Senate Bill No. 321–Senator Shaffer

 

March 17, 2003

____________

 

Referred to Committee on Human Resources and Facilities

 

SUMMARY—Makes various changes concerning coverage of prescription drugs by Medicaid fee-for-service program. (BDR 38‑763)

 

FISCAL NOTE:  Effect on Local Government: No.

                           Effect on the State: Yes.

 

~

 

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

 

AN ACT relating to public welfare; creating a Drug Utilization Review Board within the Department of Human Resources to develop drug utilization review programs for any Medicaid fee-for-service program that provides coverage for prescription drugs to outpatients; setting forth requirements for any program that requires prior authorization for a prescription drug within a Medicaid fee-for-service program; 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 9, inclusive, of this

1-3  act.

1-4  Sec. 2.  As used in sections 2 to 9, inclusive, of this act,

1-5  “Review Board” means the Drug Utilization Review Board

1-6  established by section 3 of this act.

1-7  Sec. 3.  1.  There is hereby created within the Department a

1-8  Drug Utilization Review Board to develop and assess a

1-9  retrospective drug utilization review program and a prospective

1-10  drug utilization review program for any Medicaid fee-for-service

1-11  program established in the State of Nevada that provides coverage

1-12  for prescription drugs to outpatients.

2-1  2.  The Review Board consists of the following 11 members

2-2  appointed by the Director:

2-3  (a) Three active physicians licensed pursuant to chapter 630 of

2-4  NRS appointed from a list of not less than six names submitted by

2-5  the Board of Medical Examiners;

2-6  (b) One active osteopathic physician licensed pursuant to

2-7  chapter 633 of NRS appointed from a list of not less than two

2-8  names submitted by the State Board of Osteopathic Medicine;

2-9  (c) Five active registered pharmacists registered pursuant to

2-10  chapter 639 of NRS appointed from a list of not less than seven

2-11  names submitted by the State Board of Pharmacy;

2-12      (d) One member of the public representing recipients of

2-13  services provided pursuant to a Medicaid fee-for-service program

2-14  who is a resident of this state; and

2-15      (e) One person representing the pharmaceutical industry who

2-16  is a resident of this state appointed from a list of not less than two

2-17  names submitted by the Pharmaceutical Research and

2-18  Manufacturers of America.

2-19      3.  To the extent practicable, the members of the Review

2-20  Board must be representative of the various geographic areas of

2-21  this state.

2-22      4.  Of the members of the Review Board first appointed, one

2-23  physician licensed pursuant to chapter 630 of NRS, one registered

2-24  pharmacist and the member of the public must be appointed for

2-25  initial terms of 2 years. All other appointments must be for a term

2-26  of 3 years. A member may, if he still possesses the requisite

2-27  qualifications for appointment, be reappointed for not more than

2-28  three additional terms of 3 years and one partial term if the partial

2-29  term is the result of being appointed to fill a vacancy of a member

2-30  of the Review Board in accordance with subsection 6.

2-31      5.  The Review Board shall elect from its members a

2-32  Chairman and Vice Chairman. The Chairman and Vice

2-33  Chairman shall serve a term of 1 year and may be reelected.

2-34      6.  A vacancy occurring in the membership of the Review

2-35  Board must be filled in the same manner as the original

2-36  appointment except, if applicable, that such appointments must be

2-37  made from a new list submitted by the relevant board or entity.

2-38      7.  The Review Board shall meet at least twice a year and at

2-39  the times and places specified by the call of the Chairman of the

2-40  Review Board.

2-41      Sec. 4.  Any meeting of the Review Board must be conducted

2-42  in accordance with the provisions of chapter 241 of NRS. Any

2-43  documents relating to a decision made by the Review Board must

2-44  be made available to any interested person. The Review Board

2-45  shall provide the opportunity for any person present at a meeting

3-1  of the Review Board to comment on the information presented to

3-2  the Review Board or any decisions of the Review Board made

3-3  during the meeting.

