mHealth Israel_Synchronizing Reimbursement and Regulatory Activities_Amir Inbar_Mediclever
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Synchronizing Reimbursement and Regulatory Activities by Amir Inbar, CEO, Mediclever.
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mHealth Israel_Synchronizing Reimbursement and Regulatory Activities_Amir Inbar_Mediclever
- 1. 1 / 18 Copyright Š 2016 Mediclever Ltd. Synchronizing Reimbursementand RegulatoryActivities Navigate your reimbursement pathway smarter. UK Office: ⢠27 Old Gloucester St., London WC1N 3AX ⢠uk@mediclever.com ⢠+44.208.099.7435 Israel Office: ⢠3b Lubetkin St., Herzliya 46409036 ⢠il@mediclever.com ⢠+972.9.835.6790 US Office: ⢠616 Corporate Way, Suite 2-4683, Valley Cottage, NY 10989 ⢠us@mediclever.com ⢠+1.845.570.2910 About Services Resources Š Copyright 2016 Mediclever Ltd. All rights reserved. Neither this presentation nor any information it contains may be published, reproduced or used for any commercial purpose without prior written approval from Mediclever.
- 2. 2 / 18 Copyright Š 2016 Mediclever Ltd. In a Nut Shell ⢠Weâve successfully guided hundreds of life science clients from around the world in commercializing their medical devices, pharmaceuticals and apps. ⢠We assume full responsibility for the entire process of obtaining reimbursement, hospital funding or out-of-pocket payment - from start to finish. ⢠Learn more about our unique approach here. ⢠Coordinate and manage the provision of Regulatory, Quality, and Clinical Research services. ⢠Synchronize these activities with our clientsâ reimbursement activities. OurPartners ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote
- 3. 3 / 18 Copyright Š 2016 Mediclever Ltd. Reimbursement LandscapeOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms The purpose of this step is to understand the current reimbursement environment relevant for your device/drug. a. Available reimbursement mechanisms: Are there any specific codes, payment rates and coverage policies that address the device or drug? If not, which new mechanisms need to be developed (e.g., a new code, an expansion of a coverage policy, a new payment rate to an existing code or all of the above)? ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote
- 4. 4 / 18 Copyright Š 2016 Mediclever Ltd. Reimbursement LandscapeOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms b. Decision Makers Healthcare Providers Payers The purpose of this step is to understand the current reimbursement environment relevant for your device/drug. a. Available reimbursement mechanisms: Are there any specific codes, payment rates and coverage policies that address the device or drug? If not, which new mechanisms need to be developed (e.g., a new code, an expansion of a coverage policy, a new payment rate to an existing code or all of the above)? b. Decision makers: ⢠In case available existing mechanisms were identified in the above 1a, the main decision makers are healthcare providers. No need to approach payers. ⢠In case new mechanisms need to be developed, the main decision makers are typically payers. ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote
- 5. 5 / 18 Copyright Š 2016 Mediclever Ltd. Reimbursement LandscapeOurPartners The purpose of this step is to understand the current reimbursement environment relevant for your device/drug. a. Available reimbursement mechanisms: Are there any specific codes, payment rates and coverage policies that address the device or drug? If not, which new mechanisms need to be developed (e.g., a new code, an expansion of a coverage policy, a new payment rate to an existing code or all of the above)? b. Decision makers: ⢠In case available existing mechanisms were identified in the above 1a, the main decision makers are healthcare providers. No need to approach payers. ⢠In case new mechanisms need to be developed, the main decision makers are typically payers. c. Reimbursement strategy: An outline of the typical path for obtaining third-party reimbursement or any other sort of funding, including milestones and timelines, along with an initial reimbursement strategy for the device or drug in each of the selected countries. 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote
- 6. 6 / 18 Copyright Š 2016 Mediclever Ltd. Reimbursement LandscapeOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote C a s e S t u d y existing reimbursed codes. The company was left with one of two options: 1) Develop new reimbursement mechanisms for their product â a long and costly process, or: 2) Redesign the product to fit under existing pressure settings â another costly alternative requiring a new clinical study and regulatory clearance. Had the company conducted the Reimbursement Landscape in time, setting the appropriate pressure range would be easy and would mean having a reimbursed device in the market today. One of our clients developed and launched a product in the US market which included a pressure pump. Unfortunately, the pressure settings employed by the pump deviated from the allowable range specified under the
- 7. 7 / 18 Copyright Š 2016 Mediclever Ltd. Regulatory LandscapeOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers 2.Regulatory Landscape ⢠Regulatory status ⢠Device classification ⢠Intended use & indications for use ⢠Regulatory route Class III Class II Class I US Class I* Class I Class IIa Class IIb Class III EU ⢠In parallel, or immediately after the Reimbursement Landscape Report is submitted, our partners provide the Regulatory Landscape Report to determine the productâs classification, intended use, indications for use and the anticipated regulatory route. ⢠Sometimes regulatory status and classification are different between EU and US, and this needs to be taken into account when formulating regulatory, reimbursement and marketing strategies. ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote * Non-sterile without measuring function
- 8. 8 / 18 Copyright Š 2016 Mediclever Ltd. Regulatory LandscapeOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers 2.Regulatory Landscape ⢠Regulatory status ⢠Device classification ⢠Intended use & indications for use ⢠Regulatory route Class III Class II Class I US Class I* Class I Class IIa Class IIb Class III EU ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote * Non-sterile without measuring function C a s e S t u d y One of our clients asked us to start working on their reimbursement strategy after applying for, and receiving, the regulatory clearance. Unfortunately, the wording that was used in the regulatory application substantially decreased the likelihood of reimbursement. Consequently, the company re-applied for the regulatory clearance, this time, with a modified indication for use. Needless to say, this delayed the launch of the product resulting in substantial loss to the company. In this stage we make sure both reimbursement and regulatory strategies are aligned.
