Advocacy Update

• CAP President Testifies During Congressional Hearing on Oversight of Laboratory-Developed Tests
• CMS Updates New Conversion Factor for Physician Payments
• Pathologists Send More Than 800 Messages to Senate to Stop Gene Patent Reform
• CMS Reopens 2023 MIPS Extreme and Uncontrollable Circumstances Applications
• CAP Engages in CDC Meeting to Improve Laboratory Preparedness for Future Pandemics
• New HHS Artificial Intelligence Health Care Task Force Begins to Form
• CAP and Maryland Pathologists Successful in Blocking Written Estimate Bill
• FDA Releases Plans on Guidance for Responsible Use of AI for Medical Products
• Take Our News Quiz for March

On March 21, CAP President Donald Karcher, MD, FCAP, provided testimony to the House Energy and Commerce Subcommittee on Health during a hearing entitled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule.” Dr. Karcher firmly stated the CAP’s opposition to the Food and Drug Administration (FDA) proposed regulation on the oversight of laboratory-developed tests (LDTs) and advocated for policy solutions that target full regulation of only the highest risk LDTs.

“The CAP believes a balanced, risk-based approach to the federal oversight of laboratory-developed tests (LDTs) is needed to promote continued innovation, meet patient needs, and ensure that each test is valid, safe, and reliable,” Dr. Karcher said in his statement for the record. “Through the years, the CAP has advocated for three main principles for LDT oversight: protect patients, ensure continued access to safe and innovative diagnostic tests, and develop a framework that is the least burdensome for pathologists and their laboratories.”

During the hearing, both members of the House and testifying witnesses agreed that they do not support the current FDA LDT proposed rule without significant changes. The majority of witnesses, including Dr. Karcher, called for Congress to consider the Verifying Accurate, Leading-edge, IVCT Development (VALID) Act. This legislation would overhaul the FDA’s approach to regulating in vitro clinical tests (IVCTs), including LDTs, and ensure uniform standards in clinical lab diagnostic testing.

Dr. Karcher’s full written testimony can be found at the following link. Watch the committee hearing here.

The Centers for Medicare & Medicaid Services (CMS) has updated its website to reflect the new Medicare Physician Fee Schedule conversion factor. This is a result of the Consolidated Appropriation Act, 2024, which starting March 9 included an additional 1.68% update to the 2024 conversion factor that offset a portion of the 3.37% cut to physician payments that went into effect on January 1, 2024. The 2024 conversion factor for dates of service January 1 through March 8, 2024, was $32.74. The CMS has now established the new conversion factor of $33.2875 for dates of service March 9 through December 31.

The CMS also released updated payment files, including the Medicare Physician Fee Schedule, and associated abstract files, the Ambulatory Surgical Center (ASC) Fee Schedule, and Anesthesia file. Additionally, the RVU files have also been updated, and they show a conversion factor of $33.2875.

The CAP has developed an impact table to provide code level payment levels resulting from the new conversion factor.

Due to a recent grassroots advocacy network action alert, CAP members answered the call in a big way. A total of 444 CAP members sent 813 messages to their Senators urging them to oppose the Patent Eligibility Restoration Act of 2023.

Ten years ago, the Supreme Court ruled 9-0 in Association for Molecular Pathology v. Myriad Genetics that human genes were products of nature, not intellectual property, and that exclusive patent rights over genes should never be granted to anyone. Last year, Sens. Thom Tillis (R-NC) and Chris Coons (D-DE) introduced S 2140, the Patent Eligibility Restoration Act of 2023. The bill would eliminate the judicially created exceptions to patent eligibility, thereby overturning the Supreme Court precedent on this issue.

The CAP strongly opposes S 2140. If enacted, it would permit patenting of human genes and naturally occurring associations between genes and disease. Gene sequences and pathogenic variants would no longer be protected from patent eligibility as ‘products of natural phenomena.’ The negative consequences of S 2140 would include additional barriers and decreased access to lifesaving genomic tests, loss of access to confirmatory testing, and substantially increased costs of implicated diagnostic testing.

Take action! Contact your Senator and urge them to oppose S. 2140 if it comes up in the Judiciary Committee.

In response to the February cyberattack on Change Healthcare, the Centers for Medicare and Medicaid Services (CMS) has reopened applications for Extreme and Uncontrollable Circumstances (EUC) exceptions for submission of 2023 MIPS data. The application will be open until the end of the extended data submission period: April 15, 2024 at 8 pm ET.

