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Future of ESWT in North America

Posted by Sunny Jacob - Bayshore on 7/28/02 at 09:14 (090789)

Following is my prediction for ESWT for the next 5 years in USA:
More manufacturers will attempt to get FDA approval in USA, one of the biggest markets in the world.
The use of electromagnetic and piezoelectric shock wave generators will become more popular and electrohydraulic generators will be used only for special applications
FDA submissions and approval will change to all tendinopathies, not location specific.
More orthopedic surgeons will use EWT in their clinics as an alternative procedure prior to attempt surgery.
ESWT will be considered by many as a first line of treatment after a short conventional treatment period.
USA will become the market for ESWT equipment and competition will increase.
Some misuse will be inevitable.
More patients will demand low intensity multiple session ESWT without anesthesia.
Some providers will persuade patients to receive single session using local anesthesia (substantial saving in provider time and equipment use).
Treatment fees will be lowered, but not below $1,000 per patient.
If a clinic operator tries to compete with a fee below $1,000, they may face business failure.
Instead of selling the equipment, some manufacturers will place the equipment with the providers on a fee splitting base (already being done in U.S.A.).
Other manufacturers will try to maintain the current price range, ors slightly lower.
More insurance companies will cover the cost of ESWT treatment.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 09:20 (090790)

Good posting . You forgot the most important thing. All North American monies will be the same currency. Hey why not, done in Europe . No reason why we can't do it in North America. I am serious.

It is also my understanding, cause I am paying this that the fee per patient, is a software use fee not a fee split fee. Fee splitting in the USA is illegal. I understand the fee surcharge but I hate it.

Re: Future of ESWT in North America

john h on 7/28/02 at 10:11 (090793)

Sunny: It is and has been a very common practice In the U.S. for sometime for hospitals to lease MRI and other such high price equipment on a per use basis with a middleman who buys the equipment direct from the manufacturer. This obviously drives the price up. I know of a group of Doctors and the middleman who assembled them to form a company to do such leasing on a per use basis. They are all millionaires over an over. They not only lease medical equipment to the hospitals but lease such items as T.V.'s that go in each room. Being Doctors they probably have influence on the hospitals in the leasing and use of such equipment which seems unethical to me. It is sort of like Ophmologist prescribing you glasses and then selling them to you which has now been prohibited. Nephrologist still own dialysis clinics which seems to be unethical in my mind because who are they going to send their patients to who need dialysis.

Re: Future of ESWT in North America

David L - Sonorex on 7/28/02 at 13:13 (090806)

Sunny,
You have advanced some very well thought out predictions and in my opinion that is exactly how the market will develop. I think that this is something that insurance companies will want to cover if the price is attractive to them. They know exactly what the average cost is to treat a patient with, for example,plantar fasciitis or tennis elbow and if ESWT can reduce that cost by reducing multiple visits to physicians, MRI costs, physical therapy costs, and it is widely available and demanded by patients, they will cover it.
ESWT is about to get a lot of coverage across the US and I predict that it will only take one major league baseball player who had ESWT to be able to stay on the mound this fall during the World Series and patients will be scrambling to get it.
Apparantly there are 17 million NEW cases of tendinitis diagnosed in the US each year. Your predictions are bang-on.
David Lowy
Sonorex

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 13:40 (090808)

Do we have any studies where it shows that early ESWT treatments are benefical and more cost effective then orthosis, casting, physical therapy, etc Right now the way it is being used as an alternative to foot surgery I don't see the real big cost savings. The real big dollars have usually be sent by the time six months of treatment has passed. We need to prove that ESWT can be a first line of treatment and not as a treatment way down the road .

Re: Future of ESWT in North America

Pauline on 7/28/02 at 15:38 (090816)

My question is: Once the cost of the machine is recovered why should the cost of treatment be so high? ESWT machines are no where as complicated to up keep as an MRI machine and the in office models are within the price range of a private practice let alone a large group.

It would seem to me the cost of operation would be based on the price the doctor is setting for treatment plus the cost he wants to add for his service very similar to an x-ray machine. I'm speaking now of only in office machines not the Ossaton which requires surgical center costs and anesthesia etc,

I don't see the magic here for the continued high costs of in office ESWT treatments unless doctors are wanting to artifically keep the these costs up until insurance coverage arrives.

If a physician purchased the machine and it's paid for, it would seem he could lower his cost dramatically taking into account up keep of course.

However, it's to his advantage to keep the cost up because if and when insurance companies begin to cover ESWT they will pay what the going rate is. If every doctor's office has set their fee at $1500 per foot that's what the insurance companies will pay or agree to pay a portion of. If on the other hand all the physicians dropped their fee to $500 per foot the insurance companies coming on board would cover the lower fee or a portion of it as well.

So in my mind it's to the doctors advantage to keep the costs of ESWT high. Insurance coverage will eventually come and why not get paid higher fees than lower ones.

Put the cost of purchasing these Office ESWT machines in prospective. Many people including doctors own homes costing more than these machines and there is much more up keep to a house.

Re: Future of ESWT in North America

rob. a on 7/28/02 at 15:41 (090817)

I will add this as a possiblity to the future of ESWT. Since roughly 40% of americans have to go to a primary care physician before they can go to a specialist( and that number is growing ), I think that the primary doctors will get involved with office based ESWT as well as pain management doctors who also will do office based treatments.I also think that the next generation of ESWT devices will be table top devices and will cost much less which will bring the cost well under $1,000 a treatment. I think these devices will show up under a different classifacation then the new ones and will only require a 510K submission and will enter the market withen 2-3 years. If ESWT is done office base like other pain management treatments then we are looking roughly at $400-$500 a treatment.

