House
File
387
-
Introduced
HOUSE
FILE
387
BY
TUREK
A
BILL
FOR
An
Act
creating
the
better
caths
for
Iowa
Act
including
a
1
review
of
the
use
and
reimbursement
of
certain
catheters
2
under
the
Medicaid
program.
3
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
4
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387
Section
1.
SHORT
TITLE.
This
Act
shall
be
known
as
the
1
“Better
Caths
for
Iowa
Act”.
2
Sec.
2.
FINDINGS.
The
general
assembly
finds
all
of
the
3
following:
4
1.
Di(2-ethylhexyl)phthalate
(DEHP)
belongs
to
a
family
5
of
chemicals
called
phthalates:
toxic,
endocrine-disrupting
6
chemicals
which
are
added
to
certain
plastic
products
to
7
increase
their
flexibility.
There
is
no
question
that
the
use
8
of
DEHP
in
medical
devices
harms
patients.
The
evidence
of
9
patient
exposure
to
DEHP
and
other
toxins
during
the
course
10
of
clinical
care
is
well
established
and
science
continues
to
11
demonstrate
the
need
to
reduce
patient
risk
from
such
exposure.
12
2.
Exposure
to
phthalates
like
DEHP
can
do
lasting
harm
13
to
child
brain
development
and
increases
children’s
risks
for
14
learning,
attention,
and
behavior
disorders.
15
3.
A
pregnant
woman’s
exposure
to
phthalates,
which
is
16
known
to
decrease
fetal
testosterone,
can
harm
reproductive
17
tract
development
in
male
babies
which
may
have
lifelong
18
consequences.
19
4.
Phthalates
in
medical
devices
like
catheters
have
been
20
shown
to
leach
into
soft
tissue
from
the
plastic,
a
reason
21
phthalates
have
been
banned
in
children’s
toys
by
the
United
22
States
food
and
drug
administration
(FDA)
as
children
often
23
hold
toys
or
put
them
in
their
mouths
for
long
periods
of
time.
24
5.
Exposure
to
phthalates
can
come
from
multiple
sources
25
simultaneously,
including
from
food
and
food
contact
substances
26
and
other
products.
Therefore,
assessing
risks
from
individual
27
phthalates
may
underestimate
the
health
risks
from
exposure
to
28
mixtures
of
phthalates.
29
6.
Research
shows
that
women
have
higher
exposure
to
30
phthalates
found
in
care
products
than
men.
31
7.
Studies
have
shown
that
African
American
and
Latina
women
32
have
higher
exposure
to
certain
phthalates
compared
with
white
33
women.
34
8.
In
a
nationally
representative
sample,
African
35
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American
women
had
higher
exposures
to
a
real-world
mixture
of
1
hormonally
active
phthalates
compared
with
white
women.
2
9.
Studies
have
shown
that
people
with
disabilities
who
use
3
catheters
experience
bladder
cancer
at
four
times
the
national
4
average.
5
10.
A
population-based
retrospective
cohort
study
published
6
in
September
2021
in
Ontario,
Canada,
proves
the
correlation
7
between
long-term
catheterization
and
bladder
cancer
incidence
8
and
mortality.
In
that
study,
thirty-six
thousand
nine
hundred
9
three
patients
with
long-term
catheterization
were
compared
10
to
one
hundred
ten
thousand
seven
hundred
nine
patients
11
without
a
history
of
catheterization
using
HealthCanada
12
records.
Patients
in
the
catheter
group
develop
bladder
cancer
13
four
times
more
often
than
the
noncatheter
group.
Bladder
14
cancer-specific
death
was
more
than
eight
times
higher
among
15
the
patients
who
were
long-term
catheter
users
than
the
16
noncatheter
group.
17
11.
Cancer
is
the
third
leading
cause
of
death
in
18
individuals
with
spinal
cord
injury
or
disorder
(SCI/D),
and
19
bladder
cancer
is
the
second
most
common
cancer
type
in
these
20
individuals.
21
12.
