(REPRINTED WITH ADOPTED AMENDMENTS)

 

Senate Bill No. 371–Senator Schneider

 

March 16, 2001

____________

 

Referred to Committee on Human Resources and Facilities

 

SUMMARY—Creates state committee on pain management issues. (BDR 40‑1242)

 

FISCAL NOTE:            Effect on Local Government: No.

                                    Effect on the State: No.

 

~

 

EXPLANATION – Matter in bolded italics is new; matter between brackets [omitted material] is material to be omitted.

 

AN ACT relating to public health; creating a state committee on pain management issues; prescribing the membership and duties of the committee; authorizing persons to apply to the committee for approval of research programs for pain management; providing immunity from civil and criminal liability for the possession and delivery of controlled substances and certain drugs under certain circumstances; making an appropriation; 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. Title 40 of NRS is hereby amended by adding thereto a

1-2  new chapter to consist of the provisions set forth as sections 2 to 9,

1-3  inclusive, of this act.

1-4    Sec. 2.  As used in this chapter, unless the context otherwise

1-5  requires, “state committee” means the state committee on pain

1-6  management issues.

1-7    Sec. 3.  1.  The state committee on pain management issues is

1-8  hereby created. The state committee consists of seven members appointed

1-9  by the governor as follows:

1-10    (a) Three members who are physicians licensed pursuant to chapter

1-11  630 or 633 of NRS, as applicable, and who:

1-12      (1) Are actively engaged in the practice of medicine or osteopathy

1-13  in this state;

1-14      (2) Have at least 5 years of experience in the practice of medicine

1-15  or osteopathy in this state; and

1-16      (3) Represent the specialties of practice that treat a chronic or

1-17  debilitating medical condition.

1-18    (b) Two members who are pharmacists registered pursuant to chapter

1-19  639 of NRS and who:

1-20      (1) Are actively engaged in the practice of pharmacy in this state;

1-21  and

2-1       (2) Have at least 5 years of experience in the practice of pharmacy

2-2  in this state.

2-3    (c) Two members who represent the general public and who are not

2-4  related by consanguinity or affinity within the third degree to a physician

2-5  or pharmacist who practices in this state.

2-6  The governor shall not appoint to serve on the state committee any

2-7  person who has a direct or indirect interest in a research program for

2-8  pain management.

2-9    2.  To the extent practicable, a person who is appointed to serve on

2-10  the state committee pursuant to subsection 1 must possess knowledge of

2-11  and experience in reading and interpreting research protocols and data

2-12  or possess specific knowledge of the research regarding pain

2-13  management.

2-14    3.  Within 30 days after his appointment, a member of the state

2-15  committee shall take and subscribe to an oath to carry out his duties

2-16  pursuant to this chapter in a faithful and impartial manner.

2-17    4.  The members of the state committee shall select a chairman and

2-18  vice chairman from among their membership.

2-19    5.  After the initial terms, each member of the state committee serves

2-20  a term of 3 years. A member of the state committee may not serve for

2-21  more than three consecutive terms. If a vacancy occurs on the state

2-22  committee, the vacancy must be filled in the same manner as the original

2-23  appointment for the remainder of the unexpired term.

2-24    6.  Each member of the state committee is entitled to receive for each

2-25  day or portion of a day that he attends a meeting of the state committee

2-26  or is otherwise engaged in the business of the state committee:

2-27    (a) A salary of $80; and

2-28    (b) The per diem allowance and travel expenses provided for state

2-29  officers and employees generally.

2-30    7.  The health division of the department of human resources shall

2-31  provide administrative support to the state committee.

2-32    8.  Each member of the state committee serves at the pleasure of the

2-33  governor.

2-34    Sec. 4.  1.  The state committee shall promote appropriate protocols

2-35  for pain management within this state and clinical trials of drugs. In

2-36  carrying out such duties, the state committee shall meet at least quarterly,

2-37  or at the call of the chairman, and shall:

2-38    (a) Work cooperatively with the state board of pharmacy, the board of

2-39  medical examiners, the state board of osteopathic medicine and the

2-40  University and Community College System of Nevada to establish

2-41  educational programs for health professionals to disseminate

2-42  information concerning the Model Guidelines for the Use of Controlled

2-43  Substances for the Treatment of Pain adopted in May 1998 by the

2-44  Federation of State Medical Boards of the United States, Inc.

2-45    (b) Work cooperatively with the University of Nevada School of

2-46  Medicine and apply for available federal grants to conduct clinical trials

2-47  of drugs and other research relating to pain management issues.

