Advocacy Update

• CAP Urges CMS to Increase Pathology Residency Slots, Payments for CAR T-Cell, and Quality Measurements
• AMA CPT Announces New Digital Pathology Codes
• Advocacy Win: CMS Retains Diagnostic Codes for Next Generation Sequencing
• CDC Publishes Monkeypox Virus PCR Testing Procedure
• Test Your CAP Advocacy Knowledge

In the proposed Hospital Inpatient Prospective Payment System regulation, the CAP asked the Centers for Medicare & Medicaid Services (CMS) to increase residence slots for pathology, monitor, and evaluate CAR T-cell therapies, and increase stratification of quality measures in hospital reporting programs. The CAP advocates fair payment for the value pathologists provides and reduced regulatory burdens on pathologists.

Proposed Payments for Indirect and Direct Graduate Medical Education Costs

In the June 17 letter to the CMS, the CAP outlined the critical need to increase pathology slots in residency programs. Much like our population, the physician workforce is aging, with nearly 45 percent of active physicians in the United States being 55 and older. In the letter, the CAP stated that physician shortages in specialty care are “significant and are often overlooked by policy makers at this time when primary care is at center stage.”

Payment Adjustment for CAR T-cell Clinical Trial and Expand Access Use Immunotherapy

Additionally, the CAP supported the CMS’s efforts to assess the appropriateness of the therapies assigned to MS–DRG 018 and its continued work with stakeholders to evaluate the resource costs to improve the predictability and stability of hospital payments for complex, novel cell therapies, such as CAR T-cell therapy. Pathologists play a critical role as integral members of the cancer patient management team, including patient education, care management, and providing CAR-T cell therapy clinical services. With its increased use, CAR-T-cell therapy is an expensive, evolving service with unique challenges. The CAP asked the CMS to consider these issues as the agency updates the MS-DRG 018 Chimeric Antigen Receptor (CAR) T-Cell and Other Immunotherapies.

Quality Data Reporting Requirements for Providers Changes

The CAP supported the CMS’ proposed stratification of quality measures in hospital reporting programs so clinicians can identify areas to advance health equity and made recommendations on implementation tactics. For example, the CAP suggested that the CMS “consider measures for stratification individually or by specialty rather than a one-size-fits-all approach.” Additionally, the CAP suggested that CMS:

1. Ensure that all efforts generate actionable data that reflect meaningful differences between clinicians
2. Communicate the implications of stratification prior to making any payment-related decisions
3. Provide feedback on stratification, including the ability to request that stratification is changed, removed, or added based on available data, and avoid sub-regulatory actions that could compromise the process.

Additionally, the CAP asked the CMS to consider logistics when transitioning Digital Quality Measures, data standardization, and FHIR-based reporting for electronic clinical quality measures. The CAP opposes any new requirements that would increase burden for clinicians or impose undue hardship on pathologists.

The CAP successfully advocated for the inclusion of new CPT digital pathology codes for 2023. The CAP worked with the American Medical Association (AMA) CPT Editorial Panel to add 13 new digital pathology add-on codes. The new digital pathology Category III CPT codes will be used to report additional clinical staff work and service requirements associated with digitizing glass microscope slides for primary diagnosis. The AMA CPT will also add a new heading in the Category III section and guidelines to define digital pathology digitization procedures. The CAP applauds the AMA for their public release of this information, and the CAP will provide resources throughout 2022 to inform CAP members about anticipated CPT changes.

Through its advocacy, the CAP worked with the AMA CPT Editorial Panel to improve reporting of digital pathology services. As a result, the new codes will help pathologists, pathology practices, and laboratories providing digital pathology digitization procedures appropriately report these services. The new digital pathology codes will be published on July 1, 2022, and effective on January 1, 2023.

The CMS agreed to retain over 100 diagnostic (ICD-10) codes that they proposed to remove from the Next Generation Sequencing (NGS) national coverage determination by July 1. Additionally, the Florida Medicare Administrative Contractor (MAC) proposes to retire its local coverage policy for special stains.

CMS Keeps Over 100 ICD-10 Codes

The CAP has applauded the CMS for keeping over 100 diagnostic codes in its NGS national coverage determination. In April the CAP and over 30 other medical laboratory health organizations asked the CMS not to remove the diagnostic codes from the national coverage determination for NGS as it would have resulted in non-coverage of genomic testing for many patients with advanced cancer and thousands of denied Medicare Part B claims. This is a significant victory for patients, pathologists, and other providers who rely on the tests.

Florida MAC Retires LCD

First Coast Service Options, the Medicare Administrative Contractor (MAC) for Florida, is proposing to retire its Special Histochemical Stains & Immunohistochemical Stains local coverage determination (LCD) and is accepting comments until July 23rd. The First Coast Service Options stated it wants to retire its Special Histochemical Stains & Immunohistochemical Stains LCD because “a review of the current literature revealed that the LCD and its corresponding Billing and Coding Article are neither reflective of the current standard of practice, nor having a significant impact on Medicare expenditures.” The CAP worked in concert with its Contractor Advisory Committee (CAC) representatives and other pathologists at the local level to oppose this coverage policy when it was first proposed and implemented in 2015. The CAP welcomes this recent development, and the CAP will again engage regarding this policy during the current comment period supporting the proposed retirement of the policy.

On June 6, the Centers for Disease Control and Prevention (CDC) published a Real-Time PCR test procedure to detect the Monkeypox virus. This assay is designed to detect the Monkeypox virus and is intended for international partners and laboratories interested in pursuing a laboratory-developed test (LDT). This procedure includes sequence information for primer and probe development and cycling conditions.

Public health laboratories have the capacity for the current testing demand. Laboratories with specimens suspected of containing the Monkeypox virus should contact their state or territorial public health department (contact list) as soon as possible. Please refer to the CDC Specimen Collection Guidelines for Monkeypox virus for more information.

Below are additional CDC resources:

• U.S. Monkeypox 2022: Situation Summary
• Real-time PCR assays for the specific detection of Monkeypox virus West African and Congo Basin strain DNA
• Detection of Monkeypox virus with real-time PCR assays

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