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 Senate, September 12, 2013
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 department 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 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, in consultation with the board, 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 petitions for
proposed pilot projects.
(3) The department shall not approve more than 25 pilot
projects under this section. If it determines necessary, the
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 department 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.
(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 (11).
(6) A petitioner who wishes the department 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 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 (10). The department, in consultation
with the board, may include appropriate conditions or
qualifications on its approval of a pilot project.
(8) 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.
(9) The individuals designated to review petitions under
subsection (2)(c) shall review the progress reports and the summary
of the results of the pilot project submitted under subsection (8).
Within 90 days after receipt of the summary of the results of the
pilot project under subsection (8), the individuals designated to
review 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 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. The board shall allow the petitioner to make a
presentation to the board upon request of the board.
(10) If determined appropriate by the board at the meeting at
which the written report is considered under subsection (9), 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 department, in
consultation with the board, shall not grant an extension that
would result in a specified period of time for conducting a pilot
project under this section that exceeds 36 months.
(11) 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.
