Ohio House Bill No. 8 – Biomarker Testing Coverage
Subject: Analysis of Ohio House Bill No. 8, requiring health benefit plan and Medicaid coverage of biomarker testing.
Summary:
Ohio House Bill No. 8 (H.B. No. 8) proposes the enactment of sections 3902.65 and 5164.13 of the Revised Code, mandating coverage for biomarker testing by health benefit plans and the Medicaid program in Ohio. The bill aims to ensure access to biomarker testing for diagnosis, treatment, management, and ongoing monitoring of diseases and conditions, with the intention of improving health outcomes and potentially reducing long-term healthcare costs. However, the bill explicitly excludes coverage for screening purposes. The bill also expresses the intention of the General Assembly that the coverage requirements should not lead to substantial price increases for biomarker tests.
Key Provisions and Themes:
- Mandated Coverage: The core of the bill lies in requiring health benefit plans (Section 3902.65) and the Medicaid program (Section 5164.13) to cover biomarker testing. This coverage extends to testing for:
- Diagnosis
- Treatment and appropriate management of a disease or condition
- Ongoing monitoring of a disease or condition
- Definition of Biomarker and Biomarker Testing: The bill provides clear definitions for key terms:
- Biomarker: “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to specific therapeutic intervention, including known gene-drug interactions for drugs being considered for use or already available for use. Biomarkers include, but are not limited to, gene mutations, characteristics of genes, or protein expression.”
- Biomarker Testing: “the analysis of tissue, blood, or another biospecimen for the presence of a biomarker, and includes, but is not limited to, single-analyte tests, multiplex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing.”
- Medical Necessity and Evidence-Based Support: Coverage is contingent upon the biomarker testing being “ordered and deemed medically necessary by the qualified treating health care provider working within the provider’s scope of practice.” Furthermore, the test must be “supported by medical or scientific evidence,” including:
- FDA-approved or cleared tests (labeled indications)
- Indicated tests for FDA-approved drugs
- Warnings and precautions on FDA-approved drug labels
- National Coverage Determinations from CMS
- Medicare Administrative Contractor Local Coverage Determinations
- Nationally Recognized Clinical Practice Guidelines
- Nationally recognized and peer-reviewed studies indicating that the test materially improves health outcomes
- Limiting Disruptions in Care: Both sections 3902.65(D) and 5164.13(D) emphasize minimizing disruptions in care, particularly concerning the need for multiple biopsies or biospecimen samples: “A health plan issuer shall ensure coverage as required in division (B) of this section in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.”
- Appeals Process: The bill ensures a clear appeals process for coverage determinations, referencing existing regulations:
- For health benefit plans: “…appeal of a biomarker testing coverage determination shall be handled in accordance with the health plan issuer’s appeal policy and any other relevant provision of law, including section 1751.82 or Chapter 3922. of the Revised Code.”
- For Medicaid: “…appeal of a biomarker testing coverage policy shall be handled in accordance with section 5160.31 of the Revised Code.” Both require the appeal process to be readily accessible to providers and recipients.
- Exclusion of Screening: The bill explicitly excludes coverage for biomarker testing when used for screening purposes: “Nothing in this section shall be construed to require coverage of biomarker testing for screening purposes.”
- Legislative Intent and Cost Control: Section 2 outlines the General Assembly’s intent: “It is the intent of the General Assembly to ensure coverage for appropriate biomarker testing supported by medical or scientific evidence, as defined by section 3922.01 of the Revised Code, with the goal of producing long-term healthcare cost savings and improving health outcomes for Ohioans covered under this act.” It also addresses concerns about potential price gouging: “The General Assembly does not intend to create a landscape which allows manufacturers and administrators of biomarker tests to substantially increase pricing for existing and new biomarker tests as a result of the coverage requirements for certain health insurance markets under this act.”
- Definition of Nationally Recognized Clinical Practice Guidelines: The bill defines what constitutes “Nationally recognized clinical practice guidelines”: “…evidence-based clinical practice guidelines establishing standards of care informed by a systematic review and assessment of benefits and risks of alternative care options and include recommendations intended to optimize patient care, developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and with a conflict of interest policy.”
Potential Implications:
- Improved Patient Outcomes: By increasing access to biomarker testing, the bill has the potential to facilitate more precise diagnoses, targeted treatments, and improved monitoring of diseases.
- Cost Savings: The General Assembly hopes that the bill will “produc[e] long-term healthcare cost savings” by enabling more effective and efficient treatments. This is based on the idea that using biomarkers to guide treatment decisions can prevent the use of ineffective or harmful treatments.
- Increased Healthcare Costs: The bill acknowledges that the coverage mandates could lead to price increases for biomarker tests. The General Assembly expresses its intent to prevent this, but the mechanism for doing so is not specified in the bill.
- Administrative Burden: Health plans and the Medicaid program will need to adapt their policies and procedures to comply with the new coverage requirements. This may involve updating formularies, developing clinical guidelines, and training staff.
Key Questions and Considerations:
- How will “medical necessity” be determined in practice? Who will define the criteria, and how will consistency be ensured across different health plans and providers?
- How will the state monitor and prevent potential price increases for biomarker tests?
- What resources will be available to healthcare providers to help them understand and implement the new coverage requirements?
- What impact will this bill have on health disparities in access to biomarker testing?