Advocacy Update

• Over 1,000 Pathologists Participate in the CAP’s Recess Rally!
• Common Questions Answered About the CAP’s Amicus Brief on LDTs
• CAP Warns of Negative Consequences in Proposed MAC Consolidations
• CAP Supports Updated Information Blocking Rule, Asks for Flexibilities to Reduce Patient Harm
• 6 Benefits to Joining the AMA
• Register Today for Upcoming LDT Webinar! Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
• Take Our News Quiz for October

October Recess Rally is off to a strong start! Over 1,000 pathologists have taken action through CAP's Action Center writing their local legislators opposing gene patent reform, fighting Medicare cuts, and encouraging Congress to stop the Food and Drug Administration (FDA) laboratory-developed test (LDT) final rule. Over 400 members of Congress have received close to 4,000 letters from pathologists discussing the critical issues affecting pathology since August.

Not signed up for PathNET? It’s the best and easiest way to get updates on new action alerts. You can even get text alerts sent directly to your phone. Through PathNET, pathologists can build relationships with their federal and state legislators to help ensure laboratory regulations do not place undue burden on the profession but still ensure accuracy and safety.

Don’t forget, members of Congress are back in their home states and districts until after the election for October recess. During this time, pathologists have valuable opportunities to meet with their members of Congress so they can help protect your laboratory from federal regulatory overreach and to advocate against payment cuts to pathology services.

Your representatives and senators in Congress will only act on these issues if they hear from you. Members of Congress want to hear from you, as a constituent and a physician, especially on health care policy. They are listening, as many are campaigning for your vote.

Questions? Email pathnet@cap.org.

Our laboratory-developed test (LDT) oversight FAQ webpage now includes commonly asked and answered questions about the CAP’s amicus brief court filing from October 7.

In the amicus brief, the CAP urged a US Federal District Court to vacate the FDA regulation for several reasons, including the ultimate impact on patient access to these critically important diagnostic tests and the FDA failing to adequately justify the rule’s unsustainable costs that will hinder the development of LDTs.

The CAP has raised concerns over proposed consolidations of Medicare Administrative Contractors (MACs) and the potential for adverse coverage decisions that would harm seniors and other patients. In an Oct. 4 comment letter, the CAP said the effect of the proposed consolidations may lead to exclusions or limits on coverage for Medicare populations without appropriate stakeholder input. The CAP has advocated for increased MAC consistency and transparency because consolidation and mismanaged coordination between MACs can lead to the spread of a poorly developed local coverage determination (LCD), inappropriately limiting coverage for Medicare beneficiaries.

The Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) on September 4, seeking public feedback on consolidating Medicare Administrative Contractor (MAC) jurisdictions from four to two and awarding future MAC contracts with a 10-year period of performance, from the current seven-year term.

Additionally, these decisions may not reflect the specific geographic region they are intended to serve. CAP strongly encourages CMS to address existing flaws in the current LCD process before considering any further MAC consolidations so as not to exacerbate existing problems with the local coverage process.

The CAP also said that workload distribution and cybersecurity risks are examples of consolidation aspects that require further analysis. The CAP recommended that the CMS ensure an equitable workload to help maintain a fair distribution.

The CAP voiced its approval for the objectives in a draft federal information regulation to advance interoperability and support the exchange of electronic health information, on October 3. The CAP sent comments to the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP) on ASTP’s HTI-2 Proposed Rule, supporting ASTP’s objectives to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information. The CAP cautioned that the promotion of interoperability, if done improperly, posed the risk of unintended regulatory consequences and patient harm.

The CAP’s comments included:

• Support for changes to the ASTP’s Health IT Certification Program designed to store authentication credentials to protect the confidentiality and integrity of their stored authentication credentials including updating the requirements in the “multi-factor authentication” (MFA) certification criterion.
• Support for updating the United States Core Data for Interoperability (USCDI) standard—a baseline set of data that can be commonly exchanged across care settings for a wide range of uses—in ASTP’s Health IT Certification Program by adding USCDI v4 and establishing an expiration date of January 1, 2028, for USCDI v3 for purposes of the Program. USCDI v4 is more closely aligned with CLIA requirements.
• Support for ASTP’s addition of the Laboratory Order Interface (LOI),/Laboratory Results Interface (LRI) to ASTP’s Health IT Certification Program. However, the CAP urged ASTP to proceed cautiously as implementing these standards too quickly may inflict burden on pathologists and laboratories.
• The CAP requested that for ASTP’s new certification requirements to support access, exchange, and use of diagnostic images via imaging links, pathology and clinical laboratory images be excluded from those requirements unless images are reported to the electronic health records.
• Support for information blocking enhancements updating two existing exceptions and establishing two new exceptions responding to concerns about patient privacy, care access, and electronic health information (EHI) sharing preferences.

The CAP is dedicated to helping ASTP avoid unintended consequences and patient harm in the rulemaking process.

The American Medical Association (AMA) is the physicians’ powerful ally in patient care. By becoming a member, you can play a role in shaping the future of medicine while growing professionally. AMA dues are not deductible as a charitable contribution for federal income tax purposes but may be partially deducted as a business expense. Anyone joining or renewing for 2024 must call the AMA Member Service Center at 800-262-3211 and might be eligible for a discounted rate.

Why join the AMA?

• Get exclusive member benefits and discounts
  Enjoy perks and savings to enhance your personal and professional life.
• Make your voice heard
  Join the most influential voice in medicine driving change at the federal and state levels.
• Grow professionally
  Expand your professional network and join interest-based member groups through AMA sections.
• Attend events
  Gain admission to events specifically for physicians, residents and fellows, and medical students.
• Access JAMA
  Enjoy unlimited online and mobile access to the JAMA Network journals and a print copy of JAMA. All members receive free online access to the JAMA Network™, which brings together JAMA®, JAMA Network Open™ and the 11 specialty journals. All members are also eligible to receive AMA Morning Rounds®.
• Earn CME
  Tap into the AMA Ed Hub™, with thousands of resources and courses to support lifelong learning, licensure, and certification.

Learn about AMA membership dues here.

Under the Food and Drug Administration (FDA) regulation, laboratories with laboratory-developed tests (LDTs) must have a process in place for adverse event reporting starting May 6, 2025. The CAP’s second webinar in our series will discuss existing accreditation requirements and ways laboratories can comply with the FDA rules on medical device-related adverse event reporting. Accreditation experts will review best practices that relate to quality management and review real world scenarios. Join us on Nov. 7, Noon-1 PM CT to learn more!

Speakers

• Bobbi S. Pritt, MD, FCAP, chair, Council on Scientific Affairs
• Earle S. Collum, MD, FCAP, vice chair, Council on Accreditation

Register today!

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