Changes to the checklist included restructuring requirements related to analyte-specific reagents and laboratory-developed tests to reduce redundancy.
Proposals from ACLA, CAP, and others included statistical sampling to collect hard-to-capture lab pricing data from across the industry.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
Questions posed by CMS about expanding PAMA data collection expose a rift between labs and other industry stakeholders over who should report lab prices.
CareFirst BlueCross BlueShield and United Health Group join six others in FDA's Private Payor Program for providing device makers presubmission feedback.
CLIP program requirements are comparable to requirements for CLIA accreditation but might be modified to meet Department of Defense mission needs.
The move is precipitated by CMS's decision to grant national coverage to NGS companion diagnostics when they're approved by the FDA.
Efforts by CMS and Congress to seek public comment on whether the Stark Law could be modified to accommodate value-based care have drawn divergent opinions from with the lab industry.
The lab will test samples reimbursed only by the federal government. Attis expects it will test a baseline of 3,000 toxicology samples per month by the end of 2018.
The final LCD, which expands Medicare coverage of the firm's ConfirmMDx test to all providers, becomes effective on Sept. 3.