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North Carolina House Bill H525

North Carolina 2025-2026 Regular Session

North Carolina House Bill H525 Compare Versions

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11 GENERAL ASSEMBLY OF NORTH CAROLINA
22 SESSION 2025
3-H 1
4-HOUSE BILL 525
3+H D
4+HOUSE BILL DRH10161-MGa-124
5+
56
67
78 Short Title: Reorganize & Fund Rare Disease Adv. Council. (Public)
8-Sponsors: Representatives Carney, Lambeth, Belk, and Cunningham (Primary Sponsors).
9-For a complete list of sponsors, refer to the North Carolina General Assembly web site.
10-Referred to: Appropriations, if favorable, Rules, Calendar, and Operations of the House
11-March 27, 2025
12-*H525 -v-1*
9+Sponsors: Representative Carney.
10+Referred to:
11+
12+*DRH10161 -MGa-124*
1313 A BILL TO BE ENTITLED 1
1414 AN ACT REVISING THE COMPOSITION AND DUTIES OF THE ADVISORY COUNCIL 2
1515 ON RARE DISEASES; TRANSFERRING THE COUNCIL TO THE DEPARTMENT OF 3
1616 HEALTH AND HUMAN SERVICES; AND APPROPRIATING FUNDS TO THE 4
1717 DEPARTMENT OF HEALTH AND HUMAN SERVICES TO COVER THE OPERATING 5
1818 EXPENSES OF THE COUNCIL. 6
1919 The General Assembly of North Carolina enacts: 7
2020 SECTION 1. Part 6 of Article 1B of Chapter 130A of the General Statutes reads as 8
2121 rewritten: 9
2222 "Part 6. Taylor's Law Establishing the Advisory Council on Rare Diseases. 10
2323 "§ 130A-33.65. Advisory Council on Rare Diseases; membership; terms; compensation; 11
2424 meetings; quorum. 12
2525 (a) Short Title. – This Part shall be known as Taylor's Law Establishing the Advisory 13
2626 Council on Rare Diseases. 14
2727 (a1) Establishment of Advisory Council. – There is established the Advisory Council on 15
2828 Rare Diseases within the School of Medicine of the University of North Carolina at Chapel Hill 16
2929 Department of Health and Human Services to advise the Governor, the Secretary, and the General 17
3030 Assembly on research, diagnosis, treatment, and education relating to rare diseases. This Part 18
3131 shall be known as Taylor's Law Establishing the Advisory Council on Rare Diseases. For 19
3232 purposes of this Part, "rare disease" has the same meaning as provided in 21 U.S.C. § 360bb. 20
3333 (b) Advisory Council Membership. – The advisory council shall consist of 19 members 21
3434 to be appointed as follows: 22
3535 (1) Upon the recommendation of the Dean of the School of Medicine of the 23
3636 University of North Carolina at Chapel Hill, the The Secretary shall appoint 24
3737 members to the advisory council as follows:the following 15 members: 25
3838 a. A physician Two physicians licensed and practicing in this State with 26
3939 experience researching, diagnosing, or treating rare diseases. 27
4040 b. A medical researcher with experience conducting research concerning 28
4141 rare diseases. 29
4242 c. A One registered nurse or advanced practice registered nurse licensed 30
4343 and practicing in the State with experience treating rare diseases. 31
4444 d. One rare diseases survivor. 32
45-e. One member who represents a rare diseases foundation. 33 General Assembly Of North Carolina Session 2025
46-Page 2 House Bill 525-First Edition
47-f. One representative researcher from each an academic research 1
48-institution in this State that receives any grant funding for rare diseases 2
49-research. 3
50-g. One parent of a childhood rare disease survivor. 4
51-h. One hospital administrator, or the hospital administrator's designee, 5
52-representing a hospital in the State that provides care to persons 6
53-diagnosed with a rare disease. 7
54-i. Two persons age 18 or older who have been diagnosed with a rare 8
55-disease. 9
56-j. Two persons age 18 or older who are, or were previously, caregivers 10
57-to a person diagnosed with a rare disease. 11
58-k. One representative of a rare disease patient organization that operates 12
59-in the State. 13
60-l. One pharmacist licensed and practicing in this State with knowledge 14
61-and experience regarding drugs used to treat rare diseases. 15
62-m. One representative of the life sciences, biotechnology, or 16
63-biopharmaceutical industry that either focuses on research efforts 17
64-related to the development of therapeutic products for persons 18
65-diagnosed with a rare disease or has demonstratable understanding of 19
66-the path to commercialization of such products. 20
67-n. Two representatives of a health benefit plan or health insurer, at least 21
68-one of whom is a representative of a North Carolina Medicaid 22
69-Managed Care health plan. 23
70-o. One genetic counselor with experience providing services to persons 24
71-diagnosed with a rare disease or caregivers of persons diagnosed with 25
72-a rare disease. 26
73-(2) The chairs of the Joint Legislative Oversight Committee on Health and Human 27
