News & Analysis as of

Medicare Genetic Testing

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

ArentFox Schiff

Investigations Newsletter: COVID-19 Fraud Update: DOJ Prosecutes More than 150 Defendants, 95 Criminal Cases

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COVID-19 Fraud Update: DOJ Prosecutes More than 150 Defendants, 95 Criminal Cases - Since the inception of the CARES Act, DOJ’s Fraud Section has prosecuted over 150 defendants in over 95 criminal cases. The Fraud Section...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

ArentFox Schiff

Investigations Newsletter: DOJ Announces Charges Against 138 Defendants for Alleged Health Care Fraud Schemes Resulting in $1.4...

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DOJ Announces Charges Against 138 Defendants for Alleged Health Care Fraud Schemes Resulting in $1.4 Billion in Losses, with Focus on Telemedicine - On September 17, 2021, the Department of Justice (DOJ) announced criminal...more

The Volkov Law Group

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

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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

Rivkin Radler LLP

California Laboratory Settles FCA Claims Related To Genetic Testing

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Exceltox Laboratories, LLC, a California diagnostic laboratory, is paying a $357,584 settlement to resolve allegations of False Claims Act (FCA) violations. Exceltox allegedly submitted or caused to be submitted claims for...more

ArentFox Schiff

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

ArentFox Schiff on

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

ArentFox Schiff

DOJ Announces $72.3 Million False Claims Act Settlement

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DOJ Announces $72.3 Million False Claims Act Settlement - Oklahoma Center for Orthopaedic and Multi-Specialty Surgery, its part-owner and management company, a physician group, and other affiliated entities and...more

Bradley Arant Boult Cummings LLP

Decoding DOJ’s Crackdown on Genetic Testing: High-Profile Indictments and Practical Takeaways for the Cancer and Pharma Genomics...

In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been...more

Epstein Becker & Green

Medicare Expands Access to Genetic Diagnostic Tests for Certain Ovarian and Breast Cancers

On January 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a national coverage determination (“NCD”) that authorizes Medicare coverage of next-generation sequencing (“NGS”) as a diagnostic laboratory...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

Epstein Becker & Green

Medicare’s Proposed National Coverage Determination: Expanding Access to Genetic Screening Tests for Certain Ovarian and Breast...

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On October 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed decision memo with a national coverage determination (“NCD”) that would allow for Medicare coverage of next-generation sequencing...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 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

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

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

Wilson Sonsini Goodrich & Rosati

CMS Expands Coverage of Certain Advanced Cancer Companion Diagnostic Tests Employing Next Generation Sequencing

Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more

Epstein Becker & Green

Obstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for...

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A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more

Foley & Lardner LLP

Advancing Access to Precision Medicine Act - A Bipartisan Bill

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On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R....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

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...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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