, 2021, webinar titled “Key Transaction...more

2021’s First-Half Notable Themes on The FCA Insider

As vaccination rates rise, the COVID-19 pandemic continues to reverberate through 2021. These reverberations also impacted the healthcare fraud and abuse landscape that is the basis of The FCA Insider’s coverage. To-date,...more

Texas Court Allows FCA Case to Proceed Based on Purchasing “Future Referrals”

In United States ex rel. Roshan v. E. Tex. Med. Ctr., 2020 U.S. Dist. LEXIS 252092, 2020 WL 8918651 (E.D. Tex. (Nov. 24, 2020)), a Texas federal court partially dismissed a relator’s claim alleging the defendants engaged in...more

Stark Law 2020 Settlements Return to Pre-2019 Trend

The Centers for Medicare & Medicaid Services (CMS) recently announced 2020 settlements concerning past violation or potential violations of the physician self-referral law (the Stark Law) and the number and value of such...more

CMS statement clarifies agency’s view that the Stark Law final rule is effective

Industry publication BVWire quoted a statement from the Centers for Medicare & Medicaid Services (CMS) that gives healthcare providers more certainty to rely on the much heralded final rule modernizing the physician...more

Fraud and Abuse Rules Part V: Easing Stark Law Compliance

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the regulations to the Physician Self-Referral Law (Stark Law), the federal...more

Fraud and Abuse Rules Part III: New Value-Based Arrangement Protections

As discussed in a previous McGuireWoods alert, the Department of Health and Human Services (HHS) published final rules, effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law (Stark Law), the...more

Fraud and Abuse Rules Part I: Changes to Patient Inducement and Kickback Policies

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more

Stark Law and Anti-Kickback Statute Reform: Six Key Insights for Private Equity Healthcare Affiliations

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...more

MedMal Plaintiff Uses Anti-Kickback and Stark to Avoid Summary Judgment

A federal court recently allowed a plaintiff’s state law negligence claim, which utilized the Anti-Kickback Statute (“AKS”) and federal physician self-referral law (the “Stark Law”) as legal support to survive a motion for...more

HHS Finalizes Stark Law, AKS Changes to Reduce Burdens on Healthcare Providers

On Nov. 20, 2020, the U.S. Department of Health and Human Services (HHS) published two long-awaited final rules significantly amending the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute (AKS) and...more

HHS Extends Timeline to finalize Stark Law Changes and CMP Inflation Rule

In the last two weeks, the U.S. Department of Health and Human Services (HHS) published two notices in the Federal Register delaying the publication of certain final fraud and abuse rule reforms for up to a full year. First,...more

CMS Issues Explanatory Guidance on Stark Law Blanket Waivers During COVID-19 Pandemic

On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued guidance on the scope and application of the blanket waivers to the Physician Self-Referral Law (Stark Law) issued by the Department of Health and...more

Stark Law Waivers Issued During COVID-19 Pandemic

On March 30, 2020, Department of Health and Human Services Secretary Alex Azar issued blanket waivers to permit certain financial relationships and referrals that would otherwise be sanctioned by the Physician Self-Referral...more

DOJ Announces $26.67 Million False Claims Settlement with Massachusetts-Based Laboratory

The DOJ recently announced that Boston Heart Diagnostics Corporation (Boston Heart) has agreed to pay a $26.67 million settlement related to alleged violations of the Federal Anti-Kickback Statute and the Stark Law. This...more

HHS to Ease Fraud and Abuse Rules Part 5: CMS Proposes Value-Based Arrangement Stark Exceptions

As discussed in an Oct. 9 alert, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute and the Civil...more

HHS to Ease Fraud and Abuse Rules Part 4: Proposed Revisions to the Stark Law

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback...more

HHS to Ease Fraud and Abuse Rules Part 3: Flexibility for EHR Items and Services, Donated Cybersecurity Tech

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback...more

HHS to Ease Fraud and Abuse Rules Part 2: Civil Monetary Penalty Law Changes, In-Home Dialysis Telehealth

As discussed in a previous McGuireWoods alert, on Oct. 9, the Department of Health and Human Services (HHS) announced two proposed rules to significantly amend the Physician Self-Referral Law (Stark Law), the federal...more

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