3-4  Sec. 5.  1.  The Review Board shall, with assistance from

3-5  professionals in the field of prescription drug use, develop and

3-6  recommend to the Department a retrospective drug utilization

3-7  review program and a prospective drug utilization review program

3-8  for any Medicaid fee-for-service program that provides coverage

3-9  for prescription drugs to outpatients to ensure that the drugs

3-10  prescribed pursuant to the Medicaid fee-for-service program are

3-11  appropriate, medically necessary and not likely to result in adverse

3-12  medical outcomes.

3-13      2.  The retrospective drug utilization review program must

3-14  assess and measure on an ongoing basis, and with input from

3-15  professionals, the use of prescription drugs based on a historical

3-16  review of data concerning the actual use of prescription drugs as

3-17  compared to predetermined and explicit criteria and standards for

3-18  the use of prescription drugs to determine whether the use of

3-19  prescription drugs by outpatients in the Medicaid fee-for-service

3-20  program is appropriate, medically necessary and not likely to

3-21  result in an adverse medical outcome. The retrospective drug

3-22  utilization review program must include, without limitation, the

3-23  periodic examination of data from claims of pharmacies which

3-24  provide services to outpatients receiving benefits pursuant to the

3-25  Medicaid fee-for-service program and other available information

3-26  to:

3-27      (a) Identify patterns of fraud, abuse, gross overuse or

3-28  underuse of prescription drugs, or inappropriate or medically

3-29  unnecessary care in the provision of services to outpatients

3-30  pursuant to the Medicaid fee-for-service program;

3-31      (b) Monitor, in the Medicaid fee-for-service program:

3-32          (1) The therapeutic appropriateness of prescription drugs;

3-33          (2) The overutilization or underutilization of a prescription

3-34  drug which results in the therapeutic goal of the drug not being

3-35  achieved;

3-36          (3) The use of generic prescription drugs;

3-37          (4) Whether the therapeutic effect of a prescription drug

3-38  duplicates the effect of another prescription drug or treatment;

3-39          (5) The possibility of the therapeutic effect of a prescription

3-40  drug being adversely altered by the presence of a disease or

3-41  condition other than the disease or condition for which the drug

3-42  was prescribed;

3-43          (6) The possibility of two or more prescription drugs that

3-44  are taken by a patient leading either to clinically significant

4-1  toxicity that is uncharacteristic of any one of the drugs or to

4-2  interference with the effectiveness of one or more of the drugs;

4-3       (7) Any clinically significant adverse medical effect that

4-4  may result from the use of two or more prescription drugs

4-5  together;

4-6       (8) Any prescription for an incorrect dosage of a

4-7  prescription drug or an incorrect duration of treatment with a

4-8  prescription drug; and

4-9       (9) Any clinical abuse or misuse of prescription drugs; and

4-10      (c) Develop remedial strategies to improve the quality of care

4-11  provided to outpatients pursuant to the Medicaid fee-for-service

4-12  program and to conserve money expended for prescription drugs

4-13  by both the outpatients and the Medicaid fee-for-service program.

4-14      3.  The prospective drug utilization review program must

4-15  require a registered pharmacist who provides services to

4-16  outpatients receiving benefits pursuant to the Medicaid fee-for-

4-17  service program, before filling or delivering a prescription drug, to

4-18  review the prescription to screen for potential drug therapy

4-19  problems, including, without limitation:

4-20      (a) Whether the therapeutic effect of the prescription drug

4-21  duplicates the effect of another prescription drug or treatment

4-22  being taken or received by the patient;

4-23      (b) The possibility of two or more prescription drugs that are

4-24  taken by a patient leading either to clinically significant toxicity

4-25  that is uncharacteristic of any one of the drugs or to interference

4-26  with the effectiveness of one or more of the drugs;

4-27      (c) Any clinically significant adverse medical effect that may

4-28  result from the use of two or more prescription drugs together;

4-29      (d) Any potential interactions between the prescription drug

4-30  and an allergy of the patient;

4-31      (e) A prescription for an incorrect dosage of a prescription

4-32  drug or an incorrect duration of treatment with a prescription

4-33  drug; and

4-34      (f) Any clinical abuse or misuse of prescription drugs.

