House
File
423
-
Introduced
HOUSE
FILE
423
BY
COMMITTEE
ON
HEALTH
AND
HUMAN
SERVICES
(SUCCESSOR
TO
HSB
137)
A
BILL
FOR
An
Act
relating
to
contract
pharmacies
and
covered
entities
1
that
participate
in
the
340B
drug
program.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
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Section
1.
Section
507B.4,
subsection
3,
Code
2023,
is
1
amended
by
adding
the
following
new
paragraph:
2
NEW
PARAGRAPH
.
u.
340B
drug
program.
Any
violation
of
3
chapter
510D
by
a
group
health
plan,
a
health
carrier
that
4
offers
group
or
individual
health
insurance
coverage,
a
5
third-party
administrator,
or
a
pharmacy
benefits
manager.
6
Sec.
2.
NEW
SECTION
.
510D.1
Definitions.
7
As
used
in
this
chapter,
unless
the
context
otherwise
8
requires:
9
1.
“340B
program”
means
the
program
created
pursuant
to
10
the
Veterans
Health
Care
Act
of
1992,
Pub.
L.
No.
102-585,
11
§602,
and
codified
as
section
340B
of
the
federal
Public
Health
12
Services
Act.
13
2.
“Commissioner”
means
the
commissioner
of
insurance.
14
3.
“Contract
pharmacy”
means
a
pharmacy
that
has
executed
a
15
contract
with
a
covered
entity
to
dispense
covered
outpatient
16
drugs,
purchased
by
the
covered
entity
through
the
340B
17
program,
to
eligible
patients
of
the
covered
entity.
18
4.
“Covered
entity”
means
the
same
as
defined
in
42
U.S.C.
19
§256b(a)(4).
20
5.
“Group
health
plan”
means
the
same
as
defined
in
section
21
513B.2.
22
6.
“Medicaid
managed
care
organization”
means
an
entity
23
acting
pursuant
to
a
contract
with
the
department
of
health
and
24
human
services
to
administer
the
medical
assistance
program
25
under
chapter
249A,
and
that
meets
the
definition
of
“health
26
maintenance
organization”
under
section
514B.1.
27
7.
“Pharmacy
benefits
manager”
means
the
same
as
defined
in
28
section
510B.1.
29
8.
“Similarly
situated
entity
or
pharmacy”
means
an
entity
30
or
pharmacy
located
in
Iowa
that
is
of
a
generally
comparable
31
size,
and
that
operates
in
a
market
with
similar
demographic
32
characteristics,
including
population
size,
density,
33
distribution,
and
vital
statistics,
and
reasonably
similar
34
economic
and
geographic
conditions.
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9.
“Third-party
administrator”
means
the
same
as
defined
in
1
section
510.11.
2
Sec.
3.
NEW
SECTION
.
510D.2
340B
drug
program
——
contract
3
pharmacies
and
covered
entities.
4
1.
Group
health
plans,
health
carriers
that
offer
5
group
or
individual
health
insurance
coverage,
third-party
6
administrators,
and
pharmacy
benefits
managers
shall
not
7
discriminate
against
a
covered
entity
or
a
contract
pharmacy
8
by
reimbursing
the
covered
entity
or
the
contract
pharmacy
9
for
a
prescription
drug
or
a
dispensing
fee
in
an
amount
10
less
than
the
group
health
plan,
health
carrier,
third-party
11
administrator,
or
pharmacy
benefits
manager
reimburses
a
12
similarly
situated
entity
or
pharmacy
that
is
not
a
covered
13
entity
or
a
contract
pharmacy.
14
2.
a.
Group
health
plans,
health
carriers
that
offer
15
group
or
individual
health
insurance
coverage,
third-party
16
administrators,
and
pharmacy
benefits
managers
shall
not,
17
on
the
basis
that
an
entity
is
a
covered
entity
or
that
a
18
pharmacy
is
a
contract
pharmacy,
or
that
a
covered
entity
or
19
contract
pharmacy
participate
in
the
340B
program,
impose
20
any
of
the
following
contractual
terms
and
conditions
on
the
21
covered
entity
or
the
contract
pharmacy
that
differ
from
those
22
imposed
on
a
similarly
situated
entity
or
pharmacy
that
is
not
23
a
covered
entity
or
a
contract
pharmacy:
24
(1)
Fees
or
other
assessments
that
are
not
required
by
state
25
law
or
the
Iowa
administrative
code.
26
(2)
Chargebacks,
clawbacks,
or
other
reimbursement
27
adjustments
that
are
not
required
by
state
law
or
the
Iowa
28
administrative
code.
