House
File
225
-
Introduced
HOUSE
FILE
225
BY
BODEN
A
BILL
FOR
An
Act
relating
to
the
right
to
try
Act.
1
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
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Section
1.
Section
144E.2,
Code
2023,
is
amended
to
read
as
1
follows:
2
144E.2
Definitions.
3
As
used
in
this
chapter
:
4
1.
“Eligible
facility”
means
an
institution
operating
under
5
a
federalwide
assurance
for
the
protection
of
human
subjects
6
pursuant
to
42
U.S.C.
§289(a)
and
28
C.F.R.
pt.
46.
7
1.
2.
“Eligible
patient”
means
an
individual
who
meets
all
8
of
the
following
conditions:
9
a.
Has
a
terminal
life-threatening
or
severely
debilitating
10
illness,
attested
to
by
the
patient’s
treating
physician.
11
b.
Has
considered
and
rejected
or
has
tried
and
failed
to
12
respond
to
all
other
treatment
options
currently
approved
by
13
the
United
States
food
and
drug
administration.
14
c.
Has
received
a
recommendation
from
the
individual’s
15
physician
for
an
individualized
investigational
drug,
16
biological
product,
or
device
treatment
based
on
an
analysis
17
of
the
patient’s
genomic
sequence,
human
chromosomes,
18
deoxyribonucleic
acid,
ribonucleic
acid,
genes,
gene
products
19
such
as
enzymes
and
other
types
of
proteins,
or
metabolites
.
20
d.
Has
given
written
informed
consent
for
the
use
of
the
21
individualized
investigational
drug,
biological
product,
or
22
device
treatment
.
23
e.
Has
documentation
from
the
individual’s
physician
that
24
the
individual
meets
the
requirements
of
this
subsection
.
25
2.
“Investigational
drug,
biological
product,
or
device”
26
means
a
drug,
biological
product,
or
device
that
has
27
successfully
completed
phase
1
of
a
United
States
food
and
drug
28
administration-approved
clinical
trial
but
has
not
yet
been
29
approved
for
general
use
by
the
United
States
food
and
drug
30
administration
and
remains
under
investigation
in
a
United
31
States
food
and
drug
administration-approved
clinical
trial.
32
3.
“Terminal
illness”
means
a
progressive
disease
or
medical
33
or
surgical
condition
that
entails
significant
functional
34
impairment,
that
is
not
considered
by
a
treating
physician
to
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be
reversible
even
with
administration
of
treatments
approved
1
by
the
United
States
food
and
drug
administration,
and
that,
2
without
life-sustaining
procedures,
will
result
in
death.
3
3.
“Individualized
investigational
treatment”
means
a
drug,
4
biological
product,
or
device
that
is
unique
to
and
produced
5
exclusively
for
use
by
an
individual
patient
based
on
the
6
individual
patient’s
own
genetic
profile.
“Individualized
7
investigational
treatment”
includes
but
is
not
limited
to
8
individualized
gene
therapy,
antisense
oligonucleotides,
and
9
individualized
neoantigen
vaccines.
10
4.
“Written
informed
consent”
means
a
written
document
that
11
is
signed
by
the
patient,
a
parent
of
a
minor
patient,
or
a
12
legal
guardian
or
other
legal
representative
of
the
patient
and
13
attested
to
by
the
patient’s
treating
physician
and
a
witness
14
and
that
,
at
a
minimum,
includes
all
of
the
following:
15
a.
An
explanation
of
the
products
and
treatments
currently
16
approved
by
the
United
States
food
and
drug
administration
17
for
the
disease
or
condition
life-threatening
or
severely
18
debilitating
illness
from
which
the
patient
suffers.
19
b.
An
attestation
that
the
patient
concurs
with
the
20
patient’s
treating
physician
in
believing
that
all
products
and
21
treatments
currently
approved
by
the
United
States
food
and
22
drug
administration
or
conventionally
recognized
are
unlikely
23
to
prolong
the
patient’s
life.
24
c.
Clear
identification
of
the
specific
proposed
25
individualized
investigational
drug,
biological
product,
or
26
device
treatment
that
the
patient
is
seeking
to
use.
27
d.
A
description
of
the
best
and
worst
potential
outcomes
28
of
using
the
individualized
investigational
drug,
biological
29
product,
or
device
treatment
and
a
realistic
description
of
30
the
most
likely
outcome.
The
description
shall
include
the
31
possibility
that
new,
unanticipated,
different,
or
worse
32
symptoms
might
result
and
that
death
could
be
hastened
by
33
use
of
the
proposed
individualized
investigational
drug,
34
biological
product,
or
device
treatment
.
The
description
shall
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be
based
on
the
treating
physician’s
knowledge
of
the
proposed
1
individualized
investigational
drug,
biological
product,
2
or
device
treatment
in
conjunction
with
an
awareness
of
the
3
patient’s
condition.
4
e.
