Bill Text: IA SF2238 | 2023-2024 | 90th General Assembly | Introduced
Bill Title: A bill for an act relating to prescription drug affordability, including the creation of a prescription drug affordability board.
Spectrum: Partisan Bill (Democrat 5-0)
Status: (Introduced - Dead) 2024-02-08 - Subcommittee: Edler, Costello, and Donahue. S.J. 253. [SF2238 Detail]
Download: Iowa-2023-SF2238-Introduced.html
Senate
File
2238
-
Introduced
SENATE
FILE
2238
BY
DONAHUE
,
TRONE
GARRIOTT
,
PETERSEN
,
JOCHUM
,
and
WAHLS
A
BILL
FOR
An
Act
relating
to
prescription
drug
affordability,
including
1
the
creation
of
a
prescription
drug
affordability
board.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
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Section
1.
NEW
SECTION
.
135S.1
Definitions.
1
As
used
in
this
chapter,
unless
the
context
otherwise
2
requires:
3
1.
“Biologic”
means
a
drug
that
is
produced
or
distributed
4
in
accordance
with
a
biologics
license
issued
under
42
C.F.R.
5
§601.4.
6
2.
“Biosimilar”
means
a
drug
that
is
produced
or
distributed
7
in
accordance
with
a
biologics
license
application
approved
8
under
42
C.F.R.
§262(k)(3).
9
3.
“Brand-name
drug”
means
a
drug
that
is
produced
or
10
distributed
in
accordance
with
an
original
new
drug
application
11
approved
under
21
U.S.C.
§355(c).
“Brand-name
drug”
does
not
12
include
an
authorized
generic
drug
as
defined
by
42
C.F.R.
13
§447.502.
14
4.
“Drug
product”
means
a
brand-name
drug,
a
generic
drug,
a
15
biologic
or
biosimilar,
or
an
over-the-counter
drug.
16
5.
“Employee
retirement
income
security
Act
plan”
or
“ERISA
17
plan”
means
any
self-funded
employee
welfare
benefit
plan
18
governed
by
the
requirements
of
the
Employee
Retirement
Income
19
Security
Act
of
1974,
as
codified
at
29
U.S.C.
§1001
et
seq.
20
6.
“Generic
drug”
means
any
of
the
following:
21
a.
A
retail
drug
that
is
marketed
or
distributed
in
22
accordance
with
an
abbreviated
new
drug
application,
approved
23
under
21
U.S.C.
§355(j).
24
b.
An
authorized
generic
drug
as
defined
by
42
C.F.R.
25
§447.502.
26
c.
A
drug
that
entered
the
market
before
1962
that
was
not
27
originally
marketed
under
a
new
drug
application.
28
7.
“Manufacturer”
means
an
entity
that
engages
in
the
29
manufacture
of
a
drug
product,
or
that
enters
into
a
lease
with
30
another
manufacturer
to
market
and
distribute
a
prescription
31
drug
product
under
the
entity’s
own
name,
and
that
sets
or
32
changes
the
wholesale
acquisition
cost
of
the
prescription
drug
33
product
it
manufactures
or
markets.
34
8.
“Over-the-counter
drug”
means
the
same
as
defined
in
42
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C.F.R.
§447.502.
1
9.
“Prescription
drug
affordability
board”
or
“board”
means
2
the
prescription
drug
affordability
board
created
in
section
3
135S.2.
4
10.
“Prescription
drug
affordability
stakeholder
council”
or
5
“stakeholder
council”
means
the
prescription
drug
affordability
6
stakeholder
council
created
in
section
135S.4.
7
11.
“Prescription
drug
product”
means
a
brand-name
drug,
a
8
generic
drug,
a
biologic,
or
a
biosimilar.
9
Sec.
2.
NEW
SECTION
.
135S.2
Prescription
drug
affordability
10
board.
11
1.
