2. Overview
• Introduction to U.S. reimbursement
• Strategic reimbursement plan
o Steps 1-4
• Tactics
• FDA
• Conclusion
3. Introduction to U.S. Reimbursement
• Pricing and reimbursement structure
o Patient, health service provider, and the payer
• Three payers
o Medicare, Medicaid, private
• Patient rarely pays or purchases the product,
always third party payer
• Codes used by payers to identify and price
products
• Terms:
o Payer or insurer = Insurance
4. Common Problems Companies Face
• Absence of codes that payers use to identify
products
• Denials because the product has been categorized
as investigational (depends on coverage policies)
• Payers may not approve products and write
coverage policies because of insufficient clinical data
• Payers provide inadequate payment to providers
Problems take time to resolve and require more
clinical evidence
5. Strategic Reimbursement Plan
Step 1: Who influences the use of the product
Step 2: Define the market model
Step 3: Identify coding gaps
Step 4: Determine regulatory or legislative issues
6. Step 1: Who influences the use of the product
• Medicare, Medicaid, private
• Reimbursement rates set by federal legislation
o Governs how much money providers and suppliers
receive
7. Step 2: Define the market model
• Find comparable U.S. products and codes
o HCPCS codes = Medicare uses
o CPT codes = Medicaid and private payers
o Copyrighted by AMA
• Book available for 83.84 EUR
• Next step: contact health services to determine
payment methodologies
Why use these codes?
• Important to find and match codes to find all the
coverage, pricing, and payments for reimbursement,
and find out which products may not have codes
8. Challenges
• Application for new codes takes time
o One to three years with costs
• Specific information on costs and coverage is
not officially available
o Must either purchase or contact
9. Step 3: Identify coding gaps
• Once existing products are matched with codes
o Identify which products are new to the US market
• Lack of codes for products can be disastrous
• New codes are controlled and regulated
through;
o American Medical Association (AMA)
o Centers for Medicare and Medicaid Services (CMS)
10. Step 4: Determine regulatory or legislative issues
• Changes in reimbursement result from
changes in new federal and state healthcare
provisions
o Important to know what impacts the product
• Outpatient Prospective Payment System
(OPPS) August 2000
o Introduced major change in how Medicare
reimbursed hospitals
11. Tactics
• Train key opinion leaders (KOLs) to communicate
with insurers and coding bodies
o Difference between winner and loser
• Develop relationship with specialty medical
societies
o Builds support between clinicians that use the product
and organizations with influence on reimbursement
• Organize clinical data to demonstrate cost-
effectiveness and clinical value to insurers
• Insurers look for information on new treatments
and technology
o Publish in reputable journals
13. Registration Process
Three big steps
1) Establishment Registration
a. Document to prove the device’s functions and
safety
2) Labeler Code Form
a. Used mainly with drugs
3) Product Listing
a. Document to provide FDA with details on each
product seeking approval
Registration to FDA’s import program may also be required
14. Approval Process
• Time
o Average of 252 days to approve the 510(k) for
monoclonal antibodies
• 510(k) = FDA's Premarket Notification Program
required for most reagents
15. Approval Process
• Cost
o Eligible to apply as a small business to pay less
o Small business = gross receipts and sales are equal to
or less than $100 M or 911.112.023 million EUR
o Less fees for first time registration
• Many companies available to facilitate the FDA
registration and approval process
• Other options in-state
16.
17. Approval Process
Estimated cost for registering monoclonal antibodies:
1. Annual Establishment Registration Fee $3,382
2. 510(k) $2,345
3. BLA efficacy supplement $58,624
Total $64,351
€58.701
18. Contacts For FDA Consultancy Groups
Name Website Contact
The FDA Group LLC http://www.thefdagroup.com info@thefdagroup.com
(508) 926-8330
Submit questions on
site
Registrar Corp http://www.registrarcorp.com info@registrarcorp.com
+1-757-224-0177
Maetrics
*Locations in Europe
https://www.maetrics.co.uk ukinfo@maetrics.com
+44 115 921 6200
19. Conclusions
• Much value can be placed on a great reimbursement
strategy
o Will determine Cytognos’s royalty fee or acquisition price
• Must contact local in-state insurers and health
service providers to better understand their system
• Immediate knowledge of costs and reimbursement is
available by purchasing material
• FDA registration and approval is long and costly
o Contact consultants for costs
o Find alternatives
