House
File
2253
-
Introduced
HOUSE
FILE
2253
BY
LUNDGREN
A
BILL
FOR
An
Act
relating
to
price
transparency
for
prescription
drugs
1
sold
in
this
state,
and
including
applicability
provisions.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
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Section
1.
NEW
SECTION
.
510D.1
Definitions.
1
As
used
in
this
chapter,
unless
the
context
otherwise
2
requires:
3
1.
“Commissioner”
means
the
commissioner
of
insurance.
4
2.
“Dispenser”
means
the
same
as
defined
in
21
U.S.C.
5
§360eee(3).
6
3.
“Established
name”
means
the
same
as
defined
in
21
C.F.R.
7
299.4.
8
4.
“Health
benefit
plan”
means
the
same
as
defined
in
9
514J.102.
10
5.
“Pharmaceutical
drug
manufacturer”
or
“manufacturer”
means
11
any
person
engaged
in
the
business
of
producing,
preparing,
12
converting,
processing,
packaging,
labeling,
or
distributing
13
a
prescription
drug.
“Pharmaceutical
drug
manufacturer”
or
14
“manufacturer”
does
not
include
a
wholesale
distributor
or
a
15
dispenser.
16
6.
“Prescription
drug”
means
the
same
as
defined
in
21
17
U.S.C.
§360eee(12).
18
7.
“Wholesale
acquisition
cost”
or
“cost”
means
a
19
manufacturer’s
list
price
for
a
prescription
drug
for
20
wholesalers
or
direct
purchasers
in
the
United
States,
not
21
including
prompt
pay
or
other
discounts,
rebates,
or
reductions
22
in
price,
for
the
most
recent
month
for
which
the
information
23
is
available,
as
reported
in
wholesale
price
guides
or
other
24
publications
of
drug
or
biological
pricing
data.
25
8.
“Wholesale
distributor”
means
the
same
as
defined
in
21
26
U.S.C.
§360eee(29).
27
Sec.
2.
NEW
SECTION
.
510D.2
Pharmaceutical
drug
28
manufacturers
——
annual
report.
29
Each
manufacturer
shall
provide
an
annual
report
by
30
February
15
to
the
commissioner,
in
a
format
prescribed
31
by
the
commissioner,
that
contains
the
current
wholesale
32
acquisition
cost
for
each
prescription
drug
manufactured
by
the
33
manufacturer
that
was
sold
to
a
person
in
this
state
in
the
34
immediately
preceding
calendar
year.
Within
thirty
calendar
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days
of
receipt,
the
commissioner
shall
publish
the
information
1
received
by
the
commissioner
on
a
publicly
accessible
internet
2
site.
3
Sec.
3.
NEW
SECTION
.
510D.3
Wholesale
acquisition
cost
4
increase
——
report.
5
1.
If
a
prescription
drug
sold
to
a
person
in
this
state
6
has
a
wholesale
acquisition
cost
of
one
hundred
dollars
or
7
more
for
a
thirty-day
supply
and
the
cost
increases
forty
8
percent
or
more
over
three
consecutive
calendar
years,
or
9
increases
fifteen
percent
or
more
in
a
single
calendar
year,
10
the
manufacturer
of
the
prescription
drug
shall
file
a
report
11
with
the
commissioner
within
thirty
calendar
days
of
the
date
12
on
which
the
forty
or
the
fifteen
percent
increase
in
the
cost
13
occurs.
The
report
shall
be
in
the
form
and
manner
prescribed
14
by
the
commissioner
and
shall
include
all
of
the
following
15
information:
16
a.
The
established
name
of
the
prescription
drug.
17
b.
All
brand
names,
generic
names,
proprietary
names,
and
18
nonproprietary
names
for
the
prescription
drug,
as
applicable.
19
c.
The
aggregate
manufacturer-level
research
and
development
20
costs
related
to
the
prescription
drug
for
the
most
recent
21
calendar
year
for
which
third-party
independent
audit
data
for
22
manufacturer-level
research
and
development
costs
is
available.
23
d.
All
established
names,
brand
names,
generic
names,
24
proprietary
names,
and
nonproprietary
names
for
each
25
prescription
drug
manufactured
by
the
manufacturer
that
26
received
approval
from
the
United
States
food
and
drug
27
administration
in
the
immediately
preceding
three
consecutive
28
calendar
years.
29
e.
All
established
names,
brand
names,
generic
names,
30
proprietary
names,
and
nonproprietary
names
for
each
31
prescription
drug
manufactured
by
the
manufacturer
for
which
32
a
patent
or
exclusivity
expired
in
the
immediately
preceding
33
three
consecutive
calendar
years.
