Substitute For
SENATE BILL NO. 248
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 16226 and 17754 (MCL 333.16226 and 333.17754), section 16226 as amended by 2018 PA 463 and section 17754 as amended by 2014 PA 525.
The people of the state of michigan enact:
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Sec. 16226. (1) After finding the existence of 1 or more of the grounds for disciplinary subcommittee action listed in section 16221, a disciplinary subcommittee shall impose 1 or more of the following sanctions for each violation:
Sanctions
Subdivision (a), (b)(i),
Probation, limitation, denial,
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(b)(ii), (b)(iii), (b)(iv),
suspension, revocation,
(b)(v), (b)(vi), (b)(vii),
permanent revocation,
(b)(ix), (b)(x), (b)(xi),
restitution, or fine.
or (b)(xii)
Subdivision (b)(viii)
Revocation, permanent revocation,
or denial.
Subdivision (b)(xiii)
Permanent revocation
for a violation described in
subsection (5); otherwise,
probation, limitation, denial,
suspension, revocation,
restitution, or fine.
Subdivision (b)(xiv)
Permanent revocation.
Subdivision (c)(i)
Denial, revocation, suspension,
probation, limitation, or fine.
Subdivision (c)(ii)
Denial, suspension, revocation,
restitution, or fine.
Subdivision (c)(iii)
Probation, denial, suspension,
revocation, restitution, or fine.
Subdivision (c)(iv)
Fine, probation, denial,
or (d)(iii)
suspension, revocation, permanent
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revocation, or restitution.
Subdivision (d)(i)
Reprimand, fine, probation,
or (d)(ii)
denial, or restitution.
Subdivision (e)(i),
Reprimand, fine, probation,
(e)(iii), (e)(iv), (e)(v),
limitation, suspension,
(h), or (s)
revocation, permanent revocation,
denial, or restitution.
Subdivision (e)(ii)
Reprimand, probation, suspension,
or (i)(i)
revocation, permanent
revocation, restitution,
denial, or fine.
Subdivision (e)(vi),
Probation, suspension, revocation
(e)(vii), or (e)(viii)
limitation, denial,
restitution, or fine.
Subdivision (f)
Reprimand, denial, limitation,
probation, or fine.
Subdivision (g)
Reprimand or fine.
Subdivision (j)
Suspension or fine.
Subdivision (k), (p),
Reprimand, probation, suspension,
or (r)
revocation, permanent revocation,
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or fine.
Subdivision (l)
Reprimand, denial, or
limitation.
Subdivision (m) or (o)
Denial, revocation, restitution,
probation, suspension,
limitation, reprimand, or fine.
Subdivision (n)
Revocation or denial.
Subdivision (q)
Revocation.
Subdivision (t)
Revocation, permanent revocation,
fine, or restitution.
Subdivision (u)
Denial, revocation, probation,
suspension, limitation, reprimand,
or fine.
Subdivision (v) or (x)
Probation, limitation, denial,
fine, suspension, revocation, or
permanent revocation.
Subdivision (w)
Denial, fine, reprimand,
probation, limitation,
suspension, revocation, or
permanent revocation.
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Subdivision (y)
Subject to subsection (7), fine.
(2) Determination of sanctions for violations under this section shall be made by a disciplinary subcommittee. If, during judicial review, the court of appeals determines that a final decision or order of a disciplinary subcommittee prejudices substantial rights of the petitioner for 1 or more of the grounds listed in section 106 of the administrative procedures act of 1969, 1969 PA 306, MCL 24.306, and holds that the final decision or order is unlawful and is to be set aside, the court shall state on the record the reasons for the holding and may remand the case to the disciplinary subcommittee for further consideration.
(3) A disciplinary subcommittee may impose a fine in an amount that does not exceed $250,000.00 for a violation of section 16221(a) or (b). A disciplinary subcommittee shall impose a fine of at least $25,000.00 if the violation of section 16221(a) or (b) results in the death of 1 or more patients.
(4) A disciplinary subcommittee may require a licensee or registrant or an applicant for licensure or registration who has violated this article, article 7, or article 8 or a rule promulgated under this article, article 7, or article 8 to satisfactorily complete an educational program, a training program, or a treatment program, a mental, physical, or professional competence examination, or a combination of those programs and examinations.
(5) A disciplinary subcommittee shall impose the sanction of permanent revocation for a violation of section 16221(b)(xiii) if the violation occurred while the licensee or registrant was acting within the health profession for which he or she was licensed or registered.
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(6) Except as otherwise provided in subsection (5) and this subsection, a disciplinary subcommittee shall not impose the sanction of permanent revocation under this section without a finding that the licensee or registrant engaged in a pattern of intentional acts of fraud or deceit resulting in personal financial gain to the licensee or registrant and harm to the health of patients under the licensee's or registrant's care. This subsection does not apply if a disciplinary subcommittee finds that a licensee or registrant has violated section 16221(b)(xiv).
(7) A disciplinary subcommittee shall impose a fine of $250.00 for each violation of section 16221(y). However, the aggregate fine that a disciplinary subcommittee imposes on a licensee or registrant for multiple violations of section 16221(y) must not exceed $5,000.00 in 1 calendar year.
