ORIGINAL ANALYSIS
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Diagnostics: Regulation
The Centers for Medicare and Medicaid Services has extended the comment period on proposed changes to proficiency testing to June 4.
Diagnostics: PAMA
CMS has released a new set of frequently asked questions addressing lab data collection.
Diagnostics: Regulation
On February 4, 2019 CMS released the “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance” proposed rule on.
Diagnostics: Payment Rates
CMS has released the final CY 2019 payment rates for clinical diagnostic services along with supporting instructional materials.
Diagnostics: Payment Rates
Diagnostics: Guidance
The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.
Diagnostics: OIG
OIG releases the fourth in a series of data briefs looking at Medicare spending under the Clinical Laboratory Fee Schedule.