OPTN Differences in the Opportunity for Transplantation within the US Co-chairs: S. McDiarmid MD and K. Olthoff MD Working Group 4: “Improve the Efficiency,

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Differences in the Opportunity Differences in the Opportunity for Transplantation within the for Transplantation within the

USUS

Co-chairs:Co-chairs:

S. McDiarmid MD and K. Olthoff MDS. McDiarmid MD and K. Olthoff MD

Working Group 4: “Improve the Efficiency, Effectiveness, and Equity of the OPTN’s Policies and Processes”

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Working Group 4 MembersWorking Group 4 Members

M Barr MDM Barr MD A BenediA Benedi J Burdick MDJ Burdick MD B Cosimi MDB Cosimi MD R Freeman MDR Freeman MD D La-Pointe-Rudow RND La-Pointe-Rudow RN J Lake MDJ Lake MD M Levy MDM Levy MD B Nuesse RN, BSNB Nuesse RN, BSN UNOS STAFFUNOS STAFF

C Sommers JDC Sommers JD M McBrideM McBride

P Oldham BSSP Oldham BSS P Schaeffer RN, BSNP Schaeffer RN, BSN J Shaftel RNJ Shaftel RN D Surlas RND Surlas RN R Wiesner MDR Wiesner MD H H Wong MD JDH H Wong MD JD M Zamora MDM Zamora MDGUESTSGUESTS R Durbin MBAR Durbin MBA H Krakauer MD PhDH Krakauer MD PhD A Leichtman MDA Leichtman MD G McBride RN MPHG McBride RN MPH F Port MD PhDF Port MD PhD M Stegall MDM Stegall MD

Thankyou!!

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Differences in Transplantation in the Differences in Transplantation in the USUS

Ethical ImperativeEthical Imperative Candidates for solid organ transplantation Candidates for solid organ transplantation

have life threatening diseasehave life threatening disease

Given there are not enough available Given there are not enough available organs, the allocation and distribution of a organs, the allocation and distribution of a life threatening resource should not life threatening resource should not advantage or disadvantage any one advantage or disadvantage any one individual or group of individuals, with individual or group of individuals, with similar medical characteristics, over similar medical characteristics, over anotheranother

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Federal Imperative – the Final RuleFederal Imperative – the Final Rule

““inter-transplant program variance to be as inter-transplant program variance to be as small as can be reasonably achieved in any small as can be reasonably achieved in any performance indicator”performance indicator”

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What determines variation in who gets What determines variation in who gets transplanted?transplanted?

Access to the listAccess to the list Access to the donor organAccess to the donor organ

What data demonstrates the major cause of What data demonstrates the major cause of differences in transplantation?differences in transplantation?

What is the measure we should be trying to What is the measure we should be trying to make more equitable? make more equitable?

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Performance Indicators Common to all Performance Indicators Common to all Organs Organs

Access to the waiting list Access to the waiting list Death (or removal ‘too sick’ for transplant) on Death (or removal ‘too sick’ for transplant) on

waiting listwaiting list Rate of transplantationRate of transplantation Missed opportunities when active on the listMissed opportunities when active on the list

• Rate of organ refusalRate of organ refusal DSA performanceDSA performance

• allocation efficiencyallocation efficiency

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Performance Indicators can be Performance Indicators can be evaluated for various patient groups: evaluated for various patient groups: examplesexamples

AgeAge EthnicityEthnicity Severity of illnessSeverity of illness DiagnosisDiagnosis Insurance statusInsurance status Center effectsCenter effects Patient location - geographyPatient location - geography

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Current system of geographical Current system of geographical boundaries which define patient boundaries which define patient locationlocation

UNOS defined regions.UNOS defined regions. Donor Service Areas (DSAs)Donor Service Areas (DSAs)

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HI

DEMD

MA

RI

Differences in Transplantation in the US

UNOS Regions

16

5

114

3

210

79

8

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How were Regions established?How were Regions established? With establishment of the OPTN: for With establishment of the OPTN: for

administrative and representative administrative and representative purposespurposes

Intended to recognize existing Intended to recognize existing relationships, local interests, and relationships, local interests, and diversity across countrydiversity across country

No intent necessarily to equalize No intent necessarily to equalize populations or number of centers populations or number of centers across the countryacross the country

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PR & US VI

HI

DEMD

MA

RI


Donor Service Areas

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Differences in Transplantation in Differences in Transplantation in the USthe US

How were DSAs established?How were DSAs established?

