HCFA reimbursement move slams peripheral studies
The dramatic surge of the U.S. bone densitometry market in 1996 is helping to propel the development of new bone measurement systems designed to ride the growth wave. The trend was evident at last month's Radiological Society of North America meeting, where established bone measurement companies like Lunar and Hologic rolled out new products while new players like Fuji unveiled their entries into the market.
New product introductions were found across a wide range of bone measurement technologies: Hologic and Lunar showed enhancements to their high-end product lines; Norland Medical displayed a CT-like densitometer; two makers of quantitative CT products, Image Analysis and IRIS, emphasized leaps forward in user productivity, while another, MindWays (formerly MindWaves) Software, displayed a 3-D QCT product; and CompuMed hoped to build on digital technology to offer a tabletop x-ray device.
The big news over the long haul could be plans by Norland Medical of Fort Atkinson, WI, to market a CT-like device for bone mineral analysis. XCT 3000, which is already available in the Pacific Rim, Europe, Japan, and South America, generates a cross-sectional image of bone, similar to what is possible on a full-blown CT scanner.
The image quality is magnitudes less than that of CT scanners, but Lewis Harrold, Norland vice president of product development, said the image is still good enough to see the biomechanics of the leg and hip bone, potentially allowing evaluation of patient response to drug therapy.
Another possibility is for orthopedists to scan patients following implant surgery, since the implant can be differentiated from bone. The big advantage is that XCT 3000 is compact enough to put in a doctor's office. An application for marketing in the U.S. will be submitted to the Food and Drug Administration, although the company declined to state when it plans to file. A smaller version, XCT 2000, which is capable of scanning the forearm, has been cleared by the FDA and is priced below $50,000.
Norland is best known for p-DEXA, a low-cost desktop peripheral densitometry unit whose appeal to buyers took a hit in November when the Health Care Financing Administration (HCFA), which administers Medicare, lowered the reimbursement for peripheral densitometry (densitometry at sites such as the forearm) from $124 per scan to $37.57. By comparison, reimbursement for axial (spine and hip bone measurement) slipped downward only a few dollars from $124 to $121.16.
At the RSNA meeting, Norland dropped the price of its peripheral units from $32,500 to $25,000. Despite the HCFA change, interest in these units has been strong and may get stronger, according to Harrold.
"The drop in reimbursement is mostly affecting p-DEXA and it is affecting it in a very positive way, because before (the announcement of HCFA policy), the rules were unclear," he said. "Now HCFA has clearly said what it will reimburse."
Norland also hopes to buff its image as a provider of high-end systems by eventually offering XCT 3000 globally, intending to capitalize on interest in table-based systems.
New offerings from Lunar and Hologic. Market leaders Lunar and Hologic have the advantage in the premium segment, however, because both have reputations for high-end instruments. In its RSNA booth, Lunar unveiled a new high-performance bone densitometer, DPX-IQ, which can perform a scan in one minute (SCAN 12/4/96). The system, which should begin shipping in the first quarter of 1997, is optimized for clinical use, offering the potential of scanning 100 patients per day. Prime among its advantages, in addition to speed, is software that simplifies data interpretation.
"We've taken what is a very complex report and narrowed it down to just a few numberscomparison to the young adult population and to an age-matched population," said David Weissburg, market manager for densitometry at Madison, WI-based Lunar. "This way we can show the absolute score of bone density."
The reference is an aggregate drawn from more than a dozen different studies totaling some 3000 women, he said.
Hologic of Waltham, MA, also expanded the capabilities of its product line with the introduction of QDR 4500 Elite, the company's newest addition to the Acclaim series of table densitometers.
"This new model is building on the very strong technology core of QDR 4500," said Wade Fox, Hologic director of marketing.
Elite offers a more powerful computer, enhanced graphics, and a high-quality printer, in combination with software that reduces effort and promises increased productivity for users. The modular design of the system allows software upgrades as they become available from the company. The installed base of QDR 4500 densitometers will be able to upgrade in early 1997 to the Elite configuration for about $8000.
CompuMed of Manhattan Beach, CA, wants to put a portable x-ray device based on charge-coupled device (CCD) technology in physicians' offices. The filmless system, tentatively dubbed OsteoView, would digitally translate x-rays into bone mineral measurements based on data regarding bones in the hand. The technology is being developed under license with the University of Massachusetts, which holds a patent on the use of CCDs for doing quantitative BMD measurements.
