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Recap of the Latest Advocacy News from April-June 2024
In this Issue:
Congressional News
CAP President Meets with Congress and Seeks Relief from Burdens of FDA LDT Rule
On June 4, CAP President Donald Karcher, MD, FCAP met with multiple members of the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions. Following the release of the overly burdensome laboratory-developed tests (LDT) regulation by the US Food and Drug Administration (FDA), the CAP has sought to engage with congressional leaders to advocate for legislative solutions that reduce regulatory burdens on laboratories and allow for continued innovation of tests.
CAP Recommends Ways Senators Can Stabilize Physician Payment System, Grow Workforce
On April 11, the Senate Finance Committee held a hearing, “Bolstering Chronic Care through Medicare Physician Payment” to discuss how to update and strengthen Medicare’s guarantee of high-quality health benefits for the next generation of America’s seniors. The CAP submitted a statement for the record outlining a number of policy recommendations to help stabilize the physician payment system, grow the health care workforce, increase oversight of insurer-imposed policies that impact patient care, and look at meaningful sources of health spending to fund reform.
Over 1,100 Messages from the CAP Encourage Congress to Protect Access to Laboratory Services
Over 350 pathologists responded to an Action Alert from the CAP encouraging members to reach out to their legislators and urge them to support the Saving Access to Laboratory Services Act (SALSA). Over 1,100 messages were sent to members of Congress, including 24 CAP members who took action for the first time. SALSA will give the Centers for Medicare and Medicaid Services (CMS) new authority to collect private market data through statistically valid sampling from all laboratory segments for the widely available test services where previous data collection was inadequate.
Medicare and Federal Health Care News
CAP Remains Concerned with FDA Moving Forward with LDT Final Rule
On April 29, The Food and Drug Administration (FDA) released the final regulation on the oversight of laboratory-developed tests (LDTs) with some changes advocated for by the CAP. The CAP had opposed the regulation as written and called for several improvements that would ensure patient access to testing and allow for the continued innovation of new tests. CAP President Donald Karcher, MD, FCAP, testified before the House Energy and Commerce Subcommittee on Health to firmly state the CAP’s opposition to the FDA’s oversight plan and advocate for policy solutions that target full regulation on only the highest-risk LDTs.
New Resource! The CAP’s Laboratory-Developed Test Oversight Webpage
How will you determine if a test meets Food and Drug Administration (FDA) regulatory requirements for laboratory-developed tests (LDTs)? Confused on how and when you will need to be compliant with the new rule? The CAP has combined multiple resources on one easy to follow webpage that provides the following:
- The stage/phase one requirements beginning May 6, 2025
- A place to submit questions about FDA LDT oversight
- The May 2024 CAP webinar: Preparing for Implementation of FDA’s Laboratory-Developed Test Final Rule and downloadable presentation slides
- Frequently asked questions
- Resource documents
- Links to CAP legislative action on LDT’s dating back to 2010
Check it out and “favorite” the link: Laboratory-Developed Test Oversight. The site will be updated regularly as new information and resources become available.
Flawed Special Stains Policy Finally Revised After Years of Persevering Advocacy by the CAP
In response to direct advocacy by the CAP, Medicare Administrative Contractors (MACs) Palmetto GBA and Wisconsin Physicians Service updated their Local Coverage Determinations (LCDs) for Special Histochemical Stains and Immunohistochemical Stains (‘special stains’). The policy revisions are the result of extensive advocacy by the CAP and its members over the past ten years, and a direct response to the CAP’s formal reconsideration request initiated in December 2021. The revised LCDs, which become effective July 14, 2024, expand coverage for Lynch Syndrome tumor screening for microsatellite instability (MSI) / DNA mismatch repair by removing the age limitation, and coverage for IHC for breast pathology to include Ki-67 in a specific population of breast cancer patients. Additional modifications to the LCD coverage criteria allow for greater flexibility for testing in areas like breast, lung, and prostate pathology. Overall, the LCD is less prescriptive and offers clearer actionable guidance for pathologists and other physicians seeking to be compliant in reporting a single service. Further, the updates help to restore physician judgment, as supported by medical evidence.
CMS Implements Insurance Enrollment and Health Coverage Rule Supported by CAP
On March 27, the Centers for Medicare and Medicaid Services (CMS) unveiled the Streamlining the Medicaid, Children’s Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes final rule that will remove barriers to enrollment and build on the Affordable Care Act’s (ACA’s) coverage protections. The final regulation adopted several accesses to health insurance provisions supported by the CAP. The CAP also supported increasing health coverage in both the Health Equity and Accountability Act and by providing comments in the 2021 budget reconciliation package. In addition, the CAP supported providing premium tax credits to help pay for plans on Affordable Care Act marketplace.
