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Department of Health and Human Services (HHS) 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

Wiley Rein LLP

Wiley Consumer Protection Download (September 11, 2023)

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Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

Wiley Rein LLP

Wiley Consumer Protection Download (July 10, 2023)

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Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

Cozen O'Connor

The State AG Report – 6.22.2023

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •It’s No Batman, but California Teams up to Stop Organized...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

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

Hogan Lovells

California and Florida contribute to web of state genetic privacy protections

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States continue to enact laws targeting the protection of genetic data with two important developments in California and Florida. California’s Genetic Information Privacy Act (“GIPA”), which came into effect on January 1,...more

ArentFox Schiff

Investigations Newsletter: New York Pharmacy Owners Charged in $30 Million COVID-19 Health Care Fraud and Money Laundering Case

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New York Pharmacy Owners Charged in $30 Million COVID-19 Health Care Fraud and Money Laundering Case - On December 21, 2020, the Department of Justice (DOJ) announced that two owners of over a dozen New York-area...more

Rivkin Radler LLP

HHS, DOJ Release Fraud and Abuse Report

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The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion,...more

Holland & Knight LLP

Sequence of Events: Genetic Testing Offers Significant Promise, But Coverage and Access Limited

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In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...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 LLP

Data Privacy + Cybersecurity Insider - October 2019

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Consistent with our experience, security firm McAfee has confirmed in a report that ransomware attacks have doubled in 2019. Medical providers have been hit hard this year, and one provider, Wood Ranch Medical, located in...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

Foley & Lardner LLP

HHS and Medicare Asked to Expand Coverage for Genetic Tests

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Fifteen members of Congress have asked the Department of Health and Human Services (HHS) and the Medicare Payment Advisory Commission (Medicare) to examine how the federal government can help improve patient access to genetic...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

Mintz - Health Care Viewpoints

Health Care Reform Update -- November 25, 2013

In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled. Excerpt from...more

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