5 Tips to Overcoming Claim or Appeal Denials for Your Innovative Medical Device.

Introduction:

Payer denials can be confusing and too many of them can undermine a reimbursement strategy based on demonstrating utilization. While some denials are based upon the lack of supportive clinical data, many denials are the product of ineffective advocacy or missing details. While the easiest approach to overcoming denials is to work with an experienced reimbursement support hotline vendor like Argenta, understanding the basics of why denials happen can help guide overall strategy and increase the likelihood that a reimbursement strategy is going to be successful.

1. Thoroughly review the denial letter and take time to identify and understand any reasoning presented. Denials often state the reason for the denial and outline next steps for the patient. Following the outlined process and addressing the reasons for the denial are first steps to making an appeal process run smoothly. When you read a denial ask yourself:

• Why was the request denied?
• What type of policy or criteria is the payer using?
• What is the type of health plan the patient has?
• Is it an emergency or lifesaving technology for patient?
• Where there any mistakes made with the applicable billing and coding?

2. Be persistent, patient, and prepared . Unless the technology is lifesaving or has a high community impact, it may not receive the most thorough evaluation during the initial review process. However, every time you submit a claim or appeal you will be slowly educating the payer. When filing an appeal for a service or procedure involving medical technology that is considered experimental or investigational:

• Build your appeal documentation package clearly and carefully with a clear patient story and history substantiated with records
• Provide data that supports what you are proposing for the patient since new technologies will require peer reviewed published clinical data to be covered by payers
• Make sure there are clear expectations with the patient and that the patient understands that agreeing to pursue appeals may mean being committed for an extended period of time
• If an additional supporting information that further describes the technology’s clinical outcomes is available, consider including it in the package.

3. Focus on the unique circumstances of the patient that is the subject of the appeal . Write an organized and focused letter that builds upon the medical need for approval and describes why reconsideration for this patient is critical. It is essential to convey the benefit a patient will gain from the technology.

• Demonstrate why the appeal case is different from a typical case and why no other treatment is acceptable for this patient
• Outline any and all previous treatments/therapies related to the illness or injury that have not been successful
• Focus on applicable peer reviewed clinical data that shows the same favorable net health outcome as you are requesting for the patient
• If there is a similar device that is covered, discuss the equivalence and highlight why that similar device is not appropriate for this patient
• Use emotive storytelling to describe each case

4. Know your audience and understand the background of your reviewer. Depending on the type and level of review, or appeal, different staff with varying levels of training will be looking at your submission. For your initial submission, the individual reviewing your submission for approval at the payer level is usually a staff member in a utilization management department. The staffer reviewing your case could possibly be reviewing review hundreds of requests per day. The submission should be concise and informative.

• Make it easy to see how you are meeting the payer’s requirements by including the appropriate forms and authorizations when necessary
• If your review requires advanced or specialized clinical knowledge, state so early in the request such as asking for a same specialist review
• Determine the level of review that will be applied and make it easy to find the elements that show that the standard is met

5. Determine the appropriate appeal pathway early in the process. Every case is different. Different patients may have different basis for being eligible to the same care. Every payer has its own set of policies and procedures and each insurance plan within a payer may have its own criteria and benefits. States have differing external review process and some states or plans use the Federal process. The appeal pathway should be designed to follow the correct approach in a timely fashion. Every patient’s case is different. Every product is different. Every payer’s understanding of the situation is different. Consideration of these differences is crucial.

• Every patient with employer provided healthcare plan has a member’s handbook or summary plan description and there are meaningful differences between these documents across payers and plans
• Knowing the right request to make at the appropriate time is one of the keys to success. Re-Determination, Re-consideration, Single Case Agreement, Benefit Exception Approval, Administrative Law Judge Review, Department of Appeal Board Reviews, and Federal Court (Judicial) Review are all different appeal activities utilized at different times
• If a patient is eligible for a third-party external review, understand the steps that are required to trigger it, because often times the steps are not always the same
• Peer to peer reviews can be a powerful tool but only if used on appropriate cases
• Self-funded grandfathered ERISA plans can be exempt from the Affordable Care Act protections and can have unique appeal pathways that exclude a patient from an appeal or external review of a pre-service review.

Even the most promising medical device technologies can end up in the dustbin of history by not demonstrating adequate utilization. Demonstrating early utilization most often means fighting for coverage of a new technology on a case by case basis. It requires providers and patients to be willing to advocate for the product and building a successful case story to support the claim. If you do not have the internal staff to support your reimbursement efforts, Argenta can help. Over decades in practice we have accumulated relationships with industry leaders and policymakers at payers across the country that can help you promote access to care. Not only can we help you develop a successful strategy, we can work cooperatively to implement it with market access staff, reimbursement support, or case management support.

​Learn more about to overcome claim or appeal denials for your innovative medical device or therapeutic technology from our experienced reimbursement support hotline consultants -talk to Argenta Advisors today.