Generally intended as the first unit of organ Generally intended as the first unit of organ distributiondistribution

DSA territories designated by CMSDSA territories designated by CMS Variable in terms of:Variable in terms of:

- Number of transplant centers- Number of transplant centers

- Square mileage; inclusion of a part of a state, - Square mileage; inclusion of a part of a state, entire state, or multiple statesentire state, or multiple states

- Population, candidate/donor ratios and - Population, candidate/donor ratios and characteristics, and procurement ratescharacteristics, and procurement rates

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Given different sources of possible variation Given different sources of possible variation why focus on geographic differences based why focus on geographic differences based on DSAs and UNOS regions?on DSAs and UNOS regions?

Together they form the basis of the current Together they form the basis of the current allocation and distribution system for allocation and distribution system for deceased donor organs.deceased donor organs.

Boundaries of DSAs and UNOS regions not Boundaries of DSAs and UNOS regions not developed for purposes of organ developed for purposes of organ distribution - distribution - a system that is feasible to be a system that is feasible to be changedchanged

Most other variables – age, ethnicity, Most other variables – age, ethnicity, disease etc can not be changed with disease etc can not be changed with possible exceptions of insurance/payor possible exceptions of insurance/payor status and center effectsstatus and center effects

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As we consider geography:As we consider geography: Policies of organ distribution have Policies of organ distribution have

been built on a basic principle of been built on a basic principle of patient and donor location:patient and donor location:

local first, region second, national local first, region second, national lastlast

Is this valid for all organs?Is this valid for all organs? IsIs kidney different?kidney different?

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Patient Location – the effect of Patient Location – the effect of ‘geography’: Issues-‘geography’: Issues-• Who owns the organ – the locale in Who owns the organ – the locale in

which it was recovered?which it was recovered?

““the unifying force of biology requires at the unifying force of biology requires at least a national perspective”least a national perspective”

Henry KrakauerHenry Krakauer

• Are patients harmed by geographic Are patients harmed by geographic variations in access to transplantation?variations in access to transplantation?

• Some regional variation is to be Some regional variation is to be expected – how much is acceptable?expected – how much is acceptable?

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Who gets transplanted?Who gets transplanted?Performance Indicator:Performance Indicator:

Access to the Waiting ListAccess to the Waiting List

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Access to the Waiting ListingAccess to the Waiting Listing

Is this the purview of the OPTN/UNOS?Is this the purview of the OPTN/UNOS? Is the scope of our concern only after a Is the scope of our concern only after a

candidate is listed?candidate is listed?

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Access to the waiting list dependent Access to the waiting list dependent on:on:

Incidence and prevalence of end-organ Incidence and prevalence of end-organ failurefailure

Medical practice patterns Medical practice patterns Referral patternsReferral patterns Listing criteriaListing criteria Patient educationPatient education Insurance/payor regional differencesInsurance/payor regional differences

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Should the OPTN try to influence medical care and Should the OPTN try to influence medical care and practice for patients eligible for transplantation?practice for patients eligible for transplantation?

YESYES: : Otherwise the benefit of transplantation is Otherwise the benefit of transplantation is denied to this group of eligible, yet unlisted, denied to this group of eligible, yet unlisted, eligible patientseligible patients

Within the scope of the Final Rule’s requirement to Within the scope of the Final Rule’s requirement to develop standardized listing criteria as well as develop standardized listing criteria as well as policies to address socioeconomic impediments policies to address socioeconomic impediments to transplantationto transplantation

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Available Data Evaluating Access to Available Data Evaluating Access to Waiting ListWaiting List• Quantitative for kidney – good data available Quantitative for kidney – good data available

from USRDSfrom USRDS

• Qualitative for heart and liverQualitative for heart and liver - based on an estimate of the incidence of end - based on an estimate of the incidence of end

stage disease in a given population unit stage disease in a given population unit compared to the actual percent of the compared to the actual percent of the predicted eligible population actually listed predicted eligible population actually listed

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Alan Leichtman MD

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Who gets transplanted?Who gets transplanted?