34
f.
A
statement
detailing
the
factor
or
factors
that
played
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any
role
in
the
increase
in
cost
of
the
prescription
drug
1
and
an
explanation
for
the
factor
or
factors’
impact
on
the
2
increase
in
cost
of
the
prescription
drug.
3
2.
All
information
and
data
a
manufacturer
submits
to
the
4
commissioner
must
be
consistent
in
detail
and
quality
with
the
5
information
and
data
submitted
in
the
manufacturer’s
annual
6
report
filed
with
the
United
States
securities
and
exchange
7
commission
on
form
10-k.
8
3.
a.
Information
provided
by
a
pharmaceutical
drug
9
manufacturer
to
the
commissioner
pursuant
to
this
section
10
that
may
reveal
any
of
the
following
as
related
to
a
specific
11
prescription
drug
or
class
of
prescription
drugs
shall
12
be
considered
a
confidential
record,
and
be
recognized
13
and
protected
as
a
trade
secret
pursuant
to
section
22.7,
14
subsection
3:
15
(1)
The
amount
the
manufacturer
charges
a
specific
health
16
carrier,
specific
pharmacy
benefit
manager,
or
a
specific
17
dispenser.
18
(2)
The
dollar
value
of
the
rebates
the
manufacturer
19
provides
a
specific
health
carrier,
specific
pharmacy
benefit
20
manager,
or
a
specific
dispenser.
21
(3)
The
identity
of
a
specific
health
carrier,
specific
22
pharmacy
benefit
manager,
or
a
specific
dispenser.
23
b.
Within
sixty
calendar
days
of
receipt
of
the
information
24
pursuant
to
this
section,
the
commissioner
shall
publish
all
25
nonconfidential
information
received
by
the
commissioner
on
the
26
same
publicly
accessible
internet
site
referenced
in
section
27
510D.2.
28
Sec.
4.
NEW
SECTION
.
510D.4
Rules.
29
The
commissioner
shall
adopt
rules
pursuant
to
chapter
17A
30
as
necessary
to
administer
this
chapter.
31
Sec.
5.
NEW
SECTION
.
510D.5
Enforcement.
32
The
commissioner
may
take
any
action
within
the
33
commissioner’s
authority
to
enforce
compliance
with
this
34
chapter.
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Sec.
6.
NEW
SECTION
.
510E.1
Definitions.
1
As
used
in
this
chapter
unless
the
context
otherwise
2
requires:
3
1.
“Commissioner”
means
the
commissioner
of
insurance.
4
2.
“Covered
person”
means
the
same
as
defined
in
section
5
514J.102.
6
3.
“Health
benefit
plan”
means
the
same
as
defined
in
7
section
514J.102.
8
4.
“Health
care
professional”
means
the
same
as
defined
in
9
section
514J.102.
10
5.
“Health
carrier”
means
the
same
as
defined
in
section
11
514J.102.
12
6.
“Pharmaceutical
drug
manufacturer”
or
“manufacturer”
means
13
any
person
engaged
in
the
business
of
producing,
preparing,
14
converting,
processing,
packaging,
labeling,
or
distributing
15
a
prescription
drug.
“Pharmaceutical
drug
manufacturer”
or
16
“manufacturer”
does
not
include
a
wholesale
distributor
or
a
17
dispenser.
18
7.
“Prescription
drug”
means
the
same
as
defined
in
21
19
U.S.C.
§360eee(12).
20
8.
“Prescription
drug
benefit”
means
a
health
benefit
21
plan
providing
for
third-party
payment
or
prepayment
for
22
prescription
drugs.
23
9.
“Specialty
drug”
means
a
prescription
drug
that
a
health
24
carrier
has
designated
as
a
specialty
drug
and
that
has
either
25
of
the
following
characteristics:
26
a.
The
United
States
food
and
drug
administration
has
27
designated
the
prescription
drug
an
orphan
drug.
28
b.
The
manufacturer
of
the
prescription
drug
or
the
United
29
States
food
and
drug
administration
restricts
distribution
of
30
the
prescription
drug
to
a
limited
number
of
distributors.
31
10.
“Utilization
review”
means
the
same
as
defined
in
32
section
514F.7.
33
11.
“Utilization
review
organization”
means
the
same
as
34
defined
in
section
514F.7.
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Sec.
7.
NEW
SECTION
.
510E.2
Health
carriers
——
annual
1
report.
2
1.
