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320
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Introduced
HOUSE
FILE
320
BY
BRADLEY
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:
2
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Section
1.
Section
144E.2,
Code
2025,
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
45
C.F.R.
pt.
46,
and
7
subject
to
the
federalwide
assurance
laws,
rules,
policies,
and
8
guidelines
including
renewals
and
updates.
9
1.
2.
“Eligible
patient”
means
an
individual
who
meets
all
10
of
the
following
conditions
specified
under
paragraph
“a”
or
11
“b”
:
12
a.
(1)
Has
a
terminal
illness,
attested
to
by
the
patient’s
13
treating
physician.
14
b.
(2)
Has
considered
and
rejected
or
has
tried
and
failed
15
to
respond
to
all
other
treatment
options
approved
by
the
16
United
States
food
and
drug
administration.
17
c.
(3)
Has
received
a
recommendation
from
the
individual’s
18
physician
for
an
investigational
drug,
biological
product,
or
19
device.
20
d.
(4)
Has
given
written
informed
consent
for
the
use
of
21
the
investigational
drug,
biological
product,
or
device.
22
e.
(5)
Has
documentation
from
the
individual’s
physician
23
that
the
individual
meets
the
requirements
of
this
subsection
24
paragraph
“a”
.
25
b.
(1)
Has
a
life-threatening
or
severely
debilitating
26
illness,
attested
to
by
the
patient’s
treating
physician.
27
(2)
Has
considered
all
other
treatment
options
currently
28
approved
by
the
United
States
food
and
drug
administration.
29
(3)
Has
received
a
recommendation
from
the
individual’s
30
physician
for
an
individualized
investigational
treatment,
31
based
on
an
analysis
of
the
patient’s
genomic
sequence,
human
32
chromosomes,
deoxyribonucleic
acid,
ribonucleic
acid,
genes,
33
gene
products
such
as
enzymes
and
other
types
of
proteins,
or
34
metabolites.
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(4)
Has
given
written
informed
consent
for
the
use
of
the
1
individualized
investigational
treatment.
2
(5)
Has
documentation
from
the
individual’s
physician
that
3
the
individual
meets
the
requirements
of
this
paragraph
“b”
.
4
3.
“Individualized
investigational
treatment”
means
a
drug,
5
biological
product,
or
device
that
is
unique
to,
and
produced
6
exclusively
for
use
by,
an
individual
patient,
based
on
the
7
individual
patient’s
own
genetic
profile.
“Individualized
8
investigational
treatment”
includes
but
is
not
limited
to
9
individualized
gene
therapy,
antisense
oligonucleotides,
and
10
individualized
neoantigen
vaccines.
11
2.
4.
“Investigational
drug,
biological
product,
or
12
device”
means
a
drug,
biological
product,
or
device
that
has
13
successfully
completed
phase
1
of
a
United
States
food
and
drug
14
administration-approved
clinical
trial
but
has
not
yet
been
15
approved
for
general
use
by
the
United
States
food
and
drug
16
administration
and
remains
under
investigation
in
a
United
17
States
food
and
drug
administration-approved
clinical
trial.
18
3.
5.
“Terminal
illness”
means
a
progressive
disease
19
or
medical
or
surgical
condition
that
entails
significant
20
functional
impairment,
that
is
not
considered
by
a
treating
21
physician
to
be
reversible
even
with
administration
of
22
treatments
approved
by
the
United
States
food
and
drug
23
administration,
and
that,
without
life-sustaining
procedures,
24
will
result
in
death.
25
4.
6.
“Written
informed
consent”
means
a
written
document
26
that
is
signed
by
the
patient,
a
parent
of
a
minor
patient,
or
a
27
legal
guardian
or
other
legal
representative
of
the
patient
and
28
attested
to
by
the
patient’s
treating
physician
and
a
witness
29
and
that
includes
,
at
a
minimum,
all
of
the
following:
30
a.
If
the
patient
is
an
eligible
patient
as
specified
in
31
subsection
2,
paragraph
“a”
:
32
(1)
An
explanation
of
the
products
and
treatments
approved
33
by
the
United
States
food
and
drug
administration
for
the
34
disease
or
condition
from
which
the
patient
suffers.
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b.
(2)
An
attestation
that
the
patient
concurs
with
the
1
patient’s
treating
physician
in
believing
that
all
products
2
and
treatments
approved
by
the
United
States
food
and
drug
3
administration
are
unlikely
to
prolong
the
patient’s
life.
4
c.
(3)
Clear
identification
of
the
specific
proposed
5
investigational
drug,
biological
product,
or
device
that
the
6
patient
is
seeking
to
use.
7
d.
(4)
A
description
of
the
best
and
worst
potential
8
outcomes
of
using
the
investigational
drug,
biological
product,
9
or
device
and
a
realistic
description
of
the
most
likely
10
outcome.
