President Donald Trump’s executive order of Jan. 30, 2017, has created a great deal of uncertainty for healthcare organizations and a major challenge for the FDA.

The “one-in, two-out” order created a regulatory cap for fiscal year 2017. “Unless prohibited by law, whenever an executive department or agency publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed,” states the Presidential Executive Order on Reducing Regulation and Controlling Regulatory Costs.

All agency heads are directed that the total incremental cost of all new regulations, including repealed regulations, to be finalized this year shall be no greater than zero, it states.

It also states that any new incremental costs associated with new regulations shall be offset by the elimination of existing costs associated with at least two prior regulations. Heads of agencies will receive guidance on how to implement this order, including processes for standardizing measurement and estimation of regulatory costs.

Any proposed rulemaking notices that were not yet finalized would appear to be indefinitely stalled. Also, any new regulations published before Trump’s inauguration could be repealed. The order also will make it difficult for implementation of the 21st Century Cures Act, which was signed into law in December.

As of Case Management Advisor’s press time, the full implications of the executive order were not fully understood. CMA will provide updates in April.

The Trump Administration’s move to repeal the Affordable Care Act also has created uncertainty for hospitals and other providers, and the American Hospital Association (AHA) addressed its concerns in a letter to the president on Jan. 27, 2017.

The letter, signed by 72 hospital associations and organizations, outlined hospitals’ and health systems’ top priorities as the president deliberates the future of the ACA. These priorities include the following:

  • “If the ACA is to be repealed, the potential repeal and replace should be done simultaneously, and ensure that the 22 million people receiving coverage continue to receive adequate coverage.
  • “If repeal and replace cannot be accomplished simultaneously, the reductions to hospitals and health systems included in the ACA should be restored to ensure there are sufficient resources to provide to the uninsured.
  • “Further reductions to hospitals and health systems should not be considered during either reconciliation or the replace debate.
  • “Any Medicaid restructuring should continue the federal-state partnership that ensures beneficiaries and providers continue to have access to high-quality healthcare coverage, provides sufficient funding, and treats expansion and non-expansion states in an equitable manner.
  • “Significant regulatory reform to address the burden faced by hospitals and health systems needs to be implemented by both the legislative and executive branches.
  • “Continued efforts to improve the healthcare system and make care more affordable should be supported by moving to fee-for-value-based payment that provides incentives for clinically integrated coordinated care.”