Florida lawmakers hope new rules governing controlled substances will mitigate the damaging effects of the opioid crisis. Because understanding the 160-ish page House Bill 21 (HB 21) is a daunting task, physicians should know its key components.
"We're a bit worried as an organization there'll be a large number of physicians and other providers in the community who are unaware of the impact of this bill and may be noncompliant," said Fraser Cobbe, executive director of Orange County Medical Society and Seminole County Medical Society and conference host of an educational webinar on the implementation of the bill.
For example, in North Carolina, after similar controlled-substance legislation was implemented via the NC STOP ACT on Jan. 1, thousands of unaware physicians continued prescribing controlled substances in the same manner.
"We want to make sure we don't repeat that experience in Florida," he said.
Mandatory Physician Education
Perhaps the most urgent aspect of HB 21 revolves around mandatory physician education. Before Jan. 31, 2019, all DEA-registered medical providers must take a Board of Medicine-approved 2-hour CME course on prescribing controlled substances. This educational component must be repeated with every license renewal.
"The best way physicians will understand the implications of this bill is by taking the course ASAP," emphasized Cobb. "It'll provide a more official overview of the legislation and various components and penalties for noncompliance."
So far, Florida Medical Association, Florida Osteopathic Medical Association, Florida Association of Family Physicians and Florida College of Emergency Physicians are approved providers for the new mandatory course. Online courses will be available; some are free. The medical societies of Orange and Seminole counties will provide the course twice this summer: July 13 and Aug. 18.
"Even if you no longer write for opioids or other scheduled drugs, every person registered with the DEA and authorized to prescribe controlled substances must take this course," he said. PAs and ARNPs are already mandated to take a 3-hour course to prescribe as required by legislation passed in 2016 allowing both groups the ability to prescribe controlled substances.
Mandatory Review of the Prescription Drug Monitoring Database (E-FORCSE)
Effective July 1, prior to prescribing a controlled substance, every prescriber must consult the database to review the controlled substance dispensing history of patients 16 or older. The only exception: scripting a nonopioid Schedule V.
"If the database isn't operational by fault of the database or your own technical difficulties, the bill requires you to document the reason why the database wasn't consulted," Cobbe said. "However, in that case, you cannot prescribe more than a 3-day supply of a controlled substance."
Because there's no strict timeframe on when to check the database prior to writing the script, "use common sense and best practice," suggested Cobbe.
Limitations on Prescribing Controlled Substances
Limitations of this component of the bill only relates to acute pain, not chronic pain treatment. Acute pain doesn't include pain related to cancer, a terminal condition, palliative care, or a traumatic injury with an Injury Severity Score of 9 or higher.
Possibly the most controversial part of the bill involves the 3-day maximum for a prescription of Schedule II controlled substances (listed in the bill) for the treatment of acute pain.
"However, there's a pathway to write a script for up to seven days," Cobbe pointed out.
The conditions of prescribing up to a 7-day supply for any Schedule II controlled substance for acute pain, not just opioids, the practitioner must demonstrate that more than a 3-day supply is medically necessary to treat the patient's pain as an acute medical condition. The magic script words: ACUTE PAIN EXCEPTION. The prescriber must also adequately document in the patient's record the acute medical condition and lack of alternative treatment options to justify deviation from the 3-day supply limit.
To treat chronic pain or use an exemption to go beyond seven days, the magic script words are NON-ACUTE PAIN. As a reminder, this requirement doesn't apply when prescribing a nonopioid controlled substance listed in Schedule V.
Because federal law prohibits refills of controlled substances, additional scripts are considered new prescriptions, Cobbe said.
"Legislation doesn't say a patient is limited to three or seven days for the whole duration of their acute condition," explained Cobbe. "It's meant to be slow and low."
To alleviate physician concern about the impact of patient volume if in-person exams are mandated for subsequent prescriptions of these controlled substances, the Board of Medicine is developing rules on the Standards of Practice for Treating Acute Pain to include how often providers must see patients and review treatment plans.
Some states, but not yet Florida, are mandating e-prescribing. However, progress is being made to alter the Board of Medicine's rules prohibiting the prescription of controlled substances using telemedicine.
"Those (prescribers in states) that do, say it's great," Cobbe said. "The Board of Medicine attorney doesn't believe an in-person evaluation will be required for ongoing treatment of a condition already diagnosed and performance of a treatment plan."
Compliance & Penalties
The most prominent front-line enforcer of monitor compliance will be the pharmacist, who will view the database prior to dispensing scripts to patients to see if the patient has three additional active scripts for opioids. In that scenario, the pharmacist will file a complaint with the Board of Medicine for physician failure to consult the patients' drug history before writing a new script.
"Pharmacist interpretation will be key to smooth - or rough - implementation," said Cobbe.
Because the Board of Medicine acknowledges the sharp learning curve necessary to implement the bill, the first instance will be a non-disciplinary citation and fine. Penalties and fines will increase for additional violations.
"What do you (physicians) do if you see the patient has active scripts? The law is silent on that. But the Board's standards of care may address it, and care coordination involving other prescribers may be an answer," said Cobbe.
Mandatory Emergency Opioid Antagonist Prescription
For a prescription for a Schedule II opioid for the treatment of pain related to a traumatic injury with an Injury Severity Score of 9 or higher, the prescriber must concurrently prescribe an emergency opioid antagonist.
"This applies even if you're sticking to the 3- or 7-day limit," said Cobbe.
Mandatory Application for a Certificate of Exemption
Starting Jan. 1, 2019, physician offices exempt from pain management clinic regulations must apply for a Certificate of Exemption via the Agency for Health Care Administration and must reapply every two years.
"You shouldn't have to continue to apply for this exception every two years, which is our major concern with this language," Cobbe said.
Board of Medicine to Adopt Standards of Practice for Treatment of Acute Pain
The Board of Medicine plans to adopt rules establishing guidelines for prescribing controlled substances for acute pain, which may include evaluation of the patient, creation and maintenance of a treatment plan, obtaining informed consent and agreement for treatment, periodic review of the treatment plan, consultation, medical record review and compliance with controlled substance laws and regulations.
"The Board is going to meet with other professional boards to create these standards, so they may take a while to complete," Cobbe said.
Effective Dates of HB 21 Addressing Opioid Abuse
July 1: Mandatory checking the PDMP; restrictions in opioid prescriptions commence.
Jan. 1, 2019: Certificate of Exemption for Pain Management Clinics.
Jan. 31, 2019: Two-hour CME course requirement for all DEA-licensed providers.
TDB: Board of Medicine Standards for Treating Acute Pain.
Resources for Compliance with HB 21 - Controlled Substances
Florida Department of Health FAQ:
DEA Registration for Electronic Prescribing Controlled Substances:
E-FORCSE (Drug Monitoring Database) Home Page:
Register for the Drug Monitoring Database: