A Medical Device Daily

Two members of the Senate, Olympia Snowe (R-Maine) and Dianne Feinstein (D-California), have sent acting FDA Commissioner Andrew von Eschenbach a letter asking for an investigation concerning whether silicone breast implant maker Mentor (Santa Barbara, California) intentionally held back relevant safety data in its regulatory application.

Silicone implants were withdrawn from the market in 1992 due to safety concerns, but an FDA advisory panel recommended by a vote of 7-2 that the agency allow Mentor to resume marketing of their silicone implants with several conditions. However, the April 13 decision was preceded by one day a rejection of a similar application by Inamed , also headquartered in Santa Barbara, for its silicone breast implants.

Among the issues that have been raised by a former Mentor employee was diffusion testing for low molecular weight siloxanes, which the employee's letter to the agency said "is invalid" because of problems with "signal-to-background ratios (~0.1) and now recovery for the duration of the study." The employee's letter, posted on the web site of Public Citizen (Washington), also states that had the employee known of the discrepancy, "I would never have submitted the work to the FDA since it could not be defended."

The employee raised the charges shortly after being dismissed by Mentor.

FDA spokesperson Heidi Valetkevich said, "The agency conducted a thorough investigation into these charges and found no evidence of wrongdoing and nothing that would raise questions about the safety of the product under review or the integrity of the data submitted to FDA"

Feinstein and Snowe, however, asked von Eschenbach to "fully review all data collected by Mentor, whether or not it was originally required. If the FDA has already investigated these allegations, we request that you share with us the nature and results of this investigation."

CMS, docs square off over Part B imaging

The Center for Medicare & Medicaid Services may face mixed messages from Congress about sustainable growth and doctor's fees under Medicare Part B, but the agency is nonetheless taking a closer look at how physician groups bill for tests and scans performed in their own offices or by contracted third parties.

Proposed in August, the rules address exceptions to self-referral that CMS believes doctors are abusing. Leslie Norwalk, acting CMS co-administrator, said that doctors are pocketing the difference between what they pay for the scans and what they bill Medicare. In the past seven years, Medicare payouts for imaging have jumped an average of 20% per annum, hitting $7 billion in 2005.

One of the practices that CMS thinks less than highly of is an arrangement between physician groups and so-called "pod labs," typically located in a nearby building. This practice involves billing a doctor's office a flat fee for scans while the practice group underwrites some fixed and variable overhead, such as rent and technician's wages. Physician practices are said to benefit when they bill CMS for the standard fee despite enjoying a lower overall per-scan cost under the pod lab arrangement.

To deal with the pod lab phenomenon, the agency proposes to require that such labs occupy at least 350 square feet of floor space to qualify for the exception to self-referral. According to an article in the Oct. 23 edition of the Wall Street Journal, most pod labs are smaller than 350 square feet.

The rules, which have prodded more than 2,300 comments, would also require part-time radiologists working in doctor's offices to bill Medicare independently, rather than allowing the primary physician to bill for the procedure and keeping the difference. If enacted, the rules would take force in November.

NIH rounds out 'nanocenter' list

The National Institutes of Health has rounded up another four centers to make eight the total number of Nanomedicine Development Centers , or NDCs.

The new centers — at Georgia Institute of Technology (Atlanta), Purdue University (Lafayette, Indiana), University of California at Los Angeles and University of California Lawrence Berkeley National Laboratory (Berkeley, California) — are funded by the National Nanomedicine Initiative.

Each NDC is staffed by a slew of experts in biology, math, engineering, chemistry, physics and computer science who will dig into the physical properties of nanomaterials and how they interact with living organisms. They also will train college students in this branch of medical science.