coverage
CMS sticks with Alzheimer's registry plans
Despite pressure from Congress and advocates, CMS isn't changing its coverage plan for new Alzheimer's drugs anytime soon. Medicare this morning issued a statement about the registries it requires for patients who want to take Biogen's Aduhelm, approved in 2021, and a potential similar therapy on the horizon, Eisai's Leqembi, which the FDA could broadly approve as soon as this month, my colleague Sarah Owermohle writes.
While many lawmakers have pushed CMS to do away with the registry requirement the agency has held fast in its decision to stick with registries to build real-world evidence for the new treatments. Senate Finance Chair Ron Wyden (D-Ore.) last month urged the agency to at least clarify how people could register for the drug, especially amid concerns that rural and lower-income people could miss out.
CMS looked to defend itself in today's statement, writing that "Registries are common tools in clinical settings that have successfully gathered information on patient outcomes for decades." However it offered few details on upcoming plans, especially with Leqembi on the horizon: "CMS is working with multiple organizations that are getting ready to open their own registries. More information will be released as they come on line."
DEBT DEAL DRAMA
Advocates warn of 'fierce' science spending battles
The debt ceiling deal hammered out by the White House and congressional leadership this weekend would freeze non-defense and veterans' health spending at 2023 levels for next year and allow only a 1% bump in 2025 — –meaning health agencies could be vying for a sparse set of spending bumps next year, researchers and advocates warn in a new story from my D.C. Diagnosis co-author Sarah Owermohle.
Most are worried about dents to the NIH budget, which has steadily grown with bipartisan support over the last three decades but faces new scrutiny under GOP House control. Plus, President Biden is asking for billions more for new programs under the Advanced Research Projects Agency for Health and his relaunched Cancer Moonshot mission.
That could mean flat funding in 2024 and 2025, even as the White House strives to hit Biden promises to curb cancer deaths, reverse children's mental health care trends and mobilize Alzheimer's disease research. "The competition for funding will be particularly fierce. For NIH as well as for every other agency funded in this category," said one lobbyist familiar with the debt ceiling discussions. Read more here.
REGULATIONS
Are new PAYGO rules toothless?
Republicans have tried to sell a new provision in the debt ceiling deal as a check on the Biden administration's spending power, but budget experts and former HHS officials told STAT that it likely won't affect health care policy all that much.
The deal includes a provision that would force federal agencies to find ways to offset the cost of any new regulations they create related to programs that cost more than $1 billion. But there are big loopholes, and the policy expires after 2024.
I also examine a case study in my new story out today. It details how HHS managed to issue one of the most expensive regulations ever (the rebate rule!), despite the Trump administration similarly requiring offsets via executive order.
340B
HHS' multibillion-dollar war with hospitals
A long-simmering fight between HHS and hospitals over payment for drugs in Medicare will soon come to a head, and it could get ugly.
An eagle-eyed source spotted that HHS sent a rule to the White House Office of Management and Budget on Friday (the Friday before a long weekend, no less) that appears to outline its plan to fix certain payments for hospitals, after the Supreme Court ruled a Trump-era slash to payments to hospitals for drugs administered under the 340B program was illegal.
Medicare estimated that the impact of the Trump-era policy was roughly $2 billion per year — and the policy was in effect for five years. The fix could also pit hospitals against each other, as for-profit hospitals aren't eligible for the 340B program, and could see their payments reduced or recouped in order to make the 340B hospitals whole. Prepare for a whole lot of bellyaching no matter how things shake out, and possibly more lawsuits.
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