1.1                          A bill for an act 
  1.2             relating to health; modifying current protocols for 
  1.3             nurses; modifying prior authorization requirements for 
  1.4             prescription drugs; clarifying responsibilities for 
  1.5             administering the Ryan White act; clarifying providers 
  1.6             continuation of family community support services; 
  1.7             amending Minnesota Statutes 2000, sections 148.235, by 
  1.8             adding subdivisions; 151.37, subdivision 2; 256.01, by 
  1.9             adding a subdivision; Minnesota Statutes 2001 
  1.10            Supplement, sections 148.284; 256B.0625, subdivisions 
  1.11            13, 35. 
  1.12  BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.13     Section 1.  Minnesota Statutes 2000, section 148.235, is 
  1.14  amended by adding a subdivision to read: 
  1.15     Subd. 8.  [PRESCRIPTION BY PROTOCOL.] A registered nurse 
  1.16  may implement a protocol that does not reference a specific 
  1.17  patient and results in a prescription of a legend drug that has 
  1.18  been predetermined and delegated by a licensed practitioner as 
  1.19  defined under section 151.01, subdivision 23, when caring for a 
  1.20  patient whose condition falls within the protocol and when the 
  1.21  protocol specifies the circumstances under which the drug is to 
  1.22  be prescribed or administered. 
  1.23     Sec. 2.  Minnesota Statutes 2000, section 148.235, is 
  1.24  amended by adding a subdivision to read: 
  1.25     Subd. 9.  [VACCINE BY PROTOCOL.] A nurse may implement a 
  1.26  protocol that does not reference a specific patient and results 
  1.27  in the administration of a vaccine that has been predetermined 
  1.28  and delegated by a licensed practitioner as defined in section 
  2.1   151.01, subdivision 23, when caring for a patient whose 
  2.2   characteristics fall within the protocol and when the protocol 
  2.3   specifies the contraindications for implementation, including 
  2.4   patients or populations of patients for whom the vaccine must 
  2.5   not be administered and the conditions under which the vaccine 
  2.6   must not be administered. 
  2.7      Sec. 3.  Minnesota Statutes 2001 Supplement, section 
  2.8   148.284, is amended to read: 
  2.9      148.284 [CERTIFICATION OF ADVANCED PRACTICE REGISTERED 
  2.10  NURSES.] 
  2.11     (a) No person shall practice advanced practice registered 
  2.12  nursing or use any title, abbreviation, or other designation 
  2.13  tending to imply that the person is an advanced practice 
  2.14  registered nurse, clinical nurse specialist, nurse anesthetist, 
  2.15  nurse-midwife, or nurse practitioner unless the person is 
  2.16  certified for such advanced practice registered nursing by a 
  2.17  national nurse certification organization. 
  2.18     (b) Paragraph (a) does not apply to an advanced practice 
  2.19  registered nurse who is within six months after completion of an 
  2.20  advanced practice registered nurse course of study and is 
  2.21  awaiting certification, provided that the person has not 
  2.22  previously failed the certification examination.  
  2.23     (c) An advanced practice registered nurse who has completed 
  2.24  a formal course of study as an advanced practice registered 
  2.25  nurse and has been certified by a national nurse certification 
  2.26  organization prior to January 1, 1999, may continue to practice 
  2.27  in the field of nursing in which the advanced practice 
  2.28  registered nurse is practicing as of July 1, 1999, regardless of 
  2.29  the type of certification held if the advanced practice 
  2.30  registered nurse is not eligible for the proper certification. 
  2.31     (d) Prior to July 1, 2007, a clinical nurse specialist may 
  2.32  petition the board for waiver from the certification requirement 
  2.33  in paragraph (a) if the clinical nurse specialist is 
  2.34  academically prepared as a clinical nurse specialist in a 
  2.35  specialty area for which there is no certification within the 
  2.36  clinical nurse specialist role and specialty or a related 
  3.1   specialty.  The board may determine that an available 
  3.2   certification as a clinical nurse specialist in a related 
  3.3   specialty must be obtained in lieu of the specific specialty or 
  3.4   subspecialty.  The petitioner must be academically prepared as a 
  3.5   clinical nurse specialist in a specific field of clinical nurse 
  3.6   specialist practice with a master's degree in nursing that 
  3.7   included clinical experience in the clinical specialty, and must 
  3.8   have 1,000 hours of supervised clinical experience in the 
  3.9   clinical specialty for which the individual was academically 
  3.10  prepared with a minimum of 500 hours of supervised clinical 
  3.11  practice after graduation.  The board may grant a nonrenewable 
  3.12  permit for no longer than 12 months for the supervised 
  3.13  postgraduate clinical experience.  The board may renew the 
  3.14  waiver for three-year periods provided the clinical nurse 
  3.15  specialist continues to be ineligible for certification as a 
  3.16  clinical nurse specialist by an organization acceptable to the 
  3.17  board. 
