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 Effective August 10, 2022, some of those waivers that were once granted have been rescinded. Below is a brief description of the rescinded waivers and the impact of their rescission. The Board of Pharmacy website sets forth a full list of the current waivers and rescinded waivers.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This waiver was rescinded without any part of it becoming law.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The waiver was rescinded.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


Ohio Supreme Court Clarifies Medical Statute of Limitations

The Ohio Supreme Court issued a decision in late December that clarifies and finalizes the Ohio law regarding the period of time in which patients can assert claims for medical malpractice. The Court was examining the interplay between three different statutes being the statute of limitations, the statute of repose, and the savings statute.

Ohio Hospitals and Healthcare Clinics: It’s Time to Revisit Your Billing and Collection Practices

According to a recent Cuyahoga County case, certain healthcare entities may not be protected from liability when engaging in unfair or deceptive billing acts. This decision is consistent with the growing trend across the country to encourage price transparency and eliminate unfair surprise billing practices by health care organizations. Now is the time for hospitals and other health care organizations to revisit their billing and collection policies and procedures to confirm that they are legally defensible and consistent with best practices.

HIPAA Business Associate Agreements: Why These Contracts Matter

No one loves drafting, reading or negotiating HIPAA Business Associate Agreements (BAAs). Yet many of us need to do so, and some of us do so daily. They are often boring, dense and technical, but BAAs are important from both a legal and a business perspective, and they deserve our attention. Failure to enter a BAA when one is required can constitute a HIPAA violation that results in substantial liability, as demonstrated by certain recent Department of Health & Human Services (HHS) settlements.1 A business associate who makes a disclosure that is not authorized by the applicable BAA or required by law can be subject to civil and, in some cases, criminal penalties. Further, parties are often presented with BAAs that contain onerous one-sided indemnification and other provisions that can be devasting to an organization in the event of a HIPAA breach. The significance of a BAA is often not fully understood by the parties until something goes wrong (e.g., a HIPAA security incident or breach, an Office of Civil Rights (OCR) audit or a fracture in the relationship between the parties) and, at that point, there is limited opportunity to mitigate legal and business risk. Ideally, attention should be given at the commencement of the business associate relationship, when the parties are able, to thoughtfully addressing regulatory requirements, planning and preparing for potential adverse events and appropriately allocating risk among the parties. As with most healthcare regulatory compliance initiatives, a proactive approach with respect to BAAs is preferable. This article provides a broad overview of certain BAA requirements and some practical negotiating tips for the parties involved.

“I’m Out Of Here!” Now What?

We all know that the healthcare industry is experiencing a wave of integration. This trend has been evident for many years. Fewer physicians are willing to assume the legal, financial and other business risks associated with owning their own practices. More and more physicians, including anesthesiologists, are becoming employed by large physician groups, health systems and national providers. This shift necessarily involves not only entry into new employment arrangements but also the termination of existing relationships. And those terminations are often governed by written employment agreements, state and federal healthcare laws and employer benefit plans and other policies and procedures. Before pursuing their next opportunity, physicians should pause for a moment and first attend to the arrangement that they are leaving. Departing physicians need to understand their legal rights and obligations when leaving their current employment relationships in order to avoid unintended consequences and detrimental missteps along the way. Here are a few words of practical advice for physicians contemplating an exit from their current employment arrangements.

Investment Training for the Second and Third Generations

Consider this scenario. Mom and Dad started the business from the ground up. Over the decades it has expanded into a money-making machine. They are able to sell the business and it results in a multimillion-dollar payday for their labors. The excess money has allowed Mom and Dad to invest with various financial advising firms, several fund management groups, and directly with new startups and joint ventures. Their experience has made them savvy investors, with a detailed understanding of how much to invest, when, and where. They cannot justify formation of a full family office with dedicated investors to manage the funds, but Mom and Dad have set up a trust fund for the children to allow these investments to continue to grow over the years. Eventually, Mom and Dad pass. Their children enjoy the fruits of their labors, and, by the time the grandchildren are adults, Mom and Dad's savvy investments are gone.