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House
File
802
-
Introduced
HOUSE
FILE
802
BY
COMMITTEE
ON
HEALTH
AND
HUMAN
SERVICES
(SUCCESSOR
TO
HF
320)
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
exhausted
all
other
United
States
food
and
drug
28
administration-approved
treatment
options
by
contraindication,
29
potential
or
previous
treatment
failure,
or
actual
or
potential
30
adverse
reaction.
31
(3)
Has
received
a
recommendation
from
the
individual’s
32
physician
for
an
individualized
investigational
treatment,
33
based
on
an
analysis
of
the
patient’s
genomic
sequence,
human
34
chromosomes,
deoxyribonucleic
acid,
ribonucleic
acid,
genes,
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gene
products
such
as
enzymes
and
other
types
of
proteins,
or
1
metabolites.
2
(4)
Has
given
written
informed
consent
for
the
use
of
the
3
individualized
investigational
treatment.
4
(5)
Has
documentation
from
the
individual’s
physician
that
5
the
individual
meets
the
requirements
of
this
paragraph
“b”
.
6
3.
“Individualized
investigational
treatment”
means
a
drug,
7
biological
product,
or
device
that
is
unique
to,
and
produced
8
exclusively
for
use
by,
an
individual
patient,
based
on
the
9
individual
patient’s
own
genetic
profile,
and
is
provided
in
a
10
manner
that
is
consistent
with
a
federalwide
assurance
for
the
11
protection
of
human
subjects.
“Individualized
investigational
12
treatment”
includes
but
is
not
limited
to
individualized
13
gene
therapy,
antisense
oligonucleotides,
and
individualized
14
neoantigen
vaccines.
15
2.
4.
“Investigational
drug,
biological
product,
or
16
device”
means
a
drug,
biological
product,
or
device
that
has
17
successfully
completed
phase
1
of
a
United
States
food
and
drug
18
administration-approved
clinical
trial
but
has
not
yet
been
19
approved
for
general
use
by
the
United
States
food
and
drug
20
administration
and
remains
under
investigation
in
a
United
21
States
food
and
drug
administration-approved
clinical
trial.
22
3.
5.
“Terminal
illness”
means
a
progressive
disease
23
or
medical
or
surgical
condition
that
entails
significant
24
functional
impairment,
that
is
not
considered
by
a
treating
25
physician
to
be
reversible
even
with
administration
of
26
treatments
approved
by
the
United
States
food
and
drug
27
administration,
and
that,
without
life-sustaining
procedures,
28
will
result
in
death.
29
4.
6.
“Written
informed
consent”
means
a
written
document
30
that
is
signed
by
the
patient,
a
parent
of
a
minor
patient,
or
a
31
legal
guardian
or
other
legal
representative
of
the
patient
and
32
attested
to
by
the
patient’s
treating
physician
and
a
witness
33
and
that
includes
,
at
a
minimum,
all
of
the
following:
34
a.
If
the
patient
is
an
eligible
patient
as
specified
in
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subsection
2,
paragraph
“a”
:
1
(1)
An
explanation
of
the
products
and
treatments
approved
2
by
the
United
States
food
and
drug
administration
for
the
3
disease
or
condition
from
which
the
patient
suffers.
4
b.
(2)
An
attestation
that
the
patient
concurs
with
the
5
patient’s
treating
physician
in
believing
that
all
products
6
and
treatments
approved
by
the
United
States
food
and
drug
7
administration
are
unlikely
to
prolong
the
patient’s
life.
8
c.
(3)
Clear
identification
of
the
specific
proposed
9
investigational
drug,
biological
product,
or
device
that
the
10
patient
is
seeking
to
use.
11
d.
(4)
A
description
of
the
best
and
worst
potential
12
outcomes
of
using
the
investigational
drug,
biological
product,
13
or
device
and
a
realistic
description
of
the
most
likely
14
outcome.
The
description
shall
include
the
possibility
that
15
new,
unanticipated,
different,
or
worse
symptoms
might
result
16
and
that
death
could
be
hastened
by
use
of
the
proposed
17
investigational
drug,
biological
product,
or
device.
The
18
description
shall
be
based
on
the
treating
physician’s
19
knowledge
of
the
proposed
investigational
drug,
biological
20
product,
or
device
in
conjunction
with
an
awareness
of
the
21
patient’s
condition.
22
e.
