Washington, D.C. – The American Clinical Laboratory Association (ACLA), along with 44 stakeholders, sent a letter to Medicare Administrative Contractors (MACS), Novitas Solutions Medical Affairs and First Coast Service Options, Inc. (FCSO), raising significant concerns with their draft local coverage determinations (LCDs) that, within their jurisdictions, would harm access to clinically appropriate genetic testing for Medicare beneficiaries with cancer. The signatories united in opposition to the draft LCDs include the nation’s leading cancer-related provider groups and patient advocates. The concerns raised by the broad group echoed those detailed in a separate letter ACLA sent to the MACs on the same date.
As it currently stands, the draft LCDs, entitled “Genetic Testing for Oncology,” would automatically deny coverage for any genetic tests not currently included within at least one of three identified third-party “knowledgebases.” ACLA and fellow signatories note that this approach does not comport with the requirements of the Social Security Act and implementing guidance, nor does it give stakeholders sufficient information to evaluate the contractors’ coverage decisions through the required notice-and-comment procedures and process.
Under the draft LCDs, if a genetic test is not included in the “knowledgebases” and non-covered, a provider, organization, or Medicare beneficiary may submit a reconsideration request. However, this process is not transparent, can take years and would delay patient access to testing.
All patients, especially those with cancer, require timely access to diagnostics that inform their treatment. ACLA and stakeholders believe there is broader concern that the draft LCDs’ presumptive non-coverage approach will create additional barriers for Medicare beneficiaries seeking access to newer, and often more innovative, diagnostics.
“Medicare beneficiaries with cancer should have robust and timely access to valuable, appropriate genetic tests used to guide their treatment,” said Susan Van Meter, ACLA President. “We urge Novitas and FCSO not to finalize this LCD as drafted and instead work with stakeholders to address our significant concerns.”
Advanced Practitioner Society for Hematology and Oncology
American Cancer Society Cancer Action Network
American Clinical Laboratory Association
American College of Medical Genetics and Genomics
American Gastroenterological Association
American Society for Clinical Pathology
American Society for Radiation Oncology
Association for Molecular Pathology
Association of Community Cancer Centers
Bladder Cancer Advocacy Network (BCAN)
Blood Profiling Atlas in Cancer (BLOODPAC)
Cancer Support Community
Cancer Support Community Delaware
Cancer Support Community Greater Lehigh Valley
Caregiver Action Network
College of American Pathologists
Community Liver Alliance
FORCE: Facing Our Risk of Cancer Empowered
Free ME from Lung Cancer
GI Cancers Alliance
Gilda’s Club South Florida, Inc.
GO2 for Lung Cancer
ICAN, International Cancer Advocacy Network
Living Beyond Breast Cancer
Lung Cancer Research Foundation
National Alliance of State Prostate Cancer Coalitions
National Marrow Donor Program/Be The Match
National Ovarian Cancer Coalition
Patient Advocates In Research (PAIR)
Patient Empowerment Network
The Clearity Foundation
The Exon 20 Group
The Life Raft Group
The White Ribbon Project
Upstage Lung Cancer
The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.