Developing a successful reimbursement strategy or market access plan means seeking help from reimbursement or market access experts. However, before the parties enter into any agreement for reimbursement services, there is always at least one preliminary call. During this call, both parties are trying to learn as much as possible about each other to gauge the potential for success in a future working relationship. Consultants, for their part, are trying to provide as much detail about their skillset while learning as much as they can about the technology they will encounter. The following list of foundational reimbursement strategy issues is intended to help innovators conduct a brief self-assessment. Argenta Advisors recommends that all innovators use this list as a self-assessment prior to having a call or meeting with a reimbursement consultant to discuss their reimbursement issues or needs.
1. Have a clear and written clinical vignette outlining the expected clinical use case(s) for your medical device or test.
Creating a clear written clinical vignette is the first and most important step in reimbursement strategy. In the context of medical device or test development, a clinical vignette is an abridged report relating to a typical patient, summarizing any relevant history, physical examination findings, investigatory data, and treatment scenario. It should make it clear to a reader when (e.g., preoperative, peri-operative), where (e.g., inpatient, outpatient, ASC, MD office), and on whom (e.g., all ages, pediatric-only, Medicare age range) a particular treatment, test, or procedure will be used by a provider, along with the expected medical specialty that is being targeted. It should describe the most common course of any medical care using a particular technology.
In the reimbursement and market access strategy development phase, example vignettes describing how patient care will proceed form the foundation of the entire reimbursement process. Post-commercial launch, the reimbursement cycle begins with physician medical record notes and documentation that is then translated into billing codes and that are then submitted to third-party health insurance payers. A clear written clinical vignette in the pre-commercial launch strategy phase serves as a surrogate for physician documentation in the clinic.
For very early-stage companies, the clinical vignette may be entirely hypothetical. As the technology matures, it may be based upon a typical subject in a clinical trial. For mature products, it might be based on de-identified representative case studies from the real world. For all products, it should be based on clinical use in practice, available data, and applicable guidelines.
According to the American College of Physicians, a good clinical vignette “follow[s] the basic rules of medical communication; describe[s] in sequence the history, physical examination, investigative studies, and the patient's progress and outcome.” Additionally, it should “avoid the use of medical jargon and excessive reliance on abbreviations. Limit abbreviations to no more than three, and favor commonly used abbreviations. Always spell out the abbreviations the first time they are mentioned unless they are commonly recognized (e.g., CBC).”
A well-written clinical vignette will help a reimbursement consultant identify the potential value proposition; that is, the outcome-supported details demonstrating why payers should provide coverage and payment for your product. It is the most important foundational document and necessary for a reimbursement consultant or strategic coder to assess your technology.
2. Be prepared with details about your FDA clearance, approval, or authorization pathway, and, most importantly, the indications for use and your intended claims.
The balance between regulatory and reimbursement starts at the very beginning of development. The best practice is to get your basic regulatory strategy and information out in front of any reimbursement consultant as soon as possible at your first meeting discussing a possible strategic partnership.
The FDA regulates the label and labeling (e.g., indications for use, safety, and complications) of medical devices. Generally, the FDA considers a product to be a medical device if it is intended to diagnose, cure, mitigate, treat, or prevent disease in a human or if it is intended to affect the structure or any function of the body. A medical device is different from a drug because it does not achieve its primary intended purpose by chemical action or by being metabolized. For a claim of efficacy to be made, you must demonstrate that your product is substantially equivalent to a legally marketed product making similar claims or you must independently establish that your product is safe and effective for the intended use associated with reducing, preventing, or eliminating disease.
For established products, the easiest way to communicate this information is by sharing your FDA approval or clearance letter containing your indications for use. In the case of an exempt device, share your basis for making claims. If your product has not yet received regulatory approval, be prepared to talk about its probable regulatory pathway and your expectations as to labeling, including indications for use and claims of efficacy.
Your indications for use and intended claims should be consistent with your clinical vignette; together they create the framework for how you can talk about your medical device with payers. Regulatory missteps can have high-stakes consequences, including the scrapping of a reimbursement strategy. Additionally, reimbursement collateral and support should always be consistent with labeling; providing that information early to your reimbursement consultant is a key to success.
3. Know the standard of care or gold standard in the field of medicine of your medical device or test as well as the alternative and competing treatments available in the market.
The standard of care is a recommended treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance. Typically, the standard of care is defined by broad market adoption or through clinical guideline support from the medical community, such as medical societies or specialist societies that outline the suggested course of treatment for a disease or condition.
Tests and diagnostics are measured against the gold standard. The gold standard refers to the method or test (diagnostic, prognostic, blood test, biopsy, etc.) that the medical community has broadly adopted as the current best means of diagnosing a particular condition. The gold standard for any specific disease is not set in stone and can change over time, as the available evidence from randomized clinical trials (RCTs), guidelines, and clinician behavior changes.
When having your first meeting with a reimbursement consultant, you should be able to answer questions like, Why does your treatment matter in the continuum of care? Why would healthcare providers want to use your technology instead of another one? How does your technology improve net health outcomes over the standard of care or gold standard?
Experienced reimbursement consultants are generally familiar with multiple therapeutic areas, and are likely familiar with yours; however, you should be the person most aware of your competitive environment and be prepared to discuss it.
