SF 2470

2nd Unofficial Engrossment - 88th Legislature (2013 - 2014)

Posted on 05/08/2014 04:51 p.m.

1.1A bill for an act 1.2relating to health; providing for medical cannabis therapeutic research study; 1.3creating account; providing appointments; requiring rulemaking; requiring 1.4reports; appropriating money;amending Minnesota Statutes 2012, section 1.5256B.0625, subdivision 13d; proposing coding for new law in Minnesota 1.6Statutes, chapter 152. 1.7BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 1.8    Section 1. new text begin [152.22] MEDICAL CANNABIS THERAPEUTIC RESEARCH new text end 1.9 new text begin STUDY. new text end 1.10     new text begin Subdivision 1. new text end new text begin Definitions. new text end new text begin (a) For purposes of this section, the following terms new text end 1.11 new text begin have the meanings given. new text end 1.12 new text begin (b) "Commissioner" means the commissioner of health. new text end 1.13 new text begin (c) "Health care practitioner" means a Minnesota licensed doctor of medicine, a new text end 1.14 new text begin Minnesota licensed physician assistant acting within the scope of authorized practice, or a new text end 1.15 new text begin Minnesota licensed advanced practice registered nurse, who has the primary responsibility new text end 1.16 new text begin for the care and treatment of a person diagnosed with a qualifying medical condition new text end 1.17 new text begin under this section. new text end 1.18 new text begin (d) "Health records" means health record as defined in section 144.291. new text end 1.19 new text begin (e) "Medical cannabis" means the flowers of any species of the genus cannabis plant, new text end 1.20 new text begin or any mixture or preparation of them, including extracts and resins which contain a new text end 1.21 new text begin chemical composition determined to likely be medically beneficial by the commissioner, new text end 1.22 new text begin and that is delivered in the form of: new text end 1.23 new text begin (1) liquid, including, but not limited to, oil; new text end 1.24 new text begin (2) pill; new text end 2.1 new text begin (3) vaporized delivery method with use of liquid or oil but which does not require new text end 2.2 new text begin the use of dried leaves or plant form; or new text end 2.3 new text begin (4) any other method approved by the commissioner but which shall not include new text end 2.4 new text begin smoking. new text end 2.5 new text begin (f) "Medical cannabis manufacturer" or "manufacturer" means an entity registered new text end 2.6 new text begin by the commissioner to cultivate, acquire, manufacture, possess, prepare, transfer, new text end 2.7 new text begin transport, supply, or dispense medical cannabis, delivery devices, or related supplies and new text end 2.8 new text begin educational materials to patients with a qualifying medical condition who are enrolled new text end 2.9 new text begin in the registry program. new text end 2.10 new text begin (g) "Medical cannabis product" means medical cannabis as defined in paragraph new text end 2.11 new text begin (e) and any delivery device or related supplies and educational materials used in the new text end 2.12 new text begin administration of medical cannabis for a patient with a qualifying medical condition new text end 2.13 new text begin enrolled in the registry program. new text end 2.14 new text begin (h) "Patient" means a Minnesota resident who has been diagnosed by a health care new text end 2.15 new text begin practitioner with a qualifying medical condition and who has otherwise met any other new text end 2.16 new text begin requirements of patients under this section to participate in the registry program. new text end 2.17 new text begin (i) "Patient registry number" means a unique identification number assigned to a new text end 2.18 new text begin patient by the commissioner after the commissioner has enrolled the patient in the registry new text end 2.19 new text begin program. new text end 2.20 new text begin (j) "Registered designated caregiver" means a person who is at least 21 years old and new text end 2.21 new text begin who has been approved by the commissioner to assist a patient who has been identified new text end 2.22 new text begin by a health care provider as developmentally or physically disabled and therefore unable new text end 2.23 new text begin to self-administer medication, and who is authorized by the commissioner to administer new text end 2.24 new text begin medical cannabis to the patient only within the patient's primary place of residence; new text end 2.25 new text begin (k) "Registry program" means the patient registry established under this section. new text end 2.26 new text begin (l) "Registry verification" means the verification provided by the commissioner that new text end 2.27 new text begin a patient is enrolled in the registry program and that includes the patient's name, patient new text end 2.28 new text begin registry number, qualifying medical condition, and, if applicable, the name of the patient's new text end 2.29 new text begin registered designated caregiver or parent or legal guardian. new text end 2.30 new text begin (m) "Qualifying medical condition" means a diagnosis of the following conditions: new text end 2.31 new text begin (1) cancer; new text end 2.32 new text begin (2) glaucoma; new text end 2.33 new text begin (3) human immunodeficiency virus or acquired immune deficiency syndrome; new text end 2.34 new text begin (4) Tourette's syndrome; new text end 2.35 new text begin (5) amyotrophic lateral sclerosis; new text end 2.36 new text begin (6) seizures, including those characteristic of epilepsy; new text end 3.1 new text begin (7) severe and persistent muscle spasms, including those characteristic of multiple new text end 3.2 new text begin sclerosis; new text end 3.3 new text begin (8) Crohn's disease; or new text end 3.4 new text begin (9) any other medical condition or its treatment approved by the commissioner. new text end 3.5     new text begin Subd. 2. new text end new text begin Limitations. new text end new text begin This section does not permit any person to engage in and new text end 3.6 new text begin does not prevent the imposition of any civil, criminal, or other penalties for: new text end 3.7 new text begin (1) undertaking any task under the influence of medical cannabis that would new text end 3.8 new text begin constitute negligence or professional malpractice; new text end 3.9 new text begin (2) possessing or engaging in the use of medical cannabis on: new text end 3.10 new text begin (i) a school bus; new text end 3.11 new text begin (ii) on the grounds of any preschool or primary or secondary school; or new text end 3.12 new text begin (iii) in any correctional facility; new text end 3.13 new text begin (3) vaporizing medical cannabis pursuant to subdivision 1, paragraph (e): new text end 3.14 new text begin (i) on any form of public transportation; new text end 3.15 new text begin (ii) where the vapor would be inhaled by a minor child; or new text end 3.16 new text begin (iii) in any public place; and new text end 3.17 new text begin (4) operating, navigating, or being in actual physical control of any motor vehicle, new text