Bill Text: IA SF2231 | 2021-2022 | 89th General Assembly | Introduced
Bill Title: A bill for an act relating to pharmacy benefits managers, pharmacies, and prescription drug benefits, and including applicability provisions.(Formerly SF 2092.)
Spectrum: Committee Bill
Status: (Introduced - Dead) 2022-05-24 - Withdrawn. S.J. 929. [SF2231 Detail]
Download: Iowa-2021-SF2231-Introduced.html
Senate
File
2231
-
Introduced
SENATE
FILE
2231
BY
COMMITTEE
ON
COMMERCE
(SUCCESSOR
TO
SF
2092)
A
BILL
FOR
An
Act
relating
to
pharmacy
benefits
managers,
pharmacies,
and
1
prescription
drug
benefits,
and
including
applicability
2
provisions.
3
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
4
TLSB
5519SV
(1)
89
ko/rn
S.F.
2231
Section
1.
Section
505.26,
subsection
1,
paragraph
b,
Code
1
2022,
is
amended
to
read
as
follows:
2
b.
“Pharmacy
benefits
manager”
means
the
same
as
defined
in
3
section
510B.1
510C.1
.
4
Sec.
2.
Section
507B.4,
subsection
3,
Code
2022,
is
amended
5
by
adding
the
following
new
paragraph:
6
NEW
PARAGRAPH
.
t.
Pharmacy
benefits
managers.
Any
7
violation
of
chapter
510B
by
a
pharmacy
benefits
manager.
8
Sec.
3.
Section
510B.1,
Code
2022,
is
amended
by
striking
9
the
section
and
inserting
in
lieu
thereof
the
following:
10
510B.1
Definitions.
11
As
used
in
this
chapter,
unless
the
context
otherwise
12
requires:
13
1.
“Clean
claim”
means
a
claim
that
has
no
defect
or
14
impropriety,
including
a
lack
of
any
required
substantiating
15
documentation,
or
other
circumstances
requiring
special
16
treatment,
that
prevents
timely
payment
from
being
made
on
the
17
claim.
18
2.
“Commissioner
”
means
the
commissioner
of
insurance.
19
3.
“Cost-sharing”
means
any
coverage
limit,
copayment,
20
coinsurance,
deductible,
or
other
out-of-pocket
cost
obligation
21
imposed
by
a
health
benefit
plan
on
a
covered
person.
22
4.
“Covered
person”
means
a
policyholder,
subscriber,
or
23
other
person
participating
in
a
health
benefit
plan
that
has
24
a
prescription
drug
benefit
managed
by
a
pharmacy
benefits
25
manager.
26
5.
“Health
benefit
plan”
means
the
same
as
defined
in
27
section
514J.102.
28
6.
“Health
care
professional”
means
the
same
as
defined
in
29
section
514J.102.
30
7.
“Health
carrier”
means
the
same
as
defined
in
section
31
514J.102.
32
8.
“Maximum
allowable
cost”
means
the
maximum
amount
that
a
33
pharmacy
will
be
reimbursed
by
a
pharmacy
benefits
manager
or
a
34
health
carrier
for
a
generic
drug,
brand-name
drug,
biologic
35
-1-
LSB
5519SV
(1)
89
ko/rn
1/
16
S.F.
2231
product,
or
other
prescription
drug,
and
that
may
include
any
1
of
the
following:
2
a.
Average
acquisition
cost.
3
b.
National
average
acquisition
cost.
4
c.
Average
manufacturer
price.
5
d.
Average
wholesale
price.
6
e.
Brand
effective
rate.
7
f.
Generic
effective
rate.
8
g.
Discount
indexing.
9
h.
Federal
upper
limits.
10
i.
Wholesale
acquisition
cost.
11
j.
Any
other
term
used
by
a
pharmacy
benefits
manager
or
a
12
health
carrier
to
establish
reimbursement
rates
for
a
pharmacy.
13
9.
“Maximum
allowable
cost
list”
means
a
list
of
14
prescription
drugs
that
includes
the
maximum
allowable
cost
15
for
each
prescription
drug
and
that
is
used,
directly
or
16
indirectly,
by
a
pharmacy
benefits
manager.
17
10.
“Pharmacist”
means
the
same
as
defined
in
section
18
155A.3.
19
11.
“Pharmacy”
means
the
same
as
defined
in
section
155A.3.
20
12.
“Pharmacy
acquisition
cost”
means
the
cost
to
a
pharmacy
21
for
a
prescription
drug
as
invoiced
by
a
wholesale
distributor.
22
13.
“Pharmacy
benefits
manager”
means
the
same
as
defined
23
in
section
510C.1.
24
14.
“Pharmacy
benefits
manager
affiliate”
means
a
pharmacy
or
25
a
pharmacist
that
directly
or
indirectly
through
one
or
more
26
intermediaries,
owns
or
controls,
is
owned
and
controlled
by,
27
or
is
under
common
ownership
or
control
of,
a
pharmacy
benefits
28
manager.
29
15.
