Advocacy Update

• FDA Releases LDT Compliance Guide for Laboratory Manufacturers
• How will FDA’s LDT Rule Impact Your Laboratory and Patients? Share Your Story!
• Over 350 Pathologists Urge Congress to Cosponsor SALSA Act Before August
• CAP Advocacy Expands Thyroid Cancer Molecular Testing Coverage
• HHS Puts Penalties in Place for Providers that Block the Exchange of Health Information
• CAP Urges Senate to Address Workforce Shortages in Underserved Areas
• Register Today! Proposed 2025 Medicare Physician Fee Schedule Webinar
• CDC Issues Advisory for Increased Risk of Dengue Virus Infections in the United States
• Take Our News Quiz for July

Following the Food and Drug Administration (FDA) laboratory-developed test (LDT) final regulation, the agency released: Laboratory Developed Tests: Small Entity Compliance Guide: Guidance for Laboratory Manufacturers and Food and Drug Administration Staff on June 25. This document is intended to be a guide to help laboratories that offer LDTs navigate the new regulatory requirements, and includes background information and guidance on:

• General Scope of Amendment and Phaseout Policy
• Enforcement Discretion Policies for Certain IVDs
• Amendment and Phaseout Policy
• Summary of FDA Compliance Expectations
• Requirements related to Complaints, Medical Device Reports, and Correction and Removal Reports
• Registration and Listing Requirements
• Device Labeling Requirements
• Investigational Use Requirements
• Quality System Requirements
• Premarket Review Requirements
• General Information

In addition to the above resources, the FDA’s webpages for Laboratory Developed Tests and IVD Regulatory Assistance provide more resources about how FDA regulates devices. CDRH (Center for Devices and Radiological Health) also offers additional resources for industry:

• CDRH Learn, a multi-media educational resource, featuring learning modules that address medical device laws, regulations, guidances, and policies, across the entire product life cycle; and
• Division of Industry and Consumer Education (DICE), which answers questions by phone and email from the medical device industry and hosts Device Advice:
• Comprehensive Regulatory Assistance, a web page for CDRH’s comprehensive regulatory education.

For questions about this document, contact LDTFinalRule@fda.hhs.gov. Learn more about what the CAP is doing around Laboratory-Developed Test Oversight.

Do you anticipate the Food and Drug Administration’s (FDA) laboratory-developed test final rule creating unnecessary burdens for pathologists or negatively impacting patients’ lives, innovation, or the economy in your community?

Your story could be used to help legislators understand how the oversight of tests should be based on protecting patients and providing access to safe diagnostic tests with a framework that is the least burdensome for pathologists.

Click here, fill out the form, and tell us more.

Over 350 pathologists responded to an Action Alert by the CAP sent to its grassroots advocacy network delivering over 1,150 messages to Congress encouraging legislators to cosponsor the Saving Access to Laboratory Services Act (SALSA) before they break for August recess.

Absent congressional action, pathologists and the laboratories they direct are facing a round of up to 15% in cuts to the Clinical Laboratory Fee Schedule in 2025 due to the inaccurate laboratory data collection caused by the Protecting Access to Medicare Act (PAMA). Congress has intervened multiple times in the past to pass legislation that stopped these cuts. While Congress has put in place a patch to prevent these cuts for 2024, we need a permanent solution.

Even if you've taken action on SALSA before, we need you to keep pushing. Please reach out to your members of Congress and urge them to cosponsor SALSA today!

On June 13, the Palmetto MolDX program and its participating Medicare Administrative Contractors (MACs), Cigna Government Services, Noridian and Wisconsin Physicians Service, posted final versions of a local coverage determination (LCD) regarding molecular testing for risk stratification of thyroid nodules. Palmetto and the contractors adopted recommendations from the CAP before finalizing the new coverage policy.

In an October 2023 comment letter to the MACs, the CAP opposed the LCD proposal that would have limited coverage only to patients who had not been tested with the same or similar assay for the same clinical indication. The CAP recommended that coverage include patients with multiple concurrent indeterminate nodules or who develop new nodules over time. The MACs agreed and the final coverage policy includes the CAP’s recommendations.

The coverage policy takes effect July 28, 2024, and applies to 23 states and several US territories.

The Department of Health and Human Services (HHS) is establishing disincentives for health care providers that have committed information blocking, according to a final regulation published on June 24. The CAP has opposed and argued against the penalties that could unfairly decrease pathologists’ Medicare payments.

This rule implements the part of the 21st Century Cures Act stating that a health care provider who knowingly commits information blocking— behavior that is likely to interfere with the access, exchange, or use of electronic health information (EHI)—will be subject to appropriate disincentives.