29
(3)
Professional
dispensing
fees
that
are
not
required
by
30
state
law
or
the
Iowa
administrative
code.
31
(4)
Restrictions
or
requirements
related
to
participation
32
in
standard
or
preferred
pharmacy
networks.
33
(5)
Requirements
related
to
the
frequency
or
scope
of
34
audits.
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(6)
Requirements
related
to
inventory
management
systems
1
that
utilize
generally
accepted
accounting
principles.
2
(7)
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”
,
subparagraphs
(1)
and
(2),
shall
not
be
7
construed
to
prohibit
adjustments
for
overpayments
or
other
8
errors
associated
with
an
adjudicated
claim.
9
c.
Paragraph
“a”
,
subparagraph
(7),
shall
not
be
construed
10
to
prohibit
modifiers
or
other
identifiers
on
claims
to
11
identify
whether
a
drug
was
purchased
through
the
340B
program
12
or
to
prevent
duplication
of
rebates.
13
3.
Group
health
plans,
health
carriers
that
offer
14
group
or
individual
health
insurance
coverage,
third-party
15
administrators,
and
pharmacy
benefits
managers
shall
not
do
16
any
of
the
following
on
the
basis
that
an
entity
is
a
covered
17
entity
or
that
a
pharmacy
is
a
contract
pharmacy,
or
that
a
18
covered
entity
or
a
contract
pharmacy
participates
in
the
340B
19
program:
20
a.
Place
any
restrictions
or
impose
any
requirements
on
21
an
individual
that
chooses
to
obtain
a
covered
outpatient
22
drug
from
a
covered
entity
or
a
contract
pharmacy,
whether
in
23
person,
via
courier
or
the
United
States
post
office,
or
any
24
other
form
of
delivery.
25
b.
Refuse
to
contract
with
a
covered
entity
or
a
contract
26
pharmacy
based
on
any
criteria
that
is
not
applied
equally
to
a
27
contract
with
a
similarly
situated
entity
or
pharmacy
that
does
28
not
participate
in
the
340B
drug
program.
29
c.
Impose
any
restriction
or
condition
on
a
covered
entity
30
that
interferes
with
the
covered
entity’s
ability
to
maximize
31
the
value
of
the
discounts
obtained
by
the
covered
entity
32
through
the
covered
entity’s
participation
in
the
340B
drug
33
program.
34
Sec.
4.
NEW
SECTION
.
510D.3
Enforcement.
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1.
The
commissioner
may
take
any
enforcement
action
under
1
the
commissioner’s
authority
to
enforce
compliance
with
this
2
chapter.
3
2.
After
notice
and
hearing,
the
commissioner
may
issue
any
4
order
or
impose
any
penalty
pursuant
to
section
507B.7
upon
a
5
finding
that
a
group
health
plan,
a
health
carrier
that
offers
6
group
or
individual
health
insurance
coverage,
a
third-party
7
administrator,
or
a
pharmacy
benefits
manager
violated
this
8
chapter.
9
3.
A
violation
of
this
chapter
shall
be
an
unfair
or
10
deceptive
act
or
practice
in
the
business
of
insurance
pursuant
11
to
section
507B.4,
subsection
3.
12
Sec.
5.
NEW
SECTION
.
510D.4
Rules.
13
The
commissioner
of
insurance
may
adopt
rules
as
necessary
14
to
implement
the
chapter.
15
Sec.
6.
NEW
SECTION
.
510D.5
Conflict
of
laws.
16
If
any
provision
of
this
chapter
is
inconsistent
or
in
17
conflict
with
applicable
state
or
federal
law
or
rule,
or
the
18
state
Medicaid
plan,
the
applicable
state
or
federal
law
or
19
rule,
or
the
state
Medicaid
plan,
shall
prevail
to
the
extent
20
necessary
to
eliminate
the
inconsistency
or
conflict.
21
Sec.
7.
NEW
SECTION
.
510D.6
Applicability.
22
This
chapter
shall
apply
to
covered
entities,
contract
23
pharmacies,
group
health
plans,
health
carriers
that
offer
24
group
or
individual
health
insurance
coverage,
third-party
25
administrators,
and
pharmacy
benefits
managers,
but
shall
not
26
apply
to
their
operations
under
a
contract
with
the
state
27
Medicaid
agency
or
a
Medicaid
managed
care
organization,
28
regardless
of
whether
the
covered
entity
or
contract
pharmacy
29
is
eligible
to
retain
the
340B
discounts
generated
by
the
30
covered
entities
and
contract
pharmacies.
31
EXPLANATION
32
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
33
the
explanation’s
substance
by
the
members
of
the
general
assembly.
