Senate Study Bill 3136 - Introduced SENATE FILE _____ BY (PROPOSED COMMITTEE ON JUDICIARY BILL BY CHAIRPERSON ZAUN) A BILL FOR An Act relating to the medical cannabidiol Act, and including 1 transition provisions. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 5644XC (9) 88 ss/rh
S.F. _____ Section 1. Section 124E.2, subsection 2, paragraph i, Code 1 2020, is amended to read as follows: 2 i. Untreatable Severe or chronic pain. 3 Sec. 2. Section 124E.2, subsection 2, Code 2020, is amended 4 by adding the following new paragraphs: 5 NEW PARAGRAPH . j. Autism. 6 NEW PARAGRAPH . k. Post-traumatic stress disorder. 7 Sec. 3. Section 124E.2, subsections 5 and 6, Code 2020, are 8 amended to read as follows: 9 5. “Health care practitioner” means an individual licensed 10 under chapter 148 to practice medicine and surgery or 11 osteopathic medicine and surgery , a physician assistant 12 licensed under chapter 148C, a podiatrist licensed under 13 chapter 149, an advanced registered nurse practitioner licensed 14 under chapter 152, or an advanced practice registered nurse 15 licensed under chapter 152E, who is a patient’s primary care 16 provider. “Health care practitioner” shall not include a 17 physician assistant licensed under chapter 148C or an advanced 18 registered nurse practitioner licensed pursuant to chapter 152 19 or 152E . 20 6. “Medical cannabidiol” means any pharmaceutical 21 grade cannabinoid found in the plant Cannabis sativa L. or 22 Cannabis indica or any other preparation thereof that has 23 a tetrahydrocannabinol level of no more than three percent 24 and that is delivered in a form recommended by the medical 25 cannabidiol board , approved by the board of medicine, and 26 adopted by the department pursuant to rule. 27 Sec. 4. Section 124E.2, subsection 8, Code 2020, is amended 28 by striking the subsection. 29 Sec. 5. NEW SECTION . 124E.3A Health care practitioner 30 decertification. 31 1. The department shall adopt rules to allow a health 32 care practitioner who has issued a written certification to a 33 patient to revoke the certification. 34 2. A medical cannabidiol registration card issued to 35 -1- LSB 5644XC (9) 88 ss/rh 1/ 13
S.F. _____ a patient or primary caregiver on the basis of a written 1 certification that has been revoked pursuant to subsection 1 2 shall not be valid after the date of revocation. 3 3. A patient or primary caregiver in possession of medical 4 cannabidiol after the revocation of a written certification 5 shall not be subject to a penalty under section 124E.16 for 6 thirty days after the revocation. Before the expiration of 7 thirty days after revocation, the patient or primary caregiver 8 shall return any unused medical cannabidiol to a medical 9 cannabidiol dispensary unless the patient has been recertified 10 pursuant to subsection 4. 11 4. A patient whose written certification has been 12 revoked pursuant to subsection 1 may receive a new written 13 certification pursuant to section 124E.3. If a patient 14 receives a new written certification within thirty days of 15 the revocation of the initial certification, the patient 16 or the patient’s primary caregiver may retain any medical 17 cannabidiol still in the possession of the patient or the 18 primary caregiver. A patient shall not receive more than two 19 written certifications per year. 20 Sec. 6. Section 124E.4, subsections 1 and 5, Code 2020, are 21 amended to read as follows: 22 1. Issuance to patient. 23 a. Subject Except as otherwise provided in paragraph “b” , 24 and subject to subsection 7 , the department may approve the 25 issuance of issue a medical cannabidiol registration card by 26 the department of transportation to a patient who: 27 a. (1) Is at least eighteen years of age. 28 b. (2) Is a permanent resident of this state. 29 c. (3) Submits a written certification to the department 30 signed by the patient’s health care practitioner that the 31 patient is suffering from a debilitating medical condition. 32 d. (4) Submits an application to the department, on a form 33 created by the department, in consultation with the department 34 of transportation, that contains all of the following: 35 -2- LSB 5644XC (9) 88 ss/rh 2/ 13
