Violating New Michigan Controlled Substance and Opioid Prescribing Laws Could Result in Licensure Actions

Posted by donna@healthlawcenterplc.com in Apr, 2018

In an effort to address current opioid abuse, Michigan has enacted a series of laws which impact the prescribing and dispensing of scheduled controlled substances.  While these laws also impact veterinarians, comments are limited to those who prescribe and dispense to human patients.  Failure to comply with these new laws may form the basis for disciplinary action against a health provider’s license.

Now In Effect —

Bona Fide Prescriber/Patient Relationship — A health care provider must have a bona fide prescriber/patient relationship when prescribing Schedules II – V controlled substances.  A bona fide prescriber patient relationship means:

• Treatment or counseling relationship in which the prescriber has reviewed the patient’s medical record, completed a full assessment of the patient’s medical history and current medical condition, including a relevant medical evaluation of the patient conducted either in person or by telehealth;
• Prescriber has created and maintained records of the patient’s condition in accordance with medically accepted standards;
• When prescribing a controlled substance, the prescriber must provide follow-up care to monitor the efficacy of the controlled substance in treating the patient; and
• If the prescriber is unable to provide follow-up care, he/she must refer the patient to the patient’s primary care provider for follow-up care, and if none exists, referral to another prescriber who is geographically accessible to the patient.

Licensure Actions for Failing to Maintain a Bona-Fide Prescriber/Patient Relationship — Failure to adhere to a bona fide prescriber/patient relationship may result in licensure penalties ranging from probation to permanent revocation of prescriber’s professional license.

Telemedicine — Michigan law defines telemedicine as the use of an electronic media to link patients with health care providers in different locations. The health care provider must be able to examine the patient via a real-time, interactive audio or video, or both, telecommunications system, and the patient must be able to interact with the off-site health care provider at the time the services are provided.

Overdose Education — A health care provider who treats a patient for an opioid-related overdose must provide the patient with information regarding substance use disorder prevention or treatment services.

Determine Patient’s Current Use of Controlled Substances — Before a health care provider prescribes or dispenses a controlled substance, he/she is required to ask the patient about other controlled substances the patient may be using, and record the patient’s response in the medical record.

Effective June 1, 2018 —

Registering with Michigan Automated Prescription System (MAPS) –– A prescriber must register with MAPS before prescribing or dispensing a controlled substance to a patient.

Licensure Actions for Failing to Register with MAPS — Failure to register with MAPS prior to prescribing or dispensing a controlled substance may result in licensure penalties ranging from probation to permanent revocation of prescriber’s professional license.

 Prescribing to Minors (Under 18 Years of Age, Not Emancipated) — When prescribing to a minor, the prescriber must:

• Prior to prescribing, discuss the potential risk of addiction and overdose, risk of mental and substance abuse disorders, and the risk of combining controlled substance with a benzodiazepine, alcohol or other central nervous system depressant with both the minor and parent/guardian or another adult authorized to consent to the minor’s treatment;
• Obtain the parent/guardian’s signature on the “Start Talking Consent Form” approved by the state after such discussion;
• Place the “Start Talking Consent Form” in the minor’s medical record; and
• If another adult is authorized by the minor’s parent/guardian to consent to medical treatment for the minor, the prescriber must not prescribe more than a single 72 hour supply of a controlled substance.

Licensure Actions for Failing to Discuss Risks of Opioid Abuse — Failure to provide minors and parent/guardians or another adult authorized to consent to a minor’s treatment with education requirements regarding the risks of opioid abuse may result in licensure penalties ranging from probation to permanent revocation of prescriber’s professional license.

Exceptions to Informed Consent Discussion — The aforementioned discussion and the signing of the “Start Talking Consent Form” are not required for minors when:

• Treatment is associated with or incident to a medical emergency;
• Treatment is associated with or incident to a surgery, regardless of whether the surgery is performed on an inpatient or outpatient basis;
• In the prescriber’s professional judgment, compliance with discussion requirements would be detrimental to the minor’s health or safety;
• Treatment is rendered in a hospice or an oncology department of hospital;
• Prescription for the minor is at the time of discharge from a hospice or from an oncology department of hospital; or
• Consent of the minor’s parent or guardian is not legally required for the minor to obtain treatment.

Requirements of “Start Talking Consent Form” —  Click on Consent Form — The “Start Talking Consent Form” has being developed by the State of Michigan and includes the following:

• Name and quantity of controlled substance;
• Amount of initial dose and number of refills authorized;
• Notice that the DEA has identified the drug as having potential for abuse; and
• Certification that the discussions of the danger of the prescribed controlled substance was held with minor and minor’s parent/guardian or another adult authorized to consent to minor’s treatment.

Prescribing to Adults — Before prescribing  an opioid to an adult, the prescriber must discuss:

• The dangers of opioid addiction;
• Proper disposal of opioids;
• Diversion of a controlled substance is a felony;
• If the patient is pregnant, the harm of exposing a fetus to a controlled substance, including neonatal abstinence syndrome;
• Obtain a signature on an approved consent form, certifying that the patient received opioid education; and
• File the consent form in the patient’s medical record.

Prescribing More Than a 3-Day Supply — Before prescribing or dispensing controlled substances to a patient in a quantity that exceeds a 3-day supply, the  prescriber must:

• Obtain and review a MAPS report on the patient.
• Exception to obtaining a MAPS report – if the dispensing occurs in a hospital or freestanding surgical outpatient facility and the controlled substance is administered to the patient in the hospital or facility.

Licensure Actions for Failing to Obtain MAPS Report — Failure to obtain and review a MAPS report, when required, prior to prescribing or dispensing a controlled substance in a quantity to exceed a 3-day supply may result in licensure penalties ranging from probation to permanent revocation of a professional license.

Record Keeping Requirements — A prescriber who dispenses controlled substances are required to maintain all of the following separately from other prescription records.

• All invoices and other acquisition records for each controlled substance acquired by the prescriber for not less than 5 years after the date the prescriber acquires the controlled substance;
• A log of all controlled substances dispensed by the prescriber for not less than 5 years after the date the controlled substance is dispensed; and
• Records of all other dispositions of controlled substances under the licensee’s control for not less than 5 years after the date of the disposition.

Effective July 1, 2018 –

A prescriber who treats a patient for acute pain shall not prescribe more than a 7-day supply of an opioid within a 7-day period. “Acute Pain” is defined 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.

For additional information and legal questions related to how Michigan’s new controlled substances laws impact your practice contact Donna J. Craig, RN, JD at donna@healthlawcenterplc.com.

Disclaimer and Disclosure – This article was prepared as an overview of Michigan’s new controlled substances laws and is not intended to take the place of legal advice and counsel regarding any particular circumstance or factual scenario.