Advocacy Update

• Engage and Advocate: August Recess Rally!
• Advocacy Win: Illinois Pathologists and CAP Secure New Network Adequacy Law
• CAP Meets with Industry Leaders to Mitigate Impacts of BD Blood Culture Media Bottle Shortage
• No Surprises Act Court Ruling Favors Physicians on Independent Dispute Resolution Process
• Cyberattack Creates Blood Supply Shortage in Southeast
• Help Determine Medicare Payment! Physician Practice Information and Clinician Practice Information Surveys–Extensions Available
• How will FDA’s LDT Rule Impact Your Laboratory and Patients? Share Your Story!
• Take Our News Quiz for August

August is one of the best times to protect your laboratory from regulatory overreach and advocate to stop payment cuts pathology services. Your representatives and senators in Congress will only act on these issues if they hear from you. While members of Congress have left Washington for August, they are at home meeting with constituents in your community. CAP members must take advantage of opportunities to connect and educate their legislators on pathology’s top legislative objectives.

When Congress returns to Washington, DC, in September, they will have a packed agenda with competing priorities. They need to hear from you now, so pathology issues are top of mind when they get back to Capitol Hill. Here is how you make your voice heard this month:

1. Go to the PathNET Action Center and act on these alerts:
   1. Stop Medicare cuts to clinical laboratory services: Urge Congress to enact the Saving Access to Laboratory Services Act (SALSA) to stop cuts of up to 15% and reform Medicare’s pay system for clinical lab services.
   2. Stop Medicare cuts to pathologist’s services: It’s time for Congress to address constant cuts to Medicare payment and stabilize the system.
2. Advocate Locally.
   1. In-district meetings or virtual meetings. In-district meetings are some of the most effective ways to engage with Congressional offices. Recent studies of Congressional members have shown that these in-districts meetings rank equally in effectiveness as Capitol Hill visits. You can normally request a local meeting through your legislator’s website. If a virtual meeting is more convenient for your schedule, that works too! Virtual meetings are a powerful tool that advocates can utilize. Remember that each Congressional member’s website is set up differently and the process may vary. If you need assistance, please contact pathnet@cap.org and CAP staff can help!
   2. Sign up for emails and look for informal opportunities to engage with your legislators During August recess, legislators are active back home in their communities and attend a variety of events where they can connect with constituents, so check out their emails and websites for more information on events happening locally.
3. Host a laboratory tour. Conducting a laboratory tour for a member of Congress is extremely effective and educational. It is one of the most impactful ways to help CAP members develop relationships with their members of Congress. These tours help put a face on the profession and demonstrate pathology’s crucial role in the delivery of quality health care.
4. Advocate from the comfort of home (or anywhere!) Ensure you never miss an advocacy action alert by signing up for the CAP’s grassroots text alerts.

Remember that your member of Congress wants to hear from you, as a constituent and a physician, especially on health care policy. For any further questions, please email pathnet@cap.org.

On August 9, Gov. J.B. Pritzker enacted a new health plan network adequacy law (Senate Bill 2641) spearheaded by the Illinois Society of Pathologists (ISP) and the CAP after years of advocacy.

Illinois is now the eighth state to enact the CAP’s position requiring health plans maintain robust network adequacy within in-network hospitals to provide enrollee access for physician specialists. Specifically, as of January 1, 2026, health plans must annually demonstrate to the director of the Department of Insurance that in-network hospitals have at least one radiologist, pathologist, anesthesiologist, and emergency room physician as a preferred provider in a network plan. The department may further select additional specialties for such requirements applicable to health plans.

The CAP and ISP worked closely with a multi-physician specialty coalition comprised of radiology, anesthesiology, and emergency medicine and the Illinois State Medical Society (ISMS) to advance the bill. The CAP previously advocated in 2017 for similar legislation but the bill failed in the Senate due to insurance industry opposition.

The new law will take effect on January 1, 2026.

The CAP is meeting with various stakeholders regarding the recent shortage of blood culture media bottles and serve as a resource in providing best practices for laboratories to ensure patients receive quality care and service they need. The CAP sent an alert to all CAP-accredited laboratories advising them of the disruption and provided additional resources on the CAP website.

The Centers for Medicare & Medicaid Services (CMS) relayed to the CAP the following guidance managing shortages:

• If the manufacturer extends the expiration date for the blood culture bottles, no additional studies will be required by CLIA in laboratories using the BD BACTEC test, and the test can be relied upon to be accurate.

• The use of expired reagents would be considered a test modification and would require the laboratory to establish performance specifications for a modified procedure. In addition, the test would default to high complexity.

• Laboratories that have previously used glass blood culture bottles and have their historic performance specification study will not be required to perform any additional studies when the glass bottles are released.

This follows the Centers for Disease Control and Prevention (CDC) issuing a health advisory about a critical shortage and an announcement by the Food and Drug Administration (FDA) regarding the disruption in availability of Becton Dickinson (BD) BACTEC™ blood culture media bottles on July 10.

The CDC said those affected by this shortage should immediately begin to assess their situations and develop plans and options to mitigate the potential impact of the shortage on patient care. They recommended instituting best practices to reduce unnecessary blood cultures and, when needed, contamination events or instances in which an inadequate blood volume is cultured. Ensuring the right samples are collected from the right patients, the right way the first time, could help mitigate negative impacts of the shortage.