“Pharmacy
network”
or
“network”
means
pharmacies
that
30
have
contracted
with
a
pharmacy
benefits
manager
to
dispense
31
or
sell
prescription
drugs
to
covered
persons
of
a
health
32
benefit
plan
for
which
the
pharmacy
benefits
manager
manages
33
the
prescription
drug
benefit.
34
16.
“Prescription
drug”
means
the
same
as
defined
in
section
35
-2-
LSB
5519SV
(1)
89
ko/rn
2/
16
S.F.
2231
155A.3.
1
17.
“Prescription
drug
benefit”
means
the
same
as
defined
2
in
section
510C.1.
3
18.
“Prescription
drug
order”
means
the
same
as
defined
in
4
section
155A.3.
5
19.
“Rebate”
means
the
same
as
defined
in
section
510C.1.
6
20.
“Wholesale
distributor”
means
the
same
as
defined
in
7
section
155A.3.
8
Sec.
4.
Section
510B.4,
Code
2022,
is
amended
to
read
as
9
follows:
10
510B.4
Performance
of
duties
——
good
faith
——
conflict
of
11
interest.
12
1.
A
pharmacy
benefits
manager
shall
perform
the
pharmacy
13
benefits
manager’s
duties
exercising
exercise
good
faith
and
14
fair
dealing
in
the
performance
of
its
the
pharmacy
benefits
15
manager’s
contractual
obligations
toward
the
covered
entity
a
16
health
carrier
.
17
2.
A
pharmacy
benefits
manager
shall
notify
the
covered
18
entity
a
health
carrier
in
writing
of
any
activity,
policy,
19
practice
ownership
interest,
or
affiliation
of
the
pharmacy
20
benefits
manager
that
presents
any
conflict
of
interest.
21
3.
a.
A
pharmacy
benefits
manager
shall
owe
a
fiduciary
22
duty
to
each
health
carrier
for
whom
the
pharmacy
benefits
23
manager
manages
a
prescription
drug
benefit
provided
by
the
24
health
carrier,
and
shall
discharge
its
duties
in
accordance
25
with
applicable
state
and
federal
law.
26
b.
A
health
carrier
shall
owe
a
fiduciary
duty
to
each
27
covered
person
participating
in
a
health
benefit
plan
offered
28
or
issued
by
the
health
carrier,
and
the
health
carrier
shall
29
discharge
its
duties
in
accordance
with
applicable
state
and
30
federal
law.
31
4.
A
pharmacy
benefits
manager,
health
carrier,
or
health
32
benefit
plan
shall
not
discriminate
against
a
pharmacy
33
or
a
pharmacist
with
respect
to
participation,
referral,
34
reimbursement
of
a
covered
service,
or
indemnification
if
a
35
-3-
LSB
5519SV
(1)
89
ko/rn
3/
16
S.F.
2231
pharmacist
is
acting
within
the
scope
of
the
pharmacist’s
1
license.
2
Sec.
5.
Section
510B.5,
Code
2022,
is
amended
to
read
as
3
follows:
4
510B.5
Contacting
covered
individual
persons
——
requirements.
5
A
pharmacy
benefits
manager,
unless
authorized
pursuant
to
6
the
terms
of
its
contract
with
a
covered
entity
health
carrier
,
7
shall
not
contact
any
covered
individual
person
without
8
the
express
written
permission
of
the
covered
entity
health
9
carrier
.
10
Sec.
6.
Section
510B.6,
Code
2022,
is
amended
to
read
as
11
follows:
12
510B.6
Dispensing
of
substitute
Substitute
prescription
drug
13
for
prescribed
drug
drugs
.
14
1.
The
following
provisions
shall
apply
when
if
a
pharmacy
15
benefits
manager
requests
the
dispensing
of
a
substitute
16
prescription
drug
for
a
prescribed
drug
to
prescribed
for
a
17
covered
individual
person
:
18
a.
The
pharmacy
benefits
manager
may
request
the
19
substitution
of
a
lower
priced
generic
and
therapeutically
20
equivalent
prescription
drug
for
a
higher
priced
prescribed
21
prescription
drug.
22
b.
If
the
substitute
prescription
drug’s
net
cost
to
the
23
covered
individual
person
or
covered
entity
to
the
health
24
carrier
exceeds
the
cost
of
the
prescribed
prescription
drug
25
originally
prescribed
for
the
covered
person
,
the
substitution
26
shall
be
made
only
for
medical
reasons
that
benefit
the
covered
27
individual
person
.
28
2.
A
pharmacy
benefits
manager
shall
obtain
the
approval
of
29
the
prescribing
practitioner
health
care
professional
prior
to
30
requesting
any
substitution
under
this
section
.
31
3.
A
pharmacy
benefits
manager
shall
not
substitute
an
32
equivalent
prescription
drug
contrary
to
a
prescription
drug
33
order
that
prohibits
a
substitution.
34
Sec.
7.
Section
510B.7,
Code
2022,
is
amended
by
striking
35
-4-
LSB
5519SV
(1)
89
ko/rn
4/
16
S.F.
