Successfully marketing a new medical technology is notoriously challenging because it must answer to multiple different constituencies with differing agendas. Patients may respond to ads touting a state-of-the-art product or respond to claims of increased convenience, such as a minimally invasive procedure. Additionally, patients may be prompted to seek medical care by “disturb” ads that highlight risks or describe ominous symptoms.
Physician adoption of medical technologies may also be driven by convenience and competitive advantage, but physicians will likely also be sensitive to how a new technology, such as a new office-based laboratory test, will impact their bottom lines. Healthcare facilities will be sensitive not only to the demands of physicians, but also how a new test or treatment, such as a new surgical tool or implantable device, impacts payment rates.
Finally, healthcare insurers are probably the most important audience for any product launch. Quite simply, a technology’s success is unlikely in the absence of insurance coverage and payment. Furthermore, the insurer is the one stakeholder who is most explicitly focused on evidence-based medicine, often requiring more data—in both quality and quantity—than required by the patient, physician, or facility. The key question is how to align the marketing messages across all of these constituents. Specifically, how do marketing messages targeted at patients and healthcare providers impact third-party payers?
When payers become aware of a new medical technology—based on publicity in trade publications, a new FDA clearance/approval, a new CPT or HCPCS code, or inquiries from physicians, manufacturers, or patients—one of their first decisions is whether to manage the technology through an evidence-based coverage policy. Clearly, payers can only create, implement, and update medical policies for a small subset of medical technologies, and their impact on budgets is a key consideration in this decision. While payers typically don’t have a clear picture of the full scope of the budget impact, they generally will consider both the cost of the technology per episode of care and the potential size of the target population.
Once payers decide to create a medical policy, the next decision focuses on the evidence requirement. What are the key health outcomes for a technology? What type of data is required to validate these outcomes, i.e., randomized trials or observational studies?
It is important to understand that marketing messages to physicians and patients may prompt payers to subject a medical technology to an evidence-based coverage policy AND impose a challenging evidentiary requirement, resulting in negative coverage.
Policies posted on payer websites focus entirely on the published medical literature; however, payers will also review manufacturer websites and other ancillary sources to increase their understanding of how a technology will be integrated into the healthcare delivery system. A common “disturb” point for payers is the potential size of the target population. Here is where patient and physician marketing can intersect in unexpected and negative ways with the payer’s agenda. Manufacturer websites noting that a physician can expect a high volume of referrals and direct-to-consumer ads proposing a minimally invasive solution to a chronic problem can prompt payers to prioritize a technology for an explicit coverage policy. For example, if a website for laser surgery states that “a less than one-inch incision can give you relief from chronic neck or back pain,” this statement is an immediate red flag for payers to investigate the technology further.
In the 2000s, a variety of minimally invasive procedures were promoted as alternatives for the treatment of gastroesophageal reflux disease (GERD). Some manufacturer websites encouraged patients to ask their physicians about alternatives to GERD medication. Although these campaigns successfully drew attention to minimally invasive procedures that could offer a permanent solution for GERD, they also prompted payer concerns regarding the potentially large size of the target population for the treatments. Patient-targeted marketing campaigns contributed to the payer’s focus on the impact of the immediate up-front costs of the procedures. In some cases, payers responded with explicit coverage policies featuring the extremely high evidence requirement of large, placebo-controlled randomized clinical trials with long-term follow up, far exceeding the evidence required by the FDA through the 510(k)-clearance pathway. As of the most recent republication of this article in December 2022, many of those technologies are still facing reimbursement challenges due to inconsistent coverage policies across the US.
In contrast, in the late 2010s, a similar phenomenon happened with implantable stimulators for treating sleep apnea etiologies, but with different results. The maker of an implantable hypoglossal nerve stimulator (HGNS) for treating obstructive sleep apnea (OSA) began a nationwide marketing push that included direct-to-consumer marketing. Because of the perceived breadth of the possible OSA markets, in addition to the dubious clinical results of earlier surgical options, payers raised concerns regarding the potentially large size of the target population for the new technology. Similar to GERD, many payers responded with explicit coverage policies characterized by extremely high evidence requirements. However, in the case of HGNS, the aggressive medical device market launch strategy was paired with an equally aggressive clinical data collection and reimbursement strategy. The launch was timed to coincide with the release of three-year follow up and registry data. Early adopters were then supported by a ground-up strategy that engaged the specialty societies and enabled patient access through appeals support. By the time the manufacturer released five-year follow-up data and a significant registry, HGNS had already began to receive general payer acceptance and broad coverage. In the case of HGNS, balancing the agenda of patients, providers, and payers required balancing an investment in developing clinical outcomes data and physician support with other investments as part of the national commercialization launch.
There is no easy solution to balancing the competing agendas of patients, providers, facilities, and payers. However, at the very least, manufacturers’ reimbursement and marketing departments should work together very closely to ensure that patient and provider marketing does not get ahead of payer concerns.
The following article was originally contributed by Argenta Advisors to Reimbursement Report in MedTech Intelligence (MTI) on December 3, 2015. It was then edited and republished on Nov. 17, 2020. We have chosen to update and republish it again because of its popularity. It is a deeper dive into an issue we recently discussed in our article, The 7 Market Access and Payer Outreach Mistakes That Will Haunt Your Medical Device or Therapeutic.
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