Urinary
bladder
cancer
in
SCI/D
patients
differs
22
considerably
from
urinary
bladder
cancer
in
able-bodied
23
patients.
SCI/D
patients
show
a
significantly
higher
24
proportion
of
the
more
aggressive
squamous
cell
carcinoma
than
25
that
of
the
general
population.
Consequently,
the
survival
26
rate
is
extremely
unfavorable.
27
13.
Exposure
to
phthalates
including
DEHP,
butyl
benzyl
28
phthalate
(BBzP),
and
Diisobutyl
phthalate
(DiBP)
has
been
29
positively
associated
with
prostate
cancer
in
men.
30
14.
Human
and
rodent
data
suggest
that
DEHP
induces
cancer
31
through
multiple
molecular
signals,
including
DNA
damage.
32
15.
The
European
Union
has
determined
that
DEHP
is
a
33
reproductive
toxicant
and
endocrine
disruptor,
and
in
2017
34
adopted
regulations
requiring
a
benefit-risk
assessment
before
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certain
phthalates,
including
DEHP,
can
be
used
in
medical
1
devices.
2
16.
The
state
of
California
has
determined
that
DEHP
is
a
3
reproductive
and
developmental
toxicant
and
a
carcinogen,
and
4
advises
patients
to
request
devices
that
do
not
contain
DEHP
5
when
undergoing
medical
treatment.
6
17.
In
2002,
based
on
the
FDA’s
2001
safety
assessment,
7
the
FDA
recommended
that
health
care
providers
consider
8
alternatives
to
DEHP
when
conducting
procedures
on
high-risk
9
patients.
10
18.
The
American
medical
association
passed
an
11
organizational
resolution
for
members
encouraging
alternatives
12
to
DEHP
products.
13
19.
The
American
public
health
association
issued
a
policy
14
statement
discouraging
the
use
of
DEHP
and
other
phthalates
in
15
facilities
that
serve
vulnerable
populations.
16
20.
American
patients
receiving
care
in
hospitals
and
other
17
settings
are
overexposed
to
dangerous
levels
of
phthalates.
18
This
critical
patient
safety
issue
has
been
the
subject
of
19
extensive
research
over
the
last
few
decades,
but
thus
far
the
20
guidance
to
protect
patients
from
these
harmful
chemicals
has
21
done
very
little
to
actually
reduce
the
use
of
these
chemicals
22
in
health
care
settings.
23
21.
Despite
these
findings
and
the
growing
body
of
evidence
24
that
has
confirmed
earlier
research
and
identified
additional
25
risks
of
adverse
health
effects
on
vulnerable
patients,
there
26
has
been
minimal
progress
in
the
United
States
over
the
last
27
twenty
years
in
reducing
the
use
of
DEHP
in
medical
devices.
28
22.
Since
2018,
the
office
of
inspector
general
of
the
29
United
States
department
of
health
and
human
services
has
30
recommended
a
significant
reduction
in
reimbursement
amounts
by
31
the
centers
for
Medicare
and
Medicaid
services
of
the
United
32
States
department
of
health
and
human
services
(CMS)
for
33
intermittent
catheters
as
the
Medicare
and
Medicaid
programs
34
have
paid
substantially
more
than
commercial
payors
for
35
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intermittent
urinary
catheters.
1
23.
Each
of
the
three
billing
categories
of
intermittent
2
catheters,
straight
tip,
curved
tip,
and
sterile
kit,
show
3
large
differences
between
Medicare
payments
and
acquisition
4
costs,
which
indicates
a
potential
for
substantial
savings
5
both
to
the
Medicare
program
and
Medicare
beneficiaries
who
6
share
responsibility
for
payment
of
the
Medicare-allowed
7
reimbursement
amount.
8
24.
Nearly
twenty
years
after
the
FDA’s
first
guidance
9
was
issued
on
phthalates,
the
time
has
finally
come
to
take
10
aggressive
and
necessary
steps
forward
to
protect
the
lives
of
11
Iowa
Medicaid
patients.
