Bills › 88th General Assembly

SF 2363Withdrawn · HF 2589 became law instead · June 3, 2020

Relating to the medical cannabidiol Act, and including transition provisions

Sponsored by the Senate Judiciary Committee

Topics:Courts & civil lawHealth care

Same legislation: HSB 653, SSB 3136, HF 2589

Where it is now

  1. Done: IntroducedFebruary 10, 2020
  2. Done: SubcommitteeFebruary 10, 2020
  3. Done: Senate committeeFebruary 19, 2020
  4. Done: Passes the SenateJune 3, 202032–17
  5. Skipped: House committeeSkipped
  6. Done: Passes the HouseMarch 10, 202052–48
  7. Done: To the GovernorJune 16, 2020
  8. Done: Signed into lawJune 29, 2020

HF 2589 became law → The same legislation passed as HF 2589, so this version was set aside. Go to HF 2589 What’s a funnel?

What’s in it

This bill relates to the medical cannabidiol Act. The bill adds autism and post-traumatic stress disorder to the list of debilitating medical conditions for which a written certification for a medical cannabidiol registration card may be issued. The bill replaces “untreatable pain” with “severe or chronic pain” on the list of debilitating medical conditions. The bill adds licensed physician assistants, podiatrists, advanced registered nurse practitioners, and advanced practice registered nurses to the list of health care practitioners that may issue written certifications for a medical cannabidiol registration card.

Read the full explanation

The bill removes the percent tetrahydrocannabinol (THC) limit from the definition of medical cannabidiol. The bill instead prohibits a patient or a primary caregiver from purchasing more than grams of THC in a 90-day period. The bill allows medical cannabidiol dispensaries to access the registry of medical cannabidiol patients to verify that a patient or primary caregiver has not purchased more than grams of THC in a 90-day period. The bill also allows a health care practitioner to access the registry of medical cannabidiol patients in order to monitor the amount of medical cannabidiol purchased by the health care practitioners’s patient or the primary caregiver of a patient. The bill removes the board of medicine from the process of amending the acceptable form and quantity of medical cannabidiol. The bill directs the department of public health to adopt rules allowing a health care practitioner who has issued a written certification for a medical cannabidiol registration card to a patient to revoke that certification. A medical cannabidiol registration card issued on the basis of a written certification shall no longer be valid. A patient or primary caregiver with a revoked written certification has days to dispose of medical cannabidiol still in the possession of the patient or primary caregiver or to receive another written certification. A patient or primary caregiver shall not receive more than two written certifications per year. The bill removes provisions preventing a patient or a primary caregiver from receiving a medical cannabidiol registration card if the patient or primary caregiver has been convicted of a disqualifying felony. The bill directs the department of public health to adopt rules for issuance of a caregiver medical cannabidiol registration card to an institution, including but not limited to a school, university, nursing home, long-term care facility, correctional facility, or jail, to allow employees of the institution to administer medical cannabidiol to patients in the care of the institution. The bill also permits the department of public health to issue a medical cannabidiol registration card to a patient receiving hospice care in this state without first receiving a written certification from a health care practitioner. The bill changes the expiration date of medical cannabidiol registration cards from one year after the date of issuance to two years after the date of issuance. The bill removes the department of transportation from the process of applying for and receiving a medical cannabidiol registration card and requires the department of public health to issue medical cannabidiol registration cards and makes conforming Code changes. A medical cannabidiol registration card previously issued by the department of transportation prior to July 1, 2020, remains effective and continues in effect for the 12-month period following its issuance. The bill allows the medical cannabidiol board to meet more than four times per year. The bill requires the department of public health to adopt rules to modify the list of debilitating medical conditions for which a certification for a medical cannabidiol registration card may be issued when the medical cannabidiol board recommends such a change. The bill removes the board of medicine from the process of adding debilitating medical conditions to the list of debilitating conditions for which a written certification for a medical cannabidiol registration card may be issued. The bill makes changes with respect to medical cannabidiol manufacturers, medical cannabidiol dispensaries, and medical cannabidiol product testing. A medical cannabidiol testing laboratory must report testing results to the department of public health in addition to the manufacturer of the product being tested. The bill provides that an annual renewal fee for a medical cannabidiol manufacturer license or medical cannabidiol dispensary license shall be $2,000. The state hygienic laboratory at the university of Iowa in Iowa City shall not charge a medical cannabidiol manufacturer more than $50,000 per year for the testing of medical cannabidiol products. The bill requires the department of public health to establish a committee to review product matrices, testing protocols, and testing procedures used by medical cannabidiol testing laboratories. The committee shall consist of five members, selected by the department of public health, with three members representing independent medical cannabidiol testing laboratories and two members who are professors at regents institutions with relevant education and experience and no association with any medical cannabidiol testing laboratory. Prior to implementing any new product matrix, testing protocol, or testing procedure, a medical cannabidiol testing laboratory must submit the product matrix, protocol, or procedure to the committee for approval. A medical cannabidiol testing laboratory shall not use a new product matrix, protocol, or procedure that has not been approved by the committee or has been disapproved. Product matrices, protocols, and procedures in use prior to July 1, 2020, are not subject to review, except that a medical cannabidiol manufacturer of a product that has failed a test administered by a medical cannabidiol testing laboratory may contest the results of the test with the committee, who shall approve or disapprove the results of the test. A manufacturer of a product that failed a test that was disapproved by the committee may request that the product be tested again without the disapproved product matrix, testing protocol, or testing procedure by the committee. The bill requires the department of public health to conduct a study on the efficacy of medical cannabidiol in treating patients with debilitating medical conditions upon receipt of funding. The bill also requires the department of public health to request guarantees from agencies of the federal government providing funding to educational and long-term care facilities in the state that such facilities shall not lose such funding for allowing patients to possess and use medical cannabidiol on the grounds of the facilities.

