Medical Technology Manufacturers Call on CMS to Postpone Round Two

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.