Abortion, Drug Pricing Top Biden List of 2024 Health Challenges

Abortion rights, drug pricing, and LGBTQI+ discrimination protections will be among the top health issues facing the Biden administration in 2024, with Supreme Court activity, drugmaker lawsuits and other hurdles expected to complicate the course.

The Health and Human Services Department has spent the better part of the past year proposing regulations and issuing guidance around hot-button health issues like reproductive rights, discrimination, and rising drug costs.

The agency is heading into 2024 with a handful of proposed rules awaiting finalization, as well as guidance for implementing a landmark program allowing the government to negotiate what Medicare pays for high-cost drugs that is under attack from the pharmaceutical industry.

“This promises to be a momentous year for public health, and it could get ugly for the White House and HHS,” said Lawrence Gostin, faculty director of Georgetown University’s O’Neill Institute for National and Global Health Law.

Awaiting final sign-off from the White House is a proposal for better protecting LGBTQI+ people from bias in HHS programs. Released in the summer, the proposed rule (RIN 0945-AA19) marks a revision of a Trump administration attempt to make it easier for religious groups to secure federal grant funds.

The HHS is also moving (RIN 0945-AA18) to change another Trump-era rule that allowed health-care workers to deny care based on religious and moral beliefs.

Meanwhile, the HHS is slated to continue defending Medicare drug price negotiations in lawsuits brought by AstraZeneca, Boehringer Ingelheim, and others.

“There are a whole slew of policy challenges facing HHS” in 2024, Gostin said, with abortion access being the top item.

He said that among the tasks awaiting agency action are finding ways to facilitate travel from states with bans to states that allow reproductive services, “ensuring robust medical exceptions in laws that ban abortion,” and bracing for the Supreme Court to potentially undo Food and Drug Administration decisions on the abortion drug mifepristone, which are being challenged in FDA v. Alliance for Hippocratic Medicine.

“HHS will have to have a plan in place to reintroduce expanded access to mifepristone” should the justices uphold restrictions imposed by the US Court of Appeals for the Fifth Circuit, including one that would block the mailing of the drug, Gostin said.

The HHS has already made concrete moves to broaden abortion access.

Awaiting finalization is the agency’s proposed rule (RIN 0945-AA20) to block medical providers from sharing protected health information connected to abortions obtained in states where they are legal. Issued after the Supreme Court’s undoing of federal abortion protections in Dobbs v. Jackson Women’s Health Organization, the proposed rule would make modifications under the Health Insurance Portability and Accountability Act of 1996 to improve reproductive rights privacy.

“Privacy within the reproductive space is incredibly important,” said Michael Ulrich, a law professor at Boston University. And “HIPAA is a very misunderstood law in what it does and does not do,” he said, noting that increasing its protections could be useful.

He also noted that the HHS needs to continue to clarify that federal laws preempt conflicting state laws, particularly as “physicians and health-care providers are frankly wary of overly aggressive prosecutorial states that are criminalizing health care.”

Here are some other regulations from the HHS awaiting further action in 2024:

HHS

• In September, the HHS proposed changes that would curb disability discrimination in government-funded programs. The proposed rule (RIN 0945-AA15) would lay out requirements to block discrimination in mobile and web accessibility, medical treatment, and other areas, as well as clarify obligations against discrimination for child welfare services. Comments on the rule were due Nov. 13.
• The HHS has yet to finalize plans for health-care providers to more easily share patients’ substance use treatment records (RIN 0945-AA16) between treatment providers, by aligning them with processes under HIPAA.

FDA

• Long-awaited rules banning sales of menthol cigars and cigarettes are slated to drop in March 2024. The FDA in 2022 proposed product standards (RIN 0910-AI60 and RIN 0910-AI28) targeting menthol and other flavored tobacco products that could complicate smokers’ efforts to quit.

CMS

• The Centers for Medicare & Medicaid Services is attempting to stop manufacturers’ from misclassifying brand-name drugs as generics (RIN 0938-AU28). That can lead states to overpay for medications, thus escalating Medicaid’s drug costs.
• In another response to Dobbs, a CMS proposal (RIN 0938-AU94) would broaden access to birth control coverage under the Affordable Care Act. The proposed rule was issued in January 2023 by the CMS and the Departments of Labor and the Treasury.

—With assistance from Celine Castronuovo.