4-35      4.  A drug utilization review program developed pursuant to

4-36  this section must be based on:

4-37      (a) The American Hospital Formulary Services Drug

4-38  Information;

4-39      (b) The United States Pharmacopoeia Drug Information;

4-40      (c) Peer-reviewed medical and clinical literature;

4-41      (d) Information provided by persons involved in the provision

4-42  of health care; and

4-43      (e) Drug labeling that is approved by the United States Food

4-44  and Drug Administration.

 

5-1  Sec. 6.  The Review Board shall:

5-2  1.  Advise the Department concerning the drug utilization

5-3  review programs developed pursuant to section 5 of this act, and

5-4  make recommendations concerning any regulations which relate

5-5  to the programs;

5-6  2.  Oversee contractual agreements between the Department

5-7  and any entity involved in establishing policies or making

5-8  decisions which affect the drug utilization review programs

5-9  developed pursuant to section 5 of this act, and make

5-10  recommendations to the Department concerning such agreements;

5-11      3.  Provide providers of health care who provide services to

5-12  outpatients covered under a Medicaid fee-for-service program

5-13  with educational opportunities concerning the use of prescription

5-14  drugs;

5-15      4.  Develop and make recommendations to the Department

5-16  regarding programs for the prior authorization of prescription

5-17  drugs in accordance with the provisions of sections 7 and 8 of this

5-18  act;

5-19      5.  Develop a procedure for a person to appeal a

5-20  recommendation made by the Review Board to include a

5-21  prescription drug in the program requiring prior authorization

5-22  pursuant to sections 7 and 8 of this act after which a person may

5-23  receive a hearing by the Department on the recommendation; and

5-24      6.  Reassess and revise the drug utilization review programs

5-25  developed pursuant to section 5 of this act when necessary.

5-26      Sec. 7.  1.  Any program that requires prior authorization

5-27  for a prescription drug within a Medicaid fee-for-service program

5-28  established in the State of Nevada must be approved by the Review

5-29  Board. The Review Board must observe a policy of avoiding a

5-30  requirement for prior authorization for a prescription drug other

5-31  than to address problems of abuse, misuse or inappropriate use of

5-32  the prescription drug. The Review Board shall consider any

5-33  information provided by interested persons concerning the

5-34  program requiring prior authorization for prescription drugs,

5-35  including, without limitation, information provided by:

5-36      (a) Physicians licensed pursuant to chapter 630 of NRS;

5-37      (b) Osteopathic physicians licensed pursuant to chapter 633 of

5-38  NRS;

5-39      (c) Registered pharmacists registered pursuant to chapter 639

5-40  of NRS; and

5-41      (d) Pharmaceutical manufacturers.

5-42      2.  The Review Board shall not recommend for inclusion in

5-43  the program requiring prior authorization for prescription drugs:

5-44      (a) A drug or compound that has been approved by the

5-45  Federal Drug Administration, is newly released, has never before

6-1  been marketed and which pharmacies in this state that dispense

6-2  prescription drugs for the Medicaid fee-for-service program can

6-3  readily obtain in commercial quantities;

6-4  (b) A drug that has been approved by the Federal Drug

6-5  Administration for a new condition or as a new treatment which

6-6  pharmacies in this state that dispense prescription drugs for the

6-7  Medicaid fee-for-service program can readily obtain in

6-8  commercial quantities; or

6-9  (c) A drug that has not been included in the Medicaid fee-for-

6-10  service program for at least 12 months, unless the class of

6-11  therapeutic prescription drug of which the drug is a member is

6-12  included in the program requiring prior authorization for

6-13  prescription drugs.