74-Services, or the chairs' designees, shall serve on the advisory council. A 28
75-member of the advisory council who is designated by the chairs of the Joint 29
76-Legislative Oversight Committee on Health and Human Services may be a 30
77-member of the General Assembly. 31
78-(2a) One member appointed by the President Pro Tempore of the Senate. 32
79-(2b) One member appointed by the Speaker of the House of Representatives. 33
80-(2c) One member appointed by the Governor. 34
81-(3) The Secretary, or the Secretary's designee, shall serve as an ex officio, 35
82-nonvoting member of the advisory council. 36
83-(c) Members Length of Terms. – All initial members appointed pursuant to subsection 37
84-(b) of this section to the advisory council shall serve for a term of three years, and no member 38
85-initial member, except for the initial physician members and the initial member representing a 39
86-rare disease patient organization, shall serve more than three consecutive terms. The initial 40
87-physician members and the initial member representing a rare disease patient organization may 41
88-serve for up to four consecutive terms. Thereafter, members appointed by the President Pro 42
89-Tempore of the Senate, the Speaker of the House of Representatives, and the Governor shall 43
90-serve for a term of two years; and members appointed by the Secretary shall serve for a term of 44
91-two, three, or four years, as determined by the chair of the advisory council. 45
92-(c1) Vacancies and Removals. – Any appointment to fill a vacancy on the advisory council 46
93-created by the resignation, dismissal, death, or disability of a member shall be filled by the 47
94-appointing authority for the balance of the unexpired term. Each appointing authority may 48
95-remove any member appointed by that appointing authority for misfeasance, malfeasance, or 49
96-nonfeasance. 50 General Assembly Of North Carolina Session 2025
97-House Bill 525-First Edition Page 3
98-(d) Per Diem and Expenses. – Members of the advisory council shall receive per diem 1
99-and necessary travel and subsistence expenses in accordance with the provisions of G.S. 138-5 2
100-or G.S. 138-6 or travel and subsistence expenses in accordance with the provisions of 3
101-G.S. 120-3.1, as applicable. 4
102-(e) Administrative Support. – All administrative support and other services required by 5
103-the advisory council shall be provided by the School of Medicine of the University of North 6
104-Carolina at Chapel Hill.Department. 7
105-(f) Upon the recommendation of the Dean of the School of Medicine of the University 8
106-of North Carolina at Chapel Hill, Selection of Chair. – The Secretary shall select the chair of the 9
107-advisory council from among the members of the council. The chair shall serve in this position 10
108-until the expiration of his or her term. 11
109-(g) The chair shall convene the first meeting of the advisory council no later than October 12
110-1, 2015. Meetings and Quorum. – A majority of the council members shall constitute a quorum. 13
111-A majority vote of a quorum shall be required for any official action of the advisory council. 14
112-Following the first meeting, the advisory council shall meet at least quarterly. The advisory 15
113-council may meet more frequently upon the call of the chair or upon the request of a majority of 16
114-council members. 17
115-"§ 130A-33.66. Advisory Council on Rare Diseases; powers and duties; reports. 18
116-The advisory council shall have the following powers and duties: 19
117-(1) Advise on coordinating the Governor, the Secretary, and the General 20
118-Assembly on all of the following: 21
119-a. Coordination of statewide efforts for the to study of the incidence of 22
120-rare diseases within the State and the status of the rare disease 23
121-community. 24
122-b. Coordination of statewide efforts to increase public awareness and 25
123-understanding of rare diseases. 26
124-c. Identification of policy issues related to rare diseases and the 27
125-advancement of policy initiatives related to rare diseases at the State 28
126-and federal levels. 29
127-d. The appropriation of State funds to facilitate increased public 30
128-awareness of and improved treatment for rare diseases. 31
129-(2) Report to the Secretary, the Governor, and the Joint Legislative Oversight 32
130-Committee on Health and Human Services Services, and the Fiscal Research 33
131-Division on behalf of the General Assembly not later than January 1, 2016, 34
132-and annually thereafter, on the activities of the advisory council and its 35
133-findings and recommendations regarding rare disease research and care in 36
134-North Carolina, including any recommendations for statutory changes and 37
135-amendments to the structure, organization, and powers or duties of the 38
