Senate
File
2071
-
Introduced
SENATE
FILE
2071
BY
HATCH
A
BILL
FOR
An
Act
relating
to
prescription
drug
costs
and
practices
and
1
making
penalties
applicable.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
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DIVISION
I
1
PHARMACY
BENEFITS
MANAGERS
2
Section
1.
Section
510.21,
Code
2009,
is
amended
to
read
as
3
follows:
4
510.21
Certificate
of
registration
required.
5
1.
A
person
shall
not
act
as
or
represent
oneself
to
be
6
a
third-party
administrator
in
this
state,
other
than
an
7
adjuster
licensed
in
this
state
for
the
kinds
of
business
for
8
which
the
person
is
acting
as
a
third-party
administrator,
9
unless
the
person
holds
a
current
certificate
of
registration
10
as
a
third-party
administrator
issued
by
the
commissioner
of
11
insurance.
A
certificate
of
registration
as
a
third-party
12
administrator
is
renewable
every
three
years.
Failure
to
hold
13
a
certificate
subjects
the
third-party
administrator
to
the
14
sanctions
set
out
in
section
507B.7.
The
certificate
shall
15
be
issued
by
the
commissioner
to
a
third-party
administrator
16
unless
the
commissioner,
after
due
notice
and
hearing,
17
determines
that
the
third-party
administrator
is
not
competent,
18
trustworthy,
financially
responsible,
or
of
good
personal
and
19
business
reputation,
or
has
had
a
previous
application
for
an
20
insurance
license
denied
for
cause
within
the
preceding
five
21
years.
22
2.
An
application
for
registration
shall
be
accompanied
by
23
a
filing
fee
of
one
hundred
dollars.
After
notice
and
hearing,
24
the
commissioner
may
impose
any
or
all
of
the
sanctions
set
out
25
in
section
507B.7,
upon
finding
that
either
the
third-party
26
administrator
violated
any
of
the
requirements
of
sections
27
510.12
through
510.20
and
this
section,
or
the
third-party
28
administrator
is
not
competent,
trustworthy,
financially
29
responsible,
or
of
good
personal
and
business
reputation.
30
In
addition,
if
the
third-party
administrator
is
a
pharmacy
31
benefits
manager
as
defined
in
section
510B.2,
the
commissioner
32
may
impose
any
or
all
of
the
sanctions
set
out
in
section
33
507B.7
upon
finding
that
the
pharmacy
benefits
manager
has
34
violated
any
provision
of
chapter
510B.
35
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Sec.
2.
Section
510B.1,
subsection
7,
Code
2009,
is
amended
1
by
striking
the
subsection
and
inserting
in
lieu
thereof
the
2
following:
3
7.
“Pharmacy
benefits
management”
means
the
procurement
4
of
prescription
drugs
at
a
negotiated
rate
for
dispensing
5
within
the
state
to
covered
individuals,
the
administration
or
6
management
of
prescription
drug
benefits
provided
by
a
covered
7
entity
for
the
benefit
of
covered
individuals,
or
any
of
the
8
following
services
provided
with
regard
to
the
administration
9
of
pharmacy
benefits:
10
a.
Mail
service
pharmacy.
11
b.
Claims
processing
or
retail
network
management
and
12
payment
of
claims
to
pharmacies
for
prescription
drugs
13
dispensed
to
covered
individuals.
14
c.
Clinical
formulary
development
and
management
services.
15
d.
Rebate
contracting
and
administration.
16
e.
Certain
patient
compliance,
therapeutic
intervention,
and
17
generic
substitution
programs.
18
f.
Disease
management
programs.
19
Sec.
3.
Section
510B.3,
Code
2009,
is
amended
to
read
as
20
follows:
21
510B.3
Enforcement
——
rules
——
penalties
.
22
1.
The
commissioner
shall
enforce
the
provisions
of
this
23
chapter.
24
2.
The
commissioner
shall
adopt
rules
pursuant
to
chapter
25
17A
to
administer
this
chapter
including
rules
relating
to
all
26
of
the
following:
27
a.
Timely
payment
of
pharmacy
claims.
28
b.
A
process
for
adjudication
of
complaints
and
settlement
29
of
disputes
between
a
pharmacy
benefits
manager
and
a
licensed
30
pharmacy
related
to
pharmacy
auditing
practices,
termination
of
31
pharmacy
agreements,
and
timely
payment
of
pharmacy
claims.
32
3.