Re: Future of ESWT in North America

Pauline on 7/28/02 at 18:56 (090837)

Personally, I don't think primary doctors will have the time to get involved in ESWT. Pain management centers maybe, but I see this as a major money maker for Pods and Orthos with little malpractice attached to it. They will probably do their best to keep it out of physical therapy centers prefering to do the treatment themselves.

It's the next best thing to sliced bread. My pun 'Fast Rising Bread' Orthos may have a slight advantage because they are not restricted in the areas they can treat. More areas, more income. After marking the foot, I think many physicians will turn the treatment over to a trained tech.

If you had a non-invasive treatment that you thought might help a patient
with little risk, why wouldn't you suggest it especially if their insurance coverage ends up pick up the tab.

I do not think ESWT cost will ever drop in the U.S. unless we go to a Socialized Medicine Plan. It's to every doctors advantage to keep the cost up right now until insurance companies start picking up these bills.
You wait until you see what they are willing to pay before you start lowering any prices.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 19:03 (090839)

This is alot in the upkeep of ESWT machines. There are parts that need repalacing at great expense. Just the extended warranty is in the six figure range. Just the ultrasound probe is thousands of dollars.

I have invested over five hundred thousand dollars in my dornier epos. This technology is expense and costly to bring to the public.

The Dornier Epos is the top of its class. IT is always going to be the same story. You get what you pay for and the dornier is just in another league. It can do high, low , medium energy . There is no other machine in the world that can deliver all of these ranges.

Re: Future of ESWT in North America

Pauline on 7/28/02 at 19:19 (090843)

Dr.Z,
But don't you have 35 doctors in your group to share the cost?

Re: Future of ESWT in North America

rob. a on 7/28/02 at 19:27 (090845)

Pauline. I would agree with you if it were the doctors who set the reimburserment rate; but, since it is the insurance companies that do set it, I think you will find out that they will spend the least amount possible. If ESWT devices get reclassified like I think they will, then techs will do the treatment in doctor's offices and that is why the rates will drop. The insurance companies will look at ESWT as pain management and set rate accordingly. If you want to know what pain management services are reimburst at, ask your doctor. I think you will find it surprising low comparedf to what ESWT is getting currently.

Re: Future of ESWT in North America

rob. a on 7/28/02 at 19:41 (090846)

Another reason why I think ESWT cost will drop. Sonorex claims on its' web site that the Sonocur is an office base treatment. So already, different companies are starting to offer treatments away from the surgery centers. When insurance companies decide what the payouts should be, one of the key factors is 'fair market value'. If office base treatments becomes popular then the rates will be lower then they are now and fair market value will drop by the time a permanent CPT code is assigned. Another point I would argue is who said that any one group of physicains will have enough control to keep the cost of ESWT at thier current levels? I think you will see as more providers use the devices and the cost of the devices comes down, the market will get more competitive. It is economics 101. The more indications that ESWT will be used for, the more different kinds of medical specialist will choose to use it.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 19:57 (090849)

ESWT is a class three FDA treatment for plantar fasciitis. This will take years for the classification to change. Could be five could be ten years.
A physician will have to always do the treatment so long as it is a class three FDA treatment

Re: Future of ESWT in North America

Pauline on 7/28/02 at 20:08 (090851)

Rob,
Right now insurance companies are not setting the rate. Their not picking up the tab. Insurance companies set the rate that they are responsible for paying not what doctors are charging.

When a doctor goes to get the loan to cover the cost of his new equipment he usually provides the lender with a plan of how he plans to recover the investment. The lender may offer suggestions if they feel the rate of return isn't great enough, but the doctors are setting their own rates.

You have to take into account the operation that's being set up. Is the doctor making this a strictly 'In Office' purchase or as in Dr. Z's case a mobile unit which adds considerable expense in the Winabago itself.

It's the doctors choice if he wants to include it in his own office or go big time on wheels. Think of the competition between sites. Who's collecting the most revenue the large Rite-aid's chains or your local corner drug store.

Re: Future of ESWT in North America

Pauline on 7/28/02 at 20:18 (090852)

Dr. Z,
You wouldn't make the investment if you didn't think you could bring home the bacon. You know you have a sound investment with ESWT. I think you expect a pretty good return on this venture.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 20:44 (090860)

Right now the insurance companies are paying out more for ASC ESWT treatments. In most cases they are unwilling to see which model is better, and most cost effective.

The future of ESWT is very un certain and this is why the cost is so high.

So long as the future is uncertain the cost will be high. Its the same with loans. When the investment is safe the interest rate is low. When the investment is risky the interest will be high. Right now the cost to bring ESWT to market is very high so the cost will be high. The insurance companies will have no say.

If the insurancies drop the cost the ESWT providers will drop the insurance companies.

There is no way that the in-office model works. I have seen it and it doesn't make sense. I don't see the FDA classification for Plantar fascia changing in the near future. All companies will have to do the same FDA
trials for a class three device. This takes millions and there is no way the companies are going to give the product away.

