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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.


Florida's Recent Ruling on Arbitration Clauses

Florida’s recent ruling on arbitration clauses provides a crucial distinction in determining whether such clauses are void as against public policy and providers may have the opportunity to include arbitration clauses in their patient consent forms. On March 6, 2024, Florida’s Fourth District Court of Appeals reversed and remanded Florida’s Fifteenth Circuit Court ruling of Piero Palacios v. Sharnice Lawson. The Court of Appeals ruled that the parties’ arbitration agreement did not contradict the Legislature’s intent of Florida’s Medical Malpractice Act (the “MMA”), but rather reflects the parties’ choice to arbitrate claims entirely outside of the MMA’s framework. Therefore, the Court found that the agreement was not void as against public policy.

Corporate Transparency Act Update 3/14/24

On March 1, 2024, a federal district court in the Northern District of Alabama concluded that the Corporate Transparency Act (“CTA”) exceeded Congressional powers and enjoined the Department of the Treasury from enforcing the CTA against the plaintiffs. National Small Business United v. Yellen, No. 5:22-cv-01448 (N.D. Ala.). On March 11, 2024, the U.S. Department of Justice appealed the district court’s decision to the Eleventh Circuit Court of Appeals.

The Ohio State University Launches Its Accelerated Bachelor of Science in Nursing Program

In response to Ohio’s nursing shortage, The Ohio State University College of Nursing is accepting applications for its new Accelerated Bachelor of Science in Nursing program (aBSN). Created for students with a bachelor’s degree in non-nursing fields, the aBSN allows such students to obtain their nursing degree within 18 months. All aBSN students will participate in high-quality coursework and gain valuable clinical experience. Upon completion of the program, graduates will be eligible to take the State Board, National Council of Licensure Exam for Registered Nursing (NCLEX-RN).

Another Transparency Obligation: The FinCEN Beneficial Ownership Information Reporting Requirements

Many physician practices and healthcare businesses are facing a new set of federal transparency requirements that require action now. The U.S. Department of Treasury Financial Crimes Enforcement Network (“FinCEN”) Beneficial Ownership Information Reporting Requirements (the “Rule”), which was promulgated pursuant to the 2021 bipartisan Corporate Transparency Act, is intended to help curb illegal finance and other impermissible activity in the United States.

“In for a Penny, in for a Pound” is No Longer the Case for Florida Lawyers

On April 1, 2024, newly adopted Rule 1.041 to the Florida Rules of Civil Procedures goes into effect which creates a procedure for an attorney to appear in a limited manner in civil proceedings.  Currently, when a Florida attorney appears in a civil proceeding, he or she is reasonable for handling all aspects of the case for their client.  This new rule authorizes an attorney to file a notice limiting the attorney’s appearance to particular proceedings or specified matters prior to any appearance before the court.  For example, an attorney can now appear for the limited purpose of filing and arguing a motion to dismiss.  Once the motion to dismiss is heard by the court, the attorney may file a notice of termination of limited appearance and will have no further obligations in the case.