Bill Text: IA SSB3001 | 2023-2024 | 90th General Assembly | Introduced
Bill Title: A bill for an act relating to insurance coverage for biomarker testing.(See SF 2159.)
Spectrum: Committee Bill
Status: (Introduced - Dead) 2024-01-30 - Committee report approving bill, renumbered as SF 2159. [SSB3001 Detail]
Download: Iowa-2023-SSB3001-Introduced.html
Senate
Study
Bill
3001
-
Introduced
SENATE
FILE
_____
BY
(PROPOSED
COMMITTEE
ON
COMMERCE
BILL
BY
CHAIRPERSON
BROWN)
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.
“Consensus
statement”
means
a
statement
developed
by
14
an
independent,
multidisciplinary
panel
of
experts,
none
of
15
whom
have
a
conflict
of
interest,
who
utilize
a
transparent
16
methodology
and
reporting
structure.
A
consensus
statement
17
concerns
specific
clinical
circumstances
and
is
based
on
the
18
best
available
evidence
for
the
purpose
of
optimizing
the
19
outcomes
of
clinical
care.
20
d.
“Covered
person”
means
a
policyholder,
subscriber,
or
21
other
person
participating
in
a
policy,
contract,
or
plan
that
22
provides
for
third-party
payment
or
prepayment
of
health
or
23
medical
expenses.
24
e.
“Health
care
professional”
means
the
same
as
defined
in
25
section
514J.102.
26
f.
“Local
coverage
determinations”
means
the
same
as
defined
27
in
section
1869(f)(2)(B)
of
the
federal
Social
Security
Act.
28
g.
“National
coverage
determinations”
means
the
same
as
29
defined
in
section
1869(f)(1)(B)
of
the
federal
Social
Security
30
Act.
31
h.
“Nationally
recognized
clinical
practice
guidelines”
32
means
evidence-based
clinical
practice
guidelines
developed
by
33
independent
organizations
or
medical
professional
societies,
34
none
of
which
have
a
conflict
of
interest,
that
utilize
a
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transparent
methodology
and
reporting
structure.
Clinical
1
practice
guidelines
establish
standards
of
care
informed
2
by
a
systematic
review
of
evidence
and
assessment
of
the
3
costs
and
benefits
of
alternative
care
options
and
include
4
recommendations
intended
to
optimize
patient
care.
5
2.
Notwithstanding
the
uniformity
of
treatment
requirements
6
of
section
514C.6,
a
policy,
contract,
or
plan
providing
for
7
third-party
payment
or
prepayment
of
medical
expenses
shall
8
provide
coverage
for
biomarker
testing
for
the
purposes
of
9
diagnosis,
treatment,
appropriate
management,
or
ongoing
10
monitoring
of
a
covered
person’s
disease
or
condition
when
the
11
test
is
supported
by
medical
and
scientific
evidence,
including
12
but
not
limited
to
any
of
the
following:
13
a.
Labeled
indications
for
a
test
approved
or
cleared
by
14
the
United
States
food
and
drug
administration
or
indicated
15
tests
for
a
drug
approved
by
the
United
States
food
and
drug
16
administration.
17
b.
Centers
for
Medicare
and
Medicaid
services
of
the
18
United
States
department
of
health
and
human
services
national
19
coverage
determinations
or
Medicare
administrative
contractor
20
local
coverage
determinations.
21
c.
Nationally
recognized
clinical
practice
guidelines
and
22
consensus
statements.
23
3.
Coverage
required
under
this
section
shall
limit
24
disruptions
in
care,
including
mitigating
the
need
for
a
25
covered
person
to
undergo
multiple
biopsies
or
to
provide
26
multiple
biospecimen
samples.
27
4.
A
covered
person
and
the
covered
person’s
health
care
28
professional
shall
have
access
to
a
clear
and
convenient
29
process
available
on
the
health
carrier’s
internet
site
to
30
request
an
exception
to
coverage
provided
under
this
section.
31
5.
a.
