The 7 Market Access and Payer Outreach Mistakes That Will Haunt Your Medical Device or Therapeutic

Kristofer Munroe • Oct 01, 2020

Learn how to avoid the common mistakes that can permanently haunt the reimbursement and market access efforts for your medical device or therapeutic from experienced reimbursement consultants 

A market access campaign for a medical device being haunted

The modern workplace is filled with so much information that most modern workers have become information conduits, sorting information from one electronic pile to another. Payer medical directors face the same challenges, doing so with mountains of highly technical information with literal life and death stakes while managing billion dollar spends.


At the end of the day, payer medical directors and their staff want to ensure they get their members the highest quality care for the money they spend. However, during the day, they are bombarded with information from industry and requests from providers. The product presentations that negatively affect their workday are going to be remembered. Companies that burn up their credibility never quite get it back, and reimbursement staff and provider offices that create busywork wear down hard-earned goodwill. Through over twenty years of practice as reimbursement consultants doing market access work with medical directors at national, regional, and local payors, we compiled this list of ways to fail (or what not to do) while conducting payer outreach.


1. Send everything that could ever possibly apply to your product with no index or organizational scheme. 

“If it fits it ships” might be a good moniker for the USPS, but it is a terrible philosophy for any market access team conducting payer outreach. Most payer medical directors suggest including additional information if it is relevant and helpful to a claim, request for individual considerations, or a request to review a technology. However, including any and all information that may be relevant, is the fast track to having nothing read. We have seen medical device and therapeutic manufacturers implement payer packages attached to claims that are many hundreds of pages long and sent with no index or organizational scheme. Often when these packages are sent with a claim or preauthorization, they land at the payer in electronic faxes as enormous pdfs that are unwieldy to review or share within the company. As a result, they are not shared, and they make reviewing difficult. 

Alternatively, in support of a technology, a market access team may send an email with attachments—often with nondescript file names—containing every study ever published, as well as any relevant policy, news story, and technical manual. Unorganized attachments with unclear names can become so difficult to follow that they will be ignored.

The best practice is to send what is most relevant and helpful for reviewing the case or reviewing the technology—and nothing extra. Although it may seem challenging to sort out what is relevant and helpful, an experienced reimbursement firm like Argenta Advisors can help you develop your most effective payer dossier for claims and payer outreach. 


2. Push a medical device or therapeutic directly to the payer when providers are not currently requesting it. 

Payer medical directors have no shortage of things to do during their day. Often, they must prioritize what work to do based upon the number of people affected or the potential budgetary risk. If your medical device or therapeutic is interesting, but not yet utilized or in demand by providers for their patients, it will not garner the attention to get a full and reasonable review. Products without demand from the provider or patient may be interesting from an academic standpoint, but they seldom get the attention for a full policy review. Market access and payer outreach efforts should not outrun your company’s sales department and provider demand. Over our years of practice, we have heard constantly from medical directors that they become resentful of a medical device or therapeutic manufacturer that consistently attempts to use medical policy to get the payer to create a market to sell their product. 


3. Repeatedly use form letters instead of sincere appeals.

Payer medical directors are not always obligated to respond to market access teams from medical device or therapeutic manufacturers. Most of the time, manufacturers are not parties to a contract with the payers; therefore, the only driver compelling a response to a request or questions from a manufacturer is professional courtesy and goodwill. However, providers and patients are contract parties with payers (have privity), and those contracts most often require a response within a certain amount of time. Many manufacturers take the logical jump to use providers and patients to send in their materials. Although that is one element of an effective market access strategy, the common mistake is to send the same form letter from every patient and provider to save time and expense. Once it becomes obvious that it is a form letter campaign, the payers will respond with a form letter denial, and a non-nominal amount of goodwill will be burnt off. Patient and provider campaigns for payer outreach can be one of the most effective market access tools, but if they are not managed by an experienced reimbursement consulting firm like Argenta Advisors, they can backfire and create more hurdles for a product to establish market access. 


