20260416 PAMA Education Session at CMS / Bruce Docu Blog

20260416 PAMA education at CMS

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This is a second set of notes - see main DIHP blog for my initial posting of detailed notes plus links to powerpoints etc.

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 COPY SUMMARY

20260416 CMS PAMA 1 hr

Transcript

https://otter.ai/u/rRD0iboaRruzWyADpiS0CDoyG3c?view=summary

Overview (Notes from OTTER)

The webinar, led by Sarah Shiri losso and Sarah Harding from CMS, focused on the Clinical Laboratory Fee Schedule (CLFS) data collection and reporting process. The session covered the importance of the data for future Medicare payment rates, the updated data collection period from January 1, 2025, to June 30, 2025, and the need for applicable labs to report applicable information. Key steps include verifying lab status, registering submitters and certifiers, preparing data using the provided template, and submitting data via the CMS Enterprise Portal. The webinar also addressed common questions and provided resources for further assistance.

Action Items

• [ ] Post the recording of today’s CLFS/PAMA training webinar to the CLFS and PAMA reporting resources website immediately after the session ends.
• [ ] Respond to any outstanding questions submitted via the CLFS inquiries email address after the webinar, ensuring that all unanswered questions are addressed.
• [ ] Create and upload additional step-by-step user guide materials and short "YouTube-style" videos for submitter and certifier roles in the CLFS data collection system within the next few days.
• [ ] Publish quick reference guides on how to determine applicable laboratory status on the CLFS and PAMA reporting resources website.

Outline

Introduction and Overview of the Webinar

• Sarah Shiri losso introduces herself as the director of ambulatory services at CMS and welcomes participants to the webinar on the clinical laboratory fee schedule data collection system.
• The webinar is being recorded and will be posted on the CLFS and PAMA reporting Resources website.
• Participants are encouraged to use the Q&A button for questions, and frequently asked questions will be addressed during the second half of the session.
• Sarah Harding, the CMS Medicare policy lead on laboratory payment under Medicare, will provide an overview of the program and the CLFS data collection system.

Background and Purpose of the Webinar

• Sarah Harding explains the purpose of the webinar, which is to help participants prepare to register, submit accurate data, and understand the system and resources available.
• The webinar is focused on clearing up definitions and providing detailed instructions on the data collection process.
• The data collection period is from January 1, 2025, to June 30, 2025, and the data will be used to update Medicare clinical lab fee schedule payment rates for 2027 through 2029.
• The webinar aims to address common questions and provide resources to assist participants in the data collection process.

Detailed Instructions on Data Collection and Reporting

• Sarah Harding provides a detailed explanation of the data collection process, including the types of information that need to be reported.
• The data collection system includes the CMS Enterprise Portal, which hosts all CMS applications, and the fee for service data collection system.
• Participants need to verify their laboratory's applicable status and identify two individuals responsible for the data submission process.
• The data collection template is available online, and participants are advised not to make any changes to the template to avoid rejection.

Steps for Determining Applicable Laboratory Status

• Sarah Harding outlines the steps for determining whether a laboratory is an applicable laboratory, including evaluating the majority of Medicare revenues and calculating the threshold.
• The data collection period is from January 1, 2025, to June 30, 2025, and the data will be used to update Medicare clinical lab fee schedule payment rates for 2027 through 2029.
• Participants are advised to consult the CLFS and PAMA reporting Resources website for additional resources and guidance.
• The webinar includes detailed instructions on the data collection process, including the steps for registering, preparing data, and submitting data.

Q&A Session and Additional Resources

• Maria Durham provides a summary of key dates and upcoming tasks, including the deadline for data submission on July 31, 2026.
• Participants are encouraged to visit the CLFS and PAMA reporting Resources website for all available resources, including registration guides, user guides, and reporting templates.
• The webinar includes a Q&A session to address common questions and provide additional clarification on the data collection process.
• Participants are advised to contact the CLFS Help Desk for technical assistance and the CLFS mailbox for all other inquiries.