end 3.18 new text begin aircraft, train, or motorboat, or working on transportation property, equipment, or facilities new text end 3.19 new text begin while under the influence of medical cannabis. new text end 3.20     new text begin Subd. 3. new text end new text begin Federally approved clinical trials. new text end new text begin The commissioner may prohibit new text end 3.21 new text begin enrollment of a patient in the registry program if the patient is simultaneously enrolled in a new text end 3.22 new text begin federally approved clinical trial for the treatment of a qualifying medical condition with new text end 3.23 new text begin medical cannabis. The commissioner shall provide information to all patients enrolled in new text end 3.24 new text begin the registry program on the existence of federally approved clinical trials for the treatment new text end 3.25 new text begin of the patient's qualifying medical condition with medical cannabis, as an alternative to new text end 3.26 new text begin enrollment in the patient registry program. new text end 3.27     new text begin Subd. 4. new text end new text begin Commissioner duties. new text end new text begin (a) The commissioner shall register one in-state new text end 3.28 new text begin manufacturer for the production of all medical cannabis products within the state by new text end 3.29 new text begin December 1, 2014, unless the commissioner obtains an adequate supply of federally new text end 3.30 new text begin sourced medical cannabis products by August 1, 2014. The commissioner shall require new text end 3.31 new text begin any manufacturer application for registration to pay a fee of $20,000. If a manufacturer is new text end 3.32 new text begin not selected for registration, the commissioner shall refund $19,000 to that manufacturer. new text end 3.33 new text begin The commissioner shall continue to accept applications after December 1, 2014, if no new text end 3.34 new text begin manufacturer that meets the qualifications set forth in this subdivision applies prior to new text end 3.35 new text begin December 1, 2014. The commissioner's determination that no manufacturer exists to fulfill new text end 4.1 new text begin the duties under this section is subject to judicial review. As a condition for registration, new text end 4.2 new text begin the commissioner shall require the manufacturer to: new text end 4.3 new text begin (1) supply medical cannabis products to patients by July 1, 2015; and new text end 4.4 new text begin (2) comply with all requirements under subdivision 8. new text end 4.5 new text begin (b) The commissioner shall consider the following factors when determining which new text end 4.6 new text begin manufacturer to register: new text end 4.7 new text begin (1) the technical expertise of the manufacturer in cultivating medical cannabis and new text end 4.8 new text begin converting the medical cannabis into an acceptable delivery method under subdivision 1, new text end 4.9 new text begin paragraph (e); new text end 4.10 new text begin (2) the qualifications of the manufacturer's employees; new text end 4.11 new text begin (3) the long-term financial stability of the manufacturer; new text end 4.12 new text begin (4) the ability to provide appropriate security measures on the premises of the new text end 4.13 new text begin manufacturer; new text end 4.14 new text begin (5) whether the manufacturer has demonstrated an ability to meet the medical new text end 4.15 new text begin cannabis production needs required by this section; and new text end 4.16 new text begin (6) the manufacturer's projection and ongoing assessment of fee levels on patients new text end 4.17 new text begin with a qualifying condition. new text end 4.18 new text begin (c) The commissioner shall require the medical cannabis manufacturer to contract new text end 4.19 new text begin with an independent laboratory to test all medical cannabis produced by the manufacturer. new text end 4.20 new text begin The commissioner shall approve the laboratory chosen by the manufacturer and require new text end 4.21 new text begin that the laboratory report testing results to the manufacturer in a manner determined by new text end 4.22 new text begin the commissioner. new text end 4.23 new text begin (d) The commissioner shall make an initial determination by December 1, 2014, new text end 4.24 new text begin after reviewing medical and scientific literature, of the range of chemical compositions new text end 4.25 new text begin of any plant of the genus cannabis that will likely be medically beneficial for each of new text end 4.26 new text begin the qualifying medical conditions, including a range of recommended doses for each new text end 4.27 new text begin condition. Once determined, the commissioner shall provide a listing of the range of new text end 4.28 new text begin chemical compositions and range of dosages to the manufacturer and publish the listing on new text end 4.29 new text begin the department Web site. new text end 4.30 new text begin (e) The commissioner shall adopt rules necessary for the manufacturer to begin new text end 4.31 new text begin distribution of medical cannabis products to patients under the registry program by July 1, new text end 4.32 new text begin 2015, and have notice of proposed rules published in the State Register prior to January new text end 4.33 new text begin 1, 2015. new text end 4.34 new text begin (f) The commissioner shall, within 30 days of a deadline listed in this section, advise new text end 4.35 new text begin the public and the co-chairs of the task force on medical cannabis therapeutic research if new text end 4.36 new text begin the commissioner is unable to complete any requirements under this section by the deadline new text end 5.1 new text begin listed in this section. The commissioner shall provide a written statement as to the reason or new text end 5.2 new text begin reasons the deadline will not be met. Upon request of the commissioner, the task force shall new text end 5.3 new text begin extend any deadline by six months, but may not extend any deadline more than three times. new text end 5.4     new text begin Subd. 5. new text end new text begin Rulemaking. new text end new text begin The commissioner shall adopt rules to implement this new text end 5.5 new text begin section. Rules for which notice is published in the State Register before January 1, 2015 new text end 5.6 new text begin may be adopted using the process in section 14.389. new text end 5.7     new text begin Subd. 6. new text end new text begin Patient registry program established. new text end new text begin (a) The commissioner of health new text end 5.8 new text begin shall establish a patient registry program to evaluate data on patient demographics, new text end 5.9 new text begin effective treatment options, clinical outcomes, and quality-of-life outcomes for the new text end 5.10 new text begin purpose of making clinically significant findings regarding patients with a qualifying new text end 5.11 new text begin medical condition engaged in the therapeutic use of medical cannabis. new text end 5.12 new text begin (b) The commissioner shall: new text end 5.13 new text begin (1) give notice of the program to