WASHINGTON--AdvaMed, a 1,600-member medical technology innovator and manufacturer association, has added its voice to those urging CMS to postpone competitive bidding.

The Washington, D.C.-based organization, whose members produce nearly 90 percent of the health care technology purchased annually in the United States--and more than 50 percent of that purchased annually worldwide--has called on CMS to refrain from implementing round two of bidding until the effects of round one, scheduled to go into effect July 1, can be analyzed. CMS has already announced the next 70 areas in which round two will be implemented.

“We are concerned that patient access to life-saving, life-enhancing durable medical equipment may be compromised through the DMEPOS competitive acquisition program,” said Stephen J. Ubl, president and CEO of AdvaMed.

“We urge CMS to postpone expansion of the program to 70 additional areas under round two until it fully evaluates the impact of patient access to the most appropriate treatment,” he added.

Ubl said AdvaMed was concerned that patient access might not be ensured under competitive bidding.


“Many of Medicare's elderly and disabled patients will lose their current supplier,” Ubl said. “It is essential that these patients continue to receive high-quality care without threatening patient access to important products, which can often mean the difference between a patient being able to remain in their own home or being forced into a nursing home or hospital.”

Added Wanda Moebius, AdvaMed spokeswoman, “We are very concerned that while this program is moving forward at a very rapid speed, it doesn't seem like a lot of patients understand that, effective July 1, there could be a very significant change in their medical supplies and how they receive them ... We're just asking [CMS] to slow down and assess how this program is impacting beneficiaries.”

Ubl also questioned competitive bidding's impact on research and development of new products.

“This system may discourage investment in new, superior products,” he said, because low Medicare prices wouldn't cover such innovations or improvements.

“AdvaMed continues to advocate for revisions to improve the competitive acquisition program as it is implemented to ensure patient access to the full array of therapeutic options,” Ubl said.


AdvaMed has been lobbying against competitive bidding for some time, officials said. Last October, AdvaMed board member Richard Saxon, president and CEO of Vista, Calif.-based Biomedical Life Systems, testified before the House of Representatives' Subcommittee on Investigations and Oversight.

Saxon challenged competitive bidding on several fronts, including quality of care, access to appropriate equipment, CMS' decision not to grandfather enteral nutrition patients, the lack of recourse for providers and the elimination of some providers from the Medicare program.

“A bidding process that limits the number of suppliers providing access to these technologies may also threaten patients' access to better technology and customized DMEPOS products,” Saxon said.

He also questioned the program's impact on technological innovations. The level of research and development in the medical devices and diagnostic industry is more than three times the overall U.S. average, Saxon said, but competitive bidding could change that.

“If competitive bidding reduces prices for DMEPOS products to a point where the ability to reinvest in additional R&D is eliminated, the patient will suffer,” he said, noting that “access to quality DMEPOS and related services can often mean the difference between a patient being able to remain in their own home or being admitted to the more expensive--and in consequence, higher cost to the Medicare program--treatment care of a nursing home or hospital. DMEPOS products enable providers to give essential care to many of the frailest and sickest Medicare patients.”


Another troubling consideration, Saxon said, is that the competitive bidding process “limits the ability of small manufacturers to compete to supply these innovative and unique technologies.”

Saxon reported the medical technology manufacturing industry directly and indirectly created 1.96 million jobs; payrolls totaling $93 billion; and $355 billion in shipments/sales, making it a major player in the U.S. economy in terms of revenue and jobs.