Timely Access to Coverage Decisions Act: What It Means for Genetic Testing Labs
Short answer: The Timely Access to Coverage Decisions Act (H.R. 8500, with a Senate companion from Sens. Luján and Cotton) would put Medicare local coverage determination timelines into statute: a 60-day completeness review, a one-year action window, open public meetings, and 45 days before final LCDs take effect. It has not passed.
For molecular labs, local coverage determinations (LCDs) decide whether a test gets paid. The MolDX program drafts many of the LCDs that govern genetic testing, and the process behind them has been criticized as slow and opaque. Congress is now weighing a bipartisan fix. This article explains what the bill would change, what the process looks like today, and what lab leaders and revenue cycle teams can do while the legislation is pending. It is decision support for laboratories, not legal advice.
What is the Timely Access to Coverage Decisions Act?
H.R. 8500, the Timely Access to Coverage Decisions Act of 2026, was introduced in April 2026 by Rep. Neal Dunn with Reps. Nanette Barragán and Claudia Tenney as cosponsors. Medical Laboratory Observer reported that Reps. Dunn and Barragán reintroduced the bill on April 28, 2026. On September 28, 2026, Clinical Laboratory Products Magazine reported a bipartisan Senate bill with the same name from Sens. Ben Ray Luján (D-NM) and Tom Cotton (R-Ark.).
The College of American Pathologists, the ITEM Coalition, the American Podiatric Medical Association, and AdvaMed endorse the Senate bill, according to that report. CAP President Qihui "Jim" Zhai, MD, FCAP, said: "Patients should not face delays in care." None of the sources we reviewed report committee action or votes on either bill.
What would the bill change?
According to a published summary of the bill language, Medicare Administrative Contractors (MACs) would have 60 days to complete a completeness review of a formal LCD request or reconsideration request. If a request is incomplete, the MAC must send written notice listing what is missing. For a complete request, the MAC would have one year to act. The summary notes the bill does not require a favorable LCD, only a decision within the window.
After publishing a draft LCD, the MAC would hold one or more open public meetings within 60 days. Agendas would be posted at least 14 days ahead, and a meeting record, which may include audio or video, would be posted within 14 days after each meeting. A written public comment period of at least 30 days would start after the record is posted. Remote attendance would be allowed.
The bill would also require an expert panel that includes at least one physician, one Contractor Advisory Committee member, and one patient-advocacy entity. Final LCDs would have to include responses to comments, the full comment text, the rationale, and any new qualifying evidence. A final LCD could not take effect unless it is a logical outgrowth of the draft; otherwise the MAC would need to reissue it as a draft.
Finally, interested parties could ask the Secretary to review a MAC's final reconsideration decision on listed grounds, such as misapplied evidence, overly broad language, or conflict with other law or a national coverage determination. Qualifying evidence is defined as publicly available evidence of general acceptance, such as peer-reviewed research, systematic reviews, meta-analyses, consensus statements, and clinical guidelines.
How does the current LCD process compare?
Much of the bill codifies existing manual language. CMS revised Chapter 13 of the Medicare Program Integrity Manual in 2018, with an implementation date of January 8, 2019. Under that framework, proposed LCDs get a public comment period of at least 45 days, MACs must respond to comments, open meetings and Contractor Advisory Committee meetings are held on the evidence, and MACs must finalize or retire each proposed LCD within one year of publication. At least 45 days before the effective date, MACs post the final determination package on the MAC and CMS websites.
The difference is enforceability and specificity. A manual can be revised by CMS; a statute cannot. The bill would also add front-end deadlines that the 2018 summary does not describe, notably the 60-day completeness review and the one-year clock for complete requests, plus the logical-outgrowth standard for final policies. No source we reviewed provides data on how long LCD requests currently take, so we cannot quantify the delay the bill targets.
Why does this matter for genetic testing labs?
