relating to health; providing for medical cannabis therapeutic research study;
creating account; providing appointments; requiring rulemaking; requiring
reports; appropriating money;amending Minnesota Statutes 2012, section
256B.0625, subdivision 13d; proposing coding for new law in Minnesota
Statutes, chapter 152.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1. [152.22] MEDICAL CANNABIS THERAPEUTIC RESEARCH
1.10 Subdivision 1. Definitions. (a) For purposes of this section, the following terms
1.11have the meanings given.
1.12(b) "Commissioner" means the commissioner of health.
1.13(c) "Health care practitioner" means a Minnesota licensed doctor of medicine, a
1.14Minnesota licensed physician assistant acting within the scope of authorized practice, or a
1.15Minnesota licensed advanced practice registered nurse, who has the primary responsibility
1.16for the care and treatment of a person diagnosed with a qualifying medical condition
1.17under this section.
1.18(d) "Health records" means health record as defined in section 144.291.
1.19(e) "Medical cannabis" means the flowers of any species of the genus cannabis plant,
1.20or any mixture or preparation of them, including extracts and resins which contain a
1.21chemical composition determined to likely be medically beneficial by the commissioner,
1.22and that is delivered in the form of:
1.23(1) liquid, including, but not limited to, oil;
2.1(3) vaporized delivery method with use of liquid or oil but which does not require
2.2the use of dried leaves or plant form; or
2.3(4) any other method approved by the commissioner but which shall not include
2.5(f) "Medical cannabis manufacturer" or "manufacturer" means an entity registered
2.6by the commissioner to cultivate, acquire, manufacture, possess, prepare, transfer,
2.7transport, supply, or dispense medical cannabis, delivery devices, or related supplies and
2.8educational materials to patients with a qualifying medical condition who are enrolled
2.9in the registry program.
2.10(g) "Medical cannabis product" means medical cannabis as defined in paragraph
2.11(e) and any delivery device or related supplies and educational materials used in the
2.12administration of medical cannabis for a patient with a qualifying medical condition
2.13enrolled in the registry program.
2.14(h) "Patient" means a Minnesota resident who has been diagnosed by a health care
2.15practitioner with a qualifying medical condition and who has otherwise met any other
2.16requirements of patients under this section to participate in the registry program.
2.17(i) "Patient registry number" means a unique identification number assigned to a
2.18patient by the commissioner after the commissioner has enrolled the patient in the registry
2.20(j) "Registered designated caregiver" means a person who is at least 21 years old and
2.21who has been approved by the commissioner to assist a patient who has been identified
2.22by a health care provider as developmentally or physically disabled and therefore unable
2.23to self-administer medication, and who is authorized by the commissioner to administer
2.24medical cannabis to the patient only within the patient's primary place of residence;
2.25(k) "Registry program" means the patient registry established under this section.
2.26(l) "Registry verification" means the verification provided by the commissioner that
2.27a patient is enrolled in the registry program and that includes the patient's name, patient
2.28registry number, qualifying medical condition, and, if applicable, the name of the patient's
2.29registered designated caregiver or parent or legal guardian.
2.30(m) "Qualifying medical condition" means a diagnosis of the following conditions:
2.33(3) human immunodeficiency virus or acquired immune deficiency syndrome;
2.34(4) Tourette's syndrome;
2.35(5) amyotrophic lateral sclerosis;
2.36(6) seizures, including those characteristic of epilepsy;
3.1(7) severe and persistent muscle spasms, including those characteristic of multiple
3.3(8) Crohn's disease; or
3.4(9) any other medical condition or its treatment approved by the commissioner.
3.5 Subd. 2. Limitations. This section does not permit any person to engage in and
3.6does not prevent the imposition of any civil, criminal, or other penalties for:
3.7(1) undertaking any task under the influence of medical cannabis that would
3.8constitute negligence or professional malpractice;
3.9(2) possessing or engaging in the use of medical cannabis on:
3.10(i) a school bus;
3.11(ii) on the grounds of any preschool or primary or secondary school; or
3.12(iii) in any correctional facility;
3.13(3) vaporizing medical cannabis pursuant to subdivision 1, paragraph (e):
3.14(i) on any form of public transportation;
3.15(ii) where the vapor would be inhaled by a minor child; or
3.16(iii) in any public place; and
3.17(4) operating, navigating, or being in actual physical control of any motor vehicle,
3.18aircraft, train, or motorboat, or working on transportation property, equipment, or facilities
3.19while under the influence of medical cannabis.
