Assembly Bill No. 384–Assemblymen Koivisto, McClain, Ohrenschall, Parks, Anderson, Christensen, Claborn, Leslie and Pierce
March 17, 2003
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Referred to Committee on Health and Human Services
SUMMARY—Makes various changes concerning provision of prescription drugs pursuant to Medicaid program. (BDR 38‑775)
FISCAL NOTE: Effect on Local Government: No.
Effect on the State: Yes.
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EXPLANATION
– Matter in bolded italics is new; matter
between brackets [omitted material] is material to be omitted.
Green numbers along left margin indicate location on the printed bill (e.g., 5-15 indicates page 5, line 15).
AN ACT relating to public welfare; requiring the Department of Human Resources to develop a list of preferred prescription drugs to be used for the Medicaid program; requiring the Department to manage the use by the Medicaid program of step therapy and prior authorization for prescription drugs; creating the Pharmacy and Therapeutics Committee within the Department; and providing other matters properly relating thereto.
THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN
SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:
1-1 Section 1. Chapter 422 of NRS is hereby amended by adding
1-2 thereto the provisions set forth as sections 2 to 12, inclusive, of this
1-3 act.
1-4 Sec. 2. As used in sections 2 to 12, inclusive, of this act,
1-5 unless the context otherwise requires, the words and terms defined
1-6 in sections 3 and 4 of this act have the meanings ascribed to them
1-7 in those sections.
1-8 Sec. 3. “Committee” means the Pharmacy and Therapeutics
1-9 Committee established pursuant to section 7 of this act.
1-10 Sec. 4. “Drug Use Review Board” means the Board
1-11 established pursuant to 42 U.S.C. § 1396r-8(g)(3).
2-1 Sec. 5. 1. The Department shall, by regulation, develop a
2-2 list of preferred prescription drugs to be used for the Medicaid
2-3 program.
2-4 2. The Department shall, by regulation, establish a list of
2-5 prescription drugs which must be excluded from any restrictions
2-6 that are imposed on drugs that are on the list of preferred
2-7 prescription drugs established pursuant to subsection 1. The list
2-8 established pursuant to this subsection must include, without
2-9 limitation:
2-10 (a) Atypical and typical antipsychotic medications that are
2-11 prescribed for the treatment of a mental illness of a patient who is
2-12 receiving services pursuant to Medicaid;
2-13 (b) Prescription drugs that are prescribed for the treatment of
2-14 the human immunodeficiency virus or acquired immunodeficiency
2-15 syndrome, including, without limitation, protease inhibitors and
2-16 antiretroviral medications;
2-17 (c) Anticonvulsant medications;
2-18 (d) Antirejection medications for organ transplants;
2-19 (e) Antidiabetic medications;
2-20 (f) Antihemophilic medications; and
2-21 (g) Any prescription drug which the Committee identifies as
2-22 appropriate for exclusion from any restrictions that are imposed
2-23 on drugs that are on the list of preferred prescription drugs.
2-24 3. The regulations must provide that the Committee makes
2-25 the final determination of:
2-26 (a) Whether a class of therapeutic prescription drugs is
2-27 included on the list of preferred prescription drugs and is excluded
2-28 from any restrictions that are imposed on drugs that are on the list
2-29 of preferred prescription drugs;
2-30 (b) Which therapeutically equivalent prescription drugs will be
2-31 reviewed for inclusion on the list of preferred prescription drugs
2-32 and for exclusion from any restrictions that are imposed on drugs
2-33 that are on the list of preferred prescription drugs; and
2-34 (c) Which prescription drugs should be excluded from any
2-35 restrictions that are imposed on drugs that are on the list of
2-36 preferred prescription drugs based on continuity of care
2-37 concerning a specific diagnosis, condition, class of therapeutic
2-38 prescription drugs or medical specialty.
2-39 4. The regulations must provide that each new
2-40 pharmaceutical product and each existing pharmaceutical product
2-41 for which there is new clinical evidence supporting its inclusion
2-42 on the list of preferred prescription drugs must be made available
2-43 pursuant to the Medicaid program with prior authorization until
2-44 the Committee reviews the product or the evidence.
3-1 Sec. 6. 1. The Department shall, by regulation, establish
3-2 and manage the use by the Medicaid program of step therapy and
3-3 prior authorization for prescription drugs.
