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Ohio Board of Pharmacy COVID-19 Waiver Update

Client Alert

The State of Ohio Board of Pharmacy has issued waivers throughout the COVID-19 pandemic to aid licensed practitioners in their day-to-day operations. As the pandemic has continued over the years, the State of Ohio Board of Pharmacy has intermittently reviewed the various waivers. Effective August 10, 2022, some of those waivers that were once granted have been rescinded. Below is a brief description of the rescinded waivers and the impact of their rescission. The Board of Pharmacy website sets forth a full list of the current waivers and rescinded waivers.

Brief Title/Description of Waiver

Impact of Rescission

Extension of emergency refills for schedule III-V controlled substances permitting longer supply for each prescription and to permit more frequent refills.

Adjusted O.R.C. § 4729.281 to permit pharmacists to dispense certain refills up to 3 times without a prescription. Requires health insurance to cover these medications if the drugs were already covered by the plan.

 

Three things must be met before the pharmacist may refill the medication:

  1. The pharmacy has a record of the prescription and the prescription does not provide information for refills or a time that refills must be provided.
  2. The pharmacist is unable to obtain authorization from appropriate health care professionals.
  3. The pharmacist, using judgment, determines this drug is necessary to sustain the life of the patient, continue therapy, or will cause patient harm if not dispensed to the patient.

Authorized prescribers in an opioid treatment center are permitted to delegate personal furnishings of buprenorphine products to licensed nurses.

This waiver has now been adopted in OAC 4729:5-21-02(F)(3), so the permission to delegate personal furnishing of buprenorphine to licensed nurses is now supported by law.

Storage and use of dangerous drugs for the treatment of COVID-19 was permitted at a facility’s satellite location if the facility was a terminal distributor of dangerous drugs and complied with various standards.

This waiver was rescinded without any part of it becoming law. Satellite locations of facilities are no longer permitted to maintain possession, custody, or control of dangerous drugs.

Waiver of the 5 percent limit on wholesale sales of dangerous drugs by a licensed pharmacy, as defined in OAC 4729:5-3-09.

The waiver was rescinded. The 5 percent limit on occasional wholesale sales, as defined in OAC 4729:5-3-09, is now required again.

Suspend in-person BLS training. Pharmacists were able to meet their Basic Life Support training requirements and obtain online certifications through various organizations without having to attend in-person training.

A pharmacist must complete a BLS training curse that is offered either wholly in-person or at least partially in-person. OAC 4729:1-3-02(M) and OAC 4729:2-3-02(A)(3).

Expand the pharmacy intern supervision requirements in OAC 4729:2-1-01 for interns administering COVID-19 vaccine from a maximum number of 6 interns to a new, maximum number of 12 interns if a licensed nurse of EMS personnel is assisting. If there are two licenses nurses or two or more EMS personnel, then there can be up to 18 interns.

This expansion is rescinded and there can now be only a maximum of 6 interns being supervised by the pharmacist while administering immunizations.

National Guard personnel assigned to any Ohio-licensed pharmacy may perform technician trainee activities (4729:3-3-01) and any other COVID-19 waivers issues by the board under direct supervision of a pharmacist without registration by the board.

This authorization to permit National Guard personnel to serve as pharmacy technicians is rescinded and National Guard personnel may not operate as a pharmacy tech without registration by the board.

 

For information regarding Ohio Board of Pharmacy regulations, please contact Kate Hickner at kehickner@bmdllc.com or any member of our Healthcare & Hospital Law Practice Group


Value-Based Care Advances – CMS Issues New Final Rules for Stark and Anti-Kickback Statutes

The Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) issued two highly anticipated (and quite extensive) Final Rules to reform the Stark Law and Anti-Kickback Statute (“AKS”) regulations. The Final Rules generally take effect on January 19, 2021. The Final Rules include new safe harbors for the AKS and new exemptions to the Stark Law to allow for greater flexibility. According to the HHS, the goal of updating both laws is to make it easier for providers to engage in care coordination and value-based care programs without running afoul of the statutes. Please note that this client alert could not cover the full extent of the Final Rule changes so please contact your BMD Healthcare attorney with questions.

Mandatory Filings Under CFIUS New Rules

On September 15, 2020, the Committee on Foreign Investment in the United States (“CFIUS”) promulgated a final rule modifying its mandatory declaration requirements for certain foreign investment transactions involving “TID US businesses” (sensitive U.S. businesses dealing in critical technologies, critical infrastructure and sensitive personal data) dealing in “critical technologies” – i.e., U.S. businesses that produce, design, test, manufacture, fabricate, or develop one or more critical technologies. The new rule also makes amendments to the definition of the term “substantial interest” (used to determine whether a foreign government has a substantial interest in an entity). The final rule became effective on October 15, 2020.

IRS Guidance on Employee Retention Credit

The Employee Retention Credit created under Section 2302 of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act is a refundable tax credit against certain employment taxes equal to 50 percent of the qualified wages an eligible employer pays to employees after March 12, 2020, and before January 1, 2021. Since the adoption of the CARES Act, employers have expressed concern that if one employer acquires another employer that previously received a PPP loan, the acquirer’s entire aggregated group may no longer be eligible to claim the Employee Retention Credit.

International Sales Contracts - COVID-19 Pandemic and Force Majeure

Identity Protection PIN Available to ALL Taxpayers in January

Beginning in January 2021, the IRS will allow all taxpayers who can properly verify his/her identity to obtain an Identity Protection PIN. An Identity Protection PIN (“IP PIN”) is a six digit number assigned to a specific taxpayer to assist in preventing the misuse of a taxpayer’s social security number on fraudulent federal tax returns. Previously, only confirmed victims of identity theft who resolved his/her tax issues with the IRS were eligible for an IP PIN.