The prescribing provisions that impact physicians and other licensed prescribers were part of a larger eleven-bill legislative package. As a result, there are multiple effective dates and some provisions have already taken effect. However, the major issues impacting prescribing are set to become effective later this year. Below are the key effective dates for which prescribers need to be aware:
- March 31, 2018 – must have a bona fide prescriber-patient relationship prior to prescribing controlled substances and a mechanism for following-up directly with the patient or by referral.
- June 1, 2018 – mandatory Michigan Automated Prescription System (MAPS) check if prescribing controlled substances in a quantity that exceeds a 3 day supply.
- July 1, 2018 – cannot prescribe more than a 7-day supply of an opioid within a 7-day period if treating a patient for acute pain.
No. The law does not require all physicians to register for MAPS. Only those prescribing or dispensing controlled substance on or after June 1, 2018, will have to be registered with MAPS in order to be in compliance with the law. This requirement applies even if the scheduled drug is not an opioid.
For registration to PMP AWARxE, please visit https://michigan.pmpaware.net/login and click on “Create Account.” You will need to know your email and what password you want to use, as well as your Controlled Substance ID, DEA Number, Professional Licensee Number, and National Provider Identifier (NPI). The Michigan Department of Licensing and Regulatory Affairs (LARA) also has a MAPS webpage.
Please note, your Controlled Substance License is issued by the state of Michigan and is not the same as your DEA Number. If you don’t number your CS ID, you can find it on the state’s “Verify a License” webpage by typing in your name and selecting "Pharmacy" as your occupation. Your name and ID should appear.
View MSMS's registration tip sheet>>
Additionally, MSMS has a free webinar available by visiting https://www.MSMS.org/Education/On-Demand-Webinars (click Pain and Symptom Management for all related courses including MAPS registration) for anyone interested in learning more about the updated MAPS and how to register.
Possibly. Effective June 1, 2018, before prescribing or dispensing any controlled substance, the licensed prescriber must be registered with MAPS. This requirement applies even if the scheduled drug is not an opioid. Controlled substances include a wide range of medications, not just opioids.
You only need to register for MAPS if you will be prescribing a controlled substances. There is no cost to register for MAPS so, you may want to consider registering should you find yourself in a position where you need to prescribe such medication (e.g., taking on a locum tenens position).
According to the Michigan Department of Licensing and Regulatory Affairs, medical residents are allowed to have their own MAPS accounts under the role of “medical resident.”
The legislation doesn’t provide specifics as to how it will be enforced. However, should there be a suspected violation of the Public Health Code and an allegation made, the law already provides the Department with the ability to investigate allegations.
Therefore, prescribers will either need software that can provide an audit trail (which the Department is making available via the NarxCare risk tool when facilities and/or practices integrate their electronic health records with MAPS) or they will need to ensure that their MAPS reports are filed in the appropriate patients’ medical records. Additionally, MSMS Legal Counsel recommends placing a copy of the MAPS report in the patient’s medical record as a recommended best practice should one need to prove this step was taken during litigation. If the prescribing physician did not pull the report from MAPS he/she should indicate on the report that it was reviewed, the date and the notation should be initialed.
The law does not provide this type of timing requirement. The best practice would be to obtain the MAPS report soon before the prescription is written to make sure the prescriber is aware of all the information (within the previous 24 hours should be reasonable). If an appointment is rescheduled the MAPS report should be obtained a second time.
Beginning June 1, 2018 the law requires that a prescriber of controlled substances "obtain and review" a MAPS report. The law does not prohibit a prescribing physician's delegate from pulling a report for him/her. The best practice is for the prescribing physician to indicate on the report (which should be kept in the medical record) the date that it was reviewed and to initial.
No. The legislation ties the mandatory MAPs check to the prescribing or dispensing of controlled substances.
Beginning June 1, 2018, a MAPS report must be pulled prior to prescribing or dispensing any Schedule 2-5 controlled substance (regardless of whether it is an opioid) that is written for more than a 3-day supply. The mandatory check does not apply if the drug is dispensed AND administered in a hospital or free-standing surgical outpatient facility.