3-4 2. The Drug Use Review Board shall:
3-5 (a) Advise the Department concerning the use by the Medicaid
3-6 program of step therapy and prior authorization for prescription
3-7 drugs;
3-8 (b) Develop step therapy protocols and prior authorization
3-9 policies and procedures for use by the Medicaid program for
3-10 prescription drugs; and
3-11 (c) Review and approve, based on clinical evidence and best
3-12 clinical practice guidelines and without consideration of the cost
3-13 of the prescription drugs being considered, step therapy protocols
3-14 used by the Medicaid program for prescription drugs.
3-15 3. The Department shall not require the Drug Use Review
3-16 Board to develop, review or approve prior authorization policies or
3-17 procedures necessary for the operation of the list of preferred
3-18 prescription drugs developed for the Medicaid program pursuant
3-19 to section 5 of this act.
3-20 4. The Department shall accept recommendations from the
3-21 Drug Use Review Board as the basis for developing or revising
3-22 step therapy protocols and prior authorization policies and
3-23 procedures used by the Medicaid program for prescription drugs.
3-24 Sec. 7. 1. The Director shall create a Pharmacy and
3-25 Therapeutics Committee within the Department. The Committee
3-26 must consist of at least 9 members and not more than 11 members
3-27 appointed by the Governor based on recommendations from the
3-28 Director.
3-29 2. The Governor shall appoint to the Committee health care
3-30 professionals who have knowledge and expertise in one or more of
3-31 the following:
3-32 (a) The clinically appropriate prescribing of outpatient
3-33 prescription drugs that are covered by Medicaid;
3-34 (b) The clinically appropriate dispensing and monitoring of
3-35 outpatient prescription drugs that are covered by Medicaid;
3-36 (c) The review of, evaluation of and intervention in the use of
3-37 prescription drugs; and
3-38 (d) Medical quality assurance.
3-39 3. At least one-third of the members of the Committee and not
3-40 more than 51 percent of the members of the Committee must be
3-41 active physicians licensed to practice medicine in this state, at least
3-42 one of whom must be an active psychiatrist licensed to practice
3-43 medicine in this state. At least one-third of the members of the
3-44 Committee and not more than 51 percent of the members of the
4-1 Committee must be either active pharmacists registered in this
4-2 state or persons in this state with doctoral degrees in pharmacy.
4-3 4. A person must not be appointed to the Committee if he is
4-4 employed by, compensated by in any manner, has a financial
4-5 interest in, or is otherwise affiliated with a business or corporation
4-6 that manufactures prescription drugs.
4-7 Sec. 8. 1. The Governor shall appoint the Chairman of the
4-8 Committee from among its members.
4-9 2. After the initial terms, the term of each member of the
4-10 Committee is 2 years. A member may be reappointed.
4-11 3. A vacancy occurring in the membership of the Committee
4-12 must be filled for the remainder of the unexpired term in the same
4-13 manner as the original appointment.
4-14 4. The Committee shall meet at least once every 3 months and
4-15 at the times and places specified by a call of the Chairman of the
4-16 Committee.
4-17 5. A majority of the members of the Committee constitutes a
4-18 quorum for the transaction of business, and the affirmative vote of
4-19 a majority of the members of the Committee is required to take
4-20 action.
4-21 Sec. 9. 1. Members of the Committee serve without
4-22 compensation, except that a member of the Committee is entitled,
4-23 while engaged in the business of the Committee, to receive the per
4-24 diem allowance and travel expenses provided for state officers and
4-25 employees generally.
4-26 2. Each member of the Committee who is an officer or
4-27 employee of the State of Nevada or a local government must be
4-28 relieved from his duties without loss of his regular compensation
4-29 so that he may prepare for and attend meetings of the Committee
4-30 and perform any work necessary to carry out the duties of the
4-31 Committee in the most timely manner practicable. A state agency
4-32 or local governmental entity shall not require an officer or
4-33 employee who is a member of the Committee to make up the time
4-34 that he is absent from work to carry out his duties as a member of
4-35 the Committee or to use annual vacation or compensatory time for
4-36 the absence.