The CAP also opposed the rule because it may have the unfair consequence of one provider being penalized for another provider’s actions. On January 2, the CAP submitted a comment letter arguing that by implementing this rule, the HHS continues to make physician payment programs more complex.

The rule will use specific Centers for Medicare and Medicaid Services (CMS) payment programs to impose penalties on physicians accused of committing information blocking. If a provider does not participate in those specific CMS payment programs, there are no regulations currently in place to penalize them for committing information blocking. The penalties include:

• The potential for a hospital participating in the Medicare Promoting Interoperability Program to miss out on annual payment increases
• Earn lower quality scores in the Promoting Interoperability category of the MIPS (Merit based Incentive Payment System) program. Pathologists for whom the Promoting Interoperability category of the MIPs is not applicable cannot be held accountable for penalties.
• Be suspended from the Medicare Shared Savings Program, a major value-based payment program in Medicare

The penalties will be effective 30 days after the rule is published in the Federal Register, but disincentives under the Medicare Shared Savings Program won’t be imposed until after Jan. 1, 2025, according to the HHS.

More information can be found at healthit.gov/informationblocking

In a June 24 letter, the CAP recommended that Congress make larger investments in training slots when considering improvements to Medicare’s Graduate Medical Education (GME) program. The CAP responded to a proposal from a bipartisan group of Senators on the Senate Finance Committee, which has jurisdiction over the Medicare GME program, who are interested in advancing additional Medicare GME policies to address health care workforce shortages and gaps. Specifically, the CAP’s recommendations were for the Committee to:

• Add the Resident Physician Shortage Reduction Act to any GME related legislation that is drafted. The Resident Physician Shortage Reduction Act would provide 14,000 new Medicare-supported GME positions (for all physician types, including pathologists) over seven years. These positions would be targeted at hospitals with diverse needs, rural teaching hospitals, hospitals currently training over their Medicare caps, hospitals in states with new medical schools, and hospitals serving patients in health professional shortage areas.
• Consider dedicating a percentage of new Medicare-supported GME slots to pathology. As the Committee looks to add more primary care-specific slots, more pathologists are necessary to support an expanded primary care footprint to actualize the full benefits of access to a primary care physician for patients.
• Reauthorize and expand the Conrad 30 waiver program and pass loan deferment and forgiveness legislation to improve recruitment of physicians to work in rural or underserved communities.
• Study and publicize information about unused GME slots in combination with information about supply and demand for various physician specialties and subspecialities, including pathology.

Asking Congress to act on an issue works better with significant engagement by CAP members with their respective members. The CAP has asked its members to contact their members of Congress to urge passage of the Resident Physician Shortage Reduction Act. You can contact them here. For more information, review our issue brief.

Listen to “The Importance of Conrad 30 to Pathology” recorded in March 2024, this podcast features Andres Romero, MD, FCAP discussing the Conrad 30 waiver program and what it means to physicians like him.

On Tuesday, July 30 at Noon ET/ 11 AM CT, the CAP is offering a complementary live webinar where CAP experts will review proposed 2025 Medicare payment regulations, including the proposed Medicare Physician Fee Schedule and the Quality Payment Program 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.

Secure your attendance today.

On June 25, the Centers for Disease Control and Prevention (CDC) issued a health advisory to notify health care providers and the public of an increased risk of dengue virus (DENV) infections in the United States in 2024. From January 1 – June 24, 2024, countries in the Americas reported more than 9.7 million dengue cases, twice as many as in all of 2023 (4.6 million cases). In the United States, Puerto Rico has declared a public health emergency (1,498 cases) and a higher-than-expected number of dengue cases have been identified among US travelers (745 cases) during the first six months of 2024.

Six US territories and freely associated states are classified as areas with frequent or continuous dengue transmission: Puerto Rico, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau. In the rest of the United States, local transmission of DENV has been limited, with sporadic cases or small outbreaks in Florida, Hawaii, and Texas. However, confirmed local DENV transmission has also been reported by Arizona and California over the past two years.

The CDC advises health care providers to take these steps:

• Have increased suspicion of dengue among people with fever who have been in areas with frequent or continuous dengue transmission within 14 days before illness onset
• Order appropriate diagnostic tests for acute DENV infection: reverse transcription polymerase chain reaction [RT-PCR] and IgM antibody tests, or non-structural protein 1 [NS1] antigen tests and IgM antibody tests
• Ensure timely reporting of dengue cases to public health authorities
• Promote mosquito bite prevention measures among people living in or visiting areas with frequent or continuous dengue transmission

Click here for the CDC’s Clinical Testing Guidance for Dengue.

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