So we can guess and guess but only time will tell. I do know one thing that since this is a plantar fascia heel pain board you won't see ESWT for pf done by any other machine except a FDA class three device and right now there are only two on the market ossatron and dornier.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 20:54 (090861)

No one can ever predict the future. I do think that ESWT is an excellent treatment for plantar fasciitis and should be the treatment of choice . There have been many effective treatments and products that never made alot of money. There is alot of risk with ESWT. There are many factors that can effect the 'bacon' . There are many federal, state regulations that can effect the 'bacon'

I truely believe that ESWT should be outpatient and not ASC. The problem is will insurance companies think this. If they don't they will drive up the cost. I just hope that I don't have to shift to an ASC model with all its costs. Yes the future with ESWT is very risky.

I watched the FDA approved one machine and then take back the approval. Who knows if one day the FDA decides that ESWT must be only in an ASC or inpatient hosptial. There are alot of political powers that really control ESWT. Anyway you must believe in the techology before you can believe in the investment. I truely believe is the technology. The investment part only time will time.

Re: Future of ESWT in North America

Pauline on 7/28/02 at 22:07 (090864)

Dr Z,
I remember reading on the FDA site that if one medical device gets approved by the FDA say for P.F. as a class three device all others seeking approval for that specific treatment must apply and go through the exact same trials. The first one sets the standard for the others that follow.

They have it printed somewhere.

Re: To John

Pauline on 7/28/02 at 22:19 (090865)

Isn't also against the law for doctors to send patients to centers for treatment or testing where they hold a financial interest?

Re: Future of ESWT in North America

Pauline on 7/28/02 at 22:25 (090866)

Dr. Z,
I think you watched the FDA approve a machine that was mis-labeled get approval which was then marketed by the manufacturer for a purpose other than which it was approved. The FDA was duped and had no choice but to pull the plug on this device.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 22:45 (090867)

What I do know that is I am still going thru the red tape to get a hold of the original application that you are referring too. The Freedom of information act is not helping in this situation

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 22:51 (090869)

I still would like to know why the FDA never did a recall for that machine . That would of been the correct action to take. They allowed a company to mis-label a machine and then went after the end users. They now are allowing the same company under a new name to apply for another application. No action was ever taken against the original manufactor. So I guess crime does pay. The FDA stated that fraud was committed and allowed the original manufactor to move on .

Re: Future of ESWT in North America

David L - Sonorex on 7/29/02 at 01:45 (090877)

I agree with you about proving that this should be an earlier intervention....ie after 3 months. When someone firsts presents themselves to you with their 'heel pain' and you diagnose them with the early stages of pf, I assume that you usually prescribe rest, ice, anti-inflammatories etc. Then, after 3 months, if this doesn't help, then you move to the next level. My prediction will be that the 'next level' will be ESWT as it will be very attractive, price and outcome-wise to the insurance companies.

Re: Future of ESWT in North America

Pauline on 7/29/02 at 07:21 (090883)

Dr. Z, I think you know why and the route they took was probably the cheapest. They prevented Norland from importing and marketing the Big 'O' in this country.

They didn't allow Norland to mis-label a machine it was mis-labeled when it applied for its application. I think the idea was to get the product to market as quickly as possible following the interest it generated at the Pods convention.

Norland had made applications to the FDA prior to this one and they realized the length of time, testing and money involved between approval for a class I or a Class III device.

They tried to dupe the FDA by mis-labeling, applying for quick pre- approval as a Therapeudic Vibrator then went out and market it as an ESWT machine.

The Pods that purchased the machine were happy. They had purchased a
a relatively inexpensive medical device that was approved as a Therapeudic Viborator, but using it as an ESWT machine.

Healthronics blew the whistle because they were already in the hopper with the Ossatron.

Outside of now owning what you describe as a better machine, as an owner of the big 'O' I think your in the best position to tell us what happened on your end and why you and maybe the others that owned it stopped using it.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/29/02 at 10:30 (090895)

The dornier Epos is a better machine. In fact it is the best machine out there. The ossatron is such a small player in the ESWT worldwide market they cover less then 1% of world wide ESWT market. When I purchased the O. The FDA confirmed its approval in writing and via the phone. The FDA needs to recall this machine if in fact it was mis-labeled as they have stated many times. but if it isn't then they should allow the machine back on the market. Someone needs to step to the plate from the FDA. Either it is or it isn't . If it is then a recall is in order

Re: Future of ESWT in North America

Ed Davis, DPM on 7/29/02 at 11:53 (090900)

Sunny:

All of your predictions sound like they are on the mark.

Ed

Re: Future of ESWT in North America

Pauline on 7/29/02 at 12:09 (090901)

Dr. Z,
As long as there is no recall can't you still use the machine?

Re: Stark laws

Ed Davis, DPM on 7/29/02 at 12:47 (090905)

Pauline:

That refers to the Stark Laws. It is enforceable only for government insured, ie. Medicare.
Ed

Re: Future of ESWT in North America

john h on 7/29/02 at 13:36 (090909)

Sunny: I hope your predictions are on track. From an economic view the price should come down with more equipment, more providers, and more people aware of the product. That is sort of the way things work in the free market system. The wild card here is the FDA!

Re: Future of ESWT in North America

Dr. Zuckerman on 7/29/02 at 15:23 (090916)

No,

They have given me the option to run my own FDA trials at my expense of a few million dollars.

Re: Future of ESWT in North America

Pauline on 7/29/02 at 17:03 (090921)

So I guess they sort of pulled the plug. Maybe Norland will refund your money or prorate on a used machine. You can't be to sad because at least you had almost 3 years of use.

Re: Future of ESWT in North America

Pauline on 7/29/02 at 17:06 (090922)

Well at least you have the letter of approval you spoke about. Should have taped those phone calls Dr. Z.