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NOTES FROM ChAT GPT

Below are detailed business meeting notes from the CMS education webinar on Clinical Laboratory Fee Schedule / PAMA private payer data reporting. Source transcript:

CMS Education Webinar Notes: CLFS / PAMA Laboratory Price Reporting

CMS opened the session by welcoming laboratory stakeholders to a training webinar on the Clinical Laboratory Fee Schedule data collection system and the associated PAMA reporting requirements. CMS noted that the high level of stakeholder interest had required a midstream platform change to increase webinar capacity. The session was recorded and CMS stated that the recording would be posted to the CLFS and PAMA reporting resources website. Participants were encouraged to use the webinar Q&A function, and CMS noted that many questions had already been received through the CLFS mailbox. CMS emphasized that the purpose of the session was to help laboratories understand the reporting requirement, determine whether they are “applicable laboratories,” prepare to register in the system, submit accurate data, and use available CMS resources.

CMS explained that the statutory basis for the reporting requirement is Section 1834A of the Social Security Act, established by Section 216 of the Protecting Access to Medicare Act of 2014, commonly referred to as PAMA. Under PAMA, applicable laboratories must report certain private payer information to CMS for clinical diagnostic laboratory tests paid under the Medicare CLFS. CMS noted that the first round of PAMA data collection and reporting occurred in 2017, and that for many laboratories and even some CMS staff, this current round may feel like a new process because there has been no reporting cycle for many years. CMS attributed the delay to a series of statutory delays and pandemic-related interruptions.

CMS highlighted an important recent legislative update. The Consolidated Appropriations Act enacted February 3, 2026, updated the reporting period and the relevant data collection period. CMS explained that prior delays had created concern that the next CLFS rates could be based on 2019 data, which by the 2027–2029 rate cycle would have been roughly ten years old. Congress therefore updated the data collection period to require laboratories to report private payer data from January 1, 2025 through June 30, 2025. CMS emphasized that this updated six-month window is the period from which applicable information must be drawn.

CMS defined the core item being collected as “applicable information.” This includes, for each relevant HCPCS code on the CLFS, the private payer rate for which final payment was made during the January–June 2025 data collection period, along with the associated test volume corresponding to that specific rate. CMS stressed repeatedly that laboratories should report each distinct private payer rate separately. If a lab receives multiple different rates for the same HCPCS code, each rate should be reported on a separate line with the volume associated with that specific rate. CMS was explicit that laboratories should not average rates, should not report only the highest or lowest rate, and should not report total expenditures for a code during the collection period. The agency wants the individual rate-and-volume pairings because those data are used to calculate future Medicare CLFS payment rates.

CMS advised laboratories to benchmark suspicious values against the existing Medicare CLFS. For example, if a lab’s internal data show a private payer rate of $1,000 for a test that Medicare pays at $10, the lab should review whether the data were extracted or formatted correctly. CMS also noted that the upload system has built-in warnings for rates that appear implausibly high, such as a value that may represent total expenditures rather than a single payment rate. These warnings are intended to prompt review before certification.

CMS then described the data reporting infrastructure. Reporting begins with the CMS Enterprise Portal, which is CMS’s broader system for accessing CMS applications. Users who already have a CMS Enterprise Portal account may be able to use their existing username and password. Within the Enterprise Portal, users must access the Fee-for-Service Data Collection System, or FFS DCS, which contains several data collection modules. Laboratories must select the Clinical Laboratory Fee Schedule module, not other modules such as ASP or ground ambulance reporting. CMS acknowledged that users may see internal roles such as CLFS admin or CLFS staff, but external laboratory users should request only the submitter or certifier role.

The first substantive step for laboratories is to determine whether they are an applicable laboratory. CMS described this as the “million dollar question” and emphasized that applicability is determined at the NPI level, while reporting is organized at the TIN level. An applicable laboratory must bill Medicare Part B either under its own National Provider Identifier, or, in the case of certain hospital outreach laboratories, on the Form CMS-1450 under bill type 14X. CMS emphasized that laboratory business structures can be complex, including shared NPIs, shared physician office arrangements, and hospital outreach relationships, but the legal analysis begins with the billing NPI or 14X bill type.

CMS described the majority of Medicare revenues threshold. For a laboratory with its own NPI, the lab must calculate whether its Medicare CLFS revenue plus Medicare Physician Fee Schedule revenue, divided by its total Medicare revenue, exceeds 50 percent during the January–June 2025 data collection period. CMS emphasized an important distinction: PFS revenue is included in the applicability calculation, but PFS codes are not included in the data reported to CMS. Only CLFS codes are reported. If a laboratory attempts to upload Physician Fee Schedule codes, the upload will be rejected.

