Letters      37

Letter from North America

DIAGNOSTIC MEDICAL IMAGING: REWARDS AND REGULATIONS

Medical imaging has increasingly become a vital part of healthcare in the past decade. The progress in imaging technologies not only resulted in improved patient outcomes, but also attracted the attention of Federal regulators to curtail its unnecessary use. Advances in applied engineering, physics and mathematics were put to use in biology and medicine. With phenomenal enhancement in computing power it became possible to not only integrate these advances, but also to simplify imaging technologies for use by radiologists and physicians. Quicker and more precise diagnosis of disease within a short period of time has had a profound effect on patients. Medical imaging has redefined morbid and expensive procedures such as exploratory laparotomy.
   Imaging is now an integral part of patient care in almost every field. Most of the positive impact observed has been in the management of cancer, cardiovascular disease (CVD) and stroke, to name a few. Imaging devices are used in the screening, diagnosing and staging of cancer, guiding cancer treatment, monitoring for cancer recurrence and facilitating medical research. Screening mammography has resulted in major improvements in the case of breast cancer. Sixty-three per cent of breast cancers are now diagnosed at an early stage with an estimated 5-year survival rate of 97%. Similar trends are seen in the management of other cancers. On an average, there are 5–6 computed tomography (CT) scanners, magnetic resonance imaging (MRI) scanners, and positron emission tomography (PET) scanners per 100 000 persons in the USA. The estimates for the 2005 sales of imaging devices in the US are US$ 8.1 billion (sales for all medical devices is US$ 108 billion, and the estimate for pharmaceuticals is in the range of US$ 500 billion). Although direct costs of imaging devices appear relatively small, real costs are worth noting. Medicare spending for radiology services has increased from US$ 5.6 billion in 1998 to around US$ 10.2 billion in 2003. In 2004, the cost of imaging services reimbursed by all health insurers and paid for out-of-pocket by patients was close to US$ 100 billion, or an average of about US$ 350 per person in the USA. Moreover, the reimbursement paid to the physician for performing and interpreting an examination has historically been in part related to the total cost of the procedure. Thus, with the increase in the technical cost of the imaging equipment, the total monies generated by the procedure increase, and so does the relative amount a physician can earn.
   During this rapid growth, radiologists have enjoyed a monopoly in hospitals. With time, other physicians, especially cardiologists, have jumped in to seize the opportunity to generate revenues through imaging procedures. In spite of the recent outsourcing trend, there is still a shortage of radiologists in the USA. Part of the reason is that diagnostic imaging has become a non-stop activity, which needs far more personnel than ever. Also, the number of images to be read per scan has increased due to sophistication in software and diagnostics, which facilitate imaging of anatomical structures down to a millimetre. Another debatable feature is physician-owned freestanding imaging centres. In the past, when most imaging was conducted in a hospital, an important part of the hospital revenue stream from this service would come from a technical component. Now, the technical component is earned by physician-owners of freestanding facilities, which have become attractive avenues for investments for physicians and others. During the past decade, the number of freestanding diagnostic imaging centres owned by radiologists, other specialists, private investors, or for-profit companies has more than doubled from approximately 2500 to over 5500. In response, many private insurers have narrowed their provider networks, required that selected imaging services be authorized in advance, and imposed other constraints to stem what they assert is, in some cases, unnecessary testing. Medicare has been slower to respond, but in February 2007, Congress shocked the imaging community by approving steep reductions in Medicare payments for certain imaging services. President Bush signed the measure into law on 8 February.
   Radiologists argue that the real potential in imaging has yet to be explored. They claim that new imaging technology, especially imaging of real-time molecular processes, can be used to monitor response to therapy. Imaging can also be utilized to evaluate the response to new cardiovascular medications or devices, such as coronary CT angiography (CTA) to evaluate long term effects of statins and stents. Also, the major progress in imaging technologies will be in minimally invasive oncology treatment such as focused ultrasound ablation of tumours and radiofrequency ablation (RFA). Minimally invasive diagnostic techniques can save costs in addition to making monitoring more feasible. For example, a study claimed that if one million core needle biopsies are performed instead of surgical biopsies, the total savings could be as much as US$ 1.6 billion per year in the management of breast cancer.
   Radiologists also argue that unnecessary imaging for patients is augmented mostly because diagnostic imaging is being performed by physicians other than radiologists. Supporting this argument, by 2003, the share of Medicare payments to radiologists for imaging services had declined to 45% while the share received by cardiologists had surged to 25%. The Federal government and its agencies have instituted multiple measures to control the rising costs of diagnostic imaging. One approach some states have pursued is the use of certificate-of-need to blunt capacity growth. Michigan was the first state to require that mammograms be performed under specific rules that required machines to be in good working order and that those who operated them knew what they were doing. This was implemented because some general physicians had set up mammogram machines in their primary care practices without formal training and a few general practitioners even did mammograms on a standard chest X-ray machine. These scans were unreadable, uninterpretable and missed lesions, but the doctors still got paid for them. After Michigan took this step, Kentucky followed suit. Now there is a National Mammography Quality Control policy that has improved the use of mammography across the USA and several regulatory measures were proposed by Federal agencies.
