Multiple MolDX LCDs Open Public Meeting - October 8, 2025 - JF 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 at Noridian Healthcare Solutions.

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Noridian is presenting the following three LCDs.

Non-Next Generation Sequencing Targeting Molecular Panel Tests for Predictive Testing in Cancer. Jurisdiction E: DL40222/JF is DL4022.

We are also presenting on MolDX: Genetic Testing for Hereditary Thrombophilia, Jurisdiction E and Jurisdiction F, DL40242.

And our last one is MolDX: Biomarker Testing for Risk Stratification in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis, Jurisdiction E, DL40197, and JF is also the same, DL40197.

Before we begin the meeting, I would like to make the following announcement.

The meeting will be recorded.

The recording 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 LCDs today.

If closed captions are needed, please click the closed caption icon on the bottom right-hand corner of your screen. Presenters today, you are being allotted 10 minutes to make comments. Your line will be open when it is your turn to speak. Make sure you're not on mute within your system, or we will not be able to hear your comments.

You should be prepared to begin your comments immediately when called upon, and you will hear the moderator's voice when one-minute remains.

If you reach the end of your 10-minute time limit, your line will be muted, and we will move on to another speaker to allow all registered commenters time for their presentations.

Please speak clearly to ensure that the system will be able to translate into captions for display.

By signing in today, you are giving consent to the use of your recorded voice and your comments.

Please be mindful of sharing any personal health information during your presentation.

In addition to comments that are made today, all comments should be submitted in writing.

All written comments received will be reviewed by CMDs and recorded in the Response to Comment article.

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

Dr. Aparna Rajadhyaksha:

Thank you, Jo. Next slide, please.

So, our first policy is MolDX: Non-Next-Generation Sequencing Targeted Molecular Panel Tests for Predictive Tests in Cancer.

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So, the coverage guidance, the policy describes and clarifies coverage for molecular or proteomic panel tests for Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer.

The determination outlines the medical necessity indications, limitations, and required documentation for biomarker testing to ensure appropriate patient selection and effective utilization.

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This is a little small for me to read, so is there a way to make this bigger?

Krista Babbitt:

I can't make it any bigger.

Dr. Aparna Rajadhyaksha:

All right, no worries. What I will do then is continue.

The Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer are covered when all of the following are met.

The patient has a diagnosis of cancer for which molecular testing of the tumor will inform treatment.

At least one of the following is true.

Testing by non-next-generation sequencing is not feasible or will likely fail based on specimen type or tumor content.

NGS is not required by national consensus guideline to inform medical management decisions.

And testing by a non-NGS method will provide a rapid result that allows for the prompt and timely management of the patient.

The testing accurately identifies known, common, and necessary predictive and actionable biomarkers that can safely preclude unnecessary NGS testing, reducing NGS use in patients for whom the treatment plan would not be likely altered.

The patient has not been previously tested by a molecular panel test for the same cancer indication for the same genetic content.

No. A negative result, no clinically actionable mutations found by the non-NGS test may be followed by an NGS test that includes additional necessary non-duplicative genes and genomic positions.

The test accurately detects the most common genes and genomic positions required for identification of clinically relevant FDA-approved therapies with a companion diagnostic biomarker for the given cancer type.

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The test has been validated in the intended use population within the intended use sample types.

The test demonstrates accuracy for measured analytes comparable to NGS testing with superior turnaround times less than the ASCO recommended 10 business days from sample acquisition.

The test has satisfactorily completed TA, technical assessment, by the Molecular Diagnostic Services program to ensure analytical validity, clinical validity, and clinical utility standards are met.

Clinical validity of any analyte or profiles must be established through a study published in peer-reviewed literature for the intended use of the test in the intended population, which demonstrated reproducibility across clinical study cohorts.

If the test relies on an algorithm, the algorithm must be validated in the cohort that is not a development cohort for the algorithm.

Test utilizing a similar methodology, evaluating a similar analyte to a test for which existing coverage has been established must demonstrate equivalent or superior test performance, that is sensitivity and or specificity when used for the same indication in the same intended population.

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Note: Reference specific tests in the LCD does not automatically imply coverage, and the NGS-based panel tests must fulfill criteria outlined in the LCDs of MolDX Next-Generation Sequencing in Solid Tumors and MolDX Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies.

In addition, non-NGS-based tests for the diagnosis of BCR-ABL negative myeloproliferative neoplasms must fulfill criteria outlined in the MolDX Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms.

