Medical Device Daily Washington Editor

WASHINGTON – Anyone who has to follow the highly popular Andrew von Eschenbach as the director of the National Cancer Institute (NCI; Bethesda, Maryland) knows that matching the three-time cancer survivor's star power is nearly impossible, but the acting director at NCI, John Niederhuber, MD, will apparently take the job anyway.

President George Bush appointed Niederhuber yesterday as the 13th director of the renowned National Institutes of Health (NIH) division, the only center at NIH whose director is named directly by the White House. Despite the improbability of matching von Eschenbach's celebrity status, Niederhuber has solid credentials of his own to bring to the job.

Niederhuber has worked as NCI's chief operating officer and deputy director for translational and clinical sciences since last September. His work at NCI commenced in June 2002, when the Bush administration named him chair of the National Cancer Advisory Board. He has done double duty as the director of the NCI's lab for tumor and stem cell biology and holds a clinical appointment on the NIH clinical center medical staff.

Created in 1937, NCI is the oldest of the NIH centers and was originally named the National Advisory Cancer Council.

While at the University of Wisconsin School of Medicine (UW; Madison), Niederhuber held the position of professor of surgery and oncology and directed the NCI-designated cancer center at UW. He has held professorships at Johns Hopkins School of Medicine (Baltimore) and the University of Michigan Medical School (Ann Arbor). He earned an undergrad degree from West Virginia's Bethany College (Bethany) and a medical degree from Ohio State University School of Medicine (Columbus).

The NCI web site says that Niederhuber “is recognized for his pioneering work in hepatic artery infusion chemotherapy and was the first to demonstrate the feasibility of totally implantable vascular access devices.”

Niederhuber will have plenty of opportunities to work with his former boss and with previous FDA Commissioner Mark McClellan. In February, the FDA, NCI and the Centers for Medicare & Medicaid Services (CMS; Baltimore) announced a collaboration on development of cancer therapies dubbed the Oncology Biomarker Qualification Initiative, or OBQI. This initiative will search for biomarkers and examine the efficacy of treatment regimes and scanning technologies in an effort to put the squeeze on cancer. This collaboration will first work to validate and standardize the use of fluorodeoxyglucose-positron emission tomography (FDG-PET) scanning.

Niederhuber is said to serve on the editorial boards of 10 scientific journals and to have authored or co-authored more than 180 publications.

Industry input reflected in new DME rules

Medicare equipment firms have their hands full keeping up with regulatory requirements, and this third week of August is no exception. CMS released its quality standards for suppliers of durable medical equipment (DME) and affiliated services on Tuesday, and the avalanche of industry input seems to have had some effect on the final formulation of those standards.

CMS took in more than 5,600 comments after publishing the draft last September, which played a role in the elimination of redundant information requirements and cut the number of pages needed to describe the standards from 104 to a mere 14. The agency also dropped its requirement that providers be open 40 hours a week, opting to mandate only that hours of operation be posted. CMS also shaved product-specific standards from 15 to three.

CMS noted that accreditation of providers is a “process [that] will emphasize related processes and outcomes of services validated through unannounced onsite visits to each supplier location and during interviews with beneficiaries.” Medicare has encountered problems in the past with billings from unaccredited providers of DME, but also had to revise its rules for reimbursement for power wheelchairs and scooters last October in an effort to clamp down on fraudulent billings as well as to deal with physician and patient complaints that existing regulations were too burdensome.

The new CMS regulations come in two parts. One addresses business quality standards that “apply to all Medicare suppliers regardless of specialization,” according to the CMS announcement. The second set of regulations are product or product-category specific. Hence suppliers will have to produce documentation for two sets of compliance regimes.

Tom Ryan, chairman of the American Association of Homecare (Alexandria, Virginia), said that “[w]e are pleased to see the standards have been considerably streamlined since the initial draft.” He also noted that homecare providers must “continue to foster collaboration with CMS in this process.”

TSA screeners edgy over insulin pumps

The recent concern over liquids carried onto commercial air carriers has spilled over to sufferers of diabetes, according to dLife (Westport, Connecticut), a web portal for sufferers of diabetes. dLife reports that security screeners at the nation's airports do not always clear diabetic passengers to board planes with their insulin pumps attached, as Transportation Security Administration (TSA) regulations allow. In response, dLife hopes to organize a task force to examine TSA's security protocols.

dLife recently recommended that diabetes sufferers carry letters from their doctors explaining the pumps and the need to keep them connected to the patient (Medical Device Daily, Aug. 14, 2006).

The statement by dLife relates that passengers have been “harassed and pressured” into removing the pumps. “Separating a person with diabetes from their insulin supply can cause extreme illness, and in some cases, death,” said Nicole Johnson Baker, a diabetic who hosts dLifeTV and uses an insulin pump. The organization has penned a letter to Rep. Peter King (R-New York), who chairs the Homeland Security Committee in the House of Representatives, asking for the medical task force to be included in the review process for creating and executing transportation security initiatives.

Howard Steinberg, CEO of dLife, said that a medical task force might “help prevent future misunderstandings as new travel security sanctions are enacted.” He characterized the incidents as “critical miscommunications regarding onboard security clearance for insulin pumps.”