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Department of Justice investigation and settlements chosen as top story of 2007
The Orthopedics Today Editorial Board picks the Top 10 topics and articles that appeared last year.
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The Orthopedics Today Editorial Board is a valuable resource to our publication and our readers. The board members serve as contributors and offer commentary on our articles and special features throughout the year. They also suggest the most topical, practical and interesting presentations at their respective subspecialty meetings for us to cover in our issues. Recently, we asked our board members to rank in order the topics and articles that appeared in the publication which impacted our profession the most in 2007. These articles were culled from our coverage of hundreds of presentations during 2007, our 24 Round Table discussions, 4 Question interviews with the thought leaders in and outside orthopedics, and Point/Counterpoint debates. As usual, the members of our editorial board did not let us down.
Ranked No. 1 on the list of our Top 10 stories by an overwhelming majority of the board was coverage of an issue that rocked our profession — the announcement of the U.S. Department of Justice investigation into past consulting and professional service agreements between orthopedic device manufacturers and orthopedic surgeons, the subsequent settlement with five major device makers and the release of a partial listing of funds that many of our colleagues were receiving from industry.
The No. 2 story appearing in Orthopedics Today in 2007: the “price controls” policy of Medicare which continues to cause some orthopedic surgeons to look for alternative revenue sources and others to choose to opt out of the system entirely.
Two other issues from 2007 making the Top 10 included pay-for-performance reporting and our ongoing coverage of instituting electronic medical records into the orthopedic practice.
Throughout 2007 we enjoyed bringing you the news and features that impact your practice. We look forward to providing you with the latest orthopedic news and information in 2008.
Douglas W. Jackson, MD
Chief Medical Editor
1. Device companies reach settlement with DOJ
Most Orthopedics Today Editorial Advisory Board members universally agreed that the top story of 2007 reported in this publication was the decision by five leading orthopedic hip and knee implant companies to settle with the U.S. Department of Justice.
The settlement effectively concluded the Department of Justice’s (DOJ) investigation into whether the companies’ financial relationships and consulting agreements with orthopedic surgeons violated the federal anti-kickback statute.
Under the settlement, Zimmer, DePuy Orthopaedics, Biomet, Smith & Nephew and Stryker Orthopedics agreed to adhere to new corporate compliance procedures and 18 months of oversight by a federal monitor appointed by the DOJ.
Zimmer, DePuy, Biomet, and Smith & Nephew executed Deferred Prosecution Agreements (DPAs) with the New Jersey District Attorney’s Office and agreed to pay a total of $311 million to settle government claims under the anti-kickback statute and the civil federal False Claims Act.
Stryker Orthopedics — the fifth company involved in the investigation — voluntarily cooperated with the Attorney’s Office before any of the other companies. Because of its cooperation, Stryker entered into a Non-Prosecution Agreement with the DOJ, which requires Stryker to implement the same reforms imposed on the other four companies under the DPAs, including 18 months of federal monitoring.
In November, Matt Miksic, an orthopedic and spine device analyst for Morgan Stanley, told Orthopedics Today the settlement is “healthy” for the industry because “it enables manufacturers to remain engaged with surgeons in terms of training and product design and development, which is critical for maintaining quality and innovation in the industry, which is ultimately good for patients.”
As part of the on-going coverage of the story, in December Orthopedics Today reported that the U.S. Department of Justice also issued subpoenas to Wright Medical Group Inc. and Exactech Inc., requesting documents related to consulting arrangements with surgeons. Both companies stated that they intend to fully cooperate with the DOJ’s request.
Reference:
- Piechocki M. Implant companies, Department of Justice reach $311 million settlement. Orthopedics Today. November 2007:41.
2. Orthopedists react to proposed Medicare cuts
Orthopedic surgeons are no strangers to Medicare cuts, but the latest news from the Centers for Medicare & Medicaid Services concerning Medicare payment cuts to physicians in 2008 is making some surgeons reconsider how many Medicare patients they can treat.
The topic placed second on the list of Orthopedics Today top stories in 2007.