A
prescription
drug
affordability
board
is
created
12
for
the
purpose
of
protecting
state
residents,
particularly
13
patients
experiencing
physical
and
mental
illnesses
and
14
communities
affected
by
the
opioid
crisis;
state
and
local
15
governments;
commercial
health
plans;
health
care
providers;
16
pharmacies;
and
other
stakeholders
within
the
health
care
17
system
from
the
high
costs
of
prescription
drug
products.
18
2.
The
board
shall
be
composed
of
five
members,
appointed
by
19
the
governor,
subject
to
confirmation
by
the
senate,
who
have
20
expertise
in
health
care,
health
care
economics,
or
clinical
21
medicine.
A
member
shall
not
be
an
employee
of,
a
board
member
22
of,
or
a
consultant
to,
a
manufacturer
or
trade
association
23
for
manufacturers.
Any
conflict
of
interest,
including
24
whether
an
individual
has
an
association
such
as
a
financial
25
or
personal
association
that
has
the
potential
to
bias
or
has
26
the
appearance
of
biasing
the
individual’s
decisions
in
matters
27
related
to
the
board
or
the
conduct
of
the
board’s
activities
28
shall
be
disclosed
and
considered
when
appointing
members
to
29
the
board.
30
3.
The
members
shall
serve
five-year
terms
beginning
and
31
ending
as
provided
in
section
69.19.
Membership
on
the
board
32
shall
be
bipartisan
as
provided
in
section
69.16
and
gender
33
balanced
as
provided
in
section
69.16A.
Vacancies
shall
be
34
filed
in
the
manner
of
the
original
appointment.
The
board
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shall
select
a
chairperson
annually.
1
4.
The
board
shall
hire
an
executive
director,
general
2
counsel,
and
staff
to
support
the
board’s
activities,
who
shall
3
each
receive
a
salary
as
provided
in
the
budget
for
the
board.
4
Each
member
of
the
board
shall
receive
a
per
diem
and
shall
be
5
reimbursed
for
all
actual
and
necessary
expenses
incurred
in
6
the
performance
of
their
duties
as
a
member.
7
5.
A
majority
of
the
members
of
the
board
shall
constitute
8
a
quorum
for
the
purposes
of
conducting
the
business
of
the
9
board.
10
6.
The
board
shall
meet
in
open
session
at
least
four
times
11
annually
to
review
prescription
drug
product
information.
The
12
following
provisions
shall
also
apply
to
meetings
of
the
board:
13
a.
The
chairperson
may
cancel
or
postpone
a
meeting
if
there
14
is
no
business
to
transact.
15
b.
The
following
actions
by
the
board
shall
be
made
in
open
16
session:
17
(1)
Deliberations
on
whether
to
subject
a
prescription
drug
18
product
to
an
affordability
review.
19
(2)
Any
vote
on
whether
to
recommend
imposing
an
upper
20
payment
limit
on
purchases
and
payer
reimbursements
of
21
prescription
drug
products
in
the
state.
22
(3)
Any
significant
decision
by
the
board.
23
7.
The
board
may
meet
in
closed
session
to
discuss
24
proprietary
data
and
information.
25
8.
The
board
shall
provide
public
notice
of
each
board
26
meeting
at
least
two
weeks
in
advance
of
the
meeting.
27
Materials
for
each
meeting
shall
be
made
available
to
the
28
public
at
least
one
week
in
advance
of
the
meeting.
29
9.
The
board
shall
provide
an
opportunity
for
public
comment
30
at
each
open
meeting
of
the
board.
The
board
shall
provide
31
the
public
with
the
opportunity
to
submit
written
comments
on
32
pending
decisions
of
the
board.
33
10.
The
board
may
allow
expert
testimony
at
its
meetings,
34
including
when
the
board
meets
in
closed
session.
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11.
a.
Members
of
the
board
shall
recuse
themselves
from
1
decisions
related
to
prescription
drug
products
if
the
member,
2
or
an
immediate
family
member
of
the
member,
has
received
or
3
could
receive
either
of
the
following:
4
(1)
A
direct
financial
benefit
of
any
amount
deriving
from
5
the
result
or
finding
of
a
study
or
determination
by
or
for
the
6
board.
