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January 16, 2017


 
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New Opioid Prescribing/PMP Rule Released

There continues to be many questions about the emergency rule published by the state on Jan. 1, 2017.  MMA continues its educational programs on the law and the rule and our attorneys are available to present one, two or three hour CME program which will also count toward the three hours of education on opioid prescribing required by Dec. 31, 2017.The emergency rule can be found through this link.  The educational presentations can be given at your practice, at your medical staff or specialty society.  Many of these presentations are supported by grant funding or state contracts so there is no charge.  MMA has provided over forty such presentations and they are not only beneficial to the attendees but MMA staff also learns a great deal in the give and take regarding the issues that the new law is presenting in the practices.  To arrange a presentation at your location, contact Gail Begin at gbegin@mainemed.com or Gordon Smith at gsmith@mainemed.com.

The rule was promulgated on an emergency basis, meaning that it becomes effective immediately, with a period for public comment which will expire on an unspecified (as yet) date. The "routine technical" parts of the rule are effective for up to 90 days, while the "major substantive" parts are effective for up to 12 months while the Legislature conducts its review. The rule became effective on January 1st.

 Here is a quick summary of the rule's highlights (with primary attention to prescriber requirements):

  1. The rule defines a number of terms, such as acute and chronic pain, benzodiazepine, controlled substance (Schedules II through IV), inpatient status, prescriber and dispenser, and several others. The term "opioid medication" is limited to those opioids in Schedule II, which would mean it does not apply to Tramadol, buprenorphine, some (but not all) forms of codeine, and others. Prescribers are cautioned to check the latest version of the controlled substances list from the US Drug Enforcement Administration (DEA) to determine the Schedule of any particular medication.
  2. Prescribers are required to include the ICD-10 diagnostic code "on the prescription for any opioid which will cause the patient to exceed the 100 Morphine Milligram Equivalent aggregate daily limit." Codes are not required on prescriptions that do not exceed the limits.
  3. If a patient is claiming an exemption from the 100 MME or time limits, prescribers must include the "exemption code" on the prescription. There are 7 such codes: A (active & aftercare cancer treatment, limited to 6 months post remission); B (palliative care in conjunction with a serious illness); C (end-of-life and hospice care); D (medication assisted treatment for substance use disorder, limited to 12 consecutive months); E (pregnant person with a pre-existing opioid prescription in excess of 100 MME, only during the duration of the pregnancy); F (acute pain for a patient with an existing opioid prescription for chronic pain, with conditions); G (person in active taper of opioids, with a 6 month maximum tapering period to below 100 MME).
  4. Opioids must be prescribed electronically beginning July 1, 2017, unless a waiver is obtained from DHHS.
  5. Prescribers must check the PMP as described in the statutory law, PL 2015 c.488 (opioids and benzodiazepines, initially and every 90 days thereafter). In so doing, prescribers must review aggregate MME for the patient (including the anticipated new prescription), the number of prescribers currently prescribing controlled substances (Schedules II, III or IV) to the patient, and the number of pharmacies currently filling controlled substance prescriptions for the individual. The inpatient and long-term care exceptions apply.
  6. The PMP may be checked by the prescriber, any staff member authorized by the prescriber and the PMP, any staff member of a hospital if authorized by the hospital's CMO (for ED or inpatient treatment). The PMP will issue credentials to prescribers and authorized staff members who register as data requesters
  7. Dispensers are required to notify the PMP coordinator and decline to fill a prescription before contacting the prescriber if the patient has a contemporaneous prescription for the same substance from a different prescriber, a contemporaneous prescription being filled for the same substance by a different dispenser, or if filling the prescription would result in exceeding the MME or time limitations. Those conditions are described as "fraudulent or duplicative" prescriptions, which is the statutory requirement. The rule does not address the criteria for filling a prescription after contacting the prescriber.
  8. Licensing boards, MaineCare, and the Chief Medical Examiner's office will have access to PMP data, after meeting certain requirements. Data will also be shared with other states and Canadian provinces. Strict confidentiality rules apply to all PMP information, with criminal sanctions for violations of confidentiality.
  9. De-identified data may be provided to researchers, and aggregate information based on PMP data may be made available to the public.
  10. The PMP information will be reviewed at least quarterly to determine cases of "questionable activity by patients or prescribers." This includes the following information, as determined by the DHHS: "high number" of prescribers in a short period; "high number" of doses in a short period; overlapping "days supply" prescriptions exceeding a few days; "inappropriate combinations" of controlled substances; multiple payment methods within a short time; multiple out-of-state prescribers in a short time; multiple pharmacies on the same day, more than one pharmacy in different public health districts within one month; and "dangerous levels of specific" (but unspecified in the rule) drugs.
  11. Prescribers are immune from liability for disclosing information under these rules, and pharmacists are immune from civil liability for dispensing medication in accordance with a prescription in excess of the limits.

Please note that this summary does not address in detail the requirements for dispensers, whether they be pharmacies, providers or institutions. (There have already been substantial complaints about the burden placed on emergency department personnel by the "dispenser" requirements of the rule.) 

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