Advocacy Update

• Pathologists Urge Congress to Mitigate Medicare Cuts at CAP ‘Virtual Fly-In’
• The Biden Administration’s Executive Order on Trustworthy AI is a Broad Call for Oversight
• FDA Moves Forward with 60-Day Comment Period for LDT Regulation
• Download the Latest Pathology Workforce and Economic Trends from 2023 Practice Leader Survey Report
• CAP Asks Federal Agencies to Reduce Fees for Federal IDR Process
• State Pathology Societies and CAP Continue to Seek Expanded Coverage of Special Stains LCD
• CAP Assessing Data Standard Changes for Electronic Medical Records
• New Proposed Penalties for Blocking Electronic Health Information Do Not Apply to Most Pathologists
• AMA to Host Advocacy Insights webinar, ‘What’s next with Medicare payment reform,’ on Nov. 3
• What Will Be the Impact of the Final Fee Schedule on Your Practice?
• Take Our News Quiz for November

On October 26, over 60 pathologists participated in a “virtual fly-in” and met with their federal policy makers to lobby Congress to mitigate a 2.75% Medicare cut to pathology services in 2024. With various economic pressures and workforce shortages on pathologists, the CAP has sought relief to mitigate cuts to pathologists’ Medicare reimbursement set to take effect in January. The virtual fly-in is a week of action to fight the Medicare cuts. All CAP members can still quickly engage with their member of Congress on this issue through the CAP’s grassroots action center.

On October 30, President Joe Biden issued an executive order establishing new standards for artificial intelligence (AI) safety and security, and the protection of Americans’ privacy while advancing equity and civil rights. As part of the administration’s strategy for responsible innovation with AI, the executive order covers national security, economic security, and public health and safety. The president further directed federal agencies to step up oversight of AI technologies under their jurisdiction as the White House works with Congress on bipartisan legislation.

In terms of what may directly affect health care, the executive order:

• Requires that developers of the most powerful AI systems share their safety test results and other critical information with the US government.
• Directs the advancement of the responsible use of AI in health care and the development of affordable and life-saving drugs.
• Directs the Department of Health and Human Services (HHS) to establish a safety program to receive reports of—and act to remedy – harms or unsafe health care practices involving AI.
• Catalyzes AI research across the United States through a pilot of the National AI Research Resource—a tool that will provide AI researchers and students access to key AI resources and data—and expanded grants for AI research in vital areas like health care and climate change.
• Seeks to ensure that AI advances equity and civil rights (including in health care) by addressing algorithmic discrimination through training, technical assistance, and coordination between the Department of Justice and Federal civil rights offices on best practices for investigating and prosecuting civil rights violations related to AI.

The Biden administration is working with House and Senate leadership on drafting bipartisan legislation concerning AI. The CAP will continue to work with all federal agencies and Congress on safe and effective implementation of AI in pathology and laboratory medicine. The CAP will provide further analysis of the executive order when it is published on the Federal Register.

The US Food and Drug Administration (FDA) will proceed with a 60-day comment period for its proposed regulation on laboratory-developed tests (LDTs), the agency announced on October 30. The CAP and other organizations had requested a 120-day comment period due to the complexity and magnitude of the proposal on laboratories and patient access to LDTs.

In response to the CAP, the FDA said: “After considering the requests and other factors, including the extensive background of public comment on this topic and the public health benefits of proceeding expeditiously, FDA has determined to proceed with the standard 60-day comment period.”

The CAP remains engaged with the FDA’s proposed regulation and is preparing our comments on the proposed rule, which are due on December 4. The CAP will report more information to CAP members on this issue as news develops.

The CAP published the 2023 Practice Leaders Survey Report, providing the latest socioeconomic data on pathology practices’ structure and ownership status, case volume and revenue mix, practice staffing, and problems they are incur with coverage and payment for services. The results contained in the report published on October 26 are exclusively available to CAP members.