12
25.
At
the
very
least,
the
Iowa
Medicaid
program
should
13
not
reimburse
medical
device
manufacturers,
distributors,
or
14
suppliers
for
catheters
that
are
made
with
the
known
carcinogen
15
DEHP.
16
Sec.
3.
REVIEW
OF
CATHETERS
——
REIMBURSEMENT
SUSPENSION
17
PENDING
COMPLETION
OF
REVIEW
——
MEDICAID
PROGRAM.
18
1.
The
Medicaid
program
shall
not
reimburse
claims
for
19
catheters
made
with
Di(2-ethylhexyl)phthalate
(DEHP)
until
20
after
the
completion
and
pending
the
results
of
the
review
21
under
this
section
that
includes
the
Medicaid
director’s
22
recommendation
regarding
which
catheters
should
be
reimbursable
23
under
the
Medicaid
program.
24
2.
Pending
completion
of
the
review
under
this
section,
all
25
of
the
following
shall
also
apply:
26
a.
Notwithstanding
any
provision
of
law
to
the
contrary,
27
the
use
of
catheters
made
with
DEHP
is
deemed
unsafe
for
Iowa
28
Medicaid
recipients.
29
b.
Any
rules
previously
adopted
prescribing
the
conditions
30
under
which
any
catheter
made
with
DEHP
may
be
safely
used
are
31
void,
and
shall
have
no
force
or
effect.
32
c.
The
Medicaid
director
shall
object
to
any
notification
of
33
an
intended
use
of
catheters
made
with
DEHP
and
shall
not
adopt
34
rules
prescribing
any
conditions
under
which
any
catheter
made
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with
DEHP
may
be
safely
used
as
an
invasive
medical
device.
1
d.
In
establishing
the
safety
of
alternatives
to
catheters
2
made
with
DEHP
that
may
be
used
and
reimbursed
under
the
Iowa
3
Medicaid
program,
the
Medicaid
director
shall
consider,
in
4
addition
to
criteria
under
section
409
of
the
federal
Food,
5
Drug,
and
Cosmetic
Act,
21
U.S.C.
§348,
potential
adverse
6
effects
of
exposure
to
an
alternative
substance
on
vulnerable
7
populations,
including
pregnant
women,
infants,
children,
8
persons
with
disabilities,
the
elderly,
and
populations
with
9
high
exposure,
including
workers
who
are
exposed
through
10
production
practices
or
clinical
handling
of
the
final
product.
11
e.
The
Medicaid
director
shall
inform
Medicaid
providers
12
and
recipients
of
the
prohibition
against
reimbursement
of
13
catheters
made
with
DEHP
during
the
pendency
of
the
review
and
14
shall
make
available
to
Medicaid
providers
and
recipients
a
15
list
of
alternative
products
that
are
not
made
with
DEHP
and
16
that
are
reimbursable
under
Medicaid
when
provided
to
Medicaid
17
recipients
during
the
pendency
of
the
review.
18
3.
The
Medicaid
director
shall
cause
a
review
to
be
19
conducted
by
the
university
of
Iowa
public
policy
center
20
or
other
appropriate
state
entity
that
includes
all
of
the
21
following:
22
a.
A
historical
records
review
of
Medicaid
recipients
who
23
used
catheters
made
with
phthalate
chemicals
like
DEHP
which
24
are
subject
to
regulation
by
the
United
States
food
and
drug
25
administration
to
determine
whether
Iowa
Medicaid
recipients
26
who
use
these
medical
devices
made
with
phthalate
chemicals
27
have
a
higher
incidence
rate
of
bladder
cancer
than
the
general
28
population.
29
b.
Identification
of
the
brands
of
catheters
with
DEHP
30
that
are
correlated
with
higher
levels
of
bladder
cancer
in
31
the
Iowa
Medicaid
population
of
catheter
users
by
comparing
32
the
diagnosis
codes
associated
with
bladder
cancer
against
33
individual
patient-level
data
that
includes
catheter
billing
34
at
the
stock
keeping
unit
level
to
determine
the
DEHP
35
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concentration
of
these
devices.
