§ 1300.67.24. Outpatient Prescription Drug Copayments, Coinsurance, Deductibles, Limitations and Exclusions
(a) Every health care service plan that provides coverage for outpatient prescription drug benefits shall provide coverage for all medically necessary outpatient prescription drugs except as described in this section, subject to the requirements of Health and Safety Code section 1342.7(g).
(1) Outpatient prescription drugs are self-administered drugs approved by the Federal Food and Drug Administration for sale to the public through retail or mail-order pharmacies that require prescriptions and are not provided for use on an inpatient basis. For purposes of this section "inpatient basis" has the meaning indicated in Section 1300.67(b), and "self-administered" means those drugs that need not be administered in a clinical setting or by a licensed health care provider.
(2) Coverage for outpatient prescription drugs shall also include coverage for disposable devices that are medically necessary for the administration of a covered outpatient prescription drug, such as spacers and inhalers for the administration of aerosol outpatient prescription drugs, and syringes for self-injectible outpatient prescription drugs that are not dispensed in pre-filled syringes. For purposes of this section, the term "disposable" includes devices that may be used more than once before disposal. This section does not create an obligation for a plan to provide coverage for a durable medical equipment benefit.
(b) Standards for outpatient prescription drug benefit plans
(1) A prescription drug benefit offered by a plan shall comply with the requirements of the Knox-Keene Act and the regulations promulgated by the Director of the Department of Managed Health Care, including but not limited to Sections 1342, 1343.5,1342.7, 1363, 1363.01, 1363.03, 1363.5, 1367(e), 1367(g), 1367(h), 1367.01, 1367.20, 1367.21, 1367.22 and 1367.24 of the Act and Section 1300.67.4(a)(3)(A) of these rules.
(2) All clinical aspects of a plan's prescription drug benefit shall be developed by qualified medical and pharmacy professionals in accordance with good professional practice. The plan shall establish and document an internal process for ongoing review by qualified medical and pharmacy professionals of the clinical aspects of the prescription drug benefit, including review of limitations and exclusions, and the safety, efficacy, and utilization of outpatient prescription drugs.
(3) Plans seeking to establish limitations or exclusions on outpatient prescription drug benefits shall do so consistent with up-to-date evidence-based outcomes and current published, peer-reviewed medical and pharmaceutical literature.
(4) A plan that provides coverage for prescription drugs through a mail order pharmacy shall have written policies and procedures documenting that the plan's mail order arrangements are in compliance with the requirements of the Act and this section, and applicable California and federal laws regarding pharmacists and pharmacy services. The mail order pharmacy process shall conform effectively and efficiently with a plan's processes for prior authorization for coverage of medically necessary drugs as required by the Act, and shall include standards for timely delivery and a contingency mechanism for providing the drug if a mail order provider fails to meet the delivery standards.
(5) In reviewing copayments, coinsurance, deductibles, limitations, or exclusions for compliance with Section 1367(e) and (h) of the Act, and Section 1300.67.4(a)(3)(A) of these rules, the Department's approval or disapproval may be based upon all relevant factors, including but not limited to:
(A) The type and number of enrollees affected;
(B) The clinical efficacy of the drug(s) proposed to be limited or excluded;
(C) The availability of therapeutic equivalents or other drugs medically necessary for treatment of health conditions;
(D) The specific health plan products to which the copayment, coinsurance, deductible, limitation, or exclusion will apply;
(E) The duration of the limitation or exclusion;
(F) The rationale for the copayment, coinsurance, deductible, limitation or exclusion;
(G) The projected effect of the copayment, coinsurance, deductible, limitation, or exclusion on the affordability and accessibility of coverage;
(H) The projected comparative clinical effect, including any potential risk of adverse health outcomes, based upon utilization data and review of peer-reviewed professional literature;
(I) The overall copayment structure of the product, including whether the copayment, coinsurance, or deductible contributes to the overall out-of-pocket maximum for the product;
(J) Information regarding similar copayments, coinsurance levels, deductibles, limitations, or exclusions previously approved by the Department;
(K) Evidence-based clinical studies and professional literature;
(L) The description of the copayment, coinsurance, deductible, limitation or exclusion as compared to other benefits and products in the marketplace;
(M) Any other historical, statistical, or other information that the submitting plan considers pertinent to the request for approval of the copayments, coinsurance level, deductibles, limitation, or exclusion.
