Questions & Answers on Chapter 488, An Act to Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program
1. Given the effective date of the 100 mg MME (morphine milligram equivalent) limit on July 29, 2016, what are the options for patients who are currently receiving a daily dose of opioid medication which exceeds the daily limit?
In addition to the various statutory exceptions for cancer pain, palliative care, end-of-life and hospice care, there is an exception for "medical necessity" until January 2017 so long as the need is documented in the patient's chart. In addition, a patient who had an active prescription for such medication in excess of 100 morphine milligram equivalents per day as of July 29, 2016, may be prescribed up to 300 milligrams until July 1, 2017.
2. Can the "medical necessity" exception be used in a case where a patient is receiving over 300 MME?
That was true until the new rule came out, on January 1, 2017. There is no longer a "medical necessity exception.
3. Does the law impact the prescribing of opioid medication for treatment of substance use disorders, such as suboxone?
No it does not. The law limits prescribing of opioid medication for the management of pain and is not intended to impact opioid medication prescribed for treatment of addiction/substance use disorder.
4. Does the law apply to physicians or other prescribers employed by the Veterans Administration (VA) or to medication picked up at the VA pharmacy?
Because of the supremacy clause of the United State Constitution, federal law takes priority over state law and the VA cannot be regulated by this type of legislation. But the Department of Veterans Affairs has indicated its intent to comply with the objective of the law. VA Providers and those providers whose prescriptions are filled by the VA pharmacy should consult the VA Office of General Counsel if they have any specific questions regarding the applicability of the law to their practice.
5. If a patient lives in Maine but is seen by a prescriber in New Hampshire and any prescription issued by said physician is filled in NH, does any of the Maine law apply?
No. Maine law does not regulate the NH prescriber. An issue may be raised if the NH prescriber also had a Maine license, but that would have to be resolved at the licensing board level. Under a standard conflict of laws analysis, it is unlikely the prescriber seeing the patient in New Hampshire could be disciplined or fined in Maine, even if he or she had a Maine license.
6. Could a patient in Maine see a Maine physician and then take a script in excess of the limits to New Hampshire to be filled?
The patient might be able to get such a script filled in NH but the physician in Maine would be subject to a penalty for violating the law. The law regulates the conduct of the prescriber and the pharmacist, not the patient.
7. When can a prescriber be fined or referred to the licensing boards for violating the law?
Penalties can now be assessed, since the new PMP went online in December 2016.
8. Now that the mandate to check the Prescription Monitoring Program (PMP) has taken effect (on Jan. 1, 2017), must the prescriber check the PMP or can that still be done by a delegate registered under the license of the prescriber?
Delegates can still check on behalf of the prescriber. There was no intent to change that practice in this law. The prescriber is required to review the information checked.
9. How far in advance of writing the script may the PMP check take place?
The law as written does not specify the answer to this question. We anticipate that the rules will establish a reasonable time period, such as 24 or 48 hours before the prescription is written.
10. Who will determine whether the education a prescriber takes will qualify for the three hours of CME required as of Dec. 31, 2017 and every two years thereafter?
The licensing boards governing each category of prescriber have been given this responsibility and each board is expected to amend its rules on education to specify the process for determining whether a course will meet the requirement which simply states that the education must be on the subject of prescribing of opioid medication. We believe that related topics such as how to taper a patient and how to communicate with patients effectively about their pain and treatment options will be included but ultimately, a prescriber should check with his or her licensing board if a question arises regarding a particular course.
11. If a prescriber no longer intends to prescribe opioid medication for pain, does he or she have to take the required three hours of education?
No. The law states that the three hours of education every two years is required as "a condition of prescribing opioid medication". But if the prescriber writes even a single prescription, he or she would be required to take the education within the two-year framework. There is, however, some controversy about this, and as of April 2017 the PMP coordinator seems to be taking the position that anyone who prescribes any controlled substance must obtain the continuing education credits.
12. Can a physician be a delegate of another physician for purposes of the PMP check? How about a pharmacist?
The law does not yet address those questions. We would argue that it is appropriate for one physician, for example a surgeon, to be the delegate of an anesthesiologist. On the other hand, because of the difference between the prescriber role and the dispensing role that a pharmacist exercises, it would make sense that a pharmacist could not be a delegate of a prescribing physician. We believe the redundance of checks by the prescriber and pharmacist is intentional and positive.
13. Different MME calculators give different answers. Which is the appropriate one to use?
The PMP now performs MME conversions. Unfortunately, there is not a calculator that would allow a prescriber to determine what dosage of an intended prescription would stay under the maximum limits. The PMP Coordinator advises using the US CDC calculator for that purpose.
