Advocacy Update

• CAP Advocacy Win: Wellmark BCBS Rescinds Blanket Denials for Certain Pathology Tests
• FDA’s CDRH Announces Reclassification Process for Most High Risk IVD
• CAP Encourages Independent Laboratory Practices to Fill Out Survey Launching this Month
• CDC Offers Laboratories Access to ISO-Biorisk
• Meet the CAP Advocacy Chairs: PathPAC Chair E. Randy Eckert, MD, FCAP
• HHS Releases Voluntary Health Care Specific Cybersecurity Performance Goals
• Register for the Pathologists Leadership Summit in D.C. April 2024
• Take Our News Quiz for February

As a result of CAP advocacy, the private insurer Wellmark Blue Cross Blue Shield is rescinding provisions of their immunohistochemistry (IHC) policy that limited coverage with blanket reimbursement denials of IHC when the claim includes certain ICD 10 codes.

On January 30, Wellmark notified the CAP it would rescind medical necessity reviews of IHC, and reverse prior adverse determinations processed under the policy effective October 1, 2023. The policy had affected pathologists and laboratories practicing in Iowa and South Dakota. The CAP worked with the Iowa Association of Pathologists and others to resolve this issue.

On December 12, the CAP expressed serious concern about Wellmark’s recent policy that limited coverage for certain IHC services. In a letter that lists the 10 ICD codes, the CAP wrote: “These policies have the potential to inappropriately limit physician and other health care provider decision-making in the provision of patient care, as such policies improperly impinge on the practice of medicine by encumbering medically necessary laboratory and pathology services.”

The CAP also wrote: “Pathologists know that the right stain at the right time can make all the difference in a patient’s diagnosis, treatment, and outcome. The decision to use a certain stain should be left to the pathologist responsible for diagnosis of the case, who is best positioned to know what is needed to make that determination.”

The CAP continues to advocate with private insurers to protect access to pathology services for patients. For more information: https://www.cap.org/advocacy/payments-for-pathology-services/private-sector-advocacy.

On February 1, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) announced it started the reclassification process for most in vitro diagnostics (IVDs) that are currently class III (high risk) into class II (moderate risk). The CAP is analyzing this latest action by the FDA to understand the impact this will have on pathologists and laboratories. The majority of these tests are infectious disease and companion diagnostic IVDs.

Reclassification would allow manufacturers of certain types of tests to seek marketing clearance through the less burdensome premarket notification (510 (k) premarket notification pathway) rather than the premarket approval pathway, the most stringent type of FDA medical device review.

The CDRH would still be conducting a premarket review of reclassified tests under the 510(k) pathway. Such reclassifications may support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests, the FDA said.

The CDRH began this process several months ago. At a September 2023 panel meeting, the panel discussed and made recommendations regarding a potential future reclassification from class III to class II with special controls of three types of infectious disease diagnostic tests:

• Nucleic acid & serology based IVDs to aid in the diagnosis of Hepatitis B Virus (HBV) infection and/or for use to aid in the management of HBV infected patients.
• Serology-based IVDs to aid in detection of human parvovirus B19.
• Cell-mediated immune reactivity IVDs to aid in the identification of in vitro responses to peptide antigens that are associated with Mycobacterium TB infection &/or use as detection of effector T cells that respond to stimulation by M. tuberculosis agents.

Read more about this policy change from the FDA.

This month, Mathematica will be sending out a national survey of independent laboratory practices to collect updated and accurate data on practice and laboratory costs which are a key element of physician fee schedule payment for pathology services. The results of the survey will be sent to the Centers for Medicare and Medicaid Services to be used within their physician fee schedule payment methodology. These data have not been updated since last collected over 15 years ago and it is critically important to update these data to ensure accurate payment.

This survey, endorsed by over 170 other medical societies and associations, will serve as a supplement to the American Medical Association led Physician Practice Information Survey.

The CAP contracted with Mathematica, an independent research company with extensive experience in survey methods and health care delivery and practice costs, to conduct this survey.

Independent laboratory practices will be randomly selected to participate. The survey is focused on collecting financial information and should be completed by the person(s) at the clinician practice who can best answer questions about finances and expenses. The time it takes to complete this survey will vary depending on the size and complexity of the practice. It is critical that this survey be completed to ensure that the needed updates are made to practice expenses and costs used to ensure accurate Medicare payment.

To thank practices for their participation, Mathematica will send a summary report that compares their data with national averages. The information shared will be kept private, reported in aggregate, and used only for the purpose of informing the national estimates of practice expense per patient care hour. If you have any questions, please contact Mathematica at CPISurvey@mathematica-mpr.com, or by phone at 1-833-714-0022.

The Center for Disease Control and Prevention (CDC) Division of Laboratory Systems has been authorized to offer laboratories access to the International Organization for Standardization (ISO) - Biorisk management for laboratories and other related organizations. ISO is an independent, non-governmental international organization with a membership of 170 national standards bodies.

Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.

The CDC Division of Laboratory Systems requested that any institution wishing to gain access to the ISO will designate a point of contact (POC) to facilitate the process. Your POC will initiate the access request and assist in distributing access within the institution.

Process Overview:

1. Your institution selects a POC responsible for biorisk management, such as the Laboratory Director, Biosafety Officer, or designee.

2. The POC emails the Division of Laboratory Systems Biosafety mailbox (DLSBiosafety@cdc.gov), requesting access to the ISO 35001:2019 standard, along with your institution’s name and physical address.

