House
File
2384
H-8198
Amend
House
File
2384
as
follows:
1
1.
Page
1,
before
line
1
by
inserting:
2
<
DIVISION
I
3
PHARMACY
BENEFITS
MANAGERS
AND
PRESCRIPTION
DRUG
BENEFITS
>
4
2.
Page
2,
line
3,
by
striking
<
acquisition
>
and
inserting
5
<
invoice
>
6
3.
Page
2,
line
4,
by
striking
<
acquisition
>
and
inserting
7
<
invoice
>
8
4.
Page
2,
line
11,
by
striking
<
acquisition
>
and
inserting
9
<
invoice
>
10
5.
Page
2,
by
striking
lines
21
and
22.
11
6.
Page
2,
after
line
29
by
inserting:
12
<
___.
“Pharmacy
invoice
cost”
means
the
cost
to
a
13
pharmacy
for
a
prescription
drug
as
invoiced
by
a
wholesale
14
distributor.
>
15
7.
Page
3,
by
striking
lines
22
and
23
and
inserting:
16
<
3.
A
pharmacy
benefits
manager
shall
act
in
the
best
17
interest
of
each
health
carrier
for
whom
the
pharmacy
benefits
>
18
8.
Page
3,
by
striking
lines
27
through
31.
19
9.
Page
5,
line
18,
by
striking
<
maximum
allowable
cost
for
>
20
10.
Page
5,
line
19,
by
striking
<
that
drug
at
>
and
21
inserting
<
total
amount
that
>
22
11.
Page
5,
line
20,
after
<
order
>
by
inserting
<
is
23
reimbursed
>
24
12.
Page
5,
line
32,
after
<
the
>
by
inserting
<
pharmacies
25
participating
in
the
>
26
13.
Page
5,
line
32,
by
striking
<
plan
>
and
inserting
27
<
plan’s
network
>
28
14.
Page
5,
line
33,
by
striking
<
A
>
and
inserting
29
<
Excluding
incentives
in
value-based
programs
established
by
a
30
health
carrier
or
a
pharmacy
benefits
manager
to
promote
the
31
use
of
higher
quality
pharmacies,
a
>
32
15.
Page
6,
by
striking
lines
6
through
25
and
inserting:
33
<
7.
For
purposes
of
calculating
a
covered
person’s
34
contribution
toward
the
covered
person’s
cost-sharing,
a
35
-1-
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2384.3888
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89
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1/
8
#1.
#2.
#3.
#4.
#5.
#6.
#7.
#8.
#9.
#10.
#11.
#12.
#13.
#14.
#15.
pharmacy
benefits
manager
shall
include
all
cost-sharing
paid
1
by
the
covered
person
and
all
cost-sharing
paid
by
any
other
2
person
on
behalf
of
the
covered
person.
If,
however,
this
3
requirement
will
result
in
health
savings
account
ineligibility
4
under
section
223
of
the
Internal
Revenue
Code,
this
5
requirement
shall
only
apply
to
the
covered
person’s
deductible
6
for
a
health
savings
account
qualified-high
deductible
health
7
plan
after
the
covered
person
has
satisfied
the
minimum
8
deductible
under
section
223
of
the
Internal
Revenue
Code,
9
except
for
items
or
services
that
are
preventive
care,
in
which
10
case,
the
requirement
shall
apply
regardless
of
if
the
minimum
11
deductible
under
section
223
of
the
Internal
Revenue
Code
has
12
been
satisfied.
For
purposes
of
this
section,
“preventive
care”
13
means
the
same
as
under
section
223(c)(2)(C)
of
the
Internal
14
Revenue
Code.
>
15
16.
Page
7,
line
15,
by
striking
<
acquisition
>
and
inserting
16
<
invoice
>
17
17.
By
striking
page
7,
line
25,
through
page
8,
line
1.
18
18.
Page
8,
by
striking
lines
15
and
16
and
inserting
19
<
directly
or
indirectly
except
in
the
following
circumstances:
>
20
19.
Page
8,
before
line
17
by
inserting:
21
<
a.
The
claim
is
found
not
to
be
a
clean
claim
during
the
22
course
of
a
routine
audit.
23
b.
The
claim
submission
was
fraudulent.
24
c.
