By Megan R. Wilson

Listen to this briefing

• Shutdown day 40: Both chambers of Congress could vote to end the shutdown by the end of this week, but divisions over the enhanced premium tax credits remain.
• Nixing the black box: Federal regulators are dropping a decades-old black box warning on hormone replacement therapies used to help treat menopause symptoms, a move some doctors say could expand use of the treatments.
• Pfizer wins: Pfizer beat rival Novo Nordisk in its battle over an anti-obesity start-up company, paving the way for the company to enter the lucrative weight loss market.

Good chilly Monday afternoon, everybody, and welcome to the Health Brief. What a start to the week, huh? If you were, like me, watching C-SPAN until late last night, go ahead and get another cup of coffee. You’ve earned it. Now, I want to know: How is your organization positioning itself now that any chance of a large health package will be delayed until next year?

Send all your best health policy intel, tips, scoops and lobbying strategies to megan.wilson@washpost.com or message me on Signal at megan.434. (A programming note: While tomorrow is a holiday, I will still be landing in your inbox in the afternoon.)

This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from the Washington Post newsroom. Learn more about WP Intelligence.

	The Lead Brief

Let the negotiations begin. After 40 days in dispute, the shutdown appears on its way to resolution, but the debate over the Affordable Care Act subsidies goes on. While members on both sides of the aisle are looking to strike a deal on the subsidies, the idea of extending the expanded tax credits — even with changes demanded by Republicans — faces an uphill battle.

What happened: Enough Democrats split from their party to advance a government spending package that would temporarily fund the government. It comes along with a promise from Senate GOP leadership for a vote in the Senate by mid-December on any bill Democrats choose to address the expiring enhanced premium tax credits — a far cry from the guaranteed approval most Democrats wanted, which has led to anger among the caucus.

What the deal contains: The Senate cleared the first procedural hurdle to passing the measures to fund the government until Jan. 30, in addition to three full-year agency spending bills. The effort also would reverse all the federal firings that occurred since the shutdown began on Oct. 1 — and provide backpay for those workers.

Read The Post’s Riley Beggin and Theodoric Meyer describe the process on how things move forward: “House will return to Washington once Senate passes shutdown deal.”

→ The stopgap funding bill, if passed by both chambers, would tackle a number of outstanding health care items that lapsed at the end of September.

• That includes temporarily extending Medicare coverage for more services via telehealth and likely backpay for physicians who have provided those services to Medicare beneficiaries during the shutdown.
• It would also allocate funding for community health centers through the end of January. Community health centers serve more than 32 million patients across the country and receive 70 percent of all their federal funding through the program, which has been renewed in fits and starts over the past two years.

“We’re taking a breath of relief, but the continued short-term patches take a big toll,” Amanda Pears Kelly, the chief executive of industry group Advocates for Community Health, told me Monday morning.

Despite opposition from many House Democrats, including House Minority Leader Hakeem Jeffries (New York), the package is expected to pass in the House. Speaker Mike Johnson (R-Louisiana) wants to have a vote “as soon as possible.” While the Senate has pledged a vote on legislation to handle the enhanced Affordable Care Act premium tax credits, Johnson said last week that he’s “not promising anybody anything.” He reiterated that on Monday afternoon.

Advertisement

WHAT WE KNOW:

• Seven Democrats, and one Independent who caucuses with them, provided the votes needed to get the measures over the first procedural finish line on Sunday night. Many emphasized that they wanted to end the pain caused by the shutdown, and all of them are either retiring or aren’t up for reelection until 2028 or 2030.

→ Read the report from Leo Sands and Jennifer Hassan in the Washington Post newsroom about each of them and their explanations for their votes. “Congress now has one month to engage in serious, bipartisan negotiations to extend the Affordable Care Act’s expiring tax cuts for health insurance," said Sen. Maggie Hassan (D-New Hampshire).

• Funding the government through January means that a larger discussion about an overall health care package — which normally occurs at the end of the year — will be pushed back. Expect lobbyists for various industries to use the extra time to advocate for their priorities, including a likely return to proposals meant to overhaul the pharmacy benefit manager, or PBM, industry.
• The debate over abortion will be a hurdle Democrats must overcome to secure any extension. Antiabortion group Susan B. Anthony Pro-Life America has been lobbying conservative members for months, urging lawmakers to insert language to prevent federal dollars from funding abortions. It sent letters to senators on Friday urging them to vote against the Democrats’ offer to extend the tax credits for a year — lest they imperil their standing with the group.

Sen. Ron Wyden, a Democrat from Oregon, has countered that this would be “a backdoor national abortion ban.” Democrats argue that the Affordable Care Act already separates taxpayer funding so those dollars are not used to fund abortion services. “Republicans are spinning a tale that the government is funding abortion. It’s not,” Wyden said on the Senate floor.

WHAT WE DON’T KNOW

• The fate of the enhanced Affordable Care Act premium tax credits — initially bolstered during the pandemic — is still unclear. Senate Majority Leader John Thune (R-South Dakota) has promised Democrats a vote on the bill of their choosing to address the issue in December.

Advertisement

A large chunk of House Republicans oppose an extension of the enhanced tax credits, but others with large numbers of constituents with ACA plans have been pushing for some kind of extension. It’s not yet clear how differences will be resolved.

• How quickly insurers could revise rates — and how fast the Affordable Care Act marketplaces could reflect those revisions — if lawmakers come to a deal. Insurance commissioners have said they would allow plans to adjust their rates in the event that Congress agrees to extend the tax credits and plans have committed to working with regulators to modify rates to reflect any extension as quickly as possible. But it could take state exchanges at least a week to make changes — and that’s if they’re extended in their current form, which Republicans have argued against.

