Health policy to watch this month

Sep 03, 2024

Presented by

With Carmen Paun

Driving the Day

A quiet Capitol Building is pictured

When the Senate and House return to Capitol Hill next week, they'll face a packed agenda. | Zach Gibson/Getty Images

SUMMER HAS COME AND PASSED — This month is jam-packed with the rush to avoid a government shutdown when Congress reconvenes next Monday, the next phases of the organ transplant reform and the impending ruling on Title X funding from the Supreme Court.

Here’s what our team is watching:

The impending appropriations fight: Congress has until Oct. 1 to pass a funding bill to avoid a government shutdown.

The House-version of the HHS fiscal 2025 budget includes a 7 percent cut to the department, proposes a reorganization of the NIH and makes deep cuts to CDC funding. The Senate version also cuts HHS funding overall, curbs the NIH reorganization and restores money for HIV/AIDS programs cut in the House bill.

Lawmakers are expected to pass a stopgap that keeps spending levels steady, POLITICO’s Jordain Carney reports.

One year of organ transplant reform: September marks one year since President Joe Biden signed an overhaul of the nation’s organ transplant system into law, allowing different entities to oversee certain functions instead of awarding a single contractor. Last week, the administration announced the first new contractor, the American Institutes for Research, a nonprofit behavioral and social science research organization, which will set up an election for a new board of directors.

HHS expects to award the next round of contracts — to keep organ donations and transplants running smoothly as it transitions into a multivendor system — by the end of September.

Title X ruling: The Supreme Court is expected to rule soon in a case to decide whether HHS must dispense millions in federal family-planning grants to Oklahoma that the Biden administration withheld over the state’s refusal to provide abortion referrals to patients who request them.

It would be the high court’s biggest abortion decision since Roe v. Wade was overturned and could fuel other challenges to the Title X family-planning program.

Under rules the Biden administration finalized in 2021, clinics that get Title X funding are required to offer nondirective counseling for pregnant patients about their options, including abortion — even if the state has banned the procedure.

Oklahoma sued the administration in 2023 after it lost roughly $4.5 million in funds for refusing to comply with the abortion counseling and referral requirements.

Medicare Part D plan details: Medicare plans will soon send their annual notices of change to beneficiaries, detailing how premiums, deductibles and copays might change next year. This year, it will be crucial to watch how the impacts of the Inflation Reduction Act, including a $2,000 cap on out-of-pocket spending on drugs, will play out on premium costs.

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2024 Elections

A Heritage Foundation sign is pictured.

The Heritage Foundation says an executive order signed by President Joe Biden is unlawful. | Getty Images

HERITAGE: HHS’ VOTER PUSH ‘COERCIVE’ — Conservative pushback to a three-year-old executive order directing federal agencies to promote voter registration has ramped up with two months to go ahead of the election — and HHS is in the crosshairs.

On Friday, the Heritage Foundation, the conservative group behind Project 2025, an intended playbook for a second Trump administration, released a paper calling the executive order unlawful.

It accused HHS of encouraging providers to “take advantage of their sensitive fiduciary relationship with vulnerable individuals who are suffering from medical and health problems to ‘assist’ them to register and vote, enabling providers to persuade vulnerable patients who are dependent on them to vote in ways that advantage particular issues and particular candidates.”

“This is an inherently coercive relationship,” senior legal fellow Hans von Spakovsky wrote.

How we got here: In 2021, President Joe Biden issued an executive order that commanded federal agencies to expand access to voter registration. Since then, HHS has said health centers can provide voting information and, earlier this year, began emailing people who have signed up for a health insurance plan through the ACA marketplace with voting registration information. Republicans have increasingly targeted the EO in recent months.

On Capitol Hill, the House version of the HHS fiscal 2025 budget includes provisions banning health centers from sharing information on voter registration, calling this outside the centers’ scope of practice.

HHS didn't respond to requests for comment.

Global Health

MPOX VACCINE ROLLOUT STRATEGY — The World Health Organization is drafting a plan with other international organizations on how to allocate the mpox vaccines promised by Western governments to African countries, Carmen reports.

