CEA and Fair Process: CEA and Fair Process: Specifying the Specifying the

MEDICARE Benefit MEDICARE Benefit PackagePackage

Norman DanielsNorman Daniels

Harvard School of Public HealthHarvard School of Public Health

Toronto, December 10, 2004Toronto, December 10, 2004

Ndaniels@hsph.harvard.eduNdaniels@hsph.harvard.edu

OverviewOverview

Justice: requires meeting needs fairly under Justice: requires meeting needs fairly under resource constraints-- involves limit setting resource constraints-- involves limit setting decisions at various levels despite moral decisions at various levels despite moral disagreementsdisagreements

CEA: maximizing strategy (net aggregate CEA: maximizing strategy (net aggregate benefits) open to well-rehearsed ethical benefits) open to well-rehearsed ethical objectionsobjections

Two strategies: a) ethically weighted CEA vs b) Two strategies: a) ethically weighted CEA vs b) CEA as one input to fair deliberative processCEA as one input to fair deliberative process

Argue for (b) plus other inputs into process that Argue for (b) plus other inputs into process that is Accountable For Reasonablenessis Accountable For Reasonableness

Three Questions of JusticeThree Questions of Justice

Why is health specially important?Why is health specially important? When are health inequalities unjust?When are health inequalities unjust? How can we meet health needs fairly How can we meet health needs fairly

when we cannot meet them all?when we cannot meet them all?

I concentrate here on third, but set stage by I concentrate here on third, but set stage by talking briefly about first twotalking briefly about first two

FEO Account of Moral FEO Account of Moral Importance of health/health Importance of health/health

carecare Disease and disability are departures from Disease and disability are departures from normal functioningnormal functioning

Departures from normal functioning impair Departures from normal functioning impair opportunityopportunity

Meeting health needs promotes/protects Meeting health needs promotes/protects normal functioningnormal functioning

Principle governing meeting of health Principle governing meeting of health needs is fair equality of opportunity needs is fair equality of opportunity principleprinciple

Justice as FairnessJustice as Fairness

Hypothetical contract (Original Position)Hypothetical contract (Original Position) Simplifying AssumptionSimplifying Assumption

Normal functioning over lifespanNormal functioning over lifespan

Index of Primary Social GoodsIndex of Primary Social Goods Three PrinciplesThree Principles

Equal basic liberties; fair value of political libertiesEqual basic liberties; fair value of political liberties Fair equality of opportunityFair equality of opportunity Difference principleDifference principle

Extending JAF to Health/HCExtending JAF to Health/HC

JAF simplified to case where there is no JAF simplified to case where there is no disease, disability or premature deathdisease, disability or premature death

Open to criticism -- Arrow, Sen, others -- Open to criticism -- Arrow, Sen, others -- that theory cannot accommodate that theory cannot accommodate important variations among people that important variations among people that create inequalitiescreate inequalities

FEO account permits theory to handle FEO account permits theory to handle departures from normal functioningdepartures from normal functioning

Use Other opportunity-focused theoriesUse Other opportunity-focused theories

Health inequalities and Health inequalities and inequitiesinequities

Knowing that meeting health needs is of special Knowing that meeting health needs is of special importance does not tell us when health importance does not tell us when health inequalities are inequitiesinequalities are inequities

Not apparent if we only think about health care -- Not apparent if we only think about health care -- then inequalities in access to care might seem to then inequalities in access to care might seem to tell us all we need to know about when tell us all we need to know about when inequalities become unjustinequalities become unjust

Health inequalities are result of many socially Health inequalities are result of many socially controllable factors, not just medicine or even controllable factors, not just medicine or even traditional public healthtraditional public health

Extending FEO to Social Extending FEO to Social DeterminantsDeterminants

Health Care needs: what we need to promote, maintain, Health Care needs: what we need to promote, maintain, restore normal functioningrestore normal functioning

Includes adequate nutrition, shelter, save living and Includes adequate nutrition, shelter, save living and working environment, exercise, rest -- as well as medical working environment, exercise, rest -- as well as medical services (traditional public health)services (traditional public health)

What distribution of social determinants is needed to What distribution of social determinants is needed to promote normal functioning?promote normal functioning?

