November 12, 2014, Introduced by Rep. Poleski and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 5430 (MCL 333.5430), as added by 2006 PA 31,
and by adding section 5431a.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 5430. (1) The newborn screening quality assurance
advisory committee is created in the department. The newborn
screening
quality assurance advisory committee shall consist
consists
of 10 members and to be
appointed by the department as
follows:
(a) One individual representing a Michigan nonprofit health
care corporation or a nonprofit mutual disability insurer.
(b) One individual representing the Michigan health and
hospital association.
(c) One individual representing the Michigan state medical
society.
(d) One individual representing the Michigan osteopathic
association.
(e) One individual representing the department's medical
services administration.
(f) One individual representing the department's public health
administration.
(g) One individual who is a neonatologist with experience and
background in newborn screening.
(h) One individual representing health maintenance
organizations.
(i) Two individuals representing the general public.
(2) The newborn screening quality assurance advisory committee
shall meet annually to review the list of newborn screening tests
required
under section sections 5431 and
5431a and under department
rules, regulations, and guidelines. The newborn screening quality
assurance advisory committee shall, on an annual basis, submit a
written report to the department regarding the appropriateness of
the existing list of required newborn screening tests. The newborn
screening quality assurance advisory committee shall also include
in the report recommendations to revise the list to include
additional newborn screening tests that are nationally recognized
in the scientific literature or national standards for conditions
that can be ameliorated or treated if identified by a newborn
screening test and to remove certain tests that are no longer
supported in the scientific literature or national standard as
being effective for ameliorating or treating conditions that can be
identified by newborn screening.
(3) The newborn screening quality assurance advisory committee
shall conduct a financial review of any recommended changes to the
list of newborn screening tests and shall include in the written
report required under subsection (2) a recommendation for the
increase
or decrease in the amount charged pursuant to under
section 5431 for newborn screening tests. The recommended change
shall not exceed any net change in the amount of the actual cost of
any proposed additional tests and follow-up minus savings from any
proposed deleted tests and follow-up.
(4) Within 30 days after the department has received the
report required under subsection (2), the department may approve or
reject the recommendations of the newborn screening quality
assurance advisory committee. If the department does not reject the
recommendations or fails to act within the 30 days, then the
recommendations shall be forwarded to the standing committees in
the senate and house of representatives that consider issues
pertaining to public health for approval.
(5) Within 45 days after the recommendations are forwarded and
received, the legislature shall approve or reject those
recommendations without amendment by concurrent resolution adopted
by both standing committees of the senate and house of
representatives that consider issues pertaining to public health
and both houses of the legislature by recorded vote. If the
proposed recommendations are not submitted on a legislative session
day, the 45 days commence on the first legislative session day
after the recommendations are submitted. The 45 days shall include
not less than 9 legislative session days. If the recommendations
are not rejected within the 45-day period, the recommendations
shall
be are considered approved, shall be adopted by the
department,
and shall take effect 6 months after the
recommendations are adopted by both houses of the legislature or
considered approved as provided under this subsection.
Sec. 5431a. (1) Beginning on the date established in an order
described in subsection (3), in addition to the tests required
under section 5431, a health professional in charge of the care of
a newborn infant or, if none, the health professional in charge at
the birth of an infant shall administer or cause to be administered
to the infant a test for the presence of certain lysosomal storage
disorders known as Krabbe, Pompe, Gaucher, Fabry, and Niemann-Pick.
A test administered under this section is considered a test
required under section 5431(1) and is subject to the requirements
of and entitled to the protections provided in section 5431.
(2) The department shall monitor and determine when all of the
following requirements have been met with regard to the testing
required under subsection (1):
(a) The necessary reagents are registered with the federal
food and drug administration.
(b) The necessary reagents are available from the centers for
disease control and prevention.
(c) A quality assurance testing methodology is available for
the processes involved in the testing.
(3) Upon determining that the requirements in subsection (2)
have been met, the department shall do both of the following:
(a) Acquire and install the equipment necessary to implement
the testing required under subsection (1).
(b) Issue an order establishing a date that the testing
required under subsection (1) will begin, which date shall be
within 6 months after the department makes its determination under
subsection (2).