7
(2)
A
financial
benefit
from
any
person
that
owns,
8
manufactures,
or
provides
prescription
drug
products,
services,
9
or
items
to
be
studied
by
the
board
that
in
the
aggregate
10
exceeds
five
thousand
dollars
per
year.
11
b.
For
the
purposes
of
this
subsection,
a
financial
benefit
12
includes
honoraria,
fees,
stock,
the
value
of
the
member’s
13
or
immediate
family
member’s
stock
holdings,
and
any
direct
14
financial
benefit
deriving
from
the
finding
of
a
review
15
conducted
pursuant
to
this
chapter.
16
12.
a.
A
conflict
of
interest
shall
be
disclosed
by
the
17
board
when
hiring
board
staff,
by
the
appointing
authority
when
18
appointing
members
to
the
board
and
to
the
stakeholder
council,
19
and
by
the
board
when
a
member
of
the
board
is
recused
in
any
20
final
decision
resulting
from
a
review
of
a
prescription
drug
21
product.
A
conflict
of
interest
shall
be
disclosed
in
advance
22
of
the
first
open
meeting
after
the
conflict
is
identified
or
23
within
five
days
after
the
conflict
is
identified,
whichever
24
is
sooner.
25
b.
A
conflict
of
interest
disclosed
pursuant
to
this
section
26
shall
be
posted
on
the
internet
site
of
the
board
unless
the
27
chair
of
the
board
recuses
the
member
from
any
final
decision
28
resulting
from
a
review
of
a
prescription
drug
product.
Such
29
posting
shall
include
the
type,
nature,
and
magnitude
of
the
30
interests
of
the
member
involved.
31
13.
Members
of
the
board,
the
executive
director,
the
32
general
counsel,
board
staff,
and
third-party
contractors
shall
33
not
accept
any
gift
or
donation
of
services
or
property
that
34
indicates
a
potential
conflict
of
interest,
or
that
has
the
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appearance
of
biasing
the
work
of
the
board.
1
Sec.
3.
NEW
SECTION
.
135S.3
Powers
and
duties
of
the
board.
2
1.
To
the
extent
practicable,
the
board
shall
access
pricing
3
information
for
prescription
drug
products
by
doing
all
of
the
4
following:
5
a.
Entering
into
a
memorandum
of
understanding
with
6
another
state
to
which
manufacturers
already
report
pricing
7
information.
8
b.
Assessing
spending
for
prescription
drugs
in
the
state.
9
c.
Accessing
other
available
pricing
information
based
on
10
state
reporting
and
transparency
requirements.
11
2.
The
board
may
enter
into
a
contract
with
a
qualified,
12
independent
third
party
for
any
service
necessary
to
carry
13
out
the
powers
and
duties
of
the
board.
Unless
permission
is
14
granted
by
the
board,
a
third
party
hired
by
the
board
shall
15
not
release,
publish,
or
otherwise
use
any
information
to
which
16
the
third
party
has
access
under
its
contract
with
the
board.
17
3.
The
board
shall
adopt
rules
pursuant
to
chapter
17A
to
18
administer
this
chapter.
19
Sec.
4.
NEW
SECTION
.
135S.4
Prescription
drug
affordability
20
stakeholder
council.
21
1.
The
board
shall
create
a
prescription
drug
affordability
22
stakeholder
council
for
the
purpose
of
providing
stakeholder
23
input
to
assist
the
board
in
making
decisions
as
required
24
under
this
chapter.
The
stakeholder
council
shall
consist
of
25
nineteen
members
appointed
in
accordance
with
this
section.
26
Members
shall
include
manufacturers
of
brand-name
and
generic
27
prescription
drugs,
health
care
providers
that
dispense
or
28
administer
prescription
drugs,
prescription
drug
suppliers,
29
and
consumers
of
prescription
drugs.
A
single
organization
30
or
entity
shall
not
be
represented
by
more
than
one
council
31
member.
32
2.
a.