  3.18     <b>[EFFECTIVE DATE.]</b> This section is effective July 1, 2002. 
  3.19     Sec. 4.  Minnesota Statutes 2000, section 151.37, 
  3.20  subdivision 2, is amended to read: 
  3.21     Subd. 2.  [PRESCRIBING AND FILING.] (a) A licensed 
  3.22  practitioner in the course of professional practice only, may 
  3.23  prescribe, administer, and dispense a legend drug, and may cause 
  3.24  the same to be administered by a nurse, a physician assistant, 
  3.25  or medical student or resident under the practitioner's 
  3.26  direction and supervision, and may cause a person who is an 
  3.27  appropriately certified, registered, or licensed health care 
  3.28  professional to prescribe, dispense, and administer the same 
  3.29  within the expressed legal scope of the person's practice as 
  3.30  defined in Minnesota Statutes.  A licensed practitioner may 
  3.31  prescribe a legend drug, without reference to a specific 
  3.32  patient, by directing a registered nurse, pursuant to section 
  3.33  148.235, subdivisions 8 and 9, physician assistant, or medical 
  3.34  student or resident to adhere to a particular practice guideline 
  3.35  or protocol when treating patients whose condition falls within 
  3.36  such guideline or protocol, and when such guideline or protocol 
  4.1   specifies the circumstances under which the legend drug is to be 
  4.2   prescribed and administered.  An individual who verbally, 
  4.3   electronically, or otherwise transmits a written, oral, or 
  4.4   electronic order, as an agent of a prescriber, shall not be 
  4.5   deemed to have prescribed the legend drug.  This paragraph 
  4.6   applies to a physician assistant only if the physician assistant 
  4.7   meets the requirements of section 147A.18. 
  4.8      (b) A licensed practitioner that dispenses for profit a 
  4.9   legend drug that is to be administered orally, is ordinarily 
  4.10  dispensed by a pharmacist, and is not a vaccine, must file with 
  4.11  the practitioner's licensing board a statement indicating that 
  4.12  the practitioner dispenses legend drugs for profit, the general 
  4.13  circumstances under which the practitioner dispenses for profit, 
  4.14  and the types of legend drugs generally dispensed.  It is 
  4.15  unlawful to dispense legend drugs for profit after July 31, 
  4.16  1990, unless the statement has been filed with the appropriate 
  4.17  licensing board.  For purposes of this paragraph, "profit" means 
  4.18  (1) any amount received by the practitioner in excess of the 
  4.19  acquisition cost of a legend drug for legend drugs that are 
  4.20  purchased in prepackaged form, or (2) any amount received by the 
  4.21  practitioner in excess of the acquisition cost of a legend drug 
  4.22  plus the cost of making the drug available if the legend drug 
  4.23  requires compounding, packaging, or other treatment.  The 
  4.24  statement filed under this paragraph is public data under 
  4.25  section 13.03.  This paragraph does not apply to a licensed 
  4.26  doctor of veterinary medicine or a registered pharmacist.  Any 
  4.27  person other than a licensed practitioner with the authority to 
  4.28  prescribe, dispense, and administer a legend drug under 
  4.29  paragraph (a) shall not dispense for profit.  To dispense for 
  4.30  profit does not include dispensing by a community health clinic 
  4.31  when the profit from dispensing is used to meet operating 
  4.32  expenses. 