136-advisory council. 39
137-(3) In consultation with accredited medical schools, accredited schools of public 40
138-health, and hospitals licensed to operate in the State that provide care to 41
139-persons diagnosed with a rare disease, develop resources or recommendations 42
140-regarding quality of and access to treatment and services available within the 43
141-State for persons diagnosed with a rare disease. 44
142-(4) Advise and consult with the Department, the North Carolina Drug Utilization 45
143-Review Board, and the Medicaid Preferred Drug List Review Panel in 46
144-developing recommendations, resources, and programs relating to the 47
145-diagnosis and treatment of rare diseases. 48
146-(5) Identify additional relevant areas for the advisory council to study and 49
147-evaluate." 50 General Assembly Of North Carolina Session 2025
148-Page 4 House Bill 525-First Edition
149-SECTION 2. Effective July 1, 2025, there is appropriated from the General Fund to 1
150-the Department of Health and Human Services the sum of two hundred fifty thousand dollars 2
151-($250,000) in recurring funds for the 2025-2026 fiscal year and the sum of two hundred fifty 3
152-thousand dollars ($250,000) in recurring funds for the 2026-2027 fiscal year to be allocated to 4
153-cover the operating expenses of the Advisory Council on Rare Diseases authorized by Section 1 5
154-of this act. 6
155-SECTION 3. Except as otherwise provided, this act is effective when it becomes 7
156-law. 8
45+e. One member who represents a rare diseases foundation. 33
46+f. One representative researcher from each an academic research 34
47+institution in this State that receives any grant funding for rare diseases 35
48+research. 36
49+H.B. 525
50+Mar 26, 2025
51+HOUSE PRINCIPAL CLERK General Assembly Of North Carolina Session 2025
52+Page 2 DRH10161-MGa-124
53+g. One parent of a childhood rare disease survivor. 1
54+h. One hospital administrator, or the hospital administrator's designee, 2
55+representing a hospital in the State that provides care to persons 3
56+diagnosed with a rare disease. 4
57+i. Two persons age 18 or older who have been diagnosed with a rare 5
58+disease. 6
59+j. Two persons age 18 or older who are, or were previously, caregivers 7
60+to a person diagnosed with a rare disease. 8
61+k. One representative of a rare disease patient organization that operates 9
62+in the State. 10
63+l. One pharmacist licensed and practicing in this State with knowledge 11
64+and experience regarding drugs used to treat rare diseases. 12
65+m. One representative of the life sciences, biotechnology, or 13
66+biopharmaceutical industry that either focuses on research efforts 14
67+related to the development of therapeutic products for persons 15
68+diagnosed with a rare disease or has demonstratable understanding of 16
69+the path to commercialization of such products. 17
70+n. Two representatives of a health benefit plan or health insurer, at least 18
71+one of whom is a representative of a North Carolina Medicaid 19
72+Managed Care health plan. 20
73+o. One genetic counselor with experience providing services to persons 21
74+diagnosed with a rare disease or caregivers of persons diagnosed with 22
75+a rare disease. 23
76+(2) The chairs of the Joint Legislative Oversight Committee on Health and Human 24
77+Services, or the chairs' designees, shall serve on the advisory council. A 25
78+member of the advisory council who is designated by the chairs of the Joint 26
79+Legislative Oversight Committee on Health and Human Services may be a 27
80+member of the General Assembly. 28
81+(2a) One member appointed by the President Pro Tempore of the Senate. 29
82+(2b) One member appointed by the Speaker of the House of Representatives. 30
83+(2c) One member appointed by the Governor. 31
84+(3) The Secretary, or the Secretary's designee, shall serve as an ex officio, 32
85+nonvoting member of the advisory council. 33
86+(c) Members Length of Terms. – All initial members appointed pursuant to subsection 34
87+(b) of this section to the advisory council shall serve for a term of three years, and no member 35
88+initial member, except for the initial physician members and the initial member representing a 36
89+rare disease patient organization, shall serve more than three consecutive terms. The initial 37
90+physician members and the initial member representing a rare disease patient organization may 38
91+serve for up to four consecutive terms. Thereafter, members appointed by the President Pro 39
92+Tempore of the Senate, the Speaker of the House of Representatives, and the Governor shall 40
93+serve for a term of two years; and members appointed by the Secretary shall serve for a term of 41
94+two, three, or four years, as determined by the chair of the advisory council. 42
