A Medical Device Daily

Bayer HealthCare (Tarrytown, New York), has agreed to pay the federal government $97.5 million to settle allegations made by the U.S. Department of Justice that the company paid suppliers of diabetes products to supply patients with Bayer products rather than those of its competitors. Part of the agreement is that the company will also enter into a corporate integrity agreement with the Office of Inspector General (OIG) at the Department of Health and Human Services.

According to the Nov. 25 DoJ statement, Bayer paid 11 suppliers almost $3 million between 1998 and 2003 to drive sales to Bayer products, with the bulk of those payments going to one mail order supply house, Liberty Medical Supply (Port St. Lucie, Florida). The DoJ said Liberty took in roughly $2.5 million from Bayer between 1998 and 2002.

Liberty was itself the object of a lawsuit filed by employees who claimed the firm owned them back pay for wages not paid during working lunches. The company will have to pay $1 million to settle the case, which closed last month.

According to the DoJ statement, Bayer's payments were based on the number of patients Liberty managed to switch to Bayer supplies and were entered as advertising revenues. Gregory Katsas, assistant attorney general for the civil division, said in the statement, "Paying healthcare suppliers to place a particular brand of device with Medicare beneficiaries violates the law and will not be tolerated."

Bayer fully cooperated with government attorneys without acknowledging liability, Bayer spokeswoman Susan Yarin said, adding that the company settled "to avoid time, uncertainty and the expense of litigation."

OIG says 'aye' to DME arrangement

A recent opinion published by OIG suggests that suppliers of durable medical equipment have few peers when it comes to innovative marketing solutions.

The Nov. 19 opinion, which OIG posted a week later, concerns a proposal to place consignments of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) on site at a hospital along with personnel who are licensed to help patients with their oxygen equipment. The arrangement would allow the unnamed supplier to "place an inventory of DMEPOS in consignment closets at each hospital for distribution" for home-bound patients, although the supplier will not pay the hospital for the use of the closets.

OIG writes in the opinion that the hospital also will provide the DMEPOS company with "a desk and a phone connected to the hospital's internal telephone system to facilitate the coordination of these services with the patient's treating physician" and other staff. The supplier would not pay the hospital for these amenities either, and the patient can select another supplier.

The fact that the hospital receives no money for the closet or the desk and phone appears to be the key to this arrangement. OIG states that its willingness to not put the kibosh on this arrangement is because "no remuneration will flow from the suppliers to their potential referral sources," namely hospital staff or administrators. The supply company personnel "will not have any type of contact with the patients prior to the selection of a supplier," either.

Cancer incidence and deaths falling

The war on cancer has been in force for decades, but history shows clearly that this war will never be won with a single decisive blow. On the other hand, an announcement posted at the web site for the National Institutes of Health shows that the tide is turning, partly because the numbers of diagnoses are falling.

In the Annual Report to the Nation published in the Dec. 2 edition of the Journal of the National Cancer Institute, researchers report, that "for the first time since the report was first issued in 1998, both incidence and death rates for all cancers combined are decreasing for both men and women," according to the Nov. 1 NIH statement. The researchers indicate that this drop is "driven largely by declines in some of the most common types of cancer."

Still, the numbers indicated "large state and regional differences in lung cancer trends among women," which the statement says, "underscore[s] the need to strengthen many state tobacco control programs."

The NIH statement indicates that rates of incidence for all cancers fell by 0.8% per year between 1999 through 2005 for both sexes combined, but most of that drop-off was in men, whose rates decreased 1.8% per year from 2001 through 2005 whereas rates in women dropped by 0.6% per year over that same time frame. The drops in both death rates and diagnoses were due mainly to "the three most common cancers among men (lung, colon/rectum, and prostate) and the two most common cancers among women (breast and colon/rectum), combined with a leveling off of lung cancer death rates among women."

"While we have made progress in reducing the burden of cancer in this country, we must accelerate our efforts, including making a special effort to reach underserved cancer patients in the communities where they live," said John Niederhuber, MD, director of the National Cancer Institute at NIH.

According to the NIH statement, "the 13 states where lung cancer death rates for women are on the rise have higher percentages of adult female smokers, low excise taxes, and local economies that are traditionally dependent on tobacco farming and production." California's numbers run in a different direction, thanks at least in part to the fact that it has a comprehensive, statewide tobacco control program. The Golden State is said to be "the only state in the country to show declines in both lung cancer incidence and deaths in women."