2231
the
section
and
inserting
in
lieu
thereof
the
following:
1
510B.7
Pharmacy
networks.
2
1.
A
pharmacy
located
in
the
state
shall
not
be
prohibited
3
from
participating
in
a
pharmacy
network
provided
that
the
4
pharmacy
accepts
the
same
terms
and
conditions
as
the
pharmacy
5
benefits
manager
imposes
on
the
pharmacies
in
the
network.
6
2.
A
pharmacy
benefits
manager
shall
not
assess,
charge,
or
7
collect
any
form
of
remuneration
that
passes
from
a
pharmacy
8
or
a
pharmacist
in
a
pharmacy
network
to
the
pharmacy
benefits
9
manager
including
but
not
limited
to
claim
processing
fees,
10
performance-based
fees,
network
participation
fees,
or
11
accreditation
fees.
12
Sec.
8.
Section
510B.8,
Code
2022,
is
amended
by
striking
13
the
section
and
inserting
in
lieu
thereof
the
following:
14
510B.8
Prescription
drugs
——
point
of
sale.
15
1.
A
covered
person
shall
not
be
required
to
make
a
16
cost-sharing
payment
at
the
point
of
sale
for
a
prescription
17
drug
in
an
amount
that
exceeds
the
maximum
allowable
cost
for
18
that
drug
at
the
pharmacy
at
which
the
covered
person
fills
the
19
covered
person’s
prescription
drug
order.
20
2.
A
pharmacy
benefits
manager
shall
not
prohibit
a
pharmacy
21
from
disclosing
the
availability
of
a
lower-cost
prescription
22
drug
option
to
a
covered
person,
or
from
selling
a
lower-cost
23
prescription
drug
option
to
a
covered
person.
24
3.
Any
amount
paid
by
a
covered
person
for
a
prescription
25
drug
purchased
pursuant
to
this
section
shall
be
applied
to
any
26
deductible
imposed
by
the
covered
person’s
health
benefit
plan
27
in
accordance
with
the
health
benefit
plan
coverage
documents.
28
4.
A
covered
person
shall
not
be
prohibited
from
filling
29
a
prescription
drug
order
at
any
pharmacy
located
in
the
30
state
provided
that
the
pharmacy
accepts
the
same
terms
and
31
conditions
as
the
covered
person’s
health
benefit
plan.
32
5.
A
pharmacy
benefits
manager
shall
not
impose
different
33
cost-sharing
or
additional
fees
on
a
covered
person
based
on
34
the
pharmacy
at
which
the
covered
person
fills
the
covered
35
-5-
LSB
5519SV
(1)
89
ko/rn
5/
16
S.F.
2231
person’s
prescription
drug
order.
1
6.
A
pharmacy
benefits
manager
shall
not
require
a
covered
2
person,
as
a
condition
of
payment
or
reimbursement,
to
purchase
3
pharmacy
services,
including
prescription
drugs,
exclusively
4
through
a
mail-order
pharmacy.
5
7.
a.
A
covered
person’s
cost-sharing
for
a
prescription
6
drug
shall
be
calculated
at
the
point-of-sale
based
on
a
price
7
that
is
reduced
by
an
amount
equal
to
at
least
one
hundred
8
percent
of
all
rebates
that
have
been
received,
or
that
will
be
9
received,
by
the
health
carrier
or
a
pharmacy
benefits
manager
10
in
connection
with
the
dispensing
or
administration
of
the
11
prescription
drug.
12
b.
A
health
carrier
shall
not
be
precluded
from
decreasing
13
a
covered
person’s
cost-sharing
by
an
amount
greater
than
the
14
covered
person’s
cost-sharing
as
calculated
under
paragraph
15
“a”
.
16
8.
A
pharmacy
benefits
manager
shall
include
any
amount
17
paid
by
a
covered
person,
or
by
any
other
person
on
behalf
of
18
a
covered
person,
when
calculating
the
covered
person’s
total
19
contribution
toward
the
covered
person’s
cost-sharing.
20
9.
A
pharmacy
may
decline
to
dispense
a
prescription
drug
to
21
a
covered
person
if,
as
a
result
of
the
maximum
allowable
cost
22
list
to
which
the
pharmacy
is
subject,
the
pharmacy
will
be
23
reimbursed
less
for
the
prescription
drug
than
the
pharmacy’s
24
acquisition
cost.
25
Sec.
9.
NEW
SECTION
.
510B.8A
Maximum
allowable
cost
lists.
26
1.
Prior
to
placement
of
a
particular
prescription
drug
on
a
27
maximum
allowable
cost
list,
a
pharmacy
benefits
manager
shall
28
ensure
that
all
of
the
following
requirements
are
met:
29
a.
The
particular
prescription
drug
must
be
listed
as
30
therapeutically
and
pharmaceutically
equivalent
in
the
most
31
recent
edition
of
the
publication
entitled
“Approved
Drug
32
Products
with
Therapeutic
Equivalence
Evaluations”,
published
33
by
the
United
States
food
and
drug
administration,
otherwise
34
known
as
the
orange
book.