2-48    (c) Develop and carry out incentive programs to encourage physicians

2-49  and osteopathic physicians to locate in Nevada for the purpose of

3-1  conducting clinical trials of drugs that are appropriate to pain

3-2  management.

3-3    2.  The state committee shall hold two meetings each year at the call

3-4  of the chairman to review applications submitted to the state committee

3-5  for the approval of a research program for pain management. Within the

3-6  limits of money available to the state committee, the state committee may

3-7  hold additional meetings at the call of the chairman.

3-8    3.  Four members of the state committee constitute a quorum for the

3-9  transaction of business. A majority vote of the members present is

3-10  required to take action with respect to any matter.

3-11    Sec. 5.  1.  A person may submit an application to the state

3-12  committee for the approval of a research program for pain management.

3-13  An application must be submitted on a form provided by the state

3-14  committee.

3-15    2.  The state committee shall review each application that it receives

3-16  to determine whether:

3-17    (a) The primary purpose of the proposed research program is to treat

3-18  or alleviate a chronic or debilitating medical condition; and

3-19    (b) The proposed research program:

3-20      (1) Complies with all federal laws and guidelines for such research;

3-21      (2) Incorporates adequate safeguards to ensure that the distribution

3-22  of controlled substances and other drugs for purposes of the program is

3-23  made only to those persons who are participating in the program and is

3-24  not diverted for unlawful or unauthorized use;

3-25      (3) Adequately protects the confidentiality of those persons who

3-26  participate in the program, and provides access to the identity of those

3-27  persons by authorized employees of state and local law enforcement

3-28  agencies only as is necessary to verify the status of a person as a

3-29  participant in an approved research program;

3-30      (4) Incorporates adequate protections for the health and safety of

3-31  the persons who participate in the program; and

3-32      (5) Is likely to produce results that are scientifically and medically

3-33  valid.

3-34    3.  The state committee shall make a determination on an application

3-35  within a reasonable period after receipt of the application. A

3-36  determination of the state committee is final and not subject to appeal.

3-37  The determination of the state committee must be based upon:

3-38    (a) The review of the application pursuant to subsection 2;

3-39    (b) Materials, if any, accompanying the application;

3-40    (c) Personal interviews conducted by the state committee, if any, of the

3-41  proponents of the application; and

3-42    (d) Any other information or material relevant to the proposed

3-43  research program.

3-44    4.  If the state committee approves a research program, the state

3-45  committee shall prepare and provide to the applicant a written statement

3-46  indicating its approval of the research program in a format that may be

3-47  submitted by the applicant to the Federal Government for registration

3-48  pursuant to 21 U.S.C. § 823 in connection with the research program. A

3-49  person shall not conduct a research program for pain management until

4-1  he has obtained all necessary approvals from the Federal Government

4-2  pursuant to 21 U.S.C. § 823, regardless of whether the state committee

4-3  has approved the research program.

4-4    5.  To the extent that money is made available by legislative

4-5  appropriation or otherwise, the state committee may distribute money to

4-6  successful applicants who are registered pursuant to 21 U.S.C. § 823 to

4-7  conduct the research program. The state committee may determine the

4-8  amount of money so distributed and any conditions for receipt of the

4-9  money.

4-10    6.  If the Federal Government suspends or revokes the registration of

4-11  a person to conduct a research program, the approval of the research

4-12  program by the state committee shall be deemed revoked.

4-13    Sec. 6.  If the state committee or a member of the state committee,

4-14  acting pursuant to this chapter, initiates or assists in any proceeding

4-15  concerning an application for approval of a research program, the state

4-16  committee and its members are immune from any civil action for such

4-17  initiation or assistance or any consequential damages, if the state

4-18  committee and its members acted without malicious intent.

4-19    Sec. 7.  Except as otherwise provided in section 8 of this act, if a

4-20  person has obtained the approval of the state committee for a research

4-21  program for pain management and that person is registered to conduct

4-22  the research program by the Federal Government pursuant to 21 U.S.C.

4-23  § 823, the:

4-24    1.  Person who conducts or operates the program and any person

4-25  working under his immediate direction, supervision or instruction for the

4-26  program;

4-27    2.  Physicians and pharmacists assisting with the program and those

4-28  persons working under their immediate direction, supervision or

4-29  instruction for the program; and

4-30    3.  Persons who participate in the program,

4-31  are exempt from criminal prosecution in this state and are immune from

4-32  civil and criminal liability in this state for the possession or delivery of

4-33  any controlled substance, any dangerous drug as defined in NRS

4-34  454.201, or any other drug specific to the approved research program.