Re: Future of ESWT in North America

john h on 7/29/02 at 17:31 (090925)

Dr Z: Even with all the upkeep I bet is still chaeaper than a wife. Ok girls give me your best shot!

Re: To John

john h on 7/29/02 at 17:37 (090927)

Pauline: I have not read the law on this but am very familar with a Doctor who owns a large financial interest in several Dialysis Centers. He is a Nephrologist and is the guy who puts you on dialysis. I know him and am very familiar with the dialysis center operations having vistied them on occasion. I have posed this question to one of the investors in this operation and apparently Dialysis Centers are not a prohibitive operation for a Doctor involed in the treatment of the patients.

Re: wives and women (off topic)

Carole C in NOLA on 7/29/02 at 18:07 (090932)

John, John, John. We keep telling you that wives are such a bargain compared with girlfriends, and yet you still don't get it.

A girlfriend gets taken out to dinner (maybe $60 for both of you). A wife slaves over a hot stove and serves you a great home-cooked meal for peanuts.

A girlfriend gets taken to the show, and of course you have to buy popcorn and a soda for her in order to not seem cheap (maybe $30 for two including the gas to get there). A wife gets to watch the TV channel you selected IF she has time after doing the dinner dishes.

A girlfriend gets a dozen beautiful red roses, with a romantic poem on the card (I guess that would be about $25?). A wife gets a 39 cent trowel and spends all day Saturday on her knees in the dirt cultivating the flower bed.

See? I knew you'd get the picture. :)

That brilliant engineer that I used to date but who moved away to Connecticut, came back to New Orleans for a visit last night. He gave me three DVD's, a video tape, and two books, and all of them were carefully selected because they were ones that I would love. What with dinner and all, I figure I cost him close to $100 for the night, but believe me he didn't get what a husband can expect from a wife. LOL

Carole C

Re: Future of ESWT in North America

Dr. Zuckerman on 7/29/02 at 18:14 (090933)

They don't denial the calls took place. They admit that they did.

Re: To John

rob. a on 7/29/02 at 19:17 (090937)

Generally speaking, Stark is geared towards diagnostic equipment ownership. If it envolves some kind of corrective treatment then Stark provides some safe havens for physician ownership in the equipment they will use to correct that problem.

Re: Future of ESWT in North America

rob. a on 7/29/02 at 19:35 (090938)

I don't think the wild card is the FDA. Other OEMs are making devices that will compete with the current ESWT devices for general pain treatments. The current ESWT device manufacturers are not the ones that will change the market. When others enter the market with table top class II labeled devices, then you will see a change. You have to look beyond the current players and search some of the European companies that make table top devices. They will form alliances with distributers in the U.S. and push these boxes into the market. Since they don't have larger class III devices, they have nothing to loose by doing this. I know this will upset many people, but when HCFA decides what they want to pay out, they really won't care if the amount is so low it will discourage physicians from using ESWT. Many insurance comapnies will be in line with Medicare payouts. If you think they care about the physicians getting their investment back then you don't understand how they operate.

Re: wives and women (off topic)

wendyn on 7/29/02 at 20:56 (090941)

Carole - you're pretty funny!

I'm sure John will argue that it's not necessarily something you can EXPECT from your wife.

Re: wives and women (off topic)

Carole C in NOLA on 7/29/02 at 21:13 (090946)

(grin) I'm sure a good looking guy like John can! :)

But then, come to think of it, Frank is a pretty good looking guy too, and look what it got him when he took this girlfriend of his to dinner... nothing much except a lighter wallet. :)

We had a great time, though, all kidding aside. Things don't have to get physical to have fun.

Carole C

Re: Future of ESWT in North America

Sunny Jacob - Bayshore on 7/29/02 at 21:16 (090947)

Dr. Z.:
Regarding your point of ESWT as a first line of treatment for tendinopathies:
One has to go back about 7 years when ESWT was introduced in Germany.
During that time the early researchers and users of ESWT were orthopedic surgeons. However, the major opposition to ESWT treatment at that time in Germany, Austria and Switzerland, came from other orthopedic surgeons and physicians who earned part of their income from conventional treatment of tendinopathies.
Therefore it was cleverly stated by the manufacturers (who needed the orthopods on their side) to use 'six months chronic' as their critierion for treatment with ESWT.
Apart from that, and due to the high cost of ESWT, the physicians wanted the patients with early stage of tendinopathy to undergo the conventional cheaper treatments, i.e. rest, pain killers, physiotherapy, cortisone, etc., which of course, was a reasonable advice, especially since approx. 97% of early tendonitis can be successfully treated with conventional methods.
I do not know of any peer-reviewed clinical studies with statistically significant results that state 6 months chronic tendinopathies will achieve better results than patients with less than 6 months chronic tendinopathy.
With some embarrassment I have to admit that Bayshore in the past also generally accepted mostly only 6 months chronic patients when referred by physicians and specialists. Here in Canada we call it health care politics.
Do we treat acute patients with ESWT? Yes.
One group of patients we treat are athletes from major North American teams. Many of them are acute cases and are treated with the same success as chronic patients.
As I have stated in my previous message, I am sure that in the future ESWT will be accepted as a first line of treatment.

North-American common currency:
A very recent survey revealed that only 23% of Canadians and 14% of U.S. citizens were in favour of a common currency.

Other:
Fee splitting or surcharge, whatever it may be called to make it legal, the ultimate result is the same.

