House
File
526
-
Introduced
HOUSE
FILE
526
BY
COMMITTEE
ON
COMMERCE
(SUCCESSOR
TO
HSB
46)
A
BILL
FOR
An
Act
relating
to
price
transparency
and
cost-sharing
for
1
prescription
drugs,
and
including
applicability
provisions.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
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1115HV
(3)
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ko/rn
H.F.
526
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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526
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
more
7
for
a
thirty-day
supply
and
the
cost
increases
forty
percent
8
or
more
over
the
three
preceding
consecutive
calendar
years,
9
or
increases
fifteen
percent
or
more
in
the
preceding
calendar
10
year,
the
manufacturer
of
the
prescription
drug
shall
file
a
11
report
with
the
commissioner
within
thirty
calendar
days
of
the
12
date
on
which
the
forty
percent
or
the
fifteen
percent
increase
13
in
the
cost
occurs.
The
report
shall
be
in
the
form
and
manner
14
prescribed
by
the
commissioner
and
shall
include
all
of
the
15
following
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
35
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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
g.
The
aggregate
manufacturer-level
direct
and
4
administrative
costs
related
to
marketing
and
advertising
of
5
the
prescription
drug
for
the
immediately
preceding
calendar
6
year.
7
2.
All
information
and
data
a
manufacturer
submits
to
the
8
commissioner
must
be
consistent
in
detail
and
quality
with
the
9
information
and
data
submitted
in
the
manufacturer’s
annual
10
report
filed
with
the
United
States
securities
and
exchange
11
commission
on
form
10-k.
12
3.
a.
Information
provided
by
a
pharmaceutical
drug
13
manufacturer
to
the
commissioner
pursuant
to
this
section
14
that
may
reveal
any
of
the
following
as
related
to
a
specific
15
prescription
drug
or
class
of
prescription
drugs
shall
16
be
considered
a
confidential
record,
and
be
recognized
17
and
protected
as
a
trade
secret
pursuant
to
section
22.7,
18
subsection
3:
19
(1)
The
amount
the
manufacturer
charges
a
specific
health
20
carrier,
specific
pharmacy
benefit
manager,
or
a
specific
21
dispenser.
22
(2)
The
dollar
value
of
the
rebates
the
manufacturer
23
provides
a
specific
health
carrier,
specific
pharmacy
benefit
24
manager,
or
a
specific
dispenser.
25
(3)
The
identity
of
a
specific
health
carrier,
specific
26
pharmacy
benefit
manager,
or
a
specific
dispenser.
27
b.
Within
sixty
calendar
days
of
receipt
of
the
information
28
pursuant
to
this
section,
the
commissioner
shall
publish
all
29
nonconfidential
information
received
by
the
commissioner
on
the
30
same
publicly
accessible
internet
site
referenced
in
section
31
510D.2.
32
Sec.
4.
NEW
SECTION
.
510D.4
Rules.
33
The
commissioner
shall
adopt
rules
pursuant
to
chapter
17A
34
as
necessary
to
administer
this
chapter.
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Sec.
5.
NEW
SECTION
.
510D.5
Summary
enforcement.
1
1.
Upon
a
determination
by
the
commissioner
that
a
2
manufacturer
or
manufacturer’s
agent
has
engaged,
is
engaging,
3
or
is
about
to
engage
in
any
act
or
practice
in
violation
of
4
this
chapter,
a
rule
adopted
by
the
commissioner,
or
an
order
5
issued
by
the
commissioner
under
this
chapter,
the
commissioner
6
may
do
any
of
the
following:
7
a.
Issue
a
summary
order,
including
a
brief
statement
8
of
findings
of
fact
and
conclusions
of
law,
and
direct
the
9
manufacturer
or
manufacturer’s
agent
to
cease
and
desist
from
10
engaging
in
the
act
or
practice.
11
b.
Take
other
affirmative
action
that
in
the
judgment
of
12
the
commissioner
is
necessary
to
ensure
that
the
manufacturer
13
or
manufacturer’s
agent
comply
with
this
chapter,
and
rules
14
adopted
and
orders
issued
by
the
commissioner
under
this
15
chapter.
16
2.
a.
A
manufacturer
or
manufacturer’s
agent
that
has
17
been
issued
a
summary
order
under
this
section
may
contest
18
the
order
by
filing
a
request
for
a
contested
case
proceeding
19
and
hearing
as
provided
in
chapter
17A,
and
in
accordance
20
with
rules
adopted
by
the
commissioner.
