Protecting Access to Medicare Act (PAMA) for Laboratories

Beginning in 2017, the Protecting Access to Medicare Act (PAMA) requires certain laboratories to collect and submit private payor rates for clinical laboratory tests. Medicare will use the data it collects to set the fees for these tests starting in 2018. In addition to advocating on behalf of pathologists on PAMA, the CAP is providing additional information to help pathologists and laboratories understand who is required to submit data, deadlines for collection and reporting, and additional resources to comply with new rules. Listen to the CAP's PAMA podcast and download the podcast presentation slides (PDF, 180 KB).

Update: The final Physician Fee Schedule (PFS) rule published in 2018 made two revisions to the regulatory definition of “applicable laboratory,” effective January 1, 2019: (1) Medicare Advantage plan payments are excluded from total Medicare revenues (the denominator of the majority of Medicare revenues threshold); and (2) hospital outreach laboratories that bill for their non-patient laboratory services using the hospital's NPI must use Medicare revenues from the Form CMS-1450 14x Type of Bill (TOB) to determine whether they meet the majority of Medicare revenues threshold and low expenditure threshold.

Read the related January 2019 MLN Matters Article for more information.

The Medicare program published the 2018 CLFS utilizing a new methodology based on private payer rates for tests collected from a small segment of providers. The CAP has called this collection process flawed and continued to urge the Centers for Medicare & Medicaid Services (CMS) to delay the implementation of the new fee schedule.

As a service for CAP members, the CAP analyzed the impact of the top 100 Healthcare Common Procedure Code System (HCPCS) CLFS codes by volume, which represent 80% of total CLFS spending. Download the 2018 CLFS impact table.

Citing adverse impacts to laboratories and patients, the CAP is strongly advocating for improvements to how CMS collects data from laboratories. The CAP joined organizations representing 36 patients, labs, diagnostic manufacturers, and health care professionals in sending a letter to Congress urging “swift action to reform and modernize the CLFS as intended by PAMA and protect access to laboratory services for patients.” The CAP sent comments to CMS in response to the Physician Fee Schedule proposed rule urging CMS to make the PAMA methodology changes necessary to include all segments of the industry, thereby ensuring more accurate PAMA rates and continued access to laboratory tests for Medicare patients. The CAP sent the CMS additional comments that outline concerns from its members on October 23, 2017.

• PAMA Regulations CMS Resource Webpage
• January 22, 2019 CMS presentation on updated laboratory requirements.
• The CMS released the final CY 2019 payment rates for clinical diagnostic services along with supporting instructional materials. These rates are effective for claims with dates of service on or after January 1, 2019.
• CMS to Host PAMA Laboratory Data Collection Call
• CMS Releases CLFS 2019 Rates
• Medicare Responds to CAP Recommendations in Final 2019 Fee Schedule
• PAMA Data Collections System User Guide from the CMS.
• PAMA frequently asked questions from the CMS.
• PAMA Submission Process and Data Certification
• Reporting Data to Meet PAMA Requirements (PDF, 126 KB)
• CMS Summary of Terms for Applicable Laboratories (PDF)
• Information to Help Determine If Your Laboratory Needs to Report (PDF)
• CMS Frequently Asked Questions (PDF)