Advocacy Update

• Congress Passes Bill Giving Pathologists $19.1 Million in Additional Medicare Payment Relief through 2024
• FDA Sends Final LDT Rule to the White House for Review
• New Joint Cybersecurity Advisory Encourages Health Care Organizations to Take Action to Mitigate Threat of Ransomware
• HHS, CMS Offer Assistance in Wake of Ransomware Attack
• CAP Encourages Independent Laboratory Practices to Fill Out Survey Launching this Week
• Reminder: Viral Hemorrhagic Fever Hospital Survey Ends March 20
• New Podcast: Hill Day and the Importance of Advocacy in Washington D.C.
• Take Our News Quiz for March

On March 8, Congress passed the 2024 Consolidated Appropriations Act that included additional relief from Medicare payment cuts. Physicians will receive a boost in Medicare pay for patient services starting from the legislation’s enactment through the end of 2024.

Although the CAP appreciates the partial payment relief, the CAP continues to urge Congress to pass legislation to stop these devastating Medicare cuts for good. Temporary patches and ongoing cuts to the Medicare physician payment system have left pathology practices and patient access to care at serious risk.

The 2024 cuts are on top of the lack of an inflationary update to the physician fee schedule. According to the American Medical Association (AMA), Medicare physician pay fell 26% from 2001-2023 because physicians, unlike other Medicare providers, do not get yearly inflationary payment updates.

This new relief equates to $19.1 million dollars for pathologists as the legislation increases Medicare pay for the remainder of the year by 1.68%, meaning that overall pathology pay would increase over current 2024 levels while still being 1.04% lower in 2024 compared to last year.

Throughout 2023 and early 2024, the CAP persistently lobbied lawmakers to enact short-term Medicare payment relief. Medicare’s payment formula had cut pathology services by 2.72% in 2024 while some other physician specialties faced higher reductions.

On March 1, the Food and Drug Administration (FDA) sent a draft of the final laboratory-developed tests (LDT) regulation to the White House’s Office of Management and Budget (OMB) in the Office of Information and Regulatory Affairs for review. This signals that the FDA has finalized its review of 6,707 comments they received on the proposed rulemaking on LDTs.

The FDA plans to finalize the LDT rule by April 2024, according to a work plan published by the OMB.

Citing substantial undue regulatory burdens and costs on laboratories, the CAP called on the FDA to make significant changes to its proposed regulation of LDTs in a letter to the FDA on December 4.

The Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Department of Health and Human Services (HHS) released an update to a joint cybersecurity advisory #StopRansomware: ALPHV Blackcat on February 27 because of recent ransomware attacks primarily targeting the health care sector. Specifically, Change Healthcare, a subsidiary of UnitedHealth Group (UHG), experienced a ransomware attack originating from APHV/BlackCat. According to the Department of Justice, ALPHV/Blackcat has emerged as the second most prolific ransomware-as-a-service variant in the world based on the hundreds of millions of dollars in ransoms paid by victims around the world. UHG has indicated they have taken appropriate action to contain the incident so that customers and partners do not need to sever network connections and disrupt vital services. Read the Advisory

Actions to take today to mitigate against the threat of ransomware:

• Routinely take inventory of assets and data to identify authorized and unauthorized devices and software.
• Prioritize remediation of known exploited vulnerabilities.
• Enable and enforce multifactor authentication with strong passwords.
• Close unused ports and remove applications not deemed necessary for day-to-day operations.

Resources:

• Stopransomware.gov is a whole-of-government approach that gives one central location for ransomware resources and alerts.
• Resource to reduce the risk of a ransomware attack: #StopRansomware Guide.
• No-cost cyber hygiene services: Cyber Hygiene Services and Ransomware Readiness
• Assessment.
• Health and Human Services HPH Cybersecurity Gateway hosts the HPH CPGs and links to HHS cybersecurity resources.
• American Medical Association (AMA) webpage on Change Healthcare cybersecurity incident

Please make sure this information is seen and acted upon by the appropriate members of your organization, such as the IT department.

On March 5, the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) said they would help providers and hospitals negatively impacted by the Change Healthcare cyberattack. In a statement, the HHS and CMS said they would provide the following flexibilities to affected parties:

• On March 9, CMS announced a new opportunity for physicians impacted by the cyberattack and resulting disruptions with Change Healthcare to request advanced Medicare payments to help with cash flow disruptions. The details of the program, terms, and the steps needed to apply can be found here.

• Medicare providers needing to change clearinghouses that they use for claims processing during these outages should contact their Medicare Administrative Contractor (MAC) to request a new electronic data interchange (EDI) enrollment for the switch.

• The CMS will issue guidance to Medicare Advantage (MA) organizations and Part D sponsors encouraging them to remove or relax prior authorization, other utilization management, and timely filing requirements during these system outages. The CMS is also encouraging MA plans to offer advance funding to providers most affected by this cyberattack.

• The CMS strongly encourages Medicaid and CHIP managed care plans to adopt the same strategies of removing or relaxing prior authorization and utilization management requirements, and consider offering advance funding to providers, on behalf of Medicaid and CHIP managed care enrollees to the extent permitted by the state.

• If Medicare providers are having trouble filing claims or other necessary notices or other submissions, they should contact their MAC for details on exceptions, waivers, or extensions, or contact the CMS regarding quality reporting programs.

• The CMS has contacted all MACs to make sure they are prepared to accept paper claims from providers who need to file them. Although electronic billing is preferable for everyone, the MACs must accept paper submissions if a provider needs to file claims in that method.

• HHS said hospitals facing cash-flow issues from the IT outage can submit accelerated payment requests, like those issued during the pandemic, to their MAC’s for "individual consideration."

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

This week, Mathematica will send out a national survey of independent laboratory practices to collect updated and accurate data on practice and laboratory costs, a key element of physician fee schedule payment for pathology services. The survey results will be sent to the Centers for Medicare and Medicaid Services (CMS) to be used in 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 to inform 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.

A brief survey from the Centers for Disease Control and Prevention (CDC), the CAP, the Association for Molecular Pathology (AMP), Association of Public Health Laboratories (APHL), American Society for Microbiology (ASM), and COLA (Commission on Office Laboratory Accreditation) is being distributed to better understand the existing policies and practices in U.S. hospitals related to performing routine clinical laboratory testing on patients suspected of having a viral hemorrhagic fever (VHF). This survey is being distributed through the CAP’s partnership with the CDC, and will inform future policy and educational resources on this issue for US hospitals and the clinical laboratory community.

If you work in a hospital system, please forward this link to anyone who may be able to provide valuable insight on this topic. It should take less than 10 minutes to complete. The deadline for responses is March 20, 2024. Viral Hemorrhagic Fever survey

https://www.cap.org/advocacy/l...Listen to our new podcast featuring CAP Federal and State Affairs Committee (FSAC) Chair Matthew R. Foster, MD, MMM, FCAP. Dr. Foster discusses the CAP’s advocacy priorities and outlines what to expect when meeting directly with legislators and their staff on Hill Day to advocate for pathology and its critical impact on patient care during the 2024 Pathologist Leadership Summit. Listen to an in-depth conversation about fixing the Medicare physician fee schedule, Conrad 30, Saving Access to Laboratory Services Act (SALSA) and more.

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