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H.F. No. 400 - Opiate Epidemic Response (Minnesota Laws 2019, Chapter 63) (First Special Session - 2019)
 
Author: Senator Julie A. Rosen
 
Prepared By: Katie Cavanor, Senate Counsel (651/296-3801)
 
Date: June 28, 2019



 

Article 1 – Opiate Epidemic Response

Section 1 (16A.151, subdivision 2) requires any money received by the state from a settlement agreement, assurance of discontinuance, or court order from opioid litigation brought by the Attorney General of the state to be deposited into a separate account in the state treasury. States that this does not apply to attorney fees and costs awarded to the Attorney General, contract attorneys, or other state agency attorneys. If opioid manufacturer licensing fees are reduced, and the opiate product registration fee is repealed, requires the commissioner to transfer from this separate account to the opiate epidemic response account an amount that ensures that $20.940 million is available for distribution from the opiate epidemic response account.

Sections 2 and 3 (151.065, subdivisions 1 and 3) increase the application license fees and renewal fees for all nonopiate drug manufacturers and wholesale drug distributors to $5,000, and for opiate drug manufacturers to $55,000.

Section 4 (151.065, subdivision 7) requires that the increased license fees and the registration fee established in section 151.066 be deposited in the opiate epidemic response account.

Section 5 (151.066) establishes an annual opiate product registration fee for opiate manufacturers that sell, deliver, or distribute more than 2,000,000 units annually in this state.

Subdivision 1 defines the following terms:  manufacturers; opiate; and wholesaler.

Subdivision 2, paragraph (a) requires that by March 1 of each year beginning March 1, 2020, each manufacturer and wholesale drug distributor to report to the Board of Pharmacy every sale, delivery, or other distribution within the state of any opiate that is made to any practitioner, pharmacy, hospital, veterinary hospital, or other person who is permitted to possess controlled substances for administration or dispensing to patients that occurred the previous calendar year.  Specifies that if a manufacturer or wholesaler fails to provide this information on a timely basis, the board may assess an administrative penalty of $500 per day.

Subdivision 2, paragraph (b) requires that by March 1 of each year, beginning March 1, 2020, each owner of a pharmacy located within the state to report to the board the intracompany delivery or distribution into the state of any opiate that are not reported to the board by a licensed wholesale drug distributor.

Subdivision 3, paragraph (a) requires the board to annually assess a registration fee on any opiate manufacturer that sells, distributes, or delivers 2,000,000 or more units.

Subdivision 3, paragraph (b) establishes the annual registration fee at $250,000.

Subdivision 3, paragraph (c) authorizes the board to use the PMP data to determine whether a manufacturer is required to pay the registration fee. 

Subdivision 3, paragraph (d) requires the board to notify each manufacturer that is required to pay the annual registration fee by April 1 of each year beginning April 1, 2020.

Subdivision 3, paragraph (e). A manufacturer may dispute the amount of an invoice by filing with the board data that demonstrates that the assessment of a fee on the manufacturer was incorrect.  The board must make a decision on the dispute no later than 60 days after receiving the dispute forms.  If the board determines that the fee was incorrectly assessed, the board must refund the amount paid by the manufacturer.

Subdivision 3, paragraph (f) defines a unit as the individual dosage form of the particular drug product that is prescribed to the patient.

Subdivision 4 requires the board to evaluate the registration fee on manufacturers and the increased licensure fees on opiate manufacturers and wholesalers and whether the fee has impacted the prescribing practices for opiates by reducing the number of opiate prescriptions issued and any unintended consequences in the availability of opiates for the treatment of chronic or intractable pain, and submit the results of the evaluation to the legislature by March 1, 2024.

Subdivision 5 requires the legislature to review the reports received from the advisory council, commissioners, and Board of Pharmacy, and any other relevant information related to the opioid crisis to make a determination about whether the opiate product registration fee under this section should continue beyond July 1, 2024.

Section 6 (151.252, subdivision 1) specifies that the Board of Pharmacy shall not renew a license for a drug manufacturer unless the manufacturer pays the applicable annual registration fee under section 151.066, beginning June 1, 2020. This section also clarifies that a manufacturer of opiate-containing controlled substances is only required to pay one license fee regardless of the number of facilities.

