March 24, 2008

 

 
TOA President's Update
  

By John T. Gill, MD
President, Texas Orthopaedic Association

This message is for our friends of orthopaedics in the industry.
The Texas Orthopaedic Association invites you to schedule and budget for the 2008 Annual Meeting and Scientific Session.  The meeting will occur May 22 - 24, 2008 at The Westin Riverwalk in San Antonio, Texas. 

Our Annual Meeting and Scientific Session is the orthopaedic industry’s best resource for networking with Texas orthopaedic surgeons.  The conference regularly attracts 150-200 orthopaedists from across the state and features up-to-date information on trends in orthopaedics, hands-on workshops, resident awards, and social events.

 

Please click here for the description of our new Gold, Silver, and Bronze Sponsorship Levels as well as the Exhibit Application Form.  Please note that all opportunities are available on a first come, first serve basis.  Sign up early to achieve maximum visibility!

 

Please complete and mail the registration form with your sponsorship fee to TOA at 401 West 15th Street, Ste. 820, Austin, TX 78701.  We thank you for your continued support of the Texas Orthopaedic Association meetings.  If you have any questions, please contact the TOA administrative office at (512) 370-1505.

 

We look forward to seeing you in May in San Antonio!
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AAOS News - Heparin Issue Shines Light On Need For Overseas Inspections
 
  

According to the New York Times, concerns about the U.S. Food and Drug Administration’s (FDA’s) ability to inspect and monitor foreign drug manufacturing plants have arisen in the wake of 19 deaths that have been linked to contaminated heparin. FDA inspected 13 of 566 plants in

China that export pharmaceuticals to the United States. The U.S. Senate recently passed a budget resolution giving the agency an additional $375 million. However, President George W. Bush has threatened to veto appropriations that go beyond his requests, and one House leader states that additional money is unlikely to help, as the agency lacks the infrastructure to carry out its mission. Some in Congress are considering the implementation of a user-fee system to help pay for foreign inspections, but other experts argue that such a system may pressure investigators to become more lax with those who pay their salaries.  Read more by clicking here.
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Worth Repeating - Cross-border Purchasing And Re-Importing Of Synvisc

Originally appeared in the December 10th, 2007 TOA E-Connect, but we feel that patient safety could be at risk and this information needs to be repeated.

Dear Valued Customer,
I am writing to inform you of an emergency practice in our industry which gives us cause for concern.  Recently, there has been a

significant increase in the volume of Synvisc being re-imported into the US from foreign geographies.  While the cross-border distributors involved often claim to be purchasing Synvisc direct from Genzyme, in fact they are not.

We know that much of the Synvisc being sourced for this purpose is coming from the Middle East and Europe.  We have become aware of several instances where this product has been tampered with and re-packaged with photocopied US product information.  We have always been concerned about the quality of product that is purchased outside of our established distribution channels, since we cannot ensure that proper storage and shipping conditions have been maintained.  These concerns are substantially magnified in cases where the product has been opened or otherwise tampered with.

We appreciate your use of Synvisc and the confidence in our product that this use demonstrates.  There are established direct and wholesale channels for the purchase of FDA approved Synvisc that provide a safe and effective product.  We encourage you to use these established channels to ensure the safety and integrity of the product you are using.

Should you have any questions as follow-up to this communication, please don’t hesitate to contact your local Synvisc sales representative or call Synvisc customer service at 1-888-3-SYNVISC. 

Sincerely,

C. Ann Merrifield
President, Genzyme Biosurgery
www.genzyme.com

Tel 617-494-8484


Is the product being sold by the cross-border distributors U.S. labeled Synvisc?
No.  Genzyme only distributes Synvisc in the U.S. direct to physicians or medical practice customers or through our established wholesale vendors.  If Synvisc is being sold via the internet or by distributors that are not approved Genzyme wholesale partners it is not Synvisc that complies with U.S. labeling requirements.  To the extent that the product being sold by these cross-border distributors contains FDA approved product and patient labeling; it has been purchased outside of the U.S. tampered with and illegally repackaged.

Where is the product coming from?
Our evidence indicates that much of the product that has most recently been sold by these cross-border distributors has been sourced from the Middle East, Turkey, and Germany.