A December vote on extending the enhanced premium tax credits in the Senate would cut extremely close to the Dec. 15 deadline for people to sign up for Affordable Care Act plans if they want coverage to begin on Jan. 1. Open enrollment continues for most states through Jan. 15, but coverage wouldn’t begin until February.

• Whether the hemp issue I talked about on Friday would ultimately be included in the package. Sen. Rand Paul (R-Kentucky) has requested a separate vote to strip language from one of the appropriations bills that would cap the amount of THC — the psychoactive compound found in hemp — in hemp-derived products to 0.4 mg per container.

While appropriators said in a statement that the move preserves access to nonintoxicating CBD and industrial hemp products, Paul and hemp industry advocates argue that it would decimate the market for products — even nonintoxicating ones — endangering hundreds of thousands of jobs. “Standing up for Kentucky jobs is part of my job,” Paul said in a social media post. The U.S. Hemp Roundtable, an industry group, said in a release that 90 percent of nonintoxicating hemp-derived products have THC levels above 0.4 mg-per-container limit.

Meanwhile the American Trade Association for Cannabis and Hemp — whose membership includes cannabis companies in state-regulated marijuana markets — argues “the bill clearly distinguishes between intoxicating and nonintoxicating products, synthetic and natural products, and industrial and consumer products.” Any claims otherwise, said spokesperson Josh Glasstetter, “are baseless and self-interested.”

A new wrinkle in the fight: President Donald Trump supports the current language, which has the THC limit, according to NBC News.

→ Zooming all the way out: The longest shutdown in history is about to end without a major victory for the Democratic Party, which wanted to secure a policy win on health care. It’s a familiar feeling: The shutdowns in recent history haven’t yielded the results they were after.

A h/t to NOTUS reporter Reese Gorman for this brief summary:

	Executive Health Brief

The Food and Drug Administration will be removing a black box label on hormone replacement therapies that some doctors say has long prevented women from taking medications aimed at treating the symptoms of menopause.

Drugs meant for menopausal women — including estrogen and progesterone — have been slapped with the label for more than two decades, warning women about the risk of heart attacks, strokes, blood clots and certain cancers. A black box label, or boxed warning, is the strongest safety label the FDA can put on drugs. It generally applies to a group of drugs, rather than a specific medication.

“Hormone replacement therapy may improve the health outcomes of women at a population level more than any other intervention arguably with the exception of, say, antibiotics or vaccines,” FDA Commissioner Marty Makary told reporters Monday.

My colleagues Akilah Johnson and Rachel Roubein in the Washington Post newsroom have the whole story, including how the boxed warnings were applied in the first place.

Many argue that the research and treatments for menopause have evolved since the labels were first applied in 2003 and health risks differ depending on whether the treatment is taken vaginally or by pills, patches, gels or sprays.

→ Prior to the boxed warning, hormone replacement therapy was extremely popular among women over 50: In 2000, nearly 1 in 5 women in that age group were taking it. By 2010, less than 5 percent of women over 50 were taking hormone replacement therapy.

Major medical societies — such as the Menopause Society and the American College of Obstetricians and Gynecologists — have long endorsed reevaluating the warning label on some products, especially low-dose estrogen cream.

Removing the labels has also been a priority for Makary, my colleagues report. He said that there would still be the potential side effects or “adverse safety events” included inside the package, to encourage a “nuanced discussion” that includes the age of the woman seeking to use the medications.

Baby onesies sold by Children's Health Defense promote being unvaccinated. (Lauren Weber/Lauren Weber/TWP)

	From our notebook

The Washington Post’s Lauren Weber traveled to Texas to attend the annual conference held by Children’s Health Defense, the anti-vaccine group founded by Health Secretary Robert F. Kennedy Jr. in 2016.

Here’s a vignette from her dispatch: “‘God is an anti-vaxxer’: Inside the conference celebrating RFK Jr.’s rise.”

	Market Moves

Pfizer won out in its battle with Novo Nordisk for anti-obesity start-up Metsera — raising its bid for the company to an offer worth up to $10 billion. Novo Nordisk, which had swooped in unexpectedly last month, announced that it wouldn’t be countering.

The Federal Trade Commission had called execs at Metsera to express antitrust concerns surrounding the structure of Novo’s offer, which Metsera said posed “unacceptably high” risk for legal and regulatory challenges. Regulators, however, gave Pfizer early approval for the deal to go through.

What’s next: “Metsera remains committed to the merger with Pfizer, which Metsera believes will deliver immediate and substantial value to Metsera stockholders, and the parties expect to close promptly following the stockholder meeting on November 13,” Metsera said in a statement.

Why it matters: This gives Pfizer access to the massive — and growing — market for weight-loss medications. Metsera is developing an anti-obesity medication that’s being tested to be taken monthly — a lower frequency than many current weight-loss drugs on the market, such as Novo’s Wegovy, that are taken once per week. It’s also so far been shown to have fewer gastrointestinal side effects than the medicines currently on the market.

	What We’re Reading

“The health care battle fueling the shutdown roils North Carolina politics,” The Post’s Katie Tarrant reports from North Carolina.

“Appeals court denies Trump effort to halt full SNAP benefits for November,” according to Niha Masih, Dino Grandoni and Mark Berman at The Washington Post.

“Legal immigrants face loss of Obamacare help, threatening insurance markets,” report Politico’s Robert King and Alice Miranda Ollstein.

“How a ‘one and done’ gene-editing treatment could lower cholesterol,” reports Carolyn Y. Johnson at The Washington Post.

“Is health insurance a matter of life and death? Scientists may have an answer,” writes Todd C. Frankel at The Washington Post.

“Ten seconds in the Oval Office that overshadowed Trump’s drug-price win,” writes The Post’s Dan Diamond.

“Baby formula recalled after infant botulism outbreak,” Jennifer Hassan writes at The Washington Post.