[{"_1":2,"_99":-5,"_100":-5},"loaderData",{"_3":4,"_26":27},"root",{"_5":6,"_17":10,"_18":19,"_20":21,"_22":10,"_23":-5,"_24":-5,"_25":10},"user",{"_7":8,"_9":10,"_11":10,"_12":-5,"_13":-5,"_14":15,"_16":-5},"roles",[],"isAuthenticated",false,"isPremium","planName","subscriptionStatus","featureFlags",{},"insightsBudget","isDevelopmentHost","userPreferences",{},"recaptchaSiteKey","6LcvOJcUAAAAAHsB-gPGfGktcRlKpH7OTIU_dMTD","isImpersonating","impersonation","affiliateStatus","isFreedomPortal","routes/v2/article/layout",{"_28":29,"_30":31},"notFound",true,"relatedArticles",[32,75,87],{"_33":34,"_35":36,"_37":38,"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_55":56,"_57":58,"_59":60,"_61":62,"_63":64,"_65":66,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},"mediaId",6463734,"mediaKeyId","5785116-7e7d76b4ec2a6456ca7d9132acee7e60","parentId",5785116,"title","Lawmakers weigh faster Medicare coverage for FDA‑designated breakthrough medical devices","audioSeconds",3628,"startMs",1130000,"endMs",4758000,"viewUrl","/Search/View?dp=1&key=5785116-7e7d76b4ec2a6456ca7d9132acee7e60&start=1130&end=4758","thumbnailUrl","https://assets.pipeline.soar.com/5785116-7e7d76b4ec2a6456ca7d9132acee7e60/thumbnail_1130000.jpg","articleUrl","/articles/6463734/Lawmakers-weigh-faster-Medicare-coverage-for-FDAdesignated-breakthrough-medical-devices","mediaUrl","https://secure.pipeline.soar.com/6463734-2667765473aeb212688d3d56cd77fe53/orig.mp4?Expires=1770643611&Signature=BkMrvdib3m-co80JJ7pK006CscgPiMtH3GChWWMn2a3MTL7Cgjgef3rb3dvdutEoXNie9XVr~XKpHbRPfSe8VOdUktIHwp~Y2rDMvf3Balaxu-emx6XjvjcFdbwvWe3i0DukIhTgAhh-Ke6NzdTM3W9kbogP-eQKpUXggVV6aloUB4Upgx07DLHxbIveM7VoKih4GZMW4rLjSw7qVYSV5gNwt-DIiJQdDEPpwOnf5p6fFKVDEcPCuV7ur498rQwHSigpSsBSGKxA6M6USVxfjEnGezOm1-1oG2TCi4tHbuGOOTjHEX3lWjG4nyjc7Nt8Y71nz9-EW4O96yxsDyMRwg__&Key-Pair-Id=KUT5TJCACFTXG","author","U.S. House Committee on Energy and Commerce","date","2025-09-18T16:50:38Z","article","A House Energy and Commerce subcommittee hearing examined proposals to accelerate Medicare access to FDA‑designated breakthrough medical devices and to reform national coverage and reconsideration procedures at the Centers for Medicare & Medicaid Services (CMS).

Why it mattered: Witnesses described a persistent delay — often called the “valley of death” — between FDA authorization and Medicare coverage that can keep seniors from accessing new, potentially life‑saving technologies. Todd Brinton, corporate vice president and chief scientific officer at Edwards Lifesciences, said delays in coverage “stifle innovation” and described the company’s experience using CMS’s pilot transitional pathway. He told the subcommittee the pilot for Edwards’ Evoque transcatheter tricuspid valve replacement required about 13 months from authorization to coverage and that a broader, adequately funded transitional program could reduce such waits.

What proponents proposed: Industry witnesses urged Congress to create or expand statutory transitional coverage for FDA‑authorized breakthrough devices, including features such as a two‑year look‑back period for recently authorized technologies, consistent rules for Medicare Advantage plans, and dedicated funding to help CMS implement the pathway. Supporters argued a predictable process would encourage investment in U.S. device innovation and prevent the erosion of American competitiveness internationally.

Safety and evidence concerns: Diana Zuckerman, Ph.D., president of the National Center for Health Research, and David Lipschutz of the Center for Medicare Advocacy cautioned that many devices designated as “breakthrough” receive market authorization via less stringent premarket pathways (for example, 510(k)) and that clinical trial evidence often does not include older, Medicare‑age patients. Zuckerman testified that only a minority of the devices labeled breakthrough had publicly reported clinical trials that included older adults; she urged retaining CMS’s ability to make “reasonable and necessary” determinations based on evidence specific to Medicare beneficiaries.

Points of disagreement and suggested reforms: Committee members and witnesses debated whether a statutory transitional pathway would improperly limit CMS’s discretion or whether it would provide necessary predictability. Recommendations offered during the hearing included shortening duplicative public comment periods during NCD reconsiderations, ensuring that CMS has resources to meet timelines, and requiring post‑authorization data collection (coverage with evidence development) to protect patients while enabling access.