This
section
applies
to
the
following
classes
of
32
third-party
payment
provider
policies,
contracts,
or
plans
33
delivered,
issued
for
delivery,
continued,
or
renewed
in
this
34
state
on
or
after
January
1,
2025:
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(1)
Individual
or
group
accident
and
sickness
insurance
1
providing
coverage
on
an
expense-incurred
basis.
2
(2)
An
individual
or
group
hospital
or
medical
service
3
contract
issued
pursuant
to
chapter
509,
514,
or
514A.
4
(3)
An
individual
or
group
health
maintenance
organization
5
contract
regulated
under
chapter
514B.
6
(4)
A
plan
established
pursuant
to
chapter
509A
for
public
7
employees.
8
b.
This
section
shall
apply
to
all
of
the
following:
9
(1)
The
medical
assistance
program
under
chapter
249A.
10
(2)
The
healthy
and
well
kids
in
Iowa
(Hawki)
program
under
11
chapter
514I.
12
(3)
A
managed
care
organization
acting
pursuant
to
a
13
contract
with
the
department
of
health
and
human
services
under
14
chapter
249A,
or
with
the
healthy
and
well
kids
in
Iowa
(Hawki)
15
program
under
chapter
514I.
16
c.
This
section
shall
not
apply
to
accident-only,
17
specified
disease,
short-term
hospital
or
medical,
hospital
18
confinement
indemnity,
credit,
dental,
vision,
Medicare
19
supplement,
long-term
care,
basic
hospital
and
medical-surgical
20
expense
coverage
as
defined
by
the
commissioner,
disability
21
income
insurance
coverage,
coverage
issued
as
a
supplement
22
to
liability
insurance,
workers’
compensation
or
similar
23
insurance,
or
automobile
medical
payment
insurance.
24
6.
The
commissioner
of
insurance
shall
adopt
rules
pursuant
25
to
chapter
17A
to
administer
this
section.
26
EXPLANATION
27
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
28
the
explanation’s
substance
by
the
members
of
the
general
assembly.
29
This
bill
relates
to
health
insurance
coverage
for
biomarker
30
testing.
31
The
bill
defines
“biomarker
testing”
as
an
analysis
of
32
an
individual’s
tissue,
blood,
or
other
biospecimen
for
the
33
presence
of
a
biomarker.
“Biomarker”
is
also
defined
in
the
34
bill.
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The
bill
requires
a
health
carrier
that
offers
individual,
1
group,
or
small
group
contracts,
policies,
or
plans
in
this
2
state
that
provide
for
third-party
payment
or
prepayment
of
3
health
or
medical
expenses
to
offer
coverage
for
biomarker
4
testing
for
a
covered
person
when
the
test
is
supported
by
5
medical
and
scientific
evidence
as
detailed
in
the
bill.
6
Coverage
shall
be
provided
in
a
manner
which
limits
disruptions
7
in
a
person’s
care.
The
bill
requires
a
health
carrier
to
8
provide
a
process
on
its
internet
site
for
a
person
and
the
9
person’s
health
care
professional
to
seek
an
exception
to
10
coverage
required
under
the
bill.
11
The
bill
applies
to
third-party
payment
provider
contracts,
12
policies,
or
plans
delivered,
issued
for
delivery,
continued,
13
or
renewed
in
this
state
on
or
after
January
1,
2025,
by
the
14
third-party
payment
providers
enumerated
in
the
bill.
The
bill
15
specifies
the
types
of
specialized
health-related
insurance
16
which
are
not
subject
to
the
bill’s
coverage
requirements.
17
The
bill
applies
to
the
medical
assistance
program
18
under
Code
chapter
249A,
the
healthy
and
well
kids
in
Iowa
19
(Hawki)
program
under
Code
chapter
514I,
and
a
managed
care
20
organization
acting
pursuant
to
a
contract
with
the
department
21
of
health
and
human
services
to
administer
either
the
medical
22
assistance
program
or
the
Hawki
program.
23
The
commissioner
of
insurance
is
required
to
adopt
rules
to
24
administer
the
bill.
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