October 4, 2022
In this Issue:
- Council of Medical Specialty Societies Awards the CAP $100,000 Grant to Improve Diagnostic Excellence
- Government Funding Bill Includes FDA User Fees Without Additional Policy Riders
- FDA Issues Revised COVID Test Policy
- CAP Asked ONC to Align with CLIA Reporting Requirements to Avoid Duplication
- Updates from the FDA on the EUA Process Webinar
- Good Faith Estimates - What Pathologists Need to Know Webinar
- New Month - New Advocacy News Quiz
Council of Medical Specialty Societies Awards the CAP $100,000 Grant to Improve Diagnostic Excellence
The Council of Medical Specialty Societies (CMSS), a coalition of 48 specialty societies, awarded the CAP $100,000 grant to study how to make pathology reports more patient-centered and understandable. The CAP will use the grant to improve the patient experience of a cancer diagnosis related to the pathology report. The CAP welcomes the opportunity from the Council of Medical Specialty Societies to help identify patient priorities in pathology reports and create recommendations around patient-centered pathology reports.
These awards result from a competitive grant program administered by the CMSS and funded by the Gordon and Betty Moore for medical specialty societies to support the development of resources and programs to promote the topic of diagnostic excellence for clinician audiences.
Medical specialty societies are well-positioned to educate and disseminate effective strategies that advance diagnostic excellence among their members through educational programs, including accredited CME, peer-reviewed journals, clinical guidelines, research, and clinical registries.
In addition to selecting and providing grants to individual societies, CMSS will serve as a coordinating center to monitor and promote cross-specialty learning, improvement, collaboration, and identification of best practices in diagnostic excellence that can be shared with the broader medical community.
Government Funding Bill Includes FDA User Fees Without Additional Policy Riders
A bill funding the federal government through December 16 passed Congress on Friday to avoid a partial government shutdown. The continuing resolution funding bill also included a five-year renewal of Food and Drug Administration (FDA) user fees collection but does not include additional policy riders.
On September 27, the Senate Committee on Health, Education, Labor and Pensions, and the House Committee on Energy and Commerce agreed to reauthorize the FDA user fee with the understanding that additional policy riders would be considered for inclusion in an end of year omnibus package.
Policies debated earlier this year, including the Verifying Accurate Leading-edge IVCT Development (VALID) Act could be attached to an omnibus legislative package later this year before government funding runs out on December 16. Given the urgency to fund the government and the FDA before a September 30 deadline, lawmakers opted to enact “clean” legislation without other policies attached. Previously, the House and Senate had considered several FDA-related provisions, including measures to prevent future pandemics, oversight of dietary supplements, cosmetics regulation, generic drug manufacturing, and other bipartisan measures such as the VALID Act.
FDA Issues Revised COVID Test Policy
On September 27, the Food and Drug Administration (FDA) updated its Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) Guidance for Developers and Food and Drug Administration Staff to provide priorities and enforcement policies regarding novel coronavirus (COVID-19) tests for the duration of the public health emergency. The updates supersede the previous policy released on November 21, 2021. Recently, CAP leaders met with FDA officials to discuss issues pathologists have encountered with the emergency use authorization (EUA) process during the COVID-19 pandemic.
The guidance pertains to clinical laboratories (ie, high-complexity CLIA-certified laboratory) that modify an authorized COVID-19 molecular diagnostic test, including:
- Those EUA authorized a different entity developed tests; and
- The modifications do not change the indication for use (eg, including new/different extraction kits or instruments that would not be expected to change the indication for use); and do not change the analyte-specific reagents (eg, the modifications do not change the PCR primers and/or probes).
From the guidance, the FDA intends to focus its review of EUA requests for tests that likely have a significant public health benefit (eg, employ innovative technology) or fulfill an unmet need (eg, diagnosing infection with a new variant or subvariant). In addition, the FDA also intends to focus its review on EUA requests from or supported by tests funded by the Biomedical Advanced Research and Development Authority (BARDA) or the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx).
Test developers will be notified by email if the FDA declines to review or decides not to authorize a test/modification in an EUA request.
The FDA will not require notification or submission of a new EUA if the modifications are validated and confirmed to show equivalent performance to the original EUA and if the use of the test is limited to the clinical laboratory in which made the modification. However, for other modifications, including new specimen types, test settings (eg, point-of-care, home testing), and new patient populations (eg, asymptomatic individuals) the FDA expects clinical laboratories to submit an EUA or traditional premarket review submission.
States listed on the FDA’s website can authorize tests developed by clinical laboratories within that state for use within that laboratory. This does not include at-home tests, tests with home specimen collection, or any testing outside a high-complexity, CLIA-certified laboratory.
CAP Asked ONC to Align with CLIA Reporting Requirements to Avoid Duplication
The CAP is engaging with the Office of the National Coordinator for Health Information Technology (ONC), tasked with promoting the use of the most advanced health information technology and the electronic exchange of health information. To do this, the ONC created the United States Core Data for Interoperability (USCDI) standard, which it adopted as a standard as part of the ONC’s implementation of the 21st Century Cures Act. In addition, the USCDI standard defines how health care data must be formatted to be exchanged electronically nationwide. The USCDI standard enables the same health care data to be understood across different institutions. The CAP asked the ONC how the USCDI standard could achieve its goal without overburdening pathologists and laboratories.
In the September 30 comment letter, the CAP urged the ONC to align the USCDI with the testing reporting requirements in the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Specifically, the CAP stated that CLIA requirements are required for clinical laboratories. Those elements will consequently achieve the USCDI’s goal of developing a foundation for the nationwide electronic sharing and reporting of laboratory information to support patient care. Moreover, aligning the USCDI with CLIA requirements will avoid contradictory or duplicative reporting requirements for pathologists and laboratories.
Updates from the FDA on the EUA Process Webinar
On Tuesday, October 25 at 12 PM ET/ 11 AM CT, the CAP will offer a complimentary live webinar to discuss updates to the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) process. The FDA’s Timothy Stenzel, MD, PhD, who is the Director of the FDA Office of In Vitro Diagnostics and Radiological Health will join CAP leaders to provide pathologists with an overview of current EUA processes and take questions from participants.
Good Faith Estimates - What Pathologists Need to Know Webinar
On Wednesday, November 2 at 1 PM ET/ 12 PM CT, the CAP will offer a complimentary live webinar where CAP experts CAP experts Jonathan Myles, MD, FCAP, Chair of the Council on Government and Professional Affairs, and Theresa Emory, MD, FCAP, member of the Economic Affairs Committee, will explain what pathologists need to know for good faith estimates in compliance with the No Surprises Act regulations. Additionally, the speakers will review what pathologists and their practices must do to comply with the new regulations in 2023.
New Month - New Advocacy News Quiz
It’s October and that means all things Fall and a new Advocacy News Quiz! Last month over 60 fellow members took the quiz. See how you compare against your fellow CAP members and brag about your top scores on social!