Senate Bill #798 (2019)

AN ACT RELATING TO FOOD AND DRUGS -- OPIOID STEWARDSHIP ACT

Establishes an opioid stewardship payment program which manufacturers and distributors of opioids would pay into, to support opioid treatment programs.

View latest version | View original version
View status on official RI website

Subscribe to email updates


Changes since original draft

  • 2019 – S 0798
  • 2019 – S 0798 SUBSTITUTE A
  • ========
  • LC002256
  • LC002256/SUB A/2
  • ========
  • S T A T E O F R H O D E I S L A N D
  • IN GENERAL ASSEMBLY
  • JANUARY SESSION, A.D. 2019
  • IN GENERAL ASSEMBLY
  • JANUARY SESSION, A.D. 2019
  • ____________
  • A N A C T
  • RELATING TO FOOD AND DRUGS – OPIOID STEWARDSHIP ACT
  • Introduced By: Senators Ruggerio, Coyne, Miller, Sosnowski, and DiPalma
  • Date Introduced: April 10, 2019
  • Referred To: Senate Finance
  • Introduced By: Senators Ruggerio, Coyne, Miller, Sosnowski, and DiPalma
  • Date Introduced: April 10, 2019
  • Referred To: Senate Finance
  • It is enacted by the General Assembly as follows:
  • SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby amended by adding thereto the following chapter:
  • CHAPTER 28.10
  • OPIOID STEWARDSHIP ACT
  • 21-28.10-1. Definitions.
  • Unless the context otherwise requires, the following terms shall be construed in this chapter to have the following meanings:
  • (1) "Distribute" means to deliver a controlled substance other than by administering or dispensing to the ultimate user, including intra-company transfers between any division, affiliate, subsidiary, parent or other entity under complete common ownership and control.
  • (2) "Opioid stewardship payment" means the total amount to be paid into the opioid stewardship fund for each state fiscal year as set forth in § 21-28.10-2.
  • (3) "Ratable share" means the individual portion of the opioid stewardship payment to be paid by each manufacturer and distributor licensed under this title that sells or distributes opioids in the state of Rhode Island.
  • 21-28.10-2. Opioid stewardship payment imposed on manufacturers and distributors.
  • All manufacturers and distributors licensed or registered under this title or chapter 19.1 of title 5 (hereinafter referred to as "licensees"), that sell or distribute opioids in the state of Rhode Island shall be required to pay an opioid stewardship payment. On an annual basis, the director of the department of health shall certify to the state treasurer the amount of all revenues collected from opioid stewardship payments and any penalties imposed. The amount of revenues so certified shall be deposited quarterly into the opioid stewardship fund restricted receipt account established pursuant to § 21-28.10-11.
  • 21-28.10-3. Determination of opioid stewardship payment.
  • The total opioid stewardship payment amount shall be seven million five hundred thousand dollars ($7,500,000) annually, subject to downward adjustments pursuant to § 21-28.10- 9.
  • (1) "Department" means the Rhode Island department of health.
  • (2) "Director" means the director of the Rhode Island department of health.
  • (3) "Distribute" means distribute as defined in § 21-28-1.02.
  • (4) "Distributor" means distributor as defined in § 21-28-1.02.
  • (5) "Manufacture" means manufacture as defined in § 21-28-1.02.
  • (6) "Manufacturer" means manufacturer as defined in § 21-28-1.02.
  • (7) "Market share" means the total opioid stewardship fund amount measured as a percentage of each manufacturer's, distributor's and wholesaler's gross, in-state, opioid sales in dollars from the previous calendar year as reported to the U.S. Drug Enforcement Administration (DEA) on its Automation of Reports and Consolidated Orders System (ARCOS) report.
  • (8) "Wholesaler" means wholesaler as defined in § 21-28-1.02.
  • 21-28.10-2. Opioid registration fee imposed on manufacturers, distributors, and wholesalers.
  • All manufacturers, distributors, and wholesalers licensed or registered under this title or chapter 19.1 of title 5 (hereinafter referred to as "licensees"), that manufacture or distribute opioids shall be required to pay an opioid registration fee. On an annual basis, the director shall certify the amount of all revenues collected from opioid registration fees and any penalties imposed, to the general treasurer. The amount of revenues so certified shall be deposited quarterly into the opioid stewardship fund restricted receipt account established pursuant to § 21-28.10-10.
