Standard Drug Formulary Template

Section 2030.40  Standard Drug Formulary Template The following standards are minimum standards, and unless otherwise noted, apply to all health product formularies subject to Section 155.37 of the Code. A health insurance issuer or its designee may implement additional provisions exceeding these requirements. a)         Format of the formulary. The formulary must be in a searchable format and must include the following sections in the order listed: 1)         Cover page; 2)         Table of contents; 3)         Informational section; 4)         Categorical list of prescription drugs; and 5)         Index of prescription drugs. b)         Cover page. The cover page of the formulary must include all of the following: 1)         The title of the document; 2)         The name of the health insurance issuer offering the formulary. In the case of CMS, the field must include both the full legal name of CMS and the full legal name of the third-party administrator, administrative services organization, or pharmacy benefit manager contracted with CMS to offer the formulary for the State employee health plan; 3)         The name of each health product to which the formulary applies. Product names listed on a formulary must correspond to product names used on corresponding coverage documents, summary of benefits and coverage documents (SBCs), network provider directories, and other communications with insureds, including identification cards; 4)         The date the formulary was last updated; 5)         A notice that the formulary is subject to change and all previous versions of the formulary are no longer in effect; 6)         A direct website link/URL for the location of the electronic version of the formulary posted on the health insurance issuer's public website. The formulary must be accessible to potential covered individuals, covered individuals, providers, and the general public. The formulary is accessible if it can be viewed on the website through a clearly identifiable link or tab without requiring an individual to create or access an account or enter a policy number. If the health insurance issuer offers more than one plan, an individual must be able to easily discern which formulary applies to which plan; and 7)         A direct website link/URL for the location of, or specific instructions for locating, plan-specific coverage documents that include cost-sharing applicable to drugs for each health product to which the formulary applies, and that are posted on a health insurance issuer's public website. c)         Informational section. The informational section of the formulary must include all of the following: 1)         Instructions for contacting the health insurance issuer's customer service department. A health insurance issuer must have customer service representatives readily available during normal business hours to provide accurate, specific information concerning drug benefits, including, but not limited to: A)        information concerning drugs covered under the medical benefit of the covered individual's contract; B)        the actual dollar amount of cost sharing under the covered individual's contract for drugs subject to a deductible, copayment, coinsurance, or maximum out-of-pocket limitation; and C)        the process for submitting an exception request and requesting prior authorization and step therapy exceptions. For plan or policy years beginning on or after January 1, 2026, no formulary may include a step therapy requirement for any health product that is subject to Section 87(f) of the Managed Care Reform and Patient Rights Act. 2)         Definitions. The informational section of the formulary must have a definition section as prescribed below. A health insurance issuer may request an omission, deviation, or substitution of the stated definitions to the Director for review and approval. For plan or policy years beginning on or after January 1, 2026, the formulary for a health product that is subject to Section 87(f) of the Managed Care Reform and Patient Rights Act must not include the definition of "step therapy" or the clause about step therapy requirements in the definition of "exception request".  The following definitions are intended solely for informing consumers. A)        "Allowed amount" is the maximum amount on which the health insurance issuer bases its payment for a covered health care service. This may be called "eligible expense", "payment allowance", or "negotiated rate".  If your health care provider charges more than the allowed amount and is not part of the provider network, you may have to pay the difference. B)        "Brand name drug" is a drug that is marketed under a proprietary, trademark protected name. The brand name drug must be listed in all capital letters. C)        "Coinsurance" is a percentage of the cost of a covered health care service, which you are responsible to pay. The cost of the covered health care service is generally deemed to be the allowed amount, which may differ from the retail price that you would pay for the same service without using insurance. Typically, a coinsurance does not apply until after you have met the deductible, unless the health insurance issuer has waived or lowered the deductible for the health care service in question. D)        "Copayment" is a fixed dollar amount that you pay for a covered health care service. Typically, a copayment does not apply until after you have met the deductible, unless the health insurance issuer has waived or lowered the deductible for the health care service in question. E)        "Covered individual" is an individual enrolled in, subscribed to, or insured under a health product, whether directly or as a dependent or beneficiary. F)         "Deductible" is the amount you pay for covered health care services before your health product begins payment for all or part of the cost of the health care service under the terms of coverage. If your health product has a deductible, it may have either one deductible or separate deductibles for medical benefits and drug benefits. For some health care services, such as preventive services, the health insurance issuer might waive or lower the deductible to pay for costs of the health care service from the first dollar of coverage, but this tends not to happen for most other covered services. G)        "Drug Tier" is a group of drugs that corresponds to a specified cost sharing tier in the health product's drug coverage. The tier in which a drug