Ill. Admin. Code tit. 50, § 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are no longer in effect;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 lowercaseletters.
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 lowercaseletters;
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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.