The essential resource for your practice
Volume XXI, Number
FDA Panel Recommends Reclassification of Surgical Mesh
The Obstetrics & Gynecology Medical Devices Panel of the U.S. Food and Drug Administration (FDA) is recommending that synthetic surgical mesh be classified as a Class III device@blurbend, thereby requiring more stringent pre-market testing of these products and eliminating the ability of manufacturers to seek approval through the 510(k) process. The panel, chaired by Tommaso Falcone, MD, of the Cleveland Clinic Foundation, met to discuss the safety and effectiveness of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) from September 8-9, 2011. The hearing followed the July 2011 safety alert and white paper issued by the FDA.
The AUA, along with the Society for Female Urology and Urodynamics (SUFU), the American Urogynecologic Society (AUGS), the American Congress of Obstetricians and Gynecologists (ACOG) and the Society of Gynecologic Surgeons (SGS), provided testimony for the hearing, as did patients, regulators and industry representatives. AUA Health Policy Council member J. Christian Winters, MD, of New Orleans, provided testimony on behalf of the AUA, acknowledging the risks and benefits of mesh for both POP and SUI, pointing out that it is important to consider that complications can also occur in patients who undergo non-mesh procedures and that, in many patients, the mesh appears safe and well tolerated with improved anatomical outcomes. The AUA and other physician groups also strongly reinforced the differences between the use of mesh to treat POP vs. the use of synthetic mesh midurethral slings to treat SUI. It was noted that the AUA Guideline for the Surgical Treatment of SUI lists synthetic midurethral slings as appropriate surgical therapy, with an acceptable risk-benefit profile.
The AUA, AUGS, ACOG, SGS and SUFU stressed that patient selection, a rigorous and standardized consent process for patients and appropriate training for surgeons is critical to successful mesh surgery, and that steps should be taken to standardize education and credentialing for surgeons performing procedures with mesh. Many societies, including the AUA, pointed out a strong need for post-market surveillance of mesh, as well as patient registries to better track outcomes in those patients treated with synthetic vs. native repair.
Currently, surgical mesh is classified by the FDA as a Class II device, meaning that, as part of the FDA’s Development & Approval process, manufacturers of the products are not required to present extensive pre-clinical testing data, but rather a pre-market approval (PMA) demonstrating that the device is “at least as safe and effective” or “substantially equivalent” to a device already legally marketed in the United States. Should the FDA follow the Panel’s recommendation for a reclassification to Class III, companies—as part of the approval process—could be required to perform randomized, controlled trials to demonstrate safety and efficacy.
The FDA will consider the Panel’s recommendations on the use of mesh for POP and SUI in making its final decision, which is forthcoming. We will continue to update you on this issue in future issues of AUA publications.
Table of Contents
AUA Celebrates Another Year of Coding Seminar Success
California Congresswoman Visits Local Urology Practice
In August, Representative Laura Richardson (D-CA-37) toured a urology facility in the Los Angeles area, Urology Specialists of Southern California. AUA member Alec Koo, MD, and his staff guided Representative Richardson through the facility, and showed her how using integrated services, such as ultrasound, gives the team the ability to provide immediate answers on various urologic diseases to their patients. They also discussed how interaction and collaboration between the technical staff and the urologists lead to better patient care.@blurbend
The first stop of the tour was the pelvic floor therapy area, where the Congresswoman learned about urodynamics testing and biofeedback therapy. She was very interested in the disease processes and the treatment options available. Dr. Koo and his staff then showed Representative Richardson their in-office pathology laboratory. She was impressed with how the processing, analysis and reporting were integrated, which allowed for more immediate reporting of results. The group talked about how the use of molecular probes has advanced urology’s diagnostic capabilities, and that the facility offers tests not provided at the laboratory in their local hospital. Finally Dr. Koo’s team demonstrated their electronic medical record (EMR) system and how they use it to provide high quality care to their patients.
After a tour of the facilities, Dr. Koo and his staff had a frank discussion with Representative Richardson about legislative issues that affect patient care, such as the Sustainable Growth Rate (SGR), the use of radiation therapy services to treat prostate cancer, and the prevalence of urinary incontinence in women. They also discussed how the Meaningful Use financial incentives are essential to physician offices to help defray the high costs of purchasing EMR systems.
At the end of the visit, Representative Richardson remarked that it was a great experience for her in helping to understand the services provided in a urology office and the importance of being able to offer integrated services. Thus, by inviting Members of Congress into urology practices, the urologic community is educating lawmakers about our practices and patients. It is imperative that lawmakers have this basic understanding as they continue to discuss healthcare reform and implementation.
