| | | |   | Hello, and good morning, D.C. Diagnosis readers! I hope Congress does not ruin your holiday plans, like it appears ready to do for many of the staffers involved in lame duck negotiations and the press corps who covers them. If you have any newsy tidbits to cheer us up, send them to rachel.cohrs@statnews.com. | | | Congress could solve the FDA’s Theranos loophole 
Elizabeth holmes, founder of theranos (JUSTIN SULLIVAN/GETTY IMAGES) A regulatory loophole allowed Theranos to structure its business to avoid FDA oversight of its faulty blood tests. Now, Congress is closer than it’s been in years to a fix for that issue. It’s looking to revamp the way the government regulates diagnostics regardless of where they’re created, my co-author Sarah Owermohle and I report in a new story this morning.
The tests the FDA is seeking to regulate could have devastating consequences for patients if the results are inaccurate. They help inform decisions about treatments for diseases like cancer, for example. Right now, depending on where a test is developed, there are two different oversight systems, divided between the FDA and CMS, that hold tests to different standards.
The VALID Act, which lawmakers are currently debating related to an end-of-year government funding package, seeks to create one unified system for all tests. Talks are still extremely fluid, and it’s unclear what if any legislation on the issue will be accomplished before the end of the year.
But FDA Commissioner Rob Califf has threatened to address the issue through regulations if Congress doesn’t pass anything, so it’s going to be an important issue to watch in the coming months regardless. Read more. | Biden administration officials are in the spotlight at Milken Summit It’s that time of year for the Milken Future of Health Summit, which means a parade of Biden administration officials in the hot seat. Here are a couple highlights from the conference so far: -
ARPA-H Director Renee Wegrzyn spoke to STAT about the pressure to hire top talent, after a panel where she laid out some hopes for the new agency. -
FDA Commissioner Robert Califf reacted to a recent report criticizing the agency’s regulation of food products, my colleague John Wilkerson reports. -
Keep an eye out for an interview with CMS Administrator Chiquita Brooks-LaSure today, conducted by STAT’s very own Executive Editor, Rick Berke. | Another state submits a drug import plan (for FDA to ignore) Colorado on Monday became the fourth state to submit a plan to the FDA to import Canadian drugs, but agency staff seem in no hurry to approve them, my colleague John Wilkerson reports. Colorado’s plan identifies 112 drugs that state officials estimate would save Coloradans $53 million to $88 million annually. “Now all we need is FDA approval and Coloradans will start saving money!” according to a statement by Gov. Jared Polis, a Democrat. However, the FDA has yet to approve the import plan that Florida submitted two years ago. Florida filed a lawsuit that accuses the agency of foot dragging. New Mexico applied to import Canadian drugs a month after Florida, and New Hampshire submitted its proposal last year. | Insurance companies and their PBMs prioritize profits before your prescriptions Three insurance company pharmacy benefit managers (PBMs) control 80% of patients’ medicines. Regardless of what your doctor prescribes, they decide what medicines are covered, what medicines aren’t and what you pay for them. They use their market power to get tens of billions in rebates and discounts that should go to you. That control leaves you fighting for your medications, instead of fighting your illness. Tell Congress those savings belong to patients. Learn more. | AHA clashes with White House on immigration The hospital industry’s largest trade group in D.C. is going head-to-head with the White House on an immigration bill called the EAGLE Act, which would phase out per-country green card caps. The White House said that the bill could help relieve the immigrant visa backlog in the United States for thousands of people who have waited for visas simply because of their country of origin, and came out with a statement of support for the legislation on Tuesday. But AHA wrote in a letter to congressional leaders that they fear the policy change could lengthen the wait times for nurses “to five to seven years or more,” as nurses generally don’t qualify for H-1B visas. Instead, AHA advocates increasing the number of immigrant visas overall to accommodate demand from all sectors. The legislation does include a provision that would set aside visas for nurses and physical therapists, but AHA still isn’t satisfied. It’s unclear whether the bill can clear either the House or the Senate. | How much could a Covid-19 shot cost? With the specter of the nation’s Covid-19 public health emergency ending next year, the Kaiser Family Foundation analyzed how much the government has spent on coronavirus vaccines, and how that translates to potential price tags in an emergency-less future, Sarah writes. Pfizer has floated a price between $110 and $130 per dose; Moderna has suggested between $82 and $100. Those are each roughly three to four times the price-per-dose paid by the U.S. government, which averaged out to about $28.90 apiece for bivalent doses, according to a KFF analysis. So in the (admittedly, very unlikely) scenario that every American adult gets another coronavirus shot, it will cost the country nearly $30 billion. Of course, many adults refuse even their first shot, while most of the country is lagging on getting boosters. If just a quarter of U.S. adults get new Covid-19 shots — a projection in line with annual flu vaccines — it would cost between $6.2 and $7.4 billion. While much of that cost will be picked up by insurers, the prospect of $100-ish doses raises immediate concerns about what uninsured and under-insured people will do in a post-emergency landscape — especially given the health care disparities already exposed by the pandemic. | What we're reading - Paxlovid has been free so far. Next year, sticker shock awaits, Kaiser Health News
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Cancer patients endure an overlooked financial burden: hospital parking fees, STAT -
Medical bills remain inaccessible for many visually impaired Americans, NPR -
Biden administration unveils dashboard to track nonfatal drug overdoses, STAT - Psychedelic therapy is moving to the next frontier: workplace perk, STAT
| Thanks for reading! More next week,  | | | |
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