What is the difference between clearance, coding, coverage, and payment?

Clearance is FDA permission to market. Coding is the existence of a billing code that describes the procedure or product. Coverage is a payer's policy decision to pay for it in a defined population. Payment is the actual amount, and whether it covers the cost of using your device.

How do you map payer policy for a medical device?

Work region by region and payer by payer: identify the Medicare contractor policy for your indication, then the dominant commercial plans in each target metro, and record coverage status, evidence requirements, and prior-authorization rules per account.

What are the most common market access mistakes?

Treating reimbursement as a post-launch task, assuming an existing code implies coverage, collecting clinical evidence that does not answer payers' economic questions, and selling into regions where the local coverage policy excludes the indication.

Can you sell a device without coverage?

Sometimes — cash-pay, capital purchases, or accounts absorbing cost within a bundle — but volume stays small and repeat purchase is fragile. Most durable adoption follows coverage.

Coverage Before Contracts: A Practical MedTech Market Access Guide

Short answer

Market access is the work of making a device payable, not just legal to sell. It has four distinct parts: clearance or approval, coding, coverage, and payment. A device can be cleared, coded, and still not covered — and an uncovered device is effectively unsellable to most hospitals.

What market access actually means

Market access is the answer to "will this actually get paid for, for this patient, at this institution, and how long will that take to confirm." It's not one milestone, it's an ongoing capability: reading payer policy, building the economic case per account, and reducing the friction between "the device works" and "the hospital gets reimbursed for using it."

Case in point

Sequana Medical's alfapump: approval opened the door, but didn't fund the walk through it

FDA approved alfapump in December 2024 for recurrent or refractory ascites due to liver cirrhosis — a real, burdensome patient problem backed by real clinical data, with the POSEIDON study showing a reduction in therapeutic paracentesis and improved quality of life. The company planned a focused U.S. launch through a specialty sales team targeting liver transplant centers, a sensible beachhead.

But every center still needed education, physicians needed training, reimbursement had to work in practice, and the procedure had to fit an existing patient pathway — all of which takes time and capital. By April 2026 Sequana was reviewing strategic options, and in June 2026 it announced it would file for bankruptcy after being unable to secure financing in time.

Clearance, coding, coverage, and payment are four different things

Clearance or approval

Says a product is safe and effective for its labeled use. Nothing more.

Coding

A billing code, existing or newly created, determines how the procedure is described for payment.

Coverage

A payer's decision that it will pay for that code, for that indication, at all.

Payment

The actual amount — which varies by payer, region, and site of care.

A device can have the first without any of the other three, and each one can independently stall a sale.

How to map payer policy by region and account

Payer policy is not national in any practical sense for most devices. Coverage decisions vary by Medicare Administrative Contractor region, by commercial payer, and by whether a given hospital's payer mix even includes the plans most likely to cover you. Mapping this per target account — before it's on your priority list, not after a physician champion has already asked for it — is what turns market access from a recurring surprise into a filter you apply upfront.

Common market access mistakes that slow first sales

Assuming approval implies coverage. Treating reimbursement as a one-time confirmation rather than a per-account, per-region variable. Building the economic case generically instead of for the specific payer mix of each target hospital. And, as both cases above show, underestimating how much capital and time it takes to carry a product through the gap between "approved" and "routinely reimbursed," even when the clinical story is strong.

The signal question

Every account you're targeting has a different coverage picture, and finding that out one hospital at a time — after the clinical conversation has already started — is exactly what slows deals down. Knowing it before the account gets prioritized is what market access consulting is usually hired to do manually.

RevWorx surfaces coverage and payer signals at the account level, alongside clinical fit, so a stalled reimbursement picture shows up before it becomes a stalled deal. See how that fits the sequence in our go-to-market strategy guide or the commercialization strategy page.

Sources and notes

Sequana Medical / alfapump: the December 2024 FDA approval, POSEIDON results, and the 2026 bankruptcy filing are from Sequana's own press releases. See the FDA approval announcement and the board's bankruptcy decision.
Skysona / Bluebird Bio: the 2022 FDA approval and roughly $3 million price are widely reported. See BioPharma Dive and FiercePharma. The framing that patient-finding and referral awareness were the dominant commercial barrier rather than price alone reflects public commentary on the ultra-rare disease category generally, not a specific statement about Skysona's launch results.

Frequently asked questions

What is the difference between clearance, coding, coverage, and payment?: Clearance is FDA permission to market. Coding is the existence of a billing code that describes the procedure or product. Coverage is a payer's policy decision to pay for it in a defined population. Payment is the actual amount, and whether it covers the cost of using your device.
How do you map payer policy for a medical device?: Work region by region and payer by payer: identify the Medicare contractor policy for your indication, then the dominant commercial plans in each target metro, and record coverage status, evidence requirements, and prior-authorization rules per account.
What are the most common market access mistakes?: Treating reimbursement as a post-launch task, assuming an existing code implies coverage, collecting clinical evidence that does not answer payers' economic questions, and selling into regions where the local coverage policy excludes the indication.
Can you sell a device without coverage?: Sometimes — cash-pay, capital purchases, or accounts absorbing cost within a bundle — but volume stays small and repeat purchase is fragile. Most durable adoption follows coverage.