2019 -- H 6189

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

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A N   A C T

RELATING TO FOOD AND DRUGS -- OPIOID STEWARDSHIP ACT

     

     Introduced By: Representatives Mattiello, Shekarchi, Caldwell, Serpa, and McNamara

     Date Introduced: June 06, 2019

     Referred To: House Finance

     It is enacted by the General Assembly as follows:

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     SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby

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amended by adding thereto the following chapter:

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CHAPTER 28.10

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OPIOID STEWARDSHIP ACT

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     21-28.10-1. Definitions.

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     Unless the context otherwise requires, the following terms shall be construed in this

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chapter to have the following meanings:

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     (1) "Distribute" means to deliver a controlled substance other than by administering or

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dispensing to the ultimate user, including intra-company transfers between any division, affiliate,

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subsidiary, parent or other entity under complete common ownership and control.

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     (2) "Opioid stewardship payment" means the total amount to be paid into the opioid

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stewardship fund for each state fiscal year as set forth in § 21-28.10-2.

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     (3) "Ratable share" means the individual portion of the opioid stewardship payment to be

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paid by each manufacturer and distributor licensed under this title that sells or distributes opioids

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in the state of Rhode Island.

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     21-28.10-2. Opioid stewardship payment imposed on manufacturers and

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distributors.

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     All manufacturers and distributors licensed or registered under this title or chapter 19.1 of

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title 5 (hereinafter referred to as "licensees"), that sell or distribute opioids in the state of Rhode

 

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Island shall be required to pay an opioid stewardship payment. On an annual basis, the director of

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the department of health shall certify to the state treasurer the amount of all revenues collected

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from opioid stewardship payments and any penalties imposed. The amount of revenues so

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certified shall be deposited quarterly into the opioid stewardship fund restricted receipt account

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established pursuant to § 21-28.10-11.

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     21-28.10-3. Determination of opioid stewardship payment.

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     The total opioid stewardship payment amount shall be seven million five hundred

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thousand dollars ($7,500,000) annually, subject to downward adjustments pursuant to § 21-28.10-

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9.

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     21-28.10-4. Reports and records.

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     (a) Each manufacturer and distributor licensed to sell or distribute opioids in the state of

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Rhode Island shall provide to the director of the department of health a report detailing all opioids

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sold or distributed by such manufacturer or distributor in the state of Rhode Island. Such report

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shall include:

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     (1) The manufacturer's or distributor's name, address, phone number, federal Drug

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Enforcement Agency (DEA) registration number and controlled substance license number issued

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by the department;

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     (2) The name, address and DEA registration number of the entity to whom the opioid was

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sold or distributed;

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     (3) The date of the sale or distribution of the opioid;

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     (4) The gross receipt total, in dollars, of all opioids sold or distributed;

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     (5) The name and National Drug Code (NDC) of the opioid sold or distributed;

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     (6) The number of containers and the strength and metric quantity of controlled substance

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in each container of the opioid sold or distributed;

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     (7) The total number of morphine milligram equivalents (MMEs) sold or distributed; and

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     (8) Any other elements as deemed necessary by the director.

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     (b) Initial and future reports.

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     (1) Such information shall be reported annually to the department of health in such form

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as defined by the director; provided, however, that the initial report provided pursuant to

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subsection (a) of this section shall consist of all opioids sold or distributed in the state of Rhode

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Island for the 2018 calendar year, and must be submitted by August 1, 2019. Subsequent annual

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reports shall be submitted on April 1 of each year based on the actual opioid sales and

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distributions of the prior calendar year.

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     (2) For the purpose of such annual reporting, MMEs shall be determined pursuant to a

 

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formulation to be issued by the department and updated as the department deems appropriate.

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     21-28.10-5. Determination of ratable share.