Section 7 (256.042) establishes the Opiate Epidemic Response Advisory Council.

Subdivision 1 establishes the council to develop and implement a comprehensive and effective statewide effort to address the opioid addiction and overdose epidemic in Minnesota.  Requires the council, in consultation with the commissioner of management and budget, to select from the awarded grants projects that include promising practices or theory-based activities in which the commissioner shall conduct evaluations using experimental or quasi-experimental design.  Also requires the council, in consultation with the Commissioners of Human Services, Health, Public Safety, and Management and Budget, to establish goals on addressing the opiate epidemic and determine a baseline to use to measure progress, and set up measurable outcomes.

Subdivision 2 describes the makeup of the advisory council.

Subdivision 3 requires advisory council members to disclose to the council and recuse themselves from voting on any matter before the council if the member has a conflict of interest.

Subdivision 4, paragraph (a) requires the Commissioner of Human Services to submit a report to the legislature by March 1 of each year beginning March 1, 2020, of the grants proposed by the advisory council to be awarded for the next fiscal year.

Subdivision 4, paragraph (b) requires the commissioner to award grants from the opiate epidemic response account to proposals selected by the advisory council unless otherwise appropriated by the legislature.  Limits the amount of the grant that can be used by the grantee for administration.

Subdivision 5, paragraph (a) requires the advisory council to annually report to the legislature by January 31 of each year beginning January 31, 2021, information about the individual projects that receive grants and the overall role of the project in addressing the opioid addiction and epidemic in Minnesota.

Subdivision 5, paragraph (b) requires the Commissioner of Management and Budget to report to the legislature on the promising practices or theory-based projects that are selected for evaluation activities.

Subdivision 5, paragraph (c) requires the council in its annual report to the legislature due January 31, 2024, to include recommendations on the appropriations from the opiate epidemic response account for the specified entities in terms of continuing or adjusting the appropriation, as well as whether funding should be appropriated from the account for other purposes related to opioid abuse prevention, education, or treatment.

Section 8 (256.043) establishes the opiate epidemic response account.           

            Subdivision 1 establishes the account in the special revenue fund.

 Subdivision 2 specifies the amounts to be transferred from the account beginning in fiscal year 2021 to the Board of Pharmacy for collecting the registration fees, and the Commissioner of Public Safety for the Bureau of Criminal Apprehension for drug scientists and lab supplies and special agents. 

Subdivision 3 specifies that after the transfers in subdivision 2, funds from the account shall be appropriated to the Commissioner of Human Services to administer the advisory council and the grants awarded, and 50 percent of the remaining funds shall be distributed by the commissioner to county social service and tribal social service agencies for child protection services to children and families affected by addiction.  The remaining funds shall be awarded as grants as specified by the council unless otherwise appropriated by the legislature.

Subdivision 4 states that if the state receives a total sum of $250,000,000 as a result of a settlement or an assurance of discontinuance entered in to by the attorney general, or resulting from a court order in litigation brought by the attorney general on behalf of the state against one or more opioid manufacturers or wholesale drug distributors, or from the fees collected by the Board of Pharmacy under sections 151.065 and 151.066 that are deposited in the opiate epidemic response account, or a combination of both, the fees specified in section 151.065, subdivision 1, clause (16), and section 151.065, subdivision 3, clause (14), shall be reduced to $5,260 and the opiate registration fee in section 151.066, subdivision 3, shall be repealed.  This subdivision also specifies that the reduction in license fees and the repeal of the registration fee shall not occur before July 1, 2024.

Section 9 specifies that the first meeting of the Opiate Epidemic Response Advisory Council shall be convened by the commissioner of human services no later than October 1, 2019, and the members shall elect a chair at the first meeting.

Section 10 is a Revisor instruction to add together any fee increase to the license fees for manufacturers and wholesale drug distributors that have been enacted in the 2019 regular or special legislative sessions.

Article 2 – Other Provisions

Article 2 makes a number of changes to the prescribing requirements for opiates and to the prescription monitoring program. The article also requires a prescriber to access the data of the program before issuing a prescription order.  Finally, this article limits the quantity of opiates that can be prescribed for the treatment of acute pain.

