News & Analysis as of

Anti-Kickback Statute Genetic Testing

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 -
Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

Epstein Becker & Green on

Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more

Rivkin Radler LLP

NY Physician, Wife and Staff Admit AKS Violations

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The U.S. Attorney’s Office in Trenton, NJ announced on November 22 that primary care physician Yitzchok “Barry” Kurtzer of Monsey, NY, and his wife pleaded guilty to soliciting and receiving kickbacks and bribes in exchange...more

Venable LLP

HHS 2021 Semiannual Report to Congress Draws Attention to Genetic Testing, Durable Medical Equipment, and Opioid Disorder...

Venable LLP on

On June 6, 2022, the U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), released its spring 2022 semiannual report to Congress. The semiannual report covers the period of October 1, 2021 to...more

Harris Beach PLLC

Summary of Fraud and Abuse Enforcement Yields Insight for Health Care Compliance and Risk Assessment

Harris Beach PLLC on

The following is a summary of the federal Health and Human Services agency’s Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are based...more

Rivkin Radler LLP

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

Rivkin Radler LLP on

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

ArentFox Schiff

OIG Issues Advisory Opinion Approving Biopharmaceutical Manufacturer’s Sponsorship of Free Genetic Testing and Counseling

ArentFox Schiff on

The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more

Faegre Drinker Biddle & Reath LLP

OIG Issues Favorable Advisory Opinion for Free Genetic Testing and Counseling Program Offered by a Pharmaceutical Company

On April 11, 2022, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion No. 22-06 (AO 22-06), which approved a biopharmaceutical company’s proposed arrangement to...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Biopharmaceutical Company Arrangement to Provide Free Genetic Testing and...

King & Spalding on

Last week, OIG posted Advisory Opinion No. 22-06 regarding a biopharmaceutical company’s (BioPharm Co.) arrangement to provide free genetic testing and genetic counseling services to patients potentially eligible for...more

Mintz - Health Care Viewpoints

OIG Approves Manufacturer’s Offer of Free Genetic Testing

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a...more

Hogan Lovells

OIG green lights drug manufacturer-sponsored genetic testing program

Hogan Lovells on

On April 11, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 22-06, concluding that a pharmaceutical manufacturer’s sponsored genetic testing and...more

The Volkov Law Group

False Claims Investigations and Criminal Prosecutions: Recent Examples of Criminal Charges – a Lab Owner, A Physician and a Nurse...

The Volkov Law Group on

A False Claims Act case can easily turn into a criminal prosecution.  The Federal Bureau of Investigation often initiates criminal investigations as part of its commitment to reducing health care fraud....more

Mintz - Health Care Viewpoints

DOJ Is Already Making Good on AG Barr’s Instruction to Detect, Deter, and Punish Wrongdoing Related to Coronavirus

On March 16th, Attorney General William Barr issued a memorandum to all United States Attorneys directing each U.S. Attorney’s Office (USAO) to “prioritize the detection, investigation, and prosecution of all criminal conduct...more

Polsinelli

Genetic Testing Fraud Concerns Confirmed with Charges in One of the Largest Ever Health Care Fraud Schemes

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In one of the largest ever health care fraud schemes charged by the Department of Justice, cancer genetic testing and telemedicine are at the center of the scheme. On September 27, the DOJ announced charges against 35...more

Polsinelli

Millennium Health to Pay $256 million in False Claims Act Settlement

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Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

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