The
manufacturer
or
21
manufacturer’s
agent
shall
have
at
least
thirty
calendar
days
22
from
the
date
that
the
summary
order
is
issued
to
file
the
23
request.
If
a
hearing
is
not
timely
requested,
the
summary
24
order
shall
be
final
by
operation
of
law.
25
b.
Section
17A.18A
shall
not
apply
to
a
summary
order
issued
26
under
this
section.
27
c.
A
summary
order
issued
pursuant
to
this
section
shall
28
remain
effective
from
the
date
of
issuance
unless
overturned
by
29
a
final
decision
of
a
presiding
officer
or
by
a
final
judgment
30
of
the
court.
31
3.
A
manufacturer
or
manufacturer’s
agent
violating
32
a
summary
order
issued
under
this
section
shall
be
deemed
33
in
contempt
of
that
order.
The
commissioner
may
petition
34
the
district
court
to
enforce
the
order
as
certified
by
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the
commissioner.
The
district
court
shall
adjudge
the
1
manufacturer
or
manufacturer’s
agent
in
contempt
of
the
order
2
if
the
court
finds
after
hearing
that
the
manufacturer
or
3
manufacturer’s
agent
is
not
in
compliance
with
the
order.
The
4
court
may
assess
a
civil
penalty
against
the
manufacturer
or
5
manufacturer’s
agent
of
not
more
than
one
thousand
dollars
6
per
day
for
each
day
that
the
manufacturer
or
manufacturer’s
7
agent
is
in
violation
of
the
order.
A
civil
penalty
collected
8
pursuant
to
this
section
shall
be
deposited
as
provided
in
9
section
505.7.
The
court
may
issue
further
orders
as
the
court
10
deems
appropriate.
11
Sec.
6.
NEW
SECTION
.
510D.6
Enforcement
after
hearing.
12
1.
If,
after
a
hearing
and
contested
case
proceeding
13
pursuant
to
section
510D.5,
subsection
2,
the
commissioner
14
determines
that
a
manufacturer
or
a
manufacturer’s
agent
15
violated
this
chapter,
a
rule
adopted
by
the
commissioner,
or
16
an
order
issued
by
the
commissioner
under
this
chapter,
the
17
commissioner
shall
reduce
the
findings
to
writing
and
shall
18
issue
and
cause
to
be
served
upon
the
manufacturer
or
the
19
manufacturer’s
agent
all
of
the
following:
20
a.
A
copy
of
the
commissioner’s
findings.
21
b.
An
order
requiring
the
manufacturer
or
the
manufacturer’s
22
agent
to
cease
and
desist
from
violating
this
chapter,
a
23
rule
adopted
by
the
commissioner,
or
an
order
issued
by
the
24
commissioner
under
this
chapter.
25
2.
The
commissioner
may
take
other
affirmative
action
that
26
in
the
judgment
of
the
commissioner
is
necessary
to
ensure
that
27
the
manufacturer
or
the
manufacturer’s
agent
complies
with
this
28
chapter.
The
commissioner
may
also,
at
the
commissioner’s
29
discretion,
order
payment
of
a
civil
penalty
of
not
more
than
30
five
thousand
dollars
for
each
violation
of
this
chapter
by
the
31
manufacturer
or
the
manufacturer’s
agent.
32
3.
A
manufacturer
or
a
manufacturer’s
agent
that
violates
33
an
order
of
the
commissioner,
and
while
such
order
is
in
34
effect,
may,
after
notice
and
hearing
and
upon
order
of
the
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commissioner,
be
subject
to
a
civil
penalty
of
not
more
than
1
ten
thousand
dollars
for
each
violation
of
the
commissioner’s
2
order.
A
manufacturer
or
a
manufacturer’s
agent
violating
an
3
order
issued
by
the
commissioner
under
this
section
shall
be
4
deemed
in
contempt
of
the
order.
A
civil
penalty
collected
5
pursuant
to
this
subsection
shall
be
deposited
as
provided
in
6
section
505.7.
7
4.
A
manufacturer
or
a
manufacturer’s
agent
may
seek
8
judicial
review
of
an
action
of
the
commissioner
pursuant
to
9
chapter
17A.
To
the
extent
that
a
decision
or
order
of
the
10
commissioner
is
affirmed
in
a
judicial
review
proceeding,
the
11
court
shall
issue
an
order
directing
that
the
manufacturer
12
or
the
manufacturer’s
agent
complies
with
the
terms
of
the
13
commissioner’s
decision
or
order.
