The

Essential

Levels

of

Care

in

Italy

when

being

explicit

serves

the

devolution

of

powers

The

definition

of

an

explicit

health

benefit

package

in

Italy

has

gained

importance

because

of

devolution

of

powers

from

the

national

level

to

the

regions

The

set

of

services

to

be

guaranteed

by

the

public

sector

are

defined

at

national

level

while

regions

are

accountable

for

their

provision

This

contribution

discusses

the

entitlements

and

the

decision

criteria

adopted

by

Italian

policy-making

bodies

Entitlements

to

services

are

clearly

defined

for

few

sectors

-LRB-

mainly

outpatient

specialist

care

-RRB-

for

hospital

care

the

benefit

catalogue

is

vague

The

definition

of

the

health

benefit

package

in

Italy

is

an

essential

element

of

the

relationship

between

the

central

government

and

the

regions

It

is

argued

that

adequate

monitoring

systems

and

accountability

procedures

are

still

needed

to

make

the

essential

levels

of

care

an

effective

pivotal

element

of

the

Italian

National

Health

Service

Italy

has

a

National

Health

Service

based

on

principles

of

universalism

and

comprehensiveness

-LSB-

-RSB-

Established

in

the

Italian

National

Health

Service

-LRB-

INHS

-RRB-

absorbs

of

total

health

care

expenditure

and

it

is

financed

by

general

taxation

-LRB-

OECD

health

data

-RRB-

As

a

consequence

most

care

is

provided

free

of

charge

at

point

of

delivery

although

user

charges

apply

for

outpatient

services

and

procedures

and

to

a

lesser

extent

on

pharmaceuticals

-LSB-

-RSB-

A

major

critical

feature

of

the

INHS

rests

on

the

distribution

of

powers

between

the

central

government

and

the

regions

Mainly

created

to

reverse

the

concentration

of

state

power

occurring

during

the

Fascist

regime

the

regions

are

the

emerging

institutional

tier

of

the

country

as

they

benefit

from

a

substantial

although

controversial

devolution

of

powers

from

the

State

They

have

almost

full

control

over

approx.

Local

Health

Units

and

Independent

INHS

Hospitals

and

they

are

expected

to

cover

their

deficit

-LSB-

-RSB-

The

Italian

Constitution

revised

in

reserves

to

the

central

government

the

exclusive

power

to

set

the

so-called

essential

levels

of

care

-LRB-

Livelli

Essenziali

di

Assistenza

LEAs

-RRB-

which

must

be

guaranteed

to

all

residents

Regions

have

virtually

exclusive

powers

over

regulation

organization

administration

and

funding

of

publicly

financed

healthcare

The

Italian

Constitution

of

specifies

the

citizen

's

right

to

health

This

constitutional

guarantee

is

expressed

in

very

general

terms

Article

of

the

Constitution

says

that

The

Republic

protects

health

as

a

fundamental

right

of

the

individual

and

as

a

concern

of

collectivity

and

guarantees

free

care

to

the

indigent

The

principle

of

a

package

of

benefits

available

to

all

citizens

irrespective

of

age

social

condition

or

income

was

stated

later

in

the

law

introducing

the

INHS

in

The

expression

levels

of

care

was

mentioned

for

the

first

time

with

the

objective

to

guarantee

equal

health

care

coverage

throughout

the

country

the

State

is

to

set

objectives

for

eliminating

geographical

differences

in

social

and

health

care

conditions

-LRB-

Art.

-RRB-

and

and

to

determine

levels

of

care

to

be

guaranteed

to

all

citizens

-LRB-

Art.

-RRB-

The

same

legislation

also

introduced

another

major

feature

of

the

INHS

the

patient

's

right

to

choose

provider

and

place

of

treatment

Although

the

reform

listed

the

areas

in

which

treatments

are

to

be

delivered

under

the

INHS

it

did

not

define

the

benefits

to

be

included

and

excluded

in

detail

The

concept

of

levels

of

care

gained

prominence

in

the

legislation

reforming

the

INHS

in

The

delegation

of

new

powers

to

regions

was

coupled

with

tighter

accountability

systems

On

the

provision

side

the

regions

must

deliver

uniform

levels

of

care

while

on

the

funding

side

regions

are

mandated

to

cover

any

deficit

required

to

provide

the

LEAs

and

to

use

their

own

resources

to

provide

services

above

those

guaranteed

by

national

laws

The

reform

laid

out

a

new

logical

framework

but

it

took

time

to

establish

the

LEAs

Significant

progress

was

made

in

the

late

with

the

approval

of

the

National

Health

Plan

and

a

new

reform

approved

in

These

emphasized

the

importance

of

the

principle

of

equality

in

the

access

of

care

and

introduced

LEA

system

they

also

clearly

stated

the

criteria

that

should

inform

their

definition

human

dignity

effectiveness

appropriateness

and

efficiency

The

LEAs

notion

was

at

risk

of

remaining

an

abstract

concept

as

political

costs

and

implementation

difficulties

of

clarifying

and

limiting

INHS

coverage

were

paramount

However

substantial

progress

in

the

definitions

of

LEAs

was

necessary

to

make

sense

of

the

overall

strategy

of

redistribution

of

powers

between

the

central

government

and

the

regions

This

progress

was

made

with

the

agreement

between

the

regions

and

the

central

government

on

August

which

was

followed

by

a

governmental

decree

-LRB-

the

LEA

decree

-RRB-

At

present

this

decree

is

the

pivotal

element

of

the

Italian

health

benefit

catalogue

-LRB-

Fig.

