Advocacy Update

• Arizona Society of Pathologists, CAP Oppose Specimen Disposal Bill
• Missouri Pathologists Fight Destruction of Patient Specimens Legislation
• New Month, New Advocacy News Quiz
• House Approves Large COVID-19 Relief Bill; Includes $7.5 Billion for Vaccine Distribution
• CAP, Physician Coalition Fights Future Medicare Cuts
• CAP Meets with Top FDA Officials to Discuss COVID-19 Testing
• FDA Issues New Test Guidance for Viral Mutations of COVID-19
• FDA Authorizes Johnson & Johnson Vaccine - NATHAN TEST

The Arizona Society of Pathologists (ASP) and the CAP urged the state legislature to reject a bill requiring a clinical laboratory to dispose of any specimen within three days after a diagnostic test has been completed unless the laboratory has obtained specific patient consent. The legislative measure, HB 2812, would prohibit a laboratory from using or sharing a specimen for any purpose other than for which the lab obtained the patient’s affirmative consent. The CAP is collaborating with the ASP to ensure that regulatory burdens are reduced for pathologists in Arizona.

In a February 8 letter to AZ State Rep. Shawnna Bolick, ASP President Richard Eisen, MD, FCAP, stated the legislation would have unintended adverse medical consequences and should not be considered. “The retention of patient specimens cannot be waived or attenuated under state law. The retained use of patient specimens is fundamental to providing accurate diagnosis and care of the patient,” wrote Dr. Eisen. “Recognizing this fact . . . the Clinical Laboratory Improvement Amendments and federal regulations contemplate and stipulate periods, for as long as 10 years, to retain certain tissue specimens.” Dr. Eisen further noted that federal law in this area preempts and supersedes any state law that is not as stringent as federal law.

In addition, Dr. Eisen said that national clinical laboratory accrediting bodies, such as the CAP, have certain specimen retention requirements that exceed standards established under federal law. The purpose of national regulations and accrediting body standards in this area is to ensure the optimal, high-quality medical diagnosis and treatment for the patient. It is also to ensure an evidentiary record should the accuracy of an initial diagnosis be subject to litigation.

An essential clinical reason to retain tissue specimens to provide a medical record of what was examined but allows for a secondary or retrospective review of a patient specimen. The retained specimen can enhance the patient's initial diagnosis, prognosis, or treatment, Dr. Eisen said.

“Patient’s lives are being saved because by retaining specimens we have the ability to identify genetic biomarkers that were previously not identified nor considered significant or even identifiable at a time a specimen was taken,” he wrote. “Furthermore, the progression of a disease in a patient, as evidenced by the chronology of a specimen, constitutes an important part of the clinical record in the care of a patient and cannot be replicated if patient specimens are destroyed. We cannot ethically undertake actions that would jeopardize the health or safety of our patients. In sum, for these many legal, scientific and clinical reasons, we strongly urge that this legislation not be considered.”

The CAP will continue to follow developments on this measure.

The Missouri Society of Pathologists (MSP) and the CAP strongly oppose legislation that would make it a felony for clinical laboratories to retain a patient specimen without patient consent. The legislation mandates that any biological specimen collected or received by a laboratory shall not be released for purposes of “anonymous scientific study” unless the individual from whom the specimen was obtained consents to such a release. The CAP works with state pathology societies to enhance our advocacy strength at the state level while reducing burdens on pathologists.

At the time of collection, the individuals may direct the laboratory to return the specimen, destroy the specimen or store the specimen but not release it for anonymous scientific study. For any specimen in possession of a laboratory before the effective date of the measure (if approved), the laboratory may release the specimen for the anonymous scientific study if it contacts the individual first and receives consent. The measure was introduced on January 29 and is now pending in committee.

In February 23 testimony before the House Special Committee on Governmental Oversight, the MSP President, Chakshu Gupta, MD, FCAP argued that there are clear medical, scientific, and legal reasons by clinical laboratories must retain patient specimens:

• Regulatory requirements. CLIA requires laboratories to retain patient specimens. This federal law supersedes state law (unless the state law is more stringent).
• Patient benefits. These include the potential retrospective need to test a specimen in cases where second opinions are needed, or where advances in diagnostic science require further analysis to see if patients qualify for the most current cutting-edge treatments.
• Medicolegal issues. In legal cases of alleged medical errors, patient specimens are critical evidentiary material to document medical diagnosis accuracy or, conversely, a failure or omission in adherence to clinical standards of pathology diagnosis.
• Existing safeguards. Under the federal Health Insurance Portability and Accountability Act (HIPAA) and the Federal Policy for Protection of Human Subjects (common rule), written consent from a patient must be obtained to use an identified patient diagnostic specimen for purposes of medical research. These requirements apply to all diagnostic laboratories.

“Each patient specimen constitutes an important part of the biological chronology of disease in the patient’s medical records which cannot be replicated or destroyed,” Dr. Gupta said. “For example, the ability to retrieve an archived cancer specimen after initial diagnosis to determine whether a patient had a particular biomarker for which a new targeted therapy is available could change that patient’s prognosis and the course of treatment. For all these . . . reasons, we strongly urge your rejection of this legislation.”

The CAP will continue to track and provide updates on this legislation.

Its March and that means a new Advocacy News Quiz. Last month, over 70 pathologists took the quiz and about 50% shared their results on social media. See how you compare against your fellow CAP members’ in the February News Quiz and brag about your top scores on social!