6-14      3.  A prescription drug may not be included in the program

6-15  requiring prior authorization for prescription drugs unless:

6-16      (a) The Review Board has analyzed data from the retrospective

6-17  drug utilization review program developed pursuant to section 5 of

6-18  this act to identify the classes of therapeutic prescription drugs

6-19  whose use is not likely to be medically appropriate or medically

6-20  necessary, or is likely to result in adverse medical outcomes;

6-21      (b) The Review Board includes the entire class of therapeutic

6-22  prescription drugs of which the drug is a member in the program

6-23  requiring prior authorization;

6-24      (c) If the drug is the only member in its class of therapeutic

6-25  prescription drugs, the decision of the Review Board to include the

6-26  drug in the program requiring prior authorization applies to the

6-27  entire class of therapeutic prescription drugs and not to the drug

6-28  which is the only member of the class at the time that the decision

6-29  to include the class in the program is made;

6-30      (d) The Review Board considers the potential impact on

6-31  patient care and the potential fiscal impact of including the class

6-32  of therapeutic prescription drugs of which the drug is a member in

6-33  the program requiring prior authorization;

6-34      (e) Any consideration by the Review Board of the cost of the

6-35  drug reflects the total cost of treating the conditions for which the

6-36  class of therapeutic prescription drugs of which the drug is a

6-37  member is prescribed, including, without limitation, non-

6-38  pharmaceutical costs and costs incurred by other sectors of the

6-39  health care system in this state that may be affected by the

6-40  availability of the drug for treating recipients of the Medicaid fee-

6-41  for-service program;

6-42      (f) The Review Board considers all other alternatives to

6-43  requiring prior authorization for the class of therapeutic

6-44  prescription drugs of which the drug is a member, including,

6-45  without limitation, educating providers of health care who provide

7-1  services to patients covered under the Medicaid fee-for-service

7-2  program and patients who receive such services;

7-3  (g) The Review Board makes a formal written

7-4  recommendation to the Department that the class of therapeutic

7-5  prescription drugs of which the drug is a member be included in

7-6  the program requiring prior authorization and that

7-7  recommendation is supported by an analysis of data from the

7-8  prospective and retrospective drug utilization review programs

7-9  developed pursuant to section 5 of this act that demonstrates:

7-10          (1) The expected impact of the inclusion of the class of

7-11  therapeutic prescription drugs in the program on the clinical care

7-12  received by recipients of the Medicaid fee-for-service program for

7-13  whom the class of therapeutic prescription drugs is medically

7-14  necessary;

7-15          (2) The expected impact of the inclusion of the class of

7-16  therapeutic prescription drugs in the program on physicians who

7-17  provide services to patients covered under the Medicaid fee-for-

7-18  service program for whom the class of therapeutic prescription

7-19  drugs is medically necessary; and

7-20          (3) The expected fiscal impact of the inclusion of the class

7-21  of therapeutic prescription drugs in the program on the Medicaid

7-22  fee-for-service program;

7-23      (h) The Department accepts the recommendation of the

7-24  Review Board made pursuant to paragraph (g) and makes a

7-25  written decision that the class of therapeutic prescription drugs of

7-26  which the drug is a member should be included in the program

7-27  requiring prior authorization, without adding to or detracting

7-28  from the recommendation of the Review Board concerning the

7-29  specific drug, taking into consideration any additional clarifying

7-30  information provided by any interested person; and

7-31      (i) The Department notifies the manufacturers of all of the

7-32  drugs which are included in the class of therapeutic prescription

7-33  drugs of which the drug is a member that the drug has been

7-34  accepted for inclusion in the program requiring prior

7-35  authorization.

7-36      4.  Within 180 days after receiving a notice pursuant to

7-37  paragraph (i) of subsection 3, a manufacturer may propose a plan

7-38  of drug utilization to the Review Board to educate persons who

7-39  prescribe or dispense prescription drugs to patients covered under

7-40  the Medicaid fee-for-service program concerning criteria and

7-41  standards that are designed to identify and prevent the potential

7-42  abuse, misuse or inappropriate use of the class of therapeutic

7-43  prescription drugs of which the drug accepted for inclusion in the

7-44  program requiring prior authorization is a member. If a

7-45  manufacturer proposes a plan of drug utilization that is acceptable

8-1  to the Department pursuant to this subsection, the drug may not be

8-2  included in the program requiring prior authorization.

8-3  5.  Written notice of each decision of the Department

8-4  concerning the program that requires prior authorization for

8-5  prescription drugs within the Medicaid fee-for-service program

8-6  must be provided to the public, and the Department must provide a

8-7  period of at least 30 days after each decision during which the

8-8  public may provide comments concerning the decision to

8-9  the Department. No decision of the Department concerning the

8-10  program that requires prior authorization for prescription drugs

8-11  within the Medicaid fee-for-service program is effective until the

8-12  end of the period provided for public comment.

