GENERAL ASSEMBLY OF NORTH CAROLINA
SESSION 2025
H D
HOUSE BILL DRH40336-MRa-91
Short Title: Ensure Access to Biomarker Testing. (Public)
Sponsors: Representative Wheatley.
Referred to:
*DRH40336 -MRa-91*
A BILL TO BE ENTITLED 1
AN ACT TO ENSURE ACCESS TO AN EARLY AND ACCURATE DIAGNOSIS OF 2
DEMENTIA IN ORDER TO IMPROVE ACCESS TO CARE AND SUPPORT SERVICES 3
FOR, ENHANCE THE QUALITY OF LIFE OF, AND REDUCE THE FINANCIAL 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 specific 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 analysis 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
H.B. 567
Mar 27, 2025
HOUSE PRINCIPAL CLERK General Assembly Of North Carolina Session 2025
Page 2 DRH40336-MRa-91
(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, appropriate 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. 58-50-61 reads as rewritten: 51 General Assembly Of North Carolina Session 2025
DRH40336-MRa-91 Page 3
"§ 58-50-61. Utilization review. 1
(a) Definitions. – As used in this section, in G.S. 58-50-62, and in Part 4 of this Article, 2
the term: 3
… 4
(16a) Urgent healthcare service. – A healthcare service with respect to which the 5
application of the time periods for making a non-expedited utilization review 6
that, in the opinion of a medical doctor with knowledge of the covered person's 7
medical condition, could either (i) seriously jeopardize the life or health of the 8
covered person or the ability of the covered person to regain maximum 9
function or (ii) subject the covered person to severe pain that cannot be 10
adequately managed without the care or treatment that is the subject of the 11
utilization review. The term urgent healthcare service includes mental and 12
behavioral healthcare services. 13
… 14
(f) Time Lines for Prospective and Concurrent Reviews. Utilization Reviews Based 15
Upon Type of Healthcare Service. – As used in this subsection, the term "necessary information" 16
includes the results of any patient examination, clinical evaluation, or second opinion that may 17
be required. Prospective and concurrent determinations shall be communicated to The time line 18
for completion of a prospective or concurrent utilization review is as follows: 19
(1) Non-urgent healthcare services. – If an insurer requires a utilization review of 20
a healthcare service, then the insurer or its URO shall both render a utilization 21
review determination or noncertification and notify the covered person and the 22
covered person's provider within three business days after the insurer obtains 23
all necessary information about the admission, procedure, or health care 24
service. to make the utilization review determination or noncertification. 25
(2) Urgent healthcare services. – An insurer or its URO shall both render a 26
utilization review determination or noncertification concerning urgent 27
healthcare services and notify the covered person and the covered person's 28
provider of that utilization review determination or noncertification not later 29
than 24 hours after receiving all necessary information needed to complete the 30
review of the requested healthcare services. If the covered person's provider 31
or the insurer, or the entity conducting the review on behalf of the insurer, do 32
not both have access to the electronic health records of the covered person, 33
then this subdivision shall not apply and the utilization review will be subject 34
to the time line under subdivision (1) of this subsection. 35
(f1) Utilization Review Determination Notifications. – If an insurer or its URO certifies a 36
health care healthcare service, the insurer shall notify notification shall be sent to the covered 37
person's provider. For If an insurer or its URO issues a noncertification, the insurer shall notify 38
the covered person's provider and send then written or electronic confirmation of the 39
noncertification shall be sent to the covered person's provider and covered person. In person that 40
is in compliance with subsection (h) of this section. 41
(f2) Concurrent Review Liability. – For concurrent reviews, the insurer shall remain liable 42
for health care healthcare services until the covered person has been notified of the 43
noncertification. 44
… 45
(m) Disclosure of Utilization Review Requirements. – Information required to be 46
provided under this section shall be described in detail and in easily understandable language. 47
All of the following apply to an insurer's responsibility to disclose any utilization review 48
procedures: 49
(1) Coverage and member handbook. – In the certificate of coverage and member 50
handbook provided to covered persons, an insurer shall include a clear and 51 General Assembly Of North Carolina Session 2025