is placed determines your portion of the cost for the drug. H)        "Exception request" is a request for coverage of i) a nonformulary drug, ii) a drug being removed from the formulary, iii) a quantity of a drug above a quantity limit, or iv) a drug that is subject to a step therapy requirement. If you, your designee, or your attending or prescribing provider submits an exception request for coverage of a drug, the health insurance issuer must cover the drug when the drug is determined to be medically necessary to treat your condition. I)         "Exigent circumstances" are when you are suffering from a health condition that may seriously jeopardize your life, health, or ability to regain maximum function, or when you are undergoing a current course of treatment using a nonformulary drug. J)         "Formulary" is the complete list of drugs preferred for use and eligible for coverage under a health product, and includes all drugs covered under the outpatient or pharmacy drug benefit of the health product. Formulary is also known as a drug list or prescription drug list. K)        "Generic drug" is the same drug as its brand name equivalent in dosage, safety, strength, how it is taken, quality, performance, and intended use. A generic drug is listed in bold and italicized lowercase letters. L)        "Nonformulary drug" is a drug that is not listed on the health product's formulary as a covered drug, but may become eligible for coverage under an "exception request". M)       "Out-of-pocket cost" is copayments, coinsurance, and the applicable deductible, plus all costs for health care services that the health product does not cover. N)        "Prescribing provider" is a health care provider authorized to write a prescription to treat your health condition. O)        "Prescription" is an oral, written, or electronic order by a prescribing provider for you that contains the name of the drug, the quantity of the drug, the date of issue, the name and contact information of the prescribing provider, the signature of the prescribing provider if the prescription is in writing, and if requested by you, the health condition or purpose for which the drug is being prescribed. P)         "Prescription drug" is a drug that is prescribed by your prescribing provider and requires a prescription under applicable law. Q)        "Prior Authorization" is a health product's requirement that you or your prescribing provider obtain the health insurance issuer's authorization for a drug before the health product will cover the drug. The health insurance issuer must grant a prior authorization when it is medically necessary for you to obtain the drug. R)        "Step therapy" is a process specifying the sequence in which different prescription drugs for a given health condition are medically appropriate for you. The health insurance issuer may require you to try one or more drugs to treat your health condition before the health insurance issuer will cover a particular drug for the condition pursuant to a step therapy request. If your attending or prescribing provider submits a request for step therapy exception, the health insurance issuer must make exceptions to step therapy when the criteria are met. 3)         Definitions of any additional or different terms used in the formulary that are necessary to understand the outpatient or pharmacy drug benefit. The health insurance issuer must request review and approval from the Department for all additional or different terms used in the formulary. The request must be submitted through a filing in the Systems for Electronic Rates & Forms Filing (SERFF). No Department review and approval are required for defined terms to replace "covered individual" that the formulary's corresponding health product defines in its coverage documents. 4)         Instructions for locating a prescription drug in the categorical list of prescription drugs. The instructions must explain: A)        if a drug may be located by looking up the therapeutic category and class of the drug or the brand or generic name of the drug in the alphabetical index; and B)        if a generic equivalent for a brand name drug is not available or is not covered, the drug will not be separately listed by its generic name. 5)         A description of how drugs are listed in the categorical list of prescription drugs. At minimum, the description must explain: A)        a drug is listed alphabetically by its brand and generic names or, if only the generic equivalent is covered under the plan, then just by its generic name, in the therapeutic category and class to which it belongs; B)        the generic name of a brand name drug is included after the brand name in parenthesis and all bold and italicized lowercase letters; C)        if a generic equivalent for a brand name drug is available, and both the brand name and generic equivalents are covered, the generic drug will be listed separately from the brand name drug in all bold and italicized lowercase letters; D)        in the event a generic drug is marketed under a proprietary, trademark protected brand name, the brand name will be listed in all capital letters after the generic name in parentheses and regular typeface with first letter of each word capitalized. The description must include an example of a drug available both as a brand name drug and a generic equivalent to illustrate how such a drug is listed; and E)        if the plan only covers a generic equivalent without covering the brand name drug, and if the generic drug is not marketed under a brand name, the brand name drug might not be listed, so the reader should include a drug's generic name when searching the formulary for covered drugs.  The generic drug's name in this case will be listed in all bold and italicized lowercase letters. 6)         A description of the drug tiers in the formulary, if the drugs are grouped into tiers. The description must include tier numbers designating the tiers and must accurately describe the types of drugs placed in each tier. The same description must be used in the corresponding coverage documents. The description must explain how to determine the following: A)        which drugs on the formulary are preferred drugs or specialty drugs; and B)        the cost sharing for each drug tier, including any applicable dollar maximum amounts where allowed by law. 7)         A description of all utilization review restrictions the health insurance issuer imposes on drug coverage, including, but not limited to, prior authorization requirements, step therapy requirements, quantity limits, and network limitations on access, including, specialty pharmacy restrictions. For plan or policy years beginning on or after January 1, 2026, no formulary may include a step therapy requirement for any health product that is subject to Section 87(f) of the Managed Care Reform and Patient Rights Act. 8)         Information about the differences between drugs covered under the medical benefit and drugs covered under the outpatient or pharmacy drug benefit of the health product, and instructions on how to obtain coverage information concerning drugs covered under the medical benefit. 