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21st Century Cures Legislation Moves Forward in U.S. House

Thursday, May 28, 2015   (0 Comments)
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The U.S. House Energy and Commerce Committee voted 51-0 to approve the 21st Century Cures Act.

The Act is a culmination of an initiative led by Chairman Fred Upton (R-MI) to modernize and personalize health care, encourage greater innovation, support research, and streamline the system to deliver better, faster cures, and treatments to more patients.

The 21st Century Cures Act is full of important provisions such as: 

  • Encouraging Continuing Medical Education for Physicians: Section 3041 would exempt certain transfers of value to physicians from Sunshine reporting requirements that physicians have indicated hinder them from participation in important continuing medical education activities.
  • Facilitating Dissemination of Health Care Economic Information: Section 2101 would add clarity and facilitate dissemination of health care economic information, as defined in the section, to payers, formulary committees, or other similar entities.
  • Facilitating Responsible Communication of Scientific and Medical Developments: Section 2102 would require FDA to issue guidance on facilitating responsible, truthful, and non-misleading scientific and medical information not included in the label of drugs.

Others provisions address:

  • Breakthrough Pathway
  • Clarification of valid scientific evidence
  • Reinforcement of the least burdensome concept
  • Recognition of international standards
  • Humanitarian Device Exemption reform
  • Clinical Trials: Allowing Central IRBs
  • Streamlining the Advisory Committee Process
  • CLIA Waiver
  • Class I/II exemptions
  • 3rd Party QSR—including a the reference to future expansion of the program to include 510(k)s

The Amendment in the Nature of a Substitute (AINS) contains many other areas of interest, such as:

  • Software regulation
  • Medicare coverage of disposable Durable Medical Equipment (DME) products
  • Combination products 
  • Telehealth information request for CMS and MedPAC
  • Sunshine provision related to reprints and CME
  • Precision medicine 
  • Increased NIH funding
  • CMS ombudsman for technology
  • Improving the Local Coverage Determination Process
  • Clinical trial standardization 

The Senate is moving much slower and is unlikely to move companion legislation this year. Leaders of the Senate Committee on Health, Education, Labor, and Pensions (HELP) have begun to hold hearings and form working groups to explore some of the topics addressed in the House’s bill.

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