(5)
A
statement
that
the
patient’s
health
plan
or
23
third-party
administrator
and
provider
are
not
obligated
to
24
pay
for
any
care
or
treatments
consequent
to
the
use
of
the
25
investigational
drug,
biological
product,
or
device,
unless
26
they
are
specifically
required
to
do
so
by
law
or
contract.
27
f.
(6)
A
statement
that
the
patient’s
eligibility
for
28
hospice
care
may
be
withdrawn
if
the
patient
begins
curative
29
treatment
with
the
investigational
drug,
biological
product,
30
or
device
and
that
hospice
care
may
be
reinstated
if
this
31
treatment
ends
and
the
patient
meets
hospice
eligibility
32
requirements.
33
g.
(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
investigational
drug,
biological
product,
or
device
and
1
that
this
liability
extends
to
the
patient’s
estate
unless
2
a
contract
between
the
patient
and
the
manufacturer
of
the
3
investigational
drug,
biological
product,
or
device
states
4
otherwise.
5
b.
If
the
patient
is
an
eligible
patient
as
specified
in
6
subsection
2,
paragraph
“b”
:
7
(1)
An
explanation
of
the
currently
approved
products
and
8
treatments
for
the
disease
or
condition
from
which
the
patient
9
suffers.
10
(2)
An
attestation
that
the
patient
concurs
with
the
11
patient’s
treating
physician
in
believing
that
all
currently
12
approved
and
conventionally
recognized
products
and
treatments
13
are
unlikely
to
prolong
the
patient’s
life.
14
(3)
Clear
identification
of
the
specific
proposed
15
individualized
investigational
treatment
that
the
patient
is
16
seeking
to
use.
17
(4)
A
description
of
the
best
and
worst
potential
outcomes
18
of
using
the
individualized
investigational
treatment
19
and
a
realistic
description
of
the
most
likely
outcome.
20
The
description
shall
include
the
possibility
that
new,
21
unanticipated,
different,
or
worse
symptoms
might
result
22
and
that
death
could
be
hastened
by
use
of
the
proposed
23
individualized
investigational
treatment.
The
description
24
shall
be
based
on
the
treating
physician’s
knowledge
of
25
the
proposed
individualized
investigational
treatment
in
26
conjunction
with
an
awareness
of
the
patient’s
condition.
27
(5)
A
statement
that
the
patient’s
health
plan
or
28
third-party
administrator
and
provider
are
not
obligated
to
29
pay
for
any
care
or
treatments
consequent
to
the
use
of
the
30
individualized
investigational
treatment,
unless
they
are
31
specifically
required
to
do
so
by
law
or
contract.
32
(6)
A
statement
that
the
patient’s
eligibility
for
hospice
33
care
may
be
withdrawn
if
the
patient
begins
curative
treatment
34
with
the
individualized
investigational
treatment
and
that
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hospice
care
may
be
reinstated
if
this
treatment
ends
and
the
1
patient
meets
hospice
eligibility
requirements.
2
(7)
A
statement
that
the
patient
understands
that
the
3
patient
is
liable
for
all
expenses
consequent
to
the
use
of
4
the
individualized
investigational
treatment
and
that
this
5
liability
extends
to
the
patient’s
estate,
unless
a
contract
6
between
the
patient
and
the
manufacturer
of
the
individualized
7
investigational
treatment
states
otherwise.
8
Sec.
2.
Section
144E.3,
Code
2025,
is
amended
to
read
as
9
follows:
10
144E.3
Manufacturer
and
eligible
facility
rights.
11
1.
A
manufacturer
of
an
investigational
drug,
biological
12
product,
or
device
or
a
manufacturer
operating
within,
and
in
13
compliance
with
all
requirements
applicable
to,
an
eligible
14
facility
may
make
available
,
and
an
eligible
patient
,
as
15
applicable
under
section
144E.1,
subsection
2,
paragraph
“a”
16
or
“b”
,
may
request
from
a
manufacturer
of
an
investigational
17
drug,
biological
product,
or
device,
or
a
manufacturer
18
operating
within,
and
in
compliance
with
all
requirements
19
applicable
to,
an
eligible
facility,
the
manufacturer’s
20
investigational
drug,
biological
product,
or
device
,
or
the
21
manufacturer’s
individualized
investigational
treatment
under
22
this
chapter
.
This
chapter
does
not
require
a
manufacturer
23
of
an
investigational
drug,
biological
product,
or
device
,
or
24
of
an
individualized
investigational
treatment
to
provide
or
25
otherwise
make
available
the
investigational
drug,
biological
26
product,
or
device
,
or
the
individualized
investigational
27
treatment
to
an
eligible
patient.
