ut-20261015-R414-60: R414-60. Medicaid Policy for Pharmacy Program

1. Agency Information

Title catchline: Health and Human Services, Integrated Healthcare Building: Cannon Health Building Street address: 288 N 1460 W City, state: Salt Lake City, UT Mailing address: PO Box 143325 City, state and zip: Salt Lake City, UT 84114-3325

2. Contact Persons

Name: Phone: Email: Craig Devashrayee 801-915-4493 cdevashrayee@utah.gov Mariah Noble 385-214-1150 mariahnoble@utah.gov Please address questions regarding information on this notice to the persons listed above.

A. Rule or section catchline:

R414-60. Medicaid Policy for Pharmacy Program

B. Purpose of the new rule or reason for the change:

Based on discussions within the Division of Integrated Healthcare, the purpose of this amendment is to update and clarify, by rule, current policy for the Medicaid Pharmacy Program.

C. Summary of the new rule or change:

This amendment updates and clarifies definitions, drug coverage, coverage limitations, reimbursement, and policies for new drugs, over-the-counter drugs, compounds, and provider-administered drugs. 5. Fiscal Information Provide an estimate and written explanation of the aggregate anticipated cost or savings to:

A. State budget:

The Department of Health and Human Services (department) does not expect a fiscal impact to the state budget as the department already implements current policy through the Medicaid State Plan and the Pharmacy Services Utah Medicaid Provider Manual. Procedures for implementing these provisions are already in place, and this filing does not add to, modify, or remove any associated processes. 28 UTAH STATE BULLETIN, October 15, 2026, Vol. 2026, No. 20 NOTICES OF PROPOSED RULES

B. Local governments:

The department does not expect a fiscal impact on local governments as they neither fund nor provide pharmacy services under the Medicaid program.

C. Small businesses ("small business" means a business employing 1-49 persons):

The department does not expect a fiscal impact on small businesses as the department already implements current policy through the Medicaid State Plan and the Pharmacy Services Utah Medicaid Provider Manual. Procedures for implementing these provisions are already in place, and this filing does not add to, modify, or remove any associated processes.

D. Non-small businesses ("non-small business" means a business employing 50 or more persons):

The department does not expect a fiscal impact on non-small businesses as the department already implements current policy through the Medicaid State Plan and the Pharmacy Services Utah Medicaid Provider Manual. Procedures for implementing these provisions are already in place, and this filing does not add to, modify, or remove any associated processes. E. Persons other than small businesses, non-small businesses, state, or local government entities ("person" means any individual, partnership, corporation, association, governmental entity, or public or private organization of any character other than an agency): Medicaid members and entities outside of government or business are not expected to see a fiscal impact as the department already implements current policy through the Medicaid State Plan and the Pharmacy Services Utah Medicaid Provider Manual. Procedures for implementing these provisions are already in place, and this filing does not add to, modify, or remove any associated processes.

F. Compliance costs for affected persons:

There are no expected compliance costs for affected persons, including the state, small businesses, non-small businesses, and a Medicaid member or single entity outside of government or business, as the department already implements current policy through the Medicaid State Plan and the Pharmacy Services Utah Medicaid Provider Manual. Procedures for implementing these provisions are already in place, and this filing does not add to, modify, or remove any associated processes. 6. Regulatory Impact Summary Table Enter the cost or savings in the relevant cell. If there is no cost or savings, enter, "$0." If a cost or savings is inestimable, enter, "inestimable." Fiscal Cost FY2027 FY2028 FY2029 FY2030 FY2031 State Budget $0 $0 $0 $0 $0 Local Governments $0 $0 $0 $0 $0 Small Businesses $0 $0 $0 $0 $0 Non-Small Businesses $0 $0 $0 $0 $0 Other Persons $0 $0 $0 $0 $0 Total Fiscal Cost $0 $0 $0 $0 $0 Fiscal Benefits FY2027 FY2028 FY2029 FY2030 FY2031 State Budget $0 $0 $0 $0 $0 Local Governments $0 $0 $0 $0 $0 Small Businesses $0 $0 $0 $0 $0 Non-Small Businesses $0 $0 $0 $0 $0 Other Persons $0 $0 $0 $0 $0 UTAH STATE BULLETIN, October 15, 2026, Vol. 2026, No. 20 29 NOTICES OF PROPOSED RULES Total Fiscal Benefits $0 $0 $0 $0 $0 Net Fiscal Benefits $0 $0 $0 $0 $0 7. Regulatory Impact Analysis Approval The Commissioner of the Department of Health and Human Services, Tracy S. Gruber, has reviewed and approved this regulatory impact analysis. 8. Family Impact Information

