Advocacy Update

• LDT Webinar: Preparing for Implementation of FDA’s Laboratory-Developed Test Final Rule
• CAP Urges Horizon to Reverse Pathology Policy that Disrupts Patient Care
• HHS Creates Process for Resubmitting Improperly Batched or Bundled Claim Disputes
• Reminder: The 2024 Practice Characteristics Survey Is Open until May 10. We Need Your Participation!
• HHS Releases New AI Nondiscrimination Rule
• Take Our News Quiz for May

The Food and Drug Administration (FDA) released its final regulation on the oversight of laboratory-developed tests (LDTs) with some changes advocated for by the CAP. During this live presentation and discussion, CAP leaders will offer their initial analysis of the regulation and discuss the impact on laboratories. Join CAP President Donald Karcher, MD, FCAP; Council on Government and Professional Affairs Chair Joe Saad, MD, FCAP; Council on Scientific Affairs Chair, Brad S. Karon, MD, PhD, FCAP; and moderator Michael Fraser, PhD, CEO of the College of American Pathologists for an informative and engaging 1-hour discussion on Thursday, May 23 at 11am EST/10am CT.

Panelists will discuss:

• Overview of the final rule
• Timeline for implementation
• CAP’s recommendations adopted in final rule
• CAP’s LDT legislative advocacy efforts going forward
• Q & A

Register here!

On April 25, the CAP wrote a letter to Horizon Blue Cross Blue Shield of New Jersey opposing a policy that limits the ability for pathologists to be reimbursed for diagnostic services performed on patients. The letter follows an April 3, 2024, meeting between Horizon representatives and CAP leaders where the CAP stressed that it should be up to the patient and their doctor to determine where diagnostic services occur, with the common goal of delivering the healthiest outcome. The CAP had also written Horizon in November 2023 with similar concerns and a request for clarification around the policy update. In its most recent letter, the CAP has called on Horizon to reverse its decision to enforce this policy, and to revise it so that clinicians can continue to choose local pathologists who are part of their model of coordinated care, which is an essential element in quality patient care.

The CAP explained that differentiating where specimens are sent, and which pathologists are “credentialed,” based only on place of service results in fractured care that by its nature disrupts health care quality and adds unnecessary burden for patients and their physicians. In situations where the diagnostic biopsy leads to further hospital-based care (for example, an office-based fine-needle aspiration to diagnose cancer), the current requirement that patient samples be sent outside the local health system or care team prevents the local pathologist from participating in care coordination at the time of initial diagnosis or correlating these critical initial findings with subsequent surgical specimens obtained in the hospital. The CAP also emphasized the potential for delay in diagnosis and treatment, as well as logistical challenges and risks that are involved in this kind of policy.

The CAP will continue to engage with Horizon to ensure insurer-imposed policies do not disrupt care coordination, add patient burdens, or compromise quality care. For more on the CAP’s advocacy in the private sector, visit www.cap.org/advocacy/payments-for-pathology-services/private-sector-advocacy.

The Departments of Health and Human Services, Labor, and the Treasury (collectively, the Departments) have created a new process for resubmitting Independent Dispute Resolution (IDR) disputes that were originally improperly batched or bundled. This new resubmission process, released on May 1, is automated in the federal IDR portal used by physicians and other providers to dispute out-of-network claims for patient services.

The CAP had supported the creation of the IDR process as part of the passage of the No Surprises Act. However, the CAP has taken issue with how the administration has implemented the law over the years and opposed measures that favored the insurance industry over physicians. For example, the CAP has argued for additional flexibility around batching claims for pathology services and for decreased fees for low-dollar disputes to ensure an equitable and accessible IDR system.

Parties now have a new way to resubmit disputes that were originally improperly batched or bundled. Resubmission requests will come directly from the federal IDR portal instead of from your certified IDR entity, and initiating parties now will have a unique web form they can access via a link in their resubmission email notification to complete the resubmission process.

For additional information and instructions on how to complete and submit the new Notice of IDR Initiation – Resubmission web form, refer to the following resource link below:

• User Guide: Notice of IDR Initiation – Resubmission Web Form

Questions can be directed to the Federal IDR Questions mailbox at FederalIDRQuestions@cms.hhs.gov.

The 2024 Practice Characteristics Survey is open, and all pathologists are asked to share critical, first-hand data from their practices to assist in shaping CAP’s advocacy priorities as it captures and quantifies changes in the practice of pathology. Pathologists are facing far too many challenges that interfere with practicing and patient care. We all agree the issues are many, including (but certainly not limited to):

• Declining Medicare reimbursement
• Increasing prior authorizations
• Fulfilling staffing shortages
• Changing practice models
• Concerns over practice scope infringements
• So many more

This is why the CAP critically needs your input to build the next advocacy agenda. The information garnered from this nationwide survey will identify the changes in pathology practice and economics to better inform CAP advocacy priorities.

How do I participate?

On April 29, all board-certified pathologists practicing in the United States (with the exception of those still in training and pathologists who are Emeritus members of the CAP) should have received an email from CAP President Donald Karcher with a unique link to the survey. Please use this secure link to complete the 10-15 minute survey no later than Friday, May 10. If you are unable to locate your email invitation, please email PracticeSurvey@cap.org with your full name and preferred email and we will send your unique link to the survey.

What can I expect as follow-up?

Although all responses are confidential and will never be associated with any individual or any specific practice, we will share the anonymized aggregate results with participants to help inform and guide future decisions regarding your practice. In addition, because your input is a valued component to building a robust advocacy agenda, upon completion we invite you to select a $10 gift card from Amazon, Starbucks, or Visa as a small token of our gratitude.

The Health and Human Services (HHS) Office for Civil Rights (OCR) released the Nondiscrimination in Health Programs and Activities final rule on April 26 to implement section 1557 of the Patient Protection and Affordable Care Act (ACA) that prohibits a provider from discriminating on the basis of race, color, national origin, sex, age, or disability in a health program or activity, any part of which is receiving federal financial assistance, including credits, subsidies, or contracts of insurance. In this final rule, OCR clarified that this prohibition on discrimination extends to the use of AI.

Covered entities to this rule include recipients of federal financial assistance. In the final rule, OCR clarified that Medicare Part B is considered federal financial assistance, and that health care providers who accept federal funding from Medicare Part B are covered by this rule.

Pathologists covered under the rule need to take steps to identify and mitigate risks of discrimination in their use of AI. This provision will be effective within 300 days of 60 days after the final rule is published in the federal register.

View the HHS Final Rule: Frequently Asked Questions here.

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