Date: June 16, 2026
To: Health Insurers, Nonprofit Health Service Plans, Health Maintenance Organizations, and Private Review Agents
Re: Coverage Requirements for Biomarker Testing
The purpose of this Bulletin is to provide guidance to health insurers, nonprofit health service plans, health maintenance organizations, and private review agents (carriers) subject to §15–859 of the Insurance Article (Biomarker Law) regarding coverage for biomarker testing.
Background and Authority
In 2023, the Maryland General Assembly passed Senate Bill 805, Chapter 322, which requires carriers to provide coverage for biomarker testing. “Biomarker testing" is defined to include “the analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker."
“Biomarker testing" includes single-analyte tests, multi-plex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing. § 15-859(a)(3).
“Biomarker" is defined to mean
a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention, including known gene-drug interactions for medications being considered for use or already being administered. § 15-859(a)(2).
The Biomarker Law indicates that “[a] “Biomarker" includes gene mutations, characteristics of genes, or protein expression." § 15-859(a)(2).
This law requires coverage for biomarker testing that is used “for the purpose of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition that is supported by medical and scientific evidence, including testing:
- cleared or approved by the U.S. Food and Drug Administration;
- required or recommended for a drug approved by the U.S. Food and Drug Administration to ensure an insured or enrollee is a good candidate for the drug treatment;
- required or recommended through a warning or precaution for a drug approved by the U.S. Food and Drug Administration to identify whether an insured or enrollee will have an adverse reaction to the drug treatment or dosage;
- covered under a Centers for Medicare and Medicaid Services National Coverage Determination or Medicare Administrative contractor Local Coverage Determination; or
- supported by nationally recognized clinical practice guidelines that are:
(i) developed by independent organizations or medical professional societies using a transparent methodology and reporting structure and that have a conflict of interest policy; and
(ii) established standards of care informed by a systematic review of evidence and an assessment of the benefits and risks of alternative care options and include recommendations intended to optimize patient care." § 15-859(c).
Applicability
Section 31-116(a) of the Insurance Article provides that mandates of coverage required after December 31, 2011, will not apply to non-grandfathered, individual, and small employer markets if the mandates are not included in the State benchmark plan. In order to apply to these markets, the law would need to include express text indicating that it applies to these markets "irrespective of § 31-116(a), (c), and (d). As that express indication is not included in this mandate, the coverage requirement under § 15-859 applies to grandfathered and non-grandfathered large group health benefit plans and grandfathered individual plans.
A carrier may deny coverage for a test if the test is not medically necessary, but the application of medical necessity criteria must comply with the Biomarker Law. In order to promote uniformity in application of this law's coverage requirements, the Maryland Insurance Administration (MIA) offers four clarifications regarding interpretation of this law.
First, the law requires coverage for a biomarker test that is used for a scientifically supported purpose (as defined by the statute) and the results of which:- provide information that may be used in the formulation of a treatment or monitoring strategy that informs a patient's outcome and impacts the clinical decision; and
- include both information that is actionable and some information that cannot be immediately used in the formation of a clinical decision.
A carrier therefore must cover a biomarker test if the purpose of the test is for diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition that is supported by medical and scientific evidence, as well as by any one of the categories listed above.
It is important to note that carriers do not have discretion to apply additional or different coverage criteria. For example, where a biomarker test is covered under Local Coverage Determinations (LCD) of Medicare Administrative Contractors (MAC), a carrier may not apply coverage criteria additional to or different from those included in the LCD. Furthermore, a carrier shall ensure that coverage be provided in a manner that limits disruption in care, including the need for multiple biopsies or biospecimen samples.Secondly, because medical and scientific evidence or any one of the items listed in the categories is sufficient to meet the requirements of the law as long as the purpose criteria specified above are met, then carriers may not require multiple categories of evidence to provide coverage, and carriers must apply the least restrictive coverage criteria if multiple categories of medical and scientific evidence are satisfied by the biomarker test. For example, if a biomarker test has a labeled indication approved by the FDA and a LCD MAC that imposes coverage criteria more restrictive than the labeled indication, carriers must cover the biomarker test in accordance with its labeled indication, i.e., the less restrictive coverage criteria. Third, in the absence of medical and scientific evidence or any of the included items listed in the Biomarker Law, carriers may make determinations as to whether a test provides information for the purpose of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition in accordance with their judgment, applicable medical policies, and available evidence. Such determinations may qualify as “adverse decisions" within the definition of § 15-10A-01 and an enrollee may have the right to appeal the determination through an internal grievance process or through a complaint filed with the Insurance Commissioner, depending upon the individual circumstances of the determination which the carrier must clearly communicate to the enrollee. Fourth, in formulating any medical policy used to make coverage decisions for biomarker tests, carriers should explicitly state the requirements of the law and follow those requirements. Insofar as a carrier utilizes a medical policy that is intended to be generally applicable in multiple jurisdictions, such policy must explicitly provide that the law governs insurance policies to which it applies, and that the coverage requirements of the law prevail over any other more general or different requirements. The MIA emphasizes that clear medical policy provisions that faithfully reflect the requirements of the law are critical to effectuating access to biomarker testing. Questions about this Bulletin may be directed to the Life/Health Section of the Maryland Insurance Administration, 200 Saint Paul Place, Suite 2700, Baltimore, MD 21202, or call at 410-468-2170.
MARIE GRANT
Commissioner
By:
Signature on Original
Megan Mason
Associate Commissioner
Life and Health
