North Carolina 2025-2026 Regular Session

North Carolina House Bill H567 Compare Versions

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11 GENERAL ASSEMBLY OF NORTH CAROLINA
22 SESSION 2025
3-H 1
4-HOUSE BILL 567
3+H D
4+HOUSE BILL DRH40336-MRa-91
5+
56
67
78 Short Title: Ensure Access to Biomarker Testing. (Public)
8-Sponsors: Representatives Wheatley, Penny, Campbell, and Moss (Primary Sponsors).
9-For a complete list of sponsors, refer to the North Carolina General Assembly web site.
10-Referred to: Health, if favorable, Appropriations, if favorable, Rules, Calendar, and Operations
11-of the House
12-March 31, 2025
13-*H567 -v-1*
9+Sponsors: Representative Wheatley.
10+Referred to:
11+
12+*DRH40336 -MRa-91*
1413 A BILL TO BE ENTITLED 1
1514 AN ACT TO ENSURE ACCESS TO AN EARLY AND ACCURATE DIAGNOSIS OF 2
1615 DEMENTIA IN ORDER TO IMPROVE ACCESS TO CARE AND SUPPORT SERVICES 3
1716 FOR, ENHANCE THE QUALITY OF LIFE OF, AND REDUCE THE FINANCIAL 4
1817 IMPACT OF THE CONDITION ON NORTH CAROLINIANS. 5
1918 The General Assembly of North Carolina enacts: 6
2019 7
2120 PART I. HEALTH BENEFIT PLAN COVERAGE OF BIOMARKER TESTING 8
2221 SECTION 1.1.(a) Article 3 of Chapter 58 of the General Statutes is amended by 9
2322 adding a new section to read: 10
2423 "§ 58-3-216. Coverage of biomarker testing. 11
2524 (a) The following definitions apply in this section: 12
2625 (1) Biomarker. – A characteristic that is objectively measured and evaluated as an 13
2726 indicator of normal biological processes, pathogenic processes, or 14
2827 pharmacologic responses to a specific therapeutic intervention, including 15
2928 known gene-drug interactions for medication being considered for use or 16
3029 already being administered. This term incudes gene mutations, characteristics 17
3130 of genes, and protein expression. 18
3231 (2) Biomarker testing. – The analysis of a patient's tissue, blood, or other 19
3332 biospecimen for the presence of a biomarker. This term includes 20
3433 single-analyte tests, multi-plex panel tests, protein expression, and whole 21
3534 exome, whole genome, and whole transcriptome sequencing. 22
3635 (3) Consensus statement. – A statement that is developed by an independent 23
3736 multidisciplinary panel, aimed at specific clinical circumstances, and based 24
3837 upon the best available evidence for the purpose of optimizing the outcomes 25
3938 of clinical care. 26
4039 (4) FDA. – The United States Food and Drug Administration. 27
4140 (5) Reserved for future codification purposes. 28
4241 (6) Independent multidisciplinary panel. – A multidisciplinary panel of experts 29
4342 that utilizes a transparent methodology and reporting structure and that has a 30
4443 conflict of interest policy. 31
4544 (7) Independent organization or medical professional society. – An organization 32
4645 or medical professional society that utilizes a transparent methodology and 33
47-reporting structure and that has a conflict of interest policy. 34 General Assembly Of North Carolina Session 2025
48-Page 2 House Bill 567-First Edition
49-(8) Reserved for future codification purposes. 1
50-(9) Nationally recognized clinical practice guidelines. – Evidence-based clinical 2
51-practice guidelines developed by independent organizations or medical 3
52-professional societies that establish standards of care that are informed by a 4
53-systematic review of evidence and an assessment of the benefits and risks of 5
54-alternative care options and that include recommendations intended to 6
55-optimize patient care. 7
56-(b) A health benefit plan shall provide coverage for biomarker testing for the purposes of 8
57-diagnosis, treatment, appropriate care management, or ongoing monitoring of an insured's 9
58-disease or condition when the testing is supported by medical and scientific evidence. At a 10
59-minimum, any of the following shall be considered support for biomarker testing: 11
60-(1) Label indications for a test that has been FDA-approved or FDA-cleared. 12
61-(2) Indicated tests for an FDA-approved drug. 13
62-(3) Warnings and precautions on an FDA-approved drug label. 14
63-(4) National coverage determinations developed by the Centers for Medicare and 15
64-Medicaid Services. 16
65-(5) Local coverage determinations developed by a Medicare Administrative 17
66-Contractor. 18
67-(6) Nationally recognized clinical practice guidelines and consensus statements. 19
68-(c) Coverage required under this section shall be provided in a manner that limits 20
69-disruption in patient care, including the need for multiple biopsies or biospecimen samples." 21
70-SECTION 1.1.(b) G.S. 58-3-215, as amended by subsection (c) of this section, reads 22
71-as rewritten: 23
72-"§ 58-3-215. Genetic and biomarker information in health insurance. 24
73-(a) Definitions. – As used The following definitions apply in this section: 25
74-(1) Biomarker. – A characteristic that is objectively measured and evaluated as an 26
75-indicator of normal biological processes, pathogenic processes, or 27
76-pharmacologic responses to a specific therapeutic intervention, including 28
77-known gene-drug interactions for medication being considered for use or 29
78-already being administered. This term incudes gene mutations, characteristics 30
79-of genes, and protein expression. 31
80-(1a) "Genetic information" means information Genetic information. – Information 32
81-about genes, gene products, or inherited characteristics that may derive from 33
82-an individual or a family member. "Genetic information" does not include the 34
83-results of routine physical measurements, blood chemistries, blood counts, 35
84-urine analyses, tests for abuse of drugs, and tests for the presence of human 36
85-immunodeficiency virus. 37
86-… 38
87-(c) No insurer shall:shall do any of the following: 39
88-(1) Raise the premium or contribution rates paid by a group for a group health 40
89-benefit plan on the basis of genetic or biomarker information obtained about 41
90-an individual member of the group. 42
91-(2) Refuse to issue or deliver a health benefit plan because of genetic or biomarker 43
92-information obtained about any person to be insured by the health benefit plan. 44
93-(3) Charge a higher premium rate or charge for a health benefit plan because of 45
94-genetic or biomarker information obtained about any person to be insured by 46
95-the health benefit plan. 47
96-…." 48
97-SECTION 1.1.(c) G.S. 58-3-215(a)(2) and G.S. 58-3-215(a)(3) are repealed. 49
98-SECTION 1.1.(d) This section is effective October 1, 2025, and applies to insurance 50
99-contracts issued, renewed, or amended on or after that date. 51 General Assembly Of North Carolina Session 2025
100-House Bill 567-First Edition Page 3
101-SECTION 1.2.(a) G.S. 58-50-61 reads as rewritten: 1
102-"§ 58-50-61. Utilization review. 2
103-(a) Definitions. – As used in this section, in G.S. 58-50-62, and in Part 4 of this Article, 3
104-the term: 4
105-… 5
106-(16a) Urgent healthcare service. – A healthcare service with respect to which the 6
107-application of the time periods for making a non-expedited utilization review 7
108-that, in the opinion of a medical doctor with knowledge of the covered person's 8
109-medical condition, could either (i) seriously jeopardize the life or health of the 9
110-covered person or the ability of the covered person to regain maximum 10
111-function or (ii) subject the covered person to severe pain that cannot be 11
112-adequately managed without the care or treatment that is the subject of the 12
113-utilization review. The term urgent healthcare service includes mental and 13
114-behavioral healthcare services. 14
115-… 15
116-(f) Time Lines for Prospective and Concurrent Reviews. Utilization Reviews Based 16
117-Upon Type of Healthcare Service. – As used in this subsection, the term "necessary information" 17
118-includes the results of any patient examination, clinical evaluation, or second opinion that may 18
119-be required. Prospective and concurrent determinations shall be communicated to The time line 19
120-for completion of a prospective or concurrent utilization review is as follows: 20
121-(1) Non-urgent healthcare services. – If an insurer requires a utilization review of 21
122-a healthcare service, then the insurer or its URO shall both render a utilization 22
123-review determination or noncertification and notify the covered person and the 23
124-covered person's provider within three business days after the insurer obtains 24
125-all necessary information about the admission, procedure, or health care 25
126-service. to make the utilization review determination or noncertification. 26
127-(2) Urgent healthcare services. – An insurer or its URO shall both render a 27
128-utilization review determination or noncertification concerning urgent 28
129-healthcare services and notify the covered person and the covered person's 29
130-provider of that utilization review determination or noncertification not later 30
131-than 24 hours after receiving all necessary information needed to complete the 31
132-review of the requested healthcare services. If the covered person's provider 32
133-or the insurer, or the entity conducting the review on behalf of the insurer, do 33
134-not both have access to the electronic health records of the covered person, 34
135-then this subdivision shall not apply and the utilization review will be subject 35
136-to the time line under subdivision (1) of this subsection. 36
137-(f1) Utilization Review Determination Notifications. – If an insurer or its URO certifies a 37
138-health care healthcare service, the insurer shall notify notification shall be sent to the covered 38
139-person's provider. For If an insurer or its URO issues a noncertification, the insurer shall notify 39
140-the covered person's provider and send then written or electronic confirmation of the 40
141-noncertification shall be sent to the covered person's provider and covered person. In person that 41
142-is in compliance with subsection (h) of this section. 42
143-(f2) Concurrent Review Liability. – For concurrent reviews, the insurer shall remain liable 43
144-for health care healthcare services until the covered person has been notified of the 44
145-noncertification. 45
146-… 46
147-(m) Disclosure of Utilization Review Requirements. – Information required to be 47
148-provided under this section shall be described in detail and in easily understandable language. 48
149-All of the following apply to an insurer's responsibility to disclose any utilization review 49
150-procedures: 50 General Assembly Of North Carolina Session 2025
151-Page 4 House Bill 567-First Edition
152-(1) Coverage and member handbook. – In the certificate of coverage and member 1
153-handbook provided to covered persons, an insurer shall include a clear and 2
154-comprehensive description of its utilization review procedures, including the 3
155-procedures for appealing noncertifications and a statement of the rights and 4
156-responsibilities of covered persons, including the voluntary nature of the 5
157-appeal process, with respect to those procedures. An insurer shall also include 6
158-in the certificate of coverage and the member handbook information about the 7
159-availability of assistance from the Department's Health Insurance Smart NC, 8
160-including the telephone number and address of the Program. program. 9
161-(2) Prospective materials. – An insurer shall include a summary of its utilization 10
162-review procedures in materials intended for prospective covered persons. 11
163-(3) Membership cards. – An insurer shall print on its membership cards a toll-free 12
164-telephone number to call for utilization review purposes. 13
165-(4) Website. – An insurer shall make any current utilization review requirements 14
166-and restrictions readily accessible on its website. 15
167-…." 16
168-SECTION 1.2.(b) This section becomes effective October 1, 2025, and applies to 17
169-insurance contracts issued, renewed, or amended on or after that date. 18
170-SECTION 1.3.(a) G.S. 135-48.51 reads as rewritten: 19
171-"§ 135-48.51. Coverage and operational mandates related to Chapter 58 of the General 20
172-Statutes. 21
173-The following provisions of Chapter 58 of the General Statutes apply to the State Health Plan: 22
174-(1) G.S. 58-3-191, Managed care reporting and disclosure requirements. 23
175-(1a) G.S. 58-3-216, Coverage of biomarker testing. 24
176-…." 25
177-SECTION 1.3.(b) In accordance with G.S. 135-48.24(b) and G.S. 135-48.30(a)(7) 26
178-which require the State Treasurer to implement procedures that are substantially similar to the 27
179-provisions of G.S. 58-50-61 for the North Carolina State Health Plan for Teachers and State 28
180-Employees (State Health Plan), the State Treasurer and the Executive Administrator of the State 29
181-Health Plan shall review all practices of the State Health Plan and all contracts with, and practices 30
182-of, any third party conducting any utilization review on behalf of the State Health Plan to ensure 31
183-compliance with Section 2 of this act no later than the start of the next plan year. 32
184-SECTION 1.3.(c) Effective July 1, 2025, there is appropriated from the General 33
185-Fund to the Department of State Treasurer the sum of one million dollars ($1,000,000) in 34
186-recurring funds for each year of the 2025-2027 fiscal biennium to be used to implement the 35
187-coverage required by this section for the State Health Plan. 36
188-SECTION 1.3.(d) Except as otherwise provided, this section becomes effective 37
189-October 1, 2025, and subsection (a) of this section applies as of the start of the next plan year 38
190-following the effective date. 39
191- 40
192-PART II. MEDICAID COVERAGE OF BIOMARKER TESTING 41
193-SECTION 2.1. The Department of Health and Human Services, Division of Health 42