9)         Notice that the health insurance issuer must update the publicly posted formulary with any changes on a monthly basis. The notice must include a description of the types of changes a health insurance issuer may make to the formulary during the plan year, policy year, or other policy period, the dates on which such changes will be effective, and a description of any prior notification a health insurance issuer will provide an affected covered individual of a formulary change. At minimum, the notice must include, but not be limited to, the following information: A)        change in drug or dosage form; B)        changes in tier placement of a drug that results in an increase in cost sharing; and C)        any changes of utilization review restrictions, including any additions of these restrictions. 10)       An explanation that the presence of a drug on the formulary does not guarantee a covered individual will be prescribed that drug by his or her prescribing provider for a particular health condition. 11)       For health products subject to Section 45.1 of the Managed Care Reform and Patient Rights Act, notice that the health insurance issuer must cover nonformulary drugs when medically necessary and a detailed description of the process for requesting coverage of a nonformulary drug. A)        The description must state that the health insurance issuer must notify the covered individual or the covered individual's designee and the covered individual's attending or prescribing provider of its coverage determination within 24 hours of receipt of a request based on exigent circumstances and within 72 hours of receipt of all other exception requests. B)        For health products that are non-grandfathered health insurance coverage subject to 45 CFR 156.122 (Apr. 15, 2024) (no later editions or amendments), the description must also state that, upon approval of the exception request: i)          the health insurance issuer must provide coverage pursuant to a non-urgent request for the duration of the prescription, including refills; and ii)         the health insurance issuer must provide coverage, including refills, pursuant to a request based on exigent circumstances for the duration of the exigency. C)        For all other health products subject to Section 45.1 of the Managed Care Reform and Patient Rights Act, the description must also state that the health insurance issuer must provide coverage for 12 months following the date of approval or until renewal of the plan. D)        The description must also state a covered individual may file with the issuer or the Department a grievance or complaint relating to denial of a coverage request and that the coverage documents provide information on internal appeal and external review rights and procedures. 12)       Instructions on how to locate and fill a prescription through a network retail pharmacy, mail order pharmacy, and specialty pharmacy, as applicable. 13)       A detailed description of the process for submitting a prior authorization request. For any health product subject to Section 364.3 of the Code, the description must state that if a health insurance issuer fails to respond to a prior authorization request using the uniform electronic prior authorization form within 72 hours of receiving a non-urgent request and 24 hours of receiving a request based on exigent circumstances, the request is deemed granted. 14)       Notice of a covered individual's rights to a step therapy exception to the extent provided in Section 45.1(c) of the Managed Care Reform and Patient Rights Act, as that Section appeared before the changes made by Public Act 103-650 effective January 1, 2026. For any health product subject to Section 87(f) of the Managed Care Reform and Patient Rights Act, this provision does not apply to the formulary used for plan or policy years beginning on or after January 1, 2026. 15)       For health products that are subject to Section 25(a)(3) of the Managed Care Reform and Patient Rights Act, notice that, if a drug is removed from the formulary or placed on a less preferred or higher cost-sharing tier during the plan or policy year, an individual receiving coverage for the drug and the covered individual's prescribing provider will receive at least 60 days' notice before the formulary change that the individual's coverage for the drug will be continued at the existing level if the prescribing provider notifies the health insurance issuer that the drug is medically necessary for the covered individual. 16)       For health products that are subject to the Prior Authorization Reform Act, notice that, except for benzodiazepines, Schedule II narcotic drugs, and maintenance medications to treat a chronic or long-term condition, a prior authorization approval will be valid for the lesser of six months, the length of treatment determined by the covered individual's prescribing provider, or the renewal of the plan. For maintenance medications to treat a chronic or long-term condition, the notice must state that a prior authorization approval will be valid for the lesser of 12 months or the length of treatment determined by the covered individual's prescribing provider. 17)       For health products subject to the following provisions of the Illinois Insurance Code, a description of the coverage provided under the outpatient or pharmacy drug benefit for drugs, devices, and FDA-approved products pursuant to Sections 356w, 356z.4, 356z.4a, 356z.41, 356z.60, and 356z.62 of the Illinois Insurance Code. The description must include a detailed explanation of the requirements and process to acquire those drugs, devices, and FDA-approved products through the outpatient or pharmacy drug benefit, including off-label uses where applicable. 