Advocacy Update

March 23, 2021

In this Issue:

CAP Cautions FDA on Digital Pathology Deregulations

The CAP urged the Food and Drug Administration (FDA) to cautiously proceed with new regulations and increase flexibility for digital pathology devices under premarket notification requirements. In a March 15 letter to the agency, the CAP cautioned against moving forward with three of four digital pathology product codes because it may result in unintended consequences such as issues with lack of standardization and interoperability, and increased physician liability. At the same time, the CAP encouraged the FDA to consider the affects that digital pathology system waivers for whole slide imaging systems and management software may have on artificial intelligence tools in the future.

The CAP has advocated for reductions in regulatory burdens. In the March 15 letter, the CAP said regulatory flexibility should include a framework that can assess the totality of an open system, including the impact of individual components that may be waived. There should also be parameters to monitor and adjudicate whether waivers are appropriate.

During the pandemic, the FDA issued temporary waivers for premarket notification requirements. The CAP said it considers making waivers permanent for three of the four digital pathology product codes (QKQ, PSY, and OEO) to be premature.

“In addition, the deregulation of digital pathology components and systems should be based on robust data that are more extensive and transparent,” the CAP said in the letter. “This regulatory decision was made based on the Manufacturer and User Facility Device Experience database (MAUDE) in which medical device reports (MDRs) are submitted to the FDA by mandatory reports (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients, and consumers. For digital pathology codes, MAUDE reports three total adverse event reports none of which include any death related incidents within the last ten years.”

The current data suggest it is inadequate to assess risk the systems pose. According to a September CAP survey, 5.4% of laboratories surveyed reported using whole slide imaging systems during the public health emergency.

In addition to the CAP’s own comments, the Association for Pathology Informatics also sent a letter that was supported by the CAP, the American Society for Clinical Pathology, the Association of Directors of Anatomic and Surgical Pathology, and the Association of Pathology Chairs. The groups supported the continued FDA oversight with varying degrees for the digital pathology product codes QKQ, PSY, and OEO. However, the groups asked that the digital pathology product code PZZ (digital pathology display) be no longer required.

Download the CAP’s New CURES Act Sharing Test Results Fact Sheet

The CAP updated its fact sheet summarizing key provisions and answering pathologists’ questions on regulation regarding sharing test results with patients that is set to take effect on April 5.

Download the CAP’s fact sheet on the regulations

In November 2020, the Department of Health and Human Services (HHS) pushed back the deadline for the regulations, which include information blocking, citing implementation concerns during the coronavirus pandemic. The rules will change how many physicians, including pathologists, pass along and receive electronic health information.

The CAP’s fact sheet provides new background on the new regulations and how rules apply to pathology practices. The CAP has advocated for easing administrative burdens tied to these regulations. The fact sheet provides answers to frequently asked questions such as “Do pathologists have to change the way they report?” and “Can I bill if a patient calls me?”

With the new deadline to comply with the rules, which are required by the 21st Century Cures Act, pathologists and laboratories will have more time to become familiar with requirements. The CAP has noted that there are complex situations in which the administration will consider certain exceptions to information blocking that would warrant blocking the release of information. The American Medical Association has also created documents, Part I and Part II, with more information about these new regulations.

Prominent Political Analysts to Keynote at Pathologists Leadership Summit

Four prominent keynote speakers will help set the tone for the Pathologists Leadership Summit by addressing the current state of politics in the US, leadership, and the 2020 elections.

Karl Rove, former advisor to President George W. Bush; Michael Beschloss, Presidential Historian; and national political pollsters Peter D. Hart and Bill McInturff will be the featured keynote speakers at the Pathologists Leadership Summit.

Mr. Rove, an iconic political strategist will be the luncheon keynote speaker on May 1. While Mr. Beschloss, an award-winning historian and bestselling author of 10 books, will provide the keynote on May 2. And Mr. Hart, Leading Pollster and Public Policy Expert, and Mr. McInturff, Co-Founder of Public Opinion Strategies and Leading Pollster will provide insight into the 2020 elections as luncheon keynotes on May 3.

The Pathologists Leadership Summit is an exclusive opportunity for CAP members to elevate leadership skills, take action, and be more effective advocates for positive change—particularly now that the Spring House of Delegates Meeting and our annual Day on Capitol Hill are also part of this event.

There is no fee to attend, and educational sessions provide up to 13.25 CME credits. The Pathologists Leadership Summit will give you exclusive access to unparalleled education, training, and brainstorming sessions with key CAP leaders to inspire the leader within you.

Help us set the path to a better future. Register Now.

Transition: Becerra Confirmed as HHS Secretary

Editor's Note: Advocacy Update will feature stories about the transition to the Biden Administration and new Congress. These stories will highlight major news on the President Joe Biden's cabinet, other administrative officials, and both chambers of Congress that will enact and execute new health care policies affecting pathologists, their laboratories, and the patients they serve.

California Attorney General Xavier Becerra was confirmed as Secretary of Health and Human Services (HHS) by the Senate on March 18. He was approved by a vote of 50 to 49, becoming the first Latino Secretary of HHS, the largest federal department in terms of spending.

During his time as attorney general, Becerra led several legal challenges on health care, including a defense of the Affordable Care Act in a current case before the Supreme Court. Before he became attorney general of California in 2017, Becerra served 12 terms in Congress representing the congressional district containing the city of Los Angeles.