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All right. At this point, I would like to ask Meghan Lawson to make her comments, please.

Meghan Lawson:

Hi, this is Meghan. Can you hear me okay?

Dr. Aparna Rajadhyaksha:

Yes. Loud and clear.

Meghan Lawson:

Thank you so much. So hello, my name is Meghan Lawson.

I'm the Director of Market Access and Reimbursement at Biocartis.

We appreciate the opportunity to provide comments on the draft LCD Non-Next Generation Sequencing Targeted Molecular Panel Tests for Predictive Testing in Cancer. My comments today will also be submitted via written comment following the meeting.

We believe this draft LCD is critical to providing the best patient care.

Non-NGS molecular biomarker panels can provide results much faster than next-generation sequencing panels, allowing for physicians to have the critical information needed for treatment determination.

This gives patients the ability to be started on the appropriate treatment sooner, as well as decreases the chance that the patient will deteriorate past the point where treatment can be given.

It is our thought that non-NGS molecular biomarker tests and NGS complement each other.

The non-NGS molecular biomarker tests allow for fast critical results while NGS allows for more comprehensive results.

Because of this synergy between non-NGS molecular biomarker tests and NGS, we request that the LCD be revised to remove the word non-duplicative from criteria three.

This criteria states that an NGS panel can be done following a non-NGS molecular biomarker test if the NGS panel does not contain duplicative genes and genomic positions.

We understand the intention to prevent unnecessary duplicative testing.

However, the inclusion of the same genes and genomic positions is not duplicative as the NGS panel could detect low prevalence and rare mutations of the genes and genomic positions.

Additionally, due to test design, it may not be possible for labs to remove the duplicative genes and genomic positions from the NGS panel.

Some NGS panels are FDA cleared slash approved, which means for labs to utilize them on label, they cannot alter the content.

The removal of the duplicative genes and genomic positions, if possible, would potentially require new validation and additional work for the lab as well.

The deletion of the word non-duplicative from criteria 3 is needed to prevent non-NGS molecular biomarker tests from not being utilized to preserve reimbursement of the NGS panel.

As we consider the genes and genomic positions that receive coverage through the LCD, we recommend the removal of criteria 4 from the LCD.

This criteria states the test accurately detects the most common genes and genomic positions required for the identification of clinically relevant FDA-approved therapies with a companion diagnostic biomarker for the given cancer type.

By removing this criterion, it allows for the LCD to potentially provide coverage of critical biomarker tests that could be utilized in upcoming disease states that may not currently be associated with a companion diagnostic.

Additionally, non-NGS molecular biomarker tests are used to appropriately classify patients into different subgroups to determine the best treatment pathways, but these biomarkers are not always linked to a specific treatment.

An example would be for endometrial cancer, where guidelines recommend testing for POLI, but this biomarker does not currently have an associated companion treatment.

To ensure Medicare patients have access to novel care without delay, non-NGS molecular biomarker tests should not be limited to biomarkers associated with companion treatments.

The LCD ensures the biomarkers being tested are medically necessary as criteria two C states the biomarkers need to identify known, common and necessary predictive markers.

And additionally in criteria eight states the clinical validity of any analyzer profiles must be established through a study published in peer-reviewed literature for the intended use of the test and in the intended population.

These criteria address the need for the biomarkers to be medically necessary.

For these reasons, we request that criteria four be deleted from the LCD.

Without this LCD, patients may not receive appropriate treatment in the needed timeframe.

Due to the value this LCD provides to patients, we want to ensure that the criteria are not cumbersome, preventing the adoption of non-NGS molecular biomarker tests.

To ensure this, we suggest the consolidation of criteria six and nine.

These criteria both address the needed performance of the non-NGS molecular biomarker test, but by different comparator methods.

The current reading of the LCD could be interpreted that the non-NGS molecular biomarker test needs to have performance data against both NGS and a similar methodology.

To prevent duplication of performance needs and prevent confusion, we suggest combining these criteria and adding an OR to clarify that the test does not need multiple validation methods to be covered under the LCD.

We thank you for the opportunity to provide comments today and are happy to answer any questions or provide any additional information after the call.

Dr. Aparna Rajadhyaksha:

Thank you for your comments, Meghan.

Please do make sure that you submit your comments in writing so we can address them appropriately. We will now move on to the next LCD since we have no other speakers.

Next slide, please.

