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Legal Alert - New Prescribing Requirements

Friday, February 2, 2018   (0 Comments)
Posted by: Sara Surprenant
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To impact the current opioid epidemic in our state, Michigan lawmakers have passed several new laws addressing the prescribing of opioids and other controlled substances.  On December 27, 2017, the Lieutenant Governor signed these bills into law which go into effect throughout 2018.  Below, please find a summary and detailed explanation of the recent changes.  Please contact MAPA with any questions you may have.

SUMMARY

Public Act 246 of 2017 (House Bill 4408)

Public Act 246 adds a section to the Public Health Code to require 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 Act amends two existing sections to make failure to comply with these requirements a violation punishable by probation, limitation, denial, fine, suspension, revocation, or permanent revocation of the prescriber’s license. 
The Act also adds a section to require prescribers or health professionals to provide certain information and obtain a signed acknowledgment before prescribing an opioid to any patient.


Public Act 248 & 249 of 2017 (Senate Bill 166 & 167)

Public Act 248 amends the Public Health Code to require a licensed prescriber to obtain and review a patient's Michigan Automated Prescription System (MAPS) report before prescribing a Schedule 2 through 5 controlled substance[1] to the patient, with certain exceptions.  
The Act includes violation of that requirement as grounds for disciplinary action under the Code.
Public Act 249 amends the Public Health Code to provide that, beginning March 31, 2018, a licensed provider may 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 being prescribed the controlled substance.

Public Act 251 of 2017 (Senate Bill 274)

Public Act 251 amends the Public Health Code to allow a pharmacist to fill partially in increments a prescription for a Schedule 2 controlled substance in certain situations.  It would also limit the supply of an opioid a prescriber could prescribe to a patient being treated for acute pain, beginning July 1, 2018. 

Public Act 247 of 2017 (Senate Bill 270)
Public Act 247 requires a bona fide prescriber-patient relationship before a licensed prescriber could prescribe a schedule 2 to 5 controlled substance, with certain exceptions.  

Public Act 250 of 2017 (Senate Bill 273)
Public Act 250 amends the Public Health Code to require a licensee or registrant who treats a patient for an opioid-related overdose to provide information to the patient on substance use disorder services. 
Public Act 252 of 2017 (Senate Bill 47)
Public Act 252 requires the Department of Licensing and Regulatory Affairs (LARA) to establish by rule an electronic system for monitoring the dispensing of schedule 2 to 5 controlled substances by pharmacists, dispensing prescribers (i.e. physician assistants), or veterinarians.



DETAILED EXPLANATION*

PUBLIC ACT 246 of 2017 (House Bill 4408)
Public Act 246 adds a section to the Public Health Code to require 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 Act amends two existing sections to make failure to comply with these requirements a violation punishable by probation, limitation, denial, fine, suspension, revocation, or permanent revocation of the prescriber’s license. 
The Act also adds a section to require prescribers or health professionals to provide certain information and obtain a signed acknowledgment before prescribing an opioid to any patient.

Provision of information concerning MINORS

Specifically, beginning June 1, 2018, with some exceptions described later, the Act requires a prescriber to 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:
     o   The risks of addiction and overdose associated with the controlled substance.
     o   The increased risk of addiction to a controlled substance for an individual suffering from both mental and substance abuse disorders.
     o   The danger of taking a controlled substance containing an opioid with benzodiazepine, alcohol, or another central nervous system depressant.
     o   Any other information in the patient counseling information section of the label for the  controlled substance that is required in section 57(c)(18) of Part 201 (Labeling) of the Code of Federal Regulations (including information necessary for the patient to take the drug safely and effectively). 

Obtain the signature of the minor’s parent or guardian on a Start Talking consent form (described below). Another adult authorized to consent to the minor’s medical treatment may also sign the form, but 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 form in the minor’s medical record.

Exemptions

These requirements do not apply in any of the following circumstances:
     o   If the minor’s treatment is associated with or incident to a medical emergency.
     o   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.
     o   If, in the prescriber’s professional judgment, fulfilling the requirements would be detrimental to the minor’s health or safety.
     o   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.
     o   If the consent of the minor’s parent or guardian is not legally required for the minor to obtain treatment.

Definitions

The Act also defines all of the following terms, as used in Section 7303b:

     o   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:
     o   The name and quantity of the controlled substance being prescribed for the minor and the amount of the initial dose.
     o   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.
     o   A statement certifying that the prescriber discussed with the minor, and with the minor’s parent, guardian or authorized adult, the topics described above.
     o   The number of refills, if any, that are authorized by the prescription.
     o   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.

     Another adult authorized to consent to the minor’s medical treatment means an adult to whom a minor’s parent or guardian has given written authorization to consent to the minor’s medical treatment.