14
5.
If
the
period
for
judicial
review
of
an
order
of
the
15
commissioner
has
expired
and
no
petition
for
judicial
review
16
has
been
filed,
upon
request
of
the
commissioner,
the
attorney
17
general
shall
proceed
in
the
district
court
to
enforce
the
18
order
of
the
commissioner.
The
court
shall
issue
an
order
19
directing
that
the
manufacturer
or
the
manufacturer’s
agent
20
comply
with
the
terms
of
the
commission’s
order.
21
6.
Upon
request
of
the
commissioner,
the
attorney
general
22
shall
petition
the
district
court
to
enforce
an
order
as
23
certified
by
the
commissioner.
The
district
court
shall
24
adjudge
a
manufacturer
or
a
manufacturer’s
agent
in
contempt
25
of
the
commissioner’s
order
if
the
court
finds
after
hearing
26
that
the
manufacturer
or
the
manufacturer’s
agent
is
not
in
27
compliance
with
the
commissioner’s
order.
For
each
day
of
28
noncompliance,
the
court
may
order
a
civil
penalty
of
not
more
29
than
one
thousand
dollars
against
the
manufacturer
or
the
30
manufacturer’s
agent
and
may
issue
further
orders
as
the
court
31
deems
appropriate.
32
Sec.
7.
NEW
SECTION
.
510E.1
Definitions.
33
As
used
in
this
chapter
unless
the
context
otherwise
34
requires:
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1.
“Commissioner”
means
the
commissioner
of
insurance.
1
2.
“Covered
person”
means
the
same
as
defined
in
section
2
514J.102.
3
3.
“Dispenser”
means
the
same
as
defined
in
21
U.S.C.
4
§360eee(3).
5
4.
“Health
benefit
plan”
means
the
same
as
defined
in
6
section
514J.102.
7
5.
“Health
care
professional”
means
the
same
as
defined
in
8
section
514J.102.
9
6.
“Health
carrier”
means
the
same
as
defined
in
section
10
514J.102.
11
7.
“Pharmaceutical
drug
manufacturer”
or
“manufacturer”
means
12
any
person
engaged
in
the
business
of
producing,
preparing,
13
converting,
processing,
packaging,
labeling,
or
distributing
14
a
prescription
drug.
“Pharmaceutical
drug
manufacturer”
or
15
“manufacturer”
does
not
include
a
wholesale
distributor
or
a
16
dispenser.
17
8.
“Prescription
drug”
means
the
same
as
defined
in
21
18
U.S.C.
§360eee(12).
19
9.
“Prescription
drug
benefit”
means
a
health
benefit
plan
20
providing
for
third-party
payment
or
prepayment
of
prescription
21
drugs.
22
10.
“Specialty
drug”
means
a
prescription
drug
that
a
health
23
carrier
has
designated
as
a
specialty
drug
and
that
has
either
24
of
the
following
characteristics:
25
a.
The
United
States
food
and
drug
administration
has
26
designated
the
prescription
drug
an
orphan
drug.
27
b.
The
manufacturer
of
the
prescription
drug,
or
the
United
28
States
food
and
drug
administration,
restricts
distribution
of
29
the
prescription
drug
to
a
limited
number
of
distributors.
30
11.
“Utilization
review”
means
the
same
as
defined
in
31
section
514F.7.
32
12.
“Utilization
review
organization”
means
the
same
as
33
defined
in
section
514F.7.
34
Sec.
8.
NEW
SECTION
.
510E.2
Health
carriers
——
annual
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report.
1
1.
a.
Each
health
carrier
shall
submit
an
annual
report
2
by
February
15
to
the
commissioner,
in
the
form
and
manner
3
prescribed
by
the
commissioner,
that
contains
the
following
4
information
for
the
immediately
preceding
calendar
year,
across
5
all
of
the
health
carrier’s
health
benefit
plans
that
offer
a
6
prescription
drug
benefit:
7
(1)
The
brand
name
of
the
twenty-five
prescription
drugs
8
most
frequently
covered
by
the
prescription
drug
benefits
9
offered
by
the
health
carrier.
10
(2)
The
percent
increase
in
annual
spending
by
the
health
11
carrier
to
provide
all
prescription
drug
benefits
offered
by
12
the
health
carrier.
13
(3)
The
percent
increase
in
premiums
paid
by
covered
persons
14
attributable
to
all
prescription
drug
benefits
offered
by
the
15
health
carrier.