18)       For health products subject to Section 356z.20 of the Illinois Insurance Code, a description of how the financial requirements and treatment limitations for prescribed, orally-administered cancer medications are no more restrictive than those applied to intravenously injected or administered cancer medications covered by the health product, and how there are no separate cost-sharing requirements or treatment limitations for prescribed, orally-administered cancer medications. 19)       For health products subject to Article XXXIIB of the Illinois Insurance Code, notice that the health insurance issuer will not require the covered individual to pay for a drug at the point of sale in an amount that exceeds the lesser of the cost-sharing amount or the retail price of the drug without the drug coverage. 20)       If applicable to any drugs listed on the formulary, a detailed description of the process for requesting coverage and obtaining drugs that are subject to specialty pharmacy restrictions or other network limitations on coverage. 21)       An annotated legend or key to all abbreviations, symbols, and notations used in the formulary. d)         Categorical list of prescription drugs. 1)         Organization of the categorical list. A)        The categorical list of drugs must be organized by drug category and class based on a commonly used and widely accepted drug classification system, such as the American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classification System contained in the "AHFS Drug Information" published by the American Society of Health-Systems Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland  20184 (2025) (no later editions or amendments), or the "U.S. Pharmacopeial Convention (USP) Medicare Model Guidelines v.9.0" published by the United States Pharmacopeia Healthcare Safety and Quality Expert Committee, 7135 English Muffin Way, Frederick, Maryland  21704 (Sept. 29, 2023) (no later editions or amendments), available online at https://www.usp.org/health-quality-safety/usp-medicare-model-guidelines. The formulary must identify the drug classification system that is used. B)        Category names must appear alphabetically, and class names must appear alphabetically within a category. C)        Drugs must be listed in drug classes consistent with the drug classification system. A drug belonging to multiple drug classes must be listed in each applicable class. D)        Brand name and generic drugs must be alphabetically listed by respective brand or established name within classes. In addition to a category and class name provided by the drug classification system, the categorical list must include, where possible, a plain language description of the category and class. 2)         The categorical list must include a complete list of all covered drugs, including both generic and brand name drugs, and must include, where possible, a plain language description of a drug. A health insurance issuer may include drugs covered only under the medical benefit of the product as long as each drug is clearly identified as a drug covered only under the medical benefit. A health insurance issuer may include nonformulary drugs as long as each drug is clearly identified as a nonformulary drug. 3)         The categorical list must include column headings on the top of each page of the categorical list, and the columns must appear in the following order from left to right: A)        "Drug Name"; B)        "Drug Tier"; and C)        "Coverage Requirements and Limits". 4)         In the "Drug Name" column, the proprietary name for a brand name drug must appear in all capital letters. The established name for the brand name drug must be placed in parentheses after the brand name in all bold and italicized lowercase letters. The established name for a generic drug must appear in all bold and italicized lowercase letters. If a generic drug is sold under a brand name, the brand name must be placed in parentheses after the established name in regular typeface with the first letter of each word capitalized. 5)         The "Drug Name" column must include all covered dosage forms and strengths for each prescription drug. If there are differences in tier placement, quantity limit, prior authorization, step therapy, or other utilization restrictions or plan benefit offerings for a drug based on its differing dosage forms or strengths, the categorical list of drugs must include separate rows for the dosage forms and strengths of the drug to clearly identify the differences. 6)         The "Drug Tier" column must identify the cost sharing tier where the drug is placed, if applicable. A health insurance issuer must use a unique tier number, abbreviation, or symbol, which must be explained in the annotated legend or key of the formulary, for the following: A)        drugs, devices, and FDA-approved products covered under the outpatient or pharmacy drug benefit of the product pursuant to Sections 356w, 356z.4, 356z.4a, 356z.41, 356z.59, 356z.60, and 356z.62 of the Illinois Insurance Code. Drugs that are covered without cost-sharing must be differentiated from drugs that are subject to cost-sharing within the same tier; B)        orally-administered cancer drugs that are subject to the requirements of Section 356z.20 of the Illinois Insurance Code; C)        nonformulary drugs, if listed on the formulary; and D)        drugs covered only under the medical benefit, if listed on the formulary. 7)         The "Coverage Requirements and Limits" column must include abbreviations, notations, or symbols for all utilization review restrictions that the health insurance issuer imposes on drug coverage, including, but not limited to, prior authorization, step therapy, quantity limits, and network limitations on access, including specialty pharmacy restrictions, in addition to any other requirements, limits, or other relevant information applicable to the coverage provided for a drug. For each drug subject to quantity limits, the applicable quantity limits must be described with specificity. Each abbreviation, symbol, or notation used in the "Coverage Requirements and Limits" column must be explained in the annotated legend or key of the formulary. 8)         The annotated legend or key to all abbreviations, symbols, and notations used in the formulary must appear on each page of the categorical list. e)         Index. The index must list each covered brand name and generic drug by respective brand name or established name in alphabetical order and include the page number for the location of the drug in the categorical list of drugs.