A collection of primary source materials about laboratory diagnostics regulation and payment, including original analysis, Medicare rates, rulemakings, final determinations and other items of interest.
April 25, 2019
GAO releases report criticizing CMS’s oversight of its medical documentation requirements.
March 04, 2019
CMS releases MLN Article on determining applicable laboratory status
Diagnostics: Payment Rates
February 08, 2019
CMS posts HCPCS codes for collecting and reporting applicable lab information for the 2019 data collection period.
February 04, 2019
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.
November 28, 2018
The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.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: Payment Rates
September 21, 2018
CMS releases CY 2019 preliminary recommendations for codes reviewed during summer the 2018 Lab Public Meeting.
September 20, 2018
OIG releases the fourth in a series of data briefs looking at Medicare spending under the Clinical Laboratory Fee Schedule.
July 26, 2018
Beginning January 1, 2020, when submitting claims to Medicare for advanced diagnostic imaging services furnishing professionals and entities must certify that professionals ordering services consulted AUC applicable to the imaging modality
May 14, 2018
Frequently Asked Questions, CMS 1621 F, Medicare Program – Medicare Clinical Diagnostic Laboratory Tests Payment System, Final Rule.
December 12, 2017
On Monday December 11, the American Clinical Laboratory Association (ACLA) filed a legal challenge to CMS’s implementation of the revised Clinical Laboratory Fee Schedule (CLFS) required under Section 216 of the Protecting Access to Medicare Act (PAMA) of 2014.
March 01, 2017
Updated FAQs addressing determination of “applicable laboratory” status.
November 18, 2016
CMS instructs Medicare claims system maintainer to be ready for PAMA based CLFS.
October 12, 2016
The Protecting Access to Medicare Act requires certain laboratories to submit payment data for certain clinical diagnostic laboratory tests to CMS by March 31, 2017. CMS has promised labs that an online portal would be available to help them submit data and that CMS would provide assistance in helping labs understand their requirements.
October 05, 2016
The final lab payment amounts for several well-established tests fall well below current Medicare pricing. Stakeholders have until October 30, 2016, to request reconsideration of these rates.
September 12, 2016
CMS has released a reporting template to assist laboratories with fee-for-service data collection.
August 05, 2016
Codes subject to reporting during the first reporting period (January 1 – March 30, 2017) (File requires WinZIP to open).
October 26, 2015
E&C Hearing on “Examining the Regulation of Diagnostic Tests and Laboratory Operations” has been rescheduled to Tuesday, November 17, 2015