16
(4)
The
percentage
of
specialty
drugs
included
in
all
17
prescription
drug
benefits
offered
by
the
health
carrier
that
18
are
subject
to
utilization
review
conducted
by
a
utilization
19
review
organization.
20
(5)
The
percent
decrease
in
premiums
paid
by
covered
persons
21
attributable
to
specialty
drugs
that
are
subject
to
utilization
22
review
conducted
by
a
utilization
review
organization
that
23
are
included
in
all
prescription
drug
benefits
offered
by
the
24
health
carrier.
25
b.
An
authorized
insurer
or
an
authorized
third-party
26
administrator
that
administers
a
multiple
employer
welfare
27
arrangement
pursuant
to
section
507A.4,
subsection
9,
paragraph
28
“a”
,
subparagraph
(1),
shall
submit
the
report
required
in
29
paragraph
“a”
on
behalf
of
the
multiple
employer
welfare
30
arrangement
that
the
authorized
insurer
or
the
authorized
31
third-party
administrator
administers.
32
2.
Any
information
a
health
carrier
provides,
or
an
33
authorized
insurer
or
an
authorized
third-party
administrator
34
provides
on
behalf
of
a
multiple
employer
welfare
arrangement,
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to
the
commissioner
pursuant
to
subsection
1
that
may
reveal
1
any
of
the
following
shall
be
considered
a
confidential
record,
2
and
be
recognized
and
protected
as
a
trade
secret
pursuant
to
3
section
22.7,
subsection
3:
4
a.
The
identity
of
a
specific
health
benefit
plan.
5
b.
The
identity
of
the
specific
price
charged
by
a
specific
6
manufacturer,
pharmacy
benefit
manager,
or
dispenser
for
a
7
specific
prescription
drug
or
class
of
prescription
drugs.
8
c.
The
dollar
value
of
the
rebates
a
specific
manufacturer,
9
a
specific
pharmacy
benefit
manager,
or
a
specific
dispenser
10
provides
to
the
health
carrier.
11
3.
Prior
to
May
1
of
each
calendar
year,
the
commissioner
12
shall
publish
the
nonconfidential
data
received
by
the
13
commissioner
pursuant
to
this
section
on
the
same
publicly
14
accessible
internet
site
referenced
in
section
510D.2.
The
15
data
shall
be
aggregated
from
all
annual
reports
submitted
16
pursuant
to
subsection
1,
and
the
information
shall
be
17
made
available
to
the
public
in
a
format
that
complies
with
18
subsection
2.
19
Sec.
9.
NEW
SECTION
.
510E.3
Rules.
20
The
commissioner
shall
adopt
rules
pursuant
to
chapter
17A
21
as
necessary
to
administer
this
chapter.
22
Sec.
10.
NEW
SECTION
.
510E.4
Summary
enforcement.
23
1.
Upon
a
determination
by
the
commissioner
that
a
health
24
carrier
or
a
health
carrier’s
agent
has
engaged,
is
engaging,
25
or
is
about
to
engage
in
any
act
or
practice
in
violation
of
26
this
chapter,
a
rule
adopted
by
the
commissioner,
or
an
order
27
issued
by
the
commissioner
under
this
chapter,
the
commissioner
28
may
do
any
of
the
following:
29
a.
Issue
a
summary
order,
including
a
brief
statement
of
30
findings
of
fact
and
conclusions
of
law,
and
direct
the
health
31
carrier
or
health
carrier’s
agent
to
cease
and
desist
from
32
engaging
in
the
act
or
practice.
33
b.
Take
other
affirmative
action
that
in
the
judgment
34
of
the
commissioner
is
necessary
to
ensure
that
the
health
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carrier
or
health
carrier’s
agent
comply
with
this
chapter,
and
1
rules
adopted
and
orders
issued
by
the
commissioner
under
this
2
chapter.
3
2.
a.
A
health
carrier
or
health
carrier’s
agent
that
has
4
been
issued
a
summary
order
under
this
section
may
contest
5
the
order
by
filing
a
request
for
a
contested
case
proceeding
6
and
hearing
as
provided
in
chapter
17A,
and
in
accordance
7
with
rules
adopted
by
the
commissioner.
The
health
carrier
8
or
health
carrier’s
agent
shall
have
at
least
thirty
calendar
9
days
from
the
date
that
the
summary
order
is
issued
to
file
the
10
request.
If
a
hearing
is
not
timely
requested,
the
summary
11
order
shall
be
final
by
operation
of
law.
12
b.
Section
17A.18A
shall
not
apply
to
a
summary
order
issued
13
under
this
section.
