on the hill
The fall frenzy begins
Sarah Silbiger/Getty Images
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.
Medicare negotiation
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.
nursing homes
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.
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