Chapter 11 Rule Comments
Feb. 13, 2017
242 State St.
11 State House Station
Augusta, Maine 04333-0011
Re: 14-118 C.M.R. Chapter 11 - Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications
It is my pleasure to offer the following comments on the Chapter 11 rules on behalf of the Maine Medical Association (MMA). MMA represents and advocates for the interests of over 4000 Maine physicians, medical students and residents and fellows in training. The Association supported the amended version of Chapter 488 and was pleased to participate in the working group that assisted the Department in developing the rule. We have also spent a considerable amount of time and effort since Chapter 488 was signed into law last April educating prescribers, dispensers and patients about the law and since Jan. 1 the emergency rule. These comments are partly informed by the feedback we have received from our members at over fifty (50) CME presentations on the law, the rule and their impact. We have also talked with many patients who are currently on pain medication in excess of the maximum dose established in the law. Keeping in mind how difficult it is to perfectly balance the needs of patients in pain and the need to prevent diversion and addiction, we offer the following comments on the rules which we believe, for the most part, are consistent with the statute. But we will highlight those areas where we believe the rules go beyond the statute or are inconsistent with it.
MMA wishes to also thank the Department for the grace period for enforcement provided to prescribers announced back in December. This additional period to bring practices into compliance with the law has been very much appreciated.
In preparing these comments, we have consulted with the major health systems in the state, the Maine Hospital Association and several medical specialty societies including the Maine Academy of Family Physicians, the Maine Chapter of the American College of Emergency Physicians and the Maine Chapter of the American College of Surgeons. We believe these comments to be consistent with the views of these organizations although you will undoubtedly hear from many of these organizations directly.
SECTION 3. Definitions
1. Dispenser. By including health professionals other than pharmacists in the definition of "Dispenser", the rule imposes on emergency physicians and others the obligations of pharmacists detailed in SECTION 5, Prescription Monitoring Program Requirements. Most specifically, Section 5 C. 1 requires a dispenser to electronically furnish fifteen (15) different data elements to the PMP within the next business day of dispensing even a single opioid pill. Many of these data elements an emergency physician or other clinician dispensing a small amount of medication would not have access to. Nor do we believe that a clinician dispensing under these circumstances can obtain an NCPDP number as required in section 4(B)(1). These requirements appear to apply even if a single opioid pill is dispensed in the emergency department. We hope this is not the intent and we believe the requirement to be inconsistent with the intent of Chapter 488. We request that you amend the rule by removing from the definition of "Dispenser" the reference to, or a licensed health care professional with authority to dispense or administer prescription drugs.
16. Inpatient Status. We agree with the comments of the Maine Hospital Association that this definition of inpatient status is confusing, unnecessary and inconsistent with Chapter 488 which uses the term "inpatient setting" (32MRSA section 2210(2)(B)). It should be deleted. However, it may be useful to add a definition of surgical procedure and then include an exception to the prescribing limits when a patient, whether an inpatient or outpatient, undergoes surgery. We have become aware of a significant problem/omission in the law in that patients undergoing outpatient surgery in a day surgery unit of a hospital or in a state licensed ambulatory surgical center (ASC) are provided medication for anesthesia in connection with the surgical procedure that is in excess of the maximum dose, or may be in excess of the maximum does (100 MME) when combined with medication the patient may already be on for a chronic condition. The easiest way to fix this problem appears to be to expand the exemption for hospital inpatients to include any individual undergoing a surgical procedure. The definition of surgical procedure needs to be broad enough to include colonoscopies and other invasive procedures which require sedation or other anesthesia. It certainly was not the intent of the law to impair the ability of surgeons and anesthesiologists to effectively sedate or anesthetize patients undergoing surgery or an invasive procedure.