Re: Future of ESWT in North America

Sunny Jacob - Bayshore on 7/29/02 at 21:20 (090951)

Cost recovery of medical equipment
Pauline,
It usually takes 5 years to depreciate an equipment (based on generally accepted accounting principles). From our experience, most of the medical equipments are obsolete by that time, example kidney dialysis machines, MRI, ESWT machines, etc.
Moreover, advances in medical technology usually outpace the 5-year period. There is also pressure from patients who want to be treated in a clinic with the latest machines/technology.
You mentioned MRI. Actually the magnet, a major component of an MRI equipment, will last forever. But the expensive servicing, preventive maintenance and parts for most medical equipment make it uneconomical to retain equipment for a long period of time as repair costs increase substantially. Therefore it is also usually a business decision to replace equipment every 5 to 7 years. Reducing the service after recovering equipment cost in this way will therefore not work. Moreover, insurance companies do understand very well the costs related to the various medical procedures.

Re: Future of ESWT in North America

john h on 7/30/02 at 09:04 (090976)

Sunny: I am supprised that the high tech equipment you talk about can last for 5-7 years. Computers go obsolete about every 3 years. There is some equipment that seem to have gone on and on such as the 50 year old B-52 Bomber. It is still the most potent long range bomber in the world. Of course, the upgrades to this old aircraft have exceeded it's original cost by 400-500 percent. Everyone is now wanting the new GE MRI equipment that does not require you to be intombed in close quarters. The hospitals that have them heavily advertise them in our local papers.

Re: To Carole wives and women (off topic)

Pauline on 7/30/02 at 11:16 (090990)

Really cute post. We've got to teach women to continue the same approach after marriage. Rule # 1. Never let the gifts slide and always expect more. Yea!

Re: To Carole wives and women (off topic)

Carole C in NOLA on 7/30/02 at 11:45 (090997)

You are right! There are so many changes that would need to be made. Rule #2, everyone is responsible for their own laundry! Rule #3, if the guy doesn't open doors for you and pull out your chair at dinner, he's toast. There are about a million more rules, too.

Now that I'm single again, I get the roses but not the dirty laundry. I get taken to fine restaurants and don't have to pack the guy's lunches at 5 AM. I can offer emotional commitment without a lot of strings attached, and expect the same.

Carole C

Re: To Carole wives and women (off topic)

Tammie on 7/30/02 at 12:06 (090999)

That is so true ! I found a laugh today thank u!

Re: To Carole wives and women (off topic)

john h on 7/31/02 at 09:51 (091128)

Hey Carole I have always done my own laundry. Want a well trained husband then marry a military guy. he will do the yard, vacume, do the laundry, make the beds, mop, take out the garbage, empty the kitty litter box and put up the dishes and then go to work/

Re: To Carole wives and women (off topic)

Carole C in NOLA on 7/31/02 at 18:55 (091199)

In your dreams! My ex was career Navy. He was a heck of a mopper, but he didn't do any of those other things at all!

But wait! You are talking about marriage. But now I'm opting for the fine dining, show, and dozen red roses, not for the slaving away over a hot stove, watching the end of a TV show, and growing my own flowers. LOL

Carole

Re: To Carole wives and women (off topic)

john h on 7/31/02 at 19:06 (091203)

Carole: the Navy guys march to their own drum. I do all those things and always have. not because my wife want do them but because i am a bit hyper. i climb mountains because they are there.

Re: To Carole wives and women (off topic)

Carole C in NOLA on 7/31/02 at 19:08 (091205)

John, Mary is a lucky woman. :)

Carole C

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 09:20 (090790)

Good posting . You forgot the most important thing. All North American monies will be the same currency. Hey why not, done in Europe . No reason why we can't do it in North America. I am serious.

It is also my understanding, cause I am paying this that the fee per patient, is a software use fee not a fee split fee. Fee splitting in the USA is illegal. I understand the fee surcharge but I hate it.

Re: Future of ESWT in North America

john h on 7/28/02 at 10:11 (090793)

Sunny: It is and has been a very common practice In the U.S. for sometime for hospitals to lease MRI and other such high price equipment on a per use basis with a middleman who buys the equipment direct from the manufacturer. This obviously drives the price up. I know of a group of Doctors and the middleman who assembled them to form a company to do such leasing on a per use basis. They are all millionaires over an over. They not only lease medical equipment to the hospitals but lease such items as T.V.'s that go in each room. Being Doctors they probably have influence on the hospitals in the leasing and use of such equipment which seems unethical to me. It is sort of like Ophmologist prescribing you glasses and then selling them to you which has now been prohibited. Nephrologist still own dialysis clinics which seems to be unethical in my mind because who are they going to send their patients to who need dialysis.

Re: Future of ESWT in North America

David L - Sonorex on 7/28/02 at 13:13 (090806)

Sunny,
You have advanced some very well thought out predictions and in my opinion that is exactly how the market will develop. I think that this is something that insurance companies will want to cover if the price is attractive to them. They know exactly what the average cost is to treat a patient with, for example,plantar fasciitis or tennis elbow and if ESWT can reduce that cost by reducing multiple visits to physicians, MRI costs, physical therapy costs, and it is widely available and demanded by patients, they will cover it.
ESWT is about to get a lot of coverage across the US and I predict that it will only take one major league baseball player who had ESWT to be able to stay on the mound this fall during the World Series and patients will be scrambling to get it.
Apparantly there are 17 million NEW cases of tendinitis diagnosed in the US each year. Your predictions are bang-on.
David Lowy
Sonorex

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 13:40 (090808)

Do we have any studies where it shows that early ESWT treatments are benefical and more cost effective then orthosis, casting, physical therapy, etc Right now the way it is being used as an alternative to foot surgery I don't see the real big cost savings. The real big dollars have usually be sent by the time six months of treatment has passed. We need to prove that ESWT can be a first line of treatment and not as a treatment way down the road .