health care practitioners in the state who are new text end 5.14 new text begin eligible to serve as a health care practitioner as defined in subdivision 1, paragraph (c), new text end 5.15 new text begin and explain the purposes and requirements of the program; new text end 5.16 new text begin (2) allow each health care practitioner in the state who meets or agrees to meet the new text end 5.17 new text begin program's requirements and who requests to participate, to be included in the registry new text end 5.18 new text begin program to collect data for the patient registry; new text end 5.19 new text begin (3) provide explanatory information and assistance to each health care practitioner new text end 5.20 new text begin in understanding the nature of therapeutic use of medical cannabis within program new text end 5.21 new text begin requirements; new text end 5.22 new text begin (4) create and provide a written certification to be used by a health practitioner for new text end 5.23 new text begin the practitioner to certify whether a patient has been diagnosed with a qualifying medical new text end 5.24 new text begin condition and include in the certification an option for the practitioner to certify whether the new text end 5.25 new text begin patient, in the health care practitioner's medical opinion, is mentally or physically disabled new text end 5.26 new text begin and, as a result of that disability, the patient is unable to self-administer medication; new text end 5.27 new text begin (5) supervise the participation of the health care practitioner in conducting patient new text end 5.28 new text begin treatment and health records reporting in a manner that ensures stringent security and new text end 5.29 new text begin record-keeping requirements and that prevents the unauthorized release of private data on new text end 5.30 new text begin individuals as defined by section 13.02; new text end 5.31 new text begin (6) develop safety criteria for patients with a qualifying condition as a requirement of new text end 5.32 new text begin the patient's participation in the program, to prevent the patient from undertaking any task new text end 5.33 new text begin under the influence of medical cannabis that would constitute negligence or professional new text end 5.34 new text begin malpractice on the part of the patient; and new text end 5.35 new text begin (7) conduct research and studies based on data from health records submitted to new text end 5.36 new text begin the registry program and submit reports on intermediate or final research results to the new text end 6.1 new text begin legislature and major scientific journals. The commissioner may contract with a third new text end 6.2 new text begin party to complete the requirements of this clause. new text end 6.3 new text begin (c) The commissioner shall develop a patient application for enrollment into the new text end 6.4 new text begin registry program. The application shall be available to the patient and given to health care new text end 6.5 new text begin practitioners in the state who are eligible to serve as a health care practitioner as defined new text end 6.6 new text begin under subdivision 1, paragraph (c). The application must include: new text end 6.7 new text begin (1) the name, mailing address, and date of birth of the qualifying patient; new text end 6.8 new text begin (2) the name, mailing address, and telephone number of the qualifying patient's new text end 6.9 new text begin health care practitioner; new text end 6.10 new text begin (3) the name, mailing address, and date of birth of the patient's designated caregiver, new text end 6.11 new text begin if any, or, if the patient is under age 18, the patient's parent or legal guardian; new text end 6.12 new text begin (4) a copy of the written certification from the patient's health care practitioner that is new text end 6.13 new text begin dated within 90 days prior to submitting the application which certifies that the patient has new text end 6.14 new text begin been diagnosed with a qualifying medical condition and, if applicable, that, in the health new text end 6.15 new text begin care practitioner's medical opinion, the patient is mentally or physically disabled and, as a new text end 6.16 new text begin result of that disability, the patient is unable to self-administer medication; and new text end 6.17 new text begin (5) all other signed affidavits and enrollment forms required by the commissioner new text end 6.18 new text begin under this section, including, but not limited to, the disclosure under paragraph (e). new text end 6.19 new text begin (d) The commissioner shall register a single designated caregiver for a patient if the new text end 6.20 new text begin patient's health care provider certified that the patient, in the health care practitioner's new text end 6.21 new text begin medical opinion, is developmentally or physically disabled and, as a result of that new text end 6.22 new text begin disability, the patient is unable to self-administer medication and the caregiver has agreed, new text end 6.23 new text begin in writing, to be a patient's designated caregiver. As a condition of registration as a new text end 6.24 new text begin designated caregiver, the commissioner shall require the person: new text end 6.25 new text begin (1) to be at least 21 years of age; new text end 6.26 new text begin (2) to not already be registered as a caregiver for another patient enrolled in the new text end 6.27 new text begin registry program; new text end 6.28 new text begin (3) to agree to only possess any medical cannabis product for purposes of new text end 6.29 new text begin administration of the medical cannabis to the patient within the patient's primary place of new text end 6.30 new text begin residence; and new text end 6.31 new text begin (4) to agree that if the application is approved, the person will not be a registered new text end 6.32 new text begin designated caregiver for more than one patient. new text end 6.33 new text begin (e) The commissioner shall develop a disclosure form and require, as a condition of new text end 6.34 new text begin enrollment, all patients to sign a copy of the disclosure. The disclosure must include: new text end 6.35 new text begin (1) a statement that notwithstanding any law to the contrary, the commissioner of new text end 6.36 new text begin health, or an employee of any state agency, may not be held civilly or criminally liable for new text end 7.1 new text begin any injury, loss of property, personal injury, or death caused by any act or omission while new text end 7.2 new text begin acting within the scope of office or employment under this section; and new text end 7.3 new text begin (2) the patient's acknowledgement that enrollment in the patient registry program is new text end 7.4 new text begin conditional on the patient's agreement to meet all of the requirements of subdivision 9; new text end 7.5 new text begin (f) After receipt of a patient's application and signed disclosure, the commissioner new text end 7.6 new text begin shall enroll the patient in the registry program and assign the patient a patient registry new text end 7.7 new text begin number. A patient's enrollment in the registry program shall