35
-6-
LSB
5519SV
(1)
89
ko/rn
6/
16
S.F.
2231
b.
The
particular
prescription
drug
must
not
be
obsolete
or
1
temporarily
unavailable.
2
c.
The
particular
prescription
drug
must
be
available
for
3
purchase,
without
limitations,
by
all
pharmacies
in
the
state
4
from
a
national
or
regional
wholesale
distributor
that
is
5
licensed
in
the
state.
6
2.
For
each
maximum
allowable
cost
list
that
a
pharmacy
7
benefits
manager
uses
in
the
state,
the
pharmacy
benefits
8
manager
shall
do
all
of
the
following:
9
a.
Provide
each
pharmacy
in
a
pharmacy
network
reasonable
10
access
to
the
maximum
allowable
cost
list
to
which
the
pharmacy
11
is
subject.
12
b.
Update
the
maximum
allowable
cost
list
within
seven
13
calendar
days
from
the
date
of
an
increase
of
ten
percent
or
14
more
in
the
pharmacy
acquisition
cost
of
a
prescription
drug
on
15
the
list
by
one
or
more
wholesale
distributors
doing
business
16
in
the
state.
17
c.
Update
the
maximum
allowable
cost
list
within
seven
18
calendar
days
from
the
date
of
a
change
in
the
methodology,
or
19
a
change
in
the
value
of
a
variable
applied
in
the
methodology,
20
on
which
the
maximum
allowable
cost
list
is
based.
21
d.
Provide
a
reasonable
process
for
each
pharmacy
in
a
22
pharmacy
network
to
receive
prompt
notice
of
all
changes
to
the
23
maximum
allowable
cost
list
to
which
the
pharmacy
is
subject.
24
Sec.
10.
NEW
SECTION
.
510B.8B
Reimbursement.
25
1.
A
pharmacy
benefits
manager
shall
not
reimburse
a
26
pharmacy
or
pharmacist
for
a
prescription
drug
in
an
amount
27
less
than
the
national
average
drug
acquisition
cost
for
the
28
prescription
drug
on
the
date
that
the
drug
is
administered
or
29
dispensed.
30
2.
In
addition
to
the
reimbursement
required
under
31
subsection
1,
a
pharmacy
benefits
manager
shall
reimburse
the
32
pharmacy
or
pharmacist
a
professional
dispensing
fee
that
is
33
no
less
than
the
pharmacy
dispensing
fee
published
in
the
Iowa
34
Medicaid
enterprise
provider
fee
schedule
on
the
date
that
the
35
-7-
LSB
5519SV
(1)
89
ko/rn
7/
16
S.F.
2231
prescription
drug
is
administered
or
dispensed.
1
Sec.
11.
NEW
SECTION
.
510B.8C
Pharmacy
benefits
manager
2
affiliates
——
reimbursement.
3
A
pharmacy
benefits
manager
shall
not
reimburse
any
pharmacy
4
located
in
the
state
in
an
amount
less
than
the
amount
that
5
the
pharmacy
benefits
manager
reimburses
a
pharmacy
benefits
6
manager
affiliate
for
dispensing
the
same
prescription
drug
7
as
dispensed
by
the
pharmacy.
The
reimbursement
amount
shall
8
be
calculated
on
a
per
unit
basis
based
on
the
same
generic
9
product
identifier
or
generic
code
number.
10
Sec.
12.
NEW
SECTION
.
510B.8D
Clean
claims.
11
After
the
date
of
receipt
of
a
clean
claim
submitted
by
a
12
pharmacy
in
a
pharmacy
network,
a
pharmacy
benefits
manager
13
shall
not
retroactively
reduce
payment
on
the
claim,
either
14
directly
or
indirectly,
except
if
the
claim
is
found
not
to
be
15
a
clean
claim
during
the
course
of
a
routine
audit.
16
Sec.
13.
NEW
SECTION
.
510B.8E
Appeals
and
disputes.
17
1.
A
pharmacy
benefits
manager
shall
provide
a
reasonable
18
process
to
allow
a
pharmacy
to
appeal
a
maximum
allowable
cost,
19
or
a
reimbursement
made
under
a
maximum
allowable
cost
list,
20
for
a
specific
prescription
drug
for
any
of
the
following
21
reasons:
22
a.
The
pharmacy
benefits
manager
violated
section
510B.8A.
23
b.
The
maximum
allowable
cost
is
below
the
pharmacy
24
acquisition
cost.
25
2.
The
appeal
process
must
include
all
of
the
following:
26
a.
A
dedicated
telephone
number
at
which
a
pharmacy
may
27
contact
the
pharmacy
benefits
manager
and
speak
directly
with
28
an
individual
involved
in
the
appeal
process.
29
b.
A
dedicated
electronic
mail
address
or
internet
site
for
30
the
purpose
of
submitting
an
appeal
directly
to
the
pharmacy
31
benefits
manager.
32
c.
