Mass. Opioid Legislation Practice Guide

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On March 14, 2016, Gov. Baker signed Chapter 52 - Acts of 2016,  An Act Relative to Substance Use Treatment, Education and Prevention, a comprehensive law addressing the opioid epidemic.

Included in the law are several new legal requirements related to opioid prescribing, many of which are effective immediately. This guidance addresses several key changes to prescribing laws. All of the below requirements are effective immediately and should be incorporated into your clinical practice.

New requirements for outpatient prescribing of all opiates (Schedule II through VI)

  • For adults age 18 or older, first-time opiate prescriptions as described in paragraph (a) should be limited to a seven-day supply, unless one of the following exceptions in paragraph (b) apply:
  • Applicable opiate prescriptions: Until there is further guidance from DPH, this requirement applies to any opiate/opioid that is considered a Schedule II-VI drug. Even prescriptions in Schedule IV or V that have a low potential for abuse are covered (e.g., butorphanol, pentazocine, Talwin, propoxyphene, codeine cough suppressants, hydrocodone cough suppressant, opium preparations of 100 mg).
  • This new requirement does not apply to any prescription designed for the treatment of substance use disorder or opioid dependence (e.g., methadone, buprenorphine, or other such medications used to address withdrawal symptoms as determined by the treating clinician).
  • Providers should document in the medical record each and every time an outpatient opiate prescription is provided to a patient for such treatments to demonstrate (if audited) that the prescription qualifies for this overall exception to the prescribing limits.  (e.g., “this prescription is for the purpose of substance use disorder or opioid dependence treatment”)
  • Exceptions to seven-day supply limit: The statute allows for first time opiate prescriptions of greater than a seven-day supply if any of the following exceptions apply: prescription is for pain related to an acute medical condition, chronic pain management, pain associated with a cancer diagnoses, or palliative care.
  • If a first time opiate prescription is being written for greater than a seven-day supply pursuant to an exception, the prescriber must do the following:
    1. Document in the medical record the specific exception for which the opiate is being prescribed; and
    2. Provide brief information about the actual condition or treatment that necessitates more than seven days; and
    3. Indicate whether there were known and available non-opiate alternatives.

Special provisions for minors

For minors under age 18, every opiate prescription as described the following should be limited to a seven-day supply, unless one of the exceptions below apply:

  • Applicable opiate prescriptions: Until there is further guidance from DPH, it is also important to note that this requirement applies to any opiate/opioid that is considered a Schedule II-VI drug. So even though prescriptions in Schedule IV or V have a low potential for abuse, they would be covered  (e.g., butorphanol, pentazocine, Talwin, propoxyphene, codeine cough suppressants, Hydrocodone cough suppressant, opium preparations of 100 mg).
  • This 7-day limit does not apply to any prescription designed for the treatment of substance use disorder or opioid dependence (e.g., methadone, buprenorphine, or other such medications used to address withdrawal symptoms as determined by the treating clinician).
  • Providers should document in the medical record each and every time an outpatient opiate prescription is provided to a patient for such treatments to demonstrate (if audited) that the prescription qualifies for this overall exception to the prescribing limits.  (e.g., “this prescription is for the purpose of substance use disorder or opioid dependence treatment”)  
  • Exceptions to seven-day supply limit for minors:  The statute allows for opiate prescriptions for minors for greater than a seven day supply if the any of following exceptions apply:  prescription is for pain related to an acute medical condition, chronic pain management, pain associated with a cancer diagnoses, or palliative care
  • If an opiate prescription is being written to a minor for greater than a seven day supply pursuant to an exception, the prescriber must do the following:
    1. Document that the prescription is for either: (1) an acute medical condition, (2) chronic pain management, (3) pain associated with a cancer diagnoses, or (4) palliative care; and
    2. Provide information about the actual condition or treatment that necessitates more than 7 days; and
    3. Indicate whether there were known and available non-opiate alternatives, and
    4. Document that there was a discussion with the parent/guardian of the known risks with the specific prescription and why it is necessary for that condition/treatment.

New requirements for Schedule II opioids

For Schedule II opioid prescriptions, all requirements cited above must be achieved, and there must be documentation in the medical record:

  1. that there was a discussion with the patient of any known risks associated with the specific opioid prescription; and
  2. that you have discussed the amount to be prescribed and the option to fill the prescription in a lesser amount

There must be notation on the actual prescription that that “the patient may fill in an amount not to exceed the recommended full quantity indicated.”

New requirements for extended-release long-acting opioids in non-abuse deterrent form

  1. For any prescription of an extended-release long-acting opioids in non-abuse deterrent form, all requirements cited above must be achieved, and
  2. Note that the prescriber performed an evaluation of the patient’s current condition, known risk factors, history of substance abuse, and current medication usage; and
  3. Note that there was a discussion with the patient about the specific medication being an appropriate course of treatment based on the patient’s current medical condition or treatment

New requirements for long term pain management with extended-release long acting opioids in non-abuse deterrent form

  • For any prescription for long term pain management with extended-release long-acting opioids in non-abuse deterrent form, all requirements cited above must be achieved, and
  • The provider should enter into a pain management treatment agreement with the patient that among other things must also address in the agreement the benefits and risks of abuse/misuse.  This information must also be contained in the patient’s medical record. 
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