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| 1 | | "Hormonal therapy medication" means hormonal treatment |
| 2 | | administered to treat gender dysphoria. |
| 3 | | "Therapeutic equivalent version" means drugs, devices, or |
| 4 | | products that can be expected to have the same clinical effect |
| 5 | | and safety profile when administered to patients under the |
| 6 | | conditions specified in the labeling and that satisfy the |
| 7 | | following general criteria: |
| 8 | | (1) it is approved as safe and effective; |
| 9 | | (2) it is a pharmaceutical equivalent in that it: |
| 10 | | (A) contains identical amounts of the same active |
| 11 | | drug ingredient in the same dosage form and route of |
| 12 | | administration; and |
| 13 | | (B) meets compendial or other applicable standards |
| 14 | | of strength, quality, purity, and identity; |
| 15 | | (3) it is bioequivalent in that: |
| 16 | | (A) it does not present a known or potential |
| 17 | | bioequivalence problem and it meets an acceptable in |
| 18 | | vitro standard; or |
| 19 | | (B) if it does present such a known or potential |
| 20 | | problem, it is shown to meet an appropriate |
| 21 | | bioequivalence standard; |
| 22 | | (4) it is adequately labeled; and |
| 23 | | (5) it is manufactured in compliance with Current Good |
| 24 | | Manufacturing Practice regulations adopted by the United |
| 25 | | States Food and Drug Administration. |
| 26 | | (b) An individual or group policy of accident and health |
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| 1 | | insurance amended, delivered, issued, or renewed in this State |
| 2 | | on or after January 1, 2024 shall provide coverage for all |
| 3 | | abortifacients, hormonal therapy medication, human |
| 4 | | immunodeficiency virus pre-exposure prophylaxis, and |
| 5 | | post-exposure prophylaxis drugs approved by the United States |
| 6 | | Food and Drug Administration, and follow-up services related |
| 7 | | to that coverage, including, but not limited to, management of |
| 8 | | side effects, medication self-management or adherence |
| 9 | | counseling, risk reduction strategies, and mental health |
| 10 | | counseling. This coverage shall include drugs approved by the |
| 11 | | United States Food and Drug Administration that are prescribed |
| 12 | | or ordered for off-label use for the purposes described in |
| 13 | | this Section. On or after the effective date of this |
| 14 | | amendatory Act of the 104th General Assembly, this coverage |
| 15 | | shall include pre-PrEP HIV screening, sexually transmitted |
| 16 | | infection screening, kidney function analysis, routine |
| 17 | | laboratory testing, and routine provider visits. |
| 18 | | (c) The coverage required under subsection (b) is subject |
| 19 | | to the following conditions: |
| 20 | | (1) If the United States Food and Drug Administration |
| 21 | | has approved one or more therapeutic equivalent versions |
| 22 | | of an abortifacient drug, a policy is not required to |
| 23 | | include all such therapeutic equivalent versions in its |
| 24 | | formulary so long as at least one is included and covered |
| 25 | | without cost sharing and in accordance with this Section. |
| 26 | | (2) If an individual's attending provider recommends a |
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| 1 | | particular drug approved by the United States Food and |
| 2 | | Drug Administration based on a determination of medical |
| 3 | | necessity with respect to that individual, the plan or |
| 4 | | issuer must defer to the determination of the attending |
| 5 | | provider and must cover that service or item without cost |
| 6 | | sharing. |
| 7 | | (3) If a drug is not covered, plans and issuers must |
| 8 | | have an easily accessible, transparent, and sufficiently |
| 9 | | expedient process that is not unduly burdensome on the |
| 10 | | individual or a provider or other individual acting as a |
| 11 | | patient's authorized representative to ensure coverage |
| 12 | | without cost sharing. |
| 13 | | The conditions listed under this subsection (c) also apply |
| 14 | | to drugs prescribed for off-label use as abortifacients. |
| 15 | | (d) Except as otherwise provided in this Section, a policy |
| 16 | | subject to this Section shall not impose a deductible, |
| 17 | | coinsurance, copayment, or any other cost-sharing requirement |
| 18 | | on the coverage provided. The provisions of this subsection do |
| 19 | | not apply to coverage of procedures to the extent such |
| 20 | | coverage would disqualify a high-deductible health plan from |
| 21 | | eligibility for a health savings account pursuant to the |
| 22 | | federal Internal Revenue Code, 26 U.S.C. 223. |
| 23 | | (e) Except as otherwise authorized under this Section, a |
| 24 | | policy shall not impose any restrictions or delays on the |
| 25 | | coverage required under this Section. |
| 26 | | (f) The coverage requirements in this Section for |
