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Reimbursement Update Germany
1.S.002
July 14th, 2016 Page 1
- AiM. A company of the IGES Group.
1.S.002
Assessment in Medicine
Reimbursement Update Germany
1.S.002
July 14th, 2016 Page 2
Reimbursement Update Germany Michael Weier, AiM GmbH GTAI Webinar, - - PowerPoint PPT Presentation
Reimbursement Update Germany Michael Weier, AiM GmbH GTAI Webinar, - - PowerPoint PPT Presentation
Assessment in Medicine Reimbursement Update Germany Michael Weier, AiM GmbH GTAI Webinar, 14 July 2016 1.S.002 1.S.002 Reimbursement Update Germany AiM. A company of the IGES Group. July 14 th , 2016 Page 1 Who we are IGES Group The
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Reimbursement Update Germany
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Contents
- 1. Reimbursement Update Germany
1.1 Overview of inpatient and outpatient settings 1.2 How to maximize reimbursement on top of German DRG lump sums: the “NUB” strategy 1.3 Summary
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Reimbursement Update Germany
1.S.002
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Assessment in Medicine
- 1. Reimbursement Update Germany
1.1 Overview of inpatient and outpatient settings
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Reimbursement Update Germany
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Inpatient
Reimburseability = subject to prohibition = given, as long as no basic principles of quality of care and/or efficiency are violated
Coverage principles Germany
Outpatient
Reimburseability = subject to approval
Germany
European Market Approval – CE Mark
Innovative medical device defining a new diagnostic or therapeutic method
Source: Own Illustration
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Reimbursement Update Germany
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Reimbursement: Inpatient setting ICD- 10 GM OPS DRG
Extra rates (ZE) Innovation payments, new diagnostic or therapeutic methods (NUB)
Running costs per case Diagnosis Codes Procedure Codes One DRG (lump sum payment) per case Potentially applicable in addition to the DRG payment:
Source: Own Illustration
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Reimbursement Update Germany
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Reimbursement: Outpatient setting
Centralized coverage decision Regulations / Payment schemes Initiators Insuran- ces Health Care Providers
Separate contracts
KBV GKV- Spitzen verband
EBM G-BA SHI Scheme
De-centralized coverage decision
Single insuran- ces Health Care Providers
GKV-Spitzenverband: Federal association of statutory health insurances, KBV: GKV-registered physician association, G-BA: Joint Federal Committee, EBM: Physician Fee Schedule under the statutory health insurance scheme
Source: Own Illustration
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Reimbursement Update Germany
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Assessment in Medicine
- 1. Reimbursement Update Germany
1.2 How to maximize reimbursement on top of German DRG lump sums: the “NUB” strategy
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Reimbursement Update Germany
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The NUB process so far
- Two step approach:
- 1. Application by hospitals (to the DRG institute, InEK) September / October
- 2. If application approved: negotiations (individual hospital vs. insurances)
- So far: no official assessment of benefit / clinical evidence in this process
Source: Own illustration
Reimbursement Level = NUB negotiations yes/no Result by Jan. 31st
DRG-related NUB assessment InEK
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Reimbursement Update Germany
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The NUB process of the future
- ”Health Care Strengthening Law” introducing § 137h Social Code
Book (SGB) V
- From 2016 onwards: benefit assessment conducted by G-BA
- For methods using…
medical devices of “risk” class IIb and III
- r active implants
with an especially invasive character …providing a… new scientific theoretical concept …for which a (first-ever) NUB application …is submitted.
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The NUB process of the future
Source: Own Illustration
G-BA
Reimbursement Level = NUB negotiations yes/no Result by Jan. 31st
No communication / no interaction between InEK and G-BA DRG-related NUB assessment InEK
Rapid Benefit Assessment
Coverage status = Will GKV pay for it at all? Result 3 months after start of assessment
If method is subject to the new process, two assessment lines apply:
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Reimbursement Update Germany
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The G-BA NUB assessment outcomes
Neither “potential” nor benefit proven
Immediate decision about exclusion from SHI coverage, § 137c SGB V
No benefit proven but attested “potential to be a necessary treatment alternative”
Decision about testing regulation guideline, § 137e SGB V, within 6 months & “commonly” testing within 2 years & coverage decision on the basis of trial results
Benefit proven
Potentially official quality guideline, § 137 SGB V
Source: Own Illustration
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Reimbursement Update Germany
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Coverage with evidence development
Federal-wide coverage decision, inpatient setting
Trial Trial data
Based upon § 137e SGB V, in existence since 2012
Source: Own illustration
Co-funded by the relevant manufacturers (overhead costs) German centers
- nly
High evidence requirements expected
No benefit proven but attested “potential to be a necessary treatment alternative”
Decision about testing regulation guideline, § 137e SGB V, within 6 months & “commonly” testing within 2 years & coverage decision on the basis of trial results
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Assessment in Medicine
- 1. Reimbursement Update Germany
1.3 Summary
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Reimbursement Update Germany
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Summary
- In general, more clinical evidence required than ever
- First bricks in the wall of the inpatient „subject to prohibition“
principle in Germany
- Manufacturers have to prepare more carefully before entering
the German inpatient market
- If subject to the new NUB process, clinical evidence will play a
crucial role now – either existing (lacking) evidence, or evidence to be developed via the CED program
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Reimbursement Update Germany
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- AiM. A company of the IGES Group.
1.S.002
Assessment in Medicine
AiM GmbH Michael Weisser
- COO -