14
c.
A
summary
order
issued
pursuant
to
this
section
shall
15
remain
effective
from
the
date
of
issuance
unless
overturned
by
16
a
final
decision
of
a
presiding
officer
or
by
a
final
judgment
17
of
the
court.
18
3.
A
health
carrier
or
health
carrier’s
agent
violating
19
a
summary
order
issued
under
this
section
shall
be
deemed
20
in
contempt
of
that
order.
The
commissioner
may
petition
21
the
district
court
to
enforce
the
order
as
certified
by
the
22
commissioner.
The
district
court
shall
adjudge
the
health
23
carrier
or
health
carrier’s
agent
in
contempt
of
the
order
if
24
the
court
finds
after
hearing
that
the
health
carrier
or
health
25
carrier’s
agent
is
not
in
compliance
with
the
order.
The
court
26
may
assess
a
civil
penalty
against
the
health
carrier
or
health
27
carrier’s
agent
of
not
more
than
one
thousand
dollars
per
28
day
for
each
day
that
the
health
carrier
or
health
carrier’s
29
agent
is
in
violation
of
the
order.
A
civil
penalty
collected
30
pursuant
to
this
section
shall
be
deposited
as
provided
in
31
section
505.7.
The
court
may
issue
further
orders
as
the
court
32
deems
appropriate.
33
Sec.
11.
NEW
SECTION
.
510E.5
Enforcement
after
hearing.
34
1.
If,
after
a
hearing
and
contested
case
proceeding
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pursuant
to
section
510E.4,
subsection
2,
the
commissioner
1
determines
that
a
health
carrier
or
a
health
carrier’s
agent
2
violated
this
chapter,
a
rule
adopted
by
the
commissioner,
or
3
an
order
issued
by
the
commissioner
under
this
chapter,
the
4
commissioner
shall
reduce
the
findings
to
writing
and
shall
5
issue
and
cause
to
be
served
upon
the
health
carrier
or
the
6
health
carrier’s
agent
all
of
the
following:
7
a.
A
copy
of
the
commissioner’s
findings.
8
b.
An
order
requiring
the
health
carrier
or
the
health
9
carrier’s
agent
to
cease
and
desist
from
violating
this
10
chapter,
a
rule
adopted
by
the
commissioner,
or
an
order
issued
11
by
the
commissioner
under
this
chapter.
12
2.
The
commissioner
may
take
other
affirmative
action
that
13
in
the
judgment
of
the
commissioner
is
necessary
to
ensure
that
14
a
health
carrier
or
a
health
carrier’s
agent
complies
with
this
15
chapter.
The
commissioner
may
also,
at
the
commissioner’s
16
discretion,
order
payment
of
a
civil
penalty
of
not
more
than
17
five
thousand
dollars
for
each
violation
of
this
chapter
by
a
18
health
carrier
or
a
health
carrier’s
agent.
19
3.
A
health
carrier
or
a
health
carrier’s
agent
that
20
violates
an
order
of
the
commissioner,
and
while
such
order
is
21
in
effect,
may,
after
notice
and
hearing
and
upon
order
of
the
22
commissioner,
be
subject
to
a
civil
penalty
of
not
more
than
23
ten
thousand
dollars
for
each
violation
of
the
commissioner’s
24
order.
A
health
carrier
or
a
health
carrier’s
agent
that
25
violates
an
order
issued
by
the
commissioner
under
this
section
26
shall
be
deemed
in
contempt
of
the
order.
A
civil
penalty
27
collected
pursuant
to
this
subsection
shall
be
deposited
as
28
provided
in
section
505.7.
29
4.
A
health
carrier
or
a
health
carrier’s
agent
may
seek
30
judicial
review
of
an
action
of
the
commissioner
pursuant
to
31
chapter
17A.
To
the
extent
that
a
decision
or
order
of
the
32
commissioner
is
affirmed
in
a
judicial
review
proceeding,
the
33
court
shall
issue
an
order
directing
that
the
health
carrier
34
or
the
health
carrier’s
agent
comply
with
the
terms
of
the
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commissioner’s
decision
or
order.
1
5.
If
the
period
for
judicial
review
of
an
order
of
the
2
commissioner
has
expired
and
no
petition
for
judicial
review
3
has
been
filed,
upon
request
of
the
commissioner,
the
attorney
4
general
shall
proceed
in
the
district
court
to
enforce
the
5
order
of
the
commissioner.
