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Ohio's Recent Rule Changes to Administration of Immunizations, Outpatient Pharmacy Delivery, and Mobile Response Services

Client Alert

The Ohio Board of Pharmacy (“BOP”) and Ohio Department of Mental Health and Addiction Services (“OMHAS”) recently posted notices of Ohio Administrative Code rule changes related to the administration of immunizations (BOP), outpatient pharmacy delivery services (BOP), and mobile response and stabilization services (OMHAS).

BOP Rules

The hearing for the rules summarized below will be held on February 18, 2025.

Immunization Administration | Rule 4729:1-3-02

  • Under the amended rule, “physician” was replaced with “prescriber” throughout. The rule defines prescriber to mean a physician or a certified nurse-midwife, clinical nurse specialist, or certified nurse practitioner.
  • The rule adds new language permitting a pharmacist to administer to someone 5 years of age or older an immunization for any disease, including influenza or COVID-19. Previously, the rule permitted a pharmacist to administer immunizations for influenza, COVID-19, or any other disease (pursuant to a prescription) to anyone between 7 and 13 years of age. For individuals 13 years of age or older, a pharmacy can administer an immunization for any disease.
  • Additionally, the rule adds new language requiring the pharmacist, when administering immunizations to minors, to inform the minor’s parent or legal guardian of the importance of well child visits with a pediatrician or other primary care provider.

Immunization Administration by Pharmacy Interns | Rule 4729:2-3-03

  • This amended rule adds new language requiring a pharmacist intern, when administering immunizations to minors, to inform the minor’s parent or legal guardian of the importance of well child visits with a pediatrician or other primary care provider.

Immunization Administration | Rule 4729:3-3-06

  • Under the amended rule, a certified/registered pharmacy technician who is working under the direct supervision of a pharmacist may administer to someone 5 years of age or older an immunization for any disease, including an immunization for influenza or COVID-19. Previously, the rule permitted a pharmacist technician to administer immunizations for influenza, COVID-19, or any other disease (pursuant to a prescription) to an individual between 7 and 13 years of age.
  • Under the amended rule, for each immunization administered by a certified/registered pharmacy technician to someone who is younger than 18 years of age, the pharmacy technician must inform the minor's parent or legal guardian of the importance of well child visits with a pediatrician or other primary care provider.

Outpatient Pharmacy Delivery Services | Rule 4729:5-5-26

  • Under the new rule, an outpatient pharmacy licensed as a terminal distributor of dangerous drugs (TDDD) that delivers dispensed drugs and devices in this state must comply with the following provisions, among others. The pharmacy must:
    • Contact the patient or patient's caregiver for consent prior to any billing or delivery of a drug or device, except if the patient has provided general consent for delivery services. Consent may be provided in writing, electronically, or verbally.
    • In accordance with the patient's communication preferences, make available to the patient or patients’ caregiver the date shipped, method of delivery (e.g., mail, courier, drone, etc.), and expected arrival.
    • Take all appropriate measures to ensure temperature-sensitive drugs will be maintained within the temperature ranges recommended by the manufacturer until the delivery has been completed.
  • The pharmacy must also comply with the record-keeping requirements imposed by the Board for all delivered drugs and devices. Records must include:
    • Patient name;
    • Patient address;
    • Prescription number of drug or device being delivered;
    • Name (brand name or generic) and dosage of each drug or device being delivered; and
    • Name of the pharmacy delivery agent who performed, or attempted to perform, the delivery.
  • Additionally, except for deliveries performed by the USPS or common carrier, an outpatient pharmacy that utilizes a third-party to deliver drugs and devices must enter into a contract with the third-party to ensure (1) that the required records are provided to the contracting pharmacy, and (2) that the third-party entity agrees to cooperate with all investigations regarding the theft or significant loss of drugs and devices.

OMHAS Rule

The hearing for this rule will be held on February 13, 2025.

Mobile Response and Stabilization Service | Rule 5122-29-14

  • This new rule defines mobile response and stabilization services (MRSS), which are structured intervention and support services designed to promptly address an emotional or behavioral crisis situation with a young person. MRSS provide immediate de-escalation, rapid community-based assessment, and stabilization services to help the young person remain with their family in their home and/or community.
  • MRSS consist of three phases: screening/triage, mobile response, and stabilization. The initial response by an MRSS provider is expected to occur within 60 minutes from the time the initial call ends, followed by 72 hours of de-escalation services.
  • To be certified for MRSS, a community behavioral health services provider must be certified in one of the following services: (1) general services; (2) SUD case management services; (3) peer recovery services; (4) community psychiatric supportive treatment; or (5) therapeutic behavioral services and psychosocial rehabilitation.

If you would like more information on any of these rules changes, please contact Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Associate Jordan Burdick at jaburdick@bmdllc.com.


Corporate Transparency Act Overhauled: U.S. Entities No Longer Required to Report

The Department of Treasury has issued an interim final rule significantly altering the Corporate Transparency Act (CTA). As of March 21, 2025, all U.S.-created entities and their beneficial owners are exempt from reporting requirements. Only non-U.S. entities registered to do business in the U.S. must still report, but they are not required to disclose U.S. citizen owners. Business owners should stay informed on these changes and consult legal counsel for compliance guidance.

ODM to Implement Medicaid Work Requirements: What Providers and Medicaid Expansion Recipients Need to Know

The Ohio Department of Medicaid (ODM) has submitted a waiver to impose work requirements for Medicaid expansion recipients. If approved, the new eligibility criteria will take effect on January 1, 2026. A federal public comment period is open until April 7, 2025.

Ohio Appellate Court Rules in Favor of Gender-Affirming Care

On March 18, 2025, the 10th District Court of Appeals in Franklin County ruled that Ohio’s House Bill (HB) 68, which restricts puberty blockers and hormone therapy for minors seeking gender-affirming care, violates the Health Care Freedom Amendment and is therefore unenforceable. The court found that the law unlawfully interferes with parental rights and medical decision-making. The case, Moe v. Yost, has been remanded, and Ohio Attorney General Dave Yost intends to appeal.

HHS Revokes Public Comment Requirement on Certain Policy Changes

The U.S. Department of Health and Human Services (HHS) has revoked the Richardson Waiver, eliminating the requirement for public notice and comment on certain policy changes. This decision allows HHS to implement new policies more quickly, potentially affecting healthcare funding rules like Medicaid work requirements. While it speeds up policymaking, it also reduces opportunities for stakeholder input, raising concerns over transparency and unintended consequences for healthcare providers, states, and patients.

Don't Get Caught Dazed and Confused: Another Florida Court Weighs in on Employer Obligations to Accommodate Medical Marijuana Use

A Florida trial court ruled in Giambrone v. Hillsborough County that employers may need to accommodate off-duty medical marijuana use under the Florida Civil Rights Act (FCRA). This contrasts with prior rulings and raises new compliance challenges for employers. With the case on appeal, now is the time to review workplace drug policies.