3. Dezember 2008 , Frankfurt

L'Auberge Del Mar, Del Mar, California, USA; May 22th. 2012

Guenter Kirste, MD

Financing of Organ Donation

and Transplantation

Models of Health Care Funding

Funding Health care provider

Private

(insurance system

private

Risk adjusted

private

Bismarck Modell public

Mix of public/private

public

some private

Beveridge Modell

National health system

public

taxes

public

Semashko Modell government

taxes

government

Classification of social security in the EU

Bismark System Beveridge System Semashko System

• contribute balanced

by salary and wages

• principle of payment

in kind and

cost-refunds

• option for additional

insurance

• state budget /

tax factoring

• payment of kind

provided by national

health offerer

• option for additional

insurance

• state budget

• payment of kind

provided by national

health offerer

• no further insurance

possible

Classification of social security in the EU

Amenable mortality

Total expenditure on health

Public expenditure on health

EU vs. member state responsibility

Art. 152 (5) EGV / 168 AEUV:

„…responsibility remains of the single member state ….!?“ Mitgliedstaaten für die

EU Agenda* for

heathcare

R&D , reforming

information transfer

Control of epidemics

HIV prevention

Pandemia planning

Improving health

conditions

e.g.German

responsibility

Gesundheitsfonds

Praxisgebühr

DRGs

EBM

PKV

Composite-

responsibility

Pharmaceutical approval and research

R&D rare disease

* 2003 – 2008: EU financing the topic with 353 Mio. Euro

Is there a European Approach?:

Article 168 TFEU

(ex Article 152 TEC)

4. By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:

(a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures;

7. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them. The measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood.

Regulations on Transplantation

EU-Directive

Transplantationsgesetz (TPG)

TPG 1997 German Bundestag,

aims:

• Predictability of legal decisions

• Assignment of transplant-

medicine in patient care

• Increase organ donation

• transparency

• prevention of organ trade

Task control according to TPG

Transplant centers

waiting lists

organ harvesting

organ transplantation

Allocation

Stiftung

Eurotransplant Leiden

/ The Netherlands

Coordination of

organ donation

Deutsche Stiftung

Organtransplantation

since June 2000

DSO

Bundesärztekammer

Eurotransplant Transplantationszentren Deutsche Stiftung Organstransplantation

Verband der Angestellten- Krankenkassen (VdAK)

Deutsche Krankenhausgesellschaft

Organ Donation in Germany

Bundesministerium für Gesundheit

Ständige Kommission der BÄK

Prüfkommission nach § 12 TPG Überwachungskommission nach § 11 TPG

Wissenschaftsministerien Spenderkrankenhäuser

Sozialministerien d. L.

7 Spitzenverbände der Krankenkassen

18 Landesärzte -Kammern

16 Landeskrankenhausgesellschaften

Gemeinschafts- aufgabe

Organspende

Regierungspräsidien

Finances in Organ Donation and Transplantation

Health

insurance

company

of the

organ-

recipient

Lump sum

per Tx

registration

-lump sum

organ removal

(DSO)

§ 11 TPG

DRGs

donor-hospital

organ allocation

(ET)

§ 12 TPG

refund

organ

transplantation

(TPZ)

§ 10 TPG

• ET Budget is negotiated yearly

• Consists of a basis budget for

financing cross border tasks plus

country budget for member state

specific tasks

• For every patient put on the waiting

list a registration fee has to be paid

which is related to the forecasted

number of registrations

• In 2011 registration flat rate 626 €

per case, calculated on a basis of

6.724 registrations (total of 6.6 mio

Euro, indexed for inflation & wage

development)

• )

§ 12 (TPG): Vermittlungsstelle Eurotransplant

Basic budget for basic mandate:

• Allocation services

• Development of allocation

• External networking

• Reporting and accounting

• Supportive services

- Clearinghouse function in case of

cross border organ exchange etc.

