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S.F. No. 730 - Opiate Product Stewardship (Fourth Engrossment)
 
Author: Senator Julie A. Rosen
 
Prepared By:
 
Date: May 3, 2018



 

Article 1 - Opiate Product Stewardship

Section 1 (151.252, subd. 1) specifies that the Board of Pharmacy shall not issue a renewed license for a drug manufacturer unless the manufacturer pays the applicable registration fee under section 151.77.

Section 2 (151.47, subd. 1a) specifies that the Board of Pharmacy shall not issue a renewed license for a wholesale drug distributor unless the wholesale drug distributor pays the applicable registration fee under section 151.77.

Section 3 (151.75) establishes the Opiate Stewardship Advisory Council.

Subd. 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.  

Subd. 2 describes the makeup of the advisory council.

Subd. 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.

Subd. 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, 2019, of the grants proposed by the advisory council to be awarded for the next fiscal year.

Paragraph (b) requires the commissioner to award grants from the opiate stewardship 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.

Subd. 5, paragraph (a) requires the advisory council to annually report to the legislature by January 1 of each year beginning January 1, 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.

Paragraph (b) requires the Commissioner of Management and Budget to report to the legislature when an evaluation study on the promising practices or theory-based projects that are selected for evaluation has been completed.

Section 4 (151.76) establishes the opiate stewardship account in the special revenue fund in the state treasury.  Specifies the use of the funds beginning for fiscal year 2019.

Section 5 (151.77) establishes an annual opiate product registration fee for manufacturers and wholesale drug distributors of opiate containing controlled substances.

Subd. 1 defines the following terms:  manufacturer; opiate; and wholesaler.

Subd. 2, paragraph (a) requires that by March 1 of each year, beginning March 1, 2019, 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 during 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.

Paragraph (b) requires that by March 1 of each year, beginning March 1, 2019, each owner of a pharmacy with at least one location 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.

Subd. 3, paragraph (a) requires the board to annually assess manufacturer registration fees that in an aggregate amount total $12,000,000.  The board shall determine each manufacturer’s annual registration fee that is prorated and based on the manufacturer’s percentage of the total number of units reported to the board.

Paragraph (b) requires the board to notify each manufacturer of the manufacturer's annual registration fee by April 1 of each year beginning April 1, 2019.

Paragraph (c) authorizes the board to use the prescription monitoring program data to determine the manufacturer registration fees. 

Paragraph (d) specifies that a manufacturer may dispute the registration fee determined by the board no later than 30 days after the date of notification.  The dispute must be filed with the board in the manner and using forms specified by the board and data must be submitted that demonstrates that the fee 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 original fee was incorrect, the board must adjust the manufacturer's fee due the next year by the excess amount of the correct fee that should have been paid.

Subd. 4, paragraph (a) requires the board to annually assess wholesaler registration fees that in an aggregate amount total $8,000,000.  The board shall determine each wholesaler's annual registration fee that is prorated and based on the manufacturer's percentage of the total number of units reported to the board.  Specifies that this paragraph does not apply if a wholesaler is also licensed as a drug manufacturer.

Paragraph (b) requires the board to notify each wholesaler of the wholesaler's annual registration fee by April 1 of each year beginning April 1, 2019.

Paragraph (c) authorizes the board to use the PMP data to determine the wholesaler distribution fees.

Paragraph (d) specifies that a manufacturer may dispute the registration fee determined by the board no later than 30 days after the date of notification. The dispute must be filed with the board in the manner and using forms specified by the board and data must be submitted that demonstrates that the fee 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 original fee was incorrect, the board must adjust the wholesaler's fee due the next year by the excess amount of the correct fee that should have been paid.

Subd. 5 requires the registration fees collected by the board under this section shall be deposited to the opiate stewardship account.

Subd. 6 requires the board to evaluate the registration fee on manufacturers and wholesalers and whether the fee has impacted the prescribing practices for opiates by reducing the number of opiate prescriptions issued, and submit the results of the evaluation to the legislature by March 1, 2022.

Subd. 7 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, 2022.

Section 6 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, 2018.

Section 7 appropriates funds to the Board of Pharmacy for the collection of the opiate product registration fees; the commissioner of human services for the administration of the Opioid Product Stewardship Council; and the commissioner of public safety for Bureau of Criminal Apprehension drug scientists and lab supplies.

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.

Sections 1 and 2 (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 3 (152.126, subd. 6) requires a prescriber to access the data submitted to the extent the information relates specifically to the patient before the prescriber issues a prescription order for a controlled substance to the patient.  Specifies that this does not apply if the patient is receiving hospice care; the order is for a number of doses that is intended to last three days or less and is not subject to a refill; 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; the prescriber is a veterinarian and the patient is an animal under the veterinarian’s care; due to an emergency it is not possible to review the data before issuing a prescription order; or 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 4 (152.126, subd. 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 or pharmacies softwares beginning July 1, 2018.  The user fee must not exceed $50 per user.

Section 5 (Laws 2017 -152.11, subd. 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.  Removes the prescriber’s ability to prescribe a higher quantity for acute dental pain if in the professional clinical judgment of the practitioner more than a four-day supply is required to treat the patient’s acute pain.

 

 

 

 
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