MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms Open Public Meeting - September 13, 2024 - JE Part A

Jo Gilbertson
Good afternoon, everyone 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: Non-Next-Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms LCD Number DL39923 for Jurisdiction E and DL39927 for Jurisdiction F.

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

This meeting will be recorded. The meeting and written transcript will be posted on our website following today's meeting. All lines are currently being muted and will remain muted throughout the meeting.

Only those who registered to present will be allowed to comment on the proposed LCD today. However, we did not receive any commenters for this meeting.

All written comments received will be recorded in the Response to Comments article.

I can now turn over this meeting to Dr. Aparna Rajadhyaksha. Dr. Rajadhyaksha, you may begin.

Dr. Aparna Rajadhyaksha
Thank you. I wanted to give some policy information right now and after that, all comments I would appreciate it if you could send it in writing so we could respond.

So, for laboratories performing single gene technologies, a sequential genetic testing approach is expected.

Once a positive result is obtained and the appropriate diagnosis is established, further testing should stop. Reflex testing to the next gene will be considered reasonable and medically necessary if the following sequence of genetic tests produces a negative result.

First, BCR-ABL, if there is a negative test result, progress to the second one, which is JAK2, V67, 617, I apologize.

If that is negative, progress to 3, which is JAK exon 12, which should only be done when polycythemia vera is suspected, or if JAK2 V617 is negative, and essential thrombocythemia or myelofibrosis is suspected consider calreticulin, the CALR gene and MPL.

That, the CALR gene MPL does not require a negative JAK2 exon 12, just a negative JAK2 V617.

Next slide, please.

Genetic testing of the JAK2 V617 mutation is medically necessary when the following criteria are met:

1. Genetic testing impacts medical management: and patient would meet WHO's diagnostic criteria for myeloproliferative disease, that is polycythemia vera, essential thrombocythemia of myelofibrosis, if JAK2 V617F were identified.

Next slide, please.

For JAK2 exon 12 is performed to identify polycythemia vera is medically necessary when the following criteria are met:

• Genetic testing impacts medical management, and;
• Patient would meet WHO's diagnostic criteria for polycythemia vera.

If JAK2 exon 12 were tested and was positive, and JAK2 V617F mutation was previously completed and was negative.

Next slide, please.

The CALR gene: Genetic testing of the CALR gene only found in essential thrombocythemia and myelofibrosis is medically necessary when the following criteria met:

• Genetic testing impacts medical management; and
• JAK2 V617F mutation analysis was previously completed and negative; and
• Patient would meet WHO's criteria for myeloproliferative disease if a clonal marker was identified.

Next slide, please.

The MPL gene is medically necessary when the following criteria are met:

Genetic testing impacts medical management.

JAK2 V617F mutation analysis was previously competed and negative; and patient would meet WHO's criteria for myeloproliferative disease if a clonal marker was identified. 

Next slide

So to note here, in a single-gene sequential approach (not mandated by this policy), CALR would be a higher priority single gene test than MPL because:

• CALR mutations is more prevalent than MPL mutations in essential thrombocythemia and pre myelofibrosis patients; and
• CALR mutations are reported to predict a more indolent disease course than that of patients with JAK 2 mutations.

Next slide, please.

For laboratories performing NGS or hotspot testing platforms: molecular testing for BCR-ABL JAK 2, JAK2 exon 12, and CALR /MPL genes by NGS is covered as medically necessary for the identification of myeloproliferative disorders.

Next slide please.

That's it. Thank you. Closing the next steps.

Jo Gilbertson
Thank you Dr. Rajadhyaksha, this is Jo again. This concludes today's meeting.

Next slide please.

The comment period for this proposed LCD will remain open until September 15th, 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.

Comment information for our proposed MolDX LCDs are located at our website at noridianmedicare.com/moldx. Upon review of the comments, our medical directors will either finalize and post the final LCD or retire the proposed LCD.

Please monitor our website or register for the Listserve notifications to be informed when actions are taken to implement or retire our proposed LCD.

Do you have any final comments, Dr. Rajadhyaksha?

Dr. Rajadhyaksha
No, thank you and thank you for attending.

Jo Gilbertson
Thank you, everyone. This concludes our meeting and have a wonderful day.