Germanys healthcare market Market Participants Hospitals Health - - PowerPoint PPT Presentation
Germanys healthcare market Market Participants Hospitals Health - - PowerPoint PPT Presentation
Germanys healthcare market Market Participants Hospitals Health Insurance Sanittshuser 1 948 5 500 Nursing homes State insurance Pharmacies 13 596 113 (85%) 18 880 Private insurance Home-care nursing Physicians, 44 (11%)
Slide 2 | 13. November 2018
Market Participants
State insurance 113 (85%) Private insurance 44 (11%) Hospitals 1 948 Nursing homes 13 596 Home-care nursing 13 323 “Sanitätshäuser“ 5 500 Pharmacies 18 880 Physicians, Physiotherapists .. Health Insurance
Slide 3 | 13. November 2018
Germany‘s Reimbursement Process
Hilfsmittelverzeichnis (HMV) Product listing Review Supply Application Approval Contract
113 Health Insurances
7500 Contract
Slide 4 | 13. November 2018
HMV-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 groups more than 600 subgroups More than 1800 product types
- Approx. 30 000 products
10-digit reimbursement code Group
Mobility Braces Respitaroy
... Application
Indoors Outdoors Hand Body
... Subgroup
Functionality Weight Powered
... Type
Design Material Other features
... Product
Specific
Slide 5 | 13. November 2018
HMV-Code
XX XX XX X xxx
Slide 6 | 13. November 2018
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“
Slide 7 | 13. November 2018
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)
Slide 8 | 13. November 2018
Application process
Hilfsmittelverzeichnis (HMV) submission file forwarding File review and evaluation Internal and external experts recommendation Additional evaluation e.g. check for legal status of reimbursement confirmation Publish in HMV 3-4 months (best case scenario)
ammendments deviations
APPLICANT
Slide 9 | 13. November 2018
HMV Facts
CE mark is mandatory Additional Requirements German Social Law (SGB V) Further marketing is necessary Opens door to market participants Straightforward reimbursement Only manufacturers are registered MDR 2017/745/EU
Slide 10 | 13. November 2018