Justice is good for our health: conformance to Rawls’s Justice is good for our health: conformance to Rawls’s principles of justice as fairness flattens SES/health principles of justice as fairness flattens SES/health gradient to extent justice requires (residual gradient still gradient to extent justice requires (residual gradient still an issue) an issue)

Justice and Justice and Medicare Benefit PackageMedicare Benefit Package

Assume reasonable resource constraints (health Assume reasonable resource constraints (health care not only important good)care not only important good)

Just Health (FEO): all people entitled to make Just Health (FEO): all people entitled to make contingent claims on reasonable array of medical contingent claims on reasonable array of medical and ancillary services that meet health care needs and ancillary services that meet health care needs regardless of ability to pay (right to health care) regardless of ability to pay (right to health care)

Some medical services do not meet health care Some medical services do not meet health care needs but meet other social obligations (e.g., non-needs but meet other social obligations (e.g., non-therapeutic abortion)therapeutic abortion)

Reasonable people may disagree about Reasonable people may disagree about contents of benefit package on empirical and contents of benefit package on empirical and especially ethical groundsespecially ethical grounds

Reasonable Disagreements Reasonable Disagreements about Benefit Packageabout Benefit Package

How much priority to sickest patients? How much priority to sickest patients? (Swedish and Dutch commissions)(Swedish and Dutch commissions)

When do aggregated most benefits to more When do aggregated most benefits to more patients outweigh larger benefits to fewer patients outweigh larger benefits to fewer patients? (remember Oregon?)patients? (remember Oregon?)

When do we give people some “fair” chance When do we give people some “fair” chance at benefit rather that favor those who will at benefit rather that favor those who will have best outcomes?have best outcomes?

When do we yield to public opinion about When do we yield to public opinion about priorities even when that may not produce priorities even when that may not produce most health or fairly distributed health?most health or fairly distributed health?

Legitimacy Problem and Legitimacy Problem and Procedural JusticeProcedural Justice

Limit-setting decisions (including benefit Limit-setting decisions (including benefit package) are morally controversial, have package) are morally controversial, have winners and losers, fundamentally affect well winners and losers, fundamentally affect well beingbeing

No prior agreement on principles capable of No prior agreement on principles capable of resolving disputes about benefit packageresolving disputes about benefit package

Under what conditions (who and how) are these Under what conditions (who and how) are these decisions accepted as fair and legitimate?decisions accepted as fair and legitimate?

If no prior agreement on principles of If no prior agreement on principles of distribution, need fair process to yield decisions distribution, need fair process to yield decisions people can regard as fairpeople can regard as fair

Promise of CEAPromise of CEA

““Objective” Tool:Objective” Tool:Reflects public valuation of health states, counts Reflects public valuation of health states, counts each personeach person

We owe what worksWe owe what works::Aims to be measure of effectiveness of health Aims to be measure of effectiveness of health interventionsinterventions

We must weigh opportunity cost of alternativesWe must weigh opportunity cost of alternatives ::Weighs opportunity cost -- broadly if against Weighs opportunity cost -- broadly if against league table of CEA ratiosleague table of CEA ratiosConsiders both life extension and qualityConsiders both life extension and quality

Ethical Problems with CEAEthical Problems with CEA

Foundational: confuses social values with Foundational: confuses social values with preferences or utilities (Nord, Hausman, others)preferences or utilities (Nord, Hausman, others)

Maximizing methodology vs fairness (Harris, Maximizing methodology vs fairness (Harris, Brock, Daniels, Nord, Ubel, others)Brock, Daniels, Nord, Ubel, others) General: not even fiction about potential pareto General: not even fiction about potential pareto

improvement as in CBA, to offset fairness worryimprovement as in CBA, to offset fairness worry Best outcomes vs fair chances (age, disabilities)Best outcomes vs fair chances (age, disabilities) Priorties problem ( worst off health or SES)Priorties problem ( worst off health or SES) Aggregation problem (Oregon example)Aggregation problem (Oregon example)

CEA vs FairnessCEA vs Fairness

CEA FAIRNESS

BO vs FC BO Weighted chances

Priority to worst off

None Some--varies

Aggregation Any Some

Construct Ethically Sensitive Construct Ethically Sensitive CEACEA

Nord and others: use surveys (person trade offs) Nord and others: use surveys (person trade offs) to better capture to better capture social valuessocial values involved in involved in alternative uses of health care interventionsalternative uses of health care interventions