The
description
shall
include
the
possibility
that
11
new,
unanticipated,
different,
or
worse
symptoms
might
result
12
and
that
death
could
be
hastened
by
use
of
the
proposed
13
investigational
drug,
biological
product,
or
device.
The
14
description
shall
be
based
on
the
treating
physician’s
15
knowledge
of
the
proposed
investigational
drug,
biological
16
product,
or
device
in
conjunction
with
an
awareness
of
the
17
patient’s
condition.
18
e.
(5)
A
statement
that
the
patient’s
health
plan
or
19
third-party
administrator
and
provider
are
not
obligated
to
20
pay
for
any
care
or
treatments
consequent
to
the
use
of
the
21
investigational
drug,
biological
product,
or
device,
unless
22
they
are
specifically
required
to
do
so
by
law
or
contract.
23
f.
(6)
A
statement
that
the
patient’s
eligibility
for
24
hospice
care
may
be
withdrawn
if
the
patient
begins
curative
25
treatment
with
the
investigational
drug,
biological
product,
26
or
device
and
that
hospice
care
may
be
reinstated
if
this
27
treatment
ends
and
the
patient
meets
hospice
eligibility
28
requirements.
29
g.
(7)
A
statement
that
the
patient
understands
that
the
30
patient
is
liable
for
all
expenses
consequent
to
the
use
of
31
the
investigational
drug,
biological
product,
or
device
and
32
that
this
liability
extends
to
the
patient’s
estate
unless
33
a
contract
between
the
patient
and
the
manufacturer
of
the
34
investigational
drug,
biological
product,
or
device
states
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otherwise.
1
b.
If
the
patient
is
an
eligible
patient
as
specified
in
2
subsection
2,
paragraph
“b”
:
3
(1)
An
explanation
of
the
currently
approved
products
and
4
treatments
for
the
disease
or
condition
from
which
the
patient
5
suffers.
6
(2)
An
attestation
that
the
patient
concurs
with
the
7
patient’s
treating
physician
in
believing
that
all
currently
8
approved
and
conventionally
recognized
products
and
treatments
9
are
unlikely
to
prolong
the
patient’s
life.
10
(3)
Clear
identification
of
the
specific
proposed
11
individualized
investigational
treatment
that
the
patient
is
12
seeking
to
use.
13
(4)
A
description
of
the
best
and
worst
potential
outcomes
14
of
using
the
individualized
investigational
treatment
15
and
a
realistic
description
of
the
most
likely
outcome.
16
The
description
shall
include
the
possibility
that
new,
17
unanticipated,
different,
or
worse
symptoms
might
result
18
and
that
death
could
be
hastened
by
use
of
the
proposed
19
individualized
investigational
treatment.
The
description
20
shall
be
based
on
the
treating
physician’s
knowledge
of
21
the
proposed
individualized
investigational
treatment
in
22
conjunction
with
an
awareness
of
the
patient’s
condition.
23
(5)
A
statement
that
the
patient’s
health
plan
or
24
third-party
administrator
and
provider
are
not
obligated
to
25
pay
for
any
care
or
treatments
consequent
to
the
use
of
the
26
individualized
investigational
treatment,
unless
they
are
27
specifically
required
to
do
so
by
law
or
contract.
28
(6)
A
statement
that
the
patient’s
eligibility
for
hospice
29
care
may
be
withdrawn
if
the
patient
begins
curative
treatment
30
with
the
individualized
investigational
treatment
and
that
31
hospice
care
may
be
reinstated
if
this
treatment
ends
and
the
32
patient
meets
hospice
eligibility
requirements.
33
(7)
A
statement
that
the
patient
understands
that
the
34
patient
is
liable
for
all
expenses
consequent
to
the
use
of
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the
individualized
investigational
treatment
and
that
this
1
liability
extends
to
the
patient’s
estate,
unless
a
contract
2
between
the
patient
and
the
manufacturer
of
the
individualized
3
investigational
treatment
states
otherwise.
4
Sec.
2.
Section
144E.3,
Code
2025,
is
amended
to
read
as
5
follows:
6
144E.3
Manufacturer
and
eligible
facility
rights.
7
1.
A
manufacturer
of
an
investigational
drug,
biological
8
product,
or
device
or
a
manufacturer
operating
within,
and
in
9
compliance
with
all
requirements
applicable
to,
an
eligible
10
facility
may
make
available
,
and
an
eligible
patient
,
as
11
applicable
under
section
144E.1,
subsection
2,
paragraph
“a”
12
or
“b”
,
may
request
from
a
manufacturer
of
an
investigational
13
drug,
biological
product,
or
device,
or
a
manufacturer
14
operating
within,
and
in
compliance
with
all
requirements
15
applicable
to,
an
eligible
facility,
the
manufacturer’s
16
investigational
drug,
biological
product,
or
device
,
or
the
17
manufacturer’s
individualized
investigational
treatment
under
18
this
chapter
.
