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CMS to Revisit National Coverage Determination on NGS Tumor Testing

WASHINGTON, DC (GenomeWeb) – The Centers for Medicare & Medicaid Services will reopen a national coverage determination on next-generation sequencing panels to address the healthcare community's concerns about the negative impact the current policy would have on patients' ability to access genetic testing to learn their risk for cancer.  

While the announcement pleased labs and patient advocates that had been urging CMS to clear up this confusion, reopening the NCD also offers stakeholders another chance to try to narrow or broaden the national coverage terms for NGS tumor panels.

At the start of this year, Medicare contractor Palmetto GBA raised concerns among genetic testing labs and cancer patient advocates when it revised a local coverage determination (LCD) for BRCA1 and BRCA2 genetic testing to restrict coverage for NGS panels when performed in individuals with early-stage disease. Palmetto's revision came at CMS' direction to align the terms of the LCD with an NCD it issued a year ago for next-generation sequencing for advanced cancer patients.

Based on the language in the NCD, however, stakeholders thought the policy was restricted to when NGS panels were used to detect somatic mutations driving patients' cancer and to predict which drugs they would best respond to. BRCA testing can be used to direct treatment of PARP inhibitors in advanced cancer patients.

However, this type of testing is most readily performed to detect germline mutations in BRCA1/2 and gauge risk of breast and ovarian cancer. Medicare contractors historically have covered such tests for patients who already had cancer but didn't limit testing depending on cancer stage. Knowledge of one's genetic risk for cancer is most useful for guiding prevention strategies if this information is known earlier in the disease trajectory.

Sixty organizations and groups from all sectors of the healthcare community wrote to CMS to express their concerns, and many patient and industry groups met directly with the government payor to point out the flawed logic of this policy. At the American Clinical Laboratory Association's annual meeting here today, Tamara Syrek Jensen, director of CMS' coverage and analysis group, acknowledged that CMS' decision to reopen the NCD was influenced by numerous stakeholder groups, including ACLA, that had conveyed their concerns about applying the coverage terms for somatic NGS testing in late-stage patients to germline testing in early-stage patients.

Stakeholders argued that germline testing for early-stage cancer patients "didn't fall within the four corners of the national coverage determination," Jensen said. "We took that in and talked about that extensively in house, we talked to our lawyers, and we decided we're going to reopen this NCD."

Attendees at ACLA's annual meeting applauded Jensen's announcement. The policy, if allowed to stand, would have impacted patients' access to NGS panels for cancer risk, but it would have also been disruptive to the genetic testing industry, which in recent years has largely moved away from older technologies, such as Sanger sequencing, and transitioned to NGS for cancer risk assessments.  

Lisa Schlager, VP of public policy at the advocacy organization Facing Our Risk of Cancer Empowered, wasn't at the meeting, but commended CMS for revisiting the NCD to address stakeholders' concerns. FORCE was one of the groups that met with CMS to explain that the agency's policy would significantly hinder patients' access to genetic testing for hereditary cancer syndromes, impact their surgical and treatment decisions related to cancer prevention, and hinder their family members from learning their risk of harboring the same mutations.

"Germline testing and tumor testing are not one in the same. They cannot be lumped together under one set of coverage guidelines without differentiation," Schlager said. "It's crucial that Medicare beneficiaries with all stages of cancer have access to testing for hereditary mutations and we hope that germline testing is extracted from the policy, allowing local coverage determinations to stay."

CMS recently extended the implementation date for the revised LCD on BRCA testing from March 6 to April 8, but hasn't yet determined when it will reopen the NCD. "I don't have an exact date," Jensen said. "But it won't be months down the road. It will be done quickly."

In the meantime, however, the agency doesn't plan on stopping implementation of the revised LCD on BRCA testing. "When we do reopen this, [we will] engage early and engage often so we can have that conversation," she told the audience. "When the NCD comes out let's talk so everyone understands what we think is within the four corners of that national coverage determination, so when the final comes out, I hope there won't be any confusion or surprises."

She acknowledged that while the lab community and CMS may not always agree on all issues, CMS welcomes the opportunity to learn from stakeholders. "One of the biggest lessons for me is we need to communicate better to make sure you understand, and we understand, all the issues in the NCD, and you understand our intention when we wrote that coverage determination," she said.

The NCD was triggered by Foundation Medicine's bid for parallel review from the US Food and Drug Administration and CMS for FoundationOne CDx, a test that gauges somatic variants in 324 genes from tumor tissue samples and guides treatment decisions based on the results. In granting national coverage, CMS extended a policy that covered not just Foundation's test but similar FDA-approved NGS companion diagnostics. Foundation has been effusive about the fact that the NCD extends coverage for FoundationOne CDx in all solid tumors, not just the FDA-approved CDx indications.

There were more than 300 comments to the draft NCD, mostly supporting broad coverage of NGS tumor testing to personalize cancer treatment decisions, but reimbursement experts also pointed out several problematic areas. For example, there were concerns that if the NCD allowed coverage for NGS panels in all solid tumors, not just the FDA approved CDx indications, then this opens up the risk of driving off-label treatment use in unproven indications. There are outstanding questions about how CMS would instruct MACs to handle coverage for off-label drugs based on NGS testing.

In the final NCD, CMS deleted provisions it had proposed in the draft version that would have allowed coverage with evidence development to assess the utility of NGS in various cancer indications. Many stakeholders thought this omission was appropriate since it would have been too costly to implement while others lamented it as a missed opportunity. Once the NCD is reopened, members of the public are free to raise these points again to try to broaden or narrow the terms of the NCD.

"Our intent was not to reopen the NCD as the coverage of tumor testing appears to be well-founded," said Schlager. "However, national coverage determinations need to take current clinical practice into account."

Following CMS' finalization of the NCD a year ago, Foundation Medicine, which is owned by Roche, had highlighted in a statement that FoundationOne CDx is the only NGS assay to meet the terms of national coverage. A spokesperson for Foundation Medicine, which is owned by Roche, said that the company was not aware of the details of CMS' decision to reopen the NCD. "Foundation Medicine supports coverage of germline testing and other innovations for patients with early-stage disease as a critical part of cancer care," the spokesperson said.