Podcast - Who Owns Your DNA? Lessons Learned from 23andMe
State AG Pulse | CT AG Reacts to Genetic Data Breach
The U.S. Attorney’s Office for the Eastern District of Pennsylvania announced on April 23 that Genexe, LLC (doing business as Genexe Health) and its parent company, Immerge, Inc., along with two of their executive...more
Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more
In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more
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
On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...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
Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...more
A physician in Washington state pled guilty on September 28, 2022, to a criminal charge of conspiring to accept kickbacks related to fraudulent genetic testing. According to the Department of Justice (DOJ), the physician...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
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
Genetic testing had its origins in the 1950s when scientists discovered that an additional copy of chromosome 21 causes Trisomy 21, also known as Down syndrome. Methods for staining chromosomes were used to sort and count...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
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
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
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
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
The U.S. Department of Justice (DOJ) continues to actively target the healthcare industry for False Claims Act (FCA) and other alleged violations, and it took significant steps to further its reach into the telehealth and...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