  4.33     Sec. 5.  Minnesota Statutes 2000, section 256.01, is 
  4.34  amended by adding a subdivision to read: 
  4.35     Subd. 20.  [RYAN WHITE COMPREHENSIVE AIDS RESOURCES 
  4.36  EMERGENCY ACT.] The commissioner shall act as the designated 
  5.1   state agent for carrying out responsibilities required under 
  5.2   Title II of the federal Ryan White Comprehensive AIDS Resources 
  5.3   Emergency (CARE) Act.  These responsibilities include: 
  5.4      (1) coordinating statewide HIV/AIDS needs assessment 
  5.5   activities; 
  5.6      (2) developing the state's plan to meet identified health 
  5.7   and support service needs of people living with HIV/AIDS; 
  5.8      (3) administering federal funds designed to provide 
  5.9   comprehensive health and support services to persons living with 
  5.10  HIV/AIDS; 
  5.11     (4) administering federal funds designated for the AIDS 
  5.12  drug assistance program (ADAP); 
  5.13     (5) collecting rebates from pharmaceutical manufacturers on 
  5.14  drugs purchased with federal ADAP funds; and 
  5.15     (6) utilizing ADAP rebate funds in accordance with 
  5.16  guidelines of the federal Health Resources and Services 
  5.17  Administration. 
  5.18  Rebates collected under this subdivision shall be deposited into 
  5.19  the ADAP account in the special revenue fund and are 
  5.20  appropriated to the commissioner for purposes of this 
  5.21  subdivision. 
  5.22     Sec. 6.  Minnesota Statutes 2001 Supplement, section 
  5.23  256B.0625, subdivision 13, is amended to read: 
  5.24     Subd. 13.  [DRUGS.] (a) Medical assistance covers drugs, 
  5.25  except for fertility drugs when specifically used to enhance 
  5.26  fertility, if prescribed by a licensed practitioner and 
  5.27  dispensed by a licensed pharmacist, by a physician enrolled in 
  5.28  the medical assistance program as a dispensing physician, or by 
  5.29  a physician or a nurse practitioner employed by or under 
  5.30  contract with a community health board as defined in section 
  5.31  145A.02, subdivision 5, for the purposes of communicable disease 
  5.32  control.  The commissioner, after receiving recommendations from 
  5.33  professional medical associations and professional pharmacist 
  5.34  associations, shall designate a formulary committee to advise 
  5.35  the commissioner on the names of drugs for which payment is 
  5.36  made, recommend a system for reimbursing providers on a set fee 
  6.1   or charge basis rather than the present system, and develop 
  6.2   methods encouraging use of generic drugs when they are less 
  6.3   expensive and equally effective as trademark drugs.  The 
  6.4   formulary committee shall consist of nine members, four of whom 
  6.5   shall be physicians who are not employed by the department of 
  6.6   human services, and a majority of whose practice is for persons 
  6.7   paying privately or through health insurance, three of whom 
  6.8   shall be pharmacists who are not employed by the department of 
  6.9   human services, and a majority of whose practice is for persons 
  6.10  paying privately or through health insurance, a consumer 
  6.11  representative, and a nursing home representative.  Committee 
  6.12  members shall serve three-year terms and shall serve without 
  6.13  compensation.  Members may be reappointed once.  
  6.14     (b) The commissioner shall establish a drug formulary.  Its 
  6.15  establishment and publication shall not be subject to the 
  6.16  requirements of the Administrative Procedure Act, but the 
  6.17  formulary committee shall review and comment on the formulary 
  6.18  contents.  The formulary committee shall review and recommend 
  6.19  drugs which require prior authorization.  The formulary 
  6.20  committee may recommend drugs for prior authorization directly 
  6.21  to the commissioner, as long as opportunity for public input is 
  6.22  provided.  Prior authorization may be requested by the 
  6.23  commissioner based on medical and clinical criteria before 
  6.24  certain drugs are eligible for payment.  Before a drug may be 
  6.25  considered for prior authorization at the request of the 
  6.26  commissioner:  
  6.27     (1) the drug formulary committee must develop criteria to 
  6.28  be used for identifying drugs; the development of these criteria 
  6.29  is not subject to the requirements of chapter 14, but the 
  6.30  formulary committee shall provide opportunity for public input 
  6.31  in developing criteria; 
  6.32     (2) the drug formulary committee must hold a public forum 
  6.33  and receive public comment for an additional 15 days; and 
  6.34     (3) the commissioner must provide information to the 
  6.35  formulary committee on the impact that placing the drug on prior 
  6.36  authorization will have on the quality of patient care and 
  7.1   information regarding whether the drug is subject to clinical 
  7.2   abuse or misuse.  Prior authorization may be required by the 
