Medicare Coverage Processes: An Analysis of Procedural and Resource Concerns

As patient advocates, we’ve witnessed countless stories of hope deferred and lives put on hold while Medicare beneficiaries wait several years for access to breakthrough medical technologies that the FDA has already deemed safe and effective. This unacceptable delay between innovation and access must end. Innovation does not benefit patients without coverage.

WASHINGTON—AdvaMed, the world’s largest trade association representing medtech innovators, today welcomed a letter from U.S. Senators Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.), co-chairs of the Senate Diabetes Caucus, and U.S. Representatives Diana DeGette (D-Colo.-01) and Gus Bilirakis (R-Fla.-12), co-chairs of the U.S. House Diabetes Caucus, to Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz urging the agency not to finalize a proposal the lawmakers warned could reduce and complicate patient access to continuous glucose monitors (CGMs) and durable insulin pumps.

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 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. 

WASHINGTON, D.C.—AdvaMed, the Medtech Association, is among 67 stakeholder groups, including patient advocacy groups and state medtech and life sciences associations, urging the Centers for Medicare and Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology.