E&C Talks Faster Access to Breakthrough Care

Proposals to align FDA and CMS decisions, speed evidence development, and reduce multi-year access bottlenecks.

September 19, 2025

⚡️ NIMITZ HEALTH NEWS FLASH ⚡️ 

“Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies”

House Energy & Commerce Health Subcommittee

WITNESS & TESTIMONY

  • Dr. Todd Brinton, MD: Corporate Vice president, Advanced Technology, and Chief Scientific Officer, Edwards Lifesciences

  • Stephen Ezell: Vice President, Global Innovation Policy, and Director, Center for Life Sciences Innovation, Information technology and Innovation Foundation

  • Roger Royse: Patient Advocate and partner, Haynes and Boone, LLP

  • Dr. Diana Zuckerman, PhD: President, National Center for Health Research

  • David Lipschutz, JD: Co-Director of Law and Policy, Center for Medicare Advocacy

HEARING HIGHLIGHTS

Transitional Coverage for Breakthrough Devices (TCET vs. MCIT)

Witnesses and members emphasized the need for a statutory transitional coverage pathway to bridge the gap between FDA authorization and Medicare coverage—the “valley of death”—arguing that the current TCET program is too limited and that clearer, faster post-market evidence pathways are required. Proposals highlighted features such as a look-back period for recently authorized devices, alignment for Medicare Advantage enrollees, and added CMS resources to speed NCD reconsiderations so iterative innovations are not stranded by outdated policies. Several speakers contrasted the repealed MCIT approach with TCET, calling for an expanded, legislated pathway to deliver timely access without weakening Medicare’s “reasonable and necessary” standard.

Medicare Pathway for Multi-Cancer Early Detection (MCED)

The hearing spotlighted a bill to establish a Medicare coverage pathway for MCED blood tests after FDA approval, with supporters citing early detection benefits, low false-positive rates in leading assays after follow-up testing, and potential savings from catching cancers sooner. Testimony also surfaced caution about false negatives, downstream diagnostic cascades, and the need to preserve CMS’s independent evidence review tailored to the Medicare population; the proposal was framed as enabling timely CMS evaluation rather than mandating blanket coverage. Overall, MCED was presented as a high-impact opportunity if coupled with rigorous evidence and clear clinical workflows.

Modernizing CMS Coverage Processes (NCD/LCD)

Members and witnesses repeatedly called for more transparent, predictable, and timely CMS national and local coverage determinations, noting stakeholder frustration with opaque procedures and multi-year delays that impede beneficiary access. Recommendations included clarifying standards, accelerating reconsiderations, increasing transparency in decision rationales, and ensuring processes keep pace with iterative device updates—while maintaining Medicare’s beneficiary-focused “reasonable and necessary” review distinct from FDA’s authorization criteria. Several bills in the package targeted these process improvements alongside related access expansions.

MEMBER OPENING STATEMENTS

  • Chair Griffith (R-VA) opened by framing the hearing around four bills to speed seniors’ access to breakthrough technologies, including Medicare coverage for multi-cancer early detection (MCED) tests, a transitional coverage pathway for breakthrough devices, transparency reforms to CMS’s national and local coverage processes, and expanded diabetes self-management training. He argued agencies were too slow and opaque, and said Medicare should promptly cover FDA-authorized innovations to avoid the “valley of death” between approval and coverage. He contrasted the repealed MCIT rule with TCET and said the committee’s legislation would restore timely access and accountability.

  • Vice Ranking Member Ruiz (D-CA) stated that while he supported working on the bills under consideration, the committee also needed to address what he described as administration-driven cuts and interference harming NIH, CDC, vaccines, and cancer research. He referenced a news article, layoffs, and program halts, and warned of reduced access to vaccines and research while urging a separate hearing on these issues. He nonetheless affirmed support for aims like MCED access, faster device coverage, and diabetes self-management training.

  • Full Committee Chair Guthrie (R-KY) said the committee was continuing work to bolster seniors’ access to breakthrough technologies by enhancing Medicare coverage of FDA-approved breakthrough devices, allowing Medicare coverage of MCED tests, and improving NCD/LCD processes. He emphasized that earlier detection could improve mortality and reduce the economic burden of late-stage treatment. He supported providing four years of transitional Medicare coverage for breakthrough devices and increasing accountability and confidence in CMS processes.

