1. Rachelle S. Mercier, Esq., MPH November 6, 2015

2. PMP – What is it? A system that records schedule II-V medications that patients have been prescribed and picked up from a pharmacy. Prescription history is available from the past 12 months. The data is provided by all MA pharmacies and any out-of-state pharmacies that delivery to MA. The PMP can help providers to make clinical decisions, avoiding duplicating prescriptions, inappropriate drug- drug interaction, etc. It also can help to identify patients who may be misusing or diverting controlled substances and to offer substance use treatments to appropriate patients.

3. Updates and Changes 2014 Regulatory Changes Automatic Enrollment 2015 – Law and Regulatory Changes DPH RFR

4. 2014 DPH Regulatory Changes Automatic Enrollment All providers are being automatically enrolled in the PMP system when they apply for their MA Controlled Substances Registration (MCSR) or seek renewal. 2013: DPH started enrolling physicians, podiatrists, dentists, and prescribing pharmacists. 2015: APRNs and PAs

5. 2014 DPH Regulatory Changes Requirements for PMP Use Any provider enrolled in the PMP must consult the PMP system prior to issuing a prescription to a patient for the first time: Sched. II or III narcotic drug; Benzodiazepine; or Additional medications (Sched. IV or V) as designated by DPH. Providers may need to consult the PMP each time they issue a prescription for a Sched. II or III medication if: DPH finds the drug to be commonly misused or abused and it needs additional safeguards. **DPH must convene an Advisory Group to develop this guidance and hold a public hearing with public comment before any drug is added to the list.

6. 2014 DPH Regulatory Changes Exceptions to PMP Use Exceptions to checking the PMP allowed under regulations: Practitioners who are only authorized to prescribe, administer, possess, order, or dispense samples of controlled substances in Schedule VI; When providing care to patients who are in a hospice or inpatient facility; Practitioners providing immediate and proper treatment in a single dose or in a dose that is essential for the treatment of the patient, in accordance with M.G.L. c. 94C, § 9(b), that includes the administering of the drug during that treatment; Where emergency care is required and, in the professional opinion of the prescriber, use of the PMP is likely to result in patient harm. Practitioners who treat patients in the emergency department and either (1) do not anticipate writing a prescription Schedules II-V drug during the ED visit, or (2) do not prescribe more than a five-day supply a Schedules II-V drug; Practitioners who are unable to use the system due to operational/system level failures; Practitioners who care for patients under 96 months of age; Where a practitioner has been granted a waiver (pursuant to 105 CMR 700.012(I)); and DPH may define other exceptions in guidance – none yet!

7. 2014 Regulatory Changes Delegates Delegates are allowed! Primary Account Holder may designate support staff to use PMP on their behalf. Must have internal policy on delegate use of PMP Responsible for delegate's proper use of PMP Must update DPH within 1 business day if delegate is no longer authorized To obtain a delegate application, visit DPH’s Website.DPH’s Website. Hospitals eventually will be eligible Primary Account Holders for interns and residents to be delegates of the hospital.

8. FAQ List & Need to Know New Forms: http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug- control/ma-online-prescription-monitoring-program/ http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug- control/ma-online-prescription-monitoring-program/ What is prescribing “for the first time”? When a patient hasn’t been prescribed a Sched. II or III narcotic or benzodiazepine before from the individual prescriber OR from another authorized prescriber belonging to the same practice group within the previous 12 months. Do I need to check the PMP before prescribing take-home medication for an inpatient who has already been ordered that medication during their stay? Yes. Although there is an exception to using the MA Online PMP if you are an inpatient provider, this exception does not apply when the prescriber is providing medication at discharge or for use post-discharge. Under the regulations, a provider would be required to check the MA Online PMP, even if the prescriber provided that medication to the patient per medical orders. According to DPH, medical orders are not the same as a prescription. If you find other scenarios that seem to fall into a gray area, please let me know!