A
period
of
at
least
seven
business
days
after
the
date
33
of
a
pharmacy’s
initial
submission
of
a
clean
claim
during
34
which
the
pharmacy
may
initiate
an
appeal.
35
-8-
LSB
5519SV
(1)
89
ko/rn
8/
16
S.F.
2231
3.
A
pharmacy
benefits
manager
shall
respond
to
an
appeal
1
within
seven
business
days
after
the
date
on
which
the
pharmacy
2
benefits
manager
receives
the
appeal.
3
a.
If
the
pharmacy
benefits
manager
grants
a
pharmacy’s
4
appeal,
the
pharmacy
benefits
manager
shall
do
all
of
the
5
following:
6
(1)
Adjust
the
maximum
allowable
cost
of
the
prescription
7
drug
that
is
the
subject
of
the
appeal
and
provide
the
national
8
drug
code
number
that
the
adjustment
is
based
on
to
the
9
appealing
pharmacy.
10
(2)
Permit
the
appealing
pharmacy
to
reverse
and
rebill
the
11
claim
that
is
the
subject
of
the
appeal.
12
(3)
Make
the
adjustment
pursuant
to
subparagraph
(1)
13
applicable
to
each
pharmacy
in
the
state
subject
to
the
same
14
maximum
allowable
cost
list
as
the
appealing
pharmacy.
15
b.
If
the
pharmacy
benefits
manager
denies
a
pharmacy’s
16
appeal,
the
pharmacy
benefits
manager
shall
do
all
of
the
17
following:
18
(1)
Provide
the
appealing
pharmacy
the
national
drug
19
code
number
and
the
name
of
a
wholesale
distributor
licensed
20
pursuant
to
section
155A.17
from
which
the
pharmacy
can
obtain
21
the
prescription
drug
at
or
below
the
maximum
allowable
cost.
22
(2)
If
the
prescription
drug
identified
by
the
national
drug
23
code
number
provided
by
the
pharmacy
benefits
manager
pursuant
24
to
subparagraph
(1)
is
not
available
below
the
pharmacy
25
acquisition
cost
from
the
wholesale
distributor
from
whom
the
26
pharmacy
purchases
the
majority
of
its
prescription
drugs
for
27
resale,
the
pharmacy
benefits
manager
shall
adjust
the
maximum
28
allowable
cost
list
above
the
appealing
pharmacy’s
pharmacy
29
acquisition
cost,
and
permit
the
pharmacy
to
reverse
and
rebill
30
each
claim
affected
by
the
pharmacy’s
inability
to
procure
the
31
prescription
drug
at
a
cost
that
is
equal
to
or
less
than
the
32
previously
appealed
maximum
allowable
cost.
33
Sec.
14.
Section
510B.9,
Code
2022,
is
amended
to
read
as
34
follows:
35
-9-
LSB
5519SV
(1)
89
ko/rn
9/
16
S.F.
2231
510B.9
Submission,
approval,
and
use
of
prior
Prior
1
authorization
form
.
2
A
pharmacy
benefits
manager
shall
file
with
and
have
3
approved
by
the
commissioner
a
single
prior
authorization
4
form
as
provided
in
section
505.26
comply
with
all
applicable
5
prior
authorization
requirements
pursuant
to
section
505.26
.
6
A
pharmacy
benefits
manager
shall
use
the
single
prior
7
authorization
form
as
provided
in
section
505.26
.
8
Sec.
15.
Section
510B.10,
Code
2022,
is
amended
by
striking
9
the
section
and
inserting
in
lieu
thereof
the
following:
10
510B.10
Enforcement.
11
1.
The
commissioner
shall
take
any
enforcement
action
under
12
the
commissioner’s
authority
to
enforce
compliance
with
this
13
chapter.
14
2.
After
notice
and
hearing,
the
commissioner
may
issue
any
15
order
or
impose
any
penalty
pursuant
to
section
507B.7,
and
may
16
suspend
or
revoke
a
pharmacy
benefits
manager’s
certificate
17
of
registration
as
a
third-party
administrator
upon
a
finding
18
that
the
pharmacy
benefits
manager
violated
this
chapter,
19
or
any
applicable
requirements
pertaining
to
third-party
20
administrators
under
chapter
510.
21
3.
A
pharmacy
benefits
manager,
as
an
agent
or
vendor
of
a
22
health
carrier,
is
subject
to
the
commissioner’s
authority
to
23
conduct
an
examination
pursuant
to
chapter
507.
The
procedures
24
set
forth
in
chapter
507
regarding
examination
reports
shall
25
apply
to
an
examination
of
a
pharmacy
benefits
manager
under
26
this
chapter.
27
4.
A
pharmacy
benefits
manager
is
subject
to
the
28
commissioner’s
authority
to
conduct
a
proceeding
pursuant
29
to
chapter
507B.
The
procedures
set
forth
in
chapter
507B
30
regarding
proceedings
shall
apply
to
a
proceeding
related
to
a
31
pharmacy
benefits
manager
under
this
chapter.
32
5.
