Ensure Access to Biomarker Testing.

GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2025
H 2
HOUSE BILL 567
Committee Substitute Favorable 4/29/25

Short Title: Ensure Access to Biomarker Testing. (Public)
Sponsors:
Referred to:
March 31, 2025
*H567-v-2*
A BILL TO BE ENTITLED 1
AN ACT TO ENSURE ACC ESS TO AN EARLY AND ACCURATE DIAGNOSIS O F 2
DEMENTIA IN ORDER TO IMPROVE ACCESS TO CARE AND SUPPORT SERVICES 3
FOR, ENHANCE THE QUA LITY OF LIFE OF, AND REDUCE THE FINANCIA L 4
IMPACT OF THE CONDITION ON NORTH CAROLINIANS. 5
The General Assembly of North Carolina enacts: 6
7
PART I. HEALTH BENEFIT PLAN COVERAGE OF BIOMARKER TESTING 8
SECTION 1.1.(a) Article 3 of Chapter 58 of the General Statutes is amended by 9
adding a new section to read: 10
"§ 58-3-216. Coverage of biomarker testing. 11
(a) The following definitions apply in this section: 12
(1) Biomarker. – A characteristic that is objectively measured and evaluated as an 13
indicator of normal biological processes, pathogenic processes, or 14
pharmacologic responses to a speci fic therapeutic intervention, including 15
known gene -drug interactions for medication being considered for use or 16
already being administered. This term incudes gene mutations, characteristics 17
of genes, and protein expression. 18
(2) Biomarker testing. – The ana lysis of a patient 's tissue, blood, or other 19
biospecimen for the presence of a biomarker. This term includes 20
single-analyte tests, multi -plex panel tests, protein expression, and whole 21
exome, whole genome, and whole transcriptome sequencing. 22
(3) Consensus statement. – A statement that is developed by an independent 23
multidisciplinary panel, aimed at specific clinical circumstances , and based 24
upon the best available evidence for the purpose of optimizing the outcomes 25
of clinical care. 26
(4) FDA. – The United States Food and Drug Administration. 27
(5) Reserved for future codification purposes. 28
(6) Independent multidisciplinary panel. – A multidisciplinary panel of experts 29
that utilizes a transparent methodology and reporting structure and that has a 30
conflict of interest policy. 31
(7) Independent organization or medical professional society. – An organization 32
or medical professional society that utilizes a transparent methodology and 33
reporting structure and that has a conflict of interest policy. 34
(8) Reserved for future codification purposes. 35
General Assembly Of North Carolina Session 2025
Page 2 House Bill 567-Second Edition
(9) Nationally recognized clinical practice guidelines. – Evidence-based clinical 1
practice guidelines developed by independent organizations or medical 2
professional societies that establish standards of care that are informed by a 3
systematic review of evidence and an assessment of the benefits and risks of 4
alternative care options and that include recommendations intended to 5
optimize patient care. 6
(b) A health benefit plan shall provide coverage for biomarker testing for the purposes of 7
diagnosis, treatment, a ppropriate care management, or ongoing monitoring of an insured 's 8
disease or condition when the testing is supported by medical and scientific evidence . At a 9
minimum, any of the following shall be considered support for biomarker testing: 10
(1) Label indications for a test that has been FDA-approved or FDA-cleared. 11
(2) Indicated tests for an FDA-approved drug. 12
(3) Warnings and precautions on an FDA-approved drug label. 13
(4) National coverage determinations developed by the Centers for Medicare and 14
Medicaid Services. 15
(5) Local coverage determinations developed by a Medicare Administrative 16
Contractor. 17
(6) Nationally recognized clinical practice guidelines and consensus statements. 18
(c) Coverage required under this section shall be provided in a manner that limits 19
disruption in patient care, including the need for multiple biopsies or biospecimen samples." 20
SECTION 1.1.(b) G.S. 58-3-215, as amended by subsection (c) of this section, reads 21
as rewritten: 22
"§ 58-3-215. Genetic and biomarker information in health insurance. 23
(a) Definitions. – As used The following definitions apply in this section: 24
(1) Biomarker. – A characteristic that is objectively measured and evaluated as an 25
indicator of normal biological processes, pathogenic processes, or 26
pharmacologic responses to a specific therapeutic intervention, including 27
known gene -drug interactions for medication being considered for use or 28
already being administered. This term incudes gene mutations, characteristics 29
of genes, and protein expression. 30
(1a) "Genetic information" means information Genetic information. – Information 31
about genes, gene products, or inherited characteristics that may derive from 32
an individual or a family member. "Genetic information" does not include the 33
results of routine physical measurements, blood chemistries, blood counts, 34
urine analyses, tests for abuse of drugs, and tests for the presence of human 35
immunodeficiency virus. 36
… 37
(c) No insurer shall:shall do any of the following: 38
(1) Raise the premium or contribution rates paid by a group for a group health 39
benefit plan on the basis of genetic or biomarker information obtained about 40
an individual member of the group. 41
(2) Refuse to issue or deliver a health benefit plan because of genetic or biomarker 42
information obtained about any person to be insured by the health benefit plan. 43
(3) Charge a higher premium rate or charge for a health benefit plan because of 44
genetic or biomarker information obtained about any person to be insured by 45
the health benefit plan. 46
…." 47
SECTION 1.1.(c) G.S. 58-3-215(a)(2) and G.S. 58-3-215(a)(3) are repealed. 48
SECTION 1.1.(d) This section is effective October 1, 2025, and applies to insurance 49
contracts issued, renewed, or amended on or after that date. 50
SECTION 1.2.(a) G.S. 135-48.51 reads as rewritten: 51
General Assembly Of North Carolina Session 2025
House Bill 567-Second Edition Page 3
"§ 135-48.51. Coverage and operational mandates related to Chapter 58 of the General 1
Statutes. 2
The following provisions of Chapter 58 of the General Statutes apply to the State Health Plan: 3
(1) G.S. 58-3-191, Managed care reporting and disclosure requirements. 4
(1a) G.S. 58-3-216, Coverage of biomarker testing. 5
…." 6
SECTION 1.2.(b) This section becomes effective October 1, 2025, and applies as of 7
the start of the next plan year following the effective date. 8
9
PART II. MEDICAID COVERAGE OF BIOMARKER TESTING 10
SECTION 2.1. The Department of Health and Human Services, Division of Health 11
Benefits (DHB), shall ensure coverage for biomarker testing under the laboratory services 12
clinical coverage policies 1S -1 through 1S-13 to the same extent those services are required to 13
be covered by a health benefit plan under G.S. 58-3-216. 14
15
PART III. EFFECTIVE DATE 16
SECTION 3.1. Except as otherwise provided, this act is effective when it becomes 17
law. 18