On April 16, 2026, CMS provided a one hour webinar on PAMA lab price data reporting, which runs May June July, 2026.
CMS stated it would soon post the video on its PAMA resources page.
If of interest, I posted a copy of the video on YouTube:
And, below, see a detailed AI notes summary of the webinar.
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Here is a detailed summary of the CMS webinar transcript on PAMA / CLFS data reporting.
Overview and purpose of the webinar
CMS opened the session by explaining that the webinar was intended to train laboratories and related stakeholders on the Clinical Laboratory Fee Schedule (CLFS) data collection and reporting system. The goal was practical: help participants understand whether they are required to report, how to prepare the data, how to register in the CMS system, and how to complete submission and certification correctly. CMS emphasized that this reporting affects future Medicare CLFS payment rates, so accuracy matters. CMS also noted that interest was so high that it had to switch webinar platforms to increase capacity.
The webinar was recorded, and CMS said the recording would be posted on the CLFS and PAMA Reporting Resources website. CMS also repeatedly pointed participants to the Q&A function, the CLFS inbox, and the resource website for follow-up help.
Legal and policy background
CMS explained that the reporting requirement comes from Section 1834A of the Social Security Act, established by Section 216(a) of PAMA (Protecting Access to Medicare Act of 2014). Under that law, “applicable laboratories” must report certain private payer information for each applicable clinical diagnostic laboratory test paid under the CLFS.
CMS reminded the audience that the first round of reporting occurred in 2017, and that later rounds were delayed for several years. According to the presenter, those delays were due partly to the COVID period and partly to efforts to make sure the process was set up correctly. A key update occurred in February 2026, when the Consolidated Appropriations Act directed that reporting move forward and also updated the data collection period. CMS stressed that, without the update, it might have been forced to set 2027–2029 CLFS rates using 2019-era data, which would have been badly outdated. Instead, laboratories are now being asked to report data from January 1, 2025 through June 30, 2025.
What data must be reported
CMS defined the reportable data as “applicable information.” For each CLFS test furnished by an applicable laboratory, CMS wants:
1. The HCPCS code for the test.
2. Each private payer rate for which final payment was made during the collection period.
3. The associated volume of tests furnished at that specific rate.
CMS made a major operational point here: if a lab has multiple different private payer rates for the same HCPCS code, it must report each rate separately, along with the volume tied to that rate. Labs should not average rates, should not report only the highest or lowest rate, and should not report aggregate expenditures for the code. CMS wants the rate-by-rate detail.
CMS suggested that labs may want to compare their data against the public CLFS file as a “gut check.” For example, if a lab sees a figure that seems wildly high for a single test, that may indicate a data problem.
Applicable laboratory determination
A major portion of the webinar focused on the threshold issue: which labs must report.
CMS presented this as a three-step test.
First, a lab must bill Medicare Part B either:
a. Under its own NPI, or
b. For certain hospital outreach labs, on Form 1450 using type of bill 14x.
Second, the lab must meet the majority of Medicare revenues threshold. CMS described this as:
(Medicare CLFS revenues + Medicare PFS revenues) / total Medicare revenues > 50%
A very important nuance is that Physician Fee Schedule (PFS) revenues count in the threshold calculation, but PFS codes are not reported in the uploaded data file. In other words, PFS matters for determining whether the entity is an applicable lab, but once that determination is made, the actual reporting is limited to CLFS codes.
Third, the lab must exceed the low expenditure threshold. If its total Medicare CLFS revenues for the data collection period are less than $12,500, it is not considered an applicable laboratory and does not report.
CMS stressed that the applicability analysis begins at the NPI level, even though final reporting occurs at the TIN level. That distinction was clearly a recurring source of confusion among stakeholders.
Special rule for hospital outreach labs
CMS highlighted a change affecting hospital outreach laboratories that bill under a hospital’s NPI using type of bill 14x. According to CMS, this was an expansion from the first reporting round and was meant to capture more hospital outreach lab data.
For these labs, the same basic majority-of-Medicare-revenues concept applies, but the analysis is done using the 14x bill type. CMS indicated that many such labs are likely to meet the revenue threshold because most or all of their Medicare revenue under that billing structure comes from CLFS and/or PFS services.
