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This report originally appeared in the May 2009 issue of DOTmed Business News

Bone densitometry is beleaguered on many fronts despite a growing population in need of this life-saving and cost-saving technology. The trouble begins with osteoporosis, which is not only a silent killer but a patient one. An added problem is that individuals often don't see the necessity for screening as they do with more frightening or virulent conditions like cancer or heart disease.

"With osteoporosis there is no sense of urgency to get that test done," said Tony Orlando, President, Complete Medical Services, Shelby Township, MI. "Unlike an echo screen or nuclear stress test, bone density testing is put off in a lot of cases. So it is a point-of-care issue."

Of course, providers know the dangers. Family doctors as well as many specialists have adopted bone densitometry systems to screen and monitor patients.

"Roughly half the systems in the U.S. are in some sort of physician setting, half in radiology settings," said John Jenkins, Senior Director of Skeletal Health, Hologic. "Of the physician settings, the specialty groups like endocrinology and rheumatology are key markets. But the majority of the systems are in internal medicine practices."




It is easier for patients to be screened by their doctors than to go to a hospital for bone mineral density (BMD) testing. But the shift away from hospitals has created a problem for the technology since its use has migrated to practice settings that are most impacted by cuts in reimbursement. Medicare has progressively reduced payment for BMD testing in private practices and imaging centers to the point where many doctors just cannot support it anymore.

"Right now bone density [testing] is on the downswing because there tends to be a lack of interest in doing bone densities the lower the reimbursement goes. Some people are still getting into the business but it is not really growing," said David Denholtz, CEO, Integrity Medical Systems, Inc. and BoneDensitometers.com, Fort Myers, FL.

The market for technologies to test bone health has been in decline since 2006, according to experts polled by DOTmed.com. At the same time, the patient population in need of screening continues to grow with the aging of baby boomers. Also, new drug therapies provide a number of effective treatment options. Drug companies have stepped up educational programs to get people screened which contributes to a healthier population as well as a greater market need for technology in this field.

"What we want to accomplish is to prevent fractures; the only way to do that is to screen large populations and treat where necessary," said Jenkins. "An HMO would rather screen and use a good drug to treat rather than paying for hip surgery and medical care post-op. So we should be doing mass screening and making the equipment accessible to as many people as possible."

The importance of the screening and demand for it may overcome today's challenges and grow the market in the future.

"Bone density testing is a very important modality as osteoporosis becomes a mainstream focus of many doctors and hospitals and even research facilities," said Leon A. Gugel, President, Metropolis International, Long Island City, NY. "Every person's skeleton completely reforms every 10 years and depending on our eating habits and life styles, sometimes these changes happen for the worse and not the better. Thus screening with DXA will become a major priority."

Equipment Overview

In addition to major OEMs with portfolios in this space, independent service organizations also sell and maintain used equipment in the installed base. Many of these firms are enjoying an uptick in a down market.

"For an office-based physician to do DXA, they have to practice very good cost containment and keep the cost of equipment and ongoing service as low as possible to make a return on investment," said Orlando, whose company is a distributor of GE equipment, along with other manufacturers. "That plays well into our hands as a refurbisher. While they may not have a few years ago, today, providers are more often looking to cut costs and go with something refurbished."




"Demand has grown over the past several years and we anticipate continued growth. Because reimbursements dropped, the demand for refurbished equipment has continued to grow as clients see the benefit of buying a fully refurbished system versus new," said Krista Kotrla, Marketing Manager, Block Imaging International, Inc., Lansing, MI. "The current economic conditions have actually impacted us positively as our business experienced growth in 2008 and we anticipate an even better year in 2009."

Meanwhile, the OEMs aren't waiting around for the government to restore full funding for bone density screening, although a bill is proposed (see sidebar). Manufacturers have come up with new applications for what is turning out to be quite a versatile technology. For instance, since the DXA system can measure bone loss, why not use it to measure gain? That simple new use implies an important additional application to heart disease diagnosis, and another large population at risk.

"One of the goals we have is finding more uses for these devices. If the doctor can't justify owning a machine solely for osteoporosis testing, what else can they get out of the machine?" said Hologic's Jenkins. The company has FDA approval to use bone density scanning to look at aortic calcium, which is a major risk factor for cardiovascular disease. "When you look at the prevalence of cardiovascular disease in this country... here we have added another very useful exam to the machine."

In this application, the DXA technology takes a quick image of the lumbar and thoractic spine, which is part of the standard DXA exam, but visualizes abdominal aortic calcification to assess risk.

BMD Testing is More Than DXA

The proposed legislation to restore funding specifically mentions Dual Energy X-ray Absorptiometry. DXA (or DEXA) is by far the most widely used technology to measure bone density, although others are in use and emerging.

It's important to know that a "bone densitometer" is not necessarily a DXA machine. Other modalities also measure bone density, such as portable ultrasound for mass screening efforts. A more sensitive technology for bone health scanning is QCT, which uses CT enhanced with software and phantoms. You can get a QCT package from the CT manufacturer or from specialized companies such as Image Analysis and MindWays.

"QCT is a more sensitive measure than DXA because we are looking at only the metabolic bone," explained Roger Schulte, Vice President of Sales and Marketing, Image Analysis, Inc., Columbia, KY. "We can see bone loss much faster and we can see recovery in the event of drug therapy much faster. We can see changes in six months that take DXA two years."