Resulting transformations compress weights Resulting transformations compress weights given to utility based health states given to utility based health states

Corrected CEA (CVA not CUA) better captures Corrected CEA (CVA not CUA) better captures societal values and gives better input into societal values and gives better input into decision-makingdecision-making

Result is better democratic proxy than CEA Result is better democratic proxy than CEA (“public policy should reflect public’s values”)(“public policy should reflect public’s values”)

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Problems with weighted CEAProblems with weighted CEA

Lack of Transparency: stakeholders won’t Lack of Transparency: stakeholders won’t understand the weights and how they were understand the weights and how they were derivedderived

Methodological problems: considerable variance Methodological problems: considerable variance (framing, anchoring) and no way to explain (framing, anchoring) and no way to explain whether this is random or systematic (matters of whether this is random or systematic (matters of taste vs constellations of values)taste vs constellations of values)

Legitimacy??? -- first two problems make this no Legitimacy??? -- first two problems make this no substitute for fair deliberation; look for process substitute for fair deliberation; look for process that mirrors moral deliberation, not given by that mirrors moral deliberation, not given by weighted functionweighted function

Accountability for Accountability for Reasonableness (A4R)Reasonableness (A4R)

Publicity (transparency including reasons)Publicity (transparency including reasons) Relevant reasons (as judged by Relevant reasons (as judged by

appropriate stakeholders)appropriate stakeholders) Revisability (in light of new evidence, Revisability (in light of new evidence,

arguments, appeals)arguments, appeals) Enforceability (assurance that other Enforceability (assurance that other

conditions are met)conditions are met)

Game of Health Care DeliveryGame of Health Care Delivery• Common good of the gameCommon good of the game::

Meeting diverse health care needs fairly under resource Meeting diverse health care needs fairly under resource constraintsconstraints

Rules of the game:Rules of the game: Reasons that we agree are relevant to pursuing common Reasons that we agree are relevant to pursuing common

good or goal of the gamegood or goal of the game

““Fair-minded” people:Fair-minded” people: Eschew “mere advantage” in favor of conformity to rules or Eschew “mere advantage” in favor of conformity to rules or

reasons all can agree are aimed at common good of the reasons all can agree are aimed at common good of the gamegame

Managers: “Can patients be fair minded”?Managers: “Can patients be fair minded”? Patients: “Can managers or purchasers be fair minded”?Patients: “Can managers or purchasers be fair minded”?

Background to A4RBackground to A4R

Study of managed care decision-making (aimed Study of managed care decision-making (aimed at feasible model in hardest setting)at feasible model in hardest setting)

Applied to technology assessment, pharmacy Applied to technology assessment, pharmacy benefit design, physician incentives, and scaling benefit design, physician incentives, and scaling up ARTs in developing countriesup ARTs in developing countries

Research agenda in Canada, Norway, New Research agenda in Canada, Norway, New Zealand, various other developed and Zealand, various other developed and developing countriesdeveloping countries

Included in WHO/UNAIDS guidelines on equity Included in WHO/UNAIDS guidelines on equity in 3 by 5.in 3 by 5.

Case Law Counters DistrustCase Law Counters Distrust Presumption of similar treatment for similar casesPresumption of similar treatment for similar cases• Commitment to coherent use of reasonsCommitment to coherent use of reasons• ““Similarity” defined by reference to reasons and Similarity” defined by reference to reasons and

principlesprinciples• RebuttalRebuttal

Show relevant difference in casesShow relevant difference in cases Show rationale for revising principleShow rationale for revising principle

Public record of commitments - behavior matches Public record of commitments - behavior matches pronouncementspronouncements

Losers in A4RLosers in A4R

Relevant reasons -- but still disagreement Relevant reasons -- but still disagreement on weightson weights

Losers in procedural democracy: any Losers in procedural democracy: any reasons held by majority outweigh reasons reasons held by majority outweigh reasons advanced by minorityadvanced by minority

