April 20, 2016
Hardly a day goes by without a news story reporting a death due to opioid abuse. Opioid abuse is unique in that it does not target a single socio-economic group—affluent families, middle income families, and families in poverty have all been impacted. When it was reported in the Commonwealth in 2014 that the number of deaths related to opioid abuse exceeded the number of deaths related to motor vehicle accidents1, it caught the attention of our Governor, Attorney General, and our legislators.
This attention spurred the introduction of several pieces of legislation in the General Assembly’s 2016 Session that attempted to combat opioid abuse from a number of directions. Two bills focused on the requirement to check the Prescription Monitoring Program (“PMP”) database, which is overseen by the Director of the Department of Health Professions, prior to prescribing certain pain medications. Current law requires prescribers to check the PMP database prior to prescribing a benzodiazepine or opioid that is anticipated to have an onset of treatment of more than ninety (90) consecutive days. House Bill 293, patroned by Delegate Charniele Herring (D, Alexandria), and Senate Bill 513, patroned by Senator Siobhan Dunnavant (R, Henrico), revised Virginia Code Section 54.1-2522.1 regarding the PMP querying requirements. Beginning July 1, 2016, the statute will require prescribers of opioids to query the PMP database if treatment is anticipated to last more than fourteen (14) consecutive days. The statute will no longer require prescribers to check the PMP database when prescribing benzodiazepines. The legislation also contains six exceptions to the PMP querying requirement:
- Patients in hospice or palliative care;
- Prescriptions as part of treatment for surgical or invasive procedures which are not refillable;
- Prescriptions during inpatient hospital admissions or at discharge;
- Prescriptions to a patient in a nursing home or assisted living facility that uses a sole-source pharmacy;
- Situations where the Prescription Monitoring Program database is not operational; and
- Situations where a prescriber is unable to access the PMP database due to an emergency or disaster and documents such emergency or disaster in the patient’s medical record.
Currently, a prescriber or dispenser’s ability to access the PMP database may be delegated only to the health care professionals who are licensed, registered, or certified by a health regulatory board within the Department of Health Professions. The ability to designate, as set forth in Section 54.1-2523.2, was expanded by the legislation to include individuals who have routine access to confidential patient data and have signed a patient data confidentiality agreement. This will greatly enhance the ability of physicians to delegate to office staff or hospital administrative staff who may not be licensed but meet these new requirements.
The changes in this legislation will sunset on July 1, 2019, which means it will cease to be the law unless the sunset is removed or extended by future General Assembly Sessions. It has become more common for the Virginia General Assembly when they impose requirements to put a sunset or ending date on legislation so it can be measured and monitored. With the sunset provision came a requirement that the Director of the Department of Health Professions provide a report to the health committees at the General Assembly so they may determine if these efforts have been successful and, if so, decide whether to continue these requirements.
Testimony at Governor McAuliffe’s and Attorney General Herring’s Task Force on Prescription Drug and Heroin Abuse indicated that there are a number of unusual prescribing and dispensing patterns that would be beneficial to track and act upon. Accordingly, House Bill 657, patroned by Delegate John O’Bannon (R, Henrico), amends Section 55.1-2523.1 which addresses the criteria for “misuse” and authorizes the Director of the PMP to disclose certain information. This legislation will require the Director to develop, in consultation with the Boards of Medicine and Pharmacy, criteria to detect unusual patterns of prescribing or dispensing covered substances by prescribers or dispensers and authorizes such information to be provided to the prescribers or dispensers as well as to the Enforcement Division of the Department of Health Professions. Already permitted in this statute is the ability of the Director of the program to disclose information to the Virginia State Police Drug Diversion Program or chief law enforcement officer in a county, city, town, or campus police department for the purposes of an investigation into issues surrounding drug diversion.
A number of states have tackled the opioid abuse problem by mandating continuing medical education. Currently in Virginia, pharmacists are required to obtain a certain number of hours in continuing education related to opioid abuse pursuant to Section 54.1-3314.1. House Bill 829, patroned by Delegate Chris Stolle (R, Virginia Beach), makes amendments to Section 54.1-2912.1, which directs the Board of Medicine regarding continuing medical education. Specifically, this legislation authorizes the PMP to release to the Board of Medicine certain information on prescribers who meet certain thresholds for prescribing covered substances and has those prescribers undergo continuing medical education. Secondly, it directs the Board of Medicine to require prescribers identified by the Director to complete two hours of continuing education in each biennial year of their licensure related to “pain management, the responsible prescribing of covered substances as defined in § 54.1-2919, and the diagnosis and management of addiction.” Since physician licensure is biennial, this requirement will not trigger for physicians until 2018 when most of them renew their biennial license. Accordingly, the General Assembly sunsetted the provisions of this requirement for July 1, 2022 to enable the Board of Medicine to evaluate the effectiveness of continuing medical education.
In July of each year, the Department of Medical Assistance Services renews contracts with the managed care organizations that provide services to Medicaid enrollees (“Medicaid MCOs”). House Bill 1044, patroned by Delegate Steve Landes (R, Verona), and Senate Bill 491, patroned by Senator Emmett Hanger (R, Mount Solon), permit the PMP to provide access to physicians or pharmacists employed by a Medicaid MCO about a specific recipient or Medicaid enrollee. In particular, the new contracts with the Medicaid MCOs require them to identify enrollees who have been or should be in a patient utilization management safety program. These would be individuals that appear to use a number of different pharmacies, obtain more than a baseline number of prescriptions, or have had a frequent number of emergency room visits. The enrollees will be given notice that the PMP will be checked by their Medicaid MCO as well.
Currently, certain pharmacies are required to report to the PMP database within seven days of a prescription being dispensed. Senate Bill 287, patroned by Senator Jennifer Wexton (D, Leesburg), amends Section 54.1-2521 regarding the reporting requirements. Beginning January 1, 2017, the requirement for a dispenser to report to the PMP database will be within 24 hours or the next business day after the prescription is dispensed. Likewise, it grants access to the PMP information by dispensers who are providing clinical consultation on the care and treatment to the recipient. Current law does not permit a copy of the PMP information to be included in the patient’s medical record. This legislation permits its inclusion.
While not a part of the legislative package addressed in this advisory, it is important to note that the Department of Health Professions recently issued a guidance document on March 8, 2016 addressing requirements for physician assistants and nurse practitioners who prescribe. Specifically, this document provides that prescriptions written by a physician assistant must list the supervising physician on the prescription. Note, there is not a requirement that the supervising physician co-sign the prescription. For prescriptions issued by nurse practitioners involving Schedule II through V drugs, nurse practitioners must list their DEA number or prescription authorization number that has been issued to them by the Joint Boards. For Schedule VI drugs issued pursuant to a practice agreement, nurse practitioners must list the prescription authorization number issued by the Joint Boards, as a DEA number is not required for Schedule VI drugs.
The conclusion of the 2016 Virginia General Assembly Session on March 11, 2016 does not mark the end of efforts to reduce opioid abuse and over-prescribing. It is anticipated that more legislation will be introduced until the problem is adequately addressed. It is certainly the legislature’s intent that the recently passed legislation will give the provider community additional tools that will help stem the tide of opioid addiction.
1 “Drug deaths now outnumber highway fatalities in Virginia,” Bill McKelway, Richmond Times-Dispatch, October 11, 2015.
The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel, Johnson & Nagle, PC, is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel, Johnson & Nagle, PC be liable for any direct, indirect, or consequential damages resulting from the use of this material.