only be denied if the patient: new text end 7.8 new text begin (1) does not have written certification from a health care provider that the patient new text end 7.9 new text begin has been diagnosed with a qualifying medical condition; new text end 7.10 new text begin (2) has not signed and returned the disclosure form required under paragraph (d) to new text end 7.11 new text begin the commissioner; new text end 7.12 new text begin (3) does not provide the information required; new text end 7.13 new text begin (4) has previously been removed from the registry program for violations of new text end 7.14 new text begin subdivision 9; or new text end 7.15 new text begin (5) provides false information. new text end 7.16 new text begin (g) The commissioner shall give written notice to a patient of the reason for denying new text end 7.17 new text begin enrollment in the registry program. new text end 7.18 new text begin (h) Denial of enrollment into the registry program is considered a final decision of new text end 7.19 new text begin the commissioner and is subject to judicial review. new text end 7.20 new text begin (i) A patient's enrollment in the registry program may only be revoked if a patient new text end 7.21 new text begin violates a requirement in subdivision 9. new text end 7.22 new text begin (j) The commissioner shall develop a registry verification to provide to the health new text end 7.23 new text begin care practitioner identified in the patient's application and to the manufacturer. The new text end 7.24 new text begin registry verification shall include: new text end 7.25 new text begin (1) the patient's name and date of birth; new text end 7.26 new text begin (2) the patient registry number assigned to the patient; new text end 7.27 new text begin (3) the patient's qualifying medical condition as provided by the patient's health care new text end 7.28 new text begin provider in the written certification; and new text end 7.29 new text begin (4) the name and date of birth of the patient's registered designated caregiver, if any, new text end 7.30 new text begin or, if the patient is under age 18, the name of the patient's parent or legal guardian. new text end 7.31 new text begin (k) If the commissioner adds a delivery form under subdivision 1, paragraph (e), or a new text end 7.32 new text begin qualifying medical condition under subdivision 1, paragraph (m), the commissioner shall new text end 7.33 new text begin notify the legislature by January 15 of any year in which the commissioner wishes to make new text end 7.34 new text begin the change. The change shall be effective on August 1 of that year, unless the legislature new text end 7.35 new text begin by law provides otherwise. As part of the January submission, the commissioner shall new text end 7.36 new text begin notify the chairs and ranking minority members of the legislative policy committees new text end 8.1 new text begin having jurisdiction over health and public safety of the addition and the reasons for its new text end 8.2 new text begin addition, including any written comments received by the commissioner from the public new text end 8.3 new text begin and any guidance received from the task force on medical cannabis research. new text end 8.4 new text begin (l) Nothing in this section requires the medical assistance and MinnesotaCare new text end 8.5 new text begin programs to reimburse an enrollee or a provider for costs associated with the medical use new text end 8.6 new text begin of cannabis. Medical assistance and MinnesotaCare shall continue to reimburse providers new text end 8.7 new text begin for covered services related to treatment of a recipient's qualifying medical condition. new text end 8.8 new text begin (m) The establishment of the registry program is not intended in any manner new text end 8.9 new text begin whatsoever to condone or promote the illicit recreational use of marijuana. new text end 8.10     new text begin Subd. 7. new text end new text begin Health care practitioner duties. new text end new text begin (a) Prior to a patient's enrollment in the new text end 8.11 new text begin registry program, a health care practitioner shall: new text end 8.12 new text begin (1) determine, in the health care practitioner's medical judgment, whether a patient new text end 8.13 new text begin suffers from a qualifying medical condition as defined in subdivision 1, paragraph (m), new text end 8.14 new text begin and if so determined, provide the patient with a written certification of that diagnosis; new text end 8.15 new text begin (2) determine whether a patient is developmentally or physically disabled and, as new text end 8.16 new text begin a result of that disability, the patient is unable to self-administer medication, and, if so new text end 8.17 new text begin determined, include that determination on the patient's written certification of diagnosis; new text end 8.18 new text begin (3) advise patients, registered designated caregivers, and parents or legal guardians new text end 8.19 new text begin of patients under age 18 of the existence of any nonprofit patient support groups or new text end 8.20 new text begin organizations; new text end 8.21 new text begin (4) provide explanatory information from the commissioner to patients with new text end 8.22 new text begin qualifying medical conditions, including disclosure to all patients about the experimental new text end 8.23 new text begin nature of therapeutic use of medical cannabis, the possible risks and side effects of the new text end 8.24 new text begin proposed treatment, the application and other materials from the commissioner, and provide new text end 8.25 new text begin patients with the Tennessen warning as required by section 13.04, subdivision 2; and new text end 8.26 new text begin (5) agree to continue treatment of the patient's qualifying medical condition and new text end 8.27 new text begin report medical findings to the commissioner. new text end 8.28 new text begin (b) Upon notification from the commissioner of the patient's enrollment in the new text end 8.29 new text begin registry program, the health care practitioner shall: new text end 8.30 new text begin (1) participate in the patient registry reporting system under the guidance and new text end 8.31 new text begin supervision of the commissioner of health; new text end 8.32 new text begin (2) report health records of the patient throughout the ongoing treatment of the new text end 8.33 new text begin patient to the commissioner in a manner determined by the commissioner of health and in new text end 8.34 new text begin accordance with paragraph (c); and new text end 8.35 new text begin (3) otherwise comply with all requirements developed by the commissioner. new text end 9.1 new text begin (c) Data collected on patients by a health care practitioner and reported to the patient new text end 9.2 new text begin registry are health records under section 144.291 and are private data on individuals under new text end 9.3 new text begin section 13.02 but may be used or reported in an aggregated, nonidentifiable form as part of new text end 9.4 new text begin a scientific, peer-reviewed publication of research conducted under this section. new text end 9.5     new text