You’ve done the hard work. Your medical device has FDA clearance or approval. Clinical data supports its efficacy. Providers are interested. And yet, patients are being denied coverage and adoption is stalling.
Two of the most common and misunderstood barriers in medical device market access are silent medical policy (no policy on file) and Experimental & Investigational (E&I) medical policy determinations. Understanding these barriers and proactively building a Patient Access Program to address them can mean all the difference.
Understanding the Coverage Landscape
What Is a Silent Medical Policy?
A silent medical policy means a health plan simply has no written coverage determination for your device or its associated procedure code. This sounds neutral, but it is not because it represents and implicit denial to the provider. When there is no policy, claims processors often default to denial. Without an established coverage pathway, prior authorization requests go unanswered or are denied with vague language like “not medically necessary” or “benefit not covered.” Providers, frustrated by the administrative burden, may stop using the technology, even when they believe in the clinical value.
What Is an Experimental & Investigational (E&I) Policy?
An E&I determination is more damaging. Payers issue these when they formally classify a device or procedure as lacking sufficient clinical evidence to be considered standard of care. The consequences are severe: blanket denials, no path to medical necessity override, and an explicit message to providers that using your device puts them at financial risk.
Why Providers Alone Cannot Solve This
“When coverage is uncertain, even enthusiastic providers become reluctant adopters. The financial and administrative risk lands on their practice (and their patients) — not on the device manufacturer.”
Providers are your commercial champions, but they are not equipped to fight your coverage battles. Expecting providers to individually appeal denials, educate payer medical directors, and navigate appeals processes for a novel technology is unrealistic and unsustainable. In the absence of manufacturer support, providers make rational decisions — they stop ordering.
The Case for a Patient Access Program
A Patient Access Program (PAP) is a structured, manufacturer-supported infrastructure designed to ensure that patients can actually receive the device their provider has recommended, regardless of the current state of payer coverage policy. A PAP signals to providers that you are a committed commercial partner, not just a device vendor.
What a PAP Should Ideally Include
The most effective programs are purpose-built for the coverage environment your device operates in and include the following components:
Reimbursement Hotline
A dedicated team that providers can call for real-time guidance on coding, billing, prior authorization requirements, and appeal strategy. This is the front door of your PAP and the most visible proof of your commitment.
Prior Authorization (PA) Support
Support to providers for prior authorizations that includes strategic tailoring of submissions to each patient’s health plan based on its specific policy language (or the lack thereof). When there is a silent policy, the PA submission itself becomes your first opportunity to educate the payer.
Appeals Infrastructure
Level 1 and Level 2 appeal support, including clinical rationale letters referencing the published evidence base, specialty society guidance, etc. And finally, support with external reviews with independent review organizations. This may be the most imperative part of this process – getting cases to external review such that they are reviewed for each patient’s circumstance. Because independent review organizations are paid by the health plans themselves, this also puts pressure on the payer to cover the technology in the longer term.
The Cost of Not Having a PAP
“The absence of a patient access program is not a neutral position. It is a commercial decision with measurable consequences for provider retention, revenue growth, and coverage policy timelines.”
The temptation is to delay a Patient Access Program — to wait until coverage issues “sort themselves out” or to assume providers will manage on their own. This calculation is almost always wrong. Consider the downstream costs:
- Provider abandonment: Physicians who face repeated denials stop ordering and may be difficult to re-engage even after coverage improves.
- Slow revenue ramp: Delayed coverage means delayed commercial revenue at exactly the point in a device company’s growth where revenue velocity matters most to investors and/or to operational sustainability.
- Payer relationship damage: Providers submitting incomplete, poorly-documented PA requests create a negative impression of the device’s clinical rationale in payer medical review — an impression that can crystallize into formal E&I policy.
Conclusion: Access Is a Commercial Imperative
For medical device manufacturers marketing to providers in a landscape of silent policies and E&I classifications, a Patient Access Program is not optional infrastructure — it is foundational to commercial success. It bridges the gap between clinical adoption and payer coverage, protects the provider relationships you have invested in building, generates the evidence that payers require, and signals to the market that your device is backed by a manufacturer who stands behind it.
The question is not whether your device deserves coverage. The question is whether you have built the infrastructure to ensure that patients, and the providers who want to help them, can access it while that coverage is being established.
If you are launching into a coverage environment defined by silence and/or E&I determinations, the time to build your Patient Access Program is before your commercial launch not after your first wave of denials.
About This Article
This article is intended for medical device manufacturers, market access leaders, and commercial strategy teams navigating the U.S. payer coverage environment. It reflects general market access principles and does not constitute legal, regulatory, or reimbursement advice.
