Published 11/1/2009

Second Look – Reimbursement & Regulation

If you missed these Headline News Now items the first time around, AAOS Now gives you a second chance to review them. Headline News Now—the AAOS thrice-weekly, online update of news of interest to orthopaedic surgeons—brings you the latest on clinical, socioeconomic, and political issues, as well as important announcements from AAOS.

FDA wants more data on spinal fusion devices
The U.S. Food and Drug Administration (FDA) has ordered manufacturers of 16 dynamic stabilization systems (DSSs) or spinal fusion components to conduct postmarket surveillance studies addressing the following issues:

  • The fusion rate for DSSs compared to traditional stabilization systems
  • The incidence rate, severity, and time course of adverse events for DSSs compared to traditional systems
  • The type, incidence rate, and time course of subsequent surgical procedures for DSSs compared to traditional systems
  • The cause of failure for DSSs based on analysis of systems that have been removed from patients

FDA will review clinical data gathered from the studies and consider whether labeling changes or additional preclinical and clinical testing requirements may be necessary for the devices.

CBO: Tort reform could save $41 billion
The Congressional Budget Office (CBO) believes evidence exists to suggest that implementing a typical package of tort reform proposals could reduce healthcare spending in the United States by approximately 0.5 percent, or about $11 billion in 2009. By placing a $250,000 cap on noneconomic damages, along with a cap on punitive damages of $500,000 or two times the award for economic damages, whichever is greater, the agency estimates that mandatory spending for Medicare, Medicaid, the Children’s Health Insurance program, and the Federal Employees Health Benefits program would be reduced by roughly $41 billion over the next decade.

Government to support medical liability demonstrations

The White House will release
$25 million in grants for states and health systems to implement and evaluate evidence-based patient-safety and medical-liability demonstrations. Details regarding the program are available on the Grants.gov Web site. Three-year grants for up to $3 million each will be given on a competitive basis to implement and evaluate the demonstrations; 1-year grants of up to $300,000 and technical assistance will be available for planning demonstration projects.

Residents, faculty at high risk for burnout
According to the results of a pilot study published in Journal of Bone & Joint Surgery—American (Oct. 1, 2009), orthopaedic residents and faculty are at risk for burnout and distress, despite reporting high levels of job satisfaction. A survey of 384 orthopaedic residents and 264 full-time orthopaedic faculty members across two academic training programs found high levels of burnout in 56 percent of residents and 28 percent of faculty. Overall, 16 percent of residents and 19 percent of faculty members reported symptoms of psychological distress, with sleep deprivation common among residents and correlating positively with every distress measure. Faculty members reported greater levels of stress but greater satisfaction with work and work/life balance.

FDA warns four manufacturers
FDA has issued warning letters to four companies (Lehigh Valley Technologies, Inc. [Allentown, Pa.], Cerovene Inc. [Valley Cottage, N.Y.], Dava International Inc [Fort Lee, N.J.], and Glenmark Generics Inc. [Mahwah, N.J.]) to stop the marketing of codeine sulfate tablets that have not received FDA approval. FDA has no evidence that the products are safe and effective. FDA does not anticipate a supply problem because another manufacturer does market FDA-approved codeine sulfate tablets.

Academic ghostwriting
The New York Times (Sept. 11, 2009) reports that some journal editors are imposing tougher disclosure policies for academic authors to rein in the practice of using so-called ghostwriters. The moves are in part a response to a study published in the Journal of the American Medical Association (JAMA), which found ghostwriting rates of more than 7 percent at JAMA and PLoS Medicine, and nearly 11 percent at NEJM. Additionally, Sen. Charles E. Grassley (R-Iowa) has been conducting his own investigation into ghostwriting, and recently wrote to eight leading medical journals to inquire about their ghostwriting policies. Critics of the practice are concerned that ghostwritten articles often contain undue industry influence at the expense of objective science.

Racial health disparities costly
A report released by Johns Hopkins University and the University of Maryland finds that racial health disparities cost the United States $229 billion between 2003 and 2006. Researchers drew data from the U.S. Medical Expenditure Panel Survey, which tracks the health and healthcare costs of individuals, breaking down the figures by race and age group to determine how minority health compared in different categories. One author suggests that fixing the disparities could help pay for healthcare reform, but critics suggest that the issue is much more complex than the report suggests, stating that other factors including healthcare access, income level, culture, and genetics may all play a role.

How much charity care?
The Chicago Tribune reports that the Illinois Supreme Court is expected to rule on the issue of how much charity care a hospital must provide to qualify for property tax exemptions. Illinois has no clear definition of the amount of charity care that must be provided, and no determination as to whether unpaid medical bills and services that are offered for free should be included to determine whether a hospital receives a tax exemption. The decision could affect how nonprofit hospitals, which account for the majority of health facilities in the United States, handle the bills of uninsured Americans.

FDA concerned about device approval
Citing “multiple departures from processes, procedures, and practices,” an FDA preliminary report states that there were “definite threats” to the integrity of the medical device review process when the agency cleared the Menaflex device, manufactured by ReGen Biologics (Hackensack, N.J.), in late 2008. As a result of the questions raised in the preliminary report, FDA has commissioned the Institute of Medicine to determine whether the 510(k) process optimally protects patients and promotes innovation in support of public health. FDA also plans to review its approval of the Menaflex device. The device has not been withdrawn from the market.

