Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

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 Effective August 10, 2022, some of those waivers that were once granted have been rescinded. Below is a brief description of the rescinded waivers and the impact of their rescission. The Board of Pharmacy website sets forth a full list of the current waivers and rescinded waivers.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This waiver was rescinded without any part of it becoming law.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


Provider Relief Funds – Continued Confusion Regarding Reporting Requirements and Lost Revenues

In Fall 2020, HHS issued multiple rounds of guidance and FAQs regarding the reporting requirements for the Provider Relief Funds, the most recently published notice being November 2, 2020 and December 11, 2020. Specifically, the reporting portal for the use of the funds in 2020 was scheduled to open on January 15, 2021. Although there was much speculation as to whether this would occur. And, as of the date of this article, the portal was not opened.

Ohio S.B. 310 Loosens Practice Barrier for Advanced Practice Providers

S.B. 310, signed by Ohio Governor DeWine and effective from December 29, 2020 until May 1, 2021, provides flexibility regarding the regulatorily mandated supervision and collaboration agreements for physician assistants, certified nurse-midwives, clinical nurse specialists and certified nurse practitioners working in a hospital or other health care facility. Originally drafted as a bill to distribute federal COVID funding to local subdivisions, the healthcare related provisions were added to help relieve some of the stresses hospitals and other healthcare facilities are facing during the COVID-19 pandemic.

HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements

The federal 340B discount drug program is a safety net for many federally qualified health centers, disproportionate share hospitals, and other covered entities. This program allows these providers to obtain discount pricing on drugs which in turn allows the providers to better serve their patient populations and provide their patients with access to vital health care services. Over the years, the 340B program has undergone intense scrutiny, particularly by drug manufacturers who are required by federal law to provide the discounted pricing.

S.B. 263 Protects 340B Covered Entities from Predatory Practices in Ohio

Just before the end of calendar year 2020 and at the end of its two-year legislative session, the Ohio General Assembly passed Senate Bill 263, which prohibits insurance companies and pharmacy benefit managers (“PBMs”) from imposing on 340B Covered Entities discriminatory pricing and other contract terms. This is a win for safety net providers and the people they serve, as 340B savings are crucial to their ability to provide high quality, affordable programs and services to patients.

DOL Finalizes New Rule Regarding Independent Contractor Status, But Its Future Is In Jeopardy

On January 6, 2021, the Department of Labor announced its final rule regarding independent contractor status under the Fair Labor Standards Act. As described in a prior BMD client alert, this new rule was fast-tracked by the Trump administration after its proposal in September 2020. The new rule is set to take effect on March 8, 2021, and contains several key developments related to the "economic reality" test used to determine whether an individual is an independent contractor or an employee under the FLSA.