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H.R. 8500·119th Congress·Introduced Apr 27, 2026

Timely Access to Coverage Decisions Act of 2026

IntroducedHealthMajor
View bill text
Sponsor
Rep. Dunn, Neal P. [R-FL-2]
Committees
Energy and Commerce Committee (primary)
Last action
Apr 27, 2026

Bottom line

The bill aims to accelerate and increase the transparency of Medicare local coverage determination processes by imposing statutory deadlines and robust public engagement requirements on administrative contractors and introducing a Secretarial review mechanism for appeals.

What it actually does

This bill amends the Social Security Act to establish strict timeframes for Medicare administrative contractors (MACs) to review and make decisions on requests for new or reconsidered local coverage determinations (LCDs) under the Medicare program. It mandates a 60-day period for MACs to determine if a request is complete and a one-year deadline for a final decision. Additionally, it significantly revises the process for issuing specified LCDs, requiring enhanced transparency, public meetings, expert advice, and Secretarial review for reconsideration decisions.

Proponents argue

Proponents argue that the current LCD process is often slow and opaque, creating significant barriers to patient access for innovative treatments and technologies. They contend that this bill will ensure timely decisions, reduce administrative burdens for medical innovators and providers, and enhance transparency, ultimately benefiting Medicare beneficiaries by expediting access to necessary medical items and services and fostering innovation.

Opponents contend

Opponents might argue that imposing strict deadlines on Medicare administrative contractors could lead to rushed or less thorough reviews, potentially resulting in inappropriate coverage decisions or increased administrative costs for contractors without proportional benefit. They may also contend that the existing process, while imperfect, allows for necessary flexibility and detailed review, and that these changes could strain MAC resources.

The bill is concise and its core provisions are clearly laid out, making it accessible for an informed reader to understand its implications within a reasonable timeframe.

Section 2(a), amending Section 1862(l)(5)(E) of the Social Security Act

Establish Timelines for Initial Local Coverage Determination Requests

prominently featuredstraightforward

This provision requires Medicare administrative contractors (MACs) to determine whether a formal request for a new local coverage determination (LCD) is complete or incomplete within 60 days of receipt. If incomplete, the MAC must provide a written notification specifying the additional information needed. If the request is deemed complete, the MAC must then take action to finalize or deny the LCD within one year of the initial request date.

GroupImpactMechanismScale
GroupEntities submitting formal LCD requests (e.g., medical device manufacturers, pharmaceutical companies, provider organizations)ImpactBenefit from increased predictability and reduced waiting times for coverage decisions, potentially accelerating market access for new technologies.MechanismStatutory deadlines for MAC review processes.ScaleSystemic improvement in the efficiency of the LCD request process.
GroupMedicare administrative contractors (MACs)ImpactIncreased administrative burden and accountability for timely processing of LCD requests.MechanismNew regulatory requirements and performance metrics.ScaleRequires operational adjustments and potential resource reallocation.

Supporters argue

Supporters argue this provision directly addresses long-standing delays in the LCD process, which can hinder patient access to innovative medical technologies and services. Ensuring timely decisions fosters innovation and provides crucial certainty for providers and beneficiaries regarding coverage.

Critics contend

Critics might contend that imposing strict deadlines could force MACs to make hasty decisions without sufficient evidence review, potentially leading to inappropriate coverage or denials. They may also argue that MACs might lack the necessary resources to meet these new timeframes without additional funding or staffing.

Tradeoffs

This provision balances the desire for timely access to new medical technologies and services with the need for thorough, evidence-based review by MACs to ensure appropriate and effective coverage decisions.

Section 2(b), amending Section 1862(l)(5)(F) of the Social Security Act

Establish Timelines for Local Coverage Determination Reconsideration Requests

prominently featuredstraightforward

This section mandates that Medicare administrative contractors (MACs) determine the completeness of a formal reconsideration request for an existing LCD within 60 days. If incomplete, the MAC must provide a written notification detailing the missing information. For complete requests, the MAC must issue a final reconsideration decision within one year of receiving the initial request. The provision also defines 'formal reconsideration request' and 'interested party' to clarify who can submit such requests.

Section 2(b), amending Section 1862(l)(5)(G) of the Social Security Act

Agency Review of Reconsideration Decisions by the Secretary

prominently featuredmoderately complex

This provision allows an 'interested party' to request that the Secretary of Health and Human Services (HHS) review a Medicare administrative contractor's (MAC's) final reconsideration decision. The Secretary's review must specifically analyze whether the MAC's determination misapplied evidence, exceeded its intended scope, made an incorrect 'reasonable and necessary' determination, failed to describe clinical conditions, or conflicted with other laws or national coverage determinations.

Section 2(c), amending Section 1862(l)(5)(D) of the Social Security Act

Revised Process for Issuing Specified Local Coverage Determinations

prominently featuredhighly complex

This section redefines the process for issuing 'specified local coverage determinations' (new or substantively revised LCDs). It requires MACs to publish a draft determination, its rationale, and all relied-upon evidence. Within 60 days, MACs must convene open public meetings (with remote access and advance agendas), receive public comments, and secure advice from an expert panel including physicians, Contractor Advisory Committee members, and beneficiary advocates. MACs must post meeting records and allow a 30-day public comment period. Before finalizing, MACs must publish responses to comments, the full text of comments, the final rationale, and any new qualifying evidence, with an effective date at least 45 days later. The final determination must be a 'logical outgrowth' of the draft.

FOUND

This clause defines 'qualifying evidence' for the purpose of developing specified local coverage determinations. It specifies that qualifying evidence means 'publicly available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements, and clinical guidelines.'

Section 2(c), amending Section 1862(l)(5)(D)(iv) of the Social Security Act

Why it matters:While placing definitions at the end of the section where the term is primarily used is a standard legislative drafting practice, its critical role in guiding evidentiary standards for all new and revised LCDs means its significance can be underestimated by a casual reader.

Case for: Supporters would argue that a clear and robust definition of 'qualifying evidence' provides essential guidance to MACs and stakeholders, ensuring that LCDs are based on scientifically accepted medical information. This promotes consistency, credibility, and evidence-based decision-making in Medicare coverage.

Case against: No specific opposition is typically raised against defining 'qualifying evidence' itself. However, some might argue that the definition could be too restrictive, potentially excluding other valid forms of evidence, or conversely, not sufficiently rigorous, allowing for less robust evidence than desired in certain contexts.

Estimated impact: This definition will directly influence the evidentiary standards applied to all new and substantively revised local coverage determinations, thereby shaping which medical items and services are deemed 'reasonable and necessary' for Medicare coverage across the country.

About this analysis. AI-Generated from the official bill text and available committee reports. Gaps in available data are noted explicitly. Verify important details with the official Congress.gov record.

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