Bill Text: IA SF17 | 2019-2020 | 88th General Assembly | Introduced
Bill Title: A bill for an act relating to the coverage of direct-acting antiviral drugs for Medicaid beneficiaries living with a chronic hepatitis C virus infection.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2019-01-17 - Subcommittee: Costello, Bolkcom, and Greene. S.J. 124. [SF17 Detail]
Download: Iowa-2019-SF17-Introduced.html
Senate
File
17
-
Introduced
SENATE
FILE
17
BY
BOLKCOM
A
BILL
FOR
An
Act
relating
to
the
coverage
of
direct-acting
antiviral
1
drugs
for
Medicaid
beneficiaries
living
with
a
chronic
2
hepatitis
C
virus
infection.
3
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
4
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Section
1.
MEDICAID
PROGRAM
COVERAGE
——
DIRECT-ACTING
1
ANTIVIRAL
DRUGS
——
HEPATITIS
C
VIRUS
(HCV)
INFECTION.
2
1.
The
department
of
human
services
shall
adopt
rules
3
pursuant
to
chapter
17A,
shall
amend
all
Medicaid
managed
care
4
contracts,
and
shall
submit
any
Medicaid
state
plan
amendments
5
to
the
centers
for
Medicare
and
Medicaid
services
of
the
United
6
States
department
of
health
and
human
services
(CMS)
for
7
approval,
as
necessary,
to
require
that
direct-acting
antiviral
8
drugs
that
are
approved
by
the
United
States
food
and
drug
9
administration
(FDA)
for
the
treatment
of
chronic
HCV-infected
10
patients
as
a
medically
accepted
indication
as
defined
in
42
11
U.S.C.
§1396r-8(k)(6),
are
a
covered
outpatient
drug
under
12
the
Medicaid
program,
and
shall
be
covered
consistently
for
13
Medicaid
beneficiaries
under
both
the
fee-for-service
and
14
managed
care
methodologies
in
accordance
with
the
Medicaid
15
state
plan.
The
rules
adopted,
Medicaid
managed
care
contracts
16
amended,
and
state
plan
amendment
submitted
shall
comply
with
17
all
of
the
following
requirements:
18
a.
Coverage
for
the
outpatient
drugs
shall
be
provided
19
in
accordance
with
42
U.S.C.
§1396r-8
and
with
Medicaid
drug
20
rebate
program
notice
release
No.
172
issued
by
CMS
on
November
21
5,
2015.
22
b.
Any
limitation
on
coverage
of
such
drugs,
including
23
utilization
controls
such
as
prior
authorization
and
placement
24
on
the
preferred
drug
list,
shall
not
unreasonably
restrict
25
access
to
these
drugs
for
a
medically
accepted
indication
as
26
defined
in
42
U.S.C.
§1396r-8(k)(6),
including
that
provision
27
of
the
drugs
shall
not
be
based
on
a
beneficiary’s
Metavir
28
fibrosis
score
or
disease
severity,
shall
not
require
a
period
29
of
abstinence
from
drug
and
alcohol
abuse,
and
shall
not
30
require
prescribing
by
a
specific
provider
type.
31
c.
Coverage
shall
be
consistent
with
the
guidelines
32
published
by
the
American
association
for
the
study
of
liver
33
diseases
(AASLD),
the
infectious
diseases
society
of
America
34
(IDSA),
and
the
international
antiviral
society-USA
(IAS-USA)
35
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S.F.
17
to
the
extent
consistent
with
federal
law
and
regulation.
1
d.
If
utilization
controls
are
provided,
such
utilization
2
controls
shall
ensure
that
appropriate
access
to
the
covered
3
drugs
is
consistent
with
42
C.F.R.
§438.210,
and
specifically
4
must
ensure
that
the
drugs
are
provided
in
a
manner
that
is
5
sufficient
in
amount,
duration,
and
scope
to
reasonably
achieve
6
the
purpose
for
which
the
drugs
are
furnished
and
are
not
7
arbitrarily
denied
or
reduced
in
amount,
duration,
or
scope
8
solely
because
of
the
diagnosis,
type
of
illness,
or
condition
9
of
the
beneficiary.
10
2.
Additionally,
the
department
of
human
services
shall
do
11
all
of
the
following:
12
a.
Implement
programming
to
provide
patients
who
are
13
undergoing
and
who
have
completed
direct-acting
antiviral
HCV
14
drug
treatment
with
supportive
care
and
surveillance
to
enhance
15
their
adherence
to
regimens
and
increase
success
rates.
16
b.
