The FCA Insider

The FCA Insider

Insights and updates on False Claims Act Litigation

Category Archives: Anti-Kickback Statute

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Anti-Kickback Statute, Defense Arguments, FCA Litigation

Potential Anti-Kickback Prosecution Does Not Give Blanket Fifth Amendment Protection in a Medical Malpractice Suit

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… Continue Reading
Anti-Kickback Statute, OIG, Regulatory

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… Continue Reading
Anti-Kickback Statute

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… Continue Reading
Anti-Kickback Statute

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,… Continue Reading
Anti-Kickback Statute, OIG, Regulatory

HHS to Ease Fraud and Abuse Rules Part 1: Proposed Revisions to Existing Anti-Kickback Statute Safe Harbors

As discussed in a previous McGuireWoods alert, on Oct. 9, 2019, 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 Law. This client alert, the first in McGuireWoods’ summary series on these proposed rules,… Continue Reading
Anti-Kickback Statute, CMS Guidance, Regulatory, Stark Law

HHS Proposed Rules Seek to Remove Stark Law, Anti-Kickback Burdens on Providers

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. The proposed rules intend to further incentivize value-based arrangements and patient care coordination by expressly permitting certain activities that could… Continue Reading
Anti-Kickback Statute, Regulatory

HHS “Sprints” Toward New AKS Safe Harbors and Penalty Exceptions

The U.S. Department of Health and Human Services (HHS) has launched its “Regulatory Sprint to Coordinated Care” to accelerate the healthcare system’s transformation to a value-based system rewarding coordinated care. This “regulatory sprint” focuses on identifying regulatory provisions that may act as unnecessary obstacles to coordinated care and issuing guidance to address such obstacles. Specifically,… Continue Reading

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