Next steps: The hearing produced no votes. Members asked for written follow‑up and signaled intentions to refine legislative text to balance access, beneficiary safety, and CMS authorities.","mediaType","Video","parentTitle","Health Hearing: Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies","oneSentenceSummary","A House Energy and Commerce subcommittee hearing examined proposals to accelerate Medicare access to FDA‑designated breakthrough medical devices and to reform CMS national coverage processes.","taxTitle","Energy and Commerce: House Committee, Standing Committees - House & Senate, Congressional Hearings Compilation, Legislative, Federal","taxId",1824,"location","","headline","shortSummary",{"_33":76,"_35":36,"_37":38,"_39":77,"_41":78,"_43":79,"_45":80,"_47":81,"_49":82,"_51":83,"_53":84,"_55":56,"_57":58,"_59":85,"_61":62,"_63":64,"_65":86,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6463737,"House Energy and Commerce hearing spotlights Medicare coverage for multicancer early‑detection tests",8846,1022000,9868000,"/Search/View?dp=1&key=5785116-7e7d76b4ec2a6456ca7d9132acee7e60&start=1022&end=9868","https://assets.pipeline.soar.com/5785116-7e7d76b4ec2a6456ca7d9132acee7e60/thumbnail_1022000.jpg","/articles/6463737/House-Energy-and-Commerce-hearing-spotlights-Medicare-coverage-for-multicancer-earlydetection-tests","https://secure.pipeline.soar.com/6463737-2e192347d06a0512204143d3620dd1ce/orig.mp4?Expires=1770643611&Signature=CxK7rU-ZVhwH4qFF8nNtcPWvC31SqDmw4eM-FJ5odbaQH6mwJwwoqhP6IvZyyIg78iMsR4IvxjznubK4eWhLUKX-KwfmD1DB7v7JLGRJFM4fjGxSZzRlR7Y-r16QMY3SSFk6NMjN13WL77rNCQhnM9MVu4~nA3m3lUrHbx0a97UyEdmaVA6pkbOyE3YdN8WLmJIydnIbLD5~U22Zvf7CUE-y1C1L5uCzfuGHarKIOxwb~uVFrwaP80pCyQZIeB0nxqfWJYX~jcTNzOeyeqv3nXUaiUK5XstKf~EbrvE9vkgFv6uWTj743~wBw8ObtF0MPRrcjVgP1Eiwcw7j19p~WA__&Key-Pair-Id=KUT5TJCACFTXG","At a House Energy and Commerce subcommittee hearing, members and witnesses debated H.R. 842, the Nancy Gardner Sewell Medicare Multicancer Early Detection Screening Coverage Act, which would give the Centers for Medicare & Medicaid Services (CMS) an authority-based pathway to evaluate whether to cover FDA‑authorized blood-based multicancer early detection tests for Medicare beneficiaries.

The bill’s supporters said the tests, which analyze circulating tumor DNA from a blood draw, could detect many cancers earlier than current, organ‑specific screening programs and therefore save lives and money. Steven Ezell, vice president of global innovation policy at the Information Technology and Innovation Foundation, said, “Cancer claims over 600,000 American lives annually,” and argued that MCED tests can expand screening beyond the five cancers now commonly screened for.

Why it matters: Seniors account for most U.S. cancer diagnoses and cancer care consumes substantial Medicare dollars; lawmakers said a coverage pathway could increase timely access if FDA authorizations demonstrate clinical value. Patient testimony underscored that point. Roger Royce, a patient advocate who described being diagnosed after a liquid‑biopsy MCED test, told the subcommittee, “I only caught this through multicancer early detection. This is something that saves lives.”

What witnesses said: Todd Brinton, corporate vice president and chief scientific officer for advanced technologies at Edwards Lifesciences, described the broader problem of coverage lag after FDA authorization and said “transitional coverage policies offer a promising bridge” so patients can access therapies while additional evidence is developed. Mr. Ezell and other supporters said the bill would not mandate coverage but would create an evidence‑based process for CMS to consider coverage of FDA‑approved MCED tests.

Cautions and evidence questions: Diana Zuckerman, Ph.D., president of the National Center for Health Research, said MCED tests are “so promising, but they’re not quite ready for prime time yet,” pointing to limited clinical trial data, possible bias in studies, and concerns about false positives and false negatives. David Lipschutz, co‑director of the Center for Medicare Advocacy, expressed concern about an age‑based phase‑in included in the draft text, saying the proposal’s “arbitrary age cutoff … is based solely on cost rather than clinical consideration,” and that Medicare coverage decisions should be equitable across the Medicare population.

Policy design details discussed: Witnesses and members noted that current MCED candidates generally use genomic sequencing and machine learning to search for tumor DNA; panels described tests that screen for as many as “over 50 different types of cancers.” Proponents urged that any CMS pathway should: (1) rely on FDA authorization as a trigger for CMS review; (2) use an evidence‑based assessment of “reasonable and necessary” for Medicare patients; and (3) include clear communication about test performance, including false positive and false negative risks.

