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Hello, D.C. Diagnosis readers. The Senate Finance Committee is gearing up to hold new hearings on reducing the price of prescription drugs. Here’s a factoid that’ll make you scream into your hands about Washington gridlock: It’s been more than three years since pharmaceutical CEOs testified before that very committee, on this very issue. Oh, how young and innocent we were back then. I’m at [email protected].
A glaring gap in the newly enacted surprise billing law
If you thought the No Surprises Act was the end of all surprise medical bills, my new colleague Bob Herman has got a story you might want to read.
Under the federal law, which took effect Jan. 1, consumers can’t receive a surprise bill from a provider when they have no control over who they receive care from – like a doctor in an emergency room – but they can receive a surprise bill for lab work, even if the blood draw occurs inside the same building as their own doctor’s office. As Bob writes, surprise lab bills are a “cautionary, early warning of yet another type of service that doesn’t actually fall under the law’s protections.”
The bills, it turns out, are the byproduct of a technicality that largely depends on how a doctors’ office is defined under the law.
Confused? Angry? A little bit of both? Bob’s story will help you unpack the latest ripple in the ongoing fight over surprise bills. Read more.
Biden is flooding the country with Paxlovid … except in federal prisons
It’s no secret that the Biden administration believes Pfizer’s Covid-19 drug Paxlovid is going to be a major part of the country’s recovery from Covid-19. Already, the administration has planned to buy 20 million doses of the drug, and Biden announced last week during his State of the Union that people will soon be able to pick up the drugs at pharmacies around the country, free of charge. It’s no wonder: The drug has been proven to dramatically cut people’s risk of getting seriously sick from Covid-19.
But the situation in federal prisons is drastically different: The federal Bureau of Prisons has received just 160 courses of the drug for the roughly 150,000 people in federal prison — despite the fact that Covid-19 has absolutely ravaged the prison population.
So why is this happening? It seems the BOP just isn’t asking for the drug. A spokesperson for the federal health department, which oversees the allocation of these medicines, told me that HHS doesn’t set the allotment for prisons. The prison system has to ask for the drug – and it just hasn’t.
For more check out my new story here.
Covid budget crunch looms over government funding fight
Congress is hurtling toward yet another government funding deadline on Friday, and on top of all the other contentious issues they are weighing, they’re also trying to hash out whether to fulfill the White House’s request of $22.5 billion to fight Covid-19.
Republicans have so far balked at the request, and demanded a more thorough accounting of relief funding that has already been spent before they agree to more funding. The downward pressure appears to be working, as Sen. Roy Blunt told reporters Monday evening that the expected number has shrunk to $15 billion already.
If they can’t come to an agreement soon, it’s going to be a big problem for the Biden administration’s pandemic response, my colleague Rachel Cohrs reports. Money has been so tight that the White House put off buying more than 9 million courses of Pfizer’s antiviral drug, Paxlovid. That’s about half of the amount they had publicly promised to purchase.
That purchase alone could cost around $5 billion, based on the government’s first order. White House Press Secretary Jen Psaki said Friday that without more funds, the country will run out of oral antivirals by September.
The clearest sign yet that accelerated approval is in trouble
Rep. Frank Pallone, the powerful chair of the House Energy & Commerce Committee, introduced a new bill Monday that would dramatically tighten the rules around the FDA’s so-called accelerated approval pathway, I write in a new story for STAT.
Regardless of whether you’re a backer of the pathway, a fierce critic, or just an FDA nerd, this is a bill you’ll want to keep close eyes on. Not only would the bill make it illegal for pharma companies to fail to complete theirFDA-required follow up studies, it would automatically revoke approval for any drug that is over a year overdue for completing those studies.Talk about a firm deadline.
For more on the bill, check out my story here.
Tobacco companies and their allies are officially going into the White House
D.C. Diagnosis reported last week that the FDA had finally submitted a proposed regulation banning menthol cigarettes for White House review and that tobacco companies were likely to ramp up pressure on the White House to kill the regulation.
Well, STAT’s review of public calendars shows that pro-tobacco groups are already planning to meet with White House officials this month about the menthol rule. Americans for Tax Reform, a conservative group with a long history of allying with tobacco companies, is the first group slated to meet with White House about the menthol regulation. That meeting is scheduled for this Wednesday. The Coalition of Independent Tobacco Manufacturers will also meet with OMB later this month, according to the public schedules.
Several other groups, including the Cigar Association of America and the National Tobacco Company will also meet with OMB this month to discuss a related pending regulation, which would crack down on flavoring in cigars.
Meanwhile, Robert Califf has spoken for the first time publicly about the regulation. He tweeted his support for the regulations last week. “I saw too many people die or suffer irreversible illness due to tobacco products. These proposed rules are intended to help reduce this needless suffering,” Califf wrote, adding that the text of the proposed regulations should be released this spring.
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