3.20 Subd. 3. Federally approved clinical trials. The commissioner may prohibit
3.21enrollment of a patient in the registry program if the patient is simultaneously enrolled in a
3.22federally approved clinical trial for the treatment of a qualifying medical condition with
3.23medical cannabis. The commissioner shall provide information to all patients enrolled in
3.24the registry program on the existence of federally approved clinical trials for the treatment
3.25of the patient's qualifying medical condition with medical cannabis, as an alternative to
3.26enrollment in the patient registry program.
3.27 Subd. 4. Commissioner duties. (a) The commissioner shall register one in-state
3.28manufacturer for the production of all medical cannabis products within the state by
3.29December 1, 2014, unless the commissioner obtains an adequate supply of federally
3.30sourced medical cannabis products by August 1, 2014. The commissioner shall require
3.31any manufacturer application for registration to pay a fee of $20,000. If a manufacturer is
3.32not selected for registration, the commissioner shall refund $19,000 to that manufacturer.
3.33The commissioner shall continue to accept applications after December 1, 2014, if no
3.34manufacturer that meets the qualifications set forth in this subdivision applies prior to
3.35December 1, 2014. The commissioner's determination that no manufacturer exists to fulfill
4.1the duties under this section is subject to judicial review. As a condition for registration,
4.2the commissioner shall require the manufacturer to:
4.3(1) supply medical cannabis products to patients by July 1, 2015; and
4.4(2) comply with all requirements under subdivision 8.
4.5(b) The commissioner shall consider the following factors when determining which
4.6manufacturer to register:
4.7(1) the technical expertise of the manufacturer in cultivating medical cannabis and
4.8converting the medical cannabis into an acceptable delivery method under subdivision 1,
4.10(2) the qualifications of the manufacturer's employees;
4.11(3) the long-term financial stability of the manufacturer;
4.12(4) the ability to provide appropriate security measures on the premises of the
4.14(5) whether the manufacturer has demonstrated an ability to meet the medical
4.15cannabis production needs required by this section; and
4.16(6) the manufacturer's projection and ongoing assessment of fee levels on patients
4.17with a qualifying condition.
4.18(c) The commissioner shall require the medical cannabis manufacturer to contract
4.19with an independent laboratory to test all medical cannabis produced by the manufacturer.
4.20The commissioner shall approve the laboratory chosen by the manufacturer and require
4.21that the laboratory report testing results to the manufacturer in a manner determined by
4.23(d) The commissioner shall make an initial determination by December 1, 2014,
4.24after reviewing medical and scientific literature, of the range of chemical compositions
4.25of any plant of the genus cannabis that will likely be medically beneficial for each of
4.26the qualifying medical conditions, including a range of recommended doses for each
4.27condition. Once determined, the commissioner shall provide a listing of the range of
4.28chemical compositions and range of dosages to the manufacturer and publish the listing on
4.29the department Web site.
4.30(e) The commissioner shall adopt rules necessary for the manufacturer to begin
4.31distribution of medical cannabis products to patients under the registry program by July 1,
4.322015, and have notice of proposed rules published in the State Register prior to January
4.34(f) The commissioner shall, within 30 days of a deadline listed in this section, advise
4.35the public and the co-chairs of the task force on medical cannabis therapeutic research if
4.36the commissioner is unable to complete any requirements under this section by the deadline
5.1listed in this section. The commissioner shall provide a written statement as to the reason or
5.2reasons the deadline will not be met. Upon request of the commissioner, the task force shall
5.3extend any deadline by six months, but may not extend any deadline more than three times.
5.4 Subd. 5. Rulemaking. The commissioner shall adopt rules to implement this
5.5section. Rules for which notice is published in the State Register before January 1, 2015
5.6may be adopted using the process in section 14.389.
5.7 Subd. 6. Patient registry program established. (a) The commissioner of health
5.8shall establish a patient registry program to evaluate data on patient demographics,
5.9effective treatment options, clinical outcomes, and quality-of-life outcomes for the
5.10purpose of making clinically significant findings regarding patients with a qualifying
5.11medical condition engaged in the therapeutic use of medical cannabis.
