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.
May 09, 2020
On May 8, 2020, the FDA issued its first Emergency Use Authorization for an antigen test for the diagnosis of COVID-19. This test is authorized in moderate and high complexity labs as well as at point-of-care testing.
May 08, 2020
The FDA announced today its issuance of an Emergency Use Authorization for its first laboratory diagnostic test using at-home collected saliva samples.
April 30, 2020
CMS published a second interim final rule on COVID-19 with some key changes in the lab / diagnostic space.
April 11, 2020
CMS together with the Department of Labor and Department of Treasury issued guidance today to ensure coverage for COVID-19 testing and select other services (e.g., antibody testing) at no cost.
March 30, 2020
On March 30,CMS announced a broad range of waivers and flexibilities for providers as the country is faced with the COVID-19 public health emergency.
March 22, 2020
Since March 19, the FDA announced four additional Emergency Use Authorizations granted for diagnostic tests for COVID-19 including the first point-of-care test.
March 19, 2020
Since March 17, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19.
March 17, 2020
Since March 13, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19.
March 13, 2020
Based on its review of the evidence, FDA has concluded that molecular-based laboratory developed tests (LDTs) that are authorized for use by the singular developing laboratory are appropriate to protect the public health or safety.
March 12, 2020
CMS has announced that the two new HCPCS codes created for coronavirus testing – U0001 (for tests developed by the CDC) and U0002 (for non-CDC laboratory tests) – will be priced by the local Medicare Administrative Contractors.
March 06, 2020
CMS created a second HCPCS code that providers and laboratories may use to report Coronavirus lab testing. Code U0001 will be for the CDC testing laboratory tests for patients with SARS-CoV-2.
March 02, 2020
On February 29, 2020, the FDA issued a new guidance document (immediately in effect) on its policy for diagnostic testing in laboratories certified to perform high complexity testing under CLIA prior to EUA for COVID-19 during the public health emergency.
CMS Issues Revised Guidance on AUC Reporting
February 20, 2020
CMS issues revised guidance on where line level ordering professional information should be reported on institutional claims and with an updated list of clinical decision support mechanisms.
January 27, 2020
CMS issues its decision memo that revises and expands on the coverage for next generation sequencing (NGS) as a diagnostic laboratory test for ovarian and breast cancer when selected criteria are met.
CMS Issues Additional Guidance on AUC Reporting
January 09, 2020
CMS issues new guidance on where line level ordering professional information should be reported on institutional claims impacted by the Appropriate User Criteria Program for Advanced Diagnostic Imaging.
January 02, 2020
The enforcement discretion period that had been in place for the last 18 months regarding the laboratory Date of Service (DOS) exception policy ends on January 2, 2020.
December 09, 2019
CMS issues the claims processing requirements for the voluntary educational and operational testing period – set to begin on January 1, 2020 – for the Appropriate Use Criteria for Advanced Diagnostic Imaging.
October 29, 2019
CMS issues a proposed decision memo that would revise and expand on the coverage for next generation sequencing (NGS) as a diagnostic laboratory test for ovarian and breast cancer when selected criteria are met.
October 15, 2019
CMS has published its application for new “U” codes for advanced diagnostic laboratory tests (ADLTs) and FDA-cleared or approved clinical diagnostic laboratory tests (CDLTs).
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