3. The Division of Laboratory Systems notifies your POC via e-mail with further instructions if your institution is approved. The POC must then submit names of individuals within your institution who would like to receive the ISO standard, including the following information:

• Work email address (personal email addresses will not be accepted)
• The individual’s role in the organization

This initiative aims to streamline the process and ensure that the Division of Laboratory Systems has an organized list of individuals interested in receiving the ISO 35001:2019 standard within each organization.

The Division of Laboratory Systems recognizes this ISO standard’s importance in enhancing biorisk management in laboratories and encourages your institution to participate. For questions, contact DLSBiosafety@cdc.gov.

The CAP is sharing this notice as a resource through our partnership with the CDC. This standard does not appear on the CAP checklists nor is conformity with this standard assessed as a part of the CAP’s accreditation programs.

PathPAC is the political action committee established by the CAP in 1992 and dedicated solely to representing pathologists. PathPAC represents CAP members coming together as one and amplifies the voices of all pathologists. It provides the best opportunity to elect lawmakers to Congress that will make fair and reasonable policies towards pathology. Contributing to PathPAC also shows your support for your professional association and the advocacy efforts of CAP members and staff. Learn more!

1. How did you become interested in serving as PathPAC Chair?

Interesting question! After retiring from clinical practice, I decided to utilize some of my free time becoming involved in the activities of the CAP again. I let my interest in helping in any way I could be known to the CAP leadership, primarily through Dr. Emily Volk while she was President. Dr. Jonathan Myles, whom I had worked with previously when I was chair of the Council on Government Affairs (CGPA) and an American Medical Association (AMA) Delegate, reached out to me and asked me if I would be interested in being an advisor on the PathPAC Board. Having been on the PathPAC Board in the past from 1993 to 1999 and serving as the chair of PathPAC from 1997 to 1999, I immediately said “Yes”! After a year on the Board, the CAP Leadership asked me to chair the Board again.

2. What do you hope to accomplish during your time serving as PathPAC Chair?

My goal as PathPAC chair is to increase the number of CAP members donating to the PAC, as well as increase the total number of dollars given to the PAC. Obviously, it would be impossible for one person, even the PathPAC chair, to do that alone, so the entire PathPAC Board will be engaged in the process of educating the CAP membership on why the PAC is so important to the advocacy efforts of the College and, therefore, the importance of giving to the PAC.

3. How does CAP advocacy make a difference in the practice of pathology?

Since becoming involved in the CAP nearly 40 years ago, I have felt that the advocacy efforts of the CAP are the only meaningful efforts being undertaken in sustaining and advancing the practice of pathology. Just like all aspects of medicine, the practice of pathology is subject to the decisions of organizations outside of medicine, most notably those of the third-party insurance companies and the federal government. Through ever-evolving payment practices for medical services, insurance companies and the federal government have an enormous impact on how pathologists get paid for the services we provide our patients. Without the CAP advocating on our behalf, payment for the medical services we provide would be so restrictive that it would be economically impossible for most pathologists to stay in practice.

4. What do you think are the most important aspects of advocacy (grassroots, PathPAC, meeting with legislators, attending the Pathologists Leadership Summit) CAP members need to be involved to move the needle?

I don’t think you can just pick one or two of the CAP advocacy efforts in which CAP members need be involved. I think it takes ALL these efforts to advocate for pathology. CAP members should be engaged in grassroots activities, contribute to PathPAC, attend the Pathologists Leadership Summit, AND meet with legislators. Each of these is important for their own reason, and all are necessary to maximize the CAP’s advocacy efforts.

5. Why did you choose a career in Pathology?

Of all the medical specialties I was exposed to during medical school, pathology was the most challenging and rewarding for me. I knew very early in my medical education that I could make a significant difference in the lives of the patients I would be seeing by being a pathologist.

6. If you could invite three (3) people to dinner (living or dead), who would they be?

Jesus Christ, Abraham Lincoln, my father

In January 2024, the Department of Health and Human Services (HHS) published voluntary health care specific Cybersecurity Performance Goals to help healthcare organizations prioritize the implementation of high-impact cybersecurity practices. These goals are voluntary cybersecurity practices that organizations can prioritize to strengthen cyber preparedness, improve resiliency, and protect patient health information and safety.

The HHS cybersecurity performance goals are split into two categories: essential goals to outline minimum foundational practices for cybersecurity performance and enhanced goals to encourage adoption of more advanced practices. Essential goals include activities such as basic cybersecurity training. Enhanced goals include activities such as cybersecurity testing.

Although these cybersecurity performance goals are not currently mandatory, the HHS has indicated that they may change eventually. The HHS has noted that that with additional authorities and resources that it will request from Congress, HHS will propose incorporation of the cybersecurity performance goals into existing regulations and programs that will inform the creation of new enforceable cybersecurity standards. HHS has also noted that it may encourage the implementation of its cybersecurity performance goals via financial consequences and incentives on hospitals.

HHS is working towards and expects to seek comment on the following proposed actions:

• The Centers for Medicare &Medicaid Services (CMS) will propose new cybersecurity requirements for hospitals through Medicare and Medicaid
• HHS Office for Civil Rights (OCR) will begin an update to the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, in the Spring 2024, to include new cybersecurity requirements.

The CAP is assessing the effects that these cybersecurity performance goals would have on pathologists and laboratories if they became mandatory in the future.

Year after year, pathologists’ Medicare payments are under threat, workforce shortages are causing burnout, and cuts to clinical laboratory payment hang in the balance.

Advocate for pathology and plan to attend the Pathologists Leadership Summit in-person where you will gain unparalleled access to the education and training to make an impact on Capitol Hill and protect the future of our specialty.

The Pathologists Leadership Summit takes place, in-person only, April 13-16 in Washington, DC. Mark your calendars and register today!

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