Performance Indicators after listingPerformance Indicators after listing• Death (removal) on the listDeath (removal) on the list

• Transplant RateTransplant Rate

- both can controlled for several variables - both can controlled for several variables such as age, diagnosis, medical urgency, such as age, diagnosis, medical urgency, geographygeography

Which variable(s) is most relevant?Which variable(s) is most relevant?

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Existing Differences in Performance Existing Differences in Performance Indicators after listingIndicators after listing

Given Final Rule emphasis to prioritize Given Final Rule emphasis to prioritize allocation of DD organs by medical allocation of DD organs by medical urgency one approach to evaluating urgency one approach to evaluating geographic differences should compare geographic differences should compare death on list and transplant rates by death on list and transplant rates by severity of illness severity of illness

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How is Medical Urgency Currently How is Medical Urgency Currently Defined?Defined?

Organ Specific:Organ Specific:

• Liver: MELD/PELD systemLiver: MELD/PELD system• Heart:: status categories – 1a,1b, 2Heart:: status categories – 1a,1b, 2• Lung: risk of death without transplantLung: risk of death without transplant• Kidney: net lifetime survival benefit??Kidney: net lifetime survival benefit??

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LiverLiver• MELD/PELD severity of illness has been well MELD/PELD severity of illness has been well

validated as an accurate measure of validated as an accurate measure of probability of death within 3 months of listingprobability of death within 3 months of listing

• In place since Feb 2002In place since Feb 2002

• Extensive data already available examining Extensive data already available examining regional and DSA differences in death regional and DSA differences in death waiting and rate of transplantwaiting and rate of transplant

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Probability of Transplant and Probability of Transplant and Death/Too Sick within One Year for Death/Too Sick within One Year for

Adult Liver Registrations Added Adult Liver Registrations Added 3/1/2002-2/29/2004 By Region3/1/2002-2/29/2004 By Region

Initial MELD Score 15+Initial MELD Score 15+

0

20

40

60

80

100

1 2 3 4 5 6 7 8 9 10 11

Region

Per

cent

Probability of Tx Probability of Death

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Adult Liver Registrations Added Adult Liver Registrations Added 3/1/2002-2/29/2004 By DSA3/1/2002-2/29/2004 By DSA

Initial MELD Score 15+Initial MELD Score 15+

0

20

40

60

80

100

DSA

Per

cent


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Heart:Heart:

Severity of illness measured by status 1a, Severity of illness measured by status 1a, 1b, 21b, 2

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Adult Heart Registrations Added Adult Heart Registrations Added 1/1/2002-12/31/2004 By Region1/1/2002-12/31/2004 By Region

Status 1A at ListingStatus 1A at Listing

0

20

40

60

80

100

1 2 3 4 5 6 7 8 9 10 11

Region

Per

cent


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Adult Heart Registrations Added Adult Heart Registrations Added 1/1/2002-12/31/2004 By DSA1/1/2002-12/31/2004 By DSA

Status 1A at ListingStatus 1A at Listing

0

20

40

60

80

100

DSA

Per

cent


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Percent of Adult Heart Transplants Percent of Adult Heart Transplants Status 1AStatus 1A

for Transplants Performed During for Transplants Performed During 1/1/04-6/30/05 by DSA1/1/04-6/30/05 by DSA

0

20

40

60

80

100

DSA

Per

cent

of T

rans

plan

ts

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KidneyKidney

What is relevant measure of severity of What is relevant measure of severity of illness?illness?

How can comparable patients be How can comparable patients be identified?identified?

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Probability of Transplant and Probability of Transplant and Death/Too Sick within One Year for Death/Too Sick within One Year for Adult Kidney Registrations Added Adult Kidney Registrations Added

1/1/2002-12/31/2004 By Region1/1/2002-12/31/2004 By RegionPRA < 20% at ListingPRA < 20% at Listing

0

20

40

60

80

100

1 2 3 4 5 6 7 8 9 10 11

Region

Per

cent


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Probability of Transplant and Death/Too Probability of Transplant and Death/Too Sick within One Year for Adult Kidney Sick within One Year for Adult Kidney

Registrations Added 1/1/2002-12/31/2004 Registrations Added 1/1/2002-12/31/2004 By DSABy DSA

