Tuesday, March 13, 2018

Florida's 2018 Session - Opioids

The Florida legislative process can sometimes be difficult to follow. It seems a subject of persistent curiosity and questions. In I'm Just a Bill (March 2018), I recently provided some explanation of the way bills are named and the manner in which those bills and names evolve over the course of a session. That post documents the passage of amendments to Section 112.1815 F.S., and benefits regarding post-traumatic stress disorder (PTSD) for "first responders" in workers' compensation.

2018 saw legislation introduced regarding other issues of arguably broader impact for Florida workers' compensation. In fact, a search for "workers' compensation" on the Florida House of Representatives website returned 74 bills in the 2018 session containing those words. Many of these ended their path with "indefinitely postponed and withdrawn from consideration." They were filed, but they did not make it to fruition. About 3,000 bills are filed each session; this year about 200 of those were passed.

Perhaps the broadest workers' compensation bill in the 2018 session was House Bill 7009. Filed in November, this proposal was significantly similar to reform legislation debated in 2017. The 2017 session was discussed in The 2017 Session is Ending - What will be the Final Word (May 2017). HB 7009 passed the House, was sent to the Senate, referred to committee, and moved no further. 

But, The PTSD bill is not the only bill with workers' compensation implications that passed. Committee Substitute (CS) for Committee Substitute for House Bill 21 (CS/CS/HB21) has also been ordered "enrolled" (meaning it will be presented to the Governor for consideration). This bill includes multiple actions regarding the prescribing of opioids and other drugs in Florida. It will affect medicine in Florida, and medicine will affect workers' compensation. 

Opioids are a serious problem in Florida. U.S. News and the Associated Press recently reported that 16 Floridians each day die from the "opioid crisis." The report compares that to the tragic shooting death of 17 people at Douglas High School on February 14, 2018. At 16 per day, we have lost 432 Floridians to drugs since February 13, 2018, a stark comparison. Sixteen more will die today, and another 16 tomorrow. By the end of 2018, "Florida's opioid crisis" is projected to claim 5,840 lives. Worse, U.S. News modified that 16 with "at least"; the death toll may be higher. The impact on those who use these substances is notable, but it affects those dependent upon and close to them as well. 

Regular readers here will know that drugs are not a new topic. There are at least 30 posts in which I have addressed opioids, prescription drug monitoring programs (PDMP), pill mills, formularies and more (each listed as links at the end of this post). Medication and drugs are simply not a new problem. And, the issues directly impact workers' compensation. 

What is new in the effort to address "Florida's opioid crisis," in CS/CS/HB21? This broad bill amends Section 456.44, F.S. and Section 456.44, F.S. and Section 893.03, F.S. and Section 893.04, F.S. and Section 893.055, F.S. and more. 

in Section 456.44, F.S. Prescribers will be required "to complete a board-approved 2-hour continuing education course on prescribing controlled substances offered by a statewide professional association of physicians." This will be required for each biennial license renewal. Education shall include "current standards for prescribing controlled substances, particularly opiates, alternatives to these standards, nonpharmacological therapies, prescribing emergency opioid antagonists, and the risks of opioid addiction." furthermore, a set of "rules establishing guidelines for prescribing controlled substances for acute pain" shall be adopted. 

As a general rule "a prescription for a Schedule II opioid . . . for the treatment of acute pain must not exceed a 3-day supply." But, a 7-day supply is allowed if "medically necessary" for "an acute medical condition," but only if the prescriber documents the condition and the "lack of alternative treatment options that justify deviation." In this event, the prescription must state "ACUTE PAIN EXCEPTION." 

With any "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." Perhaps the best known is Naloxone, but there are several available. Thus, some population will leave the pharmacy with both an opioid and an overdose medication, "just in case."

CS/CS/HB21 similarly amends Section 456.44, F.S. for dispensing related to a surgical procedure. Schedule II opioids are limited to a 3-day supply, and the 7-day exception in Section 456.44, F.S. Other Scheduled II (non-opioid) and Schedule III are limited to a 14-day supply. 

Unless the patient is "known to the pharmacist," the "pharmacist must require the person purchasing, receiving, or otherwise acquiring the controlled substance to present valid photographic identification," which was "issued by a state or the Federal Government." If someone lacks identification, the pharmacist must instead "verify the validity of the prescription and the identity of the patient with the prescriber." Long-term care facilities, assisted living,facilities and hospitals are exempt from this requirement. 

CS/CS/HB21 amends Section 893.03, F.S., which lists the substances included in the various schedules. Under this provision, Schedule II would be amended to include Dihydroetorphine, Oripavine, Remifentanil, Tapentadol, Thiafentanil, Lisdexamfetamine, and Dronabinol. That last one may be of some interest as it is an oral product containing synthetic THC (medical cannabis). The amendments also add three substances to Schedule III, and 15 to Schedule IV.

CS/CS/HB21 amends Section 893.04, F.S. This section has provided constraints on how medical providers may prescribe. That has included "written or oral" prescriptions. This change will add "or electronic" to the available methods. A response to the Florida "pill mill" issue led the legislature to restrict narcotic prescriptions to the written form several years ago. Under the new law, the Schedule II prescription limitation to "written" will remain, but will also now include "or electronic." 

CS/CS/HB21 amends Section 893.055, F.S., Florida's Prescription Drug Monitoring Program (PDMP). Dispensers (pharmacy) will remain responsible for reporting prescriptions for "each controlled substance dispensed." The data provided will include the name of the person that picks up the medication "and type and issuer of the identification provided." The law empowers Florida to "enter into one or more reciprocal agreements or contracts to share prescription drug monitoring information with other states, districts, or territories," but only if those other jurisdiction's programs are "compatible (as statutorily defined) with the Florida program."

And, the amendments to Section 893.055, F.S., will now require that the database (PDMP) is consulted "before prescribing or dispensing a controlled substance for a patient age 16 or older," subject to some exceptions (the system is not operational, cannot be accessed due to power or technology failure, etc.). If the PDMP is not consulted, then the prescriber or dispenser must

document the reason he or she did not consult the system in the patient's medical record or prescription record, and shall not prescribe or dispense greater than a 3-day supply of a controlled substance to the patient.

For failing to consult the PDMP before prescribing or dispensing, without such an exception, a "prescriber or dispenser" can be issued "a nondisciplinary citation" upon a first offense, and "subsequent offense is subject to disciplinary action."


The performance of the PDMP must be reported annually to the Governor, Senate, and House. This will include outcomes such as "the rate of inappropriate use of controlled substances" and reduction in quantity "obtained by individuals attempting to engage in fraud and deceit." And, a "direct support" non-profit corporation may be created to assist with raising and investing funds for the benefit of the PDMP effort.

CS/CS/HB21 is 160 pages long, and the foregoing is merely an overview of the highlights. Those involved in the authorization or provision of medical care will want to read the bill itself. Of course, as mentioned elsewhere on this blog, the "checks and balances" we learned in school apply. Whether the foregoing becomes our law is now up to the Governor. The Governor may sign the bill into law or allow it to become law without signature, or could veto the bill.

Update, March 19, 2018 - Gov. Scott signs opioid bill.