Palmetto GBA’s MolDX Announces MRD Testing Coverage

The ruling will provide Medicare coverage testing for minimal residual illness (MRD) from December 26, 2021.

In an important advance for precision medicine, Medicare Palmetto GBA’s administrative contractor, through its Molecular Diagnostic Program (MolDX), recently finalized a Local Coverage Determination (LCD) for residual disease testing minimum (MRD)1. Following the publication of a draft policy in September 2020, the final MRD testing LCD screen was announced on November 11, 2021.

The decision, which takes effect on December 26, 2021, covers Adaptive Biotechnologies’ clonoSEQ test to detect an MRD monitor for patients with acute B-cell lymphoblastic leukemia, multiple myeloma and chronic lymphocytic leukemia. The LCD screen also creates a channel for the use of clonoSEQ in other indications.2

The LCD screen also covers Natera’s Signatera test for several indications involving patients with solid and hematopoietic cancers.3 Adaptive and Natera announced the LCD in separate press releases.2.3

In its opinion, MolDX cited National Coverage Determination (NCD) 90.2, which “allows entrepreneurs to cover next-generation sequencing tests as a diagnostic laboratory test for cancer patients under specific circumstances. “. MolDX has described 10 specific conditions that must be met for MRD testing to be covered; conditions include:

  • The patient should have a personal history of cancer of a type and stage consistent with the intended use of the MRD test.
  • Use of the test should be in accordance with National Comprehensive Cancer Network (NCCN) guidelines, “or other guidelines established as a condition requiring definitive change in patient management.”
  • The test can “identify recurrence or molecular progression” before signs of progression are present.
  • The test should demonstrate “a sensitivity and specificity of recurrence or subsequent progression” that is comparable to radiological or other evidence.

As a relatively new application of new genomic technologies, MRD assays have been highly regarded for their sensitivity and specificity in allowing the detection of extremely diluted tumor material or the monitoring of the relative increase or decrease in deposited tumor material. in the blood.

Specifically, MRD tests can be used to diagnose cancer progression, recurrence, or relapse before there is clinical, laboratory, or radiographic evidence of progression, recurrence, or relapse, as well as to detect cancer. tumor response to treatment by measuring proportional changes in the amount of tumor DNA available.

“Both of the above uses may allow physicians to better assign risk stratification, deploy alternative treatment strategies, or prevent the use of unnecessary adjuvant therapies,” the statement from MolDX said.1

Several limitations were also identified for MRD testing, including the mismatch of mutations between ctDNA and tissue, the possibility of ctDNA enrichment with alterations in treatment resistance, and the inability to detect a second ctDNA. primary tumor.

“We are delighted that MolDX has finalized the LCD display for Next Generation Sequencing Assays (NGS) for MRM, thereby increasing patient access to the critical results provided by our clonoSEQ test across the continuum of care.” said Lance Baldo, MD, medical director of Adaptive Biotechnologies. “This LCD screen paves the way for the continued expansion of clonoSEQ into routine clinical care to benefit more than 700,000 patients living with lymphoid malignancies in the United States. We look forward to continuing our work with Medicare to help evolve coverage in this rapidly evolving area. “2

“Monitoring cDNA kinetics with Signatera can identify treatment non-responders earlier than imaging alone, and independent of other biomarkers, including PD-L1 and tumor mutational burden (TMB),” said Solomon Moshkevich, general manager of oncology for Natera, in a statement. “We look forward to working with Medicare and the oncology community to make personalized monitoring and assessment of MRD accessible to cancer patients of all tumor types. “3

The references

1. MolDX: Minimal residual disease test for cancer. Press release. CMS. Published online November 11, 2021. Accessed November 19, 2021.

2. Adaptive Biotechnologies is benefiting from updated health insurance coverage for its minimal residual disease test (MRD), clonoSEQ® for patients with blood cancer. Press release. Adaptive biotechnologies. Published online November 11, 2021. Accessed November 19, 2021.

3, Medicare Releases Final Determination of Local Coverage for Pan-Cancer Immunotherapy Surveillance with Natera’s Signatera â„¢ MRD Test. Press release. Natera. Published online November 11, 2021. Accessed November 19, 2021.

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