Advocacy Update

• LDT Action Alert Added to CAP’s August Recess Rally!
• CAP Advocacy Win! New CPT Codes and Medicare RVUs for CAR-T Therapy Services Available January 2025
• Final 2023 Feedback Released for MIPS Participants
• CDC Issues Health Advisory on HPV B19
• Mpox a Public Health Emergency of Concern: WHO
• Take Our News Quiz for August

CAP members are asking Congress to intervene before the Food and Drug Administration (FDA) implements its oversight regulations on laboratory-developed tests (LDTs) in a new action alert added to our August Recess Rally. Pathologists can easily use the CAP’s PathNET Action Center to act on the LDT oversight alert and engage in other advocacy activities during a crucial time when legislators are meeting with their constituents throughout an August recess.

On August 16, hundreds of CAP members began asking their members of Congress to enact legislation like the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023 to address the oversight of LDTs before the end of 2024, as well as delay implementation of the final FDA rule. Take action now if you haven’t already!

The August recess is one of the best times to protect your laboratory from regulatory overreach and advocate to stop cuts to pathology services. Your representatives and senators in Congress will only act on these issues if they hear from you. While members of Congress have left Washington for August, they are at home meeting with constituents in your community. CAP members must take advantage of opportunities to connect and educate their legislators on pathology’s top legislative objectives. These include:

• Enact legislation on LDT oversight: Congress must pass legislation like the VALID Act and delay implementation of the FDA regulation. Download our LDT advocacy toolkit for more information.
• Stop Medicare cuts to clinical laboratory services: Urge Congress to enact the Saving Access to Laboratory Services Act (SALSA) to stop cuts of up to 15% and reform Medicare’s pay system for clinical lab services.
• Stop Medicare cuts to pathologist’s services: It’s time for Congress to address constant cuts to Medicare payment and stabilize the system.

CAP members can also use the CAP’s Action Center to request a meeting with their legislators or host a lab tour with a senator or representative.

Thanks to the CAP’s hard work and advocacy, physicians providing Chimeric Antigen Receptor T-Cell (CAR-T) Therapy, a treatment for certain types of cancer, received exciting news earlier in July: new billing codes and defined payment for their work. The CMS released the 2025 Medicare Physician Fee Schedule Proposed Rule, which included four new CPT codes to describe the procedures required for creating and administering CAR-T therapy. The CMS also established Relative Value Units (RVUs) to compensate physicians for their work related to these services. The establishment of these new codes and RVUs were the result of a multiyear effort led by the CAP.

At the May 2023 American Medical Association (AMA) CPT Editorial Panel meeting, the CAP and a multispecialty group successfully advocated for the addition of four new CPT codes to report CAR-T services and added a new subsection in the CPT manual with reporting guidelines. The codes were created as Category III codes in 2018.

The new CPT codes are:

• 3X018 Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day
• 3X019 Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage)
• 3X020 Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration
• 3X021 Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

CAP Leads Multispecialty Effort

To ensure these services were appropriately valued, the CAP led a multispecialty effort to develop and present RVU recommendations at the September 2023 AMA RUC meeting. As outlined in the proposed 2025 Medicare Physician Fee Schedule, the CMS proposed the RUC recommended work RVUs for all four CAR-T services. The CAP is pleased with this result and will urge the CMS to finalize the proposed RUC recommendations for physician work.

The AMA will assign and publish the new specific code numbers in late summer/fall for use starting January 1, 2025. Physicians will still need to use the CPT Category III temporary codes (0537T-0540T) to report the services for the rest of this calendar year.

On August 12, the Centers for Medicare and Medicaid Services (CMS) released the final 2023 performance feedback for Merit-Based Incentive Payment Systems (MIPS) participants. This includes the final score for individuals or groups who submitted data to the CMS for MIPS in 2023 and the payment adjustment that will be applied in 2025.

MIPS participants can log into their QPP account to view their final score and payment adjustment. If an individual or group believes there was an error in the calculation of their payment adjustment (eg, non-patient-facing status was not applied), targeted reviews can be submitted until 8 PM on October 11 via their QPP account. Please contact the CMS Help Desk for assistance.

The Centers for Disease Control and Prevention (CDC) published a Health Alert Network Health Advisory about current increases in human parvovirus B19 activity in the United States on August 13. Parvovirus B19 is a seasonal respiratory virus that is transmitted through respiratory droplets by people with symptomatic or asymptomatic infection.

In the first quarter of 2024, public health authorities in 14 European countries observed unusually high numbers of cases of parvovirus B19. In the United States, there is no routine surveillance for parvovirus B19, and it is not a notifiable condition. However, the CDC has recently received reports indicating increased parvovirus B19 activity in the United States. Data include increased test positivity for parvovirus B19 in clinical specimens and pooled plasma from a large commercial laboratory, and reports of clusters of parvovirus B19-associated complications among pregnant people and people with sickle cell disease.

The proportion of people with IgM antibodies, an indicator of recent infection, increased among all ages from <3% during 2022–2024 to 10% in June 2024; the greatest increase was observed among children aged 5–9 years, from 15% during 2022–2024 to 40% in June 2024. Among plasma donors, the prevalence of pooled samples with parvovirus B19 DNA >104 IU/mL increased from 1.5% in December 2023 to 19.9% in June 2024.

The World Health Organization (WHO) declared mpox a public health emergency of international concern on August 14 after a growing number of cases in Africa. WHO is working with countries and vaccine manufacturers on potential vaccine donations and coordinating with health care partners to facilitate access to vaccines, therapeutics, diagnostics, and other tools.

Mpox has been reported in the Democratic Republic of the Congo for more than a decade and the number of mpox cases increased steadily through the years. In 2023, reported cases increased significantly and already the number of cases reported so far in 2024 has exceeded last year’s total with more than 15,600 cases and 537 deaths, the WHO said.

In 2022, the multi-country outbreak of mpox led to public health emergencies being declared by WHO and the Centers for Disease Control and Prevention (CDC). Those health emergencies were declared to be over in May 2023 after there had been a sustained decline in global cases.

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