Advocacy Update

• CAP Applauds House Committee Efforts to Stop Medicare Cuts and Stabilize Pathology Payments
• CAP Gives House Panel Recommendations to Improve Health Outcomes
• What Will Be the Impact of the Final Fee Schedule on Your Practice?
• CAP Advocacy Win: FDA issues Guidance on Updating Breakpoints in AST Device Labeling
• FDA to Host Oct. 31 Webinar on Laboratory-Developed Tests Proposed Rule
• CAP Positions on Forensic Pathologists and Pathologists Assistants
• Take Our News Quiz for October

The CAP posted a statement and sent messages to members of Congress last week commending the House Energy and Commerce Committee for holding hearings on the Saving Access to Laboratory Services Act legislation to extend incentive payments for participation in eligible alternative payment models, Provider Reimbursement Stability Act of 2023, and the Improving Seniors Timely Access to Care Act of 2023. The CAP urged Congress to take up and pass these bills to improve patient care, stabilize physician payments, and reduce burdens on pathologists and laboratories.

“These important pieces of legislation will not only reduce undue burdens on pathologists and cut down on administrative obstacles to the timely diagnoses that patients deserve, they will help stabilize the physician payment system and provide much needed stability for medical laboratories and the patients they serve,” said CAP President Donald S. Karcher, MD, FCAP. “It is imperative, for patients and physicians, that Congress provide much needed relief in the form of crucial financial stability, reducing reporting burdens, and shortening prior authorization decisions for the future of health care in our nation. As the Committee continues to discuss and develop policies to reform the physician fee schedule and improve patient outcomes, the CAP asks that the Committee pass legislation to mitigate the impact of the impending Medicare cuts for 2024, and beyond, until long-term relief is enacted into law.”

The CAP issued several recommendations to the House Budget Committee Health Task Force to reduce health care spending, encourage innovation, and ensure patients receive quality, affordable health care on October 13. The CAP’s advocacy with the task force aims to protect the value of pathology services and ensure access to pathologists in communities across the United States.

In August, House Budget Committee Chair Rep. Jodey Arrington (R-TX) established the Health Care Task Force, led by Chair Rep. Michael Burgess, MD, (R-TX) to broadly examine solutions to improve patient outcomes and reduce health care spending. To help inform the panel’s work, the Health Care Task Force released a request for information (RFI) to solicit feedback from independent experts and stakeholders on solutions to improve outcomes and reduce federal health care spending in the budget.

The CAP made recommendations in a comment letter sent October 13. The recommendations focused on:

Passing legislation before the end of the year to provide relief from the Medicare cuts scheduled to take effect in 2024, Improving the Quality Payment Program by passing legislation to maintain quality measures and extending and increasing the Advanced APM Incentive Payment Reforming the Physician Fee Schedule (PFS)’s Budget Neutrality Requirement Passing bills that will place a larger investment on training future pathologists to keep up with the rising demand in the field.

The Centers for Medicare & Medicaid Services (CMS) is getting ready to release the final 2024 Medicare payment regulations, including rules for the Medicare Physician Fee Schedule and the Quality Payment Program.

On Thursday, November 30 at 3 PM ET/ 2 PM CT, the CAP will offer a complementary 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 Bosci, DO, FCAP.

Register today.

On September 29, the Food and Drug Administration (FDA) issued guidance to provide recommendations to update susceptibility test interpretive criteria (STIC) (also referred to as “breakpoints”) in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint updates posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria website. Previously, the CAP and 4 other health care organizations advocated to the FDA for regulatory oversight of breakpoints for the protection of public health. Through the combined efforts of industry, government, standards development organizations, and clinical laboratories following this new FDA guidance, patients safely will be safeguarded going forward.

A breakpoint represents a defined antibiotic concentration or zone of inhibition diameter that serves as a gatekeeper for antimicrobial use. A breakpoint enables interpretation and reporting of an AST result as “susceptible,” “intermediate,” or “resistant,” which guides clinical therapeutic decision-making.

The CAP and other groups had argued to the FDA for a clear path forward not only for breakpoint updates, but also for “bug/drug” combinations that are routinely tested and reported using Clinical and Laboratory Standards Institute (CLSI) breakpoints. Manufacturers have not been updating breakpoints and many labs do not know that the breakpoints are obsolete.

This causes widespread struggle of clinical laboratories to stay up to date with current breakpoints. The use of obsolete breakpoints limits the global public health response to antimicrobial resistance, as pathogens of serious or urgent concern can go undetected, spread to additional patients and across healthcare centers and communities.

Without receiving official acknowledgment of these life-saving breakpoints from the FDA, the CAP added breakpoint updates to all new laboratory accreditations to help mitigate the problem and protect patients.

On Tuesday, October 31 the US Food and Drug Administration (FDA) will host a webinar to provide information on the proposed rule regarding laboratory-developed tests (LDTs). Registration is not necessary. The presentation, printable slides, and transcript from the webinar will be available at CDRH Learn under “In Vitro Diagnostics.”

Separately, due to the complexity of the rule and implications for laboratory testing, the CAP is calling on the FDA to extend the comment period to at least 120-days to give stakeholders more time to review the proposal and respond. The proposed rule calls for public comment and recommendations for alternative enforcement approaches.

During the webinar, the FDA will:

• Provide an overview of the rulemaking proposal to amend the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory.
• Describe the proposed phaseout of FDA’s general enforcement discretion approach to LDTs.
• Host a Q&A session based on questions submitted by Monday, Oct. 23 at CDRHWebinars@fda.hhs.gov. Questions will not be taken during the live webinar.

Date: October 31, 2023

Time: 1:00 PM - 2:00 PM ET

Click this link to join the webinar: https://fda.zoomgov.com/j/1601249212?pwd=UnlIbThyOXN2R3gvTGJveERxRXpUdz09External

Passcode: k+S8kN

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

• U.S. Callers Dial: 833-568-8864 (Toll Free)
• For higher quality, dial a number based on your current location:
• +1 669 254 5252 US (San Jose)
• +1 646 828 7666 US (New York)
• +1 646 964 1167 US (US Spanish Line)
• +1 415 449 4000 US (US Spanish Line)
• +1 551 285 1373 US
• +1 669 216 1590 US (San Jose)
• International Caller Dial: Please check the international numbers available
• Webinar ID: 160 124 9212
• Passcode: 298020

If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

During the CAP23 meeting of the House of Delegates, a question was raised concerning the CAP’s position on the scope of practice for forensic pathologists, pathologists assistants, and the National Association of Medical Examiners (NAME) autopsy standards. To provide greater awareness of the CAP’s policies, the following points highlight the CAP’s position in this area:

• The CAP advocates the autopsy as a valuable, and in some circumstances, essential postmortem medical procedure that requires professional consultation and constitutes the practice of medicine. The consultant pathologist is a physician trained in autopsy pathology.
• The CAP advocates that chief medical examiners/directors of medical examiner systems be physicians certified in anatomic and forensic pathology by the American Board of Pathology (or an equivalent certifying organization) and have at least two years of experience practicing forensic pathology.
• Unless otherwise permitted by law, pathologists’ assistants cannot act independently of the pathologist; finalize written reports; or make preliminary, official, or other pathologic interpretations.

In 2022 in Arizona, for example, the CAP did not support a bill pertaining to pathologists assistants perform autopsies independently. The Arizona Society of Pathologists and the CAP successfully amended the bill to ensure pathologists assistants assisting with the autopsies could only do so under the direct supervision of licensed forensic pathologists More information can be accessed by CAP members on our Public Policies webpage.

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