Amended in Assembly March 30, 2016

California Legislature—2015–16 Regular Session

Assembly BillNo. 1977


Introduced by Assembly Members Wood and Waldron

February 16, 2016


An act to addbegin insert Sections 2241.8 and 4069 to the Business and Professions Code, to addend insert Section 1367.217 to the Health and Safety Code, and to add Section 10123.203 to the Insurance Code, relating tobegin delete health coverage. end deletebegin insert prescription drugs.end insert

LEGISLATIVE COUNSEL’S DIGEST

AB 1977, as amended, Wood. begin deleteHealth end deletebegin insertHealing arts: prescriptions: health end insertcoverage: abuse-deterrent opioid analgesics.

begin insert

(1) Existing law, the Medical Practice Act, provides for the licensure and regulation of physicians and surgeons by the Medical Board of California. A violation of specified provisions of the Medical Practice Act is a crime.

end insert
begin insert

This bill would prohibit a physician and surgeon from prescribing more than a 5-day supply of an opioid analgesic drug product to a patient the first time that physician and surgeon prescribes a patient such an opioid for acute pain due to surgery or injury. The bill would apply that 5-day supply limitation even if the patient has previously been prescribed such an opioid from a different physician and surgeon. Because the violation of those limitation requirements would be a crime under the Medical Practice Act, the bill would impose a state-mandated local program.

end insert
begin insert

(2) Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy.

end insert
begin insert

This bill would require a pharmacist to inform a patient receiving for the first time an opioid analgesic drug product on proper storage and disposal of the drug. The bill would also require the California State Board of Pharmacy to adopt regulations to implement that requirement.

end insert
begin insert

Because a knowing violation of these provisions would be a crime, this bill would impose a state-mandated local program.

end insert

begin insert(3)end insertbegin insertend insertExisting law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of that act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. These provisions require specified services and drugs to be covered by the various health care service plans and health insurers.

This bill would require an individual or group health care service plan or disability insurance policy issued, amended, or renewed after January 1, to provide coverage on its formulary, drug list, or other lists of similar construct for at least one abuse-deterrent opioid analgesic drug product per opioid analgesic active ingredient. The bill would require that the total amount of copayments and coinsurance an enrollee or insured is required to pay for brand name abuse-deterrent opioid analgesic drug products covered pursuant to the bill not exceed the lowest cost-sharing level applied to brand name or generic prescription drugs covered under the applicable health care service plan or insurer, as specified. The bill would prohibit a health care service plan or insurer from requiring an enrollee or an insured to first use a non-abuse-deterrent opioid analgesic drug product before providing coverage for an abuse-deterrent opioid analgesic drug product, subject to uniformly applied utilization review requirements described in the bill.

Because a willful violation of these requirements with respect to health care service plans would be a crime, this bill would impose a state-mandated local program.

begin insert(4)end insertbegin insertend insertThe California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

The people of the State of California do enact as follows:

P3    1

SECTION 1.  

The Legislature finds and declares as follows:

2(a) Abuse and misuse of opioids is a serious problem that affects
3the health, social, and economic welfare of the state.

4(b) After alcohol, prescription drugs are the most commonly
5abused substances by Americans over 12 years of age.

6(c) Almost 2,000,000 people in the United States suffer from
7substance use disorders related to prescription opioid pain relievers.

8(d) Nonmedical use of prescription opioid pain relievers can be
9particularly dangerous when the products are manipulated for
10snorting, injection, or combination with other drugs.

11(e) Deaths involving prescription opioid pain relievers represent
12the largest proportion of drug overdose deaths, greater than the
13number of overdose deaths involving heroin or cocaine.

14(f) The number of unintentional overdose deaths involving
15prescription opioid pain relievers has more than quadrupled since
161999.

17begin insert

begin insertSEC. 2.end insert  

end insert

begin insertSection 2241.8 is added to the end insertbegin insertBusiness and Professions
18Code
end insert
begin insert, to read:end insert

begin insert
19

begin insert2241.8.end insert  

(a) (1) No physician and surgeon shall prescribe
20more than a five-day supply of an opioid analgesic drug product
21to a patient the first time that physician and surgeon prescribes a
22patient such an opioid for acute pain due to surgery or injury.

23
(2) The initial prescription in paragraph (1) may be for a
24non-abuse-deterrent opioid analgesic drug product and the five-day
25supply limitation shall still apply.

26
(3) This subdivision does not apply to an opioid prescription
27for a patient in chronic pain.

28
(b) Subdivision (a) shall apply even if the patient has previously
29been prescribed such an opioid from a different physician and
30surgeon.

31
(c) For the purposes of this section, “opioid analgesic drug
32product” has the same meaning as defined in Section 1367.217 of
33the Health and Safety Code.

end insert
34begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 4069 is added to the end insertbegin insertBusiness and Professions
35Code
end insert
begin insert, to read:end insert

begin insert
36

begin insert4069.end insert  

(a) A pharmacist shall inform a patient receiving for
37the first time an opioid analgesic drug product on proper storage
P4    1and disposal of the drug. The board shall adopt regulations to
2implement this section.

3
(b) For the purposes of this section, “opioid analgesic drug
4product” has the same meaning as defined in Section 1367.217 of
5the Health and Safety Code.

end insert
6

begin deleteSEC. 2.end delete
7
begin insertSEC. 4.end insert  

Section 1367.217 is added to the Health and Safety
8Code
,begin insert immediately following Section 1367.215,end insert to read:

9

1367.217.  

