Article Written By: Carlos H. Arce, Esq.

On March 19, 2018, Governor Rick Scott signed into law House Bill 21, adding new legal requirements on healthcare providers who prescribe controlled substances, and specifically geared towards opioids. In recent years, the opioid epidemic has affected the public health of the United States. Many states have adopted new laws that add new requirements in prescribing controlled substances. Healthcare providers all across the country have had criminal charges filed against them for violations of these new laws. Therefore, it is important as a Florida healthcare provider to be aware of the new laws and changes to the current laws.

Effective July 1, 2018, House Bill 21 created changes to the current laws and added new regulations. The new law added additional requirements to Florida’s Prescription Drug Monitoring Program, more commonly known as E-FORSCE. Providers authorized to dispense or prescribe controlled substances must verify the E-FORSCE database prior to prescribing or dispensing any and all controlled substances to any patient over the age of 16 years of age. As an aside, medications under the Schedule V, that is, medications which contain any amount of opioid substance, will in effect be treated as controlled substances and require the same verification. The Florida Department of Health will be issuing non-disciplinary citations to providers who dispense or prescribe controlled substances without consulting E-FORSCE.

Florida Statutes Section 456.44, which governs the prescribing of controlled substances for “chronic nonmalignant pain”, will now include controlled substances prescribed for “acute pain”. Medicinal treatment for acute pain must not exceed a three-day supply unless the provider has reason to show why extra days are needed. If this is the case, the provider must follow specific procedures in order to comply. In the coming year, the medical boards will issue guidelines on specific evaluation procedures for patients receiving controlled substances for acute pain. The Florida Medical Association expects the Board of Medicine and Board of Osteopathic Medicine to adopt guidelines sometime after July 2018.

Other requirements specific to Pain-Management Clinic registration will go into effect July 1, 2019, which includes a required two-hour continuing education for healthcare providers who are registered with the DEA and authorized to prescribe controlled substances.

In addition to Florida’s new state law, federal agencies will now more than ever uphold and enforce laws that regulate prescribing and dispensing of both controlled substances and legend drugs. These agencies include the Drug Enforcement Administration (DEA), which administers the Controlled Substances Act (CSA); and the Food and Drug Administration (FDA), which has authority over the Food, Drug, and Cosmetic Act (FDCA). In particular, healthcare provides should be aware of the potential civil and criminal liability under the FDCA. The FDCA has been enforced and correlated with the federal Anti-Kickback Statute and the False Claims Act in relation to claims submitted to both governmental and non-governmental payers

Healthcare is a growing industry in our country, and especially, in Florida. Therefore, it is important that healthcare providers stay informed and up to date with the frequent regulatory changes. To receive more information regarding state and federal controlled substance regulations, please contact me directly by telephone at my office 954-880-9500 or by emailing me at cha@lubellrosen.com.