95+(c1) Vacancies and Removals. – Any appointment to fill a vacancy on the advisory council 43
96+created by the resignation, dismissal, death, or disability of a member shall be filled by the 44
97+appointing authority for the balance of the unexpired term. Each appointing authority may 45
98+remove any member appointed by that appointing authority for misfeasance, malfeasance, or 46
99+nonfeasance. 47
100+(d) Per Diem and Expenses. – Members of the advisory council shall receive per diem 48
101+and necessary travel and subsistence expenses in accordance with the provisions of G.S. 138-5 49
102+or G.S. 138-6 or travel and subsistence expenses in accordance with the provisions of 50
103+G.S. 120-3.1, as applicable. 51 General Assembly Of North Carolina Session 2025
104+DRH10161-MGa-124 Page 3
105+(e) Administrative Support. – All administrative support and other services required by 1
106+the advisory council shall be provided by the School of Medicine of the University of North 2
107+Carolina at Chapel Hill.Department. 3
108+(f) Upon the recommendation of the Dean of the School of Medicine of the University 4
109+of North Carolina at Chapel Hill, Selection of Chair. – The Secretary shall select the chair of the 5
110+advisory council from among the members of the council. The chair shall serve in this position 6
111+until the expiration of his or her term. 7
112+(g) The chair shall convene the first meeting of the advisory council no later than October 8
113+1, 2015. Meetings and Quorum. – A majority of the council members shall constitute a quorum. 9
114+A majority vote of a quorum shall be required for any official action of the advisory council. 10
115+Following the first meeting, the advisory council shall meet at least quarterly. The advisory 11
116+council may meet more frequently upon the call of the chair or upon the request of a majority of 12
117+council members. 13
118+"§ 130A-33.66. Advisory Council on Rare Diseases; powers and duties; reports. 14
119+The advisory council shall have the following powers and duties: 15
120+(1) Advise on coordinating the Governor, the Secretary, and the General 16
121+Assembly on all of the following: 17
122+a. Coordination of statewide efforts for the to study of the incidence of 18
123+rare diseases within the State and the status of the rare disease 19
124+community. 20
125+b. Coordination of statewide efforts to increase public awareness and 21
126+understanding of rare diseases. 22
127+c. Identification of policy issues related to rare diseases and the 23
128+advancement of policy initiatives related to rare diseases at the State 24
129+and federal levels. 25
130+d. The appropriation of State funds to facilitate increased public 26
131+awareness of and improved treatment for rare diseases. 27
132+(2) Report to the Secretary, the Governor, and the Joint Legislative Oversight 28
133+Committee on Health and Human Services Services, and the Fiscal Research 29
134+Division on behalf of the General Assembly not later than January 1, 2016, 30
135+and annually thereafter, on the activities of the advisory council and its 31
136+findings and recommendations regarding rare disease research and care in 32
137+North Carolina, including any recommendations for statutory changes and 33
138+amendments to the structure, organization, and powers or duties of the 34
139+advisory council. 35
140+(3) In consultation with accredited medical schools, accredited schools of public 36
141+health, and hospitals licensed to operate in the State that provide care to 37
142+persons diagnosed with a rare disease, develop resources or recommendations 38
143+regarding quality of and access to treatment and services available within the 39
144+State for persons diagnosed with a rare disease. 40
145+(4) Advise and consult with the Department, the North Carolina Drug Utilization 41
146+Review Board, and the Medicaid Preferred Drug List Review Panel in 42
147+developing recommendations, resources, and programs relating to the 43
148+diagnosis and treatment of rare diseases. 44
149+(5) Identify additional relevant areas for the advisory council to study and 45
150+evaluate." 46
151+SECTION 2. Effective July 1, 2025, there is appropriated from the General Fund to 47
152+the Department of Health and Human Services the sum of two hundred fifty thousand dollars 48
153+($250,000) in recurring funds for the 2025-2026 fiscal year and the sum of two hundred fifty 49
154+thousand dollars ($250,000) in recurring funds for the 2026-2027 fiscal year to be allocated to 50 General Assembly Of North Carolina Session 2025
155+Page 4 DRH10161-MGa-124
156+cover the operating expenses of the Advisory Council on Rare Diseases authorized by Section 1 1
157+of this act. 2
158+SECTION 3. Except as otherwise provided, this act is effective when it becomes 3
159+law. 4