A
statement
that
the
patient’s
health
plan
or
third-party
5
administrator
and
provider
are
not
obligated
to
pay
for
any
6
care
or
treatments
consequent
to
the
use
of
the
individualized
7
investigational
drug,
biological
product,
or
device
treatment
,
8
unless
they
are
specifically
required
to
do
so
by
law
or
9
contract.
10
f.
A
statement
that
the
patient’s
eligibility
for
hospice
11
care
may
be
withdrawn
if
the
patient
begins
curative
treatment
12
with
the
individualized
investigational
drug,
biological
13
product,
or
device
treatment
and
that
care
may
be
reinstated
if
14
this
treatment
ends
and
the
patient
meets
hospice
eligibility
15
requirements.
16
g.
A
statement
that
the
patient
understands
that
the
17
patient
is
liable
for
all
expenses
consequent
to
the
use
of
18
the
individualized
investigational
drug,
biological
product,
19
or
device
treatment
and
that
this
liability
extends
to
the
20
patient’s
estate
unless
a
contract
between
the
patient
and
21
the
manufacturer
of
the
individualized
investigational
drug,
22
biological
product,
or
device
treatment
states
otherwise.
23
Sec.
2.
Section
144E.3,
Code
2023,
is
amended
to
read
as
24
follows:
25
144E.3
Manufacturer
and
eligible
facility
rights.
26
1.
A
manufacturer
of
an
individualized
investigational
27
drug,
biological
product,
or
device
treatment
operating
28
within
an
eligible
facility
and
in
compliance
with
all
laws
29
applicable
to
an
eligible
facility
may
make
available
and
an
30
eligible
patient
may
request
the
manufacturer’s
individualized
31
investigational
drug,
biological
product,
or
device
treatment
32
under
this
chapter
.
This
chapter
does
not
require
a
33
manufacturer
of
an
individualized
investigational
drug,
34
biological
product,
or
device
treatment
to
provide
or
otherwise
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make
available
the
individualized
investigational
drug,
1
biological
product,
or
device
treatment
to
an
eligible
patient.
2
2.
A
An
eligible
facility
or
a
manufacturer
described
in
3
subsection
1
may
do
any
of
the
following:
4
a.
Provide
an
individualized
investigational
drug,
5
biological
product,
or
device
treatment
to
an
eligible
patient
6
without
receiving
compensation.
7
b.
Require
an
eligible
patient
to
pay
the
costs
of,
or
the
8
costs
associated
with,
the
manufacture
of
the
individualized
9
investigational
drug,
biological
product,
or
device
treatment
.
10
Sec.
3.
Section
144E.4,
Code
2023,
is
amended
to
read
as
11
follows:
12
144E.4
Treatment
coverage.
13
1.
This
chapter
does
not
expand
the
coverage
required
of
an
14
insurer
under
Title
XIII,
subtitle
1
.
15
2.
A
health
plan,
third-party
administrator,
or
16
governmental
agency
may
provide
coverage
for
the
cost
of
an
17
individualized
investigational
drug,
biological
product,
or
18
device
treatment
,
or
the
cost
of
services
related
to
the
use
of
19
an
individualized
investigational
drug,
biological
product,
or
20
device
treatment
under
this
chapter
.
21
3.
This
chapter
does
not
require
any
governmental
agency
22
to
pay
costs
associated
with
the
use,
care,
or
treatment
of
a
23
patient
with
an
individualized
investigational
drug,
biological
24
product,
or
device
treatment
.
25
4.
This
chapter
does
not
require
a
hospital
licensed
under
26
chapter
135B
or
other
health
care
facility
to
provide
new
or
27
additional
services
,
unless
approved
by
the
hospital
or
health
28
care
facility
.
29
Sec.
4.
Section
144E.5,
Code
2023,
is
amended
to
read
as
30
follows:
31
144E.5
Heirs
not
liable
for
treatment
debts.
32
If
a
patient
dies
while
being
treated
by
an
individualized
33
investigational
drug,
biological
product,
or
device
treatment
,
34
the
patient’s
heirs
are
not
liable
for
any
outstanding
debt
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related
to
the
treatment
or
lack
of
insurance
due
to
the
1
treatment,
unless
otherwise
required
by
law.
2
Sec.
5.
Section
144E.6,
Code
2023,
is
amended
to
read
as
3
follows:
4
144E.6
Provider
recourse.
5
1.
To
the
extent
consistent
with
state
law,
the
board
of
6
medicine
created
under
chapter
147
shall
not
revoke,
fail
7
to
renew,
suspend,
or
take
any
action
against
a
physician’s
8
license
based
solely
on
the
physician’s
recommendations
to
9
an
eligible
patient
regarding
access
to
or
treatment
with
an
10
individualized
investigational
drug,
biological
product,
or
11
device
treatment
.
12
2.
To
the
extent
consistent
with
federal
law,
an
entity
13
responsible
for
Medicare
certification
shall
not
take
action
14
against
a
physician’s
Medicare
certification
based
solely
on
15
the
physician’s
recommendation
that
a
patient
have
access
to
16
an
individualized
investigational
drug,
biological
product,
or
17
device
treatment
.