-RRB-

It

defines

the

main

areas

of

healthcare

services

to

be

guaranteed

by

the

INHS

-LRB-

positive

list

-RRB-

those

completely

excluded

by

public

coverage

-LRB-

negative

list

-RRB-

and

those

partially

covered

-LRB-

only

available

for

specific

clinical

conditions

-RRB-

Fig.

Decision

making

on

benefits

in

Italy

The

positive

list

is

based

on

the

recognition

and

systematization

of

current

legislation

-LRB-

other

decrees

laws

guidelines

etc.

-RRB-

i.e.

it

includes

all

the

services

that

the

INHS

is

actually

providing

categorized

in

three

macrolevels

of

care

-LRB-

a

-RRB-

public

health

services

-LRB-

b

-RRB-

community

care

and

-LRB-

c

-RRB-

hospital

care

-LRB-

Fig.

-RRB-

Table

displays

the

main

elements

of

LEA

decree

and

of

the

other

benefit-defining

laws

and

decrees

currently

in

force

in

Italy

The

present

contribution

focuses

on

curative

services.Fig

DPCM

November

Definition

of

national

standards

of

care

-LRB-

LEAs

-RRB-

MoH

Ministry

of

HealthTable

Benefit-defining

laws/decrees

and

catalogues

for

curative

care

services

in

Italy

-LRB-

LEAs

DPCM

November

Definition

of

Essential

Levels

of

Care

Specialist

DM

July

Specialist

outpatient

services

NPF

National

Pharmaceutical

Formulary

Prostheses

DM

Prosthetic

devices

tariffs

and

provision

modalities

Rehab

Guidelines

on

Rehabilitative

Care

adopted

on

May

Primary

National

Contract

for

Primary

Care

-RRB-

LEAsSpecialistNPFaProsthesesaRehabaPrimaryInpatient

curative

care

Day

cases

curative

care

Primary

care

Outpatient

dental

care

Specialist

outpatient

care

Alternative

medicine

Rehabilitative

care

Long-term

nursing

care

Clinical

laboratory

Emergency

rescue

Pharmaceuticals

Therapeutic

devices

Prevention

and

public

health

services

Legal

statusLegislative

decreeMinistry

DecreeAgency

administrative

actLegislative

decreeLawPresidential

decreeDecision

makerPermanent

State-Regions

Conference

MoHMinistry

of

HealthNational

Drug

AgencyMinistry

of

HealthMinistry

of

healthMinistry

of

health

Trade-Unions

of

GPsOriginal

purposeEntitlementsFee-schedulePositive

listFee-scheduleGuidelinesEntitlementsPositive/negative

definition

of

benefitsP

and

NPPPPPDegree

of

itemized

goods

procedures

only

linked

to

indicationsVaries

by

area

of

careProcedures

sometimes

linked

to

indicationsGoods

for

certain

categories

specific

indications

-LRB-

prescription

notes

-RRB-

GoodsNoPartiallyUpdatingForeseenNo

at

national

level

regular

at

regional

levelRegularly

-LRB-

annually

-RRB-

No

-LRB-

foreseen

-RRB-

NoEvery

yearsCriteria

Need

Costs

Effectiveness

Cost-effectiveness

Budget

Appropriateness

aThese

sections

-LRB-

noncurative

care

services

-RRB-

are

not

discussed

in

detail

in

the

present

all

necessary

areas

of

care

items

The

decree

also

defined

a

system

for

monitoring

LEA

implementation

across

the

country

Responsibility

for

this

was

assigned

to

a

special

technical

body

established

in

April

and

composed

of

representatives

of

the

Ministry

of

Health

the

Treasury

and

the

regional

governments

The

main

objective

of

the

commission

is

to

monitor

and

evaluate

the

actual

provision

of

services

included

in

the

LEAs

and

their

costs

In

a

new

technical

body

-LRB-

the

National

LEA

Commission

-RRB-

was

established

to

update

LEAs

on

the

basis

of

scientific

technological

and

economic

evidence

-LRB-

Ministry

decree

of

February

-RRB-

The

Commission

is

set

up

of

members

experts

of

healthcare

management

planning

and

organizational

sciences

are

nominated

by

the

Ministry

of

Health

are

regional

representatives

and

one

is

appointed

by

the

Treasury

Services

of

curative

care

in

the

health

benefit

basket

Inpatient

curative

care

Traditionally

the

services

to

be

provided

in

hospital

settings

were

never

explicitly

defined

by

the

INHS

It

has

been

rather

implicitly

recognized

that

all

types

of

services

deemed

to

be

appropriately

delivered

at

hospital

level

must

be

available

to

citizens

The

LEA

decree

defines

seven

chapters

as

broad

categories

of

services

to

be

delivered

in

the

hospital

-LRB-

a

-RRB-

emergency

services

-LRB-

b

-RRB-

ordinary

admissions

-LRB-

including

rehabilitative

and

long-term

inpatient

care

-RRB-

-LRB-

c

-RRB-

day

hospital

-LRB-

d

-RRB-

day

surgery

-LRB-

e

-RRB-

curative

home-care

-LRB-

f

-RRB-

collection

diffusion

control

of

blood-components

and

transfusion

services

and

-LRB-

g

-RRB-

organ

and

tissue

transplantation

services

In

addition

it

is

explicitly

recognized

that

some

benefits

are

available

in

hospitals

although

not

included

in

the

positive

list

of

outpatient

services

provided

under

public

coverage

-LRB-

e.g.