Sec. 17754. (1) Except as otherwise provided under article 7, article 8, and the federal act, or subsection (5), and subject to subsection (8), beginning January 1, 2021, a prescriber or his or her agent shall electronically transmit a prescription, may be transmitted electronically if the prescription is transmitted including a prescription for a controlled substance, directly to a pharmacy of the patient's choice. A prescription that is transmitted electronically under this section must be in compliance with the health insurance portability and accountability act of 1996, Public Law 104-191, or regulations promulgated under that act, 45 CFR parts 160 and 164, by a prescriber or his or her agent and the data are must not be altered or modified in the transmission process. The electronically transmitted prescription shall must include all of the following information:
(a) The name, address, and telephone number of the prescriber.
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(b) Except as otherwise authorized under section 5110, 17744a, or 17744b, the full name of the patient for whom the prescription is issued.
(c) An electronic signature or other identifier that specifically identifies and authenticates the prescriber or his or her agent.
(d) The time and date of the transmission.
(e) The identity of the pharmacy intended to receive the transmission.
(f) Any other information required by the federal act or state law.
(2) The electronic equipment or system utilized in the transmission and communication of prescriptions shall must provide adequate confidentiality safeguards and be maintained to protect patient confidentiality as required under any applicable federal and state law and to ensure against unauthorized access. The electronic transmission of a prescription shall must be communicated in a retrievable, recognizable form acceptable to the intended recipient. The electronic form utilized in the transmission of a prescription shall must not include "dispense as written" or "d.a.w." as the default setting.
(3) Before dispensing a prescription that is electronically transmitted, the pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of the transmitted prescription.
(4) An electronically transmitted prescription that meets the requirements of this section is the original prescription.
(5) The requirement to transmit a prescription electronically under subsection (1) does not apply under any of the following
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circumstances:
(a) If the prescription is issued by a prescriber who is a veterinarian licensed under this article.
(b) If the prescription is issued under a circumstance in which electronic transmission is not available due to a temporary technological or electrical failure.
(c) If the prescription is issued by a prescriber who has received a waiver from the department under subsection (6).
(d) If the prescription, including, but not limited to, a prescription issued under section 5110, is issued by a prescriber who reasonably believes that electronically transmitting the prescription would make it impractical for the patient who is the subject of the prescription to obtain the prescription drug in a timely manner and that the delay would adversely affect the patient's medical condition.
(e) If the prescription is orally prescribed under section 7333(3) or (4).
(f) If the prescription is issued by a prescriber to be dispensed outside of this state.
(g) If the prescription is issued by a prescriber who is located outside of this state to be dispensed by a pharmacy located inside of this state.
(h) If the prescription is issued and dispensed in the same health care facility and the individual for whom the prescription is issued uses the drug exclusively in the health care facility. As used in this subdivision, "health care facility" includes, but is not limited to, the following:
(i) A hospital.
(ii) A dialysis treatment clinic.
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(iii) A freestanding surgical outpatient facility.
(iv) A skilled nursing facility.
(v) A long-term care facility that provides rehabilitative, restorative, or ongoing skilled nursing care to an individual who is in need of assistance with activities of daily living.
(i) If the prescription is issued for an individual who is the patient of a hospice licensed under article 17 and the individual uses the drug exclusively while under the care of the hospice.
(j) If the prescription contains content that is not supported by the National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard.
(k) If the prescription is for a drug for which the FDA requires the prescription to contain content that cannot be transmitted electronically.
(l) If the prescription is issued under circumstances in which the prescriber is not required to include on the prescription a name of a patient for whom the prescription is issued.
(m) If the prescription is issued by a prescriber who is prescribing the drug under a research protocol.
(n) If the prescription is issued by a prescriber who is providing care to a patient who is the subject of the prescription on a voluntary, unpaid basis for which neither the patient nor a third party will be charged or billed.
(6) If a prescriber cannot meet the requirements of subsection (1) or (2), the prescriber may apply to the department for a waiver. The department shall grant a waiver to a prescriber if the department determines that the prescriber cannot meet the requirements of subsection (1) or (2) due to a technological limitation that is not reasonably within the control of the
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prescriber, such as insufficient internet connectivity or the use of a health record technology certified by the federal Centers for Medicare and Medicaid Services that does not allow for the electronic transmission of a prescription for a controlled substance, or another exceptional circumstance. A prescriber who is granted a waiver under this subsection shall notify the department in writing if he or she is subsequently able to meet the requirements of subsections (1) and (2). A waiver that is granted under this subsection is valid for a period not to exceed 1 year and is renewable.
(7) The department, in consultation with the board, shall promulgate rules to implement this section by July 1, 2020.
(8) If the federal Centers for Medicare and Medicaid Services delays the Medicare requirement for the electronic transmission of prescriptions for controlled substances beyond January 1, 2021, then the department may, by rule, delay the implementation date of subsection (1) to a date that does not extend past the date established by the federal Centers for Medicare and Medicaid Services for the Medicare requirement.
Enacting section 1. This amendatory act takes effect 90 days after the date it is enacted into law.
Enacting section 2. This amendatory act does not take effect unless Senate Bill No. 254 of the 100th Legislature is enacted into law.