Stage 3: Regulatory
Today’s Reimbursement Picture and Options for Improvement
- What reimbursement obstacles are in the way and how long will it take to clear them?
- What short-term strategies can be applied?
- What timeline should a manufacturer/investor count on?
A medical device reimbursement assessment is designed to answer these questions in detail and address specific questions that pertain to coding, coverage, payment, the payer-mix, site of service differentials, competitive product research, and trends in medical device product lines.
Our expert medical device reimbursement assessments provide a comprehensive overview of the medical device reimbursement landscape for your product and options for improvement, if needed. A reimbursement assessment is the foundation of future implementation, development and strategy.
RPI renders a comprehensive medical device reimbursement strategy to keep you up to date with important industry milestones. Our multi-year timeline lets you know:
- When to approach payer groups.
- When to apply for new codes.
- How to influence payment.
The timeline is a multi-year medical device reimbursement strategy that explains when applications start and when they should be finished. Along with the calendar, RPI will be there to strategically help you along the way.
Medical Device Marketing Consulting
Healthcare Economics – Comparative Effectiveness Research
Comparative effectiveness is the standard by which payers judge new technologies and procedures. Payers want to know how patient outcomes and provider costs of the new method compare to the current standard(s). Comparative effectiveness is a broad healthcare economics concept which includes cost effectiveness and technology assessment, but also may take into account the types of evidence previously excluded by technology assessment methods. Our health economists are experts in effectively presenting your comparative effectiveness story.
Setting the right price point and conducting the studies are important steps in determining the healthcare economic viability of your medical device.
New technologies typically lack sufficient clinical evidence to permit a full comparison with the standard of care. With outcome planning, we can help you plan for the outcomes data that will be needed to complete the evidentiary picture, then help you identify some time- and cost-efficient ways to obtain the data, and finally we can help you present it. Presenting your outcome plan to the appropriate audiences is important for securing buy-in from payers.
Read success stories of effective healthcare economics and outcome planning strategies.
If you are doing a clinical trial as part of the regulatory process, you have the pieces in place to capture valuable data to support reimbursement for a modest incremental cost. A clinical trial critique will highlight these opportunities for you.
As part of the clinical trial critique, we review gaps in the evidence needed to support reimbursement coverage and identify opportunities to fill those gaps to piggyback with your existing trial design. This is the data payers will most want to see, and capturing it will not interfere with your regulatory pathway. Please call us to discuss how a clinical trial critique can help solidify reimbursement in addition to your regulatory goals.
Expertly Evaluated by Certified Professional Coders
Assessing the appropriate codes for procedures based on new technologies or, in limited cases, for the products themselves, is a high-stakes endeavor. Using the wrong code can shortchange your customers or make them the target of billing fraud.
Why Coding Assessments Are Critical
Making sure that these codes are appropriate for your business ensures that the correct payment will be received. Coding must be scrupulously appropriate and adhere to the rules of the American Medical Association (AMA), in the case of CPT codes, and the ICD 10 Committee, in the case of ICD 10 codes.
RPI has a thorough grasp of the rules of the AMA, including both codes and their authoritative interpretation. Several of our coders are professionally certified to deal with coding assessments.
The way in which the reimbursement value of your medical device is determined, proven, and communicated is essential to generating success in the marketplace. The results of a reimbursement value analysis will have serious implications on your medical device’s clinical and market development.
There are three main aspects to reimbursement value analysis:
- Setting The Right Price
- Conducting The Right Studies
- Sending The Right Message
The medical device’s price is important to your customers and plays a significant role in medical device reimbursement.
Its important to send the correct message to the appropriate target market and at RPI, we acknowledge that this is an extensive and time-consuming undertaking. We can help you articulate and document your value effectively.
PAYER PROFILING AND SEGMENTATION
Healthcare Economics – Comparative Effectiveness Research
There are multiple aspects about the payer market that need to be understood to successfully launch and sustain a place within the medical market.
- How do you target a payer?
- What are the details that you should know?
You need to know the payers who are already receptive to your technology and those who need further payer education. RPI will profile and segment the relevant payers for you by examining their medical policies which are applicable to your product. With this knowledge, you can target appropriate actions for each payer segment and, if needed, identify additional data requirements for building payer acceptance.
- Prospective investors want hard numbers: Potential market size; current treatment strengths, weaknesses and inefficiencies; defensible pricing strategies.
- Facilities want to know why they should invest: Why devote capital and equipment and provide healthcare professional training when their facilities are already skilled at performing the current gold standard procedures?
Data Analysis of Disease Demographics
RPI has the tools and expertise to identify quality disease demographic data sources, mine that data, and then analyze it. The data are the results reported by medical providers and can help our clients target their accessible, regional, and national markets more effectively. This, in turn, allows your investments to create larger returns. RPI can help figure out where the best placement for your medical device is through data analysis of disease demographics.
The Value of Economic Analysis
While many new products enable improved outcomes and reduced costs, both the data and its presentation are subject to comparative effectiveness methodology in order to be credible.
Establishing the right price for your medical device requires three things: extensive knowledge of documented and expected clinical outcomes, documented and expected provider costs, and competitive data. The most credible data for medical device pricing generally comes from the published medical literature which can sometimes be spotty. We build our medical device pricing models on the best available documented data and probable results for your product, yet we also allow you to alter the variables in the event of new information. Multiple medical device pricing scenarios and what if exercises maximize your confidence in medical device pricing decisions.
Determining the dominate payers for specific disease states is important to medical device manufacturers. As the following pie charts demonstrate, different payer types are associated with breast and prostate cancer.
To give an example, within the realm of breast and prostate cancer, the payer-mix is very different.
Within the breast cancer market, private payers are 49% of the payer mix compared to the prostate cancer market where only 15% of the payers are private. Medicare actually leads the prostate payer market with 64%.
Knowing which types of payers from the payer-mix will dominate your product’s market enables you to choose education and advocacy methods targeted specifically to them. The right combination of clinical, regulatory, and contract expertise will vary by payer. At RPI, we equip you with the right blend of expertise for the payer-mix within your marketplace.
MEDICAL DEVICE REIMBURSEMENT
A competitive analysis brings everything into question.
- Is medical device reimbursement a competitive advantage, a disadvantage, or a neutral factor in this marketplace?
- What is the status of coding, coverage, and payment for competitive products?
- What kind of medical device reimbursement program do your competitors have in place?
Understanding your competition through competitive analysis is one of the main ways to stay ahead of the game. We provide you with your competition’s medical device reimbursement profile which not only keeps you informed but also allows you to understand what you are up against. RPI is always working to push you ahead of your competition.
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