Country specific budget:

• E.g. country specific allocation rules

(LAS)

• HU audits

§ 12 (TPG): Vermittlungsstelle Eurotransplant

Ba

sic

Budget

Co

un

try-

specific

Number of registrations

for the different countries

DRGs in Transplantation 2011

DRG Bezeichnung

Mittlere

Verweildauer Bewertung

Preis bei

BBFW

A01A Lebertransplantation mit Beatmung > 179 Stunden 58 31,636 93.763,41 € A01B

Lebertransplantation mit Beatmung > 59 und < 180 Stunden oder mit

Transplantatabstoßung oder mit kombinierter Nierentransplantation 34,7 15,545 46.072,58 € A01C

Lebertransplantation ohne Beatmung > 59 Stunden, ohne

Transplantatabstoßung, ohne kombinierte Nierentransplantation 26,9 11,898 35.263,53 € A02Z Transplantation von Niere und Pankreas 26,8 10,197 30.222,07 € A03A Lungentransplantation mit Beatmung > 179 Stunden 72,5 45,397 134.548,54 € A03B

Lungentransplantation ohne Beatmung > 179 Stunden 27 14,008 41.517,19 € A05A

Herztransplantation mit Beatmung > 179 Stunden oder Alter < 16 Jahre 76,3 47,802 141.676,52 € A05B

Herztransplantation ohne Beatmung > 179 Stunden, Alter > 15 Jahre 61,2 22,655 67.145,34 € A17A Nierentransplantation mit postoperativem Versagen des

Nierentransplantates oder Alter < 16 Jahre oder AB0-inkompatible

Transplantation 25,1 8,274 24.522,65 € A17B Nierentransplantation ohne postoperatives Versagen des

Nierentransplantates, Alter > 15 Jahre oder ohne AB0-inkompatible

Transplantation 18,4 6,279 18.609,83 € A18Z

Beatmung > 999 Stunden und Transplantation von Leber, Lunge, Herz

und Knochenmark oder Stammzelltransfusion 110,4 72,926 216.139,54 €

Organisational flat rate

DSO does not recieve an entire budget sum but recieves a lump-

compensation for every transplanted organ, negotiated yearly.

In the year 2012, the organisational flat rate is 8.151 € per transplanted

organ. 4.100 transplantations are assumed.

DSO covers all costs that occur during the donation process as well as

structural costs with this flat. DSO has contracts with organ retrieval

surgeons, neurologists, labs beside the own staff.

Exeptions: refund of costs to the donor hospitals and flight costs for non-

renal organs.

Compensation mechanisms if the fixed number of cases is not reached

or exeeded.

DSO: Budgeting systematics

DSO budget

organisational flat rate

air transportation

donor hospital reimbursement

payment for OCS

DSO budget

organisational flat rate

air transportation

donor hospital reimbursement

payment for OCS

DSO budget

organisational flat rate

includes

staff (coordinators & administration personal)

education

public raltives

safety / traceability

HLA-typing

donation process

organ retreval

IT (DSO.isys) documentation

housing

DSO budget

Compensation mechanisms

If exceeding the number of cases (organ donors), 25% of the

additional revenue (up € 1.2 million) is refunded by DSO to the central

associations of the health insurance funds.

If falling below the number of cases (organ donors), 25% of lower

revenues (up € 1.2 million) is refunded by the central associations of

the health insurance funds to the DSO.

Break/Even organisational flat rate

-20,000

-15,000

-10,000

-5,000

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 5,000

Tau

sen

d E

uro

Anzahl Transplantationen

Gesamtkosten Erlös prozessabhängige Kosten

prozessunabhängige Kosten Ergebnis vor FZ-Ausgleich Ergebnis nach FZ-Ausgleich

NORD

NORDRHEIN-

WESTFALEN

BADEN-

WÜRTTEMBERG BAYERN

MITTE

OST

Rostock

Hamburg

Marburg

Homburg Erlangen

Freiburg

Berlin

Hannover

Leipzig Essen

Mainz

München

Stuttgart

NORDOST

DSO 7 regions

14 teams, 50 TPZ

1.346 donor

Hospitals (ICU)

Regional abd. team

Headquarter

Regional supply office

Regional central office

§ 11 (TPG): Koordinierungsstelle DSO

Organisation and reimbursement of organ retrieval

Allowance for abdominal retrieval teams:

Special cases:

Kidneys en bloc: 820,00 €

Split liver, if both splits are transplanted: 1.640,00 €

1 organ (individual kidney, liver or pancreas) € 820,00

2 organs € 1.640,00

3 organs € 2.460,00

4 organs € 3.280,00

5 organs € 4.100,00

If no organ has eventually been transplanted € 290,00

Organisation and reimbursement of organ retrieval

Allowance for thoracic retrieval teams :