A
pharmacy
benefits
manager
is
subject
to
the
33
commissioner’s
authority
to
conduct
an
examination,
audit,
34
or
inspection
pursuant
to
chapter
510
for
third-party
35
-10-
LSB
5519SV
(1)
89
ko/rn
10/
16
S.F.
2231
administrators.
The
procedures
set
forth
in
chapter
510
for
1
third-party
administrators
shall
apply
to
an
examination,
2
audit,
or
inspection
of
a
pharmacy
benefits
manager
under
this
3
chapter.
4
6.
If
the
commissioner
conducts
an
examination
of
a
pharmacy
5
benefits
manager
under
chapter
507;
a
proceeding
under
chapter
6
507B;
or
an
examination,
audit,
or
inspection
under
chapter
7
510,
all
information
received
from
the
pharmacy
benefits
8
manager,
and
all
notes,
work
papers,
or
other
documents
related
9
to
the
examination,
proceeding,
audit,
or
inspection
shall
10
be
confidential
records
pursuant
to
chapter
22
and
shall
be
11
accorded
the
same
confidentiality
as
notes,
work
papers,
12
investigatory
materials,
or
other
documents
related
to
the
13
examination
of
an
insurer
as
provided
in
section
507.14.
14
7.
A
violation
of
this
chapter
shall
be
an
unfair
or
15
deceptive
act
or
practice
in
the
business
of
insurance
pursuant
16
to
section
507B.4,
subsection
3.
17
Sec.
16.
NEW
SECTION
.
510B.11
Rules.
18
The
commissioner
shall
adopt
rules
pursuant
to
chapter
17A
19
to
administer
this
chapter.
20
Sec.
17.
NEW
SECTION
.
510B.12
Severability.
21
If
a
provision
of
this
chapter
or
its
application
to
any
22
person
or
circumstance
is
held
invalid,
the
invalidity
does
23
not
affect
other
provisions
or
applications
of
this
chapter
24
which
can
be
given
effect
without
the
invalid
provision
or
25
application,
and
to
this
end
the
provisions
of
this
chapter
are
26
severable.
27
Sec.
18.
REPEAL.
Section
510B.3,
Code
2022,
is
repealed.
28
Sec.
19.
APPLICABILITY.
This
Act
applies
to
pharmacy
29
benefits
managers
that
manage
a
health
carrier’s
prescription
30
drug
benefit
in
the
state
on
or
after
the
effective
date
of
31
this
Act.
32
EXPLANATION
33
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
34
the
explanation’s
substance
by
the
members
of
the
general
assembly.
35
-11-
LSB
5519SV
(1)
89
ko/rn
11/
16
S.F.
2231
This
bill
relates
to
pharmacy
benefits
managers
(PBM),
1
pharmacies,
and
prescription
drug
benefits.
2
The
bill
provides
that
a
PBM
owes
a
fiduciary
duty
to
3
each
health
carrier
(carrier)
for
whom
the
PBM
manages
a
4
prescription
drug
benefit
(drug
benefit)
provided
by
the
5
carrier,
and
shall
discharge
its
duties
in
accordance
with
6
applicable
state
and
federal
law.
The
bill
also
provides
that
7
a
carrier
shall
owe
a
fiduciary
duty
to
each
covered
person
8
participating
in
a
health
benefit
plan
(benefit
plan)
offered
9
or
issued
by
the
carrier,
and
the
carrier
shall
discharge
10
its
duties
in
accordance
with
applicable
state
and
federal
11
law.
The
bill
prohibits
a
PBM,
carrier,
or
benefit
plan
from
12
discriminating
against
a
pharmacy
or
pharmacist
with
respect
to
13
participation,
referral,
reimbursement
of
a
covered
service,
or
14
indemnification
if
a
pharmacist
is
acting
within
the
scope
of
15
the
pharmacist’s
license.
16
The
bill
requires
a
PBM
to
allow
a
pharmacy
located
in
the
17
state
to
participate
in
a
pharmacy
network
(network)
provided
18
that
the
pharmacy
accepts
the
same
terms
and
conditions
as
19
the
PBM
imposes
on
the
pharmacies
in
the
network.
“Pharmacy
20
benefits
manager”
is
defined
in
the
bill
as
a
person
who,
21
pursuant
to
a
contract
or
other
relationship
with
a
carrier,
22
either
directly
or
through
an
intermediary,
manages
a
23
drug
benefit
provided
by
the
carrier.
“Pharmacy
network”,
24
“pharmacist”,
“pharmacy”,
“prescription
drug
benefit”,
and
25
“health
carrier”
are
also
defined
in
the
bill.
26
The
bill
prohibits
a
PBM
from
assessing,
charging,
or
27
collecting
any
form
of
remuneration
that
passes
from
a
pharmacy
28
in
the
network
to
the
PBM
including
but
not
limited
to
claim
29
processing
fees,
performance-based
fees,
network
participation
30
fees,
or
accreditation
fees.
31
The
bill
prohibits
a
covered
person
from
being
required
32
to
make
a
cost-sharing
payment
at
the
point-of-sale
for
a
33
prescription
drug
(drug)
in
an
amount
that
exceeds
the
maximum
34
allowable
cost
(MAC)
for
that
drug.