CMS also discussed the low expenditure threshold. Even if a laboratory meets the majority-of-Medicare-revenue test, it is not considered an applicable laboratory if its Medicare CLFS revenue for the relevant billing NPI is less than $12,500 during the six-month data collection period. CMS explained that this threshold was intended to reduce the reporting burden on laboratories with limited CLFS activity.

CMS separately addressed hospital outreach laboratories that bill under the hospital’s NPI using 14X type of bill. CMS explained that this was an expansion of the applicable laboratory definition compared with the first PAMA reporting cycle. For hospital outreach laboratories in this category, the numerator is CLFS plus PFS revenue under the 14X bill type, and the denominator is total Medicare revenue under the 14X bill type. CMS observed that many such outreach labs are likely to meet the majority-of-Medicare-revenue threshold because the relevant 14X Medicare revenue may consist primarily, or entirely, of CLFS and/or PFS services.

CMS emphasized that it cannot make individual applicability determinations for specific laboratories. The agency explained that it may not have sufficiently current or complete information about each laboratory’s billing structure, ownership, revenue, NPI relationships, or business model. CMS therefore expects laboratories to make a good faith determination using CMS guidance and, where needed, legal counsel. CMS pointed attendees to FAQs, flow charts, quick reference guides, videos, and other materials on the CLFS and PAMA reporting resources website. CMS specifically mentioned that several FAQ pages address physician office laboratories with shared offices, shared spaces, and shared NPIs.

The webinar then turned to user roles. Each reporting entity must identify two separate individuals: a submitter and a certifier. The submitter is selected by the laboratory, creates or uses an account in the CMS Enterprise Portal, requests the submitter role in the CLFS module, uploads the data on behalf of the relevant TIN, and notifies the certifier once data have been submitted. There can be only one submitter per TIN, although one individual may submit data for multiple TINs. The certifier must be the laboratory’s president, CFO, or an individual designated by one of those officers. The certifier creates or uses an Enterprise Portal account, requests the certifier role, reviews the submitted data, and attests to its accuracy. There can be only one certifier per TIN, and the certifier may certify on behalf of multiple TINs. CMS stressed that the submitter and certifier must be two different people.

CMS explained that submitters and certifiers must complete identity management registration through CMS’s identity verification process. Users must create a username and password, establish multifactor authentication, request access to the FFS DCS application, and request the appropriate CLFS module role. CMS advised users to use their personal identifying information during identity verification rather than business information, because the identity management system is designed for personal credentialing and business information may cause delays. CMS stated that the CLFS policy team does not see this personal information; it is maintained within CMS’s broader enterprise identity system.

CMS then described the data preparation process. Laboratories should first review the CMS-provided list of reportable HCPCS codes on the CLFS. Labs should not report codes that are not on that list, including codes paid under the Physician Fee Schedule. Laboratories should then calculate, for each CLFS HCPCS code, each distinct private payer rate for which final payment was made during the January–June 2025 data collection period, along with the volume of tests paid at that rate. CMS emphasized that laboratories should not include blank rows, should not report codes they do not perform, and should not submit empty line items.

CMS presented the data reporting template, which consists of four data columns: HCPCS code, payment rate, test volume, and NPI. CMS emphasized several times that laboratories must not alter the Excel template. They should not change the formatting, add columns, remove columns, delete tabs, move tabs, insert blank rows, or otherwise modify the structure. CMS stated that modified templates may be rejected by the upload system. The template includes an instruction tab and a data entry tab, both of which must remain intact.

CMS explained that the same HCPCS code may appear repeatedly in the template if the laboratory received multiple private payer rates for that code. This repetition is expected and appropriate. CMS also clarified a somewhat counterintuitive NPI issue. Applicability is determined at the NPI level, and submitters must register all NPIs for which they are reporting. However, once the laboratory reports at the TIN level, CMS allows the data to be aggregated under a single representative NPI within the TIN. In other words, the NPI column in the data template does not need to identify the specific NPI associated with each data row, as long as all NPIs included in the reporting have been registered in the system.

CMS advised laboratories to prepare and review the data outside the CMS system before uploading. CMS specifically recommended that the certifier pre-review the completed template before formal upload, because this may reduce the need for corrections later. If the system identifies formatting errors, the submitter—not the certifier—must correct them. If the certifier identifies substantive errors after receiving the data, the submitter must log back into the system and correct the file before final certification.