PRA < 20% at ListingPRA < 20% at Listing

0

20

40

60

80

100

DSA

Per

cent


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Pancreas Pancreas • Unique in solid organ transplantationUnique in solid organ transplantation

• The supply of solitary pancreata The supply of solitary pancreata generally is greater than the demand generally is greater than the demand

• Simultaneous Pancreas and Kidney is Simultaneous Pancreas and Kidney is limited primarily by the availability of the limited primarily by the availability of the kidneykidney

• Major issues facing pancreas and islet Major issues facing pancreas and islet allocation involve procurement and allocation involve procurement and placementplacement

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Other Sources of Differences related to Other Sources of Differences related to GeographyGeography

• DSA PerformanceDSA Performance

• Differences in donor qualityDifferences in donor quality

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Conclusions from the DataConclusions from the Data• Patient location, as currently defined by Patient location, as currently defined by

Regions and DSAs, is the most important Regions and DSAs, is the most important cause of differences in access to listing cause of differences in access to listing and transplantationand transplantation

• Is it right that where I live can dictate my Is it right that where I live can dictate my chances of getting on a list, getting a chances of getting on a list, getting a transplant and of dying on the list transplant and of dying on the list

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What is the right metric to assess What is the right metric to assess differences once listed?differences once listed?

For comparison of differences in access For comparison of differences in access to transplantation based on patient to transplantation based on patient location, what should we be seeking to location, what should we be seeking to ‘equalize’ across the US?:‘equalize’ across the US?:

• the person who is sickest?the person who is sickest?

• the person to gain the most benefit from the person to gain the most benefit from receiving an organ?receiving an organ?

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Working Group Working Group Recommendation:Recommendation:

““The access to an organ should be The access to an organ should be similar across the US for patients similar across the US for patients with a similar transplant benefit”with a similar transplant benefit”

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Benefit of Transplantation: How to Benefit of Transplantation: How to define?define?

Organ specificOrgan specific..

• For liver and heart (lung)– urgency of tx to For liver and heart (lung)– urgency of tx to save life paramountsave life paramount

• General consensusGeneral consensus - net life years gained most relevant- net life years gained most relevant

• Quality of life? how best to measureQuality of life? how best to measure - how relevant is QOL in the face of critical - how relevant is QOL in the face of critical

organ shortage for immediately life saving organ shortage for immediately life saving transplantation for liver and heart (lung) transplantation for liver and heart (lung) recipients recipients

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Liver – Benefit of TransplantLiver – Benefit of Transplant

• Using MELD score concept of who would Using MELD score concept of who would most benefit from receiving a donor liver most benefit from receiving a donor liver

at the time of offer was developedat the time of offer was developed..

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Differences in Transplantation in US

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Lung – Benefit of TransplantLung – Benefit of Transplant

Combination of :Combination of :

• risk of death without transplant risk of death without transplant

• probability of post transplant survivalprobability of post transplant survival

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Heart: Benefit Heart: Benefit

• Net life years gained with Net life years gained with transplanttransplant

• Status 1a and 1b benefit most from Status 1a and 1b benefit most from transplanttransplant

• Proposed broader sharing for 1a Proposed broader sharing for 1a and 1band 1b

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Kidney – Definition of benefitKidney – Definition of benefit

Net lifetime survival benefit = Net lifetime survival benefit =

survival with transplant – survival without survival with transplant – survival without transplanttransplant

Then compare time to transplant for Then compare time to transplant for “comparable” patients“comparable” patients

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PancreasCan use the same Net Lifetime Survival

Benefit

May not be necessary in ranking for allocation given the lack of scarcity

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Conclusions:Conclusions:

• Geography is the most important cause Geography is the most important cause of differences in access to of differences in access to transplantation both before and after transplantation both before and after listing listing

• Patients, and the lives lost, are the victim Patients, and the lives lost, are the victim of these differencesof these differences

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• Given the arbitrary geographic Given the arbitrary geographic definitions of regions and DSAs, the definitions of regions and DSAs, the differences proven by current data differences proven by current data mandate that an urgent re-evaluation of mandate that an urgent re-evaluation of the geographic units of organ the geographic units of organ distribution is undertakendistribution is undertaken

