FUTURE LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Genetic Testing for Hereditary Thrombophilia A60468

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A60468
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Article Title
Response to Comments: MolDX: Genetic Testing for Hereditary Thrombophilia A60468
Article Type
Response to Comments
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10/12/2026
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The comment period for the MolDX: Genetic Testing for Hereditary Thrombophilia DL40242 Local Coverage Determination (LCD) began on 08/28/2025 and ended on 10/12/2025. The notice period for L40242 begins on 08/27/2026 and will become effective on 10/12/2026.

The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

The following comment was submitted to Palmetto GBA, CGS, Noridian, and WPS:

On behalf of the Association for Molecular Pathology (AMP), we thank you for the opportunity to comment on the draft Local Coverage Determination (dLCD) entitled MolDX: Genetic Testing for Hereditary Thrombophilia.

AMP is an international medical and professional association representing approximately 3,100 physicians, doctoral scientists, and medical laboratory scientists (technologists) who perform or are involved with laboratory testing based on knowledge derived from molecular biology, genetics, and genomics. Membership includes professionals from academic medicine, hospital-based and private clinical laboratories, the government, and the in vitro diagnostics industry. AMP members are highly involved in the development, validation, and interpretation of molecular diagnostic tests, including hereditary thrombophilia testing.

Coverage Indications, Limitations, and/or Medical Necessity

AMP greatly appreciates Palmetto GBA generally proposing favorable coverage of hereditary thrombophilia testing; however, the Criteria for Coverage omits important clinical scenarios in which testing is both reasonable and necessary for the management of venous thromboembolism (VTE). The American Society for Hematology (ASH) has developed robust, evidence-based guidelines outlining when thrombophilia testing is warranted, and AMP requests that Palmetto GBA revise the dLCD to include all of the testing recommendations from ASH.1 Specifically, the final LCD should provide coverage for thrombophilia testing in direct alignment with Table 1, which states that testing should be provided for a number of clinical situations, the situations stated below are the only other ones applicable to the Medicare population.

The Final LCD Should Establish:

Coverage for Asymptomatic Individuals with Family History of VTE

AMP recommends incorporating language into the policy to support testing access for patients with additional VTE risk factors and a known hereditary predisposition. AMP strongly recommends coverage for asymptomatic individuals with a family history of VTE and/or hereditary thrombophilia. In alignment with the ASH guidelines, we urge Palmetto GBA to revise Criterion 1 to explicitly allow coverage for thrombophilia testing in asymptomatic individuals—particularly those with protein C, protein S, or antithrombin deficiencies. Additionally, AMP supports testing individuals with a family history of VTE who are considering Hormone Replacement Therapy.

Testing Access for Cancer Patients with Family History of VTE

AMP also recommends expanding coverage to include patients with cancer who are at low or intermediate risk for VTE but have a first-degree relative with a history of VTE. Family history in these cases represents a clinically meaningful risk factor, and access to testing should not be restricted.

The LCD Should Focus on Clinical Utility Criteria for Coverage

Criterion 4 states that a test should not include additional genetic content that has not been properly validated or has unclear clinical validity. AMP is strongly committed to ensuring that all molecular tests are high-quality, properly validated, clinically appropriate, and meaningfully contribute to patient care. We understand that the MolDX program requires a technical assessment, which is addressed in Criterion 6. We believe that aspects of Criterion 4 are duplication with other federal requirements including those established via the Clinical Laboratory Improvement Amendment program2 Because questions about validation are addressed via the technical assessment process and through other regulatory programs, we respectfully request the removal of Criterion 4 from the dLCD.

Thank you again for the opportunity to review and comment on this draft policy. We are happy to provide additional clinical or other information to assist you as you work towards finalizing the LCD.

References were provided for review.

Sincerely,

Jane S. Gibson, PhD

President, Association for Molecular Pathology

Thank you for your comment.

First, as defined in §1869(f)(2)(B) of the Social Security Act, local coverage determinations (LCDs) are determinations by Medicare administrative contractors (MACs) regarding whether or not a particular item or service is covered on a contractor-wide basis in accordance with the “reasonable and necessary” (R&N) standard in §1862(a)(1)(A) of the Act (i.e., eligible items and services are “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member”). As such, coverage by an LCD cannot extend to populations that do not fit within that framework.

Second, this LCD now covers hereditary thrombophilia testing for patients with cancer who are receiving systemic therapy in the ambulatory setting and who have a low-to-intermediate risk of VTE and a first-degree relative with a history of VTE.

Additionally, while Criterion 4 aligns with other requirements, including those established via the Clinical Laboratory Improvement Amendment program, it remains an essential requirement that merits explicit emphasis as a core coverage criterion.

2

The following comment was submitted to Palmetto GBA:

Thank you for the opportunity to review and comment on the Palmetto MolDX proposed coverage policy for MolDX: Genetic Testing for Hereditary Thrombophilia. As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.

The CAP appreciates Palmetto’s willingness to cover genetic testing for hereditary thrombophilia. Our members have reviewed the proposal and, given the level of evidence at this time, the CAP agrees with the coverage criteria outlined in the proposed policy.

Sincerely,

College of American Pathologists

Thank you for your comment in support of this policy.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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