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