A. The agency has considered this rule's impact on family health, stability, and formation: ☒

9. Citation Information Provide citations to the statutory authority for the rule. If there is also a federal requirement for the rule, provide a citation to that requirement: Section 26B-1-213 Section 26B-3-108 11. Public Notice Information The public may submit written or oral comments to the agency identified in box 1.

A. Comments will be accepted until: 11/16/2026

12. Effective Date Information This rule change MAY become effective on: 11/23/2026 (NOTE: This is the date the agency anticipates making the filing effective. It is NOT the effective date) 13. Agency Authorization Information Agency head or Tracy S. Gruber, Commissioner Date: 09/28/2026 designee and title: R414. Health and Human Services, Integrated Healthcare. R414-60. Medicaid Policy for Pharmacy Program. R414-60-2. Definitions. (1) "Covered outpatient drug" means a drug that meets the Centers for Medicare and Medicaid Services (CMS) covered outpatient drug definition as outlined in 42 CFR 447.502 (2026).[ The following provisions also apply: (a) requires a prescription for dispensing; (b) has a national drug code number; (c) is eligible for federal medical assistance percentages funds; (d) has been approved by the Food and DrugAdministration; and (e) is listed in the nationally recognized drug pricing index under contract with the Department.] (2) "Full-benefit dual eligible member" means an individual who has Medicare and Medicaid benefits. (3) "Provider-administered drug" means an outpatient drug, other than a vaccine, that is administered by a health care provider in a physician's office or other outpatient clinical setting. (4) "Rural pharmacy" means a pharmacy located in the state and is not located in Weber County, Davis County, Utah County, or Salt Lake County. ([4]5) "Urban pharmacy" means a pharmacy located in Weber County, Davis County, Utah County, Salt Lake County, or in another state. ([5]6) "Usual and customary charge" means the lowest amount a pharmacy charges the general public for a covered outpatient drug, which reflects advertised savings, discounts, special promotions, or any other program available to the general public. ([6]7) "Wholesale acquisition cost" means the list price paid by the wholesaler, distributor, and other direct accounts for drugs purchased from the wholesaler's supply. ([7]8) "Medically accepted indication" means, in accordance with 42 U.S.C. 1396r-8 (k)(6), [is ]any use: (a) approved by the Federal Food,[ and] Drug, [Administration (FDA) ]and CosmeticAct, 21 U.S.C. 301 et seq.; or[ a use] (b) supported by [on one]at least one citation in the[ of the following compendia]: ([a]i) American Hospital Formulary Service Drug Information; (ii) American MedicalAssociation Drug Evaluations; (iii) DRUGDEX Information System; or ([b]iv) United State Pharmacopeia-Drug Information.[; or 30 UTAH STATE BULLETIN, October 15, 2026, Vol. 2026, No. 20 NOTICES OF PROPOSED RULES (c) the DRUGDEX Information System.] R414-60-4. Program Coverage. (1) [C]Each covered outpatient drug[s] eligible for federal medical assistance percentages funds [are]is included in the pharmacy benefit; however, a covered outpatient drug[s] may be subject to limitations and restrictions. (2) In accordance with Subsection 58-17b-606(4), if a multi-source A-rated legend drug is available in the generic form, Medicaid reimburses only for the generic form of the drug unless: (a) reimbursing for the non-generic brand-name legend drug will result in a financial benefit to the state; (b) the treating physician demonstrates a medical necessity for dispensing the non-generic, brand-name legend drug; or (c) the generic form of the drug is unavailable in the marketplace as [defined]described in the Utah Medicaid Pharmacy Services Provider Manual. (3) 42 U.S.C 1396b(i)(23) requires Medicaid prescriptions not executed electronically to be written on tamper-resistant prescription forms.