Section 4. General Requirements
Section 4. A. 3 a. i. requires all prescribers to include the diagnosis code on the prescription for any opioid which will cause the patient to exceed the 100 MME aggregate daily limit. This requirement is not called for in Chapter 488, was never even hinted at during the considerable negotiations and discussions leading up to its enactment and is both onerous and impractical. There are over 60,000 diagnosis codes within ICD-10 and prescribers would rarely be aware of the appropriate code to go with the script. Coding is done by coders, not by clinicians and even if prescribers were educated and trained in the codes for their specialty, they would at least occasionally be prescribing from a location where it would not be possible to access the applicable code. If this requirement stands, it will be a considerable hardship for patients who will be undoubtedly delayed in their ability to get the script. We do not see any benefit from including the information on scripts exceeding the limit and there is considerable downside as noted above. We recommend that the requirement simply be deleted from the rule.
Having noted the problem with the ICD-10 codes, we wish to comment positively on the inclusion of the Exemption Codes listed in Section 4 (4.A.3.b). These seven codes can be easily learned and implemented. By using the codes as opposed to listing the exception, patient privacy is protected which we place a high value on. We do note, however, that the rule attempts to limit the statutory exemptions for cancer pain and medication-assisted therapy to six months and twelve months respectively. We do not believe these limitations are within the legal authority of the HHS to limit (the rule cannot take away what the legislature has granted to patients eligible for these exceptions) and even if the durational limits were legal, we find no justification for them. In fact, the time periods stated are not consistent with clinical practice. For instance, MMA staff was involved with a patient just this past week who was still suffering the after effects of very significant radiation therapy undergone fourteen (14) years ago. We understand that the Department has already announced its intended removal of the 12 month limitation for MAT. We hope you will take the same action with respect to the exception for cancer pain and its after effects. I believe that this request to eliminate the six month limitation for cancer is joined in by the American Cancer Society Cancer Action Network, Inc.
While we appreciate the three additional exemptions the rule adds to the four exemptions established in the law (Section 6.B), we believe that consideration needs to be given to an additional exemption that was discussed in the stakeholders group but did not make it into the emergency rule. This exemption is needed for those individuals who have tried to taper an opioid medication to get below the 100 MME in the law but have "failed" in the attempt and have suffered an objective decline in function as a result. This exemption should be allowed where the prescriber documents the functional decline, failed or inappropriate trials of alternative treatments, appropriate compliance with opioid risk assessment measures including the obtaining of an appropriate substance use disorder history, use of an appropriate consent for treatment or "contract" and appropriate surveillance for evidence of aberrant opioid use behaviors including random urine screens and pills counts (all consistent with Chapter 21 rules of the licensing boards, now under review for compliance with Chapter 488 and the rule). Stephen Hull, M.D., a physiatrist who participated in the stakeholders group, has provided similar comments. Dr. Hull notes in his comments that the exemption is not strictly evidence-based, because of the clinical studies and resulting literature supporting a conclusion that there is little to no evidence that the benefits of chronic opioid use exceeds the risks. But he goes on to suggest that, "the valuation of benefits and risks is an individual judgment that, in my opinion should result from an analysis left to the patient and prescriber." MMA strongly agrees with this conclusion. Dr. Hull also notes that even in the best withdrawal studies, the success of discontinuing opioids, while approaching 90%, is not universal. Extrapolating this percentage to the 16,000 patients who in March, 2016 were receiving opioid medication in excess of the 100 MME limit, as many as 1600 patients may not successfully taper. Even if we remove from the number those patients who may be subject to another exemption, certainly hundreds of patients would still be within the group we would expect to fail an attempted taper.
After July 1, 2017 when the exemption is lost for those patients who were already above 100 MME when the law took effect on July 29, 2016, the only current exemption that might be available to such patients is the palliative care exception. But because the palliative care exemption is limited to cases of serious illness (as defined in 22 MRSA section 1726(1)), it is simply not appropriate for most of these patients. We believe that a new exemption for a failed taper is the preferred approach. If the Department is concerned that such an exemption is too broad, you could consider an upper limit on the dosage and also consider Dr. Hull's suggestion that patients in this category be on a dose below 100 MME for at least 2 months with the provision of alternative treatments, including, where available, cognitive behavioral therapy, before becoming eligible for the exemption. Another condition might be a second opinion or required consultation, but this condition would need to be structured in a way that recognized the limited number of pain specialists in the state.