S.F. _____ (1) (a) The patient’s full name, Iowa residence address, 1 date of birth, and telephone number. 2 (2) (b) A copy of the patient’s valid photo identification. 3 (3) (c) Full name, address, and telephone number of the 4 patient’s health care practitioner. 5 (4) (d) Full name, residence address, date of birth, and 6 telephone number of each primary caregiver of the patient, if 7 any. 8 (5) (e) Any other information required by rule. 9 e. (5) Submits a medical cannabidiol registration card 10 fee of one hundred dollars to the department. If the patient 11 attests to receiving social security disability benefits, 12 supplemental security insurance payments, or being enrolled in 13 the medical assistance program, the fee shall be twenty-five 14 dollars. 15 f. Has not been convicted of a disqualifying felony offense. 16 b. Subject to subsection 7, the department may issue a 17 medical cannabidiol registration card to a patient who provides 18 documentation to the department, on a form prescribed by the 19 department, that the patient is receiving hospice care in this 20 state. 21 5. Expiration date of card. A medical cannabidiol 22 registration card issued pursuant to this section shall expire 23 one year two years after the date of issuance and may be 24 renewed. 25 Sec. 7. Section 124E.4, subsection 2, unnumbered paragraph 26 1, Code 2020, is amended to read as follows: 27 A medical cannabidiol registration card issued to a patient 28 by the department of transportation pursuant to subsection 1 29 shall contain, at a minimum, all of the following: 30 Sec. 8. Section 124E.4, subsection 3, unnumbered paragraph 31 1, Code 2020, is amended to read as follows: 32 For a patient in a primary caregiver’s care, subject to 33 subsection 7 , the department may approve the issuance of issue 34 a medical cannabidiol registration card by the department of 35 -3- LSB 5644XC (9) 88 ss/rh 3/ 13
S.F. _____ transportation to the primary caregiver who: 1 Sec. 9. Section 124E.4, subsection 3, paragraph b, 2 unnumbered paragraph 1, Code 2020, is amended to read as 3 follows: 4 Submits an application to the department, on a form created 5 by the department, in consultation with the department of 6 transportation, that contains all of the following: 7 Sec. 10. Section 124E.4, subsection 3, paragraph c, Code 8 2020, is amended by striking the paragraph. 9 Sec. 11. Section 124E.4, Code 2020, is amended by adding the 10 following new subsection: 11 NEW SUBSECTION . 3A. Issuance to an institution. The 12 department shall adopt rules for the issuance of a caregiver 13 registration card to an institution, including but not limited 14 to a school, university, nursing home, long-term care facility, 15 correctional facility, or jail, allowing employees of the 16 institution to administer medical cannabidiol to patients in 17 the care of the institution. 18 Sec. 12. Section 124E.4, subsection 4, unnumbered paragraph 19 1, Code 2020, is amended to read as follows: 20 A medical cannabidiol registration card issued by the 21 department of transportation to a primary caregiver pursuant to 22 subsection 3 shall contain, at a minimum, all of the following: 23 Sec. 13. Section 124E.4, subsection 6, Code 2020, is amended 24 by striking the subsection. 25 Sec. 14. Section 124E.5, subsection 2, Code 2020, is amended 26 to read as follows: 27 2. The medical cannabidiol board shall convene at least 28 twice but no more than four times per year. 29 Sec. 15. Section 124E.5, subsection 3, paragraph b, Code 30 2020, is amended to read as follows: 31 b. Making recommendations relating to the removal or 32 addition of debilitating medical conditions to the list of 33 allowable debilitating medical conditions for which the medical 34 use of cannabidiol under this chapter would be medically 35 -4- LSB 5644XC (9) 88 ss/rh 4/ 13
