Germanys healthcare market Market Participants Hospitals Health - PowerPoint PPT Presentation

Germany‘s healthcare market

Market Participants Hospitals Health Insurance “Sanitätshäuser“ 1 948 5 500 Nursing homes State insurance Pharmacies 13 596 113 (85%) 18 880 Private insurance Home-care nursing Physicians, 44 (11%) 13 323 Physiotherapists .. Slide 2 | 13. November 2018

Germany‘s Reimbursement Process Application Review Approval Product listing Hilfsmittelverzeichnis (HMV) Contract 113 Health Insurances 7500 Supply Contract Slide 3 | 13. November 2018

HMV-Database 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 42 product groups 06 Radiotherapy devices 25 Device for the blind more than 600 subgroups 07 Aid for the blind 26 Seating aids More than 1800 product types 08 Insoles 27 Speech devices 09 Electric stimulation devices 28 Standing aids Approx. 30 000 products 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 I. Healthcare Market 18 Vehicles for disabled III. Reimbursement 54 One-time-use product waste IV. Excursus 19 Patient care products 99 Various Slide 4 | 13. November 2018

HMV-Code 10-digit reimbursement code Product Type Group Application Subgroup X xxx XX XX XX Specific Design Mobility Indoors Functionality Material Braces Outdoors Weight Other Respitaroy Hand Powered features Body ... ... ... ... Slide 5 | 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 6 | 13. November 2018

Requirements for HMV-code • I. Functionality Statements and proofs • Declaration of Conformity • II. Safety • Medical case report • III. Special • Product test report • III.1 Indication and application • Adjustments-statement • III.2 Life time / durability • III.3 Re-use • IV. Medical benefits • V. User’s Instructions MDR 2017/745/EU • VI. Additional (MDD 93/42/EEC) Slide 7 | 13. November 2018

Application process forwarding submission file recommendation APPLICANT Additional deviations File review and evaluation evaluation e.g. check for legal Internal and external status of experts reimbursement ammendments Publish in HMV 3-4 months (best case scenario) confirmation Hilfsmittelverzeichnis (HMV) Slide 8 | 13. November 2018

HMV Facts Additional Requirements CE mark is mandatory German Social Law (SGB V) MDR 2017/745/EU Further marketing Opens door to is necessary market participants Only manufacturers Straightforward are registered reimbursement Slide 9 | 13. November 2018

Heil- und Hilfsmittelversorgungsgesetz – (HHVG) ( He a ling- and Technical-Aid Supply Law ) Delete „old“ Frequent review Database update products More patients for Limited to specific Stricter requirements case studies indications Registration fees Report: product New rules are possible changes Slide 10 | 13. November 2018

Thanks and have a successfull exhibition