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?
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.
- Summary (PDF) - Overview of key terms and concepts and how to determine whether your laboratory is an applicable laboratory
- MLN Matters Article SE19006 (PDF) - Detailed information and examples to help you determine if you need to report
- Final Rule- CLFS final rule published June 23, 2016
- CY 2019 Rule – PFS final rule published November 23, 2018
If you meet the applicable laboratory criteria, act now using this schedule:
- January – June, 2019: Collect data
- July – December, 2019: Analyze data
- January – March, 2020: Report data
You need to report every three years using this timeframe.
- CLFS Data Collection System User Guide (PDF)
- Summary of Private Payor Rate-Based CLFS (PDF)
- MLN Matters® Special Edition Article SE19006 (PDF): Revised Information for Laboratories on Data Collection and Reporting
- MLN Matters® Special Edition Article SE17002 (PDF): Additional Guidance for Clinical Laboratories as Data Reporting Begins
- CLFS Applicable Information HCPCS Codes (ZIP)
- CLFS Data Reporting Template (Updated, 11/03/2016) [ZIP, 309B] (ZIP)
- Questions about data reporting system: email@example.com
- List of Approved ADLTs (PDF)
- Application for Requesting ADLT Status (PDF)
- Guidance for Laboratories on ADLTs (PDF)
- Application for Level II HCPCS code for ADLTs and FDA Cleared or Approved CDLTs
- Notify CMS of an FDA Cleared or Approved Clinical Diagnostic Laboratory Test (CDLT)
- Application for Level II HCPCS Code for ADLTs and FDA Cleared or Approved CDLTs
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
- 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).
- CY 2018 Final Private Payor Rate-Based CLFS Payment Rates (ZIP)
- 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:
- CY 2018 - Preliminary Private Payor Rate-Based CLFS Payment Rates and Analytics (ZIP)
- Clinical Laboratory Fee Schedule (CLFS) Applicable Information Raw Data File: A raw data file showing all data submitted to CMS under PAMA (excludes HCPCS codes for 10 or fewer reporting entities (TINs)
- CY 2018 - Summary of Data Reporting for the CLFS Private Payor Rate-Based Payment System (PDF)
- CY 2018 – Clinical Laboratory Fee Schedule Test Codes Preliminary Determinations (PDF) – Crosswalking or Gapfilling
- Frequently Asked Questions CY 2019 CLFS (PDF) (Updated 9/05/2019) - Changes effective January 1, 2019 (PDF)
- Frequently Asked Questions (PDF) (Updated 3/09/2017)
- Visit CMS Sponsored Events for links to slide presentations, audio recordings, and written transcripts on the final rule and data reporting.