Advocacy - Comment Letter
Representative Dunn, Representative Barragán, and Representative Tenney:
We’re writing to thank you for your leadership in introducing H.R. 8500, the Timely Access to Coverage Decisions Act of 2026. This legislation would help to ensure that patients have access to medically necessary items and services by making the local coverage determination (LCD) process more predictable and meaningful by providing an open, transparent process and improving the Centers for Medicare and Medicaid Services (CMS) oversight of Medicare Administrative Contractors (MACs) coverage policies.
Medicare coverage policy decisions are made nationally and locally. At the local level, LCDs are developed by MACs who determine whether, and under what circumstances, to cover a particular item or service on a contractor-wide basis.
As a result of contracting reforms that have taken place over the years, MACs are responsible for much larger jurisdictions, often with fewer opportunities for stakeholders to interact with the contractor medical directors who make local medical policies. Additionally, while CMS released revisions in 2018 to Medicare’s Program Integrity Manual (PIM), which outlines the rules governing the development of LCDs, the process continues to lack transparency and sufficient stakeholder involvement to ensure that decisions are made in the best interests of patients.
Codifying key elements of the PIM would strengthen CMS oversight of the LCD process and help ensure greater transparency, consistency, and accountability across MAC jurisdictions.
Considering these challenges, it is imperative to ensure that timely coverage decisions are made by qualified health experts through a transparent process that is based on sound medical evidence. That is why H.R. 8500 is so important. This bill would require Medicare contractors to establish a timely and open process for developing LCDs that includes defined timelines for both initial LCD requests and formal reconsideration, and open public meetings with an agenda provided 14 days in advance. The Timely Access to Coverage Decisions Act would also require that the LCD development process include input by physicians, patient representatives, and industry stakeholders, and a posting of the record of such meetings within 14 days. The MAC would also have to post a record of the open public meeting prior to the end of the comment period, so the public has access to this information. Additionally, to safeguard against procedural and evidentiary errors, stakeholders would have the option to appeal a final LCD to CMS after exhausting a review by the MAC. Finally, the legislation would require the final LCD to be a logical outgrowth of the initial draft LCD.
The undersigned organizations appreciate your leadership and support for this critical legislation in order to ensure patient access to care through a more transparent and accountable process for LCDs.
Sincerely,
AdvaMed
Alliance for Wound Care Stakeholders
American Academy of Neurology
American Association of Clinical Urology
American Academy of Ophthalmology
American Association of Oral and Maxillofacial Surgeons
American Clinical Laboratory Association
American College of Emergency Physicians
American College of Physicians
American College of Radiology
American College of Obstetricians & Gynecologists
American Medical Association
American Occupational Therapy Association
American Podiatric Medical Association
American Society for Clinical Pathology
Association for Clinical Oncology
Association for Diagnostics and Laboratory Medicine
Association for Molecular Pathology
Castle Biosciences
College of American Pathologists
Congress of Neurological Surgeons
National Independent Laboratory Association
New Jersey Association of Mental Health & Addiction Agencies
New York Clinical Laboratory Association
Point of Care Testing Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery Arizona
Society of Pathologists Arkansas
Society of Pathologists Connecticut
Society of Pathologists Illinois
Society of Pathologists Kentucky
Society of Pathologists Michigan
Society of Pathologists Missouri
Society of Pathologists
North Carolina Society of Pathologists
Oklahoma Society of Pathologists