5.12(b) The commissioner shall:
5.13(1) give notice of the program to health care practitioners in the state who are
5.14eligible to serve as a health care practitioner as defined in subdivision 1, paragraph (c),
5.15and explain the purposes and requirements of the program;
5.16(2) allow each health care practitioner in the state who meets or agrees to meet the
5.17program's requirements and who requests to participate, to be included in the registry
5.18program to collect data for the patient registry;
5.19(3) provide explanatory information and assistance to each health care practitioner
5.20in understanding the nature of therapeutic use of medical cannabis within program
5.22(4) create and provide a written certification to be used by a health practitioner for
5.23the practitioner to certify whether a patient has been diagnosed with a qualifying medical
5.24condition and include in the certification an option for the practitioner to certify whether the
5.25patient, in the health care practitioner's medical opinion, is mentally or physically disabled
5.26and, as a result of that disability, the patient is unable to self-administer medication;
5.27(5) supervise the participation of the health care practitioner in conducting patient
5.28treatment and health records reporting in a manner that ensures stringent security and
5.29record-keeping requirements and that prevents the unauthorized release of private data on
5.30individuals as defined by section 13.02;
5.31(6) develop safety criteria for patients with a qualifying condition as a requirement of
5.32the patient's participation in the program, to prevent the patient from undertaking any task
5.33under the influence of medical cannabis that would constitute negligence or professional
5.34malpractice on the part of the patient; and
5.35(7) conduct research and studies based on data from health records submitted to
5.36the registry program and submit reports on intermediate or final research results to the
6.1legislature and major scientific journals. The commissioner may contract with a third
6.2party to complete the requirements of this clause.
6.3(c) The commissioner shall develop a patient application for enrollment into the
6.4registry program. The application shall be available to the patient and given to health care
6.5practitioners in the state who are eligible to serve as a health care practitioner as defined
6.6under subdivision 1, paragraph (c). The application must include:
6.7(1) the name, mailing address, and date of birth of the qualifying patient;
6.8(2) the name, mailing address, and telephone number of the qualifying patient's
6.9health care practitioner;
6.10(3) the name, mailing address, and date of birth of the patient's designated caregiver,
6.11if any, or, if the patient is under age 18, the patient's parent or legal guardian;
6.12(4) a copy of the written certification from the patient's health care practitioner that is
6.13dated within 90 days prior to submitting the application which certifies that the patient has
6.14been diagnosed with a qualifying medical condition and, if applicable, that, in the health
6.15care practitioner's medical opinion, the patient is mentally or physically disabled and, as a
6.16result of that disability, the patient is unable to self-administer medication; and
6.17(5) all other signed affidavits and enrollment forms required by the commissioner
6.18under this section, including, but not limited to, the disclosure under paragraph (e).
6.19(d) The commissioner shall register a single designated caregiver for a patient if the
6.20patient's health care provider certified that the patient, in the health care practitioner's
6.21medical opinion, is developmentally or physically disabled and, as a result of that
6.22disability, the patient is unable to self-administer medication and the caregiver has agreed,
6.23in writing, to be a patient's designated caregiver. As a condition of registration as a
6.24designated caregiver, the commissioner shall require the person:
6.25(1) to be at least 21 years of age;
6.26(2) to not already be registered as a caregiver for another patient enrolled in the
6.28(3) to agree to only possess any medical cannabis product for purposes of
6.29administration of the medical cannabis to the patient within the patient's primary place of
6.31(4) to agree that if the application is approved, the person will not be a registered
6.32designated caregiver for more than one patient.
6.33(e) The commissioner shall develop a disclosure form and require, as a condition of
6.34enrollment, all patients to sign a copy of the disclosure. The disclosure must include:
6.35(1) a statement that notwithstanding any law to the contrary, the commissioner of
6.36health, or an employee of any state agency, may not be held civilly or criminally liable for
7.1any injury, loss of property, personal injury, or death caused by any act or omission while
7.2acting within the scope of office or employment under this section; and
7.3(2) the patient's acknowledgement that enrollment in the patient registry program is
7.4conditional on the patient's agreement to meet all of the requirements of subdivision 9;
7.5(f) After receipt of a patient's application and signed disclosure, the commissioner
7.6shall enroll the patient in the registry program and assign the patient a patient registry
7.7number. A patient's enrollment in the registry program shall only be denied if the patient:
7.8(1) does not have written certification from a health care provider that the patient
7.9has been diagnosed with a qualifying medical condition;
7.10(2) has not signed and returned the disclosure form required under paragraph (d) to
7.12(3) does not provide the information required;
7.13(4) has previously been removed from the registry program for violations of
7.14subdivision 9; or
7.15(5) provides false information.
