Published 10/1/2017

Second Look – Advocacy

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).

CMS proposal withdrawn
An article on ProPublica notes that, after consideration of public comments, the U.S. Centers for Medicare ' Medicaid Services (CMS) has withdrawn a proposal that would have required private healthcare accreditors to publicly release issues noted during medical facility inspections. The agency had proposed to revise the application and reapplication process for accrediting organizations by requiring them to post survey reports and plans of corrections from CMS-approved accreditation programs on their public-facing websites. "CMS is committed to ensuring that patients have the ability to review the findings used to determine that a facility meets the health and safety standards required for Medicare participation," the agency states. "However, we believe further review, consideration, and refinement of this proposal is necessary to ensure that CMS establishes requirements, consistent with our statutory authority, that will inform patients and continue to support high-quality care."

Medicare PVBM program
A study published in JAMA Surgery (online) looks at the relationship between provider risk and performance in the 2015 Medicare Physician Value-Based Payment Modifier (PVBM) Program. The authors conducted a cross-sectional, observational study of 899 physician practices covering 5,189,880 beneficiaries. Of those, 547 practices were categorized as low-risk, 128 as high medical risk (defined as practices in the top quartile of mean Hierarchical Condition Category risk score among fee-for-service beneficiaries) only, 102 as high social risk (defined as practices in the top quartile of proportion of patients dually eligible for Medicare and Medicaid) only, and 122 as high medical and social risk. The authors found that practices categorized as low-risk performed the best on composite quality score compared to practices in any high-risk category. Practices categorized as high social risk only performed the best on the composite cost score, followed by low-risk practices, high medical and social risk practices, and finally, high medical risk only practices.

Business skills
A survey of physicians conducted by LinkedIn.com suggests that many physicians perceive business and management skills as an important factor in furthering their careers, but note that such knowledge areas are often only minimally addressed in medical training. The researchers surveyed 511 physicians working in the United States and found that the top five skills deemed most important in taking one's career to the next level were the following:

  • business and finance (47 percent)
  • productivity (44 percent)
  • practice management (44 percent)
  • computer and technology skills (37 percent)
  • hospital administration (29 percent)

Error disclosure
A study published in the Journal of Patient Safety (online) examines trends in disclosure and apology following medical errors. The researchers reviewed data on 434 medical liability claims from a private insurance database. They found that 4.6 percent (n = 20) of medical errors were disclosed to the patient at the time of the error, while 5.9 percent (n = 26) were followed by disclosure and apology. There was no incremental increase during the financial years studied (2012–2013). Of disclosed errors, 26.1 percent led to an adverse reaction and 17.4 percent were fatal. In 17.4 percent of cases, the cause of disclosed medical error was improper surgical performance. Disclosed medical errors were classified as medium severity in 67.4 percent of cases, and no apology statement was issued in 54.5 percent of medical errors classified as high severity. The researchers note that the mean age of informed patients was 52.96 years, 58.7 percent were female, and 52.2 percent were inpatients.

Readmission rates
An article in Modern Healthcare suggests that reductions in readmission rates seen under the CMS Hospital Readmissions Reduction Program may have plateaued. The writer notes that the agency's spending on readmissions fell significantly from implementation through 2014, but from 2013 through mid-2016, readmissions dropped only 0.1 percent on average. In addition, the article notes that since CMS began to dock hospitals for readmission rates, most institutions have consistently been penalized.

Federal agency funding
A proposal released by the U.S. House of Representatives Rules Committee would, if enacted, significantly reduce the budgets for the Office of the National Coordinator (ONC) and the U.S. Agency for Healthcare Research and Quality (AHRQ) but increase the budget for the U.S. Food and Drug Administration (FDA) by $500 million. Under the proposed legislation, ONC would receive just $38 million in funding, a reduction from $60 million, while AHRQ would see its budget cut from $334 million to $300 million. An article in Healthcare IT News references an ongoing debate regarding the future of AHRQ, but notes that the funding proposal, coupled with appointment of a new director in May 2017, may signal intent to continue AHRQ as an independent agency for the foreseeable future.

FDA approval process
Two studies published in The Journal of the American Medical Association (Aug. 15) suggest that many products may lack solid evidence of efficacy at the time of FDA approval. In the first, researchers reviewed the methodological quality of 83 studies supporting the approval of 78 panel-track medical device supplements. They found that 71 supplements (91 percent) were supported by a single study. Of the 83 studies, 37 (45 percent) were randomized clinical trials, 25 (30 percent) were blinded, and median follow-up duration was 180 days. Across all studies, the researchers noted a total of 150 primary end points, 121 of which (81 percent) were surrogate, and only 57 (38 percent) of which were compared with controls.

In the second, the research team reviewed publicly available FDA documents on accelerated approval of 22 drugs for 24 indications, covering 30 preapproval studies. The median number of participants enrolled in the preapproval studies was 132, and eight studies (27 percent) included fewer than 100 participants. At minimum 3-year follow-up, the research team found that only 19 of 38 (50 percent) of required confirmatory studies had been completed. Overall, postapproval requirements were completed and demonstrated efficacy in 10 of 24 indications (42 percent) based on trials that evaluated surrogate measures. Among the 14 of 24 indications (58 percent) that had not yet completed all requirements, at least one confirmatory study failed to demonstrate clinical benefit in two indications while clinical benefit had not yet been confirmed across eight indications that had been initially approved 5 or more years prior.

