The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: CMS Guidance

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CMS Guidance, Stark Law

CMS Settles Record Number of Stark Self-Disclosures

The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2021 and 2022 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the “Stark Law”). In 2022, CMS settled a record 104 self-disclosures, with settlement amounts totaling over $9,000,000 in the aggregate. These amounts are… Continue Reading
Anti-Kickback Statute, DOJ, FCA Litigation, Settlements, Stark Law

Regional Hospital System and Two Physicians Pay More Than $69 Million to Settle False Claims Act, Involving Allegations of Improper Financial Relationships With Referring Physicians

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 relator’s claims pursuant to the False Claims Act, 31 U.S.C. § 3729 (“FCA”), the Michigan Medicaid False Claim Act, MCL 400.601,… Continue Reading
Anti-Kickback Statute, CMS Guidance, Plaintiff Strategies, Stark Law

Complex AKS/Stark Complaint Survives Rule 9(b) Particularity Challenge – A Guide for FCA Complaints

In U.S. v. Genesis Global Healthcare, 2023 WL 3656925 (S.D. Ga. May 25, 2023), a Georgia district court denied three (3) Motions to Dismiss the Second Amended Complaint filed in a qui tam action brought by relators under the False Claims Act (the “FCA”) and the Georgia False Medicaid Claims Act. The court, having previously held… Continue Reading
CMS Guidance, Stark Law

CMS Streamlines Stark Law Self-Disclosures

The Centers for Medicare & Medicaid Services recently announced updates to the voluntary self-referral disclosure protocol for reporting and resolving technical violations under the physician self-referral law commonly known as the Stark Law. Read on for details about these updates, intended to streamline the reporting process and reduce burdens on self-disclosing healthcare providers.… Continue Reading
CMS Guidance, Stark Law

CMS Considers Streamlined Physician Group Stark Law Self-Disclosures

The Centers for Medicare & Medicaid Services recently announced an opportunity for public comment on its voluntary self-referral disclosure protocol (SRDP). The voluntary SRDP is a way to resolve technical violations under the physician self-referral law (commonly known as the Stark Law) by submitting information to CMS about prohibited conduct. During this period, CMS is… Continue Reading
CMS Guidance, OIG, Regulatory

Will 2022 Be The Year? OIG’s 25 Top Recommendations to Reduce Healthcare Fraud

Every year the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) releases an annual Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Unimplemented Recommendations. HHS released its most recent in Nov. 2021, outlining OIG’s top 25 unimplemented recommendations that, in OIG’s view, would most positively affect… Continue Reading
CMS Guidance, DOJ, FCA Defenses, FCA Litigation, Investigations, OIG, Regulatory, Settlements, Stark Law

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, 2021 has seen more than three dozen posts on topics ranging from False Claims Act (FCA) court opinions, U.S. Department of Justice (DOJ)… Continue Reading
CMS Guidance, Stark Law

Stark Law 2020 Settlements Return to Pre-2019 Trend

RELATED UPDATE: CMS Streamlines Stark Law Self-Disclosures (March 8, 2023) 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 settlements have returned to the pre‑2019 trends. The 2020 settlements based on voluntary submissions… Continue Reading
CMS Guidance, Regulatory, Stark Law

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 self-referral law (the Stark Law). The CMS statement stated, “The regulations finalized in [the final rule discussed in this post] are effective.” The… Continue Reading
CMS Guidance, Regulatory, Stark Law

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 Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the final in McGuireWoods’ summary series on these final… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

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 federal Anti-Kickback Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the latest in McGuireWoods’ summary series on these final… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

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 (Stark Law) and the federal Anti-Kickback Statute (AKS). This client alert, the latest in McGuireWoods’ summary series on these final rules, focuses… Continue Reading
Defense Arguments, OIG, Stark Law

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 summary judgment. In Post v. AmerisourceBergen Corporation, No. 1:19-CV-73 (N.D.W. Va. Nov. 2, 2020), Plaintiff, Frances G. Post, filed suit against Defendants,… Continue Reading
CMS Guidance, OIG, Regulatory, Stark Law

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 the Civil Monetary Penalties (CMP) Law. These new rules are a direct result of HHS’ Regulatory Sprint to Coordinated Care, and largely adopt… Continue Reading
CMS Guidance, Stark Law

Stark Law 2019 Settlements Continue Downward Trend

For updated discussion of this topic, please see our April 28, 2021 post: Stark Law 2020 Settlements Return to Pre-2019 Trend The number and value of announced settlements with the Centers for Medicare & Medicaid Services (CMS) concerning the physician self-referral law (the Stark Law) continued a downward trend in 2019. This marks the third… Continue Reading
CMS Guidance, Regulatory, Stark Law

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 Law (Stark Law). The blanket waivers protect those financial relationships and referrals (and the claims submitted as a result thereof) specifically enumerated by… Continue Reading
CMS Guidance, Damages

Federal Court Upholds CMS’ Use of Extrapolation to Claw-Back Improper Payments

A recent federal court decision should serve as an important reminder to providers that the Centers for Medicare and Medicaid Services (“CMS”) and its contractors have substantial authority to audit provider Medicare claims and to broadly apply extrapolation to calculate overpayments. In Palm Valley Health Care, Inc. v. Azar, No. 18-41067, 2020 BL 14097 (5th… Continue Reading
CMS Guidance, Regulatory

CMS Internal Memorandum Clarifies Impact of Supreme Court Decision on Enforcement Practices

The Deputy General Counsel and Chief Legal Officers at the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) recently issued an Internal Memorandum clarifying that a recent Supreme Court ruling may limit HHS’s enforcement practices going forward. Consistent with the Court’s ruling, the Memorandum clarifies that subregulatory guidance… Continue Reading
CMS Guidance, Stark Law

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 Monetary Penalties Law. This client alert, the fifth in McGuireWoods’ summary series on these proposed rules, focuses on the Centers for… Continue Reading
CMS Guidance

Changes to CMS’ Conditions of Participation Regulations for Providers Take Effect Nov. 29

Healthcare providers should begin finalizing plans to implement the Centers for Medicare and Medicaid Services’ Omnibus Burden Reductions (conditions of participation) final rule, which becomes effective Nov. 29, 2019. The final rule, issued Sept. 26, 2019, is intended to remove Medicare regulations, contained primarily in providers’ conditions of participation that CMS has identified as unnecessary,… Continue Reading
CMS Guidance, Stark Law

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 Statute (AKS) and the Civil Monetary Penalties (CMP) Law. This client alert, the fourth in McGuireWoods’ summary series on these proposed rules,… Continue Reading

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