4. Don’t assume that what you think is the problem is the problem.
Reimbursement strategy and the reimbursement process depend upon three elements: coding, coverage, and payment. None of these elements operates independently.
A popular misconception of innovators entering the medical device space is that finding or obtaining a code (e.g., CPT or HCPCS) is the ultimate step toward making your product available to patients and reimbursable by third party payers. Codes do not guarantee coverage or payment. Even more surprising, coverage does not always ensure payment. A technology can have a code and a coverage policy but still be listed at $0 payment.
Reimbursement strategy and market access issues often require solving or navigating an interwoven set of puzzle pieces, and changing one variable can impact the rest. When working with a reimbursement consultant, it is important to walk through the factors affecting each of the elements before making assumptions.
5. Know where your publication strategy has been and where it is going.
Just like “Location, Location, Location” drives real estate strategy, “Data, Data, Data” drives reimbursement strategy. While the first call with a reimbursement consultant is not going to be a full and thorough review of your outcomes evidence package, a cursory discussion or mention of a few key clinical publications, either available or in process, is important to helping your potential reimbursement consultant get their bearings on where your product stands and where a successful reimbursement strategy could take it.
It is important to note: your clinical outcomes must be available in published, peer-reviewed manuscripts. This does not include abstracts or presentations made at medical society meetings, nor does it include white papers outlining your technology.
Well-developed products that are close to market launch should be supported by a current bibliography and at least a list of key publications, including pivotal trials and a plan for real-world evidence generation. For early-stage innovators that are still at proof-of-concept stage and do not have any published peer-reviewed clinical data, it is important to at least have a sense of what your anticipated budget or expectations for data generation will be.
If you do not have a written publication strategy, stop whatever you are doing and consider what that strategy may look like on paper. The availability of clinical data is one of the most important tools in the reimbursement strategy toolbox. Good planning and execution of a publication plan can help remove one of the most confounding obstacles to a reimbursement or a market access strategy.
6. Be prepared to talk about your plans for fostering adoption among the medical community for your product.
At your first meeting with a reimbursement consultant, you will field some questions about what your efforts have been to engage with the medical community about your product. Having a snapshot of your key opinion leaders (KOLs), centers of excellence (COEs), and your work to date with applicable medical societies will be important for assessing where your plan is and where it is going.
KOLs or “champions” are the launching point for most medical devices. The availability or need to develop KOLs or COEs is something that needs to be taken into account in the earliest stages of planning a reimbursement or market access strategy. As we discussed in our post, The 6 Critical Digital Health Reimbursement Mistakes Holding Innovators Back, failing to recognize that healthcare purchasing is still dominated by physicians can hobble the launch of a technology. In addition, the physician community, through clinical physician stakeholders and champions, helps make sure that the new technology fills a clinical need and is practical to use in the real world. Additionally, support from the clinical community is the key to opening doors with payers for medical policy coverage support and at the American Medical Association CPT committee for coding support.
7. Be aware of the target geography of your sales or sales targets.
Geography matters in market access launch efforts. A common characteristic of effective reimbursement strategies is the creation of an alignment between reimbursement and sales+marketing, with respect to which reimbursement has some input into sales targeting, but ultimately follows targeted sales and provider demand. It is important to remember that reimbursement can have an impact on sales targeting strategy but cannot dictate your development and sales strategy. Different states and different cities use different mixes of various local and national health insurance payers. The mix of payers involved early on in a product launch can have long-lasting implications for a reimbursement strategy or market access plan. Being able to discuss the geography of your sales or sales targets with your reimbursement consultants gives them a picture of where the pieces are on the board and how they might be played to get you the best outcome.
Technologies near launch should be able to look to the marketing sales plan or investigator sites to obtain this information. Early-stage innovators can look to where their development partners are or where their investigation sites are likely to be.
Healthcare provider demand translates into demonstrated utilization. As discussed in our other articles, demonstrated utilization is the linchpin to an effective reimbursement strategy. Third-party payers will generally not consider a medical device or test for medical policy review and acceptance without demonstrated utilization. Being able to discuss the target geography of your sales or sales targets will help your potential reimbursement consultant gauge the potential to leverage early adopters and sync this evaluation with a targeted sales and reimbursement strategy to advance your goals.
Conclusion
Not all reimbursement consulting groups are the same and gauging fit early on is important to developing a strong working relationship with your reimbursement partner. If you are prepared to discuss the seven foundational reimbursement strategy issues discussed above, you will be able to get the most out of your time spent auditioning reimbursement consultants.
As the innovator, developer, or product manager, you are the best-informed person in the world on your technology. Although reimbursement consultants should be subject matter experts on reimbursement strategy and market access planning, you will always be the most knowledgeable subject matter expert on your product/technology. Be prepared to provide a concise outline of your technology in the marketplace as outlined above. This will enable a good reimbursement consultant to provide you with a frank and accurate assessment and help guide them in tailoring their available services to your needs.
Now that you are familiar with the 7 foundational reimbursement strategy Issues -take the next step. Contact Argenta Advisors' strategy team and reimbursement consultants to take the next step towards a successful commercialization and reimbursement strategy.
500 Victory Road, Suite 400
