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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 Effective August 10, 2022, some of those waivers that were once granted have been rescinded. Below is a brief description of the rescinded waivers and the impact of their rescission. The Board of Pharmacy website sets forth a full list of the current waivers and rescinded waivers.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This waiver was rescinded without any part of it becoming law.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The waiver was rescinded.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


Telehealth Flexibility Updates: HIPAA, DEA, and CMS

The Covid-19 Public Health Emergency (PHE) officially ended on May 11, 2023. But what does that mean for telehealth, a field that expanded exponentially during the PHE? Fortunately, many of the flexibilities will remain intact, at least temporarily. This client alert presents a brief overview of the timelines that providers need to follow, but for a more comprehensive review of telehealth flexibilities and when they will end

WEBINAR SERIES RECAP | Ending the Public Health Emergency + Post-Pandemic Check-Up

Some may take the position that the rest of the country already returned to a new “normal” following the COVID-19 pandemic.  But healthcare providers continue to implement COVID protocols and navigate the ever-changing healthcare regulations at both the federal and state levels.  It is important for healthcare providers to take time for a “Healthcare Check-Up” with the start of 2023 and the ending of the Public Health Emergency (“PHE”).

Sharp Rise in False Claims Act Cases - Navigating the FCA Waters

Recently, on April 18, 2023, the United States Supreme Court heard arguments regarding the FCA’s scienter, or mental state, requirement. To prove violation of the FCA, the statute requires that a defendant “knowingly” file false claims for payment. The term “knowingly” is defined within the statute to mean a person that acts with actual knowledge, deliberate ignorance, or reckless disregard. Circuit courts are split on how to interpret and apply the knowledge element of the FCA, and based on the Supreme Court’s decision, there will be a large impact on healthcare defendants and their businesses as well as anyone who contracts with, or receives money from, a federal program. A broader interpretation of the FCA would unnecessarily target and stifle healthcare, and other businesses, for simple errors in daily operations. This goes against the intended application of the FCA, which was to prevent fraudulent activity.

Areas of Opportunity in Columbus: Highlights from the Columbus Opportunity Summit

On April 27, 2023 Columbus Business First held its annual Columbus Opportunity Summit, bringing together business and economic development leaders to provide an update on how Central Ohio is preparing for expected growth in the coming years, an issue heightened by the arrival of Intel at its 1,000 acre site in Licking County, just outside of Columbus. The site will be home to two new chip factories with room to grow to a total of eight factories and is a $20 Billion investment.

BREAKING: Biden Administration Has Officially Ended the Two Remaining COVID Vaccine Mandates

As of May 1, 2023, the Biden Administration has officially ended the two remaining COVID vaccine mandates: (1) the Federal Contractor Mandate, and (2) the CMS Healthcare Provider Vaccine Mandate.