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Anti-Kickback Statute › Office of the Inspector General › Food and Drug Administration (FDA)

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

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Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Travel-Related Subsidies

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The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-13 (the “Opinion”) to a pharmaceutical manufacturer (the...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

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The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

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Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

Holland & Knight LLP

Key Value-Based Care Developments to Watch in 2024

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The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more

Foley & Lardner LLP

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

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In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

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Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

Harris Beach Murtha PLLC

OIG Opinion: DME Supplier Subsidy of Medicare Cost-Sharing in Cardiac Trial OK

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This favorable OIG opinion concludes that although the proposed arrangement (“Proposed Arrangement”) to subsidize Medicare cost-sharing obligations for Medicare patients in a cardiac clinical trial (“Study”) would constitute...more

McDermott Will & Schulte

OIG Issues General Compliance Program Guidance Updates

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On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

King & Spalding

OIG Issues Favorable Opinion Regarding Pharmaceutical Company’s Free 14-Day Drug Supply to Patients Experiencing a Delay in...

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On February 28, 2023, OIG posted Advisory Opinion 23-02, responding to a request by a pharmaceutical company (the Company) regarding its proposal to offer a free 14-day supply of an enzyme replacement therapy drug to patients...more

Warner Norcross + Judd

Second Circuit Rules Anti-Kickback Statute Means No “Corrupt Intent” Required for Liability

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On January 9, 2023, the U.S. Supreme Court denied Pfizer Inc.’s petition for a writ of certiorari. The denial brought the pharmaceutical company’s lawsuit challenging the breadth of the federal Anti-Kickback Statute (AKS) to...more

King & Spalding

OIG Modifies 2020 Advisory Opinion Regarding Financial Assistance for Travel, Lodging, and Other Expenses for Certain Patients by...

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On May 26, 2022, OIG issued a modification of Advisory Opinion 20-02 (2020 Opinion), which was originally issued on January 15, 2020. In the 2020 Opinion, OIG issued a favorable advisory opinion regarding a pharmaceutical...more

Rivkin Radler LLP

OIG: Biopharma Company’s Provision of Free Genetic Tests Does Not Warrant Sanctions Under AKS

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With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the...more

King & Spalding

OIG Issues Advisory Opinion Regarding Physician-Owned Device Company

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On April 20, 2022, OIG issued an advisory opinion regarding an arrangement involving a family of physicians having an ownership interest in a medical device company that manufactures products that the physicians also order. ...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

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Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

King & Spalding

OIG Determines That a Program to Provide Free Eye Drops to Eligible Patients Undergoing a Particular Treatment is Not Subject to...

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On December 6, 2021, OIG issued an advisory opinion (Advisory Opinion No. 21-19) to a pharmaceutical manufacturer regarding its arrangement to provide free eye drops to patients who are prescribed one of the manufacturer’s...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Pharmaceutical Manufacturer Arrangement to Provide Financial Assistance to...

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Last week, OIG posted Advisory Opinion No. 21-08 regarding a pharmaceutical manufacturer’s arrangement to provide financial assistance in the form of transportation, lodging, and meals to patients potentially eligible for...more

Holland & Knight LLP

OIG Issues Favorable Advisory Opinion on Manufacturer-Provided Travel Assistance

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The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Bass, Berry & Sims PLC

OIG Issues Favorable Advisory Opinion (No. 21-01) on Free Drug Program

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On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more

Rivkin Radler LLP

Free Drug Program Avoids Sanctions Under AKS

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In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program...more

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