Two things loom large over the Trump administration’s healthcare regulatory agenda in 2020: the presidential election and how the courts will decide the fate of the Affordable Care Act.
To a certain extent, nothing has changed over the uncertainty of the ACA. A federal appeals court last month declared the individual mandate unconstitutional, but it punted on what to do with the rest of law, sending it back to a lower court to make that decision. Ultimately, the case will land before the U.S. Supreme Court, but probably not until after the election. At deadline, Democratic state attorneys general were reportedly preparing to ask the high court for an expedited review.
While that process unfolds, the administration’s regulatory machine is likely to sharpen its focus on issues that officials claim benefit consumers, like price transparency, drug costs and affordability. The goal: Tie the regulatory agenda to the president’s political messaging.
“When you go into an electoral cycle like this, the agencies have to be completely in lockstep with the candidate,” said Dan Mendelson, founder of consulting firm Avalere Health and a former Clinton administration official.
With drug-pricing legislation stalled in Congress, HHS took a major step in mid-December aimed at alleviating the high costs consumers pay at the pharmacy. The Food and Drug Administration issued a proposed rule that would allow states to import drugs from Canada if they don’t pose any safety risks and would generate cost savings. The administration would also let pharmaceutical companies import the products they sell abroad and resell them in the U.S.—a policy that has support from drugmakers because it wouldn’t cut them out of the revenue stream.
“Importing efforts by states could cause unintended or unforeseen pricing impacts from a marketplace standpoint,” said Meena Datta, partner and co-leader of Sidley Austin’s healthcare practice and a member of its global life sciences team. Comments on the proposed rule are due March 7, and a final rule could be issued as soon as May.
The administration is also working on an international price index demonstration that would link Medicare Part B drug payments to the prices paid by other wealthy nations. The policy has been tied up at the White House Office of Management and Budget since last summer, but it has support from the president. It will likely remain a top priority, despite opposition from Big Pharma, which claims it will hurt the development of new treatments by cutting into their research and development budgets.
“Healthcare is going to be the No. 1 issue going into the election, so HHS will be focused on the prices that consumers pay for prescription drugs,” Mendelson said. “It’s first among equals.”