Table 1.

Overview of the fourth hurdle for ACI

Payer	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
Assessment	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)
Reimbursement	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
Publication	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;