What's next for Medicare coverage of Alzheimer's drugs

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Today's edition: An adviser to Sen. Tommy Tuberville (R-Ala.) has resigned after a Post report on his role in stalling military promotions. The Oklahoma Supreme Court struck down two of the state's abortion bans enacted last year. But first …

The Medicare agency is announcing how it plans to expand coverage for a new class of Alzheimer's drugs once the medications get full approval from the FDA.

In a statement shared with The Post, the Centers for Medicare and Medicaid Services said it would cover the costly drugs — a move the agency foreshadowed in previous statements and congressional testimony — for anyone enrolled in Medicare Part B and meets the criteria for coverage, Laurie McGinley and I report this morning.

The effort comes amid an intense lobbying campaign by patient advocates, lawmakers and drugmakers pushing for access to the first drugs shown to slow cognitive decline from the disease. The statement still left open questions on precisely how the new process, which requires registries for patients, will work. And it's likely some advocates will want to push coverage further and get rid of such registries.

The new way of covering the medications could come as soon as this summer. That's when the FDA is widely expected to grant traditional approval to the first new Alzheimer's drug, a necessary step before Medicare will expand payment.

The statement from CMS is the latest twist in a high-stakes struggle over how to handle the emergence of new therapies aimed at treating a disease that robs patients of their memories and devastates families. But the drugs have also received their share of criticism over worries they aren't highly effective, pose serious safety risks and could imperil Medicare's finances if widely used.

Medicare's policy is aimed at expanding the number of patients eligible to receive the drugs after they receive FDA approval, while allowing the agency to collect critical information on how the medications affect patients, according to a CMS official.

About the plan: The federal health insurance program would provide coverage to patients whose doctors take part in registries that collect information on how the drugs work in the real world. The medications must be administered in "appropriate settings" — those in which doctors collect clinical evidence for a registry showing how a therapy works in the real world, as opposed to the strict environment of a clinical trial.

This is different from how Medicare covers Alzheimer's drugs under the accelerated approval pathway, where patients have been required to be in tightly controlled clinical trials for coverage. It would begin on the day the FDA grants full approval — which requires more clinical evidence than for fast-track approvals — to a drug in a new class of Alzheimer's medications.

So far, none of the drugs in the new class of Alzheimer's medications have received such FDA sign off. But that could soon change.

Some advocates for the drugs may partly welcome the looming change, since it doesn't link coverage to participating in a clinical trial. But some have previously indicated they may feel the registries are burdensome and could curtail access.

Registries can be time-consuming for some practices, especially in rural and underserved areas. (The agency shared its revamped policy with The Washington Post ahead of public release and on the condition the announcement not be shared with others.)

The CMS official countered that the data requirement will be simple. Doctors and staff won't be paid for additional work, which is consistent with past practice.

This is all part of a fierce battle over Medicare coverage for Alzheimer's drugs.

On Capitol Hill, lawmakers in both parties have pressed President Biden’s Medicare agency to consider broader coverage for Alzheimer's drugs. And some, such as Rep. Anna Eshoo (D-Calif.) have publicly expressed concern that CMS officials aren't prepared to stand up a registry by this summer.

Advocacy groups such as the Alzheimer's Association have pushed Medicare for sweeping coverage of the new medications — including those cleared on an expedited basis — arguing the FDA should be the final arbiter of safety and efficacy. But critics say the FDA was too quick to approve the therapies and that Medicare has provided an important brake.

A special thanks to Laurie McGinley for her reporting help. Read our full story here.

The House passed a painstakingly negotiated bill to suspend the debt ceiling, limit federal spending and avert a default late yesterday, securing a win for Republicans and the White House that seemed out of reach just days ago, The Post's Marianna Sotomayor, Paul Kane and Rachel Siegel report.

House lawmakers approved the 99-page bill by a 314-117 bipartisan vote after weeks of touch-and-go negotiations that tested Republicans’ narrow majority of the chamber, their leader's shaky hold over his party and a White House that had long refused to compromise on the debt ceiling. Prospects were looking up after the deal survived a key procedural test earlier in the day, as the House voted to approve the rule governing floor debate despite opposition among some conservative Republicans and liberal Democrats.

What we’re watching: The legislation now heads to the Senate, where Majority Leader Chuck Schumer (D-N.Y.) has said lawmakers may need to be in Washington through the weekend to get the legislation passed before Monday — when the Treasury Department has warned that the United States will no longer be able to pay all of its bills. Such a scenario could lead to missed Medicare reimbursements to health providers and Medicaid payments to states.

President Biden:

Tonight, the House took a critical step forward to prevent a first-ever default and protect our country's hard-earned and historic economic recovery.I have been clear that the only path forward is a bipartisan compromise that can earn the support of both parties. This agreement…

The national security adviser of Sen. Tommy Tuberville (R-Ala.) has resigned after a Washington Post story revealed that he played a role in the senator's controversial bid to delay dozens of military promotions in protest of the Pentagon's new abortion policy, our colleague John Wagner reports.