Three
members
shall
be
appointed
by
the
majority
33
leader
of
the
senate,
two
members
shall
be
appointed
by
the
34
minority
leader
of
the
senate,
four
members
shall
be
appointed
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by
the
speaker
of
the
house
of
representatives,
three
members
1
shall
be
appointed
by
the
minority
leader
of
the
house
of
2
representatives,
and
seven
members
shall
be
appointed
by
the
3
governor,
subject
to
confirmation
by
the
senate.
4
b.
The
members
of
the
stakeholder
council
shall
have
5
knowledge
in
one
or
more
of
the
following
subjects:
6
(1)
The
pharmaceutical
business
model.
7
(2)
Supply
chain
business
models.
8
(3)
The
practice
of
medicine
or
clinical
training.
9
(4)
Consumer
or
patient
perspectives.
10
(5)
Health
care
costs
trends
and
drivers.
11
(6)
Clinical
and
health
services
research.
12
(7)
The
state’s
health
care
marketplace.
13
c.
The
stakeholder
council
shall
select
a
chairperson
and
14
a
co-chairperson
annually
from
the
council
membership.
The
15
members
shall
serve
three-year
staggered
terms.
16
d.
A
member
of
the
stakeholder
council
shall
not
receive
17
a
per
diem
but
shall
be
reimbursed
for
actual
and
necessary
18
expenses
incurred
in
the
performance
of
duties
as
a
member.
19
Sec.
5.
NEW
SECTION
.
135S.5
Drug
cost
affordability
review.
20
1.
The
board
shall
identify
the
following
prescription
drug
21
products
offered
for
sale
in
the
state:
22
a.
Brand-name
drugs
or
biologics
that,
as
adjusted
annually
23
for
inflation
in
accordance
with
the
consumer
price
index,
have
24
a
launch
wholesale
acquisition
cost
of
thirty
thousand
dollars
25
or
more
per
year
or
per
course
of
treatment,
or
a
wholesale
26
acquisition
cost
increase
of
three
thousand
dollars
or
more
in
27
any
consecutive
twelve-month
period.
28
b.
Biosimilar
drugs
that
have
a
launch
wholesale
acquisition
29
cost
that
is
not
at
least
fifteen
percent
lower
than
the
30
referenced
brand
biologic
at
the
time
the
biosimilar
is
31
launched.
32
c.
(1)
Generic
drugs
that,
as
adjusted
for
inflation
in
33
accordance
with
the
consumer
price
index,
have
a
wholesale
34
acquisition
cost
of
one
hundred
dollars
or
more
for
any
of
the
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following:
1
(a)
A
thirty-day
supply
lasting
a
patient
for
a
period
2
of
thirty
consecutive
days
based
on
the
recommended
dosage
3
approved
for
labeling
by
the
United
States
food
and
drug
4
administration.
5
(b)
A
supply
lasting
a
patient
fewer
than
thirty
consecutive
6
days
based
on
the
recommended
dosage
approved
for
labeling
by
7
the
United
States
food
and
drug
administration.
8
(c)
One
unit
of
the
drug
if
the
labeling
approved
by
the
9
United
States
food
and
drug
administration
does
not
recommend
10
any
finite
dosage.
11
(2)
Generic
drugs
that,
as
adjusted
for
inflation
in
12
accordance
with
the
consumer
price
index,
have
a
wholesale
13
acquisition
cost
that
increased
by
two
hundred
percent
or
14
more
during
the
immediately
preceding
twelve-month
period,
as
15
determined
by
the
difference
between
the
resulting
wholesale
16
acquisition
cost
and
the
average
of
the
wholesale
acquisition
17
cost
reported
over
the
immediately
preceding
twelve
months.
18
d.
Other
prescription
drug
products
that
may
create
19
affordability
challenges
for
the
state
health
care
system
and
20
for
patients,
including
drugs
used
to
address
public
health
21
emergencies.
22
2.
a.
