Reimbursement for device trials actually is possible
Here’s what you need to know
While the vast majority of medical devices undergoing clinical trials are eligible for reimbursement, many clinical trial sites fail to take advantage of regulatory changes that made reimbursement possible.
"I continue to be amazed at how many sites don’t now that the device clinical trials are eligible for reimbursement," says Ron Podraza, chief executive officer of Reimbursement Principles Inc. of Littleton, CO. He spoke about device trial reimbursement at the Association of Clinical Research Professionals (ACRP) 2005 conference, held April 2-6 in Orlando.
Since 1995, more than 90% of devices involved in clinical trial research for FDA purposes have been eligible for Medicare reimbursement, he says.
"The change is the result of some regulations which came out in the mid-1990s when Medicare beneficiaries were concerned that they weren’t getting early access to new treatments. There are a lot of places that either don’t know this or are reluctant to participate in the trial if it’s going to involve reimbursement," Podraza says. "And think that’s because this is so much different today than the pharmaceutical model, where generally there is little or no reimbursement and drug companies pay for the whole trial."
Now the regulations permit reimbursement that includes the cost of the device and standard of care medical procedures, he explains.
"It never includes any special record keeping or testing that is done because of the requirements of the test protocol," Podraza says. "But basically anything that’s standard of care is routinely reimbursed, and anything that is protocol-driven is ineligible for reimbursement."
Often, sponsors have internal support and can provide clinical trial sites with information and codes that will help support reimbursement claims, says Deborah Rosenfelder, BSN, CCRC, a clinical research coordinator with the University of Pittsburgh Medical Center. Rosenfelder, who has nearly three decades of research experience, also spoke at the ACRP conference about device reimbursement.
"If you need to submit information for insurance reimbursement, the sponsor can provide the medical necessity information," she says. "And sometimes if you’re going to a third-party payer, they can pull articles that have been published in peer journals, supporting why you are using the information you’ve included."
Start with medical directors
Podraza and Rosenfelder offer these strategies for obtaining coverage for device clinical trials:
• Educate Medicare contractors.
Decisions about whether a particular device is covered are made by local Medicare contractors, Podraza says. "So that means, conceivably, that you could have as many medical director decisions as you have study sites, but it’s a one-time decision," he explains. "So if the decision is in favor of covering the clinical trial, then the decision will stand for all Medicare patients in the trial."
The best strategy for ensuring coverage is to provide the medical directors, who are making the decision, with thorough education about the trial at the time the coverage decision is requested, Podraza notes.
"For private insurance, it will depend on the policy of the particular company, but I also recommend a similar educational effort, which can sometimes be done in the context of pre-authorizing the treatment for individual patients," he says.
"That’s the main difference between Medicare and private payers: Medicare does not pre-authorize," Podraza explains. "Medicare makes a single decision that applies to all beneficiaries."
It’s best to provide information that is directed toward the decision maker’s clinical interest, he notes. Provide any published literature and even unpublished results and data from work conducted to date, he adds.
"It’s also very helpful to define the patient selection criteria carefully so they will understand the benefits for a particular subgroup of patients and whether or not there are existing treatments that can provide the same benefit," Podraza says. "Very often when there is not an existing treatment that can provide the same benefit, it makes them more inclined to consider coverage favorably."
Sponsor, finance department help with coding
• Make certain the sponsor has included all necessary information.
"Sometimes when sponsors are submitting the protocol, they’ll submit reimbursement information, and that’s what you’re looking for from them," Rosenfelder says. "They should be providing what class the FDA has defined for the device, whether it’s a Class A or Class B, and then they should be able to provide you with the CPT codes for that class."
Clinical trial sites need to look at the protocol sent by the sponsor and make certain it includes the FDA approval letter, class identification, and cost associated with use of the device, she adds.
Also, individual hospital departments, including patient billing and purchasing, should check the protocol for information they’ll need, says Rosenfelder.
"Each individual site will have to identify which departments will be pulled in and working on the project," she explains. "Medical records can help with the coding, and so you need to make sure you have the appropriate CPT and DRG codes."
A site’s financial department will assist in making sure the information sent to local Medicare fiscal intermediaries is complete and accurate, Rosenfelder says. "Then you need to work with the business department to set up charge accounts in your institution," she says.
• Understand FDA criteria and the range of reimbursement decisions.
The initial determination for device trial reimbursement eligibility is made by the FDA, says Podraza.
"The FDA has criteria that it applies to each clinical trial that it authorizes; and as part of that authorization process, the FDA will say whether this is a device for which payers should consider reimbursement, or whether it’s excluded from that category," he explains. "The payers still have to make their own decisions. Just because the FDA says it’s eligible doesn’t mean it’s automatically covered."
"The most typical product you will see is where there’s almost no question about providing coverage, and it’s a device that’s had clinical acceptance for some time, like cardiac rhythm management devices, such as pacemakers, and implantable defibrillators," Podraza says. "I’ve seen drug delivery devices be approved for clinical trials where it was well understood that the drug therapy was effective, and basically the trial was intended to see if the treatment might be more effective when delivered through some kind of device."
The gray areas typically are not that big because the FDA has to make a finding before the trial is authorized to proceed, he says.
• Take care of additional details and documentation.
"When you’re ready to start with the clinical trial, you need to identify someone at the site who will know about the patient’s participation with the trial device," Rosenfelder says.
"Some facilities will want to have a compliance manager who wants to know that, and it varies from facility to facility," she says. "And here’s where you work with a billing specialist to make sure the charges are documented appropriately."
In cases where the sponsor charges the site the manufacturing cost of the device, someone will need to work with the purchasing department, Rosenfelder says.
Also, clinical trial sites will need to be aware of state laws regarding payment, as well as Medicare regulations and the site’s own policies.
Finally, sites should go through the reimbursement issue on a patient-by-patient basis, Rosenfelder says.
While the vast majority of medical devices undergoing clinical trials are eligible for reimbursement, many clinical trial sites fail to take advantage of regulatory changes that made reimbursement possible.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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