Dr. Michael Souza had mixed feelings when he saw that state health officials recently had enacted new guidance for a growing number of Rhode Island medical spas and other businesses that perform intravenous therapies.
On the one hand, he says the R.I. Department of Health’s new guidelines are restrictive. But he’s also hoping the standards will help curb the rise of businesses that are performing these services despite being uncertified and unmonitored.
“To have the rules and regulations so controlling, I think it’s gone overboard,” said Souza, founder and physician-owner of MCS Franchisee LLC, which does business as East Bay Innovative Medicine in East Providence. “But it will improve the quality of infusions and health care in Rhode Island.”
The standards issued by RIDOH in July pertain to an expanding personal care sector that has had some gray areas. Medical spas can offer a wide range of services, from traditional hairdressing and manicures to medical procedures such as Botox, fillers and laser hair removal, while IV therapy businesses can provide customers with fluids directly into the bloodstream, with or without medications, vitamins, minerals and amino acids.
The guidance, which defines licensing requirements and standards of care, comes as health officials have seen an increase in the number of medical spas and IV therapies in recent years, according to RIDOH spokesperson Annemarie Beardsworth. Failure to comply could result in disciplinary action and penalties.
And Rhode Island is not alone. Many other states, including Massachusetts and Connecticut, have issued guidelines in response to the proliferation of these types of businesses, said Patrick O’Brien, general counsel for the American Med Spa Association.
As it stands now, licensing requirements for a medical spa or IV therapy are based on the ownership structure, services offered and if any of the owners hold a professional license.
Overall, Rhode Island’s guidance is similar to many other states, O’Brien says, although he adds that Rhode Island is among the most restrictive for the scope of practices for nonphysicians.
Indeed, Souza says the guidance holds the businesses to a pharmaceutical standard, even though these types of businesses do not use pharmaceuticals or prescription medications.
Under the guidance, IV therapies are considered a practice of medicine, so they require a patient to have an evaluation, diagnosis and treatment before they can receive the treatment. As a result, Souza says he’s had several patients looking for an IV change their minds because the process would take too long.
“I think it’s overkill,” he said. “You go out in Florida and [IV therapy] is like a coffee bar. I’ve had a lot of people say, ‘No, forget it.’ So now they’re not getting fluid.”
Souza says he’s not necessarily concerned about the loss of customers but that those seeking IV therapy, which often provides hydration, will not be getting the treatments they’re looking for.
But, the guidance may crack down on “fly by night” spas and IV businesses, Souza says, many of which have opened without proper certification and are not regularly monitored.
At East Bay Innovative Medicine, Souza says, an inspector makes a monthly visit to ensure key equipment is up to standard and proper sterility is maintained. Also, each year the business must be recertified, and this can cost as much as $20,000 per year.
“I know it’s tough for them to go to each place to check the quality and inspect them … but it’s tough when only some people have to abide by the rules and others do not,” Souza said.
Meghan Hopkins, an associate attorney in Nixon Peabody LLP’s health care group, says Rhode Island’s guidance is fairly restrictive for what treatments different kinds of licenses can provide. For example, registered nurses can only provide IV fluid and oxygen therapy, which is a narrower interpretation than Massachusetts’ and Connecticut’s guidelines.
From a business perspective, allowing different kinds of medical providers to perform more services is ideal, especially as the state is facing a health provider shortage, Hopkins says.
“It burdens the business and business models,” she said, adding that some licensed providers might push back on the guidance.
Along with the scope of practice, the guidance also limits who can own medical spas and IV therapy businesses, Hopkins says, and adds red tape for owners depending on how their business is set up.
According to the guidance, if an owner or operator doesn’t have a professional license or doesn’t qualify for an exemption through a professional service corporation, or PSC, then the business needs to obtain an organized ambulatory care facility license. Rhode Island’s law allows providers such as physicians, dentists, registered nurses and physician assistants to form PSCs. Otherwise, business owners must go through a licensure review and get a recommendation from the Health Services Council before the license is issued by the Center for Health Facilities Regulation.
“The new guidance is perceived as a challenge,” Hopkins said.
