Other Articles

Multicenter Clinical Trials: Do They Get the Respect They Deserve?
They’re not fast or sexy, but they are critical…large trials, that is. With multiple sites and principal investigators who donate their time, large trials are more complex—and normally yield more actionable data—than smaller, quicker studies. But large trials don’t always get the respect they deserve. And, says at least one physician-researcher, this could affect the future of the field.

Patent Wars: Medtronic Attacks NuVasive
MSD’s lawsuit came amid a period of declining spinal implant market share – from a peak of 60% in late 1998 (just prior to being acquired by Medtronic) to, we estimate, 36% currently – and a growing sense that MSD’s reign as the king of spine was coming to a close. What’s really behind Medtronic’s attack on its former senior exec? Read on.

Spine Gainsharing Through the Looking Glass
The feds have issued their first opinion allowing a spine gainsharing proposal. In Alice in Wonderland style, Through-the-Looking-Glass logic, they said the proposal was improper but would not impose sanctions. Who is the author of such a plan and what’s her secret? Read here.

PearlDiver Data Raises New Questions About Synovial Injections
Synovial injections for painful knees have been approved for use since 1997. If the goal is to improve the quality of life for the patient, is that being accomplished? The latest numbers from the PearlDiver Patient Records Database cast doubt.

Plantar Fascia: The Annual 3 Million Patient Market
“Plantar Fascial Fibromatosis (ICD-9-D-728.71) is right up there in frequency with pain in the shoulder joint, degeneration of lumbar intervertebral discs, pain in the lower leg joint, and carpal tunnel syndrome. As usual, PearlDiver has this market mapped out.

Orthopedic Incubators: Where Little Ideas Grow Up
Business incubation, also known as acceleration, can be a wild ride. Thus it’s best to approach it armed with the solid advice of experienced professionals. Who should take this ride? What can venture financiers bring to the table? These questions and more are answered by two seasoned VC professionals.

Just Say No to CMS Potential Coverage Decision List
Unless you want to be on the receiving end of a non-coverage letter, just say no to CMS’ proposed list of potential National Coverage Decisions. You’ve got until September 28 to make your case. Read what a leading industry consultant and analyst have to say.

Staking a BIG Claim
Alphatec, the company whose IPO collapse served as an object lesson for all medical device companies, has nearly completed its turnaround. The key? New management and new technology. Exhibit A: OsseoFix™—with it Alphatec stakes a claim to the next big spinal implant market.

The Pennsylvania Orthopaedic Society
The Pennsylvania Orthopaedic Society, 1,000 members strong, tackles a variety of challenges on behalf of patients and surgeons alike. According to AAOS, they were the top state professional society in 2007. Fifty-two years in the making, here is how they did it.

Percutaneous Spine Procedures: Just Setting the Stage for Fusion?
Selective nerve root blocks, laminectomies, and percutaneous discectomies. How many times do these procedures lead to a full blown spine fusion? Using PearlDiver’s Patient Records Database, we longitudinally tracked patients to find out. All we can say is that after surveying the 3.9 million spine patients in the PearlDiver database, the answer may be different from what you’d expect!

Physicians Targeted by Whistleblowers
The whistleblowers that targeted Medtronic in 2006 are now aiming their guns on 136 physicians and distributors as we move into the next era of the “Great Disruption.” Read about their qui tam lawsuit in Boston and what it means for industry and surgeons.

Zimmer’s Bet on Compliance
Is Zimmer’s Enhanced Compliance Program going to cost it market share? Analysts demanded answers from CEO Dave Dvorak during the quarterly conference call on July 23 that also included the announcement of the Durom® cup suspension. Dig in here.

Faculty Compensation in Academic Medicine
Dr. Sanford Emery, Chair of Orthopaedics at West Virginia University, has put his M.B.A. to good use. Delving into the issue of compensation in academic medicine, Dr. Emery and his colleagues surveyed 31 orthopedic programs and conducted in-depth interviews with leaders of eight programs. Their findings include information on the compensation structure and point systems.

