By Brandy Burnette Balding
As the opioid crisis in Virginia has escalated, several new laws and regulations have been adopted that affect the Prescription Monitoring Program and its database. Many of the new laws and regulations concern a provider’s duty to query the PMP database to identify the covered substances prescribed to a patient. These query requirements have rapidly changed in the last few years, with the most specific changes appearing in the Board of Medicine’s emergency regulations that became effective two months ago.1 With this background, a close review of these shifting requirements is warranted.
Until July 1, 2016, Virginia providers were required to query the PMP database when initiating a new course of treatment that included a benzodiazepine or opiate and that was anticipated to last more than ninety consecutive days. Currently, the duty to query is triggered when the prescriber initiates a course of treatment with opioids that will last more than fourteen consecutive days. Prescribers no longer have a duty to query the database when initiating treatment with benzodiazepines.2
Legislation effective on July 1, 2016, exempts prescribers from the duty to query the database in six situations. The duty to query does not apply when (i) an opioid is prescribed for a current hospice or palliative care patient, (ii) a non-refillable opioid prescription is given to a patient as part of treatment for a surgical procedure, (iii) an opioid is prescribed during an inpatient hospitalization or at discharge, (iv) an opioid is prescribed to a patient in a nursing home or assisted living facility that uses a “sole source pharmacy,” (v) the database is not operational or available because of natural disaster or temporary technological or electrical failure, or (vi) an emergency or disaster precludes the prescriber from accessing the database, and the prescriber documents these circumstances in the medical record.3
New and Pending Requirements
Under 2017 legislation and regulations, prescribers must query the database when initiating treatment that includes an opioid prescription expected to last more than seven consecutive days.4 This statutory requirement will not go into effect until July 1, 2017, but the March 15, 2017, effective date of the emergency regulations should encourage prescribers to integrate this requirement in their practice now. The emergency regulations impose an additional query requirement. Prescribers are now required to query the database at least every three months after starting treatment of chronic pain with an opioid prescription.5
Most of the exemptions from the mandatory query requirement remain intact despite the 2017 statutes and regulations. However, the 2017 statutory and regulatory scheme alters the surgical treatment exemption. Starting in July 2017, a prescriber will not be required to query the database when giving an opioid prescription as part of treatment for a surgical procedure, so long as the prescription will not last more than fourteen days. Whether the prescription is refillable is no longer a consideration. If the prescription will last for longer than 14 days following surgery, then the database must be queried.6
Burden on Prescribers
To offset the burdens imposed by the newer query requirements, the General Assembly has extended the class of individuals to whom prescribers may delegate authority to access the PMP database. Since July 1, 2016, prescribers have been permitted to delegate authority to two groups of individuals who are employed or engaged at the same facility as the prescriber and are under the prescriber’s direct supervision. The first group is comprised of licensed, registered, or certified health care professionals. The second group consists of individuals who “have routine access to confidential patient data, and have signed a patient data confidentiality agreement.”7 The licensure requirement does not apply to the second group.
Under the new statutes, querying prescribers have access to more current information and may more confidently document the information obtained. Dispensers must now transmit reports of dispensed opioids within 24 hours or by the next business day, whichever comes later.8 Prescribers are now permitted to place the information obtained from the PMP database in the patient’s medical record—an option not available until Jan. 1, 2017.9
With only a few months between the effective dates of the emergency regulations and the 2017 legislation, prescribers will likely find it more effective to adjust their prescribing practices to meet both the existing and pending query requirements. The Board of Medicine’s decision to make the regulations effective one month after they were adopted and two days after the governor signed them should be a clear message to providers that the time for compliance is now. Consequently, prescribers should expeditiously review their prescribing practices and quickly work to ensure their treatment meets the new requirements.
Brandy Burnette Balding practices law with Hancock Daniel Johnson & Nagle at its Kingsport, Tennessee, office.
1 The regulations apply to physician assistants and doctors of medicine, osteopathic medicine, and podiatry. 18 VAC 85-21-10. Nurse practitioners are now subject to similar emergency regulations that became effective May 8, 2017. 18 VAC 90-30-220.
2 Virginia Code § 54.1-2522.1. This statute will expire on July 1, 2022, absent further action.
3 Virginia Code § 54.1-2522.1.
4 2017 Va. Acts 249; 2017 Va. Acts 252.
5 See 18 VAC 85-21-30; 18 VAC 85-21-100; 18 VAC 90-40-220. Notably, the regulations align the query requirements with limits on the number of days for which opioids may be prescribed. Opioid prescriptions for acute pain cannot exceed a seven-day supply, unless extenuating circumstances exist and the prescriber clearly documents the circumstances in the medical record. 18 VAC 85-21-40; 18 VAC 90-40-160.
6 2017 Va. Acts 249; 2017 Va. Acts 252. The new Board regulations also address opioid prescriptions as part of treatment for a surgical procedure. Any such prescriptions must be limited to fourteen consecutive days within the immediate perioperative period, unless extenuating circumstances exist and the prescriber clearly documents the circumstances in the medical record. 18 VAC 85-21-40; 18 VAC 90-40-160.
7 Virginia Code § 54.1-2523.2. This statute will expire on July 1, 2019, absent further action.
8 Virginia Code § 54.1-2521.
9 Virginia Code § 54.1-2525.