N.Y. Public Health Law § 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, 2029