Despite this advantage in detecting improvement during therapy, the much wider adoption of DXA, and the prospective data that it has amassed convinced regulators and Medicare that only DXA should be used to track patients during the course of treatment.

"Science is going in the opposite direction; we have been prohibited from scanning patients more than for the initial screening test," Schulte said. He noted that QCT is most widely used in rural hospitals that can add it on to their CT technologies affordably in lieu of acquiring DXA; and QCT is used in research. The technology is impressive and attractive. For instance, after the capital cost of the CT scanner, a QCT add-on has almost no impact on the radiology budget. QCT phantom calibration is also being applied to quantifying calcium in the descending aorta and coronary arteries.




"DXA sales are off the last few years, but the QCT by MindWays has grown with their 3D BMD product that takes advantage of the volumetric imaging capabilities of the multi-slice CT scanners," observed Greg Kramer, President, C&G Technologies, Inc., Jeffersonville, IN. "In addition, there are some innovative new capabilities coming down the road that relate to bone strength and geometry and even tissue composition that bring new utility to the product. This is a major benefit to QCT since new protocols can be added to the existing system with relative ease."

Yet another application for bone densitometry overall is to track the body mass of obese patients, another at-risk and significant population.

"Bariatric surgery is a growing procedure as are weight loss programs. So [DXA] is an incredibly useful tool," Jenkins said. "The internal medicine doctor is being tasked with treating so many disorders and this is just another tool they can use."

Ultimately, the fate of the industry may come down to motivating the patient to be tested to prevent and treat osteoporosis.

"It's a terrible disease that is not as well recognized as breast cancer or cervical cancer," Jenkins said. "Every woman knows to get a mammogram at a certain age in her life and to get a pap test. However, here you have a disease that is incredibly debilitating, results in fractures with the complications leading to many deaths every year and yet people don't know when to get their bone density checked." DM8864

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A Solid Case for BMD Testing and Funding

The facts speak for themselves. Bone mineral density testing, intervention, and monitoring are life-saving as well as cost-saving priorities for public health and funding. Here are some excerpts from recent legislation on bone health (S.769):
-DXA is a cost-effective preventive test with proven results in real world settings. DXA testing increases the number of individuals who are diagnosed and treated, resulting in a dramatic reduction in hip fractures and related costs.
-Unlike other imaging procedures, DXA remains severely underutilized with only one in four women taking advantage of the benefit every two years.
-Underutilization of bone mass measurement will strain the Medicare budget because:
-55% of the people age 50 and older in 2002 had osteoporosis or low bone mass;
-More than 61,000,000 people in the United States are projected to have osteoporosis or low bone mass in 2020, as compared to 43,000,000 in 2002;
-Osteoporosis fractures are projected to increase by almost half over the next two decades with at least 3,000,000 fractures expected to occur annually by 2025;
-The population aged 65 and older represents 89% of fracture costs; and
-The economic burden of osteoporosis fractures is projected to increase by half over the next two decades, reaching $25,300,000,000 in 2025.
-Underutilization of bone mass measurement will also strain the Medicaid budget, which funds treatment for osteoporosis in low-income Americans.
-Reimbursement under the Medicare program for DXA provided in physician offices and other non-hospital settings was reduced by half and is scheduled to be reduced by a total of 62% by 2010. This drop represents one of the largest reimbursement reductions in the history of the Medicare program. Reimbursement for VFA will also be reduced by 30% by 2010.
-The reduction in reimbursement discourages physicians from continuing to provide access to DXA or VFA in their offices. Since two-thirds of all DXA scans are performed in non-facility settings, such as physician offices, patient access to bone mass measurement will be severely compromised as physicians discontinue providing those tests in their offices, thereby exacerbating the current underutilization of the benefit.

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DOTmed Registered Bone Densitometers Equipment Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
Saulo Waisenberg, Selcon Business Solutions LLC, FL
DOTmed 100
David Denholtz, BoneDensitometers.com, FL
DOTmed Certified
John Pereira, United Medical Technologies Corp., FL
Jailyn Primus, X-Ray Service, FL
Keri Cox, Amber Diagnostics, FL
Greg Kramer, C&G Technologies, Inc., IN
DOTmed Certified/100
Stuart Ancelet, Louisiana Medical Alliance, LLC, LA
Davyn McGuire, Med Exchange International, Inc., MA
DOTmed Certified/100
John Gladstein, Medical Device Depot, MD
Krista Kotrla, Block Imaging International, Inc., MI
Tony Orlando, Complete Medical Services, MI
DOTmed Certified/100
Gary Benitez, Crown Medical International, NY
DOTmed Certified
Leon Gugel, Metropolis International, NY
DOTmed Certified/100
John Kollegger, Bay Shore Medical, LLC, NY
DOTmed 100
Jeff Weiss, Atlantis Worldwide, LLC, NY
Alan Keim, Lone Oak Medical Technologies, PA
Jason Botko, A+ Medical Company, Inc., SC
DOTmed Certified/100
Desmond Johnson, DEXAScanners, Inc., TN
Patrick Doyle, Medical Exporters, Inc., TN
DOTmed Certified
Omar D. Rodriguez, Professional Medical Equipment, Inc., TX
Mark Schiferl, Schiferl System Resources, Inc., WI

International
David Lapenat, ANDA Medical, Inc., Canada
DOTmed Certified/100
Gautam Sehgal, ADS Diagnostic Limited, India
Artemio Santacruz, Ara Electric SRL, Paraguay

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