28
2.
A
An
eligible
facility,
or
a
manufacturer
described
29
in
subsection
1
,
that
is
in
compliance
with
all
applicable
30
requirements,
may
do
any
of
the
following:
31
a.
Provide
an
investigational
drug,
biological
product,
32
or
device
,
or
an
individualized
investigational
treatment
33
to
an
eligible
patient
,
as
applicable
under
section
144E.1,
34
subsection
2,
paragraph
“a”
or
“b”
,
without
receiving
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compensation.
1
b.
Require
an
eligible
patient
,
as
applicable
under
section
2
144E.1,
subsection
2,
paragraph
“a”
or
“b”
,
to
pay
the
costs
3
of,
or
the
costs
associated
with,
the
manufacture
of
the
4
investigational
drug,
biological
product,
or
device
,
or
the
5
individualized
investigational
treatment
.
6
Sec.
3.
Section
144E.4,
Code
2025,
is
amended
to
read
as
7
follows:
8
144E.4
Treatment
coverage.
9
1.
This
chapter
does
not
expand
the
coverage
required
of
an
10
insurer
under
Title
XIII,
subtitle
1
.
11
2.
A
health
plan,
third-party
administrator,
or
12
governmental
agency
may
,
but
is
not
required
to,
provide
13
coverage
for
the
cost
of
an
investigational
drug,
biological
14
product,
or
device,
or
the
cost
of
an
individualized
15
investigational
treatment,
the
cost
of
services
related
to
the
16
use
of
an
investigational
drug,
biological
product,
or
device
,
17
or
the
cost
of
services
related
to
the
use
of
an
individualized
18
investigational
treatment
under
this
chapter
.
19
3.
This
chapter
does
not
require
any
governmental
agency
20
to
pay
costs
associated
with
the
use,
care,
or
treatment
of
a
21
patient
with
an
investigational
drug,
biological
product,
or
22
device
,
or
an
individualized
investigational
treatment
.
23
4.
This
chapter
does
not
require
a
hospital
licensed
under
24
chapter
135B
or
other
health
care
facility
to
provide
new
or
25
additional
services
,
unless
approved
by
the
hospital
or
other
26
health
care
facility
.
27
Sec.
4.
Section
144E.5,
Code
2025,
is
amended
to
read
as
28
follows:
29
144E.5
Heirs
not
liable
for
treatment
debts.
30
If
a
patient
dies
while
being
treated
by
with
an
31
investigational
drug,
biological
product,
or
device,
or
32
an
individualized
investigational
treatment,
the
patient’s
33
heirs
are
not
liable
for
any
outstanding
debt
related
to
the
34
treatment
or
lack
of
insurance
due
to
the
treatment
,
unless
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802
otherwise
required
by
law
.
1
Sec.
5.
Section
144E.6,
Code
2025,
is
amended
to
read
as
2
follows:
3
144E.6
Provider
recourse.
4
1.
To
the
extent
consistent
with
state
law,
the
board
of
5
medicine
created
under
chapter
147
shall
not
revoke,
fail
6
to
renew,
suspend,
or
take
any
action
against
a
physician’s
7
license
based
solely
on
the
physician’s
recommendations
to
8
an
eligible
patient
regarding
access
to
or
treatment
with
an
9
investigational
drug,
biological
product,
or
device
,
or
an
10
individualized
investigational
treatment
.
11
2.
To
the
extent
consistent
with
federal
law,
an
entity
12
responsible
for
Medicare
certification
shall
not
take
action
13
against
a
physician’s
Medicare
certification
based
solely
on
14
the
physician’s
recommendation
that
a
patient
have
access
to
15
an
investigational
drug,
biological
product,
or
device
,
or
an
16
individualized
investigational
treatment
.
17
Sec.
6.
Section
144E.7,
Code
2025,
is
amended
to
read
as
18
follows:
19
144E.7
State
interference.
20
An
official,
employee,
or
agent
of
this
state
shall
not
21
block
or
attempt
to
block
an
eligible
patient’s
access
to
an
22
investigational
drug,
biological
product,
or
device
,
or
to
an
23
individualized
investigational
treatment
.
Counseling,
advice,
24
or
a
recommendation
consistent
with
medical
standards
of
care
25
from
a
licensed
physician
is
not
a
violation
of
this
section
.
26
Sec.
7.
