Date: September 14, 1995
For Release: Immediately
Contact: HCFA Press Office (202) 690-6145
Medicare Extends Coverage for New Medical Devices
HHS Secretary Donna E. Shalala announced today that the Medicare program will extend its coverage to pay for new generations of medical devices while they are still being studied for marketing approval.
"We want Medicare beneficiaries to have access to the latest in safe medical technology, " Secretary Shalala said. "This policy is a significant step on behalf of these patients, and at the same time it encourages technological development that can benefit all of us."
The policy will be carried out by the Health Care Financing Administration, working in cooperation with the Food and Drug Administration.
"This policy means Medicare will pay for most new medical devices prior to marketing approval, when they are used as a part of an approved clinical trial," Shalala said. "At the same time, we will continue to protect patient safety. And we will help promote development and advancement of device technology."
Under federal law, Medicare can cover only "reasonable and necessary" services, and therefore the program does not pay for "experimental" devices since fundamental questions of safety and effectiveness of such devices have not been established. In the past, Medicare has treated all devices in Investigational Device Exemption trials as "experimental."
But under the new policy, FDA will assist HCFA in identifying "non-experimental" devices that are undergoing clinical trials. Typically these will be new versions of proven technologies that are already covered by Medicare. While they are new generations of technology and still require clinical testing, the basic functioning and safety of the general type of device have been determined.
HCFA Administrator Bruce C. Vladeck said that "when we can feel confident in the basic reliability of these device types, and they represent appropriate treatment, Medicare should pay to make them available to beneficiaries who want to take part in the clinical trials."
Reimbursement rates would be the same as for comparable approved devices, Vladeck said.
"All these new medical devices need to undergo clinical trials, but most of these devices actually represent refinements and improvements to existing devices," said FDA Commissioner David A. Kessler, M.D. "This is an opportunity for teamwork between HCFA and FDA to help stimulate product development and make new generations of technology available more quickly."
Medicare coverage for devices in clinical trials should accelerate patient enrollment in the trials and encourage innovation, Kessler said.
To ensure safety and effectiveness, FDA requires testing whenever a device incorporates a new design or uses new materials, is labeled for a new use or produced by a new manufacturer, or otherwise undergoes a change from an approved product. Patients must give informed consent to take part in any clinical trial under FDA rules. About 1,200 device trials are currently approved by FDA.
A regulation incorporating the new policy will be published in the Federal Register next week, and the policy is expected to take effect in late 1995, Vladeck said.