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• The data are compelling: the magnitude The data are compelling: the magnitude of the differences in opportunity for of the differences in opportunity for transplantation for patients within the US transplantation for patients within the US is in direct contravention of both ethical is in direct contravention of both ethical principles of providing life saving principles of providing life saving medical care without prejudice, and the medical care without prejudice, and the mandate of the Final Rulemandate of the Final Rule

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Conclusions:Conclusions:• We know better now how to rank the We know better now how to rank the

order in which patients should be order in which patients should be transplanted based on their degree of transplanted based on their degree of medical urgency, (allocation) but we medical urgency, (allocation) but we have made little progress in getting the have made little progress in getting the organ to the appropriately identified organ to the appropriately identified patients (distribution).patients (distribution).

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• Transplant benefit, defined for Transplant benefit, defined for each organ, is the metric by which each organ, is the metric by which comparable access to comparable access to transplantation should be transplantation should be measured.measured.

• Transplant benefit is inherently Transplant benefit is inherently just – not a utility tooljust – not a utility tool

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Timeline for ProgressTimeline for Progress• Definition and evaluation of transplant Definition and evaluation of transplant

benefit are currently at different stages benefit are currently at different stages for each organfor each organ

• Will need experience with new systemsWill need experience with new systems

• Evaluations of accuracy and Evaluations of accuracy and completenesscompleteness

• Then able to begin measuring Then able to begin measuring differences in access for candidates with differences in access for candidates with similar transplant benefitsimilar transplant benefit

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Question:Question:

• System will need to accept some degree System will need to accept some degree of variationof variation

• How much is acceptable?How much is acceptable?

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Challenges in Changing DistributionChallenges in Changing Distribution• Limiting cold ischemia time – what is Limiting cold ischemia time – what is

reasonable?reasonable?

• Organ specificOrgan specific

• Does it vary with donor qualityDoes it vary with donor quality

• Is there any justification for the current Is there any justification for the current concept of ‘local first’ for liver, heart, concept of ‘local first’ for liver, heart, lung donors?lung donors?

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Challenges in Changing Challenges in Changing DistributionDistribution• Currently the local preference concept is Currently the local preference concept is

driven by the OPO being the initiating driven by the OPO being the initiating factor in donor distributionfactor in donor distribution

• Broader sharing of donor livers and Broader sharing of donor livers and hearts already in place and modeling hearts already in place and modeling predicts that death on the waiting list will predicts that death on the waiting list will be reducedbe reduced

• How ‘broad’ can ‘broad’ be ?How ‘broad’ can ‘broad’ be ?

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Challenges in Changing DistributionChallenges in Changing Distribution• Should units of distribution be based on Should units of distribution be based on

equalizing population density?equalizing population density?

• Distance from donor to recipient based Distance from donor to recipient based on population density in place for kidney on population density in place for kidney distribution in New Englanddistribution in New England

• Should distance from donor to potential Should distance from donor to potential recipient be a factor?recipient be a factor?

- concentric circles based on distance - concentric circles based on distance from donor: in place for heart from donor: in place for heart distributiondistribution

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Previous attempts to change Previous attempts to change distribution units.distribution units.• In 2000-2001 liver models were examined In 2000-2001 liver models were examined

changing organ distribution boundaries changing organ distribution boundaries – pre MELD– pre MELD

• Combined contiguous DSAs in 7 Combined contiguous DSAs in 7 different configurations to cover different configurations to cover populations >9 millionpopulations >9 million

• 17 different allocation sequences 17 different allocation sequences modeledmodeled

• Inter-region variation reduced but fewer Inter-region variation reduced but fewer transplants and more deathstransplants and more deaths

Freeman et al. Liver Trans 2002; 8:659Freeman et al. Liver Trans 2002; 8:659

WHY??WHY??