This
chapter
does
not
require
a
manufacturer
19
of
an
investigational
drug,
biological
product,
or
device
,
or
20
of
an
individualized
investigational
treatment
to
provide
or
21
otherwise
make
available
the
investigational
drug,
biological
22
product,
or
device
,
or
the
individualized
investigational
23
treatment
to
an
eligible
patient.
24
2.
A
An
eligible
facility,
or
a
manufacturer
described
25
in
subsection
1
,
that
is
in
compliance
with
all
applicable
26
requirements,
may
do
any
of
the
following:
27
a.
Provide
an
investigational
drug,
biological
product,
28
or
device
,
or
an
individualized
investigational
treatment
29
to
an
eligible
patient
,
as
applicable
under
section
144E.1,
30
subsection
2,
paragraph
“a”
or
“b”
,
without
receiving
31
compensation.
32
b.
Require
an
eligible
patient
,
as
applicable
under
section
33
144E.1,
subsection
2,
paragraph
“a”
or
“b”
,
to
pay
the
costs
34
of,
or
the
costs
associated
with,
the
manufacture
of
the
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investigational
drug,
biological
product,
or
device
,
or
the
1
individualized
investigational
treatment
.
2
Sec.
3.
Section
144E.4,
Code
2025,
is
amended
to
read
as
3
follows:
4
144E.4
Treatment
coverage.
5
1.
This
chapter
does
not
expand
the
coverage
required
of
an
6
insurer
under
Title
XIII,
subtitle
1
.
7
2.
A
health
plan,
third-party
administrator,
or
8
governmental
agency
may
,
but
is
not
required
to,
provide
9
coverage
for
the
cost
of
an
investigational
drug,
biological
10
product,
or
device,
or
the
cost
of
an
individualized
11
investigational
treatment,
the
cost
of
services
related
to
the
12
use
of
an
investigational
drug,
biological
product,
or
device
,
13
or
the
cost
of
services
related
to
the
use
of
an
individualized
14
investigational
treatment
under
this
chapter
.
15
3.
This
chapter
does
not
require
any
governmental
agency
16
to
pay
costs
associated
with
the
use,
care,
or
treatment
of
a
17
patient
with
an
investigational
drug,
biological
product,
or
18
device
,
or
an
individualized
investigational
treatment
.
19
4.
This
chapter
does
not
require
a
hospital
licensed
under
20
chapter
135B
or
other
health
care
facility
to
provide
new
or
21
additional
services
,
unless
approved
by
the
hospital
or
other
22
health
care
facility
.
23
Sec.
4.
Section
144E.5,
Code
2025,
is
amended
to
read
as
24
follows:
25
144E.5
Heirs
not
liable
for
treatment
debts.
26
If
a
patient
dies
while
being
treated
by
with
an
27
investigational
drug,
biological
product,
or
device,
or
28
an
individualized
investigational
treatment,
the
patient’s
29
heirs
are
not
liable
for
any
outstanding
debt
related
to
the
30
treatment
or
lack
of
insurance
due
to
the
treatment
,
unless
31
otherwise
required
by
law
.
32
Sec.
5.
Section
144E.6,
Code
2025,
is
amended
to
read
as
33
follows:
34
144E.6
Provider
recourse.
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1.
To
the
extent
consistent
with
state
law,
the
board
of
1
medicine
created
under
chapter
147
shall
not
revoke,
fail
2
to
renew,
suspend,
or
take
any
action
against
a
physician’s
3
license
based
solely
on
the
physician’s
recommendations
to
4
an
eligible
patient
regarding
access
to
or
treatment
with
an
5
investigational
drug,
biological
product,
or
device
,
or
an
6
individualized
investigational
treatment
.
7
2.
To
the
extent
consistent
with
federal
law,
an
entity
8
responsible
for
Medicare
certification
shall
not
take
action
9
against
a
physician’s
Medicare
certification
based
solely
on
10
the
physician’s
recommendation
that
a
patient
have
access
to
11
an
investigational
drug,
biological
product,
or
device
,
or
an
12
individualized
investigational
treatment
.
13
Sec.
6.
Section
144E.7,
Code
2025,
is
amended
to
read
as
14
follows:
15
144E.7
State
interference.
16
An
official,
employee,
or
agent
of
this
state
shall
not
17
block
or
attempt
to
block
an
eligible
patient’s
access
to
an
18
investigational
drug,
biological
product,
or
device
,
or
to
an
19
individualized
investigational
treatment
.
