By: Mary Corkins
It’s that time of year! Many medical device manufacturers anticipating good news from the FDA in early 2015 are busy preparing budgets and trying to prepare for product launch. The Affordable Care Act (a.k.a. Obamacare) will continue to impact pre-launch and early launch adoption of new technology medical devices. We will all need to stay tuned regarding the 3% device tax burden. But none of these issues change the need for a well run reimbursement field team!
Over this 3-part series, The Reimbursement Group (TRG) will provide thoughtful review and consideration on this topic during the month of December 2014. We’ll identify major elements and try to provide some direction in this area.
Before evaluating your reimbursement development needs, there are significant basic processes that are non-reimbursement that that should be finalized, documented, and implemented. Direct sales representatives, distributors, or a combination? Primary and Secondary markets? Production facilities, redundancies, inventories? Initial platform product or building a portfolio?
After these decisions, manufacturers need to make decisions about field activities and building out reimbursement support teams. Although there is a chronological order to these elements, neither reimbursement strategic or tactical plans should be an afterthought. There is variability for reimbursement support needs based on a number of factors including clinical specialty, first-to-market product initiatives, clinical evidence development/planning, and regulatory pathway. However, not all elements are unique. There are common elements that should be identified and valued:
- Possible displaced clinical diagnostics or therapeutics
- Possible adjunct clinical diagnostics or therapeutics
- Coding, Charting, and reporting recommendations for your device
- Specific detail concerning your device episode of care – resources, setting, duration, length of stay, economics, etc.
- Defined global care period
You will need answers to these elements in order to make appropriate, educated projections on your reimbursement needs. In developing and supporting many successful launches, TRG (firstname.lastname@example.org) can provide manufacturers with the metrics for establishing and scaling reimbursement field teams.
- How many FTEs?
- What training or credentials are appropriate?
- When do you begin payor policy efforts?
- How do you measure reimbursement goals?
- What are the deliverables from the Reimbursement department?
- Who should they report to?
- What should the Reimbursement budget look like?
- Who will manage your reimbursement plans?
Do you think you have an expert already on staff who knows all the important reimbursement details? Please….tell me it’s not your Marketing Director! Stop it, you’re killin’ me! I have known and worked with several very talented marketing people….and I would not consider any of these individuals for building and managing Reimbursement field support. There are even fewer marketing people who would want the job! The skills do not translate. CEO’s, please stop asking your marketing people to develop and execute your reimbursement plan! It’s not the same language, not the same urgency, not the same skill set, not the same relationship.
Hiring the wrong person to develop and implement your reimbursement plan is the single, biggest mistake that manufacturers make in this area.
The second biggest failure in setting up your reimbursement field team? Set up your Reimbursement department to report up through your Sales department. These two groups must work together, effectively, and when they do it’s a thing of beauty. However, there are times when their goals are seemingly diametrically opposed. For example, sales is working to build physician demand and support product adoption. The reimbursement person is working to build Insurance coverage and policy for labeled indications. It’s short-term versus long-term focus and timelines. For this reason, there must be a separate, rational voice in neutral territory.
The final significant element for consideration in kicking off your reimbursementfield staff development is deciding what to build out internally, and what to outsource. Do you want to outsource its planning? Management? Is your product best supported via appropriately experienced internal staff? Both options have advantages, but the best selection is generally achieved after consideration of the following:
- Internal staff: PMA pathway, platform product, distributor model, ongoing clinical research, first-to-market technology, complicated or changing treatment algorithm, significant evidentiary development needs, paradigm shift.
- Outsourcing: 510(k) pathway, subsequent product launch, distributor or direct sales, mature market, coding/charting challenges, evolutionary technology, early exit strategy.
Depending on your specific needs and after thoughtful consideration of A & B, above, manufacturers should obtain the best qualified staffing that they can afford – whether outsourced, contracted, or retained. Yes, it’s still true….you get what you pay for! For those organizations seeking to retain talent, Suzanne Bohen (email@example.com), Emerson Professionals, is a very well connected executive search consultant in the area of reimbursement management for the medical device industry. TRG also provides outsourced Call Center, Case Management, augmented field staffing, and other reimbursement tactical support.
If you’d like to discuss the content of this document in more detail, TRG (www.trgltd.com) can walk you through these considerations and help you flesh out your processes and needs. We’ll be developing the Goals/Deliverables of an effective Reimbursement Field Staff in Part 2 of 3, next week.