The
bill
defines
the
MAC
35
-12-
LSB
5519SV
(1)
89
ko/rn
12/
16
S.F.
2231
as
the
maximum
amount
that
a
pharmacy
will
be
reimbursed
by
a
1
PBM
or
a
carrier
for
a
generic
drug,
brand-name
drug,
biologic
2
product,
or
other
drug
and
that
may
include
the
average
or
3
national
average
acquisition
cost;
the
average
manufacturer
4
price;
the
average
wholesale
price;
the
brand
or
generic
5
effective
rate;
discount
indexing;
federal
upper
limits;
6
wholesale
acquisition
cost;
or
any
other
term
used
by
a
PBM
7
or
carrier
to
establish
reimbursement
rates
for
a
pharmacy.
8
“Covered
person”
is
defined
in
the
bill.
9
A
PBM
cannot
prohibit
a
pharmacy
from
disclosing
the
10
availability
of
a
lower-cost
drug
option
to
a
covered
person,
11
or
from
selling
a
lower-cost
drug
option
to
a
covered
person.
12
The
bill
requires
that
any
amount
paid
by
a
covered
person
13
for
a
drug
in
the
circumstances
detailed
in
the
bill
must
14
be
applied
to
any
deductible
imposed
by
the
covered
person’s
15
health
benefit
plan
in
accordance
with
the
plan’s
coverage
16
documents.
Under
the
bill,
a
covered
person
cannot
be
17
prohibited
from
filling
a
drug
order
at
any
pharmacy
located
18
in
the
state
if
the
pharmacy
accepts
the
same
terms
and
19
conditions
as
the
covered
person’s
benefit
plan.
A
PBM
cannot
20
impose
different
cost-sharing
or
additional
fees
on
a
covered
21
person
based
on
the
pharmacy
at
which
a
covered
person
fills
22
their
prescription.
A
PBM
cannot
require
a
covered
person,
23
as
a
condition
of
payment
or
reimbursement,
to
purchase
24
pharmacy
services,
including
drugs,
exclusively
through
25
a
mail-order
pharmacy.
The
bill
requires
that
a
covered
26
person’s
cost-sharing
for
a
drug
shall
be
calculated
at
the
27
point-of-sale
based
on
a
price
that
is
reduced
by
an
amount
28
equal
to
at
least
100
percent
of
all
rebates
that
have
been
29
received,
or
that
will
be
received,
by
the
health
carrier
or
30
a
PBM
in
connection
with
the
dispensing
or
administration
of
31
the
drug.
A
health
carrier
may
decrease
a
covered
person’s
32
cost-sharing
by
a
greater
amount.
“Rebate”
is
defined
in
the
33
bill.
A
PBM
shall
include
any
amount
paid
by
a
covered
person,
34
or
by
any
other
person
on
behalf
of
a
covered
person,
when
35
-13-
LSB
5519SV
(1)
89
ko/rn
13/
16
S.F.
2231
calculating
the
covered
person’s
total
contribution
toward
the
1
covered
person’s
cost-sharing.
“Cost-sharing”
is
defined
in
2
the
bill.
The
bill
allows
a
pharmacy
to
decline
to
dispense
3
a
drug
to
a
covered
person
if,
as
a
result
of
the
maximum
4
allowable
cost
list
(MACL)
to
which
the
pharmacy
is
subject,
5
the
pharmacy
will
be
reimbursed
less
than
the
pharmacy’s
6
acquisition
cost.
“Pharmacy
acquisition
cost”
is
defined
in
7
the
bill.
“Maximum
allowable
cost
list”
is
defined
in
the
8
bill
as
a
list
of
prescription
drugs
that
includes
the
MAC
for
9
each
drug
and
that
is
used,
directly
or
indirectly,
by
a
PBM.
10
“Pharmacy
acquisition
cost”
is
also
defined
in
the
bill.
11
The
bill
requires
that
prior
to
placement
of
a
particular
12
drug
on
a
MACL,
a
PBM
must
ensure
that
the
drug
is
listed
as
13
therapeutically
and
pharmaceutically
equivalent
in
the
most
14
recent
edition
of
the
“Approved
Drug
Products
with
Therapeutic
15
Equivalence
Evaluations”,
published
by
the
United
States
16
food
and
drug
administration;
the
drug
cannot
be
obsolete
or
17
temporarily
unavailable;
and
the
drug
must
be
available
for
18
purchase
by
all
pharmacies
in
the
state
from
a
national
or
19
regional
wholesale
distributor
that
is
licensed
in
the
state.
20
“Wholesale
distributor”
is
defined
in
the
bill.
21
The
bill
requires
a
PBM
to
provide
each
pharmacy
in
a
22
network
reasonable
access
to
the
MACL
to
which
the
pharmacy
is
23
subject,
and
to
update
each
MACL
within
seven
calendar
days
24
from
the
date
of
an
increase
of
10
percent
or
more
in
the
25
pharmacy
acquisition
cost
of
a
drug
by
one
or
more
wholesale
26
distributors
doing
business
in
the
state.