Each
health
carrier
shall
submit
an
annual
report
3
by
February
1
to
the
commissioner,
in
the
form
and
manner
4
prescribed
by
the
commissioner,
that
contains
the
following
5
information
for
the
immediately
preceding
calendar
year,
across
6
all
of
the
health
carrier’s
health
benefit
plans
that
offer
a
7
prescription
drug
benefit:
8
a.
The
brand
name
of
the
twenty-five
prescription
drugs
most
9
frequently
covered
by
the
prescription
drug
benefits
offered
10
by
the
health
carrier.
11
b.
The
percent
increase
in
annual
spending
by
the
health
12
carrier
to
provide
all
prescription
drug
benefits
offered
by
13
the
health
carrier.
14
c.
The
percent
increase
in
premiums
paid
by
covered
persons
15
attributable
to
all
prescription
drug
benefits
offered
by
the
16
health
carrier.
17
d.
The
percentage
of
specialty
drugs
included
in
all
18
prescription
drug
benefits
offered
by
the
health
carrier
that
19
are
subject
to
utilization
review
conducted
by
a
utilization
20
review
organization.
21
e.
The
percent
decrease
in
premiums
paid
by
covered
persons
22
attributable
to
specialty
drugs
that
are
subject
to
utilization
23
review
conducted
by
a
utilization
review
organization
that
24
are
included
in
all
prescription
drug
benefits
offered
by
the
25
health
carrier.
26
2.
Any
information
a
health
carrier
provides
to
the
27
commissioner
pursuant
to
subsection
1
that
may
reveal
any
of
28
the
following
shall
be
considered
a
confidential
record,
and
be
29
recognized
and
protected
as
a
trade
secret
pursuant
to
section
30
22.7:
31
a.
The
identity
of
a
specific
health
benefit
plan.
32
b.
The
identity
of
the
specific
price
charged
by
a
specific
33
manufacturer,
pharmacy
benefit
manager,
or
dispenser
for
a
34
specific
prescription
drug
or
class
of
prescription
drugs.
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c.
The
dollar
value
of
the
rebates
a
specific
manufacturer,
1
a
specific
pharmacy
benefit
manager,
or
a
specific
dispenser
2
provides
to
the
health
carrier.
3
3.
Prior
to
May
1
of
each
calendar
year,
the
commissioner
4
shall
publish
the
nonconfidential
data
received
by
the
5
commissioner
pursuant
to
this
section
on
the
same
publicly
6
accessible
internet
site
referenced
in
section
510D.2.
The
7
data
shall
be
aggregated
from
all
annual
reports
submitted
8
pursuant
to
subsection
1,
and
the
information
shall
be
9
made
available
to
the
public
in
a
format
that
complies
with
10
subsection
2.
11
Sec.
8.
NEW
SECTION
.
510E.3
Rules.
12
The
commissioner
shall
adopt
rules
pursuant
to
chapter
17A
13
as
necessary
to
administer
this
chapter.
14
Sec.
9.
NEW
SECTION
.
510E.4
Enforcement.
15
The
commissioner
may
take
any
action
within
the
16
commissioner’s
authority
to
enforce
compliance
with
this
17
chapter.
18
Sec.
10.
APPLICABILITY.
19
1.
The
section
of
the
Act
that
requires
a
pharmaceutical
20
drug
manufacturer
to
submit
an
annual
report
to
the
21
commissioner
containing
the
current
wholesale
acquisition
cost
22
for
each
of
the
manufacturer’s
prescription
drugs
is
applicable
23
to
all
manufacturers
that
manufactured
any
prescription
drug
24
that
is
sold
to
a
person
in
this
state
on
or
after
January
1,
25
2021.
26
2.
The
section
of
the
Act
that
requires
a
pharmaceutical
27
drug
manufacturer
to
submit
an
annual
report
to
the
28
commissioner
containing
information
related
to
an
increase
29
in
the
wholesale
acquisition
cost
of
a
prescription
drug
30
manufactured
by
the
manufacturer
is
applicable
to
all
31
manufacturers
that
manufactured
any
prescription
drug
that
is
32
sold
to
a
person
in
this
state
on
or
after
January
1,
2021.
33
3.
The
section
of
the
Act
that
requires
a
health
carrier
34
to
submit
an
annual
report
to
the
commissioner
related
to
all
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of
the
health
carrier’s
health
benefit
plans
that
offer
a
1
prescription
drug
benefit
is
applicable
to
all
health
benefit
2
plans
providing
for
third-party
payment
or
prepayment
of
health
3
or
medical
expenses
that
provide
a
prescription
drug
benefit
4
that
have
been
delivered,
issued
for
delivery,
continued,
or
5
renewed
in
this
state
on
or
after
January
1,
2021.
6
EXPLANATION
7
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
8
the
explanation’s
substance
by
the
members
of
the
general
assembly.