Among the most notable findings from the survey, nearly 60% or more of practice leader respondents reported that it was “difficult” to hire most categories of laboratory staff. Additionally, the report highlighted the following:

• Overall, 72% percent of practice leaders reported that their practice had some kind of detrimental effect due to decreased reimbursement rates of pathology services over the last five years.
• Thirty percent of practice leaders reported that pathologists in their practice perform some kind of remote sign-out, including 9% whose practices used digital pathology primary diagnosis.
• There were substantial increases in the share of respondents whose practice decided not to join or renew participation in a particular health plan/insurer network in the last two years; who have been denied participation in a network in which they were previously a participating provider; and who attempted to join a network but were denied participation.

The 2023 survey asked questions about practice demographics (including questions on practice structure, case volume, and staffing levels), case mix revenue and sources (including questions on both AP and non-AP services), hiring and staffing, and market and regulatory issues regarding coverage and payment for pathology services.

Download the full 2023 Practice Leader Survey report.

For questions on the report, please email practicesurvey@cap.org.

The CAP strongly urged the departments of the Treasury, Labor, and Health and Human Services to reconsider increasing the independent dispute resolution (IDR) process administrative fee from $50 to $150 per party, as any increase in the administrative fee amount imposes added burdens and potentially a complete barrier for physicians in accessing the federal IDR process and is especially difficult for pathologists.

In an October 24 letter to the departments, the CAP urged the government to reduce the administrative fee amount for disputes that involve low-dollar claims. The CAP argued that by precluding the overwhelming majority of pathology claims from the IDR process, this administrative fee amount would inject a serious inequity into the process and undercut the critical balance the legislation sought to achieve. The CAP also supports a proposal to set the ranges for certified independent dispute resolution (IDR) entity fees in notice and comment rulemaking, with the certified IDR entities providing their fees on an annual basis. Further, while the IDR entity fee is returned to the prevailing party, the CAP proposes the Departments consider the upfront finances needed when setting the certified IDR entity fee ranges.

In the letter, the CAP encouraged the departments to maintain predictability and consistency with the administrative fee process. The CAP has worked closely with Congress and other stakeholders in the development of the No Surprises Act and has repeatedly called for protections that keep patients out of the middle of billing disputes.

On October 27, the Departments released the proposed rule. The CAP has repeatedly asked for a more formalized open negotiation process, which they are proposing, as well as more flexible batching, which is being provided in particular for pathology. The CAP continues to believe that regulations must support an equitable and balanced system for resolving payment disputes, to ensure fair reimbursement for out-of-network services and IDR process that is accessible to all.

For more information read: No Surprises Act Independent Dispute Resolution Process Proposed Rule Fact Sheet.

State pathology societies and the CAP called on the Medicare Administrative Contractor (MAC) Wisconsin Physician Services (WPS) to remove certain coverage limitations to its Special Stains and Immunohistochemical Stains Local Coverage Determination (LCD). The CAP has long advocated for changes to the LCD and is collaborating with state pathology societies and subject experts to make necessary changes supported by medical evidence.

On October 25, WPS hosted a public meeting to hear comments for its proposed revisions to the LCD. Vaishali M. Pansare, MD, FCAP, Chief of Pathology at Beaumont Hospitals in Michigan; and, Matthew Wasco, MD, FCAP, Department of Pathology, Trinity Health Medical Group in Michigan presented evidence challenging the current limits of immunohistochemistry (IHC) and special stains for prostate pathology and kidney tumors. Pathology Contractor Advisory Committee members representing the Missouri pathology state society provided additional comments on the clinical necessity of IHC and special stains for prostate and renal tumors.

The CAP will send formal comments to the MAC on its proposed revisions by November 11, urging further coverage for IHC/special stains and additional clarification to the LCD language. The CAP maintains the MAC revisions do not go far enough and continues to advocate to further expand coverage of this LCD.

On October 23, the Office of the National Coordinator for Health IT (ONC) changed version 4 of the United States Core Data for Interoperability (USCDI) to ensure accuracy of electronic health records. The CAP is assessing these changes and the implications that they have for pathologists, though the changes are not expected to be significant.