(c) Copayments, Coinsurance and Deductibles
(1) A plan's prescription drug benefit shall provide that if the pharmacy's retail price for a prescription drug is less than the applicable copayment amount, the enrollee shall not be required to pay any more than the retail price.
(2) Proposed copayment structures or ranges, coinsurance, or deductibles submitted to the Director for approval shall be based upon a methodology that is fully described and documented, and that complies with the standards set forth in this Section. A plan may use actual cost data on prescription drugs or, for contracted services or products, nationally recognized data sources used by the plan in developing the contract rates.
(3) A copayment or percentage coinsurance shall not exceed 50 percent of the cost to the plan as described in subsection (c)(5) and (6). A percentage coinsurance shall meet one of the following additional requirements:
(A) Have a maximum dollar amount cap on the percentage coinsurance that will be charged for an individual prescription;
(B) Apply towards an annual out-of-pocket maximum for the product; or
(C) Apply towards an annual out-of-pocket maximum for the prescription drug benefit.
(4) In addition to compliance with this subsection (c), copayments and coinsurances shall comply with the standards identified at subsection (b), including that they shall be reasonable so as to allow access to medically necessary outpatient prescription drugs, and the Department's determination may be based on all relevant factors as provided in subsection (b)(5).
(5) The "cost to the plan" means the actual cost incurred by the plan or its contracting provider to acquire and dispense a covered outpatient prescription drug, without subtracting or otherwise considering any copayment or coinsurance amount to be paid by enrollees. The cost to the plan may include average cost calculations as described in this section, and shall include all discounts and other prospective cost and pricing arrangements, as applicable. Plans shall account for any rebates and other retrospective cost and pricing arrangements for outpatient prescription drugs by verifying that the rebates and other retrospective cost and pricing arrangements for outpatient prescription drugs are applied by the plan to reduce costs for the plan's subscribers.
(6) Compliance with the requirement not to exceed 50 percent of the actual cost to the plan may be met by various methods including the three methods described below. A plan may propose a different method, which shall be filed with the Department prior to implementation by the plan and supported by information and documentation sufficient to satisfy the Department as to the validity of the calculation methodology.
(A) Average Cost in Each Tier. This copayment represents the average plan cost per drug in a tier and is calculated in the following manner:
1.The copayment is for one tier in a multi-tier prescription drug benefit. (EXAMPLE: the Name Brand tier.)
2.Add together the plan's cost for all the drugs in that tier. (EXAMPLE: the Name Brand tier covers X drug which costs the plan $50 per prescription, Y drug which costs $100 per prescription, and Z drug which costs the plan $75 per prescription-added together for a total cost of $225.)
3.Divide the cost determined according to 2 above by the total number of drugs in that same tier. (EXAMPLE: there are 3 drugs in the Name Brand tier which cost the plan $225, $225/3 = $75.)
4.The copayment may not exceed 50 percent of the average cost of drugs in the tier to which it applies. (EXAMPLE: 50% of $75 = $37.50. The copayment for the Name Brand tier may not exceed $37.50.)
(B) Weighted Average Cost in Each Tier. This copayment is the same as the average per tier except that the prescriptions actually covered by the plan are used in the calculation.
1.The copayment is for one tier in a multi-tier prescription benefit. (EXAMPLE: the Name Brand tier.)
2.Calculate the number of prescriptions for drugs in that tier actually covered by the plan. (EXAMPLE: the plan covered the cost of 10 prescriptions in the Name Brand tier.)
3.Add together the cost for all the drugs covered in 2 above. (EXAMPLE: the plan covered three prescriptions for X drug (3 x $50= $150), three for Y drug (3 x $100 = $300) and four for Z drug (4 x $75 = $300). $150 + $300 + $300 = $750 total cost for prescriptions in that tier covered by the plan.)
