Although CMS has been issuing NCDs for years, about 10 years ago the agency began making the process more transparent. Now the agency is increasingly stressing the importance of evidence of improved health outcomes in the Medicare population, often citing lack of evidence, relevant outcomes, or applicability to the Medicare population when denying or limiting coverage.
According to published reports, 52 NCDs were issued from 2005 to 2008. The top reasons for denials were a limited number of patients studied (71%) and a lack of relevant outcomes or a lack of a proper control group (58% each).
One recent example: CMS' decision not to cover CT colonography, saying clinical trials showing the benefit of the screening technique could not be generalized, since the mean age of trial participants was lower than that of Medicare patients.
"The burden of proof is shifting, so that assessments begin with the presumption that a technology will not be covered unless its use is supported by reliable scientific evidence of improved outcomes in relevant populations," Peter Neumann, ScD, and Sean Tunis, MD, wrote in a paper for the New England Journal of Medicine in February 2010.
"Some physicians may be concerned about stricter evidentiary requirements, perceiving them as impeding access to important medical advances," they wrote. "Others may be disturbed by the idea of interference by ?big government' in the doctor-patient relationship. Still others may suspect the motives underlying the requirement for evidence reviews, seeing the trend as part of a cost-containment agenda. ... Product manufacturers will undoubtedly fear that more time-consuming and costly hurdles will be placed in the path of reimbursement for their products."
But, the authors argued, the shift is both necessary and beneficial. Physicians and patients are better off knowing which technologies are most likely to improve health. And as Medicare spending drops, the program will be under increasing pressure to ensure dollars are directed to services providing known benefits. "Citizens and taxpayers should feel reassured that tax revenues are spent appropriately," they wrote. "Manufacturing and clinical researchers should increase their focus on generating more relevant and meaningful data."
That's the reality-based conversation Pecora hopes will soon begin. "Is there anything wrong with saying, ?Look, if something is not any better or marginally better, but not materially better, and it cost a whole lot more, should it be approved?' No, of course not. Any rational person would say that." The trick, he adds, is defining what is marginally better.
The call for innovation
As the debate over the costs and benefits of imaging technology continues, some voices are calling for increased innovation as the key to striking a balance between cost and quality.
"Innovation will be a savior of medicine," Khatib says. "Promoting innovation, promoting that environment where innovation thrives is going to be a key factor in a successful planning and implementation of all of these wonderful ideas such as early detection."
Many hospitals and practices are pinning their hopes on teleradiology to drive down costs while maintaining—or even improving—quality and patient and physician satisfaction.
By day, Slimmer's practice offers remote coverage to small and rural hospitals that have difficulty recruiting specialists, struggle with high turnover rates, or don't have enough resources for total coverage and areas without multispecialty practices. Eagle also loans out radiologists to serve on-site. By night and on weekends they contract out to a national radiology practice, Virtual Radiologic.
The hybrid tactic is unusual, but it vastly improves access, throughput, and quality while reducing costs, he says.
"All of the radiology imaging is being processed by all of our doctors at the same time," Slimmer says. "It's really efficient for them, because they in essence have multiple doctors looking at their facility's studies, drastically reducing their turnaround times."
When first developing the business model, Slimmer and his partner debated whether to hire a picture archiving and communications system administrator and maintain the digital images and data themselves. Instead, they partnered with Virtual Radiologic to manage some of the more high-cost and high-risk aspects, using their staff, infrastructure, equipment, and operations center to augment their own services to their hospital customers.
One hospital, for example, had a 36-hour turnaround time for results. Now it's four hours. Those kinds of improvements can lead to better patient and physician satisfaction and, in turn, more referrals.
Teleradiology "does tap the technology in appropriate ways. It's a very good example of how you can truly utilize technology to have best outcomes," says Khatib. Using teleradiology services facilitates what he calls the art of responding to a turbulent healthcare environment in terms of volume fluctuations, response times, accuracy, access to appropriate specialties and modalities and technology and innovation.
There's a fine line between balancing costs and quality—but the key to finding that balance is to always consider the patient's best interest, Khatib says. "Quality and cost-effective care should be defined by evidence-based outcomes. Quality patient care is at the center of every decision we make."