certain

pharmaceuticals

or

diagnostic

tests

-RRB-

While

the

detailed

spectrum

of

services

to

be

provided

by

the

hospitals

is

not

explicitly

defined

national

and

regional

fee-schedules

regulate

their

funding

Since

January

Italian

hospitals

have

been

financed

mainly

according

to

nationally

predetermined

rates

based

on

classification

into

diagnosis-related

groups

-LRB-

DRGs

-RRB-

-LSB-

-RSB-

Regions

are

free

to

modify

the

rates

according

to

their

own

standards

but

must

take

the

national

rate

as

the

maximum

level

-LSB-

-RSB-

To

a

certain

extent

DRG

lists

may

be

interpreted

as

the

catalogue

of

hospital

services

and

benefits

covered

by

the

INHS

This

interpretation

however

should

be

done

with

some

caution

DRGs

are

divided

in

two

major

groups

surgical

and

medical

The

interventions

to

which

surgical

DRGs

refer

are

expected

to

be

offered

and

funded

Therefore

surgical

DRGs

define

a

sort

of

list

of

services

available

to

patients

For

medical

DRGs

the

situation

is

different

as

the

classification

includes

all

possible

diagnoses

including

those

for

which

hospital

admissions

may

not

been

appropriate

Therefore

medical

DRGs

do

not

define

a

list

of

services

to

be

guaranteed

but

rather

economic

constraints

according

to

which

providers

act

Thus

although

implicitly

the

tariff

values

assigned

to

DRGs

influence

the

specific

content

of

the

services

provided

in

each

diagnosis

category

In

Italy

as

well

as

in

other

countries

determining

tariffs

for

specific

diagnosis

and

treatments

is

seen

as

detrimental

to

the

adoption

of

innovative

technologies

Fixed

and

outdated

tariffs

may

discourage

the

adoption

of

new

expensive

technologies

and

may

force

hospitals

to

look

for

alternative

source

of

funding

often

resulting

in

wide

disparities

of

their

availability

to

citizen

Regional

authorities

may

react

to

the

deficiencies

in

national

policy

with

a

variety

of

measures

as

it

is

illustrated

in

the

case

of

Drug

Eluting

Stents

-LRB-

DES

-RRB-

Since

their

introduction

into

the

European

market

in

DES

have

been

gradually

implemented

in

clinical

practice

in

Italy

mainly

by

hospitals

in

the

north

of

the

country

Several

position

papers

and

recommendations

have

been

provided

by

scientific

societies

-LRB-

e.g.

Italian

Group

for

Heamodynamics

Studies

GISE

-RRB-

study

groups

local

committees

-LRB-

e.g.

Emilia-Romagna

Cardiology-Cardiosurgery

Committee

-RRB-

in

order

to

guide

the

adoption

of

DES

Early

updating

of

reimbursement

policies

has

been

advocated

by

Italian

cardiologists

hospital

administrators

and

patients

to

allow

this

technology

to

be

economically

sustainable

by

the

hospitals

-LSB-

-RSB-

Faced

with

continuously

growing

clinical

and

economic

evidence

some

regional

authorities

started

to

adopt

different

policy

measures

-LSB-

-RSB-

In

the

Lombardy

Region

revolutionized

its

DRG

classification

by

creating

three

new

DRGs

to

cover

stent

reimbursement

and

to

encourage

utilization

Other

regions

-LRB-

Emilia

Romagna

Lazio

Marche

Puglia

-RRB-

allowed

for

particular

DRG

tariff

increase

while

the

Campania

Region

established

a

special

regional

fund

for

DES

reimbursement

In

addition

Emilia-Romagna

and

recently

Sicily

established

a

regional

registry

to

monitor

the

rate

of

adoption

of

the

new

technology

and

its

effectiveness

in

real-life

conditions

The

final

aim

is

to

identify

the

target

populations

for

which

the

new

technology

would

be

most

beneficial

Most

of

the

regions

still

have

not

updated

in

any

way

their

reimbursement

policies

thus

limiting

to

certain

extent

the

diffusion

of

the

device

on

their

territory

The

example

on

DES

illustrates

the

existence

of

wide

variations

across

the

regions

concerning

how

to

fund

innovative

technologies

Similar

situations

may

be

found

in

other

sectors

of

health

care

However

the

issue

is

not

that

simple

when

we

consider

that

one

of

the

fundamental

rights

of

Italian

citizens

is

the

freedom

of

choice

of

provider

and

place

of

care

-LSB-

-RSB-

making

regions

responsible

for

the

cost

of

treatment

provided

to

their

residents

in

other

regions

Day

cases

of

curative

care

Services

available

in

day

hospital

regime

are

defined

as

diagnostic

rehabilitation

and

curative

care

delivered

as

alternative

to

ordinary

hospitalization

when

the

services

to

be

provided

require

due

to

their

nature

or

complexity

of

provision

medical

or/and

nurse

continuous

assistance

not

available

in

the

outpatient

-LRB-

ambulatory

-RRB-

setting

-LRB-

Presidential

decree

October

-RRB-

Regarding

inpatient

care

services

available

in

day

hospital

are

not

explicitly

defined

but

rather

there

are

specific

criteria

for

the

service

to

be

considered

appropriately

delivered

in

this

regime

Guidelines

are

defined

at

national

level

and

they

refer

mostly

to

organizational

aspects

of

services

provision

rather

than

their

specific

types

-LRB-

i.e.