The USCDI is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. The ONC changed the vocabulary standards for the Specimen Condition Acceptability and Result Interpretation data elements in the laboratory class as follows:

• For Specimen Condition Acceptability (which we submitted to ONC as Condition and Disposition of Specimens), the ONC is now requiring either SNOMED CT or HL7 Code System SpecimenCondition. Before, SNOMED CT was the only required vocabulary standard.
• For Result Interpretation, the ONC is now requiring either SNOMED CT or HL7 Code System ObservationInterpretation. Before, SNOMED CT was required and HL7 Code System ObservationInterpretation was optional.

The ONC also clarified that the Result Unit of Measure data element was limited to quantitative results. This change is in line with CAP’s advocacy efforts ensuring electronic health record elements are aligned with existing regulatory requirements.

Most individual pathologists will not be penalized under a new proposed rule that will levy fines on physicians for failing to comply with patient access to medical record provisions in the 21st Century Cures Act. Previously, the CAP had advocated for there to be expanded and additional exceptions to the information blocking rule and for the government to issue clear guidance on what constitutes information blocking.

On October 30, the CMS and the ONC published the 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking proposed rule, which would implement penalties to physicians and other providers for blocking patients from their own electronic health information, except in very limited circumstances. This will not apply to most individual pathologists, but it will apply to hospital systems and pathologists in large groups that report to the Quality Payment Program and are subject to the Promoting Interoperability category. Pathologists for whom the Promoting Interoperability category of the Merit Based Incentive Payment System (MIPS) is not applicable could not be held accountable for penalties under this proposed rule.

Of note, the ONC and CMS recognize that the proposed rule does not apply to all clinicians. Thus, they included in the proposed rule a Request for Information on additional disincentives to be considered in future rulemaking that would apply to health care providers that are not implicated by the disincentives proposed in this rule.

Information blocking is a practice by an "actor" that is likely to interfere with the access, exchange, or use of electronic health information (EHI), except as required by law or specified in an information blocking exception. The CAP has known there would be penalties against information blocking established because Congress passed the 21st Century Cures Act in 2016. The CAP has long advocated for expanded and additional exceptions for the information blocking rules.

On November 15, the ONC and CMS will host an information session on the proposed rule. For more information on blocking regulations go to the HHS’ website on information blocking.

Payment cuts and temporary fixes have become predictable in Medicare physician payment over the past decade—leaving physician practices and patient access to care at serious risk. The American Medical Association (AMA) is working to change that by urging lawmakers to work with the physician community to permanently reform the system. Congress needs to establish a permanent, annual inflationary Medicare physician payment update that keeps up with the cost of practicing medicine and encourages practice innovation.

The webinar topics include:

• Where Medicare payment reform stands now
• How the AMA, alongside state and national medical specialty societies, is pushing for permanent payment reform
• How you can get involved in these advocacy efforts

Moderator:

• Willie Underwood III, MD, MSc, MPH, Chair, AMA Board of Trustees

Speakers:

• G. Ray Callas, MD, President Elect, Texas Medical Association
• Katie Orrico, Senior Vice President, Health Policy and Advocacy, American Association of Neurological Surgeons/Congress of Neurological Surgeons

Todd Askew, Senior Vice President, Advocacy, American Medical Association

Date: Friday, November 3, 2023

Time: 2:00 PM - 3:00 PM ET

Click this link to register now.

The CMS is getting ready to release the final 2024 Medicare payment regulations, including rules for the Medicare Physician Fee Schedule and the Quality Payment Program.

On Thursday, November 30 at 3 PM ET/ 2 PM CT, the CAP will offer a complementary live webinar where CAP experts will review final regulations that will impact Medicare payment for services and pathologists’ participation in the quality initiatives. Webinar presenters will be the Council on Government and Professional Affairs Chair A. Joe Saad, MD, CPE, FCAP; Economic Affairs Committee Chair Ronald McLawhon, MD, PhD, FCAP; and Quality and Clinical Data Registry Affairs Committee Chair Gregary Bosci, DO, FCAP.

Register today.

Are you up to speed on CAP advocacy news? Take our new monthly news quiz and see how many you can get right and share your results on social media.

Take the quiz.