The administration has been building some of its initiatives on a legal footing that it now argues is completely invalid.
Republicans have ceaselessly called for the Affordable Care Act to be repealed and replaced since its passage nine years ago, and President Donald Trump has carried that mission from the campaign trail into the White House. That much is obvious.
What may be less obvious is the extent to which the healthcare policymaking agenda touted by Trump's own administration hinges on legal authorities established by the ACA itself. Certain programs intertwine with the ACA in ways that are especially relevant now that the Department of Justice has said it won't defend even a single provision of the sprawling Obama-era law.
While members of Trump's health policy team may merely have been doing their best to operate within an inherited legal framework, they have invested considerable time, energy, and resources into programs that would be invalidated with the rest of the ACA, if the DOJ gets its way.
Ashley Ridlon, MSc, who is vice president of health policy for Evolent Health and was a field director for the Center for Medicare & Medicaid Innovation (CMMI) during the Obama administration, says the Trump administration has taken some programs created by the ACA in a different direction—such as CMMI's latest value-based payment models or the Medicare Shared Savings Program's more aggressive path to two-sided risk—while still relying on the ACA for their statutory authority.
"Whether they like the origin or not, they are working in these programs," Ridlon tells HealthLeaders.
Timothy S. Jost, JD, professor emeritus at the Washington and Lee University School of Law in Lexington, Virginia, says the political debate is overlooking many of the ACA's consequential but lesser-known provisions.
"I think that the Trump administration is focused—as are many people, generally—on the private insurance reforms, the exchanges, the protections added to private insurance and the exchanges," Jost tells HealthLeaders. "But there's a whole lot more in the Affordable Care Act, and the effect of repealing it would be just huge."
Macro-level impacts on nationwide coverage rates aside, invalidating the following ACA-related items could be especially consequential to key pieces of the Trump administration's own healthcare agenda:
- Experiments in value-based payment models: The ACA created CMMI, also known as the CMS Innovation Center, to help nudge U.S. healthcare toward a value-based system. Trump administration officials bashed the Obama administration's CMMI strategy last summer, then they named a new CMMI director, Adam Boehler, to take the center in a new direction.
Since then, Health and Human Services Secretary Alex Azar has excitedly teased the potential benefits of forthcoming CMMI models, and the Centers for Medicare & Medicaid Services has used CMMI models to address a number of the administration's priorities, including interoperability of electronic health information for patients, maternal opioid misuse, and more. But the statutory authority on which all of that is based would go away if the ACA is invalidated in its entirety.
- Efforts to reduce drug costs through biosimilars: The ACA gave authority to the Food and Drug Administration for a shorter path to approval for biosimilars, or generic biologics. "That has been, as I understand it, a fairly big part of the FDA's agenda under the Trump administration," Jost says.
FDA Commissioner Scott Gottlieb, MD, unveiled a "Biosimilar Action Plan" last summer to put downward pressure on drug prices by increasing competition. The plan makes no mention of the ACA by name, but it does mention the Biologics Price Competition and Innovation Act (BPCI Act), which was rolled into the ACA to establish an abbreviated pathway for approvals of biosimilar and interchangeable products. Congress could, of course, reauthorize the BPCI Act as a standalone item if it were invalidated with the rest of the ACA, but that would require a level of political will that is far from certain.
- Healthcare reforms for native Americans: The ACA also incorporated the Indian Health Care Improvement Act (IHCIA), which authorized appropriations without an expiration date and included several updates from the previous version passed in 1976. Those changes gave the Indian Health Services (IHS) director more authority; allowed tribes and their organizations to buy health benefits for IHS beneficiaries; directed the IHS to establish comprehensive programs for behavioral health, prevention, and treatment; and more, according to a 2010 IHS announcement.
- Expanded treatment for HIV/AIDS and opioid addiction: During his State of the Union address last month, Trump set the bold goal of ending the HIV/AIDS epidemic in the U.S. within a decade, and Trump administration officials have repeatedly vowed to combat the opioid epidemic by expanding and enhancing access to treatment options. But treatment for each of these conditions relies heavily on Medicaid, and invalidating the ACA's Medicaid expansions would undercut efforts to offer more and better treatment, Jost says.
- Protections for people with preexisting conditions: Trump and fellow Republicans claimed during campaigns for last fall's midterm elections that they want legal protections to ensure that people with preexisting medical conditions have access to health insurance. But their legislative proposals—which have generally offered less protection than the ACA does—have thus far failed to muster sufficient backing on Capitol Hill, so invalidating the ACA would leave Americans without some of the protections they have come to expect.
Invalidating the entire ACA on appeal could disrupt the Trump administration's own agenda, but the disruption could be minimized by swift legislative action, Ridlon says.
"It could potentially hamstring their efforts to advance value if these programs were to go away, at least in the near term until Congress can reinstate them," she says.
Spokespeople for HHS, CMS, IHS, and FDA referred HealthLeaders' questions to the DOJ, which responded to questions with a short statement that did not answer them.
The DOJ's shift in position has been criticized not only by Democrats but also by hospital groups and some Republicans. House Minority Leader Kevin McCarthy told Trump that he disagrees with the DOJ's new position, Axios reported, citing unnamed sources.
Sen. Susan Collins, R-Maine, told Axios on the record that she's "surprised" and "appalled" by the DOJ's shift on the ACA case.
Politico's Eliana Johnson and Burgess Everett reported that Azar and Attorney General William Barr had objected to the DOJ's shift in position, which was driven by the White House. Azar reportedly noted during a meeting late last year that Republicans didn't have anything to put in the ACA's place, though HHS refuted Politico's report of a dispute.
Trump, who is reportedly "relieved" by news of Barr's summary of Special Counsel Robert Mueller's report, seems to see Republican leadership on healthcare reform as a winning issue, even as others in his party worry Democrats have an edge in this territory.
"The Republican Party will become 'The Party of Healthcare!'" he wrote Tuesday in a tweet.
Democrats, meanwhile, have spotted the DOJ's shift as an opening to renew their emphasis on healthcare policy talk.
—Steven Porter is an associate content manager and online news editor for HealthLeaders, a Simplify Compliance brand.
Some programs have taken a new direction under the Trump administration but still have their statutory roots in the ACA.
If the ACA were invalidated, some of the administration's own healthcare priorities would be hamstrung until Congress settles on a replacement.
The DOJ's shift has been criticized by some Republicans and seen by Democrats as an opportunity to score political points.