Context and concerns raised by members: Ranking Member Diana DeGette and others framed the MCED discussion alongside broader concerns about federal research funding and the pipeline of cancer therapeutics. Several members pressed witnesses on how to avoid overdiagnosis and on the need for additional trials that include older adults, who are the principal Medicare population.

Next steps: The subcommittee took testimony for the record and invited further written questions; no vote occurred at the hearing. Members said they expect to continue refining the statutory language and to consider stakeholder input on evidence standards, eligibility criteria, and implementation logistics.

Ending note: Proponents and skeptics agreed on one point during the hearing: earlier detection can change outcomes for individual patients, and the committee’s decisions will shape how and when Medicare beneficiaries can access emerging MCED technologies.","At a House Energy and Commerce subcommittee hearing, members and witnesses debated H.R. 842, the Nancy Gardner Sewell Medicare Multicancer Early Detection Screening Coverage Act, which would give CMS an authority-based pathway to evaluate whether to cover FDA‑authorized blood‑based multicancer early detection tests for Medicare beneficiaries.",{"_33":88,"_35":36,"_37":38,"_39":89,"_41":90,"_43":91,"_45":92,"_47":93,"_49":94,"_51":95,"_53":96,"_55":56,"_57":58,"_59":97,"_61":62,"_63":64,"_65":98,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6463728,"Subcommittee hears support for expanding Medicare access to diabetes self‑management training",5419,1230000,6649000,"/Search/View?dp=1&key=5785116-7e7d76b4ec2a6456ca7d9132acee7e60&start=1230&end=6649","https://assets.pipeline.soar.com/5785116-7e7d76b4ec2a6456ca7d9132acee7e60/thumbnail_1230000.jpg","/articles/6463728/Subcommittee-hears-support-for-expanding-Medicare-access-to-diabetes-selfmanagement-training","https://secure.pipeline.soar.com/6463728-981a7bf7962c1359c0e96e76197194e1/orig.mp4?Expires=1770643611&Signature=hgBJs59YZ-Jv6DFXzQKIcnDPZN0VKwvgYwLLXZnPQUp1oDmsTktjJd4gAFicGofEJS9Xxv9d4XrKjWuEBnKDTFEb8BDedry80nyAcvjl3KvICdtk0gWfn4f6igWhsVpwmEjzmtkh8ayP3udbFaBKdVBPCggZhNWcns5XwR6hjUSALyuSSLhk6lNSnwCUxLBldUvE-F794AoYmuorx7WmWAMt4h6GkvegPZjzlMKwT3udXu0oD2FQRxytfPW21X4tyFVnEgvc4FEsj6EpQP6E7jPib08~xtTyLnj4lTwAUJWLJuR2plg1Gm2pEkDrfsL~N0Ja0PaQQbL~x7ONT9do2Q__&Key-Pair-Id=KUT5TJCACFTXG","A House Energy and Commerce subcommittee hearing included testimony backing H.R. 3826, the Expanding Access to Diabetes Self‑Management Training (DSMT) Act, a bipartisan bill intended to broaden Medicare beneficiaries’ access to diabetes education and training.

Why it mattered: Witnesses and members described DSMT as an evidence‑based intervention that teaches patients to manage glucose, use insulin appropriately, and adopt self‑care behaviors that reduce hospitalizations and long‑term complications. Representative Kim Schrier, M.D., a physician and bill sponsor who testified during the hearing, said DSMT helps patients “take better charge of the disease.”

What witnesses said: David Lipschutz of the Center for Medicare Advocacy told the subcommittee he “has no concerns” about the DSMT expansion bill and supports policies that increase access to preventive and chronic‑disease education. Witnesses highlighted DSMT’s association with reduced diabetes‑related complications, improved self‑care, and lower health‑system costs.

Context and related concerns: Members used the DSMT discussion to raise broader public health concerns. Ranking Member Diana DeGette and others noted administration proposals and agency actions they said would reduce funding for preventive programs such as the National Diabetes Prevention Program at CDC; speakers warned those cuts could undermine the broader prevention infrastructure that helps reduce the burden of diabetes.

Next steps: The committee accepted testimony and written questions for the record; no vote occurred. Members indicated they would continue work on the language to assure broader access and coordination with Medicare Advantage plans and community providers.","Witnesses and members voiced bipartisan support for H.R. 3826 to broaden Medicare coverage of diabetes self‑management training (DSMT). Proponents described DSMT as a proven tool to improve outcomes and reduce costs; the committee also heard concerns about broader federal public health funding and program cuts.","actionData","errors"]

Article not found

Lawmakers weigh faster Medicare coverage for FDA‑designated breakthrough medical devices

House Energy and Commerce hearing spotlights Medicare coverage for multicancer early‑detection tests

Subcommittee hears support for expanding Medicare access to diabetes self‑management training