Numerous Michigan House and Senate bills affecting the prescribing of controlled substances were enacted into law in late 2017.
Many of the new laws incorporate recommendations from Michigan’s October 2015 Prescription Drug & Opioid Abuse Task Force report to combat prescription drug and opioid abuse in Michigan. These laws have effective dates ranging from March 27, 2018 to July 1, 2018. These newly enacted provisions are in addition to existing federal and Michigan laws and rules regulating the prescribing, administration and dispensing of controlled substances by Michigan physicians and other licensed prescribers. For example, the Public Health Code (the “Code”) presently provides that before prescribing or dispensing a controlled substance to a patient, a licensed prescriber shall ask the patient about other controlled substances the patient may be using. The Code states that the prescriber shall record the patient’s response in the patient’s medical or clinical record. Except as may be noted otherwise, this article does not address existing laws and rules.
Michigan physicians need to be aware of these new requirements, because they are conditions of licensed practice by all licensed prescribers. A failure to comply, among other potential consequences, a may result in a licensing disciplinary action, even if the legislation does not specify an express sanction for a violation of one of the newly enacted provisions.
Important new provisions include the express requirement for the existence of a bona fide prescriber-patient relationship before prescribing controlled substances for the patient, as well as the prescriber’s obligation to furnish or refer the patient for follow-up care.
Physicians also need to know that beginning June 1, 2018, a new “start talking consent form” will be needed for use with minors who are prescribed a controlled substance containing an opioid, subject to certain exceptions. The legislation does not require the Michigan Department of Licensing and Regulatory Affairs (“LARA”) to develop and publish that form, thereby placing the burden on individual physicians or their professional associations to develop compliant forms. The legislation additionally requires that beginning on June 1, 2018, prescribers must make certain disclosures to all patients before prescribing a controlled substance that is an opioid, other than for inpatient use, and that prescribers are required to obtain the signature of the patient or the patient’s representative on a form to be published by LARA.
Physicians will need to keep a look out for new administrative rules that LARA may publish, due to the legislation.
Patient’s MAPS Report, Bona Fide Prescriber-Patient Relationship and Follow-Up Care
Public Acts 248 and 249 of 2017 require that beginning June 1, 2018, a licensed prescriber must obtain and review a patient’s Michigan Automated Prescription System (“MAPS”) report before prescribing more than a 3-day supply of a Schedule 2 through 5 controlled substance to the patient. This requirement does not apply under any of the following circumstances:
- If the dispensing occurs in a licensed hospital or freestanding surgical outpatient facility and the controlled substance is administered to the patient in that hospital or facility.
- If the dispensing occurs in a veterinary hospital or clinic and the controlled substance is administered to an animal in that hospital or clinic.
- If the controlled substance is prescribed by a licensed prescriber who is a veterinarian and the controlled substance will be dispensed by a pharmacist.
Beginning June 1, 2018, licensed prescribers must register with the MAPS system before prescribing or dispensing a controlled substance to a patient.
Public Acts 247 and 249 of 2017 provide that beginning March 31, 2018, a licensed provider shall not prescribe a controlled substance listed in Schedules 2 to 5, unless the prescriber is in a bona fide prescriber-patient relationship with the patient for whom the controlled substance is being prescribed, except as may be provided otherwise in administrative rules (which so far have not been promulgated). The legislation defines a “bona fide prescriber-patient relationship” as a treatment or counseling relationship between a prescriber and a patient in which both of the following are present: (1) the prescriber has reviewed the patient’s relevant medical or clinical records and completed a full assessment of the patient’s medical history and current medical condition, including a relevant medical evaluation of the patient conducted in person or via telehealth; and (2) the prescriber has created and maintained records of the patient’s condition in accordance with medically accepted standards.
Not later than the end of December, 2018, LARA, in consultation with the Michigan Board of Medicine, the Michigan Board of Osteopathic Medicine and Surgery, the Michigan Board of Dentistry, the Michigan Board of Podiatric Medicine and Surgery, the Michigan Board of Optometry, the Michigan Task Force on Physician’s Assistants, and the Michigan Board of Nursing may promulgate rules describing the circumstances under which a bona fide prescriber-patient relationship is not required for purposes of prescribing a schedule 2 to 5 controlled substance under the legislation. The rules may include an alternative requirement for prescribing a schedule 2 to 5 controlled substance when a bona fide prescriber-patient relationship is not required.