In one of its last acts of 2007, Congress passed a bill that temporarily suspended a proposed 10.1% physician Medicare reimbursement cut that was scheduled to take effect on January 1 and replaced it with a 0.5% payment update for the first 6 months of 2008.
However, some medical groups expect that physicians could face an even larger reimbursement cut later next year if Congress fails to intervene again by July 1.
In the his editorial in the July issue of Orthopedics Today, Chief Medical Editor, Douglas W. Jackson, MD, drew a line in the sand declaring, “As an individual physician, I personally will opt out of Medicare as a participating physician if the scheduled 2008 cuts occur.”
He said he will stay in the Medicare clan for the first 6 months of 2008. “The cut they proposed had reached beyond the bottom line I am willing to accept,” he said.
Reference:
- Jackson DW. A time for personal decisions: More Medicare cuts are scheduled for 2008. Orthopedics Today. July 2007:3.
3. Research defines new trends in infection control
The challenge of preventing and managing musculoskeletal infections gained even greater media attention last year, and a number of key studies covered by Orthopedics Today in 2007.
Image: Duncan CP |
Robert L. Barrack, MD’s, investigation that determined that early detection was key for tackling post-TKA infections was highlighted in the June issue.
Barrack reported, “Early, accurate diagnosis is critical in managing the infected knee, yet there is not uniform agreement in what even constitutes an infection.”
In a prospective study of 120 patients with 127 painful prosthetic hips, FDG-PET imaging was 90.5% accurate in differentiating between infected and noninfected painful hips, Javad Parvizi, MD, FRCS, said at the 17th Annual Open Scientific Meeting of the Musculoskeletal Infection Society.
“It is possible that this may become a very promising diagnostic tool in the future,” he said in an article that appeared in November.
In August, the Centers for Medicare and Medicaid Services announced it would no longer reimburse hospitals for “preventable conditions.” Two of these conditions include methicillin-resistant Staphylococcus aureus (MRSA) and surgical site infections.
And while most researchers in 2007 focused on the risk of infection following hip and knee replacement, Kyle J. Jeray, MD, reminded us in our June and November issues that surgeons should also be vigilant about preventing MRSA infections of the hand.
Reference:
- DiMarcantonio T. Review of infected TKA cases reveals a few lessons and caveats for diagnosis. Orthopedics Today. June 2007:10.
4. Pay-for-performance incentives to continue in 2008
The announcement by the CMS early in 2007 to prolong its hospital pay-for-performance demonstration project for an additional 3 years and expand the criteria for payment incentives ranked as the fourth most important story of the year.
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“We think that this has been a substantial success so far, so we wanted to continue that success,” Mark Wynn, the CMS director of the division of payment policy and demonstrations, told Orthopedics Today in April. “But more specifically, to allow us to extend it and to test additional payment models … that would give Medicare some additional information as it considers moving toward hospital pay-for-performance.”
The announcement to extend the Premier Hospital Quality Incentive Demonstration comes on the heels of the project’s second-year results. During that time, more than 250 participating hospitals showed an overall increase of 11.8 percentage points across the five clinical focus areas: hip and knee replacement, acute myocardial infarction, coronary artery bypass graft, heart failure and community-acquired pneumonia.
CMS awarded nearly $9 million to 115 of the best performing centers, according to a CMS press release.
And evidence-based medicine plays a fundamental role in achieving the ultimate goal of pay-for-performance initiatives: improving health care quality, Joshua J. Jacobs, MD, told Orthopedics Today in September.
Reference:
- Brockenbrough G. CMS to continue its hospital P4P project 3 more years, same penalties now on tap. Orthopedics Today. April 2007:45.
5. Researchers report latest data on artificial discs
Investigators were busy in 2007 reporting the latest clinical findings involving several artificial spine discs, including those in investigational device exemption trials.
In reporting from the North American Spine Society 22nd Annual Meeting, Orthopedics Today quoted Matthew F. Gornet, MD, as he reported the results a prospective, randomized, multicenter trial of nearly 600 patients who received either total disc replacement (TDR) using the Maverick prosthesis (Medtronic) or anterior lumbar interbody fusion (ALIF) using bone graft and an LT-Cage (Medtronic Sofamor Danek). At 24 months postoperatively, the investigators discovered that the TDR group showed statistically better improvements compared to the fusion group in the ODI and patient satisfaction scores at all postoperative follow-up points.
