Senate
File
2016
-
Introduced
SENATE
FILE
2016
BY
CARLIN
A
BILL
FOR
An
Act
relating
to
continuity
of
care
and
nonmedical
switching
1
by
health
carriers,
health
benefit
plans,
and
utilization
2
review
organizations,
and
including
applicability
3
provisions.
4
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
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Section
1.
NEW
SECTION
.
514F.8
Continuity
of
care
——
1
nonmedical
switching.
2
1.
Definitions.
For
the
purpose
of
this
section:
3
a.
“Authorized
representative”
means
the
same
as
defined
in
4
section
514J.102.
5
b.
“Commissioner”
means
the
commissioner
of
insurance.
6
c.
“Cost
sharing”
means
any
coverage
limit,
copayment,
7
coinsurance,
deductible,
or
other
out-of-pocket
expense
8
requirement.
9
d.
“Coverage
exemption”
means
a
determination
made
by
a
10
health
carrier,
health
benefit
plan,
or
utilization
review
11
organization
to
cover
a
prescription
drug
that
is
otherwise
12
excluded
from
coverage.
13
e.
“Coverage
exemption
determination”
means
a
determination
14
made
by
a
health
carrier,
health
benefit
plan,
or
utilization
15
review
organization
whether
to
cover
a
prescription
drug
that
16
is
otherwise
excluded
from
coverage.
17
f.
“Covered
person”
means
the
same
as
defined
in
section
18
514J.102.
19
g.
“Demonstrated
bioavailability”
means
the
same
as
defined
20
in
section
155A.3.
21
h.
“Discontinued
health
benefit
plan”
means
a
covered
22
person’s
existing
health
benefit
plan
that
is
discontinued
by
a
23
health
carrier
during
open
enrollment
for
the
next
plan
year.
24
i.
“Formulary”
means
a
complete
list
of
prescription
drugs
25
eligible
for
coverage
under
a
health
benefit
plan.
26
j.
“Generic
name”
means
the
same
as
defined
in
section
27
155A.3.
28
k.
“Health
benefit
plan”
means
the
same
as
defined
in
29
section
514J.102.
30
l.
“Health
care
professional”
means
the
same
as
defined
in
31
section
514J.102.
32
m.
“Health
care
services”
means
the
same
as
defined
in
33
section
514J.102.
34
n.
“Health
carrier”
means
the
same
as
defined
in
section
35
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514J.102.
1
o.
“Interchangeable
biological
product”
means
the
same
as
2
defined
in
section
155A.3.
3
p.
“Nonmedical
switching”
means
a
health
benefit
plan’s
4
restrictive
changes
to
the
health
benefit
plan’s
formulary
5
after
the
current
plan
year
has
begun
or
during
the
open
6
enrollment
period
for
the
upcoming
plan
year,
causing
a
covered
7
person
who
is
medically
stable
on
the
covered
person’s
current
8
prescribed
drug
as
determined
by
the
prescribing
health
care
9
professional,
to
switch
to
a
less
costly
alternate
prescription
10
drug.
11
q.
“Open
enrollment”
means
the
yearly
time
period
during
12
which
an
individual
can
enroll
in
a
health
benefit
plan.
13
r.
“Utilization
review”
means
the
same
as
defined
in
514F.7.
14
s.
“Utilization
review
organization”
means
the
same
as
15
defined
in
514F.7.
16
2.
Nonmedical
switching.
With
respect
to
a
health
carrier
17
that
has
entered
into
a
health
benefit
plan
with
a
covered
18
person
that
covers
prescription
drug
benefits,
all
of
the
19
following
apply:
20
a.
A
health
carrier,
health
benefit
plan,
or
utilization
21
review
organization
shall
not
limit
or
exclude
coverage
of
22
a
prescription
drug
for
any
covered
person
who
is
medically
23
stable
on
such
drug
as
determined
by
the
prescribing
health
24
care
professional,
if
all
of
the
following
apply:
25
(1)
The
prescription
drug
was
previously
approved
by
the
26
health
carrier
for
coverage
for
the
covered
person.
27
(2)
The
covered
person’s
prescribing
health
care
28
professional
has
prescribed
the
drug
for
the
covered
person’s
29
medical
condition
within
the
previous
six
months.
30
(3)
The
covered
person
continues
to
be
an
enrollee
of
the
31
health
benefit
plan.
32
b.
Coverage
of
a
covered
person’s
prescription
drug,
as
33
described
in
paragraph
“a”
,
shall
continue
through
the
last
day
34
of
the
covered
person’s
eligibility
under
the
health
benefit
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plan,
inclusive
of
any
open
enrollment
period.
1
c.
Prohibited
limitations
and
exclusions
referred
to
in
2
paragraph
“a”
include
but
are
not
limited
to
the
following:
3
(1)
Limiting
or
reducing
the
maximum
coverage
of
4
prescription
drug
benefits.