4-35    Sec. 8.  The provisions of this chapter do not:

4-36    1.  Authorize the possession or delivery of any controlled substance,

4-37  any dangerous drug as defined in NRS 454.201 or any other drug for

4-38  purposes other than those related to a research program that has been

4-39  approved by the state committee and authorized by federal law;

4-40    2.  Require an insurer, organization for managed care or any person

4-41  or entity who provides coverage for a medical or health care service to

4-42  pay for or reimburse a person participating in an approved research

4-43  program for pain management for costs associated with that research;

4-44    3.  Protect a person against prosecution or civil liability for any act

4-45  involving the possession or delivery of a controlled substance, any

4-46  dangerous drug as defined in NRS 454.201 or any other drug in a

4-47  manner not authorized pursuant to this chapter; or

5-1    4.  Require an employer or any operator of a place of public

5-2  accommodation to authorize research relating to pain management on its

5-3  premises or otherwise make accommodations for such research.

5-4    Sec. 9.  1.  The state committee shall adopt regulations prescribing

5-5  the:

5-6    (a) Process for submission of an application by a person for the

5-7  approval of a research program pursuant to section 5 of this act;

5-8    (b) Criteria and type of investigation that will be applied by the state

5-9  committee in determining whether to approve an application;

5-10    (c) Conditions, if any, under which the state committee may allow a

5-11  person to resubmit an application that has been denied by the state

5-12  committee; and

5-13    (d) Except as otherwise provided in subsection 6 of section 5 of this

5-14  act, conditions under which the state committee may revoke its approval

5-15  of a research program.

5-16    2.  The state committee may adopt such regulations:

5-17    (a) As the state committee determines are necessary to carry out its

5-18  duties pursuant to this chapter.

5-19    (b) Not inconsistent with the constitution or laws of the United States,

5-20  or of this state, as the state committee determines are necessary to protect

5-21  the public with regard to research relating to pain management.

5-22    Sec. 10.  Chapter 453 of NRS is hereby amended by adding thereto a

5-23  new section to read as follows:

5-24    The provisions of this chapter do not apply to the extent that they are

5-25  inconsistent with the provisions of sections 2 to 9, inclusive, of this act.

5-26    Sec. 11.  Chapter 630 of NRS is hereby amended by adding thereto a

5-27  new section to read as follows:

5-28    The board shall adopt regulations governing the use of controlled

5-29  substances for the treatment of pain. The regulations must be

5-30  substantially similar to the Model Guidelines for the Use of Controlled

5-31  Substances for the Treatment of Pain adopted in May 1998 by the

5-32  Federation of State Medical Boards of the United States, Inc., to the

5-33  extent that the board determines that the model guidelines are

5-34  appropriate for use in this state.

5-35    Sec. 12.  NRS 630.3066 is hereby amended to read as follows:

5-36    630.3066  A physician is not subject to disciplinary action solely for

5-37  [prescribing] :

5-38    1.  Prescribing or administering to a patient under his care:

5-39    [1.] (a) Amygdalin (laetrile), if the patient has consented in writing to

5-40  the use of the substance.

5-41    [2.] (b) Procaine hydrochloride with preservatives and stabilizers

5-42  (Gerovital H3).

5-43    [3.] (c) A controlled substance which is listed in schedule II, III, IV or

5-44  V by the state board of pharmacy pursuant to NRS 453.146, if the

5-45  controlled substance is lawfully prescribed or administered for the

5-46  treatment of intractable pain in accordance with accepted standards for the

5-47  practice of medicine.

5-48    2.  Conducting or assisting with a research program that has been

5-49  approved by the state committee on pain management issues pursuant to

6-1  section 5 of this act if the person who conducts the research program is

6-2  registered pursuant to 21 U.S.C. § 823 and conducts the research in

6-3  accordance with state and federal law.

6-4    Sec. 13.  Chapter 633 of NRS is hereby amended by adding thereto a

6-5  new section to read as follows:

6-6    The board shall adopt regulations governing the use of controlled

6-7  substances for the treatment of pain. The regulations must be

6-8  substantially similar to the Model Guidelines for the Use of Controlled

6-9  Substances for the Treatment of Pain adopted in May 1998 by the

6-10  Federation of State Medical Boards of the United States, Inc., to the

6-11  extent that the board determines that the model guidelines are

6-12  appropriate for use in this state.