The
claim
submission
was
a
duplicate
submission
of
a
25
claim
for
which
the
pharmacy
had
already
received
payment.
>
26
20.
Page
8,
line
19,
by
striking
<
cost,
>
and
inserting
<
cost
27
or
reimbursement
rate
>
28
21.
Page
8,
by
striking
line
20.
29
22.
Page
8,
line
24,
after
<
cost
>
by
inserting
<
or
the
30
reimbursement
rate
>
31
23.
Page
8,
line
25,
by
striking
<
acquisition
>
and
inserting
32
<
invoice
>
33
24.
Page
8,
line
33,
by
striking
<
seven
>
and
inserting
34
<
thirty
>
35
-2-
HF
2384.3888
(1)
89
ko/rn
2/
8
#16.
#17.
#18.
#19.
#20.
#21.
#22.
#23.
25.
Page
9,
line
7,
after
<
cost
>
by
inserting
<
or
the
1
reimbursement
rate
>
2
26.
Page
9,
line
11,
by
striking
<
rebill
>
and
inserting
3
<
resubmit
>
4
27.
Page
9,
by
striking
lines
13
through
15
and
inserting:
5
<
(3)
Make
the
adjustment
pursuant
to
subparagraph
(1)
6
applicable
to
all
of
the
following:
7
(a)
Each
pharmacy
that
is
under
common
ownership
with
the
8
pharmacy
that
submitted
the
appeal.
9
(b)
Each
pharmacy
in
the
state
that
demonstrates
the
10
inability
to
purchase
the
prescription
drug
for
less
than
the
11
established
maximum
allowable
cost
or
reimbursement
rate.
>
12
28.
Page
9,
line
22,
after
<
cost
>
by
inserting
<
or
13
reimbursement
rate
>
14
29.
Page
9,
line
26,
by
striking
<
acquisition
>
and
inserting
15
<
invoice
>
16
30.
Page
9,
line
29,
by
striking
<
list
>
and
inserting
<
or
17
the
reimbursement
rate
>
18
31.
Page
9,
line
30,
by
striking
<
acquisition
>
and
inserting
19
<
invoice
>
20
32.
Page
9,
line
30,
by
striking
<
rebill
>
and
inserting
21
<
resubmit
>
22
33.
Page
9,
line
33,
after
<
cost
>
by
inserting
<
or
the
23
reimbursement
rate
>
24
34.
Page
10,
line
12,
by
striking
<
shall
>
and
inserting
25
<
may
>
26
35.
Page
10,
by
striking
lines
22
through
27
and
inserting:
27
<
3.
A
pharmacy
benefits
manager
shall
be
subject
to
the
28
commissioner’s
authority
to
conduct
an
examination
pursuant
to
29
chapter
507.
>
30
36.
Page
11,
line
19,
by
striking
<
shall
>
and
inserting
31
<
may
>
32
37.
Page
11,
line
29,
before
<
This
>
by
inserting
<
1.
>
33
38.
Page
11,
line
29,
after
<
This
>
by
inserting
<
division
34
of
this
Act
>
35
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HF
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(1)
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ko/rn
3/
8
#25.
#26.
#27.
#28.
#29.
#30.
#31.
#32.
#33.
#34.
#35.
#36.
#37.
39.
Page
11,
after
line
32
by
inserting:
1
<
2.
The
following
applies
to
all
health
benefit
plans
2
delivered,
issued
for
delivery,
continued,
or
renewed
in
this
3
state
on
or
after
January
1,
2023:
4
The
section
of
this
division
of
this
Act
amending
section
5
510B.8,
subsection
7.
>
6
40.
Page
11,
before
line
33
by
inserting:
7
<
DIVISION
___
8
PHARMACIES
AND
COVERED
ENTITIES
——
340B
DRUG
PROGRAM
9
Sec.
___.
NEW
SECTION
.
510D.1
Definitions.
10
As
used
in
this
chapter,
unless
the
context
otherwise
11
requires:
12
1.
“340B
program”
means
the
program
created
pursuant
to
the
13
Veterans
Health
Care
Act
of
1992,
Pub.
L.
No.
102-585,
section
14
602,
and
codified
as
section
340B
of
the
federal
Public
Health
15
Services
Act.
16
2.