[ as follows:] (a) A prescriber shall write any Medicaid prescription not executed electronically on a tamper-resistant prescription form[s] [must]that includes[ each of the following]: (i) one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form; (ii) one or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber; and (iii) one or more industry-recognized features designed to prevent the use of counterfeit prescription forms. (b)(i) Documentation by the pharmacy of verbal confirmation of a prescription that the prescriber or prescriber's agent has not written on a tamper-resistant prescription form[ by the prescriber or the prescriber's agent] satisfies the tamper-resistant requirement. (ii) The pharmacy shall include in [D]documentation of [the]a verbal confirmation [must include ]the date, time, and name of the individual who verified the validity of the prescription. (c)(i) Apharmacy [must]shall maintain documentation that: (A) a Medicaid member or authorized representative has received a prescription for a covered outpatient drug; and[. The documentation must] (B) clearly identif[y]ies the covered outpatient drug and the date [it]the drug was received. (ii) The Division of Integrated Healthcare (division) shall waive the proof of delivery requirement for Non-Controlled and Controlled Schedule III to V[Schedule 2] prescriptions. (iii) In accordance with Subsection [R414-60-4](3)(c)(i), the proof of delivery requirement remains for Controlled Schedule [2]II (CII) medications [that includes]requiring a signature or other documentation. The pharmacy shall document member receipt as stated in Subsection [R414-60-4](3)(c)(i). (d) If there is a [C]claim[s] for a covered outpatient drug[s] not dispensed to a Medicaid member or the member's authorized representative within 14 days[ must be reversed and]: (i) the division shall reverse the claim; and (ii) the pharmacy shall return any payment from Medicaid[ must be returned]. R414-60-5. Limitations. (1) Medicaid may place limitations on drugs in accordance with 42 U.S.C. 1396r-8 or in consultation with the Drug Utilization Review Board. Medicaid includes these limitations in the Pharmacy Services Provider Manual and attachments. These limitations are incorporated by reference in Section R414-1-5 and may include: (a) quantity limits or cumulative limits for a drug or drug class for a specified period; (b) therapeutic duplication limits, which may be placed on drugs within the same or similar therapeutic categories; (c) step therapy, including documentation of therapeutic failure with one drug before another drug may be used; or (d) prior authorization. (2) Apharmacy may dispense a covered outpatient drug that requires prior authorization for up to a 72-hour supply without obtaining prior authorization during a medical emergency. (3) Adrug listed as non-preferred on the Preferred Drug List [(PDL) ]may require prior authorization [as authorized by]in accordance with Section 26B-3-105. (4) Adrug may be restricted and is reimbursable only if dispensed by an individual pharmacy or pharmacies. (5) Medicaid does not cover any drug not eligible for federal medical assistance percentages funds. (6) Medicaid does not cover any outpatient drug included in the Medicare Prescription Drug Benefit-Part D for any full-benefit dual eligible member. (7) Medicaid does not cover any drug provided to a member during an inpatient hospital stay, neither as an outpatient pharmacy benefit nor separately payable from the Medicaid payment for the inpatient hospital services. (8) Medicaid covers prescription cough and cold preparations meeting the definition of a covered outpatient drug. (9) Medicaid pays for no more than a one-month supply of a covered outpatient drug for each dispensing, except that: (a) Medicaid may cover a medication on the Utah Medicaid Three-Month Supply [Medication]Required List, attachment to the Pharmacy Services Provider Manual, for up to a three-month supply for each dispensing; and (b) Medicaid may cover prenatal vitamins for a pregnant woman, multiple vitamins with or without fluoride for a child who is zero through five years of age, and fluoride supplements through 16 years of age.