CMS Guidance, Stark Law July 13, 2022

CMS Considers Streamlined Physician Group Stark Law Self-Disclosures

By Gretchen Townshend, Timothy Fry and McGuireWoods LLP

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 accepting public comments on an updated SRDP submission process that could reduce the burdens on physician groups by limiting the information required to be disclosed to only a single form per disclosure instead of separate physician information forms for each physician included in a voluntary disclosure. This proposal may streamline the current SRDP process for physician group practices when they face technical violations of the Stark Law.

Read on for more details and information about commenting on this proposal.

DOJ, FCA Litigation June 9, 2022

Supreme Court Signals Interest in Clarifying Pleading Requirements in False Claims Act Suits

By Michael J. Podberesky, John S. Moran, David Pivnick, Laura Colombell Marshall and Vinu G. Joseph

The Supreme Court (Court) will soon decide whether to take up a critical (and long-running) issue concerning applicability of Federal Rule of Civil Procedure 9(b) pleading standards in False Claim Act (FCA) suits. To satisfy Rule 9(b)’s particularity requirement for fraud allegations, FCA plaintiffs generally have needed to detail specific false claims submitted by defendants. The question that has divided federal courts for more than a decade is whether a plaintiff instead may plead the submission of false claims more generally without identifying specific claims if they provide sufficient reliable indicia that false claims were submitted—such as the qui tam plaintiff’s personal knowledge of or participation in the alleged fraudulent practices that are the basis of the FCA action. The issue is particularly salient in cases where the government declines intervention and the whistleblower (or relator), who is often a former employee of the defendant, may not have access to the relevant invoices at issue.[1]

OIG May 17, 2022

OIG Permits Healthcare Organization’s Smartphone Loan Program For Telehealth Services

By Timothy Fry, Kristen H. Chang and McGuireWoods LLP

On April 22, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion (no. 22-08) (the “Advisory Opinion”) approving a healthcare organization loaning smartphones to promote telehealth care that it provides to underserved populations. The Advisory Opinion provides context for healthcare organizations that may similarly want to loan out smartphones to patients to assist such patients in obtaining reimbursed telehealth services, which otherwise could be considered renumeration to induce referrals and federal Anti-Kickback Statute (AKS) and Beneficiary Inducements Civil Monetary Penalty (CMP) repercussions.

Anti-Kickback Statute, OIG, Regulatory May 4, 2022

OIG Approves Physician-Owned Medical Device Company With Several Safeguards

By Timothy Fry and McGuireWoods LLP

On April 20, the U.S. Department of Health and Human Services Office of Inspector General issued a favorable advisory opinion regarding physician ownership of a medical device company that manufactures products ordered by the physician owners and other affiliated physicians.

Read our alert to learn more about the opinion, which offers a path forward for these ownership arrangements but makes it clear that physician owners and their counsel must structure them carefully.

Anti-Kickback Statute May 3, 2022

California Court: Fair Market Value Payments May Not Avert Anti-Kickback Liability

By Kate Hardey, Timothy Fry, Royce DuBiner and McGuireWoods LLP

In February 2022, the U.S. District Court for the Central District of California denied a defendant’s motion to dismiss a qui tam action alleging that the defendant had violated the federal Anti-Kickback Statute (AKS). In its ruling, the court noted that “even some fair-market value payments will qualify as illegal kickbacks.”

Click here to read more.

Anti-Kickback Statute May 2, 2022

District Court Adopts Middle of the Road Approach in Determining Causation in Anti-Kickback Statute-Based False Claims Act Case

By Brett Barnett, Cassandra M. Burns and Timothy Fry

The U.S. District Court for the District of Maryland recently weighed in on the appropriate causation standard when evaluating whether a claim “result[s] from” a violation of the Anti-Kickback Statute sufficient to constitute a false or fraudulent claim for purposes of the False Claims Act. In U.S. ex rel. Fitzer v. Allergan, Inc., the court adopted a middle of the road approach under which a causal link between the remuneration and the claim is required, but a showing that the remuneration succeeded in producing the prescription is not.

FCA Defenses April 28, 2022

COVID Nursing Home Patient Safety Failures Not Actionable under FCA in New York

By Timothy Fry, Brett Barnett and McGuireWoods LLP

In Conte v. Kingston NH Operations LLC, 2022 U.S. Dist. LEXIS 21686, *1, 2022 WL 356753, a New York District court granted a defendant’s motion to dismiss an employee’s false claims allegations under the False Claims Act (the “FCA”) and the New York False Claims Act (the “NYFCA”). The case stemmed from allegedly improper patient care and workspace safety during the COVID-19 pandemic, which the plaintiff brought against a New York nursing home operator under both the FCA and NYFCA. Despite multiple alleged COVID-related deaths and demonstrated care issues that the court acknowledged were present, the court dismissed the case as such allegations were not actionable under these fraud and abuse statutes.

Anti-Kickback Statute March 31, 2022

District Court finds that AKS Violations are Per Se Material

By Brett Barnett, Timothy Fry and Garrison B. Ambrose

Last month, the Central District of California granted the government’s affirmative motion for partial summary judgment in U.S. v. Reliance Medical Sys., 2022 WL 524062 (C.D. Cal. Feb. 2, 2022). The Reliance Medical case involved an FCA action based on a theory that certain physician-owned distributorships (PODs) violated the Anti-Kickback Statute (AKS). As detailed below, the Central District found – in accordance with the substantial majority of other courts – that violations of the AKS are material under the FCA.

FCA Litigation March 28, 2022

Largest-Ever Small-Business Contracting Fraud Settlement Related to Pass-Through Subcontracting

By Edwin O. Childs, Michael J. Podberesky, Todd R. Steggerda, Jason M. Vespoli and McGuireWoods LLP

Federal contractors should take note of a $48.5 million False Claims Act settlement between the Department of Justice and TriMark USA LLC — the largest-ever FCA settlement based on allegations of small-business set-aside contracting fraud. DOJ alleged that TriMark had a plan to circumvent specific small-business contracting requirements by providing significant assistance to three small companies — distributors and resellers for TriMark products — in obtaining set-aside contracts they would pass along to TriMark for performance.

Read on to learn why manufacturers, suppliers, developers and distributors that closely influence and control their distribution networks and reseller partners should take note of this settlement and ensure they have adequate compliance policies and procedures in place to avoid similar conduct allegations and repercussions.

DOJ March 25, 2022

Eye Care Practice Settles with Government for Employing Excluded Individual

By Colin P. McCarthy, Timothy Fry, Brett Barnett and McGuireWoods LLP

On March 18, the Department of Justice (“DOJ”) and the Connecticut Attorney General announced that a Connecticut eye care practice and its owners had agreed to pay $192,699 to resolve allegations that the practice improperly employed an individual who was excluded by the Department of Health and Human Services’ Office of Inspector General (“OIG”) from federal health care programs. Continue Reading

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Insights and updates on False Claims Act Litigation