Amended in Senate July 7, 2015

Amended in Senate June 24, 2015

Amended in Assembly June 1, 2015

Amended in Assembly May 20, 2015

Amended in Assembly May 4, 2015

Amended in Assembly April 7, 2015

California Legislature—2015–16 Regular Session

Assembly BillNo. 339


Introduced by Assembly Member Gordon

(Coauthor: Assembly Member Atkins)

February 13, 2015


An act to amend Sections 1367.24 and 1367.205 of, and to addbegin delete Section 1342.71end deletebegin insert Sections 1342.71, 1367.41, and 1367.42end insert to, the Health and Safety Code, and to amend Section 10123.192 of, and to add Sections 10123.193 and 10123.201 to, the Insurance Code, relating to health care coverage.

LEGISLATIVE COUNSEL’S DIGEST

AB 339, as amended, Gordon. Health care coverage: outpatient prescription drugs.

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 the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Existing law requires a health care service plan or insurer that provides prescription drug benefits and maintains one or more drug formularies to make specified information regarding the formularies available to the public and other specified entities. Existing law also specifies requirements for those plans and insurers regarding coverage and cost sharing of specified prescription drugs.

This bill wouldbegin delete requireend deletebegin insert require, with respect toend insert a nongrandfathered group health care service plan contract or health insurance policy that is offered, renewed, or amended on or after July 1, 2016, and a nongrandfathered individual health care service plan contract or health insurance policy that is offered, renewed, or amended on or after January 1, 2017, and that provides coverage for outpatient prescription drugs,begin delete to provide coverage for medically necessary prescription drugs, including those for which there is not a therapeutic equivalent. The bill would require copayments, coinsurance, and other cost sharing for these drugs to be reasonable, and would requireend delete that the copayment, coinsurance, or any other form of cost sharing for a covered outpatient prescription drug for an individual prescription not exceedbegin delete end deletebegin delete124end deletebegin delete of the annual out-of-pocket limit applicable to individual coverageend deletebegin insert $250, except as specified,end insert for a supply of up to 30 days.begin delete The bill would require these cost sharing limitations for a plan contract or policy that is a high deductible health plan to apply only once an enrollee’s or insured’s deductible has been satisfied for the year.end delete The bill would make these cost-sharing limits applicable only to covered outpatient prescription drugs that constitute essential health benefits, as defined. The bill would require a plan contract or policy to coverbegin insert aend insert single-tabletbegin delete and extended releaseend delete prescription drugbegin delete regimens, unless the plan or insurer can demonstrate that multitablet and nonextended release drug regimens, respectively, are clinically equally or more effective,end deletebegin insert regimenend insertbegin insert for combination drug treatments that include antiend insertbegin insertretrovirals,end insert as specified. The bill would prohibit, except as specified, a plan contract or policy from placingbegin delete prescription medications that treat a specific condition on theend deletebegin insert more than 50% of drugs approved by the United States Food and Drug Administration that are in the same drug class into the 2end insert highest cost tiers of a drug formulary. The bill would require a plan contract or policy to use specified definitions for each tier of a drug formulary.begin insert The bill would make related findings and declarations.end insert

begin insert

This bill would require a health insurer that provides coverage for outpatient prescription drugs to provide coverage for medically necessary prescription drugs, including those for which there is not a therapeutic equivalent, and, for an insurer, would require copayments, coinsurance, and other cost sharing for outpatient prescription drugs to be reasonable.

end insert

Existing law requires every health care service plan that provides prescription drug benefits to maintain an expeditious process by which prescribing providers may obtain authorization for a medically necessary nonformulary prescription drug, and requires these plans to maintain specified information that is required to be made available to the Director of the Department of Managed Health Care upon request.

This bill would also impose these requirements on a health insurer that provides prescription drug benefits, as provided. The bill would require a plan or insurer to respond to authorization requests for nonformulary prescription drugs within specified timeframes. The bill would authorizebegin delete a plan orend deletebegin insert anend insert insurer to require step therapy, as defined, when more than one drug is appropriate for the treatment of a medical condition, subject to specified requirements. The bill would requirebegin delete a plan orend deletebegin insert anend insert insurer that requires step therapy to have an expeditious process in place to authorize exceptions to step therapy when medically necessary and to conform effectively and efficiently with continuity of care requirements. The bill, with regard to anbegin delete enrollee orend delete insured changingbegin delete plans orend delete policies, would prohibit a newbegin delete plan orend delete insurer from requiring the enrollee or insured to repeat step therapy when that person is already being treated for a medical condition by a prescription drug, as specified. The bill, except as specified, would require a plan or insurer that provides essential health benefits to allow an enrollee or insured to access his or her prescription drug benefits at an in-network retail pharmacy, and would authorize a plan or insurer to charge an enrollee or insured a different cost sharing for obtaining a covered drug at a retail pharmacy, and would require that cost-sharing amount to count towards the plan’s or insurer’s annual out-of-pocket limitation, as specified.

This bill would require a plan or insurer to maintain a pharmacy and therapeutics committee that is responsible for developing, maintaining, and overseeing any drug formulary list, as provided. The bill would require the committee to, among other things, evaluate and analyze treatment protocols and procedures related to the plan’s or insurer’s drug formulary at least annually.

Existing law requires the Department of Managed Health Care and the Department of Insurance to jointly develop a standard formulary template by January 1, 2017, and requires plans and insurers to use that template to display formularies, as specified. Existing law requires the standard formulary template to include specified information.

This bill would require the standard formulary template to include additional specified information, including which medications are covered, including both generic and brand name.

Because a willful violation of the bill’s requirements relative to health care service plans would be a crime, this bill would impose a state-mandated local program.

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.

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:

P4    1

SECTION 1.  

Section 1342.71 is added to the Health and Safety
2Code
, to read:

3

1342.71.  

(a) begin insertThe Legislature hereby finds and declares all of
4the following:end insert

begin insert

5(1) The federal Patient Protection and Affordable Care Act, its
6implementing regulations and guidance, and related state law
7prohibit discrimination based on a person’s expected length of
8life, present or predicted disability, degree of medical dependency,
9quality of life, or other health conditions, including benefit designs
10that have the effect of discouraging the enrollment of individuals
11with significant health needs.

end insert
begin insert

12(2) The Legislature intends to build on existing state and federal
13law to ensure that health coverage benefit designs do not have an
14unreasonable discriminatory impact on chronically ill individuals,
15and to ensure affordability of outpatient prescription drugs.

end insert
begin insert

16(3) Assignment of all or most prescription medications that treat
17a specific medical condition to the highest cost tiers of a formulary
18may effectively discourage enrollment by chronically ill individuals,
19and may result in lower adherence to a prescription drug treatment
20regimen.

end insert

21begin insert(b)end insert A nongrandfathered group health care service plan contract
22that is offered, amended, or renewed on or after July 1, 2016, shall
P5    1comply with this section. A nongrandfathered individual health
2care service plan contract that is offered, amended, or renewed on
3or after January 1, 2017, shall comply with this section. The
4cost-sharing limits established by this section apply only to
5outpatient prescription drugs covered by the contract that constitute
6essential health benefits, as defined in Section 1367.005. This
7section does not apply to Medi-Cal managed care contracts.

begin delete

8(b) (1) A health care service plan that provides coverage for
9outpatient prescription drugs shall cover medically necessary
10prescription drugs.

