Medical Device Daily Washington Editor
Japan's regulatory apparatus for medical devices has long struck industry as needlessly obstructionist, but the efforts of industry and the U.S. government have pried open the clamshell at least somewhat, and a recent announcement gives hope to device makers that one of the world's most promising markets may be worth more effort.
In a July 6 publication, Tokyo and Washington reported a new round of moves designed to increase patient access to new medical technologies in the world's tenth most populous nation. The report, which covers pharmaceuticals, electronics and intellectual property considerations as well, deals with, among other things, the perennially sticky issue of medical device pricing.
The document notes that the foreign average price (FAP) rule will henceforth be more open to the views of device makers and will also take currency exchange rates into account in setting the prices the Ministry of Health, Labor and Welfare (MHLW) will pay. The FAP, which uses an average of prices from four comparator countries, was revised last year, the document notes, to reduce the number of functional device categories affected and to phase in announced price cuts, which were capped at 25%.
Pricing reforms will also extend to advanced imaging modalities, the document notes, with an advisory committee known as a Chuikyo (short for Central Social Insurance Medical Council), taking up such matters. MHLW is said in the document to have "established new premiums for coronary artery CT and heart MRI." The Ministry also promises to keep an eye on the functional categories into which devices and diagnostics are shoehorned, noting that it had expanded the number of functional categories by 15 in the two-year period ending April 2008.
MHLW is also offering to make more public comment periods longer than 30 days, and to make more regulatory documents available in English.
Steve Ubl, President/CEO of the Advanced Medical Technology Association (Washington), said in a statement that the association's members "are pleased that the two governments recognize the vital contributions that advanced medical technologies can make to Japan's healthcare needs."
OIG releases report on ultrasound
The Office of Inspector General (OIG) at the Department of Health and Human Services has published a July 10 report on variations in the use of ultrasound imaging by Medicare-billing providers, and to no surprise found a substantial amount of that geographic variance takes place in the retirement mecca of Florida.
The OIG report notes that the Centers for Medicare & Medicaid Services coughed up about $2 billion in 2007 to cover the cost of about 17 million ultrasound procedures and that of the top 20 U.S. counties in terms of total charges for that year, nine were in the Sunshine State. According to OIG's analysis, these 20 counties, five of which were in New York, "accounted for 16% of Part B spending on ultrasound despite having only 6% of Medicare beneficiaries." Per-beneficiary spending in these counties averaged triple the average rate of the rest of the nation.
As healthcare analysts often discover, capacity has a lot to do with geographic spending disparities. The OIG report states "the ratio of ultrasound providers in high-use counties was [more than] three times that of the rest of the country." OIG said, however, that its analysis of questionable claims showed that the high-utilization areas were no more likely than others to generate claims that seemed conspicuous.
NIH offers new items for licensing
The National Institutes of Health (NIH) is offering another set of inventions for licensing to industry for development, and those in the cardiovascular space might find one of the offerings quite intriguing.
According to the July 9 edition of the Federal Register, Ozgur Kocaturk of the National Heart, Lung and Blood Institute at NIH has come up with a device "that can non-invasively secure surgical suture loops when combined with a percutaneous delivery system." The device in question is described as a guidewire that is "percutaneously conveyed to the atrium of the heart and is used to secure the 'cerclage' suture encircling the mitral valve annulus" during valve repair procedures. According to NIH, this approach to securing surgical loops helps to maintain the tension of the sutures on the valve annulus, thus helping valve leaflets to function more normally.
This device is also said to allow adjustments to the tension of the suture, although whether such adjustments are possible after removal of the catheter is unclear from the notice. The device is said to be MRI-compatible.
Among the other available inventions is a quantitative polymerase chain reaction (qPCR) assay for detection of the John Cunningham (JC) virus, which is thought to opportunistically induce progressive multifocal leukoencephalopathy in patients with acquired immune deficiency syndrome. NIH says that this assay is sufficiently specific to detect JC virus in cerebrospinal fluid as well as in blood and blood products. Also among the other numerous offerings is a series of novel osteobiological proteins that could prove useful in treatment of osteoporosis and other conditions, including deterioration of connective tissues and cartilage.
Appearing on this list are a cartilage-derived morphogenic protein, an uncharacterized bone morphogenic protein, and a product described as "tissue-fate modifying protein." This last product is purported to perhaps offer therapies for Huntington's and Alzheimer's diseases and exerts its effect by means of the WnT signaling pathway. This cellular mechanism, conducted by a series of more than 10 proteins, is important in embryogenesis but abnormalities in this mechanism have been implicated in the formation of some cancers. According to NIH, the WnT series of proteins is also involved in the development of osteoarthritis and osteoporosis.