“Contract
pharmacy”
means
a
pharmacy
that
has
executed
a
17
contract
with
a
covered
entity
to
dispense
covered
outpatient
18
drugs,
purchased
by
the
covered
entity
through
the
340B
19
program,
to
eligible
patients
of
the
covered
entity.
20
3.
“Covered
entity”
means
the
same
as
defined
in
42
U.S.C.
21
§256b(a)(4).
22
4.
“Group
health
plan”
means
the
same
as
defined
in
section
23
513B.2.
24
5.
“Medicaid
managed
care
organization”
means
an
entity
that
25
is
under
contract
with
the
Iowa
department
of
human
services
26
to
provide
services
to
Medicaid
recipients
and
that
also
meets
27
the
definition
of
“health
maintenance
organization”
in
section
28
514B.1.
29
6.
“Pharmacy
benefits
manager”
means
the
same
as
defined
in
30
section
510B.1.
31
7.
“Similarly
situated
entity
or
pharmacy”
means
an
entity
32
or
pharmacy
that
is
of
a
generally
comparable
size,
and
that
33
operates
in
a
market
with
similar
demographic
characteristics,
34
including
population
size,
density,
distribution,
and
vital
35
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#39.
#40.
statistics,
and
reasonably
similar
economic
and
geographic
1
conditions.
2
8.
“Third-party
administrator”
means
the
same
as
defined
in
3
section
510.11.
4
Sec.
___.
NEW
SECTION
.
510D.2
340B
drug
program
——
contract
5
pharmacies
and
covered
entities.
6
1.
Group
health
plans,
health
insurance
issuers
that
offer
7
group
or
individual
health
insurance
coverage,
third-party
8
administrators,
and
pharmacy
benefits
managers
shall
not
9
discriminate
against
a
covered
entity
or
a
contract
pharmacy
10
by
reimbursing
the
covered
entity
or
the
contract
pharmacy
11
for
a
prescription
drug
or
for
a
dispensing
fee
in
an
amount
12
less
than
the
group
health
plan,
health
insurance
issuer,
13
third-party
administrator,
or
pharmacy
benefits
manager
14
reimburses
a
similarly
situated
entity
or
pharmacy
that
is
not
15
a
covered
entity
or
a
contract
pharmacy.
16
2.
a.
Group
health
plans,
health
insurance
issuers
that
17
offer
group
or
individual
health
insurance
coverage,
third-
18
party
administrators,
and
pharmacy
benefits
managers
shall
not,
19
solely
on
the
basis
that
an
entity
is
a
covered
entity
or
that
20
a
pharmacy
is
a
contract
pharmacy,
or
that
a
covered
entity
21
or
contract
pharmacy
participates
in
the
340B
program,
impose
22
any
of
the
following
contractual
terms
and
conditions
on
the
23
covered
entity
or
the
contract
pharmacy
that
differ
from
those
24
imposed
on
a
similarly
situated
entity
or
pharmacy
that
is
not
25
a
covered
entity
or
a
contract
pharmacy:
26
(1)
Fees,
chargebacks,
clawbacks,
adjustments,
or
other
27
assessments
that
are
not
required
by
state
law
or
the
Iowa
28
administrative
code.
29
(2)
Professional
dispensing
fees
that
are
not
required
by
30
state
law
or
the
Iowa
administrative
code.
31
(3)
Restrictions
or
requirements
related
to
participation
32
in
standard
or
preferred
pharmacy
networks.
33
(4)
Requirements
related
to
the
frequency
or
scope
of
34
audits.
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(5)
Requirements
related
to
inventory
management
systems
1
that
utilize
generally
accepted
accounting
principles.
2
(6)
Requirements
related
to
mandatory
disclosure
either
3
directly
or
through
a
third
party,
except
disclosures
required
4
by
federal
law,
of
prescription
orders
that
are
filled
with
5
covered
outpatient
drugs
obtained
through
the
340B
program.
6
b.
Paragraph
“a”
,
subparagraph
(1),
shall
not
be
construed
7
to
prohibit
adjustments
for
overpayments
or
other
errors
8
associated
with
an
adjudicated
claim.
9
c.
Paragraph
“a”
,
subparagraph
(6),
shall
not
be
construed
10
to
prohibit
modifiers
or
identifiers
to
prevent
duplication
of
11
rebates.