11(2) A health care service plan that provides coverage for
12outpatient prescription drugs shall cover a medically necessary
13prescription drug for which there is not a therapeutic equivalent.

14(c) Copayments, coinsurance, and other cost sharing for
15outpatient prescription drugs shall be reasonable so as to allow
16access to medically necessary outpatient prescription drugs. In
17proposing cost sharing, the health care service plan shall consider
18the impact of cost sharing on medication adherence as
19demonstrated in peer-reviewed literature.

20(d)

end delete

21begin insert(c)end insert Consistent with federal law and guidance, and
22notwithstanding Section 1342.7 and any regulations adopted
23pursuant to that section, a health care service plan that provides
24coverage for outpatient prescription drugs shall demonstrate that
25the formulary or formularies maintained by the health care service
26plan do not discourage the enrollment of individuals with health
27conditions and do not reduce the generosity of the benefit for
28enrollees with a particular condition.

29(1) begin deleteA end deletebegin insertFor combination drug treatments that include
30antiend insert
begin insertretrovirals, a end inserthealth care service plan contract shall cover a
31single-tablet drug regimen that is as effective as a multitablet
32regimen unless the health care service plan is able to demonstrate
33to the director, consistent with clinical guidelines and
34peer-reviewed scientific and medical literature, that the multitablet
35regimen is clinically equally or more effective and more likely to
36result in adherence to a drug regimen. begin delete A health care service plan
37contract shall cover an extended release prescription drug that is
38clinically equally or more effective than a nonextended release
39product unless the health care service plan is able to demonstrate
40to the director, consistent with clinical guidelines and
P6    1peer-reviewed scientific and medical literature, that the
2nonextended release product is clinically equally or more effective
3than the extended release product.end delete

begin delete

4(2) A health care service plan contract shall not place most or
5all of the prescription medications that treat a specific condition
6on the highest cost tiers of a formulary unless the health care
7service plan can demonstrate that such placement does not reduce
8the generosity of the benefits for enrollees with a particular
9condition. If there is more than one treatment that is the standard
10of care for a specific condition, the health care service plan shall
11not place most or all prescription medications that treat that
12condition on the highest cost tiers. This shall not apply to any
13medication for which there is a therapeutic equivalent available
14on a lower cost tier.

end delete
begin insert

15(2) No more than 50 percent of drugs approved by the United
16States Food and Drug Administration (FDA) that are in the same
17drug class may be assigned to the two highest cost tiers of a drug
18formulary. All health care service plan formularies shall include
19at least one drug in the lower cost tiers if all FDA-approved drugs
20in the same drug class would otherwise qualify for the highest cost
21tiers and at least three drugs in that class are available as
22FDA-approved drugs . The drug or drugs assigned to the lower
23cost tiers pursuant to this paragraph shall be the drug or drugs
24that were most often prescribed during the immediately preceding
25plan year, based on the health care service plan’s experience.

end insert

26(3) For coverage offered in the individual market, the health
27care service plan shall demonstrate that the formulary or
28formularies maintained for coverage in the individual market are
29the same or comparable to those maintained for coverage in the
30group market.

begin delete

31(4) A health care service plan shall demonstrate to the director
32that any limitation or utilization management is consistent with
33and based on clinical guidelines and peer-reviewed scientific and
34medical literature.

end delete
begin delete

35(e)

end delete

36begin insert(d)end insert (1) With respect to an individual or group health care service
37plan contract subject to Section 1367.006, the copayment,
38coinsurance, or any other form of cost sharing for a covered
39outpatient prescription drug for an individual prescriptionbegin insert for a
40supply of up to 30 daysend insert
shall not exceed begin delete one-twenty-fourth of the
P7    1annual out-of-pocket limit applicable to individual coverage under
2Section 1367.006 for a supply of up to 30 days.end delete
begin insert two hundred fifty
3dollars ($250), except as provided in paragraphs (2) and (3).end insert

begin insert

4(2) With respect to products with actuarial value at, or
5equivalent to, the bronze level, cost sharing for a covered
6outpatient prescription drug for an individual prescription for a
7supply of up to 30 days shall not exceed five hundred dollars
8($500).

end insert
begin delete

9(2)

end delete

10begin insert(3)end insert For a health care service plan contract that is a “high
11deductible health plan” under the definition set forth in Section
12223(c)(2) of Title 26 of the United States Code, paragraph (1) of
13this subdivision shall apply only once an enrollee’s deductible has
14been satisfied for the year.

begin delete

15(f)

end delete

16begin insert(e)end insert (1) If a health care service plan contract maintains a drug
17formulary grouped into tiers, including a fourth tier or specialty
18tier, a health care service plan contract shall use the following
19definitions for each tier of the drug formulary:

20(A) Tier one shall consist of begin delete preferred generic drugs and
21preferred brand name drugs if the cost to the health care service
22plan for a preferred brand name drug is comparable to those for
23generic drugs.end delete
begin insert most generic drugs and low cost preferred brand
24drugs.end insert

25(B) Tier two shall consist of nonpreferred generic drugs,
26preferred brand name drugs, and any other drugs recommended
27by the health care service plan’s pharmacy and therapeutics
28committee based on safety and efficacy and not solely based on
29the cost of the prescriptionbegin delete drug.end deletebegin insert drug, and which generally have
30a preferred and often less costly therapeutic alternative at a lower
31tier.end insert

32(C) Tier three shall consist of nonpreferred brand name drugs
33that are recommended by the health care service plan’s pharmacy
34and therapeutics committee based on safety and efficacy and not
35solely based on the cost of the prescription drug.

