Breaking News

A debt ceiling deal, the saga of pain device fraud, & Sen. Warren launches new abortion rights interrogation

May 30, 2023
Reporter, D.C. Diagnosis Writer

Hello and happy Tuesday, D.C. Diagnosis readers! I hope you had a nice and sunny long weekend and some BBQ classics — though not at the prices suggested in the latest ad from RunawayRx, a California Association of Health Plans effort to lobby against high drug costs. Send news and tips to sarah.owermohle@statnews.com.

congress

Debt ceiling deal avoids (most) health care cuts

The White House and top Republicans finally reached a debt ceiling agreement this weekend that would leave out rumored Medicare and Medicaid cuts and fend off potential payment delays for thousands of providers and pharmacists. 

The deal puts limits on discretionary spending across the government and puts work requirements on certain federal aid programs, but it avoids some of the most controversial health policy changes that had come up in recent weeks.  Of course, Congress still has to actually pass the bill and get it to President Biden's desk before June 5 — no small feat in this political environment.. 

If the agreement stays on track, the entire health care sector can breathe a sigh of relief that federal payments won't stall this week. The disruptions to hospitals, insurers, and other providers would have been severe. 

However Republicans have also secured a provision to claw back billions of dollars of Covid-19 relief funds, including nearly $20 billion to HHS, as part of the agreement. Importantly, though, it preserves the funding for Next Gen, the program working to develop the next iteration of Covid vaccines.


devices

Pain device fraud exposes payment struggles

What happens when medical device companies start designing their products with the goal of … maximizing their Medicare reimbursement? STAT's Lizzy Lawrence has a fascinating deep dive on one company that did exactly that (and ended up with executives charged with fraud.) 

Stimwave first launched a peripheral nerve device – a tiny implant with a battery on top of the skin – after FDA approval in 2016. The device offered a less invasive and risky path to pain relief than implanted battery options — but plans balked at paying a premium, especially since CMS didn't have a payment code for this new type of pain device. So Stimwave invented an implanted battery, first with copper then plastic attachments that former employees say made no meaningful changes to the implant's effectiveness.

The fake component let Stimwave sell their devices for thousands of dollars more than they otherwise could, Lizzy writes. And the company's CEO, Laura Perryman, pushed staffers to lie to physicians about the plastic part being medically necessary. That was seen as an easier road to reimbursement (and higher prices) than lobbying for a new code from CMS, which is notoriously slow-moving on new payments, former employees said. Dive into the whole saga and Stimwave's struggles here. 



Congress

Warren questions health groups on state abortion limits

Sen. Elizabeth Warren (D-Mass.) late last week launched a new round of questioning on states' abortion bans and mifepristone limits, dispatching a batch of letters to major doctor and provider organizations. The letters arrive as mifepristone access hangs in the balance with a federal appeals court.

But it's not just mifepristone that Warren is asking about. In inquires to the American Medical Association, Physicians for Reproductive Health, National Nurses United, the American Pharmacists Association, and the American Hospital Association, she and other Democratic senators also ask about access to misoprostol, a legal and slightly less effective abortion pill. 

When Warren asked a similar round of questions last summer, the organizations reported there were rising concerns about providers' liability and patients' access to broader reproductive health care. However there's not much Warren and co. can do to reverse those trends, with a split Congress and abortion access playing out in federal courts.


DRUG PRICING

Is Medicare drug price negotiation safe from lawsuits?

My colleague John Wilkerson noticed a report by nonpartisan congressional researchers that should save drug industry lawyers several hours on Westlaw researching Supreme Court rulings on judicial review of Medicare decisions.

The Inflation Reduction Act actually restricts the courts from reviewing aspects of the new Medicare drug negotiation process, including the drugs chosen for negotiation and the maximum price that Medicare will pay for them. 

The Congressional Research Service, the research arm of Congress, looked into whether that language will hold up. The experts said it might preclude some lawsuits, but it is not clear that all of Medicare's actions will be exempt from judicial review. There are compelling arguments that certain agency actions are still open to legal challenges, and the IRA itself is fuzzy in some areas. Read more from John here


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What we're reading

  • Texas wants to wean trans youth off meds in a 'safe and medically appropriate' way. Doctors say that's impossible, STAT
  • Tally of Covid-19 cases after CDC conference climbs to 181, The Washington Post
  • Texas wants to wean trans youth off meds in a 'safe and medically appropriate' way. Doctors say that's impossible, STAT
  • Maternity's most dangerous time: After new mothers come home, The New York Times

Thanks for reading! More on Thursday,


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