  • 21-28.10-3. Determination of market share and registration fee.
  • (1) The total opioid stewardship fund amount shall be five million dollars ($5,000,000) annually, subject to downward adjustments pursuant to § 21-28.10-7.
  • (2) Each manufacturer's, distributor's, and wholesaler's annual opioid registration fee shall be based on that licensee's in-state market share.
  • (3) The following sales will not be included when determining a manufacturer's, distributor's, or wholesaler's market share:
  • (i) The gross, in-state opioid sales attributed to the sale of buprenorphine or methadone;
  • (ii) The gross, in-state opioid sales sold or distributed directly to opioid treatment programs, data-waivered practitioners, or hospice providers licensed pursuant to chapter 17 of title 23;
  • (iii) Any sales from those opioids manufactured in Rhode Island, but whose final point of delivery or sale is outside of Rhode Island; and
  • (iv) Any sales of anesthesia or epidurals as defined in regulation by the department.
  • (4) The department shall provide to the licensee, in writing, on or before October 15, 2019, the licensee's market share for the 2018 calendar year. Thereafter, the department shall notify the licensee, in writing, on or before October 15 of each year, of its market share for the prior calendar year based on the opioids sold or distributed for the prior calendar year.
  • 21-28.10-4. Reports and records.
  • (a) Each manufacturer and distributor licensed to sell or distribute opioids in the state of Rhode Island shall provide to the director of the department of health a report detailing all opioids sold or distributed by such manufacturer or distributor in the state of Rhode Island. Such report shall include:
  • (1) The manufacturer's or distributor's name, address, phone number, federal Drug Enforcement Agency (DEA) registration number and controlled substance license number issued by the department;
  • (2) The name, address and DEA registration number of the entity to whom the opioid was sold or distributed;
  • (3) The date of the sale or distribution of the opioid;
  • (a) Each manufacturer, distributor, and wholesaler licensed to manufacture or distribute opioids in the state of Rhode Island shall provide to the director a report detailing all opioids sold or distributed by such manufacturer or distributor in the state of Rhode Island. Such report shall include:
  • (1) The manufacturer's, distributor's, or wholesaler's name, address, phone number, DEA registration number, and controlled substance license number issued by the department;
  • (2) The name, address, and DEA registration number of the entity to whom the opioid was sold or distributed;
  • (3) The date of the sale or distribution of the opioids;
  • (4) The gross receipt total, in dollars, of all opioids sold or distributed;
  • (5) The name and National Drug Code (NDC) of the opioid sold or distributed;
  • (6) The number of containers and the strength and metric quantity of controlled substance in each container of the opioid sold or distributed;
  • (7) The total number of morphine milligram equivalents (MMEs) sold or distributed; and
  • (8) Any other elements as deemed necessary by the director.
  • (5) The name and National Drug Code of the opioids sold or distributed;
  • (6) The number of containers and the strength and metric quantity of controlled substance in each container of the opioids sold or distributed; and
  • (7) Any other elements as deemed necessary or advisable by the director.
  • (b) Initial and future reports.
  • (1) Such information shall be reported annually to the department of health in such form as defined by the director; provided, however, that the initial report provided pursuant to subsection (a) of this section shall consist of all opioids sold or distributed in the state of Rhode Island for the 2018 calendar year, and must be submitted by August 1, 2019. Subsequent annual reports shall be submitted on April 1 of each year based on the actual opioid sales and distributions of the prior calendar year.
  • (2) For the purpose of such annual reporting, MMEs shall be determined pursuant to a formulation to be issued by the department and updated as the department deems appropriate.
  • 21-28.10-5. Determination of ratable share.
  • Each manufacturer and distributor licensed to sell or distribute opioids in the state of Rhode Island shall pay a portion of the total opioid stewardship payment amount. The ratable share shall be calculated as follows:
  • (1) The total amount of MMEs sold or distributed in the state of Rhode Island by the licensee for the preceding calendar year, as reported by the licensee pursuant to § 21-28.10-4, shall be divided by the total amount of MMEs sold in the state of Rhode Island by all licensees pursuant to this chapter to determine the licensee payment percentage. The licensee payment percentage shall be multiplied by the total opioid stewardship payment. The product of such calculation shall be the licensee's ratable share. The department shall have the authority to adjust the total number of a licensee's MMEs to account for the nature and use of the product, as well as the type of entity purchasing the product from the licensee, when making such determination and adjust the ratable share accordingly.
