Pursuant to Section 456.44(3)(a), Florida Statutes, and Rule 64B-9.013(3)(a), Florida Administrative Code, a practitioner must evaluate a patient by taking a complete medical history and performing a physical examination prior to prescribing a controlled substance to a patient. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place via a telemedicine visit. However, under current Florida law, only controlled substances used to treat psychiatric disorders may be prescribed using telemedicine technology, that is audio and video technology commonly referred to as telepsychiatry. Specifically, Rule 64B8-9.0141(4) states, “controlled substances shall not be prescribed through the use of telemedicine except for the treatment of psychiatric disorders.” Psychiatric disorders include Substance Use Disorders since the DSM-V classifies addiction as a mental health condition. Although the Standards for Telemedicine Practice under Rule 64B-9.0141, Florida Administrative Code, allows licensed practitioners to prescribe controlled substances for psychiatric disorders via telehealth technology, the federal law has lagged somewhat behind.
The Drug Enforcement Administration (DEA) is responsible for monitoring the supply and distribution of all controlled substances. All medical providers, pharmacies, manufacturers of pharmaceuticals, and distributors of pharmaceuticals must be registered with the DEA. DEA registrants are governed by an ever-growing web of federal laws and regulations which if violated may result in revocation of registration, fines, and/or criminal prosecution. Therefore, it is important when starting a business or purchasing an existing business requiring DEA registration to be proactive and prepared for periodic administrative inspections or audits.
The Diversion Control Unit is tasked with monitoring compliance and empowered to conduct inspections by the Controlled Substances Act (CSA). Under the CSA, diversion investigators have the authority to (1) inspect, copy, and verify records required to be kept (e.g., prescription and inventory records); (2) inspect equipment; (3) make a physical inventory of controlled substances; (4) collect samples of controlled substances; and/or (5) inspect any other records appropriate for verification under the CSA. However, there are limits to what can be inspected (unless an owner or agent of the owner consents). Inspections do not extend to financial data, sales data (other than shipping data), or pricing data.
adminDEA Inspection and Audits: An Introductory Guide
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.