§ 3323 — Opioid stewardship fund

New York § 3323

• Jurisdiction: New York
• Law PBH: Public Health
• Title 2-A: Opioid Stewardship Act
• Art. 33: Controlled Substances

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* § 3323. Opioid stewardship fund. 1. Definitions:\n (a) "Opioid stewardship payment" shall mean the total amount to be\npaid into the opioid stewardship fund for each state fiscal year as set\nforth in subdivision two of this section.\n (b) "Ratable share" shall mean the individual portion of the opioid\nstewardship payment to be paid by each manufacturer and distributor\nlicensed under this article that sells or distributes opioids in the\nstate of New York.\n (c) Notwithstanding any inconsistent provision of law to the contrary,\n"distribute" shall mean to deliver a controlled substance other than by\nadministering or dispensing to the ultimate user, including\nintra-company transfers between any division, affiliate, subsidiary,\nparent or other entity under complete common ownership and control. For\npurposes of this section, "distribute" shall not include controlled\nsubstances surrendered to reverse distributors, or donated to recipient\nentities or third-party intermediaries pursuant to the unused\nprescription drug donation and redispensing program of section two\nhundred eighty-b of this chapter.\n 2. Opioid stewardship payment imposed on manufacturers and\ndistributors. All manufacturers and distributors licensed under this\narticle (hereinafter referred to as "licensees"), that sell or\ndistribute opioids in the state of New York shall be required to pay an\nopioid stewardship payment. On an annual basis, the commissioner shall\ncertify to the state comptroller the amount of all revenues collected\nfrom opioid stewardship payments and any penalties imposed. The amount\nof revenues so certified shall be deposited quarterly into the opioid\nstewardship fund established pursuant to section ninety-seven-aaaaa of\nthe state finance law. No licensee shall pass the cost of their ratable\nshare amount to a purchaser, including the ultimate user of the opioid,\nor such licensee shall be subject to penalties pursuant to subdivision\nten of this section.\n 3. Determination of opioid stewardship payment. The total opioid\nstewardship payment amount shall be one hundred million dollars\nannually, subject to downward adjustments pursuant to subdivision nine\nof this section.\n 4. Reports and records. Each manufacturer and distributor licensed\nunder this article that sells or distributes opioids in the state of New\nYork shall provide to the commissioner a report detailing all opioids\nsold or distributed by such manufacturer or distributor in the state of\nNew York. Such report shall include:\n (a) the manufacturer's or distributor's name, address, phone number,\nfederal Drug Enforcement Agency (DEA) registration number and controlled\nsubstance license number issued by the department;\n (b) the name, address and DEA registration number of the entity to\nwhom the opioid was sold or distributed;\n (c) the date of the sale or distribution of the opioid;\n (d) the gross receipt total, in dollars, of all opioids sold or\ndistributed;\n (e) the name and National Drug Code (NDC) of the opioid sold or\ndistributed;\n (f) the number of containers and the strength and metric quantity of\ncontrolled substance in each container of the opioid sold or\ndistributed;\n (g) the total number of morphine milligram equivalents (MMEs) sold or\ndistributed; and\n (h) any other elements as deemed necessary by the commissioner.\n 4-a. Initial and future reports. (a) Such information shall be\nreported annually to the department in such form as defined by the\ncommissioner, provided however that the initial report provided pursuant\nto subdivision four shall consist of all opioids sold or distributed in\nthe state of New York for the two thousand seventeen calendar year, and\nmust be submitted by August 1, 2018. Subsequent annual reports shall be\nsubmitted on April first of each year based on the actual opioid sales\nand distributions of the prior calendar year.\n (b) For the purpose of such annual reporting, MMEs shall be determined\npursuant to a formulation to be issued by the department and updated as\nthe department deems appropriate.\n 5. Determination of ratable share. Each manufacturer and distributor\nlicensed under this article that sells or distributes opioids in the\nstate of New York shall pay a portion of the total opioid stewardship\npayment amount. The ratable share shall be calculated as follows:\n (a) The total amount of MMEs sold or distributed in the state of New\nYork by the licensee for the preceding calendar year, as reported by the\nlicensee pursuant to subdivision four of this section, shall be divided\nby the total amount of MME sold in the state of New York by all\nlicensees pursuant to this article to determine the licensee payment\npercentage. The licensee payment percentage shall be multiplied by the\ntotal opioid stewardship payment. The product of such calculation shall\nbe the licensee's ratable share. The department shall have the authority\nto adjust the total number of a licensee's MMEs to account for the\nnature and use of the product, as well as the type of entity purchasing\nthe product from the licensee, when making such determination and adjust\nthe ratable share accordingly.