Health officials are furiously working on proposals to fulfill President Donald Trump's promises to lower U.S. drug costs, but his repeated vows to provide "beautiful" healthcare to all 330 million Americans must rely on a sharply divided Congress, a top administration official acknowledged.
CMS Administrator Seema Verma
"I think that we've been very clear that some of the changes that need to be made are outside of our scope," Centers for Medicare and Medicaid Services Administrator Seema Verma told reporters on Aug. 15 about implementing Trump's healthcare plan. "I think to some degree, we've taken things as far as we can in terms of the regulatory changes that we've made."
Last week, White House Counselor Kellyanne Conway confirmed Trump plans to outline his healthcare package in a September speech, though she said it would not be a replacement for the Affordable Care Act.
"We're not here to repeal and replace Obamacare," Conway told reporters Aug. 7.
A number of administration officials, including Trump, have said they want to keep key provisions of the ACA in place, like the 2010 law's protections for patients with preexisting medical conditions, CMS' Center for Medicare and Medicaid Innovation and the U.S. Food and Drug Administration's pathway for approving lower-cost biologic therapies, or biosimilars.
But Verma insisted Trump's plan "won't be like the Affordable Care Act," despite keeping many parts of the law.
She declined to provide details about what Trump's plan would include and what provisions from the ACA the administration wants Congress to kill.
Trump's plan is expected to come in the form of a set of principles, Verma confirmed.
Beyond that, she admitted the administration needs Congress to do the work of devising and passing a healthcare package — an action that may become more urgent if a Texas district judge's December 2018 ruling that the ACA is unconstitutional is upheld.
A decision from the U.S. Court of Appeals for the 5th Circuit is currently pending on the case — a ruling that is expected to be appealed to the U.S. Supreme Court no matter which side wins.
White House Counselor Kellyanne Conway
Verma insisted the administration has already made a lot of headway in implementing Trump's healthcare agenda through various actions it has taken, such as extending short-term limited-duration plans, though most of those policies do not cover people with preexisting conditions or they charge those patients more.
"It's an option for people," Verma said. "No one's forcing them to buy that."
She said the Trump administration has tried to ensure Americans understand when they buy those short-term plans — policies critics call "junk" or "skimpy" insurance — that they know what they are getting.
"It might not work for everybody, but it could be a lifeline for some individuals," Verma said.
But she admitted it will take more than what the administration can do alone to make health insurance more affordable for Americans.
Drug pricing proposals
Verma declined to provide any timelines of when Trump would issue his "favored nations" executive order — something he promised on July 5 was coming "very shortly" — or when the administration would officially unveil its proposal to test an international drug pricing payment index model for expensive injectable medicines covered by Medicare.
The favored nations executive order would require drugmakers to offer the U.S. government the lowest prices paid by other developed nations for prescription medicines.
The demonstration projects for the international pricing index, or IPI, model would be carried out by the Center for Medicare and Medicaid Innovation, which was established by Congress in 2010 under the ACA to test new payment and delivery models that might reduce expenditures.
The administration initially issued an advance notice of proposed rulemaking — a bureaucratic mechanism used to gauge public opinion ahead of making a formal proposal — for the IPI in October 2018.
The proposal has been under review by the White House Office of Management and Budget since June.
But Verma said the administration was working "fast and furious" on finalizing it.
"It's a top priority for my department," she said.
Verma acknowledged, however, that once issued, the proposal would need to undergo another round of public comment before it could be adopted.
The U.S. drug industry has staunchly opposed it, calling it an attempt to impose "foreign price controls from countries with socialist healthcare systems that deny their citizens access and discourage innovation."
U.S. and Canadian drug trade groups are also opposed to two pathways the Trump administration outlined on July 31 for importing cheaper medicines into the U.S. — plans that policy experts have been skeptical will ever be implemented.
The administration recently experienced two drug pricing setbacks when it abandoned its proposal to ban rebates paid by middlemen and a judge blocked a rule to require list prices in television commercials. Trump's drug pricing reform czar is also leaving next week.
Verma noted her office was working closely with lawmakers on Capitol Hill to provide technical assistance on various House and Senate legislative packages aimed at lowering drug prices and healthcare costs.
"We're reviewing drafts. We're reviewing things in advance to kind of give them that guidance," she said. "We're very active and continue to be active."