Engineering an Unfair Advantage
After $1.2 billion in equity capital, what did the tissue engineering pioneers accomplish between 1990 and 2000? For one thing, LifeCell, Integra and Osiris. For another, a generation of wiser, tougher managers who are targeting the big orthopedic markets. Now all they ask for is an unfair advantage. Are the big guys ready?

The Pain of Fashion! 4 Million Patients Every Year and Growing
Eighty-eight percent of all women wear shoes that are too small. Fifty-five percent developed bunions. Despite costs that can reach as high as $20,000 per procedure, four million patients every year seek surgical relief. Want to know the footprint of this market? Read on.

Oxiplex® – “Not Approvable”
The FDA’s Orthopaedic and Rehabilitation Devices Advisory Panel said FzioMed’s Oxiplex gel was safe but not proven to be effective, and therefore, not approvable. Did statistics get in the way of something that’s needed, works for some and is safe? Decide for yourself.

Tiger’s Knee and the Cruel Twist to the Sport of Golf
At the U.S. Open in June, Tiger Woods played through intense knee pain to stay on the leader board. His next appointment is with an orthopedic surgeon. Last year there were 103,000 golfing related orthopedic injuries reported. That’s $2.4 billion in medical care. For more on this important and growing market segment read on.

How can orthopedic surgeons from Topeka to Tacoma have their voices heard all the way to Washington, DC? Through the AAOS Political Action Committee (PAC). Explains Dr. Stuart Weinstein, the Ignacio V. Ponseti Chair and Professor of Orthopaedic Surgery at the University of Iowa, and Chair of the PAC, “The AAOS Political Action Committee is the largest medical specialty society PAC in Washington. This is particularly impressive given that orthopedic surgeons represent only 3% of all physicians nationwide. If orthopedists want to make an impact on the issues most affecting our profession, getting involved with our PAC is the most expedient way to accomplish that goal.”

In the mid-1980s several prescient orthopedists took stock of the present and peered into the future of the field. They saw that they had to act or be acted upon. Says Dr. Weinstein, “The AAOS PAC began in 1999 because the Academy was seeking to become more active on the healthcare policy front. Those who formed the original committee could see that healthcare was a rapidly expanding industry and was becoming more heavily regulated. Those guiding AAOS at the time felt we needed to be at the table discussing the issues of the day. They wanted to ensure we would have a stake in making sure patients had access to orthopedic care and that AAOS was an active rather than a passive player in the process. As a 501(c)(3), however, AAOS was prohibited from political action. The AAOS therefore formed the American Association of Orthopaedic Surgeons, a 501(c)(6) organization and then formed the modern day Ortho PAC as a Separate Segregated Fund. The PAC was thus formed as a structure whereby the committee’s funds are kept separate from those of AAOS.”

So how does someone come to join those orthopedists making strides in the halls of Congress? “Our Chair, Secretary, and Treasurer are all appointed through the AAOS committee appointment process. The job descriptions are posted online, orthopedists apply for a position, and recommendations are made to the AAOS Appointment Committee. This committee then makes recommendations to the AAOS Board of Directors. There are also slotted seats on the PAC for representatives of the Board of Counselors and Board of Specialty Societies. We also have input from the state orthopedic societies, who elect someone to sit on the PAC.”

Not tied to the donkey or elephant, the AAOS PAC is nothing if not practical. Explains Dr. Weinstein, “We are pragmatic, not ideological, as there are a myriad of issues that must be dealt with. We support candidates who reflect our positions on various issues, all of which affect access to healthcare and the quality of healthcare. Our positions are decided on by the AAOS Board of Directors and the Council on Advocacy. And we don’t make donations solely to Democrats or Republicans. Many candidates support our side of the issue on one thing and not on another. The PAC gives us an opportunity, when we meet with our representatives, senators, or aides, to frame our position in any given debate. Some people don’t know that political action committees emanate from the first amendment right to petition Congress. We take part in this tradition collectively through the AAOS PAC.”

And like many efforts of significance in the field, fundraising is part of the work. “Our solicitation activities are limited to members of AAOS,” says Dr. Weinstein. “When the PAC approaches members for donations, we attempt to educate them as to the importance of advocacy. We want them to know that this is their opportunity to have a voice and have their concerns heard. We solicit annually by mail and phone, and we have an informational booth at the annual AAOS meeting. The political landscape these days is such that many people are motivated to contribute to our activities. Healthcare is a major issue in this presidential campaign and the healthcare system is truly under a microscope. It is not too difficult to find issues that energize people to make a contribution.”