- 9. 9 / 18 Copyright Š 2016 Mediclever Ltd. Preparations for Clinical Study OurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers At the next stage, when the company prepares for its clinical study (if needed, see chart below), it typically: ⢠Implements the relevant parts of its Quality Management System (e.g., Design Controls and other QS aspects essential for US and EU pre-study compliance). ⢠Writes its clinical study protocol. 2.Regulatory Landscape ⢠Regulatory status ⢠Device classification ⢠Intended use & indications for use ⢠Regulatory route Class III Class II Class I US Class I* Class I Class IIa Class IIb Class III EU 5.Clinical Study Protocol â˘Review and/or write protocol 3.Quality Management System ⢠Design Control procedures ⢠Other QS aspects essential for US and EU pre- study compliance ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote
- 10. 10 / 18 Copyright Š 2016 Mediclever Ltd. Reimbursement PlanningOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers Prior to initiating a clinical study, we plan how to generate the required reimbursement-related âevidenceâ, from the identified Decision Makersâ (i.e. Healthcare Providersâ / Payersâ) perspective: a. Value Story: Highlights the clinical AND economic benefits of the new product. b. Economic Model: Quantifies the economic benefit, allows for sensitivity analysis and utilized as a pricing tool. c. Reimbursement Related Parameters: Integrated in the study protocol. d. Stakeholdersâ Feedback: Used to validate decision makersâ agreement to pay for the product based on the presented plan. a. Value story b. Economic model c. Reimbursement issues for clinical study protocol d. Stakeholdersâ feedback 4.Reimbursement Planning 2.Regulatory Landscape ⢠Regulatory status ⢠Device classification ⢠Intended use & indications for use ⢠Regulatory route Class III Class II Class I US Class I* Class I Class IIa Class IIb Class III EU 5.Clinical Study Protocol â˘Review and/or write protocol 3.Quality Management System ⢠Design Control procedures ⢠Other QS aspects essential for US and EU pre- study compliance ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote
- 11. 11 / 18 Copyright Š 2016 Mediclever Ltd. Reimbursement PlanningOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers a. Value story b. Economic model c. Reimbursement issues for clinical study protocol d. Stakeholdersâ feedback 4.Reimbursement Planning 2.Regulatory Landscape ⢠Regulatory status ⢠Device classification ⢠Intended use & indications for use ⢠Regulatory route Class III Class II Class I US Class I* Class I Class IIa Class IIb Class III EU 5.Clinical Study Protocol â˘Review and/or write protocol 3.Quality Management System ⢠Design Control procedures ⢠Other QS aspects essential for US and EU pre- study compliance ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote C a s e S t u d y One of our clients developed clinical data for their product and invited us to help them develop specific reimbursement mechanisms for it. All payers were impressed by the developed clinical 'evidence', but wanted the company to also present data regarding a few economic aspects. Since these economic aspects were not observed during the company's previous clinical trial, the company had to perform a new trial to gather the requested data. Had the company thought about its reimbursement strategy prior to initiating the clinical trials, those economic aspects could have been easily integrated into their previous trials making the investment in a new trial, and the delay in the sale of their product, redundant.
- 12. 12 / 18 Copyright Š 2016 Mediclever Ltd. Clinical StudyOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers a. Value story b. Economic model c. Reimbursement issues for clinical study protocol d. Stakeholdersâ feedback 4.Reimbursement Planning ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote 2.Regulatory Landscape ⢠Regulatory status ⢠Device classification ⢠Intended use & indications for use ⢠Regulatory route Class III Class II Class I US Class I* Class I Class IIa Class IIb Class III EU 5.Clinical Study Protocol â˘Review and/or write protocol 3.Quality Management System ⢠Design Control procedures ⢠Other QS aspects essential for US and EU pre- study compliance 6.Perform Clinical Study â˘Clinical Eval. Report Now, the clinical study may be conducted and the resulting âevidenceâ, substantiating the claims in the Value Story, should be published. The Clinical Evaluation Report (CER) should now be prepared, based on official European guidance. CER may also be useful for US submissions.