[for up to a three-month supply for each dispensing; (c) Medicaid may cover contraceptives for up to a three-month supply for each dispensing; and UTAH STATE BULLETIN, October 15, 2026, Vol. 2026, No. 20 31 NOTICES OF PROPOSED RULES (d) Medicaid may cover a long-acting injectable antipsychotic drug in accordance with Section R414-60-12 for up to a three-month supply for each dispensing.] (10)(a) Medicaid pays for a prescription refill for non-controlled substances only if 80% of the previous prescription has been exhausted[, except for a controlled substance]. (b) Medicaid pays for a prescription refill for a controlled substance after 85% of the previous prescription has been exhausted. (11) Medicaid covers treatments for fertility preservation and in vitro fertilization, only as described in the Utah Medicaid Provider Manual, for individuals who receive medical treatment that includes surgery, radiation, chemotherapy, or another medical intervention that poses the risk of sterility or leads to iatrogenic infertility. (12) Medicaid does not cover: (a) a drug for weight loss, except for specific indications; (b) a drug for the treatment of sexual dysfunction; (c) a drug for cosmetic purposes; (d) vitamins[;], except [for]as listed in Subsection (9)(b)[ prenatal vitamins for a pregnant woman, vitamin drops for a child who is zero through five years of age, and fluoride supplements]; (e) an over-the-counter (OTC) drug [(OTC) ]not included on the Utah Medicaid [PDL ]Preferred Drug List and Resources document[attachment to the Pharmacy Services Provider Manual]; (f) a drug for which the manufacturer requires, as a condition of sale, that associated tests and monitoring services are purchased exclusively from the manufacturer or [it]the manufacturer's designee; (g) a drug given by a hospital to a patient at discharge; (h) breast milk, breast milk substitutes, baby food, or medical foods[. P], though prescription metabolic products for congenital errors of metabolism are covered through the [D]durable [M]medical [E]equipment benefit; and (i) a drug available only through a single-source distribution program, unless the distributor is enrolled with Medicaid as a pharmacy provider. (13) A claim for opioids used for the treatment of non-cancer pain is subject to the following limitations or restrictions set forth by the division[Division of Integrated Healthcare (DIH)]: (a) initial fill limits; (b) monthly limits; (c) quantity limits; (d) additional limits for a child or pregnant woman; (e) daily morphine milligram equivalents (MME)[ and cumulative morphine equivalents daily (MED)] limits; (f) concurrent use of opioids with high-risk drugs as defined by [DIH]the division; or (g) concurrent use of opioid medications in a Medicaid member[s] who also receives medication-assisted treatment (MAT) for opioid use disorder. (14) An antipsychotic medication prescribed to a Medicaid member who is 19 years of age or younger is limited as follows: (a) no use of multiple antipsychotic drugs; (b) no off-label use; (c) no use outside established age guidelines; and (d) no doses higher than FDArecommendations. [ (15) An exception may be granted as appropriate through the prior authorization process. ] (1[6]5) An attention[-] deficit[/] hyperactivity disorder (ADHD) stimulant medication is subject to the following limitations or restrictions set forth by [DIH]the division for Medicaid members: (a) age limits; [ (b) monthly limits; (c) quantity limits;] ([d]b) cross-class limitations for concurrent use of an amphetamine class with methylphenidate class in children less than 18 years of age; or ([e]c) the use of no more than twoADHD stimulants by a member of any age. [ (17) Medicaid evaluates exceptions toADHD stimulant policy for medical necessity on a case-by-case basis. ] (1[8]6) The ["]dispense as written["] (DAW-1) code may override [the non-preferred ]a prior authorization requirement for selected non-preferred [antipsychotic ]medications if the prescriber writes "dispense as written" on a prescription. (17) The department may grant an exception as appropriate through the prior authorization process. R414-60-7. Reimbursement. (1) Apharmacy may not submit a charge to Medicaid that exceeds the pharmacy's usual and customary charge. (2) Covered outpatient drugs are reimbursed as outlined inAttachment 4.19-B of the Medicaid State Plan. (3) A pharmacy that participates in the 340B program and uses medications obtained through the 340B program to bill Medicaid [must]shall submit the 340B acquisition cost of the medication on the claim. (4) A pharmacy that participates in the [f]Federal [s]Supply [s]Schedule (FSS) and uses medications obtained through the schedule to bill Medicaid [must]shall submit the FFS acquisition cost of the medication on the claim unless the claim is reimbursed as a bundled charge or all-inclusive rate. (5) Apharmacy that obtains and uses medications at a nominal price must submit the acquisition cost of the medication on the claim. (6)[(a)] Dispensing fees are outlined inAttachment 4.19-B of the Medicaid State Plan. 32 UTAH STATE BULLETIN, October 15, 2026, Vol. 2026, No. 20 NOTICES OF PROPOSED RULES ([b]a) Medicaid pays the lesser of: (i) the assigned dispensing fee; or (ii) the submitted dispensing fee. [(7)(a)](b) Medicaid pays a pharmacy only one dispensing fee every 24 days for each covered outpatient drug. ([b]c) In the event the Medicaid point of sale system experiences a system interruption that results in extensive downtime and increased administrative workload for pharmacy providers, the Medicaid division director may waive the 24-day limit on dispensing fees. [(8)(a)](7)(a) Medicaid may only pay a dispensing and administration fee to a provider who administers a vaccine to a Medicaid member who is 18 years of age or younger but may not reimburse a provider for the vaccine product.[ Medicaid pays a provider that immunizes a Medicaid member who is 19 years of age or older for the cost of the immunization plus a dispensing fee.] (b) AMedicaid member who is 18 years of age or younger shall obtain any vaccine through the Vaccines for Children Program. [ (b) Medicaid pays the lesser of: (i) the allowed charges; or (ii) the submitted charges. (9) Aprovider that immunizes a Medicaid member who is 18 years of age or younger may only be eligible for a dispensing fee with no reimbursement for the immunization. Immunizations for Medicaid members who are 18 years of age or younger must be obtained through the Vaccines for Children program. ] ([10]8) Diabetic supplies listed on the Utah Medicaid [PDL ]Preferred Drug List are reimbursed at the lesser of: (a) the wholesale acquisition cost with no dispensing fee; or (b) [or ]the billed charges. ([11]9) Pursuant to Section 58-17b-805, a dispensing medical practitioner may prescribe and dispense medication directly to a patient if providing outpatient cancer therapy. Details of reimbursement are found on the Medicaid website at http://health.utah.gov/stplan/lookup/CoverageLookup.php. R414-60-8. Mandatory Patient Counseling. (1) A Medicaid member[s,] or [their]authorized representative[s,] [must]shall receive counseling that fulfills the requirements of 42 U.S.C. 1396r-8 each time a covered outpatient medication is dispensed. (2) If a Medicaid member or authorized representative refuses the offer of counseling, a pharmacy facility is not required to provide that Medicaid member or authorized representative with counseling, in accordance with Section R156-17b-610[ does not require counseling if a Medicaid member or their representative refuses the offer of counseling]. (a) Only a pharmacist, pharmacy intern, or designated medical practitioner may provide [oral]verbal counseling [to a member or member's representative and]or answer questions concerning prescription drugs. (3) The pharmacy facility shall document the offer of counseling [must be documented ]and [producible]make that documentation available to the department upon request. (4) [W]Apharmacy