Today's Law As Amended

PDF |Add To My Favorites |Track Bill | print page

AB-2486 Opioid Prevention and Rehabilitation Act.(2017-2018)



SECTION 1.

 Division 10.4 (commencing with Section 11730) is added to the Health and Safety Code, to read:

DIVISION 10.4. OPIOID PREVENTION AND REHABILITATION ACT

11730.
 This division shall be known, and may be cited, as the Opioid Prevention and Rehabilitation Act.

PART 1. Definitions

11731.
 For purposes of this division, the following definitions apply:
(a) “Department” means the State Department of Public Health.
(b) “Opioid stewardship payment” means the total amount to be paid into the Opioid Prevention and Rehabilitation Program Fund for each fiscal year, as described in Section 11734.
(c) “Ratable share” means the individual portion of the opioid stewardship payment to be paid by each manufacturer or wholesaler that is subject to this division.
(d) “Opioid” means an opiate or any synthetic or semisynthetic narcotic that has opiate-like activities but is not derived from opium and has effects similar to natural opium alkaloids, and any derivatives thereof.
(e) “Opiate” means the dried, condensed juice of a poppy, Papaver somniferum, that has a narcotic, soporific, analgesic, and astringent effect.
(f) “Distribute” or “distribution” means the delivery for sale of an opioid drug other than by administering or dispensing to the ultimate user, including intracompany transfers between any division, affiliate, subsidiary, parent, or other entity under complete common ownership and control.

PART 2. Opioid Sale or Distribution Reporting

11732.
 Commencing with the 2020–21 fiscal year, and for each fiscal year thereafter, a manufacturer or wholesaler that sells or distributes opioid drugs in this state shall submit to the department a report that details all opioid drugs sold or distributed by the manufacturer or wholesaler in this state during the preceding fiscal year. To the extent permitted by federal law, the report shall include all of the following information:
(a) The name, address, telephone number, federal Drug Enforcement Agency (DEA) registration number, and license number of the manufacturer or wholesaler, as applicable.
(b) The name, address, and DEA registration number of the entity to which the opioid drug was sold or distributed.
(c) The date of the sale or distribution of the opioid drug.
(d) The gross receipt total, in dollars, of all opioid drugs sold or distributed.
(e) The name and National Drug Code (NDC) of the opioid drug sold or distributed.
(f) The number of containers and the strength and metric quantity of controlled substances in each container of the opioid drug sold or distributed.
(g) The total number of morphine milligram equivalents (MMEs) attributed to the opioid drugs sold or distributed. MMEs shall be determined pursuant to a formulation that is issued by the department and updated as the department deems necessary to determine the ratable share pursuant to Section 11733.
(h) Any other elements relating to the sale or distribution of the opioid drug, as the department deems necessary to determine the ratable share pursuant to Section 11733.

PART 3. Ratable Share Determination

11733.
 (a) Commencing with the 2020–21 fiscal year, and for each fiscal year thereafter, the department, in consultation with the California State Board of Pharmacy, shall calculate the ratable share of a manufacturer or wholesaler that is subject to Section 11732, according to all of the following steps:
(1) The total number of morphine milligram equivalents (MMEs) attributed to opioid drugs sold or distributed in this state by the manufacturer or wholesaler for the preceding fiscal year, as reported pursuant to Section 11732, shall be divided by the total number of MMEs sold or distributed in this state by all manufacturers and wholesalers subject to this division for the preceding fiscal year, in order to determine the payment percentage for the manufacturer or wholesaler.
(2) The payment percentage shall be multiplied by the payment stewardship payment, as described in Section 11734.
(3) The product of the calculation described in paragraph (2) shall be the manufacturer or wholesaler’s ratable share.
(4) For purposes of the calculation of the ratable share, the total number of MMEs attributed to opioid drugs sold or distributed by a manufacturer or wholesaler shall not include either of the following:
(A) The number of MMEs attributed to opioid drugs that are manufactured in this state but the final point of delivery or sale of which is outside this state.
(B) The number of MMEs attributed to buprenorphine, methadone, or morphine.
(b) The department shall notify the manufacturer or wholesaler, in writing, of the value of the ratable share for that manufacturer or wholesaler.
(c) (1) The manufacturer or wholesaler shall have the opportunity to appeal the ratable share determination by submitting information to the department explaining why the ratable share determined pursuant to this section is erroneous or otherwise not warranted.
(2) Upon receipt of the information described in paragraph (1), if the department determines that all or a portion of the ratable share is not warranted, the department may do one of the following:
(A) Adjust the ratable share if the payment has not yet been made.
(B) Adjust the assessment of the ratable share in the following fiscal year by decreasing the ratable share by the amount that was overpaid in the current fiscal year.
(C) Refund the amount that was overpaid.

PART 4. Ratable Share Payment

11734.
 (a) Commencing with the 2020–21 fiscal year, and for each fiscal year thereafter, a manufacturer or a wholesaler subject to this division shall make quarterly payments, to the department, of the manufacturer’s or wholesaler’s corresponding ratable share of the opioid stewardship payment.
(b) A manufacturer or wholesaler shall not pass the cost of the ratable share payment to the purchaser of the opioid drug, including the ultimate user of the opioid drug.
(c) All ratable share payments described in subdivision (a), less refunds and the department’s administrative costs, shall be deposited quarterly into the Opioid Prevention and Rehabilitation Program Fund established pursuant to Section 11736.
(d) (1) The opioid stewardship payment shall be equal to one hundred million dollars ($100,000,000) for each fiscal year, which shall be the amount used to calculate the ratable share for a manufacturer or wholesaler pursuant to Section 11733.
(2) Notwithstanding paragraph (1), the combined sum of ratable share payments by manufacturers and wholesalers may be less than one hundred million dollars ($100,000,000) in a fiscal year, if the department makes adjustments to the ratable share of a manufacturer or wholesaler pursuant to Section 11733.

PART 5. Penalties

11735.
 (a) A manufacturer or wholesaler that fails to comply with the reporting requirements described in Section 11732 shall be subject to a civil penalty not exceeding one thousand dollars ($1,000) per calendar day.
(b) A manufacturer or wholesaler that fails to make a ratable share payment pursuant to subdivision (a) of Section 11734 shall be subject to a civil penalty of not less than 10 percent of, and not greater than 300 percent of, the ratable share payment that is due.
(c) A manufacturer or wholesaler that fails to comply with subdivision (b) of Section 11734, by passing the cost of the ratable share payment to the purchaser of the opioid drug, shall be subject to a civil penalty not exceeding one million dollars ($1,000,000) per incident.

PART 6. Opioid Prevention and Rehabilitation Program Fund

11736.
 (a) There is hereby created in the State Treasury the Opioid Prevention and Rehabilitation Program Fund.
(b) Notwithstanding Section 13340 of the Government Code, all moneys in the fund are continuously appropriated to the department to carry out the purposes described in Section 11736.5.
11736.5.
 (a) The department shall distribute moneys in the fund to counties on an annual basis pursuant to subdivision (b) for purposes of opioid prevention and rehabilitation programs.
(b) Distribution of moneys in the fund to counties shall be based on county needs, using the most recent data of only the following information, as provided by the department:
(1) The ratio of opioid overdose deaths per county population.
(2) The ratio of opioid overdose emergency department visits per county population.
(3) The ratio of opioid overdose hospitalizations per county population.
SEC. 2.
 This act provides for a tax levy within the meaning of Article IV of the California Constitution and shall go into immediate effect.