Bill Text: IA SF2159 | 2023-2024 | 90th General Assembly | Introduced
Bill Title: A bill for an act relating to insurance coverage for biomarker testing.(Formerly SSB 3001.)
Spectrum: Committee Bill
Status: (Introduced - Dead) 2024-04-09 - Withdrawn. S.J. 764. [SF2159 Detail]
Download: Iowa-2023-SF2159-Introduced.html
Senate
File
2159
-
Introduced
SENATE
FILE
2159
BY
COMMITTEE
ON
COMMERCE
(SUCCESSOR
TO
SSB
3001)
A
BILL
FOR
An
Act
relating
to
insurance
coverage
for
biomarker
testing.
1
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
2
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Section
1.
NEW
SECTION
.
514C.36
Biomarker
testing
——
1
coverage.
2
1.
As
used
in
this
section,
unless
the
context
otherwise
3
requires:
4
a.
“Biomarker”
means
a
characteristic
that
is
objectively
5
measured
and
evaluated
as
an
indicator
of
normal
biological
6
processes,
pathogenic
processes,
or
pharmacologic
responses
to
7
a
specific
therapeutic
intervention,
including
but
not
limited
8
to
genetic
mutations
or
protein
expression.
9
b.
“Biomarker
testing”
means
the
analysis
of
an
individual’s
10
tissue,
blood,
or
other
biospecimen
for
the
presence
of
a
11
biomarker,
including
but
not
limited
to
single-analyte
tests,
12
multiplex
panel
tests,
or
whole
genome
sequencing.
13
c.
“Clinical
utility”
means
a
biomarker
test
result
14
provides
information
used
in
the
formulation
of
a
treatment
or
15
monitoring
strategy
that
informs
a
covered
person’s
outcomes
16
and
impacts
clinical
decisions.
The
most
appropriate
biomarker
17
test
may
include
both
information
that
is
actionable
and
18
information
that
cannot
be
immediately
used
in
the
formulation
19
of
a
clinical
decision.
20
d.
“Consensus
statement”
means
a
statement
developed
by
21
an
independent,
multidisciplinary
panel
of
experts,
none
of
22
whom
have
a
conflict
of
interest,
who
utilize
a
transparent
23
methodology
and
reporting
structure.
A
consensus
statement
24
concerns
specific
clinical
circumstances
and
is
based
on
the
25
best
available
evidence
for
the
purpose
of
optimizing
the
26
outcomes
of
clinical
care.
27
e.
“Covered
person”
means
a
policyholder,
subscriber,
or
28
other
person
participating
in
a
policy,
contract,
or
plan
that
29
provides
for
third-party
payment
or
prepayment
of
health
or
30
medical
expenses.
31
f.
“Health
care
professional”
means
the
same
as
defined
in
32
section
514J.102.
33
g.
“Local
coverage
determinations”
means
the
same
as
defined
34
in
section
1869(f)(2)(B)
of
the
federal
Social
Security
Act.
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h.
“National
coverage
determinations”
means
the
same
as
1
defined
in
section
1869(f)(1)(B)
of
the
federal
Social
Security
2
Act.
3
i.
“Nationally
recognized
clinical
practice
guidelines”
4
means
evidence-based
clinical
practice
guidelines
developed
by
5
independent
organizations
or
medical
professional
societies,
6
none
of
which
have
a
conflict
of
interest,
that
utilize
a
7
transparent
methodology
and
reporting
structure.
Clinical
8
practice
guidelines
establish
standards
of
care
informed
9
by
a
systematic
review
of
evidence
and
assessment
of
the
10
costs
and
benefits
of
alternative
care
options
and
include
11
recommendations
intended
to
optimize
patient
care.
12
2.
Notwithstanding
the
uniformity
of
treatment
requirements
13
of
section
514C.6,
a
policy,
contract,
or
plan
providing
for
14
third-party
payment
or
prepayment
of
medical
expenses
shall
15
provide
coverage
for
biomarker
testing
for
the
purposes
of
16
diagnosis,
treatment,
appropriate
management,
or
ongoing
17
monitoring
of
a
covered
person’s
disease
or
condition
when
the
18
test
provides
clinical
utility
as
demonstrated
by
medical
and
19
scientific
evidence,
including
but
not
limited
to
any
of
the
20
following:
21
a.
Labeled
indications
for
a
test
approved
or
cleared
by
22
the
United
States
food
and
drug
administration
or
indicated
23
tests
for
a
drug
approved
by
the
United
States
food
and
drug
24
administration.
25
b.
Centers
for
Medicare
and
Medicaid
services
of
the
26
United
States
department
of
health
and
human
services
national
27
coverage
determinations
or
Medicare
administrative
contractor
28
local
coverage
determinations.
29
c.