36(D) Tier four shall consist ofbegin delete specialtyend delete drugs that are biologics,
37begin delete which, according to theend deletebegin insert drugs that theend insert federal Food and Drug
38Administration or thebegin delete manufacturer, require distributionend delete
39begin insert manufacturer requires to be distributedend insert through a specialty
40begin delete pharmacy or theend deletebegin insert pharmacy, drugs that require theend insert enrollee to have
P8    1special training begin delete for self-administration or special monitoring.
2Specialty drugs may include prescription drugs that cost more than
3the Medicare Part D threshold if those drugs are recommended for
4Tier four by the health care service plan’s pharmacy and
5therapeutics committee based on safety and efficacy, but placement
6shall not be solely based on the cost of the prescription drug.end delete
begin insert or
7clinical monitoring for self-administration, or drugs that cost the
8health plan more than six hundred dollars ($600) net of rebates.end insert

9(2) This section does not require a health care service plan
10contract to include a fourthbegin delete tier, but if a health care service plan
11contract includes a fourth tier, the health care service plan contract
12shall comply with this section.end delete
begin insert tier.end insert

begin delete

13(3) This section does not require the health care service plan’s
14pharmacy and therapeutics committee to consider the cost of the
15prescription drug to the health care service plan.

end delete
begin delete

16(g)

end delete

17begin insert(f)end insert A health care service plan contract shall ensure that the
18placement of prescription drugs on formulary tiers isbegin delete not based
19solely on the cost of the prescription drug to the health care service
20plan, but isend delete
based on clinically indicated, reasonable medical
21management practices.

begin delete

22(h)

end delete

23begin insert(g)end insert This section shall not be construed to require a health care
24service plan to impose cost sharing. This section shall not be
25construed to require cost sharing for prescription drugs that state
26or federal law otherwise requires to be provided without cost
27sharing.

begin delete

28(i)

end delete

29begin insert(h)end insert This section does not require or authorize a health care
30service plan that contracts with the State Department of Health
31Care Services to provide services to Medi-Cal beneficiaries to
32provide coverage for prescription drugs that are not required
33pursuant to those programs or contracts, or to limit or exclude any
34prescription drugs that are required by those programs or contracts.

35

SEC. 2.  

Section 1367.24 of the Health and Safety Code is
36amended to read:

37

1367.24.  

(a) (1) Every health care service plan that provides
38prescription drug benefits shall maintain an expeditious process
39by which prescribing providers may obtain authorization for a
40medically necessary nonformulary prescription drug. On or before
P9    1July 1, 1999, every health care service plan that provides
2prescription drug benefits shall file with the department a
3description of its process for responding to authorization requests
4for nonformulary drugs. Any changes to this process shall be filed
5with the department pursuant to Section 1352. The plan shall
6provide that the enrollee, the enrollee’s designee, or the enrollee’s
7prescribing provider may seek an authorization for a nonformulary
8prescription drug.

9(2) Each plan shall respond to an authorization request within
1072 hours following receipt of the authorization request for a
11nonurgent authorization. If the plan grants the authorization request,
12the plan shall provide coverage of the nonformulary drug for the
13duration of the prescription, including refills.

14(3) Each plan shall provide that an urgent authorization may be
15obtained within 24 hours if an enrollee is suffering from a health
16condition that may seriously jeopardize the enrollee’s life, health,
17or ability to regain maximum function, or if an enrollee is
18undergoing a current course of treatment using a nonformulary
19prescription drug. A plan that grants an exception based on these
20urgent circumstances shall provide coverage of the nonformulary
21prescription drug for the duration of that urgent condition.

begin delete

22(4) If a plan imposes step therapy, the plan shall provide an
23expeditious process to authorize an exception to step therapy when
24medically necessary and to conform effectively and efficiently
25with continuity of care requirements of this chapter and federal
26law, and any regulations issued thereunder. The process to
27authorize an exception to step therapy shall be consistent with this
28section, including the timelines provided in this section.

29 (5)

end delete

30begin insert (4)end insert Each plan shall provide a written description of its most
31current process to its prescribing providers. For purposes of this
32section, a prescribing provider shall include a provider authorized
33to write a prescription, pursuant to subdivision (a) of Section 4040
34of the Business and Professions Code, to treat a medical condition
35of an enrollee.

36(b) Any plan that disapproves a request made pursuant to
37subdivision (a) by a prescribing provider to obtain authorization
38for a nonformulary drug shall provide the reasons for the
39disapproval in a notice provided to the enrollee. The notice shall
40indicate that the enrollee may file a grievance with the plan if the
P10   1enrollee objects to the disapproval, including any alternative drug
2or treatment offered by the plan. The notice shall comply with
3subdivision (b) of Section 1368.02.

4(c) The process described in subdivision (a) by which
5prescribing providers may obtain authorization for medically
6necessary nonformulary drugs shall not apply to a nonformulary
7drug that has been prescribed for an enrollee in conformance with
8the provisions of Section 1367.22.

begin delete

9(d) (1) A plan shall maintain a pharmacy and therapeutics
10committee that shall be responsible for developing, maintaining,
11and overseeing any drug formulary list. If the plan delegates
12responsibility for the formulary to any entity, the obligation of the
13plan to comply with this chapter shall not be waived.

14(2) The pharmacy and therapeutics committee board membership
15shall conform with both of the following:

16(A) Represent a sufficient number of clinical specialties to
17adequately meet the needs of enrollees.

18(B) Consist of a majority of individuals who are practicing
19physicians, practicing pharmacists, and other practicing health
20professionals who are licensed to prescribe drugs.

21(3) Members of the board shall abstain from voting on any issue
22in which the member has a conflict of interest with respect to the
23issuer or a pharmaceutical manufacturer.

24(4) At least 20 percent of the board membership shall not have
25a conflict of interest with respect to the issuer or any
26pharmaceutical manufacturer.

27(5) The pharmacy and therapeutics committee shall meet at least
28quarterly and shall maintain written documentation of the rationale
29for its decisions regarding the development of, or revisions to, the
30formulary drug list.

31(6) The pharmacy and therapeutics committee shall do all of
32the following:

33(A) Develop and document procedures to ensure appropriate
34drug review and inclusion.

35(B) Base clinical decisions on the strength of the scientific
36evidence and standards of practice, including assessing
37peer-reviewed medical literature, pharmacoeconomic studies,
38outcomes research data, and other related information.

39(C) Consider the therapeutic advantages of drugs in terms of
40safety and efficacy when selecting formulary drugs.

P11   1(D) Review policies that guide exceptions and other utilization
2management processes, including drug utilization review, quantity
3limits, and therapeutic interchange.

4(E) Evaluate and analyze treatment protocols and procedures
5related to the plan’s formulary at least annually.

6(F) Review and approve all clinical prior authorization criteria,
7step therapy protocols, and quantity limit restrictions applied to
8each covered drug.

9(G) Review new federal Food and Drug
10Administration-approved drugs and new uses for existing drugs.

11(H) Ensure the plan’s formulary drug list or lists cover a range
12of drugs across a broad distribution of therapeutic categories and
13classes and recommended drug treatment regimens that treat all
14disease states and does not discourage enrollment by any group
15of enrollees.

16(I) Ensure the plan’s formulary drug list or lists provide
17appropriate access to drugs that are included in broadly accepted
18treatment guidelines and that are indicative of general best practices
19at the time.