A
violation
of
this
chapter
is
subject
to
the
sanctions
33
and
penalties
as
specified
in
section
510.21.
34
Sec.
4.
Section
510B.4,
Code
2009,
is
amended
to
read
as
1
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follows:
2
510B.4
Performance
of
duties
——
good
faith
——
conflict
of
3
interest
——
required
practices
.
4
1.
A
pharmacy
benefits
manager
shall
perform
the
pharmacy
5
benefits
manager’s
duties
exercising
good
faith
and
fair
6
dealing
in
the
performance
of
its
contractual
obligations
7
toward
the
covered
entity.
8
2.
A
pharmacy
benefits
manager
shall
notify
the
covered
9
entity
in
writing
of
any
activity,
policy,
practice
ownership
10
interest,
or
affiliation
of
the
pharmacy
benefits
manager
11
that
directly
or
indirectly
presents
any
conflict
of
interest
12
pursuant
to
the
requirements
of
this
chapter
.
13
3.
A
pharmacy
benefits
manager
owes
a
fiduciary
duty
to
a
14
covered
entity
and
shall
discharge
that
duty
in
accordance
with
15
the
provisions
of
state
and
federal
law.
16
4.
A
pharmacy
benefits
manager
shall
perform
its
duties
with
17
care,
skill,
prudence,
and
diligence
and
in
accordance
with
the
18
standards
of
conduct
applicable
to
a
fiduciary
in
an
enterprise
19
of
a
like
character
and
with
like
aims.
20
5.
a.
A
pharmacy
benefits
manager
shall
provide
to
a
21
covered
entity
all
financial
and
utilization
information
22
requested
by
the
covered
entity
relating
to
the
provision
of
23
benefits
to
covered
individuals
through
that
covered
entity
and
24
all
financial
and
utilization
information
relating
to
services
25
to
that
covered
entity.
26
b.
A
pharmacy
benefits
manager
shall
disclose
to
the
covered
27
entity
all
financial
terms
and
arrangements
for
remuneration
28
of
any
kind
that
apply
between
the
pharmacy
benefits
manager
29
and
any
prescription
drug
manufacturer
or
labeler,
including
30
but
not
limited
to
formulary
management
and
drug
switching
31
programs,
educational
support,
claims
processing
and
pharmacy
32
network
fees
that
are
charged
from
retail
pharmacies
and
data
33
sales
fees.
34
c.
A
pharmacy
benefits
manager
disclosing
information
under
35
this
subsection
may
designate
that
material
as
confidential.
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Information
designated
as
confidential
by
a
pharmacy
benefits
2
manager
and
disclosed
to
a
covered
entity
under
this
subsection
3
shall
not
be
disclosed
by
the
covered
entity
to
any
person
4
without
the
consent
of
the
pharmacy
benefits
manager,
except
5
that
disclosure
may
be
made
in
a
court
filing
under
state
law
6
governing
deceptive
trade
practices
or
when
authorized
by
state
7
law
or
ordered
by
a
court
for
good
cause
shown
or
made
in
a
8
court
filing
under
seal
unless
or
until
otherwise
ordered
by
a
9
court.
10
d.
Nothing
in
this
subsection
limits
the
authority
of
the
11
attorney
general
to
investigate
violations
of
this
chapter.
12
Sec.
5.
Section
510B.6,
Code
2009,
is
amended
to
read
as
13
follows:
14
510B.6
Dispensing
of
substitute
prescription
drug
for
15
prescribed
drug
——
passing
on
payments
or
benefits
.
16
1.
The
following
provisions
shall
apply
when
a
pharmacy
17
benefits
manager
requests
the
dispensing
of
a
substitute
18
prescription
drug
for
a
prescribed
drug
to
a
covered
19
individual:
20
a.
The
pharmacy
benefits
manager
may
request
the
21
substitution
of
a
lower
priced
generic
and
therapeutically
22
equivalent
drug
for
a
higher
priced
prescribed
drug.
23
b.
If
the
substitute
drug’s
net
cost
to
the
covered
24
individual
or
covered
entity
exceeds
the
cost
of
the
prescribed
25
drug,
the
substitution
shall
be
made
only
for
medical
reasons
26
that
benefit
the
covered
individual.
27
2.
A
pharmacy
benefits
manager
shall
obtain
the
approval
28
of
the
prescribing
practitioner
prior
to
requesting
any
29
substitution
under
this
section.
30
3.
A
pharmacy
benefits
manager
shall
not
substitute
an
31
equivalent
prescription
drug
contrary
to
a
prescription
drug
32
order
that
prohibits
a
substitution.
