Bill Text: MI HB4154 | 2019-2020 | 100th Legislature | Introduced
Bill Title: Health; pharmaceuticals; annual report on the costs associated with prescription drugs; require manufacturers of prescription drugs to file under certain circumstances. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding sec. 17748e.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2019-02-07 - Bill Electronically Reproduced 02/06/2019 [HB4154 Detail]
Download: Michigan-2019-HB4154-Introduced.html
HOUSE BILL No. 4154
February 6, 2019, Introduced by Rep. Vaupel and referred to the Committee on Government Operations.
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding section 17748e.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17748e. (1) Beginning in 2019, a manufacturer shall file
an annual report with the department of health and human services
on costs associated with a prescription drug for the preceding
calendar year if the prescription drug meets 1 of the following and
is distributed for sale in this state by the manufacturer:
(a) The prescription drug is remanufactured resulting in a
decrease in the prescription drug's shelf life.
(b) The prescription drug has an annual wholesale acquisition
price of $10,000.00 or more.
(c) The prescription drug has a wholesale acquisition price of
$10,000.00 or more per course of treatment.
(d) The prescription drug has a wholesale acquisition price
that has increased by a total of 25% or more during the 5 years
immediately preceding the calendar year covered by the report or by
5% or more during the preceding calendar year.
(2) A report filed under subsection (1) must be filed on or
before May 1 of each year, beginning May 1, 2019, in a form and
manner prescribed by the department of health and human services
and must contain an itemized account of all of the following
information for the calendar year covered by the report:
(a) Total costs paid by the manufacturer and any predecessor
manufacturer for manufacturing and distributing the prescription
drug.
(b) Costs paid by the manufacturer or any predecessor
manufacturer for researching and developing the prescription drug,
including, but not limited to, all of the following:
(i) Costs for researching and developing the prescription drug
with money made available to the manufacturer or predecessor
manufacturer through a federal, state, or other governmental
program or through a subsidy, grant, or other form of monetary
support.
(ii) After-tax research and development costs for the
prescription drug.
(iii) Costs of clinical trials for the prescription drug.
(c) Research and development costs paid by a third party for
the prescription drug.
(d) Costs paid by the manufacturer or any predecessor
manufacturer for acquiring the prescription drug, including, but
not limited to, costs paid for purchasing a patent or licensing the
prescription drug or costs paid to acquire a property right to the
prescription drug.
(e) The costs paid by the manufacturer for marketing and
advertising the prescription drug to consumers of the prescription
drug, including any costs associated with offering and redeeming
coupons or other discounts including rebates.
(f) The aggregate rebates paid by the manufacturer to pharmacy
benefit managers that are related to the use of the prescription
drug by health insurers.
(3) In addition to the itemized accounting of the costs
described in subsection (2), a report filed under subsection (1)
must contain all of the following information for the calendar year
covered by the report:
(a) Each increase in the wholesale acquisition price of the
prescription drug for that year, expressed as a percentage of the
wholesale acquisition price, and the date on which each increase
occurred.
(b) The price for the prescription drug that is charged to
consumers of the prescription drug who are located in a country
other than the United States, as required by the department of
health and human services.
(4) A manufacturer must obtain an audit by an independent
third party of a report prepared under this section before the
report is filed under subsection (1). The manufacturer shall select
the third party from among a list of potential auditors made
available by the department of health and human services.
(5) After completing an audit under subsection (4), the third
party that conducted the audit shall file a summary of the audit
with the department of health and human services on or before May 1
of the following year, in a form and manner prescribed by the
department of health and human services. The manufacturer shall pay
all costs associated with auditing and filing a summary under this
subsection.
(6) The department of health and human services shall post on
its internet website a searchable database with data from the
reports filed under subsection (1) and any information that the
department of health and human services determines is necessary to
assist the general public in understanding the data.
(7) A manufacturer that fails to file the report required
under subsection (1) is subject to an administrative fine of
$100,000.00 per month for every month that the report is not filed
in accordance with this section.
(8) The department of health and human services, in
consultation with the department and the board, may promulgate
rules to implement this section.
