Advocacy Update

• CAP Engages with First Coast, Novitas on New Digital Pathology Code Policy
• CMS Releases MIPS Payment Adjustments for 2022, Which Are Higher Than Previous Years
• CAP Sends Medicare Recommendations to Improve Coverage of Emerging Technologies
• PHOTO: Dr. Jared Abbott, Dr. Renee Ellerbroek and Rep. Zach Nunn
• Take Our News Quiz for August
• Editor’s Note

The CAP requested a meeting with First Coast Service Options, a Medicare Administrative Contract (MAC), servicing providers in Florida, Puerto Rico, and the U.S. Virgin Islands as well as Novitas, providers in DC, Delaware, Maryland, New Jersey, and Pennsylvania, to discuss a new requirement for pathologists to document how the digitization of glass microscope slides is medically reasonable and necessary when submitting claims. According to First Coast, an example of a potentially reasonable and necessary service includes if a slide requires an outside consultation that would normally require mailing of the slide, digitization could potentially be medically reasonable and necessary if either the slide represents the only slide demonstrating the pathology of interest (and loss of the slide would mean loss of irreplaceable material), or the consultation is required urgently and mailing a slide would take too much time and the delay would put the patient’s health at risk.

After August 5, 2023, failure to provide a statement on Item 19 of the CMS-1500 claim to document the need for the digitization of glass microscope slides may result in claims rejected as unprocessable.

The CAP plans to address concerns about these requirements with First Coast Service Options at an upcoming meeting as well as send correspondence outlining how this creates an unnecessary documentation burden on pathologists.

The Centers for Medicare & Medicaid Services (CMS) released Merit-based Incentive Payment System (MIPS) performance feedback and final scores for the 2022 performance year, which determines whether a physician will receive a positive, neutral, or negative payment adjustment on Medicare services furnished in 2024. MIPS-eligible pathologists should view this information on the Quality Payment Program (QPP) website.

The CAP appreciates that the positive payment adjustments are increasing, but the 2022 MIPS scoring numbers are higher because they include a bonus pool for fewer high performers, and also likely more negative payment adjustments since the COVID exemption was no longer automatic in 2022. However, the bonus pool no longer exists after 2022. Additionally, the proposed 2024 Medicare proposed rule for the QPP makes it more difficult to reach these levels of performance: scoring complexity changes the amount measures are worth, the performance threshold increases, and data completeness requirements increase. The CAP expects that 2023 scores may not be as high as 2022, especially for high performers.

The CMS has released several resources for more information, including:

• 2022 MIPS Performance Feedback FAQ – Highlights what performance feedback is, who receives the feedback, and how to access it on the Quality Payment Program website.
• 2022 MIPS Performance Feedback Patient-Level Data Reports Supplement – Reviews the data included, and answers questions about the downloadable patient-level reports included in performance feedback.
• 2024 MIPS Payment Year Payment Adjustment User Guide – Reviews information about the calculation and application of MIPS payment adjustments, and answers frequently asked questions.

If a physician believes there was an error in the calculation of the MIPS final score, he or she should request an appeal, which the CMS calls a targeted review, by October 9, 2023. For more information about how to request a targeted review, please refer to the 2022 Targeted Review User Guide.

The CAP’s registry offers the highest scoring opportunities for pathologists. If you have any questions or want to talk to the CAP about MIPS, email mips@cap.org.

The CAP is advocating for the Medicare program to include a new pathway to cover innovative tests and add transparency measures on how coverage decisions are made. On August 28, the CAP sent a letter for the Center for Medicare and Medicaid Services (CMS) with recommendations to improve a proposed procedural notice outlining a new Medicare coverage pathway that will achieve "more timely and predictable access to new medical technologies for people with Medicare,” the CAP said.

According to the CMS, the new transitional coverage for emerging technologies pathway for breakthrough devices would support improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population. Under this new pathway, the Food and Drug Administration (FDA)-designated breakthrough devices that fall within a Medicare benefit category can obtain national coverage for three to five years, pending the development of evidence.

The CMS acknowledged that diagnostic tests, as devices, would be eligible for the new pathway. The CMS stated, however, that coverage determinations for most diagnostic laboratory tests granted breakthrough designation should continue to be made by the Medicare Administrative Contractors (MAC) through existing pathways instead of leveraging the new pathway.

In the letter to CMS, the CAP stated its concerns with the following:

• Inclusion of diagnostic tests in TCET pathway – The CAP is urging the CMS to remove the language suggesting that coverage for diagnostic tests qualifying for breakthrough designation should continue to be determined by the MACs through existing pathways. The CAP further encourages the CMS to evaluate future ways to broaden the pathway to include innovative medical technologies beyond FDA-designated breakthrough devices and existing Medicare benefit categories.
• Transparency - The CAP has concerns about the unspecified criteria the CMS may use to prioritize innovative technologies the agency believes have “the potential to benefit the greatest number of individuals with Medicare.” The CAP is alarmed about coverage pathways that have the potential to arbitrarily decide which technologies receive a head start or other advantage in the traditional coverage process.
• Timelines and stakeholder involvement - While the CMS is attempting to improve both predictability and transparency, there are gaps in the pathway timeline. The CMS acknowledges some timeframes may take longer, such as with the evidence preview and FDA market authorization. Given these gaps, it is unclear if the proposed timeline for the pathway is realistic.
• Sharing evidence with MACs - The CAP supports an opt-in approach where a manufacturer would voluntarily notify the CMS of its interest in pursuing the pathway and can withdraw from the process at any point. If a manufacturer withdraws from the process during the premarket stage, the CAP believes that the CMS should make every effort to ensure the protection of a developer or manufacturer’s proprietary information about a device that it has developed.

The CAP has applauded the CMS’ continuing commitment to ensuring Medicare beneficiaries have more timely and predictable access to new and innovative medical technologies and will continue to work with the agency to move this new Medicare coverage pathway forward.

Jared Abbott, MD, PhD, FCAP and Renee Ellerbroek, MD, FCAP attended a political fundraiser in Iowa where they met with Rep. Zach Nunn (R-IA), Rep. Mariannette Miler-Meeks, MD (R-IA) Rep. Jason Smith (R-MO) and Sen. Joni Ernst (R-IA). They discussed Medicare physician fee cuts, scheduling a lab tour and the House Financial Services Committee interest in learning more about the private health insurance markets.

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Editor’s Note

Due to the Labor Day holiday, the next edition of Advocacy Update will be September 12. If important news breaks, the CAP will send a special edition of the newsletter or post information on our Twitter account @CAPDCAdvocacy.