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Industry groups representing lab personnel strongly oppose CLIA's current practice of allowing personnel with nursing degrees to perform moderate- and high-complexity testing.
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.
The lab industry's appeal to CMS follows Missouri's Medicaid agency's reduction of lab reimbursements from 100 percent to 80 percent of Medicare rates.
At the ACLA conference this week, FDA Commissioner Gottlieb outlined his vision for the agency in the realm of LDTs.
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 OIG recommends that CMS direct Medicare contractors to recover the improper payments from providers and strengthen system edits to prevent further improper payments.
The investment bank gave the company's stock an Outperform rating with a target price of $90 per share.
Executives at two commercial payors said they'd follow CMS' lead when it comes to patients covered under Medicare but beyond that their support for the agency's policy is less clear.
The registry from the American Society for Clinical Pathology aims to eventually collect metrics on how lab services impact patient outcomes.