- 13. 13 / 18 Copyright Š 2016 Mediclever Ltd. QMS CompletionOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers a. Value story b. Economic model c. Reimbursement issues for clinical study protocol d. Stakeholdersâ feedback 4.Reimbursement Planning ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote At this stage, if the company has not already done so, the quality management system can be completed to ensure it complies with US and/or European requirements. 2.Regulatory Landscape ⢠Regulatory status ⢠Device classification ⢠Intended use & indications for use ⢠Regulatory route Class III Class II Class I US Class I* Class I Class IIa Class IIb Class III EU 5.Clinical Study Protocol â˘Review and/or write protocol 3.Quality Management System ⢠Design Control procedures ⢠Other QS aspects essential for US and EU pre- study compliance 6.Perform Clinical Study â˘Clinical Eval. Report 7.Quality Manag. System â˘FDA QSR / ISO 13485
- 14. 14 / 18 Copyright Š 2016 Mediclever Ltd. Regulatory ApplicationOurPartners 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers Healthcare Providers Payers a. Value story b. Economic model c. Reimbursement issues for clinical study protocol d. Stakeholdersâ feedback 4.Reimbursement Planning ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote The company may now submit the Technical File or the Design Dossier (in Europe) or apply for FDA Clearance / Approval (in the US). If granted, it could start selling its products. To obtain reimbursement, see the next slide⌠2.Regulatory Landscape ⢠Regulatory status ⢠Device classification ⢠Intended use & indications for use ⢠Regulatory route Class III Class II Class I US Class I* Class I Class IIa Class IIb Class III EU 5.Clinical Study Protocol â˘Review and/or write protocol 3.Quality Management System ⢠Design Control procedures ⢠Other QS aspects essential for US and EU pre- study compliance 6.Perform Clinical Study â˘Clinical Eval. Report 7.Quality Manag. System â˘FDA QSR / ISO 13485 8.Prep. / App. â˘Design dossier â˘PMA â˘510(k) â˘Technical file
- 15. 15 / 18 Copyright Š 2016 Mediclever Ltd. 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers 6.Perform Clinical Study â˘Clinical Eval. Report 7.Quality Manag. System â˘FDA QSR / ISO 13485 8.Prep. / App. â˘Design dossier â˘PMA â˘510(k) â˘Technical file 9.Implementation a. User base, Obtain stakeholdersâ support b. Utilize existing reimbursement mechanisms or: c. Apply for new reimbursement mechanisms a. Value story b. Economic model c. Reimbursement issues for clinical study protocol d. Stakeholdersâ feedback 4.Reimbursement Planning Reimbursement Application Healthcare Providers Payers ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote In case we identified existing reimbursement mechanisms (Codes, Coverage, Payment) in Step 1 (Reimbursement Landscape), we ⢠Compile the Value Story, Economic Model and the published âevidenceâ into a dossier that serves as a sales tool under existing reimbursement mechanisms.
- 16. 16 / 18 Copyright Š 2016 Mediclever Ltd. 1.Reimbursement Landscape a. Available reimbursement mechanisms c. Reimbursement strategy b. Decision Makers 6.Perform Clinical Study â˘Clinical Eval. Report 7.Quality Manag. System â˘FDA QSR / ISO 13485 8.Prep. / App. â˘Design dossier â˘PMA â˘510(k) â˘Technical file 9.Implementation a. User base, Obtain stakeholdersâ support b. Utilize existing reimbursement mechanisms or: c. Apply for new reimbursement mechanisms a. Value story b. Economic model c. Reimbursement issues for clinical study protocol d. Stakeholdersâ feedback 4.Reimbursement Planning Reimbursement Application Healthcare Providers Payers ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote In case we identified existing reimbursement mechanisms (Codes, Coverage, Payment) in Step 1 (Reimbursement Landscape), we ⢠Compile the Value Story, Economic Model and the published âevidenceâ into a dossier that serves as a sales tool under existing reimbursement mechanisms. Otherwise: ⢠After verifying a sufficient user-base and support from the medical community, we will apply for new codes, coverage policies and favorable payment rates.
- 17. 17 / 18 Copyright Š 2016 Mediclever Ltd. Thank you for Reviewing ⢠Additional Free Articles ⢠Speak with a Reimbursement Expert ⢠Get our Quote To access additional articles, speak with one of our reimbursement consultants or receive a formal quote for our services, use the links on the top right corner. UK Office: ⢠27 Old Gloucester St., London WC1N 3AX ⢠uk@mediclever.com ⢠+44.208.099.7435 Israel Office: ⢠3b Lubetkin St., Herzliya 46409036 ⢠il@mediclever.com ⢠+972.9.835.6790 US Office: ⢠616 Corporate Way, Suite 2-4683, Valley Cottage, NY 10989 ⢠us@mediclever.com ⢠+1.845.570.2910 ⢠Coordinate a meeting with a reimbursement consultant during the J.P. Morgan Annual Healthcare Conference / Biotech Showcase: January 9-13, 2017. San Francisco, CA
- 18. 18 / 18 Copyright Š 2016 Mediclever Ltd.