Biden plans healthcare actions; support grows for former FDA deputy for top job

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After spending his first days in office signing executive orders aimed at improving the U.S. response to the COVID-19 pandemic and speeding some economic relief to American families, President Joe Biden will turn his attention this week to taking actions on other measures, including healthcare.

Biden plans to focus on an issue per day: Buy American Jan. 25, equity Jan. 26, climate Jan. 27, healthcare Jan. 28 and immigration Jan. 29.

With the U.S. Senate split at 50-50 — a tie that could be broken on legislation by Vice President Kamala Harris — and Democrats holding a small majority in the House, Biden is expected to rely more heavily on his executive powers to tackle much of his healthcare agenda. Those executive actions are likely to include undoing much of what Democrats have called "sabotage" by the Trump administration of the Affordable Care Act, said Larry Levitt, executive vice president for health policy at the nonpartisan, nonprofit Kaiser Family Foundation.

Biden could restore the outreach and enrollment funding intended to educate consumers about the ACA's healthcare plans and help Americans sign up on the government's marketplace — money the Trump administration cut by 90% — Levitt wrote in a Jan. 19 commentary published online by the Journal of the American Medical Association.

The president could also place restrictions on short-term limited duration plans, Levitt said. The Trump administration extended the market for the short-term policies in 2018. But critics have called them "junk" or "skimpy" insurance because they do not provide the protections mandated by the ACA, like the bans against denying coverage or higher charges for Americans with preexisting medical conditions.

Biden could also use his executive powers to give states greater flexibility to strengthen Medicaid, the government's insurance program for low-income Americans. In particular, the president could make it easier for states to experiment with a public option through Medicaid waivers, Levitt said.

Biden wants to expand on the ACA by permitting Americans to opt into public insurance coverage, while keeping the private insurance market in place.

The president will need Congress' cooperation to get a public option adopted broadly in the U.S. but he is unlikely to garner enough support from Republicans to do so, said Lanhee Chen, a fellow in American public policy studies at the conservative-leaning Hoover Institution and director of domestic policy studies at Stanford University.

Biden should instead turn his attention to lowering Americans' costs for drugs and medical visits, Chen wrote in a Jan. 21 CNN op-ed.

A bipartisan bill aimed at lowering drug costs from Sens. Ron Wyden, D-Ore., and Chuck Grassley, R-Iowa, could get across the finish line if it had presidential leadership, Chen said. The Wyden-Grassley legislation would cap out-of-pocket costs in Medicare's prescription drug benefit, require manufacturers that increase their list prices faster than inflation to pay a rebate, and mandate price transparency measures for companies seeking to unveil a new product or increase prices on an existing drug.

A number of the provisions in the Wyden-Grassley bill reflect measures in a bill adopted in December 2019 by the U.S. House. But the House bill would also give the federal government the power to negotiate drug prices for public programs and private payers — authority Biden supports but Republicans have widely rejected.

US awaits Biden CMS, FDA picks

Meanwhile, Biden has yet to reveal his picks to lead the U.S. Centers for Medicare and Medicaid Services and the Food and Drug Administration — two agencies key for carrying out healthcare and COVID-19 activities.

Biden's nominee to lead the U.S. Department of Health and Human Services, Xavier Becerra, is awaiting Senate confirmation — an action not likely to happen until into February.

The Biden administration named a number of acting agency heads Jan. 20, including Norris Cochran at HHS, Elizabeth Richter at CMS and Janet Woodcock at FDA.

North Carolina Health and Human Services Secretary Mandy Cohen's name emerged in late 2020 as a potential contender to lead CMS, while Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins University, has been mentioned frequently as a top candidate for FDA commissioner. Sharfstein was principal deputy commissioner at the FDA during the Obama administration. He is also a former secretary of the Maryland health department.

In a Jan. 24 op-ed in Stat News, Daniel Carpenter, professor of government at Harvard University, and Gregg Gonsalves, assistant professor at the Yale School of Public Health, said Sharfstein's record of "diverse service" in national, state and local government positions him well to respond to the FDA's challenges at a time when the commissioner "needs to be attentive to a range of audiences in Congress, the scientific community, the American people and the biopharma industry."

Former Baltimore City Health Commissioner Leana Wen also endorsed Sharfstein for the top FDA job.

"It's time for exceptional public health leadership," Wen tweeted.

Seven former FDA commissioners — appointed by Republicans and Democrats — have supported the idea of making the regulator an independent agency, moving it out of HHS.

Three days before exiting his post Jan. 20, Stephen Hahn, who was repeatedly pressured by former President Donald Trump to move faster in authorizing COVID-19 vaccines, tweeted that it was "an opportune time to engage in a public discussion regarding FDA as an independent agency."

But in a Jan. 18 commentary in Nature Medicine, Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania, and her colleagues argued that redesigning the FDA as an independent agency risks sacrificing too much democratic accountability.

"It is preferable to protect the FDA's integrity by drawing a line between its broad policy decisions, which elected and appointed officials may appropriately influence, and decisions about specific applications before the agency, which should be shielded from such influence," they wrote.