begin Subd. 8. new text end new text begin Manufacturer of medical cannabis duties. new text end new text begin (a) The manufacturer of new text end 9.6 new text begin medical cannabis shall provide a reliable and ongoing supply of all medical cannabis new text end 9.7 new text begin products needed for the registry program. new text end 9.8 new text begin (b) All cultivation, harvesting, manufacturing, and packing of cannabis must take new text end 9.9 new text begin place in an enclosed, locked facility at a physical address provided to the commissioner new text end 9.10 new text begin during the registration process. new text end 9.11 new text begin (c) The medical cannabis manufacturer shall produce medical cannabis with new text end 9.12 new text begin chemical compositions as determined by the commissioner. new text end 9.13 new text begin (d) The medical cannabis manufacturer shall contract with a laboratory, subject to new text end 9.14 new text begin the commissioner's approval of the laboratory and any additional requirements set by the new text end 9.15 new text begin commissioner, for purposes of testing all medical cannabis manufactured by the medical new text end 9.16 new text begin cannabis manufacturer as to content, contamination, and consistency to verify the medical new text end 9.17 new text begin cannabis meets the requirements of subdivision 1, paragraph (e). new text end 9.18 new text begin (e) The manufacturer must process and prepare any cannabis plant material into a new text end 9.19 new text begin form allowable under subdivision 1, paragraph (e), prior to distribution of any medical new text end 9.20 new text begin cannabis. new text end 9.21 new text begin (f) The manufacturer shall require that any employee licensed as a pharmacist new text end 9.22 new text begin pursuant to chapter 151 and the rules promulgated pursuant to that chapter be the only new text end 9.23 new text begin employees to distribute the medical cannabis to a patient. new text end 9.24 new text begin (g) The manufacturer shall only distribute medical cannabis products to the patient new text end 9.25 new text begin or, if the patient is under age 18, to the patient's parent or legal guardian. new text end 9.26 new text begin (h) Prior to distribution of any medical cannabis products to any patient or, if the new text end 9.27 new text begin patient is under age 18, the patient's parent of legal guardian, the manufacturer shall: new text end 9.28 new text begin (1) verify that the manufacturer has received the registry verification from the new text end 9.29 new text begin commissioner for that individual patient; new text end 9.30 new text begin (2) verify that the person requesting the distribution of medical cannabis is the new text end 9.31 new text begin patient, or, if the patient is under age 18, the patient's parent or legal guardian, listed in the new text end 9.32 new text begin registry verification, in accordance with section 152.11, subdivision 2d; new text end 9.33 new text begin (3) assign a tracking number to each individual medical cannabis product; new text end 9.34 new text begin (4) ensure that any employee of the manufacturer licensed by a pharmacist pursuant new text end 9.35 new text begin to chapter 151 and the rules promulgated pursuant to that chapter has consulted with new text end 9.36 new text begin the patient to determine the proper dosage for the individual patient based on the new text end 10.1 new text begin recommendations of the range of chemical compositions of the medical cannabis and the new text end 10.2 new text begin range of proper dosages provided by the commissioner; new text end 10.3 new text begin (5) properly label each medical cannabis product with individually identifying new text end 10.4 new text begin information, including: new text end 10.5 new text begin (i) the patient's name and date of birth; new text end 10.6 new text begin (ii) the name and date of birth of the patient's registered designated caregiver, or, new text end 10.7 new text begin if the patient is under age 18, the name of the patient's parent or legal guardian, if either new text end 10.8 new text begin were included on the registry verification; new text end 10.9 new text begin (iii) the patient's registry number; new text end 10.10 new text begin (iv) the chemical composition of the medical cannabis; and new text end 10.11 new text begin (v) the dosage; and new text end 10.12 new text begin (6) ensure that the medical cannabis distributed to a patient contains a maximum of a new text end 10.13 new text begin 30-day supply of the dosage determined for that patient. new text end 10.14 new text begin (i) If the patient has a registered designated caregiver, the manufacturer shall deliver new text end 10.15 new text begin properly labeled medical cannabis products to the patient or the patient's registered new text end 10.16 new text begin designated caregiver but only at the patient's primary residence. The manufacturer shall new text end 10.17 new text begin verify that the person to whom the medical cannabis product is being delivered is either new text end 10.18 new text begin the patient or the patient's registered designated caregiver, in accordance with section new text end 10.19 new text begin 152.11, subdivision 2d. The manufacturer shall not distribute medical cannabis products new text end 10.20 new text begin to a registered designated caregiver at the premises of the manufacturer. new text end 10.21 new text begin (j) The manufacturer shall report to the commissioner, on a monthly basis, the new text end 10.22 new text begin following information on each individual patient from the month prior to the report: new text end 10.23 new text begin (1) the amount and dosages of medical cannabis products distributed; new text end 10.24 new text begin (2) the chemical composition of the medical cannabis; and new text end 10.25 new text begin (3) the tracking number assigned to any medical cannabis product distributed. new text end 10.26 new text begin (k) The operating documents of the manufacturer must include: new text end 10.27 new text begin (1) procedures for the oversight of the manufacturer and procedures to ensure new text end 10.28 new text begin accurate record keeping; and new text end 10.29 new text begin (2) procedures for the implementation of appropriate security measures to deter and new text end 10.30 new text begin prevent the theft of cannabis and unauthorized entrance into areas containing cannabis. new text end 10.31 new text begin (l) The manufacturer shall not share office space with, refer patients to a health care new text end 10.32 new text begin practitioner, or have any financial relationship with a health care practitioner. new text end 10.33 new text begin (m) The manufacturer shall not permit any person to consume cannabis on the new text end 10.34 new text begin property of the manufacturer. new text end 10.35 new text begin (n) The manufacturer is subject to reasonable inspection by the commissioner. new text end 11.1 new text begin (o) For purposes of this section only, the medical cannabis manufacturer is not new text end 11.2 new text begin subject to the Board of Pharmacy licensure or regulatory requirements under chapter 151. new text end 