The EU, some of its member states and the U.S. have together pledged nearly 1 million doses of Jynneos, the vaccine used in North America and Europe during the 2022-2023 mpox outbreak, the director-general of the Africa Centers for Disease Control and Prevention told African health ministers in a meeting last week.

But the timeline for when the vaccines will start flowing into the Democratic Republic of Congo and other affected countries, such as Burundi, remains unclear. That’s because some bureaucratic steps still need to happen, a WHO official said Friday, are still being ironed out, such as ensuring adequate storage capacity as well as preparing and convincing people at risk to be vaccinated.

The U.S. has pledged 50,000 doses. Meanwhile, Nigeria became the first African country to receive Jynneos from the U.S. on Aug. 27 since the WHO declared mpox an international health emergency in mid-August for the second time in three years.

Why it matters: Global health officials are on the alert for a potential resurgence of mpox, fearing it will again spread worldwide. Their concerns are heightened by a new variant, clade 1b, which is still being studied to determine whether it’s more dangerous or more transmissible than the clade IIb that caused the outbreak in the U.S. and Europe.

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Opioids

TELEHEALTH DRAFT GETS SIDE-EYED — A second proposal by the Drug Enforcement Administration to tighten pandemic-era rules that made it easier to prescribe drugs virtually is getting pushback from opioid use disorder advocates and a senior Democrat, Ben reports.

Why it matters: The proposal, which hasn't been released and could change, allows no more than half a provider’s prescriptions to be given virtually. If finalized, it would be a substantial blow to many telemedicine providers who rely mostly or exclusively on virtual care.

Background: The current rules, finalized during the pandemic when public health officials were trying to help people isolate, expire at the end of the year, but it’s unclear whether the Biden administration will be able to find consensus on new rules. HHS and the DEA are at odds over the draft proposal, according to a former DEA official who spoke to POLITICO on condition of anonymity to discuss the private deliberations.

The agency backed off its first proposal following a flood of protests.

The reactions: “As currently reported, the DEA’s proposal provides an even worse solution than the one put forth under the first proposed rule. This arcane approach would represent a significant step back for patients who rely on telemedicine for critical medications,” Sen. Mark Warner (D-Va.) said in a statement. “The pandemic proved that the vast majority of health care providers can successfully provide quality health care through telehealth.”

The DEA didn’t respond to a request for comment. HHS declined to comment, citing the ongoing rulemaking.

Opioid use disorder treatment providers and advocates are also disappointed by the potential new rules. Most patients with opioid use disorder don’t receive treatment, and buprenorphine — itself an opioid — has shown promise in helping patients wean themselves off more dangerous opioids.

“The public health challenge here is people with opioid use disorder not being on treatment when there is a treatment. Let’s remove barriers,” said Dr. Anand Parekh, chief medical adviser at the Bipartisan Policy Center and an Obama administration HHS official.

Names in the News

Alison Barkoff is joining the George Washington University Milken Institute School of Public Health as a professor of health law and policy and the director of the Hirsh Health Law and Policy Program later this year. She has been an HHS principal deputy administrator since 2021, performing the duties of the Administration for Community Living Administrator and Assistant Secretary for Aging.

WHAT WE'RE READING

The New York Times reports on a new study finding that dialysis might not prolong an older patient’s life by very much.

CNN reports that the NIH has stopped its research on Havana Syndrome, citing coercion of participants found during an internal review.

A message from Tobacco-Free Kids Action Fund:

E-cigarettes now more addictive than ever.

E-cigarette makers are hooking kids with illegal vapes featuring kid-friendly flavors and built-in video games. These products contain more nicotine than ever — some have as much nicotine as 20 packs of cigarettes.

Over 2.1 million kids use e-cigarettes, and 90% use flavored products — almost all of which are illegal. Now, with students heading back to school, we are calling on FDA and other federal agencies to take action. It's time to protect kids and remove all illegal e-cigarettes from store shelves.

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