As has been the tradition for incoming administrations, the Trump Administration has ordered a regulatory freeze and review of final rules published by the Obama Administration that had not yet gone into effect.  In a January 20, 2017 memo to the heads of executive departments and agencies, Assistant to the President and Chief of Staff Reince Priebus directed agencies to temporarily postpone the effective date of such regulations for 60 days (March 21, 2017) unless such action would impact health, safety, or financial or national security.  During the review period, the agencies are expected to review the regulations and, as necessary, effect further delay through notice and comment rulemaking.

Recent final health policy regulations expected to be delayed as part of this regulatory review include:

  • A January 5, 2017 Health Resources and Services Administration final rule that sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (effective date:  March 6, 2017).
  • A January 12, 2017 Office of Inspector General final rule to amend its exclusion authority rules to incorporate statutory changes, early reinstatement provisions, and policy changes, and to clarify existing regulatory provisions (effective date: February 13, 2017).
  • A January 18, 2017 Substance Abuse and Mental Health Services Administration (SAMHSA) final rule intended to modernize federal regulations governing the confidentiality of substance abuse records (effective date:  February 17, 2017).
  • A January 19, 2017 Centers for Disease Control and Prevention final rule to strengthen the federal government’s ability to prevent the introduction, transmission, and spread of communicable diseases into the United States and interstate (effective date:  February 21, 2017).

A major Centers for Medicare & Medicaid Services final rule published January 3, 2017 establishes mandatory Medicare episode payment models (EPM) for acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment procedures furnished in designated geographic areas.  While this rule is effective February 18, 2017, major provisions of the rule are not actually applicable until July 1, 2017 and presumably will not be impacted by the regulatory review (although the new Administration could potentially take separate steps in the interim to revise the terms of the EPM program).