If the product is not U.S. labeled Synvisc how can it contain the FDA approved product and patient labeling?
We believe that many of the cross-border distributors are purchasing Synvisc in other parts of the world, re-packaging it and replacing the non-U.S. labeling with a photocopy of the FDA approved package insert.  This practice causes us (Genzyme) great concern because to ensure a safe and effective product, the product must not be tampered with.  This also poses a potential safety hazard to the patient, as there is no way for us to ensure that this product was handled appropriately.   

Why does Genzyme care if I buy Synvisc labeled for non-U.S. use?
Once our product has been sold to our approved vendors outside of the U.S. we lose control of our ability to track the product and assure that it has been handled properly to ensure safety.  We have no way of ensuring that any of the product that is being provided by these cross-border distributors has been handled using Genzyme’s approved distribution methods.  Therefore the product being offered by these cross-border distributors may be unsafe or ineffective.  These concerns are magnified due to recent situation were the packaging has been opened and tampered with. 

What is Genzyme doing to stop this dangerous activity?
Genzyme is currently working with its global distributors to stop this activity and ensure that Synvisc is only being distributed through approved distributors.
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Ruling Favors Orthopedists On Definition Of The Foot
 
  

By Corrie MacLaggan
AMERICAN-STATESMAN STAFF
Wednesday, March 19, 2008

When is the ankle part of the foot?

Never, according to the Texas Medical Association, which is celebrating

a state appeals court ruling that it interprets as saying the two body parts are distinct. Friday's ruling — which reverses a lower court's decision — says the state board that licenses podiatrists exceeded its authority when it created a definition of the foot that includes the ankle.

The ankle-foot debate has raged for years between medical doctors and podiatrists, who have both claimed the ankle as their bodily turf and fought over it in courtrooms. The debate has reached the point that the two sides can disagree about the existence of the ankle.

"You don't have an ankle," said Mark Hanna, a lawyer for the Texas Podiatric Medical Association, which is a party in the case with the board. "The foot actually includes the ankle. If you took the foot off the leg, there is nothing lying there that's the ankle."

That makes no sense, said Dr. David Teuscher, an orthopedic surgeon in Beaumont who said treating the ankle is complicated enough to require medical school training.

"If they say the ankle doesn't exist, why do they want to operate on it?" asked Teuscher, immediate past president of the Texas Orthopaedic Association. "Everyone knows what an ankle is."

The Texas State Board of Podiatric Medical Examiners bypassed the Legislature to create its ankle-is-part-of-the-foot definition in 2001. Podiatrists say they've been treating ankles for decades and accuse doctors of trying to limit competition. The medical association says podiatrists should stick to corns, calluses and diabetic foot care.

The podiatrists plan to appeal the court's decision — which they don't interpret as saying the ankle and the foot are different, Hanna said

At stake is the job description of the state's 900 podiatrists.

"If people wish to practice medicine, they should attend and complete medical school," said the Texas Medical Association's president, Dr. William Hinchey. The ruling "protects Texas patients."

Orthopedists like Teuscher must complete four years of medical school, plus a one-year internship and a four-year residency. Podiatrists must complete four years of podiatry school and an internship of at least one year, though some have more extensive training.

Thomas Zgonis, a San Antonio podiatrist, completed four years of training after podiatry school and specializes in reconstructive foot and ankle surgery.

"I have saved all these diabetic patients' feet" from being amputated, he said. "All of a sudden you wake up one day and you question this?" He said that if he were told he couldn't practice on the ankle, "I would have to quit my practice. It would be a disaster. These people are crazy."

The debate is a traditional medical turf battle, said state Sen. Bob Deuell, R-Greenville, a physician and the vice chairman of the Senate Committee on Health and Human Services. "There are battles between ophthalmologists and optometrists, and there are battles between orthopedists and podiatrists."

In this battle, Deuell sides with the orthopedists.

"There are some (podiatrists) out there who are very good above the foot," he said, "but they've never convinced me that it was possible to have the entire profession be taught to do that."

The podiatry board decided to define the foot in 2001 because the state law that defines podiatry does not define what a foot is. The board said that caused confusion among podiatrists, insurance companies and hospitals. The board's definition included the tibia (shin bone) and fibula (calf bone) "in their articulation with the talus and all bones to the toes."