In addition to the bona fide prescriber-patient relationship requirement, the prescriber must provide or refer the patient to another licensed prescriber for follow-up care. The legislation provides that if a licensed prescriber prescribes a controlled substance, the prescriber shall provide follow-up care to the patient to monitor the efficacy of the use of the controlled substance as a treatment of the patient’s medical condition. If the licensed prescriber is unable to provide follow-up care, the prescriber must refer the patient to the patient’s primary care provider for follow-up care or, if the patient does not have a primary care provider, the prescriber must refer the patient to another licensed prescriber who is geographically accessible to the patient for follow-up care.
Providers who violate the preceding provisions are subject to licensing disciplinary actions. Violations are generally punishable by probation, limitation, denial, fine, suspension, revocation, or permanent revocation. Although violation of the requirements to register with MAPS and to obtain and review a MAPS report before prescribing a controlled substance is also subject to these same sanctions, if LARA has a reasonable basis to believe that a licensee has failed to register or to obtain and review a MAPS report, LARA is not required to investigate and may issue a letter notifying the licensee of the violation. The legislation specifies that such a letter is not considered discipline. The circumstances in and the extent to which LARA may invoke this provision remain to be seen.
Provision of Substance Use Disorder Services Information
Public Act 250 of 2017, effective March 27, 2018, requires a licensee or registrant who treats a patient for an opioid-related overdose to provide information to the patient on substance use disorder services. “Substance use disorder services” means substance use disorder prevention services or substance use disorder treatment and rehabilitation services, or both, as those terms are defined in the Mental Health Code. “Substance use disorder prevention services” are services that are intended to reduce the consequences of substance use disorders in communities by preventing or delaying the onset of substance abuse and that are intended to reduce the progression of substance use disorders in individuals. Substance use disorder prevention is an ordered set of steps that promotes individual, family, and community health; prevents mental and behavioral disorders; supports resilience and recovery; and reinforces treatment principles to prevent relapse. “Substance use disorder treatment and rehabilitation services” means providing identifiable recovery-oriented services including early intervention and crisis intervention counseling services for individuals who are current or former individuals with substance use disorder; referral services for individuals with substance use disorder, their families, and the general public; and planned treatment services, including chemotherapy, counseling, or rehabilitation for individuals physiologically or psychologically dependent upon or abusing alcohol or drugs.
Limiting Prescriptions for Controlled Substances
Public Act 251 of 2017 broadens the grounds on which a pharmacist may fill partially in increments a prescription for a Schedule 2 controlled substance in specified circumstances, beginning on March 27, 2018. Until then and except for a terminally ill patient whose terminal illness the pharmacist documents pursuant to administrative rules, a prescription for a Schedule 2 controlled substance must not be filled more than 90 days after the date on which it was issued. The legislation provides that the 90-day limit applies except as provided below.
Presently, and limited to a terminally ill patient, a prescription for a Schedule 2 controlled substance may be partially filled in increments for not more than 60 days after the date on which the prescription was issued. The legislation permits a pharmacist to partially fill a prescription for a Schedule 2 controlled substance in increments in one of the following circumstances:
- The pharmacist was unable to supply the full quantity prescribed or the patient requested a smaller quantity than what was prescribed, in which case the prescription would have to be filled within 30 days after the date it was issued.
- The prescription was filled upon the oral prescription of a practitioner, in which case it would have to be filled within 72 hours after the first partial filling.
- The prescription was for a terminally ill patient, in which case the prescription would have to be filled within 60 days after the date on which it was issued.
Beginning July 1, 2018, if a prescriber is treating a patient for acute pain, a prescriber shall not prescribe more than a 7-day supply of an opioid within a 7-day period. “Acute pain” means 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.
Consent for Minors and Provision of Information to All Patients Prescribed Opioids
Public Act 246 of 2017 requires a prescriber to discuss certain issues and obtain a signed parental consent form before issuing the first prescription to a minor in a single course of treatment for a controlled substance containing an opioid. The legislation also requires prescribers or health professionals to provide certain information and obtain a signed acknowledgment before prescribing an opioid to any patient. Failure to comply with these requirements are grounds for licensing discipline punishable by probation, limitation, denial, fine, suspension, revocation, or permanent revocation of the prescriber’s license.