We also endorse the suggestion by Dr. Hull that exemption code G be subject to a "hold" for up to six months in the circumstance in which a critical medical issue such as the need for mental health care (severe depression or suicidality occurring during and very likely resulting from the taper), or when the question of substance use disorder is raised in the process of a taper and resources for mental health or substance use disorder treatment are not readily available.
Section 5. Prescription Monitoring Program
I note my comments earlier regarding the expansive definition of the term "dispenser" in this section of the rule. In addition, there are a number of additional comments to make regarding Section 5.
2. Exceptions. While the exemptions in 22 MRSA section 7253(3) are noted, it was the intent of the drafters of chapter 488 that the exceptions for cancer, hospice care, end of life care and palliative care also be exempt from the requirement to check the PMP. I have attached to these comments a memo shared with the Joint Standing Committee on Health and Human Services during consideration of L.D. 1646 which resulted in Chapter 488. The memo substantiates the intent of the drafters and the rule could grant this exemption. If not, there is an L.D. pending before the legislature which also would accomplish this. During the past few months, we have had substantial opportunity to consider this specific issue and it is now our opinion that the exemption still should apply to cancer, hospice and end of life care, but that prescribers using the palliative care exemption to maintain a dose of opioid medication greater than the aggregate limit should still be checking the PMP.
We also believe that the Department should consider a limited exception for benzodiazepine prescriptions to the requirement in the statute for PMP checks every 90 days. Given that the statute is primarily focused on opioid medication, loosening up the requirements for benzodiazepine medication should be considered.
3. Dispenser Requirements. Subsection 3.a.4 requires a dispenser to notify the PMP coordinator and decline to fill a prescription until the dispenser is able to contact the prescriber if the dispenser has reason to believe that the prescription is fraudulent or duplicative. The language then goes on to state that the prescription will be considered fraudulent or duplicative if filling the script would result in exceeding the MME limit or durational limit (7 days for acute and 30 days for chronic). MMA strongly opposes this requirement, seeing no benefit to having this information sent to the PMP office when a call to the prescriber would in most cases clear up any issue. It may be that the prescriber simply forgot to include an exemption code or to write chronic pain on the script. To label this conduct as fraud is damaging to one's reputation, is unnecessary and harmful to the goodwill of the healthcare community which is important to successful implementation of the law and rule.
MMA wishes to endorse two recommendations made by EMHS and perhaps others. With respect to dispenser requirements in Section 4.B, we agree that dispensers should be able to provide a patient with an early refill of their prescription without fear that they are violating the law limiting the duration of opioid medication for pain to seven days for acute pain and thirty days for chronic pain. These early refills should be limited to acts of nature (snow storms, hurricanes, etc.) or personal circumstances (elderly patient loses some of the medication). To eliminate the possibility of diversion, early refills should be an occasional event and not a pattern for the particular patient. It is possible that a limit should be established for this early refill, i.e., no earlier than five days prior to refill date.
We also endorse the proposal by EMHS that the rule provide for the establishment of an advisory committee that could make recommendations for additional exceptions to DHHS and the Legislature. This group should be made up of pain specialists, physiatrists, palliative care specialists, primary care physicians, surgeons and pharmacists. Clinicians prescribing for pain such as nurse practitioners and physician assistants should also be represented.
Finally, I would not want our failure to mention the July 1, 2017 mandate for electronic prescribing of all opioid scripts to be interpreted as a continuing endorsement of this aggressive timeline. The announcement by the Department to have a waiver application process in place by April 1 is helpful but puts many prescribers and healthcare institutions in a difficult position now as purchasing decisions have to be made sufficiently in advance of July 1 to implement the requirement. MMA believes that if the Department cannot have a waiver application ready before April 1, the July 1 deadline should be pushed off until Jan.1, 2018. This timeline also will give the legislature an opportunity to consider necessary amendments to the statutory language such as an exemption in the case of a power failure, a circumstance that we are not unfamiliar with here in Maine.
Thank you for the opportunity to present these comments. We appreciate the hard work that has gone into the emergency rule and stand willing to assist the Department in any way as the implementation of Chapter 488 continues.
Gordon Smith, Esq.
Executive Vice President
Maine Medical Association