How To Build Strong Medtech Payer Relations

By Edward Black, founder and principal, Reimbursement Strategies

“Payer relations” is a broad term that describes the ongoing process of working with payers to obtain, maintain, or expand positive coverage decisions. It is also broadly referred to as payer advocacy or market access. This article will focus on initiation of that process, and the important aspects of planning and executing this critical component of an overall reimbursement strategy.

Start The Process With Good Clinical Study Data

Good clinical studies are the most important piece of data to have as the payer relations process begins. These studies are published in peer-reviewed journals, with study subjects that represent the beneficiaries covered by the payer, outcomes that show net health benefits, and large enough study cohorts for statistically significant and clinically significant outcomes. 

Improved outcomes, quality of care, enhanced patient experience, and cost effectiveness are top-of-mind in today’s healthcare climate. This environment requires that a reimbursement plan be fully vetted, with clinical study and regulatory planning, so outcomes for reimbursement purposes are identified early and can be incorporated into overall planning. This strategy will accelerate time-to-market while maximizing the financial resources invested in all three development areas.

Give Payers An Education, Not A Sales Pitch

The best approach to communicating with payers is based upon an educational process, not a sales process. There is a big difference: A sales process is designed to impress, to convince a buyer that the technology is better than competing wares by presenting the features and benefits in a way that will sway the buyer to purchase. But payers are not buyers or purchasers in the usual marketplace definitions. Rather, they objectively evaluate and assess technologies based on specific criteria and within a preset framework.

Approach payers to educate them about the technology, speaking from an understanding of their perspective. Payers care about significant changes in outcome that are demonstrated by statistically significant, objective outcomes in clinical studies — decreased morbidity or mortality, fewer hospital readmissions, lower blood pressure levels, etc. Additionally, clinically significant outcomes are also reviewed: how the patient’s quality of life is impacted, patient experience, decrease in side effects, etc. 

This educational approach begins with a clinical dossier, built on the foundation of good clinical data. The dossier presents the disease state or unmet health need as the basis for why the technology was developed. Note that this is not a statement about the market size and/or the potential revenue stream for the manufacturer; that would be part of a sales process. Rather, it is an objective review that presents the problem based upon publically available health statistics from government agencies, patient advocacy groups, or professional medical societies. 

Include an algorithm of care, or a continuum of care, that outlines the current treatment path. Explain the technology and how this procedure, product, or medical service fits into the treatment path — either adding a previously nonexistent therapy, replacing an outmoded therapy, substituting for surgery, etc. Describe the benefits for the patient, the provider, and the healthcare system (society). For many years, the pharmaceutical industry has used a standard template when collecting data for consideration of coverage and payment. This approach is fast becoming an industry standard for medical devices, as well.

Payers will review technology that has already passed regulatory hurdles. In some instances, investigative therapies may be covered, but this is the exception, not the norm.  Therapies tagged “Category A Experimental” by the FDA don’t have a chance of being covered by private payers, except in the rarest of clinical circumstances. The dossier includes any relevant government agency clearances or approvals, along with copies of supporting documents, such as FDA 510(k) paperwork. 

Review the clinical study data to show the net health outcomes for both the short term and long term. The short-term outcomes may only cover the prescribed treatment duration, for example, six weeks of drug therapy, 30-day surgical mortality data. Payers also require data that shows long-term health benefits ranging from two to five years, depending upon the disease state. Three-year data has become almost a requirement. 

This is why it is so important to have the reimbursement plan well-integrated with the clinical study plan. This will impact the overall business plan, as the revenue stream may be interrupted while ongoing studies are needed to demonstrate long-term health benefits.

Compare and contrast the new technology/therapy to existing treatments. Present how it is as beneficial as, or more beneficial than, existing therapies. For example, are there fewer side effects, longer-term health benefits, lower need for retreatment, etc.? Resist the temptation to turn this step into a sales process; just stick to the facts. Putting these facts into their positive light is fine, but exaggeration or elaboration is easily detected by an experienced medical policy decision maker. Such efforts always compromise dossier integrity and are very difficult to overcome. Objective, head-to-head studies may be lacking, so review published clinical studies. Remember always that payers are focused on data and evidence-based medicine.

Finally, honestly present any adverse events, including both major adverse events (failed procedures, need for retreatment, serious injury, etc.) and less severe adverse events (dry mouth, urinary tract infection, or quality of life changes). Payers will also want to know if the technology is being used outside of study centers. In order to isolate clinical outcomes and eliminate factors that may cloud results, clinical study trials are conducted under tight controls, with set inclusion and exclusion criteria for patients. Technologies that are disseminated into general use have demonstrated to the payer that there is an adequate amount of usage outside of tightly controlled clinical settings.

Understand Your Audience

Spend some time to review payer websites and to determine how their medical policies are created. This provides you with an idea of how each payer approaches a disease state, how it evaluates clinical studies, what criteria must be met before a technology will be covered (e.g., medication must be tried and fail before surgery can be considered), and what coding is used to report therapies. Look at both public and private payer websites, as criteria may differ from payer to payer.

Payer relations continue to evolve as the healthcare landscape and healthcare priorities change. This is an acquired skill set that requires experience, knowledge, and preferably a clinical background. Of the three fundamental issues that constitute reimbursement — coding, coverage, and payment — coverage is the most challenging for technologies today.

Watch for future articles on this subject, coverage during clinical trials, and medical science liaisons.