Advocacy Update

• CAP Advocacy Secures Increases for Cancer Coverage and Physician Reimbursement
• Download CAP’s Latest Pathology Workforce and Economic Trends from 2024 Practice Characteristics Survey Report
• CAP Pushes for Payment and LDT Regulation Reform Through End of 2024
• UnitedHealthcare Announces Physicians Need to Submit Z-Codes with CPT Codes Starting Feb. 1
• FDA Releases 2025 Medical Device Guidance Documents
• Webinar: What Will Be the Impact of the Final 2025 Fee Schedule on Your Practice?

Newly released payment regulations from the Centers for Medicare & Medicaid Services (CMS) include additional payment and expanded coverage policies advocated for by the CAP. Following the CAP’s initial analysis on November 1, there are more changes affecting pathologists and laboratories detailed in the 2025 final Physician Fee Schedule and Quality Payment Program Regulation and the Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgical Center Payment System Final Rule.

CAP Defeats Hospital Payment Change

The CMS had proposed to move surgical pathology tissue exam by a pathologist (CPT code 88309) to the lower Ambulatory Payment Classification (APC) 5673 “Level 3 Pathology” from APC 5674 “Level 4 Pathology.” If this proposed change had been finalized, it would have resulted in a 57% decrease in the payment amount and would not have aligned with the much more complex set of resources required to examine these specimens.

The CAP argued in a letter to the CMS that the service includes complex Level VI surgical pathology evaluation representing the most complex surgical pathology tissue examinations by pathologists requiring arduous specimen preparation. Additionally, the proposed reassignment created a resource cost rank order anomaly with other physician services (such as CPT code 88307 APC 5673 “Level 3 Pathology”) and the technical costs will not be fully recovered from each unit of service. The CAP stated that the unique complexity of specimens associated with these services warrants a level 4 pathology APC.

Because of the CAP’s advocacy efforts, the CMS maintained the APC assignment of APC 5674 for CPT code 88309 which was finalized by the CMS in the HOPPS Final Rule.

Expansion of Colorectal Cancer Coverage

Beginning on January 1, 2025, the CMS will expand its coverage of screening services for colorectal cancer to include Computed Tomography Colonography. The CAP supported previous proposals to expand coverage of colorectal cancer screening coverage. Expansion would directly advance health equity by promoting access and removing barriers for much needed cancer prevention and early detection within rural communities and communities of color that are especially impacted by the incidence of colorectal cancer, the CAP said in a letter to the CMS on September 9.

Additionally, the CMS finalized a proposal to remove coverage of double contrast barium enema. Finally, complete colorectal cancer screening tests that include a follow-on screening colonoscopy after a Medicare covered non-invasive stool-based colorectal screening test, or a Medicare covered blood-based biomarker screening, will not have to pay cost-sharing for the follow-on colonoscopy.

Fine Needle Aspiration Codes Not Misvalued

In the 2025 Medicare Physician Fee Schedule, the CMS noted that an interested party previously nominated fine needle aspiration services, CPT codes 10004, 10005, 10006, and 10021, as potentially misvalued and suggested that they should be re-reviewed. The CAP had stated in a letter to the CMS, that these codes were not potentially misvalued and therefore should not be re-evaluated. In the final rule, the CMS agreed with the CAP and indicated are not potentially misvalued.

The CAP published the 13th edition of the 2024 Practice Characteristics Survey Report on November 12, available only to CAP members. The survey provides a primary source of basic data about board-certified pathologists, how they practice, and how they are being compensated. It also tracks the latest changes in the workforce and new trends such as adoption of digital pathology technology, insurance company prior authorization mandates, and how immigration policy affects hiring decisions.

Highlights from the report include:

• 63% of practice leaders plan to hire at least one pathologist in the next three years.
• Half of respondents anticipate no change in gross income from 2023 to 2024 and 11% expect a decrease.
• 17% of practice leaders were approached by private equity investors but opted not to sell.
• 40% of practice leaders reported that, over the last two years, visa requirements either prevented them from considering certain candidates for open positions, prevented them from hiring certain candidates, or both.
• The most significant scope of practice infringements reported by pathologists in their practice over the past 24 months came from cytotechnologists, pathologists’ assistants, non-PhD laboratory scientists, and Doctors of Clinical Laboratory Science (DCLS).
• 10% percent of practice leaders reported that pathologists in their practice use remote sign-out for primary diagnosis.
• 28% of practice leaders reported that their practice digitizes slides using Whole-Slide Imaging, up from 20% in 2022.