18
Sec.
6.
Section
144E.7,
Code
2023,
is
amended
to
read
as
19
follows:
20
144E.7
State
interference.
21
An
official,
employee,
or
agent
of
this
state
shall
not
22
block
or
attempt
to
block
an
eligible
patient’s
access
to
an
23
individualized
investigational
drug,
biological
product,
or
24
device
treatment
.
Counseling,
advice,
or
a
recommendation
25
consistent
with
medical
standards
of
care
from
a
licensed
26
physician
is
not
a
violation
of
this
section
.
27
Sec.
7.
Section
144E.8,
Code
2023,
is
amended
to
read
as
28
follows:
29
144E.8
Private
cause
of
action.
30
1.
This
chapter
shall
not
create
a
private
cause
of
action
31
against
a
manufacturer
of
an
individualized
investigational
32
drug,
biological
product,
or
device
treatment
or
against
any
33
other
person
or
entity
involved
in
the
care
of
an
eligible
34
patient
using
the
individualized
investigational
drug,
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biological
product,
or
device
treatment
for
any
harm
done
1
to
the
eligible
patient
resulting
from
the
individualized
2
investigational
drug,
biological
product,
or
device
treatment
,
3
if
the
manufacturer
or
other
person
or
entity
is
complying
in
4
good
faith
with
the
terms
of
this
chapter
and
has
exercised
5
reasonable
care.
6
2.
This
chapter
shall
not
affect
any
mandatory
health
care
7
coverage
for
participation
in
clinical
trials
under
Title
XIII,
8
subtitle
1
.
9
Sec.
8.
REPEAL.
Section
144E.9,
Code
2023,
is
repealed.
10
EXPLANATION
11
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
12
the
explanation’s
substance
by
the
members
of
the
general
assembly.
13
This
bill
relates
to
Code
chapter
144E,
the
right
to
try
Act.
14
Under
current
law,
an
“eligible
patient”
under
the
Code
15
chapter
is,
in
part,
a
person
who
has
a
terminal
illness.
16
Under
the
bill,
an
“eligible
patient”
is
instead,
in
part,
a
17
person
who
has
a
life-threatening
or
severely
debilitating
18
illness.
19
Under
current
law,
the
Code
chapter
applies
to
an
20
“investigational
drug,
biological
product,
or
device”
21
meaning
a
drug,
biological
product,
or
device
that
has
22
successfully
completed
phase
I
of
a
United
States
food
and
drug
23
administration
(FDA)-approved
clinical
trial
but
has
not
yet
24
been
approved
for
general
use
by
the
FDA
and
that
remains
under
25
investigation
in
an
FDA-approved
clinical
trial.
Under
the
26
bill,
the
Code
chapter
instead
applies
to
an
“individualized
27
investigational
treatment”,
meaning
a
drug,
biological
product,
28
or
device
that
is
unique
to
and
produced
exclusively
for
use
29
by
an
individual
patient
based
on
the
individual
patient’s
30
own
genetic
profile
and
includes
individualized
gene
therapy,
31
antisense
oligonucleotides,
and
individualized
neoantigen
32
vaccines.
33
The
bill
amends
the
definition
under
the
Code
chapter
for
34
“written
informed
consent”
to
reflect
the
changes
made
to
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“eligible
patient”
and
the
application
of
the
Code
chapter
to
1
individualized
investigational
treatments.
2
The
bill
provides
a
definition
of
“eligible
facility”
to
3
mean
an
institution
that
is
operating
under
a
federalwide
4
assurance
for
the
protection
of
human
subjects
pursuant
5
to
federal
law.
The
bill
amends
provisions
relating
to
6
a
manufacturer’s
rights
under
the
Code
chapter
to
provide
7
that
a
manufacturer
of
an
individualized
investigational
8
treatment
operating
within
an
eligible
facility
and
in
9
compliance
with
all
laws
applicable
to
an
eligible
facility
10
may
make
available,
and
an
eligible
patient
may
request,
the
11
manufacturer’s
individualized
investigational
treatment
under
12
the
Code
chapter.
However,
the
Code
chapter
does
not
require
13
a
manufacturer
of
an
individualized
investigational
treatment
14
to
provide
or
otherwise
make
available
the
individualized
15
investigational
treatment
to
an
eligible
patient.
The
bill
16
provides
that
an
eligible
facility
or
a
manufacturer
may
17
provide
an
individualized
investigational
treatment
to
an
18
eligible
patient
without
receiving
compensation,
or
require
an
19
eligible
patient
to
pay
the
costs
of,
or
the
costs
associated
20
with,
the
manufacture
of
the
individualized
investigational
21
treatment.
22
The
bill
makes
other
conforming
changes
in
the
Code
chapter
23
to
reflect
the
bill
provisions.
24
The
bill
repeals
Code
section
144E.9,
which
provides
that
25
the
Code
chapter
shall
not
be
construed
to
allow
a
patient’s
26
treating
physician
to
assist
the
patient
in
committing
or
27
attempting
to
commit
suicide.
28
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