(a) Notwithstanding any other law, an individual
10or group health care service plan issued, amended, or renewed on
11or after January 1, that provides coverage for an opioid analgesic
12drug product shall comply with all of the following:

13(1) The plan shall provide coverage on its formulary, drug list,
14or other lists of similar construct for at least one abuse-deterrent
15opioid analgesic drug product per opioid analgesic active
16ingredient.

17(2) Notwithstanding any deductible, the total amount of
18copayments and coinsurance an enrollee is required to pay for
19brand name abuse-deterrent opioid analgesic drug products covered
20pursuant to this section shall not exceed the lowest cost-sharing
21 level applied to brand name prescription drugs covered under the
22applicable health care service plan.

23(3) Notwithstanding any deductible, the total amount of
24copayments and coinsurance an enrollee is required to pay for
25generic abuse-deterrent opioid analgesic drug products covered
26pursuant to this section shall not exceed the lowest cost-sharing
27level applied to generic prescription drugs covered under the
28applicable health care service plan.

29(4) The plan shall not require an enrollee to first use a
30non-abuse-deterrent opioid analgesic drug product before providing
31coverage for an abuse-deterrent opioid analgesic drug product.
32This paragraph shall not be construed to prevent a health care
33service plan from applying utilization review requirements,
34including prior authorization, to abuse-deterrent opioid analgesic
35drug products, provided that those requirements are applied to all
36 opioid analgesic drug products with the same type of drug release,
37immediate or extended.begin insert This paragraph shall not be construed to
38preclude the use of a non-abuse-deterrent opioid for the initial
39prescription for a fiveend insert
begin insert-day supply.end insert

P5    1(b) The following definitions shall apply for purposes of this
2section:

3(1) “Abuse-deterrent opioid analgesic drug product” means a
4brand or generic opioid analgesic drug product approved by the
5federal Food and Drug Administration (FDA) with
6abuse-deterrence labeling claims indicating its abuse-deterrent
7properties are expected to deter or reduce its abuse.

8(2) “Cost sharing” means any coverage limit, copayment,
9coinsurance, deductible, or other out-of-pocket expense
10requirement.

11(3) “Opioid analgesic drug product” means a drug product that
12contains an opioid agonist and that is indicated by the FDA for the
13treatment of pain, whether in an immediate release or extended
14release formulation and whether or not the drug product contains
15any other drug substance.

16

begin deleteSEC. 3.end delete
17
begin insertSEC. 5.end insert  

Section 10123.203 is added to the Insurance Code, to
18read:

19

10123.203.  

(a) Notwithstanding any other law, an insurer
20issuing, amending, or renewing a policy of individual or group
21disability insurance on or after January 1, that provides coverage
22for an opioid analgesic drug product shall comply with all of the
23following:

24(1) The insurer shall provide coverage on its formulary, drug
25list, or other lists of similar construct for at least one
26abuse-deterrent opioid analgesic drug product per opioid analgesic
27active ingredient.

28(2) Notwithstanding any deductible, the total amount of
29copayments and coinsurance an insured is required to pay for brand
30name abuse-deterrent opioid analgesic drug products covered
31pursuant to this section shall not exceed the lowest cost-sharing
32level applied to brand name prescription drugs covered under the
33applicable policy.

34(3) Notwithstanding any deductible, the total amount of
35copayments and coinsurance an insured is required to pay for
36generic abuse-deterrent opioid analgesic drug products covered
37pursuant to this section shall not exceed the lowest cost-sharing
38level applied to generic prescription drugs covered under the
39applicable policy.

P6    1(4) The insurer shall not require an insured to first use a
2non-abuse-deterrent opioid analgesic drug product before providing
3coverage for an abuse-deterrent opioid analgesic drug product.
4This paragraph shall not be construed to prevent an insurer from
5applying utilization review requirements, including prior
6authorization, to abuse-deterrent opioid analgesic drug products,
7provided that those requirements are applied to all opioid analgesic
8drug products with the same type of drug release, immediate or
9extended.begin insert This paragraph shall not be construed to preclude the
10use of a non-abuse deterrent opioid for the initial prescription for
11a fiveend insert
begin insert-day supply.end insert

12(b) The following definitions shall apply for purposes of this
13section:

14(1) “Abuse-deterrent opioid analgesic drug product” means a
15brand or generic opioid analgesic drug product approved by the
16federal Food and Drug Administration (FDA) with
17abuse-deterrence labeling claims indicating its abuse-deterrent
18properties are expected to deter or reduce its abuse.

19(2) “Cost sharing” means any coverage limit, copayment,
20coinsurance, deductible, or other out-of-pocket expense
21requirement.

22(3) “Opioid analgesic drug product” means a drug product that
23contains an opioid agonist and that is indicated by the FDA for the
24treatment of pain, whether in an immediate release or extended
25release formulation and whether or not the drug product contains
26any other drug substance.

27

begin deleteSEC. 4.end delete
28
begin insertSEC. 6.end insert  

No reimbursement is required by this act pursuant to
29Section 6 of Article XIII B of the California Constitution because
30the only costs that may be incurred by a local agency or school
31district will be incurred because this act creates a new crime or
32infraction, eliminates a crime or infraction, or changes the penalty
33for a crime or infraction, within the meaning of Section 17556 of
34the Government Code, or changes the definition of a crime within
35the meaning of Section 6 of Article XIII B of the California
36Constitution.



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