20(e) (1) A health care service plan may impose prior
21authorization requirements on prescription drug benefits, consistent
22with the requirements of this chapter.

23(2) (A) When there is more than one drug that is appropriate
24for the treatment of a medical condition, a plan may require step
25therapy. A plan that requires step therapy shall comply with the
26requirements specified in paragraph (4) of subdivision (a).

27(B) In circumstances where an enrollee is changing plans, the
28new plan shall not require the enrollee to repeat step therapy when
29that enrollee is already being treated for a medical condition by a
30prescription drug provided that the drug is appropriately prescribed
31and is considered safe and effective for the enrollee’s condition.
32Nothing in this section shall preclude the new plan from imposing
33a prior authorization requirement pursuant to this section for the
34continued coverage of a prescription drug prescribed pursuant to
35step therapy imposed by the former plan, or preclude the
36prescribing provider from prescribing another drug covered by the
37new plan that is medically appropriate for the enrollee.

38(3) A plan shall provide coverage for the medically necessary
39dosage and quantity of the drug prescribed for the treatment of a
P12   1medical condition consistent with professionally recognized
2standards of practice.

3(4) A plan that provides essential health benefits shall allow an
4enrollee to access prescription drug benefits at an in-network retail
5pharmacy unless the prescription drug is subject to restricted
6distribution by the federal Food and Drug Administration or
7 requires special handling, provider coordination, or patient
8education that cannot be provided by a retail pharmacy. A health
9care service plan that provides essential health benefits may charge
10an enrollee a different cost sharing for obtaining a covered drug
11at a retail pharmacy, but all cost sharing shall count toward the
12plan’s annual limitation on cost sharing consistent with Section
131367.006.

14(f)

end delete

15begin insert(d)end insert The process described in subdivision (a) by which enrollees
16may obtain medically necessary nonformulary drugs, including
17specified timelines for responding to prescribing provider
18authorization requests, shall be described in evidence of coverage
19and disclosure forms, as required by subdivision (a) of Section
201363, issued on or after July 1, 1999.

begin delete

21(g)

end delete

22begin insert(e)end insert Every health care service plan that provides prescription
23drug benefits shall maintain, as part of its books and records under
24Section 1381, all of the following information, which shall be
25made available to the director upon request:

26(1) The complete drug formulary or formularies of the plan, if
27the plan maintains a formulary, including a list of the prescription
28drugs on the formulary of the plan by major therapeutic category
29with an indication of whether any drugs are preferred over other
30drugs.

31(2) Records developed by the pharmacy and therapeutic
32committee of the plan, or by others responsible for developing,
33modifying, and overseeing formularies, including medical groups,
34individual practice associations, and contracting pharmaceutical
35benefit management companies, used to guide the drugs prescribed
36for the enrollees of the plan, that fully describe the reasoning
37behind formulary decisions.

38(3) Any plan arrangements with prescribing providers, medical
39groups, individual practice associations, pharmacists, contracting
40pharmaceutical benefit management companies, or other entities
P13   1that are associated with activities of the plan to encourage
2formulary compliance or otherwise manage prescription drug
3benefits.

begin delete

4(h)

end delete

5begin insert(f)end insert If a plan provides prescription drug benefits, the department
6shall, as part of its periodic onsite medical survey of each plan
7undertaken pursuant to Section 1380, review the performance of
8the plan in providing those benefits, including, but not limited to,
9a review of the procedures and information maintained pursuant
10to this section, and describe the performance of the plan as part of
11its report issued pursuant to Section 1380.

begin delete

12(i)

end delete

13begin insert(g)end insert The director shall not publicly disclose any information
14reviewed pursuant to this section that is determined by the director
15to be confidential pursuant to state law.

begin delete

16(j)

end delete

17begin insert(h)end insert For purposes of this section,begin delete the following definitions shall
18apply:end delete

19begin delete(1)end deletebegin deleteend deletebegin delete“Authorization”end deletebegin insert “authorizationend insertbegin insertend insert means approval by the
20health care service plan to provide payment for the prescription
21drug.

begin delete

22(2) “Step therapy” means a type of protocol that specifies the
23sequence in which different prescription drugs for a given medical
24condition and medically appropriate for a particular patient are to
25be prescribed.

end delete
begin delete

26(k)

end delete

27begin insert(i)end insert (1) Nonformulary prescription drugs shall include any drug
28for which an enrollee’s copayment or out-of-pocket costs are
29different than the copayment for a formulary prescription drug,
30except as otherwise provided by law or regulation or in cases in
31which the drug has been excluded in the plan contract pursuant to
32Section 1342.7.

33(2) If a nonformulary drug is authorized consistent with this
34section, the cost sharing shall be the same as for a formulary drug
35consistent with subdivision (e) of Section 1342.71.

begin insert

36(j) Nothing in this section shall be construed to affect an
37enrollee’s or subscriber’s eligibility to submit a grievance to the
38department for review under Section 1368 or to apply to the
39 department for an independent medical review under Section
P14   11370.4 or Article 5.55 (commencing with Section 1374.30) of this
2chapter.

end insert
begin delete

3(l)

end delete

4begin insert(k)end insert Nothing in this section shall be construed to restrict or impair
5the application of any other provision of this chapter, including,
6but not limited to, Section 1367, which includes among its
7requirements that a health care service plan furnish services in a
8manner providing continuity of care and demonstrate that medical
9decisions are rendered by qualified medical providers unhindered
10by fiscal and administrative management.

11begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 1367.41 is added to the end insertbegin insertHealth and Safety
12Code
end insert
begin insert, end insertimmediately following Section 1367.4begin insert, to read:end insert

begin insert
13

begin insert1367.41.end insert  

(a) A plan shall maintain a pharmacy and
14therapeutics committee that shall be responsible for developing,
15maintaining, and overseeing any drug formulary list. If the plan
16delegates responsibility for the formulary to any entity, the
17obligation of the plan to comply with this chapter shall not be
18waived.

19(b) The pharmacy and therapeutics committee board
20membership shall conform with both of the following:

21(1) Represent a sufficient number of clinical specialties to
22adequately meet the needs of enrollees.

23(2) Consist of a majority of individuals who are practicing
24physicians, practicing pharmacists, and other practicing health
25professionals who are licensed to prescribe drugs.

26(c) Members of the board shall abstain from voting on any issue
27in which the member has a conflict of interest with respect to the
28issuer or a pharmaceutical manufacturer.

29(d) At least 20 percent of the board membership shall not have
30a conflict of interest with respect to the issuer or any
31pharmaceutical manufacturer.

32(e) The pharmacy and therapeutics committee shall meet at
33least quarterly and shall maintain written documentation of the
34rationale for its decisions regarding the development of, or
35revisions to, the formulary drug list.

