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Utah

legislature

in

February,

2013

[11]

.

This

bill mandated

CMV

testing

of

newborns

under

three

weeks

of

age

who

fail

their

newborn

hearing

screen(s).

Utah

became

the

first

state

to

implement

this

targeted

hearing

loss

driven

testing

approach

for

CMV

diagnosis when

the

bill was

signed

into

law

in

June

2013.

Data

from

Utah’s

newborn

hearing

screening

program

show

that

during

the

first

year

of

implementation

of

the

law

89%

of

newborns underwent

the

two hearing

screens

and

that 63% of

the

children

who

failed

the

two

newborn

hearing

screens

were

screened

for CMV

(

n

= 244). Among

the

children

screened,

5%

(12

infants)

tested

positive

for

CMV.

Some

of

these

CMV

positive

infants were

found

to

have

normal

hearing

following

audiologic

evaluation.

The

enormous

potential

health

burden

of

congenital

CMV

suggests

that

it

is vital

that we assess

the benefits of early detection

relative

to

the potentially significant costs of early CMV

testing and

treatment.

To

date,

only

one

such

cost

analysis

has

been

done

and

the

authors

found

targeted

newborn

screening

in

the United

Kingdom

to

be

cost

effective

[12]

. Given

the

differences

in

health

insurance

in

the

United

Kingdom,

it

is

unclear

if

these

study

findings would

extrapolate

to

the

United

States.

As

other

states,

including Texas, Hawaii,

Illinois and Connecticut,

consider or have

recently

passed

similar

legislation,

there

is

a

need

to

perform

a

cost–benefit

analysis

to

inform

public

policy

in

the United

States.

This

analysis

uses

an

ex-ante

approach

and

a

governmental

accounting perspective

to assess

the projected costs and benefits of

the Utah

law.

2. Materials

and methods

2.1.

Determining

costs &

benefits

Costs

fell

cleanly

into

two

categories:

administrative

costs

and

medical

costs.

Administrative

costs

were

those

incurred

by

the

Department

of

Health

for

both

the

education

and

screening

components

of

the

program.

The

government

also

bears

the

medical

costs

for

those

affected

infants

covered

by

the

public

insurance programs

(CHIP & Medicaid). Medical costs

include both

the

CMV

screening

test

and

the

differential

cost

of

treatment

for

CMV-positive

infants.

Benefits were

narrowly

defined

as medical

costs

avoided

that would have

otherwise been

incurred had

there

not been

early

screening

and

intervention. Benefits

to

individuals,

families,

and

private

insurers were

not

considered

and

cases

of

CMV prevented

entirely

through

education

and prevention

efforts

were also not captured

in

this analysis. The analysis thus provides a

conservative estimate, as

societal and even governmental benefits

from

the

law

certainly

exceed what

is

captured

here.

2.2.

Quantifying

costs

and

benefits

Administrative costs were drawn

from

the

legislative fiscal note

accompanying

the original bill

[13]

. Department of Health officials

confirmed

the

fiscal

note

was

an

accurate

estimate

of

actual

program

costs. The figures used

in

the analysis

include a one-time

startup

cost

of

$4000

and

an

annual

ongoing

appropriation

of

$30,800

1

.

Calculating

medical

costs

and

cost

avoidance

(benefits)

required

calculating

the

number

of

estimated

screenings

each

year

as

well

as

the

rate

of

positive

screenings

that

would

be

referred

for

further

evaluation

and

treatment.

For

infants

who

tested

positive

but

who

were

found

to

have

normal

hearing

following

audiological

evaluation,

only

the

cost

of

their

screening

is

included

in

the

analysis.

Screening

costs

and

additional

treatment

costs

are

included

for

infants with

confirmed

hearing

loss

2

.

The

cost

of

the

screening

itself was

$66

per

infant

3

.

The analysis only considers

the costs

for

those children

likely

to

be

on

public

insurance

because

we

are

using

a

governmental

perspective.

We

estimated

the

proportion

of

publicly

insured

infants

using

a

range

of

values

and

varied

them

in

our

sensitivity

analysis

to

test

the

impact

of

our

assumptions

4

.

All

infants

with

confirmed

hearing

loss

will

incur

medical

treatment

costs.

