Dive Brief:

• CMS is planning to reevaluate its national coverage decision on the use of next generation sequencing in patients with advanced cancers, according to Cowen Washington Research Group analysts.

• Tamara Syrek Jensen, CMS director of the Coverage and Analysis Group, told the American Clinical Laboratory Association Tuesday the coverage decision will be reopened "soon." 

• CMS has been under pressure to reconsider the policy amid concerns it will stop early-stage cancer patients from accessing NGS testing.

Dive Insight:

CMS published its decision memo on NGS in advanced cancers 12 months ago and was set to implement it earlier this month. The targeted implementation date recently slipped to April in the face of pushback from healthcare groups, which have expressed concerns that the policy will stop Medicare beneficiaries with early-stage cancers from accessing NGS tests.

The pushback has sparked a response from CMS. In disclosing the delay, CMS said it is "sensitive to the concerns of its stakeholders regarding the interpretation of this policy" and promised to work with Medicare administrative contractors to make the required changes to claims processing.

CMS could go further still, while it hasn't formally reopened the NCD or disclosed why it would take such a step, the fact that an agency official said it is likely taking the course of action has led to speculation that it may be set to address concerns with the policy.

"CMS reopening the NCD so soon after it was introduced likely means they are strongly considering a change, in our view," analysts at Cowan wrote in a note to investors.

The reopening of the NCD could bring clarity to a situation that has led to accusations of "significant policy overreach" by CMS and fears that patients with genetic predispositions to cancer will suffer "unintended consequences."

CMS began work on the policy to provide coverage for Foundation Medicine's F1CDx. However, the release of CMS instructions to contractors on the non-coverage of some tests raised concerns that the policy may have farther-reaching consequences. Those concerns were amplified in January when contractors changed their policies in ways that could stop Stage 1 and 2 cancer patients from accessing BRCA testing.