Physicians and other prescribers prescribing controlled substances must be registered with MAPS to continue that prescribing on and after June 1, 2018. Also, beginning March 31, 2018, there must be a “bona fide prescriber-patient relationship” in order to prescribe a controlled substance.
The law does not address this situation nor does it provide an exception from the requirement that a prescriber obtain and review a MAPS report applicable when MAPS is down or a prescriber does not have access to the internet.
There are two instances in which written informed consent is required effective June 1, 2018. In both instances, the consent forms are required to be included in the patient’s medical record.
- “Before issuing for a minor the first prescription in a single course of treatment for a controlled substance containing an opioid, regardless of whether the prescriber modifies the dosage during the course of treatment.” A “Start Talking Consent Form” is required to be signed acknowledging the receipt and discussion of specified information.
- Before a controlled substance that is an opioid is prescribed to a patient. Patients need to sign a form that is to be “prescribed” by the Michigan Department of Health and Human Services acknowledging that he/she received information regarding the danger of opioid addiction, how to properly dispose of unused controlled substances, the fact that the delivery of a controlled substance is a felony under MI law, and the short- and long-term effects of exposing a fetus to a controlled substance (if the patient is pregnant or a female of reproductive age).
Yes, to both questions, based on the current language in the legislation that was passed. If the legislation is changed or contrary guidance is issued MSMS will communicate that information to members.
If the narcotic is dispensed and administered in a hospital or freestanding surgical outpatient facility the requirement that a MAPS report be obtained and reviewed does not apply. Once the patient leaves the hospital or freestanding surgical outpatient facility or if the narcotic is dispensed but not administered prior to the patient leaving then all requirements (pulling a MAPS report, consent etc.) must be complied with by the prescriber.
The law requires that following your providing the information on the dangers of opioids to a patient you must obtain the patients signature on a form (prescribed by the Michigan Department of Health and Human Services) indication that the patient received the information. This signed form is to be included in the patient’s medical record.
These forms are not currently available. However, MSMS Legal Counsel is creating templates as is the Michigan Department of Health and Human Services. According to the Michigan Department of Health and Human Services, they are considering merging both the minor consent (“start talking consent form”) and the patient information consent requirements into a single document with a separate line for guardians/parents to sign saying they have received the information if the patient is a minor. MDHHS anticipates this will be available electronically on their website by June 1.
According to the Department of Licensing and Regulatory Affairs Agency’s Bureau of Professional Licensing, a prescriber could potentially delegate the responsibility of obtaining informed consent to another health professional in accordance with existing law (MCL 333.16215).
A “covering physician” must comply with the statute to be considered to be in a “bona fide” prescriber-patient relationship (i.e. reviewed the patient’s records, evaluated, added evidence of this as well as the prescription to the medical record, etc).
Beginning on June 1, 2018 before any prescription of a controlled substance that is an opioid you must both obtain and review a MAPS report and provide the information on the dangers of opioid addiction (and obtain the patients signature on the consent form to be kept in the medical record).
A bona fide prescriber-patient relationship may exist in the absence of an in-person visit. The law provides that the patient's medical evaluation may be done in-person or via telehealth (as described in MCL 333.16283).
Until the law is clarified or authoritative guidance is issued, the best practice would be to do so each time an opioid prescription is given, even a refill.
Only in the case of an emergency or if another exception applies.
In Michigan, the age of majority is 18.
Yes, the state is creating this form. We expect that it will available from the MDHHS website in May 2018. MSMS Legal Counsel is also drafting a sample form that will meet the Act’s requirements.
Beginning July 1, 2018, if prescribing an opioid for “acute pain,” the prescription cannot be written for more than a 7-day supply within a 7-day period. “Acute pain” is defined in the legislation as “pain that is the normal, predicted physiological response to a noxious chemical or a thermal or mechanical stimulus and is typically associated with invasive procedures, trauma, and disease and usually lasts for a limited amount of time.”