6-13    Sec. 14.  NRS 633.521 is hereby amended to read as follows:

6-14    633.521  An osteopathic physician is not subject to disciplinary action

6-15  solely for [prescribing] :

6-16    1.  Prescribing or administering to a patient under his care:

6-17    [1.] (a) Amygdalin (laetrile), if the patient has consented to the use of

6-18  the substance.

6-19    [2.] (b) Procaine hydrochloride with preservatives and stabilizers

6-20  (Gerovital H3).

6-21    [3.] (c) A controlled substance which is listed in schedule II, III, IV or

6-22  V by the state board of pharmacy pursuant to NRS 453.146, if the

6-23  controlled substance is lawfully prescribed or administered for the

6-24  treatment of intractable pain in accordance with accepted standards for the

6-25  practice of osteopathic medicine.

6-26    2.  Conducting or assisting with a research program that has been

6-27  approved by the state committee on pain management issues pursuant to

6-28  section 5 of this act if the person who conducts the research program is

6-29  registered pursuant to 21 U.S.C. § 823 and conducts the research in

6-30  accordance with state and federal law.

6-31    Sec. 15.  NRS 639.2176 is hereby amended to read as follows:

6-32    639.2176  The board shall adopt regulations [necessary] :

6-33    1.  Necessary to carry out the purposes of NRS 639.2171 to 639.2176,

6-34  inclusive, which must include the methods of determining accredited

6-35  programs, the number of hours of continuing professional education

6-36  necessary to constitute a continuing education unit, the number of units

6-37  required of each pharmacist during the period for which a certificate is

6-38  issued and such other regulations consistent with NRS 639.2171 to

6-39  639.2176, inclusive, as the board may determine to be necessary.

6-40    2.  Requiring each registered pharmacist to be knowledgeable

6-41  concerning the Model Guidelines for the Use of Controlled Substances

6-42  for the Treatment of Pain adopted in May 1998 by the Federation of

6-43  State Medical Boards of the United States, Inc., to the extent that the

6-44  board determines that the model guidelines are appropriate for use in

6-45  this state.

6-46    Sec. 16.  1.  There is hereby appropriated from the state general fund

6-47  to the health division of the department of human resources the sum of

6-48  $5,000 for the payment of:

7-1    (a) The salaries, per diem allowances and travel expenses of the

7-2  members of the state committee on pain management issues created by

7-3  section 3 of this act; and

7-4    (b) Incidental expenses of the health division incurred in providing

7-5  administrative assistance to the state committee on pain management

7-6  issues.

7-7    2.  Any remaining balance of the appropriation made by subsection 1

7-8  must not be committed for expenditure after June 30, 2003, and reverts to

7-9  the state general fund as soon as all payments of money committed have

7-10  been made.

7-11    Sec. 17.  1.  On or before October 1, 2001, the governor shall appoint

7-12  the following members to the state committee on pain management issues

7-13  to terms expiring September 30, 2003:

7-14    (a) Two members pursuant to paragraph (a) of subsection 1 of section 3

7-15  of this act;

7-16    (b) One member pursuant to paragraph (b) of subsection 1 of section 3

7-17  of this act; and

7-18    (c) One member pursuant to paragraph (c) of subsection 1 of section 3

7-19  of this act.

7-20    2.  On or before October 1, 2001, the governor shall appoint the

7-21  following members to the state committee on pain management issues to

7-22  terms expiring on September 30, 2004:

7-23    (a) One member pursuant to paragraph (a) of subsection 1 of section 3

7-24  of this act;

7-25    (b) One member pursuant to paragraph (b) of subsection 1 of section 3

7-26  of this act; and

7-27    (c) One member pursuant to paragraph (c) of subsection 1 of section 3

7-28  of this act.

7-29    Sec. 18.  The state committee on pain management issues shall:

7-30    1.  On or before July 1, 2002, submit a report of its progress to the

7-31  director of the legislative counsel bureau for transmittal to the legislative

7-32  committee on health care; and

7-33    2.  On or before January 1, 2003, submit a full report of its activities

7-34  and any findings or recommendations to the director of the legislative

7-35  counsel bureau for transmittal to the 72nd session of the Nevada

7-36  legislature.

7-37    Sec. 19.  This act becomes effective upon passage and approval for the

7-38  purpose of appointing the members of the state committee on pain

7-39  management issues and on October 1, 2001, for all other purposes.

 

7-40  H