Genetic testing coverage in much of the country is set by MolDX LCDs. Two recent examples show the cadence labs already work against. Noridian announced on August 27, 2026 that two MolDX LCDs were finalized with an effective date of October 12, 2026: L40242 (Genetic Testing for Hereditary Thrombophilia) and L40222 (Non-Next Generation Sequencing Targeted Molecular Panel Tests for Targeted Therapy in Cancer). That is 46 days between announcement and effective date, consistent with the 45-day lead time. See our analysis of the hereditary thrombophilia LCD and the non-NGS targeted panel LCD.
Comment windows also matter. Bionano Laboratories announced a proposed MolDX LCD for genome-wide detection of structural variants in hematologic neoplasms on September 10, 2026, with public comment open through October 11, 2026. The proposed policy would cover suspected hematologic malignancies, including leukemias, lymphomas, and myelomas, at initial diagnosis, progression, or relapse, when testing informs diagnosis or clinical management and follows current expert or professional guidelines. Our post on optical genome mapping coverage covers the earlier proposal.
For a laboratory, the practical value of statutory deadlines is predictability. A lab deciding whether to launch a test, build a validation, or hire a billing team needs to know when a coverage decision will arrive and what evidence the MAC will weigh. The bill's evidence definition and published-rationale requirements would also make it easier to prepare a reconsideration request that meets the MAC's expectations.
What should labs and RCM teams do now?
First, treat the bill as pending. Monitor Congress.gov for H.R. 8500 and the Senate companion, and do not build forecasts that assume enactment. Second, use the process that exists. The comment periods on proposed LCDs are the current opportunity to influence policy, and submissions that cite peer-reviewed evidence and guidelines are the type the bill itself would define as qualifying evidence.
Third, build an LCD calendar. Track proposed LCDs, comment deadlines, and final effective dates for the tests you run, and map each to the ICD-10 codes and documentation your claims need. Fourth, tighten documentation before an LCD takes effect, not after the first denial. Our guide to genetic testing denials outlines common failure points. Platforms such as ScreenMyGene can help centralize order-level documentation and coverage checks, but coverage strategy remains a decision for lab leadership and compliance.
Frequently asked questions
Has the Timely Access to Coverage Decisions Act passed?
No. The sources we reviewed report only introduction and reintroduction of H.R. 8500 in April 2026 and a Senate bill reported September 28, 2026. They report no committee action or votes. Labs should treat it as pending legislation and monitor Congress.gov rather than assume it will change current LCD timelines.
Does the bill guarantee that a requested LCD will be favorable?
No. A summary of the bill language states it does not require a favorable LCD. It would require MACs to act on a complete formal request or reconsideration request within one year and to explain their rationale, including responses to public comments, in the final policy.
What is the 60-day completeness review?
Under the bill, a MAC would have 60 days to review a formal LCD request or reconsideration request for completeness. If anything is missing, the MAC must send written notice listing the missing items, so requesters know what to fix before the one-year clock applies.
How much notice do labs get before a final LCD takes effect?
Current policy described in the bill summary is 45 days after posting. Recent MolDX examples fit that: two LCDs announced August 27, 2026 took effect October 12, 2026, 46 days later. The bill would preserve the 45-day interval in statute.
Who supports the Senate version?
Clinical Laboratory Products Magazine reported on September 28, 2026 that CAP, the ITEM Coalition, the American Podiatric Medical Association, and AdvaMed endorse the bipartisan bill from Sens. Luján and Cotton. Endorsements do not change the bill's pending status, so labs should keep working to current LCD procedures.
This article is for educational and informational purposes only and is not legal, financial, coding, or medical advice. Laboratories should consult qualified counsel, compliance, and billing professionals about their specific situation.
Sources: Congress.gov, H.R. 8500 (119th Congress); Discoveries in Health Policy, "H.R. 8500: Ensuring Timely LCDs" (May 2026); Medical Laboratory Observer, "Medicare LCD reform back in focus" (2026); Clinical Laboratory Products Magazine, "Bipartisan Senate Bill Targets Delays in Medicare Local Coverage Determinations" (Sept. 28, 2026); National Law Review, "CMS Rolls Out Revised Local Coverage Determination Process" (Oct. 29, 2018); Noridian Medicare JE, "MolDX LCD Finalized, Effective October 12, 2026"; BioSpace, Bionano Laboratories press release (Sept. 10, 2026).