Medical Device Reimbursement Process
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Transcript of Medical Device Reimbursement Process
1/16
Service Package for Life Science
Start-Ups
Regulatory, Reimbursement, Quality and
Clinical Research
In Europe and the USA
UK Office:
27 Old Gloucester St.,
London WC1N 3AX
+44.208.099.7435
Israel Office:
6 Ha-Teena St.,
Modiin 71799
+972.50.837.1711
Amir Inbar,
CEO
Mediclever Ltd.
www.mediclever.com
2/16
2.Regulatory Landscape Report
• Regulatory status
• Device classification
• Intended use & indications for use
• Regulatory route
8.Prep. / App.
•Design dossier
•Technical file
•PMA
•510(k)
In a nut shell…
Main Decision Makers
Healthcare Providers
Payers
• Establish user base, Obtain stakeholders’ support
• Utilize existing reimbursement mechanisms or:
• Apply for new reimbursement mechanisms
9.Implementation1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
• Value story
• Economic model
• Reimbursement issues for clinical study protocol
• Stakeholders’ feedback
4.Evidence Planning
More Info / Pricing
Class III
Class II
Class I
US
Class I (NS/M)
Class I (S/M)
Class IIa
Class IIb
Class III
EU
6.Perform Clinical Study
•Clinical Eval. Report
7.Quality Manag. System
Reg
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•FDA QSR / ISO 13485
5.Clinical Study Protocol
3.Quality Management System
• Design Control procedures
• Other QS aspects essential for US and EU pre-study compliance
•Review and/or write protocol
3/16
In a nut shell…R
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Mediclever provides Reimbursement consulting
services in Europe and the USA.
Our partners coordinate and manage the
provision of Regulatory, Quality, and Clinical
Research services in Europe and the USA, in
collaboration with Mediclever.
4/16
Reimbursement Landscape Report
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reim
bu
rsem
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t • In order to define the existing reimbursement scenario for a new product (drug or device), we start with the Reimbursement Landscape Report.
In the Reimbursement Landscape Report we:
• Analyze the relevant market/s, providing numbers of currently conducted procedures, type of Payers (insurance companies) that finance them and overall spending.
• Find out whether there are any existing codes, coverage policies and payment mechanisms that could be utilized or compared to, by the new medical product.
5/16
Main Decision Makers
Healthcare Providers
Payers
Decision Makers and Initial Strategy
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reim
bu
rsem
en
t This enables us to:
• Define the most relevant Decision Makers for the reimbursement of your new product.
• Formulate an initial reimbursement strategy for your new product in the selected markets (Europe, US).
6/16
2.Regulatory Landscape Report
• Regulatory status
• Device classification
• Intended use & indications for use
• Regulatory route
Regulatory Landscape Report
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reg
ula
tory
, Q
uality
an
d C
lin
ical
Researc
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Reim
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t • In parallel, or immediately after the Reimbursement Landscape Report is submitted, our partners provide the Regulatory Landscape Report to determine the product’s classification, intended use, indications for use and the anticipated regulatory route.
Class III
Class II
Class I
US
Class I (NS/M)
Class I (S/M)
Class IIa
Class IIb
Class III
EU
• 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.
Main Decision Makers
Healthcare Providers
Payers
7/16
Main Decision Makers
Healthcare Providers
Payers
2.Regulatory Landscape Report
• Regulatory status
• Device classification
• Intended use & indications for use
• Regulatory route
Preparations for Clinical Study
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reg
ula
tory
, Q
uality
an
d C
lin
ical
Researc
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Reim
bu
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t 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.
Class III
Class II
Class I
US
Class I (NS/M)
Class I (S/M)
Class IIa
Class IIb
Class III
EU
5.Clinical Study Protocol
3.Quality Management System
• Design Control procedures
• Other QS aspects essential for US and EU pre-study compliance
•Review and/or write protocol
8/16
Main Decision Makers
Healthcare Providers
Payers
2.Regulatory Landscape Report
• Regulatory status
• Device classification
• Intended use & indications for use
• Regulatory route
Evidence Planning
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reg
ula
tory
, Q
uality
an
d C
lin
ical
Researc
h
Reim
bu
rsem
en
t
Class III
Class II
Class I
US
Class I (NS/M)
Class I (S/M)
Class IIa
Class IIb
Class III
EU
5.Clinical Study Protocol
3.Quality Management System
• Design Control procedures
• Other QS aspects essential for US and EU pre-study compliance
• Value story
• Economic model
• Reimbursement issues for clinical study protocol
• Stakeholders’ feedback
4.Evidence Planning
More Info / Pricing
At this stage, long before the clinical
study actually begins, we will plan the
required ‘evidence’ for the
reimbursement of your new product:
• Value Story: Lay out the clinical AND
economic benefits of using your new
product, from the identified Decision
Makers’ perspective.
• Economic Model: Quantify the
economic benefit, allow for sensitivity
analysis and later on, use it as a
sales tool.
• Reimbursement Related Parameters:
Integrate in the study protocol.
• Stakeholders’ Feedback: Don’t
gamble. Verify with our network
partners, representing relevant
Decision Makers, that they will indeed
finance the use of your new product if
the claims in the Value Story are
proven according to the presented
clinical study protocol.