S.F. _____ beneficial. The department shall adopt rules to modify the 1 list of allowable debilitating medical conditions consistent 2 with recommendations of the board. 3 Sec. 16. Section 124E.5, subsection 4, Code 2020, is amended 4 to read as follows: 5 4. Recommendations made by the medical cannabidiol board 6 pursuant to subsection 3 , paragraphs “b” and “e” , shall be made 7 to the board of medicine department for consideration, and if 8 approved, shall be adopted by the board of medicine department 9 by rule. 10 Sec. 17. Section 124E.6, subsection 4, Code 2020, is amended 11 to read as follows: 12 4. The department shall require each medical cannabidiol 13 manufacturer to contract with the state hygienic laboratory at 14 the university of Iowa in Iowa City or an independent medical 15 cannabidiol testing laboratory to perform spot-check testing 16 of the medical cannabidiol produced by the manufacturer as 17 provided in section 124E.7 . The department shall require that 18 the laboratory report testing results to the manufacturer 19 and the department in a manner determined by the department 20 pursuant to rule. 21 Sec. 18. Section 124E.6, Code 2020, is amended by adding the 22 following new subsection: 23 NEW SUBSECTION . 6. A medical cannabidiol manufacturer 24 shall pay a renewal fee of two thousand dollars per year to the 25 department to renew a medical cannabidiol manufacturer license 26 in addition to any other requirement imposed by the department 27 by rule. 28 Sec. 19. Section 124E.7, subsection 1, Code 2020, is amended 29 to read as follows: 30 1. A medical cannabidiol manufacturer shall contract with 31 the state hygienic laboratory at the university of Iowa in Iowa 32 City or an independent medical cannabidiol testing laboratory 33 to perform spot-check testing of the medical cannabidiol 34 manufactured by the medical cannabidiol manufacturer as to 35 -5- LSB 5644XC (9) 88 ss/rh 5/ 13
S.F. _____ content, contamination, and consistency. The cost of all 1 laboratory testing shall be paid by the medical cannabidiol 2 manufacturer. The state hygienic laboratory shall not charge 3 a medical cannabidiol manufacturer more than fifty thousand 4 dollars per year to perform spot-check testing. 5 Sec. 20. NEW SECTION . 124E.7A Medical cannabidiol testing 6 laboratory —— review committee. 7 1. The department shall establish a committee to review 8 product matrices, testing protocols, and testing procedures 9 used by the state hygienic laboratory at the university of Iowa 10 in Iowa City and any independent medical cannabidiol testing 11 laboratory operating in this state not later than September 1. 12 2. a. The committee shall consist of the following members, 13 selected by the department: 14 (1) Three members representing independent medical 15 cannabidiol testing laboratories. 16 (2) Two members who shall be professors at regents 17 institutions with relevant education and experience, as 18 determined by rule of the department, who are not associated 19 with the state hygienic laboratory at the university of Iowa 20 in Iowa City or any independent medical cannabidiol testing 21 laboratory. 22 b. Members shall serve for a period of time as determined by 23 rules of the department. 24 3. Prior to implementing any new product matrix, testing 25 protocol, or testing procedure, the state hygienic laboratory 26 at the university of Iowa in Iowa City and any independent 27 medical cannabidiol testing laboratory operating in this 28 state shall submit the new product matrix, testing protocol, 29 or testing procedure to the committee. The committee shall 30 approve or disapprove of the product matrix, testing protocol, 31 or testing procedure by a simple majority vote. The state 32 hygienic laboratory at the university of Iowa in Iowa City 33 and any independent medical cannabidiol testing laboratory 34 operating in this state shall not use a new product matrix, 35 -6- LSB 5644XC (9) 88 ss/rh 6/ 13
S.F. _____ testing protocol, or testing procedure until it has been 1 approved by the committee, and shall not use a new product 2 matrix, testing protocol, or testing procedure that has been 3 disapproved by the committee. Product matrices, testing 4 protocols, and testing procedures in use prior to July 1, 2020, 5 shall not be subject to approval by the committee except as 6 provided in subsection 4. 