12
3.
Group
health
plans,
health
insurance
issuers
that
offer
13
group
or
individual
health
insurance
coverage,
third-party
14
administrators,
and
pharmacy
benefits
managers
shall
not
do
any
15
of
the
following:
16
a.
Place
any
restrictions
or
impose
any
requirements
on
17
an
individual
that
chooses
to
obtain
a
covered
outpatient
18
drug
from
a
covered
entity
or
a
contract
pharmacy,
whether
in
19
person,
via
courier
or
the
United
States
post
office,
or
any
20
other
form
of
delivery.
21
b.
Refuse
to
contract
with
a
covered
entity
or
a
contract
22
pharmacy
based
on
any
criteria
that
is
not
applied
equally
to
23
contract
with
a
similarly
situated
entity
or
pharmacy
that
does
24
not
participate
in
the
340B
drug
program.
25
c.
Impose
any
restriction
or
condition,
as
identified
by
26
the
commissioner
by
rule,
on
a
covered
entity
that
interferes
27
with
the
covered
entity’s
ability
to
maximize
the
value
of
the
28
discounts
obtained
by
the
covered
entity
through
the
covered
29
entity’s
participation
in
the
340B
drug
program.
30
Sec.
___.
NEW
SECTION
.
510D.3
Penalties.
31
The
commissioner
of
insurance
shall
impose
a
civil
penalty,
32
not
to
exceed
five
thousand
dollars
per
violation
per
day,
on
33
any
entity
that
violates
this
chapter.
34
Sec.
___.
NEW
SECTION
.
510D.4
Rules.
35
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8
The
commissioner
of
insurance
may
adopt
rules
as
necessary
1
to
implement
the
chapter.
2
Sec.
___.
NEW
SECTION
.
510D.5
Applicability.
3
1.
This
chapter
shall
apply
to
covered
entities,
contract
4
pharmacies,
group
health
plans,
health
insurance
issuers
5
that
offer
group
or
individual
health
insurance
coverage,
6
third-party
administrators,
and
pharmacy
benefits
managers,
7
regardless
of
whether
the
covered
entity
or
contract
pharmacy
8
is
eligible
to
retain
the
discounts
generated
by
the
covered
9
entity’s
or
contract
pharmacy’s
participation
in
the
340B
10
program.
11
2.
This
chapter
shall
not
apply
to
any
of
the
following:
12
a.
Covered
entities,
contract
pharmacies,
group
health
13
plans,
health
insurance
issuers
that
offer
group
or
individual
14
health
insurance
coverage,
third-party
administrators,
and
15
pharmacy
benefits
managers
when
acting
pursuant
to
a
contract
16
with
any
of
the
following:
17
(1)
A
Medicaid
managed
care
organization.
18
(2)
The
Iowa
department
of
human
services
to
provide
19
services
to
medical
assistance
program
recipients
pursuant
to
20
chapter
249A.
21
b.
The
medical
assistance
program
under
chapter
249A.
22
Sec.
___.
NEW
SECTION
.
510D.6
Inconsistencies
and
23
conflicts.
24
1.
To
the
extent
that
any
provision
of
this
chapter
is
25
inconsistent
or
conflicts
with
an
applicable
federal
law,
rule,
26
or
regulation,
such
federal
law,
rule,
or
regulation
shall
27
prevail
to
the
extent
necessary
to
eliminate
the
inconsistency
28
or
conflict.
29
2.
To
the
extent
that
any
provision
of
this
chapter
is
30
inconsistent
or
conflicts
with
the
state’s
medical
assistance
31
state
plan,
the
state’s
medical
assistance
state
plan
shall
32
prevail
to
the
extent
necessary
to
eliminate
the
inconsistency
33
or
conflict.
>
34
41.
Title
page,
line
1,
after
<
pharmacies,
>
by
striking
35
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89
ko/rn
7/
8
<
and
>
1
42.
Title
page,
line
2,
after
<
benefits,
>
by
inserting
<
and
2
contract
pharmacies
and
covered
entities
that
participate
in
3
the
340B
drug
program,
>
4
43.
By
renumbering,
redesignating,
and
correcting
internal
5
references
as
necessary.
6
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of
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8/
8
#42.
#43.