Medical Device Daily Washington Editor

The National Institutes of Health has published a list of patented items that are available for licensing, and one of the more interesting technologies on the list is a self-expanding stent for use in valve replacement procedures. Also on the list, however, are a diagnostic technology for detection of a pathogen that causes Query fever and a Java-based computer program that generates three-dimensional Venn diagrams.

According to NIH's June 8 announcement in the Federal Register, the stent invention can be used to craft a "self-expandable stent with an elastic tubular latticework having radial and longitudinal directions" that can provide "secure implantation with adaptable apposition of the prosthesis in the aorta." This use of the stent would require building into the stent "four-sided polygons and longitudinal rods" to do the job. Interested parties can contact Michael Shmilovich at the NIH Office of Technology Transfer.

Also on the technology transfer list is the aforementioned computer program described as a Java-based "interactive Venn diagram software designed for microarray analysis." The program, presumably able to run on a variety of platforms, is capable of "displaying multiple conditions in a single graphic along with producing a text output of genes that are the product of these conditional intersections." NIH states that the program "can display any number of comparisons and will automatically create [gene] lists from all intersections."

As for the diagnostics on the list, the description of a method of sterile production of Coxiella burnetti, the gram-negative bacteria that gives rise to Query fever, does not describe the technology in any detail. This announcement notes, however, that there are currently no licensed vaccines other than Q-Vax, which apparently can generate "flu-like symptoms." However, sterile production of C. burnetti could lead to production of a hypoallergenic vaccine. The underlying technology is also of interest at NIH because of its potential use in "other obligate, intracellular bacteria of public health significance."

NIH is also offering for license a new chimerical protein that can attach to the GP 120 protein that resides on the surface of the human immunodeficiency virus, offering a possible preventive for acquired immune deficiency syndrome.

CMS reopens PET/FDG for bone cancer

The Centers for Medicare and Medicaid Services has decided to reopen consideration of the use of positron emission tomography (PET) using fluorodeoxyglucose (FDG) to identify bone metastasis of cancer, and according to at least one observer, the move is prompted by the continuing short supply of technetium-99, a radioisotope that is produced in only a handful of processing sites around the world.

Atomic Energy of Canada (Mississauga, Ontario) reported last month that it would suspend production of technetium-99 (Medical Device Daily, May 27, 2009), and has since posted a June 2 announcement that it has commenced with removal of the rods of radioactive precursor from the reactor, a process expected to take three to four weeks. AEC did not offer an estimate of how long repairs would take, given that it has not yet had a first-hand look at the inside of the reactor vessel, which is said to have sprung a persistent leak.

In a June 8 statement, the Society for Nuclear Medicine (SNM; Reston, Virginia) offered a diagnosis of the new coverage analysis. The statement remarks that the long-term prospects for supplies of technetium-99 are almost as shaky as short-term prospects and that "because of the severity of the radioisotope supply crisis and the long-term duration of the anticipated outage, CMS has opened" the current reimbursement memo for another look.

SNM's president, Robert Atcher, PhD, is quoted as saying that the medical community "is in crisis right now" and that patients are either unable to get tested or have to deal with "more radiation dose, less accuracy, more cost or more invasive techniques."

According to CMS, the request for re-examination of the coverage status came from within the agency, and CMS said it will take comments until July 4, an interesting date to cut off a comment period. The agency expects to complete the analysis by Dec. 4, 2009 and publish a final decision memo on March 4, 2010.

Physician group busted by FTC

The Federal Trade Commission has announced a settlement of price-fixing charges with a provider group, and the outcome might be an object lesson in playing games with physician reimbursement fees.

According to the June 4 FTC announcement, Alta Bates Medical Group (San Francisco) commenced in 2001 with "collective negotiations for fee-for-service contracts," that the organization's 600 physicians would provide. FTC states that Bates "proposed, rejected and countered offers to insurers without consulting with its individual physician members regarding the prices" each doctor would have had to accept to provide services, informing the doctors of the fee schedule "only after the group had approved the negotiated prices." The FTC statement also alleges "an unlawful concerted refusal to deal," a complaint made in connection with a contract Alta had discussed with Kaiser Permanente (Oakland, California). That complaint evidently was made in connection with Bates' refusal to allow its physicians to participate in a healthcare plan operated by Kaiser in the San Francisco bay area.

FTC did not indicate that it had opted to impose any penalties on Bates, noting only that the organization would have to clear with FTC "certain contacts with insurers." The agency will take comments on the proposed remedy until July 6.

Cindy Mann named to key CMS post

U.S. Health and Human Services Secretary Kathleen Sebelius reported the appointment of Cindy Mann to serve as director of the Center for Medicaid and State Operations (CMSO), part of the Centers for Medicare & Medicaid Services.

Mann most recently served as a research professor and executive director of the Center for Children and Families at Georgetown University's (Washington) Health Policy Institute.

"Cindy Mann has decades of experience in health care financing at the federal and state level, and vast knowledge of health care policy," said Sebelius. "She has devoted her career to working on behalf of children and families, the elderly and people with disabilities. She will be an outstanding leader at CMSO, particularly as the nation moves forward with healthcare reform."

Mann previously served as director of the Family and Children's Health Programs at CMSO from 1999-2001; in that capacity she played a key role in implementing Medicaid and the Children's Health Insurance Program.

"Cindy has been instrumental in recent efforts to expand health care coverage in our country," said Sebelius. "Her knowledge of healthcare issues and management experience will be a great asset to CMSO and to the millions of Americans who rely on Medicaid."