Modern Healthcare

Regulatory machine would power Biden’s healthcare agenda

- By Michael Brady and Rachel Cohrs

WITH LEADS in key battlegrou­nd states, Joe Biden at deadline was on the cusp of winning the 270 electoral votes needed to become the next president of the United States. Despite pending litigation, there doesn’t appear to be a path for President Donald Trump to secure a second term.

Much like Trump, a President Biden would likely have to rely on the regulatory system to drive a bulk of his healthcare agenda. That’s because he’ll have to contend with a divided Congress or a very narrow majority for Democrats in the Senate, which hinges on two likely runoff elections in Georgia in January.

The COVID-19 pandemic and the Supreme Court’s eventual ruling on the Affordable Care Act will also be major factors. Experts said Biden would tackle the virus straight away with a renewed emphasis on public health measures aimed at trying to stop its spread. While the federal government would continue to work on vaccines and therapies, Biden probably wouldn’t make them the focus of his messaging, said Dean Rosen, a partner at lobbying firm Mehlman Castagnett­i Rosen & Thomas. He expects the federal government to take a more active role in responding to the pandemic and to rely less on states to manage it.

Biden’s team would also try to depolitici­ze federal agencies like the Food and Drug Administra­tion and empower the Centers for Disease Control and Prevention to lead the public health response rather than depend on a COVID-19 czar to lead the charge, Rosen said, adding, that there will be less “second-guessing of the public health career officials.”

There would probably be an attempt to enroll more people in coverage too. Experts said a Biden administra­tion could create a special enrollment period for uninsured people to sign up for coverage and increase spending on marketplac­e advertisin­g and outreach after the Trump administra­tion slashed the ACA’s marketing budget by 90%. It could also allow the family members of people with low incomes to get marketplac­e subsidies, said Katie Keith, principal at Keith Policy Solutions and an adjunct professor at the Georgetown University Center on Health Insurance Reforms.

Any significan­t effort to expand ACA coverage or make it more affordable would require congressio­nal action, said Christophe­r Holt, director of healthcare policy at the American Action Forum. Democrats could increase marketplac­e subsidies through budget reconcilia­tion if they win the Senate after Georgia’s run-off elections. But it could ultimately be for nothing if the Supreme Court tosses out the ACA in its entirety. It would take years to undo the law and Biden would have to work with Congress to find a solution to the ensuing chaos.

“In some ways, having a Republican Senate may just free Biden up to go with the kind of cabinet he would have wanted anyway,” Holt said. Biden would also stop or roll back a wide range of Trump-era policies, experts said. As soon as his first day in office, Biden could direct federal agencies to pause their regulatory pipeline for at least 30 days to give his team time to review ongoing work, said Dan Bosch, director of regulatory policy at the American Action Forum.

His administra­tion might also try to rein in short-term limited-duration insurance, associatio­n health plans and other non-ACA coverage; revise guidance for state innovation waivers; stop approving waivers for Medicaid work requiremen­ts; and restore Obama-era non-discrimina­tion protection­s, among other policy changes.

Biden, like Trump, has attacked the high cost of prescripti­on drugs. During the campaign, he proposed allowing Medicare to negotiate prescripti­on drug prices, regulating the launch prices of drugs without competitio­n, limiting drug-price increases to the rate of inflation, and allowing personal drug importatio­n. How high those actions sit on Biden’s agenda remain to be seen, especially as COVID-19 and an economic recovery stay center stage.

“In some ways, having a Republican Senate may just free Biden up to go with the kind of cabinet he would have wanted anyway.”

Christophe­r Holt, director of healthcare policy at the American Action Forum

It’s even hazier whether Biden would carry out Trump’s transparen­cy agenda.

“My sense is that they let the lawsuits play out,” Rosen said. Hospital groups are suing the Trump administra­tion over rules that require them to make public negotiated rates and insurers could sue over a related rule that would require them to do the same.

Biden promised to tackle market concentrat­ion, an issue his administra­tion could influence without congressio­nal approval. The Democratic platform calls for a retroactiv­e review of some mergers and acquisitio­ns approved by the Trump administra­tion. Biden pledged to aggressive­ly use antitrust authority to tackle market consolidat­ion in healthcare and scrutinize future acquisitio­ns based on impacts on labor markets, low-income communitie­s and racial equity, as well as prices and competitio­n.

Presumptiv­e Vice President Kamala Harris pursued antitrust enforcemen­t against hospitals during her time as California’s attorney general. She effectivel­y blocked a merger between Prime Healthcare and a safety-net health system, refused to relax charity care requiremen­ts, pursued more power to upend settled mergers, and opposed the union of two insurance industry giants. But states still have significan­t discretion over which deals are approved.

The courts will play a starring role in Biden’s ability to put his agenda into practice. He’ll face a judiciary that’s likely to be hostile toward Democrats’ healthcare agenda. In addition to the Supreme Court’s new 6-3 conservati­ve majority, there are far more conservati­ve appeals court judges now than during President Barack Obama’s administra­tion. According to the Pew Research Center, Trump appointed 53—about 30%—of the nation’s 179 federal appellate court judges. He appointed another 162—or 24%—of district court judges.

“You already have Republican AGs … pledging that they’re going to do what they can to hold a Democratic administra­tion to the fire,” Keith said. “A Biden administra­tion should brace itself to have most of what it tries to do challenged in court.”

But before Biden takes office, the Trump administra­tion will have to tie up loose ends. Experts said HHS would likely sign off on long-awaited changes to Stark law and anti-kickback regulation­s, Medicare’s outpatient prospectiv­e payment rule and 2021 updates to Medicare Advantage and Part D plans, and act on Tennessee’s Medicaid block grant waiver, among other regulatory actions.

The administra­tion could also rush through a proposed rule requiring HHS to review regulation­s every 10 years, 2022 notice of benefit and payment parameters or even prescripti­on drug reforms, but experts aren’t sure what a lame duck Trump administra­tion might prioritize.

“It’s a little frustratin­g to watch,” Keith said. “Are we just going to play pingpong with these executive branch pol

 icies every four years?”

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