1
c.
A
comparison
of
the
average
lifetime
cost
of
care
for
a
2
Medicaid
recipient
who
uses
catheters
with
the
average
lifetime
3
cost
of
care
of
a
Medicaid
recipient
who
has
bladder
cancer
4
treatment.
5
d.
Consideration
of
the
disproportionate
exposure
of
6
invasive
medical
devices
containing
phthalate
chemicals
on
7
members
of
communities
of
color
and
with
disabilities,
and
the
8
health
effects
of
such
exposure
on
members
of
such
communities,
9
including
any
increased
risk
of
cancer,
endocrine
disruption,
10
effects
on
reproductive
health,
and
other
risks
to
human
11
health.
12
4.
No
later
than
July
1,
2025,
the
Medicaid
director
shall
13
issue
a
report
on
the
findings
of
the
review,
submit
the
report
14
to
the
governor
and
the
general
assembly,
and
post
the
report
15
on
the
department
of
health
and
human
services
internet
site.
16
The
report
shall
include
the
Medicaid
director’s
recommendation
17
as
to
which
catheters
should
be
reimbursed
under
the
Medicaid
18
program,
including
specifically
whether
catheters
made
with
19
DEHP
should
be
reimbursed
under
the
Medicaid
program.
20
5.
For
the
purposes
of
this
section,
catheters
include
21
intermittent
and
indwelling
catheters.
22
EXPLANATION
23
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
24
the
explanation’s
substance
by
the
members
of
the
general
assembly.
25
This
bill
relates
to
the
use
and
reimbursement
of
certain
26
catheters
under
the
Medicaid
program.
27
The
bill
shall
be
known
as
the
“Better
Caths
for
Iowa
Act”.
28
The
bill
includes
findings
relating
to
the
use
of
29
phthalates,
a
family
of
toxic
endocrine-disrupting
chemicals
30
that
include
Di(2-ethylhexyl)phthalate
or
DEHP,
that
when
31
added
to
certain
plastic
products
increase
their
flexibility.
32
These
products
include
catheters.
The
findings
include
33
that
American
patients
receiving
care
in
hospitals
and
other
34
settings
are
overexposed
to
dangerous
levels
of
phthalates;
35
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9
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387
exposure
to
phthalates
can
do
lasting
harm
to
child
brain
1
development
and
increases
children’s
risks
for
learning,
2
attention,
and
behavior
disorders;
a
pregnant
woman’s
exposure
3
to
phthalates
can
harm
reproductive
tract
development
in
4
male
babies
which
may
have
lifelong
consequences;
phthalates
5
have
been
banned
from
use
in
children’s
toys
in
the
United
6
States;
women
have
higher
exposure
to
phthalates
found
in
7
care
products
than
men;
African
American
and
Latina
women
8
have
higher
exposure
to
certain
phthalates
compared
with
9
white
women;
persons
with
disabilities
who
use
catheters
10
experience
bladder
cancer
at
four
times
the
national
average;
11
little
has
been
done
to
protect
patients
from
these
harmful
12
chemicals
to
actually
reduce
the
use
of
these
chemicals
in
13
health
care
settings;
that
the
three
billing
categories
of
14
intermittent
catheters,
straight
tip,
curved
tip,
and
sterile
15
kit,
show
large
differences
between
Medicare
payments
and
16
acquisition
costs,
indicating
the
potential
for
substantial
17
savings
both
to
the
Medicare
program
and
Medicare
beneficiaries
18
who
share
responsibility
for
payment
of
the
Medicare-allowed
19
reimbursement
amount;
and
that
at
the
very
least,
the
20
Iowa
Medicaid
program
should
not
reimburse
medical
device
21
manufacturers,
distributors,
or
suppliers
for
catheters
that
22
are
made
with
the
known
carcinogen
DEHP.