WITNESS OPENING STATEMENTS

  • Dr. Brinton began by describing long innovation cycles followed by a coverage “valley of death” that denied beneficiaries timely access after FDA authorization. He highlighted Edwards’ TCET pilot experience with the Evoke transcatheter tricuspid valve replacement and said a recent NCD had already improved access for patients with no options. He urged a legislative transitional pathway with a look-back period, consistent Medicare Advantage coverage, and modernization of the NCD reconsideration process.

  • Mr. Ezell argued the biggest opportunity was to pass the bipartisan MCED screening coverage bill. He explained that blood-based MCED tests could detect many cancers earlier, potentially transforming screening and lowering mortality and costs, and he noted the bill would authorize CMS to evaluate coverage after FDA approval without mandating it. He urged Congress to act to make these innovations accessible when people need them.

  • Mr. Royse recounted that an MCED “liquid biopsy” flagged pancreatic cancer despite no symptoms, enabling an early-stage diagnosis and treatment he believed saved his life. He contrasted his outcome with his brother’s late-stage diagnosis and death, attributing the difference to early detection. He warned that test cost can be a barrier for older adults and urged passage of MCED coverage so outcomes like his could become ordinary.

  • Dr. Zuckerman cautioned that many medical devices, including some labeled “breakthrough,” lacked rigorous clinical trials in Medicare-age patients because most devices proceed via 510(k). She emphasized that Medicare’s “reasonable and necessary” standard differed from FDA’s and said weak or younger-patient evidence could make some devices unsuitable for broad Medicare coverage. She also flagged MCED uncertainties, including false positives and false negatives, and urged careful, evidence-based coverage policy.

  • Mr. Lipschutz opened by underscoring that “reasonable and necessary” is Medicare’s guiding coverage standard and a beneficiary and program protection. He said the deliberative Medicare process examines the actual Medicare population and noted concerns raised in research about evidentiary shortcomings for some breakthrough devices. He indicated general support for transparency reforms and diabetes self-management training while signaling reservations about other proposals.

QUESTION AND ANSWER SUMMARY

  • Rep. Guthrie (R-KY) asked for a walk through FDA’s 510(k) process and the extent of FDA’s ongoing post-market engagement, and Dr. Brinton emphasized the need for Medicare policies that encourage research and uptake of MCED tests.

    Rep. Guthrie asked whether Medicare coverage of MCED would spur more research; witnesses indicated it would.

  • Rep. Harshbarger (R-TN) pressed on how long CMS reconsiderations and comment periods took and argued they should be shortened to speed access. She asked how Medicare should prioritize coverage pathways for high-burden cardiovascular diseases and probed gaps in Medicare Advantage coverage of breakthrough technologies. Dr. Brinton described lengthy timeframes, urged expanding transitional coverage beyond TCET’s annual cap, and noted inconsistency in MA plan coverage pre-NCD.

  • Rep. Ruiz (D-CA) linked early detection to improved outcomes and to probe how predictable FDA–CMS processes and federal research funding affected innovation and access. He criticized proposed NIH and CDC cuts as undermining medical progress. He reiterated support for MCED coverage but warned that research funding cuts would set progress back.

  • Rep. Bilirakis (R-FL) focused on the breakthrough devices bill and diabetes self-management training, citing long lags—often six years—between FDA authorization and Medicare coverage. He asked how the bill would preserve U.S. competitiveness and what evidence development manufacturers undertake during transitional coverage. Witnesses supported expanding the TCET-style capacity beyond five technologies per year and described collaborative evidence generation to meet Medicare’s “reasonable and necessary” standard.

  • Rep. Pallone (D-NJ) questioned whether the breakthrough devices bill would erode Medicare’s “reasonable and necessary” standard and hinder CMS’s ability to protect beneficiaries. He asked for an explanation of why breakthrough devices should still undergo CMS’s deliberative NCD/LCD processes tailored to the Medicare population. Mr. Lipschutz emphasized differences between FDA and CMS standards and cited research showing evidentiary shortcomings for some breakthrough devices.

