Protecting access to medicare act pama laboratory

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U.S. Dept. of Health & Human Services

Guidance for PAMA regulations including overview and FAQ.

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: March 23, 2018

DELAY. IMPORTANT UPDATE: The next data reporting period is January 1, 2024 through March 31, 2024, will be based on the original data collection period of January 1, 2019 through June 30, 2019.

• On December 29, 2022, Section 4114 of Consolidated Appropriations Act, 2023 revised the next data reporting period for CDLTs that are not ADLTs and the phase-in of payment reductions under the Medicare private payor rate-based CLFS. The next data reporting period of January 1, 2024 through March 31, 2024, 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 2027, 2030, etc.).
• 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 statutory phase-in of payment reductions resulting from private payor rate implementation is extended, that is, through CY 2026. There is a 0.0 percent reduction for CYs 2021, 2022, and 2023 and payment may not be reduced by more than 15 percent for CYs 2024 through 2026.

Year for CDLT Rates

Based on Data Collection Period

Based on Data Reporting Period

January 1, 2016 – June 30, 2016

January 1, 2017 – May 30, 2017

January 1, 2016 – June 30, 2016

January 1, 2017 – May 30, 2017

January 1, 2016 – June 30, 2016

January 1, 2017 – May 30, 2017

January 1, 2016 – June 30, 2016

January 1, 2017 – May 30, 2017

January 1, 2016 – June 30, 2016

January 1, 2017 – May 30, 2017

January 1, 2019 – June 30, 2019

January 1, 2024 – March 31, 2024

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.

• 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: clfshelpdesk@dcca.com
• List of Approved ADLTs (PDF) (Updated 03/29/2023)
• 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

• 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

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:

• 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 03/29/2022)
• Frequently Asked Questions CY 2019 CLFS (PDF) (Updated 09/05/2019) - Changes effective January 1, 2019
• Frequently Asked Questions (PDF) (Updated 03/09/2017)
• Visit CMS Sponsored Events for links to slide presentations, audio recordings, and written transcripts on the final rule and data reporting.

• Final rules: CLFS_Inquiries@cms.hhs.gov.
• Data collection system: clfshelpdesk@dcca.com

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.

Date Published: 12/31/2020