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Challenges in Changing DistributionChallenges in Changing Distribution

• Focus was only on patient location - no Focus was only on patient location - no account taken of medical urgencyaccount taken of medical urgency

• Need to “focus more on the patients Need to “focus more on the patients who need it most, more than where they who need it most, more than where they live” live” FreemanFreeman

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Recommendations to the Board:Recommendations to the Board:

• Establish a central resource of expertise Establish a central resource of expertise – both clinical and statistical, to develop – both clinical and statistical, to develop organ specific proposals to reduce organ specific proposals to reduce differences in transplantation, as a result differences in transplantation, as a result of patient location, of patient location, for patients with a for patients with a similar transplant benefitsimilar transplant benefit

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• Require each organ specific committee Require each organ specific committee to examine and discuss the proposals to examine and discuss the proposals and concepts, requesting additional data and concepts, requesting additional data and modeling as needed, and propose and modeling as needed, and propose policies that would reduce geographic policies that would reduce geographic differencesdifferences

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• Consider the effect of allowing Consider the effect of allowing local/regional variances to continue – local/regional variances to continue – may confound effects of new policiesmay confound effects of new policies

• Consider the likely impact, and response Consider the likely impact, and response from small centers, if ‘local first’ concept from small centers, if ‘local first’ concept is largely made obsoleteis largely made obsolete

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• Require a progress report from each Require a progress report from each committee in one year after central committee in one year after central resource provides initial conceptsresource provides initial concepts

• After initial proposals are made involve After initial proposals are made involve the transplant community as a whole to the transplant community as a whole to develop broad based consensusdevelop broad based consensus

• Aim to convene a Consensus Aim to convene a Consensus Conference within 2 years Conference within 2 years

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Ask not what your country can do for you,but what you can do for your country. John F. Kennedy

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High RR of Waitlisting Does Not by High RR of Waitlisting Does Not by Itself Explain a Low RR of Deceased Itself Explain a Low RR of Deceased

Donor TransplantDonor Transplant

(R(R22 = 0.17; p < 0.0001) = 0.17; p < 0.0001)

Rat

e o

f D

ecea

sed

Do

no

r T

ran

spla

nt

Rate of Waitlisting

0.00

0.50

1.00

1.50

2.00

2.50

0.00 0.50 1.00 1.50 2.00

N=20

N=10

N=5

N=16

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WLRR>1, TxRR >1 WLRR>1, TxRR<1 WLRR<1, TxRR >1 WLRR<1, TxRR <1

HI

Waitlisting Rate* (WLRR) and Deceased Donor Transplantation Rate (TxRR)* by

State, 1996-2004WA

OR

CO

NM

AZ

UT

MT

CA

AK

NV

ID

WY

NJPA

NY

CT

RIMA

VT

MI

MN

IA

MO

NE

IN OH

WI

IL

ND

SD

KS

TX

OKAR

LA

TN

MS AL

WV VA

NC

SC

GA

FL

DC

DEMD

*WLRR is adjusted for age, gender, ESRD cause, incidence year, comorbid conditions, dialysis unit type, employment at incidence, insurance, and BMI and censored at death, living donor transplant, or end of study; TxRR is adjusted for age, gender, ESRD cause, incidence year, comorbid conditions, dialysis unit type, employment at incidence, insurance, and BMI and censored at removal from the waitlist or end of study. Compared to National Average of 1.0.

KY

MENH


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A tale of two cities, two patients A tale of two cities, two patients and one liver…..and one liver…..

Mr A and Mr B both have hepatitis C and are listed on the Mr A and Mr B both have hepatitis C and are listed on the same day for a liver transplant. Mr A lives in Loonyville, same day for a liver transplant. Mr A lives in Loonyville, California. His doctors tell him he is very sick and that California. His doctors tell him he is very sick and that over the next 3 months he only has a 50:50 living chance over the next 3 months he only has a 50:50 living chance of getting a liver before he dies. of getting a liver before he dies.

Mr B lives 25 miles away from Mr B in Normaltown Mr B lives 25 miles away from Mr B in Normaltown Oregon. His doctors tell him that even without a new liver Oregon. His doctors tell him that even without a new liver he has a better than 80% chance of being alive in 3 he has a better than 80% chance of being alive in 3 monthsmonths

A donor liver becomes available in Mr B’s hometown 2 A donor liver becomes available in Mr B’s hometown 2 months after he is listed and he is transplanted. 2 weeks months after he is listed and he is transplanted. 2 weeks later Mr A, 25 miles away, dies.later Mr A, 25 miles away, dies.

Can this happen in the land of equal opportunity??Can this happen in the land of equal opportunity??

Documents

OPTN Differences in the Opportunity for Transplantation within the US Co-chairs: S. McDiarmid MD and K. Olthoff MD Working Group 4: “Improve the Efficiency,