5
(2)
Increasing
cost
sharing
for
a
covered
prescription
6
drug.
7
(3)
Moving
a
prescription
drug
to
a
more
restrictive
tier
if
8
the
health
carrier
uses
a
formulary
with
tiers.
9
(4)
Removing
a
prescription
drug
from
a
formulary,
unless
10
the
United
States
food
and
drug
administration
has
issued
a
11
statement
about
the
drug
that
calls
into
question
the
clinical
12
safety
of
the
drug,
or
the
manufacturer
of
the
drug
has
13
notified
the
United
States
food
and
drug
administration
of
a
14
manufacturing
discontinuance
or
potential
discontinuance
of
the
15
drug
as
required
by
section
506C
of
the
Federal
Food,
Drug,
and
16
Cosmetic
Act,
as
codified
in
21
U.S.C.
§356c.
17
d.
A
drug
product
with
the
same
generic
name
and
18
demonstrated
bioavailability,
or
an
interchangeable
biological
19
product,
shall
be
considered
equivalent
to
the
prescription
20
drug
prescribed
by
the
covered
person’s
health
care
21
professional.
22
3.
Coverage
exemption
determination
process.
23
a.
To
ensure
continuity
of
care,
a
health
carrier,
health
24
plan,
or
utilization
review
organization
shall
provide
a
25
covered
person
and
prescribing
health
care
professional
26
with
access
to
a
clear
and
convenient
process
to
request
a
27
coverage
exemption
determination.
A
health
carrier,
health
28
plan,
or
utilization
review
organization
may
use
its
existing
29
medical
exceptions
process
to
satisfy
this
requirement.
The
30
process
shall
be
easily
accessible
on
the
internet
site
of
the
31
health
carrier,
health
benefit
plan,
or
utilization
review
32
organization.
33
b.
A
health
carrier,
health
benefit
plan,
or
utilization
34
review
organization
shall
respond
to
a
coverage
exemption
35
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determination
request
within
seventy-two
hours
of
receipt.
In
1
cases
where
exigent
circumstances
exist,
the
health
carrier,
2
health
benefit
plan,
or
utilization
review
organization
shall
3
respond
within
twenty-four
hours
of
receipt.
If
a
response
by
4
the
health
carrier,
health
benefit
plan,
or
utilization
review
5
organization
is
not
received
within
the
applicable
time
period,
6
the
coverage
exemption
shall
be
deemed
granted.
7
c.
A
coverage
exemption
shall
be
expeditiously
granted
for
a
8
discontinued
health
benefit
plan
if
a
covered
person
enrolls
in
9
a
comparable
plan
offered
by
the
same
health
carrier,
and
all
10
of
the
following
conditions
apply:
11
(1)
The
covered
person
is
medically
stable
on
a
prescription
12
drug
as
determined
by
the
prescribing
health
care
professional.
13
(2)
The
prescribing
health
care
professional
continues
14
to
prescribe
the
drug
for
the
covered
person
for
the
covered
15
person’s
medical
condition.
16
(3)
In
comparison
to
the
discontinued
health
benefit
plan,
17
the
new
health
benefit
plan
does
any
of
the
following:
18
(a)
Limits
or
reduces
the
maximum
coverage
of
prescription
19
drug
benefits.
20
(b)
Increases
cost
sharing
for
the
prescription
drug.
21
(c)
Moves
the
prescription
drug
to
a
more
restrictive
tier
22
if
the
health
carrier
uses
a
formulary
with
tiers.
23
(d)
Excludes
the
prescription
drug
from
the
health
benefit
24
plan’s
formulary.
25
d.
Upon
granting
of
a
coverage
exemption
for
a
drug
26
prescribed
by
a
covered
person’s
prescribing
health
care
27
professional,
a
health
carrier,
health
benefit
plan,
or
28
utilization
review
organization
shall
authorize
coverage
no
29
more
restrictive
than
that
offered
in
a
discontinued
health
30
benefit
plan,
or
than
that
offered
prior
to
implementation
of
31
restrictive
changes
to
the
health
benefit
plan’s
formulary
32
after
the
current
plan
year
began.
33
e.
If
a
determination
is
made
to
deny
a
request
for
a
34
coverage
exemption,
the
health
carrier,
health
benefit
plan,
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or
utilization
review
organization
shall
provide
the
covered
1
person
or
the
covered
person’s
authorized
representative
and
2
the
authorized
person’s
prescribing
health
care
professional
3
with
the
reason
for
denial
and
information
regarding
the
4
procedure
to
appeal
the
denial.
Any
determination
to
deny
a
5
coverage
exemption
may
be
appealed
by
a
covered
person
or
the
6
covered
person’s
authorized
representative.
7
f.