36(f) The pharmacy and therapeutics committee shall do all of the
37following:

38(1) Develop and document procedures to ensure appropriate
39drug review and inclusion.

P15   1(2) Base clinical decisions on the strength of the scientific
2evidence and standards of practice, including assessing
3peer-reviewed medical literature, pharmacoeconomic studies,
4outcomes research data, and other related information.

5(3) Consider the therapeutic advantages of drugs in terms of
6safety and efficacy when selecting formulary drugs.

7(4) Review policies that guide exceptions and other utilization
8management processes, including drug utilization review, quantity
9limits, and therapeutic interchange.

10(5) Evaluate and analyze treatment protocols and procedures
11related to the plan’s formulary at least annually.

12(6) Review and approve all clinical prior authorization criteria,
13step therapy protocols, and quantity limit restrictions applied to
14each covered drug.

15(7) Review new federal Food and Drug Administration-approved
16drugs and new uses for existing drugs.

17(8) Ensure that the plan’s formulary drug list or lists cover a
18range of drugs across a broad distribution of therapeutic
19categories and classes and recommended drug treatment regimens
20that treat all disease states and do not discourage enrollment by
21any group of enrollees.

22(9) Ensure that the plan’s formulary drug list or lists provide
23appropriate access to drugs that are included in broadly accepted
24treatment guidelines and that are indicative of general best
25practices at the time.

end insert
26begin insert

begin insertSEC. 4.end insert  

end insert

begin insertSection 1367.42 is added to the end insertbegin insertHealth and Safety
27Code
end insert
begin insert, to read:end insert

begin insert
28

begin insert1367.42.end insert  

(a) A plan that provides essential health benefits
29shall allow an enrollee to access prescription drug benefits at an
30in-network retail pharmacy unless the prescription drug is subject
31to restricted distribution by the federal Food and Drug
32Administration or requires special handling, provider coordination,
33or patient education that cannot be provided by a retail pharmacy.

34(b) A nongrandfathered individual or small group health plan
35contract may charge an enrollee a different cost sharing for
36obtaining a covered drug at a retail pharmacy, but all cost sharing
37shall count toward the plan’s annual limitation on cost sharing
38consistent with Section 1367.006.

end insert
P16   1

begin deleteSEC. 3.end delete
2begin insertSEC. 5.end insert  

Section 1367.205 of the Health and Safety Code is
3amended to read:

4

1367.205.  

(a) In addition to the list required to be provided
5under Section 1367.20, a health care service plan that provides
6prescription drug benefits and maintains one or more drug
7formularies shall do all of the following:

8(1) Post the formulary or formularies for each product offered
9by the plan on the plan’s Internet Web site in a manner that is
10accessible and searchable by potential enrollees, enrollees,
11providers, the general public, the department, and federal agencies
12as required by federal law or regulations.

13(2) Update the formularies posted pursuant to paragraph (1)
14with any change to those formularies on a monthly basis.

15(3) No later than six months after the date that a standard
16formulary template is developed under subdivision (b), use that
17template to display the formulary or formularies for each product
18offered by the plan.

19(b) (1) By January 1, 2017, the department and the Department
20of Insurance shall jointly, and with input from interested parties
21from at least one public meeting, develop a standard formulary
22template for purposes of paragraph (3) of subdivision (a). In
23developing the template, the department and Department of
24Insurance shall take into consideration existing requirements for
25reporting of formulary information established by the federal
26Centers for Medicare and Medicaid Services. To the extent feasible,
27in developing the template, the department and the Department of
28Insurance shall evaluate a way to include on the template, in
29addition to the information required to be included under paragraph
30(2), cost-sharing information for drugs subject to coinsurance.

31(2) The standard formulary template shall include the
32notification described in subdivision (c) of Section 1363.01, and
33as applied to a particular formulary for a product offered by a plan,
34shall do all of the following:

35(A) Include information on cost sharing tiers and utilization
36controls, including prior authorization or step therapy requirements,
37for each drug covered by the product.

38(B) Indicate any drugs on the formulary that are preferred over
39other drugs on the formulary.

P17   1(C) Include information to educate enrollees about the
2differences between drugs administered or provided under a health
3care service plan’s medical benefit and drugs prescribed under a
4health care service plan’s prescription drug benefit and about how
5to obtain coverage information regarding drugs that are not covered
6under the plan’s prescription drug benefit.

7(D) Include information to educate enrollees that health care
8service plans that provide prescription drug benefits are required
9to have a method for enrollees to obtain prescription drugs not
10listed in the health plan drug formulary if the drugs are deemed
11medically necessary by a clinician pursuant to Section 1367.24.

12(E) Include information on which medications are covered,
13including both generic and brand name.

14(F) Include information on what tier of the plan’s drug formulary
15each medication is in.

16(c) For purposes of this section, “formulary” means the complete
17list of drugs preferred for use and eligible for coverage under a
18health care service plan product and includes the drugs covered
19under the pharmacy benefit of the product.

20

begin deleteSEC. 4.end delete
21begin insertSEC. 6.end insert  

Section 10123.192 of the Insurance Code is amended
22to read:

23

10123.192.  

(a) A health insurer that provides prescription drug
24benefits and maintains one or more drug formularies shall do all
25of the following:

26(1) Post the formulary or formularies for each product offered
27by the insurer on the insurer’s Internet Web site in a manner that
28is accessible and searchable by potential insureds, insureds,
29providers, the general public, the department, and federal agencies
30as required by federal law or regulations.

31(2) Update the formularies posted pursuant to paragraph (1)
32with any change to those formularies on a monthly basis.

33(3) No later than six months after the date that a standard
34formulary template is developed under subdivision (b), use that
35template to display the formulary or formularies for each product
36offered by the insurer.

37(b) (1) By January 1, 2017, the department and the Department
38of Managed Health Care shall jointly, and with input from
39interested parties from at least one public meeting, develop a
40standard formulary template for purposes of paragraph (3) of
P18   1subdivision (a). In developing the template, the department and
2Department of Managed Health Care shall take into consideration
3existing requirements for reporting of formulary information
4established by the federal Centers for Medicare and Medicaid
5Services. To the extent feasible, in developing the template, the
6department and the Department of Managed Health Care shall
7evaluate a way to include on the template, in addition to the
8information required to be included under paragraph (2),
9cost-sharing information for drugs subject to coinsurance.

10(2) The standard formulary template shall include a notification
11that the presence of a drug on the insurer’s formulary does not
12guarantee that an insured will be prescribed that drug by his or her
13prescribing provider for a particular medical condition. As applied
14to a particular formulary for a product offered by an insurer, the
15standard formulary template shall do all of the following:

16(A) Include information on cost sharing tiers and utilization
17controls, including prior authorization or step therapy requirements,
18for each drug covered by the product.

