Medicare Reimbursement: Medicare Coverage of Breakthrough Technologies (S. 1717); Transitional Coverage for Emerging Technologies (TCET)/Medicare Coverage for Innovative Technology (MCIT) Unique Device Identifier (UDI) in Medicare claims form FDA Reform: Medical device shortage reporting; domestic production of medical products; use of real-world data (RWD) and real-world evidence (RWE) FDA Modernization: modeling non-animal studies for medical device studies; Medical Device Electronic Labeling Act (H.R. 1539); draft legislation "Safe Medical Device Repair Act" third party right to repair Biotechnology: reduce regulatory barriers; align public-private investment Nursing Workforce Shortage
H.R. 1 the "One Big Beautiful Bill Act" specifically the TCJA Provisions: corporate tax rate; incentives to promote U.S. manufacturing; research and development amortization; bonus depreciation; construction of workforce housing; new market tax credit (H.R. 1103)
Beneficial Owner
USDA Sec. 502 low-income, rural areas in need of affordable housing proposals for workforce development
EPA Regulation of Ethylene Oxide NESHAP Rule and FIFRA Interim Decision Re-Registration PFAS issues: Fluoro Polymers [Per- and polyfluoroalkyl (PFAS) type(s) of substances used in medical devices]
Workforce Development
Tariffs levied by the Administration
NIL issue: "SCORE Act" draft legislation