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| 1 | | abortifacients do not, pursuant to 42 U.S.C. 18054(a)(6), |
| 2 | | apply to a multistate plan that does not provide coverage for |
| 3 | | abortion. |
| 4 | | (g) If the Department concludes that enforcement of any |
| 5 | | coverage requirement of this Section for abortifacients may |
| 6 | | adversely affect the allocation of federal funds to this |
| 7 | | State, the Department may grant an exemption to that |
| 8 | | requirement, but only to the minimum extent necessary to |
| 9 | | ensure the continued receipt of federal funds. |
| 10 | | (Source: P.A. 102-1117, eff. 1-13-23; 103-462, eff. 8-4-23.) |
| 11 | | Section 10. The Prior Authorization Reform Act is amended |
| 12 | | by adding Section 52 as follows: |
| 13 | | (215 ILCS 200/52 new) |
| 14 | | Sec. 52. Prior authorization for certain prescription |
| 15 | | drugs; prohibited. A health insurance issuer may not require |
| 16 | | prior authorization for the following prescription drug types |
| 17 | | and their therapeutic equivalents approved by the United |
| 18 | | States Food and Drug Administration: human immunodeficiency |
| 19 | | virus pre-exposure prophylaxis and post-exposure prophylaxis |
| 20 | | medication or human immunodeficiency virus treatment |
| 21 | | medication. |
| 22 | | Section 15. The Illinois Public Aid Code is amended by |
| 23 | | changing Section 5-5.12 and by adding Section 5-54 as follows: |
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| 1 | | (305 ILCS 5/5-5.12) (from Ch. 23, par. 5-5.12) |
| 2 | | Sec. 5-5.12. Pharmacy payments. |
| 3 | | (a) Every request submitted by a pharmacy for |
| 4 | | reimbursement under this Article for prescription drugs |
| 5 | | provided to a recipient of aid under this Article shall |
| 6 | | include the name of the prescriber or an acceptable |
| 7 | | identification number as established by the Department. |
| 8 | | (b) Pharmacies providing prescription drugs under this |
| 9 | | Article shall be reimbursed at a rate which shall include a |
| 10 | | professional dispensing fee as determined by the Illinois |
| 11 | | Department, plus the current acquisition cost of the |
| 12 | | prescription drug dispensed. The Illinois Department shall |
| 13 | | update its information on the acquisition costs of all |
| 14 | | prescription drugs no less frequently than every 30 days. |
| 15 | | However, the Illinois Department may set the rate of |
| 16 | | reimbursement for the acquisition cost, by rule, at a |
| 17 | | percentage of the current average wholesale acquisition cost. |
| 18 | | (c) (Blank). |
| 19 | | (d) The Department shall review utilization of narcotic |
| 20 | | medications in the medical assistance program and impose |
| 21 | | utilization controls that protect against abuse. |
| 22 | | (e) When making determinations as to which drugs shall be |
| 23 | | on a prior approval list, the Department shall include as part |
| 24 | | of the analysis for this determination, the degree to which a |
| 25 | | drug may affect individuals in different ways based on factors |
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| 1 | | including the gender of the person taking the medication. |
| 2 | | (f) The Department shall cooperate with the Department of |
| 3 | | Public Health and the Department of Human Services Division of |
| 4 | | Mental Health in identifying psychotropic medications that, |
| 5 | | when given in a particular form, manner, duration, or |
| 6 | | frequency (including "as needed") in a dosage, or in |
| 7 | | conjunction with other psychotropic medications to a nursing |
| 8 | | home resident or to a resident of a facility licensed under the |
| 9 | | ID/DD Community Care Act or the MC/DD Act, may constitute a |
| 10 | | chemical restraint or an "unnecessary drug" as defined by the |
| 11 | | Nursing Home Care Act or Titles XVIII and XIX of the Social |
| 12 | | Security Act and the implementing rules and regulations. The |
| 13 | | Department shall require prior approval for any such |
| 14 | | medication prescribed for a nursing home resident or to a |
| 15 | | resident of a facility licensed under the ID/DD Community Care |
| 16 | | Act or the MC/DD Act, that appears to be a chemical restraint |
| 17 | | or an unnecessary drug. The Department shall consult with the |
| 18 | | Department of Human Services Division of Mental Health in |
| 19 | | developing a protocol and criteria for deciding whether to |
| 20 | | grant such prior approval. |
| 21 | | (g) The Department may by rule provide for reimbursement |
| 22 | | of the dispensing of a 90-day supply of a generic or brand |
| 23 | | name, non-narcotic maintenance medication in circumstances |
| 24 | | where it is cost effective. |
| 25 | | (g-5) On and after July 1, 2012, the Department may |
| 26 | | require the dispensing of drugs to nursing home residents be |
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| 1 | | in a 7-day supply or other amount less than a 31-day supply. |
| 2 | | The Department shall pay only one dispensing fee per 31-day |