7.16(g) The commissioner shall give written notice to a patient of the reason for denying
7.17enrollment in the registry program.
7.18(h) Denial of enrollment into the registry program is considered a final decision of
7.19the commissioner and is subject to judicial review.
7.20(i) A patient's enrollment in the registry program may only be revoked if a patient
7.21violates a requirement in subdivision 9.
7.22(j) The commissioner shall develop a registry verification to provide to the health
7.23care practitioner identified in the patient's application and to the manufacturer. The
7.24registry verification shall include:
7.25(1) the patient's name and date of birth;
7.26(2) the patient registry number assigned to the patient;
7.27(3) the patient's qualifying medical condition as provided by the patient's health care
7.28provider in the written certification; and
7.29(4) the name and date of birth of the patient's registered designated caregiver, if any,
7.30or, if the patient is under age 18, the name of the patient's parent or legal guardian.
7.31(k) If the commissioner adds a delivery form under subdivision 1, paragraph (e), or a
7.32qualifying medical condition under subdivision 1, paragraph (m), the commissioner shall
7.33notify the legislature by January 15 of any year in which the commissioner wishes to make
7.34the change. The change shall be effective on August 1 of that year, unless the legislature
7.35by law provides otherwise. As part of the January submission, the commissioner shall
7.36notify the chairs and ranking minority members of the legislative policy committees
8.1having jurisdiction over health and public safety of the addition and the reasons for its
8.2addition, including any written comments received by the commissioner from the public
8.3and any guidance received from the task force on medical cannabis research.
8.4(l) Nothing in this section requires the medical assistance and MinnesotaCare
8.5programs to reimburse an enrollee or a provider for costs associated with the medical use
8.6of cannabis. Medical assistance and MinnesotaCare shall continue to reimburse providers
8.7for covered services related to treatment of a recipient's qualifying medical condition.
8.8(m) The establishment of the registry program is not intended in any manner
8.9whatsoever to condone or promote the illicit recreational use of marijuana.
8.10 Subd. 7. Health care practitioner duties. (a) Prior to a patient's enrollment in the
8.11registry program, a health care practitioner shall:
8.12(1) determine, in the health care practitioner's medical judgment, whether a patient
8.13suffers from a qualifying medical condition as defined in subdivision 1, paragraph (m),
8.14and if so determined, provide the patient with a written certification of that diagnosis;
8.15(2) determine whether a patient is developmentally or physically disabled and, as
8.16a result of that disability, the patient is unable to self-administer medication, and, if so
8.17determined, include that determination on the patient's written certification of diagnosis;
8.18(3) advise patients, registered designated caregivers, and parents or legal guardians
8.19of patients under age 18 of the existence of any nonprofit patient support groups or
8.21(4) provide explanatory information from the commissioner to patients with
8.22qualifying medical conditions, including disclosure to all patients about the experimental
8.23nature of therapeutic use of medical cannabis, the possible risks and side effects of the
8.24proposed treatment, the application and other materials from the commissioner, and provide
8.25patients with the Tennessen warning as required by section 13.04, subdivision 2; and
8.26(5) agree to continue treatment of the patient's qualifying medical condition and
8.27report medical findings to the commissioner.
8.28(b) Upon notification from the commissioner of the patient's enrollment in the
8.29registry program, the health care practitioner shall:
8.30(1) participate in the patient registry reporting system under the guidance and
8.31supervision of the commissioner of health;
8.32(2) report health records of the patient throughout the ongoing treatment of the
8.33patient to the commissioner in a manner determined by the commissioner of health and in
8.34accordance with paragraph (c); and
8.35(3) otherwise comply with all requirements developed by the commissioner.
9.1(c) Data collected on patients by a health care practitioner and reported to the patient
9.2registry are health records under section 144.291 and are private data on individuals under
9.3section 13.02 but may be used or reported in an aggregated, nonidentifiable form as part of
9.4a scientific, peer-reviewed publication of research conducted under this section.
9.5 Subd. 8. Manufacturer of medical cannabis duties. (a) The manufacturer of
9.6medical cannabis shall provide a reliable and ongoing supply of all medical cannabis
9.7products needed for the registry program.