A
health
carrier,
health
benefit
plan,
or
utilization
8
review
organization
shall
uphold
or
reverse
a
determination
to
9
deny
a
coverage
exemption
within
seventy-two
hours
of
receipt
10
of
an
appeal
of
denial.
In
cases
where
exigent
circumstances
11
exist,
a
health
carrier,
health
benefit
plan,
or
utilization
12
review
organization
shall
uphold
or
reverse
a
determination
to
13
deny
a
coverage
exemption
within
twenty-four
hours
of
receipt.
14
If
the
determination
to
deny
a
coverage
exemption
is
not
upheld
15
or
reversed
on
appeal
within
the
applicable
time
period,
the
16
denial
shall
be
deemed
reversed
and
the
coverage
exemption
17
shall
be
deemed
approved.
18
g.
If
a
determination
to
deny
a
coverage
exemption
is
19
upheld
on
appeal,
the
health
carrier,
health
benefit
plan,
20
or
utilization
review
organization
shall
provide
the
covered
21
person
or
the
covered
person’s
authorized
representative
and
22
the
covered
person’s
prescribing
health
care
professional
with
23
the
reason
for
upholding
the
denial
on
appeal
and
information
24
regarding
the
procedure
to
request
external
review
of
the
25
denial
pursuant
to
chapter
514J.
Any
denial
of
a
request
for
a
26
coverage
exemption
that
is
upheld
on
appeal
shall
be
considered
27
a
final
adverse
determination
for
purposes
of
chapter
514J
and
28
is
eligible
for
a
request
for
external
review
by
a
covered
29
person
or
the
covered
person’s
authorized
representative
30
pursuant
to
chapter
514J.
31
4.
Limitations.
This
section
shall
not
be
construed
to
do
32
any
of
the
following:
33
a.
Prevent
a
health
care
professional
from
prescribing
34
another
drug
covered
by
the
health
carrier
that
the
health
care
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professional
deems
medically
necessary
for
the
covered
person.
1
b.
Prevent
a
health
carrier
from
doing
any
of
the
following:
2
(1)
Adding
a
prescription
drug
to
its
formulary.
3
(2)
Removing
a
prescription
drug
from
its
formulary
if
the
4
drug
manufacturer
has
removed
the
drug
for
sale
in
the
United
5
States.
6
5.
Enforcement.
The
commissioner
may
take
any
enforcement
7
action
under
the
commissioner’s
authority
to
enforce
compliance
8
with
this
section.
9
Sec.
2.
APPLICABILITY.
This
Act
applies
to
a
health
benefit
10
plan
that
is
delivered,
issued
for
delivery,
continued,
or
11
renewed
in
this
state
on
or
after
January
1,
2023.
12
EXPLANATION
13
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
14
the
explanation’s
substance
by
the
members
of
the
general
assembly.
15
This
bill
relates
to
the
continuity
of
care
for
a
covered
16
person
and
nonmedical
switching
by
health
carriers,
health
17
benefit
plans,
and
utilization
review
organizations.
18
The
bill
defines
“nonmedical
switching”
as
a
health
benefit
19
plan’s
restrictive
changes
to
the
health
benefit
plan’s
20
formulary
after
the
current
plan
year
has
begun
or
during
the
21
open
enrollment
period
for
the
upcoming
plan
year,
causing
a
22
covered
person
who
is
medically
stable
on
the
covered
person’s
23
current
prescribed
drug
as
determined
by
the
prescribing
24
health
care
professional,
to
switch
to
a
less
costly
alternate
25
prescription
drug.
26
The
bill
provides
that
during
a
covered
person’s
eligibility
27
under
a
health
benefit
plan,
inclusive
of
any
open
enrollment
28
period,
a
health
plan
carrier,
health
benefit
plan,
or
29
utilization
review
organization
shall
not
limit
or
exclude
30
coverage
of
a
prescription
drug
for
the
covered
person
if
the
31
covered
person
is
medically
stable
on
the
drug
as
determined
32
by
the
prescribing
health
care
professional,
the
drug
was
33
previously
approved
by
the
health
carrier
for
coverage
for
34
the
person,
and
the
covered
person’s
prescribing
health
care
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2016
professional
has
prescribed
the
drug
for
the
person’s
medical
1
condition
within
the
previous
six
months.
The
bill
includes,
2
as
prohibited
limitations
or
exclusions,
reducing
the
maximum
3
coverage
of
prescription
drug
benefits,
increasing
cost
sharing
4
for
a
covered
drug,
moving
a
drug
to
a
more
restrictive
tier,
5
and
removing
a
drug
from
a
formulary.
