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 Law). In 2023, CMS settled an agency record 176 self-disclosures, with settlement amounts totaling over $12,000,000 in the aggregate. Both totals exceeded its
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OIG Plans New Guidance for Medicare Advantage and Nursing Homes
On Feb. 21, the Office of Inspector General of the U.S. Department of Health and Human Services announced the first four subsectors for which it will publish industry segment-specific compliance program guidance. Guidance published in 2024 will focus on Medicare Advantage and nursing facilities. Subsequent guidance will focus on hospitals and clinical laboratories.
$12M Default Judgment Results from Purchasing Prescriptions
A large damage award serves as a significant reminder to file an appearance in a False Claims Act (FCA) case.
In late August of 2022, the Government filed suit against AZ Diabetic and the owner, Hisham Zaghal (Zaghal), in the Eastern District of Virginia, alleging violations under the False Claims Act (FCA), stemming from over
Life Sciences Companies Face Continuing Compliance Challenges in Developing Value-Based and Value-Added Models
The U.S. Department of Health and Human Services Office of Inspector General recently issued Advisory Opinion 23-08, continuing its long-held position that the provision of value-added items and services implicates fraud and abuse laws, including the Federal Anti-Kickback Statute and the Beneficiary Inducement Civil Monetary Penalty law.
Read on to learn how manufacturers, distributors, and
Off-Label “Free Speech” Theory Does Not Fly for Convicted Former Medical Device Executives in 1st Circuit
A federal appeals court recently upheld misdemeanor convictions of two former executives of Acclarent Inc, a medical device manufacturer, for commercially distributing an adulterated and misbranded medical device by misleading the FDA regarding the intended use of the device. In United States v. Facteau (89 F.4th 1 (1st Cir. 2023)) the First Circuit Court of
OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers
On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued its General Compliance Program Guidance for healthcare providers and other industry stakeholders. The guidance follows OIG’s previous announcement about a modernization initiative and signifies a major update to OIG’s prior approach to providing guidance on effective compliance
A Failed Constitutional Challenge to the AKS Safe Harbor Provision – More to come?
This past summer, in United States v. Booker, a North Carolina district court ruled against a challenge to the constitutionality of Congress’s delegation of authority to promulgate safe harbors to the Anti-Kickback Statute (AKS). In filing a motion for acquittal, Defendant Donald Booker argued the AKS “Safe Harbor Provision,” which grants the Secretary of
The Growing Causal Divide: But-For Causation in AKS/FCA Actions
In United States v. Regeneron, the District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims to federal healthcare programs to prevail in Anti-Kickback Statute (AKS) and False Claims Act (FCA) actions. The District Court’s ruling
HHS Advisory Opinion Approves Profit-Based Bonus Plan for Bona Fide Physician Employees
On Oct. 13, the U.S. Department of Health and Human Services Office of Inspector General issued an advisory opinion approving a physician practice’s proposal to pay bonuses to each of its employed physicians based on net profits derived from the facility fee generated by procedures the physician performed at the practice’s ambulatory surgery center.
DOJ Settles Self-Reported Referral Incentives With Dermatology Practice Manager
On Sept. 13, the U.S. Attorney’s Office for the Northern District of Texas announced a settlement with Oliver Street Dermatology Management LLC to resolve self-reported allegations that its acquisition of several dermatology practices violated the Stark Law, the Anti-Kickback Statute and the False Claims Act.
Read on for details about this matter, plus helpful guidance