Section 1 (145C.05, subdivision 2) allows a health care directive to include instructions to prohibit the administration, dispensing, or prescribing of an opioid. States that these instructions should not be construed to limit opioid use for the treatment of substance abuse, opioid dependence, or an overdose, unless otherwise prohibited in the directive.

Section 2 (145C.17) requires a health care provider, at the request of the patient or health care agent, to enter into the patient’s health record any instructions relating to the use of opioids.

Section 3 (151.01, subdivision 27) includes in the definition of pharmacy the intermuscular and subcutaneous administration of drugs used for the treatment of alcohol or opioid dependence and treatment of mental health conditions.

Section 4 (151.37, subdivision 12) adds correctional employees of a state or local political subdivision, volunteer firefighters, and licensed school nurses or certified public health nurses employed by or under contract with a school board, to the list of persons who may administer opiate antagonists, if authorized by a physician or other specified health care professional and other requirements are met. Provides an immediate effective date.

Section 5 (152.105, subdivision 2) allows county sheriffs to satisfy the requirement to maintain a collection receptacle for the disposal of controlled substances and other drugs, by providing public educational information and making an alternative method available to the public, at no charge, for safely destroying unwanted legend drugs, including at-home drug deactivation and disposal products, so long as the alternative method meets the requirements of the Minnesota Pollution Control Agency, the FDA, and the Board of Pharmacy.

Section 6 (152.11, subdivision 1) prohibits the dispensing of an opiate or narcotic pain reliever listed in schedule II through IV more than 30 days after the date on which the prescription was issued.  Specifies that no subsequent refills may be dispensed more than 30 days after the previous date on which the prescription was initially filled or refilled. States that once authorized refills for Schedule III or IV opiate or narcotic pain relievers have been used up or expired, no additional authorization may be accepted and if continued therapy is necessary, a new prescription must be issued.

Section 7 (152.11, subdivision 2d) requires the person purchasing a controlled substance to present a valid photographic identification, unless the person is known to the dispenser. States that this includes veterinarians who dispense a controlled substance and requires this for any purchase of a controlled substance regardless of whether they are covered by a third party payer.

Section 8 (152.11, subdivision 4) limits the quantity of opiates and narcotics that can be prescribed at any one time for the treatment of acute pain to a quantity not to exceed a seven-day supply for an adult, and not to exceed a five-day supply for a minor under the age of 18, unless in the prescriber’s professional judgment a higher quantity for acute pain is required to treat the patient’s acute pain.

Section 9 (152.126, subdivision 6) requires a prescriber to access the PMP data submitted to the extent the information relates to the patient before the prescriber issues a prescription order for a schedule II through IV opiate controlled substance to the patient or at least once every three months for patients receiving an opiate for chronic pain or participating in opioid addiction treatment.  Specifies that this does not apply if: (1) the patient is receiving hospice care, palliative care, or end of life care; (2) the patient is bring treated for pain due to cancer or the treatment of cancer; (3) the order is for a number of doses that is intended to last five days or less and is not subject to a refill; (4) the prescriber and patient have current or ongoing relationship of over a year; (5) the prescription is issues within 14 days of surgery or three days of oral surgery or follows the protocols established by the opioid prescribing improvement program; (6) the prescription is prescribed or administered during an inpatient hospital stay; (7) the controlled substance is lawfully administered by injection, or any other means by the prescriber, a pharmacist or by the patient at the direction of a prescriber and in the presence of the prescriber or pharmacist; (8) due to an emergency it is not possible to review the data before issuing a prescription order; or (9) the prescriber is unable to access the data due to operational or other technical failure of the program if the failure is reported to the board.

Section 10 (214.12, subdivision 6) specifies that the boards of medical practice, nursing, dentistry, optometry, and podiatric medicine shall require licensees with the authority to prescribe controlled substances to obtain at least two hours of continuing education credits on best practices in prescribing opioids and controlled substances, unless the licensee is participating in the opioid prescribing improvement program under section 256B.0638. This section expires January 1, 2023.

Article 3 – Appropriations

Article 3 appropriates money in fiscal year 2020 from the general fund.  Requires the Commissioner of Human Services to do a onetime transfer of money from the opiate epidemic response account to the general fund by June 30, 2021, that equals the amount appropriated in fiscal year 2020 from the general fund.

 

 

 

 

 
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