9. 2015 Updates FY16 Budget Language - Section 89 Amends M.G.L. Ch. 94C, §24A: “…(c) For the purposes of monitoring the prescribing and dispensing of all schedule II to V, inclusive, controlled substances and additional drugs, as authorized in subsection (a), the department shall promulgate regulations including, but not limited to, (1) a requirement that each pharmacy that delivers a schedule II to V, inclusive, controlled substance or a substance classified as an additional drug by the department to the ultimate user shall submit to the department, by electronic means, information regarding each prescription dispensed for a drug included under subsection (a); and (2) a requirement that each pharmacy collects and reports, for each prescription dispensed for a drug under subsection (a), a customer identification number and other information associated with the customer identification number, as specified by the department. Each pharmacy shall submit the information in accordance with transmission methods and frequency requirements promulgated by the department; provided, however, that the information shall be submitted at least once every 24 hours7 days…” Hastens reporting for pharmacies to be within 24 hours (formerly 7 days)

10. 2015 Updates DPH proposed regulations: 105 CMR 700.012(A)(5) (5) The information required by 105 CMR 700.012 shall be transmitted to the Department or its agent in accordance with any procedures established by the Commissioner or designee by the end of the next business day and shall include data for all controlled substances dispensed since the previous transmission or report at least once every seven days and no later than ten days after dispensing, or as otherwise specified in guidelines of the Department, by use of encrypted electronic device or electronic transmission method in a format approved by the Commissioner or designee. Public hearing held on 09/18/15 Final language (above) presented to PHC on 10/21/15 Approved by PHC

11. Possible Upcoming Changes… Governor’s Opiate Legislation: HB3817 Among other provisions not related to the PMP: It would require ALL prescribers to use the PMP before prescribing any opiate, amending MGL Ch. 94C, Sec. 24A as follows: “The department shall promulgate rules and regulations relative to the use of the prescription monitoring program by registered participants, which shall include requiring participants to utilize the prescription monitoring program prior to the issuance, to a patient for the first time, of a prescription for a narcotic drug that is contained in schedule II or III. The department may require participants to utilize the prescription monitoring program prior to the issuance, to a patient for the first time, of benzodiazepines or any other schedule IV or V prescription drug, which is commonly abused and may lead to physical or psychological dependence or which causes patients with a history of substance dependence to experience significant addictive symptoms. The regulations shall specify the circumstances under which such narcotics may be prescribed without first utilizing the prescription monitoring program; provided, however, that said regulations shall require every provider to use the prescription monitoring program prior to prescribing an opiate. The regulations may also specify the circumstances under which support staff may use the prescription monitoring program on behalf of a registered participant. When promulgating the rules and regulations, the department shall also require that pharmacists be trained in the use of the prescription monitoring program as part of the continuing education requirements mandated for licensure by the board of registration in pharmacy, under section 24A of chapter 112. The department shall also study the feasibility and value of expanding the prescription monitoring program to include schedule VI prescription drugs.”

12. Possible Upcoming Changes… Senate’s Substance Use Prevention Bill – SB 2022 Among other provisions not related to the PMP: Would include gabapentin in the PMP Use of PMP data for provider prescribing analysis Would require it for any prescription of ER-LA opioid in a non-abuse deterrent form Would establish a non-opiate directive form that would be recorded in EHRs and the PMP

13. Other Updates DPH is in the process of updating the PMP RFR was published this summer DPH is evaluating bids and vendors

14. PMP Information and Troubleshooting DPH Drug Control Program (DCP) and Virtual Gateway (VG) websites: DCP Main Site: http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug-control/http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug-control/ DCP PMP Specific: http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug- control/ma-online-prescription-monitoring-program/http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/drug- control/ma-online-prescription-monitoring-program/ Virtual Gateway: http://www.mass.gov/vghttp://www.mass.gov/vg Credential retrieval/Log-in assistance VG Customer Service: M-F 8:30am-5pm 1-800-421-0983 or 617-847-6578 for TYY www.mass.gov/vg/loginassistance Requires: user pin number (4 digits) and D.O.B. Technical Assistance Drug Control Program – 617-983-6700 Other issues mapmp.dph@state.ma.us PMP Hotline: 617-753-7310 If all else fails… Rachelle Mercier at MHA rmercier@mhalink.org 781-262-6064

15. Thank you! Questions? Rachelle S. Mercier, Esq., MPH rmercier@mhalink.org 781-262-6064