Re: Future of ESWT in North America

Pauline on 7/28/02 at 15:38 (090816)

My question is: Once the cost of the machine is recovered why should the cost of treatment be so high? ESWT machines are no where as complicated to up keep as an MRI machine and the in office models are within the price range of a private practice let alone a large group.

It would seem to me the cost of operation would be based on the price the doctor is setting for treatment plus the cost he wants to add for his service very similar to an x-ray machine. I'm speaking now of only in office machines not the Ossaton which requires surgical center costs and anesthesia etc,

I don't see the magic here for the continued high costs of in office ESWT treatments unless doctors are wanting to artifically keep the these costs up until insurance coverage arrives.

If a physician purchased the machine and it's paid for, it would seem he could lower his cost dramatically taking into account up keep of course.

However, it's to his advantage to keep the cost up because if and when insurance companies begin to cover ESWT they will pay what the going rate is. If every doctor's office has set their fee at $1500 per foot that's what the insurance companies will pay or agree to pay a portion of. If on the other hand all the physicians dropped their fee to $500 per foot the insurance companies coming on board would cover the lower fee or a portion of it as well.

So in my mind it's to the doctors advantage to keep the costs of ESWT high. Insurance coverage will eventually come and why not get paid higher fees than lower ones.

Put the cost of purchasing these Office ESWT machines in prospective. Many people including doctors own homes costing more than these machines and there is much more up keep to a house.

Re: Future of ESWT in North America

rob. a on 7/28/02 at 15:41 (090817)

I will add this as a possiblity to the future of ESWT. Since roughly 40% of americans have to go to a primary care physician before they can go to a specialist( and that number is growing ), I think that the primary doctors will get involved with office based ESWT as well as pain management doctors who also will do office based treatments.I also think that the next generation of ESWT devices will be table top devices and will cost much less which will bring the cost well under $1,000 a treatment. I think these devices will show up under a different classifacation then the new ones and will only require a 510K submission and will enter the market withen 2-3 years. If ESWT is done office base like other pain management treatments then we are looking roughly at $400-$500 a treatment.

Re: Future of ESWT in North America

Pauline on 7/28/02 at 18:56 (090837)

Personally, I don't think primary doctors will have the time to get involved in ESWT. Pain management centers maybe, but I see this as a major money maker for Pods and Orthos with little malpractice attached to it. They will probably do their best to keep it out of physical therapy centers prefering to do the treatment themselves.

It's the next best thing to sliced bread. My pun 'Fast Rising Bread' Orthos may have a slight advantage because they are not restricted in the areas they can treat. More areas, more income. After marking the foot, I think many physicians will turn the treatment over to a trained tech.

If you had a non-invasive treatment that you thought might help a patient
with little risk, why wouldn't you suggest it especially if their insurance coverage ends up pick up the tab.

I do not think ESWT cost will ever drop in the U.S. unless we go to a Socialized Medicine Plan. It's to every doctors advantage to keep the cost up right now until insurance companies start picking up these bills.
You wait until you see what they are willing to pay before you start lowering any prices.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 19:03 (090839)

This is alot in the upkeep of ESWT machines. There are parts that need repalacing at great expense. Just the extended warranty is in the six figure range. Just the ultrasound probe is thousands of dollars.

I have invested over five hundred thousand dollars in my dornier epos. This technology is expense and costly to bring to the public.

The Dornier Epos is the top of its class. IT is always going to be the same story. You get what you pay for and the dornier is just in another league. It can do high, low , medium energy . There is no other machine in the world that can deliver all of these ranges.

Re: Future of ESWT in North America

Pauline on 7/28/02 at 19:19 (090843)

Dr.Z,
But don't you have 35 doctors in your group to share the cost?

Re: Future of ESWT in North America

rob. a on 7/28/02 at 19:27 (090845)

Pauline. I would agree with you if it were the doctors who set the reimburserment rate; but, since it is the insurance companies that do set it, I think you will find out that they will spend the least amount possible. If ESWT devices get reclassified like I think they will, then techs will do the treatment in doctor's offices and that is why the rates will drop. The insurance companies will look at ESWT as pain management and set rate accordingly. If you want to know what pain management services are reimburst at, ask your doctor. I think you will find it surprising low comparedf to what ESWT is getting currently.

Re: Future of ESWT in North America

rob. a on 7/28/02 at 19:41 (090846)

Another reason why I think ESWT cost will drop. Sonorex claims on its' web site that the Sonocur is an office base treatment. So already, different companies are starting to offer treatments away from the surgery centers. When insurance companies decide what the payouts should be, one of the key factors is 'fair market value'. If office base treatments becomes popular then the rates will be lower then they are now and fair market value will drop by the time a permanent CPT code is assigned. Another point I would argue is who said that any one group of physicains will have enough control to keep the cost of ESWT at thier current levels? I think you will see as more providers use the devices and the cost of the devices comes down, the market will get more competitive. It is economics 101. The more indications that ESWT will be used for, the more different kinds of medical specialist will choose to use it.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 19:57 (090849)

ESWT is a class three FDA treatment for plantar fasciitis. This will take years for the classification to change. Could be five could be ten years.
A physician will have to always do the treatment so long as it is a class three FDA treatment

Re: Future of ESWT in North America

Pauline on 7/28/02 at 20:08 (090851)

Rob,
Right now insurance companies are not setting the rate. Their not picking up the tab. Insurance companies set the rate that they are responsible for paying not what doctors are charging.

