Amended in Assembly March 26, 2015

California Legislature—2015–16 Regular Session

Assembly BillNo. 623


Introduced by Assembly Member Wood

February 24, 2015


An act tobegin delete amend Section 1367.22 ofend deletebegin insert add Section 4069 to the Business and Professions Code, to add Section 1367.217 toend insert the Health and Safety Code,begin insert and to add Section 10123.203 to the Insurance Code,end insert relating to prescription drugs.

LEGISLATIVE COUNSEL’S DIGEST

AB 623, as amended, Wood. begin deletePrescription drugs. end deletebegin insertAbuse-deterrent opioid analgesic drug products.end insert

Existing 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.begin insert Existing law also provides for the regulation of health insurers by the Department of Insurance.end insert These provisions require specified services and drugs to be covered by the various plans.begin delete The act prohibits specified health care service plan contracts that cover prescription drug benefits from limiting or excluding coverage for a drug for an enrollee under specified conditions, including if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee.end delete

begin delete

This bill would make technical, nonsubstantive changes to that provision. This bill would also state the intent of the Legislature to enact legislation to address the problem of prescription opioid pain reliever abuse and would make related findings and declarations.

end delete
begin insert

This bill would, where an abuse-deterrent opioid analgesic drug product, as defined, is available, prohibit a health care service plan or insurer from requiring the use of opioid analgesic drug products without the abuse-deterrent properties in order to access abuse-deterrent opioid analgesic drug products. The bill would require a health care service plan or insurer to allow a provider to prescribe, and if otherwise covered, to provide coverage for, a less than 30-day supply of an opioid analgesic drug product. 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.

end insert
begin insert

Existing law, the Pharmacy Law, the knowing violation of which is a crime, provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy. Existing regulations require a pharmacist to provide oral consultation to his or her patient or the patient’s agent in all care settings upon request or whenever the pharmacist deems it warranted.

end insert
begin insert

This bill would require a pharmacist to inform a patient receiving an opioid analgesic drug product on proper storage and disposal of the drug, and authorizes this information to be included as part of the required oral consultation. Because a violation of this requirement would be a crime, the bill would impose a state-mandated local program.

end insert
begin insert

The 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.

end insert
begin insert

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

end insert

Vote: majority. Appropriation: no. Fiscal committee: begin deleteno end deletebegin insertyesend insert. State-mandated local program: begin deleteno end deletebegin insertyesend insert.

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

P2    1

SECTION 1.  

The Legislature finds and declares the following:

2(a) Prescription and over-the-counter (OTC) drugs are, after
3marijuana and alcohol, the most commonly abused substances by
4Americans over 14 years of age.

5(b) Over two million people in the United States suffer from
6substance use disorders related to prescription opioid pain relievers.

P3    1(c) More people die from overdoses of prescription opioid pain
2relievers than from all other drugs combined, including heroin and
3cocaine.

4(d) Prescription opioid pain relievers can have effects similar
5to heroin when taken in doses or in ways other than prescribed,
6and research now suggests that abuse of these drugs may lead to
7heroin abuse.

8(e) Prescription opioid pain relievers can be particularly
9dangerous when snorted, injected, or combined with other drugs
10or alcohol.

11begin insert

begin insertSEC. 2.end insert  

end insert

begin insertSection 4069 is added to the end insertbegin insertBusiness and Professions
12Code
end insert
begin insert, to read:end insert

begin insert
13

begin insert4069.end insert  

(a) A pharmacist shall inform a patient receiving an
14opioid analgesic drug product on proper storage and disposal of
15the drug. This information may be included as part of the oral
16consultation required under Section 1707.2 of Title 17 of the
17California Code of Regulations.

18(b) For purposes of this section, “opioid analgesic drug
19product” has the same meaning as defined in Section 1367.217 of
20the Health and Safety Code.

end insert
21begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 1367.217 is added to the end insertbegin insertHealth and Safety
22Code
end insert
begin insert, to read:end insert

begin insert
23

begin insert1367.217.end insert  

(a) Where an abuse-deterrent opioid analgesic drug
24product is available, a health care service plan shall not require
25the use of opioid analgesic drug products without the
26abuse-deterrent properties in order to access abuse-deterrent
27opioid analgesic drug products.

28(b) This section shall not be construed to prevent a health care
29service plan from applying prior authorization requirements to
30abuse-deterrent opioid analgesic drug products, provided that
31those same requirements are applied to versions of those opioid
32analgesic drug products without the abuse-deterrent properties.

33(c) A health care service plan shall allow a provider to
34prescribe, and if otherwise covered, shall provide coverage for, a
35less than 30-day supply of an opioid analgesic drug product.

