national coverage determination

An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.

The move is precipitated by CMS's decision to grant national coverage to NGS companion diagnostics when they're approved by the FDA.

A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.

The policy states that lab tests without FDA's blessing may pursue local coverage via Medicare contractors, but national coverage requires premarket approval or clearance.

The final determination also adds coverage for FDA-approved tests in stage III patients, and for repeat testing if patients receive a new primary diagnosis.

These lobbying efforts aim to shore up willingness among legislators to step in and halt implementation of the NCD if certain provisions remain in the final version.

For full-year 2017, the company reported $152.9 million in revenues, up 31 percent over 2016.

A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.

The investment bank gave the company's stock an Outperform rating with a target price of $90 per share.

Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.

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