19(B) Indicate any drugs on the formulary that are preferred over
20other drugs on the formulary.

21(C) Include information to educate insureds about the differences
22between drugs administered or provided under a health insurer’s
23medical benefit and drugs prescribed under a health insurer’s
24prescription drug benefit and about how to obtain coverage
25information about drugs that are not covered under the health
26insurer’s prescription drug benefit.

27(D) Include information to educate insureds that health insurers
28that provide prescription drug benefits are required to have a
29method for insureds to obtain prescription drugs not listed in the
30health insurer’s drug formulary if the drugs are deemed to be
31medically necessary by a clinician pursuant to Section 1367.24 of
32the Health and Safety Code, as required by clause (iv) of
33subparagraph (A) of paragraph (2) of subdivision (a) of Section
3410112.27.

35(E) Include information on which medications are covered,
36including both generic and brand name.

37(F) Include information on what tier of the health insurer’s drug
38formulary each medication is in.

39(c) The commissioner may adopt regulations as may be
40necessary to carry out the purposes of this section. In adopting
P19   1regulations, the commissioner shall comply with Chapter 3.5
2(commencing with Section 11340) of Part 1 of Division 3 of Title
32 of the Government Code.

4(d) For purposes of this section, “formulary” means the complete
5list of drugs preferred for use and eligible for coverage under a
6health insurance product and includes the drugs covered under the
7pharmacy benefit of the product.

8

begin deleteSEC. 5.end delete
9begin insertSEC. 7.end insert  

Section 10123.193 is added to the Insurance Code, to
10read:

11

10123.193.  

(a)begin insertend insertbegin insertThe Legislature hereby finds and declares all
12of the following:end insert

begin insert

13(1) The federal Patient Protection and Affordable Care Act, its
14implementing regulations and guidance, and related state law
15prohibit discrimination based on a person’s expected length of
16life, present or predicted disability, degree of medical dependency,
17quality of life, or other health conditions, including benefit designs
18that have the effect of discouraging the enrollment of individuals
19with significant health needs.

end insert
begin insert

20(2) The Legislature intends to build on existing state and federal
21law to ensure that health coverage benefit designs do not have an
22unreasonable discriminatory impact on chronically ill individuals,
23and to ensure affordability of outpatient prescription drugs.

end insert
begin insert

24(3) Assignment of all or most prescription medications that treat
25a specific medical condition to the highest cost tiers of a formulary
26may effectively discourage enrollment by chronically ill individuals,
27and may result in lower adherence to a prescription drug treatment
28regimen.

end insert

29begin insert(b)end insert A nongrandfathered group policy of health insurance that
30is offered, amended, or renewed on or after July 1, 2016, shall
31comply with this section. A nongrandfathered individual policy
32of health insurance that is offered, amended, or renewed on or after
33January 1, 2017, shall comply with this section. The cost-sharing
34limits established by this section apply only to outpatient
35prescription drugs covered by the policy that constitute essential
36health benefits, as defined by Section 10112.27.

begin delete

37(b)

end delete

38begin insert(c)end insert (1) A policy of health insurance that provides coverage for
39outpatient prescription drugs shall cover medically necessary
40prescription drugs.

P20   1(2) A policy of health insurance that provides coverage for
2outpatient prescription drugs shall cover a medically necessary
3prescription drug for which there is not a therapeutic equivalent.

begin delete

4(c)

end delete

5begin insert(d)end insert Copayments, coinsurance, and other cost sharing for
6outpatient prescription drugs shall be reasonable so as to allow
7access to medically necessary outpatient prescription drugs.begin delete In
8proposing cost sharing, the health insurer shall consider the impact
9of cost sharing on medication adherence as demonstrated in
10peer-reviewed literature.end delete

begin delete

11(d)

end delete

12begin insert(e)end insert Consistent with federal law and guidance, a policy of health
13insurance that provides coverage for outpatient prescription drugs
14shall demonstrate that the formulary or formularies maintained by
15the health insurer do not discourage the enrollment of individuals
16with health conditions and do not reduce the generosity of the
17benefit for insureds with a particular condition.

18(1) begin deleteA end deletebegin insertFor combination drug treatments that include
19antiretrovirals, a end insert
policy of health insurance shall cover a
20single-tablet drug regimen that is as effective as a multitablet
21regimen unless the health insurer is able to demonstrate to the
22commissioner, consistent with clinical guidelines and
23peer-reviewed scientific and medical literature, that the multitablet
24regimen is clinically equally or more effective and more likely to
25result in adherence to a drug regimen. begin delete A policy of health insurance
26shall cover an extended release prescription drug that is clinically
27equally or more effective than a nonextended release product unless
28the health insurer is able to demonstrate to the commissioner,
29consistent with clinical guidelines and peer-reviewed scientific
30and medical literature, that the nonextended release product is
31clinically equally or more effective than the extended release
32product.end delete

begin delete

33(2) A policy of health insurance shall not place most or all of
34the prescription medications that treat a specific condition on the
35highest cost tiers of a formulary unless the health insurer can
36demonstrate that such placement does not reduce the generosity
37of the benefits for insureds with a particular condition. If there is
38more than one treatment that is the standard of care for a specific
39condition, the health insurer shall not place most or all prescription
40medications that treat that condition on the highest cost tiers. This
P21   1shall not apply to any medication for which there is a therapeutic
2equivalent available on a lower cost tier.

end delete
begin insert

3(2) No more than 50 percent of drugs approved by the United
4States Food and Drug Administration (FDA) that are in the same
5drug class may be assigned to the two highest cost tiers of a drug
6formulary. All health insurer formularies shall include at least
7one drug in the lower cost tiers if all FDA-approved drugs in the
8same drug class would otherwise qualify for the highest cost tiers
9and at least three drugs in that class are available as
10FDA-approved drugs. The drug or drugs assigned to the lower
11cost tiers pursuant to this paragraph shall be the drug or drugs
12that were most often prescribed during the immediately preceding
13plan year, based on the health insurer’s experience.

end insert

14(3) For coverage offered in the individual market, the health
15insurer shall demonstrate that the formulary or formularies
16maintained for coverage in the individual market are the same or
17comparable to those maintained for coverage in the group market.

