Setting Limits Fairly

1
Setting Limits Fairly

• Norman Daniels
• PIH, HSPH
• ndaniels_at_hsph.harvard.edu
• Sweden
• June 17, 2003

2
Context

• Inequitable system in U.S.
• Fragmented, decentralized decisions
• Strong market ideology -- failure of managed care
  to contain costs, now consumer driven plans
  (rapidly rising costs, relaxation of constraints)
• No national leadership
• Close study of contexts of decision-making in
  private sector
• Is there fair process applicable across sectors?

3
Overview of Argument

• Justice requires limits
• Principles too general, controversial
• Just limits require fair process
• Fair process assures accountability for
  reasonableness
• Accountability for reasonableness necessary for
  legitimacy
• Applications, implications

4
Justice Requires Limit Setting

• Obvious from utilitarian perspective
• Same from Equal Opportunity Account
• Disease/disability impair opportunity
• Promoting normal functioning protects opportunity
• Healthcare competes with other goals of justice,
  other important goods
• Entitlements to healthcare are system relative

5
Types of Limit-Setting DecisionsRaising
Questions of Fairness

• Treatment/Enhancement
• Proven/Experimental
• Practice Guidelines
• Cost-Worthiness
• Priorities
• Aggregation
• Fair Chances/Best Outcomes

Patient Goals vs Goals of Others
Unsolved Problems
6
Proven vs Unproven(Especially Last Chance)

• Proven
• Stewardship
• Conserve resources
• Allocate them to meet needs fairly
• Only obligations of justice to provide effective
  treatments
• Obligations to determine effectiveness

• Unproven
• Urgency
• Immediate need for identified victim
• Individual variation
• Possibility of trial?

7
Priorities Problem

• Maximin (maximum priority to worst off)
• No priority to worst off
• Some priority to worst off how much? Who says?
• Philosophical research may yield answers, not
  short or mid-term consensus valuable as input to
  fair process

8
Aggregation Problem

• When do modest benefits to larger numbers
  outweigh larger benefits to smaller numbers?
• CEA any aggregation acceptable
• No aggregation acceptable
• Middle ground how characterized?

9
Social Attitudes to Trade-offs and to Risks

• Direct valuation of trade-offs in life saving
  contexts
• Non-maximizing attitudes (Nord, Ubel, Dolan)
• Nords result that liberals in Norway were more
  inclined to favor worst off than conservatives
  (less straightforwardly maximizers)
• Valuation of Risks
• Control, novelty, concentration, etc -- how much
  weight to give these factors in resource
  allocation decisions

10
Patient Perspective on Limit Setting(Individual
or Population)

• Your drug or procedure or other care is not
  covered
• Why not?

• Contract exclusion
• enhancement
• experimental
• Not cost effective
• Not cost worthy
• Too expensive
• Lower priority

• Unsafe
• Ineffective
• Inappropriate

• Cuts profits
• Employers
• Plans

IS DENIAL TO ME or to US FAIR? DOES THE PLAN OR
AGENCY HAVE MORAL AUTHORITY?
11
Scope Of Legitimacy Problem

• Individual insurers (private plans)
• Social insurance or other public schemes
• In universal coverage and non-universal coverage
  systems
• In developed or developing countries
• Must be addressed in just or unjust systems

12
Fair Procedures

• Market accountability?
• Voting?
• Deliberative democratic process

13
Two Concepts of Accountability Market
Accountability

• Market accountability
• Information about performance and options
  available to purchasers and enrollees
• Choice of plan legitimizes limits
• Choice of paying out of pocket
• Buying medical insurance is not like buying car
• Uncertainty
• About needs
• About quality for price
• Exit problem
• No choice for 50 of employees with insurance
• No exit

14
Two Concepts of Accountability Accountability
for Reasonableness

• Four conditions on process
• Publicity
• Reasons or rationales for important decisions and
  indirect limit-setting structures publicly
  available
• Relevance
• Fair-minded people agree they are aimed at
  pursuing appropriate patient care under resource
  constraints
• Revisability/Appeals
• Fair Appeals procedure
• Enforcement/Regulation

