CMS Releases National Coverage Determination on Next Generation Sequencing

CMS just released a National Coverage Determination (NCD) entitled, Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer ASH, along with over 300 other groups including physician specialty societies, patient advocacy groups, and industry groups, submitted comments on the proposal. In response to this advocacy, CMS significantly revised the policy removing both the coverage with evidence development requirements and non-coverage portions of the proposal. These revisions represent a significant victory for stakeholders who were concerned that the proposal would drastically limit patient access to NGS-based testing.

The final policy will allow local Medicare Administrative Contractors to continue to provide coverage for NGS-based tests that are not automatically covered by the NCD. Several local coverage determinations that provide coverage for hematological malignancies will now remain in effect.

CMS expanded the coverage portion of the policy as well. NGS-based tests will be covered under the NCD when the following requirements are met:

• The patient has a) either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and b) either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and c) decided to seek further cancer treatment.
• The diagnostic laboratory test using NGS must have a) FDA approval or clearance as a companion in vitro diagnostic; b) an FDA approved or cleared indication for use in that patient’s cancer; and c) results provided to the treating physician for management of the patient using a report template to specify treatment options.