   The executive director of MedPAC, Mark E. Miller, testified that during the period from 1999 through 2003, the volume and complexity of imaging services grew by 45%. This is more than twice as fast as all physicians’ services, which grew by 22% during the same period. He also noted the absence of a clear link between the delivery of more imaging services and better outcomes for patients, a wide variation in the quality of images that are produced and their interpretations, and the reduction in standards of quality that apply when imaging services are delivered in physicians’ offices as compared with hospitals. His commission of 16 members unanimously recommended that Congress direct the Secretary of the Department of Health and Human Services (DHHS) to set quality standards for all providers who bill Medicare for performing diagnostic imaging services and interpreting these diagnostic tests. They also recommended that the Secretary should measure physicians’ use of imaging services ‘so that physicians can confidentially compare their practice patterns with those of their peers’; that the secretary should expand the National Correct Coding Initiative to improve the Initiative’s ability to detect improper claims for imaging services; that the Secretary should reduce payments for multiple procedures for imaging of contiguous body parts; and that the Secretary should strengthen the rules that govern the investments that physicians may make to facilities to which they refer Medicare patients. Radiologists anticipated that the recently passed Deficit Reduction Act of 2005 would reduce the fees for imaging studies of contiguous body parts taken in the same imaging session, and they were right. Those fees are due to decline by 25% next year and 25% the year after that.
   The trend in use and overuse of diagnostic imaging is also observed in India. With a population exceeding 1 billion and a gross national product (GNP) that surpassed US$ 800 billion, India has begun to attract the attention of US medical device manufacturers. The country’s GNP is projected to grow 4% per year through the end of the century. The Indian healthcare industry is estimated at US$ 22 billion and the medical device market is estimated at US$ 1.85 billion and growing at 15% per year.
   Diseases with increasing use of diagnostic imaging such as CVD and cancer are on the rise in India. India is home to 60 million coronary heart disease (CHD) patients, with 30% below the age of 40. Two million deaths in India occur annually due to CVD. The World Health Organization (WHO) estimates that by 2010, as much as 60% of the world’s CHD patients will be from India. Cancer is also becoming a growing concern in India with an estimated 100 000 suffering from cancer in 2007 versus 53 000 in 1985. Unfortunately, 70% of the cancers are detected very late. Breast cancer is of particular concern with over 80 000 women in India diagnosed annually and 40 000 dying annually. India is also home to over 1 million patients suffering from stroke, which is the sixth major cause of disability-adjusted life years. Strokes are the cause of 1.2% of the total deaths in India. India also faces the challenge of making healthcare affordable and accessible to patients not just in urban India but also in rural India and across a wide range of economic affordability.
   No one has better realized the potential of future diagnostic imaging in India than General Electric (GE). GE is investing heavily in its ‘In India for India’ strategy. The healthcare division is tapping into the resources of the GE global research facility, The Jack Welch Technology Centre located in Bangalore, and the expertise of its global medical diagnostics team in the US. The Centre presently employs over 2700 scientists, researchers and engineers, with over 60% having advanced degrees. The Centre has filed for more than 405 patents for research and development activities in Bangalore and been granted over 70 to date. GE Healthcare, a division of the US$ 150 billion General Electric Company, has entered into a strategic alliance with Manipal Health Systems to conduct clinical studies of its diagnostic products in India. The trials will be conducted at the Bangalore-based Manipal Hospital, where GE Healthcare has set up the world’s first integrated development centre (IDC). This IDC has equipment bought by the hospital for US$ 7 million and has invested another US$ 1.5–2 million for setting up the infrastructure of this facility. The information generated from the Indian IDC will be combined with data from other centres globally and contribute towards the development of new contrast and molecular imaging agents or new indications for existing agents. The GE equipment for clinical studies includes LightSpeed VCT, Discovery STe 16-slice PET/CT scanner, Dual Head Gamma with CT, and TwinSpeed High Definition Magnetic Resonance (HDMR) imaging systems. The GE Healthcare Indian division employs over 1000 engineers for research and development (up from only 150 in 2000), with 50% having advanced degrees such as a PhD or MS. Till February 2007, GE Healthcare in India has filed more than 400 invention disclosures with 128 patents granted, including 80 international patents and 40 country patents.
   In this scenario, it is important to define the role of the new imaging modalities and their cost-effectiveness not only in resource-poor countries such as India but also in the wealthier nations of the world.