This

analysis

considers

the

added

costs

to

the

government

per

patient

with

confirmed

congenital

CMV

and

a

diagnosis of sensorineural hearing

loss. Treatment of CMV-induced

hearing

loss will

likely be

identical

to other

types of hearing

loss

in

infants except

for

the prescription of antiviral medication and

tests

to monitor

the patient during

treatment

5

. The

cost data presented

here

represent

the

cost

to

the

provider without

any markup

for

profit margins and

include $4453

for

the antiviral medication

for 6

months

and

$385.63

for

testing. As

such

they may underestimate

the

costs

from

a

private

insurance

perspective

but may

overesti-

mate

the

costs

from

a

Medicaid

reimbursement

perspective.

Absent

the

ability

to

secure Medicaid

reimbursement

rates,

these

cost

data were

our

best

estimates.

We present different hypothetical models

that

include avoiding

cochlear

implantation

in

patients

treated with

antiviral

therapy.

Cochlear

implantation

is

one

of

the

most

costly

factors

in

the

analysis.

Cochlear

implants

cost

$47,800

per

year

($95,600

for

bilateral) whereas hearing aids are $2000;

thus, avoiding

implants

will

save

anywhere

from

$46,800

to

$93,600

per

patient

[5]

.

A

transparent

cost

benefit

analysis

must

include

several

iterations

of

the

analysis,

varying

the

assumptions

to

illustrate

how

sensitive

the

results

are

to

particular

choices made.

Because

most

costs

related

to newborn hearing

loss are

incurred

in

the first

year or

two of

life, no discounting

is necessary

for

this analysis as all

costs andbenefits occurmore or less in the present.Manyof the costs

and benefits that will accrue

in the

future are to

individuals,

families

and

educational

institutions

rather

than

to

the

government.

In our

estimation,

the

society-wide

benefits

of

early

detection

and

intervention

far

exceed

those

presented

here.

For

the

following

models, all calculations project

forward

two years

into

the program.

3. Results

The

initial model

presented

in

Table

1

provides

a

baseline.

It

assumes

that

the

rate of public

insurance

coverage

for

infants will

1

In

the

second

year

additional

funding was

given,

but

administrators

note

this

funding was

to

be used

exclusively

for

the

educational

component

of

the

law

and

was

thus

excluded

from

our

analysis, which

evaluates

the

screening

component

alone.

2

Of

these

9

CMV

positive

children,

5

had

confirmed

hearing

loss

after

further

testing. All of

these children are at

risk of developing more extensive hearing

loss

in

early

childhood

as

CMV

induced

hearing

loss

is

progressive,

but we

are

unable

to

consider

these more

distant

potential

costs

for

the

subgroup without

confirmed

hearing

loss

(

n

= 4)

due

to

lack

of

data.

3

Medical

costs were calculated using a multi-hospital

cost accounting database.

Though

we’d

prefer

to

use

Medicaid/CHIP

cost

reimbursement

figures,

limited

access

to

such

data

required we

use

hospital

cost

as

a

proxy.

4

Data

from

the Census Bureau

indicates

that 23% of Utah

children

(all

ages)

are

on public

insurance, but national data broken down by age

indicates

that

insurance

rates

for

the

youngest

children

tend

to

be much

higher,

45.2%

[14]

2013

Annual

Social

and

Economic

Supplement

Current

Population

Survey,

City,

2013.

Utah

Department of Health data

indicates

that 37.5% of

children born

in 2013 were born

on public

insurance

[15]

Bergevin A,

Personal Communication with Kobi Young

at

the

Utah

Department

of

Health,

City,

2014.

All

of

these

data

points

represent

historical

coverage

rates

and do not

account

for

changes

caused

by

the Affordable

Care

Act

(ACA)

and

potential

Medicaid

expansion

in

the

state.

Even

without

Medicaid

expansion,

the

state

estimates

that

using

current

eligibility

guidelines,

63.5–80%

of

children

are

eligible

for

CHIP

or

Medicaid;

if

larger

numbers

of

individuals start

taking advantage of

their eligibility

from

the ACA,

then state public

insurance

for

infants

could

reach

higher

rates

than

ever

before.

5

Use

of

antiviral medications

to

treat

hearing

loss

in

otherwise

asymptomatic

CMV patients

is

still experimental. We assume a majority of patients will

choose

to

undergo

antivirals

because

preliminary

data

shows

that

to

be

the

case

in Utah.

A.

Bergevin

et

al.

/

International

Journal

of

Pediatric Otorhinolaryngology

79

(2015)

2090–2093

116