Under the new laws, the supply limits only apply to “acute pain.” See definition above. However, prescribers and patients should check with patients’ insurance plans as payers are implementing their own supply limits.
If your prescription will result in the dispensing of more than a 3-day supply you should comply with the requirements of the new law even though it is possible that the patient may not actually take the drug for more than 3 days.
The "bona fide prescriber-patient relationship" must continue to exist. This may require an in person evaluation of the patient.
The law does not carve out situations involving the prescribing of cough and cold medicines containing opioid ingredients. Therefore, they are subject to the same requirements as any Schedule 2-5 controlled substance and any requirement specific to the prescribing of opioids such as informed consent and the 7-day limit for acute pain.
You will have to determine for each drug whether it is listed as a controlled substance on Schedules 2 through 5.
“Opioid drugs” is defined in Michigan Administrative Code Rule 418.10109(i) as “opiate analgesics, narcotic analgesics, or any other Schedule C (II-III) controlled substance as identified in United States Code Controlled Substances Act of 1970, 21. U.S.C. §812. Opioid analgesics are the class of drugs, such as morphine, codeine, and methadone, that have the primary indication for the relief of pain.”
The specific information is not included in the new law. It may be included on the consent form to be developed and provided by the Michigan Department of Health and Human Services or in other clarification of the law or guidance to be issued. The Centers for Disease Control and Prevention website, www.cdc.gov, has excellent information and materials on the use and dangers of opioids.
Only the new requirements applicable to minors contain an exception for a medical emergency. This law defines "Medical Emergency" as a situation that, in the prescriber's good-faith medical judgement, creates an immediate threat of serious risk to the life or physical health of the minor.
Consent forms (mandated) and MAPS reports (recommended) will need to be included in patients’ medical records. Additionally, in order to meet the definition of a bona fide prescriber-patient relationship, the prescriber must review the patient’s relevant records, complete a full assessment of the patient’s medical history and current medical condition, and properly document information about the patient’s condition.
There are always opportunities to enhance one’s knowledge on various topics and opioid stewardship is no exception. Training will be needed on the recently passed legislation, MAPS utilization, safe opioid prescribing, recognizing signs of addiction, best practices for treating and when to refer, MAT, etc.
MSMS currently has available the following on-demand webinars: Pain and Opioid Management, The CDC Guidelines, Treatment of Opioid Dependence, The Role of the Laboratory in Toxicology and Drug Testing, and Michigan Automated Prescription System (MAPS) Update. Additionally, there will be several in-person education sessions available in 2018.
Currently, physicians are required to earn three hours of pain and symptom management CME during their licensure renewal cycle. This requirement took effect in December 2017 and counts toward the overall 150 hours that are required.
The Michigan Board of Medicine has been discussing the possibility of adding a requirement for opioid specific CME.
The way the legislation was written, it assigns most of the responsibilities to licensed prescribers and dispensing prescribers. In a few instances, exceptions are provided based on where the prescribing or dispensing is occurring.
For purposes of the mandatory MAPS check for controlled substances in a quantity that exceeds three days, there is an exception if the dispensing occurs in licensed hospital or freestanding surgical center and is administered to the patient on-site. However, the language does not provide for such an exception when the dispensing and administration occurs in a nursing homes or hospice.
In regards to the informed consent that must be obtained when prescribing an opioid to a minor, one of the exceptions provided is “if the minor’s treatment is rendered in a hospice or oncology department of a hospital or if the prescription is issued at the time of discharge from one of those facilities.”
The informed consent requirements for other patients prescribed opioids applies unless the opioid is prescribed for “inpatient use.”
In regards to the MAPS reporting requirement when dispensing a controlled substance to a patient, nursing homes and hospices, as well as other health facilities and agencies licensed under Article 17 of the Public Health Code, will continue to be exempt from that requirement when the “controlled substance is dispensed by a dispensing prescriber in a quantity adequate to treat the patient for not more than 48 hours.” The exemption for hospitals will no longer include the quantity restriction of 48 hours.