When a doctor goes to get the loan to cover the cost of his new equipment he usually provides the lender with a plan of how he plans to recover the investment. The lender may offer suggestions if they feel the rate of return isn't great enough, but the doctors are setting their own rates.

You have to take into account the operation that's being set up. Is the doctor making this a strictly 'In Office' purchase or as in Dr. Z's case a mobile unit which adds considerable expense in the Winabago itself.

It's the doctors choice if he wants to include it in his own office or go big time on wheels. Think of the competition between sites. Who's collecting the most revenue the large Rite-aid's chains or your local corner drug store.

Re: Future of ESWT in North America

Pauline on 7/28/02 at 20:18 (090852)

Dr. Z,
You wouldn't make the investment if you didn't think you could bring home the bacon. You know you have a sound investment with ESWT. I think you expect a pretty good return on this venture.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 20:44 (090860)

Right now the insurance companies are paying out more for ASC ESWT treatments. In most cases they are unwilling to see which model is better, and most cost effective.

The future of ESWT is very un certain and this is why the cost is so high.

So long as the future is uncertain the cost will be high. Its the same with loans. When the investment is safe the interest rate is low. When the investment is risky the interest will be high. Right now the cost to bring ESWT to market is very high so the cost will be high. The insurance companies will have no say.

If the insurancies drop the cost the ESWT providers will drop the insurance companies.

There is no way that the in-office model works. I have seen it and it doesn't make sense. I don't see the FDA classification for Plantar fascia changing in the near future. All companies will have to do the same FDA
trials for a class three device. This takes millions and there is no way the companies are going to give the product away.

So we can guess and guess but only time will tell. I do know one thing that since this is a plantar fascia heel pain board you won't see ESWT for pf done by any other machine except a FDA class three device and right now there are only two on the market ossatron and dornier.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 20:54 (090861)

No one can ever predict the future. I do think that ESWT is an excellent treatment for plantar fasciitis and should be the treatment of choice . There have been many effective treatments and products that never made alot of money. There is alot of risk with ESWT. There are many factors that can effect the 'bacon' . There are many federal, state regulations that can effect the 'bacon'

I truely believe that ESWT should be outpatient and not ASC. The problem is will insurance companies think this. If they don't they will drive up the cost. I just hope that I don't have to shift to an ASC model with all its costs. Yes the future with ESWT is very risky.

I watched the FDA approved one machine and then take back the approval. Who knows if one day the FDA decides that ESWT must be only in an ASC or inpatient hosptial. There are alot of political powers that really control ESWT. Anyway you must believe in the techology before you can believe in the investment. I truely believe is the technology. The investment part only time will time.

Re: Future of ESWT in North America

Pauline on 7/28/02 at 22:07 (090864)

Dr Z,
I remember reading on the FDA site that if one medical device gets approved by the FDA say for P.F. as a class three device all others seeking approval for that specific treatment must apply and go through the exact same trials. The first one sets the standard for the others that follow.

They have it printed somewhere.

Re: To John

Pauline on 7/28/02 at 22:19 (090865)

Isn't also against the law for doctors to send patients to centers for treatment or testing where they hold a financial interest?

Re: Future of ESWT in North America

Pauline on 7/28/02 at 22:25 (090866)

Dr. Z,
I think you watched the FDA approve a machine that was mis-labeled get approval which was then marketed by the manufacturer for a purpose other than which it was approved. The FDA was duped and had no choice but to pull the plug on this device.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 22:45 (090867)

What I do know that is I am still going thru the red tape to get a hold of the original application that you are referring too. The Freedom of information act is not helping in this situation

Re: Future of ESWT in North America

Dr. Zuckerman on 7/28/02 at 22:51 (090869)

I still would like to know why the FDA never did a recall for that machine . That would of been the correct action to take. They allowed a company to mis-label a machine and then went after the end users. They now are allowing the same company under a new name to apply for another application. No action was ever taken against the original manufactor. So I guess crime does pay. The FDA stated that fraud was committed and allowed the original manufactor to move on .

Re: Future of ESWT in North America

David L - Sonorex on 7/29/02 at 01:45 (090877)

I agree with you about proving that this should be an earlier intervention....ie after 3 months. When someone firsts presents themselves to you with their 'heel pain' and you diagnose them with the early stages of pf, I assume that you usually prescribe rest, ice, anti-inflammatories etc. Then, after 3 months, if this doesn't help, then you move to the next level. My prediction will be that the 'next level' will be ESWT as it will be very attractive, price and outcome-wise to the insurance companies.

Re: Future of ESWT in North America

Pauline on 7/29/02 at 07:21 (090883)

Dr. Z, I think you know why and the route they took was probably the cheapest. They prevented Norland from importing and marketing the Big 'O' in this country.

They didn't allow Norland to mis-label a machine it was mis-labeled when it applied for its application. I think the idea was to get the product to market as quickly as possible following the interest it generated at the Pods convention.

Norland had made applications to the FDA prior to this one and they realized the length of time, testing and money involved between approval for a class I or a Class III device.

They tried to dupe the FDA by mis-labeling, applying for quick pre- approval as a Therapeudic Vibrator then went out and market it as an ESWT machine.

