Dr. Jeff T.H. Pon was sworn in as the new OPM Director this afternoon. Here’s a link to Dr. Pon’s bio. Good luck, Dr. Pon. 

The FEHBlog notes that following yesterday’s announcement of Cigna’s plan to acquire Express Scripts, the three largest health insurers outside of the Blue Cross Association will be linked to prescription drug managers United Healthcare lead the way with Optum Rx which has grown internally and by acquisition and CVS Health is acquiring Aetna. Several Blue Cross licensees own Prime Therapeutics and Anthem, another large Blues licensee, is looking into adding a PBM. The combined businesses have more data to explore in an effort to control costs. It’s interesting that in 2011 OPM required the nationwide FEHB plans to competitively bid their PBM contracts every three years. Before long, those carriers likely will be competitively bidding a medical network and PBM package periodically.

The FEHBlog has noted that OPM’s focus per the call letter is on controlling opioid prescriptions, The pendulum already has swung away from over prescribing those dangerous drugs. Street opioids like heroin and fentanyl remain a problem that FEHB plans can’t address. The FEHBlog’s concern is with caring for the thousands of people whom the opioid crisis has harmed. That concern was hammered home by an article in today’s Wall Street Journal about how “The [opioid] addiction crisis that is killing tens of thousands of Americans every year is also creating a financial crisis for many families, compounding the anguish caused by a loved one’s destructive illness. Families are burning through savings and amassing huge debt paying for rehab that often doesn’t work.”  The first step needs to be reaching a medical professional consensus on treatment. This is a mess.

OPM’s call letter also ask carriers to discuss in their benefit and rate proposal the “carrier’s genetic
testing strategy, scope of included testing, and any applicable vendor partnerships.”  In this regard, the Wall Street Journal reports today about the Food and Drug Administration’s March 6 decision  to authorize 23andMe to sell BRCA tests directly to consumers for $199. 23andMe’s tests looks for “three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent.” The mutations are present in about 2% of that group. The Journal reports that

Under Commissioner Scott Gottlieb, the FDA has begun to ease the path to market of tests from an industry—called the laboratory-developed test business—that makes thousands of diagnostic tests and generates billions of dollars in annuals sales. In interviews and a policy address this week, Dr. Gottlieb laid out details of his lab-test deregulatory efforts, including the 23andMe decision.

This new direction for the FDA generally reverses course from Obama-era plans to more closely scrutinize this industry. “Lab-developed” diagnostic tests are those developed and used at hospitals and corporate labs to test blood and other cell samples sent in by doctors and hospitals. These differ from the traditional lab business, in which companies sell diagnostic equipment to hospitals. * * * 

The test worries some experts in the field. The American Cancer Society’s medical and scientific director, Otis Brawley, said these mutations are a very “incomplete picture of a person’s true cancer risk. Most doctors don’t understand this stuff, and that’s what genetic counselors are for.”

Rita Redberg, a cardiologist and editor of JAMA Internal Medicine, said she would want to see evidence that the 23andMe test is truly of benefit. “Unless this is going to save lives, we shouldn’t be rushing this out to the general public,” she said.

In any event, the Affordable Care Act requires FEHB plans and other health plans to cover with no member cost sharing “genetic counseling and BRCA testing, if appropriate [and performed in-network], for a woman as determined by her health care provider.

 Finally NPR reports that the U.S. Justice Department and 45 state attorneys general filed a lawsuit against a group of generic drug manufacturers “claiming that generic-drug prices are fixed and the alleged collusion may have cost U.S. business and consumers more than $1 billion.” The lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania.  “In their complaint they suggest — but don’t allege — that the price-fixing conspiracy also involved drug distributors. Prosecutors are sending more subpoenas and planning a new complaint.” The FEHBlog will keep an eye on this case.

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