News & Analysis as of

Office of the Inspector General Genetic Testing

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

King & Spalding

OIG Review Identifies 378 Labs That Allegedly Billed Medicare Part B at Questionably High Levels for COVID-19 Tests

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OIG issued a report last week examining alleged billing irregularities relating to COVID-19 tests (the Report). The Report explains that in response to increased Medicare Part B spending on COVID-19 tests in 2020, OIG...more

Rivkin Radler LLP

[Webinar] Lunch and Learn Series: A Survey of OIG’s 2022 Advisory Opinions: What They Could Mean for Your Organization - January...

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Please join us for the first Lunch and Learn of 2023, as Geoffrey Kaiser and Jeffrey Ehrhardt present on the OIG. The program will: 1. Discuss select Advisory Opinions from last year on a variety of topics,...more

Venable LLP

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

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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

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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

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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

ArentFox Schiff

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

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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...

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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

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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

Department of Justice Brings Criminal Charges Against 35 Individuals for Involvement in $2.1 Billion in Fraudulent Genetic Testing...

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The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #210 – HHS Office of Inspector General Issues Fraud Alert for Genetic Testing Scam Targeting Seniors

Everyone knows how I feel about those home genetic testing kits—most people don’t understand that when they send their DNA to a private company that it is not protected by HIPAA or any other law, and the company can legally...more

Polsinelli

Genetic Testing Fraud Gains Concern of Congress and Multiple Government Agencies

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Since the United States Department of Health and Human Services Office of Inspector General (HHS-OIG) alerted the industry about genetic testing scams two months ago, the public, multiple government agencies, and Congress...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - June 2019

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Vicious malware continues to be deployed by China-based attackers. A new strain of malware, dubbed “HiddenWasp,” which has the ability to remotely infect computers, has been discovered by a security researcher at Intezar. The...more

Mintz - Health Care Viewpoints

OIG Issues Fraud Alert Regarding Fraudulent Genetic Testing Schemes

Earlier this week the OIG took the somewhat unusual step of issuing a fraud alert directed to Medicare beneficiaries (rather than to Medicare providers) regarding “fraud schemes” that involve genetic testing. According to the...more

Robinson+Cole Data Privacy + Security Insider

OIG Issues Alert to Warn of ‘Free’ Genetic Testing Scams Seeking to Steal Information

On June 3, 2019, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert to notify consumers about genetic testing fraud schemes (the Alert)....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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