Artificial Voice for Cancer Patients Faces Uncertain Future Due to Medicare Problems

For several hundred throat cancer patients each year, the UltraVoice voice synthesizer offers the hope of speaking clearly again after the larynx is removed. Yet the future of this technology - and cancer patients' ability to receive it - is uncertain.

Medicare patients make up about 80% of the 700 patients each year who could benefit from the voice synthesizer. The program significantly underpays for the device and has delayed correcting the problem for several years. As a result, the small private company near Philadelphia that makes the UltraVoice is losing $1,500 on each implant and may not be able to remain in operation.

Cancer Patients Face Barrier to Breakthrough Voice Technology Due to Medicare Under-payment and Delays.

• After undergoing a one-and-a-half year review at FDA, UltraVoice received marketing clearance in 1993. That same year the manufacturer, UltraVoice, Ltd., applied to Medicare for reimbursement.

• Two years later, in 1995, Medicare's regional contractors established coverage and reimbursement policy for the device. The contractors set reimbursement based on initial pricing for the device provided by the company.

• However, the local contractors placed restrictions on coverage of the device that reduced the number of eligible patients. This means Medicare patients who have limited speech ability through other treatments but would like to speak better using the UltraVoice often can not receive it.

• As a result of the coverage policy, UltraVoice sold significantly fewer of the products than originally anticipated and was losing money under the rates established by the carriers.

• UltraVoice contacted HCFA about the problem in September 1996, and remained in discussions with them until mid-1998. At that time, the agency requested additional data from the company. UltraVoice gathered the data and returned to HCFA in January 1999.

• Agency officials then told the company that additional information was needed, but would not specify what kind of information. HCFA rejected UltraVoice's request to visit the agency to discuss the issue.

• With its options exhausted after 7 years, UltraVoice now is uncertain how long it will be able to remain in operation and continue providing its voice synthesizer to cancer patients.

Company delays R&D due to Medicare uncertainty.

• UltraVoice has put on hold further research and development of its voice synthesizer technology as a result of Medicare under-payment and delays. The company says it can not afford to bring to market new products and face the same problems.

• One potential application of the technology is using it in the emergency room so medical personnel can communicate with patients who have breathing tubes in their throats and could not otherwise talk.

Medicare must be improved to prevent problems like those encountered by UltraVoice and ensure that patients gain timely access to breakthrough medical technologies.

• The case of UltraVoice illustrates how Medicare's coding and payment systems often fail to account for advances in medical technology.

• Medicare should have in place sound methods for setting payments amounts for durable medical equipment that reflect a product's value. HCFA should explain the rationale for its decisions and provide the data it used to make them. It also needs clear procedures for manufacturers, providers and other stakeholders to request payment adjustments.

• Pending bipartisan legislation, the Medicare Patient Access to Technology Act (H.R. 4395), would make these changes. One important section of the bill would address problems in Medicare payment policy for laboratory tests and durable medical equipment.

• The bill also would improve patient access to innovative technologies by requiring Medicare to: report annually on the timeliness of its decisions; issue temporary codes for new technologies and procedures and update its codes every quarter; update its payment systems annually; and create open procedures and sound methods for setting lab test reimbursement policy.

  QUOTES OF THE WEEK "From the very first day of use I could speak. It's like a miracle." -Margaret Estrada, who could not speak for one-and-a-half years after removal of her larynx until she received an Ultra Voice system. "I do not know how much longer Ultra Voice will be able to survive as a company given the staggering losses we have experienced and continue to suffer." -David Baraff, General Manager, Ultra Voice, Ltd., February 2000.