The HHS includes several agencies, including the National Institutes of Health, the Centers for Disease Control and Prevention, the FDA, and the Centers for Medicare & Medicaid Services.

House Passes CAP-Supported Legislation to Stop Medicare Budget Cuts

The House passed legislation to prevent a 2% cut from hitting physician Medicare payments beginning April 1. The CAP supported the bipartisan bill that passed with a 246-175 vote on March 19. The bill, HR 1868, will now go to the Senate for consideration. The CAP will urge senators to approve the bill.

In a March 15 letter, the CAP strongly supported bipartisan congressional action to stop the Medicare budget sequester cuts and provide critical relief for pathologists who have been on the front lines to fight the pandemic. Similar legislative measures have also been enacted during this health crisis. The bill passed by the House would extend a moratorium on the 2% Medicare sequestration cuts through the end of the year. It also fixes an issue with the recently passed American Rescue Plan Act of 2022 that is needed to prevent an additional sequester cut that would be triggered in early 2022.

CAP Activates Grassroots Advocacy to Stop Cuts

The CAP is urging pathologists to write their elected officials and tell them to support the legislation. Using the CAP’s action center, it is easy for pathologists to contact members of Congress on this issue. Just login with your email and ZIP code to send messages to Congress in less than a minute.

The AMA, the CAP, and 127 medical and state organizations have also lobbied Congress to relieve the financial burdens of the COVID-19 pandemic on physicians during the current national emergency. In a February 12 letter to congressional leaders in the House and the Senate, the CAP joined the groups to support legislation that would suspend a 2% across-the-board cut.

CAP Obtains More Clarification on UnitedHealthcare’s Designated Diagnostic Provider Program

Effective July 1, 2021, and subject to state regulatory approval, the insurer UnitedHealthcare is launching a new benefit design where outpatient diagnostic laboratory services will only be covered for fully insured commercial plan members when they are delivered by a “Designated Diagnostic Provider.” The CAP initially met with UnitedHealthcare leaders on February 19 to discuss the insurer’s upcoming plan changes and address a number of concerns. In response to CAP member questions, the CAP met again with UnitedHealthcare on March 22 to secure additional clarification on the Designated Diagnostic Provider program.

During the March 22 meeting, UnitedHealthcare confirmed to the CAP that there is no hard deadline to complete the required questionnaire and that evaluations will be on an ongoing process. The insurer did state that completing the questionnaire earlier is better: UnitedHealthcare is currently suggesting providers who complete it online by May 15 will ensure inclusion in current beneficiary plan materials/education.

Further, UnitedHealthcare shared that they are making adjustments to the questionnaire to make it easier for all pathology groups to apply, and completion should be done by/at the taxpayer identification number (TIN) level. The Designated Diagnostic Provider benefit design applies to any provider billing laboratory services using POS codes 19, 22, or 81, and includes the entire laboratory and pathology suite of CPT codes. Invitations to apply were sent out based on claims. CAP members can email the insurer for help.

To become a Designated Diagnostic Provider, providers will need to meet certain quality and efficiency requirements. In response to concerns raised by the CAP, UnitedHealthcare clarified they would not expect a hospital laboratory to meet the same efficiency requirements that they would for freestanding laboratories, and that they want to work with all in-network providers to make sure they meet efficiency standards. UnitedHealthcare also commented that they recognize health care is local and that community-based pathology is important, so there will be some room for adjustments/variability in efficiency standards with that in mind. The CAP will continue to engage with the insurer to ensure access to pathology and laboratory services across all settings.

For more information, visit the UnitedHealthcare Designated Diagnostic Provider page.

HHS Creates Interagency Group to Coordinate Efforts on COVID-19 Variants

On March 22, the CAP participated in the Centers for Disease Control and Prevent (CDC) Laboratory Outreach Communication System meeting. The CAP was represented by Council on Government and Professional Affairs Chair Jonathan Myles, MD, FCAP, who engaged on the following issues:

  • The Department of Health and Human Services (HHS) established a SARS-CoV-2 Interagency Group to improve coordination among the CDC), National Institutes of Health (NIH), Food and Drug Administration, Biomedical Advanced Research and Development Authority (BARDA), and Department of Defense (DoD). This interagency group will be focused on the rapid characterization of emerging variants and actively monitors their potential impact on critical SARS-CoV-2 countermeasures, including vaccines, therapeutics, and diagnostics. Each variant class includes possible attributes of lower classes; variants status make escalate or deescalate based on scientific evidence. The categories are variants of interest, variants of concern, and variants of high-consequence. Currently, most of the variants being monitored by the CDC fall into variants of interests (New York and Brazil) while the remainder of the variants fall into the area of concern (California, South Africa, United Kingdom). The CDC provide data at the federal and state levels for each variant types found in the US.
  • Representatives of the University of Illinois provided results from longitudinal testing study using antigen, RT-PCR, and culture.
  • A CMS official provided an update on the revised CLIA program FAQs which allows laboratories performing and reporting genomic sequencing results to public health laboratories can do so without following CLIA regulations. However, if the laboratory reports sequencing results to patients, they must comply with CLIA regulations.

The FDA’s Tim Stenzel answered questions provided about FDA emergency use authorizations, variant impact testing performance, and regulatory requirements for direct to consumer testing versus home testing. The FDA continues to update its FAQs and will provide timely communications on variants impact on testing performance as more data becomes available.

Take the March Advocacy News Quiz

Think you have the Advocacy know-how? Test it out in our monthly 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 March News Quiz and share your results on social!

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