9.8(b) All cultivation, harvesting, manufacturing, and packing of cannabis must take
9.9place in an enclosed, locked facility at a physical address provided to the commissioner
9.10during the registration process.
9.11(c) The medical cannabis manufacturer shall produce medical cannabis with
9.12chemical compositions as determined by the commissioner.
9.13(d) The medical cannabis manufacturer shall contract with a laboratory, subject to
9.14the commissioner's approval of the laboratory and any additional requirements set by the
9.15commissioner, for purposes of testing all medical cannabis manufactured by the medical
9.16cannabis manufacturer as to content, contamination, and consistency to verify the medical
9.17cannabis meets the requirements of subdivision 1, paragraph (e).
9.18(e) The manufacturer must process and prepare any cannabis plant material into a
9.19form allowable under subdivision 1, paragraph (e), prior to distribution of any medical
9.21(f) The manufacturer shall require that any employee licensed as a pharmacist
9.22pursuant to chapter 151 and the rules promulgated pursuant to that chapter be the only
9.23employees to distribute the medical cannabis to a patient.
9.24(g) The manufacturer shall only distribute medical cannabis products to the patient
9.25or, if the patient is under age 18, to the patient's parent or legal guardian.
9.26(h) Prior to distribution of any medical cannabis products to any patient or, if the
9.27patient is under age 18, the patient's parent of legal guardian, the manufacturer shall:
9.28(1) verify that the manufacturer has received the registry verification from the
9.29commissioner for that individual patient;
9.30(2) verify that the person requesting the distribution of medical cannabis is the
9.31patient, or, if the patient is under age 18, the patient's parent or legal guardian, listed in the
9.32registry verification, in accordance with section 152.11, subdivision 2d;
9.33(3) assign a tracking number to each individual medical cannabis product;
9.34(4) ensure that any employee of the manufacturer licensed by a pharmacist pursuant
9.35to chapter 151 and the rules promulgated pursuant to that chapter has consulted with
9.36the patient to determine the proper dosage for the individual patient based on the
10.1recommendations of the range of chemical compositions of the medical cannabis and the
10.2range of proper dosages provided by the commissioner;
10.3(5) properly label each medical cannabis product with individually identifying
10.5(i) the patient's name and date of birth;
10.6(ii) the name and date of birth of the patient's registered designated caregiver, or,
10.7if the patient is under age 18, the name of the patient's parent or legal guardian, if either
10.8were included on the registry verification;
10.9(iii) the patient's registry number;
10.10(iv) the chemical composition of the medical cannabis; and
10.11(v) the dosage; and
10.12(6) ensure that the medical cannabis distributed to a patient contains a maximum of a
10.1330-day supply of the dosage determined for that patient.
10.14(i) If the patient has a registered designated caregiver, the manufacturer shall deliver
10.15properly labeled medical cannabis products to the patient or the patient's registered
10.16designated caregiver but only at the patient's primary residence. The manufacturer shall
10.17verify that the person to whom the medical cannabis product is being delivered is either
10.18the patient or the patient's registered designated caregiver, in accordance with section
10.19152.11, subdivision 2d. The manufacturer shall not distribute medical cannabis products
10.20to a registered designated caregiver at the premises of the manufacturer.
10.21(j) The manufacturer shall report to the commissioner, on a monthly basis, the
10.22following information on each individual patient from the month prior to the report:
10.23(1) the amount and dosages of medical cannabis products distributed;
10.24(2) the chemical composition of the medical cannabis; and
10.25(3) the tracking number assigned to any medical cannabis product distributed.
10.26(k) The operating documents of the manufacturer must include:
10.27(1) procedures for the oversight of the manufacturer and procedures to ensure
10.28accurate record keeping; and
10.29(2) procedures for the implementation of appropriate security measures to deter and
10.30prevent the theft of cannabis and unauthorized entrance into areas containing cannabis.
10.31(l) The manufacturer shall not share office space with, refer patients to a health care
10.32practitioner, or have any financial relationship with a health care practitioner.
10.33(m) The manufacturer shall not permit any person to consume cannabis on the
10.34property of the manufacturer.
10.35(n) The manufacturer is subject to reasonable inspection by the commissioner.
11.1(o) For purposes of this section only, the medical cannabis manufacturer is not
11.2subject to the Board of Pharmacy licensure or regulatory requirements under chapter 151.