number

of

beds

assigned

for

day

hospital

services

must

be

at

least

of

the

total

-RRB-

The

situation

is

very

similar

as

regards

day

surgery

care

National

guidelines

provide

a

list

of

possible

interventions

that

may

be

performed

in

day

care

setting

as

an

alternative

to

normal

hospital

care

The

list

includes

about

interventions

itemized

by

service

delivered

and

grouped

according

to

the

organ

or

system

of

organs

they

refer

to

-LRB-

e.g.

respiratory

system

interventions

cardiovascular

system

interventions

-RRB-

Outpatient

curative

care

primary

care

All

patients

in

Italy

are

registered

with

a

general

practitioner

-LRB-

GP

-RRB-

or

a

pediatrician

who

is

in

charge

for

providing

most

primary

care

referring

to

specialists

and

prescribing

diagnostic

interventions

and

drugs

The

citizen

's

can

freely

choose

his

or

her

own

GP

given

the

limit

of

maximum

number

of

enrolled

patients

Primary

care

services

provided

by

GPs

are

outlined

broadly

in

the

National

Contract

for

General

Practitioners

which

is

the

most

important

document

regulating

various

aspect

of

primary

care

The

National

Contract

is

a

result

of

negotiations

between

the

government

and

representatives

of

general

practitioners

organized

in

various

trade

unions

Once

reached

the

content

of

the

National

Contract

is

legislated

through

a

Decree

approved

by

the

Ministry

of

Health

-LRB-

i.e.

the

agreement

is

a

binding

by

law

-RRB-

Regions

are

autonomous

in

establishing

further

agreements

-LRB-

Accordi

Integrativi

Regionali

-RRB-

aimed

mainly

at

identifying

the

most

appropriate

organizational

arrangements

for

the

provision

of

services

set

at

national

level

The

regional

agreements

may

define

additional

services

to

be

provided

in

primary

care

The

categories

of

services

that

primary

care

physicians

are

obliged

to

provide

under

the

National

Contract

are

defined

broadly

as

-LRB-

a

-RRB-

essential

services

acute

and

chronic

disease

management

in

line

with

best

practice

indications

and

in

agreement

with

the

patient

-LRB-

b

-RRB-

health

promotion

activities

-LRB-

c

-RRB-

patient

management

within

programmed

and

integrative

domiciliary

care

coordinated

with

providers

of

specialist

and

rehabilitative

care

services

and

-LRB-

d

-RRB-

community

services

defined

on

the

basis

of

regional

agreements

The

National

Contract

also

encourages

various

forms

of

integration

between

primary

care

physicians

and

district

services

such

as

social

and

home

care

Additionally

the

National

Contract

obliges

Local

Health

Units

to

guarantee

continuity

of

care

i.e.

primary

care

services

h

a

day

days

a

week

Organizational

arrangements

are

decided

at

regional

level

Outpatient

dental

care

Public

coverage

of

dental

care

services

has

always

been

a

debated

issue

in

the

Italian

NHS

Current

legislation

explicitly

excludes

almost

all

types

of

dental

services

from

the

nationally

defined

benefit

package

Some

limited

care

is

available

to

special

groups

of

patients

defined

according

to

age

and

to

specific

clinical

conditions

This

explicit

and

rather

broad

exclusion

of

dental

care

services

at

national

level

had

an

impact

on

regional

health

policies

Numerous

regions

have

adopted

measures

to

guarantee

some

types

of

dental

care

services

to

citizens

An

example

of

regionally

defined

benefit

catalogue

for

dental

care

services

is

that

in

Veneto

region

defined

by

Regional

decree

The

regional

decree

defines

the

list

of

services

available

free

of

charge

or

subject

to

copayment

for

special

patient

categories

The

list

of

services

is

available

under

set

conditions

only

for

the

residents

of

Veneto

Region

while

nonresidents

are

fully

charged

Beneficiaries

are

identified

according

to

age

income

employment

status

and

presence

of

specific

disease

criteria

-LRB-

a

-RRB-

dental

health

care

in

developmental

age

-LRB-

years

-RRB-

preventive

diagnostic

and

curative

services

for

patients

under

the

age

of

years

orthodontic

care

for

patients

under

the

age

of

nonsurgical

treatment

of

paradental

pathology

for

patients

under

age

-LRB-

b

-RRB-

dental

and

prosthetic

care

to

very

low-income

residents

-LRB-

per

year

-RRB-

affected

by

chronic

-LRB-

e.g.

cardiac

insufficiency

psychosis

-RRB-

and

rare

-LRB-

e.g.