Consent and Provision of information concerning minors. Beginning June 1, 2018, subject to specified exceptions, a prescriber must do both of the following:
- Discuss all of the following with a minor and the minor’s parent or guardian, or another adult authorized to consent to the minor’s medical treatment, before issuing to the minor the first prescription in a single course of treatment for a controlled substance containing an opioid, regardless of whether the prescriber modifies the dose during the course of treatment:
- The risks of addiction and overdose associated with the controlled substance.
- The increased risk of addiction to a controlled substance for an individual suffering from both mental and substance abuse disorders.
- The danger of taking a controlled substance containing an opioid with benzodiazepine, alcohol, or another central nervous system depressant.
- Any other information in the patient counseling information section of the label for the controlled substance that is required by federal regulations, which includes information for the patient to take the drug safely and effectively.
- Obtain the signature of the minor’s parent or guardian on “start talking consent form.” Another adult authorized to consent to the minor’s medical treatment may also sign the form, but this is limited to an adult to whom a minor’s parent or guardian has given written authorization to consent to the minor’s medical treatment, and in that case the prescriber may only prescribe up to a single 72-hour supply of the controlled substance. The prescriber must include the signed “start talking consent form” in the minor’s medical record.
These requirements do not apply in any of the following circumstances:
- If the minor’s treatment is associated with or incident to a medical emergency.
- If the minor’s treatment is associated with or incident to a surgery, regardless of whether the surgery is performed on an inpatient or outpatient basis.
- If, in the prescriber’s professional judgment, fulfilling the requirements would be detrimental to the minor’s health or safety.
- 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.
- If the consent of the minor’s parent or guardian is not legally required for the minor to obtain treatment.
A start talking consent form must be a separate document from any other document that a prescriber uses to obtain informed consent and must contain all of the following:
- The name and quantity of the controlled substance being prescribed for the minor and the amount of the initial dose.
- A statement indicating that a controlled substance is a drug or other substance that the U.S. Drug Enforcement Administration has identified as having a potential for abuse.
- A statement certifying that the prescriber discussed with the minor, and with the minor’s parent, guardian or authorized adult, the topics described above.
- The number of refills, if any, that are authorized by the prescription.
- A space for the signature of the minor’s parent, guardian, or authorized adult to consent to the minor’s medical treatment, and a space for the date signed.
The legislation defines the following terms:
- “Medical emergency” means a situation that, in the prescriber’s good-faith medical judgment, creates an immediate threat of serious risk to the life or physical health of the minor.
- “Minor” means an individual under 18 years old who is not emancipated.
Provision of information to all patients. Additionally, Public Act 246 requires that, beginning June 1, 2018, a licensed prescriber or other health professional must provide information on all of the following to a patient or patient’s representative before prescribing an opioid for other than inpatient use:
- The danger of opioid addiction.
- How to properly dispose of an expired, unused, or unwanted controlled substance.
- That the delivery of a controlled substance is a felony under Michigan law.
- If the patient is pregnant or is a female of reproductive age, the short- and long- term effects of exposing a fetus to a controlled substance.
After providing this information, the licensed prescriber or other health professional must obtain the patient’s or patient representative’s signature on a form published by LARA acknowledging receipt. The signed form must be included in the patient’s medical record.
The disclosure and signature provisions do not apply if the controlled substance is prescribed for inpatient use. The disclosure and signature provisions apply to patients who are minors. “Patient’s representative” means a guardian of a patient, if appointed, or a parent, guardian, or person acting in loco parentis, if the patient is a minor, unless the minor lawfully obtained health care without the consent or notification of a parent, guardian, or other person acting in loco parentis.
Public Act 165 of 2017 (effective February 11, 2018) provides that if, after consulting with a patient, a pharmacist determines in the exercise of his or her professional judgment that dispensing additional quantities of a prescription drug is appropriate for the patient, the pharmacist may dispense, at one time, additional quantities of the prescription drug up to the total number of dosage units authorized by the prescriber on the original prescription for the patient and any refills of the prescription. A pharmacist may not do so for a prescription for a controlled substance, except for a controlled substance included in schedule 5 that does not contain an opioid.
Public Act 252 of 2017 (effective March 27, 2018) addresses exemptions for the dispensing of a controlled substance from MAPS reporting requirements by hospitals, other health facilities and agencies, and veterinarians. It also require a prescriber to obtain and review a patient’s data on MAPS before dispensing or prescribing buprenorphine, or a drug containing buprenorphine and methadone, to a patient in a substance use disorder program. A prescriber must also report the information to MAPS when dispensing those drugs to a patient in a substance use disorder program, if federal law does not prohibit reporting.
