Site-neutral specter lingers

The House Energy and Commerce health subcommittee didn't take as big of a bite out of hospitals' Medicare payments as Republicans had hoped in a markup on Wednesday, but the prospect isn't completely off the table yet.

The subcommittee advanced a first swing at a highly controversial policy area that aims to equalize payment for physicians' services, regardless of whether they are provided in a hospital or a doctor's office. The humbler provision still would result in more than $3 billion in savings to the federal government.

Full committee chair Cathy McMorris Rodgers (R-Wash.) says she's still interested in working on the issue, so don't count any future action out yet.

The subcommittee also advanced bills related to transparency regulations, the 340B drug discount program, and more — read the full rundown here.

insurers

Senators warn MA plans they can't rely on algorithms to deny care

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PATRICK SEMANSKY/AP

The Senate called a hearing and is demanding internal documents from insurers, warning that they can't just rely on algorithms to deny patients' care.

"I want to put these companies on notice," Sen. Richard Blumenthal (D-Conn.) said. "If you deny life-saving coverage to seniors, we are watching. We will expose you. We will demand better. We will pass legislation if necessary. But action will be forthcoming."

The hearing comes on the heels of a STAT investigation by my colleagues Bob Herman and Casey Ross that found Medicare Advantage insurers are routinely relying on proprietary algorithms as a basis for denying care.

New regulations in April made it clear that insurers have to base coverage decisions on patients' individual circumstances instead of using algorithms. Bob and Casey have more on the testimony, and the prospects for any further measures in Congress.

reproductive rights

Appeals court begins politically charged abortion pill hearing

A federal appeals court on Wednesday heard opening arguments in a case that will determine whether the commonly used abortion drug mifepristone can stay on the market — and it quickly turned political, my D.C. Diagnosis co-author Sarah Owermohle reports.

The judges — two Trump appointees and a George W. Bush appointee — bucked Biden administration arguments that a recent Texas court order to pull mifepristone off the market represented an "unprecedented" attack on FDA authority. They also questioned whether telehealth prescribing is safe and if FDA even had jurisdiction, since pregnancy is not an illness — a narrow understanding of FDA's regulatory oversight that could ripple into other drug areas.

U.S. Deputy Assistant Attorney General Sarah Harrington tried to counter these arguments, noting complications from the pill — first approved more than two decades ago — are exceedingly rare. The judges seemed skeptical. The case is likely to return to the conservative-majority Supreme Court, which last month issued a stay to keep mifepristone on the market but punted the broader questions back to the appeals court for Wednesday's hearing. Read more.

fda

Teeming with lawyers

My colleague John Wilkerson is at the Food and Drug Law Institute's big conference this week, and Wednesday's panels featured FDA officials, congressional staff, and lawyers talking about everything from rare drug incentives to the future of the FDA's ability to interpret the laws it enforces. Here are a few highlights:

Everyone's interested in a 2021 federal appeals court ruling that upended FDA's interpretation of exclusivity granted to rare drugs. The court ruled that so-called orphan exclusivity applies to entire disease states. FDA's long-standing policy is that the exclusivity applies only to the indications for which drugs are approved, and the agency essentially said it will ignore the ruling, except for the specific product that was subject to the lawsuit.
A related legal issue that also received a lot of attention is an upcoming lawsuit before the Supreme Court over whether judges should defer to federal agency interpretations of the laws they enforce. If the high justices overrule that long-standing doctrine, expect FDA to go slow on regulations and big decisions. My story on that is here.
Industry lawyers tried out a new line of attack against state and federal government efforts to curb spending on drugs that get accelerated approval: Now, they're arguing that those restrictions run counter to health equity efforts. That's come up a bit in the conversation about Medicare's limits on paying for Alzheimer's drugs like Biogen's Aduhlem before now, but we heard a number of folks bring it up Wednesday.

addiction

Biden administration says 'all options are on the table' to increase methadone access

As opioid overdose deaths have skyrocketed in recent years, a growing number of doctors, patient advocates, and public health experts have pushed to allow for patients to receive methadone, a common addiction medication, the same way they receive any other medication: at a doctor's office or pharmacy.

A top Biden administration official told my colleague Lev Facher that he's convened meetings with HHS and the DEA to discuss policy options.

"All options are on the table right now," Rahul Gupta, the director of the White House Office of National Drug Control Policy, said.

Read the full dispatch here, including a new policy Gupta floated that the government hasn't formally proposed yet.

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What we're reading

AI leaders issue a plea to Congress: Regulate us, and quickly, STAT
Drug shortages near an all-time high, leading to rationing, New York Times
FTC move to block the Amgen-Horizon deal highlights concerns over negotiations with insurers, STAT
The one abortion law Democrats aren't rushing to repeal, Politico
Depression hits new high among Americans, per survey, STAT