4-37 Sec. 10. 1. The Department shall, by regulation, set forth
4-38 the duties of the Committee which must include, without
4-39 limitation:
4-40 (a) Identifying the prescription drugs which should be
4-41 included on the list of preferred prescription drugs developed by
4-42 the Department for the Medicaid program pursuant to section 5 of
4-43 this act and the prescription drugs which should be excluded from
4-44 any restrictions that are imposed on drugs that are on the list of
4-45 preferred prescription drugs;
5-1 (b) Identifying classes of therapeutic prescription drugs for its
5-2 review and performing a clinical analysis of each drug included in
5-3 each class that is identified for review; and
5-4 (c) Reviewing at least annually all classes of therapeutic
5-5 prescription drugs on the list of preferred prescription drugs
5-6 developed by the Department for the Medicaid program pursuant
5-7 to section 5 of this act.
5-8 2. The Department shall, by regulation, require the
5-9 Committee to:
5-10 (a) Base its decisions on evidence of clinical efficacy and
5-11 safety without consideration of the cost of the prescription drugs
5-12 being considered by the Committee;
5-13 (b) Review new pharmaceutical products in as expeditious a
5-14 manner as possible; and
5-15 (c) Consider new clinical evidence supporting the inclusion of
5-16 an existing pharmaceutical product on the list of preferred
5-17 prescription drugs developed by the Department for the Medicaid
5-18 program and new clinical evidence supporting the exclusion of an
5-19 existing pharmaceutical product from any restrictions that are
5-20 imposed on drugs that are on the list of preferred prescription
5-21 drugs in as expeditious a manner as possible.
5-22 3. The Department shall, by regulation, authorize the
5-23 Committee to:
5-24 (a) In carrying out its duties, exercise clinical judgment and
5-25 analyze peer review articles, published studies, and other medical
5-26 and scientific information; and
5-27 (b) Establish subcommittees to analyze specific issues that
5-28 arise as the Committee carries out its duties.
5-29 Sec. 11. 1. The Advisory Committee to the Pharmacy and
5-30 Therapeutics Committee and the Drug Use Review Board
5-31 consisting of three members is hereby created in the Department
5-32 to advise the Committee and the Drug Use Review Board
5-33 concerning prescription drugs that are used by seniors, persons
5-34 who are mentally ill or persons with disabilities.
5-35 2. The Director of the Department shall appoint to the
5-36 Advisory Committee:
5-37 (a) One member appointed from a list of persons provided to
5-38 the Department by the American Association of Retired Persons or
5-39 any successor organization;
5-40 (b) One member appointed from a list of persons provided to
5-41 the Department by the Alliance for the Mentally Ill of Nevada or
5-42 any successor organization; and
5-43 (c) One member appointed from a list of persons provided to
5-44 the Department by the Statewide Independent Living Council
5-45 established in this state pursuant to 29 U.S.C. § 796d.
6-1 3. The Director shall appoint the Chairman of the Advisory
6-2 Committee from among its members.
6-3 4. After the initial terms, the term of each member of the
6-4 Advisory Committee is 2 years. A member may be reappointed. A
6-5 vacancy occurring in the membership of the Advisory Committee
6-6 must be filled for the remainder of the unexpired term in the same
6-7 manner as the original appointment.
6-8 5. Members of the Advisory Committee serve without
6-9 compensation, except that a member of the Advisory Committee is
6-10 entitled, while engaged in the business of the Advisory Committee,
6-11 to receive the per diem allowance and travel expenses provided for
6-12 state officers and employees generally.
6-13 6. Each member of the Advisory Committee who is an officer
6-14 or employee of the State of Nevada or a local government must be
6-15 relieved from his duties without loss of his regular compensation
6-16 so that he may prepare for and attend meetings of the Advisory
6-17 Committee and perform any work necessary to carry out the duties
6-18 of the Advisory Committee in the most timely manner practicable.
6-19 A state agency or local governmental entity shall not require an
6-20 officer or employee who is a member of the Advisory Committee to
6-21 make up the time that he is absent from work to carry out his
6-22 duties as a member of the Advisory Committee or to use annual
6-23 vacation or compensatory time for the absence.
6-24 Sec. 12. 1. The Department may, to carry out its duties set
6-25 forth in sections 2 to 12, inclusive, of this act and to administer the
6-26 provisions of sections 2 to 12, inclusive, of this act:
6-27 (a) Adopt regulations; and
6-28 (b) Enter into contracts for any services.
6-29 2. Any regulations adopted by the Department pursuant to
6-30 sections 2 to 12, inclusive, of this act must be adopted in
6-31 accordance with the provisions of chapter 241 of NRS.