23
The
bill
provides
the
Medicaid
program
shall
not
reimburse
24
claims
for
catheters
made
with
DEHP,
until
after
the
completion
25
and
the
results
of
the
review
required
under
the
bill
including
26
the
recommendation
of
the
Medicaid
director
regarding
27
reimbursement
of
catheters
under
the
Medicaid
program.
28
Pending
completion
of
the
review
under
the
bill,
the
use
of
29
catheters
made
with
DEHP
is
deemed
unsafe
for
Iowa
Medicaid
30
recipients;
any
rules
previously
adopted
prescribing
the
31
conditions
under
which
any
catheter
made
with
DEHP
may
be
32
safely
used
are
void,
and
shall
have
no
force
or
effect;
33
the
Medicaid
director
shall
object
to
any
notification
of
an
34
intended
use
of
catheters
made
with
DEHP
and
shall
not
adopt
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rules
prescribing
any
conditions
under
which
any
catheter
1
made
with
DEHP
may
be
safely
used
as
an
invasive
medical
2
device;
and
in
establishing
the
safety
of
alternatives
to
3
catheters
made
with
DEHP
that
may
be
used
and
reimbursed
4
under
the
Iowa
Medicaid
program,
the
Medicaid
director
shall
5
consider,
in
addition
to
criteria
provided
under
federal
law,
6
the
potential
adverse
effects
of
exposure
to
an
alternative
7
substance
on
vulnerable
populations,
including
pregnant
women,
8
infants,
children,
persons
with
disabilities,
the
elderly,
9
and
populations
with
high
exposure,
including
workers
who
are
10
exposed
through
production
practices
or
clinical
handling
of
11
the
final
product.
The
Medicaid
director
is
required
to
inform
12
Medicaid
providers
and
recipients
of
the
prohibition
against
13
reimbursement
of
catheters
made
with
DEHP
during
the
pendency
14
of
the
review
and
make
available
to
Medicaid
recipients
and
15
providers
a
list
of
alternative
products
that
are
not
made
with
16
DEHP
and
that
are
reimbursable
under
Medicaid
when
provided
to
17
Medicaid
recipients
during
the
pendency
of
the
review.
18
The
Medicaid
director
shall
cause
a
review
to
be
conducted
of
19
catheters,
including
a
historical
records
review
of
Medicaid
20
recipients
who
used
catheters
made
with
phthalate
chemicals
21
including
DEHP,
to
determine
whether
Iowa
Medicaid
recipients
22
who
use
these
medical
devices
have
a
higher
incidence
rate
of
23
bladder
cancer
than
the
general
population;
identification
of
24
the
brands
of
catheters
with
DEHP
that
are
correlated
with
25
higher
levels
of
bladder
cancer
in
the
Iowa
Medicaid
population
26
of
catheter
users;
a
comparison
of
the
average
lifetime
cost
27
of
care
for
a
Medicaid
recipient
who
uses
catheters
with
the
28
average
lifetime
cost
of
care
for
a
Medicaid
recipient
who
has
29
bladder
cancer
treatment;
consideration
of
the
disproportionate
30
exposure
of
invasive
medical
devices
containing
phthalate
31
chemicals
on
members
of
communities
of
color
and
with
32
disabilities,
and
the
health
effects
of
such
exposure
on
33
members
of
such
communities,
including
any
increased
risk
of
34
cancer,
endocrine
disruption,
effects
on
reproductive
health,
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and
other
risks
to
human
health.
No
later
than
July
1,
2025,
1
the
Medicaid
director
shall
issue
a
report
on
the
findings
of
2
the
review,
submit
the
report
to
the
governor
and
the
general
3
assembly,
and
post
the
report
on
the
department
of
health
and
4
human
services
internet
site.
The
report
shall
include
a
5
recommendation
as
to
whether
catheters
made
with
DEHP
should
be
6
reimbursed
under
the
Medicaid
program.
7
Under
the
bill,
catheters
include
intermittent
and
8
indwelling
catheters.
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