Also in 2007, 3- to 4-year results were reported from a Texas investigation showed that artificial disc replacement using the ProDisc achieved better results than circumferential fusion in all parameters tested, including Visual Analog Scale, Oswestry Disability Index (ODI), and patient satisfaction scores.
And in August, we reported that the CMS announced that it will not provide coverage for performing lumbar artificial disc replacement in Medicare patients older than 60 years. However, the agency did not make a national coverage determination for Medicare beneficiaries aged 60 years and younger, “leaving such determinations to be made on a local basis,” according to a CMS memo.
Reference:
- Brockenbrough G. Preop nasal screening for S. aureus lowered postop spine infection rates. Orthopedics Today. December 2007:48.
6. Challenges of performing hip resurfacing worrisome
Hip resurfacing was the sixth most popular Orthopedics Today topic in 2007, a year that included one hip resurfacing product recall, FDA approval of a new prosthesis, and many surgeons discussing at national and international orthopedic meetings whether femoral resurfacing during hip arthroplasty is efficacious and safe.
The predominant theme throughout Orthopedics Today’s coverage of this subject was the extent to which successful outcomes with hip resurfacing arthroplasty depended on patient selection and surgeon experience.
Diane L. Back, FRCS, who has studied a number of hip resurfacing variables, told Orthopedics Today in May, that skilled surgeons involved in one of her studies estimated they needed to complete 10 to 20 resurfacing cases for their learning curve.
“Results actually showed that it took 55 to 60 cases for most of our surgeons to get the femoral component where they actually planned it,” Back said.
Orthopedists Paul E. Beaulé, MD, FRCS, of Ottawa, and Pascal-André Venditolli, MD, of Quebec, noted in an October article that the best applications of hip resurfacing arthroplasty were perhaps in young patients and those desiring to return to their presurgical level of activity.
In the August issue, Beaulé contended the 15% to 30% failure rates some reported can be mitigated through patient selection among young arthritic patients.
“I think these are exciting times in hip arthroplasty. We are minimizing the time to recovery with improved surgical techniques, better pain management, lower risk of dislocation, and an earlier return to work so patients can have a greater capacity to live their lives to the fullest,” he said.
Venditolli’s randomized study of conventional vs. surface replacement arthroplasty (SRA) found similar complication rates between the two.
“It also suggest that SRA results in better function and improved patient activity,” based on UCLA activity scores, he said in October.
Reference:
- Rapp Sm. Learning curve may be longer than thought for placing hip resurfacing components. Orthopedics Today. May 2007:12.
7. More clinicians considering adding EMR systems
More orthopedists are integrating — or giving careful consideration to adding — an electronic medical records system to their clinic, anticipating gains in storage and speed of information retrieval and transmission. As a result, Orthopedics Today started an on-going series of articles addressing the issues important to this technology and the story earned a place in the Top 10 topics of the year.
At the federal level, the Office of the National Coordinator for Health Information Technology, part of the Department of Health & Human Services announced it is focused on instituting a national EMR network. Also, the private, nonprofit Certification Commission for Healthcare Information Technology is charged with developing standards to certify electronic medical records (EMR) systems.
Last January, A. Herbert Alexander, MD, of Ketchum, Idaho, told Orthopedics Today than when searching out an EMR system, orthopedists should do their homework and select one that offers the necessary features for their specific office.
Systems that allow for both writing prescriptions and e-prescribing are important to meet the capabilities of different pharmacies, he said. Just as important: EMR systems should provide report acquisition and management capabilities. This feature allows the office to scan records from other practices or hospitals and manage the documents.
Most importantly, the ideal EMR system should be able to “communicate” effectively with other EMR systems across town and across the country, he said.
Reference:
- DiMarcantonio T. Going totally electronic: What to consider and how to construct your digital office. Orthopedics Today. January 2007:35.
8. New guidelines drafted for DVT, PE prophylaxis
Orthopedic surgeons wishing to prevent or treat deep venous thrombosis or pulmonary embolism in their patients are faced with many questions about which prophylaxis methods to select.
