Washington, D.C. – AdvaMed, the Medtech Association, today welcomed introduction in the U.S. Senate of bipartisan legislation to expedite Medicare coverage of FDA-“breakthrough”-designated medical technologies and diagnostic tests. The legislation, the Ensuring Patient Access to Critical Breakthrough Products Act, introduced by Sen. Todd Young (R-IN) and Sen. Alex Padilla (D-CA), is similar to H.R. 1691, which the U.S. House of Representatives Ways and Means Committee passed on a bipartisan basis in June. Continue reading
Category Archives: Advocacy and Regulations
Leaders call on Congress to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA)
The purpose of the Pandemic and All-Hazards Preparedness Act is “to improve the Nation’s public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural.”Continue reading
Mixed Perspectives on the 2 year anniversary of the Inflation Reduction Act
August 16, 2024, marks the 2 year anniversary of the Inflation Reduction Act (IRA). One of the most talked about and written about policies of the current administration, The IRA has far reaching impacts. Whether they are positive or negative is a matter of perspective.Continue reading
CMS Publishes Final TCET Rule to Guide Medtech Innovators
In June of 2023, the comment period for the proposed rule on Transitional Coverage for Emerging Technologies (TCET) through the national coverage determination (NCD) process under the Social Security Act closed. The draft rule has been released for public inspection and the final rule will be published on August 12, 2024.Continue reading
FTC Releases Interim Staff Report on Prescription Drug Middlemen
Report details how prescription drug middleman profit at the expense of patients by inflating drug costs and squeezing Main Street pharmacies (FTC Press release – July 9, 2024)Continue reading
New Video Explains the Impact of The Bayh Dole Act on American Innovation
Bayh-Dole Coalition Launches Campaign Against Proposed March-in Framework.
Ranking Member Cassidy Seeks Information from Stakeholders on Regulation of Clinical Tests
WASHINGTON – Today, U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, requested information from stakeholders on ways to improve regulation of clinical tests in the United States. Continue reading
Chairs Rodgers and Guthrie Announce Health Subcommittee Hearing on Regulation of Diagnostic Tests
The Energy and Commerce Health Subcommittee will hold a hearing, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule” on Thursday, March 21 at 10:00 AM EDT.
The E&C hearing will be live streamed starting at 7 AM AZ/PDT via https://energycommerce.house.gov/Continue reading
Supporting Innovation – Now is the Time to Speak Up About R&D Expensing
Changes to the tax code revised the way R&D Expenses are treated at tax time. Congress created the policy that is now diverting dollars away from essential R&D. Congress can fix this. You can help them understand why they need to. Continue reading
Bill for Funding the Arizona Health Innovation Trust Fund Passes Senate Appropriations
SB1019: appropriation; health innovation trust fund received its first hearing in Arizona’s Senate Health and Human Services Committee on January 16, 2024 and passed with unanimous support. On January 30, 2024, the bill received a do pass recommendation from Senate Appropriation with a vote of 7 ayes, 2 nays and 1 not voting
As currently written, SB1019 appropriates $5M to the Arizona Health Innovation Trust Fund, and declares that it is the Legislature’s intent that the Fund, consisting of monies appropriated by the Legislature, gifts or grants donated or given to the Fund and earnings from the Fund, steadily grow to ultimately maintain a permanent endowment balance of at least $200 million. SB1019 is now is eligible for consideration by the Senate Rules Committee.Continue reading