  • Rep. Schrier (D-WA) highlighted her diabetes self-management training bill and then pressed on MCED test performance and clinical management implications. She cautioned about false reassurance from false negatives and asked about downstream testing cascades and how to handle positive MCED results with uncertain origin. Dr. Zuckerman described potential burdens from follow-up scans and biopsies when initial positives did not lead to actionable findings.

  • Rep. Dunn (R-FL) underscored the “valley of death” between FDA authorization and CMS coverage and asked whether MCED coverage would reduce patient and family burdens. He also voiced support for reforms to increase transparency and timeliness in NCD/LCD decisions. Witnesses affirmed that the MCED bill would create a pathway that did not get ahead of the science while facilitating appropriate Medicare review and access.

  • Rep. Veasey (D-TX) argued that large proposed NIH cuts threatened U.S. leadership in medical innovation and would slow progress against cancer, then asked about the value of maintaining research funding while advancing MCED coverage. Mr. Ezell linked federal R&D to downstream innovation and explained how early detection could also accelerate biomarker-driven drug development.

    Rep. Veasey reiterated his support for the bipartisan MCED bill.

  • Rep. Crenshaw (R-TX) stated that CMS had become a “valley of death” after FDA authorization and said Medicare must be a bridge to innovation, not a barrier. He framed the committee’s legislation as patient-first and aimed at ensuring seniors were not left behind.

  • Rep. Joyce (R-PA) highlighted how coverage delays affect seniors and asked whether earlier access to breakthrough devices and MCED would improve outcomes and reduce invasive care. He also elicited testimony from the patient witness that early detection had likely saved his life. He closed by framing the bills as bipartisan opportunities to improve care.

  • Rep. Kelly (D-IL) emphasized the bill’s broad support and low false-positive rates among leading MCED tests and tied coverage to reducing disparities. She urged timely access for seniors at highest risk and situated MCED within efforts to dismantle barriers to screening and diagnosis.

  • Rep. Balderson (R-OH) asked about risks to seniors and the Medicare program if Congress failed to create an MCED coverage pathway. Mr. Ezell testified that congressional action would send a strong signal to industry, drive innovation, and still leave CMS to make evidence-based coverage determinations after FDA approval.

  • Rep. DeGette (D-CO) briefly interjected to note ongoing bipartisan work on a “Cures 2.1” package aimed at CMS approval and funding issues, signaling alignment with parts of the committee’s agenda.

  • Rep. Fletcher (D-TX) supported the hearing’s aims while criticizing broader cuts to research and health programs, and she asked for affirmation of the importance of restoring R&D funding. Mr. Ezell called federal R&D “seed corn” for future technologies and jobs and urged sustained investment for economic and national security.

  • Rep. Miller-Meeks (R-IA) cited cancer’s cost and incidence in Medicare and championed the MCED bill she co-authored, then asked about the complementarity of public and private research and whether NIH should share in royalties. Mr. Ezell described the respective roles of public basic research and private clinical development and agreed both sectors were essential.

  • Rep. Carter (D-LA) underscored the human and economic toll of cancer and argued HR 842 would enable earlier detection and better outcomes. He also criticized attacks on science funding while discussing the need to use every tool against cancer.

  • Rep. Obernolte (R-CA) said MCED could both improve outcomes and reduce spending, then asked how to balance concerns about detecting lesions that might never progress versus missing treatable disease. He referenced literature questioning whether MCED finds untreatable late cancers or indolent lesions and asked how policymakers should think about those outcomes. He framed the discussion around minimizing harm from false positives while not overlooking actionable disease.

  • Rep. Cammack (R-FL) closed by arguing that CMS processes were slow and opaque, leaving seniors waiting for FDA-cleared innovations, and she called for transparency, accountability, and patient-centric decision-making. She tied the reforms to the needs of more than 68 million Medicare beneficiaries, including Florida seniors, and advocated removing barriers that deny timely access to breakthrough devices, MCED tests, and diabetes care.