Glaxo stops funding commercial medical education
The Associated Press reports that GlaxoSmithKline PLC will stop funding educational programs run by commercial medical education and communication companies in favor of programs given by national professional medical associations or teaching hospitals and their affiliates, who will need to be accredited to seek grants from the company. Additionally, before the end of 2009, the company will begin publishing fees it pays to health professionals for meeting presentations and consulting services.

New HHS rules on security breaches
New regulations from the U.S. Department of Health and Human Services (HHS) require all physicians covered by Health Insurance Portability and Accountability Act (HIPAA) to notify patients if a security breach involving medical information occurs. Under the regulations, healthcare professionals and other HIPAA-covered entities must promptly notify affected individuals; the HHS Secretary and the media (in cases where a breach affects more than 500 individuals) also must be notified. Breaches affecting fewer than 500 individuals will be reported to the HHS Secretary on an annual basis. The regulations also require business associates of covered entities to notify the covered entity of breaches at or by the business associate. The requirements took effect Sept. 23, 2009, and apply in addition to any notification obligations imposed by state law.

Physicians don’t follow up electronic alerts
A study published in the Archives of Internal Medicine (Sept. 28, 2009) finds that critical imaging results are often not followed up on by physicians, even when alerts are sent using advanced electronic health record (EHR) systems. The researchers used tracking software to determine when alert notifications generated through the EHR were opened by recipients at a single outpatient tertiary care U.S. Department of Veterans Affairs facility from November 2007 to June 2008. Of 123,638 imaging studies, 1,196 images (0.97 percent) generated alerts. Physicians failed to open 217 (18.1 percent) within 2 weeks of transmission. The alerts were less likely to be read when the ordering providers were trainees and when the alerts were sent to multiple providers. Follow-up within 4 weeks was lacking in 92 cases (7.7 percent of all alerts). Nearly all abnormal results lacking timely follow-up at 4 weeks were eventually found to have a measurable clinical impact.

Practice revenue report
According to the Medical Group Management Association’s (MGMA) Cost Survey: 2009 Reports based on 2008 Data, revenues for multispecialty group practices declined in 2008 by 1.9 percent. The drop was the first in several years and may be attributable to a decline in patient volume and an increase in bad debt from fee-for-service charges. From 2006-2008, the number of patients dropped 11.3 percent, while the number of procedures performed dropped nearly 10 percent. Among orthopaedic practices, revenues were up 2.94 percent.

EDs not caring for patients fast enough
A study in the Annals of Emergency Medicine (Oct. 5, 2009) reports that most patients were seen by a physician in the recommended time frame in only 30 percent of emergency departments (EDs), and only 13.8 percent of EDs achieved the triage target for patients who needed to see a doctor within one hour. The retrospective cross-sectional study looked at a random sample of 35,849 patient visits to 364 nonfederal U.S. hospital EDs in 2006 and measured median wait times, visit lengths, proportion of patients treated within the time recommended, and proportion of patients dispositioned within 4 or 6 hours. Variation in time to be treated was largely patient-dependent, but variation of stay was hospital-dependent.

New PhRMA clinical trial guidelines
The Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group, has implemented new clinical trial guidelines. The voluntary guidelines call for acknowledging anyone who contributes to, writes or revises parts of a study, helps an author, or has final approval over what is published. They also call on companies to post “summary results” of all clinical trials, including those for drugs dropped from development, although the guidelines do exempt trials of experimental drugs that are still in development. The guidelines also prohibit physicians who have an ownership interest in a drug from participating in clinical trials involving that drug.

Improving patient care with teamwork
A study in the American Journal of Orthopedics (July 2009) finds that a hospitalist comanagement model may help improve orthopaedic patient care. The authors selectively enrolled 86 consecutive patients in an academic medical center hospitalist-orthopaedic surgery co-management patient care program, and compared a variety of factors to a constructed control group of 54 patients who underwent similar surgeries immediately preceding the program. The observed-to-expected ratio for hospital length of stay for patients in the program was 0.693, compared to 0.862 for the control group, while the overall observed-to-expected cost of care remained virtually unchanged.

Injurious falls by seniors a factor in increasing use of EDs
According to a statistical brief released by the U.S. Agency for Healthcare Research and Quality, elderly adults had more than 2.1 million ED visits for injurious falls in 2006 and accounted for 1 in 10 ED visits among patients aged 65 years and older. The most common reasons for injurious fall-related ED visits among the elderly were fractures (41.0 percent), followed by superficial/contusion injuries (22.6 percent) and open wounds (21.4 percent). Hip fractures accounted for about 1 in 8 injurious fall-related ED visits among the elderly. Additionally, elderly patients seen in the ED for injurious falls and subsequently admitted to the hospital were more likely to be discharged to long-term care than ED patients admitted to the hospital with other conditions (65.7 percent versus 28.4 percent).

According to data published online in the Annals of Emergency Medicine, the proportion of ED users in the United States increased from 12.7 percent to 13.8 percent from 1996 to 2005. Increasing proportions of elderly and those who perceived themselves to be in poor or fair physical health among ED users were found in both raw and population-adjusted trends. The nationally representative data was drawn from the Medical Expenditure Panel Survey, 1996 to 2005.