December 20, 2017 | Today’s News

FDA issues safety alert regarding gadolinium-based contrast agents for MRI; Sanofi updates Synvisc-One recall notice

The U.S. Food and Drug Administration (FDA) is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Published research has suggested evidence of a link between GBCAs and nephrogenic systemic fibrosis in kidney patients, and recent studies have found that patients without impaired renal function may also show deposits of gadolinium. The agency issued a MedWatch safety alert regarding gadolinium retention on May 22, 2017. After additional review and consultation, FDA is requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of the contrast agents. In addition, the agency is requiring a new medication guide be made available to patients prior to receiving a GBCA.

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FDA issues safety alert regarding gadolinium-based contrast agents for MRI; Sanofi updates Synvisc-One recall notice

On Dec. 11, 2017, Sanofi Genzyme initiated a voluntary product recall for a single lot of Synvisc-One ^® (hylan G-F 20) syringes lot 7RSL021 due to the presence of microbial contamination. The company has now identified the contaminant as Methylobacterium thiocyanatum and states that a literature search suggests that M. thiocyanatum may be susceptible to amikacin, gentamicin, ciprofloxacin, and trimethoprim-sulfamethoxazole.

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Congress passes tax bill that includes repeal of ACA individual mandate

The U.S. Congress has passed a tax overhaul bill that, among other things, repeals the Affordable Care Act (ACA) mandate for individuals to carry health insurance. According to Politico, President Donald J. Trump lauded the move as essentially a repeal of the ACA. “When the individual mandate is being repealed, that means Obamacare is being repealed,” Mr. Trump explained. “Because they get their money from the individual mandate…Obamacare has been repealed in this bill.” The president is expected to sign the bill into law.

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A study published in the January issue of the Journal of Orthopaedic Trauma suggests that lateral patient position during femoral nailing may not increase risk of pulmonary complication or longer intensive care unit (ICU) stay. Members of the research team conducted a retrospective, cohort study of 848 patients with femoral shaft fractures who were treated with intramedullary fixation at a single, Level 1 trauma center. Compared to supine patient position, they found that treating patients with femoral nailing in the lateral position was associated with a 1.88 day reduction in ICU length of stay and a 1.29 day decrease in postoperative time on a ventilator. However, the findings were not statistically significant.

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Data from a study published online in the journal JAMA Internal Medicine suggest that living with a prescription opioid user may increase one’s own risk of prescription opioid use. The authors conducted a retrospective, cohort study using administrative healthcare claims data on 12,695,280 people who were exposed to prescription opioids and 6,359,639 people who were exposed to prescription NSAIDS through an index prescription to a household member. They estimate that risk of opioid initiation in the subsequent year was 11.83 percent among individuals exposed to prescription opioids in the household, and 11.11 percent among individuals exposed to prescription NSAIDs—a risk difference of 0.71 percent. The authors suggest that the association “may reflect both increased access to these products as well as shared risk factors, such as prescriber preference and prescription drug monitoring.”

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A study published in the December issue of the journal Health Affairs looks at the performance of participants in the first year of the Physician Value-Based Payment Modifier program—a precursor to the upcoming Medicare Merit-based Incentive Payment System (MIPS) The researchers state that 1,010 practices met participation criteria, of which 899 had at least one attributed beneficiary. Of those, 263 (29.3 percent) failed to report performance data and received a 1 percent payment penalty. The researchers write that, among the 636 practices that reported performance data, those that elected quality tiering and those with high use of electronic health records displayed better performance on quality and costs compared to other practices.

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The Association of American Medical Colleges reports that, for the first time, the number of women enrolling in U.S. medical schools has exceeded the number of men. Women represented 50.7 percent of 21,338 new enrollees during 2017, compared with 49.8 percent in 2016. Since 2015, the number of female matriculants has grown by 9.6 percent, while the number of male matriculants declined by 2.3 percent. The organization notes that, although the majority of matriculants this year were female, males represented 50.4 percent of overall applicants.

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California

A coalition of healthcare plans and providers in California has endorsed an initiative to ease the administrative burden for clinicians who report a variety of quality data for accountable care organizations (ACOs). Under the initiative, participants will use a unified, standard set of quality performance measures for ACO reporting. The set currently includes 18 measures, but is expected to increase over time to approximately 35. According to the nonprofit Integrated Healthcare Association, which announced the plan, the initiative will also enable providers to more easily benchmark their performance against each other. The ACO measurement and benchmarking initiative will launch in 2018.

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Last call: Orthopaedic Video Theater Committee

The last day to submit an application for a position on the Orthopaedic Video Theater Committee is Dec. 31, 2017. This committee selects and evaluates electronic media programs featured in the Orthopaedic Video Theater at the AAOS Annual Meeting. The following openings are available:

• Chair
• Member—shoulder and elbow
• Member—spine
• Member—sports medicine and arthroscopy

Applicants for the chair position must be active fellows with a strong interest in video and multimedia as tools for orthopaedic education. Applicants for the member positions must be active fellows, candidate members, candidate member applicants for fellowship, associate members osteopathic, or resident members with a practice emphasis in the relevant topic.

Learn more and submit your application…  (member login required)