  • (2) The licensee's total amount of MMEs sold or distributed, as well as the total amount of MMEs sold or distributed by all licensees under this chapter, used in the calculation of the ratable share, shall not include the MMEs of those opioids which are:
  • (i) Manufactured in Rhode Island, but whose final point of delivery or sale is outside of Rhode Island;
  • (ii) Sold or distributed to entities certified to operate as chemical dependency professionals, or hospice providers licensed pursuant to chapter 17 of title 23; or
  • (iii) The MMEs attributable to buprenorphine, methadone or morphine.
  • (3) The department shall provide to the licensee, in writing, on or before October 15, 2019, the licensee's ratable share for the 2018 calendar year. Thereafter, the department shall notify the licensee in writing annually on or before October 15 of each year based on the opioids sold or distributed for the prior calendar year.
  • 21-28.10-6. Payment of ratable share.
  • The licensee shall make payments quarterly to the department with the first payment of the ratable share; provided that, the amount due on January 1, 2020 shall be for the full amount of the first annual payment, with additional payments to be due and owing on the first day of every quarter thereafter.
  • 21-28.10-7. Rebate of ratable share.
  • In any year for which the director determines that a licensee failed to report required information as required by this chapter, those licensees complying with this chapter shall receive a reduced assessment of their ratable share in the following year equal to the amount in excess of any overpayment in the prior payment period.
  • 21-28.10-8. Licensee opportunity to appeal.
  • A licensee shall be afforded an opportunity to submit information to the department to justify why the ratable share provided to the licensee, pursuant to § 21-28.10-5, or amounts paid thereunder are in error or otherwise not warranted. If the department determines thereafter that all or a portion of such ratable share, as determined by the director pursuant to §21-28.10-5, is not warranted, the department may:
  • (1) Adjust the ratable share;
  • (2) Adjust the assessment of the ratable share in the following year equal to the amount in excess of any overpayment in the prior payment period; or
  • Such information shall be reported annually to the department via ARCOS or in such other form as defined or approved by the director; provided, however, that the initial report provided pursuant to subsection (a) of this section shall consist of all opioids sold or distributed in the state of Rhode Island for the 2018 calendar year, and shall be submitted by August 1, 2019. Subsequent annual reports shall be submitted by April 1 of each year based on the actual opioid sales and distributions of the prior calendar year.
  • 21-28.10-5. Payment of market share.
  • The licensee shall make payments quarterly to the department with the first payment of its market share due on January 1, 2020; provided, that the amount due on January 1, 2020 shall be for the full amount of the payment for the 2018 calendar year, with subsequent payments to be due and owing on the first day of every quarter thereafter.
  • 21-28.10-6. Rebate of market share.
  • In any year for which the director determines that a licensee failed to report information required by this chapter, those licensees complying with this chapter shall receive a reduced assessment of their market share in the following year equal to the amount in excess of any overpayment in the prior payment period.
  • 21-28.10-7. Licensee opportunity to appeal.
  • (a) A licensee shall be afforded an opportunity to submit information to the department documenting or evidencing that the market share provided to the licensee (or amounts paid thereunder), pursuant to § 21-28.10-3(4), is in error or otherwise not warranted. The department may consider and examine such additional information that it determines to be reasonably related to resolving the calculation of a licensee's market share, which may require the licensee to provide additional materials to the department. If the department determines thereafter that all or a portion of such market share, as determined by the director pursuant to § 21-28.10-3(4), is not warranted, the department may:
  • (1) Adjust the market share;
  • (2) Adjust the assessment of the market share in the following year equal to the amount in excess of any overpayment in the prior payment period; or
  • (3) Refund amounts paid in error.
  • 21-28.10-9. Department annual review.