4.Divide the total cost determined according to 3 above by the number of prescriptions from step 2. (EXAMPLE: $750/10 = $75.)
5.The copayment may not exceed 50 percent of the weighted average cost of drugs in the tier to which it applies. (EXAMPLE: 50% of $75 = $37.50. The copayment for the Name Brand tier may not exceed $37.50.)
(C) Weighted Average Cost Across All Tiers. This copayment is the same as the weighted average per tier except that there is one copayment calculated using the number of prescriptions for all tiers covered by the plan.
1.The copayment is for all tiers in a multi-tier prescription benefit. (EXAMPLE: the Name Brand tier and the Generic tier.)
2.Calculate the number of prescriptions for drugs in that tier actually covered by the plan. (EXAMPLE: Ten prescriptions under the Name Brand tier (three for X drug, three for Y drug and four for Z drug, ten prescriptions under the Generic tier (three for drug A, three for drug B and four for Drug C for a total of twenty drugs.)
3.Add together the cost for all the drugs covered in 2 above. (EXAMPLE: the ten Name Brand drugs cost $750 (from previous example) plus the Generic drugs, three for A drug (3 x $5 = $15), three for B drug (3 x $10 = $30) and four for C drug (4 x $15 = $60) (Generic total = $105) ($750 + $105 = $855 cost for all the drugs covered in the Name Brand and Generic tiers.)
4.Divide the total cost across tiers determined according to 3 above by the number of prescriptions from step 2. (EXAMPLE: $855/20 = $42.75)
5.The copayment may not exceed 50 percent of the weighted average cost of drugs in all the tiers in the prescription drug benefit to which it applies. (EXAMPLE: 50% of $42.75 = $21.38. The copayment for all tiers may not exceed $21.38.)
Plans that provide coverage for outpatient prescription drug benefits may apply the following limitations:
(1) A plan may impose prior authorization requirements on prescription drug benefits, consistent with the requirements of the Act and regulations.
(2) When there is more than one drug that is appropriate for the treatment of a medical condition, a plan may require step therapy. A plan that requires step therapy shall 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 of the Act and regulations. In circumstances where an enrollee is changing plans, the new plan may not require the enrollee to repeat step therapy when that enrollee is already being treated for a medical condition by a prescription drug provided that the drug is appropriately prescribed and is considered safe and effective for the enrollee's condition. Nothing in this section shall preclude the new plan from imposing a prior authorization requirement pursuant to Section1367.24 for the continued coverage of a prescription drug prescribed pursuant to step therapy imposed by the former plan, or preclude the prescribing provider from prescribing another drug covered by the new plan that is medically appropriate for the enrollee. For purposes of this section, "step therapy" means a type of protocol that specifies the sequence in which different prescription drugs for a given medical condition and medically appropriate for a particular patient are to be prescribed.
(3) A plan shall provide coverage for the medically necessary dosage and quantity of the drug prescribed for the treatment of a medical condition consistent with professionally recognized standards of practice.
(A) A plan may limit the amount of the drug dispensed at any one time to a 30-day supply or, if the treatment is for less than 30 days, for the medically necessary amount of the drug.
(B) A plan may impose a requirement that maintenance drugs be dispensed in a two months or greater supply.
(C) A plan may establish a mandatory mail order process for maintenance drugs when dispensed in a three months supply or greater quantities, but shall not impose any fees or costs for mandatory mail order prescriptions other than the applicable copayment or coinsurance. A plan shall not require an enrollee to fill a prescription by mail if the prescribed drug is not available to be filled in that manner.
(D) For purposes of this section, "maintenance drugs" means those outpatient prescription drugs that are prescribed for the enrollee on a continual basis to treat a chronic condition.
(4) Plans may require enrollees who are prescribed drugs for smoking cessation to be enrolled in or to have completed a smoking cessation program, if covered by the plan prior to or concurrent with receiving the prescription drug.
(5) Other limitations that the Department may approve pursuant to Section 1342.7 of the Act and this section.
