HB-5805, As Passed Senate, June 12, 2018
April 12, 2018, Introduced by Reps. Bizon, Vaupel, Canfield, Noble, Hornberger, Sheppard, Calley, Pagel, Ellison, Garrett, Graves and Tedder and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 17755 (MCL 333.17755), as amended by 2018 PA
41.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17755. (1) Except as provided in subsection (3), when a
pharmacist receives a prescription for a brand name drug product or
biological drug product, the pharmacist may, or when a purchaser
requests a lower cost generically equivalent drug product or
interchangeable biological drug product, the pharmacist shall
dispense a lower cost but not higher cost generically equivalent
drug product or interchangeable biological drug product if
available in the pharmacy. If a drug or biological drug product is
dispensed that is not the prescribed brand, the purchaser must be
notified and the prescription label must indicate both the name of
the brand prescribed and the name of the brand dispensed and
designate each respectively. Except as otherwise provided in
section 17756, if the dispensed drug or biological drug product
does not have a brand name, the prescription label must indicate
the generic name of the drug dispensed or the proprietary name of
the biological drug product dispensed.
(2)
If a pharmacist dispenses a substitutes
a lower cost
generically equivalent drug product or interchangeable biological
drug product to a purchaser who is not submitting a claim to a
third-party
payment source, the pharmacist shall pass
on the
savings
in cost to the charge the purchaser or to the third party
payment
source if the prescription purchase is covered by a third
party
pay contract. The savings in cost is the difference between
the
wholesale cost to the pharmacist of the 2 drug products.not
more than the current selling price for the lower cost drug
product.
(3) The pharmacist shall not dispense a generically equivalent
drug product or interchangeable biological drug product under
subsection (1) if any of the following apply:
(a) The prescriber, in the case of a prescription in writing
signed by the prescriber, writes in his or her own handwriting
"dispense as written" or "d.a.w." on the prescription.
(b) The prescriber, having preprinted on his or her
prescription blanks the statement "another brand of a generically
equivalent product, identical in dosage, form, and content of
active ingredients, may be dispensed unless initialed d.a.w.",
writes in his or her own handwriting the initials "d.a.w." in a
space, box, or square adjacent to the statement.
(c) The prescriber, in the case of a prescription other than
one in writing signed by the prescriber, expressly indicates that
the prescription is to be dispensed as communicated.
(4) A pharmacist may not dispense a drug product with a total
charge that exceeds the total charge of the drug product originally
prescribed, unless agreed to by the purchaser.
(5) Except as otherwise provided in subsection (6), within 5
days after dispensing an interchangeable biological drug product,
the dispensing pharmacist or his or her designee shall communicate
to the prescriber the specific interchangeable biological drug
product provided to the patient, including the name of the
interchangeable biological drug product and its manufacturer. The
communication required under this subsection must be made as
follows:
(a) By making an entry that is electronically accessible to
the prescriber through an interoperable electronic medical records
system, an electronic prescribing technology, a pharmacy benefit
management system, a health information exchange, or a pharmacy
record. An entry made as described in this subdivision is presumed
to provide notice to the prescriber.
(b) If the methods described in subdivision (a) are not
available, then by facsimile, telephone, electronic transmission,
or other prevailing means.
(6) Subsection (5) does not apply if either of the following
occurs:
(a) There is no FDA-licensed interchangeable biological drug
product for the product prescribed.
(b) A refill authorization does not change the product that
was dispensed on the prior filling of the prescription.
(7) The board shall maintain a link on its website to the
current Purple Book.
(8) Beginning June 1, 2018 and annually thereafter, the
department shall submit a report on all of the following to the
house and senate standing committees on health policy, the speaker
of the house of representatives, and the senate majority leader:
(a) A list of each biological drug product that the FDA had
previously determined to be therapeutically equivalent as set forth
in the Orange Book that is now included in the Purple Book.
(b) The anticipated date that every biological drug product
that the FDA has determined to be therapeutically equivalent as set
forth in the Orange Book will be included in the Purple Book.
(9) As used in this section:
(a) "Orange Book" means "Approved Drug Products with
Therapeutic
Equivalence Evaluations," Evaluations",
an FDA
publication that is commonly referred to as the "Orange Book".
(b) "Purple Book" means "Lists of Licensed Biological Products
with Reference Product Exclusivity and Biosimilarity or
Interchangeability Evaluations", an FDA publication that is
commonly referred to as the "Purple Book".
Enacting section 1. This amendatory act takes effect 90 days
after the date it is enacted into law.