LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis

A60219

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A60219
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Article Title
Response to Comments: MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis
Article Type
Response to Comments
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07/03/2025
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The comment period for DL39987 MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis Local Coverage Determination (LCD) began on 08/29/2024 and ended on 10/12/2024. The notice period for L39987 begins on 07/03/2025 and will become effective on 08/17/2025.

The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

The following comment was submitted to CGS, Palmetto GBA, WPS:
Thank you for your attention to the important matter of genetic testing for amyloidosis, a diverse group of heritable conditions that can cause sudden death and significant morbidity and mortality. We have read the proposed LCD and encourage approval of this determination.

We suggest to the following changes to this LCD:

1) In the third bullet point under “Coverage Indications, Limitations, and/or Medical Necessity,” change “African American descent” to “African descent.”

2) Add the following ICD-10 codes to “ICD-10-CM Codes that Support Medical Necessity”:

  • 2025 ICD-10-CM Diagnosis Code E85.89: Other amyloidosis
  • 2025 ICD-10-CM Diagnosis Code E85.81: Light chain (AL) amyloidosis
  • 2025 ICD-10-CM Diagnosis Code E85.82: Wild-type transthyretin-related (ATTR) amyloidosis

In addition, we would appreciate clarification on how a clinical diagnosis of ATTR is defined. Does MolDX plan to defer to a patient’s physician’s clinical judgment in making the diagnosis?

We wish to express our sincere gratitude for developing this policy. Genetic testing is essential for diagnosis and treatment of many cardiac conditions including amyloidosis, and Medicare coverage of these tests will be lifesaving.

Thank you for your comments. “African American descent” has been replaced with “African ancestry” in the third bullet. ICD-10 codes that support a diagnosis of hereditary transthyretin amyloidosis are included in the billing and coding article. Clinical diagnoses are made by healthcare professionals, references to expert consensus recommendations can be found in the bibliography.

2

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

Thank you for the opportunity to review and comment on proposed coverage policies for MolDX: Genetic Testing for Heritable Thoracic Aortic Disease and MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis. 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.

We commend MolDX for recognizing the vital importance of the role that molecular testing plays in the identification and treatment of Hereditary Transthyretin Amyloidosis (hATTR) and Heritable Thoracic Aortic Disease (HTAD). Given the level of evidence at this time, the CAP agrees with the coverage parameters outlined in the proposed policies. However, we offer the following recommendation regarding one of the criteria for coverage that is mandated in both policies:

Coverage Indications, Limitations, and/or Medical Necessity

Testing is covered when ALL the following are met:

The test does not include additional genetic content that could be considered harmful to the patient.

CAP recommendation: The current statement does not specify how genetic content that could be considered as harmful to the patient is defined. Further, we question the necessity of this criterion and recommend that Noridian define or provide an example of what is meant by this statement or remove it from these policies.

Thank you again for providing us the opportunity to comment on these proposed policies.
Reference provided for review.

Thank you for your comments. The fifth bullet has been modified to “The test does not include additional genetic content that is not properly validated, or of unclear clinical validity or utility such that it could reasonably or possibly be mis-utilized by the patient or treating physician and result in impaired patient outcomes” for additional clarity.

3

The following comment was submitted to Palmetto GBA:

Thank you for your attention to the important matter of genetic testing for amyloidosis, a (diverse group of) heritable condition(s) that can cause sudden death and significant morbidity and mortality. I have read the proposed LCD in its entirety and find it to be very well written and researched. I encourage approval of this determination. If any changes are to be made, I suggest adding the name “ATTRv” to the “hATTR” as the former is the approved nomenclature per the International Society of Amyloidosis and the latter is used often by pharma and patients as it seems to roll of the tongue easier.

Again, my sincere gratitude for developing this policy. Genetic testing is essential for diagnosis and treatment of many cardiac conditions including aortopathies/amyloidosis, and Medicare coverage of these tests will be lifesaving.

Thank you for your comments. Reference to ATTRv can be found in the background section of the summary of evidence.

4

The following comment was submitted to Palmetto GBA:

I support Medicare coverage for the Molecular testing for Identification and Management of Hereditary Transthyretin Amyloidosis.

Thank you for your comment.

5

The following comment was submitted to Palmetto GBA:

Genetic testing is a crucial part of the diagnostic process for hereditary Amyloidosis. Therefore, it is imperative that it be covered!

Thank you for your comment.

6

The following comment was submitted to WPS:

Thank you for your attention to the important matter of genetic testing for amyloidosis, a heritable condition that can cause significant morbidity and mortality. I have read the proposed LCD in its entirety and find it to be very well written and researched. I encourage approval of this determination.

Again, my sincere gratitude for developing this policy. Genetic testing is essential for diagnosis and treatment of many cardiac conditions including amyloidosis, and Medicare coverage of these tests will be lifesaving.

Thank you for your comment.

7

The following comment was submitted to WPS:

Thank you for considering coverage of genetic testing for cardiac amyloidosis that can cause significant disability and fast progression to death if it is not treated promptly. I am a cardiovascular genetic counselor. The cardiologists I work with and I often order genetic testing for patients with cardiac amyloidosis because of how much it helps their medical care. The proposed LCD clearly explains the need for and value of genetic testing in patients with cardiac amyloidosis. I encourage approval of this determination. Genetic testing is essential for diagnosis and treatment of many cardiovascular conditions like cardiac amyloidosis, and Medicare coverage of these tests will be lifesaving for affected patients and their family members.

Thank you for your comment.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Keywords

  • Hereditary Transthyretin Amyloidosis