6-32 Sec. 13. NRS 232.320 is hereby amended to read as follows:
6-33 232.320 1. Except as otherwise provided in subsection 2, the
6-34 Director:
6-35 (a) Shall appoint, with the consent of the Governor,
6-36 administrators of the divisions of the Department, who are
6-37 respectively designated as follows:
6-38 (1) The Administrator of the Aging Services Division;
6-39 (2) The Administrator of the Health Division;
6-40 (3) The State Welfare Administrator;
6-41 (4) The Administrator of the Division of Child and Family
6-42 Services; and
6-43 (5) The Administrator of the Division of Health Care
6-44 Financing and Policy.
7-1 (b) Shall administer, through the divisions of the Department,
7-2 the provisions of chapters 210, 423, 424, 425, 427A, 432A to 442,
7-3 inclusive, 446 to 450, inclusive, of NRS, NRS 127.220 to 127.310,
7-4 inclusive, 422.001 to 422.410, inclusive, and sections 2 to
7-5 12, inclusive, of this act, 422.580, 432.010 to 432.139, inclusive,
7-6 444.003 to 444.430, inclusive, and 445A.010 to 445A.055,
7-7 inclusive, and all other provisions of law relating to the functions of
7-8 the divisions of the Department, but is not responsible for the
7-9 clinical activities of the Health Division or the professional line
7-10 activities of the other divisions.
7-11 (c) Shall, after considering advice from agencies of local
7-12 governments and nonprofit organizations which provide social
7-13 services, adopt a master plan for the provision of human services in
7-14 this state. The Director shall revise the plan biennially and deliver a
7-15 copy of the plan to the Governor and the Legislature at the
7-16 beginning of each regular session. The plan must:
7-17 (1) Identify and assess the plans and programs of the
7-18 Department for the provision of human services, and any
7-19 duplication of those services by federal, state and local agencies;
7-20 (2) Set forth priorities for the provision of those services;
7-21 (3) Provide for communication and the coordination of those
7-22 services among nonprofit organizations, agencies of local
7-23 government, the State and the Federal Government;
7-24 (4) Identify the sources of funding for services provided by
7-25 the Department and the allocation of that funding;
7-26 (5) Set forth sufficient information to assist the Department
7-27 in providing those services and in the planning and budgeting for the
7-28 future provision of those services; and
7-29 (6) Contain any other information necessary for the
7-30 Department to communicate effectively with the Federal
7-31 Government concerning demographic trends, formulas for the
7-32 distribution of federal money and any need for the modification of
7-33 programs administered by the Department.
7-34 (d) May, by regulation, require nonprofit organizations and state
7-35 and local governmental agencies to provide information to him
7-36 regarding the programs of those organizations and agencies,
7-37 excluding detailed information relating to their budgets and payrolls,
7-38 which he deems necessary for his performance of the duties
7-39 imposed upon him pursuant to this section.
7-40 (e) Has such other powers and duties as are provided by law.
7-41 2. The Governor shall appoint the Administrator of the
7-42 Division of Mental Health and Developmental Services.
7-43 Sec. 14. The Department of Human Resources shall:
7-44 1. On or before January 1, 2004, adopt final regulations
7-45 required to carry out the provisions of this act.
8-1 2. On or before July 1, 2004, apply to the Federal Government
8-2 to amend the State Plan for Medicaid as necessary to ensure that the
8-3 State Plan for Medicaid is consistent with the provisions of this act.
8-4 3. Submit a quarterly report concerning its progress toward
8-5 preparing, submitting and obtaining federal approval of the
8-6 amendment described in subsection 2 to the Interim Finance
8-7 Committee and the Legislative Committee on Health Care, until the
8-8 date on which the amendment is approved by the Federal
8-9 Government.
8-10 Sec. 15. 1. As soon as practicable after July 1, 2003, the
8-11 Governor shall appoint to the Pharmacy and Therapeutics
8-12 Committee, so that the terms of the members are staggered, half of
8-13 the members to serve initial terms of 1 year and the other half of the
8-14 members to serve initial terms of 2 years.
8-15 2. As soon as practicable after July 1, 2003, the Director of the
8-16 Department of Human Resources shall appoint to the Advisory
8-17 Committee to the Pharmacy and Therapeutics Committee and the
8-18 Drug Use Review Board one member to serve an initial term of 1
8-19 year and two members to serve initial terms of 2 years.
8-20 Sec. 16. This act becomes effective upon passage and approval
8-21 for the purpose of adopting regulations by the Department of
8-22 Human Resources and on July 1, 2003, for all other purposes.
8-23 H