Heart € 1.100,00

Lung (en-bloc) € 1.100,00

Single lung € 1.100,00

2 Single lungs (2 recipients) € 2.200,00

Heart and lung (en-bloc) € 2.200,00

Heart and Single lung € 2.200,00

Heart and 2 Single lungs € 3.300,00

If no organ has eventually been transplanted

€ 290,00

Reimbursement of brain death diagnosis

internal consultant (Monday-Friday) 300,-- €

external consultant (Monday-Friday) 480,-- €

internal consultant (Weekend/bank holidays) 460,-- €

external consultant (Weekend/bank holidays) 640,-- €

DSO budget

flat rate / organisational

air transportation

donor hospital reimbursement

payment for OCS

Establishing an air transport network responsible for the organisation

of all national and international transports of organ retrieval teams and

organs.

DSO: Air transport - extrarenal organs

Main goals and principles:

quality, safety and economic efficiency

medical necessities, CIT

consideration of transport distance

avoiding „empty“ flights

rare use of cost-intensive jets

trustworthy und competent partners

DSO: Air transport - extrarenal organs

Air transport of extrarenal organs

In 2011, the lump sum for an air transport of an extrarenal organ is

6.753 € per transplanted organ for which a separate flight is carried out.

Unsuccessful operations are included in the lump sum and will noch be

refunded separately. The lump sum is based on the assumption that 970

air transports will be carried out in 2011.

If the number of 970 flights is exeeded 50 % of the additional proceeds

will be refunded to payers. If the number of flights is lower than 970

flights 50 % of the lacking revenues will be refunded by the payers.

DSO budget

flat rate / organisational

air transportation

donor hospital reimbursement

payment for OCS

InEK Institute for the Hospital Remuneration System

May 2001: The Head Association of the health

insurers (Bund), Association of Private health

insurers and the German Hospital Federation

found the Institute for the Hospital

Rumuneration System as a private limited

company (PLC).

Since 2007 the institute operates under the

name InEK GmbH.

The Institute supports the contractual partners of self-administration

and their boards in implementing and continuously developing the

German-Diagnosis Related Groups-System (§ 17b KHG)

Post Mortem Organ Donation

Consultation

on

Organ

Donation Brain Death

Diagnosis

Therapy of underlying desease

Fee / day, Flat fee (Health Insurance)

Next of Kin/

Consent

(1)

Organ

Protective

Therapy /

Diagnostics

(2)

Organ

Removal

(3)

Post mortem efforts

Flat fee (DSO): Process completed: 3.679 €

Process interrupted:

(1): 200 €, (2): 759 €, (3): 2.907 €

Reimbursement

Time

• Initial calculation by InEK

• Case definition of post mortal organ donation

DSO: Reimbursement of costs to donor hospitals

Module Presumed number of cases Amount

Discontinued while on intensive

care unit due to refusal

601 213 €

Discontinued while on intensive

care unit prior to organ removal

48 1.351 €

Discontinued during organ

removal

20 2.226 €

Single-organ recovery 161 2.226 €

Multiple-organ recovery 1098 3.587 €

Total budget 4.860.157 €

DSO: Reimbursement of costs to donor hospitals

Module Calculated Costs Difference

compared to

2011

Discontinued while on intensive

care unit due to refusal

259 € + 22 %

Discontinued while on intensive

care unit prior to organ removal

795 € - 41 %

Discontinued during organ

removal

2.907 € + 31 %

Single-organ recovery 2.907 € + 31 %

Multiple-organ recovery

3.679 € plus 200 € for

additional instrumental

diagnostic procedures

+ 3 %

Total increase + 10 %

DSO: Reimbursement of costs to donor hospitals

DSO: Reimbursement of costs to donor hospitals

• Every year, the contract partners

agree on lump sums for the

reimbursement of costs to donor

hospitals.

• Modular lump sums for each possible

result of a donation process :

discontinued before or during organ

removal, actually performed

donation) are paid out by DSO in

order to cover the costs that incur in

the donor hospital.

• The reimbursement does not depend

on the fact whether a transplantation

is carried out or not!

Actual trends in ownership

of german hospitals…

DSO budget

flat rate / organisational

air transportation

donor hospital reimbursement

payment for OCS

OCS Organ Care System

Challenge: Financing the OCS™

• Disposible costs

• The recipient‘s health insurance

pays a flat rate of 43.881,00 Euro

per transplanted heart to DSO

• in addition to organisational and air

transport flat rates.

Benefit for the patient has to be

proven....