11.3 Subd. 9. Patient duties. (a) A patient shall apply to the commissioner for enrollment
11.4in the registry program by submitting an application, as defined in subdivision 6, paragraph
11.5(c), and an annual registration fee as determined under subdivision 13, paragraph (a).
11.6(b) As a condition of continued enrollment, a patient shall agree to:
11.7(1) continue to receive regularly scheduled treatment for their qualifying medical
11.8condition from their health care practitioner; and
11.9(2) report changes in their qualifying medical condition to their health care
11.11 Subd. 10. Confidentiality. (a) Data in patient files with both the commissioner and
11.12the health care practitioner, and data submitted to or by the medical cannabis manufacturer,
11.13are private data on individuals or nonpublic data as defined in section 13.02.
11.14(b) Data kept or maintained by the commissioner may not be used for any purpose
11.15not provided for in this section and may not be combined or linked in any manner with
11.16any other list or database.
11.17 Subd. 11. Protections for registry program participation; criminal and civil. (a)
11.18There is a presumption that a patient enrolled in the registry program under this section is
11.19engaged in the authorized use of medical cannabis.
11.20(b) The presumption may be rebutted by evidence that conduct related to use of
11.21medical cannabis was not for the purpose of treating or alleviating the patient's qualifying
11.22medical condition or symptoms associated with the patient's qualifying medical condition
11.23pursuant to this section.
11.24(c) For the purposes of this section only, the following are not violations under
11.26(1) use or possession of medical cannabis products by a patient enrolled in the
11.27registry program, or possession by the parent or guardian of a patient under age 18;
11.28(2) possession of medical cannabis products by a registered designated caregiver,
11.29only if the registered designated caregiver is in possession of the medical cannabis
11.30products within the primary residence of the individual patient in which the caregiver has
11.31been registered to assist;
11.32(3) possession, dosage determination, or sale of medical cannabis by the medical
11.33cannabis manufacturer or employees of the manufacturer; and
11.34(4) possession of medical cannabis products by any person while carrying out the
11.35duties required under this section.
12.1(d) Medical cannabis obtained and distributed pursuant to this section and associated
12.2property is not subject to forfeiture under sections 609.531 to 609.5316.
12.3(e) The commissioner, the commissioner's staff, and any health care practitioner are
12.4not subject to any civil or disciplinary penalties by the Board of Medical Practice or by any
12.5business, occupational, or professional licensing board or entity, solely for the participation
12.6in the registry program under this section. Nothing in this section prohibits a professional
12.7licensing board for sanctioning actions outside of those actions allowed under this section.
12.8(f) Notwithstanding any law to the contrary, the commissioner of health, or an
12.9employee of any state agency, may not be held civilly or criminally liable for any injury,
12.10loss of property, personal injury, or death caused by any act or omission while acting
12.11within the scope of office or employment under this section.
12.12 Subd. 12. Discrimination prohibited. (a) No school or landlord may refuse to
12.13enroll or lease to and may not otherwise penalize a person solely for the person's status as
12.14a patient enrolled in the registry program under this section, unless failing to do so would
12.15violate federal law or regulations or cause the school or landlord to lose a monetary or
12.16licensing-related benefit under federal law or regulations.
12.17(b) For the purposes of medical care, including organ transplants, a registry program
12.18enrollee's use of medical cannabis under this section is considered the equivalent of the
12.19authorized use of any other medication used at the discretion of a physician and does
12.20not constitute the use of an illicit substance or otherwise disqualify a qualifying patient
12.21from needed medical care.
12.22(c) Unless a failure to do so would violate federal law or regulations or cause an
12.23employer to lose a monetary or licensing-related benefit under federal law or regulations,
12.24an employer may not discriminate against a person in hiring, termination, or any term or
12.25condition of employment, or otherwise penalize a person, if the discrimination is based
12.26upon either of the following:
12.27(1) the person's status as a patient enrolled in the registry program under this section;
12.29(2) a patient's positive drug test for cannabis components or metabolites, unless the
12.30patient used, possessed, or was impaired by medical cannabis on the premises of the place
12.31of employment or during the hours of employment.
