MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis and MolDX: Genetic Testing for Heritable Thoracic Aortic Disease Open Public Meeting - October 10, 2024 - JE Part B

Jo Gilbertson
Good afternoon and welcome to Noridian's open public meeting. My name is Jo Gilbertson and I am one of the Medical Policy Specialists here at Noridian Healthcare Solutions. We will be presenting the following LCD. MolDX Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis. LCD number DL39948 for JE and DL39950 for JF and MolDX Genetic Testing for Hereditable Thoracic Aortic Disease LCD, DL39944 for JE and DL39946 for JF.

Before we begin the meeting, I'd like to make the following announcements.

This meeting will be recorded. Recording and written transcripts will be posted to our website following today's meeting. All lines are currently being muted and will remain muted throughout the meeting. Only those registered to present will be allowed to comment on the proposed LCD today, however, we do not have any commenters on these policies.

All written comments received will be recorded in the Response To Comments article. Next slide, please.

I will now turn this meeting over to Dr. Aparna Rajadhyaksha. You may begin.

Dr. Aparna Rajadhyaksha
Thank you. Next slide, please.

So I wanted to give you a little bit of information on this policy and the basis for it. So this policy is on Transthyretin Amyloidosis.

This is a protein which is destabilized, leading to monomers, and these form amyloid fibrils.

These fibrils are deposited in certain organs, including the heart, eyes, digestive tract, nervous system, and kidneys.

There are two types of Transthyretin Amyloidosis.

The first is the hereditary form, also referred to as variant form, caused by mutations or pathogenic variants in the TTR gene, and this is inherited in an autosomal dominant manner.

This is usually deposited in the cardiovascular system and in the peripheral nervous system.

Then there is a sporadic non-genetic form called the wild type.

Where also called wtATTR, and here the amyloid fibrils are deposited almost entirely in the myocardium, resulting in ATTR cardiomyopathy.

Next slide, please.

Okay, so when is this covered?

The contractor will cover molecular diagnostic tests for use and evaluation and management of beneficiaries suspected of having hereditary transthyretin amyloidosis when all of the following criteria are met.

The patient has a clinical diagnosis of ATTR or has a family history of ATTR or has cardiac features suggestive of ATTR cardiomyopathy or has progressive sensory motor and/or autonomic neuropathy and has one or more additional features suggestive of hereditary ATTR according to expert consensus and society guidelines.

Next slide, please.

Okay.

The patient has been appropriate counseled regarding the tests and potential results.

The results of the test will be used to aid in treatment decision.

The test performed includes at least the minimum genetic content with definitive or well-established guidelines based evidence required for clinical decision-making for its intended use that can be reasonably detected by the test.

The patient has not been tested with the same or similar assay.

If a previous test was performed with similar duplicative genetic content, a subsequent test is only reasonable and necessary if the non-duplicative content of the second test is reasonable and medically necessary.

A single variant may be tested if it is the only variant considered to be reasonable and necessary for the patient, given that it is a known familial variant.

The test has successfully completed a technical assessment that ensures the test is reasonable and necessary as described above.

Next slide, please.

I will hand this over back to Jo Gilbertson for closing and next steps.

Thank you.

Jo Gilbertson
Thank you, Dr. Rajadhyaksha.

In closing, we would like to communicate the next steps in the policy development process.

Next slide, please.

The comment period for the proposed LCD will remain open until October 12, 2024. As noted earlier, all comments to be considered by our Medical Directors for the proposed LCD must be submitted in writing. Written comments can be emailed to policydraft@noridian.com or mailed to the address on your screen. Common information for our proposed LCDs are located on our website at noridianmedicare.com/moldx.

Upon review of these comments, our Medical Directors will either finalize and post the final LCD or retire the Proposed LCD. Please monitor our website or register for Listserv notifications to be informed when actions are taken to implement or retire our proposed LCDs.

Dr. Aparna, do you have any final comments?

Dr. Aparna Rajadhyaksha
No, thank you. We look forward to your comments if you have any in writing and will accordingly respond. Thank you.

Jo Gilbertson
This concludes our meeting for today. Have a great rest of your day.