metabolic

diseases

immunodeficiency

-RRB-

conditions

and

-LRB-

c

-RRB-

specialist

curative

care

-LRB-

excluding

prosthetics

-RRB-

for

anthalgic

emergency

cases

caused

by

infections

of

caries

and

of

paradental

pathologies

of

traumatic

events

Specialized

outpatient

care

Specialized

ambulatory

services

including

specialist

visits

diagnostic

and

curative

interventions

are

provided

either

by

LHUs

or

by

accredited

public

and

private

facilities

Patients

are

allowed

to

access

specialist

care

only

after

approval

by

their

general

practitioner

who

is

responsible

for

the

referral

Once

the

general

practitioner

has

authorized

the

visit

or

the

procedure

the

patient

is

free

to

choose

any

provider

among

those

accredited

by

the

NHS

anywhere

in

Italy

A

list

of

outpatient

services

including

diagnostic

procedures

specialist

visits

and

laboratory

tests

was

drawn

up

in

and

its

original

purpose

was

to

define

reimbursement

fees

of

providers

Since

then

the

national

list

of

services

has

not

been

updated

However

regional

authorities

have

often

revised

their

fee

schedules

The

main

criteria

including

services

are

effectiveness

-LRB-

based

on

solid

scientific

evidence

-RRB-

and

costs

The

benefits

are

classified

in

three

different

sections

-LRB-

a

-RRB-

specialist

outpatient

care

-LRB-

including

clinical

laboratory

and

diagnostic

imaging

-RRB-

provided

under

INHS

coverage

-LRB-

a

positive

list

of

services

explicitly

defined

and

enumerated

mainly

without

specific

link

to

clinical

conditions

-RRB-

-LRB-

b

-RRB-

specialist

services

available

only

for

specific

indications

-LRB-

positive

list

of

services

limited

to

special

patient

categories

-RRB-

and

-LRB-

c

-RRB-

specialist

outpatient

care

not

covered

by

the

INHS

-LRB-

negative

list

-RRB-

Regions

are

free

to

deliver

additional

services

for

which

they

are

financially

responsible

These

services

should

be

marked

separately

in

the

fee

schedule

and

added

to

the

list

in

accordance

with

the

coding

system

in

place

The

positive

list

of

specialist

outpatient

services

is

itemized

by

service

delivered

The

items

-LRB-

approx.

-RRB-

are

grouped

into

categories

on

the

basis

of

system

of

organs

the

intervention

refers

to

-LRB-

e.g.

respiratory

system

interventions

-RRB-

Each

category

is

further

divided

according

to

the

specific

organ

-LRB-

e.g.

trachea

and

larynges

interventions

-RRB-

Finally

each

subcategory

contains

a

list

of

specific

services

-LRB-

e.g.

laryngoscope

-RRB-

Some

services

in

the

positive

list

are

limited

to

special

settings

-LRB-

e.g.

where

special

equipments

are

available

-RRB-

Services

that

are

available

only

to

special

patients

categories

-LRB-

i.e.

limited

for

specific

clinical

conditions

-RRB-

include

about

items

mainly

laboratory

and

diagnostic

examinations

that

are

very

costly

-LRB-

e.g.

positron

emission

tomography

-RRB-

or

in

some

way

controversial

-LRB-

palliative

pain

treatments

-RRB-

All

other

outpatient

curative

care

Numerous

services

of

physiotherapy

are

excluded

from

the

national

benefit

package

Many

regions

however

have

approved

their

inclusion

in

the

regional

benefits

so

to

generate

substantial

variability

across

the

country

Lombardy

for

example

includes

all

services

listed

on

the

national

negative

list

while

Veneto

and

Friuli

Venezia

Giulia

authorize

water

rehabilitation

Almost

all

regions

provide

anthalgic

electrotherapy

ultrasound

therapy

mesotherapy

and

laser

therapy

The

national

benefit

package

explicitly

excludes

all

types

of

alternative

and

complementary

medicine

leaving

it

to

the

regions

to

decide

whether

to

provide

some

of

these

services

to

their

citizens

Only

of

the

regions

have

invested

in

this

category

of

services

-LRB-

a

-RRB-

acupuncture

is

available

in

Piedmont

Valle

d'Aosta

Umbria

and

Tuscany

-LRB-

b

-RRB-

homeopathy

is

available

in

Valle

d'Aosta

-LRB-

limited

to

specific

clinical

conditions

-RRB-

and

-LRB-

c

-RRB-

chiropractic

services

are

available

in

Valle

d'Aosta

only

for

spinal

cord

pathologies

Spa

treatment

is

available

for

a

limited

number

of

pathologies

identified

as

those

for

which

thermal

treatment

may

provide

actual

benefits

-LRB-

based

on

scientific

evidence

-RRB-

The

list

of

pathologies

is

explicitly

defined

in

a

Ministry

decree

-LRB-

-RRB-

and

includes

rheumatic

diseases

-LRB-

e.g.

osteoarthrosis

and

other

degenerative

forms

extrajoint

rheumatisms

-RRB-

respiratory

diseases

-LRB-

e.g.

chronic

pulmonary

diseases

-RRB-

and

dermatological

diseases

-LRB-

e.g.

psoriasis

-RRB-

Discussion

Almost

year

since

its

inception

the

Italian

NHS

has

an

explicit

system

of

national

services

guaranteed

to

all

its

citizens

The

concept

of

providing

a

limited

set

of

services

under

the

INHS

is

now

well

established

Entitlements

to

services

in

particular

areas

-LRB-

mainly

outpatient

care

-RRB-

are

now

clearly

defined

and

some

services

-LRB-

e.g.

