House
File
2668
-
Enrolled
House
File
2668
AN
ACT
RELATING
TO
INSURANCE
COVERAGE
FOR
BIOMARKER
TESTING.
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
Section
1.
NEW
SECTION
.
514C.36
Biomarker
testing
——
coverage.
1.
As
used
in
this
section,
unless
the
context
otherwise
requires:
a.
“Biomarker”
means
a
characteristic
that
is
objectively
measured
and
evaluated
as
an
indicator
of
normal
biological
processes,
pathogenic
processes,
or
pharmacologic
responses
to
a
specific
therapeutic
intervention,
including
but
not
limited
to
genetic
mutations
or
protein
expression.
b.
“Biomarker
testing”
means
the
analysis
of
an
individual’s
tissue,
blood,
or
other
biospecimen
for
the
presence
of
a
biomarker,
including
but
not
limited
to
single-analyte
tests,
multiplex
panel
tests,
or
whole
genome
sequencing.
c.
“Clinical
utility”
means
sufficient
medical
and
scientific
evidence
indicating
that
the
use
of
a
biomarker
test
will
provide
meaningful
information
that
affects
treatment
decisions
and
guides
improvement
of
net
health
outcomes,
including
an
improved
quality
of
life
or
longer
survival.
d.
“Consensus
statement”
means
a
statement
developed
by
an
independent,
multidisciplinary
panel
of
experts,
none
of
whom
have
a
conflict
of
interest,
who
utilize
a
transparent
methodology
and
reporting
structure.
A
consensus
statement
concerns
specific
clinical
circumstances
and
is
based
on
the
House
File
2668,
p.
2
best
available
evidence
for
the
purpose
of
optimizing
the
outcomes
of
clinical
care.
e.
“Covered
person”
means
a
policyholder,
subscriber,
or
other
person
participating
in
a
policy,
contract,
or
plan
that
provides
for
third-party
payment
or
prepayment
of
health
or
medical
expenses.
f.
“Health
care
professional”
means
the
same
as
defined
in
section
514J.102.
g.
“Local
coverage
determinations”
means
the
same
as
defined
in
section
1869(f)(2)(B)
of
the
federal
Social
Security
Act.
h.
“National
coverage
determinations”
means
the
same
as
defined
in
section
1869(f)(1)(B)
of
the
federal
Social
Security
Act.
i.
“Nationally
recognized
clinical
practice
guidelines”
means
evidence-based
clinical
practice
guidelines
developed
by
independent
organizations
or
medical
professional
societies,
none
of
which
have
a
conflict
of
interest,
that
utilize
a
transparent
methodology
and
reporting
structure.
Clinical
practice
guidelines
establish
standards
of
care
informed
by
a
systematic
review
of
evidence
and
assessment
of
the
costs
and
benefits
of
alternative
care
options
and
include
recommendations
intended
to
optimize
patient
care.
2.
Notwithstanding
the
uniformity
of
treatment
requirements
of
section
514C.6,
a
policy,
contract,
or
plan
providing
for
third-party
payment
or
prepayment
of
medical
expenses
shall
provide
coverage
for
biomarker
testing
for
the
purposes
of
diagnosing,
treating,
appropriately
managing,
or
monitoring
a
disease
or
condition
in
a
covered
person
when
the
biomarker
testing
has
demonstrated
clinical
utility,
including
but
not
limited
to
any
of
the
following:
a.
Labeled
indications
for
a
test
approved
or
cleared
by
the
United
States
food
and
drug
administration
or
indicated
tests
for
a
drug
approved
by
the
United
States
food
and
drug
administration.
b.
Centers
for
Medicare
and
Medicaid
services
of
the
United
States
department
of
health
and
human
services
national
coverage
determinations
or
Medicare
administrative
contractor
local
coverage
determinations.
c.
Nationally
recognized
clinical
practice
guidelines
and
House
File
2668,
p.
3
consensus
statements.
3.
Coverage
required
under
this
section
shall
limit
disruptions
in
care,
including
mitigating
the
need
for
a
covered
person
to
undergo
multiple
biopsies
or
to
provide
multiple
biospecimen
samples.
4.
A
covered
person
and
the
covered
person’s
health
care
professional
shall
have
access
to
a
clear
and
convenient
process
available
on
the
health
carrier’s
internet
site
to
request
an
exception
to
coverage
provided
under
this
section.
5.
a.
This
section
applies
to
the
following
classes
of
third-party
payment
provider
policies,
contracts,
or
plans
delivered,
issued
for
delivery,
continued,
or
renewed
in
this
state
on
or
after
January
1,
2025:
(1)
Individual
or
group
accident
and
sickness
insurance
providing
coverage
on
an
expense-incurred
basis.
(2)
An
individual
or
group
hospital
or
medical
service
contract
issued
pursuant
to
chapter
509,
514,
or
514A.
(3)
An
individual
or
group
health
maintenance
organization
contract
regulated
under
chapter
514B.
(4)
A
plan
established
pursuant
to
chapter
509A
for
public
employees.
b.
This
section
shall
apply
to
all
of
the
following:
(1)
The
medical
assistance
program
under
chapter
249A.
(2)
The
healthy
and
well
kids
in
Iowa
(Hawki)
program
under
chapter
514I.
(3)
A
managed
care
organization
acting
pursuant
to
a
contract
with
the
department
of
health
and
human
services
under
chapter
249A,
or
with
the
healthy
and
well
kids
in
Iowa
(Hawki)
program
under
chapter
514I.
c.
This
section
shall
not
apply
to
accident-only,
specified
disease,
short-term
hospital
or
medical,
hospital
confinement
indemnity,
credit,
dental,
vision,
Medicare
supplement,
long-term
care,
basic
hospital
and
medical-surgical
expense
coverage
as
defined
by
the
commissioner,
disability
income
insurance
coverage,
coverage
issued
as
a
supplement
to
liability
insurance,
workers’
compensation
or
similar
insurance,
or
automobile
medical
payment
insurance.
6.
The
commissioner
of
insurance
may
adopt
rules
pursuant
to
chapter
17A
to
administer
this
section.
House
File
2668,
p.
4
Sec.
2.
DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
——
REQUIRED
REPORT.
Before
November
1,
2025,
the
department
of
health
and
human
services
shall
report
the
number
of
biomarker
tests
provided
during
fiscal
year
2025,
and
the
resulting
cost
of
providing
the
biomarker
tests
during
fiscal
year
2025,
to
individuals
pursuant
to
this
Act
that
are
covered
by
the
medical
assistance
program
under
chapter
249A
and
the
healthy
and
well
kids
in
Iowa
(Hawki)
program
under
chapter
514I.
______________________________
PAT
GRASSLEY
Speaker
of
the
House
______________________________
AMY
SINCLAIR
President
of
the
Senate
I
hereby
certify
that
this
bill
originated
in
the
House
and
is
known
as
House
File
2668,
Ninetieth
General
Assembly.
______________________________
MEGHAN
NELSON
Chief
Clerk
of
the
House
Approved
_______________,
2024
______________________________
KIM
REYNOLDS
Governor