September 20, 2017
The Director of the Virginia Department of Health Professions is charged, pursuant to Va Code § 54.1-2520, with establishing, maintaining and administering Virginia’s Prescription Monitoring Program (PMP). The initiation and ongoing operation of the Program was financed through a settlement reached with Purdue Frederick. Ralph Orr serves as Program Director for the PMP.
Reports to the PMP are made by dispensers when covered substances are dispensed. “Dispensers” is a defined term in Va Code § 54.1-2519 that generally applies to outpatient pharmacies, community pharmacies, mail order pharmacies, and physician licensed to dispense locations, such as urgent care centers and offices. “Dispense” is also a defined term and does not include the administration of controlled substances in settings such as inpatient hospitals. The “covered substances” that have to be reported to the PMP is defined to include Schedule II, III and IV drugs as well as all drugs of concern. During the 2017 Session of the Virginia General Assembly, legislation was passed to add Gabapentin[1] (Neurontin) as a drug of concern. This was achieved by passage of House Bill 2164, patroned by Delegate Todd Pillion. The legislation was effective upon signature of the Governor and reporting requirements began on May 31, 2017.
Initially, dispensers were required to report to the PMP within seven business days. During the 2016 Session of the Virginia General Assembly, Chapter 309 was passed, which amended Va Code § 54.1-2521 to require reports by dispensers be made to the PMP within “24 hours of dispensing or the dispensers next business day, whichever comes later.” The Director of the Department of Health Professions is assisted by an advisory panel to give guidance on analysis and reporting that can be obtained through the data submitted to the PMP. On August 28, 2016, the advisory panel approved initial criteria to be used in generating prescriber[2] reports in an effort to identify unusual occurrences or prescriber practices. The criteria included identification of any prescriber or pharmacy with a patient over 2,000 Morphine Milligram Equivalents (MME) or a prescriber or pharmacy with 10 or more patients over 1,000 MME. Analysis run on these criteria resulted in 18 cases being submitted to the enforcement division for investigation. The results of the 18 cases are as follows: three cases were being addressed in other investigations already; one case is in probable cause review, meaning it is being evaluated to determine if disciplinary action will proceed with issuance of a notice; four cases will close with no violation; two cases were closed as being undetermined; and eight cases are under further review regarding specific PMP data.
On September 14, 2017, the PMP advisory panel met again and analyzed the criteria to determine if any changes need to be made. The panel recommended that the PMP identify the top 25 dispensers and prescribers on a quarterly basis. In addition to the initial criteria for August 2016, the panel recommended to add the criteria for the MME to include two identical criteria for both prescribers and dispensers. The two-pronged criteria require the PMP to identify five or more patients who are receiving over 750 MMEs and to identify 25 or more patients with over 500 MMEs.
The PMP recently sent notice to all prescribers, and posted on their respective PMP dashboards, an alert that the next round of prescriber reports will be sent out on the morning of October 5, 2017. Prescribers were also asked to verify information in advance of the release of these reports, including verification of DEA registration number, the healthcare specialty information that they have submitted, and their email address. Of note, a prescriber’s email address is used as the prescriber’s user name in the PMP.
Given the automatic enrollment of prescribers on renewal of their licenses, pursuant to legislation enacted by the General Assembly, the PMP has seen a significant uptick in registered users. At present, physicians total 32,145 registered users in the Program. Nurse Practitioners and Clinical Nurse Specialists total 5,442. Physician Assistants total 2,807.
Of note, the General Assembly passed legislation in 2016 to authorize prescribers or dispensers to delegate the authority to access the PMP to individuals with whom they work. Specifically, Va Code § 54.1-2523.2 authorizes a prescriber or dispenser to delegate to “individuals who are employed or engaged at the same facility and under the direct supervision of the prescriber or dispenser” In addition, one of two requirements must be met. First, the individual must be “licensed, registered, or certified by a health regulatory board under the Department of Health Professions or in another jurisdiction, or have routine access to confidential patient data and have signed a patient data confidentiality agreement.” At present, the PMP has 3,250 delegates who fall in the category of licensed and have 1,289 delegates who are unlicensed. Caution: A delegate must be a registered user of the PMP. A prescriber or dispenser cannot simply provide the user name and password for a delegate to use to access the PMP.
Prescribers and dispensers should take greater advantage of the ability to identify a delegate that can be registered to access patient reports. For example, many physicians are unaware that clerical staff working in their office can be eligible to serve as a delegate, provided they meet the statutory requirements. Hospital and health systems are also encouraged to review their internal policies on who can have access to confidential patient information so that they can maximize the use of delegates for their dispensers and prescribers.
Queries to Virginia’s PMP totaled approximately 5 million in the calendar year 2016. Year to date in 2017, inquiries have reached levels close to 7.5 million. One rationale for the significant increase stems from efforts to have total integration of the PMP into the Electronic Health Records (EHR) of prescribers and dispensers. For example, if a prescriber wants to access the PMP, they must log out of their EHR system, obtain internet access, submit a query to the PMP, search on the dashboard for the necessary information on the patient and when they return to the EHR, they have been timed out and must log in again. Integration enables the ability of an icon to be present in the EHR such that the prescriber can click on the icon, obtain the necessary information on the patient from the PMP and avoid the need to log in and log out.
In 2017, Virginia’s PMP received a $3.1 million grant from PurduePharma to enable Virginia’s PMP to assist in funding integration of PMP and EHRs. Virginia’s PMP is operated on a platform through a contract with Appriss. Appriss has developed technology referred to as NarxCare that will assist in achieving integration. The PMP has already worked with Bayview Physicians, Sentara Health System, Kroger pharmacies and other systems to achieve integration.
Any prescribers or dispensers who are interested in accessing the grant funding are encouraged to submit requests through www.dhp.virginia.gov/dhp_programs/pmp/.
CONCLUSION
It is recommended that all prescribers make sure that they are aware of the resources and information available through the PMP, that their information is current and up-to-date with the program and that they take the time to review the upcoming prescriber reports slated to be released on October 5.
In addition, prescribers and dispensers are encouraged to review their current protocol and practices regarding the use of delegates who are registered to access the PMP information can be a great time saving asset to physicians, nurse practitioners, and physician assistants, as well as other prescribers when providing patient care.
If you have any questions or would like additional information, please contact Scott Johnson.
[1] Many patients are prescribed Gabapentin for a variety of reasons and on its own, the drug has reportedly a low risk of being abused. However, when the drug is combined by patients as a part of opioid misuse, Gabapentin provides a synergistic effect that heightens a “mellow high.” Some substance abuse misusers report that Gabapentin is very effective at controlling their withdrawals from drug or alcohol symptoms. The street name for Gabapentin is “Johnnies.” Finally, the Office of the Chief Medical Examiner reports that toxicology studies on the OCME cases detect the presence of Gabapentin all the time.
[2] A prescriber is defined in Va Code § 54.1-2519 as ” a practitioner licensed in the Commonwealth who is authorized pursuant to §§ 54.1-3303 and 54.1-3408 to issue a prescription for a covered substance or a practitioner licensed in another state to so issue a prescription for a covered substance.”
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.
