Radiologists are among the specialists least susceptible to lures from industry players angling for an ethically iffy “in” to push more goods and services—a happy fact in this age of Open Payments. But that doesn’t mean rads are immune. With this in mind, three radiologists at the University of Washington in Seattle propose a methodical approach to evaluating new products and managing relationships with vendors.
Donald Perry, MD, Derek Khorsand, MD, and Michael McNeeley, MD, had their pointers published online Feb. 6 in Current Problems in Diagnostic Radiology.
The paper outlines seven components that can help radiologists keep all interactions ethical without sacrificing access to information that can drive innovation:
1. Evaluate company, validity and motives. Begin by ascertaining whether the offering is a clinical or research tool, the authors advise. If it’s clinical, check its FDA approval status and request published materials plus competitor info. “Beware of offers to support research, do a ‘quality improvement’ project, or to provide discounted or free products,” they add, as such pitches may just be slick ways for the vendor to bypass a formal competitive evaluation—which could violate hospital compliance or present a conflict of interest.
2. Scrutinize the value of the product. The authors suggest figuring out whether the product or service would add value by some measure—convenience, patient or provider comfort—without doing much to positively impact clinical outcomes. “[P]erform a separate assessment specifically evaluating how this product adds value to patient care and to what degree,” they write. “Then compare these aspects of the product to similar functioning products already used within the department and ascertain and try to quantify the incremental value.”
3. Determine reimbursement. Is CMS willing to pay for any billable charges related to the product or service? How about private payers? “[O]rganize a preliminary business plan,” the authors write, “including a thorough evaluation of the scope of the problem the proposed technology addresses, how it does so, the clinical and financial aspects of acquiring and maintaining the technology, and an analysis of any possible revenue of the technology may generate.”
4. Evaluate ongoing support and sustainability. Launch a discussion with the vendor on aspects of product usage such as user training, repair, service, maintenance and support. “This step will help to assess the potential effect of owning this product on departmental resources.”
5. Present your findings and conclusions on the product or service to colleagues within your division—and solicit their input. Then go to colleagues in other departments who would be affected by the product or service, and compile their feedback as well. “With all of this information in hand, you are ready to request a meeting with your site medical and administrative directors to present a balanced and objective view of options.”
6. Be patient. Evaluation by your hospital’s purchasing department, including a full-blown RFP process, may be necessary. And even if your requisition is approved, it may have to get in line behind other departments’ requisitions until capital becomes available.
7. Provide feedback to the vendor for improvements. “You should plan to reassess the product quarterly to evaluate if it is still best serves the patient’s needs and assess for any possibly superior competitive products,” the authors write. “Throughout this process, remember that institutional guidelines have been implemented to help providers avoid potential ethical dilemmas or conflicts of interest.”
Perry et al. note that, while these steps center on physician-led acquisition of new technology, they may be applied quite broadly to evaluate a company and its products when considering, for example, partnering with industry for research funding, device development or helping bring a new technology to market.
“There are still debates among physicians suggesting that hyperscrutiny of the physician-industry relationship will only inhibit collaboration and hamper innovation, whereas others feel strongly that even more stringent measures should be applied,” the authors conclude. “It is our experience that methodically applied principles can find a balance between protective regulation and productive collaboration.”
Radiology, they add, “is a rapidly advancing specialty and has always had a close association with technology and medical devices. Such a cutting edge specialty can also add value by applying clear methods to maintain appropriate relationships and critique new products in efforts to help discover and adopt technology that offers safer, more affordable, more efficient, more accessible and higher quality care.”