Table 1

Overview of the fourth hurdle for ACI


Germany, Statutory

Health Insurance

England, National

Health Service

USA, Medicare

USA, Blue Cross

Blue Shield

Trigger of coverage decisions

All hospital services are covered unless excluded explicitly. Evaluation upon request of entitled parties (no manufacturers)

All ambulatory services are excluded unless included explicitly. Evaluation upon request of entitled parties (no manufacturers)

Technologies with significant health benefits, social/political effects, impact on NHS resources and added value through guidance by NICE

Initiation of National Coverage Determination: Internally by CMS, external request by interested or aggrieved parties. Only services with considerable impact on the program are evaluated

Initiation of Local Coverage Determination: Internally by the contractor in case of need and in the absence of a NCD

Initiation on company-level, e.g. with Anthem internally by Medical Directors; externally by physicians, manufacturers, HTA organizations

Deciding committee

G-BA, Commission for hospital services [27]

G-BA, Commission for ambulatory services [27]

Independent Appraisal Committee on behalf of NICE [28]

CMS [78]

Contractor's Medical Director [78]

Mostly committee or Medical Director


Review of evidence of medical benefit in patient-relevant endpoints [15,30,35,42]; HTA potentially by the Institute of Quality and Efficiency in Health Care

Cost-utility model based on all evidence available by contracted technology assessment team; threshold area about £20–30.000/QALY) [79]

Review of evidence of medical benefit; HTA potentially by Agency for Healthcare Research and Quality; by other HTA institution; or by Medicare Coverage Advisory Committee [8]

Review of evidence of medical benefit; HTA potentially by external institution [8]

Review of evidence of medical benefit; HTA potentially by Technology Evaluation Committee or other HTA institution [9]

Criteria for Appraisal

Expedience, necessity and efficiency

Effectiveness and cost-effectiveness

Reasonable and necessary

Reasonable and necessary

Medically necessary (Approval, evidence for net health benefits, as beneficial as established alternatives, attainable outside investigational settings)


In-patient: DRGs

Out-patient: Fee for service

Global budgets for PCTs; DRGs paid by PCTs for hospital services

DRGs/Fee-for-service/budgets (MCOs)

Management of service provision

e.g. quality assessment of doctors

e.g. requirement of participation in clinical trial

e.g. preauthorization

Participation of company

Consideration of written comments

Comments about open issues, HTAs and provisional decision; submission of model, appeal possible

Defined periods for comments of all interested parties

Heterogeneous; contractors are required to permit participation

Heterogeneous; mainly participation of medical experts


Amongst others, current open issues, assessment reports and decisions are available through the internet

Process, assessment and appraisal available through the internet

Current open issues and decisions are available through the internet

Written communication in the jurisdiction of the contractor; also available through the internet

Heterogeneous; medical policies often available through the internet

Abbreviations: CMS Centers for Medicare and Medicaid Services; DRG Diagnosis-Related Group; G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee); HTA Health Technology Assessment; MCO Managed Care Organization; NICE National Institute of Health and Clinical Excellence; PCT Primary Care Trust;

Rogowski et al. BMC Health Services Research 2008 8:194   doi:10.1186/1472-6963-8-194

Open Data