Priorities pile up for HHS, FDA, CMS, NIH, and other health agencies

WASHINGTON — The nation’s health agencies already have a long to-do list for 2023.

Top officials have promised reforms in the food, drug, and public health departments as frustrations mount over the federal response to Covid-19 and last year’s widespread baby formula shortages. Biden administration appointees are racing to fix pandemic-exposed cracks in the systems for mental health care, addiction treatment, and health coverage, even as millions of people are likely to be kicked out of Medicaid, the federal program serving low-income people with few resources. There’s still no one leading the National Institutes of Health.

And while Congress delivered many of the president’s requests in the end-of-year spending package last month, it also dropped several provisions that would have given federal health regulators more authority. 

Republicans also continued to block more coronavirus funding, the death knell for administration hopes for more resources to combat the pandemic. That means this year will be shaped by commercial insurers’ coverage of tests, vaccines, and treatments, said one senior Biden official, who added that a potential need to update vaccines yet again — to better shield against new variants — could make it more difficult to quickly supply new vaccines through commercial insurers.

“Put all that all in the context of no money and little appetite [among the public] to pay attention,” said the official. “But really, the virus doesn’t care.”

Outside of the unwinding coronavirus response, here are some other health priorities we’re tracking: 

The search continues for a top scientist, now two

It has now been more than a year since longtime NIH Director Francis Collins stepped down, but the White House is moving very slowly on naming a successor and is not close to finalizing its choice, according to three people with knowledge of the deliberations. 

While Collins is still close by, serving as a special adviser to the president (and the agency is being led by acting director Lawrence Tabak), the vacancy list is growing. Anthony Fauci retired last month after nearly four decades leading the National Institute of Allergy and Infectious Diseases, where he became the public face of the nation’s response to outbreaks from HIV to swine flu, Zika, and the coronavirus.

Scientists are worried that the openings will be felt in the new Congress, where GOP lawmakers have already warned of probes into the Covid-19 response and research spending. Though Fauci divided Republicans during the pandemic, both he and Collins maintained many bipartisan relationships on Capitol Hill and testified frequently, defending and justifying the sprawling NIH and its growing budget. 

Some researchers have floated establishing term limits for these roles, an idea that has garnered support from Republicans as well. The discussion comes amid efforts to stand up the new Advanced Research Projects Agency for Health, which is housed in NIH and built around the premise that its director and top officials will have set terms. 

FDA will forge ahead on regulatory reforms

The Food and Drug Administration is set for a busy year. Though lawmakers ultimately dropped an omnibus provision that would have given the agency more authority over tests developed in academic or hospital labs, Commissioner Robert Califf has pledged to do it anyway through rulemaking.

FDA is also in the midst of a reckoning over how it regulates tobacco products like vapes and its handling of food issues including the baby formula shortage spurred by a factory shutdown earlier this year. A recent report from outside advisers recommended setting up an interagency task force to better handle tobacco issues. The advisers suggested breaking food out of the department entirely or at minimum establishing a new deputy commissioner position focused on food.

Finally, Congress packed some provisions around accelerated approval into the omnibus bill after prolonged negotiations sparked by the agency’s controversial approval of Alzheimer’s drug Aduhelm. FDA’s authority to require clinical trials as part of the speedier approval pathway is now explicit, though the language was softened from an earlier version that would have mandated those trials already be underway.

CMS braces for Medicaid cliff, seismic drug-pricing regulation

The possibility of new FDA regulations pales in comparison to the waves that the Centers for Medicare and Medicaid Services will make this year when it releases its first rule on negotiating the prices of costly drugs. Already, some Republicans have introduced legislation to peel back that authority while others have pledged to bring CMS Administrator Chiquita Brooks LaSure in front of key committees to explain the agency’s next steps.

Elsewhere, the prospect of Medicaid coverage cliffs looms large. A provision in the omnibus spending bill allows states to begin kicking ineligible people out of the program at the start of April, ending a pandemic-era freeze on coverage terminations that saw the program balloon by 30% to cover 83.5 million people. 

HHS said in a report this summer that ending the freeze would likely result in roughly 8.2 million people losing enrollment, though an estimated 6.8 million of those would still be eligible to be in the program. 

Future of the climate office uncertain

A modest request for $3 million to fund the health agency’s nascent climate change office did not make it into the budget, leaving the small program unfunded and in uncharted territory. 

The department has been running for just over a year with a bare-bones staff detailed from other corners of HHS like Sharunda Buchanan, interim director of the office’s environmental justice work, who is technically still employed by the Centers for Disease Control and Prevention. 

Now the office under assistant secretary Rachel Levine will need to justify its existence. Levine and staff traveled the country last year hearing from state officials and local advocates about how the warming climate has impacted air quality, water access, and exposure to harmful toxins. The question this year will be how a handful of federal health officials can make an impact on those challenges.

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.