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Limited Data Does Not Preclude Payer Coverage – Humanitarian Device Exemptions: A Case Study

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An Avalere Health study commissioned by The Pew Charitable Trusts examined how payers cover medical devices that come to market and what role the extent of evidence generated to seek FDA approval impacts downstream coverage and payment for these devices.

In conducting this study Avalere looked at two FDA regulatory approval pathways with different standards of evidentiary burden. Through the standard Premarket Approval (PMA) process, data must show that the device is safe and effective. Under a different pathway, FDA can grant Humanitarian Device Exemptions (HDEs) for medical devices that address rare conditions. These are reviewed mainly for safety and probable or likely benefit to patients, though effectiveness is not confirmed.

Avalere evaluated how variations in the evidence packages associated with these two device pathways result in similarities and/or differences in reimbursement. Avalere studied 10 HDEs and the evidence used to approve them and three PMA devices approved in the recent past (within five years), including those that had been particularly novel or generated significant media attention. To understand requirements for payer coverage, Avalere analyzed data from several large US commercial payers, as well as publicly available information on Medicare and Medicaid coverage decisions.

Contrary to common wisdom, Avalere found that payers often cover humanitarian use devices despite the limited data, thus providing patients with a therapeutic option when no alternatives exist. The study also found that PMA devices that come to market with more evidence are not always covered by payers.

See the Pew site for more info.

Download Avalere’s full case study as a PDF, below.

For more information on FDA’s HDE, contact Lakshman Ramamurthy at

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