     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.

The Act includes failure to comply with these requirements (discussing the topics listed above with the minor and parent, guardian, or authorized adult, and obtaining a signed consent form) among violations of the Code under Section 16221. The Department of Licensing and Regulatory Affairs would investigate allegations of violation as it does for the 21 offenses currently listed in that section. If the allegations are substantiated, the prescriber would be subject to probation, limitation, denial, fine, suspension, revocation, or permanent revocation of his or her license by a disciplinary subcommittee.

Provision of information to ALL PATIENTS

Additionally, the Act 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 acknowledging receipt and include the signed form in the patient’s medical or clinical file.

Public Act 248 & 249 of 2017 (Senate Bill 166 & 167)

PA 248 amends the Public Health Code to require a licensed prescriber to obtain and review a patient's Michigan Automated Prescription System (MAPS) report before prescribing a Schedule 2 through 5 controlled substance[1] to the patient, with certain exceptions.  

The Act includes violation of that requirement as grounds for disciplinary action under the Code.

PA 248
amends Part 73 of the Public Health Code (MCL 333.7303a), which pertains to the Manufacture, Distribution, and Dispensing of Controlled Substances.  The Act would require a licensed prescriber to 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 would take effect beginning June 1, 2018, and would not apply under any of the following circumstances:
•         If the dispensing occurs in a hospital or freestanding surgical outpatient facility and the controlled substance is administered to the patient in that hospital or facility. (This exception is already carved out in Section 7333a of the Code and retained, with some changes, in SB 47, which would amend that section).
•         If the dispensing occurs in a veterinary hospital or clinic and the controlled substance is administered to the patient 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.

Additionally under the Act, beginning June 1, 2018, licensed prescribers must register with the MAPS system before prescribing or dispensing a controlled substance to a patient.

PA 249 amends the Public Health Code to provide that, beginning March 31, 2018, a licensed provider may 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 being prescribed the controlled substance. Additionally, with certain exceptions, the prescriber must provide follow-up care or refer the patient to a licensed prescriber for follow-up care. (These changes are also included in Public Act 247’17.)

The Act would also amend the sections of the Public Health Code (MCL 333.16221 and 333.16226) that list the grounds for disciplinary subcommittee action and the sanctions that may be administered if those grounds are substantiated. Specifically, these Acts would include violation of the requirements described in SBs 166 and 167, as well as failure to provide certain information about opioids before prescribing them (as required in SB 272), as grounds for disciplinary action. Violation of the requirement to be in a bona fide prescriber-patient relationship, or to provide the patient with certain information, would be punishable by probation, limitation, denial, fine, suspension, revocation, or permanent revocation

Violation of the requirements to register with MAPS and to obtain and review a MAPS report before prescribing a controlled substance would be punishable by denial, fine, reprimand, probation, limitation, suspension, revocation, or permanent revocation.

However, 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 letter would not be considered discipline.

Public Act 249 also incorporate the recently enacted offenses concerning female genital mutilation (Public Acts 68 to 79 of 2017)[3] into the Code. It would consider conviction of certain female genital mutilation-related offenses to be grounds for personal disqualification, punishable by permanent revocation of a license. A certified copy of the court record would be considered conclusive evidence of the conviction.

Public Act 251 of 2017 (Senate Bill 274)

Public Act 251 amends the Public Health Code to allow a pharmacist to fill partially in increments a prescription for a Schedule 2 controlled substance in certain situations.  It would also limit the supply of an opioid a prescriber could prescribe to a patient being treated for acute pain, beginning July 1, 2018. 

Specifically, the Act states that a pharmacist may partially fill in increments a prescription for a Schedule 2 controlled substance in any of the following three instances:

•         The pharmacist is unable to supply the full quantity of the controlled substance prescribed or the patient requests a smaller quantity of the controlled substance than was prescribed. A prescription that was partially filled under this section must not be filled more than 30 days after the prescription was issued.
•         The prescription was filled upon the oral prescription of a practitioner.  The pharmacist who fills this prescription must record the quantity dispensed and maintain that documentation. A prescription partially filled under this section must not be filled more than 72 hours after the first partial filling.
•         The prescription is for a terminally ill patient whose terminal illness is documented by the pharmacist as required by the Michigan Board of Pharmacy or its designated or established authority. A prescription partially filled under this section must not be filled more than 60 days after the prescription was issued.

Currently under the Code, a prescription may only be filled partially under the third instance—in the case of a terminally ill patient.

The Act also creates a new section of the Code which would provide that a prescriber treating a patient for acute pain may not prescribe more than a seven-day supply of an opioid within a seven-day period.

Acute pain as used in that section would mean pain that is the normal, 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.