\n (b) The licensee's total amount of MME sold or distributed, as well as\nthe total amount of MME sold or distributed by all licensees under this\narticle, used in the calculation of the ratable share shall not include\nthe MME of those opioids which are: (i) manufactured in New York state,\nbut whose final point of delivery or sale is outside of New York state;\n(ii) sold or distributed to entities certified to operate pursuant to\narticle thirty-two of the mental hygiene law, or article forty of the\npublic health law; or (iii) the MMEs attributable to buprenorphine,\nmethadone or morphine.\n (c) The department shall provide to the licensee, in writing, on or\nbefore October fifteenth, two thousand eighteen, the licensee's ratable\nshare for the two thousand seventeen calendar year. Thereafter, the\ndepartment shall notify the licensee in writing annually on or before\nOctober fifteenth of each year based on the opioids sold or distributed\nfor the prior calendar year.\n 6. Payment of ratable share. The licensee shall make payments\nquarterly to the department with the first payment of the ratable share,\nprovided that the amount due on January first, two thousand nineteen\nshall be for the full amount of the first annual payment, with\nadditional payments to be due and owing on the first day of every\nquarter thereafter.\n 7. Rebate of ratable share. In any year for which the commissioner\ndetermines that a licensee failed to report required information as\nrequired by this section, those licensees complying with this section\nshall receive a reduced assessment of their ratable share in the\nfollowing year equal to the amount in excess of any overpayment in the\nprior payment period.\n 8. Licensee opportunity to appeal. A licensee shall be afforded an\nopportunity to submit information to the department to justify why the\nratable share provided to the licensee, pursuant to paragraph (c) of\nsubdivision five of this section, or amounts paid thereunder are in\nerror or otherwise not warranted. If the department determines\nthereafter that all or a portion of such ratable share, as determined by\nthe commissioner pursuant to subdivision five of this section, is not\nwarranted, the department may: (a) adjust the ratable share; (b) adjust\nthe assessment of the ratable share in the following year equal to the\namount in excess of any overpayment in the prior payment period; or (c)\nrefund amounts paid in error.\n 9. Department annual review. The department shall annually review the\namount of state operating funds spent in the office of alcoholism and\nsubstance abuse services (OASAS) budget for opioid prevention, treatment\nand recovery. The commissioner of OASAS shall certify to the department\nthe amount of annual spending for such services, utilizing available\ninformation on patient demographics and the actual cost of services\ndelivered by the state and by state-funded providers. The certification\nof such spending shall begin in state fiscal year two thousand\neighteen-nineteen, and continue annually thereafter. The total amount of\nsuch spending shall be provided to the department by the commissioner of\nOASAS no later than June thirtieth of each year. There shall be no\nstewardship fund payments beginning on July first in the event state\noperating funds spent in the OASAS budget for opioid prevention,\ntreatment and recovery in the most recently reported year is equal to or\nless than state operating funds spent for such purposes in state fiscal\nyear two thousand nine-ten.\n 10. Penalties. (a) The department may assess a civil penalty in an\namount not to exceed one thousand dollars per day against any licensee\nthat fails to comply with subdivisions four and four-a of this section.\n (b) In addition to any other civil or criminal penalty provided by\nlaw, where a licensee has failed to pay its ratable share in accordance\nwith subdivision six of this section, the department may also assess a\npenalty of no less than ten percent and no greater than three hundred\npercent of the ratable share due from such licensee.\n (c) Where the ratable share, or any portion thereof, has been passed\non to a purchaser by a licensee, the commissioner may impose a penalty\nnot to exceed one million dollars per incident.\n * NB Repealed June 30, 2029\n