NY Pub Health L § 3323 (2021)
2021 New York Laws PBH - Public Health Article 33 - Controlled Substances Title 2-A - Opioid Stewardship Act 3323 - Opioid Stewardship Fund.

* § 3323. Opioid stewardship fund. 1. Definitions:  (a)  "Opioid  stewardship  payment"  shall mean the total amount to be paid into the opioid stewardship fund for each state fiscal year as  set forth in subdivision two of this section.  (b)  "Ratable  share"  shall mean the individual portion of the opioid stewardship payment to be paid  by  each  manufacturer  and  distributor licensed  under  this  article  that sells or distributes opioids in the state of New York.  (c) Notwithstanding any inconsistent provision of law to the contrary, "distribute" shall mean 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. For purposes of this section,  "distribute"  shall  not  include  controlled substances  surrendered to reverse distributors, or donated to recipient entities  or  third-party  intermediaries   pursuant   to   the   unused prescription  drug  donation  and  redispensing  program  of section two hundred eighty-b of this chapter.   2.  Opioid  stewardship   payment   imposed   on   manufacturers   and distributors.    All  manufacturers and distributors licensed under this article  (hereinafter  referred  to  as  "licensees"),  that   sell   or distribute  opioids in the state of New York shall be required to pay an opioid stewardship payment. On an annual basis, the  commissioner  shall certify  to  the  state comptroller 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 established pursuant to section  ninety-seven-aaaaa  of the  state finance law. No licensee shall pass the cost of their ratable share amount to a purchaser, including the ultimate user of the  opioid, or  such  licensee shall be subject to penalties pursuant to subdivision ten of this section.   3. Determination of  opioid  stewardship  payment.  The  total  opioid stewardship   payment  amount  shall  be  one  hundred  million  dollars annually, subject to downward adjustments pursuant to  subdivision  nine of this section.   4.  Reports  and  records.  Each manufacturer and distributor licensed under this article that sells or distributes opioids in the state of New York shall provide to the commissioner a report  detailing  all  opioids sold  or distributed by such manufacturer or distributor in the state of New York. Such report shall include:  (a) 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;  (b)  the  name,  address  and DEA registration number of the entity to whom the opioid was sold or distributed;  (c) the date of the sale or distribution of the opioid;  (d) the gross receipt total,  in  dollars,  of  all  opioids  sold  or distributed;  (e)  the  name  and  National  Drug  Code  (NDC) of the opioid sold or distributed;  (f) the number of containers and the strength and metric  quantity  of controlled   substance   in   each  container  of  the  opioid  sold  or distributed;  (g) the total number of morphine milligram equivalents (MMEs) sold  or distributed; and  (h) any other elements as deemed necessary by the commissioner.   4-a.  Initial  and  future  reports.  (a)  Such  information  shall be reported annually to the department in  such  form  as  defined  by  the  commissioner, provided however that the initial report provided pursuant to  subdivision four shall consist of all opioids sold or distributed in the state of New York for the two thousand seventeen calendar year,  and must  be submitted by August 1, 2018. Subsequent annual reports shall be submitted on April first of each year based on the actual  opioid  sales and distributions of the prior calendar year.  (b) 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.   5. Determination of ratable share. Each manufacturer  and  distributor licensed  under  this  article  that sells or distributes opioids in the state of New York shall pay a portion of the  total  opioid  stewardship payment amount. The ratable share shall be calculated as follows:  (a)  The  total amount of MMEs sold or distributed in the state of New York by the licensee for the preceding calendar year, as reported by the licensee pursuant to subdivision four of this section, shall be  divided by  the  total  amount  of  MME  sold  in  the  state of New York by all licensees pursuant to this article 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.  (b) The licensee's total amount of MME sold or distributed, as well as the  total amount of MME sold or distributed by all licensees under this article, used in the calculation of the ratable share shall not  include the  MME of those opioids which are: (i) manufactured in New York state, but whose final point of delivery or sale is outside of New York  state; (ii)  sold  or  distributed to entities certified to operate pursuant to article thirty-two of the mental hygiene law, or article  forty  of  the public  health  law;  or  (iii)  the MMEs attributable to buprenorphine, methadone or morphine.  (c) The department shall provide to the licensee, in  writing,  on  or before  October fifteenth, two thousand eighteen, the licensee's ratable share for the two thousand  seventeen  calendar  year.  Thereafter,  the department  shall  notify  the licensee in writing annually on or before October fifteenth of each year based on the opioids sold or  distributed for the prior calendar year.   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  first,  two  thousand  nineteen 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.   7.  Rebate  of  ratable  share. In any year for which the commissioner determines that a licensee failed  to  report  required  information  as required  by  this  section, those licensees complying with this section 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.   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  paragraph  (c)  of subdivision  five  of  this  section,  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  commissioner  pursuant  to subdivision five of this section, is not warranted, the department may: (a) adjust the ratable share; (b)  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 (c) refund amounts paid in error.   9. Department annual review. The department shall annually review  the amount  of  state  operating funds spent in the office of alcoholism and substance abuse services (OASAS) budget for opioid prevention, treatment and recovery. The commissioner of OASAS 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  two  thousand eighteen-nineteen, and continue annually thereafter. The total amount of such spending shall be provided to the department by the commissioner of OASAS  no  later  than  June  thirtieth  of each year. There shall be no stewardship fund payments beginning on July first  in  the  event  state operating  funds  spent  in  the  OASAS  budget  for  opioid prevention, treatment and recovery in the most recently reported year is equal to or less than state operating funds spent for such purposes in state  fiscal year two thousand nine-ten.   10.  Penalties.  (a)  The  department may assess a civil penalty in an amount not to exceed one thousand dollars per day against  any  licensee that fails to comply with subdivisions four and four-a of this section.  (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  subdivision  six of this section, the department may also assess a penalty of no less than ten percent and no greater  than  three  hundred percent of the ratable share due from such licensee.  (c)  Where  the ratable share, or any portion thereof, has been passed on to a purchaser by a licensee, the commissioner may impose  a  penalty not to exceed one million dollars per incident.   * NB Repealed June 30, 2024