11.3     new text begin Subd. 9. new text end new text begin Patient duties. new text end new text begin (a) A patient shall apply to the commissioner for enrollment new text end 11.4 new text begin in the registry program by submitting an application, as defined in subdivision 6, paragraph new text end 11.5 new text begin (c), and an annual registration fee as determined under subdivision 13, paragraph (a). new text end 11.6 new text begin (b) As a condition of continued enrollment, a patient shall agree to: new text end 11.7 new text begin (1) continue to receive regularly scheduled treatment for their qualifying medical new text end 11.8 new text begin condition from their health care practitioner; and new text end 11.9 new text begin (2) report changes in their qualifying medical condition to their health care new text end 11.10 new text begin practitioner. new text end 11.11     new text begin Subd. 10. new text end new text begin Confidentiality. new text end new text begin (a) Data in patient files with both the commissioner and new text end 11.12 new text begin the health care practitioner, and data submitted to or by the medical cannabis manufacturer, new text end 11.13 new text begin are private data on individuals or nonpublic data as defined in section 13.02. new text end 11.14 new text begin (b) Data kept or maintained by the commissioner may not be used for any purpose new text end 11.15 new text begin not provided for in this section and may not be combined or linked in any manner with new text end 11.16 new text begin any other list or database. new text end 11.17     new text begin Subd. 11. new text end new text begin Protections for registry program participation; criminal and civil. new text end new text begin (a) new text end 11.18 new text begin There is a presumption that a patient enrolled in the registry program under this section is new text end 11.19 new text begin engaged in the authorized use of medical cannabis. new text end 11.20 new text begin (b) The presumption may be rebutted by evidence that conduct related to use of new text end 11.21 new text begin medical cannabis was not for the purpose of treating or alleviating the patient's qualifying new text end 11.22 new text begin medical condition or symptoms associated with the patient's qualifying medical condition new text end 11.23 new text begin pursuant to this section. new text end 11.24 new text begin (c) For the purposes of this section only, the following are not violations under new text end 11.25 new text begin this chapter: new text end 11.26 new text begin (1) use or possession of medical cannabis products by a patient enrolled in the new text end 11.27 new text begin registry program, or possession by the parent or guardian of a patient under age 18; new text end 11.28 new text begin (2) possession of medical cannabis products by a registered designated caregiver, new text end 11.29 new text begin only if the registered designated caregiver is in possession of the medical cannabis new text end 11.30 new text begin products within the primary residence of the individual patient in which the caregiver has new text end 11.31 new text begin been registered to assist; new text end 11.32 new text begin (3) possession, dosage determination, or sale of medical cannabis by the medical new text end 11.33 new text begin cannabis manufacturer or employees of the manufacturer; and new text end 11.34 new text begin (4) possession of medical cannabis products by any person while carrying out the new text end 11.35 new text begin duties required under this section. new text end 12.1 new text begin (d) Medical cannabis obtained and distributed pursuant to this section and associated new text end 12.2 new text begin property is not subject to forfeiture under sections 609.531 to 609.5316. new text end 12.3 new text begin (e) The commissioner, the commissioner's staff, and any health care practitioner are new text end 12.4 new text begin not subject to any civil or disciplinary penalties by the Board of Medical Practice or by any new text end 12.5 new text begin business, occupational, or professional licensing board or entity, solely for the participation new text end 12.6 new text begin in the registry program under this section. Nothing in this section prohibits a professional new text end 12.7 new text begin licensing board for sanctioning actions outside of those actions allowed under this section. new text end 12.8 new text begin (f) Notwithstanding any law to the contrary, the commissioner of health, or an new text end 12.9 new text begin employee of any state agency, may not be held civilly or criminally liable for any injury, new text end 12.10 new text begin loss of property, personal injury, or death caused by any act or omission while acting new text end 12.11 new text begin within the scope of office or employment under this section. new text end 12.12     new text begin Subd. 12. new text end new text begin Discrimination prohibited. new text end new text begin (a) No school or landlord may refuse to new text end 12.13 new text begin enroll or lease to and may not otherwise penalize a person solely for the person's status as new text end 12.14 new text begin a patient enrolled in the registry program under this section, unless failing to do so would new text end 12.15 new text begin violate federal law or regulations or cause the school or landlord to lose a monetary or new text end 12.16 new text begin licensing-related benefit under federal law or regulations. new text end 12.17 new text begin (b) For the purposes of medical care, including organ transplants, a registry program new text end 12.18 new text begin enrollee's use of medical cannabis under this section is considered the equivalent of the new text end 12.19 new text begin authorized use of any other medication used at the discretion of a physician and does new text end 12.20 new text begin not constitute the use of an illicit substance or otherwise disqualify a qualifying patient new text end 12.21 new text begin from needed medical care. new text end 12.22 new text begin (c) Unless a failure to do so would violate federal law or regulations or cause an new text end 12.23 new text begin employer to lose a monetary or licensing-related benefit under federal law or regulations, new text end 12.24 new text begin an employer may not discriminate against a person in hiring, termination, or any term or new text end 12.25 new text begin condition of employment, or otherwise penalize a person, if the discrimination is based new text end 12.26 new text begin upon either of the following: new text end 12.27 new text begin (1) the person's status as a patient enrolled in the registry program under this section; new text end 12.28 new text begin or new text end 12.29 new text begin (2) a patient's positive drug test for cannabis components or metabolites, unless the new text end 12.30 new text begin patient used, possessed, or was impaired by medical cannabis on the premises of the place new text end 12.31 new text begin of employment or during the hours of employment. new text end 12.32 new text begin (d) A person shall not be denied custody of or visitation rights or parenting time new text end 12.33 new text begin with a minor solely for the person's status as a