Plans that provide coverage for outpatient prescription drug benefits are not required to provide coverage for prescription drugs that meet the following conditions:
(1) When prescribed for cosmetic purposes. For purposes of this section "cosmetic" means drugs solely prescribed for the purpose of altering or affecting normal structures of the body to improve appearance rather than function.
(2) When prescribed solely for the treatment of hair loss, sexual dysfunction, athletic performance, cosmetic purposes, anti-aging for cosmetic purposes, and mental performance. Drugs for mental performance shall not be excluded from coverage when they are used to treat diagnosed mental illness or medical conditions affecting memory, including, but not limited to, treatment of the conditions or symptoms of dementia or Alzheimer's disease.
(3) When prescribed solely for the purposes of losing weight, except when medically necessary for the treatment of morbid obesity. Plans may require enrollees who are prescribed drugs for morbid obesity to be enrolled in a comprehensive weight loss program, if covered by the plan, for a reasonable period of time prior to or concurrent with receiving the prescription drug.
(4) When prescribed solely for the purpose of shortening the duration of the common cold.
(5) Drugs that are available over the counter. A plan shall not exclude coverage of an entire class of prescription drugs when one drug within that class becomes available over the counter. A plan that seeks to exclude coverage for an entire class of drugs when more than one drug within that class become available over the counter, shall first file a notice of material modification and obtain the Department's prior approval in accordance with Section 1342.7 of the Act and this regulation.
(6) Replacement of lost or stolen drugs.
(7) Drugs when prescribed by non-contracting providers for non-covered procedures and which are not authorized by a plan or a plan provider except when coverage is otherwise required in the context of emergency services.
(8) Other categories of prescription drugs approved by the Department pursuant to Section 1342.7 of the Act and this section.
(f) Oversight of Plan and Provider Compliance
A plan shall have written policies and procedures for its outpatient prescription drug benefits, and quality assurance systems in place for the early identification and swift correction of problems in the accessibility and availability of outpatient prescription drug benefits. A contract between a health care service plan and a prescription drug benefit provider shall include provisions, terms and conditions sufficient to ensure that the standards and requirements of this regulation are met.
(1) Any exclusion or limitation on a prescription drug benefit that is not described at subsections (d) or (e) may not be applied to any plan's prescription drug benefit unless a plan has filed a notice of material modification with the Department and received approval by Order to apply the exclusion or limitation. The Order of approval may be issued subject to specified terms and conditions, or for specified periods, as the Department may determine are necessary and appropriate. Following issuance of an Order approving an exclusion or limitation, any other licensed plan may apply the same exclusion or limitation to its prescription drug benefit if it files an amendment with the Department not less than 30 days prior to implementation of the exclusion or limitation, and represents that it is exactly the same as that previously approved by Order, provides specific reference to the Order number and date issued, and addresses any specified terms and conditions upon such Order, as applicable.
(2) A plan may meet the material modification filing requirements of subsection (g)(1) with respect to exclusions and limitations contained in contracts issued, renewed or amended on or before January 1, 2007, by filing within six months of the effective date of this regulation a report disclosing and describing all such exclusions and limitations on prescription drug benefits covered under all subscriber contracts subject to the requirements of Section 1342.7 of the Act. The Department will provide an expeditious review of the exclusions and limitations disclosed in the report.(1. New section filed 11-3-2000 as an emergency; operative 11-3-2000 (Register 2000, No. 44). A Certificate of Compliance must be transmitted to OAL by 3-5-2001 or emergency language will be repealed by operation of law on the following day. 2. Certificate of Compliance as to 11-3-2000 order transmitted to OAL 3-5-2001 and filed 4-16-2001 (Register 2001, No. 16). 3. Amendment of section heading and repealer and new section and Note filed 6-26-2006; operative 7-26-2006 (Register 2006, No. 26).)
Note: Authority cited: Sections 1342.7, 1344 and 1346, Health and Safety Code. Reference: Sections 1342, 1342.7, 1343.5, 1363, 1363.01, 1363.03, 1363.5, 1367, 1367.01, 1367.215, 1367.24, 1367.25, 1367.45, 1367.51, 1374.72 and 1375.1, Health and Safety Code; see also SB 842. ch.791, Stats. 2002.
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