Page 4 DRH40336-MRa-91
comprehensive description of its utilization review procedures, including the 1
procedures for appealing noncertifications and a statement of the rights and 2
responsibilities of covered persons, including the voluntary nature of the 3
appeal process, with respect to those procedures. An insurer shall also include 4
in the certificate of coverage and the member handbook information about the 5
availability of assistance from the Department's Health Insurance Smart NC, 6
including the telephone number and address of the Program. program. 7
(2) Prospective materials. – An insurer shall include a summary of its utilization 8
review procedures in materials intended for prospective covered persons. 9
(3) Membership cards. – An insurer shall print on its membership cards a toll-free 10
telephone number to call for utilization review purposes. 11
(4) Website. – An insurer shall make any current utilization review requirements 12
and restrictions readily accessible on its website. 13
…." 14
SECTION 1.2.(b) This section becomes effective October 1, 2025, and applies to 15
insurance contracts issued, renewed, or amended on or after that date. 16
SECTION 1.3.(a) G.S. 135-48.51 reads as rewritten: 17
"§ 135-48.51. Coverage and operational mandates related to Chapter 58 of the General 18
Statutes. 19
The following provisions of Chapter 58 of the General Statutes apply to the State Health Plan: 20
(1) G.S. 58-3-191, Managed care reporting and disclosure requirements. 21
(1a) G.S. 58-3-216, Coverage of biomarker testing. 22
…." 23
SECTION 1.3.(b) In accordance with G.S. 135-48.24(b) and G.S. 135-48.30(a)(7) 24
which require the State Treasurer to implement procedures that are substantially similar to the 25
provisions of G.S. 58-50-61 for the North Carolina State Health Plan for Teachers and State 26
Employees (State Health Plan), the State Treasurer and the Executive Administrator of the State 27
Health Plan shall review all practices of the State Health Plan and all contracts with, and practices 28
of, any third party conducting any utilization review on behalf of the State Health Plan to ensure 29
compliance with Section 2 of this act no later than the start of the next plan year. 30
SECTION 1.3.(c) Effective July 1, 2025, there is appropriated from the General 31
Fund to the Department of State Treasurer the sum of one million dollars ($1,000,000) in 32
recurring funds for each year of the 2025-2027 fiscal biennium to be used to implement the 33
coverage required by this section for the State Health Plan. 34
SECTION 1.3.(d) Except as otherwise provided, this section becomes effective 35
October 1, 2025, and subsection (a) of this section applies as of the start of the next plan year 36
following the effective date. 37
38
PART II. MEDICAID COVERAGE OF BIOMARKER TESTING 39
SECTION 2.1. The Department of Health and Human Services, Division of Health 40
Benefits (DHB), shall ensure coverage for biomarker testing under the laboratory services 41
clinical coverage policies 1S-1 through 1S-13 to the same extent those services are required to 42
be covered by a health benefit plan under G.S. 58-3-216. DHB shall ensure its policies and 43
procedures for the prior authorization of any service covered under this section are in compliance 44
with Section 2.2 of this act. 45
SECTION 2.2.(a) For purposes of this section, the term "urgent prior authorization 46
request" is defined as a request for which a time line for decision longer than 72 hours could 47
seriously jeopardize the beneficiary's life, health, or ability to attain, maintain, or regain 48
maximum function, in the opinion of the beneficiary's healthcare provider. 49 General Assembly Of North Carolina Session 2025
DRH40336-MRa-91 Page 5
SECTION 2.2.(b) If prior authorization is required for any service covered under 1
Section 2.1 of this act, the time line for completion of a review of that prior authorization request 2
shall be as follows: 3
(1) For urgent prior authorization requests, DHB shall ensure that the prior 4
authorization request is either approved or denied and notice is given to the 5
beneficiary and beneficiary's healthcare provider within 24 hours after DHB 6
receives all information needed to complete a review of the request for prior 7
authorization. 8
(2) For non-urgent prior authorization requests, DHB shall ensure that the prior 9
authorization request is either approved or denied and notice is given to the 10
beneficiary and beneficiary's healthcare provider within 72 hours after DHB 11
receives all information needed to complete a review of the request for prior 12
authorization. 13
14
PART III. EFFECTIVE DATE 15
SECTION 3.1. Except as otherwise provided, this act is effective when it becomes 16
law. 17