Advocacy Update

• CAP Cites Patient Safety Concerns as it Opposes CLIA Lab Director Proposals
• How the CAP Won a Labor-Rate Change to Increase Pathologists’ Medicare Pay
• CDC Recommends Repeat Testing to Verify Monkeypox
• California Pathologists, CAP Amend Prior Authorization ‘Gold Card’ Legislation
• Last Week to Test Your Advocacy News Chops
• Editor’s Note: Next CAP Advocacy Update is September 13

To maintain the highest standards in diagnostic medicine, the CAP opposed several changes to the Centers for Medicare & Medicaid Services (CMS) staffing qualifications recommendations in a proposed 2023 CLIA regulation. These adverse changes included the qualifications for doctorate level scientists, the consideration of the doctor of clinical laboratory scientist (DCLS), the expansion of other degree types eligible to be laboratory directors, and technical supervisor qualifications for immunohematology qualifications.

Overall, the CAP was supportive of many of the regulatory changes proposed by the CMS. However, there were areas of concern. In an August 29 letter to the CMS, the CAP outlined its opposition to the updated CMS qualifications for laboratory directors. The CAP firmly opposed the inclusion of a DCLS degree and the expansions of other types of degrees, such as a master’s degree, as qualifications to lead laboratory teams. In the letter, the CAP said, “While the CAP supports the agency effort to clarify doctorate-level degrees within CLIA, we strongly oppose the inclusion of the DCLS degree as a qualifying degree under CLIA.”

Additionally, the CAP opposed lowering the standards to include other degrees to qualify for Technical Supervisor Qualifications for Immunohematology. The CAP also disagreed with the CMS’s proposal for nurses as high-complexity personnel.

The CAP said it believed a nursing degree is not equivalent to a bachelor’s degree necessary to perform high-complexity testing, and therefore it should be a separate qualifying degree. Nurses perform laboratory-related functions such as point-of-care testing (POCT), specimen collection, and test ordering, which are not their primary job functions, but rather secondary tasks performed outside of the central laboratory. Unlike laboratorians in the central laboratory, nurses often have minimal time to reflect on the total testing process. In addition, nurses may have the understanding in terms of clinical knowledge but not in the laboratory medicine practice, which we believe a separate qualifying degree will better provide the skills, experience, and training necessary to perform these limited laboratory-related functions.

Nevertheless, the CAP was supportive of many of the regulatory changes proposed by the CMS. For instance, the CAP supports the CLIA proposals that address practice and technology changes, such as the updates to the Histocompatibility regulations, especially the recognition of virtual crossmatching; the creation of qualification algorithms for testing personnel instead of specific degrees; allowance of respiratory therapists with an associate degree to qualify as a technical consultant; the removal of the physical science degree; and, allowing military trained individuals to qualify as testing personnel once they move to the private sector.

CMS Allows Additional Time for Public Comment

Last week, the CMS extended the comment period for the proposed CLIA regulation to September 26 to give stakeholder more time to offer input. The CAP had joined an effort led by the American Society for Clinical Pathology (ASCP) to successfully urge the agency to move the deadline.

In the proposed 2023 Medicare Physician Fee Schedule released July 7, the CMS announced changes to the histotechnologist’s clinical labor rate that is used in the valuation of the technical components and global payment of all of pathology’s most frequently billed services. Increases in all clinical labor rates will be phased in over the next three years and the histotechnologist’s labor increase represents a rate greater than 16% than what the CMS previously finalized. Since final 2022 regulation until the proposed 2023 regulation, the CAP worked to achieve the increase that will have a positive effect on how much pathologists are paid for the technical component of pathology services.

When the CMS published its Final 2022 Medicare Physician Fee Schedule, the CAP immediately identified a rank order anomaly between the clinical labor rates of laboratory technicians and histotechnologists. The CAP then setup a meeting with the CMS to persuading the agency to correct the mistake.

The CAP conducted its due diligence to provide evidence to fix the error. The CAP reviewed a variety of data points that convinced CMS officials to change the rates. This information included:

• Per minute rate rank orders of all the CMS clinical labor types based on the Bureau of Labor Statistics.
• Historical precedence for wage differentials between laboratory technologists and laboratory technicians.
• Current open histotechnologist job offerings
• And, published wage data from the American Society for Clinical Pathology.

The CAP’s recommendations to fix the issue were published in the 2023 proposed physician fee schedule. Specifically, the CAP recommended within CMS’s practice expense methodology for the histotechnologist’s clinical labor rate per minute to increase from $0.37 to $0.64 (+73%) and laboratory technician/histotechnologist labor rate be increased by 71% to a rate of $0.60, rather than to $0.55 as finalized last year. The changes to these clinical labor rates will restore the proper rank order of the rates from what the CMS had altered in its final 2022 ruling. The CMS agreed with the CAP’s recommendations and has proposed the corrected rates as requested by the CAP in the 2023 Medicare fee schedule.

To prevent false positive test results, the Centers for Disease Control & Prevention (CDC) recommended on August 23 that laboratory professionals perform repeat testing to verify positive diagnostic results for orthopoxvirus or monkeypox virus DNA in specimens with high cycle threshold (Ct) values from persons who do not meet identified epidemiologic risk criteria for monkeypox.

The CDC recommended that laboratories review test results (including raw data, PCR curves, etc.) carefully before reporting the results. Since the molecular tests (eg, real-time PCR tests) are very sensitive, cross-contamination is possible.

If laboratories obtain a high Ct value (generally ~34 or higher), the CDC recommends to immediately re-extract and retest to ensure there was no cross-contamination. The CDC suggests this approach based on high Ct value alone, even in the absence of epidemiologic information. When possible, re-extract and re-test before you report results. Below are further CDC laboratory resources:

• Monkeypox Information for Laboratory Personnel
• How to Report Results from Orthopoxvirus, Non-Variola Orthopoxvirus, and Monkeypox Virus Laboratory Diagnostic Testing
• Laboratory Procedures and Biosafety Guidelines
• U.S. Monkeypox 2022: Situation Summary
• CDC Laboratory Outreach Communication System (LOCS)

On August 2, the California Society of Pathologists (CSP) and the CAP in partnership with the California Medical Association (CMA) successfully amended Senate Bill 250 to include a payment safeguard to protect against adverse claims impacts on pathologists and patients.

The groups inserted an amendment mirroring the CAP’s statutory payment safeguard language, previously advocated for, and included in the AMA’s model prior authorization reform legislation. The CAP has been actively engaged as states pursue “gold cards” which exempt qualified providers from prior authorization requirements for select services who have previously demonstrated high performance and adherence to evidence-based medicine.

The California legislation prohibits health care plans and insurers from requiring prior authorization from contracted health professionals for services if it would have been approved no less than 90% of the prior authorization tests in the most recent annual contracted period.

The legislation failed in the 2022 session and will likely be reintroduced next year with CAP’s-CSP’s-CMA’s amendments. The CAP continues to monitor state proposals to ensure pathologists and clinical laboratories are not subject to denials and reductions of payment because of whether the qualified provider failed to use a laboratory benefit management program, or otherwise availed a waiver for prior authorization in the ordering of the laboratory service.

It’s the last week to take the August Advocacy News Quiz. See how you compare against your fellow CAP members and brag about your top scores on social!     

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Your Advocacy Update newsletter will take a scheduled break September 6 for the Labor day holiday. The next issue will be on September 13, 2022. For more immediate updates, please check out our Twitter feed @CAPDCAdvocacy.