The
court
shall
issue
an
order
6
directing
that
the
health
carrier
or
the
health
carrier’s
agent
7
comply
with
the
terms
of
the
commission’s
order.
8
6.
Upon
request
of
the
commissioner,
the
attorney
general
9
shall
petition
the
district
court
to
enforce
an
order
as
10
certified
by
the
commissioner.
The
district
court
shall
11
adjudge
a
health
carrier
or
a
health
carrier’s
agent
in
12
contempt
of
the
commissioner’s
order
if
the
court
finds
after
13
hearing
that
the
health
carrier
or
the
health
carrier’s
agent
14
is
not
in
compliance
with
the
commissioner’s
order.
For
each
15
day
of
noncompliance,
the
court
may
order
a
civil
penalty
of
16
not
more
than
one
thousand
dollars
against
a
health
carrier
or
17
a
health
carrier’s
agent
and
may
issue
further
orders
as
the
18
court
deems
appropriate.
19
Sec.
12.
NEW
SECTION
.
514M.1
Definitions.
20
1.
“Carrier”
means
an
entity
subject
to
the
insurance
laws
21
and
regulations
of
this
state,
or
subject
to
the
jurisdiction
22
of
the
commissioner,
that
offers
at
least
one
health
plan
in
23
this
state.
24
2.
“Cost-sharing
requirement”
means
any
copayment,
25
coinsurance,
deductible,
or
other
out-of-pocket
expense
26
obligation
required
of
or
on
behalf
of
an
enrollee
in
order
27
for
the
enrollee
to
receive
a
specific
health
care
service,
28
including
a
prescription
drug,
covered
by
the
enrollee’s
health
29
plan.
30
3.
“Enrollee”
means
an
individual
who
is
eligible
to
obtain
31
health
care
services
under
a
health
plan.
32
4.
“Health
care
services”
means
an
item
or
service
for
the
33
prevention,
treatment,
cure,
or
healing
of
an
illness,
injury,
34
or
physical
disability.
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5.
“Health
plan”
means
a
policy,
contract,
certificate,
or
1
agreement
offered
or
issued
by
a
carrier
to
provide,
deliver,
2
arrange
for,
pay
for,
or
reimburse
any
of
the
costs
of
health
3
care
services.
4
6.
“Interchangeable
biological
product”
means
the
same
as
5
defined
in
section
155A.3.
6
7.
“Internal
Revenue
Code”
means
the
Internal
Revenue
Code
7
as
defined
in
section
422.3.
8
8.
“Person”
means
a
natural
person,
corporation,
mutual
9
company,
unincorporated
association,
partnership,
joint
10
venture,
limited
liability
corporation,
trust,
estate,
11
foundation,
not-for-profit
organization,
government
or
12
governmental
subdivision,
or
government
or
governmental
agency.
13
9.
“Specialty
drug”
means
the
same
as
defined
in
section
14
510E.1.
15
Sec.
13.
NEW
SECTION
.
514M.2
Cost-sharing
calculation.
16
1.
A
carrier
shall
include
all
cost-sharing
amounts
paid
by
17
an
enrollee,
or
need-based
payments
paid
by
another
person
on
18
behalf
of
the
enrollee,
as
part
of
the
carrier’s
calculation
19
of
an
enrollee’s
contribution
to
the
enrollee’s
applicable
20
cost-sharing
requirement.
This
requirement
does
not
apply
21
to
cost-sharing
amounts
paid
by
an
enrollee,
or
by
another
22
person
on
behalf
of
an
enrollee,
for
a
specialty
drug
or
a
23
prescription
drug
for
which
a
medically
appropriate
A-rated
24
generic
equivalent
or
an
interchangeable
biological
product
is
25
available
to
the
enrollee.
26
2.
Subsection
1
shall
not
apply
to
a
state-regulated
27
high-deductible
health
plan
to
the
extent
it
results
in
the
28
plan’s
failure
to
qualify
as
a
high-deductible
health
plan
29
pursuant
to
section
223
of
the
Internal
Revenue
Code.
30
3.
If
a
provision
of
subsection
1
conflicts
with
a
federal
31
law
or
regulation
as
applied
to
a
specific
carrier
or
to
a
32
specific
circumstance,
the
provision
shall
remain
in
full
force
33
and
effect
for
all
carriers
and
in
all
circumstances
in
which
34
the
federal
conflict
does
not
exist.
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Sec.
14.
NEW
SECTION
.
514M.3
Applicability.
