Wednesday, May 15, 2024

UCSF: New paper on state biomarker laws

 See a new paper from UCSF reviewing the latest on state biomarker laws.

Here’s the UCSF press release:

JAMA publication by TRANSPERS Collaborators Addresses Rapid Emergence of State Biomarker Testing Insurance Coverage Laws.  

In JAMA article published May 13, The State of State Biomarker Testing Insurance Coverage Laws, by Lin et. al., the authors tackle the complicated topic of states legislating access to medical care. In response to perceived barriers to access to care, states have enacted legislation to mandate terms and conditions of insurance coverage for a variety of circumstances, such as cancer screening and mental health treatment parity. Recently, there have been increasing numbers of states that have passed legislation mandating that insurers cover “biomarker testing.” 

This review of legislation from 15 states mandating coverage of biomarker testing finds that their impact may be limited by their lack of reach and implementation challenges. While these laws attempt to expand access to coverage, that may not always be the case since more than 50% of the population may not be covered by legislative mandates governing insurance coverage. Additionally, such insurance mandates may not affect inequities in access. Finally, there is little guidance for implementation in the legislation. 

The authors conclude that current laws are likely to have limited effect, particularly concerning improving health equity, and additional approaches will likely be needed to improve patient access and outcomes. 

This study was led by Grace Lin, MD, MAS (UCSF School of Medicine) and TRANSPERS (UCSF Center for Translational and Policy Research) founding director Kathryn A. Phillips, PhD, with Janet Coffman, PhD, MPP, MA (UCSF Institute for Health Policy Studies). TRANSPERS is in the Department of Clinical Pharmacy at UCSF and is affiliated with the Philip R. Lee Institute for Health Policy Studies.


AI Corner

You may have herd of the new AI assistant, Chat GPT 4o.  It summarized the paper this way, automatically:

State Biomarker Testing Insurance Coverage Laws: 
An Overview

The landscape of state biomarker testing insurance coverage laws is rapidly evolving, driven by the need to address disparities in healthcare access. These laws mandate insurance coverage for biomarker testing, particularly for cancer subtypes, to ensure patients can access necessary treatments. However, the effectiveness and impact of these laws remain under scrutiny.

Legislative Efforts and Challenges

States have enacted various laws to improve access to cancer screenings and mental health treatments, yet the effectiveness of such mandates is debatable. For instance, mental health parity laws have had limited impact on service usage and spending. With biomarker testing, barriers like cost and inconsistent insurance coverage persist, leading to advocacy for legislative mandates.

Current State Laws

Since 2021, fifteen states have passed legislation requiring coverage for biomarker testing, with twelve including Medicaid. These laws generally define biomarkers similarly and do not exclude specific tests. Most require coverage for diagnosis, management, and monitoring, but not for screening.

Implementation and Effectiveness

The laws face challenges in implementation due to their broad language and lack of specificity. Issues like FDA approval focus on safety and efficacy rather than clinical utility, potentially complicating coverage decisions. Moreover, state mandates may not significantly impact those most affected by healthcare disparities, such as the uninsured or certain Medicaid populations.

Policy Implications

The impact of state biomarker testing laws is limited by their reach and implementation challenges. Policymakers and stakeholders must monitor these laws' effects and explore additional strategies beyond insurance mandates to enhance access and equity in healthcare. Non-legislative programs or federal legislation may be necessary to achieve broader, equitable access to biomarker testing.In conclusion, while state laws mandating biomarker testing coverage are a step toward improving access to personalized cancer treatments, their current limitations suggest that a multifaceted approach is essential to address ongoing disparities in healthcare access and outcomes.

For further details, please refer to the full article published in JAMA here.