7 4. A medical cannabidiol manufacturer of a product that has 8 failed a test administered by the state hygienic laboratory 9 at the university of Iowa in Iowa City or an independent 10 medical cannabidiol testing laboratory operating in this state 11 may dispute the result and request that the committee review 12 a product matrix, testing protocol, or testing procedure 13 used in testing the product. The committee shall approve or 14 disapprove of the result, and in the case of disapproval, shall 15 explain the reason for disapproval. A medical cannabidiol 16 manufacturer of a product tested using a product matrix, 17 testing protocol, or testing procedure disapproved of by the 18 committee may request that the product be tested again without 19 the disapproved product matrix, testing protocol, or testing 20 procedure. 21 5. The department shall adopt rules to administer this 22 section. 23 Sec. 21. Section 124E.8, Code 2020, is amended by adding the 24 following new subsection: 25 NEW SUBSECTION . 5. A medical cannabidiol dispensary shall 26 pay an annual renewal fee of two thousand dollars to the 27 department to renew a medical cannabidiol dispensary license 28 in addition to any other requirement imposed by the department 29 by rule. 30 Sec. 22. Section 124E.9, Code 2020, is amended by adding the 31 following new subsections: 32 NEW SUBSECTION . 13. A medical cannabidiol dispensary 33 may employ a pharmacist or pharmacy technician licensed or 34 registered pursuant to chapter 155A. 35 -7- LSB 5644XC (9) 88 ss/rh 7/ 13
S.F. _____ NEW SUBSECTION . 14. A medical cannabidiol dispensary shall 1 not dispense more than a combined total of twenty-five grams 2 of tetrahydrocannabinol to a patient and the patient’s primary 3 caregiver in a ninety-day period. 4 Sec. 23. Section 124E.11, subsection 1, paragraph b, 5 subparagraph (1), subparagraph divisions (a) and (c), Code 6 2020, are amended to read as follows: 7 (a) To authorized employees or agents of the department and 8 the department of transportation as necessary to perform the 9 duties of the department and the department of transportation 10 pursuant to this chapter . 11 (c) To authorized employees of a medical cannabidiol 12 dispensary, but only for the purpose purposes of verifying 13 that a person is lawfully in possession of a medical 14 cannabidiol registration card issued pursuant to this chapter 15 and that a patient or primary caregiver has not purchased 16 tetrahydrocannabidiol in excess of the amount authorized by 17 this chapter . 18 Sec. 24. Section 124E.11, subsection 1, paragraph b, 19 subparagraph (1), Code 2020, is amended by adding the following 20 new subparagraph division: 21 NEW SUBPARAGRAPH DIVISION . (e) To a health care 22 practitioner, but only for the purpose of monitoring the 23 amount of medical cannabidiol purchased by the health care 24 practitioner’s patient or the primary caregiver of a patient. 25 Sec. 25. Section 124E.11, subsection 2, paragraph c, Code 26 2020, is amended to read as follows: 27 c. Establish the form and quantity of medical cannabidiol 28 allowed to be dispensed to a patient or primary caregiver 29 pursuant to this chapter as appropriate to serve the medical 30 needs of patients with debilitating medical conditions, subject 31 to recommendation by the medical cannabidiol board and approval 32 by the board of medicine department . 33 Sec. 26. Section 124E.12, subsections 6 and 7, Code 2020, 34 are amended to read as follows: 35 -8- LSB 5644XC (9) 88 ss/rh 8/ 13
S.F. _____ 6. The department , the department of transportation, 1 and any health care practitioner, including any authorized 2 agent or employee thereof, are not subject to any civil 3 or disciplinary penalties by the board of medicine or any 4 business, occupational, or professional licensing board or 5 entity, solely for activities conducted relating to a patient’s 6 possession or use of medical cannabidiol as authorized under 7 this chapter . Nothing in this section affects a professional 8 licensing board from taking action in response to violations of 9 any other section of law. 10 7. Notwithstanding any law to the contrary, the department, 11 the department of transportation, the governor, or any employee 12 of any state agency shall not be held civilly or criminally 13 liable for any injury, loss of property, personal injury, or 14 death caused by any act or omission while acting within the 15 scope of office or employment as authorized under this chapter . 16 Sec. 27. NEW SECTION . 124E.20 Observational effectiveness 17 study. 