After
identifying
prescription
drug
products
as
23
required
by
subsection
1,
the
board
shall
determine
whether
24
to
conduct
an
affordability
review
for
each
identified
25
prescription
drug
product
by
seeking
stakeholder
council
input
26
about
the
prescription
drug
product
and
considering
the
average
27
patient
cost
share
of
the
prescription
drug
product.
28
b.
Relevant
information
for
conducting
an
affordability
29
review
may
include
any
document
or
research
related
to
the
30
manufacturer’s
selection
of
the
introductory
price
or
a
price
31
increase
of
the
prescription
drug
product,
including
lifecycle
32
management,
net
average
prices
in
the
state,
market
competition
33
and
context,
projected
revenue,
and
the
estimated
value
or
cost
34
effectiveness
of
the
prescription
drug
product.
Failure
of
a
35
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manufacturer
to
provide
the
board
with
relevant
information
for
1
an
affordability
review
shall
not
affect
the
board’s
authority
2
to
conduct
such
a
review.
3
3.
An
affordability
review
conducted
by
the
board
shall
4
determine
whether
the
prescription
drug
product
that
is
fully
5
consistent
with
the
labeling
approved
by
the
United
States
food
6
and
drug
administration
or
standard
medical
practice
has
led
or
7
will
lead
to
affordability
challenges
for
the
state
health
care
8
system
or
high
out-of-pocket
costs
for
patients.
To
the
extent
9
practicable,
in
determining
whether
a
prescription
drug
product
10
has
led
or
will
lead
to
an
affordability
challenge,
the
board
11
shall
consider
the
following
factors:
12
a.
The
wholesale
acquisition
cost
for
the
prescription
drug
13
product
sold
in
the
state.
14
b.
The
average
monetary
price
concession,
discount,
or
15
rebate
the
manufacturer
provides,
or
is
expected
to
provide,
16
to
health
plans
in
the
state
as
reported
by
manufacturers
17
and
health
plans,
expressed
as
a
percentage
of
the
wholesale
18
acquisition
cost
for
the
prescription
drug
product
under
19
review.
20
c.
The
total
amount
of
the
price
concession,
discount,
or
21
rebate
the
manufacturer
provides
to
each
pharmacy
benefits
22
manager
operating
in
the
state
for
the
prescription
drug
23
product
under
review,
as
reported
by
manufacturers
and
pharmacy
24
benefits
managers,
expressed
as
a
percentage
of
the
wholesale
25
acquisition
cost
for
the
prescription
drug
under
review.
26
d.
The
price
at
which
therapeutic
alternatives
have
been
27
sold
in
the
state.
28
e.
The
average
monetary
concession,
discount,
or
rebate
the
29
manufacturer
provides,
or
is
expected
to
provide,
to
health
30
plan
payors
and
pharmacy
benefits
managers
in
the
state
for
31
therapeutic
alternatives.
32
f.
The
cost
to
health
plans
based
on
patient
access
33
consistent
with
the
United
State
food
and
drug
administration
34
label
indications
and
recognized
standard
medical
practice.
35
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g.
The
impact
on
patient
access
resulting
from
the
cost
of
1
the
prescription
drug
product
relative
to
insurance
benefit
2
design.
3
h.
The
current
or
expected
dollar
value
of
drug-specific
4
patient
access
programs
that
are
supported
by
the
manufacturer.
5
i.
The
relative
financial
impacts
to
the
costs
of
health,
6
medical,
or
social
services
as
can
be
quantified
and
compared
7
to
baseline
effects
of
existing
therapeutic
alternatives.
8
j.
The
average
patient
copay
or
other
cost-sharing
for
the
9
prescription
drug
product
in
the
state.
10
k.
Any
information
a
manufacturer
chooses
to
provide.
11
l.
Any
other
factors
as
determined
by
the
board
through
12
rules
adopted
by
the
board.
13
4.
If
the
board
finds
that
the
spending
on
a
prescription
14
drug
product
reviewed
under
this
section
has
led
or
will
lead
15
to
an
affordability
challenge,
the
board
shall
submit
a
report
16
to
the
general
assembly
of
the
board’s
findings,
including
17
a
recommended
upper
payment
limit
for
the
prescription
drug
18
product.
