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Yesterday, the OIG released a Special Fraud Alert related to: (1) marketing arrangements between Medicare Advantage Organizations ('MAOs') and health care professionals ('HCPs'), and (2) arrangements between HCPs and MA [...]

As part of our work with clients and preparing for Let's Talk Compliance events, we often notice trends through the questions we receive. The following physician compensation compliance topics are [...]

Headlines that Matter for Companies and Executives in Regulated Industries On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether [...]

Highlights The HHS-OIG released a favorable opinion regarding patient and caregivers travel, lodging, meals and associated expenses paid by pharmaceutical manufacturers The proposed arrangement satisfies the 'promote access to care [...]

On June 7, 2024, a petition for writ of certiorari was filed with the Supreme Court of the United States asking that it resolve a critical legal issue pertaining to [...]

On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, [...]

Byline: David S. Schumacher The U.S. District Court in Boston has become ground zero for a simmering dispute about one of the U.S. Department of Justice's most potent anti-fraud tools, [...]

On Sept. 13, 2023, the U.S. Attorney's Office for the Northern District of Texas announced a settlement with Oliver Street Dermatology Management LLC. Oliver Street agreed to pay the United [...]

As a part of the Consolidated Appropriations Act, 2023 (CAA), Congress passed new exceptions to the Physician Self-Referral Law (Stark Law) and the federal Anti-Kickback Statute (AKS) allowing certain healthcare [...]

In this issue: FCA defendants may be in for a 'SuperValu' when the Supreme Court reevaluates the FCA's scienter requirements SCOTUS denies Pfizer cert. leaving heartless HGG OIG kickbacks ruling [...]

A Greenville-based health care system will pay more than $36 million to the United States in a settlement to resolve allegations of false claims. St. Francis Physician Services, Inc., St. [...]

In this issue: Court dismissed relator's claims against hospital for allegedly fraudulent sleep tests where relator lacked personal knowledge of specific false claims, but permitted claims based on relator's own [...]

Earlier this month a federal judge unsealed a federal qui tam relator complaint originally filed in January 2020 by Dr. Jay Radhakrishnan and Dr. William Julien against Arizona-based Modern Vascular [...]

In Short The Situation: The practice of manufacturers making available to customers favorable and even zero-interest financing for significant purchases of medical devices is understood to be common and often [...]

A recent settlement involving a Medicare Advantage plan should serve as a reminder that the federal Anti-Kickback Statute (AKS) is broad and far-reaching, both on its face and in practice. [...]

OIG Advisory Opinion 22-14 (June 29, 2022) could have significant implications for how life sciences companies (pharmaceutical, medical device, and diagnostics test makers) contribute towards continuing education ('CE') programs for [...]

A recent decision may make it harder for defendants to obtain dismissal of an FCA case on the grounds that a relator has failed to plead facts that would refute [...]

A court in the District of Maryland again dismissed a declined qui tam action in which the relator, a bariatric surgeon, alleged that two medical device companies violated the AKS [...]

On March 2, 2022, the Department of Health and Human Services, Office of Inspector General (OIG) published Advisory Opinion No. 22-04 (the 'Opinion'), analyzing a program whereby the Requestor provides [...]

In June, the U.S. District Court for the Northern District of Illinois held that a medical management company (MPI) violated the Anti-Kickback Statute (AKS), False Claims Act, and Illinois False [...]

On September 8, 2021, the U.S. Department of Justice (DOJ) announced that it reached a $17 million settlement with BAYADA, a Moorestown, New Jersey-based home-health company, and certain of its [...]

The Office of Inspector General ('OIG') issued an advisory opinion regarding a proposed arrangement between a licensed offeror of Medicare Supplemental Health Insurance ('Medigap') policies (the 'Medigap Plan'), and a [...]

By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January [...]

The Department of Health and Human Services ('HHS'), in collaboration with the Centers for Medicare & Medicaid Services ('CMS') and the Office of the Inspector General ('OIG'), has issued two [...]

As part of its recent rulemaking process, the Centers for Medicare and Medicaid Services (CMS) finalized a new exception to the Physician Self-Referral Law (the Stark Law) to protect arrangements [...]

On January 19, 2021, the final rule updating the safe harbors under the federal Anti-Kickback Statute ('AKS') and adding a new exception to the Beneficiary Inducements Civil Monetary Penalties ('CMP') [...]

In the closing days of the Trump administration, OIG finalized a controversial rule (the 'Final Rule') to amend the discount safe harbor ('Discount Safe Harbor') to the federal Anti-Kickback Statute [...]

New and modified safe harbors to the Stark Law and Anti-Kickback statue allow healthcare providers and entities more flexibility to create and expand telehealth platforms in compliant fashion. On November [...]

On December 2, 2020, both the Health and Human Services Office of Inspector General ('OIG') and Centers for Medicare & Medicaid Services ('CMS') issued final rules amending the Anti-Kickback Statute [...]

On November 20, 2020, the Health and Human Resources Office of Inspector General ('OIG') issued the long-awaited final rule to overhaul various aspects of the Anti-Kickback Statute and Civil Monetary [...]

On Nov. 16, 2020, the Department of Health and Human Services Office of the Inspector General (OIG) issued a Special Fraud Alert related to speaker programs sponsored by pharmaceutical and [...]

As mentioned in our earlier report, on November 20, 2020, The Department of Health and Human Services (HHS) Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services [...]

Byline: Paige Winfield Cunningham Sometimes well-intentioned laws have harmful consequences. Today, the Trump administration will move to ease rules designed three decades ago to prevent fraud and bribery by doctors, [...]

Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) [...]

On September 17, 2018, the Office of Inspector General ('OIG') issued Advisory Opinion No. 18-10 regarding a proposed arrangement in which a surgical device and wound care product manufacturer ('Manufacturer') [...]