A
prescription
drug
6
may,
however,
be
removed
from
a
formulary
if
the
United
States
7
food
and
drug
administration
issues
a
statement
regarding
the
8
clinical
safety
of
the
drug,
or
the
manufacturer
of
the
drug
9
notifies
the
United
States
food
and
drug
administration
of
a
10
manufacturing
discontinuance
or
potential
discontinuance
of
the
11
drug
as
required
by
section
506c
of
the
Federal
Food,
Drug,
12
and
Cosmetic
Act.
The
bill
provides
that
a
drug
product
with
13
the
same
generic
name
and
demonstrated
bioavailability,
or
an
14
interchangeable
biological
product,
is
considered
equivalent
to
15
the
prescription
drug
prescribed
by
the
covered
person’s
health
16
care
professional.
17
The
bill
requires
a
covered
person
and
prescribing
health
18
care
professional
to
have
access
to
a
process
to
request
a
19
coverage
exemption
determination.
The
bill
defines
“coverage
20
exemption
determination”
as
a
determination
made
by
a
21
health
carrier,
health
benefit
plan,
or
utilization
review
22
organization
whether
to
cover
a
prescription
drug
that
is
23
otherwise
excluded
from
coverage.
24
A
coverage
exemption
determination
request
must
be
approved
25
or
denied
by
the
health
carrier,
health
benefit
plan,
or
26
utilization
review
organization
within
72
hours,
or
within
24
27
hours
if
exigent
circumstances
exist.
If
a
determination
is
28
not
received
within
the
applicable
time
period
the
coverage
29
exemption
is
deemed
granted.
30
The
bill
requires
a
coverage
exemption
to
be
expeditiously
31
granted
for
a
health
benefit
plan
that
is
discontinued
for
the
32
next
plan
year
if
a
covered
person
enrolls
in
a
comparable
33
plan
offered
by
the
same
health
carrier,
and
in
comparison
34
to
the
discontinued
health
benefit
plan,
the
new
health
35
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2016
benefit
plan
limits
or
reduces
the
maximum
coverage
for
a
1
prescription
drug,
increases
cost
sharing
for
the
prescription
2
drug,
moves
the
prescription
drug
to
a
more
restrictive
3
tier,
or
excludes
the
prescription
drug
from
the
formulary.
4
If
a
coverage
exemption
is
granted,
the
bill
requires
an
5
authorization
of
coverage
that
is
no
more
restrictive
than
6
that
offered
in
the
discontinued
health
benefit
plan,
or
than
7
that
offered
prior
to
implementation
of
restrictive
changes
8
to
the
health
benefit
plan’s
formulary
after
the
current
plan
9
year
began.
If
a
determination
is
made
to
deny
a
request
for
10
a
coverage
exemption,
the
reason
for
denial
and
the
procedure
11
to
appeal
the
denial
must
be
provided
to
the
requestor.
Any
12
determination
to
deny
a
coverage
exemption
may
be
appealed
to
13
the
health
carrier,
health
benefit
plan,
or
utilization
review
14
organization.
A
determination
to
uphold
or
reverse
denial
of
15
a
coverage
exemption
must
be
made
within
72
hours
of
receipt
16
of
an
appeal,
or
within
24
hours
if
exigent
circumstances
17
exist.
If
a
determination
is
not
made
within
the
applicable
18
time
period,
the
denial
is
deemed
reversed
and
the
coverage
19
exemption
is
deemed
approved.
20
If
a
determination
to
deny
a
coverage
exemption
is
upheld
on
21
appeal,
the
reason
for
upholding
the
denial
and
the
procedure
22
to
request
external
review
of
the
denial
pursuant
to
Code
23
chapter
514J
must
be
provided
to
the
individual
who
filed
the
24
appeal.
Any
denial
of
a
request
for
a
coverage
exemption
that
25
is
upheld
on
appeal
is
considered
a
final
adverse
determination
26
for
purposes
of
Code
chapter
514J
and
is
eligible
for
a
request
27
for
external
review
by
a
covered
person
or
the
covered
person’s
28
authorized
representative
pursuant
to
Code
chapter
514J.
29
The
bill
shall
not
be
construed
to
prevent
a
health
care
30
professional
from
prescribing
another
drug
covered
by
the
31
health
carrier
that
the
health
care
professional
deems
32
medically
necessary
for
the
covered
person.
33
The
bill
shall
not
be
construed
to
prevent
a
health
carrier
34
from
adding
a
drug
to
its
formulary
or
from
removing
a
drug
35
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S.F.
2016
from
its
formulary
if
the
drug
manufacturer
removes
the
drug
1
for
sale
in
the
United
States.
2
The
bill
allows
the
commissioner
to
take
any
necessary
3
enforcement
action
under
the
commissioner’s
authority
to
4
enforce
compliance
with
the
bill.
5
The
bill
is
applicable
to
health
benefit
plans
that
are
6
delivered,
issued
for
delivery,
continued,
or
renewed
in
this
7
state
on
or
after
January
1,
2023.
8
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