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S.F. No. 751 - Opiate Epidemic Response (4th Engrossment)
 
Author: Senator Julie A. Rosen
 
Prepared By: Katie Cavanor, Senate Counsel (651/296-3801)
 
Date: March 22, 2019



 

Article 1 - Opiate Epidemic Response

Sections 1 and 2 (151.065) increases the application fees for all nonopiate drug manufacturers and wholesale drug distributers to $5,000, and for opiate drug manufactuers to $55,000.

Section 3 (151.065, subdivision 7) requires that the increased fees be deposited in the opiate epidemic response account.

Section 4 (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 $100 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, 2023.

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, 2023.

Section 5 (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 6 (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.  

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 1 of each year beginning January 1, 2022, 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.

Section 7 (256.043) establishes the opiate epidemic response account in the special revenue fund in the state treasury.  Specifies the use of the funds beginning for fiscal year 2020.

Section 8 specifies that the first meeting of the Opiate Stewardship Advisory Council shall be convened by the commissioner of human services no later than October 1, 2019, and the first report under section 256.042 is due no later than January 31, 2022.

Section 9 specifies that if the state receives a settlement, payout, or judgement from any lawsuit against an opiate drug manufacturer in an amount greater than $20,000,000, the license fee increases in section 151.065, and the registration fee assessed in section 151.066 shall be reduced to $5,000 until the legislature reviews the fee. This section also requires that any money received by the state due to a lawsuit shall be deposited into a seperate account in the state treasury.

Article 2 - Other Opiate 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 (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 2 (151.37, subdvision 12) authorizes an employee of a correctional facility to administer opiate antagonists.

Section 3 (152.105, subdivision 2) authorizes a sheriff to implement a medicine disposal program instead of maintaining or contracting for the maintenance of a collection receptacle for the disposal of prescription drugs. The medicine disposal program must include providing public educational information and making materials available for safely destroying prescription drugs that meet the requirements of the Minnesota PCA, the FDA, and the Board of Pharmacy.

Sections 4 and 5 (152.11) prohibit 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.  If not dispensed within 30 days of the date of the prescription, a new prescription must be issued.

Section 6 (151.11, subdivision 2d) requires the person purchasing a controlled substance to present a valid photographc identification, unless the person is known to the dispenser. States that this includes vetrinarians 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 7 (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 8 (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 administed 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 9 (152.126, subdivision 10) authorizes the Board of Pharmacy to modify its contract with its vendor to authorize the vendor to provide a service to prescribers and pharmacies that would allow them to access the PMP database from within the electronic health record system or pharmacy software used by the prescriber and pharmacists.  It also authorizes the board to collect an annual user fee to cover the annual cost of integrating the program with the prescriber’s electronic health records system beginning July 1, 2019.  The user fee must not exceed $50 per user.

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, 2024.

Section 11 requires the Health Services Policy Committee to evaluate and make recommendations on the integration on nonpharmacologic pain management that are clinically viable; reduce or eliminate chronic pain; improve functional status; and prevent addiction on opiates or other pain medications. The commissioner of human services shall report recommendations to the legislature by August 1, 2021, including recommendations to develop and implement a pilot program.

Section 12 appropriates money.

 
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