Collaborate
with
the
department
of
public
health,
17
bureau
of
HIV,
STD,
and
hepatitis
to
provide
surveillance
and
18
determine
the
return
on
investment,
benefits,
and
outcomes
19
resulting
from
the
provision
of
treatment
to
all
chronic
20
HCV-infected
Medicaid
beneficiaries,
including
due
to
averting
21
new
infections.
22
EXPLANATION
23
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
24
the
explanation’s
substance
by
the
members
of
the
general
assembly.
25
This
bill
relates
to
coverage
of
direct-acting
antivrial
26
drugs
for
a
chronic
hepatitis
C
virus
(HCV)
infection
under
the
27
Medicaid
programs.
28
The
bill
requires
the
department
of
human
services
(DHS)
to
29
adopt
rules
pursuant
to
Code
chapter
17A,
amend
all
Medicaid
30
managed
care
contracts,
and
submit
any
Medicaid
state
plan
31
amendments
to
the
centers
for
Medicare
and
Medicaid
services
32
of
the
United
States
department
of
health
and
human
services
33
(CMS)
for
approval,
as
necessary,
to
require
that
direct-acting
34
antiviral
drugs
that
are
approved
by
the
United
States
food
35
-2-
LSB
1054XS
(2)
88
pf/rh
2/
4
S.F.
17
and
drug
administration
(FDA)
for
the
treatment
of
chronic
1
HCV-infected
patients
as
a
medically
accepted
indication
are
2
a
covered
outpatient
drug
under
the
Medicaid
program,
and
3
shall
be
covered
consistently
for
Medicaid
beneficiaries
under
4
both
the
fee-for-service
and
managed
care
methodologies
in
5
accordance
with
the
Medicaid
state
plan.
6
The
bill
requires
that
the
rules
adopted,
and
state
plan
7
amendment
submitted,
shall
comply
with
all
of
the
following
8
requirements:
9
1.
Coverage
for
the
outpatient
drugs
shall
be
provided
10
in
accordance
with
42
U.S.C.
§1396r-8
and
with
Medicaid
drug
11
rebate
program
notice
release
No.
172
issued
by
CMS
on
November
12
5,
2015.
13
2.
Any
limitation
on
coverage
of
such
drugs,
including
14
utilization
controls
such
as
prior
authorization
and
placement
15
on
the
preferred
drug
list,
shall
not
unreasonably
restrict
16
access
to
these
drugs
for
a
medically
accepted
indication,
17
including
that
provision
of
the
drugs
shall
not
be
based
on
a
18
beneficiary’s
Metavir
fibrosis
score
or
disease
severity,
shall
19
not
require
a
period
of
abstinence
from
drug
and
alcohol
abuse,
20
and
shall
not
require
prescribing
by
a
specific
provider
type.
21
3.
Coverage
shall
be
consistent
with
the
guidelines
22
published
by
the
American
association
for
the
study
of
liver
23
diseases
(AASLD),
the
infectious
diseases
society
of
America
24
(IDSA),
and
the
international
antiviral
society-USA
(IAS-USA)to
25
the
extent
consistent
with
federal
law
and
regulation.
26
4.
If
utilization
controls
are
provided,
such
utilization
27
controls
shall
ensure
that
appropriate
access
to
the
covered
28
drugs
is
consistent
with
federal
regulations,
and
specifically
29
must
ensure
that
the
drugs
are
provided
in
a
manner
that
is
30
sufficient
in
amount,
duration,
and
scope
to
reasonably
achieve
31
the
purpose
for
which
the
drugs
are
furnished
and
are
not
32
arbitrarily
denied
or
reduced
in
amount,
duration,
or
scope
33
solely
because
of
the
diagnosis,
type
of
illness,
or
condition
34
of
the
beneficiary.
35
-3-
LSB
1054XS
(2)
88
pf/rh
3/
4
S.F.
17
The
bill
also
requires
DHS
to
implement
programming
to
1
provide
patients
who
are
undergoing
and
who
have
completed
2
direct-acting
antiviral
HCV
drug
treatment
with
supportive
care
3
and
surveillance
to
enhance
their
adherence
to
regimens
and
4
increase
success
rates,
and
to
collaborate
with
the
department
5
of
public
health,
bureau
of
HIV,
STD,
and
hepatitis,
to
provide
6
surveillance
and
determine
the
return
on
investment,
benefits,
7
and
outcomes
resulting
from
the
provision
of
treatment
to
all
8
chronic
HCV-infected
Medicaid
beneficiaries,
including
due
to
9
averting
new
infections.
10
-4-
LSB
1054XS
(2)
88
pf/rh
4/
4