This portion of the webinar suggests CMS is trying to draw more hospital outreach activity into the PAMA dataset than in the earlier cycle.
Why CMS will not tell labs whether they are applicable
CMS said many labs have asked CMS to make individualized determinations on whether they qualify as applicable laboratories, but CMS said it cannot do that case-by-case. The reason given was that applicability depends on entity-specific facts such as current billing arrangements, revenue structure, shared NPIs, and changing business models—details CMS may not have or may not have accurately. Therefore, labs themselves must make a good-faith determination using CMS guidance, FAQs, flowcharts, and other materials. CMS explicitly suggested consulting legal counsel if there is uncertainty.
This is an important takeaway: CMS is offering guidance, but it is not taking responsibility for individualized applicability rulings.
Roles in the reporting process: submitter and certifier
Each reporting entity at the TIN level must identify two separate people:
Submitter – uploads the data.
Certifier – reviews and certifies the accuracy of the data.
CMS emphasized several rules here:
There can be only one submitter per TIN.
There can be only one certifier per TIN.
The submitter and certifier must be different people.
A single individual may serve in that role for multiple TINs.
The certifier must be the President or CFO of the applicable laboratory, or someone designated by one of them.
CMS explained that these constraints are partly security-driven, to prevent unauthorized access to lab data.
CMS registration and identity verification
To participate, the submitter and certifier must register through the CMS Enterprise Portal and complete identity verification. CMS described the process as involving the broader fee-for-service data collection system (FFS DCS), inside which users must select the CLFS module.
CMS repeatedly warned that users may see other modules and roles in the portal, including internal roles such as “CLFS admin” or “CLFS staff,” but labs should request only the appropriate submitter or certifier role in the clinical laboratory fee schedule module.
A notable operational point: users must register using personal identifying information, not business information, because the identity verification process depends on personal credentials. CMS tried to reassure listeners that the CLFS policy team itself does not see or handle that personal information.
Preparing the data file
CMS advised labs to prepare the report using the official Excel template posted on the resource site and available inside the system. The template contains only four columns:
HCPCS code
Payment rate
Volume
NPI
The presenter repeatedly stressed: do not alter the template. Do not change formatting, add columns, remove tabs, insert blank rows, or otherwise modify the file structure. Doing so may cause the upload to fail.
CMS also repeated several related instructions:
Report only CLFS HCPCS codes from the CMS list.
Do not report PFS codes in the upload file.
Do not include codes your lab did not perform.
Do not average rates for a code.
Do not report total expenditures instead of rates.
TIN and NPI reporting nuance
This was one of the more subtle and potentially important parts of the webinar.
CMS said applicability is determined at the NPI level, but data submission is made at the TIN level, and data may be aggregated across NPIs within that TIN. The template still requires an NPI column, but CMS said the same representative NPI can be repeated; labs do not have to break out which payment rates came from which individual NPI, as long as all relevant NPIs are registered in the system.
So the rule appears to be:
Evaluate applicability using the correct NPI-based framework.
Register all NPIs for which you are reporting.
Submit one file per TIN.
Aggregate the data within that TIN in the template.
That is an important administrative simplification, even if it may sound counterintuitive.
Portal workflow
CMS walked through the portal screens at a high level.
For the submitter, the basic workflow is:
Log into the CMS Enterprise Portal.
Enter the CLFS module under FFS DCS.
Associate the laboratory TIN with all relevant NPIs.
Upload the CLFS data file.
Generate a one-time password (OTP) for the certifier.
For the certifier, the workflow is:
Log into the same system.
Associate with the same TIN/NPI structure.
Enter the OTP provided by the submitter.
Review the uploaded data.
Certify its accuracy and submit.
CMS described the OTP as the secure handoff mechanism between submitter and certifier.
Review, correction, and finality
CMS strongly recommended that labs review the data thoroughly before upload and certification. The system may catch certain formatting errors, but if the certifier identifies a problem after upload, only the submitter can make corrections. The certifier cannot edit the file.
