Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

Compounding GLP-1 Drugs - Recent Updates

Client Alert

More individuals are utilizing weight loss medication than ever before. With the rise in usage, providers must be aware of when, how, and why they are able to prescribe or create compounded GLP-1 drugs.       

Recent guidance from the Ohio Board of Pharmacy (“BOP”) indicates that providers should generally use the FDA approved GLP-1 drug, rather than a non-FDA approved compounded version of the medication. Importantly, if a GLP-1 drug is commercially available, it cannot be copied through compounding. Currently, compounded copies of Tirzepatide and Semaglutide are not permitted.  

There are two exceptions that allow a provider to compound a GLP-1 drug: (1) if the drug is not commercially available, and (2) if the compounded drug “includes a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the commercially available product.” The identified change must be documented appropriately on the prescription or order.

The BOP also prohibits a provider from using certain ingredients in compounding. For example, Retatrutide and Cagrilintide are not permitted to be used in compounding. In addition, providers cannot use salt forms when compounding GLP-1 drugs. 

While compounded GLP-1 drugs do serve a purpose, such as serving an individualized patient need, the United States Food and Drug Administration (“FDA”) has stated its concern with using any non-FDA approved GLP-1 drug. According to the FDA, one of the potential concerns is that the compounded drug may contain the incorrect amount of an active ingredient, leading to adverse effects. If using a compounded GLP-1 medication, providers will want to ensure that they are creating and storing the compounded drugs correctly, that they are not utilizing drugs labeled “for research purposes only,” and that any active ingredients purchased are from an FDA registered and Ohio licensed distributor.

To learn more about how drug compounding regulations can impact your practice, please contact BMD Member Jeana Singleton at jmsingleton@bmdllc.com or 330-253-2001. 


Advanced Practice Providers and Telemedicine Start-Up Surge

Throughout the COVID-19 pandemic, we heard a lot about “surges” that happened all over the country regarding the virus. One of the other interesting “surges” we have followed is the “surge” in new healthcare business start-ups, particularly businesses owned by advanced practice providers, such as nurse practitioners, physician assistants, certified nurse midwives, clinical nurse specialists, and certified registered nurse anesthetists (“Advanced Practice Providers” or “APPs”). One of the hottest areas in the healthcare start-up surge has been the creation of practices that are telemedicine focused.

Ohio Department of Health Releases Updated Charge Limits for Medical Records

Under Ohio law, a healthcare provider or medical records company that receives a request for a copy of a patient's medical record may charge an amount in accordance with the limits set forth in Ohio Revised Code Section 3701.741. The allowable amounts are increased or decreased annually by the average percentage of increase or decrease in the consumer price index for all urban consumers, prepared by the United States Department of Labor, Bureau of Labor Statistics, for the immediately preceding calendar year over the calendar year immediately preceding that year, as reported by the Bureau. The Director of the Ohio Department of Health makes this determination and adjusts the amounts accordingly. The list is then published, here.

No Surprises Act Compliance (Published by NAMAS, 2/25/22)

The Department of Health and Human Services published three parts to the No Surprises Act towards the end of 2021, which took effect January 1, 2022. The Act is intended to protect consumers from “balance billing,” which occurs when a patient receives a bill with a higher price than they may have anticipated because they did not have knowledge that the provider or facility was out-of-network. The purpose of this article is to note certain requirements that compliance employees will need to be aware of at their facilities, including notice and consent, good faith estimates, and public disclosures.

No Surprises Act and You (Published in the SCMS Winter 2022 Newsletter)

Legislation has been adopted by the United States Congress and the Ohio Legislature known as the “No Surprises Act” which attempts to regulate billing by professionals and facilities to patients who are not in networks with those facilities or providers at those facilities. The federal bill was triggered by some sensational news stories of patients being billed for tens of thousands of dollars for emergency care when the hospital was out of the network under the patient’s insurance plans.

Are You Impacted by the Project Labor Agreement Executive Order?

Project Labor Agreements (PLAs) are a quasi-collective bargaining agreement between employers and unions. They establish the terms and conditions of employment, including dispute resolution. They are put into place on specific projects and apply to the contractor, whether it is union or non-union. Employees hired on the project will be treated as union.