Advocacy Update

• ICYMI: CAP Advocacy Protects Pathology Payments in the Proposed 2025 Medicare Physician Fee Schedule
• ONC Releases Information Sharing Proposed Rule Without LIS Certification
• You Can Help Determine Medicare Payment! Physician Practice Information Survey from the AMA and Mathematica Survey Extended Through August
• Reminder: CAP Urges Independent Laboratory Practices to Fill Out Survey Ending in August
• Possible Shortage of Blood Culture Media Bottles from BD Life Sciences
• How will FDA’s LDT Rule Impact Your Laboratory and Patients? Share Your Story!
• Register Today! Proposed 2025 Medicare Physician Fee Schedule Webinar
• Take Our News Quiz for July

The proposed 2025 Medicare Physician Fee Schedule released on July 10 highlights the continuous advocacy efforts by the CAP to protect the value of pathology services. Due to the CAP’s efforts, the Centers for Medicare & Medicaid Services (CMS) has proposed to increase the relative values of three apheresis services, provide coverage for four new CAR T-cell services, and increase the clinical labor rates for key laboratory clinical labor types. The proposed 2025 Medicare Physician Fee Schedule does, however, include cuts to physicians, including pathologists, and other providers such as independent laboratories. These cuts largely stem from the expiration of two congressional Medicare pay relief packages that were intended to offset the previously finalized cuts in the 2023 and 2024 Medicare Physician Fee Schedules. The CAP strongly opposes these cuts and is actively lobbying Congress to mitigate the decreases before they take effect.

The CAP will provide comments to the CMS within the next 60 days on the proposals that impact the specialty. Briefly, here are the key issues influencing payment for pathology services in the 2025 proposed rule:

• The continued budget neutrality adjustments and the expiration of congressional relief continue to negatively affect pathologists and other specialties throughout the physician fee schedule. Download the impact table showing the proposed changes to pathology services in 2025.
• The CMS increases Medicare Quality Payment Program (QPP) requirements for 2025, making it more difficult for eligible clinicians to thwart off payment penalties.
• Learn more: Register for the CAP’s July 30 webinar providing a comprehensive overview of the proposed fee schedule changes to pathology services and the QPP.

In its proposed 2025 Quality Payment Program regulations the CMS will:

• Leave the performance threshold to 75 points for 2025. The CAP supports CMS’ decision not to raise it.
• Maintain the data completeness threshold at 75 points for 2025, a previously finalized policy
• Not add or remove any measures from the Pathology Specialty Measure Set
• Reduce the available options for Improvement Activities, including several IAs that are commonly performed by pathologists

The CAP continues to advocate for pathologists’ success in the MIPS program. We encourage practices (and their billing companies) to review the scoring changes and contact CAP at mips@cap.org to understand the availability of higher-scoring measures and how to best report them.

On July 10, the Office of the National Coordinator for Health Information (ONC) released Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed regulation. The HTI-2 proposed rule is a continuation of ONC’s efforts to advance interoperability and improve information sharing among patients, providers, payers, and public health. The rule does not include laboratory information system (LIS) certification despite the request for information on LIS certification in the HTI-1 proposed rule.

This proposed regulation is a continuation of the ONC’s HTI-1 rule, which the CAP submitted comments on in June 2023, supporting the overall objectives of the proposed rule.

The current provisions in the HTI-2 proposed regulation that could have implications for laboratory and pathology data include:

• The United States Core Data for Interoperability (USCDI) standard is a baseline set of data that can be commonly exchanged across care settings for a wide range of uses and is a required part of certain certification criteria in the Health IT Program. In the HTI-2 Proposed Rule, ONC proposes to add USCDI v4 and establish an expiration date of January 1, 2028, for USCDI v3 for purposes of the Health IT Program. The CAP advocated in favor of this in its comments, noting that USCDI v4 is more closely aligned with CLIA requirements.
• ONC is proposing several changes to existing certification criteria as well as the creation of new certification criteria related to health IT for public health. Some of these changes impact the way that certified health IT (which does not include LISs) communicate to laboratories and receive pathology data. The CAP is currently assessing these changes.
  
