Advocacy Update

• CAP Advocacy Spurs Senate Support for Medicare Pay Increase
• CAP, AMA Ask Congress for 2025 Medicare Pay Fix
• Closing Briefs Filed in Lawsuits Against FDA LDT Oversight
• FDA Responds to Question from CAP on LDT Oversight
• CAP Tells FDA to Pause Change Control Plan Guidelines
• Webinar: What Will Be the Impact of the Final 2025 Fee Schedule on Your Practice?
• Trump Nominates New Leads for CMS, CDC, and FDA
• CDC Flags First Case of MPXV in US
• Editor's Note: Next Regular Advocacy Update is December 10

A bipartisan group of 40 senators signed a November 21 letter to Senate leadership urging them to address the 2.8% Medicare payment cut set to go into effect January 1, 2025. More than 650 CAP members asked their senators to sign the letter in 1,300 messages sent to lawmakers earlier this month.

Pathologists used the CAP's Action Center to encourage senators to support the proposal. The senators said the 2025 cut represents the fifth consecutive year that the Medicare program has published a physician fee schedule lowering payments to physicians. "The persistent instability in the health care sector—due, in part, to consistent payment cuts—impacts the ability of physicians and clinicians to provide the highest quality of care," they said.

Read the letter

The CAP joined with the American Medical Association (AMA) and dozens of specialty and state medical societies in calling on congressional leadership to prevent a 2.8% cut to 2025 Medicare physician payment rates before the end of this year.

The coalition affirmed its support for a 1.8% payment rate increase for 2025, the groups said in a November 15 letter to House and Senate leaders. "By securing a positive update that aligns with a portion of rising practice expenses, Congress can provide essential stability for physicians in 2025 allowing time for comprehensive reform to the Medicare physician payment system to begin in earnest in the 119th Congress," the physician groups said.

Read the letter

Plaintiffs filed closing legal briefs late on November 25 in the lawsuit seeking to overturn the Food and Drug Administration regulation for laboratory-developed tests (LDTs). The American Clinical Laboratory Association (ACLA) and Association for Molecular Pathology (AMP) again asked the federal courts to vacate the regulation set to take effect May 6, 2025.

Read the ACLA brief

Read the AMP brief

The CAP has filed its own amicus brief urging the court to stop the FDA LDT rule from being implemented. Read the CAP's amicus brief to the court cases ACLA et al. v. FDA, and AMP et al. v. FDA, US District Court Eastern District of Texas. The FDA is scheduled to file its closing brief by December 23.

The Food and Drug Administration (FDA) answered a question submitted by the CAP on the oversight of laboratory-developed tests (LDTs). The CAP has submitted more than 200 questions collected from pathologists and laboratories. Here is the FDA's response to one of those questions:

Question: There is confusion about the regulatory obligations for LDTs developed after the issuance dates. We have received many questions about how to classify the tests, what documentation is needed, and can laboratories bring these systems online now.

Answer: FDA classifies in vitro diagnostics (IVDs) manufactured by laboratories, including laboratory developed tests, in the same way it does other IVD test systems.

Test systems are a set of components—such as reagents, instruments, and other articles—that function together to produce a test result. Test systems include components and are accompanied by instructions for use for sample preparation and pre-analytical processing. Classification of the test system is based on the intended use and risk of the test system.

The most efficient method for an IVD manufacturer to determine the classification of a device type that has already been classified by FDA is by searching the product classification database, included on the resources and references page of the webinar slide deck. Searching FDA's 510(k), premarket approval (PMA), and De Novo databases may also be helpful in understanding what specific IVDs fall within a given device type and how such IVDs are regulated.

An IVD may be of a type that has not already been classified by FDA and, therefore, would not be in the product classification database. As a reminder, device types that have not been classified by FDA previously, and that were not on the market prior to the enactment of the Medical Device Amendments on May 28, 1976, are automatically Class III unless they are reclassified by FDA. If an IVD has not been classified, manufacturers should assess the risk of their IVD and submit the appropriate premarket submission based on the assessed risk. If the manufacturer believes their IVD is high risk, a PMA is likely required. If the manufacturer believes their IVD is low or moderate risk, the IVD may be eligible for de novo classification. The de novo process provides a pathway to class I or class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

FDA FAQ

The FDA hosts an FAQ page with answers to common questions about LDT oversight. If you cannot find the answer you're looking for, please contact FDA at LDTFinalRule@fda.hhs.gov.

With the Food and Drug Administration (FDA) planning to implement new oversight rules for laboratory-developed tests (LDTs), the CAP strongly urged the agency to delay final draft guidance entitled Predetermined Change Control Plans for Medical Devices. The CAP is concerned that the guidance, in combination with the LDT rulemaking, will result in a significant reduction in the number of highly accurate LDTs.

A Predetermined Change Control Plan is documentation developed by a test developer and submitted to the FDA to outline planned modifications and assessments of those modifications to a device. The plan is reviewed as part of premarket submission, negating the need for additional market submissions for future modifications.

The CAP noted that medical practice undergoes continuous process change because of drug development and advancements in medicine. Clinical laboratories adapt and change in parallel to support or extend clinical practice. In addition to concerns over the timing of the guidance, the CAP said it would create additional regulatory burden and uncertainty for laboratory-based developers as most clinical laboratories frequently use and modify low-risk tests to address clinical needs for their local patient populations.

Read the CAP's letter to the FDA

The Centers for Medicare & Medicaid Services (CMS) released the final 2025 Medicare payment regulations, including rules for the Medicare Physician Fee Schedule and the Quality Payment Program.

On Wednesday, December 4 at 1:00 PM CT/2:00 PM ET, the CAP will offer a complimentary 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 Bocsi DO, FCAP.

Register today

President-elect Donald Trump announced his picks for CMS, CDC, and FDA last week.

Mehmet Oz, MD, is asked to lead the Centers for Medicare & Medicaid Services (CMS). Dr. Oz is a cardiothoracic surgeon and former television host.

Former Florida representative Dave Weldon is nominated as director of the Centers for Disease Control and Prevention (CDC). Weldon previously served on the House Labor and Health and Human Services Appropriations Subcommittee in Congress.

Johns Hopkins gastrointestinal surgeon Marty Makary, MD, is nominated as commissioner of the Food and Drug Administration (FDA). All nominees require Senate confirmation.

The CAP will continue to provide updates on the presidential and congressional transition.

On November 18, the Centers for Disease Control and Prevention (CDC) issued a health alert with information about the first case of clade I mpox (MPXV) diagnosed in the United States. The alert includes recommendations to clinicians about preventing, diagnosing, treating, and reporting MPXV cases. There have been no changes to CDC clinical guidance on MPXV since HAN Health Update 516.

Clinicians should follow specimen collection guidelines (including collecting two swabs per 2-3 lesions) to ensure specimen availability for clade-specific testing, the CDC said. This testing will help distinguish cases that are part of the ongoing clade II mpox global outbreak from those that are part of this clade I outbreak. The CDC recommends sending clinical specimens to a laboratory that can perform clade-specific MPXV testing as quickly as possible. If you need assistance locating relevant laboratories in your area, email poxvirus@cdc.gov.

Read here for more details and recommendations

Due to the Thanksgiving holiday, the CAP's next weekly Advocacy Update newsletter will be sent on December 10.