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This entry was published on 2018-07-13
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SECTION 3323
Opioid stewardship fund
Public Health (PBH) CHAPTER 45, ARTICLE 33, TITLE 2-A
* § 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