Additional recommendations for laboratory professionals include:

• Determine the type of blood culture bottles your laboratory or facility uses and whether this shortage will impact you.
• Implement practices to optimize the use of blood cultures at your facility. Doing so may be helpful even for facilities not affected by the shortage.
• Take steps to prevent blood culture contamination. Contamination can negatively affect patient care and may require the collection of more blood cultures to help determine whether contamination has occurred.
• Ensure that the appropriate volume is collected when collecting blood for culture. Underfilling bottles decreases the sensitivity to detect bacteremia/fungemia and may require additional blood cultures to be drawn to diagnose an infection.
• If your laboratory or facility will be impacted by the bottle shortage, determine whether you have alternative options for blood cultures (eg, working with a nearby facility or sending samples out to a laboratory not affected by the shortage).
• Monitor current and future supplies of blood culture bottles at your laboratory or facility and report any potential shortages or interruptions to the FDA.
• If your facility will be impacted by the bottle shortage, convene a group of local laboratory and clinical experts to determine how a limited supply of blood culture bottles will be prioritized for use in your facility.

Additional Resources:

• CDC Health Advisory
• Medical Device Shortages List | FDA

Circuit Court judges on August 6 upheld a 2023 ruling that vacated parts of the federal government’s regulations implementing the independent dispute resolution (IDR) process under the No Surprises Act. Specifically, the Circuit Court upholds the decision that the government’s regulations had improperly weighted the qualifying payment amount (QPA) during IDR determinations.

In September 2022, the Texas Medical Association sued the Department of Health and Human Services (HHS) arguing that a provision in the No Surprises Act final rule unfairly favored insurance companies. The lawsuit argued that during payment disputes between providers and insurance companies, independent arbiters were to first consider the insurer-set QPA when deciding a payment amount for providers. The regulations also placed greater weight on the QPA compared to other factors due to a flawed “double counting” prohibition. The CAP had also identified these issues and called on the federal government to change its rules. In February 2023, a district court judge agreed with the Texas Medical Association and struck down the problematic portions of the regulations.

On August 6, the Circuit Court judges confirmed that this framework conflicted with the goals of the No Surprises Act and also ruled in favor of the Texas Medical Association. Because the regulations in question were previously struck down by the lower court decision, the IDR process will continue as is, without weighting the QPA more heavily than any other factor. Future rulemaking on this issue is expected, and it is unclear what further actions the government will take. The CAP will notify members of any further developments.

On July 29, OneBlood, a blood collector serving Florida, Georgia, North Carolina, and South Carolina, was the victim of a ransomware attack impacting its software systems and hindering its blood processing and labeling capabilities. The attack created a blood shortage for 250 hospitals in the region. On August 8, OneBlood released a statement saying they have “returned to normal course of business for distribution of blood products to hospitals following a ransomware event.”

According to the Department of Health and Human Services (HHS), reports of cyber incidents have increased as the health care sector is particularly vulnerable to cybersecurity risks. Health care facilities are attractive targets for cyber criminals in light of their size, technological dependence, sensitive data, and unique vulnerability to disruptions.

• Review the latest cybersecurity federal alerts and advisories.
• Access educational materials designed by HHS to give HIPAA covered entities and businesses insight into how to respond to a cyber-related security incident.
• Access American Medical Association (AMA) resources for physicians and health care staff to protect patient health records and other data from cyberattacks.

For additional information visit our Cybersecurity webpage.

The CAP strongly urges all pathology practices to respond to either the AMA Physician Practice Information or the CAP’s Clinician Practice Information survey as soon as possible. Both surveys close at the end of August. If your practice is planning to participate in either survey, or would like to, you can ask for an extension and a link to the surveys.

The CAP is one of more than 170 health care organizations supporting these national studies by the AMA, the CAP, and Mathematica that will collect representative data on physician practice expenses. The aim of these two surveys is to better understand the costs faced by today’s physician practices to support physician payment advocacy.

To request an extension or receive a new link to either survey please contact Mathematica directly advising them of your intention to complete a survey. Mathematica sent links to the surveys multiple times in the past year to pathology and independent laboratory practices. If you no longer have access to either link or would like to take either survey, please contact Mathematica, and ask for a new link.

If you work for a pathology practice, please request to complete the AMA’ Physician Practice Information Survey (PPI). If you work for an independent laboratory, please request to complete the Clinician Practice Information (CPI) Survey.

Email Mathematica Directly for a Survey link and Extension

Email: Danielle Whicher dwhicher@mathematica-mpr.com, or Martha Kovac mkovac@mathematica-mpr.com
Phone: 1-833-714-0022

These studies will serve as an opportunity to communicate accurate financial information to policymakers, including members of Congress and the Centers for Medicare & Medicaid Services (CMS). The surveys focus on collecting financial information and should be completed by the person(s) at the 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 to inform the national estimates of practice expense per patient care hour.

If you have any questions, please contact Mathematica at PPISurvey@mathematica-mpr.com regarding the PPI survey and CPISurvey@mathematica-mpr.com regarding the CPI survey or by phone at 1-833-714-0022.

Again, the CAP strongly urges all pathologist practices to respond as soon as possible. For more information read the Physician Practice Information Survey Methodology Report.

Do you anticipate the Food and Drug Administration’s (FDA) laboratory-developed test final rule creating unnecessary burdens for pathologists or negatively impacting patients’ lives, innovation, or the economy on your community? Your story could be used to help legislators understand how the oversight of tests should be based on protecting patients and providing access to safe diagnostic tests with a framework that is the least burdensome for laboratories.

Fill out the form, and tell us more.

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