An Ohio Court of Appeals recently weighed in on the proper protocols one must take in order to successfully assert one’s Fifth Amendment Constitutional Right against self-incrimination in relation to a discovery request in a civil case that may have incriminating affects in an ongoing anti-kickback statute (AKS) investigation. The Fifth Amendment of the United
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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
Supreme Court Signals Interest in Clarifying Pleading Requirements in False Claims Act Suits
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.
OIG Permits Healthcare Organization’s Smartphone Loan Program For Telehealth Services
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
OIG Approves Physician-Owned Medical Device Company With Several Safeguards
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
California Court: Fair Market Value Payments May Not Avert Anti-Kickback Liability
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.”
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District Court Adopts Middle of the Road Approach in Determining Causation in Anti-Kickback Statute-Based False Claims Act Case
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
COVID Nursing Home Patient Safety Failures Not Actionable under FCA in New York
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
District Court finds that AKS Violations are Per Se Material
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,
Eye Care Practice Settles with Government for Employing Excluded Individual
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