On March 19, 2018, Governor Rick Scott signed into law House Bill 21 (“HB21”). The 205 page Bill imposes new obligations on practitioners and carries penalties for non-compliance. Unless otherwise noted, the provisions of this law go into effect on July 1, 2018.
In sum, HB 21 amends various sections of law to increase the regulation, training, and reporting required when controlled substances are prescribed and dispensed. This blog post provides the highlights of the bill and should not be construed as a substitute for reading it in it’s entirely. The Bill can be found at:
https://www.flsenate.gov/Session/Bill/2018/21.
Florida Statute section 456.44-Controlled Substance Prescribing- governs the prescribing of controlled substances for the treatment of “chronic non-malignant pain.” HB21 amends the statute to add a new section governing the prescribing of controlled substance for the treatment of “acute pain.” If a prescriber writes a prescription for a Schedule II opioid for the treatment of pain other than “acute pain” (such as for chronic non-malignant pain), or for pain that is excluded from the definition of “acute pain,” the prescriber must indicate “NON-ACUTE PAIN” on the prescription.
HB 21 Bill defines “acute pain” as the normal, predicted, physiological, and time- limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness.
The term specifically does not include pain related to:
Cancer;
A terminal condition;
Palliative care to provide relief of symptoms related to an incurable, progressive illness or injury;
Or a serious traumatic injury with an Injury Severity Score “ISS” (established medical score to assess trauma severity) of nine (9) or greater.
HB 21 provides restrictions on certain prescriptions written to treat acute pain by:
Requiring applicable healthcare regulatory boards to create guidelines for prescribing controlled substances for the treatment of acute pain. (The guidelines are to include: evaluation of the patient, creation and maintenance of treatment plan, obtaining informed consent and agreement for treatment, periodic review of the treatment plan, consultation, medical records review, and compliance with controlled substance laws and regulations. It is likely that the guidelines will be adopted sometime after the July 1st effective date of the legislation)
Limiting a prescription for an opioid listed in Schedule II to no more than three (3) days if prescribed to treat acute pain as defined. This limit is increased to seven (7) days if determined to be medically necessary by the prescribing practitioner and with proper documentation. The prescription will need to say "acute pain exception" and the patient's record will need to include documentation of the acute condition and a lack of alternative treatment that justifies the seven-day supply.
Requiring a prescriber to co-prescribe an opioid antagonist when prescribing controlled substances for serious traumatic injury.
The Bill provides for a couple exemptions. It allows practitioners to dispense controlled substances in connection with a surgical procedure to the limits described above. Moreover, the Bill creates an exemption to allow a physician to dispense Schedule II and III controlled substances approved by the FDA for the Medication-Assisted Treatment “MAT” of his or her own patients. MAT is the use of anti-craving medicine along with comprehensive therapy and support to help address issues related to opioid dependence. Additionally, the Bill explicitly authorizes electronic prescriptions for controlled substances and adds and reschedules substances to the various schedules of controlled substances. Please familiarize yourself with the new scheduling which can be found in the Bill’s full version.
***It is important to note that the standards regarding the treatment of chronic, non-malignant pain are unchanged. The three (3) to seven (7) day limit on prescribing Schedule II opioids only applies to acute pain – not chronic non-malignant pain.
The Bill substantially rewords the Prescription Drug Monitoring Program (“PDMP” or “E-FORCSE”) and makes a number of changes regarding database reporting, checking and access to information. As passed in 2009, the law required dispensers of controlled substances to report to the database within seven (7) days. The law did not require physicians to check the database prior to prescribing a controlled substance.
HB 21 states:
Schedule V controlled substances must be included in the list of drugs that are reported to the PDMP;
Prescribing practitioners are required to consult the PDMP before prescribing controlled substances. (A prescriber or dispenser must review a patient’s controlled substance dispensing history before prescribing or dispensing controlled substances for a patient who is 16 years of age or older. This requirement applies to all controlled substances, not just opioids.)
The Department of Health is allowed to coordinate and share PDMP data with other states PDMPs and to enter into contracts to establish secure connections between the PDMP and prescribing or dispensing healthcare practitioners electronic health records; and
Prescribers and dispensers with Veteran’s Affairs, the military, and the Indian Health Services, and Florida Medical Examiners are allowed access to data in the PDMP.
HB 21 explicitly states, “a prescriber or dispenser must consult the system to review a patient’s controlled substance dispensing history before prescribing or dispensing controlled substance for a patient age 16 or older.” Therefore, until clarified by the Department of Health, it appears that practitioners must check the database each time they prescribe or dispense controlled substances, regardless of whether the patient is an existing patient or not. It is important to note, the requirement for checking the PDMP database applies for the prescription of almost any controlled substance, for any reason. It does not matter if the prescription is for acute pain or chronic non-malignant pain.
If a database is not operational or cannot be accessed by the prescriber or dispenser, the practitioner can prescribe or dispense the controlled substance; however, must document the reason why the database was not consulted and cannot prescribe or dispense more than a three (3) day supply.
As of January 1, 2018, the dispensing of a controlled substance must be reported to the database no later the close of the next business day. If a dispenser usually dispenses controlled substances in Florida, but has no dispensing transactions to report for the proceeding seven (7) day period, the dispenser must report this information to E-FORCESE by filing a “Zero Report” as described in the Dispenser’s Implementation Guide, which can be found at:
http://rxsentry.net/assets/files/flpdms/2017/FL_RxSentry_Dispensers_Implementation_Guide_ASAP_4.2.pdf
Please be aware, the Department of Health is required to issue a non-disciplinary citation to any prescriber or dispenser who fails to consult the database prior to prescribing or dispensing a controlled substance. Moreover, a practitioner who willfully and knowingly fails to report the dispensing of a controlled substance commits a misdemeanor of the first degree. In addition, HB21 also increases the penalty from a third degree felony to second degree felony for a patient or healthcare practitioner who knowingly obtains or provides a controlled substance that is not medically necessary and creates a new third degree felony for unlawfully possessing and using tableting or encapsulation machines.
Moreover, HB21 requires all practitioners authorized to prescribe controlled substances to complete a two (2) hour training course prior to biannual licensure renewal on the safe and effective prescribing of controlled substances. The Bill further states that if a clinic is exempt from the requirement that they register as a pain management clinic, they must obtain and maintain a Certificate of Exemption from the Department of Health. The Certificate of Exemption requirement goes into effect on January 1, 2019.