9
This
bill
relates
to
price
transparency
for
prescription
10
drugs
sold
in
this
state.
11
The
bill
requires
a
manufacturer
to
file
an
annual
report
12
with
the
commissioner
of
insurance
(commissioner)
that
13
discloses
the
wholesale
acquisition
cost
for
all
prescription
14
drugs
manufactured
by
the
manufacturer
that
were
sold
to
a
15
person
in
this
state
in
the
immediately
preceding
calendar
16
year.
“Wholesale
acquisition
cost”
or
“cost”
is
defined
in
the
17
bill
as
the
manufacturer’s
list
price
for
a
prescription
drug
18
for
wholesalers
or
direct
purchasers
in
the
United
States,
not
19
including
prompt
pay
or
other
discounts,
rebates,
or
reductions
20
in
price,
for
the
most
recent
month
for
which
the
information
21
is
available,
as
reported
in
wholesale
price
guides
or
other
22
publications
of
drug
or
biological
pricing
data.
Within
30
23
calendar
days
of
receipt,
the
commissioner
is
required
to
24
publish
this
information
from
the
annual
reports
on
a
publicly
25
accessible
internet
site.
26
If
a
prescription
drug
sold
to
a
person
in
this
state
has
a
27
cost
of
$100
or
more
for
a
30-day
supply
and
the
cost
increases
28
40
percent
or
more
over
three
consecutive
calendar
years,
or
29
increases
15
percent
or
more
in
a
single
calendar
year,
the
30
manufacturer
of
the
prescription
drug
must
file
a
report
with
31
the
commissioner
within
30
calendar
days
of
the
date
on
which
32
the
40
or
15
percent
increase
in
cost
occurs.
This
requirement
33
is
applicable
to
all
manufacturers
that
manufactured
34
prescription
drugs
that
are
sold
to
a
person
in
this
state
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on
or
after
January
1,
2021.
The
report
must
include
the
1
information
detailed
in
the
bill.
Certain
information
provided
2
by
a
manufacturer,
as
detailed
in
the
bill,
is
considered
a
3
confidential
record
and
is
required
to
be
protected
as
a
trade
4
secret.
Within
60
calendar
days
of
receipt,
the
commissioner
5
is
required
to
publish
the
nonconfidential
information
on
6
the
same
publicly
accessible
internet
site
on
which
the
7
manufacturer’s
annual
report
information
is
published.
8
The
bill
requires
each
health
carrier
to
submit
an
annual
9
report
by
February
1
to
the
commissioner
that
contains
10
information
as
detailed
in
the
bill
across
all
of
the
health
11
carrier’s
health
benefit
plans.
This
requirement
is
applicable
12
to
all
health
benefit
plans
providing
for
third-party
payment
13
or
prepayment
of
health
or
medical
expenses
that
provide
a
14
prescription
drug
benefit
that
have
been
delivered,
issued
15
for
delivery,
continued,
or
renewed
in
this
state
on
or
after
16
January
1,
2021.
“Health
carrier”
is
defined
in
the
bill
as
an
17
entity
subject
to
the
insurance
laws
and
regulations
of
this
18
state,
or
subject
to
the
jurisdiction
of
the
commissioner,
19
including
an
insurance
company
offering
sickness
and
accident
20
plans,
a
health
maintenance
organization,
a
nonprofit
health
21
service
corporation,
a
plan
established
pursuant
to
Code
22
chapter
509A
for
public
employees,
or
any
other
entity
23
providing
a
plan
of
health
insurance,
health
care
benefits,
24
or
health
care
services.
Certain
information
provided
by
25
a
health
carrier,
as
detailed
in
the
bill,
is
considered
a
26
confidential
record
and
must
be
protected
as
a
trade
secret.
27
Prior
to
May
1
of
each
year,
the
commissioner
must
publish
the
28
nonconfidential
data
received
by
the
commissioner
on
the
same
29
publicly
accessible
internet
site
on
which
the
manufacturers’
30
information
is
published.
The
data
must
be
aggregated
from
the
31
annual
reports
submitted
by
all
health
carriers.
32
The
bill
directs
the
commissioner
to
adopt
rules
as
33
necessary
to
administer
the
requirements
outlined
in
the
34
bill
and
allows
the
commissioner
to
take
any
action
within
35
-8-
LSB
5492YH
(2)
88
ko/rn
8/
9
H.F.
2253
the
commissioner’s
authority
to
enforce
compliance
with
the
1
requirements
outlined
in
the
bill.
2
-9-
LSB
5492YH
(2)
88
ko/rn
9/
9