August 14, 2018

New requirements for opioid prescribing now effective

Answer:  Last December seven bills became law that in various ways regulate the prescribing of opioids and other controlled substances. This legislation leaves much to be desired. These new laws are spread over numerous new statutes and amendments to existing statutes. There are multiple effective dates,[i] for the new requirements and they are confusing, contain requirements that overlap, inconsistent and ill-defined terms, etc. The Michigan Department of Health and Human Services (“MDHHS”) has been issuing guidance on the application of these laws (which can be found at: www.michigan.gov/mimapsinfo) which has resolved some of the confusion.

Here is a summary of the requirements currently in effect that I believe will apply if you prescribe opioids or other controlled substances to patients for pain following procedures performed in your practice:

The following requirements became effective June 1, 2018:
  • You must register with the Michigan Automated Prescription System (“MAPS”) prior to prescribing or dispensing a controlled substance.
  • Prior to prescribing or dispensing a controlled substance to a patient in a quantity exceeding a three day supply you must obtain and review a MAPS report on that patient.
  • You must discuss and provide certain information to patients (or the patient’s parent or guardian). This requirement differs for minor and adult patients.
    • You must discuss the following with minor patients prior to issuing the first prescription for a controlled substance containing an opioid in a single course of treatment:
      1. The risks of addiction and overdose;
      2. The increased risk of addiction for those suffering from mental and substance abuse disorders;
      3. The dangers of combining opioids with benzodiazepine, alcohol or central nervous systems depressants; and
      4. Other information in the patient counseling section of the drug label required by federal law.
    • Prior to prescribing an opioid to an adult patient you must provide information regarding:
      1. The danger of opioid addiction;
      2. How to properly dispose of an expired, unused or unwanted controlled substance;
      3. The delivery of a controlled substance is a felony under Michigan law; and
      4. If the patient is pregnant or a female of reproductive age the effects of a controlled substance exposure to a fetus.
  • If the patient is a minor, you must obtain the signature of a parent or guardian on a “Start Talking Consent Form”.
  • If the patient is not a minor, obtain the patient’s signature on the consent form issued by MDHHS.[ii]  
The following requirement became effective July 1, 2018:
  • Prescriptions of opioids for the treatment of acute pain cannot exceed a seven day supply in a seven 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.” This would include pain resulting from dental procedures.
  • There are differing exceptions to each requirement (e.g. for medical emergencies, inpatient/outpatient surgery, hospice care, etc.) that generally will not be applicable to dental procedures performed in an office setting.

[i] The effective date for the new bona fide prescriber-patient relationship (MCL 333.7303a(2)) was originally March 31, 2018 but has been extended to the earlier of March 31, 2019 or the date administrative code rules clarifying this new requirement are issued.

[ii] MDHHS has issued a combined “Start Talking” consent form that may be used for all (minors and adults) patients. This form can be obtained online at: www.michigan.gov/lara/0,4601,7-154-72600_72603_55478_85991—,00.html.

Attorneys

Daniel J. Schulte

Practice Areas

Health Care Law