Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer® System Procedure

WASHINGTON, D.C. – AdvaMed, the Medtech Association, recently published a technical performance and safety bulletin titled, “Remote Device Operations: Common Challenges and Mitigation Strategies” to help health care providers, device manufacturers, and IT teams navigate the complex landscape of remotely managing medical devices.

WASHINGTON—AdvaMed, the medtech association, today thanked the U.S. House Energy and Commerce Health Subcommittee for highlighting the need for Medicare coverage of FDA-authorized breakthrough medtech and releasing a discussion draft of breakthrough coverage legislation at a hearing, “Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies.” 

WASHINGTON—AdvaMed, the medtech association, today welcomed U.S. House of Representatives Committee on Ways and Means passage of legislation providing Medicare coverage of FDA-designated and authorized breakthrough medtech. AdvaMed also urged legislators to add diagnostic tests to the measure, the Ensuring Patient Access to Critical Breakthrough Products Act, H.R. 5343. 

WASHINGTON—AdvaMed, the medtech association, welcomed today’s CMS’ announcement of the details of the $50 billion Rural Health Transformation Program. This program gives states the chance to access the latest health care technologies that best suit their needs to improve health outcomes for rural Americans.

WASHINGTON—AdvaMed, the medtech association, today welcomed the introduction in the U.S. House of Representatives and Senate of the bipartisan Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act by Reps. Richard Hudson (R-N.C.), Scott Peters (D-Calif.), Gus Bilirakis (R-Fla.), Raja Krishnamoorthi (D-Ill.) and Brian Fitzpatrick (R-Pa.) and Sens. Thom Tillis (R-N.C.) and Raphael Warnock (D-Ga.)

WASHINGTON, D.C.—AdvaMed, the medtech association, today announced a town hall featuring FDA Center for Devices and Radiological Health (CDRH) Director Michelle Tarver and fellow CDRH senior leaders at The MedTech Conference hosted by AdvaMed in San Diego in October. The town hall participants will update the audience on the center’s strategic direction and priorities and take questions.

WASHINGTON, D.C.—AdvaMed, the world’s largest trade association representing medtech innovators, today urged the Centers for Medicare and Medicaid Services (CMS) to fix “serious flaws” in its proposed rule to restart competitive bidding for durable medical equipment in Medicare, citing risks to patient safety, fewer product choices for beneficiaries, and cost increases that would result if the rule stands. 

Christopher L. White, Esq., AdvaMed’s General Counsel & Chief Policy Officer, on why this year’s legal, compliance & regulatory programming is mission-critical as medtech leaders navigate uncertainty, shifting enforcement priorities, and a rapidly changing global legal landscape.