15
Growth Hormone Therapy Illustration

• Biosynthetic Growth Hormone
• Announced policy (Medical Directors Letter)
• Only for children with Growth Hormone Deficiency
  or Turners Syndrome
• Only for those with drug benefit
• Unstated reasons (interviews, minutes)
• Growth hormone not shown effective for non-GHD at
  time of decision (NB Can change with evidence)
• Shortness disadvantageous, but not a disease or
  disability (NB Moral issue about goals of
  medicine important to be explicit)

16
Game of Healthcare Delivery

• Common good of the game
• Meeting diverse healthcare needs fairly under
  resource constraints
• Rules of the game
• Reasons that we agree are relevant to pursuing
  common good or goal of the game
• Fair-minded people
• Eschew mere advantage in favor of conformity to
  rules or reasons all can agree are aimed at
  common good of the game
• Managers Can patients be fair-minded?
• Patients Can managers or purchasers be
  fair-minded?

17
Case Law Counters Distrust

• Presumption of similar treatment for similar
  cases
• Commitment to coherent use of reasons
• Similarity defined by reference to reasons and
  principles
• Rebuttal
• Show relevant difference in cases
• Show rationale for revising principle
• Public record of commitments - behavior matches
  pronouncements

18
Relevant Reasons

• Clearer cases
• Safety
• Efficacy
• Treatment/enhancement
• Problem cases
• Profitability
• Market stability
• Most cases
• Cost and cost effectiveness
• Urgency vs proof of efficacy

19
Some Implications

• Implicit vs explicit rationing debate
• Divergent results of fair process
• Consumer voice
• Social learning curve
• Contribution to democratic deliberation

20
Middle PathBetween Explicit And Implicit

• Explicit
• Transparency about reasons
• Case Law accumulation of precedents
• Implicit
• Not all reasons agreed upon prior to fair process
• Decisions made at various levels with expert
  input
• Best of both worlds
• Justifiability
• Flexibility

21
Divergent ResultsTreating Equals Similarly?

• Formal principle of justice treat like cases
  alike
• Fair process can lead to similar cases getting
  different results if different decision-makers
  weigh issues differently
• Political issue in many systems
• Is this violation of formal principle?
• Does fair process mean we have different cases?
• Analogy to coin toss

22
Consumer/Community Voice

• Weakness of traditional justifications
• Improves democracy
• Proxy consent
• Facilitates accountability for reasonableness
• Improves transparency
• Improves deliberation about relevant reasons
• Requires institutional support

23
Applications

• New technologies
• Last chance therapies
• Formulary construction
• Developing country applications

24
Ethical Template

• Maps hierarchy to reasonable rationales
• Framework for ethical evaluation of
• Plan design
• Plan implementation
• Useful to
• Purchasers, unions
• Benefit managers
• Members
• Physicians
• Pharmacists
• Legislators/regulators

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Ethical Template (cont.)
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Improving Accountability

• In Plan Design
• Articulation of template connecting goals,
  types of purchaser, plausible rationales
• Involvement of stakeholders in development of
  template
• In Plan Adoption
• Review of goals
• Refinement for specific case
• Involvement of stakeholders
• In Plan Implementation
• Transparency carried over from plan design and
  plan adoption
• Appeals process, with feedback to reconsideration
  of plan design

27
Last Chance Therapies

• Third rail of limit setting
• Child B in England (Ham and Pickard 1998)
• Similar cases in Norway, New Zealand, elsewhere
• BC/BS experience in Oregon
• Lessons
• Desperate family
• Process is key
• Opportunity for social learning
• Reasonable limits can be sustained

28
Social Learning

• Most countries have had little public discussion
  of limit setting
• Evidence that public education and discussion
  facilitates acceptance of reasonable limits
• Accountability for reasonableness contributes to
  that social learning model of transparency
• Learning about reasonable limits possible at
  every stage of development

29
New Areas of Work

• Meeting on value added of SLF/ Aug 2003
• Consumer Voice
• Defined Contribution template approach
• External Review mental health and other
• Formulary web page and consumer, clinician
  education