Compliance Issues Associated With Infusion Therapy Services
In-home infusion therapy services in major metropolitan centers are trendy and popular. Some of these business ventures serve traditional patient populations. Others market themselves as “wellness services” and offer rehydration and custom vitamin cocktails for people who are working or playing hard. While these businesses can be profitable, there are pitfalls for the unwary.
The first potential misstep is with business formation. The majority of states, including Arizona, have some prohibition against the “corporate practice of medicine.” These restrictions are state-specific, but dictate who can own and operate a business engaged in the practice of medicine. There are also state specific rules about whether and when a physician can be an “employee” of an entity. To navigate these waters, it is a good idea to consult with an attorney.
The next step is figuring out who can do what. It might be surprising to some people to learn that the answer is not the same in every state. For this reason, before starting an infusion business venture, it is important to know who is licensed to prescribe the infusion and who is permitted to perform mobile or in-home infusion services in every state in which you intend to do business.
If your business model involves compounded medications, beware. Unless you purchase your solutions off the rack from a 503(b)-compounding pharmacy, the solutions should be custom made pursuant to a patient-specific prescription. If the infused solutions are “customized” on site, for example by adding vitamins, and there is not a prescription from an appropriately licensed health care provider for the drug as administered, the practice may run afoul of state law.
503(a) compounding pharmacies that serve infusion therapy businesses may also get into hot water if they are not careful to ensure they have clean and valid prescriptions. This can be especially challenging in a telehealth environment. There are also potential concerns with compounding large batches of the same formulation for the same company repeatedly as it is possible the FDA may view this as drug manufacturing and manufacturing of an unapproved drug.
Savvy business owners retain legal counsel to educate them about potential sources of liability and help put appropriate safeguards in place before problems arise. Although rare, serious injuries can and do occur from infused solutions. For example, in February 2021, a California woman was hospitalized and treated for suspected septic shock and multi-organ failure after receiving an IV-vitamin infusion in her home. The patient’s blood cultures grew Pseudomona Flurescens, a gram-negative bacterium. An inspection of the medical clinic that compounded the solution revealed unsanitary conditions.
There are also important considerations for business owners when deciding how to market their business. In addition to state consumer protection laws, there are federal regulations to keep in mind. Over the past couple of years, the FTC has sent out warning letters to businesses that made unsupported claims in public facing materials that claim their infusions can cure medical conditions.
The law firm of Boesen & Snow focuses on healthcare law solutions and has experience representing compounding pharmacies, licensed healthcare professionals, and healthcare businesses including infusion centers. If you have questions, please don’t hesitate to reach out. We’re here to help.
Boesen & Snow (602) 900-8562.