Public Act 247 of 2017 (Senate Bill 270)

Public Act 247 amends the Public Health Code to provide that, beginning March 31, 2018, a licensed provider may 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 being prescribed the controlled substance.  Instances in which a bona fide relationship are not required may be defined by the Department of Licensing and Regulatory Affairs (LARA), in consultation with certain interested parties (described below) within a year of the date this Act takes effect.  Additionally, with certain exceptions, the prescriber must provide follow-up care or refer the patient to a licensed prescriber for follow-up care.  Finally, the Act would prescribe disciplinary sanctions for violation of the relationship requirement.

The Act 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:

•         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.
•         The prescriber has created and maintained records of the patient's condition in accordance with medically accepted standards. 

(A prescriber is defined in Section 17708 of the Code as a licensed dentist, a licensed doctor of medicine, a licensed doctor of osteopathic medicine and surgery, a licensed doctor of podiatric medicine and surgery, a licensed physician's assistant, a licensed optometrist certified under Part 174 to administer and prescribe therapeutic pharmaceutical agents, an advanced practice registered nurse as that term is defined in Section 17201 who meets the requirements of Section 17211a, a licensed veterinarian, or another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery.)

Exceptions to a bona fide prescriber-patient relationship

Within one year of the date this Act takes effect, LARA, in consultation with certain interested parties, 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, as otherwise required in this Act.  The interested parties would include: 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. 

In instances in which the parties determine a bona fide prescriber-patient relationship is not required, the parties may prescribe an alternative requirement which must be met in order to prescribe a schedule 2 to 5 controlled substance.

Follow-up care

Under the Act, if a licensed prescriber prescribes a controlled substance under the new rule, the prescriber must provide follow-up care to monitor the efficacy of the controlled substance as a treatment of the patient's medical condition.  If unable to provide follow-up care, the prescriber must refer the patient for follow up care to the patient's primary care provider or, if the patient does not have a primary care provider, to another licensed prescriber who is geographically accessible to the patient.

Violation of the bona fide prescriber-patient relationship

Additionally, the Act adds violation of the new requirement for a bona fide prescriber-patient relationship when prescribing certain controlled substances to the list of grounds for disciplinary subcommittee action.  When one of these grounds is alleged, LARA must investigate the allegation, and may hold hearings, administer oaths, and order the taking of relevant testimony in the course of its investigation. After its investigation, LARA must provide a copy of the administrative complaint to the appropriate subcommittee.  If the subcommittee finds that one or more of the grounds exist, it must proceed with the sanctions detailed in Section 16226 of the Code.

Under the Act, if the requirement is violated, a prescriber would be subject to probation, limitation, denial, fine, suspension, revocation, or permanent revocation.

Public Act 250 of 2017 (Senate Bill 273)

Public Act 250 amends the Public Health Code to require 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 as used in the Act includes both of the following, as defined in Section 100d of the Mental Health Code (MCL 330.1100d):

•         Substance use disorder prevention services: 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: 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. 

Public Act 252 of 2017 (Senate Bill 47)

Public Act 252 requires the Department of Licensing and Regulatory Affairs (LARA) to establish by rule an electronic system for monitoring the dispensing of schedule 2 to 5 controlled substances by pharmacists, dispensing prescribers (i.e. physician assistants), or veterinarians. However, it currently provides that those rules exempt the following circumstances from the reporting requirements:

•         The administration of a controlled substance directly to a patient.
•         The dispensing from a health facility licensed under Article 17 of a controlled substance by a dispensing prescriber in a quantity adequate to treat a patient for not more than 48 hours

The Act would reword those instances somewhat to distinguish the rules for hospitals from those for health facilities or agencies, and to add a specific exception for veterinarians. It would exempt the dispensing of a controlled substance from MAPS reporting requirements in the following instances:

•         A hospital that is licensed under Article 17 that administers the controlled substance to an individual who is an inpatient.
•         A health facility or agency licensed under Article 17 if the controlled substance is dispensed by a dispensing prescriber in a quantity adequate to treat the patient for not more than 48 hours.
•         A veterinary hospital or clinic that administers the controlled substance to an animal that is an inpatient.

The Act would also repeal Rule 62e of the Board of Pharmacy – Controlled Substances administrative rules, which uses language similar to that currently in Section 7333a to describe the exemptions from the reporting requirements for pharmacists, dispensing prescribers, and veterinarians. (R 338.3162e of the Michigan Administrative Code)

Finally, the Act would 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.

The Act takes effect 90 days after its enactment.


*This information is copied directly from the House Fiscal analysis of enacted laws. More information can be found by clicking the hyperlinked Public Act or at legislature.mi.gov.


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