Tech & Innovation in Healthcare

Find out what reimbursement pathways are available.

Healthcare is full of medical devices both standard and revolutionary. And without teams of people who understand the medical coding and revenue cycle processes, the companies that design, develop, and distribute those devices may be left with red in their accounting ledger.

Learn how medical coders are needed to ensure medical device manufacturers receive payment for their equipment.

Why Are Coders Needed for Medical Device Manufacturers?

Regardless of whether a company develops catheters, X-ray machines, or pacemakers, it should receive accurate reimbursement for the device when it goes into healthcare settings.

“Some fancy engineer comes up with this really cool device, and they say, ‘Look, this is what we’ve done,’ and no one ever stops to ask who’s going to pay for it,” David Davis, MBA, of Market Access Experts, said during his session, “The Role of Coders in Medical Device Manufacturing,” at AAPC’s HEALTHCON 2025.

Other questions that device manufacturers will have to answer during the development process include:

• What’s the CPT^® code for the device?
• What’s the HCPCS Level II code for the device?
• How long does it take for the codes to be approved?
• Is the company going to be able to thrive until all the above questions fall into place?

According to Davis, several of the people in the position of trying to ensure payment for medical devices are in marketing. However, medical coders are better suited to answer these questions because they have boots-on-the-ground experience with collecting reimbursement for healthcare services.

“We don’t want marketers and people that are doing marketing in coding. Companies get in trouble for giving the wrong codes,” Davis explained.

Beyond reviewing CPT^® and HCPCS Level II codes, coders can assist in these areas:

• Hotlines: Customers call into a company with coding questions regarding the product on the market and which code to report.
• Informational media: Companies can have medical coders help develop brochures to hand out to physicians, staff members, and hospitals. These brochures will have coding, reimbursement, and payment information on them.
• Explain the reimbursement process: Coders can explain to the manufacturer’s staff and even the CEO how medical codes work and the reimbursement process.

“Some people at these companies do not know how these processes work, and it would shock you,” Davis said.

What Teams Help Secure Reimbursement?

Taking the company’s device from development to market, and eventually getting its use reimbursed, requires a team that knows the healthcare revenue industry. Medical coders can fit the roles needed within the organization in several areas.

Those who enter a reimbursement strategy position can examine what is needed for the company to secure a CPT^® or HCPCS Level II code for the company’s device. This would involve knowing what agencies the manufacturer will need to work with, understanding what data is needed for a CPT^® code, and attending CPT^® Editorial Panel meetings.

Coders on the reimbursement communications team are responsible for creating the brochures about the product and including necessary coding and reimbursement information. They will also ensure the coding information on the product website is accurate.

The field reimbursement team goes out and talks to the hospitals about the device and the reimbursement process. This is the team that would establish the new technology add-on payment (NTAP) or the transitional pass-through payment (TPT). The team may also sit down with physicians and hospital staff to review correct coding. Coders on this team will also participate in value analysis committee (VAC) discussions. The VAC is responsible for reviewing every device that enters a hospital before it is deployed.

What Different Ways Are Companies Reimbursed?

Before a device can fully hit the market, it needs to go through several rounds of trials to ensure its safety and efficacy. One such trial is Investigational Device Exemption (IDE) trials that are reimbursable by the Centers for Medicare & Medicaid Services (CMS). A device manufacturer works with CMS and applies for the IDE trial. If approved, the company receives a trial number that healthcare providers will use on the CMS-1500 forms when it submits the claim to Medicare. That number allows the trial to be reimbursed by CMS, but not private payers.

As mentioned above, manufacturers can use TPT or NTAP pathways to receive reimbursement for the devices. The TPT payment under the Medicare hospital Outpatient Prospective Payment System (OPPS) is reserved to provide Medicare beneficiaries access to new medical devices, drugs, and biologicals while providing payment to the healthcare organization. The NTAP pathway is used for “new medical services and technologies used in the inpatient setting,” according to CMS.

“You would also work with AdvaMed, Medical Device Manufacturers Association [MDMA], other policymakers, and other companies through AdvaMed and through some of these associations,” Davis explained.

AdvaMed has a strategic value initiative that “develop[s] an approach and principles for assessing the value of medical technologies that can be adopted by health systems, payers, [medical technology] companies, and other stakeholders,” according to its website.

Mike Shaughnessy, BA, CPC, Production Editor, AAPC