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.
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:
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
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:
Medicare coverage of disposable Durable Medical Equipment (DME) products
Telehealth information request for CMS and MedPAC
Sunshine provision related to reprints and CME
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.