1
This
chapter
applies
to
all
health
plans
delivered,
issued
2
for
delivery,
continued,
or
renewed
in
this
state
on
or
after
3
January
1,
2022.
4
Sec.
15.
RETROACTIVE
APPLICABILITY.
5
1.
The
section
of
this
Act
that
requires
a
pharmaceutical
6
drug
manufacturer
to
submit
an
annual
report
to
the
7
commissioner
containing
the
current
wholesale
acquisition
cost
8
for
each
of
the
manufacturer’s
prescription
drugs
is
applicable
9
to
all
manufacturers
that
manufactured
any
prescription
drug
10
that
is
sold
to
a
person
in
this
state
on
or
after
January
1,
11
2021.
12
2.
The
section
of
this
Act
that
requires
a
pharmaceutical
13
drug
manufacturer
to
submit
a
report
to
the
commissioner
14
containing
information
related
to
an
increase
in
the
wholesale
15
acquisition
cost
of
a
prescription
drug
manufactured
by
16
the
manufacturer
is
applicable
to
all
manufacturers
that
17
manufactured
any
prescription
drug
that
is
sold
to
a
person
in
18
this
state
on
or
after
January
1,
2021.
19
3.
The
section
of
this
Act
that
requires
a
health
carrier
20
to
submit
an
annual
report
to
the
commissioner
related
to
all
21
of
the
health
carrier’s
health
benefit
plans
that
offer
a
22
prescription
drug
benefit
is
applicable
to
all
health
benefit
23
plans
providing
for
third-party
payment
or
prepayment
of
health
24
or
medical
expenses
that
provide
a
prescription
drug
benefit
25
that
have
been
delivered,
issued
for
delivery,
continued,
or
26
renewed
in
this
state
on
or
after
January
1,
2021.
27
EXPLANATION
28
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
29
the
explanation’s
substance
by
the
members
of
the
general
assembly.
30
This
bill
relates
to
price
transparency
and
cost-sharing
for
31
prescription
drugs.
32
The
bill
requires
a
manufacturer
to
file
an
annual
report
33
with
the
commissioner
of
insurance
(commissioner)
that
34
discloses
the
wholesale
acquisition
cost
for
all
prescription
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drugs
manufactured
by
the
manufacturer
that
were
sold
to
a
1
person
in
this
state
in
the
immediately
preceding
calendar
2
year.
“Wholesale
acquisition
cost”
or
“cost”
is
defined
in
the
3
bill
as
the
manufacturer’s
list
price
for
a
prescription
drug
4
for
wholesalers
or
direct
purchasers
in
the
United
States,
not
5
including
prompt
pay
or
other
discounts,
rebates,
or
reductions
6
in
price,
for
the
most
recent
month
for
which
the
information
7
is
available,
as
reported
in
wholesale
price
guides
or
other
8
publications
of
drug
or
biological
pricing
data.
Within
30
9
calendar
days
of
receipt,
the
commissioner
is
required
to
10
publish
the
information
from
the
annual
reports
on
a
publicly
11
accessible
internet
site.
12
If
a
prescription
drug
sold
to
a
person
in
this
state
13
has
a
cost
of
$100
or
more
for
a
30-day
supply
and
the
cost
14
increases
40
percent
or
more
over
the
three
preceding
calendar
15
years,
or
increases
15
percent
or
more
in
the
preceding
16
calendar
year,
the
manufacturer
of
the
prescription
drug
must
17
file
a
report
with
the
commissioner
within
30
calendar
days
18
of
the
date
on
which
the
40
or
15
percent
increase
in
cost
19
occurs.
This
requirement
is
applicable
to
all
manufacturers
20
that
manufactured
prescription
drugs
that
are
sold
to
a
21
person
in
this
state
on
or
after
January
1,
2021.
The
report
22
must
include
the
information
detailed
in
the
bill.
Certain
23
information
provided
by
a
manufacturer,
as
detailed
in
the
24
bill,
is
considered
a
confidential
record
and
is
required
25
to
be
protected
as
a
trade
secret.
Within
60
calendar
days
26
of
receipt,
the
commissioner
is
required
to
publish
the
27
nonconfidential
information
on
the
same
publicly
accessible
28
internet
site
on
which
the
manufacturer’s
annual
report
29
information
is
published.
30
The
bill
requires
each
health
carrier
to
submit
an
annual
31
report
by
February
15
to
the
commissioner
that
contains
32
information
as
detailed
in
the
bill
across
all
of
the
health
33
carrier’s
health
benefit
plans.