33
4.
If
a
pharmacy
benefits
manager
makes
a
substitution
in
34
which
the
substitute
drug’s
net
cost
to
the
covered
individual
35
or
covered
entity
exceeds
the
cost
of
the
prescribed
drug,
the
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pharmacy
benefits
manager
shall
disclose
to
the
covered
entity
2
the
cost
of
both
drugs
and
any
benefit
or
payment
directly
3
or
indirectly
accruing
to
the
pharmacy
benefits
manager
as
a
4
result
of
the
substitution.
5
5.
The
pharmacy
benefits
manager
shall
transfer
in
full
6
to
the
covered
entity
any
benefit
or
payment
received
in
any
7
form
by
the
pharmacy
benefits
manager
either
as
a
result
of
8
a
prescription
drug
substitution
under
subsection
4
or
as
a
9
result
of
the
pharmacy
benefits
manager
substituting
a
lower
10
priced
generic
and
therapeutically
equivalent
drug
for
a
higher
11
priced
prescribed
drug.
12
6.
A
pharmacy
benefits
manager
that
derives
any
payment
or
13
benefit
for
the
dispensing
of
a
prescription
drug
within
the
14
state
based
on
volume
of
sales
for
certain
prescription
drugs
15
or
classes
or
brands
of
drugs
within
the
state
shall
pass
that
16
payment
or
benefit
on
in
full
to
the
covered
entity.
17
Sec.
6.
NEW
SECTION
.
510B.8
Market
conduct
review
and
18
audit.
19
The
commissioner
may
review
compliance
with
this
chapter
by
20
pharmacy
benefits
managers
through
market
conduct
reviews
and
21
audits,
and
may
assess
an
annual
fee
proportional
to
the
cost
22
to
the
division
of
insurance
associated
with
conducting
the
23
market
conduct
review
and
audit.
A
market
conduct
review
and
24
audit
shall
be
completed
at
least
once
every
three
years
for
25
each
pharmacy
benefits
manager
certified
in
the
state.
26
DIVISION
II
27
SECTION
340B
PRESCRIPTION
DRUG
PURCHASING
28
Sec.
7.
LEGISLATIVE
INTENT.
It
is
the
intent
of
the
general
29
assembly
to
reduce
prescription
drug
costs
to
the
state
by
30
ensuring
maximum
use
of
prescription
drug
pricing
available
31
through
section
340B
of
the
federal
Public
Health
Service
Act.
32
Sec.
8.
WORKGROUP
AND
REPORT.
33
1.
The
department
of
public
health
shall
convene
a
34
workgroup
to
study
the
feasibility
of
providing
discounted
35
prescription
drugs
to
the
most
vulnerable
of
Iowa’s
citizens
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through
the
use
of
section
340B
of
the
federal
Public
Health
2
Service
Act,
42
U.S.C.
§
256b
(1999).
The
workgroup
shall
3
include
representatives
of
340B
hospitals,
the
corrections
4
system,
the
medical
assistance
program,
low-income
nonprofit
5
advocacy
organizations,
and
a
representative
of
federally
6
qualified
health
centers
or
a
related
federally
qualified
7
health
centers’
association.
The
workgroup,
in
collaboration
8
with
the
department
of
public
health,
shall
work
with
other
9
state
agencies,
representatives
of
state
employees,
and
10
representatives
of
health
care
providers
and
facilities
in
the
11
state
to
provide
all
of
the
following
information:
12
a.
Covered
entities.
A
description
of
all
health
care
13
providers
and
facilities
in
the
state
potentially
eligible
for
14
designation
as
“covered
entities”
under
section
340B,
including
15
but
not
limited
to
all
hospitals
eligible
as
disproportionate
16
share
hospitals;
recipients
of
grants
from
the
United
States
17
public
health
service;
federally
qualified
health
centers;
18
federally
qualified
look-alikes;
state-operated
AIDS
drug
19
assistance
programs;
Ryan
White
CARE
Act
Title
I,
Title
II,
and
20
Title
III
programs;
tuberculosis,
black
lung,
family
planning,
21
and
sexually
transmitted
disease
clinics;
hemophilia
treatment
22
centers;
public
housing
primary
care
clinics;
and
clinics
for
23
homeless
people.
24
b.
Potential
applications
and
benefits.