12.32(d) A person shall not be denied custody of or visitation rights or parenting time
12.33with a minor solely for the person's status as a patient enrolled in the registry program
12.34under this section, and there shall be no presumption of neglect or child endangerment
12.35for conduct allowed under this section, unless the person's behavior is such that it creates
13.1an unreasonable danger to the safety of the minor as established by clear and convincing
13.3 Subd. 13. Fees; medical cannabis registry account. (a) The commissioner shall
13.4collect an enrollment fee of $200 from qualified patients enrolled under this section. If the
13.5patient receives Social Security disability, Supplemental Security Insurance payments, or
13.6is enrolled in medical assistance or MinnesotaCare then the fee shall be $50. The fees
13.7shall be payable annually and are due on the anniversary date of the patient's enrollment.
13.8The fee amount shall be deposited in the medical cannabis registry account in the state
13.9treasury and credited to the state government special revenue fund.
13.10(b) The medical cannabis manufacturer may charge patients enrolled in the registry
13.11program a reasonable fee for costs associated with the operations of the manufacturer.
13.12The manufacturer may charge fees associated with the delivery of medical cannabis
13.13pursuant to subdivision 8, paragraph (i), but shall only charge the fee to those patients
13.14who received the delivery service. The manufacturer may establish a sliding scale of
13.15patient fees based upon a qualifying patient's household income and may accept private
13.16donations to reduce patient fees.
13.17 Subd. 14. Nursing facilities. Nursing facilities licensed under chapter 144A, or
13.18boarding care homes licensed under section 144.50, may adopt reasonable restrictions on
13.19the use of medical cannabis by persons receiving services. The restrictions may include a
13.20provision that the facility will not store or maintain the patient's supply of medical cannabis,
13.21that the facility is not responsible for providing the medical cannabis for qualifying patients,
13.22and that medical cannabis be consumed only in a place specified by the facility. Nothing
13.23contained in this section shall require the facilities to adopt such restrictions, and no
13.24facility shall unreasonably limit a qualifying patient's access to or use of medical cannabis.
Sec. 2. Minnesota Statutes 2012, section 256B.0625, subdivision 13d, is amended to
Subd. 13d. Drug formulary.
(a) The commissioner shall establish a drug
formulary. Its establishment and publication shall not be subject to the requirements of the
Administrative Procedure Act, but the Formulary Committee shall review and comment
on the formulary contents.
(b) The formulary shall not include:
(1) drugs, active pharmaceutical ingredients, or products for which there is no
(2) over-the-counter drugs, except as provided in subdivision 13;
(3) drugs or active pharmaceutical ingredients used for weight loss, except that
medically necessary lipase inhibitors may be covered for a recipient with type II diabetes;
(4) drugs or active pharmaceutical ingredients when used for the treatment of
impotence or erectile dysfunction;
(5) drugs or active pharmaceutical ingredients for which medical value has not
(6) drugs from manufacturers who have not signed a rebate agreement with the
Department of Health and Human Services pursuant to section 1927 of title XIX of the
Social Security Act
14.10(7) medical cannabis as defined under section 152.22.
(c) If a single-source drug used by at least two percent of the fee-for-service
medical assistance recipients is removed from the formulary due to the failure of the
manufacturer to sign a rebate agreement with the Department of Health and Human
Services, the commissioner shall notify prescribing practitioners within 30 days of
receiving notification from the Centers for Medicare and Medicaid Services (CMS) that a
rebate agreement was not signed.
Sec. 3. [152.23] MEDICAL CANNABIS MANUFACTURER ACCOUNT.
14.18 Subdivision 1. Creation of account. (a) A medical cannabis manufacturer account
14.19is created in the state government special revenue fund for the purpose of carrying out
14.20the commissioner's responsibilities associated with the regulation of medical cannabis
14.21manufacturers under section 152.22.
14.22 (b) The account shall be kept in the state treasury and shall be paid out in the manner
14.23prescribed by law.
14.24 (c) The account shall consist of the money paid by the medical cannabis
14.25manufacturer as provided in this section. Money in the account is appropriated to the
14.26commissioner of health for the purposes of this section.
14.27 Subd. 2. Medical cannabis manufacturer; fees and expenses. When the
14.28commissioner of health audits, inspects, examines, or visits a medical cannabis
14.29manufacturer, the manufacturer of medical cannabis shall pay into the medical cannabis
14.30manufacturer account the per diem salaries and necessary expenses of the employees of the
14.31Department of Health who are conducting or participating in the examination, inspection,
14.32visit, or desk audit. The per diem salary fee shall be determined by the commissioner.