dental

and

thermal

care

-RRB-

are

explicitly

excluded

In

the

area

of

hospital

care

entitlements

remain

broad

and

general

although

a

strong

reference

to

appropriateness

criteria

and

the

use

of

DRGs

contribute

to

make

benefits

more

explicit

in

this

setting

as

well

As

in

other

countries

in

Italy

a

clear

definition

of

the

benefits

provided

by

the

statutory

system

is

thought

to

be

beneficial

for

several

reasons

it

can

contribute

to

a

better

allocation

of

resources

help

to

reassure

patients

about

their

rights

and

responsibilities

and

facilitate

the

development

of

supplementary

insurance

-LSB-

-RSB-

In

addition

the

definition

of

the

health

benefit

package

in

Italy

is

also

an

essential

element

in

the

relationship

between

the

central

government

and

the

regions

The

system

of

LEAs

is

the

means

to

keep

management

and

policy

powers

at

regional

level

while

assuring

national

guarantees

In

this

sense

the

basic

package

is

primarily

a

policy

devise

to

keep

regions

accountable

to

national

standards

A

constitutional

reform

aimed

at

a

new

redistribution

of

powers

between

the

central

and

regional

authorities

is

presently

under

parliamentary

discussion

This

specifies

that

powers

on

health

matters

are

exclusively

in

the

hands

of

regions

provided

that

national

principles

are

respected

If

this

reform

is

approved

the

basic

package

would

gain

even

more

importance

Therefore

we

foresee

the

need

for

substantial

investments

to

further

specify

the

content

of

the

package

and

more

importantly

to

develop

adequate

monitoring

systems

and

accountability

procedures

In

our

opinion

two

issues

are

particularly

critical

in

this

respect

First

the

coherence

between

benefits

and

resources

made

available

requires

an

adequate

governance

system

At

present

Italy

does

not

have

a

higher

Chamber

-LRB-

it

may

be

introduced

in

the

Constitution

reform

under

discussion

-RRB-

in

which

regions

are

represented

and

where

negotiations

between

them

and

the

central

government

can

take

place

within

an

appropriate

institutional

framework

At

present

the

devolution

process

lacks

adequate

rules

to

govern

negotiations

and

conflicts

The

risk

of

institutional

conflicts

endless

negotiations

legal

disputes

and

lack

of

coordination

is

very

real

and

hitherto

affects

mainly

the

health

care

sector

It

should

be

clear

that

without

adequate

governance

mechanisms

conflicts

between

the

two

central

and

regional

authorities

and

between

the

regions

themselves

may

result

in

further

acceleration

of

the

fragmentation

of

the

INHS

The

second

issue

concerns

an

adequate

infrastructure

to

sustain

the

national

government

as

guarantor

of

health

care

rights

Without

an

appropriate

information

system

and

new

jurisdictional

powers

the

national

tier

can

not

ensure

its

guarantor

role

To

implement

effective

national

guarantees

the

central

government

needs

to

develop

the

benefit

package

to

implement

an

effective

monitoring

system

and

to

design

appropriate

rules

to

force

regions

to

act

adequately

On

the

other

hand

these

conditions

are

also

needed

to

ensure

that

resources

available

to

the

regions

are

compatible

with

the

cost

of

the

provision

of

services

included

in

the

benefit

package

-LSB-

-RSB-

It

has

been

suggested

that

LEAs

serve

two

main

policy

goals

equality

and

cost-containment

-LSB-

-RSB-

An

explicit

definition

of

the

guarantees

provided

Italians

is

a

major

mechanism

to

promote

equality

in

the

access

of

care

while

limiting

coverage

may

be

a

strong

tool

to

contain

costs

In

theory

the

two

objectives

are

compatible

as

explicitness

of

coverage

can

coexist

with

a

different

extent

of

the

benefit

package

In

practice

however

LEAs

may

results

in

an

overall

system

to

defend

the

basic

principle

of

the

INHS

from

the

risk

of

poor

funding

Should

radical

policies

aimed

at

reducing

the

ambitious

goals

of

the

INHS

prevail

LEAs

may

become

the

main

pillar

of

the

system

A

few

reflections

can

be

made

about

the

criteria

adopted

in

Italy

to

build

the

benefit

package

Effectiveness

-LRB-

in

most

cases

efficacy

-RRB-

as

confirmed

by

scientific

evidence

is

the

dominant

criterion

in

defining

the

package

Need

criteria

have

been

also

used

ailments

for

minor

conditions

-LRB-

cough

sore

throat

minor

headache

-RRB-

cosmetic

surgery

and

ritual

circumcisions

-RRB-

are

excluded

on

the

basis

of

various

interpretations

of

the

need

criteria

In

general

clinical

and

organizational

appropriateness

is

promoted

as

well

As

the

former

requires

that

treatments

and

procedures

are

applied

only

to

patients

with

particular

clinical

conditions

the

latter

tries

to

assure

that

patients

are

treated

in

the

most

adequate

-LRB-

and

often

cheapest

-RRB-

setting

Overall

the

use

of

appropriateness

criteria

suggests

that

benefit

catalogues

should

be

made

of

detailed

lists

of

services

for

particular

clinical

conditions

rather

than

simple

lists

of

services