4. Cherry-pick outcomes data.

Of course, you are going to put your best foot forward when presenting your medical device or therapeutic technology to a payer. However, only acknowledging the favorable data for your product is a fast way to lose credibility and send payer teams searching for additional data to understand your product. Unless a product has only been studied a limited amount, it is likely that some negative data is out there. While no one expects you to put together a presentation, executive summary, or clinical dossier focused on the unfavorable data, addressing it in a way that distinguishes it from the case at hand or the current patient population can help you maintain credibility and strengthen your case. Placing negative data in an appropriate context while not undermining your arguments is difficult, but an experienced reimbursement consulting firm like Argenta Advisors can help you learn how to present all your data with our medical director discussions and focus groups. 


5. Position your product with only clinical data or only economic data.

Since the late 2000s, the drumbeat of value has been getting louder. At the time of the writing of this article in mid-2020, the drumbeat of value is taking over the band. At one point, being able to position a product as better than its comparators was enough to get coverage, but that is not the current environment. Argenta has offered medical director focus groups since 2001, and since that time, the discussions at the table have shifted. Price has moved from being an afterthought to being one of the first questions. “Well that technology looks great, but the only thing that could hold it up is price” is now one of the most common statements in our focus groups. While better than and cheaper than the comparator is ideal, we know that is not always commercially feasible. Developing a coherent value proposition in support of the benefit your product brings and the reasoning for its cost is now a prerequisite. Cost matters, and the strength of the lens applied to review “medical necessity” increases as product or treatment cost rises.

Although the drumbeat of value has become the loudest, it is still not a drum solo. Positioning a product solely on its economic benefit or on its price being lower than the current standard of care telegraphs the possible issues with the clinical data, clinical utility, or demand. Less costly than the comparator can be a strong argument, but only if there is published peer-reviewed data demonstrating clinical superiority or equivalency to the comparator. 


6. Be inconsistent in messaging between payer materials and website marketing materials.

Decision-makers at the payers conduct independent research using Google in addition to medical journal reviews. A manufacturer website that tells an inconsistent story from the executive summary or other payer positioning documents creates a risk of causing payer disenfranchisement. For example, a manufacturer approaching payers with a focus on patient need and benefits to the healthcare system that then dedicates it website to how much money an office practice could make by switching to its product is undermining its own credibility. Payers often need help understanding new technology, but they will not accept that help from someone who has given away their credibility. As frustrating as it can sometimes be to get a new product covered, an important goal of a manufacturer is to maintain their credibility and avoid an adversarial relationship with the payer.


7. Fail to position your medical device or therapeutic with clinical utility or fail to describe the positive net health outcomes delivered by your medical device or therapeutic. 

Does your clinical data show that your product is effective in a meaningful way? We all set out to develop and market technology that improves patient outcomes, but whether the improvement is clinically meaningful is subjective. 

Imagine a product that improves the ability to walk for a person with an uneven gait. Intuition will tempt you to take for granted that the product is “medically necessary.” However, getting a patient to return to a normal gait may not be inherently “medically necessary.” It might not be medically necessary to walk to the store two minutes faster if a comparator product the patient already uses works but is slower and is also one-fourth of the cost. However, if the manufacturer can show with data that the product reduces or eliminates other complications such as falls and that those falls would have otherwise been injury-producing, the company that produces the more expensive product may have a stronger position in demonstrating medical necessity for coverage.


There are some questions to ask when determining if this imaginary product improves net health outcomes in a meaning full way. Does the data demonstrate real cost savings and the prevention or treatment of real harm to patients? Does the data show a reduction of ER visits for fracture treatment, concussions, and/or other resource cost to the system? 


Remember market access and payer out reach mistakes can haunt you. 

Getting your message out to the payer community can be challenging, but by committing any of the above common errors, it can become a Sisyphean task. Companies that burn up their credibility never quite get it back and can be haunted buy those mistakes for years. Reimbursement staff and provider offices that create busywork wear down hard-earned goodwill. Remember, payer medical directors and their staff want to ensure that their members get the highest quality care at the lowest cost. If your goal is to produce the best product to help patients, then your goal should naturally align with the payer. If you are not sure how to position your product to show that your mission is aligned with the payer mission, the reimbursement consultants at Argenta Advisors can help.


Contact Argenta Advisors' market access team for help avoiding these mistakes today >>

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