Changed since by amendments S-5091, H-8128; see Amendments.

Full bill text · What changed before it passed1

Senate subcommittee

Named February 17, 2020 (as SSB 3136). On February 18, 2020 it recommended passage.

Three legislators hear a bill first and recommend what the committee should do; it’s the best time to weigh in. How to take part

Fiscal note

AI summary This bill changes the Iowa Medical Cannabidiol Program by expanding the list of qualifying medical conditions, adding more types of certifying health care practitioners, and changing how registration cards are issued and renewed. The changes are estimated to decrease program revenues by $474,000 in fiscal year 2021, $186,000 in fiscal year 2022, $474,000 in fiscal year 2023, $186,000 in fiscal year 2024, and $474,000 in fiscal year 2025. The Department of Transportation is projected to save an estimated $27,000 annually, and the Department of Public Health faces an estimated $25,000 cost in fiscal year 2021 to update its tracking system. The total impact of increased patient applications and the need for additional staff cannot be estimated.2

Read the fiscal note

Description

Senate File 2363 amends the Iowa Medical Cannabidiol (mCBD) Program. Changes relevant to the fiscal impact include:

  • Revises “untreatable pain” to “severe or chronic pain” on the list of debilitating medical conditions for which mCBD may be used.
  • Adds autism and post-traumatic stress disorder to the list of debilitating medical conditions for which mCBD may be used.
  • Expands the definition of “health care practitioner” to include physician assistants, podiatrists, advanced registered nurse practitioners, and advanced practice registered nurses, and makes conforming Program changes.
  • Removes mCBD Program participation restrictions on felons.
  • Removes the Department of Transportation (DOT) from the mCBD registration card issuing process, and requires the Department of Public Health (DPH) to issue the registration cards to patients, and makes conforming changes.
  • Removes the restriction on mCBD containing more than 3.0% tetrahydrocannabinol (THC).
  • Adds a restriction that an mCBD dispensary cannot dispense more than a combined total of 25 grams of THC to a patient or primary caregiver in a 90-day period.
  • Extends the validity time period for an mCBD registration card from one year to two years.
  • Caps the annual renewal fee at $2,000 for mCBD manufacturers and dispensaries.

