Medical Device Daily Washington Editor

As a recent hearing in the House Small Business Committee suggests, the competitive bidding program for durable medical equipment and prosthetics, orthotics and supplies (DMEPOS) has not won a huge following on Capitol Hill despite the fact that Congress mandated the program in the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (a.k.a., Medicare Modernization Act or MMA). A recent pair of identical letters addressed to several members of the House Ways & Means Committee highlights the growing anxiety felt on Capitol Hill over the program.

The June 2 letters, signed by more than 130 members of the House of Representatives from both parties, asked that the addressees "support legislation to delay implementation of this program until outstanding issues can be resolved." Winning bidders from the first round are scheduled to start operations July 1, and the second round of bids will start doing business a year later.

The letters, one of which is addressed to the chairman and the ranking member of the Ways & Means health subcommittee, Rep. Pete Stark (D-California) and Rep. Dave Camp (R-Michigan) respectively, state that many companies who have been in business for decades have been excluded from the program "through no fault of their own," adding that bidders have been rejected for lack of financial information when the bidder had evidence that they had submitted such data.

The signees added that home oxygen bids were rejected "for allegedly bidding too low on certain individual items while other providers based outside the market area were offered contracts for similarly priced bids." The letter recommends "more transparency from CMS" on the bidding process and asks that the first round be suspended for a year.

A House staffer who asked not to be identified told Medical Device Daily that some House members were not in favor of competitive bidding in 2003, when MMA was passed, and that some of the bill's supporters are hearing from constituents about the bidding. He said that the idea making the rounds at the moment is to delay implementation of the first round of bidding until next year so the House can re-examine the program.

Any legislative tweaks may come out of the House as a stand-alone or tucked into a bill for Medicare funding, the staffer said, and the Senate is said to be sympathetic to the call for a delay. The House is considering fee cuts to DME providers under the current program to offset the savings lost due to the suspension of the program.

Anesthesia monitor maker gets warning

Safer Sleep (Nashville, Tennessee) and FDA apparently went through quite a process in sorting out findings from the most recent inspection of the firm's plant, given that the inspection took place last November and that FDA finally inked a warning letter for that inspection May 27.

Perhaps more remarkable is the apparent state of disinformation exhibited by the company on the quality systems regulations (QSR). Although the company's web site touts the principal product, the SAFERsleep device, as "user friendly and field-proven in over 25,000 anesthetics," the warning letter pinned the company down on 10 fairly routine QSR violations.

According to FDA, the company was unable to provide any documentation "of validation of the embedded software in the ... device" and had not established procedures for corrective and preventive action. The warning letter also cited Safer Sleep for lack of procedures for quality audits, and said that the firm had not appointed a management representative for quality systems. FDA indicated that Safer Sleep "presented the investigator with a new, written quality policy prior to the close of the inspection," but that the company could not document that "the policy has been implemented."

Danny Gardner, Safer Sleep's president for U.S. operations, told Medical Device Daily that the company "is restructuring its quality program to be fully consistent with the FDA quality systems regulation."

PTO publishes fee schedule for FY09

The U.S. Patent and Trademark Office published an announcement in the Federal Register earlier this week on the fee schedule for patent applications for fiscal 2009. PTO will accept comments on the proposed fee schedule until July 3.

Using the Consumer Price Index as a fee adjustment, PTO proposes to charge a basic filing fee for a design application of $370 for a "non-small entity" and half that amount, or $185, for a small entity. The notice did not list the previous fees charged, but PTO said that the CPI measurement will be for the year ending September 30, 2008.

A filing for a patent that includes a search of patents in Japan or in Europe will cost the small entity $510 in FY09, and the big entities will pay twice that amount, or $1,020.

According to subsection 1.27 of chapter 37 of the Code of Federal Regulations, a small entity is defined as anyone "who has not assigned, granted, conveyed, or licensed, and is under no obligation under contract or law to assign, grant, convey, or license, any rights in the invention."

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