• The proposed rule would update two existing information blocking exceptions and establish two new exceptions.
  • Proposed new Protecting Care Access Exception would, under specified conditions, cover actors’ limiting electronic health information (EHI) sharing in order to reduce a risk of potentially exposing patients, providers, or persons who facilitate care to legal action based on the mere fact that they sought, obtained, provided, or facilitated lawful reproductive health care. The Protecting Care Access Exception would also apply where an actor limits sharing of a patient’s EHI potentially related to reproductive health care in order to protect that patient from potential exposure to legal action.
  • Proposed new Requestor Preferences Exception would provide actors a framework under which they can be confident they will not be committing information blocking if they agree to a requestor’s ask for restrictions on when, under what conditions, and how much EHI is made available to that requestor.
  • Revisions to existing exceptions would:
    • Expand application of the existing Privacy Exception to further support more actors’ practices protecting the privacy of patients’ health information.
    • Update the existing Infeasibility Exception to offer actors more clarity and more flexibility under certain conditions. Other proposals would also enhance clarity around the codified definitions of certain terms for information blocking purposes.

The CAP is currently assessing the effects these provisions will have on pathologists and laboratories and will submit comments that advocate for regulations to protect patients without overburdening pathologists and laboratories.

For more information, the ONC will be hosting an information session on Wednesday, July 17 at 2:00 PM ET. Register for the session here.

Download the HTI-2 Proposed Rule Fact Sheet Here.

The CAP strongly urges all physicians who are selected for the survey to respond as soon as possible.

The CAP is one of more than 170 health care organizations supporting a national study by the 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. 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 has been extended through at least the end of July.

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.

If you work for an independent laboratory, you can make a difference in determining your Medicare payment by participating in a CAP/Mathematica led survey effort. Be on the lookout for an email from Mathematica regarding the Clinician Practice Information (CPI) Survey as it an extremely important component of the methodology for which the Centers for Medicare and Medicaid Services (CMS) uses to determine your Medicare reimbursement.

The data firm Mathematica has sent out a national survey of independent laboratory practices to collect updated and accurate data on practice and laboratory costs which are a key element of physician fee schedule payment for pathology services. The survey results will be used by the Centers for Medicare and Medicaid Services for its physician fee schedule payment methodology. These data have not been updated since last collected over 15 years ago and it is critically important to update these data to ensure accurate payment.

This survey, endorsed by over 170 other medical societies and associations, will serve as a supplement to the American Medical Association led Physician Practice Information Survey.

The CAP contracted with Mathematica, an independent research company with extensive experience in survey methods and health care delivery and practice costs, to conduct this survey.

Independent laboratory practices will be randomly selected to participate. The survey is focused on collecting financial information and should be completed by the person(s) at the clinician practice who can best answer questions about finances and expenses. The time it takes to complete this survey will vary depending on the size and complexity of the practice. It is critical that this survey be completed to ensure that the needed updates are made to practice expenses and costs used to ensure accurate Medicare payment.

To thank practices for their participation, Mathematica will send a summary report that compares their data with national averages. The information shared will be kept private, reported in aggregate, and used only to inform the national estimates of practice expense per patient care hour. If you have any questions, please contact Mathematica at CPISurvey@mathematica-mpr.com, or by phone at 1-833-714-0022.

On June 11, BD Life Sciences sent a letter to inform BD BACTEC Blood Culture System Users that they may experience intermittent delays in supply of some BD BACTEC blood culture media bottles over the coming months. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are working with BD Life Sciences to learn more about these supply challenges and to ensure impacted users are informed regarding best practices for blood culture utilization and quality assurance.

Please review the FDA recommendations for the development of prioritization and conservation strategies regarding the use of blood culture media bottles.

Do you anticipate the Food and Drug Administration’s (FDA) laboratory-developed test (LDT) final rule creating unnecessary burdens for pathologists or negatively impacting patients’ lives, innovation, or the economy on your community? Your story could be used to help legislators understand how the oversight of tests should be based on protecting patients and providing access to safe diagnostic tests with a framework that is the least burdensome for laboratories.

Fill out the form, and tell us more.

On Tuesday, July 30 at Noon ET/ 11 AM CT, the CAP is offering a complementary live webinar where CAP experts will review proposed 2025 Medicare payment regulations, including the proposed Medicare Physician Fee Schedule and the Quality Payment Program 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.

Secure your attendance today.

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