Local, State, Federal

New Technologies: Quick, but Costly
New NEMA Standards for MRI

New Technologies: Quick, but Costly

In years past, new drugs and devices were generally produced by well-funded developers who had the steady revenue stream and time to conduct often long-lasting randomized clinical trials before introducing these products to the market. However, the current marketplace is fueled by the rapid development of new technologies often produced by smaller, single-product developers.

This in turn has led to a great increase in the number of available products and increased the burden on regulatory agencies, such as the FDA, to approve new products quickly, contributing to the overall increase in health care costs in the United States. In their article in the November issue of the Journal of the American College of Radiology titled “A Changing Paradigm in the Study and Adoption of Emerging Health Care Technologies: Coverage with Evidence Development,” Paul E. Wallner, DO, and Andre Konski, MD, MBA, look into how the rapid introduction of new technology along with diverging interests of the various stakeholders drives the increasing cost of health care delivery.

In a for-profit health care system, the stakeholders’ goals and demands are not always in line with each other, the authors note.

Technology developers and vendors look to gain entry into the marketplace and receive consumer acceptance as quickly as possible so that they receive a quick return on their investment. Health care providers, in addition to being driven by patient care and outcomes, may also have competitive and ambitious motives or just an overall belief that a new product should work.

Patients and their families, in an effort to receive the best treatment possible, can be driven by the sense that new technologies must be superior to older, more established ones. The payors themselves, such as Medicare and Blue Cross Blue Shield, are driven to stabilize the industry in order to reduce costs.

Effort must be made to align these stakeholders’ goals. New drugs and devices are often given regulatory approval based on “limited evaluations of small numbers of patients, with relatively short follow-up and no attempt to compare the clinical or economic value with that of existing devices for similar indications,” yet payors make payment decisions in large part based on evidence from scientific studies, the report states. In order to help rectify this situation, the Centers for Medicare and Medicaid Services (CMS) introduced the idea of “coverage with evidence development” (CED) in 2005 and revised it in 2006, as the authors deemed the original as “ill-conceived and misunderstood.”

One of the elements of CED was to provide “coverage with study participation” in situations where a new treatment looks promising but does not have the available scientific evidence behind it to warrant coverage.

In CED, the payors provide the coverage in exchange for the patients’ participation in a trial that will possibly provide enough scientific evidence to warrant coverage for future patients.

The authors conclude that CED is, in general, a faster and less costly method of obtaining evidence than randomized clinical trials that bodes well for developers and vendors.

Also, CED enables many patients to receive health care they could not have afforded otherwise. Nevertheless, there are issues that CED is driven by cost and gives too much control to the payors, who can use their authority to develop the research methodology. Also, there are concerns that patients could be forced to participate in these clinical trials in order to receive coverage.

To illustrate the need for more comprehensive evidence, the authors cite the National Emphysema Treatment Trial, which began in 1995 as a collaboration between CMS and the National Institutes of Health to determine if lung volume reduction surgery (LVRS) was indeed superior to pulmonary rehabilitation.

The 7-year trial showed that not all patients benefited from the surgery; some were worse off than those treated with the less aggressive rehabilitation alone. Following the trial, Medicare modified its coverage to include only those patients shown to benefit from the surgery.

The cost of the trial was estimated at $35 million plus $100 million in the associated clinical care. The cost to Medicare for continuing coverage of LVRS in those patients who did not benefit was estimated to be $150 million per year.

As of now, CED is hardly used in radiation oncology or general oncology policy decision-making because of the fields’ comfort and familiarity with randomized controlled trials and registries. However, the authors suggest that CED trials would be particularly suited for procedures or devices of “high clinical impact or high cost” and give an example involving a comparison of proton-beam irradiation with intensity-modulated radiation therapy.

—Ed Wilson

New NEMA Standards for MRI

Three new standards for diagnostic magnetic resonance imaging have been published by the National Electrical Manufacturers Association (NEMA) as a guide for equipment manufacturers, users, and prospective buyers about MRI performance, safety, service, and other system specifications.

NEMA standards address MRI performance, safety, service, and other system specifications.

The standards were produced by the Medical Imaging & Technology Alliance (MITA), a division of NEMA that represents manufacturers of medical diagnostic imaging equipment including MRI, CT, x-ray, and ultrasound products. They are developed through a voluntary consensus standards process by the medical diagnostic imaging industry for the measurement of performance parameters governing image quality of MRI systems.

Electronic versions of the new MRI standards can be downloaded for free at www.nema.org/stds. A hard copy also may be purchased on the Web site for $37. The new standards include:

  • MS 6-2008 Determination of Signal-to-Noise Ratio (SNR) and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MRI defines a method for evaluating single-channel, nonvolume, special-purpose radio-frequency coils used for MRI to receive a signal from a limited region of interest. These include linear or quadrature combined surface coils, flexible coils, pairs of coils (such as Helmholtz coils), or coils that partially surround a specific tissue, such as the calf or other extremity. In most cases, these surface coils have a nonuniform signal distribution. This standard provides a means for measuring and reporting the SNR and uniformity of signal intensity in images acquired with surface coils to evaluate coil performance and effectiveness.
  • MS 8-2008 Characterization of the Specific Absorption Rate (SAR) for MRI Systems describes calorimetric and pulse-energy methods to determine the SAR in either a phantom or a patient for development and verification of various predictive safety algorithms. The pulse-energy method permits the use of low-duty cycle scans for the test, but either method may be used. Radiofrequency magnetic fields are used in MRI to interrogate a region of interest.
  • MS 9-2008 Characterization of Phased Array Coils for Diagnostic MRIs defines test methods for measuring the SNR and image uniformity of MR images produced using receive-only phased array coils. These quantities are helpful in evaluating the impact of system changes on performance or in demonstrating effectiveness for FDA applications. The measurement methods have been designed for compatibility with existing NEMA methods for determining the SNR and signal intensity uniformity of head, body, and special-purpose coil images.

—Verina Palmer Martin