18(4) A health insurer shall demonstrate to the commissioner that
19any limitation or utilization management is consistent with and
20based on clinical guidelines and peer-reviewed scientific and
21medical literature.

begin delete

22(e)

end delete

23begin insert(f)end insert (1) With respect to an individual or group policy of health
24insurance subject to Section 10112.28, the copayment, coinsurance,
25 or any other form of cost sharing for a covered outpatient
26prescription drug for an individual prescriptionbegin insert for a supply of up
27to 30 daysend insert
shall not exceed begin delete one-twenty-fourth of the annual
28out-of-pocket limit applicable to individual coverage under Section
2910112.28 for a supply of up to 30 days.end delete
begin insert two hundred fifty dollars
30($250), except as provided in paragraphs (2) and (3).end insert

begin insert

31(2) With respect to products with actuarial value at or equivalent
32to the bronze level, cost sharing for a covered outpatient
33prescription drug for an individual prescription for a supply of up
34to 30 days shall not exceed five hundred dollars ($500).

end insert
begin delete

35(2)

end delete

36begin insert(3)end insert For a policy of health insurance that is a “high deductible
37health plan” under the definition set forth in Section 223(c)(2) of
38Title 26 of the United States Code, paragraph (1) of this subdivision
39shall apply only once an insured’s deductible has been satisfied
40for the year.

begin delete

P22   1(f)

end delete

2begin insert(g)end insert (1) If a policy of health insurance maintains a drug
3formulary grouped into tiers, including a fourth tier or specialty
4tier, a policy of health insurance shall use the following definitions
5for each tier of the drug formulary:

6(A) Tier one shall consist of begin delete preferred generic drugs and
7preferred brand name drugs if the cost to the health insurer for a
8preferred brand name drug is comparable to those for generic
9drugs.end delete
begin insert most generic drugs and lowend insertbegin insert-cost preferred brand drugs.end insert

10(B) Tier two shall consist of nonpreferred generic drugs,
11preferred brand name drugs, and any other drugs recommended
12by the health insurer’s pharmacy and therapeutics committee based
13on safety and efficacy and not solely based on the cost of the
14prescription drug.

15(C) Tier three shall consist of nonpreferred brand name drugs
16that are recommended by the health insurer’s pharmacy and
17therapeutics committee based on safety and efficacy and not solely
18based on the cost of the prescriptionbegin delete drug.end deletebegin insert drug, and which
19generally have a preferred and often less costly therapeutic
20alternative at a lower tier.end insert

21(D) Tier four shall consist ofbegin delete specialtyend delete drugs that are biologics,
22begin delete which, according to theend deletebegin insert drugs that theend insert federal Food and Drug
23Administration or thebegin delete manufacturer, require distributionend delete
24begin insert manufacturer requires to be distributedend insert through a specialty
25begin delete pharmacy or theend deletebegin insert pharmacy, drugs that require theend insert insured to have
26special training begin delete for self-administration or special monitoring.
27Specialty drugs may include prescription drugs that cost more than
28the Medicare Part D threshold if those drugs are recommended for
29Tier four by the health insurer’s pharmacy and therapeutics
30committee based on safety and efficacy, but placement shall not
31be solely based on the cost of the prescription drug.end delete
begin insert or clinical
32monitoring for self-administration, or drugs that cost the health
33insurer more than six hundred dollars ($600) net of rebates.end insert

34(2) This section does not require a policy of health insurance to
35include a fourthbegin delete tier, but if a policy of health insurance includes a
36fourth tier, the policy of health insurance shall comply with this
37section.end delete
begin insert tier.end insert

begin delete

38(3) This section does not require the health insurer’s pharmacy
39and therapeutics committee to consider the cost of the prescription
40drug to the health insurer.

end delete
begin delete

P23   1(g)

end delete

2begin insert(h)end insert This section shall not be construed to require a health insurer
3to impose cost sharing. This section shall not be construed to
4require cost sharing for prescription drugs that state or federal law
5otherwise requires to be provided without cost sharing.

begin delete

6(h)

end delete

7begin insert(i)end insert A policy of health insurance shall ensure that the placement
8of prescription drugs on formulary tiersbegin delete is not based solely on the
9cost of the prescription drug to the health insurer, butend delete
is based on
10clinically indicated, reasonable medical management practices.

11

begin deleteSEC. 6.end delete
12begin insertSEC. 8.end insert  

Section 10123.201 is added to the Insurance Code, to
13read:

14

10123.201.  

(a) (1) Every health insurer that provides
15prescription drug benefits shall maintain an expeditious process
16by which prescribing providers may obtain authorization for a
17medically necessary nonformulary prescription drug. On or before
18July 1, 2016, every insurer that provides prescription drug benefits
19shall file with the commissioner a description of its process for
20responding to authorization requests for nonformulary drugs. Any
21changes to this process shall be filed with the commissioner. The
22insurer shall provide that the insured, the insured’s designee, or
23the insured’s prescribing provider may seek an authorization for
24a nonformulary prescription drug.

25(2) Each insurer shall respond to an authorization request within
2672 hours following receipt of the authorization request for a
27nonurgent authorization. If the insurer grants the authorization
28request, the insurer shall provide coverage of the nonformulary
29drug for the duration of the prescription, including refills.

30(3) Each insurer shall provide that an urgent authorization may
31be obtained within 24 hours if an insured is suffering from a health
32condition that may seriously jeopardize the insured’s life, health,
33or ability to regain maximum function, or if an insured is
34undergoing a current course of treatment using a nonformulary
35prescription drug. An insurer that grants an exception based on
36these urgent circumstances shall provide coverage of the
37nonformulary prescription drug for the duration of that urgent
38condition.

39(4) If an insurer imposes step therapy, the insurer shall provide
40an expeditious process to authorize an exception to step therapy
P24   1when medically necessary and to conform effectively and
2efficiently with continuity of care requirements of this part and
3federal law, and any regulations issued thereunder. The process
4to authorize an exception to step therapy shall be consistent with
5this section, including the timelines provided in this section.

6(5) Each insurer shall provide a written description of its most
7current process to its prescribing providers. For purposes of this
8section, a prescribing provider shall include a provider authorized
9to write a prescription, pursuant to subdivision (a) of Section 4040
10of the Business and Professions Code, to treat a medical condition
11of an insured.

12(b) Any insurer that disapproves a request made pursuant to
13subdivision (a) by a prescribing provider to obtain authorization
14for a nonformulary drug shall provide the reasons for the
15disapproval in a notice provided to the insured. The notice shall
16indicate that the insured may file a grievance with the insurer if
17the insured objects to the disapproval, including any alternative
18drug or treatment offered by the insurer. The notice shall comply
19with Section 10133.661.

20(c) (1) An insurer shall maintain a pharmacy and therapeutics
21committee that shall be responsible for developing, maintaining,
22and overseeing any drug formulary list. If the insurer delegates
23responsibility for the formulary to any entity, the obligation of the
24insurer to comply with this part shall not be waived.

25(2) The pharmacy and therapeutics committee board membership
26shall conform with both of the following:

27(A) Represent a sufficient number of clinical specialties to
28adequately meet the needs of insureds.

29(B) Consist of a majority of individuals who are practicing
30physicians, practicing pharmacists, and other practicing health
31professionals who are licensed to prescribe drugs.