Download the full 2024 Practice Characteristics Survey Report .

For questions on the report, please email practicesurvey@cap.org.

- Login and membership required

With Congress returning to Washington, DC following the November election, the CAP is strongly advocating to pass legislation to stop payment cuts to physicians and protect pathologists and laboratories from overregulation in 2025. Through the remainder of 2024, is the CAP is focused on:

Medicare reform

The CAP is mobilizing CAP grassroots advocates to get cosponsors for, and urge the passage of, the Medicare Patient Access and Practice Stabilization Act of 2024. The CAP will continue contacting and engaging House and Senate leadership and the key committees: Senate Finance, House Ways and Means, and House Energy and Commerce.

Take action now!

Laboratory-Developed Test (LDT) Regulation Reform

The CAP is also pushing for passage of legislation for the oversight of LDTs in lieu of the Food and Drug Administration (FDA) LDT final rule, or a delay in the implementation of the rule.

Take action now!

The CAP continues to engage with member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, the House Energy and Commerce Committee, and House and Senate leadership. In the coming weeks, there will be meetings with lead congressional offices on the Verifying Accurate Leading-edge IVCT Development Act (VALID).

Visit our Lobbying and Political Action page for more information.

On November 1, UnitedHealthcare notified the CAP that physicians will need to begin submitting the Z-Code with the CPT code beginning Feb. 1, 2025, for Medicaid plans. They are working with providers offering assistance as they register for Z-Codes. They also are reaching out to providers with reminders and status updates. Information about how to obtain a Z-Code and the status of the provider’s registration can be found at the following link: DEX (dexzcodes.com). The list of CPT codes can be found here: DEX test code registry phase list - UnitedHealthcare commercial plans (uhcprovider.com).

The CAP has opposed this requirement for specific Z-code identifiers on claims to receive payment. In a letter dated May 31, 2024, the CAP urged UnitedHealthcare to reconsider the new requirements claiming they are needlessly disruptive, burdensome, and financially demanding for pathologists and impede patient access to medically necessary testing.

Additionally, UnitedHealthcare is expanding the use of Z-Codes for certain molecular diagnostic test services on facility and professional claims to its Medicaid benefit plans. Providers may begin registering tests that are in scope for phase 1 of the Z-Codes for their Medicaid implementation now. As a reminder, if providers have already registered their tests as part of the Medicare or commercial benefit plan implementation, they will not need to register again and can use the same Z-Code and CPT code combination for Medicaid plans.

Providers with questions or who need assistance should email united_genetics@uhc.com.

Each year, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) identifies the guidance documents (medical devices and radiation-emitting products) to be included in CDRH’s annual guidance agenda for their upcoming fiscal year (October 1 -September 30).

The agency recently released a list of the 2025 guidance documents that the FDA intends to develop, were issued as drafts, or previously issued as final guidance, with the goal of receiving feedback about whether any should be revised or withdrawn.

Among the priority guidance documents CDRH intends to publish during FY 2025, CAP Advocacy will monitor the following:

Final guidance topics:

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff
• Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)

Draft guidance topics:

• Artificial Intelligence-Enabled Device Software Functions:
• Lifecycle Management Considerations and Pre-market Submission Recommendations Enforcement Discretion Policy for Certain Laboratory Developed Tests for Unmet Needs
• Frequently Asked Questions

In addition to advocating on behalf of the specialty, the CAP is a resource and partner as your laboratory prepares for upcoming regulations. See the latest resources, webinars, and advocacy efforts offered by the CAP to help prepare for the five-stage phaseout policy on the CAP’s Laboratory-Developed Test Oversight page.

The Centers for Medicare & Medicaid Services (CMS) released the final 2025 Medicare payment regulations, including rules for the Medicare Physician Fee Schedule and the Quality Payment Program.

On December 4 at 2 PM ET/ 1 PM CT, the CAP will offer a complimentary live webinar where CAP experts will review final regulations that will impact Medicare payment for services and pathologists’ participation in the quality initiatives. Webinar presenters will be the Council on Government and Professional Affairs Chair A. Joe Saad, MD, CPE, FCAP; Economic Affairs Committee Chair Ronald McLawhon, MD, PhD, FCAP; and Quality and Clinical Data Registry Affairs Committee Chair Gregary Bocsi DO, FCAP.

Register today.