The
upper
payment
limit
recommendation
shall
be
made
19
after
considering
the
cost
of
administering
the
prescription
20
drug
product,
the
cost
of
delivering
the
prescription
drug
21
product
to
consumers,
and
other
relevant
administrative
costs
22
related
to
the
prescription
drug
product.
23
5.
Any
information
submitted
to
the
board
in
accordance
with
24
this
section
shall
be
subject
to
public
inspection
only
to
the
25
extent
provided
under
section
22.1.
26
6.
This
section
shall
not
be
construed
to
prevent
a
27
manufacturer
from
marketing
a
prescription
drug
product
28
approved
by
the
United
States
food
and
drug
administration
in
29
this
state
while
the
prescription
drug
product
is
under
review
30
by
the
board.
31
Sec.
6.
NEW
SECTION
.
135S.6
Reporting
requirements.
32
1.
On
or
before
December
31,
2024,
and
annually
thereafter,
33
the
board
shall
submit
a
report
to
the
general
assembly
that
34
includes
all
of
the
following:
35
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a.
Price
trends
for
prescription
drug
products
sold,
1
distributed,
and
administered
in
the
state.
2
b.
Any
recommendations
regarding
further
legislation
needed
3
to
improve
prescription
drug
affordability
in
the
state.
4
2.
On
or
before
July
1,
2025,
the
board
shall
submit
5
a
report
to
the
general
assembly
on
the
operation
of
the
6
generic
drug
market
in
the
United
States,
including
a
review
7
of
physician-administered
drugs,
that
considers
the
prices
of
8
generic
drugs
on
a
year-over-year
basis,
the
degree
to
which
9
generic
drug
prices
affect
yearly
insurance
premium
changes,
10
annual
changes
in
insurance
cost-sharing
for
generic
drugs,
11
the
potential
for
and
history
of
drug
shortages,
the
degree
12
to
which
generic
drug
prices
affect
yearly
state
Medicaid
13
spending,
and
any
other
relevant
issues.
14
EXPLANATION
15
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
16
the
explanation’s
substance
by
the
members
of
the
general
assembly.
17
This
bill
relates
to
prescription
drug
affordability
18
measures,
including
the
creation
of
a
prescription
drug
19
affordability
board.
20
The
bill
provides
definitions
used
in
the
bill.
21
The
bill
creates
the
prescription
drug
affordability
board
22
(board)
for
the
purpose
of
protecting
stakeholders
within
the
23
health
care
system
from
the
high
costs
of
prescription
drug
24
products
(product
or
products).
The
bill
provides
for
the
25
membership
and
functioning
of
the
board;
the
hiring
of
an
26
executive
director
and
other
staff
for
the
board;
salaries,
27
per
diems,
and
reimbursement
of
expenses
of
the
executive
28
director,
general
counsel,
staff,
and
members;
and
other
29
provisions
that
apply
to
the
meetings
of
the
board.
The
board
30
shall
meet
in
open
session
at
least
four
times
annually
to
31
review
product
information,
and
may
meet
in
closed
session
to
32
discuss
proprietary
data
and
information.
The
board
shall
33
provide
public
notice
of
each
board
meeting
at
least
two
weeks
34
in
advance
of
the
meeting,
make
materials
for
each
meeting
35
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available
to
the
public
in
advance
of
the
meeting,
provide
an
1
opportunity
for
public
comment
at
each
open
meeting
of
the
2
board,
and
provide
the
opportunity
for
the
public
to
submit
3
written
comments
on
pending
decisions
of
the
board.
4
The
board
may
allow
expert
testimony
at
its
meetings,
5
including
when
the
board
meets
in
closed
session.
Members
6
of
the
board
shall
recuse
themselves
from
decisions
related
7
to
products
if
the
member,
or
an
immediate
family
member
of
8
the
member,
has
received
or
could
receive
certain
financial
9
benefits
from
the
work
of
the
board.