34
This
bill
relates
to
contract
pharmacies
and
covered
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entities
that
participate
in
the
340B
program.
The
bill
1
defines
“340B
program”,
“contract
pharmacy”,
and
“covered
2
entity”.
3
Group
health
plans
(plans),
health
carriers
that
offer
group
4
or
individual
health
insurance
coverage
(carriers),
third-party
5
administrators
(administrators),
and
pharmacy
benefits
managers
6
(PBM)
are
prohibited
from
discriminating
against
a
covered
7
entity
or
a
contract
pharmacy
by
reimbursing
the
covered
8
entity
or
the
contract
pharmacy
for
a
prescription
drug
or
9
a
dispensing
fee
in
an
amount
less
than
the
plan,
carrier,
10
administrator,
or
PBM
reimburses
a
similarly
situated
entity
or
11
pharmacy
that
is
not
a
covered
entity
or
a
contract
pharmacy.
12
“Similarly
situated
entity
or
pharmacy”
is
defined
in
the
bill.
13
Plans,
carriers,
administrators,
and
PBMs
shall
not,
on
the
14
basis
that
an
entity
is
a
covered
entity
or
that
a
pharmacy
15
is
a
contract
pharmacy,
or
that
a
covered
entity
or
contract
16
pharmacy
participates
in
the
340B
program,
impose
certain
17
contractual
terms
and
conditions,
as
described
in
the
bill,
on
18
the
covered
entity
or
contract
pharmacy
that
differ
from
those
19
imposed
on
a
similarly
situated
entity
or
pharmacy
that
is
not
20
a
covered
entity
or
a
contract
pharmacy.
Plans,
carriers,
21
administrators,
and
PBMs
are
also
prohibited
from,
on
the
22
basis
that
an
entity
is
a
covered
entity
or
that
a
pharmacy
is
23
a
contract
pharmacy,
or
that
a
covered
entity
or
a
contract
24
pharmacy
participates
in
the
340B
program,
placing
restrictions
25
or
imposing
requirements
on
individuals
that
choose
to
obtain
26
a
covered
outpatient
drug
from
a
covered
entity
or
a
contract
27
pharmacy,
whether
in
person,
via
courier
or
the
United
States
28
post
office,
or
any
other
form
of
delivery;
refusing
to
29
contract
with
a
covered
entity
or
a
contract
pharmacy
based
on
30
any
criteria
that
is
not
applied
equally
to
a
contract
with
a
31
similarly
situated
entity
or
pharmacy
that
does
not
participate
32
in
the
340B
program;
or
imposing
any
restriction
or
condition
33
on
a
covered
entity
that
interferes
with
the
covered
entity’s
34
ability
to
maximize
the
value
of
the
discounts
obtained
by
the
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covered
entity
through
the
covered
entity’s
participation
in
1
the
340B
program.
2
“Group
health
plan”
and
“third-party
administrator”
are
3
defined
in
the
bill.
4
The
commissioner
of
insurance
(commissioner)
may
take
any
5
enforcement
action
under
the
commissioner’s
authority
to
6
enforce
compliance
with
the
bill.
After
notice
and
hearing,
7
the
commissioner
may
issue
any
order
or
impose
any
penalty
8
pursuant
to
Code
section
507B.7
upon
a
finding
that
a
plan,
a
9
carrier,
an
administrator,
or
a
PBM
violated
any
provision
of
10
the
bill.
11
A
violation
of
the
bill
shall
be
an
unfair
or
deceptive
12
act
or
practice
in
the
business
of
insurance
pursuant
to
Code
13
section
507B.4(3).
14
The
commissioner
may
adopt
rules
as
necessary
to
implement
15
the
bill.
16
If
any
provision
of
the
bill
is
inconsistent
or
in
conflict
17
with
applicable
state
or
federal
law
or
rule,
or
the
state
18
Medicaid
plan,
the
state
or
federal
law
or
rule,
or
the
19
state
Medicaid
plan,
shall
prevail
to
the
extent
necessary
to
20
eliminate
the
inconsistency
or
conflict.
21
The
bill
applies
to
covered
entities,
contract
pharmacies,
22
plans,
carriers,
administrators,
and
PBM,
but
shall
not
apply
23
to
their
operations
under
a
contract
with
the
state
Medicaid
24
agency
or
a
Medicaid
managed
care
organization,
regardless
of
25
whether
the
covered
entity
or
contract
pharmacy
is
eligible
to
26
retain
the
340B
discounts
generated
by
the
covered
entities
and
27
contract
pharmacies.
“Medicaid
managed
care
organization”
is
28
defined
in
the
bill.
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