More importantly, once the certifier certifies the submission, the submission is essentially closed. CMS said the lab will no longer be able to enter more data for that TIN, and in fact may no longer be able to view the submitted data in the system due to security design. If corrections are needed after certification, the lab must contact the CLFS help desk.
That means labs should treat certification as the final lock-down step and do significant pre-review before the certifier pushes the last button.
Timeline and deadlines
CMS then laid out the reporting calendar:
Labs can already begin determining applicability and preparing data.
Submitters and certifiers can begin creating CMS portal accounts now.
May 1, 2026: the CLFS reporting link becomes available in the system and upload can begin.
July 31, 2026, at 11:59 p.m. Eastern: all submissions are due.
CMS explicitly urged labs not to wait until July 31. That warning likely reflects anticipated bottlenecks with registration, identity verification, file formatting, and certification.
CMS then described the next downstream milestones:
Summer 2026: CMS analyzes the data.
Fall 2026: a public/FACA meeting occurs.
Fall 2026: payment determinations are proposed and finalized.
January 1, 2027: updated CLFS payment rates take effect.
So the webinar framed the July 2026 reporting not as an isolated compliance exercise, but as the basis for 2027 payment-setting.
Resources and outreach
CMS repeatedly promoted the CLFS and PAMA Reporting Resources website as the central source for:
registration guide
submitter guide
certifier guide
HCPCS reporting list
data templates
videos
FAQs
quick reference guides
upcoming fact sheets
webinar recording
CMS said it had also sent outreach through certified letters, emails, MLN Connects, social media, and professional organizations including NILA, CLC, AAFP, AMA, PACDA, and MGMA. The message was that CMS is trying to spread the word broadly, but it expects stakeholders and trade associations to help labs navigate the details.
Q&A portion: main answers
The final section addressed a few specific questions.
On what counts in “total Medicare revenues” for the denominator, CMS said it includes the sum of all Medicare fee-for-service payments under Parts A and B, Part D prescription drug payments, and associated beneficiary deductible and coinsurance for services furnished during the collection period. For hospital outreach labs using 14x, the denominator is total Medicare revenues under that billing construct.
On whether the collection period is based on payment date or date of service, CMS answered that reporting is based on the date final payment is made, not the date of service.
On why CMS cannot tell a lab whether it is applicable, CMS repeated that the determination depends on facts the lab knows better than CMS, so the lab must make a good-faith determination, with counsel if needed.
On whether a recently closed lab must report, CMS did not provide a categorical answer. Instead, it pointed to the regulation and recommended that such an entity consult legal counsel.
On whether a lab that is not an applicable lab may still report, CMS said no—if you are not an applicable lab, you should not report.
On whether CLIA-waived labs are exempt, CMS said no. A CLIA-waived certificate does not automatically exempt the lab; such labs still must go through the applicability analysis.
Overall tone and practical implications
The webinar was less about policy controversy and more about compliance operations. CMS’s tone was practical and somewhat defensive: it acknowledged widespread confusion, staffing limitations, and the unusual fact that many participants—and even some CMS personnel—were handling this process for the first time in years.
The main practical themes were:
First, CMS is very focused on getting labs to self-assess whether they are applicable, rather than asking CMS to bless individual cases.
Second, CMS wants labs to pay close attention to the distinction between CLFS reporting and PFS relevance only for threshold calculations.
Third, CMS is clearly trying to prevent common reporting mistakes: averaging rates, using wrong codes, altering the template, waiting until the deadline, or misunderstanding the TIN/NPI structure.
Fourth, the security and system architecture matter. The registration, role assignment, OTP process, and final certification steps are all tightly controlled, and mistakes may slow a lab down.
Bottom line
The webinar’s core message was that laboratories should immediately do four things:
1. Determine whether they are an applicable laboratory.
2. Identify a submitter and a certifier for each TIN.
3. Gather January–June 2025 private payer rate and volume data for CLFS codes only, using the CMS template exactly as provided.
4. Be ready to upload beginning May 1, 2026, and finish well before July 31, 2026.
The biggest conceptual points were that applicability is based on a structured revenue test, that reporting is limited to CLFS codes, and that CMS expects laboratories—not CMS—to make the applicability determination in good faith.
