There is a new development in one of the whistleblower lawsuits filed against several lab companies that offered specialty cardiology tests. Earlier this month, the Department of Justice announced a settlement with Quest Diagnostics involving its acquisition of Berkeley HeartLab, which was acquired by Quest in 2011. The DOJ said that Quest agreed to pay $6 million to settle the qui tam case, which was originally filed in 2011 by physician Michael Mayes, MD.
MORE ON: Berkeley HeartLab
Quest Diagnostic’s acquisition of Berkeley HeartLab came about in an indirect manner. From October 2007 through May 2011, Berkeley was a wholly-owned subsidiary of Celera Corporation. Then, in May 2011, Quest purchased Celera and thereby also became the owner of Berkeley HeartLab. Court documents in the whistleblower case describe how it took Quest until January 2012 to discontinue the alleged illegal inducements that were offered to physicians by Berkeley HeartLab. According to court papers, it was shortly after that date that Berkeley HeartLab became insolvent, in part because physicians directed their lab test referrals to other labs that continued to offer similar inducements.
CONSUMER USE OF GENE TESTS A THREAT TO INSURERS
23andMe recently obtained clearance from the Food and Drug Administration to sell certain genetic tests directly to consumers. The New York Times reports that consumer’s access to genetic tests that assess an individual’s risk of dementia (such as the ApoE4 gene) may have an interesting consequence—the end of long-term care insurance. According to Times reporter Gina Kolata, there are 5.5 million people in the United States who have Alzheimer’s Disease. These individuals also represent 50% of all nursing home patients. Because a consumer-ordered genetic test does not appear in a patient’s permanent health record, it is possible that only consumers with high risk of dementia or Alzheimer’s Disease would purchase long-term care insurance. That would distort the risk pool and make this type of coverage unprofitable for insurers.
• Natera of San Carlos, Calif., named Gail Marcus as a new member of its board of directors. Marcus has held executive positions at Calloway Labs, Tatum LLC, Caris Diagnostics, UnitedHealthcare, Caremark, AdvancePCS, and Cigna.
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