EUC applications will be accepted at the QPP website but only for disruptions related to the Change Healthcare cyberattack. Applications for other reasons will not be accepted.

An accepted EUC application will not override data that has already been submitted to CMS and CMS will not reweight any MIPS performance category for which data has already been submitted.

In addition, on March 5, the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) said they would help providers and hospitals negatively impacted by the Change Healthcare cyberattack. In a statement, the HHS and CMS said they would provide flexibilities to affected parties. Read more.

For more information, visit CMS’ announcement of EUC reopening or email the QPP Help Desk at qpp@cms.hhs.gov.

On March 20-21, the Centers for Disease Control and Prevention (CDC) hosted a meeting on laboratory preparedness for future pandemics. The CDC sought the perspectives from the CAP organization in the laboratory and public health sector to guide the design of a National Laboratory Response System to improve the nation’s response to future pandemics. CAP CEO Michael Fraser, PhD, MS, CAE, FCPP represented the CAP at the meeting.

Organizations like the CAP can play a key role in supporting members through these events, but also work to ensure a “warm state” of preparedness so that when a pandemic hits, testing capacity can surge faster and more efficiently. Dr. Fraser also noted that developing a National Laboratory Response System will require “continued advocacy efforts and systems building amongst the entire lab community, and the CAP stands ready to advance the role pathologists and community laboratories in pandemic preparedness.”

On October 30, President Joe Biden issued an executive order establishing new standards for artificial intelligence (AI) safety and security, and the protection of Americans’ privacy while advancing equity and civil rights. The executive order directed the Health and Human Services Department (HHS) to create a comprehensive plan for assessing AI before it goes to market and monitor performance and quality once the technology is in use.

As a result of the order, HHS has created a task force made up of senior members of the CMS, the FDA, the Office of the National Coordinator, the National Institutes of Health (NIH) and the CDC. This task force is required to develop a strategic plan including policies and frameworks on responsible deployment and use of AI and AI-enabled technologies in the health sector. Already, the task force has coordinated work to publish guiding principles for addressing racial biases in healthcare algorithms.

The task force has specific working groups around core issues in AI:

• drugs and devices
• research and discovery
• critical infrastructure
• biosecurity public
• health healthcare and human services
• internal operations
• ethics and responsibility

Those working groups raise questions and bring suggestions to senior leadership on the task force, which meet monthly and provide guidance on how to proceed. The task force also plans to engage with the private sector to get their perspective on where it should focus.

The Maryland Society of Pathologists (MSP), with the support of CAP, effectively blocked consideration of legislation that would have required written estimates of services, prior to performing the service, and patient consent on all out-of-network pathology and laboratory services. House Bill 1148 /Senate Bill 1104, was introduced at the request of the Maryland Attorney General and has been formally withdrawn.

The MSP in its opposition noted that: “Of great medical concern, under this legislation, a clinical laboratory or pathologist receiving a patient specimen from a referring physician would not be able to provide timely, medically necessary specimen analysis, pending certain notifications to the patient and administrative determinations regarding the patient's insurance status. This requirement would impede performance of health care not only for all out-of-network patients, but also for any patient when insurance status is not readily ascertainable by the laboratory upon receiving the specimen.”

The CAP has effectively blocked several written estimate requirements at the state level, arguing that such requirements should only apply to scheduled health care services provided directly to patients. Due to state pathology society and CAP advocacy, multiple states have structured their out-of-network written estimate laws to conform with the CAP’s position.

On March 14, the FDA Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) jointly published a paper titled Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.

These FDA centers plan to facilitate careful management of AI technologies throughout the product life cycle to help address ongoing model performance, risk management, and regulatory compliance of AI systems in real-world applications.

The centers are organizing their actions around four areas of focus regarding the uses of AI across the medical product life cycle:

• Foster collaboration to safeguard public health
• Advance the development of regulatory approaches that support innovation
• Promote the development of standards, guidelines, best practices, and tools for the medical product life cycle
• Support research related to the evaluation and monitoring of AI performance.

The FDA has noted that it will issue the following guidance for medical products:

• Final guidance on marketing submission recommendations for predetermined change control plans for AI-enabled device software functions.
• Draft guidance on life cycle management considerations and premarket submission recommendations for AI-enabled device software functions
• Draft guidance on considerations for the use of AI to support regulatory decision-making for drugs and biological products

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