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     Each manufacturer and distributor licensed to sell or distribute opioids in the state of

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Rhode Island shall pay a portion of the total opioid stewardship payment amount. The ratable

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share shall be calculated as follows:

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     (1) The total amount of MMEs sold or distributed in the state of Rhode Island by the

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licensee for the preceding calendar year, as reported by the licensee pursuant to § 21-28.10-4,

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shall be divided by the total amount of MMEs sold in the state of Rhode Island by all licensees

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pursuant to this chapter to determine the licensee payment percentage. The licensee payment

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percentage shall be multiplied by the total opioid stewardship payment. The product of such

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calculation shall be the licensee's ratable share. The department shall have the authority to adjust

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the total number of a licensee's MMEs to account for the nature and use of the product, as well as

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the type of entity purchasing the product from the licensee, when making such determination and

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adjust the ratable share accordingly.

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     (2) The licensee's total amount of MMEs sold or distributed, as well as the total amount

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of MMEs sold or distributed by all licensees under this chapter, used in the calculation of the

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ratable share, shall not include the MMEs of those opioids which are:

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     (i) Manufactured in Rhode Island, but whose final point of delivery or sale is outside of

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Rhode Island;

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     (ii) Sold or distributed to entities certified to operate as chemical dependency

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professionals, or hospice providers licensed pursuant to chapter 17 of title 23; or

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     (iii) The MMEs attributable to buprenorphine, methadone or morphine.

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     (3) The department shall provide to the licensee, in writing, on or before October 15,

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2019, the licensee's ratable share for the 2018 calendar year. Thereafter, the department shall

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notify the licensee in writing annually on or before October 15 of each year based on the opioids

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sold or distributed for the prior calendar year.

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     21-28.10-6. Payment of ratable share.

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     The licensee shall make payments quarterly to the department with the first payment of

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the ratable share; provided that, the amount due on January 1, 2020 shall be for the full amount of

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the first annual payment, with additional payments to be due and owing on the first day of every

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quarter thereafter.

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     21-28.10-7. Rebate of ratable share.

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     In any year for which the director determines that a licensee failed to report required

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information as required by this chapter, those licensees complying with this chapter shall receive

 

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a reduced assessment of their ratable share in the following year equal to the amount in excess of

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any overpayment in the prior payment period.

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     21-28.10-8. Licensee opportunity to appeal.

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     A licensee shall be afforded an opportunity to submit information to the department to

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justify why the ratable share provided to the licensee, pursuant to § 21-28.10-5, or amounts paid

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thereunder are in error or otherwise not warranted. If the department determines thereafter that all

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or a portion of such ratable share, as determined by the director pursuant to §21-28.10-5, is not

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warranted, the department may:

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     (1) Adjust the ratable share;

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     (2) Adjust the assessment of the ratable share in the following year equal to the amount in

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excess of any overpayment in the prior payment period; or

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     (3) Refund amounts paid in error.

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     21-28.10-9. Department annual review.

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     The department shall annually review the amount of state operating funds spent in the

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offices dedicated to substance use disorders within the department of behavioral healthcare,

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developmental disabilities and hospitals (BHDDH), the executive office of health and human

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services (EOHHS), the department of children, youth and families (DCYF), the Rhode Island

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department of education (RIDE), the Rhode Island office of veterans' affairs (RIOVA), the

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department of corrections (DOC), and the department of labor and training (DLT), for opioid

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prevention, treatment and recovery. The directors of BHDDH, EOHHS, DCYF, RIDE, RIOVA,

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DOC, and DLT shall certify to the department the amount of annual spending for such services,

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utilizing available information on patient demographics and the actual cost of services delivered

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by the state and by state-funded providers. The certification of such spending shall begin in state

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fiscal year 2019, and continue annually thereafter. The total amount of such spending shall be

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provided to the department by the directors of BHDDH, EOHHS, DCYF, RIDE, RIOVA, DOC,

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and DLT no later than June 30 of each year. The director shall certify to the governor the amount

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of annual spending for such services, utilizing available information on patient demographics and

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the actual cost of services delivered by the state and by state-funded providers.

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     21-28.10-10. Penalties.

