October 20, 2022
Although many at-home and in-person health care services were paused or discontinued during the COVID-19 pandemic, the demand for IV hydration care at home is officially back. Patients seeking hydration recovery after sickness, for hangovers, or for general wellness are turning to mobile IV infusion service providers for convenient care at home. As these businesses proliferate in Virginia, they are learning that the legal and regulatory landscape is difficult to navigate. For this reason, we can expect legislative and regulatory activity regarding this business model in the future. Until that time where more clarity is provided, we highlight two areas of focus for anyone wishing to start a mobile IV hydration business.
STEP 1: APPLY FOR A HOME CARE ORGANIZATION LICENSE
For the last several years, most companies providing mobile IV hydration services have been operating in a gray area without much direction as to what type of licenses or permits it must have. We now know for certain that any business wishing to provide IV infusion services in a patient’s home must apply for a Home Care Organization (HCO) license from the Virginia Department of Health.
An HCO is defined in the Code of Virginia, in part, as an organization that provides “[p]harmaceutical services, including services provided in a patient’s residence, which include the dispensing and administration of a drug or drugs….” The associated regulations go on to describe the procedures that must be followed for administering “home infusion therapy medications,” which would include an IV cocktail containing prescription medications like Zofran or Toradol.
Lastly, it is important to note that anyone operating an HCO without a license is guilty of a class 6 felony. Such operation can result in an immediate order to cease providing services. Class 6 felonies can carry jail time, a $2,500 fine, or both, depending on the circumstances. To date, we are not aware of any enforcement actions against mobile IV providers operating without a license.
STEP 2: ENSURE SCOPE OF PRACTICE IS COMMENSURATE WITH SERVICES PROVIDED
The operational process for providing IV infusion services in a patient’s home involves several layers. For starters, there must be a bona fide practitioner-patient relationship that results in a valid prescription. The prescription may involve a cocktail of medications, which may require certain training for sterile mixing or compounding, depending on the process and medications involved.
The IV cocktail may be dispensed by a pharmacy pursuant to a valid prescription, delivered to the patient’s home, and administered by a properly licensed registered nurse, nurse practitioner, or physician’s assistant. In the alternative, a licensed physician or licensed autonomous practice nurse practitioner may prescribe and administer the medication on site.
Careful attention should be given to the practitioner’s license and associated scope of practice. Practice outside of the practitioner’s scope can result in disciplinary action by the Department of Health Professions. And unlawful practice without a license can result in criminal prosecution.
Obtaining an HCO license can be a tricky and burdensome process. Furthermore, navigating regulations and scope of practice issues can be complicated. For assistance and direction in this process, please contact a member of the Governmental Relations team.
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The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.