facility shall deliver any written information on a prescription order [delivered ]to a Medicaid member and shall be [in the ]format that information [of]as a patient information leaflet[s]. R414-60-9. New Drug Products. (1) [A]The Drug Utilization Review Board may review a new drug product, including a new size or strength of an existing approved product, [may be reviewed by the DUR Board ]to determine whether the drug should be subject to restrictions or limitations. (2) [N]Anew drug[s] may be withheld from coverage for no more than 12 weeks while the Drug Utilization Review Board evaluates potential restrictions or limitations[ are being evaluated]. R414-60-10. Over-the-Counter Drugs. (1) Medicaid covers an OTC drug[s] if the drug is listed on the Preferred Drug List and Pharmacy Coverage Resources document[Utah Medicaid PDL and Resources attachment to the Pharmacy Services Provider Manual, incorporated by reference in Section R414-1-5]. (2) For a Medicaid member who resides in a nursing facility, Medicaid does not cover an OTC drug under the outpatient pharmacy benefit. Reimbursement for an OTC drug is included in the nursing facility daily rate and not reimbursed separately through the pharmacy program[For a Medicaid member who resides in a nursing home, OTC drugs on the approved list are not a benefit through the outpatient pharmacy program. The nursing-home rate of reimbursement includes payment for OTC drugs]. R414-60-11. Compounds. (1) A compounded drug consists of two or more ingredients. Medicaid may only reimburse a pharmacy[ies] for [the]an ingredient that: (a) meets the definition of a covered outpatient drug[,]; and (b) is not [except for those listed]described [as non-covered drugs ]in Section R414-60-5. (2) Qualified personnel shallprepareany compounded non-sterile prescription inanenvironment thatcomplieswiththe requirements of the United States Pharmacopeia-National Formulary Chapter <795>.[Compounded non-sterile prescriptions must be prepared by personnel and in settings as defined in the United States Pharmacopeia and National Formulary Chapter <795>.] (3)(a) Qualified personnel shall prepare any compounded sterile prescription in a facility that complies with the requirements of the United States Pharmacopeia-National Formulary Chapter <797>. UTAH STATE BULLETIN, October 15, 2026, Vol. 2026, No. 20 33 NOTICES OF PROPOSED RULES (b) A facility shall perform appropriate testing to ensure the final product meets applicable sterility, potency, and purity standards.[ Compounded sterile prescriptions must be prepared by personnel and in settings that have certified they adhere to the United States Pharmacopeia/National Formulary chapter <797> standard, and test the final product for sterility, potency, and purity.] (4) Medicaid does not cover bulk powders for compounded prescriptions. R414-60-12. Provider-Administered Drugs[Long-Acting Injectable Antipsychotic Drugs and Drugs for the Treatment of Opioid Use Disorders]. (1) [A provider-administered drug is an outpatient drug, other than a vaccine, that is administered by a health care provider in a physician's office or other outpatient clinical setting. (2) ]Medicaid may only reimburse for a provider-administered drug if the drug qualifies as a covered outpatient drug in accordance with 42 U.S.C 1396r-8. ([3]2) Apharmacy facility shall dispense select provider-administered or provider-observed drugs directly to the prescribing provider or the provider's authorized staff, as identified on the Preferred Drug List.[Selected provider-administered or provider-observed drugs must be dispensed directly to the provider or provider's staff. These include the following: (a) long-acting injectable antipsychotics; and (b) long-acting injectable drugs for the treatment of opioid use disorders.] KEY: Medicaid Date of Last Change: [January 20, ]2026 Notice of Continuation: March 11, 2022 Authorizing, and Implemented or Interpreted Law: 26B-1-213; 26B-3-108 NOTICE OF SUBSTANTIVE CHANGE TYPE OF FILING: Amendment Filing ID: 58274