Bill Text: MI SB0373 | 2013-2014 | 97th Legislature | Engrossed
Bill Title: Health; pharmaceuticals; board of pharmacy to approve pilot project for innovative applications; allow. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding sec. 17723.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Passed) 2013-12-31 - Assigned Pa 0267'13 With Immediate Effect [SB0373 Detail]
Download: Michigan-2013-SB0373-Engrossed.html
SB-0373, As Passed House, December 4, 2013
HOUSE SUBSTITUTE FOR
SENATE BILL NO. 373
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding section 17723.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17723. (1) Subject to this section, the board may approve
a pilot project that is designed to utilize new or expanded
technology or processes and to provide patients with better
pharmacy products or provide pharmacy services in a more efficient
manner. The board shall ensure that a pilot project it approves
under this section is focused on maintaining or improving patient
care in the delivery of pharmacy services and improving patient
outcomes. The department may charge petitioners a filing fee
sufficient to cover the department's costs incurred while
administering and monitoring the pilot project under this section.
(2) The department shall do all of the following:
(a) Establish and administer a process to receive, review, and
accept or deny petitions for proposed pilot projects.
(b) Establish time frames for the receipt, review, and
approval or denial of petitions for proposed pilot projects.
(c) Designate the individuals who will review and evaluate
petitions for proposed pilot projects.
(3) The board shall not approve more than 10 pilot projects
under this section. If it determines necessary, the board or
department may further limit the number of approved pilot projects
based on the scope and type of petitions for proposed pilot
projects received.
(4) The board shall not approve a pilot project that does any
of the following:
(a) Expands the definition of the practice of pharmacy.
(b) Provides for the therapeutic substitution or substitution
of medical devices used in patient care.
(c) Allows a pharmacy or pharmacist to be involved with a
pilot project if the pharmacy's or pharmacist's license is not
current or is under investigation for or subject to a sanction for
a violation of this act.
(5) The department, in consultation with the board, may grant
to a petitioner conducting an approved pilot project under this
section an exception to a rule promulgated under this part. The
department shall not grant an exception under this subsection from
any law relating to the practice of pharmacy. The department shall
grant an exception under this subsection for a specified period of
time, which period must not exceed 18 months unless extended under
subsection (12).
(6) A petitioner who wishes the board to consider a pilot
project for approval under this section shall submit to the
department a petition that contains all of the following
information:
(a) The name, address, telephone number, electronic mail
address, and Michigan license number of the pharmacist responsible
for overseeing the proposed pilot project.
(b) The specific location where the proposed pilot project
will be conducted. The petitioner shall include the Michigan
license number of the pharmacy and a statement that the Michigan
license of the pharmacy and any pharmacist involved with the pilot
project is current, is not under investigation for or subject to a
sanction for a violation of this act, and will remain in good
standing for the duration of the pilot project.
(c) A detailed summary of the proposed pilot project that
includes all of the following:
(i) The goals, hypothesis, and objectives, as applicable, of
the proposed pilot project.
(ii) A full explanation of the proposed pilot project and how
the project will be conducted.
(iii) The initial time frame for the pilot project, including
the proposed start date and length of the project, which initial
time frame must not exceed 18 months.
(iv) All background information and literature review, as
applicable, to support the proposed pilot project.
(v) If applicable, identification of the rules promulgated
under this part from which the petitioner is requesting an
exception as provided in subsection (5) in order to complete the
proposed pilot project and a request for that exception.
(vi) If applicable, procedures the petitioner will use during
the proposed pilot project to ensure that the public's health and
safety are not compromised as a result of an exception to a rule
being granted under subsection (5).
(vii) The procedures the petitioner will use to protect the
identity and privacy of patients in accordance with existing
federal and state law and consistent with regulations promulgated
under the health insurance portability and accountability act of
1996, Public Law 104-191.
(7) Upon approval of a petition for a pilot project, the
department shall specify a time period for the operation of that
pilot project, which period must not exceed 18 months unless
extended under subsection (11). The department, in consultation
with the board, may include appropriate conditions or
qualifications on the approval of a pilot project. The department
or board may suspend the operation of a pilot project if it
determines that the petitioner or any person involved with the
pilot project has deviated the operation of the pilot project from
the plan of operation that was approved.
(8) If determined appropriate for the pilot project approved
under this section, the board or department may require the
petitioner to notify patients that pharmacy services are being
provided as part of a pilot project. If required under this
subsection, the petitioner shall notify patients in the manner
required by the board or department.
(9) The petitioner shall allow the department to inspect and
review pilot project documentation and the pilot project site at
any time during the review process and after the pilot project is
approved. The pharmacist responsible for overseeing an approved
pilot project shall forward all of the following to the department:
(a) Progress reports at intervals specified by the department.
(b) A summary of the results of the project and conclusions
drawn from the results of the project within 3 months after
completion of the pilot project.
(10) The individuals designated to review and evaluate
petitions under subsection (2)(c) shall review the progress reports
and the summary of the results of the pilot project submitted under
subsection (9). Within 90 days after receipt of the summary of the
results of the pilot project under subsection (9), the individuals
designated to review and evaluate petitions under subsection (2)(c)
shall submit a written report to the department regarding the
results of the pilot project. The department shall provide a copy
of the written report submitted under this subsection to the board.
The individuals designated to review and evaluate petitions under
subsection (2)(c) shall submit a copy of the written report to the
petitioner at least 2 weeks before the board meeting at which the
report will be considered by the board. Upon the request of the
petitioner, the board shall allow the petitioner to make a
presentation to the board.
(11) If determined appropriate by the board at the meeting at
which the written report is considered under subsection (10), and
if approved by the department, the specified period of time for
conducting a pilot project under subsection (7) may be extended for
an additional period of up to 18 months. The board or department
shall not grant an extension that would result in a specified
period of time for conducting a pilot project under this section to
exceed 36 months.
(12) If the department, in consultation with the board,
determines that a pilot project for which an exception to a rule
has been granted under subsection (5) should be extended so that
rules may be promulgated in order to allow the pilot project to be
conducted on a permanent basis, the department may extend the
exception to the rule for an additional period of up to 18 months.
Enacting section 1. This amendatory act takes effect 90 days
after the date it is enacted into law.
