Advocacy Update

• AMA Releases 30 New Digital Pathology CPT Codes Developed by the CAP
• CAP Urges Pathologists to Respond to AMA-Mathematica Physician Practice Expense Survey to Ensure Accurate Medicare Pay Rates
• New Penalties for Blocking Electronic Health Information Do Not Apply to Physicians
• CAP Urges FDA to Ensure Post-Market Surveillance Burdens Don’t Fall to Pathologists for AI Software
• Register: Proposed 2024 Medicare Physician Fee Schedule Webinar
• Take Our News Quiz for July

The American Medical Association’s (AMA) CPT Editorial Panel released the new CAP developed CPT codes on June 30. e f. The CAP worked with the AMA CPT Editorial Panel to establish new digital add-on codes. These 30 additional digital pathology CPT code numbers, descriptors and revised guidelines are available now allowing pathology practices time to implement the new codes into their billing systems ahead of the January 1, 2024 effective date.

Digital pathology enables the acquisition, management, and interpretation of pathology information generated from digitized glass microscope slides. The new CPT codes are intended to capture and report additional clinical staff work and service requirements associated with digitizing glass microscope slides for primary diagnosis. Category III add-on codes 0751T-0763T, and new codes 0827T-0856T may be reported in addition to the appropriate Category I service code when the digitization procedure of glass microscope slides is performed and reported in conjunction with the Category I code for the primary service. Digital pathology CPT guidelines were also revised clarifying that each Category III add-on code is reported as a one-to-one unit of service for each primary pathology service code.

As a result of CAP advocacy, the new codes will help pathologists, pathology practices, and laboratories providing digital pathology digitization procedures appropriately report these services. The new digital pathology code numbers descriptors and guidelines were released June 30 and will be effective January 1, 2024. The early release of these new Category III codes will assist practices as they prepare to integrate the new codes into their billing systems ahead of the 2024 effective date.

The CAP is one of more than 170 health care organizations supporting a new national study by the American Medical Association (AMA) and Mathematica that will collect representative data on physician practice expenses. The aim of the AMA Physician Practice Information Survey is to better understand the costs faced by today’s physician practices to support physician payment advocacy.

Pathologists and their practices must watch for invitations to complete the survey. Invitations and reminders about the costs survey will come from PPISurvey@mathematica-mpr.com with the subject line: “American Medical Association requests your input on physician practice expense and patient care hours.” Invitations and reminders about physician hours worked will come from PhysicianHoursSurvey@mathematica-mpr.com with the subject line: “Please help to update accurate physician payments.” Your input will ensure future pathology payment rates are accurate.

The study will serve as an opportunity to communicate accurate financial information to policymakers, including members of Congress and the Centers for Medicare & Medicaid Services (CMS). The survey will be administered from July 2023 – April 2024.

Physicians will be randomly selected to participate. If contacted, you will receive a $100 stipend for participating in the survey and your individual practice data will be kept private. Participation is voluntary but critical to the success of efforts to support accurate resource-based physician payment.

Again, the CAP strongly urges all physicians who are selected for the surveys to respond as soon as possible. For more information read the Physician Practice Information Survey Methodology Report.

The Department of Health and Human Services (HHS) Office of Inspector General published a final regulation to implement penalties for blocking patients from their own electronic health information. Importantly, the penalties apply to health information technology vendors, exchanges, and networks, but also do not apply to physicians and other providers of health care. The HHS will develop a separate rule establishing disincentives for physicians and other providers.

Information blocking is a practice by an "actor" that is likely to interfere with the access, exchange, or use of electronic health information (EHI), except as required by law or specified in an information blocking exception. The CAP has known there would be penalties against information blocking established because Congress passed the 21st Century Cures Act in 2016. Up until now, the government has used enforcement discretion to not penalize vendors or providers while regulations are implemented. The Office of Inspector General regulation will levy fines up to $1 million per information blocking violation.

The latest HHS regulation implementing information blocking penalties defined entities that are subject to an information blocking penalty as:

• health IT developers of certified health IT,
• entities offering certified health IT,
• health information exchanges, and
• health information networks.

Enforcement of the information blocking penalties will begin 60 days after publication of the final rule. For more information on blocking regulations go to the HHS’ website on information blocking.

While the CAP is in support of draft guidance concerning market submission of artificial intelligence and machine learning medical software, the CAP urged the US Food and Drug Administration to take the necessary steps to ensure regulatory burden is not transferred to pathologists that are required to provide local verification of enabled device software functions.

The FDA published its regulatory approach tailored to artificial intelligence/machine learning (AI/ML)-enabled devices to increase patients’ access to safe and effective AI/ML-enabled devices in April. The guidance proposes recommendations on what information manufacturers should include in an FDA marketing submission so that they can alter their AI/ML software over time without needing to fill out another FDA marketing submission. The CAP analyzed the draft guidance and provided the FDA with feedback on June 30. Because of the expected impact of these technologies on the practice of pathology and laboratory medicine, and the need to adhere to CLIA in the laboratory setting, the CAP has a keen interest in the regulatory approach for AI/ML technologies.

In the June 30 letter, the CAP supported the concepts proposed within the current draft guidance however, for clinical laboratories to meet CLIA requirements, it is imperative that performance monitoring or regulatory responsibilities do not place undue burden on pathologists or other physicians.

Read the CAP’s full comments

Do you know how much your Medicare pay will increase or decrease in 2024? Register in advance for our proposed 2024 Medicare Physician Fee Schedule webinar on July 26 at 1 PM ET/ Noon CT. During this session, you will learn the latest Medicare payment policies concerning individual pathology services and the Quality Payment Program next year.

Our expert presenters will also answer your questions. They are Jonathan Myles, MD, FCAP, chair, Council on Government and Professional Affairs; Diana Cardona, MD, FCAP, chair, Quality and Clinical Data Registry Affairs Committee; and Ronald W. McLawhon MD, PhD, FCAP, chair, Economic Affairs Committee. Secure your attendance for this complementary program today.

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