The
bill
provides
for
10
disclosure
of
conflicts
of
interest
relative
to
the
work
of
the
11
board,
and
prohibits
the
members
of
the
board,
the
executive
12
director,
the
general
counsel,
board
staff,
and
third-party
13
contractors
from
accepting
certain
gifts
or
donations.
14
The
bill
provides
that,
to
the
extent
practicable,
the
board
15
shall
access
pricing
information
for
products
through
various
16
means
including
by
entering
into
memoranda
of
understanding
17
with
another
state
to
which
manufacturers
already
report
18
pricing
information;
assessing
spending
for
prescription
19
drugs
in
this
state;
and
accessing
other
available
pricing
20
information
based
on
state
reporting
and
transparency
21
requirements.
The
board
may
enter
into
a
contract
with
a
22
qualified,
independent
third
party
for
any
service
necessary
to
23
carry
out
the
powers
and
duties
of
the
board,
and
shall
adopt
24
rules
to
administer
the
bill.
25
The
bill
requires
the
board
to
create
a
prescription
drug
26
affordability
stakeholder
council
(council)
to
assist
the
27
board
in
making
decisions.
The
council
shall
consist
of
19
28
members
including
manufacturers
of
brand-name
and
generic
29
prescription
drugs,
providers
that
dispense
or
administer
30
prescription
drugs,
prescription
drug
suppliers,
and
consumers
31
of
prescription
drugs.
Members
are
appointed
by
the
majority
32
leader
of
the
senate,
the
minority
leader
of
the
senate,
the
33
speaker
of
the
house
of
representatives,
the
minority
leader
of
34
the
house
of
representatives,
and
the
governor.
The
members
of
35
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2238
the
council
shall
have
knowledge
in
certain
areas
as
specified
1
in
the
bill.
The
bill
provides
for
the
annual
selection
of
a
2
chairperson
and
co-chairperson,
terms,
and
reimbursement
of
3
actual
and
necessary
expenses
of
the
members.
4
The
board
is
required
to
identify
certain
brand-name
drugs
5
or
biologics,
biosimilars,
generic
drugs,
and
other
products
6
that
may
create
affordability
challenges
for
the
state
health
7
care
system
and
for
patients,
including
drugs
used
to
address
8
public
health
emergencies.
9
After
identifying
the
products,
the
board
shall
determine
10
whether
to
conduct
an
affordability
review
by
seeking
council
11
input
about
the
product
and
considering
the
average
patient
12
cost
share
of
the
product.
The
bill
specifies
relevant
13
information
that
may
be
included
in
conducting
an
affordability
14
review.
If
the
board
finds
that
the
spending
on
a
product
15
reviewed
has
led
or
will
lead
to
an
affordability
challenge,
16
the
board
shall
submit
a
report
to
the
general
assembly
of
the
17
board’s
findings,
including
a
recommended
upper
payment
limit.
18
The
upper
pay
limit
for
the
product
shall
be
determined
by
19
considering
the
cost
of
administering
the
product,
the
cost
20
of
delivering
the
product
to
consumers,
and
other
relevant
21
administrative
costs
related
to
the
product.
Any
information
22
submitted
to
the
board
in
accordance
with
the
bill
is
subject
23
to
public
inspection
only
to
the
extent
provided
under
the
24
state’s
open
records
law.
25
The
bill
requires
the
board,
on
or
before
December
31,
2024,
26
and
annually
thereafter,
to
submit
to
the
general
assembly
a
27
report
that
includes
price
trends
for
products
in
the
state;
28
and
any
recommendations
regarding
further
legislation
needed
29
to
improve
prescription
drug
affordability
in
the
state.
On
30
or
before
July
1,
2025,
the
board
shall
submit
a
report
to
the
31
general
assembly
on
the
operation
of
the
generic
drug
market
in
32
the
United
States
that
considers
the
prices
of
generic
drugs
33
on
a
year-over-year
basis,
the
degree
to
which
generic
drug
34
prices
affect
yearly
insurance
premium
changes,
annual
changes
35
-12-
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5700XS
(7)
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13