14.33 Subd. 3. Purposes for which the account may be spent. The commissioner shall
14.34use the fund for the payment of per diem salaries and expenses of special examiners and
14.35appraisers, the expenses of the commissioner of health or designee, and employees of the
15.1department when actively participating in any visit, audit, inspection, or examination of
15.2the medical cannabis manufacturer. Expenses include meals, lodging, transportation, and
Sec. 4. [152.24] IMPACT ASSESSMENT OF MEDICAL CANNABIS
15.6 Subdivision 1. Task force on medical cannabis therapeutic research. (a) A
15.723-member task force on medical cannabis therapeutic research is created to conduct an
15.8impact assessment of medical cannabis therapeutic research. The task force shall consist
15.9of the following members:
15.10 (1) two members of the house of representatives, one selected by the speaker of the
15.11house, the other selected by the minority leader;
15.12 (2) two members of the senate, one selected by the majority leader, the other
15.13selected by the minority leader;
15.14 (3) four members representing consumers or patients enrolled in the registry
15.15program, including at least two parents of patients under age 18;
15.16 (4) four members representing health care providers, including one licensed
15.18 (5) four members representing law enforcement, one from the Minnesota Chiefs of
15.19Police Association, one from the Minnesota Sheriff's Association, one from the Minnesota
15.20Police and Peace Officers Association, and one from the Minnesota County Attorneys
15.22 (6) four members representing substance use disorder treatment providers; and
15.23 (7) the commissioners of health, human services, and public safety.
15.24 (b) Task force members listed under paragraph (a), clauses (3), (4), (5), and (6), shall
15.25be appointed by the governor. Members shall serve on the task force at the pleasure of
15.26the appointing authority.
15.27 (c) There shall be two cochairs of the task force chosen from the members listed
15.28under paragraph (a). One cochair shall be selected by the speaker of the house and
15.29the other cochair shall be selected by the majority leader of the senate. The expense
15.30reimbursement for members of the task force is governed by section 15.059.
15.31 (d) Members of the task force other than those in paragraph (a), clauses (1), (2), and
15.32(7), shall receive expenses as provided in section 15.059, subdivision 6.
15.33 Subd. 2. Impact assessment. The task force shall hold hearings to conduct
15.34an assessment that evaluates the impact of the use of medical cannabis and evaluate
16.1Minnesota's activities and other states' activities involving medical cannabis, and offer
16.3 (1) program design and implementation;
16.4 (2) the impact on the health care provider community;
16.5 (3) patient experiences;
16.6 (4) the impact on the incidence of substance abuse;
16.7 (5) access to and quality of medical products;
16.8 (6) the impact on law enforcement and prosecutions;
16.9 (7) public awareness and perception; and
16.10 (8) any unintended consequences.
16.11 Subd. 3. Reports to the legislature. (a) The cochairs shall submit the following
16.12reports to the chairs and ranking minority members of the legislative committees and
16.13divisions with jurisdiction over health and human services, public safety, judiciary, and
16.15 (1) by February 1, 2015, a report on the design and implementation of the registry
16.17 (2) every two years thereafter, a complete report on the impact assessment.
16.18 (b) The task force may make recommendations to the legislature on whether to add
16.19or remove conditions from the list of qualifying medical conditions.
16.20 Subd. 4. Expiration. The task force on medical cannabis therapeutic research
16.21does not expire.
Sec. 5. APPROPRIATIONS, MEDICAL CANNABIS RESEARCH.
16.23 Subdivision 1. Health Department. $2,795,000 is appropriated in fiscal year
16.242015 from the general fund to the commissioner of health for implementing the medical
16.25cannabis therapeutic research study in this act. The base for this appropriation is $829,000
16.26in fiscal year 2016 and $728,000 in fiscal year 2017.
16.27 Subd. 2. Legislative Coordinating Commission. $24,000 is appropriated in
16.28fiscal year 2015 from the general fund to the Legislative Coordinating Commission to
16.29administer the task force on medical cannabis therapeutic research and for the task force to
16.30conduct the impact assessment on the use of cannabis for medicinal purposes.
16.31 Subd. 3. Health Department base. The base appropriation for the commissioner
16.32of health from the state government special revenue fund is increased by $631,000 in
16.33fiscal year 2016 and fiscal year 2017 for costs associated with operations of the medical
16.34cannabis manufacturers under Minnesota Statutes, section 152.22, subdivision 13.
Sec. 6. EFFECTIVE DATE.
17.2Sections 1 to 5 are effective July 1, 2014.