CMS should hold off the launch of a national competitive bidding program for mail-order diabetic testing supplies until it has a chance to analyze experience from its round one bidding in select markets, according to AdvaMed.

In Aug. 24 ¹ comments on the 2011 Medicare physician fee schedule, the trade group says the agency has not indicated "precisely when" CMS expects to go ahead with a national competitive bidding program for diabetes testing supplies beyond that it would be "at some point after 2010."

Average payments for diabetes testing supplies will drop 56% in the nine test markets participating in round one, CMS announced earlier this summer. This is significantly higher than the overall average 32% cut expected from the bidding program, which includes eight product categories in addition to mail-order diabetes supplies (² Also see "DME Competitive Bidding: 32% Cost-Cutting Expected From Revived Program" - Medtech Insight, 5 July, 2010.).

"AdvaMed is concerned that such savings will compromise quality of care for beneficiaries," the industry group writes. It asks CMS to develop tools to assess any changes to quality of care that result from the payment reductions, especially given that diabetic supplies have not been included in previous competitive bidding demonstration projects.

AdvaMed wants CMS to wait until the round one bidding experience is complete before making an assessment on a national program, as "data from the early months may not be reflective of how the program ultimately functions."

The agency expects to award all winning round one bidding contracts this month. Payments will reflect the bidding contracts beginning Jan. 1, 2011, for the nine product categories in nine markets.

As CMS implements its round one bidding program, AdvaMed says, it should educate diabetic patients that they can continue to receive replacement supplies at local pharmacies, which are not subject to competitive bidding rates, and not just by mail.

AdvaMed Wants Bidders To Offer More Test Strips

The industry group also made a special request to CMS that winning bidders under the program should be required to show they can furnish 95% of diabetic test strips on the market. CMS had proposed a 50% requirement.

In consulting with its member diabetes-testing-supplies manufacturers, AdvaMed determined that CMS should require bidders to offer 95% of test strips in order to help "protect beneficiary access to diabetes testing supplies without requiring switching or disruption in testing."

According to AdvaMed, "Patients and physicians select blood glucose monitoring systems based upon key clinical features important to the individual patient. Such features help ensure compliance with prescribed testing regimens."

Compliance-Monitoring Capabilities Questioned

Whether the policy is finalized at 50% or 95%, AdvaMed says, questions remain over whether CMS has the resources to monitor compliance to make sure beneficiaries have access to their preferred products.

"CMS has never detailed its plan for holding winning bidders accountable for making available to beneficiaries the products enumerated in their bids," AdvaMed says. "Nor has it indicated how it will monitor compliance with a non-discrimination requirement that requires suppliers to offer their Medicare customers the same range of products as those offered to their non-Medicare customers."

The association advises CMS to require winning bidders to adopt several policies to discourage them from switching customers to products other than the ones requested by the prescribing physician.

For example, CMS could monitor supplier toll-free ordering lines or use secret shoppers to see whether winning bidders are following the rules.

In addition, participating durable medical equipment suppliers could be required to notify a patient's physician before supplying a diabetes test strip other than the one prescribed.

CMS should also clarify anti-switching policy as it relates to products that must be substituted due to updated FDA standards, discontinued product lines or damaged products in a way that protects "the need of patients for choice and education regarding available product options," AdvaMed says.

- Monica Hogan ( ³ m.hogan@elsevier.com )

Industry Urges Delay In Nationwide Bidding For Mail-Order Diabetes Supplies

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