Image: Barrack RL |
They must also balance the risks, costs and duration of deep venous thrombosis (DVT) treatment, as well as select the best agent to give the optimal patient care.
In 2007, Orthopedics Today addressed the topic in a variety of formats, including Round Table discussions, Point/Counterpoint debates and podium presentations.
“The prevalence of DVT is really shocking,” said Robert L. Barrack, MD. Still, “Not all patients need prophylaxis. We just don’t know which ones do,” he said in the September issue.
Orthopedists now recognize that a combination approach might be optimal because no single modality works well in every total joint replacement (TJR) case, he said.
“Ideally, we should have something that is effective, low-risk and cost-effective,” Barrack said in our September article on pharmacologics in TJR.
Some help arrived via new clinical guidelines issued in the spring by the American Academy of Orthopaedic Surgeons (AAOS) for preventing symptomatic pulmonary embolism (PE) in patients undergoing total hip or knee replacement. Before that, the only guidelines were those developed by the American College of Chest Physicians.
Barrack predicts that the new AAOS guidelines will give TJR surgeons more latitude in treatment options and their duration, while de-emphasizing aggressive pharmacologic treatments.
Reference:
- Rapp SM. Aggressive pharmacologic protocols may be associated with TJR complications. Orthopedics Today. September 2007:18.
9. Tissue banks, policies come under scrutiny
One of the more controversial issues affecting musculoskeletal care providers in 2007 was allograft tissue bank regulation, in light of recent scandals involving the illegal procurement and sale of tissue.
Variations in the tissue bank industry and disregard for FDA guidelines by some tissue banks are leading orthopedic surgeons like John Cherf, MD, to call for more regulation.
“I typically do not welcome more regulation in health care,” Cherf, of Chicago, told Orthopedics Today in January. “However, a healthy donor industry is critical to orthopedics. Quality grafts are essential for patient safety. Two recent problems have raised concerns about the integrity of the allograft supply chain.”
Amid the recent scandals, some surgeons are concerned with whether tissue banks are truly complying with the latest FDA guidelines that were released in 2005.
“It is unfortunate that the practices of a small number of firms in this industry are going to make it a lot tougher on everyone else,” Cherf said.
Still, there has been progress.
“It is my impression and experience that the risks and safety concerns in using allografts are minimal. As a result of the standards that have been established and followed by most legitimate tissue banks, the risks to patients is extremely small,” said Douglas W. Jackson, MD, chief medical editor of Orthopedics Today.
“More government regulation will result in increased costs and add another level of bureaucracy to enforce and oversee allograft utilization. Most of the problems that have and will occur are very infrequent and usually involve individual human mistakes.”
Reference:
- DiMarcantonio T. Health care industry welcoming more regulation over donor tissue banks. Orthopedics Today. January 2007:52.
10. Large Swedish study: CTS rarer after keyboard use
Image: Papachristos A |
In November Orthopedics Today published a report on the surprising results which emerged from a population study of 2,465 Swedish workers and their risk for carpal tunnel syndrome, adding fuel to the debate on whether a positive connection exists between the condition and keyboard use.
Among working-age adults, Swedish researchers found 2.6% prevalence of carpal tunnel syndrome (CTS) in people who used a keyboard on the job more than 4 hours per day. They detected a 5.2% prevalence for those who did not use keyboards at work at all (P =.032, for trend).
“Intense keyboard use at work seems to be associated with a lower risk of CTS,” said Isam Atroshi, MD, PhD, of Hässleholm, Sweden, who presented results at the American Society for Surgery of the Hand annual meeting.
Researchers found 2.9% CTS prevalence in workers who keyboarded 1 to 4 hours per day and 4.9% in those who used a keyboard less than1 hour daily. They identified subjects via a questionnaire on work factors and pain/numbness, a physical exam and nerve conduction studies diagnosing CTS in symptomatic people willing to enter the study.
Reference:
- Rapp SM. Large Swedish population study finds CTS symptoms rare with heavy keyboard use. Orthopedics Today. November 2007:58.