8-13      6.  The Review Board shall review the need for any

8-14  prescription drug to be included within a program requiring prior

8-15  authorization not later than 12 months after the original inclusion

8-16  of the prescription drug within the program.

8-17      Sec. 8.  1.  Any program that requires prior authorization

8-18  for a prescription drug within a Medicaid fee-for-service program

8-19  established in the State of Nevada must provide for the approval or

8-20  denial of the use of the prescription drug via telephone, facsimile

8-21  or electronic transmission within 24 hours after the receipt of a

8-22  request for the prior authorization for the prescription drug.

8-23      2.  In an emergency situation, including, without limitation, a

8-24  situation in which an approval or denial of the use of a

8-25  prescription drug is unavailable, the program of prior

8-26  authorization must provide for the approval of:

8-27      (a) A 72-hour supply of the prescription drug; or

8-28      (b) At the discretion of the Review Board, a supply of the

8-29  prescription drug that is greater than the amount set forth in

8-30  paragraph (a) and that is sufficient to assure a minimum effective

8-31  duration of therapy for an acute intervention,

8-32  paid for by the Medicaid fee-for-service program.

8-33      3.  The program of prior authorization must authorize a

8-34  prescription for:

8-35      (a) A dose, duration or refill of a prescription drug;

8-36      (b) A prescription drug that duplicates the effect of another

8-37  prescription drug or treatment;

8-38      (c) A prescription drug whose therapeutic effect might be

8-39  adversely altered by the presence of a disease or condition other

8-40  than the disease or condition for which the drug was prescribed;

8-41      (d) A prescription drug which might when taken with another

8-42  prescription drug prescribed to the patient lead either to clinically

8-43  significant toxicity that is uncharacteristic of any one of the drugs

8-44  or to interference with the effectiveness of one or more of the

8-45  drugs; or

9-1  (e) A prescription drug which might when taken with another

9-2  prescription drug prescribed to the patient result in a clinically

9-3  significant adverse medical effect,

9-4  that is not authorized by the program if the person who prescribed

9-5  the prescription knows of and accepts the potential complications

9-6  involved in such a prescription.

9-7  4.  The program of prior authorization shall work with

9-8  persons who prescribe prescription drugs to patients covered

9-9  under the Medicaid fee-for-service program to develop an efficient

9-10  process for the submission of a request for prior authorization. To

9-11  the extent possible, the process must be directly related to the

9-12  interaction between the person who is prescribing the prescription

9-13  drug and the patient, and must not consist of separate tasks

9-14  required by the person who is prescribing the prescription drug.

9-15      Sec. 9.  To ensure that the use of prescription drugs is

9-16  appropriate, medically necessary and not likely to result in adverse

9-17  medical outcomes in any Medicaid fee-for-service program that

9-18  provides coverage for prescription drugs, the Department must

9-19  implement the retrospective drug utilization review program and

9-20  the prospective drug utilization review program developed by the

9-21  Review Board pursuant to section 5 of this act.

9-22      Sec. 10.  NRS 422.240 is hereby amended to read as follows:

9-23      422.240  1.  Money to carry out the provisions of NRS

9-24  422.001 to 422.410, inclusive, and sections 2 to 9, inclusive, of this

9-25  act and 422.580, including, without limitation, any federal money

9-26  allotted to the State of Nevada pursuant to the program to provide

9-27  Temporary Assistance for Needy Families and the Program for

9-28  Child Care and Development, must be provided by appropriation by

9-29  the Legislature from the State General Fund.

9-30      2.  Disbursements for the purposes of NRS 422.001 to 422.410,

9-31  inclusive, and sections 2 to 9, inclusive, of this act and 422.580

9-32  must be made upon claims duly filed, audited and allowed in the

9-33  same manner as other money in the State Treasury is disbursed.

9-34      Sec. 11.  This act becomes effective on July 1, 2003.

 

9-35  H