Section
144E.8,
Code
2025,
is
amended
to
read
as
27
follows:
28
144E.8
Private
cause
of
action.
29
1.
This
chapter
shall
not
create
a
private
cause
of
action
30
against
a
manufacturer
of
an
investigational
drug,
biological
31
product,
or
device
,
or
an
individualized
investigational
32
treatment,
against
an
eligible
facility,
or
against
any
other
33
person
or
entity
involved
in
the
care
of
an
eligible
patient
34
using
the
investigational
drug,
biological
product,
or
device
,
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or
the
individualized
investigational
treatment
for
any
harm
1
done
to
the
eligible
patient
resulting
from
the
investigational
2
drug,
biological
product,
or
device,
or
the
individualized
3
investigational
treatment,
if
the
manufacturer
,
eligible
4
facility,
or
other
person
or
entity
is
complying
in
good
faith
5
with
the
terms
of
this
chapter
and
has
exercised
reasonable
6
care.
7
2.
This
chapter
shall
not
affect
any
mandatory
health
care
8
coverage
for
participation
in
clinical
trials
under
Title
XIII,
9
subtitle
1
.
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”
also
includes
an
17
individual
who
has
a
life-threatening
or
severely
debilitating
18
illness,
who
has
exhausted
all
other
treatment
options,
who
19
has
received
a
recommendation
from
the
individual’s
physician
20
for
individualized
investigational
treatment,
who
has
given
21
written
informed
consent,
and
who
has
documentation
from
22
the
individual’s
physician
that
the
individual
meets
these
23
requirements.
24
Under
current
law,
the
Code
chapter
applies
to
an
25
“investigational
drug,
biological
product,
or
device”,
26
meaning
a
drug,
biological
product,
or
device
that
has
27
successfully
completed
phase
I
of
a
United
States
food
and
28
drug
administration
(FDA)-approved
clinical
trial
but
has
not
29
yet
been
approved
for
general
use
by
the
FDA
and
that
remains
30
under
investigation
in
an
FDA-approved
clinical
trial.
Under
31
the
bill,
the
Code
chapter
also
applies
to
an
“individualized
32
investigational
treatment”,
meaning
a
drug,
biological
product,
33
or
device
that
is
unique
to
and
produced
exclusively
for
use
34
by
an
individual
patient
based
on
the
individual
patient’s
35
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802
own
genetic
profile
and
includes
individualized
gene
therapy,
1
antisense
oligonucleotides,
and
individualized
neoantigen
2
vaccines.
3
The
bill
amends
the
definition
for
“written
informed
4
consent”
to
reflect
the
changes
made
to
“eligible
patient”
5
and
the
application
of
the
Code
chapter
to
individualized
6
investigational
treatments.
7
“Eligible
facility”
is
defined
as
an
institution
that
is
8
operating
under
a
federalwide
assurance
for
the
protection
9
of
human
subjects
pursuant
to
federal
law.
The
bill
amends
10
provisions
relating
to
a
manufacturer’s
rights
under
the
11
Code
chapter
to
also
apply
to
eligible
facilities.
The
bill
12
provides
that
a
manufacturer
of
an
investigational
drug,
13
biological
product,
or
device
or
a
manufacturer
operating
14
within,
and
in
compliance
with
all
requirements
applicable
15
to,
an
eligible
facility
may
make
available,
and
an
eligible
16
patient
may
request
from
a
manufacturer
of
an
investigational
17
drug,
biological
product,
or
device,
or
a
manufacturer
18
operating
within,
and
in
compliance
with
all
requirements
19
applicable
to,
an
eligible
facility,
the
manufacturer’s
20
investigational
drug,
biological
product,
or
device,
or
the
21
manufacturer’s
individualized
investigational
treatment.
22
However,
the
Code
chapter
does
not
require
a
manufacturer
of
23
an
individualized
investigational
treatment
to
provide
or
24
otherwise
make
available
the
individualized
investigational
25
treatment
to
an
eligible
patient.
The
bill
provides
that
an
26
eligible
facility
or
a
manufacturer
that
is
in
compliance
with
27
all
applicable
requirements
may
provide
an
individualized
28
investigational
treatment
to
an
eligible
patient
without
29
receiving
compensation,
or
require
an
eligible
patient
to
pay
30
the
costs
of,
or
the
costs
associated
with,
the
manufacture
of
31
the
individualized
investigational
treatment.
32
The
bill
makes
conforming
changes
in
the
Code
chapter.
33
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