Comments on Proposed Rule RE: Chapter 21, Use of Controlled Substances for Treatment of Pain


Dennis Smith, Esq.
Executive Director
Board of Licensure in Medicine
137 State House Station
Augusta, Maine 04333-0137

sent via e-mail to

Re:  02-373 Ch. 21, Use of Controlled Substances for Treatment of Pain

Proposed rule number:  2017-PO45.PO46, PO 47, PO48

Date:   June 1, 2017


Dear Dennis:

The Maine Medical Association is pleased to provide the following comments on the above referenced Proposed rule.  The Association represents the interests of over 4000 Maine physicians, medical students and residents.  We appreciate the very significant effort that went into getting the five participating licensing boards together on this proposal.  We support the intent of conforming the existing Chapter 21 Rule to the Chapter 488 and its implementing rule adopted by the Department of Human Services.  We also support the intent of taking significant steps to impact on the overprescribing of opioid medication.  However, the are some parts of the proposal which are inconsistent with Chapter 488, as it is likely to be amended in the coming weeks and there are other portions of the proposed rule which we believe create an undue burden on prescribers, particularly in primary care.  By adopting the principle of Universal Precautions and deleting the current language in Chapter 21 which states that the Boards will not take disciplinary action again a clinician for deviating from the rule when contemporaneous medical records document reasonable cause for deviation, the proposed rule removes the critical element of judgment from medical practice in so far as the prescribing of controlled substances for pain is involved.  Our specific comments follow:

Section 1.  Purpose.    We have no objection to the purpose statement but suggest updating the data to include the 2016 overdose statistics (376 deaths representing a 40% increase over 2015).  You might also wish to note the progress that was made in decreasing opioid prescribing from 2013 through 2016.  Data from IMS shows a 21.5% reduction in the number of opioid prescriptions written in the state which was the 4th greatest drop of the 50 states (all states saw a reduction). 

We are also concerned with the language in the next to last paragraph of Section 1 which obligates clinicians to offer or arrange evidence-based treatment for patients with opioid use disorder.  In some parts of the sstate, there are no treatment options available.  We do not believe this obligation can be put on clinicians without there being a state program making treatment resources available in all parts of the state.

In the last paragraph of Section 1 reference is made to Board evaluation of allegations of inappropriate prescribing and we repeat our concern expressed above that there is no recognition of the occasional need to deviate from a standard of practice based upon the unique needs of a patient.  The appropriateness of deviation should be acknowledged so long as documention is in the record of the reason for the deviation.

SECTION 2.  Definitions

Item 16 defining palliative care and item 17  defining serious illness should be amended to conform to the language approved by the committee of jurisdiction in the Legislature this past week.  We expect the bills to pass with an emergency preamble so hopefully the timing of the changes will not hold up the adoption of this Rule.

Our only other comment on the definitions relates to the definition of Controlled Substances (7).  We don't object to the definition but we do oppose the use of this term in several sections of the document instead of limiting the application of the Rule to opioid medication as Chapter 488 does.  There are several places in the draft where by using the term Controlled Substances the impact of the Rule is broadened significantly from the reach of Chapter 488.  And this broader reach would impose a very significant administrative burden on primary care physicians and other prescribers.  As the intent behind Chapter 488 is to limit prescribing of opioid medication for pain, we do not see how the inclusion of all controlled substances is furthering that goal.

SECTION 3.  Principles of Proper Pain Management

2.  Universal Precautions.

While universal precautions is an appropriate aspirational goal, it is neither appropriate not medically sound to mandate a series of precautionary steps on every patient prescribed opioid medication for pain without preserving some discretion and judgment on the part of the prescriber based upon the unique needs of the patient.  While we understand that utilizing guidelines would likely not meet the goal of impacting on practice, at least noting that occasionally it may not be necessary to perform all of the elements of an evaluation and risk assessment should be added.   A good example may be a patient arriving in an emergency department with an obvious fracture.  It may not be an appropriate use of scarce resources to consider all 11 elements in the comprehensive risk assessment included in this Section.  The overly broad scope of this requirement is also demonstrated by the use of the term controlled substances rather than limiting its application to opioids prescribed for pain.

B.  Treatment with Controlled Substances

We again note the problem associated with inconsistent use of the terms controlled substances and opioids.  The title of B referes to Controlled Substances.  But the substantive provisions appear limited to opioids.  Clarification is needed, but we would hope the clarification would involve limiting these requirements to opioid medication.

(2) Initiating or Continuing Prior Opioid Therapy

We believe that (d) (ii) could be deleted as your effective date would likely be after the July 1, 2017 date.

(e) Exceptions to Dosage Limits

(i) Regarding the exception for active cancer or cancer treatment, the limitation to six months for aftercare has been eliminated from the HHS Final Rule so this limitation should not appear in this rule either.

(f)  Prescription Requirements/Restrictions

(ii)  The final HHS rule only retained the ICD 10 provision in cases where the palliative care exception is used.  The same change should be made here as well.

(7)  Discontinuing Opioid Therapy

We are concerned with the obligation regarding managing withdrawal or referring to an addiction specialist.  While this would normally be the case, there are areas in the state where there are no such spacialists so that in a case where the prescriber is not skilled in tapering they may be forced to work outside of their appropriate scope.

C.  Informed Consent

While the requirement of a written signed consent form when prescribing any controlled substance (should be limited to opioids) is reasonable in most cases, there are occasional instances where the written form may not be possible so there should be an opportunity to document a necessary deviation from the requirement.

E.  Treatment Agreement

We repeat the comments made in C. above.  In other words, there should be recognition in the rule that these agreements are not appropriate in every single instance.

F.  Urine Drug Screens and Random Pill Counts.

Again, in most instances, these requirements should be met, but there should be room for exceptions.

SECTION 4.  Continuing Medical Education (CME)

We note that of the five boards proposing the joint rule, apparently only BOLIM has chosen to broaden the statutory requirement to apply to all licensees rather than just those licensees who continue to prescribe opioid medication.  We would be interested in knowing the rationale for requiring the three hours of all MDs but not all DOs.

We appreciate the opportunity to make these comments and again express our thanks to all board members and staff for their diligent effort in preparing the new rule following passage of Chapter 488.

Gordon Smith, Esq.
Executive Vice President
Maine Medical Association