Published 11/1/2014

Second Look—Advocacy

Study questions evidence base for innovative devices
A study published online in The BMJ finds a lack of high-quality evidence supporting the use of five substantial, well-known, and already implemented device innovations in orthopaedics—ceramic-on-ceramic bearings (hip), modular femoral necks (hip), uncemented monoblock cups (hip), high flexion knee replacement, and gender-specific knee replacement. The systematic review of 118 studies (94 unique study cohorts) on 15,384 implants across 13,164 patients found that comparative evidence per device innovation ranged from four low-to-moderate quality retrospective studies on modular femoral necks to 56 studies of varying quality, including seven high-quality (randomized) studies, on high flexion knee replacement. Overall, none of the five device innovations was found to improve functional or patient-reported outcomes.

Furthermore, the authors found higher revision occurrence associated with modular femoral necks and ceramic-on-ceramic bearings in hip replacement and with high flexion knee implants. They write that in some cases, “existing devices may be safer to use in total hip or knee replacement.”

False Claims Act complaint focuses on PODs
The U.S. Department of Justice (DOJ) has filed a complaint under the False Claims Act, alleging that a medical device manufacturer made improper payments to surgeons through the use of physician-owned distributorships (PODs). Under the POD model, hospitals purchase medical devices from the POD, while surgeons who perform procedures using the implants are often owners or investors in the POD.

The agency alleges that four surgeons who were investors or owners of PODs received payments to perform surgeries using a preferred manufacturer’s implants. DOJ also alleges that some of the spinal fusions performed were medically unnecessary or more extensive than what was medically necessary. One observer notes that the lawsuit may be significant, as “it appears to be the first time any of the government’s POD investigations have caused the government to file its own [False Claims Act] lawsuit based on the theory” that a physician’s return on investment may be a kickback.

EHRs and physician time
Information from a research letter published online in the journal JAMA Internal Medicine suggests that use of electronic health records (EHRs) may reduce the time some physicians have available to treat patients. The research team drew data from 411 survey responses regarding the use of EHRs in medical practices. They found that 89.8 percent of respondents reported that at least one data management function was slower after EHR adoption.

In addition, 33.9 percent of respondents said the time spent finding and reviewing patient data took longer, 63.9 percent said the time spent taking notes increased, and 32.2 percent said they spent more time reading other clinicians’ notes. Overall, the research team noted that the mean time loss for attending physicians was 48 minutes per clinic day, and the mean time loss for trainees was 18 minutes per day.

Impact of reducing readmissions after TKA
According to evidence published in Clinical Orthopaedics and Related Research (October), although associated with a positive contribution margin, unplanned total knee arthroplasty (TKA) readmissions may reduce an institution’s total profit—an effect that will likely increase as the U.S. Centers for Medicare & Medicaid Services (CMS) increases penalties for readmissions. The researchers conducted a retrospective review of 3,218 primary TKAs performed at a single, academic hospital network. For TKA visit with readmission, the median profit and contribution margins were $2,855 and $13,901, respectively; for TKA visit without readmission, they were $5,300 and $11,652. The researchers estimate that readmission penalties could reach $6.21 million per year for their hospital network.

Societal value of TKA
Data from a study published online in the journal Value in Health suggest a net societal benefit to the use of TKA procedures. The authors examined the impact of an Oregon policy for public employees that required additional cost-sharing for high-cost procedures such as TKA. They used a Markov model to estimate the societal impact in terms of quality of life, direct costs, and indirect costs of higher co-pays for TKA, and found that TKA for a working population can generate societal benefits that offset its costs. The authors note that delay in receiving surgical care reduced the societal savings from TKA.

These items originally appeared in AAOS Headline News Now, a thrice-weekly enewsletter that keeps AAOS members up to date on clinical, socioeconomic, and political issues, with links to more detailed information. Subscribe at www.aaos.org/news/news.asp (member login required)