O O O O O O O O B O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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Pneumomediastinum in the neonatal and paediatric intensive care unit The incidence , aetiology and pathophysiology of pneumomediastinum -LRB- PM -RRB- , an uncommon and potentially serious disease in neonates and children , were evaluated . A retrospective chart review of all patients diagnosed with PM who were hospitalised in the intensive care unit of the University Children 's Hospital Zürich , Switzerland , from 2000 to 2006 , was preformed . We analysed the incidence , severity and causes of PM and investigated the possible differences between neonatal and non-neonatal cases . Seven children and nine neonates were identified with PM . All patients had a good outcome . Six cases of PM in the group of children older than 4 weeks were deemed to be caused by trauma , infection and sports , whereas one case was idiopathic . All nine neonatal cases presented with symptoms of respiratory distress . We were able to attribute four cases of neonatal PM to pulmonary infection , immature lungs and ventilatory support . Five neonatal cases remained unexplained after careful review of the hospital records . In conclusion , PM in children and neonates has a good prognosis . Mostly , it is associated with extrapulmonary air at other sites . It is diagnosed by chest X-ray alone . We identified mechanical events leading to the airway rupture in most children > 4 weeks of life , whereas we were unable to identify a cause in half of the neonates studied -LRB- idiopathic PM -RRB- . Introduction Pneumomediastinum -LRB- PM -RRB- is defined as a mediastinal air leak . The experimental works of Macklin and Macklin provided insights into its pathophysiology -LSB- 4 , 5 -RSB- ; alveolar rupture occurs because of a pressure gradient between the alveolus and the surrounding tissues . This gradient develops either through overinflation of the alveolus or a reduction of interstitial pressure . The air that subsequently leaks into the interstitial tissue diffuses toward the peribronchial and perivascular tissue , and then towards the mediastinum , the neck and into the subcutaneous tissue . However , due to pressure equalisation between the affected and adjacent alveoli in the lungs , the interalveolar walls remain intact and the lungs inflated . The diagnosis of PM is confirmed by frontal chest roentgenogram , including the cervical region . Typical radiological signs of PM include the continuous diaphragm sign -LRB- interposition of air between the pericardium and the diaphragm , which becomes visible in the central mediastinal part -RRB- and linear bands of mediastinal air parallelling the left side of the heart and the descending aorta -LRB- pleura is shown as a fine opaque line -RRB- with extension superiorly along the great vessels into the neck . In infants , the `` spinnaker sign '' -LRB- an upwards and outwards deviation of thymic lobes -RRB- can be seen when the thymus is raised above the heart by pneumomediastinal air that elevates the thymus and separates it from the cardiac silhouette beneath -LSB- 2 -RSB- . Various causes of PM are found in the literature , such as airway obstruction -LRB- e.g. foreign body aspiration -RRB- , iatrogenic -LRB- e.g. mechanical ventilation -RRB- , infections -LRB- e.g. pneumonia -RRB- , obstructive lung disease -LRB- e.g. asthma -RRB- , toxic effects -LRB- e.g. smoking -RRB- , trauma -LRB- e.g. chest trauma -RRB- , Valsalva manoeuvres -LRB- e.g. vomiting -RRB- and the weakness of tissue -LRB- e.g. anorexia nervosa -RRB- . In spontaneous PM , the underlying lung is healthy and the air leak is thought to be atraumatic -LSB- 3 -RSB- . In neonates , known predisposing factors are mixed lung diseases , such as pneumonia or meconium aspiration syndrome , with coexisting atelectasis and airway obstruction -LSB- 1 -RSB- . However , only scarce literature is found about neonates with PM . In this study , we retrospectively analysed the incidence , severity and causalities of PM in neonates and children > 4 weeks of life admitted to our intensive care unit , and we investigated the possible differences between the groups . Material and methods We retrospectively reviewed all records of children diagnosed with PM who were hospitalised in the interdisciplinary neonatal and paediatric intensive care unit of the University Children 's Hospital in Zürich , Switzerland , between January 2000 and September 2006 . The patients were divided into two groups according to their age : neonates -LRB- under 4 weeks of age -RRB- and children -LRB- over 4 weeks of age -RRB- . We were interested in the causes of PM as documented by the treating physicians , the types and results of radiologic investigations performed , any invasive interventions used to treat PM , the severity of the PM and the length of stay in the intensive care unit . Results About 1,200 children are admitted to our intensive care unit per year . The incidence of PM in our intensive care unit was 0.08 % for children > 4 weeks of age and 0.1 % for neonates . In all patients , PM was diagnosed by chest X-ray and all had a positive outcome related to the PM . All five patients with pneumopericardium -LRB- PP -RRB- did not suffer from any complications -LRB- e.g. pericardial tamponade -RRB- . Seven children were > 4 weeks of age -LRB- Table 1 -RRB- . Their mean age was 7.1 years -LRB- range 1.3 -- 15.8 years -RRB- . In addition to PM , two children of this group had subcutaneous emphysema -LRB- SE -RRB- , two a pneumothorax -LRB- PT -RRB- and two a PP . Different causes were found for the air trapping . There were two traumatic aetiologies -LRB- rib fracture after a severe car accident , lesion in the hypopharynx after a fall -RRB- . Two children were diagnosed with obstructive bronchitis and in one child , barotrauma occurred intraoperatively due to a clamped expiratory tube during mechanical ventilation -LRB- Fig. 1 -RRB- . One child had exercised vigorously three days before hospitalisation , which may have caused the PM . In one adolescent , PM occurred spontaneously . All children were hospitalised in the intensive care unit for one to seven days , depending on the severity of their underlying disease . Only two children required pleural drainage and intubation . All other children were treated for their underlying conditions and received oxygen therapy . Diagnostics for the PM other than chest X-rays were performed in four patients . All of these had received a thoracic CT scan . In one child , who also had a huge subcutaneous emphysema and dysphagia , the reason for the air trapping could only be found by means of a laryngotracheoscopy , which showed a traumatic lesion in the hypopharynx . The patient 's history revealed that she had fallen onto a piece of wood by her neck . Table 1Results for the group of children > 4 weeks of lifeAir leakAetiologyAge -LRB- years -RRB- Intubation -LRB- after diagnosis -RRB- Pleural drainageDiagnostic testsDays in ICUPM , PP , SESpontaneous/3 days earlier intensive sport15 .8 NoNoChest X-ray 3 × 2PM , PTTraumatic7 .53 daysYesCT/chest X-ray 3 × 5PM , SE Traumatic -LRB- lesion in hypopharynx -RRB- 1.3 NoNoCT/chest X-ray 3 × , oesophagogram with contrast medium , laryngotracheoscopy4PM , PPIatrogenic : equipment failure with barotrauma during mechanical ventilation2 .3 NoNoChest X-ray 2 × 2PMSpontaneous15 .4 NoNoChest X-ray/CT1PM Obstructive bronchitis5 .6 NoNoChest X-ray 2 × / CT2PM , PTObstructive bronchitis1 .97 daysYesChest X-ray 7 × 7Fig . 