Counseling,
advice,
20
or
a
recommendation
consistent
with
medical
standards
of
care
21
from
a
licensed
physician
is
not
a
violation
of
this
section
.
22
Sec.
7.
Section
144E.8,
Code
2025,
is
amended
to
read
as
23
follows:
24
144E.8
Private
cause
of
action.
25
1.
This
chapter
shall
not
create
a
private
cause
of
action
26
against
a
manufacturer
of
an
investigational
drug,
biological
27
product,
or
device
,
or
an
individualized
investigational
28
treatment,
against
an
eligible
facility,
or
against
any
other
29
person
or
entity
involved
in
the
care
of
an
eligible
patient
30
using
the
investigational
drug,
biological
product,
or
device
,
31
or
the
individualized
investigational
treatment
for
any
harm
32
done
to
the
eligible
patient
resulting
from
the
investigational
33
drug,
biological
product,
or
device,
or
the
individualized
34
investigational
treatment,
if
the
manufacturer
,
eligible
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facility,
or
other
person
or
entity
is
complying
in
good
faith
1
with
the
terms
of
this
chapter
and
has
exercised
reasonable
2
care.
3
2.
This
chapter
shall
not
affect
any
mandatory
health
care
4
coverage
for
participation
in
clinical
trials
under
Title
XIII,
5
subtitle
1
.
6
EXPLANATION
7
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
8
the
explanation’s
substance
by
the
members
of
the
general
assembly.
9
This
bill
relates
to
Code
chapter
144E,
the
right
to
try
Act.
10
Under
current
law,
an
“eligible
patient”
under
the
Code
11
chapter
is,
in
part,
a
person
who
has
a
terminal
illness.
12
Under
the
bill,
an
“eligible
patient”
also
includes,
in
part,
13
a
person
who
has
a
life-threatening
or
severely
debilitating
14
illness.
15
Under
current
law,
the
Code
chapter
applies
to
an
16
“investigational
drug,
biological
product,
or
device”,
17
meaning
a
drug,
biological
product,
or
device
that
has
18
successfully
completed
phase
I
of
a
United
States
food
and
19
drug
administration
(FDA)-approved
clinical
trial
but
has
not
20
yet
been
approved
for
general
use
by
the
FDA
and
that
remains
21
under
investigation
in
an
FDA-approved
clinical
trial.
Under
22
the
bill,
the
Code
chapter
also
applies
to
an
“individualized
23
investigational
treatment”,
meaning
a
drug,
biological
product,
24
or
device
that
is
unique
to
and
produced
exclusively
for
use
25
by
an
individual
patient
based
on
the
individual
patient’s
26
own
genetic
profile
and
includes
individualized
gene
therapy,
27
antisense
oligonucleotides,
and
individualized
neoantigen
28
vaccines.
29
The
bill
amends
the
definition
for
“written
informed
30
consent”
to
reflect
the
changes
made
to
“eligible
patient”
31
and
the
application
of
the
Code
chapter
to
individualized
32
investigational
treatments.
33
“Eligible
facility”
is
defined
as
an
institution
that
is
34
operating
under
a
federalwide
assurance
for
the
protection
35
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H.F.
320
of
human
subjects
pursuant
to
federal
law.
The
bill
amends
1
provisions
relating
to
a
manufacturer’s
rights
under
the
2
Code
chapter
to
also
apply
to
eligible
facilities.
The
bill
3
provides
that
a
manufacturer
of
an
investigational
drug,
4
biological
product,
or
device
or
a
manufacturer
operating
5
within,
and
in
compliance
with
all
requirements
applicable
6
to,
an
eligible
facility
may
make
available,
and
an
eligible
7
patient
may
request
from
a
manufacturer
of
an
investigational
8
drug,
biological
product,
or
device,
or
a
manufacturer
9
operating
within,
and
in
compliance
with
all
requirements
10
applicable
to,
an
eligible
facility,
the
manufacturer’s
11
investigational
drug,
biological
product,
or
device,
or
the
12
manufacturer’s
individualized
investigational
treatment.
13
However,
the
Code
chapter
does
not
require
a
manufacturer
of
14
an
individualized
investigational
treatment
to
provide
or
15
otherwise
make
available
the
individualized
investigational
16
treatment
to
an
eligible
patient.
The
bill
provides
that
an
17
eligible
facility
or
a
manufacturer
that
is
in
compliance
with
18
all
applicable
requirements
may
provide
an
individualized
19
investigational
treatment
to
an
eligible
patient
without
20
receiving
compensation,
or
require
an
eligible
patient
to
pay
21
the
costs
of,
or
the
costs
associated
with,
the
manufacture
of
22
the
individualized
investigational
treatment.
23
The
bill
makes
conforming
changes
in
the
Code
chapter.
24
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