194-Benefits (DHB), shall ensure coverage for biomarker testing under the laboratory services 43
195-clinical coverage policies 1S-1 through 1S-13 to the same extent those services are required to 44
196-be covered by a health benefit plan under G.S. 58-3-216. DHB shall ensure its policies and 45
197-procedures for the prior authorization of any service covered under this section are in compliance 46
198-with Section 2.2 of this act. 47
199-SECTION 2.2.(a) For purposes of this section, the term "urgent prior authorization 48
200-request" is defined as a request for which a time line for decision longer than 72 hours could 49
201-seriously jeopardize the beneficiary's life, health, or ability to attain, maintain, or regain 50
202-maximum function, in the opinion of the beneficiary's healthcare provider. 51 General Assembly Of North Carolina Session 2025
203-House Bill 567-First Edition Page 5
46+reporting structure and that has a conflict of interest policy. 34
47+(8) Reserved for future codification purposes. 35
48+H.B. 567
49+Mar 27, 2025
50+HOUSE PRINCIPAL CLERK General Assembly Of North Carolina Session 2025
51+Page 2 DRH40336-MRa-91
52+(9) Nationally recognized clinical practice guidelines. – Evidence-based clinical 1
53+practice guidelines developed by independent organizations or medical 2
54+professional societies that establish standards of care that are informed by a 3
55+systematic review of evidence and an assessment of the benefits and risks of 4
56+alternative care options and that include recommendations intended to 5
57+optimize patient care. 6
58+(b) A health benefit plan shall provide coverage for biomarker testing for the purposes of 7
59+diagnosis, treatment, appropriate care management, or ongoing monitoring of an insured's 8
60+disease or condition when the testing is supported by medical and scientific evidence. At a 9
61+minimum, any of the following shall be considered support for biomarker testing: 10
62+(1) Label indications for a test that has been FDA-approved or FDA-cleared. 11
63+(2) Indicated tests for an FDA-approved drug. 12
64+(3) Warnings and precautions on an FDA-approved drug label. 13
65+(4) National coverage determinations developed by the Centers for Medicare and 14
66+Medicaid Services. 15
67+(5) Local coverage determinations developed by a Medicare Administrative 16
68+Contractor. 17
69+(6) Nationally recognized clinical practice guidelines and consensus statements. 18
70+(c) Coverage required under this section shall be provided in a manner that limits 19
71+disruption in patient care, including the need for multiple biopsies or biospecimen samples." 20
72+SECTION 1.1.(b) G.S. 58-3-215, as amended by subsection (c) of this section, reads 21
73+as rewritten: 22
74+"§ 58-3-215. Genetic and biomarker information in health insurance. 23
75+(a) Definitions. – As used The following definitions apply in this section: 24
76+(1) Biomarker. – A characteristic that is objectively measured and evaluated as an 25
77+indicator of normal biological processes, pathogenic processes, or 26
78+pharmacologic responses to a specific therapeutic intervention, including 27
79+known gene-drug interactions for medication being considered for use or 28
80+already being administered. This term incudes gene mutations, characteristics 29
81+of genes, and protein expression. 30
82+(1a) "Genetic information" means information Genetic information. – Information 31
83+about genes, gene products, or inherited characteristics that may derive from 32
84+an individual or a family member. "Genetic information" does not include the 33
85+results of routine physical measurements, blood chemistries, blood counts, 34
86+urine analyses, tests for abuse of drugs, and tests for the presence of human 35
87+immunodeficiency virus. 36
88+… 37
89+(c) No insurer shall:shall do any of the following: 38
90+(1) Raise the premium or contribution rates paid by a group for a group health 39
91+benefit plan on the basis of genetic or biomarker information obtained about 40
92+an individual member of the group. 41
93+(2) Refuse to issue or deliver a health benefit plan because of genetic or biomarker 42
94+information obtained about any person to be insured by the health benefit plan. 43
95+(3) Charge a higher premium rate or charge for a health benefit plan because of 44
96+genetic or biomarker information obtained about any person to be insured by 45
97+the health benefit plan. 46
98+…." 47
99+SECTION 1.1.(c) G.S. 58-3-215(a)(2) and G.S. 58-3-215(a)(3) are repealed. 48
100+SECTION 1.1.(d) This section is effective October 1, 2025, and applies to insurance 49
