Next CLFS Data Reporting Period for Clinical Diagnostic Laboratory Tests - DELAYED
- On December 10, 2021, the “Protecting Medicare and American Farmers from Sequester Cuts Act” (S. 610) was passed and delayed the reporting requirement under Section 1834A of the Act and also delayed the application of the 15% phase-in reduction.
- 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, 2023 through March 31, 2023, 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 2026, 2029, 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 CYs 2021 and 2022, and payment may not be reduced by more than 15 percent for CYs 2023 through 2025.
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 | 0.0% |
2023 | January 1, 2016 – June 30, 2016 | January 1, 2017 – March 31, 2017 | 15% |
2024 | January 1, 2019 – June 30, 2019 | January 1, 2023 – March 21, 2023 | 15% |
2025 | January 1, 2019 – June 30, 2019 | January 1, 2023 – March 31, 2023 | 15% |
| 2026 | January 1, 2019 – June 30, 2019 | January 1, 2023 – March 31, 2023 | N/A |
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:
- 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
- Final Rule- Physician Fee Schedule published December 28, 2020
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, 2023: Report data
How do I report private payor data?
- Webinar Slides November 10, 2021 (PDF)
- Video Recording November 10, 2021 | Password for video recording: W&KZ@=7?
- Summary of Private Payor Rate-Based CLFS (PDF) – (Updated 04/20/2021)
- 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 (Updated, 03/05/2020) (ZIP)
- CLFS Data Reporting Template (Updated, 11/03/2016) [ZIP, 309B] (ZIP)
- CLFS Data Collection System User Guide (PDF)
Advanced Diagnostic Laboratory Tests (ADLTs)
- Questions about data reporting system: [email protected]
- List of Approved ADLTs (PDF) (Updated 06/22/2021)
- 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 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
- 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
Questions?
- Frequently Asked Questions CY 2021 CLFS (PDF) – (Updated 04/20/2021)
- 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.
More Questions?
- Final rules: [email protected].
- Data collection system: [email protected]
