Skip to main content

Table 1 Overview of the fourth hurdle for ACI

From: Clearing up the hazy road from bench to bedside: A framework for integrating the fourth hurdle into translational medicine

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
  1. 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;