Background

Sales of mCBD through the Iowa mCBD Program began in December 2018. The mCBD Program transitioned to a fee-sustained program and does not include any General Fund revenues in the FY 2020 budget. Iowa currently licenses two mCBD manufacturers and five mCBD dispensaries. A high-level summary of the mCBD Program revenues and total expenditures from the State Accounting System is presented in the following table.FY 2016 FY 2017 FY 2018 FY 2019

Estimated

FY 2020 Beginning Balance 0$ 0$ 0$ 165,187$ 692,246$ General Fund 25,000$ 22,100$ 322,100$ 322,100$ 0$ Card Fees 0 650 171,225 232,381 190,790 Manufacturer Fees 0 0 0 300,000 200,000 Dispensary Fees 0 0 0 300,000 200,000 Annual Revenues 25,000$ 22,750$ 493,325$ 1,154,481$ 590,790$ Total Resources 25,000$ 22,750$ 493,325$ 1,319,668$ 1,283,036$ Total Expenses 25,000$ 22,750$ 328,138$ 627,422$ 1,283,036$ Carry Forward Balance 0$ 0$ 165,187$ 692,246$ 0$

Assumptions

  • Under current law, total card revenue for FY 2020 is estimated at $288,000.
  • Since sales began in December 2018, there is not sufficient data available to forecast new enrollment versus renewal enrollment at this time. For the purposes of this estimate, all cards issued in FY 2020 will be renewed in FY 2021. New enrollment, while foreseeable, is excluded.
  • Expanding the list of debilitating medical conditions for which mCBD may be used and allowing for more certifying health care practitioners will increase patient access to mCBD.
  • The $2,000 annual fee for manufacturers and dispensaries listed in the Bill will limit the DPH authority in Iowa Code section 124E.11(2)(f) to charge fees for regulation.
  • The fee DPH would assess manufacturers and dispensaries in FY 2021 and future fiscal years under current law will be $200,000 annually.
  • The cost of an mCBD registration card is established in Iowa Code and cannot be changed by the DPH. Registration cards for patients are $100 unless the patient is on Social Security disability benefits, supplemental security income payments, or is a Medicaid recipient, then the fee is $25. Caregiver cards are $25, and 15.0% of enrolled patients have caregivers who get cards.
  • An estimated 40.0% of patients qualify for the reduced fee card.
  • The mCBD Program retains fees at the end of the fiscal year for use in the following fiscal year. The estimated amount of fee revenue to carry forward into FY 2021 is $500,000.
  • The Seed-to-Sale tracking system will require updates to comply with the new purchasing cap.
  • The data collection and reporting on patient outcomes study language is permissive.

Fiscal Impact

Moving to a biennial registration card issuance cycle will decrease revenues to the mCBD Program. Capping manufacturer and dispensary regulatory fees will decrease revenues to the mCBD Program. The estimated impact of these two changes are outlined in the table below. To the extent that more patients qualify for the Program and more certifying health care practitioners are available to certify conditions, there will be increased applications and fees to the DPH for mCBD registration. The scope of this impact is unknown. It takes approximately 1,560 patient and caregiver card applications to generate $100,000 in fee revenue. If the application volume increases enough, the DPH will need to hire additional registration clerks at approximately $47,000 for every 3,000 applications received in a given year. While revenues would decrease in FY 2021, the estimated balance carryforward would be sufficient to fund the Program. FY 2022 is difficult to forecast due to the unknown impact of additional covered conditions and certifying health care practitioners. Costs associated with updating the patient tracking system for the DPH to issue cards are estimated at $25,000 in FY 2021. The DOT operating budget is projected to save an estimatedRegistration

Card Fees

Manufacturer

Fees

Dispensary

Fees

Registration

Card Fees

Manufacturer

Fees

Dispensary

Fees

FY 2021 288,000$ 100,000$ 100,000$ 0$ 4,000$ 10,000$ -474,000$ FY 2022 288,000 100,000 100,000 288,000 4,000 10,000 -186,000 FY 2023 288,000 100,000 100,000 0 4,000 10,000 -474,000 FY 2024 288,000 100,000 100,000 288,000 4,000 10,000 -186,000 FY 2025 288,000 100,000 100,000 0 4,000 10,000 -474,000 Current Law SF 2363

Fee Revenue

Fiscal Impact

$27,000 annually, due to no longer having to issue registration cards. The DPH may contract for data collection and reporting on patient outcomes if the budget has sufficient capacity.

Sources

  • Department of Public Health
  • Department of Transportation
  • LSA analysis and calculations

Reading a fiscal note3

Iowa Code it changes

Creates§124E.20§124E.3A§124E.7A

Amends§124E.11§124E.12§124E.2§124E.4§124E.5§124E.6§124E.7§124E.8§124E.9

How the Code works4

Lobbying

15 for · 6 against · 29 undecided · Who →

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