Following her practice visit, Representative Richardson, whose father died of prostate cancer, became a co-sponsor of the Prostate Outreach, Screening, Testing, Access and Treatment Effectiveness (PROSTATE) Act of 2011, H.R. 2159, which was drafted by the AUA. Additionally, on September 22, 2011, she was a featured speaker at the AUA’s Capitol Hill Meet & Greet, an educational event where Members of Congress were invited to share their personal experience with prostate cancer since many speakers were either survivors or family members of someone who battled the disease. See the upcoming December Health Policy Brief for more information on and photos of the Meet & Greet and a reception that evening, which was held in conjunction with the Congressional Black Caucus Foundation’s 2011 Legislative Conference.
For more information about this visit, or for help arrange a visit to your practice, e-mail GovernmentRelations@AUAnet.org.
For The Record
Adoption of EHR is Only a Step in the Journey to Quality Improvement
An article in the September 1, 2011, issue of the New England Journal of Medicine (NEJM) cites studies supporting the authors’ contention “that simple adoption of EHRs [electronic health records] does not necessarily improve the quality of care and that quality does not appear to improve even over a number of years among EHR users.”1@blurbend
Although some institutions (such as Better Health Greater Cleveland) have published studies in NEJM showing improvement in the quality of care resulting from the use of health technology, the September article explains that these trends are generally attributable to internally-developed EHR systems in place for two or more decades.
The Meaningful Use (MU) incentives promulgated by the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, have boosted the adoption of commercial EHR packages. Even some of the longstanding users of internally-designed systems found it less expensive to adopt commercial EHRs rather than upgrade their existing systems to qualify for MU certification.
The NEJM article explains that the emphasis of users so far has been in jumping through the necessary hoops to receive the Stage 1 incentives and that attention to the “change management, processes, and clinical-decision support that will improve care” is still on the bottom of the priority list. The article notes that virtually every discussion with practicing urologists about quality measurement, whether in the context of the Physician Quality Reporting System (PQRS) or the quality measures associated with MU, results in expressions of skepticism that the required measures do anything to actually improve outcomes of care.
To improve care, the authors make three recommendations:
- Providers must insist that their systems be upgraded to include features that will enhance efficiency, quality measurement and patient safety.
- Post-implementation testing should be conducted to determine if clinical information systems are safe and effective in use.
- Federal funding should be provided for more research into whether technological innovation actually leads to improved clinical outcomes.
CMS Begins Testing Electronic Submission of Medical Documentation to Reviewers
Every year, Medicare review contractors, including Recovery Audit Contractors (RACs), Comprehensive Error Rate Testing (CERT) contractors and Medicare Administrative Contractors (MACs), request more than 1 million medical records, which they compare with billing data to determine the potential for overpayments. To date, the vast majority of these documents are submitted in paper format via mail or fax. With the push toward electronic record keeping, the Centers for Medicare & Medicaid Services (CMS) has launched a test of electronic submission of medical documentation (esMD) to determine the feasibility for contractors to request and providers to supply this documentation in electronic format (direct upload from EHR or PDF transmissions).
According to one source (link removed), “esMD utilizes the technology of the Nationwide Health Information Network, called CONNECT-compatible gateways, to keep the documentation secure as it moves from the provider to the requesting contractor.” In Phase 1 of CMS’ pilot testing, the review contractors will still contact providers on paper but the provider has the option to submit documentation electronically if they use a clearing house or an EHR vendor who has been approved as “Health Information Handler (HIH).” Interested providers who have placed their paper documents in remote storage or who have scanned all their paper records should check with their vendor and clearing house to investigate their options to submit using esMD. More information can be found on the CMS Web site here (link removed).
For more information, please e-mail rr&q@AUAnet.org.
1David C. Classen, MD, and David W. Bates, MD
N Engl J Med 2011; 365:855-858 September 1, 2011, Finding the Meaning in Meaningful Use
AUA Response to USPSTF PSA Recommendations
Over the past three weeks, the AUA has been actively working to respond to new recommendations from the U.S. Preventive Services Task Force (USPSTF) regarding the use of the prostate-specific antigen (PSA) test. The AUA continues to stand by its recommendations that men talk to their doctors about the PSA test, and believes that the USPSTF is doing men a great disservice by discouraging the use of the test. To date, the AUA has been featured in more than 1,200 news articles, and our audio news release has been aired more than 4,000 times and has reached more than 16 million Americans.@blurbend AUA members have also responded not only by submitting comments to the USPSTF, but also by sending 270 letters to their local newspapers and 155 letters to Congress.
Click here to view more information about the AUA’s response.