Setting the September calendar in health care

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The fall frenzy begins

Ah, that back-to-school feeling. The halls of Congress are full again and the schedule is packed. While the budget deadline looms, lawmakers are likely to extend current funding for a few more months. Other priorities can’t wait, though.

One is the Pandemic All-Hazards Reauthorization Act, which must be passed by the end of the month if HHS’s Assistant Secretary for Preparedness and Response wants to keep working (especially as a recently-elevated operating division). ASPR Dawn O’Connell has said that she wants the department to keep three pandemic-era authorities: Hiring flexibility to quickly scale up during emergencies, the ability to construct manufacturing buildings, and the authority to acquire certain technologies. ASPR relied on a mix of partnerships from the Defense Department to FEMA to get that done during Covid-19, but those authorities are ending this month.

A House committee advanced a bare-bones bill that doesn’t grant those powers, while the Senate version would let ASPR strike capacity-building contracts. But in both markups, otherwise bipartisan talks were bogged down by amendments, one to bar certain research and one to address drug shortages. Those amendments didn’t make it through the committees, but could be resurrected during negotiations over the two versions.

We can also expect some pressure this month for the Senate HELP committee to finally hold a confirmation hearing for Biden’s NIH director nominee, Monica Bertagnolli. During recess, she agreed to a demand by Sen. Elizabeth Warren (D-Mass.) that she not join any pharmaceutical board for at least four years after her tenure. While that’s a big concession from the oncologist, Warren doesn’t set the HELP calendar — Sen. Bernie Sanders (I-Vt.) does, and he has refused to hold a hearing until the White House makes more drug pricing concessions.

98 problems but an exemption ain’t one

J&J’s Stelara is one of the first 10 medicines that will be included in its new drug price negotiation program. But had the therapy been approved 98 days later, it may not have made the list at all, D.C.D. co-author Rachel Cohrs writes.

How this works: There’s a loophole in the law that allows drugs with competitors coming to market soon to escape negotiation, at least for a couple years. But Stelara was approved by the FDA 98 days too early to qualify for that exemption. That same cutoff also means the drug will face dramatically bigger discounts in the negotiation process — the company is stuck with 60% minimum discounts off the drug’s price, instead of 25%.

Compounding the bad luck: Drugmakers could avoid Medicare’s negotiated prices if biosimilars hit the market before it sets in. But the way J&J has set up its settlements with biosimilar makers, it appears that it may miss a separate deadline for that relief, too — also by a matter of months. More from Rachel.

CMS plunges ahead on nursing home staffing

The agency on Friday released a much-contested draft rule aimed at bolstering staffing in nursing homes and long-term care facilities. President Biden ordered CMS to do so roughly 18 months ago, but the proposal has dragged. And advocates were already up in arms, as days before CMS published the proposal, a leaked document showed the agency wasn’t preparing to assign a required staffing level.

Instead, the new rule would require that each resident have .55 hours of attention a day from a registered nurse and 2.45 hours from nurse aides. It would also require at least one registered nurse onsite 24 hours a day and would strengthen some facility assessments.

While that’s likely a relief for nursing homes that argue there can’t be a one-size-fits-all staff requirement for facilities, nurses and advocates quickly blasted the rule. “After repeated delays spurred by industry influence, we have a weak and disappointing proposal that does little to improve the quality of care or stop the mistreatment of nursing home staff,” Rep. Lloyd Doggett (D-Tex.), who has pushed for higher standards for years, said in a statement.

What’s the Republican addiction plan?

Republican presidential candidates say they’ll stop fentanyl at the border. But few have laid out addiction treatment strategies, if they have them at all. That could reflect a broader trend in America, STAT’s Lev Facher writes. Voters haven’t forgotten about the opioid crisis, but have grown cynical of grand plans to scale up the country’s fractured treatment system.

Whether or not their militaristic stances on border control and drug dealer crackdowns will ever become reality, Republican candidates appear to have largely settled on a powerful message: That the Biden administration’s border policies have failed not only when it comes to immigration, but also when it comes to the drug crisis.

Only upstart former biotech executive Vivek Ramaswamy has come close to touting treatment in his campaign platform, and it’s not clear whether that — making psychedelics more available — is any more viable than border crackdowns or fentanyl reclassifications. More from Lev.

Humana sues over Medicare audit

The major insurer on Friday filed suit against the federal government, arguing that this year’s new rule to claw back overpayments from it and other Medicare Advantage insurers violates federal law due to its “shifting justifications and erroneous legal reasoning.”

This was somewhat expected: Humana executives signaled earlier this year that they’d consider the move if CMS went forward with a plan to audit overpayments by reviewing the codes and diagnoses that Medicare Advantage recorded for their members and compare those conditions with medical records. More on the arguments from Bob Herman.

What we’re reading

No longer brushed off: A Minnesota clinic tries to rewrite medicine’s approach to miscarriage, STAT

Mitch McConnell may be experiencing small seizures, doctors suggest, The New York Times

FTC settles with Amgen over $28 billion deal for Horizon, STAT

Highways are the next antiabortion target. One Texas town is resisting, The Washington Post