Take the News Quiz

On February 27, the House approved the $1.9 trillion American Rescue Plan legislative package, which includes increased vaccine distribution and provisions to support COVID-19 testing. The bill passed by a party-line vote of 219-212 and now goes to Senate for further consideration. The CAP supports several provisions in the bill that increase resources for testing, including genomic sequencing, and state and local assistance for health care workers. The CAP has also asked Congress to include additional financial assistance to pathologists and laboratories.

In the House-passed legislation, the Centers for Disease Control and Prevention (CDC) would receive $7.5 billion for COVID-19 vaccine distribution. The legislation also provides the Department of Health and Human Services (HHS) roughly $50 billion for testing programs, contact tracing, and mitigation, including creating a national strategy and contact tracing of COVID-19; and $7.6 billion for efforts related to establishing, expanding, and sustaining a public health workforce, and to make awards to state, local, and territorial public health departments. The legislation also includes $25.2 billion for addressing health disparities and protecting vulnerable populations. While the package includes several key health care items, it does not include any additional resources for a Provider Relief Fund.

Outside of health care provisions in the bill, the legislation would provide $1,400 stimulus checks to eligible Americans and $350 billion in aid to states, cities, and local communities.

The CAP is opposing steep Medicare cuts scheduled to take effect in 2022 and is engaging with Congress to educate lawmakers on the impacts such a cut will have on pathology practices. The CAP, along with a coalition representing more than 350,000 physicians, has asked the House and Senate to make critical reforms to the Medicare system to stop deep reimbursement cuts for certain specialties, including pathologists, in future years.

In February 22 letters to House and the Senate, the physician coalition asked Congress to address a budget neutrality requirement for the Medicare Physician Fee Schedule (MPFS) that is causing the reductions in payment.

“We want to call your attention to the continued critical need for reforms to the Medicare system and additional work required to resolve deficiencies in the [fee schedule], including addressing the budget neutrality requirement which can lead to arbitrary reductions to reimbursement unrelated to the cost of providing care,” the coalition members stated. “A secondary goal of the fee schedule should be to reflect the modern health care delivery system in which different health care professionals work collaboratively to advance appropriate health outcomes for their patients. Unfortunately, these goals are not reflected given that there are additional scheduled deep cuts to providers who are reimbursed under the MPFS for 2022, 2023, and 2024 that will negatively impact patient care and diminish practitioners’ small businesses, further slowing our nation’s health and economic recovery from the pandemic.”

At the end of 2020, the CAP, along with the coalition, supported a bipartisan effort that alleviated payment cuts to providers, which were set to take effect under the 2021 Medicare Physician Fee Schedule.

The Food and Drug Administration’s (FDA) leadership convened the meeting on March 1 to update the laboratory community on the current state of their COVID-19 activities. Acting FDA Commissioner Janet Woodcock, MD, and Jeff Shuren, MD, Director of the Center for Device and Radiological Health reinforced that career officials would make regulatory determinations based on science not politics.

CAP President Patrick Godbey, MD, FCAP, President-elect Emily Volk, MD, FCAP, and Jonathan Myles, MD, FCAP, who serves as chair of the Council on Government and Professional Affairs, represented the CAP. The CAP leaders, on behalf of pathologists, discussed several issues, which included the agency’s regulatory policy for laboratory-developed tests. Following a question from the CAP, the FDA officials said the agency would not make significant policy changes without sharing guidance and information with the laboratory community.

On the topic of reporting cycle threshold values, the meeting participants discussed limitations when reporting these values because of difficulties comparing different tests and platforms diagnosing COVID-19. The CAP has developed an FAQ document on cycle threshold values.

The CAP also raised with the FDA persistent problems with obtaining diagnostic supplies for COVID-19 tests and will remain engaged with agency officials to solve issues laboratories are encountering during the pandemic.

On February 23, the FDA issued new guidance for evaluating the impact of viral mutations on COVID-19 tests. Test developers can use the new guidance during the development and post-authorization of their COVID-19 tests for emerging and future variants. The FDA guidance is for COVID-19 molecular and antigen tests that detect the SARS-CoV-2 virus and serology tests that detect antibodies to the virus.

In summary, the new FDA guidance:

• Applies to COVID-19 test developers of molecular and antigen diagnostic tests, and serology tests issued an Emergency Use Authorization (EUA), COVID-19 test developers that are offering their tests as outlined in the FDA’s testing guidance, and COVID-19 test developers pursuing an EUA from the FDA.
• Provides recommendations on information to include in EUA requests or supplemental EUA requests.
• Describes the FDA’s activities to understand better the public health impact of new virus variants and the potential impact on authorized COVID-19 tests.

This policy will remain in effect for the duration of the public health emergency.

The FDA authorized the emergency use of a coronavirus vaccine from Johnson & Johnson, adding the third vaccine for the public. The single-dose vaccine was cleared on February 27, and can be used by people ages 18 and older, one day after an independent FDA advisory committee had endorsed the shot.

The Johnson & Johnson vaccine is unlike the previously authorized vaccines from Pfizer and Moderna, which are given as two-dose regimens. The company has said it will have 4 million doses available upon authorization and can deliver 20 million doses by the end of March. Johnson & Johnson has promised the U.S. government 100 million doses by the end of June.

The CAP has encouraged pathologists and laboratory staff to get their vaccines once they have access.

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