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     (a) The department may assess a civil penalty in an amount not to exceed one thousand

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dollars ($1,000) per day against any licensee that fails to comply with this chapter.

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     (b) In addition to any other civil or criminal penalty provided by law, where a licensee

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has failed to pay its ratable share in accordance with § 21-28.10-6, the department may also

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assess a penalty of no less than ten percent (10%) and no greater than three hundred percent

 

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(300%) of the ratable share due from such licensee.

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     21-28.10-11. Opioid stewardship fund - restricted receipt account.

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     (a) There is hereby established in the custody of the department of health and the

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administrator of the division of taxation, a restricted receipt account to be known as the "opioid

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stewardship fund."

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     (b) Monies in the opioid stewardship fund shall be kept separate and shall not be

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commingled with any other monies in the custody of the state treasurer and the administrator of

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the division of taxation.

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     (c) The opioid stewardship fund shall consist of monies appropriated for the purpose of

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such account, monies transferred to such account pursuant to law, contributions consisting of

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promises or grants of any money or property of any kind or value, or any other thing of value,

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including grants or other financial assistance from any agency of government and monies

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required by the provisions of this chapter or any other law to be paid into or credited to this

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account.

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     (d) Monies of the opioid stewardship fund, when allocated, shall be available, subject to

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the approval of the director of the budget, to support programs operated by the Rhode Island

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department of behavioral healthcare, developmental disabilities and hospitals (BHDDH), the

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executive office of health and human services (EOHHS), the department of children, youth and

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families (DCYF), the Rhode Island department of education (RIDE), the Rhode Island office of

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veterans' affairs (RIOVA), the department of corrections (DOC), the department of labor and

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training (DLT) or agencies certified, authorized, approved or otherwise funded by the Rhode

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Island department of health to provide opioid treatment, recovery and prevention and education

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services.

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     (e) At the request of the budget director, the state comptroller shall transfer monies to

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support the costs of opioid treatment, recovery, prevention, education services, and other related

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programs, from the opioid stewardship fund to any other fund of the state to support this purpose.

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     (f)(1) Notwithstanding the provisions of any general or special law, no monies shall be

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available from the opioid stewardship fund until a certificate of allocation and a schedule of

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amounts to be available therefor shall have been issued by the director, and a copy of such

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certificate filed with the general treasurer's office, the chairperson of the house finance committee

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and the chairperson of the senate finance committee.

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     (2) Such certificate may be amended from time to time by the director, and a copy of

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such amendment shall be filed with the treasurer, the chairperson of the house finance committee

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and the chairperson of the senate finance committee.

 

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     21-28.10-12. Allocation.

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     The monies, when allocated, shall be paid out of the opioid stewardship fund, and subject

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to the approval of the director pursuant to the provisions of this chapter.

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     21-28.10-13. Severability.

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     If any clause, sentence, paragraph, subdivision, or section of this act shall be adjudged by

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any court of competent jurisdiction to be invalid, such judgment shall not affect, impair, or

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invalidate the remainder thereof, but shall be confined in its operation to the clause, sentence,

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paragraph, subdivision, or section directly involved in the controversy in which such judgment

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shall have been rendered. It is hereby declared to be the intent of the legislature that this act

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would have been enacted even if such invalid provisions had not been included herein.

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     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- OPIOID STEWARDSHIP ACT

***

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     This act would establish an opioid stewardship payment program requiring manufacturers

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and distributors of opioids to pay an amount, based on the amount of opioids manufactured or

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distributed, into a fund which would be used to support programs operated by the department of

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behavioral healthcare, developmental disabilities and hospitals (BHDDH), the executive office of

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health and human services (EOHHS), the department of children, youth and families (DCYF), the

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Rhode Island department of education (RIDE), the Rhode Island office of veterans' affairs

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(RIOVA), the department of corrections (DOC), the department of labor and training (DLT) or

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agencies certified, authorized, approved or otherwise funded by the Rhode Island department of

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health (DOH) to provide opioid treatment, recovery and prevention and education services.

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     This act would take effect upon passage.

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