So what are some of the issues the PAC is trying to address? States Dr. Weinstein, “The Medicare payment formula has been a problem for a long time. Most members of Congress now understand that the formula is flawed and in need of attention. The repercussions are of great importance in that Medicare beneficiaries lose access to care because offices can’t afford to treat them. Another issue that we are devoted to is that of liability reform. With outrageous premiums for orthopedic surgeons, doctors are limiting their ER coverage, trauma work, and high-risk surgeries, all of which involve a much higher liability risk and raise premiums. Then there is the ever-worsening issue of insurance paperwork. We continuously advocate for lessening the regulatory burden on doctors.”

Continues Dr. Weinstein, “Regarding pay for performance, our position is that it should be rolled out correctly. The criteria for doctors should be developed by specialists who provide the care. It should also be risk-adjusted to account for the differences between performing a hip replacement on a 60-year-old patient with diabetes and performing the same operation on someone who does not have this condition. Lastly, the criteria should be pilot tested to ensure that it applies in both rural and urban areas.”

And although it would be helpful to have X-ray vision to see through things on Capitol Hill, the PAC members must use only their intellect, networking skills, and patience to address yet another issue…imaging. “An orthopedic surgeon should have the ability to do imaging in his office,” says Dr. Weinstein. “The surgeon is the one doing the history and physical and deciding what is the most appropriate image to order. It is not practical for the patient to have to go elsewhere or be seen by someone who doesn’t do the physical exams and histories. Imaging is one of the highest costs in Medicare, so when the issue of doctor payments is addressed each year in Congress, imaging comes up. In the Senate last year there was the State Children’s Health Insurance Program (SCHIP). The House of Representatives had the Children’s Health and Medicare Protection Act (CHAMP), a program that addressed the issues in a broader context. Under the CHAMP Act the doctors’ payment formula was addressed and reasonable solutions were proposed, including those to address the imaging issue.”

Touting a recent success story, Dr. Weinstein notes, “Last year there was a proposal to cut reimbursement for total hip and knee replacements and hip fracture surgery. AAOS and the specialty societies swung into action and traveled to Washington with data showing the benefits of total hip and knee replacements. These are in fact some of the most cost-effective operations in the world. One study showed that a total hip replacement was even more cost-effective than renal transplant. If things had gone awry on Capitol Hill, it would have affected access to care for Medicare patients. Doctors are getting reimbursed less and less all the time; meanwhile the cost of doing business is on the rise. But we were successful this time. Because of the strength of the AAOS PAC and the data we provided to CMS, we were able to prevent cuts and restore reimbursement for those three surgeries.”

And in that “Power to the People” town, the strength of the PAC data is augmented by the strength of its people. Dr. Weinstein: “The superb AAOS staff in Washington works full time to monitor legislation, regulatory issues, and research concerns. We routinely work as partners to address issues that concern our field.”

Continues Dr. Weinstein, “We are also grateful for the support we get from our membership. We are acutely aware of the responsibility we have to represent their concerns. Ideally, all AAOS members would become members of the PAC. It is intellectually stimulating, affords one the opportunity to make a difference on a large scale, and provides the chance to form relationships with one’s representative or senator. Ultimately, I see this kind of involvement in the field as part of the responsibility of being an orthopedic surgeon.”

Even those who take that message to heart, however, might feel discouraged at the length of time it takes to settle certain issues…especially given that surgeons are accustomed to the relatively speedy resolution of problems. Dr. Weinstein provides another perspective. “If you have watched for years and seen no movement on an issue, realize that advocacy battles are like watching a movie as opposed to a snapshot. You have to be in it for the long haul as advocacy wins are long-term battles. We try to help our members have reasonable expectations by communicating clearly and thoroughly on each issue.”

So if you are concerned about the orthopedic issues of the day, enjoy networking, and like the interplay of forces in our nation’s capital, sign on to the AAOS Political Action Committee.