A
listing
of
25
potential
applications
of
section
340B
and
the
potential
26
benefits
to
public,
private,
and
third-party
payors
for
27
prescription
drugs,
including
but
not
limited
to:
28
(1)
Application
to
inmates
and
employees
in
juvenile
29
correctional
facilities,
county
jails,
and
state
correctional
30
institutions.
31
(2)
Maximizing
the
use
of
section
340B
within
state-funded
32
managed
care
plans.
33
(3)
Including
section
340B
providers
in
state
bulk
34
purchasing
initiatives.
35
(4)
Utilizing
sole
source
contracts
with
section
340B
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providers
to
furnish
high-cost
chronic
care
drugs.
2
c.
Section
340B
discounts.
Discounts
available
through
3
section
340B
contracts,
including
estimated
cost
savings
to
4
the
state
as
a
result
of
retail
markup
avoidance,
negotiated
5
subceiling
prices,
and
coordination
with
the
medical
assistance
6
program
in
order
to
minimize
costs
to
the
program
and
to
other
7
purchasers
of
prescription
drugs.
8
d.
Identification
of
resources.
The
resources
available
to
9
potential
applicants
for
designation
as
covered
entities
for
10
the
application
process,
establishing
a
section
340B
program,
11
restructuring
the
health
care
system,
or
other
methods
of
12
lowering
the
cost
of
prescription
drugs.
The
resources
shall
13
include
state
and
federal
agencies
and
private
philanthropic
14
grants
to
be
used
for
the
purposes
of
this
section.
15
2.
The
workgroup
shall
report
its
findings
to
the
governor
16
and
the
general
assembly
not
later
than
December
15,
2010.
17
EXPLANATION
18
This
bill
relates
to
the
cost
of
prescription
drugs
19
including
practices
of
pharmacy
benefits
managers
and
the
20
federal
section
340B
program.
21
Division
I
of
the
bill
relates
to
pharmacy
benefits
22
managers.
Pharmacy
benefits
managers
are
considered
23
third-party
administrators
under
current
law,
and
the
bill
24
provides
that
in
addition
to
violations
of
law
relating
to
25
third-party
administrators,
if
a
pharmacy
benefits
manager
26
violates
provisions
of
law
relating
to
pharmacy
benefits
27
managers,
the
sanctions
and
penalties
applicable
to
third-party
28
administrators
apply
to
such
violations.
The
bill
redefines
29
“pharmacy
benefits
management”
to
include
specific
services
30
including
mail
services
pharmacy
and
specifies
required
31
practices
of
pharmacy
benefits
managers
including
the
fiduciary
32
duties,
provision
of
financial
and
utilization
information,
and
33
disclosure
of
financial
terms
and
arrangements
for
remuneration
34
between
the
pharmacy
benefits
manager
and
any
prescription
drug
35
manufacturer
or
labeler.
The
bill
also
requires
a
pharmacy
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2071
benefits
manager
to
disclose
payments
or
benefits
to
a
pharmacy
2
benefits
manager
for
substitution
of
prescription
drugs,
and
to
3
transfer
any
payment
or
benefit
to
the
covered
entity
that
is
4
realized
through
substitution
or
based
on
volume
of
sales.
The
5
bill
also
authorizes
the
commissioner
of
insurance
to
perform
a
6
market
conduct
review
and
audit
at
least
every
three
years
for
7
each
pharmacy
benefits
manager.
8
Division
II
of
the
bill
relates
to
prescription
drug
9
purchasing
through
section
340B
of
the
federal
Public
Health
10
Services
Act
(the
section
340B
program).
The
bill
provides
11
that
it
is
the
intent
of
the
general
assembly
to
reduce
12
prescription
drug
costs
to
the
state
by
ensuring
maximum
use
of
13
prescription
drug
pricing
available
through
the
section
340B
14
program
and
directs
the
department
of
public
health
to
convene
15
a
workgroup
to
study
the
feasibility
of
providing
discounted
16
prescription
drugs
to
the
most
vulnerable
of
Iowa’s
citizens
17
through
the
section
340B
program.
The
bill
specifies
the
18
membership
of
the
workgroup,
and
specifies
the
information
the
19
workgroup
is
to
provide
regarding
covered
entities
under
the
20
section
340B
program,
potential
applications
and
benefits,
21
section
340B
discounts,
and
identification
of
resources.
The
22
bill
directs
the
workgroup
to
report
its
findings
to
the
23
governor
and
the
general
assembly
no
later
than
December
15,
24
2010.
25
-8-
LSB
5726XS
(5)
83
pf/nh
8/
8