Losers in democratic deliberation (A4R): Losers in democratic deliberation (A4R): only relevant reasons play role in only relevant reasons play role in deliberation, so losers feel less that might deliberation, so losers feel less that might makes rightmakes right

MIDDLE PATHMIDDLE PATHBETWEEN EXPLICIT AND BETWEEN EXPLICIT AND

IMPLICITIMPLICIT ExplicitExplicit

Transparency about reasonsTransparency about reasons Case Law accumulation of precedentsCase Law accumulation of precedents

ImplicitImplicit Not all reasons agreed upon prior to fair processNot all reasons agreed upon prior to fair process Decisions made at various levels with expert inputDecisions made at various levels with expert input

Best of Both WorldsBest of Both Worlds Justifiability Justifiability FlexibilityFlexibility

Inputs to Benefit Package Inputs to Benefit Package deliberationdeliberation

CEA: some pairwise comparisons, get ethically CEA: some pairwise comparisons, get ethically acceptable answer; useful information about acceptable answer; useful information about aggregate effectsaggregate effects

Nord transformation to CVA (or other survey Nord transformation to CVA (or other survey inputs showing public attitudes); more clarity about inputs showing public attitudes); more clarity about public attitudes departing from standard CEApublic attitudes departing from standard CEA

Philosophical argument about relevant reasons Philosophical argument about relevant reasons and best conclusionsand best conclusions

Empirical evidence about safety, efficacyEmpirical evidence about safety, efficacy Inputs from from deliberation at different Inputs from from deliberation at different

institutional levelsinstitutional levels

Publicity:Publicity:Does decision-maker Does decision-maker

(at whatever level):(at whatever level): Provide public access to full rationalesProvide public access to full rationales Hold public hearings, wide consultationsHold public hearings, wide consultations Make rationales comprehensibleMake rationales comprehensible Use stakeholder involvement in generating Use stakeholder involvement in generating

rationales to promote transparencyrationales to promote transparency Make public objections from other levelsMake public objections from other levels

Relevant Reasons: Relevant Reasons: Does Decision-maker:Does Decision-maker:

Gather relevant evidence,Gather relevant evidence,Distinguish ethical issuesDistinguish ethical issuesWelcome relevant stakeholders to deliberationWelcome relevant stakeholders to deliberationSupport, empower stakeholders with info, respectSupport, empower stakeholders with info, respectRespect disagreements, seek agreementRespect disagreements, seek agreementDeliberate about process for resolving disputesDeliberate about process for resolving disputesDevelop rationales inclusive of points of disagreementDevelop rationales inclusive of points of disagreementGive adequate room for local discretion and authorityGive adequate room for local discretion and authorityInsist on fair process at other levelsInsist on fair process at other levels

Revisability:Revisability:Does decision-maker:Does decision-maker:

Invite disagreements from other levelsInvite disagreements from other levels Respect need for iterative decision-makingRespect need for iterative decision-making Assure decision-makers at other levels they have Assure decision-makers at other levels they have

responsibility to raise objections, provide opportunity to responsibility to raise objections, provide opportunity to do sodo so

Assure appropriate stakeholders involved in revising Assure appropriate stakeholders involved in revising decisionsdecisions

Provide mechanism for appealsProvide mechanism for appeals Use appeals to improve quality of decision-making?Use appeals to improve quality of decision-making?

Enforcement:Enforcement:Does decision-maker:Does decision-maker:

Make itself accountable to lower levels for carrying out Make itself accountable to lower levels for carrying out fair process?fair process?

Challenge decisions when fair process missing?Challenge decisions when fair process missing? Seek international agreements and national regulations Seek international agreements and national regulations

on elements of fair processon elements of fair process Seek agreements across levels of decision-making on Seek agreements across levels of decision-making on

components of fair processcomponents of fair process

Improving Fair ProcessImproving Fair Process

Training for fair processTraining for fair process Research for fair processResearch for fair process

Descriptive record of processes usedDescriptive record of processes used Research questions developed for assessing Research questions developed for assessing

compliance with fair processcompliance with fair process Research questions for drawing lessons from benefit Research questions for drawing lessons from benefit

package decision-making, including effectspackage decision-making, including effects Specific time frame and funding for such researchSpecific time frame and funding for such research