But then-Texas Attorney General John Cornyn rejected that, writing in a formal opinion that it "unreasonably extends the practice of podiatry to include treatment of the tibia and fibula, parts of the body that are not located in the foot."

But District Judge Darlene Byrne in Travis County disagreed, siding with the podiatrists. Last week's ruling by the Texas 3rd Court of Appeals overturned that.

cmaclaggan@statesman.com; (512) 445-3548

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2008 Update on Workers’ Compensation Networks and Fee Guidelines - A Personal Perspective
  

(A personal perspective)
By Stephen Norwood, MD

Over the past several years, orthopaedic surgeons, as well as most practicing physicians in Texas have been put through the meat grinder when it comes to treating injured workers. It would be fair to say that many have just given up on the whole business. I dropped out for

several years but have been treating comp patients again over the past two years after the legislature agreed to re-configure the Division of Worker’s Compensation, to fall under the management of the Texas Department of Insurance. This legislation included the certification of new Worker’s Compensation Networks, as an employer-selected alternative to the typical non-network system.

Although it has been some time since I served as TOA Work Comp committee chair, I have continued to work behind the scenes participating with the TMA ad hoc Work Comp committee and several workgroups for TDI and DWC. I testified for TMA and TOA on several successful Comp clean-up bills in the last session, the most notable having to do with Texas-licensed, appropriate-specialty peer review. After much prodding from others, I even helped form a physician-sponsored Work Comp Network.

One of the great fears that most physicians had about Networks entering the picture was that they would discount from the already poor fee schedule. In fact, that is exactly what some of them initially tried to do. The worst example was a pre-certification notice that a major group-health carrier was planning to pay 85% Medicare for these services. Fortunately, that never panned out because essentially no providers signed up, but it had a chilling effect, nonetheless. Limited numbers of doctors signed contracts with new networks that discounted between 5-20% off the 125% Medicare rate. When TDI reviewed some of these discounted networks, they discovered that there were often missing gaps in the specialty provider panels, or what TMA would call “Inadequate Networks”.

There are now 32 TDI-Certified Worker’s Compensation Networks, not to be confused with “voluntary networks” which will be phased out. In other “network” states like California and Oregon, it has taken five to six years for these markets and products to stabilize. It is believed that up to 70% of Texas Comp care will eventually occur in a network setting, so there is a transition going on. Although the Texas Association of Business was the catalyst demanding networks in the first place, most businesses have taken a wait-and-see approach to these products, and discounts from standard insurance premium rates have been small so far. Even so, the big boys like Texas Mutual have converted over 20% of their customers and are beginning to develop a track record and understand the cost-savings involved.

To be frank, my whole interest in this business was to get the payments to physicians increased, and the certification of the Physicians Cooperative of Texas (PCT) went a long way in pushing that concept. Even though we were initially only TDI-Certified for Austin/San Antonio and Dallas, the contracts paid well above the fee schedule, and the physician panels were robust with the necessary specialists. The major competitors learned quickly that physicians would no longer sign any contract thrown across their desks, and most gradually increased their rates to the fee schedule level and above. Meanwhile, we have been fighting forever for relief from the misguided 125% Medicare physician fee schedule, and finally have achieved some success. The brand-new DWC fee schedule will pay approximately 139% for E&M and 174% for Surgeries beginning March 2008.

This will lead to at least some resurgence of interest in physician participation. Most doctors decide either to take Work Comp or not. Once a provider commits to treat injured workers again, they will want to consider signing perhaps two or three of the Network contracts, depending on participation of local businesses. Obviously, a combination of decent payment and the expectation of a reasonable number of referrals are important in contracting.

My network, Physicians Cooperative of Texas, was acquired in November 2007 by Omni Health Systems, who operate two of the largest Comp networks in Oregon and Montana. They have an excellent track record of paying physicians well, and share essentially all of the core values of our physician sponsored network. They will operate as Majoris Health Systems in Texas. I will continue to serve as Medical Director and look forward to their experience in network growth and employer contracting.

The intent of House Bill 7 three years ago was to make Worker’s Compensation look a lot more like Group-Health plans. Only time will tell if that can be achieved, but there are signs of hope with physician payment increases and competition in the network market. With the addition of electronic claims handling (finally), even improvement on the “Hassle Factor” side of Comp might improve. As always, the glass is half full.

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