patient enrolled in the registry program new text end 12.34 new text begin under this section, and there shall be no presumption of neglect or child endangerment new text end 12.35 new text begin for conduct allowed under this section, unless the person's behavior is such that it creates new text end 13.1 new text begin an unreasonable danger to the safety of the minor as established by clear and convincing new text end 13.2 new text begin evidence. new text end 13.3     new text begin Subd. 13. new text end new text begin Fees; medical cannabis registry account. new text end new text begin (a) The commissioner shall new text end 13.4 new text begin collect an enrollment fee of $200 from qualified patients enrolled under this section. If the new text end 13.5 new text begin patient receives Social Security disability, Supplemental Security Insurance payments, or new text end 13.6 new text begin is enrolled in medical assistance or MinnesotaCare then the fee shall be $50. The fees new text end 13.7 new text begin shall be payable annually and are due on the anniversary date of the patient's enrollment. new text end 13.8 new text begin The fee amount shall be deposited in the medical cannabis registry account in the state new text end 13.9 new text begin treasury and credited to the state government special revenue fund. new text end 13.10 new text begin (b) The medical cannabis manufacturer may charge patients enrolled in the registry new text end 13.11 new text begin program a reasonable fee for costs associated with the operations of the manufacturer. new text end 13.12 new text begin The manufacturer may charge fees associated with the delivery of medical cannabis new text end 13.13 new text begin pursuant to subdivision 8, paragraph (i), but shall only charge the fee to those patients new text end 13.14 new text begin who received the delivery service. The manufacturer may establish a sliding scale of new text end 13.15 new text begin patient fees based upon a qualifying patient's household income and may accept private new text end 13.16 new text begin donations to reduce patient fees. new text end 13.17     new text begin Subd. 14. new text end new text begin Nursing facilities. new text end new text begin Nursing facilities licensed under chapter 144A, or new text end 13.18 new text begin boarding care homes licensed under section 144.50, may adopt reasonable restrictions on new text end 13.19 new text begin the use of medical cannabis by persons receiving services. The restrictions may include a new text end 13.20 new text begin provision that the facility will not store or maintain the patient's supply of medical cannabis, new text end 13.21 new text begin that the facility is not responsible for providing the medical cannabis for qualifying patients, new text end 13.22 new text begin and that medical cannabis be consumed only in a place specified by the facility. Nothing new text end 13.23 new text begin contained in this section shall require the facilities to adopt such restrictions, and no new text end 13.24 new text begin facility shall unreasonably limit a qualifying patient's access to or use of medical cannabis. new text end 13.25    Sec. 2. Minnesota Statutes 2012, section 256B.0625, subdivision 13d, is amended to 13.26read: 13.27    Subd. 13d. Drug formulary. (a) The commissioner shall establish a drug 13.28formulary. Its establishment and publication shall not be subject to the requirements of the 13.29Administrative Procedure Act, but the Formulary Committee shall review and comment 13.30on the formulary contents. 13.31    (b) The formulary shall not include: 13.32    (1) drugs, active pharmaceutical ingredients, or products for which there is no 13.33federal funding; 13.34    (2) over-the-counter drugs, except as provided in subdivision 13; 14.1    (3) drugs or active pharmaceutical ingredients used for weight loss, except that 14.2medically necessary lipase inhibitors may be covered for a recipient with type II diabetes; 14.3    (4) drugs or active pharmaceutical ingredients when used for the treatment of 14.4impotence or erectile dysfunction; 14.5    (5) drugs or active pharmaceutical ingredients for which medical value has not 14.6been established; and 14.7    (6) drugs from manufacturers who have not signed a rebate agreement with the 14.8Department of Health and Human Services pursuant to section 1927 of title XIX of the 14.9Social Security Act. new text begin ; and new text end 14.10 new text begin (7) medical cannabis as defined under section 152.22. new text end 14.11    (c) If a single-source drug used by at least two percent of the fee-for-service 14.12medical assistance recipients is removed from the formulary due to the failure of the 14.13manufacturer to sign a rebate agreement with the Department of Health and Human 14.14Services, the commissioner shall notify prescribing practitioners within 30 days of 14.15receiving notification from the Centers for Medicare and Medicaid Services (CMS) that a 14.16rebate agreement was not signed. 14.17    Sec. 3. new text begin [152.23] MEDICAL CANNABIS MANUFACTURER ACCOUNT. new text end 14.18     new text begin Subdivision 1. new text end new text begin Creation of account. new text end new text begin (a) A medical cannabis manufacturer account new text end 14.19 new text begin is created in the state government special revenue fund for the purpose of carrying out new text end 14.20 new text begin the commissioner's responsibilities associated with the regulation of medical cannabis new text end 14.21 new text begin manufacturers under section 152.22. new text end 14.22     new text begin (b) The account shall be kept in the state treasury and shall be paid out in the manner new text end 14.23 new text begin prescribed by law. new text end 14.24     new text begin (c) The account shall consist of the money paid by the medical cannabis new text end 14.25 new text begin manufacturer as provided in this section. Money in the account is appropriated to the new text end 14.26 new text begin commissioner of health for the purposes of this section. new text end 14.27     new text begin Subd. 2. new text end new text begin Medical cannabis manufacturer; fees and expenses. new text end new text begin When the new text end 14.28 new text begin commissioner of health audits, inspects, examines, or visits a medical cannabis new text end 14.29 new text begin manufacturer, the manufacturer of medical cannabis shall pay into the medical cannabis new text end 14.30 new text begin manufacturer account the per diem salaries and necessary expenses of the employees of the new text end 14.31 new text begin Department of Health who are conducting or participating in the examination, inspection, new text end 14.32 new text begin visit, or desk audit. The per diem salary fee shall be determined by the commissioner. new text end 14.33     new text begin Subd. 3. new text end new text begin Purposes for which the account may be spent. new text end new text begin The commissioner shall new text end 14.34 new text begin use the fund for the payment of per diem salaries and expenses of special examiners and new text end 14.35 new text begin appraisers, the expenses of the commissioner of health or designee, and employees of the new text end 15.1 new text begin