Public Act 253 of 2017 (effective March 27, 2018) amends the Social Welfare Act to provide that an eligible individual may receive medically necessary acute medical detoxification for opioid use disorder, medically necessary inpatient care at an approved facility, or care in an appropriately licensed substance use disorder treatment facility.
Public Act 254 of 2017 (effective March 27, 2018) requires the Prescription Drug and Opioid Abuse Commission to develop and provide recommendations for the instruction of students on prescription opioid drug abuse to the Michigan Department of Education by July 1, 2018. These must include recommendations for instruction on the prescription drug epidemic and the connection between prescription opioid abuse and addiction to other drugs.
Public Act 255 of 2017 (effective March 27, 2018) requires the Michigan Department of Education to make available a model program of instruction based on those recommendations to school districts and public school academies and to ensure that the model program, at least, is included in the state’s Model Core Curriculum content standards and the health education component of the Merit Curriculum graduation requirements.
Frequently Asked Questions and Answers
Q: Is an in-person patient encounter required to establish a bona-fide prescriber-patient relationship for purposes of the Code?
A: No. The medical evaluation required to establish a bona-fide prescriber-patient relationship may be conducted either in-person or via telehealth, as defined in the Code. Before furnishing a medical evaluation by telehealth, physicians should review the Code’s requirements for telehealth services generally, including the requirement to obtain the patient’s consent to telehealth services, and in particular the requirements for prescribing a drug as a telehealth service, as well as the requirements of federal law.
Notwithstanding the Code’s provisions, physicians and others prescribing controlled substances in telehealth encounters must comply with additional requirements imposed by federal law. Under federal law, a controlled substance cannot be lawfully prescribed on the basis of a telehealth encounter unless the prescribing physician has conducted at least one in-person medical evaluation of the patient, subject to limited exceptions that likely will not apply to most physicians and other prescribers. In addition, the prescription must be for a legitimate medical purpose in the usual course of the prescriber’s professional practice. Physicians and other prescribers who fail to comply with these requirements violate the Controlled Substances Act and, subject to the provisions of the Act, are exposed to criminal sanctions.
Q: My practice’s informed consent form for minors already includes the information required in the start talking consent form. Does that satisfy the Code’s requirements?
A: No. The start talking consent form must be on a form that is separate from any other document that a prescriber uses to document informed consent for the treatment of a minor.
Q: I prescribe controlled substances, but I do not dispense controlled substances. Do I still need to register with MAPS?
A: Yes. Beginning June 1, 2018, if you prescribe or dispense controlled substances, you must be registered with MAPS. In addition, before prescribing controlled substances in excess of a 3-day supply to a patient, you must first obtain and review a MAPS report. The same requirement applies to physicians who dispense controlled substances. Keep in mind that registration with MAPS is in addition to obtaining a Michigan controlled substances license and registering with the U.S. Drug Enforcement Administration. Physicians who dispense must additionally obtain a Michigan drug control license.
Q: How do I register with MAPS? Can my staff access MAPS for me?
A: Physicians can register with MAPS online via LARA’s website. LARA’s homepage is www.michigan.gov/lara. Navigate to Professional Licensing, and from there to Michigan Automated Prescription System (MAPS).
A physician’s staff member, whether licensed or unlicensed, is required to register directly with MAPS as a delegate to the physician in order to run patient prescription reports for the physician. All queries run by a delegate are attributed to the prescriber for whom the delegate runs reports. Only registered users are permitted to access the MAPS systems. Physicians and other registered MAPS users are not permitted to let unregistered persons use their MAPS credentials to log into the MAPS system.
More information on physician and delegate registration and use is available in the MAPS registration and user support manuals published on LARA’s website.
Q: How does the new legislation affect delegated prescribing of controlled substances?
A: The new legislation does not per se further restrict or expand the ability of physicians to delegate the prescribing of controlled substances under existing regulatory standards. Physicians remain responsible for compliance with all applicable laws and rules affecting the prescribing of controlled substances under their delegated authority. Physicians should review and update as necessary their agreements with physician’s assistants and/or advanced practice registered nurses to incorporate the standards of the new legislation and any related protocols developed by the physician’s practice for compliance with the new legislation.