18 The department shall, upon receipt of funding, conduct 19 an observational effectiveness study in cooperation with 20 patients and health care practitioners and pursuant to rules 21 of the department in order to study the effectiveness of 22 medical cannabidiol in the treatment of debilitating medical 23 conditions. 24 Sec. 28. PROTECTION OF FEDERAL FUNDING. The department 25 of public health shall request guarantees from the agencies 26 of the federal government providing funding to educational 27 and long-term care facilities that facilities with policies 28 allowing patients to possess medical cannabidiol on the grounds 29 of the facilities consistent with chapter 124E or allowing 30 facility staff to administer medical cannabidiol to a patient 31 shall not lose eligibility for any federal funding due to such 32 policies. 33 Sec. 29. TRANSITION PROVISIONS. A medical cannabidiol 34 registration card issued by the department of transportation 35 -9- LSB 5644XC (9) 88 ss/rh 9/ 13
S.F. _____ prior to July 1, 2020, remains effective and continues in 1 effect as issued for the twelve-month period following its 2 issuance. 3 EXPLANATION 4 The inclusion of this explanation does not constitute agreement with 5 the explanation’s substance by the members of the general assembly. 6 This bill relates to the medical cannabidiol Act. 7 The bill adds autism and post-traumatic stress disorder 8 to the list of debilitating medical conditions for which a 9 written certification for a medical cannabidiol registration 10 card may be issued. The bill replaces “untreatable pain” with 11 “severe or chronic pain” on the list of debilitating medical 12 conditions. The bill adds licensed physician assistants, 13 podiatrists, advanced registered nurse practitioners, and 14 advanced practice registered nurses to the list of health care 15 practitioners that may issue written certifications for a 16 medical cannabidiol registration card. 17 The bill removes the 3 percent tetrahydrocannabinol (THC) 18 limit from the definition of medical cannabidiol. The bill 19 instead prohibits a patient or a primary caregiver from 20 purchasing more than 25 grams of THC in a 90-day period. The 21 bill allows medical cannabidiol dispensaries to access the 22 registry of medical cannabidiol patients to verify that a 23 patient or primary caregiver has not purchased more than 25 24 grams of THC in a 90-day period. The bill also allows a health 25 care practitioner to access the registry of medical cannabidiol 26 patients in order to monitor the amount of medical cannabidiol 27 purchased by the health care practitioners’s patient or the 28 primary caregiver of a patient. 29 The bill removes the board of medicine from the process 30 of amending the acceptable form and quantity of medical 31 cannabidiol. 32 The bill directs the department of public health to adopt 33 rules allowing a health care practitioner who has issued a 34 written certification for a medical cannabidiol registration 35 -10- LSB 5644XC (9) 88 ss/rh 10/ 13
S.F. _____ card to a patient to revoke that certification. A medical 1 cannabidiol registration card issued on the basis of a written 2 certification shall no longer be valid. A patient or primary 3 caregiver with a revoked written certification has 30 days 4 to dispose of medical cannabidiol still in the possession of 5 the patient or primary caregiver or to receive another written 6 certification. A patient or primary caregiver shall not 7 receive more than two written certifications per year. 8 The bill removes provisions preventing a patient or a 9 primary caregiver from receiving a medical cannabidiol 10 registration card if the patient or primary caregiver has been 11 convicted of a disqualifying felony. 12 The bill directs the department of public health to 13 adopt rules for issuance of a caregiver medical cannabidiol 14 registration card to an institution, including but not limited 15 to a school, university, nursing home, long-term care facility, 16 correctional facility, or jail, to allow employees of the 17 institution to administer medical cannabidiol to patients 18 in the care of the institution. The bill also permits the 19 department of public health to issue a medical cannabidiol 20 registration card to a patient receiving hospice care in this 21 state without first receiving a written certification from a 22 health care practitioner. 