PAMA Regulations

IMPORTANT UPDATE

Next CLFS Data Reporting Period for Clinical Diagnostic Laboratory Tests

  • Section 1834A of the Act, as established by Section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for Clinical Diagnostic Laboratory Tests (CDLTs) under the CLFS. The CLFS final rule “Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule” (CMS-1621-F) was published in the Federal Register on June 23, 2016. The CLFS final rule implemented section 1834A of the Act. Under the CLFS final rule, reporting entities must report to CMS certain private payer rate information (applicable information) for their component applicable laboratories. The data collection period (the period where applicable information for an applicable laboratory is obtained from claims for which the laboratory received final payment during the period) was from January 1, 2019 through June 30, 2019.
  • The next data reporting period of January 1, 2022 through March 31, 2022, will be based on the original data collection period of January 1, 2019 through June 30, 2019.
  • After the next data reporting period, there is a three-year data reporting cycle for CDLTs that are not ADLTs, (that is 2025, 2028, etc.).
  • The statutory phase-in of payment reductions resulting from private payor rate implementation is extended, that is, through CY 2024. There is a 0.0 percent reduction for CY 2021, and payment may not be reduced by more than 15 percent for CYs 2022 through 2024.
     

Year for CDLT Rates

Based on Data Collection Period

Based on Data Reporting Period

Reduction Cap

2020

January 1, 2016 June 30, 2016

January 1, 2017 – May 30, 2017

10%

2021

January 1, 2016 June 30, 2016

January 1, 2017 – May 30, 2017

0.0%

2022

January 1, 2016 June 30, 2016

January 1, 2017 – March 31, 2017

15%

2023

January 1, 2019 June 30, 2019

January 1, 2022 – March 31, 2022

15%

2024

January 1, 2019 June 30, 2019

January 1, 2022 – March 21, 2022

15%

2025

January 1, 2019 June 30, 2019

January 1, 2022 – March 31, 2022

N/A


   
Do I need to submit private payor rates? 
When do I submit private payor rates? 
How do I report private payor data? 
Advanced Diagnostic Laboratory Tests (ADLTs)  
How do I notify CMS of FDA Cleared or Approved CDLTs? 
Where do I find CY 2018 private payor rates and supporting information? 
Questions?

Do I need to submit private payor rates?

The Protecting Access to Medicare Act of 2014 (PAMA) required significant changes to how Medicare pays for clinical diagnostic laboratory tests under the Clinical Laboratory Fee Schedule (CLFS). Effective January 1, 2018, the payment amount for most tests equals the weighted median of private payor rates. Payment rates under the private payor rate-based CLFS are updated every three years. 

If you are a laboratory, including an independent laboratory, a physician office laboratory or hospital outreach laboratory that meets the definition of an applicable laboratory you are required to report information including laboratory test HCPCS codes, associated private payor rates, and volume data.

Learn more:

  

When do I submit private payor rates?

If you meet the applicable laboratory criteria, act now using this schedule:

  • January – June, 2019: Collect data
  • July – December, 2019: Analyze data
  • January – March, 2022: Report data

  

How do I report private payor data?

 

Advanced Diagnostic Laboratory Tests (ADLTs)

 

Notify CMS of FDA Cleared or Approved CDLTs

 

Where do I find CY 2018 private payor rates and supporting information?

CMS published the final payment rates and supporting documentation for the new private payor rate-based CLFS payment system.  These rates were implemented on January 1, 2018.  The files include: 

Final Payment Rates and Crosswalking/Gapfilling Determinations 

  1. CY 2018 Final Crosswalking/Gapfilling Determinations (PDF) (for new and existing laboratory test codes for which CMS received no applicable information to calculate a private payor rate-based CLFS payment amount).
  2. CY 2018 Final Private Payor Rate-Based CLFS Payment Rates (ZIP)
  3. HCPCS Codes with Revised Final CY 2018 Private Payor Rate-Based CLFS Payment Rates and Clarifications Regarding the Weighted Median Calculations (PDF)

 

CLFS Preliminary Payment Rates and Supporting Documentation:

 

Questions?

More Questions:

  

Page Last Modified:
09/08/2021 04:15 PM