department when actively participating in any visit, audit, inspection, or examination of new text end 15.2 new text begin the medical cannabis manufacturer. Expenses include meals, lodging, transportation, and new text end 15.3 new text begin mileage. new text end 15.4    Sec. 4. new text begin [152.24] IMPACT ASSESSMENT OF MEDICAL CANNABIS new text end 15.5 new text begin THERAPEUTIC RESEARCH. new text end 15.6     new text begin Subdivision 1. new text end new text begin Task force on medical cannabis therapeutic research. new text end new text begin (a) A new text end 15.7 new text begin 23-member task force on medical cannabis therapeutic research is created to conduct an new text end 15.8 new text begin impact assessment of medical cannabis therapeutic research. The task force shall consist new text end 15.9 new text begin of the following members: new text end 15.10     new text begin (1) two members of the house of representatives, one selected by the speaker of the new text end 15.11 new text begin house, the other selected by the minority leader; new text end 15.12     new text begin (2) two members of the senate, one selected by the majority leader, the other new text end 15.13 new text begin selected by the minority leader; new text end 15.14     new text begin (3) four members representing consumers or patients enrolled in the registry new text end 15.15 new text begin program, including at least two parents of patients under age 18; new text end 15.16     new text begin (4) four members representing health care providers, including one licensed new text end 15.17 new text begin pharmacist; new text end 15.18     new text begin (5) four members representing law enforcement, one from the Minnesota Chiefs of new text end 15.19 new text begin Police Association, one from the Minnesota Sheriff's Association, one from the Minnesota new text end 15.20 new text begin Police and Peace Officers Association, and one from the Minnesota County Attorneys new text end 15.21 new text begin Association; new text end 15.22     new text begin (6) four members representing substance use disorder treatment providers; and new text end 15.23     new text begin (7) the commissioners of health, human services, and public safety. new text end 15.24     new text begin (b) Task force members listed under paragraph (a), clauses (3), (4), (5), and (6), shall new text end 15.25 new text begin be appointed by the governor. Members shall serve on the task force at the pleasure of new text end 15.26 new text begin the appointing authority. new text end 15.27     new text begin (c) There shall be two cochairs of the task force chosen from the members listed new text end 15.28 new text begin under paragraph (a). One cochair shall be selected by the speaker of the house and new text end 15.29 new text begin the other cochair shall be selected by the majority leader of the senate. The expense new text end 15.30 new text begin reimbursement for members of the task force is governed by section 15.059. new text end 15.31     new text begin (d) Members of the task force other than those in paragraph (a), clauses (1), (2), and new text end 15.32 new text begin (7), shall receive expenses as provided in section 15.059, subdivision 6. new text end 15.33     new text begin Subd. 2. new text end new text begin Impact assessment. new text end new text begin The task force shall hold hearings to conduct new text end 15.34 new text begin an assessment that evaluates the impact of the use of medical cannabis and evaluate new text end 16.1 new text begin Minnesota's activities and other states' activities involving medical cannabis, and offer new text end 16.2 new text begin analysis of: new text end 16.3     new text begin (1) program design and implementation; new text end 16.4     new text begin (2) the impact on the health care provider community; new text end 16.5     new text begin (3) patient experiences; new text end 16.6     new text begin (4) the impact on the incidence of substance abuse; new text end 16.7     new text begin (5) access to and quality of medical products; new text end 16.8     new text begin (6) the impact on law enforcement and prosecutions; new text end 16.9     new text begin (7) public awareness and perception; and new text end 16.10     new text begin (8) any unintended consequences. new text end 16.11     new text begin Subd. 3. new text end new text begin Reports to the legislature. new text end new text begin (a) The cochairs shall submit the following new text end 16.12 new text begin reports to the chairs and ranking minority members of the legislative committees and new text end 16.13 new text begin divisions with jurisdiction over health and human services, public safety, judiciary, and new text end 16.14 new text begin civil law: new text end 16.15     new text begin (1) by February 1, 2015, a report on the design and implementation of the registry new text end 16.16 new text begin program; and new text end 16.17     new text begin (2) every two years thereafter, a complete report on the impact assessment. new text end 16.18     new text begin (b) The task force may make recommendations to the legislature on whether to add new text end 16.19 new text begin or remove conditions from the list of qualifying medical conditions. new text end 16.20     new text begin Subd. 4. new text end new text begin Expiration. new text end new text begin The task force on medical cannabis therapeutic research new text end 16.21 new text begin does not expire. new text end 16.22    Sec. 5. new text begin APPROPRIATIONS, MEDICAL CANNABIS RESEARCH. new text end 16.23     new text begin Subdivision 1. new text end new text begin Health Department. new text end new text begin $2,795,000 is appropriated in fiscal year new text end 16.24 new text begin 2015 from the general fund to the commissioner of health for implementing the medical new text end 16.25 new text begin cannabis therapeutic research study in this act. The base for this appropriation is $829,000 new text end 16.26 new text begin in fiscal year 2016 and $728,000 in fiscal year 2017. new text end 16.27     new text begin Subd. 2. new text end new text begin Legislative Coordinating Commission. new text end new text begin $24,000 is appropriated in new text end 16.28 new text begin fiscal year 2015 from the general fund to the Legislative Coordinating Commission to new text end 16.29 new text begin administer the task force on medical cannabis therapeutic research and for the task force to new text end 16.30 new text begin conduct the impact assessment on the use of cannabis for medicinal purposes. new text end 16.31     new text begin Subd. 3. new text end new text begin Health Department base. new text end new text begin The base appropriation for the commissioner new text end 16.32 new text begin of health from the state government special revenue fund is increased by $631,000 in new text end 16.33 new text begin fiscal year 2016 and fiscal year 2017 for costs associated with operations of the medical new text end 16.34 new text begin cannabis manufacturers under Minnesota Statutes, section 152.22, subdivision 13. new text end 17.1    Sec. 6. new text begin EFFECTIVE DATE. new text end 17.2 new text begin Sections 1 to 5 are effective July 1, 2014. new text end