The
PBM
must
also
27
update
a
MACL
within
seven
calendar
days
from
the
date
of
a
28
change
in
the
methodology,
or
a
change
in
a
value
of
a
variable
29
applied
in
the
methodology,
on
which
the
MACL
is
based.
The
30
PBM
is
also
required
to
provide
a
process
for
each
pharmacy
in
31
a
network
to
receive
prompt
notice
of
all
changes
to
a
MACL.
32
The
bill
provides
that
a
PBM
shall
not
reimburse
a
pharmacy
33
or
pharmacist
for
a
drug
in
an
amount
less
than
the
national
34
average
drug
acquisition
cost
for
the
drug
on
the
date
that
35
-14-
LSB
5519SV
(1)
89
ko/rn
14/
16
S.F.
2231
the
drug
is
administered
or
dispensed.
In
addition
to
the
1
reimbursement,
a
PBM
shall
reimburse
the
pharmacy
or
pharmacist
2
a
professional
dispensing
fee
that
is
no
less
than
the
pharmacy
3
dispensing
fee
published
in
the
Iowa
Medicaid
enterprise
4
provider
fee
schedule
on
the
date
that
the
drug
is
administered
5
or
dispensed.
6
The
bill
prohibits
a
PBM
from
reimbursing
a
pharmacy
located
7
in
the
state
in
an
amount
less
than
the
amount
that
the
PBM
8
reimburses
a
PBM
affiliate
for
dispensing
the
same
drug
as
the
9
pharmacy.
“Pharmacy
benefits
manager
affiliate”
is
defined
in
10
the
bill.
11
The
bill
provides
that
after
the
date
of
receipt
of
a
clean
12
claim
submitted
by
a
pharmacy,
a
PBM
cannot
retroactively
13
reduce
payment
on
the
claim,
either
directly
or
indirectly,
14
except
if
the
claim
is
found
not
to
be
a
clean
claim
during
the
15
course
of
a
routine
audit.
“Clean
claim”
is
defined
in
the
16
bill.
17
The
bill
requires
a
PBM
to
provide
a
process
for
pharmacies
18
to
appeal
a
MAC,
or
a
reimbursement
made
under
a
MACL.
The
19
requirements
for
the
appeal
process
are
detailed
in
the
bill.
20
The
commissioner
of
insurance
(commissioner)
is
required
21
to
take
any
enforcement
action
under
the
commissioner’s
22
authority
to
enforce
compliance
with
the
bill.
After
notice
23
and
hearing,
the
commissioner
may
issue
any
order
or
impose
24
any
penalty
pursuant
to
Code
section
507B.7,
and
may
suspend
25
or
revoke
a
PBM’s
certificate
of
registration
as
a
third-party
26
administrator
upon
a
finding
that
the
PBM
violated
any
27
requirements
of
the
bill,
or
any
applicable
requirements
28
pertaining
to
third-party
administrators
under
Code
chapter
29
510.
30
A
PBM
is
subject
to
the
commissioner’s
authority
to
conduct
31
an
examination
pursuant
to
Code
chapter
507
and
a
proceeding
32
pursuant
to
Code
chapter
507B.
A
PBM
is
also
subject
to
33
the
commissioner’s
authority
to
conduct
an
examination,
34
audit,
or
inspection
pursuant
to
Code
chapter
510.
If
the
35
-15-
LSB
5519SV
(1)
89
ko/rn
15/
16
S.F.
2231
commissioner
conducts
an
examination,
a
proceeding,
an
audit,
1
or
an
inspection,
all
information
received
from
the
PBM,
and
2
all
documents
related
to
the
examination,
proceeding,
audit,
or
3
inspection
are
confidential
records
pursuant
to
Code
chapter
4
22.
5
A
violation
of
the
bill
is
an
unfair
or
deceptive
act
or
6
practice
in
the
business
of
insurance
pursuant
to
Code
section
7
507B.4,
for
which
the
commissioner
may
issue
an
order
or
impose
8
a
penalty.
9
The
bill
requires
the
commissioner
to
adopt
rules
to
10
administer
the
bill.
11
If
a
provision
of
the
bill
or
its
application
to
any
person
12
or
circumstance
is
held
invalid,
the
invalidity
does
not
affect
13
other
provisions
or
applications
of
the
bill
that
can
be
given
14
effect
without
the
invalid
provision
or
application.
15
The
bill
makes
conforming
changes
to
Code
sections
510B.2,
16
510B.4,
510B.5,
510B.6,
and
510B.9.
17
The
bill
repeals
Code
section
510B.3
which
is
replaced
in
18
large
part
by
new
Code
section
510B.10
(enforcement).
19
The
bill
applies
to
PBMs
that
manage
a
health
carrier’s
20
prescription
drug
benefit
in
the
state
on
or
after
the
21
effective
date
of
the
bill.
22
-16-
LSB
5519SV
(1)
89
ko/rn
16/
16