Nationally
recognized
clinical
practice
guidelines
and
30
consensus
statements.
31
3.
Coverage
required
under
this
section
shall
limit
32
disruptions
in
care,
including
mitigating
the
need
for
a
33
covered
person
to
undergo
multiple
biopsies
or
to
provide
34
multiple
biospecimen
samples.
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4.
A
covered
person
and
the
covered
person’s
health
care
1
professional
shall
have
access
to
a
clear
and
convenient
2
process
available
on
the
health
carrier’s
internet
site
to
3
request
an
exception
to
coverage
provided
under
this
section.
4
5.
a.
This
section
applies
to
the
following
classes
of
5
third-party
payment
provider
policies,
contracts,
or
plans
6
delivered,
issued
for
delivery,
continued,
or
renewed
in
this
7
state
on
or
after
January
1,
2025:
8
(1)
Individual
or
group
accident
and
sickness
insurance
9
providing
coverage
on
an
expense-incurred
basis.
10
(2)
An
individual
or
group
hospital
or
medical
service
11
contract
issued
pursuant
to
chapter
509,
514,
or
514A.
12
(3)
An
individual
or
group
health
maintenance
organization
13
contract
regulated
under
chapter
514B.
14
(4)
A
plan
established
pursuant
to
chapter
509A
for
public
15
employees.
16
b.
This
section
shall
apply
to
all
of
the
following:
17
(1)
The
medical
assistance
program
under
chapter
249A.
18
(2)
The
healthy
and
well
kids
in
Iowa
(Hawki)
program
under
19
chapter
514I.
20
(3)
A
managed
care
organization
acting
pursuant
to
a
21
contract
with
the
department
of
health
and
human
services
under
22
chapter
249A,
or
with
the
healthy
and
well
kids
in
Iowa
(Hawki)
23
program
under
chapter
514I.
24
c.
This
section
shall
not
apply
to
accident-only,
25
specified
disease,
short-term
hospital
or
medical,
hospital
26
confinement
indemnity,
credit,
dental,
vision,
Medicare
27
supplement,
long-term
care,
basic
hospital
and
medical-surgical
28
expense
coverage
as
defined
by
the
commissioner,
disability
29
income
insurance
coverage,
coverage
issued
as
a
supplement
30
to
liability
insurance,
workers’
compensation
or
similar
31
insurance,
or
automobile
medical
payment
insurance.
32
6.
The
commissioner
of
insurance
shall
adopt
rules
pursuant
33
to
chapter
17A
to
administer
this
section.
34
EXPLANATION
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The
inclusion
of
this
explanation
does
not
constitute
agreement
with
1
the
explanation’s
substance
by
the
members
of
the
general
assembly.
2
This
bill
relates
to
health
insurance
coverage
for
biomarker
3
testing.
4
The
bill
defines
“biomarker
testing”
as
an
analysis
of
5
an
individual’s
tissue,
blood,
or
other
biospecimen
for
the
6
presence
of
a
biomarker.
“Biomarker”
is
also
defined
in
the
7
bill.
8
The
bill
requires
a
health
carrier
that
offers
individual,
9
group,
or
small
group
contracts,
policies,
or
plans
in
this
10
state
that
provide
for
third-party
payment
or
prepayment
of
11
health
or
medical
expenses
to
offer
coverage
for
biomarker
12
testing
for
a
covered
person
when
the
test
provides
clinical
13
utility
as
demonstrated
by
medical
and
scientific
evidence
14
as
detailed
in
the
bill.
“Clinical
utility”
is
defined
in
15
the
bill.Coverage
shall
be
provided
in
a
manner
which
limits
16
disruptions
in
a
person’s
care.
The
bill
requires
a
health
17
carrier
to
provide
a
process
on
its
internet
site
for
a
person
18
and
the
person’s
health
care
professional
to
seek
an
exception
19
to
coverage
required
under
the
bill.
20
The
bill
applies
to
third-party
payment
provider
contracts,
21
policies,
or
plans
delivered,
issued
for
delivery,
continued,
22
or
renewed
in
this
state
on
or
after
January
1,
2025,
by
the
23
third-party
payment
providers
enumerated
in
the
bill.
The
bill
24
specifies
the
types
of
specialized
health-related
insurance
25
which
are
not
subject
to
the
bill’s
coverage
requirements.
26
The
bill
applies
to
the
medical
assistance
program
27
under
Code
chapter
249A,
the
healthy
and
well
kids
in
Iowa
28
(Hawki)
program
under
Code
chapter
514I,
and
a
managed
care
29
organization
acting
pursuant
to
a
contract
with
the
department
30
of
health
and
human
services
to
administer
either
the
medical
31
assistance
program
or
the
Hawki
program.
32
The
commissioner
of
insurance
is
required
to
adopt
rules
to
33
administer
the
bill.
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