A Medical Device Daily

In the continuing saga concerning government reimbursement vs. no reimbursement for powered mobility equipment, The Scooter Store (TSS; San Antonio, Texas) yesterday issued a response to counterclaims filed on April 29 by the Department of Justice (DoJ) on behalf of the Centers for Medicare & Medicaid Services (CMS; Baltimore). The Scooter Store, which calls itself the country’s largest supplier of power mobility products, said its new filing follows a separate suit that it filed May 27 seeking payment from Medicare for power mobility equipment delivered to the program’s beneficiaries.

In the May 27 complaint, TSS contends that CMS “continues to wrongly deny valid reimbursement claims submitted in compliance with physicians’ orders.” It further contends that these claims “should be paid because, prior to submitting any Medicare claim, it received a congressi-onally approved Certificate of Medical Necessity [CMN] from the patient’s treating physician.”

It added: “The treating physician completed and signed the CMN and certified the accuracy of the information subject to penalty of law.”

Mike Pfister, TSS president, said the claims were properly submitted and should be paid. “We have followed the law and physicians’ orders, and government contractors seem to keep creating reasons to deny claims . . . [E]ven officials within CMS have admitted that they have violated the law as a result of their effort to drive down utilization of the power mobility benefit.”

The complaint further alleges that CMS contractors have demanded that TSS and other suppliers routinely supply them with “volumes of information” in addition to the CMN, “in violation of HHS’s own policies and the laws governing the Medicare program.” The complaint references internal CMS communications that show “that government contractors had, for a number of years, been applying unapproved review criteria to claims in violation of the Paperwork Reduction Act.”

Pfister said that the congressionally approved CMN was intended to “avoid confusion and bring integrity to the Medicare program. Unfortunately, CMS’s present approach is having the opposite effect.”

In a separate action reported by the company, TSS said it also filed a “motion to dismiss” recent counterclaims filed by the DoJ in pending litigation, arguing that the counterclaims admit that reimbursement claims filed by TSS included “all legally-required paperwork and physician certifications.”

According to the motion, the counterclaims make no argument that supports the claim that TSS violated the False Claims Act. Instead, TSS said, the claim offers “conclusory allegations or legal conclusions masquerading as factual conclusions.”

Pfister called the government’s counterclaims “baseless and without merit” and that they represent “a smoke screen” to hide its own “unlawful behavior.” The government’s arguments, it said, “actually prove that TSS has acted lawfully and in the best interest of Medicare beneficiaries, because the government admits” its claims were based on the certified conclusions of treating physicians.

Pfister asserted the compliance of TSS with the law and that it has provided its mobility equipment “in accordance with physician orders and tried to navigate the confusing set of demands being issued by government contractors.”

The Scooter Store, which has 70 locations in 42 states, reports providing power mobility products to more than 205,000 disabled seniors.

In other legalities:

• LMA International (Hague, the Netherlands) reported that through its wholly owned subsidiary, The Laryngeal Mask Co., it has filed a lawsuit against Tyco Healthcare Nederland BV, an affiliate of Tyco International (Pembroke, Bermuda). The lawsuit, alleging infringement of European patent No. EP 0 794 808 B1 in the Netherlands and other European countries, was initiated May 31. LMA said it follows the legal proceedings against Tyco Healthcare in Germany for a similar patent infringement claim initiated in April.

LMA accuses the Tyco subsidiary of selling and importing laryngeal masks in the Netherlands and other European countries that infringe European patent No. EP 0 794 808 B1. The product is marketed under the trade names Mallinckrodt and LaryngoSeal.

LMA’s patent relates to a feature that appears in certain of the LMA laryngeal mask airway devices used during medical operations to ventilate the lungs of an unconscious patient. It said: “However, if an instrument [for example, an endotracheal tube] is passed through the mask, the epiglottis . . . may sometimes interfere with the path of the inserted instrument. The patent in question prevents this by introducing a specially designed bar across the air supply aperture of the mask.” Three of LMA’s products incorporate this feature: the reusable and single-use LMA Fastrach airways, and the LMA CTrach airway.

LMA said that a judgment is expected in two to three months and that if its claim is successful, Tyco Healthcare Nederland BV, “under a penalty payment, will be required to refrain from marketing the LaryngoSeal in the Netherlands and other European countries and to render account to LMA by providing information regarding the names and addresses of customers and recipients.”

LMA’s primary product line is the LMA laryngeal mask airway range of supraglottic airway management devices.

• Canadian operators who sold defective HIV test kits over the Internet have settled U.S. Federal Trade Commission charges of making deceptive advertising claims. The settlement bars the defendants from selling the “Discreet” HIV test kits to U.S. consumers, unless approved by the FDA, and prohibits them from making false or misleading claims about any medical diagnostic device or service.

The order also provides for notification to purchasers of the Discreet kits and requires destruction of hundreds of the defective kits seized by the U.S. Customs Service and Federal Express.

In May 2004, the FTC filed a suit in U.S. District Court against Seville Marketing and its principal, Gregory Stephen Wong, both of British Columbia. The agency alleged that defendants deceptively advertised that the Discreet test results were 99.4% accurate.

“In fact,” the FTC said, “testing conducted by the Centers for Disease Control and Prevention [Atlanta] and submitted to the court showed that 59.3% of tested kits provided inaccurate results, including both inaccurate HIV-positive results and inaccurate HIV-negative results.”

The FTC said that the case was brought with the “substantial assistance” of the CDC, the FDA, U.S. Customs and Border Protection, and the British Columbia Business Practices and Consumer Protection Authority.