•Review and/or write protocol
9/16
Main Decision Makers
Healthcare Providers
Payers
2.Regulatory Landscape Report
• Regulatory status
• Device classification
• Intended use & indications for use
• Regulatory route
Evidence Planning
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reg
ula
tory
, Q
uality
an
d C
lin
ical
Researc
h
Reim
bu
rsem
en
t
Class III
Class II
Class I
US
Class I (NS/M)
Class I (S/M)
Class IIa
Class IIb
Class III
EU
5.Clinical Study Protocol
3.Quality Management System
• Design Control procedures
• Other QS aspects essential for US and EU pre-study compliance
• Value story
• Economic model
• Reimbursement issues for clinical study protocol
• Stakeholders’ feedback
4.Evidence Planning
More Info / Pricing
•Review and/or write protocol
Raise funding:
• At this stage, in order to finance
their clinical trial, many
companies raise their growth
funding round (also referred as
Series A round).
Seed Funding Round A
10/16
Main Decision Makers
Healthcare Providers
Payers
2.Regulatory Landscape Report
• Regulatory status
• Device classification
• Intended use & indications for use
• Regulatory route
Clinical Study
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reg
ula
tory
, Q
uality
an
d C
lin
ical
Researc
h
Reim
bu
rsem
en
t
Class III
Class II
Class I
US
Class I (NS/M)
Class I (S/M)
Class IIa
Class IIb
Class III
EU
5.Clinical Study Protocol
3.Quality Management System
• Design Control procedures
• Other QS aspects essential for US and EU pre-study compliance
• Value story
• Economic model
• Reimbursement issues for clinical study protocol
• Stakeholders’ feedback
4.Evidence Planning
More Info / Pricing
6.Perform Clinical Study
•Clinical Eval. Report
Now, the clinical trial may be
conducted and the resulting
‘evidence’, 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.
•Review and/or write protocol
Seed Funding Round A
11/16
Main Decision Makers
Healthcare Providers
Payers
2.Regulatory Landscape Report
• Regulatory status
• Device classification
• Intended use & indications for use
• Regulatory route
Completion of Quality Management System
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reg
ula
tory
, Q
uality
an
d C
lin
ical
Researc
h
Reim
bu
rsem
en
t
Class III
Class II
Class I
US
Class I (NS/M)
Class I (S/M)
Class IIa
Class IIb
Class III
EU
5.Clinical Study Protocol
3.Quality Management System
• Design Control procedures
• Other QS aspects essential for US and EU pre-study compliance
• Value story
• Economic model
• Reimbursement issues for clinical study protocol
• Stakeholders’ feedback
4.Evidence Planning
More Info / Pricing
6.Perform Clinical Study
•Clinical Eval. Report
Completion of QMS
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.
7.Quality Manag. System
•FDA QSR / ISO 13485
•Review and/or write protocol
Seed Funding Round A
12/16
Main Decision Makers
Healthcare Providers
Payers
2.Regulatory Landscape Report
• Regulatory status
• Device classification
• Intended use & indications for use
• Regulatory route
Regulatory Application
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reg
ula
tory
, Q
uality
an
d C
lin
ical
Researc
h
Reim
bu
rsem
en
t
Class III
Class II
Class I
US
Class I (NS/M)
Class I (S/M)
Class IIa
Class IIb
Class III
EU
5.Clinical Study Protocol
3.Quality Management System
• Design Control procedures
• Other QS aspects essential for US and EU pre-study compliance
• Value story
• Economic model
• Reimbursement issues for clinical study protocol
• Stakeholders’ feedback
4.Evidence Planning
More Info / Pricing
6.Perform Clinical Study
•Clinical Eval. Report
7.Quality Manag. System
•FDA QSR / ISO 13485
8.Prep. / App.
•Design dossier
•Technical file
•PMA
•510(k)
At this point the company may
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…
•Review and/or write protocol
Seed Funding Round A
13/16
• Establish user base, Obtain stakeholders’ support
• Utilize existing reimbursement mechanisms or:
• Apply for new reimbursement mechanisms
9.Implementation
Main Decision Makers
Healthcare Providers
Payers
Reimbursement Application
1.Reimbursement Landscape Report
• Relevant, codes, coverage & payment
• Reimbursement strategy
More Info / Pricing
Reg
ula
tory
, Q
uality
an
d C
lin
ical
Researc
h
Reim
bu
rsem
en
t
5.Clinical Study Protocol
• Value story
• Economic model
• Reimbursement issues for clinical study protocol
• Stakeholders’ feedback
4.Evidence Planning
More Info / Pricing
6.Perform Clinical Study
•Clinical Eval. Report
7.Quality Manag. System
•FDA QSR / ISO 13485
8.Prep. / App.
•Design dossier
•Technical file
•PMA
•510(k)
In case existing reimbursement mechanisms
(Codes, Coverage, Payment) were allocated in
the Reimbursement Landscape Report, we will
• Compile the Value Story, Economic Model and
the published ‘evidence’ into a dossier that
would be used to convince Healthcare
Providers to purchase your new product.
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.
•Review and/or write protocol
Seed Funding Round A
14/16
15/16
Costs
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16/16
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