Podcast - Who Owns Your DNA? Lessons Learned from 23andMe
State AG Pulse | CT AG Reacts to Genetic Data Breach
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more
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
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
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
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
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
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
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
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
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 individuals...more
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
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
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
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 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
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
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
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
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
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
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
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
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
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