ARTICLE
27 December 2017

Trump Administration Outlines Planned Regulatory — and Deregulatory — Actions for 2018

RS
Reed Smith

Contributor

The Trump Administration has updated its "Unified Agenda of Regulatory and Deregulatory Actions," which lists the scope and anticipated timing of pending and future regulations
United States Food, Drugs, Healthcare, Life Sciences
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The Trump Administration has updated its "Unified Agenda of Regulatory and Deregulatory Actions," which lists the scope and anticipated timing of pending and future regulations. In releasing the agenda, the Administration highlights its "ongoing progress toward the goals of more effective and less burdensome regulation," including its plans to finalize three deregulatory actions for every new regulatory action in fiscal year 2018.  For instance, the Administration intends to issue a proposed regulation to "remove unnecessary and outdated requirements from the conditions of participation for the Medicare and Medicaid programs for Long-Term Care facilities." Other planned HHS regulatory and deregulatory actions include, among many others:

  • Annual proposed updates to Medicare provider payment rates and policies;
  • A proposed CMS rule to establish requirements for third parties that provide financial assistance to patients for premiums to enroll in coverage provided by a qualified health plan;
  • A proposed CMS rule to provide Medicare coverage of certain devices under investigation through a clinical research study and certain associated routine care items and services in that research, under the proposed Expedited Coverage of Innovative Technology (ExCITe) coverage pathway;
  • A proposed CMS rule to provide an exception to Medicaid fee-for-service access to care documentation requirements for states with high managed care penetration rates;
  • A proposed CMS rule to repeal Health Plan Identifier regulations; and
  • A proposed HRSA 340B drug pricing program ceiling price and manufacturer civil monetary penalties rule.

More generally, HHS intends to take regulatory actions "aimed at improving service delivery through meaningful information sharing, supporting consumer autonomy and decision-making, and better aligning programs with the most current science." At the same time, "HHS is committed to streamlining and clarifying its regulations to reduce unnecessary burden" while protecting public health. The Department also intends to continue its focus on addressing fraud, waste and abuse.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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ARTICLE
27 December 2017

Trump Administration Outlines Planned Regulatory — and Deregulatory — Actions for 2018

United States Food, Drugs, Healthcare, Life Sciences

Contributor

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