  • The department shall annually review the amount of state operating funds spent in the offices dedicated to substance use disorders within the department of behavioral healthcare, developmental disabilities and hospitals (BHDDH), the executive office of health and human services (EOHHS), the department of children, youth and families (DCYF), the Rhode Island department of education (RIDE), the Rhode Island office of veterans' affairs (RIOVA), the department of corrections (DOC), and the department of labor and training (DLT), for opioid prevention, treatment and recovery. The directors of BHDDH, EOHHS, DCYF, RIDE, RIOVA, DOC, and DLT shall certify to the department the amount of annual spending for such services, utilizing available information on patient demographics and the actual cost of services delivered by the state and by state-funded providers. The certification of such spending shall begin in state fiscal year 2019, and continue annually thereafter. The total amount of such spending shall be provided to the department by the directors of BHDDH, EOHHS, DCYF, RIDE, RIOVA, DOC, and DLT no later than June 30 of each year. The director shall certify to the governor the amount of annual spending for such services, utilizing available information on patient demographics and the actual cost of services delivered by the state and by state-funded providers.
  • 21-28.10-10. Penalties.
  • (b) Any person aggrieved by a decision of the department relating to the calculation of market share may appeal that decision to the superior court, which shall have power to review such decision, and the process by which such decision was made, as prescribed in chapter 35 of title 42.
  • (c) A licensee shall also have the ability to appeal its assessed opioid registration fee if the assessed fee amount exceeds the amount of profit the licensee obtains through sales in the state of products described in § 21-28.10-3. The department may, exercising discretion as it deems appropriate, waive or decrease fees as assessed pursuant to § 21-28.10-3 if a licensee can demonstrate that the correctly assessed payment will pose undue hardship to the licensee's continued activities in state. The department shall be allowed to request, and the licensee shall furnish to the department, any information or supporting documentation validating the licensee's request for waiver or reduction under this subsection. Fees waived under this section shall not be reapportioned to other licensees which have payments due under this chapter.
  • 21-28.10-8. Departmental annual reporting.
  • By January of each calendar year, the department of behavioral healthcare, developmental disabilities and hospitals (BHDDH), the executive office of health and human services (EOHHS), the department of children, youth and families (DCYF), the Rhode Island department of education (RIDE), the Rhode Island office of veterans' affairs (RIOVA), the department of corrections (DOC), and the department of labor and training (DLT) shall report annually to the governor, the speaker of the house, and the senate president which programs in their respective departments were funded using monies from the opioid stewardship fund and the total amount of funds spent on each program.
  • 21-28.10-9. Penalties.
  • (a) The department may assess a civil penalty in an amount not to exceed one thousand dollars ($1,000) per day against any licensee that fails to comply with this chapter.
  • (b) In addition to any other civil or criminal penalty provided by law, where a licensee has failed to pay its ratable share in accordance with § 21-28.10-6, the department may also assess a penalty of no less than ten percent (10%) and no greater than three hundred percent (300%) of the ratable share due from such licensee.
  • 21-28.10-11. Opioid stewardship fund - restricted receipt account.
  • (a) There is hereby established in the custody of the department of health and the administrator of the division of taxation, a restricted receipt account to be known as the "opioid stewardship fund."
  • (b) Monies in the opioid stewardship fund shall be kept separate and shall not be commingled with any other monies in the custody of the state treasurer and the administrator of the division of taxation.
  • (b)(1) In addition to any other civil penalty provided by law, where a licensee has failed to pay its market share in accordance with § 21-28.10-5, the department may also assess a penalty of no less than ten percent (10%) and no greater than three hundred percent (300%) of the market share due from such licensee.
  • (2) In addition to any other criminal penalty provided by law, where a licensee has failed to pay its market share in accordance with § 21-28.10-5, the department may also assess a penalty of no less than ten percent (10%) and no greater than fifty percent (50%) of the market share due from such licensee.
  • 21-28.10-10. Creation of opioid stewardship fund.
  • (a) There is hereby established, in the custody of the department, a restricted receipt account to be known as the "opioid stewardship fund."
  • (b) Monies in the opioid stewardship fund shall be kept separate and shall not be commingled with any other monies in the custody of the department.
  • (c) The opioid stewardship fund shall consist of monies appropriated for the purpose of such account, monies transferred to such account pursuant to law, contributions consisting of promises or grants of any money or property of any kind or value, or any other thing of value, including grants or other financial assistance from any agency of government and monies required by the provisions of this chapter or any other law to be paid into or credited to this account.