36(d) For purposes of this section, the following definitions shall
37apply:

38(1) “Abuse-deterrent opioid analgesic drug product” means a
39brand or generic opioid analgesic drug product approved by the
40federal Food and Drug Administration with abuse-deterrence
P4    1labeling claims that indicate the drug product is expected to result
2in a meaningful reduction in abuse.

3(2) “Opioid analgesic drug product” means a drug product in
4the opioid analgesic drug class that is prescribed to treat moderate
5to severe pain or other conditions, whether in immediate release
6or extended release or long-acting form and whether or not
7combined with other drug substances to form a single drug product
8or dosage form.

end insert
9begin insert

begin insertSEC. 4.end insert  

end insert

begin insertSection 10123.203 is added to the end insertbegin insertInsurance Codeend insertbegin insert, to
10read:end insert

begin insert
11

begin insert10123.203.end insert  

(a) Where an abuse-deterrent opioid analgesic
12drug product is available, an insurer shall not require the use of
13opioid analgesic drug products without the abuse-deterrent
14properties in order to access abuse-deterrent opioid analgesic
15drug products.

16(b) This section shall not be construed to prevent an insurer
17from applying prior authorization requirements to abuse-deterrent
18opioid analgesic drug products, provided that those same
19requirements are applied to versions of those opioid analgesic
20drug products without the abuse-deterrent properties.

21(c) An insurer shall allow a provider to prescribe, and if
22otherwise covered, shall provide coverage for, a less than 30-day
23supply of an opioid analgesic drug product.

24(d) For purposes of this section, the following definitions shall
25apply:

26(1) “Abuse-deterrent opioid analgesic drug product” means a
27brand or generic opioid analgesic drug product approved by the
28federal Food and Drug Administration with abuse-deterrence
29labeling claims that indicate the drug product is expected to result
30in a meaningful reduction in abuse.

31(2) “Opioid analgesic drug product” means a drug product in
32the opioid analgesic drug class that is prescribed to treat moderate
33to severe pain or other conditions, whether in immediate release
34or extended release or long-acting form and whether or not
35combined with other drug substances to form a single drug product
36or dosage form.

end insert
37begin insert

begin insertSEC. 5.end insert  

end insert
begin insert

No reimbursement is required by this act pursuant to
38Section 6 of Article XIII B of the California Constitution because
39the only costs that may be incurred by a local agency or school
40district will be incurred because this act creates a new crime or
P5    1infraction, eliminates a crime or infraction, or changes the penalty
2for a crime or infraction, within the meaning of Section 17556 of
3the Government Code, or changes the definition of a crime within
4the meaning of Section 6 of Article XIII B of the California
5Constitution.

end insert
begin delete
6

SEC. 2.  

It is the intent of the Legislature to enact legislation
7to address the problem of prescription opioid pain reliever abuse.

8

SEC. 3.  

Section 1367.22 of the Health and Safety Code is
9amended to read:

10

1367.22.  

(a) A health care service plan contract, issued,
11amended, or renewed on or after July 1, 1999, that covers
12prescription drug benefits shall not limit or exclude coverage for
13a drug for an enrollee if the drug previously had been approved
14for coverage by the plan for a medical condition of the enrollee
15and the plan’s prescribing provider continues to prescribe the drug
16for the medical condition, provided that the drug is appropriately
17prescribed and is considered safe and effective for treating the
18 enrollee’s medical condition. This section shall not preclude the
19prescribing provider from prescribing another drug covered by the
20plan that is medically appropriate for the enrollee, nor shall
21anything in this section be construed to prohibit generic drug
22substitutions as authorized by Section 4073 of the Business and
23Professions Code. For purposes of this section, a prescribing
24provider shall include a provider authorized to write a prescription,
25pursuant to subdivision (a) of Section 4059 of the Business and
26Professions Code, to treat a medical condition of an enrollee.

27(b) This section does not apply to coverage for any drug that is
28prescribed for a use that is different from the use for which that
29drug has been approved for marketing by the federal Food and
30Drug Administration. Coverage for different-use drugs is subject
31to Section 1367.21.

32(c) This section shall not be construed to restrict or impair the
33application of any other provision of this chapter, including, but
34not limited to, Section 1367, which includes among its
35requirements that plans furnish services in a manner providing
36continuity of care and demonstrate that medical decisions are
37rendered by qualified medical providers unhindered by fiscal and
38administrative management.

39(d) This section does not prohibit a health care service plan from
40charging a subscriber or enrollee a copayment or a deductible for
P6    1prescription drug benefits or from setting forth, by contract,
2limitations on maximum coverage of prescription drug benefits,
3provided that the copayments, deductibles, or limitations are
4reported to, and held unobjectionable by, the director and set forth
5to the subscriber or enrollee pursuant to the disclosure provisions
6of Section 1363.

end delete


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