Healthcare Regulators –Support, Judge, Jury

& Executioner?

Jan Maarten van den Berg, MDPhilippe Michel, MD, PhD

Links of interest

NONE

The problemData based on the Dutch situation

• Some operations are so complex that minimal experience is required

• 10 fold difference in mortality between • 1/year and 20/year

• You commission a report to analyze the problem and give recommendations on changes

DilemmaWe don’t know how what change:

Yes No

• The Health Care Council published the report on concentrating high risk procedures in 40 hospitals in 1991

• Result: no change for 15 years.

Yes

Go to no(t enough)

• Add Power: the government should set the minimal requirements:

Not enoughThe problem is not enough power behind the change:

Yes No

• The government set the minimal requirements on valvular implants;

• The result: 10 > court cases; eventually all lost. All potential hospitals started procedure

Yes

Go to no(t enough)

• Do more research!

Not enoughThe problem is not enough evidence!:

Yes No

• Somebody already did:

• Approximately 6000 articles on volume

• And used lots of creativity: many different cut of points.

• Result: More fuel for discussions, unfit for decisions

Yes

Go to no(t enough)

The individual complexity of each operation is crucial

• Set minimal standards for each operation

Yes No

Yes

• Every specialty sets it’s own standards: • Result:

– Lengthy discussions! (see evidence)– My operation is more complex than yours

• Race for higher numbers

– Large number of variable standards with tendency to regression: Urology

– Internal divisions in professional bodies

Yes

• One standard norm (20/year), with exceptions• Result:

– short discussions– Predictable outcome, anticipation possible– Large number of standards

– But are standards followed?

No: the critical process is learning of complex procedures

Minimum standards are compulsory

• (that’s why they are minimal)

Yes No

Yesminimum standards are compulsory

• Result: – main discussion before acceptation– Gives authority to professional bodies– Encourages implementation– Large break in culture

• Result: – delay in implementation. Appeal process first.– Inspection becomes arbiter of conflict– Main discussion after implementation– Discussion with small hospitals

No: in exceptional circumstances (e.g. distance) a lower number is acceptable

First line of controll should be

Insurers Government

Insurers

• First step in selective contracts• Implementation within 1 (one) year• Adhere to professionals standards

– (if not see you in court)• Involvement of patient bodies

– If not suspicion of motives• New system of data collection• No final decision

Insurers

• Political process• Appeal through parliament and courts• First line: requires constant focus and

manpower• Good as second line, always in combination• To flexible to serve as first line

Government / inspection

Implementing standards has visible results

Yes No

• Concentrating Pancreatic resections halves national operative mortality (11 > 5% in 4 years)

• Concentrating Oesophaguscardia resections halves operative mortality (12 > 3% in 4 years in one region)

• For 10 interventions 30 day mortality 25% reduction

Yes

• There is no discernible difference in mortality in concentrating high volume /low risk operations.

• But lack of improvement is excellent indicator– What prevents people from learning?

No

Summary of Dutch actions

• Report publication

• Minimal requirement publication

• Literature review publication

• Professional society decisions

• Minimum standard setting

• Control

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• Engage professionals

and hospitals

• Bring evidence

• Involve professional

societies

• Regulate

• Control

objectivesAction

Professional or administrative regulation?

• Solutions that are envisaged today may not apply tomorrow

• Changes start at the local level and depend on professional engagement

• Local improvement needs to link – the quality dimensions of efficacy, safety and access – to the patient’s pathway

• Now evidence that patient centeredness and involvement improve outcomes

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Designing safer health care through responsive regulationHealy J, Braithwaite J

MJA 2006; 184: S56–S59

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National report

Minimal requirements

Minimum standard compulsory

Prof societies defining their own requirements

Literature review

Control

Any missing initiatives you would advise Holland to do???

• “Enforced self-regulation is often more promising than a “command and control” strategy.

• Research evidence on the responsive regulatory pyramid and its options offers lessons for health care policy makers and managers.

• Start at the base of the regulatory pyramid: try persuasion first; move up the pyramid to secure compliance, and then be willing to move back down.

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Designing safer health care through responsive regulationHealy J, Braithwaite J

MJA 2006; 184: S56–S59

Dilemmathe problem is awareness:

• Publishing data on differences in mortality is enough?

Yes No

The Amsterdam Academic Medical Centre (AMC)

Published the result and published the change after publication in a number of leading dutch magazines:

Change: 0Go to no(t enough)

Yes

Not enough

• There is evidence for a perfect cut off point

The problem is the wrong concept:

Yes No

• Cut off points are an artifact out of the field of epidemiology

• Divide population in two groups and find a difference:

• The cut off point is the desciptor of the division, not the cause

Yes

insufficient

perfect

5 per year

No: gradual changeThe limit is a policy decision!

Mortality

Numbers / year

In terms of conclusion…• Policy reports change little• Professional bodies should set the standard• Enough research has to be be done• The decision is political with professional bodies involvement• A general standard is preferable• Minimal standards are really minimal• Insurers first line, inspection/regulator second• Results can be spectacular for the right topics• Administrative and professional regulation hand-in-hand • … and don’t forget separate evaluation and decision bodies