Advocacy Update

• New CAP Report on Health Insurer Interference in Patient Care
• CAP, AMA Grassroots Advocacy to Mitigate Medicare Cuts Gets Bipartisan House Support
• Read FDA Responses to LDT Questions
• Register for CAPs Upcoming LDT Webinar: Ready Your Laboratory for the FDA’s Stage 1: Adverse Event Reporting Requirement
• FDA Plans Webinar about Total Product Life Cycle Approach to IVDs
• UnitedHealthcare Implements Phase 2 of Z-code Requirement
• CMS Announces Automatic Extreme and Uncontrollable Circumstances Exceptions for MIPS-Eligible Clinicians Impacted by Hurricanes
• US Works to Rebuild IV Solution Supply after Hurricane Helene
• Take Our News Quiz for October

On October 15, the CAP released a new report detailing how insurer interference impacts pathologists and patients. Insurer interference happens when private insurance companies dictate medical decisions to boost revenue under the guise of controlling costs. Pathologists report more of these instances in the private health sector, with insurers restricting patient-physician and physician-physician relationships by limiting the number of in-network physicians or exclusively contracting with providers and facilities. These disruptions create barriers that prevent pathologists from providing patients with the necessary care.

In the report, the CAP identified five recommendations to address insurer interference:

• Require adequate networks that include hospital/facility-based physicians.
• Restrict in-network steering/tiering and prohibit economic/cost-only network criteria.
• Maintain physician-led team-based care.
• Include regular monitoring/audits and meaningful enforcement.
• Increase antitrust scrutiny.

Download the white paper here. Watch a video statement from CAP President Donald Karcher, MD, FCAP here.

The CAP’s grassroots network, along with the American Medical Association (AMA) and other physician groups, answered the call during our October Recess Rally by urging congressional representatives to sign onto a House letter telling leadership to stop 2025 Medicare cuts. The letter included 233 co-signers (140 Democrats, 93 Republicans). It was led by Reps. Mariannette Miller-Meeks (R-IA), Jimmy Panetta (D-CA), Greg Murphy (R-NC), Raul Ruiz (D-CA), Larrry Bucshon (R-IN), Kim Schrier (D-WA), John Joyce (R-PA), and Ami Bera (D-CA).

House members want their colleagues to pass legislation to replace pending Medicare payment cuts with an inflationary payment update, make targeted adjustments to the Medicare Physician Fee Schedule’s budget neutrality requirements, and limit yearly changes to the conversion factor.

Pathologists are projected to receive a 2.4% cut in pathology payments in 2025.

With the proposed cut for 2025, over the last six years, payments to pathologists have decreased by approximately 7% while physician practice costs (medical supplies, lab personnel, professional liability insurance) have increased more than 17%. With inflation, in 2025 alone, pathologists are anticipated to experience a net 6% reduction in revenues as Medicare reimbursement is expected to fall by as much as 2.4% while expenses are expected to increase by 3.6%.

The Centers for Medicare & Medicaid Services (CMS) are expected to release the final 2025 Medicare Physician Fee Schedule on or about November 1, 2024.

The Food and Drug Administration (FDA) has posted its responses to the most commonly asked questions about its rule on laboratory-developed tests (LDTs). The questions were received through the FDA’s mailbox address, ldtfinalrule@fda.hhs.gov.

The FDA’s responses are on its FAQ page and here:

• Definitions and General Oversight
• Phaseout Policy and Enforcement Discretion Policies
• Labeling
• Premarket Review
• Investigational Use
• Specific Test Categories or Technologies
• Resources and Interactions with FDA

If you have a question about a specific test, the FDA suggests you contact the agency through the pre-submission process, which includes an opportunity for a meeting regarding such a test.

Under the FDA regulation, laboratories with LDTs must have a process in place for adverse event reporting starting May 6, 2025. The CAP’s second webinar in its series focused on implementation of the rule 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 associated with quality management and discuss real world scenarios. Join the webinar on November 7, from 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!

Watch a recording of the first webinar, Understanding the Impact of the FDA’s LDT Risk Classification on Your Laboratory by clicking here.

The FDA will host a webinar for laboratories and other interested parties to discuss its Total Product Life Cycle (TPLC) approach to the oversight of in vitro diagnostic products (IVDs). The TPLC approach allows the FDA to review and monitor medical devices throughout their life cycle by considering all available information on safety and effectiveness. Join the webinar on Thursday, October 24, from 1PM - 2 PM ET to learn more!

Registration is not necessary.

The FDA expects high turnout for the event. The agency recommends you join early to ensure access. A recording and transcript of webinar will be posted to the FDA’s website for those who miss the presentation.

Meeting Link: https://fda.zoomgov.com/j/1616994355?pwd=cWZhS2RucTU4ZUNLbGF5ZFN5Wlo5dz09External Link Disclaimer

Passcode: %KeTf9

Despite objections from the CAP, UnitedHealthcare will implement phase 2 of its Z-code requirement. Tests subject to phase 2 will need to include the appropriate Z-code on claims beginning with dates of service on or after November 1, 2024, to be considered for reimbursement.

The CAP has opposed this requirement for specific Z-code identifiers on claims to receive payment. In a letter dated May 31, 2024, the CAP urged UnitedHealthcare to reconsider the new requirements claiming they are needlessly disruptive, burdensome, and financially demanding for pathologists and impede patient access to medically necessary testing.

UnitedHealthcare requires providers to submit the appropriate unique test identifier (DEX Z-Code®) and appropriate CPT code for Molecular Diagnostic Tests (MDT) and other molecular pathology services. More information about the Palmetto DEX Z-Code® and how to obtain one can be found at https://app.dexzcodes.com.

Impacted laboratories that need assistance can contact the insurer at united_genetics@uhc.com.

The CMS has announced that MIPS-eligible clinicians in areas affected by Hurricanes Beryl, Debby, Francine, and Helene will automatically have all four MIPS performance categories reweighted to 0% and receive a score equal to the performance threshold, resulting in a neutral payment adjustment for the 2026 payment year.

The Extreme and Uncontrollable Circumstances exceptions can be overridden if a clinician submits data on two or more MIPS performance categories (e.g., quality and improvement activities). The QPP Participation Look Up tool will be updated in December with all qualifying events that trigger the EUC. Those impacted by hurricanes are encouraged to see the CMS MIPS Extreme and Uncontrollable Circumstances website for more information.

A factory that produces intravenous (IV) fluids will be rebuilt using the Defense Production Act. The Baxter International factory was flooded during Hurricane Helene in September. Damage to the plant made worse a nationwide shortage of IV fluids. As a result, some hospitals have postponed surgeries and procedures.

According to an October 9 letter written by Health and Human Services (HHS) Secretary Xavier Becerra, the Baxter facility “provides a significant portion of the IV solution, irrigation fluid and peritoneal solution supply in the United States. There were shortages of normal saline IV fluids, normal saline irrigation fluid, sterile water irrigation and dextrose 5% IV fluids pre-dating Hurricane Helene, and the Baxter disruption is worsening IV fluid constraints.”

The FDA will rely on temporary imports of some IV fluid products from overseas to help meet patient needs while the shortage continues.

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