The Timely Access to Coverage Decisions Act establishes a 60-day review timeline for MACs and mandates stakeholder input on proposed LCDs.
US Senators Ben Ray Luján (D-NM) and Tom Cotton (R-Ark) have introduced the Timely Access to Coverage Decisions Act, bipartisan legislation designed to make the Medicare coverage determination process more predictable, transparent, and rooted in medical evidence.
In the Medicare program, National Coverage Determinations and Local Coverage Determinations (LCDs) dictate whether specific medical services, procedures, and diagnostic technologies are considered reasonable and necessary within a Medicare Administrative Contractor (MAC) jurisdiction. However, the existing system for issuing and revising coverage decisions often leads to prolonged delays and uncertainty for clinical laboratories, healthcare providers, and patients as clinical evidence advances.
Establishing Timelines and Increasing Transparency
The proposed legislation introduces key procedural benchmarks to streamline coverage determinations and expand public participation. Under the bill, MACs would be required to review formal LCD requests and reconsideration requests to determine whether they are complete within 60 days.
To bolster transparency throughout the process, MACs would also be mandated to hold public meetings on proposed LCDs, provide advance notice of meeting agendas, and make all meeting records publicly accessible. In addition, contractor administrators would be required to seek input from an expert panel that includes patients, physicians, and industry stakeholders.
The bill also addresses policy shifts between preliminary and finalized decisions. Final LCDs would have to be a logical outgrowth of the draft LCD, and any updates failing to meet that standard would need to be reissued as a draft LCD before being finalized. The measure also provides for additional oversight by the Centers for Medicare & Medicaid Services following the completion of certain reconsideration requests.
Pathology and Laboratory Community Response
The legislation has garnered support from laboratory and medical specialty organizations, including the College of American Pathologists.
“Patients should not face delays in care because Medicare coverage decisions are developed through processes that lack transparency, consistency, or meaningful stakeholder input,” says Qihui “Jim” Zhai, MD, FCAP, president of the College of American Pathologists, in a release. “Local Coverage Determinations play an important role in ensuring access to medically necessary services, and it is critical that these policies are based on clear evidence and informed by practicing physicians and patients. This legislation represents an important step toward improving the LCD process by strengthening transparency, increasing accountability, and creating more opportunities for stakeholder engagement.”
Lawmakers noted that the current administrative framework has struggled to keep pace with rapid developments in diagnostics and therapeutics.
“Medicare beneficiaries should not have to wait years for cutting edge treatments while medical science and technology advance rapidly,” says Ben Ray Luján, US senator, in a release. “Patients deserve a coverage process that is timely, transparent, and informed by qualified health experts. My Timely Access to Coverage Decisions Act will bring greater accountability and certainty to Medicare coverage decisions so patients can access the care they need without unnecessary delays.”
Support for the measure extends across multiple medical and industry sectors, including endorsements from the ITEM Coalition, the American Podiatric Medical Association, and AdvaMed.
“By setting clear expectations for Local Coverage Determination reviews and strengthening transparency and accountability, the Timely Access to Coverage Decisions Act would help reduce unnecessary delays and make the process more predictable for patients, providers, and innovators,” says Scott Whitaker, president and CEO of AdvaMed, in a release.
