NEW YORK – Labs, patient advocacy groups, and professional societies have weighed in over the past few months on the Centers for Medicare & Medicaid Services' reopened draft national coverage decision addressing coverage for next-generation sequencing panel tests for cancer.
And the verdict is a big thumbs down.
CMS decided to reopen the NCD, originally issued in March 2018, due to overwhelming pressure from stakeholders who felt that the government payors' subsequent interpretation of how the NCD would impact coverage of germline testing would be critically detrimental to cancer patients.
While stakeholders are hopeful that CMS will take a flexible approach and issue a new NCD in the fall addressing their concerns, recent changes within the agency's leadership may hinder timely action, according to one reimbursement expert.
The reaction to the revised language in the NCD was still overwhelmingly negative, with patient advocacy groups, professional associations, and molecular diagnostics companies calling the language too vague, and criticizing CMS for lacking understanding of the different types of genetic testing and when they are used in patient care.
The issue started earlier this year, when Medicare contractor Palmetto revised a local coverage determination limiting coverage for germline NGS tests.
CMS had previously released the NCD related to NGS test panels for guiding treatment for advanced cancer patients, but the wording was vague enough that many believed the national coverage policy was restricted to somatic testing while germline testing wouldn't be affected.
But with Palmetto's new LCD, it became clear that CMS didn't interpret it that way, and germline testing would be impacted along with somatic testing, overriding years of local coverage determinations.
"Previously, anybody who had a cancer diagnosis and met specific criteria that pointed to the possibility of hereditary breast and ovarian cancer syndrome would qualify for the germline testing," said Lisa Schlager, VP of community affairs and public policy at the patient advocacy organization Facing Our Risk of Cancer Empowered.
But Palmetto's LCD was more restrictive, saying it would only cover NGS tests if the patient had late-stage cancer and was seeking additional treatment. It also limited the number of times a patient could be tested.
The LCD specifically stated NGS testing coverage was limited to patients who hadn't been previously tested using the same NGS test for the same primary diagnosis of cancer. Medicare would only cover repeat testing if the cancer diagnosis was new.
After public outcry, CMS decided in April to reopen the comment period on the draft NCD.
Many professionals in the field felt the NCD's limits on the number of tests showed a fundamental misunderstanding of how NGS testing works.
"Evidence shows that it is vital to repeat the same NGS-based test at the time of relapse, in order to compare to any change from baseline results," Roy Silverstein, president of the American Society of Hematology, said in a public comment on the proposal. "These tests help to detect clonal evolution or mutations and have the capacity to change the prognosis and the treatment options available."
Diagnostics companies also chimed in about the clinical usefulness of germline NGS testing, with representatives from Invitae, Roche, and Caris Life Sciences, among others, posting comments on the reopened NCD recommending CMS reverse its decision and leave the decision up to individual contractors.
Invitae emphasized how important germline testing can be when used on early stage cancer patients to figure out next steps for treatment, while Guardant Health addressed the potential limits the NCD could put on diagnostics companies' new ideas.
Helmy Eltoukhy, CEO of Guardant Health, said in its public comment the NCD, as it is currently written, will "unintentionally stifle innovation in a critical area of medical practice and potentially block future patients from accessing life-saving advances in diagnostic technology."
Reimbursement expert Bruce Quinn also mentioned the hindrance to innovation with limiting coverage to only one test per cancer. For companies looking to enter areas such as leukemia or lymphoma monitoring, an NGS test could be used every six months, he said.
"Because it takes years to change an NCD, having noncoverage in place makes innovation harder," Quinn said in an email.
Another issue brought up by patient advocacy groups and laboratory organizations is the potential coverage inconsistencies if the NCD remains the same.
In its public comment on the reopened NCD, the American Clinical Laboratory Association said the broad language was "concerning and confusing."
Among its concerns is how NGS-based testing would be covered if other sequencing methods were still covered, as well.
"MACs could continue to cover a test using Sanger sequencing but not NGS technology, and a patient who is commercially insured would have access to a broader array of NGS-based testing options than an otherwise identically situated Medicare beneficiary," said Julie Khani, president of the ACLA, in the comment.
Further adding to the confusion is the fact that NGS is a technological method used to capture genomic data, not a specific test.
Quinn said that since multiple tests can be done on the platform, limiting the coverage doesn't track.
"If presently covered tests were simply migrated to an NGS platform, it would become noncovered even though it was exactly the same test," said Quinn. "That makes no sense."
Beyond the issues present with limiting germline testing, reopening the NCD's comment period allowed stakeholders to address other concerns about the language of the decision.
Multiple brain cancer advocacy groups, including the National Brain Tumor Society, have noted that brain cancers aren't classified in the same way as solid tumors and have asked CMS to clarify the level of brain cancer progression that would qualify for covered testing.
Brain cancer progression is characterized with grades instead of stages, and there's been confusion over whether Medicare covering NGS testing for "advanced stage" cancers is the same as covering the testing for higher grade brain cancers.
Blood cancer advocacy groups have also raised similar concerns with the NCD's language, since blood cancers are also not staged in the same way as other solid tumors.
Although the new proposal isn't due until October 29, there's been some upheaval at the agency that has caused concern for how much can be done by the deadline.
One of the main CMS staffers working on the NCD, Katherine Szarama, left the agency in July, which Quinn said changes the agency's ability to navigate the proposal, because anyone new who is brought on will need to be brought up to speed on the complex topics of germline testing and NGS technology.
It's unclear the extent to which CMS' final NCD will reflect the numerous concerns from stakeholders, even on the germline testing issue, where there is overwhelming consensus among otherwise disparate groups.
"We had heard some rumors and hearsay that in fact they were going to be more flexible," said Schlager. "But at this point we have not heard what direction it's going to go in."
CMS has a variety of options. They could decide to do full coverage or noncoverage, or they could add specific qualifications, Szarama said last week during a panel discussion at the Next Generation Diagnostic Summit in Washington, DC. Those qualifications could include coverage with evidence development or coverage at each contractor's discretion.
Quinn has some ideas about what they could do to fix the decision. He said he thinks they should create an option allowing multiple tests to be covered based on their FDA labels or on local contractor decisions. He also said the NCD should cover costs for NGS testing for advanced cancer based on their FDA-approved labels, while also being flexible to cover new tests which might not be for advanced cancer or might require repeat testing.
To many stakeholders, CMS may not be grasping the scale of what the NCD would be addressing if both somatic and germline testing were included.
"It is possible that they did not truly understand the implications of the policy that they were publishing," Schlager said.