Risk stratification
A study in Spine (online) compares predictors of surgical site infection (SSI) and hospital readmission after lumbar fusion in the United States, Denmark, and Japan, and finds wide variation among the three countries, suggesting a need for population-specific risk stratification models. The authors determined and compared predictors from three prospective databases: the National Neurosurgery Quality and Outcomes Database (N2QOD), DaneSpine, and the Japan Multicenter Spine Database (JAMSD). They found that predictive variables differed in the three databases for both readmission and SSI. Factors predictive for hospital readmission were the American Society of Anesthesiologists (ASA) grade in N2QOD, fusion levels in DaneSpine, and sex in JAMSD. For SSI, sex, diabetes, and length of stay were predictive in JAMSD, while no predictors were identified in N2QOD or DaneSpine. The authors noted that patient and procedure selection differ in the three countries, limiting the ability to directly pool data from different regions.

Humanitarian missions
Findings from a study in the World Journal of Surgery (online) suggest that increased specialization in surgical education may leave American surgeons on humanitarian missions poorly equipped to perform basic procedures commonly needed in war zones and disaster sites. The research team retrospectively analyzed cases performed by American College of Graduate Medical Education (ACGME) general surgery graduates from 2009 to 2015 and cases performed at select Médecins Sans Frontières (MSF) facilities from 2008 to 2012. Just one-third of major surgery performed in MSF projects corresponds to typical ACGME general surgical training. The authors report that ACGME general surgery residents spend a majority of their training (56 percent) engaged in advanced general surgical or specialty procedures with no direct corollary in MSF projects. Furthermore, U.S. surgeons working in humanitarian environments may be unaccustomed to working with alternative, low-technology methods for completing the same general surgical procedures they may perform at home with advanced equipment and supplies.

Pricing information
A study published in Health Affairs (August) suggests that, despite trends toward an increase in the availability of price data and patient cost sharing, comparatively few patients seek out pricing information. The research team surveyed 2,996 nonelderly adults in the United States who had received medical care during the previous year. They found that only 13 percent of respondents who had some out-of-pocket spending in their last healthcare encounter had sought pricing information prior to receiving care, and just 3 percent had compared costs across providers before receiving care. The research team states that common barriers to price shopping included difficulty obtaining price information and a desire not to disrupt existing provider relationships.

Widespread opioid use
A study in Annals of Internal Medicine (Aug. 1) suggests that more than one-third of U.S. adults may have taken prescription opioids during 2015. The research team reviewed information on 51,200 participants in the 2015 National Survey on Drug Use and Health. It projects that 91.8 million (37.8 percent) of U.S. civilian, noninstitutionalized adults used prescription opioids, 11.5 million (4.7 percent) misused them, and 1.9 million (0.8 percent) had a use disorder. Among adults taking prescription opioids, 12.5 percent reported misuse, and of those, 16.7 percent reported a prescription opioid use disorder. Misuse and use disorders were most commonly reported in adults who were uninsured, unemployed, low income, or had behavioral health problems. Among adults with misuse, 59.9 percent stated that they had used opioids without a prescription and 40.8 percent obtained prescription opioids for free from friends or relatives for their most recent episode of misuse.

Accessible opioids
Findings published in JAMA Surgery (online) suggest that many postoperative prescription opioids are unused and remain accessible. The research team analyzed six studies covering 810 unique patients. Across all six studies, 67 percent to 92 percent of patients reported having unused opioids. Of all opioid tablets obtained by surgical patients, 42 percent to 71 percent went unused. Reasons given for stopping or not taking opioids included adequate pain control and opioid-induced adverse effects. Further, the research team notes that in two studies examining storage safety, 73 percent to 77 percent of patients reported that their prescription opioids were not stored in locked containers. All studies reported low rates of anticipated or actual disposal, but no study reported more than 9 percent of patients who followed FDA-recommended disposal methods.

Sustained use of opioids
According to a study in JAMA Surgery (online), "most of the events that led to sustained prescription opioid use were not hospital events and associated procedures, but diagnoses that were either nonspecific or associated with spinal or other conditions for which opioid administration is not considered standard of care." The study identified 117,118 patients, insured through TRICARE, who met the criteria for sustained prescription opioid use and were considered opioid naïve. Overall, only 800 patients (0.7 percent) received their initial opioid prescription following an inpatient encounter, with 0.4 percent having undergone an inpatient procedure. Among all the patients, the most common diagnosis associated with the initial opioid prescription was other ill-defined conditions (30.6 percent). Spinal conditions were among the most frequent diagnoses in both civilian and military settings, while spine and orthopaedic disorders were the most prominent among specific categories of conditions associated with the initial opioid prescription. To reduce the risk of sustained opioid use, the authors suggest better leveraging of best practices in prescribing combined with improved documentation of the rationale for opioid prescriptions.

Opioid e-prescribing
A bill under consideration in the U.S. House of Representatives would, if enacted, apply more stringent oversight of how opioids and other addictive drugs are dispensed under Medicare. If enacted, the Every Prescription Conveyed Securely Act would amend title XVIII of the Social Security Act to require e-prescribing of controlled substances under Medicare Part D.