Dive Brief:

• Sixty-three healthcare companies and organizations are pressing CMS to revise its current interpretation of the national coverage determination (NCD) for next generation sequencing (NGS), saying the approach will restrict patient access to essential clinical tests and adversely affect cancer care and outcomes.
• The groups in a letter to CMS Administrator Seema Verma said the new interpretation reverses previously established policy and implies NGS-based testing will no longer be covered for many Medicare beneficiaries, particularly early-stage cancer patients who may have a genetic predisposition based on family history or other criteria.
• The letter is signed by leading healthcare providers, academic medical centers, patient advocacy groups, industry associations, test manufacturers and laboratories.

Dive Insight:

Clinical studies show that genetic variations in a patient's cancer, along with other factors, can predict how an individual is likely to respond to specific treatments. Laboratory diagnostic tests can use next generation sequencing as a technique for measuring the cancer's genetic variations.

CMS, in its decision memo on the NCD for next generation sequencing, said it determined that the evidence is sufficient to cover lab tests that use NGS under certain conditions. The coverage, effective March 16, 2018, includes testing for beneficiaries with recurrent, relapsed, refractory or metastatic cancer, or advanced stages III or IV cancer if the beneficiary was not tested previously with the same NGS test.

In the letter to Verma, the healthcare groups contend CMS has instructed Medicare administrative contractors to apply the terms of the NCD to certain NGS-based tests that would result in non-coverage for patient with early-stage cancer.

"Our organizations believe that the inclusion of NGS-based testing for germline mutations represents significant policy overreach by CMS that will have unintended consequences on the care delivered to Medicare beneficiaries, particularly those who may have a genetic predisposition to cancer based on a family history or other relevant criteria," the letter states.

Medicare administrative contractors (MACs) previously implemented local coverage determinations that included germline mutations for breast, ovarian and colon cancers, but the NCD reverses those established policies for patients who do not have advanced cancer, the groups said.

"Our organizations urge CMS to revise its current interpretation of the NCD by limiting it to somatic tumor testing and to communicate this change to the MACs," they said.

The groups emphasized that NGS-based testing has become the standard of care for cancer patients.

"Rather than creating additional barriers, we urge CMS to consider the collective comments from this diverse community of health care organizations and reinstate coverage for these medically necessary hereditary cancer tests," Mary Steele Williams, executive director of the Association for Molecular Pathology, said in a separate statement. "Without precision diagnostics, there is no precision medicine."