Organ Donation in Germany (Age of Organ Donors)

Organ Donation in Germany Proportion of each age group

0%

10%

20%

30%

40%

50%

ND NO OS BY BW MI NW ND NO OS BY BW MI NW ND NO OS BY BW MI NW ND NO OS BY BW MI NW

Stand 05.01.2012

≤ 15 years 16-54 years 55-64 years ≥ 65 years

Germany

3.4 3.1 3.0 3.3 3.1 3.5 3.1 3.4 3.3 2.9 3.3 3.2 3.3 3.3 2.0

2.2

2.4

2.6

2.8

3.0

3.2

3.4

3.6

3.8

Nord Nord-Ost Ost Bayern Baden-Württemb.

Mitte NRW

Stand 05.01.2012

2010 2011

Removed and transplanted organs per donor

per Region 2010 und 2011

Germany 3,3

1.200 Spender (2011)

Extended Criteria Donor (ECD)

• Virus hepatitis

(alternatively HBS Ag+, anti-HBC+ or anti HCV+)

• Sepsis with positive blood culture

• Meningitis

• Tumour malignancy in anamnesis

• drug abuse

Figure 1. Times to Equal Risk of Mortality and Equal Cumulative Mortality for Expanded Criteria Donor (ECD) Kidney Recipients vs Patients Receiving Standard Therapy A, Time to

equal risk of mortality for ECD kidney recipients vs patients receiving standard therapy (combined group of non-ECD recipients and wait-listed patients still receiving dialysis) as

reference group.

Merion, R. M. et al. JAMA 2005;294:2726-2733

Copyright restrictions may apply.

Figure 2. Algorithm for Expanded Criteria Donor (ECD) Kidney Transplant Acceptance Percentages shown represent the proportion of the total US kidney transplant waiting list as

of November 1, 2004 (N = 61 448) that corresponds to each decision point.

Merion, R. M. et al. JAMA 2005;294:2726-2733

Copyright restrictions may apply.

C. Moers et. al.

The Cost-Effectiveness of Organ Preservation

H. Groen et.al.: Cost Effectiveness of Hypothermic Machine Preservation versus Static Cold Storage Renal

DRGs in Transplantation 2011

DRG Bezeichnung

Mittlere

Verweildauer Bewertung

Preis bei

BBFW

A01A Lebertransplantation mit Beatmung > 179 Stunden 58 31,636 93.763,41 € A01B

Lebertransplantation mit Beatmung > 59 und < 180 Stunden oder mit

Transplantatabstoßung oder mit kombinierter Nierentransplantation 34,7 15,545 46.072,58 € A01C

Lebertransplantation ohne Beatmung > 59 Stunden, ohne

Transplantatabstoßung, ohne kombinierte Nierentransplantation 26,9 11,898 35.263,53 € A02Z Transplantation von Niere und Pankreas 26,8 10,197 30.222,07 € A03A Lungentransplantation mit Beatmung > 179 Stunden 72,5 45,397 134.548,54 € A03B

Lungentransplantation ohne Beatmung > 179 Stunden 27 14,008 41.517,19 € A05A

Herztransplantation mit Beatmung > 179 Stunden oder Alter < 16 Jahre 76,3 47,802 141.676,52 € A05B

Herztransplantation ohne Beatmung > 179 Stunden, Alter > 15 Jahre 61,2 22,655 67.145,34 € A17A Nierentransplantation mit postoperativem Versagen des

Nierentransplantates oder Alter < 16 Jahre oder AB0-inkompatible

Transplantation 25,1 8,274 24.522,65 € A17B Nierentransplantation ohne postoperatives Versagen des

Nierentransplantates, Alter > 15 Jahre oder ohne AB0-inkompatible

Transplantation 18,4 6,279 18.609,83 € A18Z

Beatmung > 999 Stunden und Transplantation von Leber, Lunge, Herz

und Knochenmark oder Stammzelltransfusion 110,4 72,926 216.139,54 €

Summary: organ donation/transplantation

• Each EU member state has own regulations – role of the EU

• Impact of the German Transplant law

• Payments of Insurance company of the recipient, organ

transplantation as G-DRGs.

• Efforts for allocation, registration flat for ET

• Efforts of the donor hospitals due to organ donation, payback through

DSO (flat)

• Transport and retrieval, organisational flatrate for DSO

• Challenge: eg new preservation methods (OCS)

Summary: organ donation/transplantation

PRINCEPLE:

Transparency and no financial incentives !