  7.3   commissioner before certain formulary drugs are eligible for 
  7.4   payment.  The formulary shall not include:  
  7.5      (i) drugs or products for which there is no federal 
  7.6   funding; 
  7.7      (ii) over-the-counter drugs, except for antacids, 
  7.8   acetaminophen, family planning products, aspirin, insulin, 
  7.9   products for the treatment of lice, vitamins for adults with 
  7.10  documented vitamin deficiencies, vitamins for children under the 
  7.11  age of seven and pregnant or nursing women, and any other 
  7.12  over-the-counter drug identified by the commissioner, in 
  7.13  consultation with the drug formulary committee, as necessary, 
  7.14  appropriate, and cost-effective for the treatment of certain 
  7.15  specified chronic diseases, conditions or disorders, and this 
  7.16  determination shall not be subject to the requirements of 
  7.17  chapter 14; 
  7.18     (iii) anorectics, except that medically necessary 
  7.19  anorectics shall be covered for a recipient previously diagnosed 
  7.20  as having pickwickian syndrome and currently diagnosed as having 
  7.21  diabetes and being morbidly obese; 
  7.22     (iv) drugs for which medical value has not been 
  7.23  established; and 
  7.24     (v) drugs from manufacturers who have not signed a rebate 
  7.25  agreement with the Department of Health and Human Services 
  7.26  pursuant to section 1927 of title XIX of the Social Security Act.
  7.27     The commissioner shall publish conditions for prohibiting 
  7.28  payment for specific drugs after considering the formulary 
  7.29  committee's recommendations.  An honorarium of $100 per meeting 
  7.30  and reimbursement for mileage shall be paid to each committee 
  7.31  member in attendance.  
  7.32     (c) The basis for determining the amount of payment shall 
  7.33  be the lower of the actual acquisition costs of the drugs plus a 
  7.34  fixed dispensing fee; the maximum allowable cost set by the 
  7.35  federal government or by the commissioner plus the fixed 
  7.36  dispensing fee; or the usual and customary price charged to the 
  8.1   public.  The pharmacy dispensing fee shall be $3.65, except that 
  8.2   the dispensing fee for intravenous solutions which must be 
  8.3   compounded by the pharmacist shall be $8 per bag, $14 per bag 
  8.4   for cancer chemotherapy products, and $30 per bag for total 
  8.5   parenteral nutritional products dispensed in one liter 
  8.6   quantities, or $44 per bag for total parenteral nutritional 
  8.7   products dispensed in quantities greater than one liter.  Actual 
  8.8   acquisition cost includes quantity and other special discounts 
  8.9   except time and cash discounts.  The actual acquisition cost of 
  8.10  a drug shall be estimated by the commissioner, at average 
  8.11  wholesale price minus nine percent, except that where a drug has 
  8.12  had its wholesale price reduced as a result of the actions of 
  8.13  the National Association of Medicaid Fraud Control Units, the 
  8.14  estimated actual acquisition cost shall be the reduced average 
  8.15  wholesale price, without the nine percent deduction.  The 
  8.16  maximum allowable cost of a multisource drug may be set by the 
  8.17  commissioner and it shall be comparable to, but no higher than, 
  8.18  the maximum amount paid by other third-party payors in this 
  8.19  state who have maximum allowable cost programs.  The 
  8.20  commissioner shall set maximum allowable costs for multisource 
  8.21  drugs that are not on the federal upper limit list as described 
  8.22  in United States Code, title 42, chapter 7, section 1396r-8(e), 
  8.23  the Social Security Act, and Code of Federal Regulations, title 
  8.24  42, part 447, section 447.332.  Establishment of the amount of 
  8.25  payment for drugs shall not be subject to the requirements of 
  8.26  the Administrative Procedure Act.  An additional dispensing fee 
  8.27  of $.30 may be added to the dispensing fee paid to pharmacists 
  8.28  for legend drug prescriptions dispensed to residents of 
  8.29  long-term care facilities when a unit dose blister card system, 
  8.30  approved by the department, is used.  Under this type of 
  8.31  dispensing system, the pharmacist must dispense a 30-day supply 
  8.32  of drug.  The National Drug Code (NDC) from the drug container 
  8.33  used to fill the blister card must be identified on the claim to 
  8.34  the department.  The unit dose blister card containing the drug 
  8.35  must meet the packaging standards set forth in Minnesota Rules, 
  8.36  part 6800.2700, that govern the return of unused drugs to the 
  9.1   pharmacy for reuse.  The pharmacy provider will be required to 
  9.2   credit the department for the actual acquisition cost of all 
  9.3   unused drugs that are eligible for reuse.  Over-the-counter 
  9.4   medications must be dispensed in the manufacturer's unopened 
  9.5   package.  The commissioner may permit the drug clozapine to be 
  9.6   dispensed in a quantity that is less than a 30-day supply.  
