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Trump’s 2 for 1 Approach to Deregulation:
Help or Hindrance to Healthcare Innovation?
by Stacie Heller
On January 30, President Trump checked another box off his campaign promise list by issuing an executive order (Order) intended to reduce federal regulations. The Order requires federal agencies to eliminate two regulations for each new regulation the agency introduces and
to offset the incremental cost of new legislation; however, the new Order does not require the repeal of the two regula- tions be done simultaneously with the release of additional rules. The Order directs the Of ce of Management and Budget (OMB) to count how much the federal government saves on eliminated regulations; federal agencies will then be allowed to use those savings toward the cost of any new regulations they adopt.
The directive gives room for interpretation, particularly by the new OMB director — former South Carolina Congressman Mick Mulvaney — who will have the exibility to determine how and when the Order is carried out, and how it will apply to health- care regulations. In a press statement after the Order’s release, an unidenti ed White House of cial said, “[the executive order] vests tremendous power and responsibil- ity in the OMB director to ensure the president's direction in how we manage this across the government.”
What does the Executive Order mean for healthcare and access
to new therapies?
Immediate industry response to the Order was positive, with American Hospital Association President and CEO Rick Pollack describing the order as a “good rst step.” Pollack said the regulatory burden imposed on hospitals is “substan- tial and unsustainable,” adding, “reducing the administrative complexity of healthcare would allow providers to spend more time on patients, not paperwork.”
Scott Whitaker, CEO of the Advanced Medical Technology Association, issued similar comments, noting the Association has “long maintained that any regulation needs to bene t patients and foster innova- tion, and the medical technology industry has developed a strong working relation- ship with key agencies, such as [FDA] and [CMS] in support of those principles.”
It is still unclear what effect the Order will have on the highly regulated healthcare industry.
Long known as a proponent of deregulation, newly installed OMB Director Mulvaney has yet to issue guidance on the Order, ginning up widespread speculation on the Order’s potential effect to the health- care industry. The Order comes in a year when a raft of new regulations were set to roll out, including those under the 21st Centur y Cures Act and the Medicare Access and CHIP Reauthorization Act’s Quality Payment Program (MACRA), not to mention the dozens of regulations facing the healthcare industry in a “typical” year.
The 21st Century Cures Act requires
a number of new regulations aimed at speeding up processes in the FDA, such as one that builds on the agency's current review process for accelerated review pathways for drugs and medical devices. The order could be further complicated because some regulations are technically deregulations, as in the case of MACRA, which intends to streamline several CMS quality programs into one and, signi cantly, the Affordable Care Act’s an- ticipated repeal and replacement. Further adding to the list of new rules expected this year would be those associated with the CHIP and FDA User Fee Agreement reauthorization legislation required by the end of September.
Implementing the new regulatory Order may be dif cult given the Trump admin- istration’s evolving domestic policy goals. As Congress passes new healthcare legislation, even deregulation in the new world order will require new rules.
About the author
Stacie Heller is the Vice President of Policy at AmerisourceBergen.
The Senate confirmed Rep. Mick Mulvaney (R-SC) to lead the Office of Management and Budget in February. Mulvaney, described as a persistent critic of federal spending, is now in charge of setting fiscal priorities for President Donald Trump. Mr. Mulvaney was a founding member of the House Freedom Caucus and a vocal propo- nent of spending cuts and reworking regulations. He’s on record as fiercely opposed to the Affordable Care Act and in favor of cuts to Medicare and Med- icaid spending — views not specifically espoused by President Trump.
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