2019-05-German Reimbursement WelfareTech FINAL - Read-Only · Slide 2| 24.05.2019 Market...
Transcript of 2019-05-German Reimbursement WelfareTech FINAL - Read-Only · Slide 2| 24.05.2019 Market...
Germany‘s healthcare market
Slide 2 | 24.05.2019
Market Participants
State insurance109 (85%)
Private insurance44 (11%)
Hospitals1 948
Nursing homes13 596
Home-care nursing13 323
“Sanitätshäuser“7 500
Pharmacies18 880
Physicians, Physiotherapists ..
Health Insurance
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Germany‘s Reimbursement Process
Hilfsmittelverzeichnis(HMV)
Product listing
Review
Supply
Application
Approval
Contract
109 HealthInsurances
Contract
Healthcare-Provider
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HMV/PHMV -Database
I. Healthcare Market III. Reimbursement IV. Excursus
Group Product types Group Product types
01 Suction devices 20 Positioning support
02 Adaption aids 21 Measurement-device for bodily funcions
03 Application aids 22 Mobility aids
04 Bathing aids 23 Orthoses
05 Braces 24 Breast prostheses
06 Radiotherapy devices 25 Device for the blind
07 Aid for the blind 26 Seating aids
08 Insoles 27 Speech devices
09 Electric stimulation devices 28 Standing aids
10 Walking aids 29 Stoma products
11 Aids against decubitus 31 Shoes
12 Aids for tracheostoma 32 Therapeutical motion devices
13 Hearing aids 33 Toilet aids
14 Respiratory devices 50 Aids to ease care
15 Incontinence aids 51 Aids for body hygene
16 Communication aids 52 Aids for independent living/mobility
17 Aids for compression-therapy 53 Aids for pain relief
18 Vehicles for disabled 54 One-time-use product waste
19 Patient care products 99 Various
42 product groupsmore than 600 subgroups
More than 1800 product typesApprox. 30 000 products
Online information:https://hilfsmittel.gkv-spitzenverband.de/home.actionhttps://www.rehadat-gkv.de/
Products for care„Pflegehilfsmittelverzeichnis“
10-digit reimbursement code
Group
MobilityBraces
Respitaroy
...
Application
IndoorsOutdoors
HandBody
...
Subgroup
FunctionalityWeight
Powered
...
Type
DesignMaterial
Other features
...
Product
Specific
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HMV-Code
XX XX XX X xxx
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Reimbursable Products (SGB V)
“...only products with one of the functionalities below can be listed”
• Necessary for the medical treatment success
• Prevent an imminent disability
• Compensate for disability
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Requirements for HMV-code
• I. Functionality• II. Safety• III. Special• III.1 Indication and application• III.2 Life time / durability• III.3 Re-use• IV. Medical benefits• V. User’s Instructions• VI. Additional
Statements and proofs• Declaration of Conformity• Medical case report• Product test report• Adjustments-statement
MDR 2017/745/EU(MDD 93/42/EEC)
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Application process
Hilfsmittelverzeichnis(HMV/PHMV)
submission fileforwarding
File review andevaluation
Internal and externalexperts
recommendation
Additional evaluation
e.g. check for legal status of
reimbursement
confirmation
Publishin HMV/PHMV 3-4 months
(best case scenario)
ammendments
deviations
APPL
ICAN
T
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Reimbursement amounts?
Fixed amount only forspecial products
Basically, contracts aboutproduct types and services
Contract partners:Health insurance andhealthcare provider
Clearing center as optional service provider
109Health-Insurances
70.000Healthcare-Provider
Contract
Clearing center(service provider)
Sanitätshäuser, pharmacies, audiologists, optcians, care servicesorthopadic shoemakeretc.
Barmer, TK, KKH, AOK (regional), IKK, DAK, BKK etc.
optadata,AZH, acriba, optica etc.
Contract Contract
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HMV Facts
CE mark is mandatory Additional RequirementsGerman Social Law (SGB V)
Further marketingis necessary
Opens door tomarket participants
Straightforwardreimbursement
Only manufacturersare registered
MDR 2017/745/EU
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Heil- und Hilfsmittelversorgungsgesetz – (HHVG)(Healing- and Technical-Aid Supply Law)
Frequent review Delete „old“ products
Stricter requirements
New rules
More patients forcase studies
Registration feesare possible
Report:product changes
Database update
Limited to specificindications
Thank you very much!
Contact:Olaf Meyer(Division Manager International Reimbursement)Beo MedConsulting BERLIN [email protected]+49 30 31804530