  9.7   Whenever a generically equivalent product is available, payment 
  9.8   shall be on the basis of the actual acquisition cost of the 
  9.9   generic drug, unless the prescriber specifically indicates 
  9.10  "dispense as written - brand necessary" on the prescription as 
  9.11  required by section 151.21, subdivision 2. 
  9.12     (d) For purposes of this subdivision, "multisource drugs" 
  9.13  means covered outpatient drugs, excluding innovator multisource 
  9.14  drugs for which there are two or more drug products, which: 
  9.15     (1) are related as therapeutically equivalent under the 
  9.16  Food and Drug Administration's most recent publication of 
  9.17  "Approved Drug Products with Therapeutic Equivalence 
  9.18  Evaluations"; 
  9.19     (2) are pharmaceutically equivalent and bioequivalent as 
  9.20  determined by the Food and Drug Administration; and 
  9.21     (3) are sold or marketed in Minnesota. 
  9.22  "Innovator multisource drug" means a multisource drug that was 
  9.23  originally marketed under an original new drug application 
  9.24  approved by the Food and Drug Administration. 
  9.25     (e) The basis for determining the amount of payment for 
  9.26  drugs administered in an outpatient setting shall be the lower 
  9.27  of the usual and customary cost submitted by the provider; the 
  9.28  average wholesale price minus five percent; or the maximum 
  9.29  allowable cost set by the federal government under United States 
  9.30  Code, title 42, chapter 7, section 1396r-8(e), and Code of 
  9.31  Federal Regulations, title 42, section 447.332, or by the 
  9.32  commissioner under paragraph (c). 
  9.33     (f) Prior authorization shall not be required or utilized 
  9.34  for any antihemophilic factor drug prescribed for the treatment 
  9.35  of hemophilia and blood disorders where there is no generically 
  9.36  equivalent drug available unless the commissioner determines 
 10.1   that prior authorization is necessary for patient safety.  This 
 10.2   paragraph applies to any supplemental drug rebate program 
 10.3   established or administered by the commissioner. 
 10.4      Sec. 7.  Minnesota Statutes 2000, section 256B.0625, 
 10.5   subdivision 35, is amended to read: 
 10.6      Subd. 35.  [FAMILY COMMUNITY SUPPORT SERVICES.] (a) Medical 
 10.7   assistance covers family community support services as defined 
 10.8   in section 245.4871, subdivision 17.  In addition to the 
 10.9   provisions of section 245.4871, and to the extent authorized by 
 10.10  rules promulgated by the state agency, medical assistance covers 
 10.11  the following services as family community support services: 
 10.12     (1) services identified in an individual treatment plan 
 10.13  when provided by a trained mental health behavioral aide under 
 10.14  the direction of a mental health practitioner or mental health 
 10.15  professional; 
 10.16     (2) mental health crisis intervention and crisis 
 10.17  stabilization services provided outside of hospital inpatient 
 10.18  settings; and 
 10.19     (3) the therapeutic components of preschool and therapeutic 
 10.20  camp programs. 
 10.21     (b) Notwithstanding the provisions of Minnesota Rules, 
 10.22  parts 9505.0324, subpart 2, 9505.0326, subpart 2, and 9505.0327, 
 10.23  subpart 2, a provider of family community support services, 
 10.24  home-based mental health services, or therapeutic support of 
 10.25  foster care services under contract with a county may continue 
 10.26  to provide existing services to a child, and may provide new 
 10.27  services to that child, if the child is placed in foster care, 
 10.28  or the child and family relocate, outside the original county of 
 10.29  residence.