| 3 | | supply. |
| 4 | | (h) Effective July 1, 2011, the Department shall |
| 5 | | discontinue coverage of select over-the-counter drugs, |
| 6 | | including analgesics and cough and cold and allergy |
| 7 | | medications. |
| 8 | | (h-5) The On and after July 1, 2012, the Department shall |
| 9 | | impose utilization controls, including, but not limited to, |
| 10 | | prior approval on specialty drugs, oncolytic drugs, drugs for |
| 11 | | the treatment of HIV or AIDS, immunosuppressant drugs, and |
| 12 | | biological products in order to maximize savings on these |
| 13 | | drugs. The Department may adjust payment methodologies for |
| 14 | | non-pharmacy billed drugs in order to incentivize the |
| 15 | | selection of lower-cost drugs. For drugs for the treatment of |
| 16 | | AIDS, the Department shall take into consideration the |
| 17 | | potential for non-adherence by certain populations, and shall |
| 18 | | develop protocols with organizations or providers primarily |
| 19 | | serving those with HIV/AIDS, as long as such measures intend |
| 20 | | to maintain cost neutrality with other utilization management |
| 21 | | controls such as prior approval. For hemophilia, the |
| 22 | | Department shall develop a program of utilization review and |
| 23 | | control which may include, in the discretion of the |
| 24 | | Department, prior approvals. The Department may impose special |
| 25 | | standards on providers that dispense blood factors which shall |
| 26 | | include, in the discretion of the Department, staff training |
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| 1 | | and education; patient outreach and education; case |
| 2 | | management; in-home patient assessments; assay management; |
| 3 | | maintenance of stock; emergency dispensing timeframes; data |
| 4 | | collection and reporting; dispensing of supplies related to |
| 5 | | blood factor infusions; cold chain management and packaging |
| 6 | | practices; care coordination; product recalls; and emergency |
| 7 | | clinical consultation. The Department may require patients to |
| 8 | | receive a comprehensive examination annually at an appropriate |
| 9 | | provider in order to be eligible to continue to receive blood |
| 10 | | factor. |
| 11 | | (i) On and after July 1, 2012, the Department shall reduce |
| 12 | | any rate of reimbursement for services or other payments or |
| 13 | | alter any methodologies authorized by this Code to reduce any |
| 14 | | rate of reimbursement for services or other payments in |
| 15 | | accordance with Section 5-5e. |
| 16 | | (j) On and after July 1, 2012, the Department shall impose |
| 17 | | limitations on prescription drugs such that the Department |
| 18 | | shall not provide reimbursement for more than 4 prescriptions, |
| 19 | | including 3 brand name prescriptions, for distinct drugs in a |
| 20 | | 30-day period, unless prior approval is received for all |
| 21 | | prescriptions in excess of the 4-prescription limit. Drugs in |
| 22 | | the following therapeutic classes shall not be subject to |
| 23 | | prior approval as a result of the 4-prescription limit: |
| 24 | | immunosuppressant drugs, oncolytic drugs, anti-retroviral |
| 25 | | drugs, and, on or after July 1, 2014, antipsychotic drugs. On |
| 26 | | or after July 1, 2014, the Department may exempt children with |
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| 1 | | complex medical needs enrolled in a care coordination entity |
| 2 | | contracted with the Department to solely coordinate care for |
| 3 | | such children, if the Department determines that the entity |
| 4 | | has a comprehensive drug reconciliation program. |
| 5 | | (k) No medication therapy management program implemented |
| 6 | | by the Department shall be contrary to the provisions of the |
| 7 | | Pharmacy Practice Act. |
| 8 | | (l) Any provider enrolled with the Department that bills |
| 9 | | the Department for outpatient drugs and is eligible to enroll |
| 10 | | in the federal Drug Pricing Program under Section 340B of the |
| 11 | | federal Public Health Service Act shall enroll in that |
| 12 | | program. No entity participating in the federal Drug Pricing |
| 13 | | Program under Section 340B of the federal Public Health |
| 14 | | Service Act may exclude fee-for-service Medicaid from their |
| 15 | | participation in that program, however, entities defined in |
| 16 | | Section 1905(l)(2)(B) of the Social Security Act are excluded |
| 17 | | from this requirement. This subsection does not apply to |
| 18 | | outpatient drugs billed to Medicaid managed care |
| 19 | | organizations. |
| 20 | | (Source: P.A. 102-558, eff. 8-20-21; 102-778, eff. 7-1-22.) |
| 21 | | (305 ILCS 5/5-54 new) |
| 22 | | Sec. 5-54. Prior authorization for certain prescription |
| 23 | | drugs; prohibited. The fee-for-service medical assistance |
| 24 | | program and a Medicaid managed care organization may not |
| 25 | | require prior authorization for the following prescription |