  • (d) Monies of the opioid stewardship fund, when allocated, shall be available, subject to the approval of the director of the budget, to support programs operated by the Rhode Island department of behavioral healthcare, developmental disabilities and hospitals (BHDDH), the executive office of health and human services (EOHHS), the department of children, youth and families (DCYF), the Rhode Island department of education (RIDE), the Rhode Island office of veterans' affairs (RIOVA), the department of corrections (DOC), the department of labor and training (DLT) or agencies certified, authorized, approved or otherwise funded by the Rhode Island department of health to provide opioid treatment, recovery and prevention and education services.
  • (e) At the request of the budget director, the state comptroller shall transfer monies to support the costs of opioid treatment, recovery, prevention, education services, and other related programs, from the opioid stewardship fund to any other fund of the state to support this purpose.
  • (f)(1) Notwithstanding the provisions of any general or special law, no monies shall be available from the opioid stewardship fund until a certificate of allocation and a schedule of amounts to be available therefor shall have been issued by the director, and a copy of such certificate filed with the general treasurer's office, the chairperson of the house finance committee and the chairperson of the senate finance committee.
  • (2) Such certificate may be amended from time to time by the director, and a copy of such amendment shall be filed with the treasurer, the chairperson of the house finance committee and the chairperson of the senate finance committee.
  • 21-28.10-12. Allocation.
  • The monies, when allocated, shall be paid out of the opioid stewardship fund, and subject to the approval of the director pursuant to the provisions of this chapter.
  • 21-28.10-13. Severability.
  • (d) Monies of the opioid stewardship fund shall be available to provide opioid treatment, recovery, prevention, education services, and other related programs, subject to appropriation by the general assembly.
  • 21-28.10-11. Allocation.
  • The monies, when allocated, shall be paid out of the opioid stewardship fund and subject to the approval of the director and the approval of the director of the department of behavioral healthcare, developmental disabilities and hospitals (BHDDH), pursuant to the provisions of this chapter.
  • 21-28.10-12. Severability.
  • If any clause, sentence, paragraph, subdivision, or section of this act shall be adjudged by any court of competent jurisdiction to be invalid, such judgment shall not affect, impair, or invalidate the remainder thereof, but shall be confined in its operation to the clause, sentence, paragraph, subdivision, or section directly involved in the controversy in which such judgment shall have been rendered. It is hereby declared to be the intent of the legislature that this act would have been enacted even if such invalid provisions had not been included herein.
  • SECTION 2. This act shall take effect upon passage.
  • ========
  • LC002256
  • ========
  • 21-28.10-13. Rules and regulations.
  • The director may prescribe rules and regulations, not inconsistent with law, to carry into effect the provisions of chapter 28.10 of title 21, which rules and regulations, when reasonably designed to carry out the intent and purpose of this chapter, are prima facie evidence of its proper interpretation. Such rules and regulations may be amended, suspended, or revoked, from time to time and in whole or in part, by the director. The director may prescribe, and may furnish, any forms necessary or advisable for the administration of this chapter.
  • SECTION 2. This act shall take effect upon passage. ======== LC002256/SUB A/2 ========
  • EXPLANATION
  • BY THE LEGISLATIVE COUNCIL
  • OF
  • A N A C T
  • RELATING TO FOOD AND DRUGS – OPIOID STEWARDSHIP ACT
  • ***
  • This act would establish an opioid stewardship payment program requiring manufacturers and distributors of opioids to pay an amount, based on the amount of opioids manufactured or distributed, into a fund which would be used to support programs operated by the department of behavioral healthcare, developmental disabilities and hospitals (BHDDH), the executive office of health and human services (EOHHS), the department of children, youth and families (DCYF), the Rhode Island department of education (RIDE), the Rhode Island office of veterans' affairs (RIOVA), the department of corrections (DOC), the department of labor and training (DLT) or agencies certified, authorized, approved or otherwise funded by the Rhode Island department of health (DOH) to provide opioid treatment, recovery and prevention and education services.
  • This act would take effect upon passage.
  • ========
  • LC002256
  • LC002256/SUB A/2
  • ========

Votes

RIBIT does not have any votes for this legislation yet.
(Vote tracking on RIBIT is still a work-in-progress, so make sure to check the official RI website, too!)