Following a speech that seemed more campaign rhetoric than policy, President Donald Trump signed an executive order Thursday that's his answer to the Democrats' proposed Medicare for All Act.
Intended to protect and expand the choice seniors have under Medicare, the executive order, which Trump called "very historic," builds on the aspects of Medicare that work well, including the market-based approaches in the current system, and seeks to crack down on fraud, waste and abuse.
The order also calls for Medicare beneficiaries to have quicker access to breakthrough medical devices, innovative therapies and other new technologies. The order tasks the Department of Health and Human Services (HHS) with proposing regulatory changes, within one year, to streamline the approval, coverage and coding process so innovative products are brought to market faster and to ensure that such products are appropriately reimbursed and widely available.
Specifically, the executive order directs HHS to:
• adopt regulations and guidance to minimize and appropriately eliminate the time and steps between FDA approval and coverage decisions by the Centers for Medicare and Medicaid Services (CMS);
• clarify "the application of coverage standards, including the evidence standards CMS uses in applying its reasonable-and-necessary standard, the standards for deciding appeals of coverage decisions, and the prioritization and timeline for each National Coverage Determination process in light of changes made to local coverage determination processes;
• identify challenges to using parallel FDA and CMS review and propose changes to address those challenges;
• modify the value-based insurance design payment model to remove disincentives for private Medicare Advantage plans to cover items and services that use new technologies not covered by fee-for-service Medicare when those items and services can save money and improve the quality of care.
Whether the coverage help offered by the executive order comes to fruition could depend on the outcome of next year's presidential election. Given the one-year timeline outlined in the order, HHS' proposed changes are due just weeks ahead of the election. Thus, unless HHS quickly churns out those proposals, there wouldn't be time for them to go through the rule-making process and to be implemented before what could be the end of Trump's presidency.
In signing the executive order Thursday at an event in The Villages, Fla., Trump said it is the latest of many steps his administration has taken to protect vulnerable Americans and make health care, especially prescription drug prices, more affordable. But he promised it wouldn't be the last.
Reiterating his oft-repeated claim that prescription drug prices are coming down for the first time in more than 50 years, the president said, "We're going to get them a lot lower," adding that more steps would be announced soon on ways to do just that.
Some are already in the works. Trump said HHS is working with Florida's governor to implement a program that will enable that state to import drugs from Canada and elsewhere to take advantage of more affordable drug prices in other countries. He said he expects Florida will begin importing prescription drugs in "a little while."
As more states begin to shop and negotiate for imported drugs, Trump said drug companies eventually will have to lower the prices they offer in the U.S. "American patients must no longer be forced to subsidize lower prices in other countries," he added.
The president also used the occasion to hint that he will be nominating a new FDA commissioner soon – someone who would be "a little bit unconventional" choice.