NEW YORK – In light of public comments to a draft local coverage decision released in September, Medicare Administrative Contractor National Government Services has revised its coverage criteria for next-generation sequencing tests for solid tumors.
In the final decision, released earlier this month, the MAC addresses concerns voiced by industry stakeholders to its draft LCD, and test developers and labs believe that the changes will likely improve reimbursement prospects for comprehensive genomic profiling in the MAC's jurisdiction. The final LCD will go into effect on April 1 in several New England states, New York, Illinois, Wisconsin, and Minnesota, and it outlines the circumstances in which National Government Services will cover NGS tests that assess alterations in more than 50 genes in solid tumors.
The vagueness of the language in the draft LCD made it difficult for stakeholders to discern when National Government Services was proposing to cover large NGS panels, according to diagnostic reimbursement expert and consultant Bruce Quinn. In a post on his Discoveries in Health Policy blog, he wrote that in the first draft, the MAC proposed to cover tests only "when a more limited panel of five to 50 genes is insufficient," without further clarification. This, wrote Quinn, "could have led to a lot of confusion during chart-by-chart audits" to determine whether a five-to-50 gene panel had been ordered and proved insufficient.
National Government Services has now clarified that "annoyingly vague" draft LCD language about what exactly it will cover, Quinn explained in an interview, and specified that large NGS panels will be covered for advanced cancer patients who have not been tested for the same genes and are seeking further treatment. Covered tests will be those that detect genes and genomic positions listed in Category 1 or 2A of the most current version of the National Comprehensive Cancer Network's Biomarkers Compendium.
Since the Centers for Medicare & Medicaid Services released its national coverage determination for NGS tests for advanced cancer patients in 2018, Quinn has noted improvements in cancer patients' access to comprehensive genomic profiling. That determination specifically extended national coverage for NGS tests that have been approved by the US Food and Drug Administration as companion diagnostics but left it up to the MACs to develop policies covering laboratory-developed NGS cancer tests without the agency's approval or clearance.
As such, coverage for NGS tests that fall in this latter category continues to vary depending on the MAC jurisdiction that the lab performing testing is in, Quinn said. For example, labs performing NGS profiling in nearly 30 states are covered by policies promulgated within the MolDx program, which are overseen by four MACs: Palmetto, Noridian, CGS, and Wisconsin Physicians Services.
MolDx has relatively broad coverage criteria for NGS profiling, but National Government Services has been more "conservative." In Quinn's view, this variation in local coverage actually drove more testing to labs in the more coverage-permissive MAC jurisdictions, and other MACs lacked the pressure to make any changes. Although Quinn said he doesn't know for sure what ultimately moved National Government Services to issue coverage criteria for NGS cancer testing, he assumes ongoing complaints and recommendations from academic and research labs played a part in the new decision.
Under the revised, final LCD, National Government Services will cover not only comprehensive genomic profiling tests that gauge genetic variants, such as single nucleotide variants, insertions/deletions, copy number alterations, structural variants, and splice-site variants, but also patterns of mutations like DNA mismatch repair deficiency, microsatellite instability, and total mutational burden. The MAC has also agreed to cover RNA sequencing to detect structural rearrangements, such as fusions/translocations, and functional splicing mutations.
Joe Lennerz, medical director at Massachusetts General Hospital's Center for Integrated Diagnostics, said that the final version is "appropriately broad" and that a wide group of patients can benefit from the decision. The inclusion of RNA sequencing-based detection of structural rearrangements is "highly progressive," he added.
A more streamlined path
Stakeholders who closely read National Government Services' draft LCD, like Robert Dumanois, director of reimbursement strategy at Thermo Fisher Scientific — a firm that has its NGS test kits installed in numerous hospital and cancer center labs — said that while the original decision was a "heck of a step in the right direction," there was confusion and backlash about what kind of regulatory approval a test needed for coverage.
The draft LCD required a test to have either FDA approval or analytical validation data published in multiple peer-reviewed studies, which could be difficult for labs developing their own tests. The final version has reduced the publication requirement from multiple studies to just one and added a third criteria under which a test may be covered: certification by a third party that the lab meets the New York State Department of Health's Clinical Laboratory Evaluation Program review standards.
That third option "makes it much easier" for tests to be covered under this LCD, Dumanois said, and provides three different pathways for labs to take. For NGS test developers and labs, the coverage decision is a welcome expansion from the CMS NCD, which requires a test to be FDA approved and have a CDx claim. Meeting that bar requires significant time, money, and paperwork, Dumanois said, adding that in contrast, the National Government Services' LCD "affords the ability to get tests covered on a far more routine basis."
"We hope this allows comprehensive genomic profiling to expand dramatically in labs and with providers," Dumanois said.
The additional NYSDOH accreditation pathway is significantly different than what the MolDx program requires, Lennerz noted. Palmetto GBA, the MAC that initiates coverage through the MolDx program, does its own additional quality assessment of diagnostic tests it is considering for coverage, which, in Lennerz's view, makes the submission process through National Government Services more "streamlined."
National Government Services' standards for NGS test coverage aren't any easier to meet than Palmetto's, Lennerz clarified, but it does require one less administrative step, which can mean it takes less time and effort to reach a coverage decision.
Eric Loo, a pathologist at Dartmouth-Hitchcock Medical Center in New Hampshire whose lab is under National Government Services' jurisdiction, said that the original LCD was "quite restrictive," but noted that the final decision has changed "mostly favorably."
The requirement in the draft that tests have either FDA approval or supporting data published in a peer-reviewed journal was an "impediment" to access, in Loo's view, particularly if a test is limited to one lab and developed in house, like the 170-gene solid tumor panel his lab runs. Furthermore, it's difficult for labs to validate and commercialize their tests, so the additional certification pathway is a much needed source of relief, he noted.
In comments to the draft LCD, laboratorians had also wondered if National Government Services would stop covering tests if labs changed panels to reflect updates to NCCN's biomarker testing guidelines. Dumanois noted that the final LCD offers "some flexibility" to make adjustments to panels as NCCN guidelines evolve. "One challenge with this category of testing is that the only thing you can guarantee is that the guidelines will change," he said.
Overall, Loo said the new policy will help labs like his "get paid for our services." Before the decision, his lab was getting requests for NGS testing but wasn't getting paid to perform them. "Clinical staff really need these tests" to inform the care of cancer patients, he said.
Loo, Lennerz, and Dumanois all noted that the policy excludes other cancer-related uses of NGS testing, including liquid biopsy, but Lennerz said that this LCD is not a "one-stop shop" and that solid tumor and hematology have different reimbursement schemes. Loo is optimistic that more circulating tumor DNA tests will be covered in the future.
'The government did the right thing'
Some industry stakeholders are hopeful that National Government Services' LCD forecasts broader acceptance of comprehensive genomic profiling, both within other Medicare contractors and among commercial payors. MGH's Lennerz believes this LCD is a "clear signal that comprehensive genotyping should be the standard of care" for advanced cancer patients. In this case, "the government did the right thing," he added.
Although coverage for NGS panels varies among commercial payors, they are undoubtedly keeping a close watch on the activities of MACs. Lennerz is hopeful that permissive coverage from MACs could positively influence commercial payors to more readily cover comprehensive genomic profiling as a part of standard cancer care.
Dumanois was less optimistic about how this LCD might influence commercial payors. National Government Services' LCD "doesn't necessarily change the way commercial payors will react" because it's "harder to assume" those payors will follow CMS, he said. Although he is "seeing progress" toward covering comprehensive genomic profiling in the private insurance arena, that "evolution is moving slower than any of us want," he said.