CAP Opposes Expansion of CLIA Oversight of Personnel, Supports AI Regulation at CLIAC Meeting
At an April 10 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), managed by the Centers for Disease Control and Prevention (CDC), Diana Cardona, MD, MBA, FCAP governor of the board of the CAP, delivered the CAP’s positions on the three topics up for consideration by the committee – the opposition to expansion of CLIA oversight, support of slowing down or pausing a regulatory framework for Artificial Intelligence (AI) and Machine Learning (ML) that requires verification and validation of AI/ML-based tools and centers the role of the pathologist in clinical decision-making and how clinical guidelines and standards such as the CAP Checklist can best be used to improve quality and not be referenced in regulations.
FDA Releases Plans on Guidance for Responsible Use of AI for Medical Products
On March 14, the FDA Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) jointly published a paper titled Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together. These FDA centers plan to facilitate careful management of AI technologies throughout the product life cycle to help address ongoing model performance, risk management, and regulatory compliance of AI systems in real-world applications.
Resources for Pathologists Affected by Change Healthcare Cyberattack
On February 21, Change Healthcare experienced a cybersecurity attack that resulted in disruptions in claims processing, delayed prior authorization requests, and other major impacts on physician practices. The Department of Health and Human Services (HHS) compiled information, resources, and tools from health plans and payers for providers in need of assistance – find that document online here. Make sure to check out the CAP’s newest resource: Cyberattacks and Cybersecurity in Health Care and check back for the latest information and updates.
Private Payor News
CAP Urges Horizon to Reverse Pathology Policy that Disrupts Patient Care
On April 25, the CAP wrote a letter to Horizon Blue Cross Blue Shield of New Jersey opposing a policy that limits the ability for pathologists to be reimbursed for diagnostic services performed on patients. The letter follows an April 3, 2024, meeting between Horizon representatives and CAP leaders. The CAP has called on Horizon to reverse its decision to enforce this policy, and to revise it so that clinicians can continue to choose local pathologists who are part of their model of coordinated care, which is an essential element in quality patient care.
UnitedHealthcare Implements Z-code Requirement June 1
After multiple delays, UnitedHealthcare began the implementation of the Z-code requirement on June 1. UnitedHealthcare originally announced the Z-code requirement was going to be implemented in August 2023. However, the CAP met with UnitedHealthcare and was successful in getting them to delay this requirement until the previously announced date of April 1. The CAP opposes this requirement for specific Z-code identifiers on claims to receive payment, as it would be confusing and result in complex workflow processes that will be difficult for CAP members.
State News
TSP and CAP Amend Tennessee Bill to Resolve Concerns Over Laboratory Operations
The Tennessee Society of Pathologists (TSP), the CAP, and the Tennessee Medical Association (TMA) successfully amended Tennessee legislation (SB 2230/HB 2545) relative to medical laboratory operations in a rural hospital setting on March 19. The bill would have adversely limited pathologist medical directors in supervising laboratories, created a new state mandated credentialing for medical laboratory supervisors, and improperly impeded the accreditation of hospital clinical laboratories by the CAP.
State Advocacy Win! Tennessee Governor Signs Test Results Bill Safeguarding Pathologists from Legal Risks
On May 6, the Tennessee Gov. Bill Lee (R) signed (SB 2012/ HB 2011) into law displacing the information-blocking requirements of the federal 21st Century Cures Act for certain test results and pathology reports. The Tennessee Society of Pathology (TSP), the CAP, and the Tennessee Medical Association (TMA) successfully amended the legislation to address pathologist concerns with the initial bill. The TSP and CAP worked to safeguard pathologists and laboratories from federal legal risks under the Cures Act considered to be information blocking, resulting from delays in the release of diagnostic testing results to patients.
Illinois Senate Passes Network Adequacy Bill, House Action Pending
On April 11, the Illinois State Senate, by an overwhelming majority, passed health plan network adequacy legislation, advocated by a multi-specialty coalition of medical societies, including the Illinois Society of Pathologists (ISP) and the CAP. The legislation now moves to the Illinois House for consideration. The legislation requires health plans to submit to the Illinois Department of Insurance, information demonstrating that they have contracted with hospital-based physician specialists, including pathologists, radiologists, anesthesiologists, and emergency room physicians at in-network hospitals and facilities.
CSP and CAP Support Pathology Remote Review and Sign Out Bill in California
The California Society of Pathologists and the CAP strongly support Assembly Bill 2107 authorizing pathologists and laboratory personnel to remotely review clinical laboratory data, digital results, and digital images under CLIA. The CAP advocates for the continuation of this waiver to preserve quality, ensure continuity of care for patients, and provide necessary flexibility as needed for clinical laboratories and pathologists.
State Advocacy Win! CAP and DC Pathologists Successfully Advocate to Repeal Laboratory Licensure Law
On May 29, District of Columbia Mayor Muriel Bowser enacted a CAP-amended “Health Occupations Revision General Amendment Act of 2023” (B25-0545), successfully repealing DC’s 2015 clinical laboratory licensure law.
The CAP worked closely with the DC Hospital Association (DCHA), the Medical Society of the District of Columbia (MSDC), and numerous DC pathology leaders to strongly urge the repeal of the law. The DC government never operationalized the law following the 2015 enactment. They had several times, most recently this year, attempted implementation.