Advocacy Update

September 27, 2022

In this Issue:

CAP Meets with FDA Officials to Discuss the Emergency Use Authorization Process

CAP leaders met with the Food and Drug Administration (FDA) to discuss issues pathologists have encountered with the emergency use authorization (EUA) process during the COVID-19 pandemic, especially as it relates to some laboratories reporting delays in obtaining EUAs for SARS-CoV-2 laboratory-developed tests (LDTs). With the monkeypox virus outbreak creating a potential need for increased LDTs, the CAP relayed concerns from its members about the lengthy approval time for EUAs.

CAP President Emily E. Volk, MD, FCAP and Council of Government and Professional Affairs Chair Jonathan L. Myles, MD, FCAP met with FDA staff on September 19 to discuss pathologists’ concerns with the FDA’s EUA process, including delays, burden on laboratories, and costs. Dr. Volk and Dr. Myles specifically requested input from the FDA on how they plan to address delays, as new submissions can take up to a year for review; how to increase and improve communication with laboratories; the regulatory process for COVID-19 LDTs when the EUA process is rescinded (eg, 510k submission); and, how the CAP can engage with the FDA on solutions.

The FDA has noted several reasons leading to issues with the EUA process during the COVID-19 pandemic. These include a large number of submissions at the onset of the pandemic. The FDA has responded by engaging a third party to speed review and despite delays, the agency has allowed laboratories to offer SARS-CoV-2 laboratory tests to patients even if FDA reviews of their submissions are pending.

HHS Inspector General Issues Report on FDA EUA Process

On September 21, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published findings of a review of the FDA’s EUA process entitled “FDA Repeatedly Adapted Emergency Use Authorization Policies to Address the Need for COVID-19 Testing.” The OIG interviewed the FDA and surveyed test developers to complete the report. Early on in the pandemic, the FDA had worked with more than 400 test developers through its pre-EUA and EUA processes and issued 117 EUAs for tests by late May 2020, according to the report. As of May 2022, the FDA issued EUAs for over 400 tests including 348 diagnostic and 85 serology tests.

The report found the FDA made “calculated decisions to increase the availability of COVID-19 testing, but these decisions often came at a potential cost to test quality.” An FDA analysis of 125 EUA requests for LDTs found 82 tests had design or validation problems and the agency cited similar issues with commercial tests.

To address this and other policy issues, the HHS OIG recommended that the FDA:

  • Assess and, as appropriate, revise guidance for test EUA submissions
  • Develop a suite of EUA templates for future emergencies involving novel pathogens
  • Expand the FDA Center for Devices and Radiological Health’s existing device-tracking platform to facilitate EUA submission and monitoring
  • Expand and improve resources for test developers on the EUA process (Note: the FDA has issued EUA guidance for monkeypox testing).
  • Establish formal communication channels between FDA and the laboratory community, to be used in emergencies that require testing (Note: the report cites the memorandum of understanding the CAP signed with the FDA, Centers for Disease Control and Prevention, and organizations like American Clinical Laboratory Association).
  • Work with federal partners to implement lessons learned about a national testing strategy that go beyond the EUA process

The FDA concurred with the OIG’s recommendations and noted it has put several into current practice.

AHA, AMA Dismiss Federal Surprise Billing Case, But Remain Concerned

On September 20, the American Hospital Association (AHA) and the American Medical Association (AMA) moved to dismiss their lawsuit against the Biden administration’s regulation for the independent dispute resolution process created by the No Surprises Act. The CAP had previously filed an amicus brief in support of the legal challenge by the AHA and AMA.

In the filing to dismiss the suit, the AHA and AMA said the case became moot after the administration released a final rule in August. However, the AHA, the AMA, and the CAP still are concerned about the No Surprises Act regulation’s process developed by the Centers for Medicare & Medicaid Services (CMS) and will continue to advocate for changes.

On August 19, the Biden administration released the Requirements Related to Surprise Billing final rule, which follows a separate court decision that struck down part of an earlier policy related to the independent dispute resolution process. The final regulation instructed independent dispute resolution arbiters to consider an insurer's median contracted in-network rate and any additional information – including physician training and experience, patient acuity, and more – when determining the correct payment for a surprise bill.

Check out resources for pathologists on the No Surprises Act and its regulations.

AMA, CAP and Over 120 Medical Associations Call for Congress to Stop 2023 Medicare Cuts

The CAP, the American Medical Association (AMA), and over 120 national and state medical professional groups urged congressional leadership to stabilize the Medicare physician payment system and stop reimbursement cuts in 2023. Throughout 2022, the CAP has urged Congress to mitigate the upcoming Medicare cuts. The CAP advocates for protecting the value of pathology services and fights against Medicare cuts to pathologists.

In the September 22 letter to congressional leadership, the group outlined how the proposed 2023 Medicare Physician Fee Schedule would cut the Medicare conversion factor by approximately 4.5%, which does not account for inflation. As a result, nationwide, physician practices face statutory payment cuts without annual inflationary updates, along with significant administrative barriers, while still dealing with staffing and medical supply issues resulting from the pandemic.

In the letter, the group stated that “according to an AMA analysis of Medicare Trustees data, Medicare physician payment has been reduced 20% adjusted for inflation from 2001–2021. The Medicare physician payment system lacks an adequate annual physician payment update, unlike those that apply to other Medicare provider payments. Physicians are the only Medicare provider not receiving an inflationary update in 2023.”

The AMA and the groups urged Congress to:

  • Provide relief from the scheduled -4.42% budget neutrality cut in Medicare physician fee schedule payments.
  • End the statutory annual pay freeze and provide a Medicare Economic Index (MEI) update for the coming year.
  • Extend the 5% Advanced Alternative Payment Model (AAPM) participation incentive and halt the impossible-to-meet revenue threshold increase for five years to encourage more physicians to transition from fee-for-service into APMs.
  • Waive a 4% PAYGO sequester also set to take effect next year.

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.

Register now

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