Catch up quick: The Post's Ben Terris reported Friday that Morgan Murphy had presented Tuberville with multiple options for trying to block the Defense Department's new policy, which provides paid leave and reimbursement for service members who travel out of state to obtain an abortion.

Tuberville chose the strategy of using his senatorial powers to delay military promotions that are subject to confirmation by the chamber. More than 200 promotions, which are typically approved swiftly with no controversy, have since been stalled, John writes.

Notable: Murphy told Politico, which was first to report his resignation, that he thought The Post's story "overstated" his role and that he stepped down out of respect for Tuberville.

Sen. Tommy Tuberville (R-Ala.):

The burden is not on me to undo an illegal policy. The burden is on the Biden administration to follow the law. I will continue to stand up to the most politicized Pentagon in American history. https://t.co/jRWhjSYYsl

The Oklahoma Supreme Court struck down two of the state's abortion bans yesterday, affirming the right to terminate a pregnancy in life-threatening situations, The Post's Kim Bellware reports.

In a 6-3 ruling, the state's highest court tossed out the laws. The procedure is still largely prohibited in the conservative state due to a pre- Roe ban from 1910 that prohibits abortions in most cases.

Key context: Yesterday's ruling affects a pair of laws passed last year that employed a novel legal strategy first used in Texas that empowers private citizens to sue any individual who performs or enables an abortion for up to $10,000 in damages.

The ruling held that the citizen enforcement aspect of the law could unconstitutionally thwart a woman from receiving a lifesaving abortion. The court found that doctors should be able to determine when it was medically necessary to perform the procedure without waiting until the patient's life or health was in imminent danger, Kim writes.

Oklahoma Gov. Kevin Stitt (R):

I again wholeheartedly disagree with the Oklahoma Supreme Court's use of activism to create a right to an abortion in Oklahoma.As governor, I will continue to do my part to fight to protect the lives of the unborn. My full statement here: https://t.co/MkGzuEtXlw

Planned Parenthood Great Plains:

Today's ruling clarifies emergency situations, but most Oklahomans still don't have access to care. We’re relieved the court has upheld abortion rights in emergencies, but our fight for access continues. We’re here to help you reach the care you deserve. https://t.co/zDL5lnao2C

The Food and Drug Administration greenlit a second vaccine to protect older adults against the respiratory ailment RSV yesterday, approving Pfizer's Abrysvo for people ages 60 and older, the company announced.

The decision comes less than a month after the agency signed off on GSK's shot for the same age group, making it the world's first vaccine approved to prevent lower respiratory tract disease caused by the virus.

Both shots still face more steps before they can hit the market. The companies are aiming to roll the shots out this fall ahead of the winter RSV season, pending recommendations from the Centers for Disease Control and Prevention and its vaccine advisers, who are scheduled to meet on the issue later this month.

The FDA issued warning letters to 29 retailers and one distributor yesterday for allegedly selling various unauthorized Puff and Hyde brand disposable e-cigarettes, as part of the agency's larger effort to crack down on the sale of illegal tobacco products that are popular with the youth.

FDA Commissioner Robert Califf:

Protecting our nation's youth from tobacco products – including disposable e-cigarettes – is a top priority for the FDA. We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law. https://t.co/exxLDYmnu8

More than 8,200 people have filed claims with the federal health department alleging injuries or death from coronavirus vaccines — but don't expect a decision on them anytime soon, Ian Lopez reports for Bloomberg News.

The Department of Health and Human Services's Countermeasures Injury Compensation Program has reached just 749 decisions on claims related to covid treatments, with only four cases resulting in compensation as of May 1, according to federal data. An HHS spokesperson told Ian that the deluge of covid claims in recent years have exceeded the CICP's previous caseload.

Coronavirus vaccine injuries are rare, with more than 676 million doses having been administered nationwide since the shots were rolled out in late 2020.

CVS warns PBM reforms ‘could lead to higher costs’ (By Bob Herman | Stat)

Health Care Coalition Jockeys Over Medi-Cal Spending, Eyes Ballot Initiative (By Angela Hart and Samantha Young | KFF Health News )

Tennessee woman gets emergency hysterectomy after doctors deny early abortion care (By Nadine El-Bawab | ABC News)

In today's first @washingtonpost TikTok, drugmaker Eli Lilly has agreed to pay a $13.5 million settlement in a class-action lawsuit alleging systemic overpricing of insulin.Eli Lilly will also keep its $35-a-month cap on out-of-pocket costs for four years. pic.twitter.com/uR01YyKerP

Thanks for reading! See y'all tomorrow.