News & Insights

2017 prescribing requirements add burdens to physician practice

Michigan Medicine - Michigan State Medical Society (March/April 2018)

By Daniel Schulte, MSMS Legal Counsel
March 12, 2018

QUESTION:

Can you explain the new requirements for physicians when prescribing drugs?

ANSWER:

In December seven bills were signed into law effecting controlled substance (with and without opioids) prescribing and substance abuse disorder services. The Michigan Legislature and the Governor’s office enacted these laws in response to well publicized concerns regarding drug misuse, diversion and addiction. These laws fail, for the most part, to reflect the concerns of and points raised by and advocated for by MSMS and other organizations representing prescribers. There are several unanswered questions regarding the meaning of these laws and how they are to be applied and enforced. MSMS is working to educate its members and will be seeking guidance/clarification. Here, in a nutshell, is what is known regarding the new requirements for physicians (the new laws apply to all prescribers):

Effective March 27, 2018:

Physicians who treat a patient for an opioid-related overdose are required to provide information to the patient on “substance abuse disorder services”. It is not known at this time whether the Michigan Department of Health and Human Services (“MDHHS”) will be developing this information for physicians to use in fulfilling this requirement.

When administering a controlled substance directly to a patient, physicians must report the dispensing to the Michigan Automated Prescription System (“MAPS”).

Effective March 31, 2018:

Physicians may not prescribe a controlled substance listed in schedules 2 to 5 unless the physician is in a “bona fide prescriber-patient relationship” with the patient. This requires that a treatment or counseling relationship between the physician and patient exists in which: (a) the physician 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 (b) the prescriber has created and maintained records of the patient’s condition in accordance with medically accepted standards. In addition, the physician must either provide follow up care to monitor the efficacy of the use of the controlled substance or refer the patient to the patient’s primary care physician or another physician acceptable to the patient for follow up care.

Effective June 1, 2018:

Before prescribing a controlled substance physicians must be registered with MAPS.

Before prescribing or dispensing a controlled substance in a quantity that exceeds a 3-day supply physicians must obtain and review a MAPS report.

Before prescribing a controlled substance that is an opioid physicians must:

  • Provide information to the patient or the patient’s representative on 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 and 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 including neonatal abstinence syndrome; and
  • Obtain the patient’s informed consent on a form to be prescribed by the Michigan Department of Health and Human Services (“MDHHS”). To date, this form has not been made available.

Before issuing an initial prescription for an opioid in a single course of treatment to a minor physicians must:

  • Discuss with the minor and the minor’s parent or guardian: (1) the risks of addiction and overdose; (2) the increased risks of addiction for patients with underlying mental health or existing substance use disorders; (3) the danger of taking an opioid along with a benzodiazepine, alcohol or another central nervous system depressant; and (4) any other information in the patient counseling information section of the label for the controlled substance that is required under federal law.
  • Document the informed consent on a “Start Talking Consent Form” containing the statements required by statute (MSMS will be making a form available to members).

Effective July 1, 2018:

When treating patients for “acute pain” physicians may not prescribe more than a 7-day supply or and opioid within a 7-day period. Acute paid is defined as the normal, predicted physiological response to a noxious chemical or thermal or mechanical stimulus and is typically associated with invasive procedures, trauma and disease and usually lasts for a limited amount of time.”

The new laws contain exceptions applicable in medical emergencies and when the dispensing and administration ration takes place in a hospital. MSMS will be providing information with a complete description of the exceptions to each requirement.


About Daniel Schulte ...

Daniel J. Schulte has more than 20 years experience representing small business owners in all aspects of transactional, operational and regulatory legal matters. A Certified Public Accountant as well as an attorney, Dan is the firm's managing partner and chair of the Health Care Practice Group.  

He regularly advises and counsels concerning the formation of business entities, the preparation and review of business and corporate contracts, the purchase and sale of ownership interests in businesses and/or their assets, and the purchase, sale and leasing of real estate. 

A significant component of Dan’s practice involves representing healthcare professionals in state regulatory matters, including disciplinary and other licensing disputes with the State of Michigan, and federal regulatory matters including fraud and abuse issues. 

He also counsels on the anti-kickback and Stark laws, preparation of compliance programs, and responding to and negotiating settlements in connection with government enforcement actions.

Dan is well-known for his knowledge and experience in the area of association law, and is primarily responsible for the firm’s representation of the Michigan State Medical Society the Michigan Dental Association and the Michigan Osteopathic Association.  His work related to association law includes the drafting and review of new legislation and the preparation of Amicus Curiae Briefs for filing in Michigan’s Supreme Court and Court of Appeals on a variety of topics affecting health care professionals practicing in Michigan.

Dan writes articles and presents frequently before legal, medical and business groups on a variety of topics, including HIPAA, the HITECH Act, the Stark Law, the fraud and abuse laws, health care compliance plans, business succession planning, asset protection, and estate and tax planning. 

He is ranked among The Best Lawyers in America®, and has been named a “Michigan Super Lawyer” by Thomson Reuters.

Images above right from Detroit Medical News

 


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