1Pneumomediastinum -LRB- PM -RRB- , subcutaneous emphysema -LRB- SE -RRB- and pneumopericardium -LRB- PP -RRB- in a 2-year-old intubated patient The group of children older than 4 weeks stayed in the intensive care unit for a mean of 3.2 days -LRB- range 1 -- 7 days -RRB- , depending on the severity of the PM and the underlying disease . Compared to the neonatal group , the length of stay in the intensive care unit was shorter . However , most neonates stayed in the intensive care unit longer , primarily because of comorbid conditions and not because of the PM . We found nine neonates who were diagnosed with PM -LRB- Table 2 -RRB- ; two premature and seven term infants , all of whom presented with signs of respiratory distress . Three neonates were also diagnosed with a PP , one with SE and five with a PT . Birth weight ranged from 2,150 g to 4,140 g -LRB- mean 3,340 g -RRB- . Five children were born vaginally and four by caesarean section . All children were vigorous at birth and none required resuscitation with bag mask ventilation or surfactant . Before arriving in the intensive care unit , where the diagnosis of PM was confirmed by chest X-ray , two infants had received ventilatory support by CPAP and one of the premature infants had to be intubated for respiratory failure . During hospitalisation in the intensive care unit , two children deteriorated and required mechanical ventilation for three and four days , respectively , and two other children needed CPAP for a few hours . Only one child received pleural drainage . All children received oxygen therapy and specific therapy for their underlying disease . The age at admission to the intensive care unit ranged from a few hours to four days . One neonate was admitted to the intensive care unit due to convulsions and developed a PM on day six of life . The treating physicians felt that the PM may have been associated with a Valsalva manoeuvre , which occurred during the seizure . Other causes of PM were a pulmonary infection due to maternal infection and a possible barotrauma due to peak inspiratory pressure of 25 cm H2O in a mechanically ventilated premature neonate . Two newborns had PM related to CPAP and four neonates were diagnosed with spontaneous PM . Neonates stayed in the intensive care unit for 3 -- 13 days -LRB- mean 5.6 days -RRB- , depending on the severity of the underlying diseases . Table 2Results for the group of neonatesAir leakAetiologyBirth weightGestational age -LRB- weeks -RRB- Mode of deliveryMechanical ventilation before diagnosisDuration of ventilatory support after diagnosisPleural drainageDays in ICUPMSpontaneous4 ,140 g40 0/7VaginalNoNoNo4PM , PP , SEPremature lungs , barotrauma2 ,150 g34 4/7Caesarian section Pip max . 25 cm H203 days -LRB- intubation -RRB- No4PM , PT , PPPremature lungs , spontaneous or CPAP2 ,480 g35 6/7VaginalCPAP4 days -LRB- intubation -RRB- Yes6PM , PTSpontaneous3 ,485 g38 1/7Caesarian sectionNoNoNo3PM , PTSpontaneous3 ,440 g37 5/7VaginalNo6 hours -LRB- CPAP -RRB- No3PM , PPSpontaneous2 ,830 g39 1/7Caesarian sectionNoNoNo13PM , PTSpontaneous3 ,970 g38 5/7Caesarian sectionNoNoNo9PM , PTPulmonary infection due to maternal infection3 ,440 g38 5/7VaginalCPAP1 day -LRB- CPAP -RRB- No5PMConvulsions or spontaneous4 ,130 g40 5/7VaginalNoNoNo4 Discussion All children with PM had a good outcome without any complications due to air trapping . In the group of children older than 4 weeks , only two children developed a respiratory insufficiency , leading to mechanical ventilation . In both of them , respiratory failure was related to their underlying condition -LRB- polytrauma with haematothorax and severe obstructive bronchitis , respectively -RRB- . These were also the children who stayed longest in the intensive care unit . All other children were treated with oxygen only and stayed in the intensive care unit until they improved clinically and radiographically . Regarding radiologic diagnostics , four patients of the group of children > 4 weeks of life had CT scans -LRB- three of them had been done in outside clinics from where the patients had been admitted to our intensive care unit -RRB- . Retrospectively , the utility of the CT scans was put into question , as these scans did not change the patient management . The only patient in whom the CT scan changed management was the child with polytrauma . In this patient , other intrathoracic injuries needed to be ruled out . In the group of neonates , it was much more difficult to find the aetiology of the PM , since all neonates had presented with respiratory disease , and radiologic investigations were partially performed only after the use of CPAP or tracheal intubation . Five of the nine neonates had a spontaneous PM without risk factors , such as mechanical respiratory support -LRB- bag mask ventilation after birth , CPAP , mechanical ventilation -RRB- or restrictive lung disease . Three of these five babies were delivered by caesarean section . In the remaining four newborns , possible mechanical incidents leading to the air leak could be revealed : mechanical ventilation with high inspiratory pressure , CPAP , pulmonary infection and convulsion . Further investigations are needed to find the aetiology of spontaneous PM in healthy , term neonates . In conclusion , PM in children and neonates has a good prognosis . Mostly , it is associated with extrapulmonary air at other sites . It is diagnosed by chest X-ray alone . Whereas in older children mechanical events leading to the airway rupture can be revealed in most cases , about half of the neonates in our series suffered from PM without obvious reason .

B O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O

pneumomediastinum
pneumopericardium
subcutaneous emphysema
air leak