23 The bill changes the expiration date of medical cannabidiol 24 registration cards from one year after the date of issuance to 25 two years after the date of issuance. 26 The bill removes the department of transportation from the 27 process of applying for and receiving a medical cannabidiol 28 registration card and requires the department of public health 29 to issue medical cannabidiol registration cards and makes 30 conforming Code changes. A medical cannabidiol registration 31 card previously issued by the department of transportation 32 prior to July 1, 2020, remains effective and continues in 33 effect for the 12-month period following its issuance. 34 The bill allows the medical cannabidiol board to meet more 35 -11- LSB 5644XC (9) 88 ss/rh 11/ 13
S.F. _____ than four times per year. 1 The bill requires the department of public health to 2 adopt rules to modify the list of debilitating medical 3 conditions for which a certification for a medical cannabidiol 4 registration card may be issued when the medical cannabidiol 5 board recommends such a change. The bill removes the board 6 of medicine from the process of adding debilitating medical 7 conditions to the list of debilitating conditions for which a 8 written certification for a medical cannabidiol registration 9 card may be issued. 10 The bill makes changes with respect to medical cannabidiol 11 manufacturers, medical cannabidiol dispensaries, and medical 12 cannabidiol product testing. A medical cannabidiol testing 13 laboratory must report testing results to the department of 14 public health in addition to the manufacturer of the product 15 being tested. The bill provides that an annual renewal fee 16 for a medical cannabidiol manufacturer license or medical 17 cannabidiol dispensary license shall be $2,000. The state 18 hygienic laboratory at the university of Iowa in Iowa City 19 shall not charge a medical cannabidiol manufacturer more 20 than $50,000 per year for the testing of medical cannabidiol 21 products. 22 The bill requires the department of public health to 23 establish a committee to review product matrices, testing 24 protocols, and testing procedures used by medical cannabidiol 25 testing laboratories. The committee shall consist of five 26 members, selected by the department of public health, with 27 three members representing independent medical cannabidiol 28 testing laboratories and two members who are professors at 29 regents institutions with relevant education and experience and 30 no association with any medical cannabidiol testing laboratory. 31 Prior to implementing any new product matrix, testing protocol, 32 or testing procedure, a medical cannabidiol testing laboratory 33 must submit the product matrix, protocol, or procedure to 34 the committee for approval. A medical cannabidiol testing 35 -12- LSB 5644XC (9) 88 ss/rh 12/ 13
S.F. _____ laboratory shall not use a new product matrix, protocol, or 1 procedure that has not been approved by the committee or has 2 been disapproved. Product matrices, protocols, and procedures 3 in use prior to July 1, 2020, are not subject to review, 4 except that a medical cannabidiol manufacturer of a product 5 that has failed a test administered by a medical cannabidiol 6 testing laboratory may contest the results of the test with the 7 committee, who shall approve or disapprove the results of the 8 test. A manufacturer of a product that failed a test that was 9 disapproved by the committee may request that the product be 10 tested again without the disapproved product matrix, testing 11 protocol, or testing procedure by the committee. 12 The bill requires the department of public health to conduct 13 a study on the efficacy of medical cannabidiol in treating 14 patients with debilitating medical conditions upon receipt 15 of funding. The bill also requires the department of public 16 health to request guarantees from agencies of the federal 17 government providing funding to educational and long-term care 18 facilities in the state that such facilities shall not lose 19 such funding for allowing patients to possess and use medical 20 cannabidiol on the grounds of the facilities. 21 -13- LSB 5644XC (9) 88 ss/rh 13/ 13