14. Is the Maine Medical Association planning to provide opioid education that meets the statutory requirements?
Yes, we are developing such course material and plan to work with the licensing boards to ensure that it meets the requirements that will be adopted. We already have a one-hour program on the new opioid law that you can have us present to your practice, and our MICIS (Maine Independent Clinical Information Service) program has several half-hour modules on various aspects of opioid prescribing, tapering, and naloxone available.. Because the licensing board criteria have not yet been adopted, we cannot guarantee that these programs as they currently exist will meet the requirements, but the technical expertise is present. The MMA is dedicated to providing board-approved opioid education as soon as the boards set the criteria.
15. Do I have to do a PMP check for a short term benzodiazepine prescription? Even for one day’s worth?
Yes. The PMP check requirement applies to all opioid and benzodiazepine prescriptions and refills, at the outset and every 90 days thereafter. So for the initial prescription, regardless of whether it is for one day or 90 days, a check is required.
16. Is there an exemption from the limits for chronic pain treatment?
No, there are only the exemptions listed in the statute and, for the time being, the “medically necessary” exemption. For chronic pain to be exempted it must fall within one of the other exemptions. When the rules are done, we expect there will be some modifications to the exemptions.
17. Some patients are upset that they will not be able to get the pills they once were getting at the strength they once did. What feedback could you give us about why this part of the law was included? What are doctors saying about it?
When the law was passed, there were over 16,000 patients in Maine who were over 100 morphine milligram equivalents, which the CDC in Atlanta considers a dangerously high dose. Many of these patients can and should be tapered down to a more appropriate dose. There is a lot of medical literature now demonstrating that these mega doses of opioid medication do not even help the patient in the long term and these high doses are impacting the rate of overdose death. In other words, there is more risk than benefit. Based on CDC data, prescribers in Maine prescribed, on a per capita basis, the most extended release opioid medication in the country. Number 1. That is not something to be proud of. Result: one person still dying every day, 1030 babies born annually in withdrawal and 80% of heroin users began with prescription drugs.
18. I have a patient with Limb Girdle Muscular Dystrophy. He is wheelchair bound and has been on chronic pain meds for about 10 years that I have been caring for him. He is well above the 100 mg morphine equivalent. How to I find out more about an exception for him or will I be forced to wean him down which I will do if needed? I don’t think he is palliative at this stage but has significantly severe illness. If there isn’t a decision on patients like this yet when will they be made? How do I navigate this issue?
Here are some thoughts on that issue. Until July 1, 2017, you can prescribe up to 300 MME. After that time, the patient will need to fit into one of the new exemptions being developed by the state DHHS through rule-making. The rules are still going through the legislative approval process, and there are several bills pending in the 128th Legislature that deal with this issue. We know this is not easy for patients or physicians.
19. If we have a hospice patient or cancer patient on opioids (thus there is an exclusion), are we supposed to simply write HOSPICE or CANCER on the actual prescription or how exactly do we get this exception? Is there a form? After we check the PMP on a particular patient, is there a record of that? How does the pharmacist who is dispensing the med know that we have checked the PMP?
The pharmacists will not know whether you checked the PMP and they are not given enforcement authority under the statute. It is the responsibility of the prescriber, or his or her delegate to check it. If it is not done, the prescriber can be fined or referred to the applicable licensing board. You should print out a copy of the report and include it in the patient's record so that you have proof of the fact that you did check if you are challenged, but I would not imagine a pharmacy asking for it. The new rule lists eight exemption codes, one of which you should include on the prescription if an exemption is being claimed.
20. I know that nursing home patients are officially excluded. However, my assisted living patients who lives in the same building (just on a different floor) may also be on opiates, however the RN administers their medications. Thus there is an exclusion for this. Again, how can these patients officially qualify for the exclusion?
If I understand your question, the patient in the assisted living facility is exempt from the limits under the exception for medication directly ordered or administered to a person in...a long-term care facility or a residential care facility.
21. Part of the new law, section 28, says that "opioid medication" refers only to Schedule II opioids. Xodeine and Tramadol are in Schedules III and IV. Are they covered by the limits and the requirement to check the PMP?
The short answer is yes, they are.
The definition of “opioid medication” as including only Schedule II opioids is in the pharmacy section of the statutes. As such, it relates to the interpretation of the laws on electronic prescribing, partial dispensing and pharmacist immunity on the MME limits issue. It does NOT relate to the laws governing prescribers.
The only other definition of opioids in Maine statutes is for the term "Opioid analgesic drug product" meaning “a drug product in the opioid analgesic drug class” not limited to a particular schedule. That definition is in the “Health Plan Improvement Act” in the Maine Insurance Code, Title 24-A.
Because of this analysis, it is our opinion that when the statutes governing prescribers refer to opioids or opioid medication, they include all opioids on any schedule. Thus tramadol and codeine would be included.