101+contracts issued, renewed, or amended on or after that date. 50
102+SECTION 1.2.(a) G.S. 58-50-61 reads as rewritten: 51 General Assembly Of North Carolina Session 2025
103+DRH40336-MRa-91 Page 3
104+"§ 58-50-61. Utilization review. 1
105+(a) Definitions. – As used in this section, in G.S. 58-50-62, and in Part 4 of this Article, 2
106+the term: 3
107+… 4
108+(16a) Urgent healthcare service. – A healthcare service with respect to which the 5
109+application of the time periods for making a non-expedited utilization review 6
110+that, in the opinion of a medical doctor with knowledge of the covered person's 7
111+medical condition, could either (i) seriously jeopardize the life or health of the 8
112+covered person or the ability of the covered person to regain maximum 9
113+function or (ii) subject the covered person to severe pain that cannot be 10
114+adequately managed without the care or treatment that is the subject of the 11
115+utilization review. The term urgent healthcare service includes mental and 12
116+behavioral healthcare services. 13
117+… 14
118+(f) Time Lines for Prospective and Concurrent Reviews. Utilization Reviews Based 15
119+Upon Type of Healthcare Service. – As used in this subsection, the term "necessary information" 16
120+includes the results of any patient examination, clinical evaluation, or second opinion that may 17
121+be required. Prospective and concurrent determinations shall be communicated to The time line 18
122+for completion of a prospective or concurrent utilization review is as follows: 19
123+(1) Non-urgent healthcare services. – If an insurer requires a utilization review of 20
124+a healthcare service, then the insurer or its URO shall both render a utilization 21
125+review determination or noncertification and notify the covered person and the 22
126+covered person's provider within three business days after the insurer obtains 23
127+all necessary information about the admission, procedure, or health care 24
128+service. to make the utilization review determination or noncertification. 25
129+(2) Urgent healthcare services. – An insurer or its URO shall both render a 26
130+utilization review determination or noncertification concerning urgent 27
131+healthcare services and notify the covered person and the covered person's 28
132+provider of that utilization review determination or noncertification not later 29
133+than 24 hours after receiving all necessary information needed to complete the 30
134+review of the requested healthcare services. If the covered person's provider 31
135+or the insurer, or the entity conducting the review on behalf of the insurer, do 32
136+not both have access to the electronic health records of the covered person, 33
137+then this subdivision shall not apply and the utilization review will be subject 34
138+to the time line under subdivision (1) of this subsection. 35
139+(f1) Utilization Review Determination Notifications. – If an insurer or its URO certifies a 36
140+health care healthcare service, the insurer shall notify notification shall be sent to the covered 37
141+person's provider. For If an insurer or its URO issues a noncertification, the insurer shall notify 38
142+the covered person's provider and send then written or electronic confirmation of the 39
143+noncertification shall be sent to the covered person's provider and covered person. In person that 40
144+is in compliance with subsection (h) of this section. 41
145+(f2) Concurrent Review Liability. – For concurrent reviews, the insurer shall remain liable 42
146+for health care healthcare services until the covered person has been notified of the 43
147+noncertification. 44
148+… 45
149+(m) Disclosure of Utilization Review Requirements. – Information required to be 46
150+provided under this section shall be described in detail and in easily understandable language. 47
151+All of the following apply to an insurer's responsibility to disclose any utilization review 48
152+procedures: 49
153+(1) Coverage and member handbook. – In the certificate of coverage and member 50
154+handbook provided to covered persons, an insurer shall include a clear and 51 General Assembly Of North Carolina Session 2025
155+Page 4 DRH40336-MRa-91
156+comprehensive description of its utilization review procedures, including the 1
157+procedures for appealing noncertifications and a statement of the rights and 2
158+responsibilities of covered persons, including the voluntary nature of the 3
159+appeal process, with respect to those procedures. An insurer shall also include 4
160+in the certificate of coverage and the member handbook information about the 5