An
authorized
insurer
or
34
an
authorized
third-party
administrator
that
administers
a
35
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multiple
employer
welfare
arrangement
must
submit
the
required
1
report
on
behalf
of
the
multiple
employer
welfare
arrangement
2
that
the
insurer
or
the
third-party
administrator
administers.
3
This
requirement
is
applicable
to
all
health
benefit
plans
4
providing
for
third-party
payment
or
prepayment
of
health
or
5
medical
expenses
that
provide
a
prescription
drug
benefit
that
6
have
been
delivered,
issued
for
delivery,
continued,
or
renewed
7
in
this
state
on
or
after
January
1,
2021.
“Health
carrier”
is
8
defined
in
the
bill
as
an
entity
subject
to
the
insurance
laws
9
and
regulations
of
this
state,
or
subject
to
the
jurisdiction
10
of
the
commissioner,
including
an
insurance
company
offering
11
sickness
and
accident
plans,
a
health
maintenance
organization,
12
a
nonprofit
health
service
corporation,
a
plan
established
13
pursuant
to
Code
chapter
509A
for
public
employees,
or
any
14
other
entity
providing
a
plan
of
health
insurance,
health
15
care
benefits,
or
health
care
services.
As
detailed
in
the
16
bill,
certain
information
provided
by
a
health
carrier,
or
an
17
authorized
insurer
or
an
authorized
third-party
administrator
18
on
behalf
of
a
multiple
employer
welfare
arrangement,
is
19
considered
a
confidential
record
and
must
be
protected
as
a
20
trade
secret.
Prior
to
May
1
of
each
year,
the
commissioner
21
must
publish
the
nonconfidential
data
received
by
the
22
commissioner
on
the
same
publicly
accessible
internet
site
on
23
which
the
manufacturers’
information
is
published.
The
data
24
must
be
aggregated
from
the
annual
reports
submitted
by
all
25
health
carriers.
26
The
bill
directs
the
commissioner
to
adopt
rules
as
27
necessary
to
administer
the
requirements
outlined
in
the
28
bill.
The
bill
details
the
commissioner’s
authority,
and
29
the
process
to
enforce
that
authority,
for
manufacturers’,
30
manufacturers’
agents’,
health
carriers’
or
health
carriers’
31
agents’
violations
of
a
provision
of
the
bill,
a
rule
adopted
32
by
the
commissioner,
or
of
an
order
issued
by
the
commissioner.
33
The
bill
also
allows
the
commissioner,
or
the
court,
to
34
order
payment
of
penalties
for
certain
violations
as
outlined
35
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in
the
bill.
Manufacturers,
manufacturer’s
agents,
health
1
carriers,
and
health
carrier’s
agents
may
request
a
contested
2
case
proceeding,
or
seek
judicial
review
of
an
action
of
the
3
commissioner,
in
certain
circumstances
as
detailed
in
the
bill.
4
The
bill
also
requires
a
carrier
to
include
all
cost-sharing
5
amounts
paid
by
an
enrollee
of
a
health
plan,
or
by
another
6
person
on
behalf
of
an
enrollee,
as
part
of
the
carrier’s
7
calculation
of
an
enrollee’s
contribution
to
the
enrollee’s
8
applicable
cost-sharing
requirement.
This
does
not
9
apply
to
cost-sharing
incurred
for
a
specialty
drug
or
a
10
prescription
drug
for
which
an
A-rated
generic
equivalent
or
an
11
interchangeable
biological
product
is
available.
“Cost-sharing
12
requirement”
is
defined
in
the
bill
as
any
copayment,
13
coinsurance,
deductible,
or
other
out-of-pocket
expense
14
obligation
required
of
or
on
behalf
of
an
enrollee
in
order
15
for
the
enrollee
to
receive
a
specific
health
care
service,
16
including
a
prescription
drug,
covered
by
the
enrollee’s
health
17
plan.
This
requirement
applies
to
all
health
plans
delivered,
18
issued
for
delivery,
continued,
or
renewed
in
this
state
on
19
or
after
January
1,
2022.
The
bill
excludes
state-regulated
20
high-deductible
health
plans
(HDHP)
from
the
requirement
if
21
it
will
result
in
the
plan
not
qualifying
as
an
HDHP
under
22
section
223
of
the
Internal
Revenue
Code.
The
bill
also
23
prohibits
application
of
the
requirement
to
a
carrier
or
to
a
24
circumstance
in
a
manner
that
will
conflict
with
a
federal
law
25
or
a
federal
regulation.
26
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