CMS described the submitter workflow. After logging into the CMS Enterprise Portal and accessing the FFS DCS application, the submitter selects the CLFS module. The submitter’s home page includes a business process flow. The submitter must associate the laboratory TIN with the relevant NPI information, upload the data file using the provided template, and generate a one-time password for the certifier. This one-time password links the certifier to the submitted data and is intended as a security measure to ensure that only the appropriate certifier can view and certify the submission.

CMS described the certifier workflow. The certifier logs into the system, associates themselves with the relevant TIN and NPI information, enters the one-time password provided by the submitter, reviews the data, and certifies its accuracy. Certification must occur inside the CMS data collection system. CMS stated that a laboratory cannot certify its data by emailing CMS or the CLFS inquiries mailbox. Reporting is not complete until certification is completed in the system. Once data are certified, the submission is closed, and the laboratory will no longer be able to enter additional data for that TIN or view the data in the system. If corrections are needed after certification, the laboratory must contact the CLFS help desk.

CMS then reviewed key dates. Laboratories can begin determining applicable lab status, selecting submitters and certifiers, and preparing their data immediately. Submitters and certifiers can create CMS Enterprise Portal accounts now. The CLFS reporting link becomes available in the FFS DCS application tile on May 1, 2026, and submitters can begin uploading data at that time. All submissions are due by 11:59 p.m. Eastern Time on July 31, 2026. CMS strongly advised laboratories not to wait until the deadline. After the reporting window closes, CMS will analyze the data during summer 2026. CMS also noted that a public meeting and a FACA meeting will occur later in 2026, with proposed and final payment determinations in fall 2026. The resulting CLFS payment rates will be effective January 1, 2027.

CMS reviewed available resources. The CLFS and PAMA reporting resources website includes registration guides, submitter and certifier user guides, the HCPCS code list, reporting templates, system videos, FAQs, quick reference guides on applicable laboratory status, and forthcoming fact sheets. CMS noted that it has received a high volume of questions and is turning recurring questions into fact sheets in real time. CMS also described outreach efforts, including certified letters sent in March to potentially applicable laboratories, email communications, MLN Connects articles, social media posts, and engagement with professional organizations such as AACC, NILA, CLC, AAFP, AMA, PACDA, and MGMA. CMS encouraged laboratories that belong to these organizations to seek additional help and resources through them.

During the Q&A, CMS clarified that total Medicare revenues, for purposes of the denominator in the majority-of-Medicare-revenues test, means the sum of all Medicare fee-for-service payments under Parts A and B, prescription drug payments under Part D, and associated Medicare beneficiary deductible or coinsurance for services furnished during the collection period. However, for hospital outreach laboratories determining applicability under the 14X type of bill, the denominator is total Medicare revenue under the 14X bill type.

CMS clarified that the data collection period is based on the date final payment was made, not the date of service. Therefore, laboratories should report private payer rates for which final payment occurred between January 1 and June 30, 2025, regardless of whether the underlying service date occurred earlier.

CMS reiterated during Q&A that it cannot tell an individual laboratory whether it is an applicable lab. The agency stated that laboratories must make their own good faith determinations because applicability depends on entity-specific billing structure, revenue data, and operational information that CMS may not possess. CMS recommended that laboratories consult legal counsel if uncertainty remains after reviewing CMS guidance.

CMS was asked whether a laboratory that has closed must report. CMS responded that under the regulation at 42 CFR § 414, a reporting entity must report applicable information for each clinical diagnostic laboratory test furnished by its component applicable laboratories during the corresponding data collection period. CMS did not provide a definitive blanket answer for closed laboratories and recommended that such laboratories consult legal counsel to determine whether they must report.

CMS also clarified that laboratories that are not applicable laboratories should not report. In response to another question, CMS stated that CLIA-waived laboratories are not categorically exempt from the reporting requirement. A laboratory that performs only CLIA-waived tests must still evaluate whether it meets the applicable laboratory definition using the same steps described in the webinar.

Overall, the webinar’s main operational message was that laboratories should begin early, determine applicability carefully at the NPI level, identify separate submitter and certifier roles at the TIN level, use CMS’s unmodified reporting template, report each distinct private payer rate and associated volume separately, avoid including non-CLFS codes, and complete both upload and certification before the July 31, 2026 deadline. CMS repeatedly emphasized that most mistakes can be avoided by using the official template, consulting the HCPCS code list, reviewing CMS’s published FAQs and guides, and allowing enough time before the deadline to address registration, formatting, identity verification, and data correction issues.