161+availability of assistance from the Department's Health Insurance Smart NC, 6
162+including the telephone number and address of the Program. program. 7
163+(2) Prospective materials. – An insurer shall include a summary of its utilization 8
164+review procedures in materials intended for prospective covered persons. 9
165+(3) Membership cards. – An insurer shall print on its membership cards a toll-free 10
166+telephone number to call for utilization review purposes. 11
167+(4) Website. – An insurer shall make any current utilization review requirements 12
168+and restrictions readily accessible on its website. 13
169+…." 14
170+SECTION 1.2.(b) This section becomes effective October 1, 2025, and applies to 15
171+insurance contracts issued, renewed, or amended on or after that date. 16
172+SECTION 1.3.(a) G.S. 135-48.51 reads as rewritten: 17
173+"§ 135-48.51. Coverage and operational mandates related to Chapter 58 of the General 18
174+Statutes. 19
175+The following provisions of Chapter 58 of the General Statutes apply to the State Health Plan: 20
176+(1) G.S. 58-3-191, Managed care reporting and disclosure requirements. 21
177+(1a) G.S. 58-3-216, Coverage of biomarker testing. 22
178+…." 23
179+SECTION 1.3.(b) In accordance with G.S. 135-48.24(b) and G.S. 135-48.30(a)(7) 24
180+which require the State Treasurer to implement procedures that are substantially similar to the 25
181+provisions of G.S. 58-50-61 for the North Carolina State Health Plan for Teachers and State 26
182+Employees (State Health Plan), the State Treasurer and the Executive Administrator of the State 27
183+Health Plan shall review all practices of the State Health Plan and all contracts with, and practices 28
184+of, any third party conducting any utilization review on behalf of the State Health Plan to ensure 29
185+compliance with Section 2 of this act no later than the start of the next plan year. 30
186+SECTION 1.3.(c) Effective July 1, 2025, there is appropriated from the General 31
187+Fund to the Department of State Treasurer the sum of one million dollars ($1,000,000) in 32
188+recurring funds for each year of the 2025-2027 fiscal biennium to be used to implement the 33
189+coverage required by this section for the State Health Plan. 34
190+SECTION 1.3.(d) Except as otherwise provided, this section becomes effective 35
191+October 1, 2025, and subsection (a) of this section applies as of the start of the next plan year 36
192+following the effective date. 37
193+ 38
194+PART II. MEDICAID COVERAGE OF BIOMARKER TESTING 39
195+SECTION 2.1. The Department of Health and Human Services, Division of Health 40
196+Benefits (DHB), shall ensure coverage for biomarker testing under the laboratory services 41
197+clinical coverage policies 1S-1 through 1S-13 to the same extent those services are required to 42
198+be covered by a health benefit plan under G.S. 58-3-216. DHB shall ensure its policies and 43
199+procedures for the prior authorization of any service covered under this section are in compliance 44
200+with Section 2.2 of this act. 45
201+SECTION 2.2.(a) For purposes of this section, the term "urgent prior authorization 46
202+request" is defined as a request for which a time line for decision longer than 72 hours could 47
203+seriously jeopardize the beneficiary's life, health, or ability to attain, maintain, or regain 48
204+maximum function, in the opinion of the beneficiary's healthcare provider. 49 General Assembly Of North Carolina Session 2025
205+DRH40336-MRa-91 Page 5
204206 SECTION 2.2.(b) If prior authorization is required for any service covered under 1
205207 Section 2.1 of this act, the time line for completion of a review of that prior authorization request 2
206208 shall be as follows: 3
207209 (1) For urgent prior authorization requests, DHB shall ensure that the prior 4
208210 authorization request is either approved or denied and notice is given to the 5
209211 beneficiary and beneficiary's healthcare provider within 24 hours after DHB 6
210212 receives all information needed to complete a review of the request for prior 7
211213 authorization. 8
212214 (2) For non-urgent prior authorization requests, DHB shall ensure that the prior 9
213215 authorization request is either approved or denied and notice is given to the 10
214216 beneficiary and beneficiary's healthcare provider within 72 hours after DHB 11
215217 receives all information needed to complete a review of the request for prior 12
216218 authorization. 13
217219 14
218220 PART III. EFFECTIVE DATE 15
219221 SECTION 3.1. Except as otherwise provided, this act is effective when it becomes 16
220222 law. 17