Andrew Lisiecki, CompuMed vice president of technology, believes that OsteoView could be a commercial product in about a year. The company offers an absorptiometry system that generates OsteoGrams, radiographs of the hand that are interpreted by its partner Merck, which is using the technology to promote its osteoporosis drug Fosamax (SCAN 9/13/95).
"With (the desktop) OsteoView system, the exam could be done in the physician's office in a relatively short period of time with results immediately available," Lisiecki said.
CompuMed last month also announced a technology development agreement with Varian Associates of Palo Alto, CA, in which CompuMed will develop a new generation of x-ray densitometers based on Varian's amorphous silicon digital detectors. CompuMed will receive exclusive worldwide marketing rights to the detectors for appendicular bone mass measurement and automated arthritis detection. CompuMed is scheduled to receive a pre-510(k) detector evaluation kit early this year.
QCT vendors branch out. Another company developing a cost-effective bone measurement device is Image Analysis of Columbia, KY. The vendor is working on a desktop bone densitometer that president Ben Arnold hopes will be in clinical trials within six months.
"It is a modification of the x-ray source, the detector, and the calibration method that is different from conventional DEXA devices, allowing me to build a device that is significantly less expensive to manufacture," Arnold said.
No other details about the product are available, except that its list price will likely be less than $40,000.
The development of such a product will be a major change in direction for the company. Image Analysis has been the standard-bearer of quantitative CT since the company's introduction nearly a decade ago of a phantom-based system that allows bone analysis on standard CT scanners. Calcium hydroxyapatite reference samples are positioned with the patient in the region of interest (ROI) of the CT scan. Data coming off the CT are interpreted by software to isolate bone mineral densitometry (BMD) measurements of trabecular bone.
At the RSNA meeting, Image Analysis unveiled a new version of the analysis portion of the system, with highly automated software running on a Sun Microsystems workstation. The software, which has been patented by the company, automatically locates the ROI, calculates the measurements, and generates a color-coded report.
"We have taken keystrokes out of the operation, put in error-checking routines, put in quality assurance measurements, and made it very easy for the operator to use," Arnold said.
Image Analysis technology has been marketed by GE for several years, but at the RSNA conference GE chose to highlight the product at its booth for the first time, recognizing not only the growing interest in BMD but also the sophistication of the new Image Analysis product.
Like Image Analysis, IRIS (Institute for Radiological Image Sciences) offers a QCT product, but one that does not require the use of a phantom. At the RSNA show, the company highlighted the DICOM compatibility of its PC-based PC/QCT product, which is licensed for sale by Picker International. The new capability allows the PC to pull data directly off an Ethernet network, rather than having to download data from the scanner to a diskette.
"They can just basically push the images to the PC and when there is a slow period, the technologist can go over and process the reports," said Steve Dyer, a radiological physicist at IRIS, which is based in Frederick, MD.
Another quantitative CT product is QCT PRO, which seeks to exploit CT's ability to provide 3-D data sets. The software, developed by MindWays Software of South San Francisco, CA, runs on a PC, yet has the power to do 3-D serial image registration, which promises to reduce patient repositioning errors. BMD measurements of the hip, spine, and other sites can be performed using either 2-D or 3-D data sets.
"Working with a 3-D data set, it gives you the equivalent of 1-mm resolution in all dimensions, as opposed to the conventional QCT type of technique where you take a single image and you hope that the patient hasn't moved from the time that you do your scout view," said Christopher Cann, one of the developers of the QCT software at MindWays.
The software also has the potential to be applied to new QCT applications, including coronary artery calcification analysis.
"There is a scoring system (for calcification) and we have done some work in terms of trying to develop that further," Cann said. "That is a work-in-progress."
Data for this type of analysis are currently found only on Imatron Ultrafast CT scanners.
Finally, Fuji Medical Systems USA of Stamford, CT, got into the bone densitometry act at the RSNA meeting with a modification of its FCR computed radiography reader. FCR DX-A consists of software that can be added to an FCR workstation for bone densitometry applications. Fuji's CR plates can be used with any x-ray system, enabling clinicians to conduct bone densitometry without having to buy a dedicated system. FCR DX-A is being tested overseas, and U.S. marketing will begin when the system has 510(k) clearance, according to the company.