32(3) Members of the board shall abstain from voting on any issue
33in which the member has a conflict of interest with respect to the
34issuer or a pharmaceutical manufacturer.

35(4) At least 20 percent of the board membership shall not have
36a conflict of interest with respect to the issuer or any
37pharmaceutical manufacturer.

38(5) The pharmacy and therapeutics committee shall meet at least
39quarterly and shall maintain written documentation of the rationale
P25   1for its decisions regarding the development of, or revisions to, the
2formulary drug list.

3(6) The pharmacy and therapeutics committee shall do all of
4the following:

5(A) Develop and document procedures to ensure appropriate
6drug review and inclusion.

7(B) Base clinical decisions on the strength of the scientific
8evidence and standards of practice, including assessing
9peer-reviewed medical literature, pharmacoeconomic studies,
10outcomes research data, and other related information.

11(C) Consider the therapeutic advantages of drugs in terms of
12safety and efficacy when selecting formulary drugs.

13(D) Review policies that guide exceptions and other utilization
14management processes, including drug utilization review, quantity
15limits, and therapeutic interchange.

16(E) Evaluate and analyze treatment protocols and procedures
17related to the insurer’s formulary at least annually.

18(F) Review and approve all clinical prior authorization criteria,
19step therapy protocols, and quantity limit restrictions applied to
20each covered drug.

21(G) Review new federal Food and Drug
22Administration-approved drugs and new uses for existing drugs.

23(H) Ensure the insurer’s formulary drug list or lists cover a range
24of drugs across a broad distribution of therapeutic categories and
25classes and recommended drug treatment regimens that treat all
26disease states and does not discourage enrollment by any group
27of insureds.

28(I) Ensure the insurer’s formulary drug list or lists provide
29 appropriate access to drugs that are included in broadly accepted
30treatment guidelines and that are indicative of general best practices
31at the time.

32(d) (1) A health insurer may impose prior authorization
33requirements on prescription drug benefits, consistent with the
34requirements of this part.

35(2) (A) When there is more than one drug that is appropriate
36for the treatment of a medical condition, a health insurer may
37require step therapy. A health insurer that requires step therapy
38shall comply with the requirements specified in paragraph (4) of
39subdivision (a).

P26   1(B) In circumstances where an insured is changing policies, the
2new policy shall not require the insureds to repeat step therapy
3when that insured is already being treated for a medical condition
4by a prescription drug provided that the drug is appropriately
5prescribed and is considered safe and effective for the insured’s
6condition. Nothing in this section shall preclude the new policy
7from imposing a prior authorization requirement pursuant to
8subdivision (a) for the continued coverage of a prescription drug
9prescribed pursuant to step therapy imposed by the former policy,
10or preclude the prescribing provider from prescribing another drug
11covered by the new policy that is medically appropriate for the
12insured.

13(3) An insurer shall provide coverage for the medically
14necessary dosage and quantity of the drug prescribed for the
15treatment of a medical condition consistent with professionally
16recognized standards of practice.

17(4) An insurer that provides essential health benefits shall allow
18an insured to access prescription drug benefits at an in-network
19retail pharmacy unless the prescription drug is subject to restricted
20distribution by the federal Food and Drug Administration or
21requires special handling, provider coordination, or patient
22education that cannot be provided by a retail pharmacy. An insurer
23that provides essential health benefits may charge an insured a
24different cost sharing for obtaining a covered drug at a retail
25pharmacy, but all cost sharing shall count toward the policy’s
26annual limitation on cost sharing consistent with Section 10112.28.

27(e) The process described in subdivision (a) by which insureds
28may obtain medically necessary nonformulary drugs, including
29specified timelines for responding to prescribing provider
30authorization requests, shall be described in evidence of coverage
31and disclosure forms, as required by Section 10603, issued on or
32after January 1, 2016.

33(f) Every health insurer that provides prescription drug benefits
34 shall maintain all of the following information, which shall be
35made available to the commissioner upon request:

36(1) The complete drug formulary or formularies of the insurer,
37if the insurer maintains a formulary, including a list of the
38prescription drugs on the formulary of the insurer by major
39therapeutic category with an indication of whether any drugs are
40preferred over other drugs.

P27   1(2) Records developed by the pharmacy and therapeutic
2committee of the insurer, or by others responsible for developing,
3modifying, and overseeing formularies, including medical groups,
4individual practice associations, and contracting pharmaceutical
5benefit management companies, used to guide the drugs prescribed
6for the insureds of the insurer, that fully describe the reasoning
7behind formulary decisions.

8(3) Any insurer arrangements with prescribing providers,
9medical groups, individual practice associations, pharmacists,
10contracting pharmaceutical benefit management companies, or
11other entities that are associated with activities of the insurer to
12encourage formulary compliance or otherwise manage prescription
13drug benefits.

14(g) If an insurer provides prescription drug benefits, the
15commissioner shall, as part of its market conduct examination,
16review the performance of the insurer in providing those benefits,
17including, but not limited to, a review of the procedures and
18information maintained pursuant to this section, and describe the
19performance of the insurer as part of its report issued as part of its
20market conduct examination.

21(h) The commissioner shall not publicly disclose any information
22reviewed pursuant to this section that is determined by the
23commissioner to be confidential pursuant to state law.

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

26(1) “Authorization” means approval by the health insurer to
27provide payment for the prescription drug.

28(2) “Step therapy” means a type of protocol that specifies the
29sequence in which different prescription drugs for a given medical
30condition and medically appropriate for a particular patient are to
31be prescribed.

32(j) (1) Nonformulary prescription drugs shall include any drug
33for which an insured’s copayment or out-of-pocket costs are
34different than the copayment for a formulary prescription drug,
35except as otherwise provided by law or regulation.

36(2) If a nonformulary drug is authorized consistent with this
37section, the cost sharing shall be the same as for a formulary drug
38consistent with subdivision (e) of Section 10123.193.

begin insert

39(k) Nothing in this section shall be construed to affect an
40insured’s or policyholder’s eligibility to submit a complaint to the
P28   1department for review or to apply to the department for an
2independent medical review.

end insert
begin delete

3(k)

end delete

4begin insert(l)end insert Nothing in this section shall be construed to restrict or impair
5the application of any other provision of this part.

6

begin deleteSEC. 7.end delete
7begin insertSEC. 9.end insert  

No reimbursement is required by this act pursuant to
8Section 6 of Article XIII B of the California Constitution because
9the only costs that may be incurred by a local agency or school
10district will be incurred because this act creates a new crime or
11infraction, eliminates a crime or infraction, or changes the penalty
12for a crime or infraction, within the meaning of Section 17556 of
13the Government Code, or changes the definition of a crime within
14the meaning of Section 6 of Article XIII B of the California
15Constitution.



O

    93