Jo Gilbertson:

Aparna, I think you put yourself on mute.

Dr. Aparna Rajadhyaksha:

I'm sorry. My bad.

The next one would be, the next LCD would be MolDX Biomarker Testing for Stratification in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis.

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Right. This policy describes coverage for molecular or proteomic biomarker tests for the diagnosis and management of liver fibrosis in the setting of metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis.

In accordance with American Association for the Study of Liver Disease Guidance, the term MASLD will be used as a replacement for non-alcoholic fatty liver disease and NASH as a replacement for non-alcoholic steatohepatitis.

As comparisons have found, a near-complete overlap between the recently defined MASLD population and the historical NAFLD population results from biomarker validation studies among patients with NAFLD, NAS would be considered applicable to patients with MASLD/NASH.

Other types of chronic liver disease include, but not limited to, metabolic dysfunction and alcoholic associated liver disease, alcohol associated liver disease, viral hepatitis and autoimmune hepatitis are considered separate entities with distinct etiologies, natural histories and management and are therefore not encompassed under this policy.

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The criteria for coverage include the patient is an adult with clinical suspicion or diagnosis of MASLD or NASH based on current professional society guidelines, a primary risk assessment based on non-molecular proteomic lab testing as outlined by consensus guidelines does not indicate low risk. Liver stiffness measurements by imaging, magnetic resonance elastography is indeterminate or not performed.

The results of the test will be used to directly aid in pending management decisions, such as referral to a specialist, performance of a liver biopsy, and eligibility for pharmacological therapy, as documented in the patient's medical record.

Testing is not performed for more than once within a 12-month period, nor within 12 months following a liver biopsy.

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Clinical validity of any analytes or profiles must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population with demonstrated reproducibility across clinical study cohorts.

If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm.

The test has satisfactorily completed a technical assessment by the MolDX program.

Molecular and proteomic tests utilizing a similar methodology, evaluating similar analytes as a test for which existing coverage has been established must demonstrate equivalent or superior test performance that is sensitivity and or specificity when used for the same indication in the same intended use population.

New tests that become available with significantly improved performance may render old tests no longer compliant with this policy.

At this time, there are no comments for this policy.

I will go on to the third LCD that is up for comment, which is Genetic Testing for Hereditary Thrombophilia.

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The coverage guidance, this policy defines coverage for LDTs, or lab-developed tests, FDA-cleared and FDA-approved clinical lab tests for hereditary thrombophilia, including NGS tests.

The policy scope is specific for hereditary germline testing.

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Criteria for coverage.

Genetic testing for hereditary thrombophilia is covered when all of the following are met.

One, the patient presents with venous thromboembolism and at least one of the following is true.

The patient presents with venous thromboembolism that is associated with non-surgical major transient or hormonal risk factors as defined by ASH guidelines.

The patient presents with cerebral or splanchnic venous thrombosis in settings where short-term primary treatment is a standard of care, such as settings where anticoagulation will otherwise be discontinued and testing will inform the decision for long-term anticoagulation.

Genetic testing will guide venous thromboembolism clinical management, example, duration of anticoagulation.

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

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

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The test does not include additional genetic content that is not properly validated or of unclear clinical validity or utility, such as there could be reasonable expectation of misutilization by the patient or treating physician, resulting in impaired patient outcomes.

The testing does not conflict with other applicable policies, specifically provisions of repeat germline testing, as defined in LCDs L38351 and L38353.

The test has satisfactorily completed a TA by the MolDX program.

At this point, I will turn the presentation back over to Jo Gilbertson for closing and next steps.

Thank you.

Jo Gilbertson:

Thank you, Dr. Rajadhyaksha.

Next slide, please.

The comment period for the proposed LCDs will remain open until October 12, 2025. All comments to be considered by our medical directors for the proposed LCDs 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 LCD is located on our website at noridianmedicare.com.

Upon review of the comments, our medical directors will either finalize or retire the proposed LCD.

Responses to comments will be viewable in the Response to Comment article.

Please monitor our website or register for listserv notifications to be informed of actions taken on our proposed LCDs.

Again, all comments to be considered by our medical directors for the proposed LCD must be submitted in writing.

Dr. Rajadhyaksha, do you have anything else would like to say before we end this meeting?

Dr. Aparna Rajadhyaksha:

No, thank you.

Jo Gilbertson:

This concludes our meeting for today. Thank you for attending the Noridian Open Public Meeting.