By: Matthew Fischer
There are no off the shelf solutions when it comes to starting a new stem cell business or adding a new component to a practice. Between navigating regulations, receiving training, and marketing the service, there’s a lot to address in a short time. Trying to do it all yourself? You may be a highly trained clinician, but given healthcare’s ever-changing regulatory environment, seeking out experienced counsel at the outset will save lots of time and money in the long run. To get started, here is a short summary of what to expect.
Stem Cell Business – Corporate Structure
The first issue is always protection when starting a business or adding a new service. Take the case of an orthopedic physician that wants to add stem cell treatments (e.g. PRP) to his or her practice. The initial inclination is usually to create a new entity separate from the medical practice. What the physician is likely unaware of is that this may create exposure to state self-referral laws. Typically, under these types of laws, intent is not a requirement to find a physician liable for wrongdoing. Therefore, is it important to determine if your state has this type of law and if so, how to structure the new venture before moving forward.
The FDA has the authority to regulate stem cell products. Most products are regulated by the FDA as a HCT/P while others are not. Many direct-to-consumer providers are unsure about what this means and need to know what they are able to do and say. Thus, it is imperative to be up to date on the issues and know what boundaries have been set by the FDA.
Scope of Practice
Stepping out of your scope of practice can be a legal issue and endanger the license you worked so hard for. With the rise of stem cell science and treatments, many state boards have warned physicians that they could face potential disciplinary action for failing to meet the prevailing professional standard of care or for performing an experimental procedure without first obtaining full, informed consent. Therefore, is it important to discuss the addition of new treatments with counsel before starting. Another issue relates to delegation. Many physicians would like to have a mid-level practitioner (i.e. NP or PA) assist or provide injections. Once again, state regulations need to be reviewed to determine who can provide treatments and what level of supervision is required.
There is no universal formula for a stem cell business. The sheer amount and scope of healthcare statutes and regulations makes it increasingly difficult for a provider or even for an attorney inexperienced in healthcare matters to grasp the laws’ nuances. In order to protect yourself and your practice, it is important to work with someone who will understand the variables and help you plan accordingly.