The Pods that purchased the machine were happy. They had purchased a
a relatively inexpensive medical device that was approved as a Therapeudic Viborator, but using it as an ESWT machine.

Healthronics blew the whistle because they were already in the hopper with the Ossatron.

Outside of now owning what you describe as a better machine, as an owner of the big 'O' I think your in the best position to tell us what happened on your end and why you and maybe the others that owned it stopped using it.

Re: Future of ESWT in North America

Dr. Zuckerman on 7/29/02 at 10:30 (090895)

The dornier Epos is a better machine. In fact it is the best machine out there. The ossatron is such a small player in the ESWT worldwide market they cover less then 1% of world wide ESWT market. When I purchased the O. The FDA confirmed its approval in writing and via the phone. The FDA needs to recall this machine if in fact it was mis-labeled as they have stated many times. but if it isn't then they should allow the machine back on the market. Someone needs to step to the plate from the FDA. Either it is or it isn't . If it is then a recall is in order

Re: Future of ESWT in North America

Ed Davis, DPM on 7/29/02 at 11:53 (090900)

Sunny:

All of your predictions sound like they are on the mark.

Ed

Re: Future of ESWT in North America

Pauline on 7/29/02 at 12:09 (090901)

Dr. Z,
As long as there is no recall can't you still use the machine?

Re: Stark laws

Ed Davis, DPM on 7/29/02 at 12:47 (090905)

Pauline:

That refers to the Stark Laws. It is enforceable only for government insured, ie. Medicare.
Ed

Re: Future of ESWT in North America

john h on 7/29/02 at 13:36 (090909)

Sunny: I hope your predictions are on track. From an economic view the price should come down with more equipment, more providers, and more people aware of the product. That is sort of the way things work in the free market system. The wild card here is the FDA!

Re: Future of ESWT in North America

Dr. Zuckerman on 7/29/02 at 15:23 (090916)

No,

They have given me the option to run my own FDA trials at my expense of a few million dollars.

Re: Future of ESWT in North America

Pauline on 7/29/02 at 17:03 (090921)

So I guess they sort of pulled the plug. Maybe Norland will refund your money or prorate on a used machine. You can't be to sad because at least you had almost 3 years of use.

Re: Future of ESWT in North America

Pauline on 7/29/02 at 17:06 (090922)

Well at least you have the letter of approval you spoke about. Should have taped those phone calls Dr. Z.

Re: Future of ESWT in North America

john h on 7/29/02 at 17:31 (090925)

Dr Z: Even with all the upkeep I bet is still chaeaper than a wife. Ok girls give me your best shot!

Re: To John

john h on 7/29/02 at 17:37 (090927)

Pauline: I have not read the law on this but am very familar with a Doctor who owns a large financial interest in several Dialysis Centers. He is a Nephrologist and is the guy who puts you on dialysis. I know him and am very familiar with the dialysis center operations having vistied them on occasion. I have posed this question to one of the investors in this operation and apparently Dialysis Centers are not a prohibitive operation for a Doctor involed in the treatment of the patients.

Re: wives and women (off topic)

Carole C in NOLA on 7/29/02 at 18:07 (090932)

John, John, John. We keep telling you that wives are such a bargain compared with girlfriends, and yet you still don't get it.

A girlfriend gets taken out to dinner (maybe $60 for both of you). A wife slaves over a hot stove and serves you a great home-cooked meal for peanuts.

A girlfriend gets taken to the show, and of course you have to buy popcorn and a soda for her in order to not seem cheap (maybe $30 for two including the gas to get there). A wife gets to watch the TV channel you selected IF she has time after doing the dinner dishes.

A girlfriend gets a dozen beautiful red roses, with a romantic poem on the card (I guess that would be about $25?). A wife gets a 39 cent trowel and spends all day Saturday on her knees in the dirt cultivating the flower bed.

See? I knew you'd get the picture. :)

That brilliant engineer that I used to date but who moved away to Connecticut, came back to New Orleans for a visit last night. He gave me three DVD's, a video tape, and two books, and all of them were carefully selected because they were ones that I would love. What with dinner and all, I figure I cost him close to $100 for the night, but believe me he didn't get what a husband can expect from a wife. LOL

Carole C

Re: Future of ESWT in North America

Dr. Zuckerman on 7/29/02 at 18:14 (090933)

They don't denial the calls took place. They admit that they did.

Re: To John

rob. a on 7/29/02 at 19:17 (090937)

Generally speaking, Stark is geared towards diagnostic equipment ownership. If it envolves some kind of corrective treatment then Stark provides some safe havens for physician ownership in the equipment they will use to correct that problem.

Re: Future of ESWT in North America

rob. a on 7/29/02 at 19:35 (090938)

I don't think the wild card is the FDA. Other OEMs are making devices that will compete with the current ESWT devices for general pain treatments. The current ESWT device manufacturers are not the ones that will change the market. When others enter the market with table top class II labeled devices, then you will see a change. You have to look beyond the current players and search some of the European companies that make table top devices. They will form alliances with distributers in the U.S. and push these boxes into the market. Since they don't have larger class III devices, they have nothing to loose by doing this. I know this will upset many people, but when HCFA decides what they want to pay out, they really won't care if the amount is so low it will discourage physicians from using ESWT. Many insurance comapnies will be in line with Medicare payouts. If you think they care about the physicians getting their investment back then you don't understand how they operate.

Re: wives and women (off topic)

wendyn on 7/29/02 at 20:56 (090941)

Carole - you're pretty funny!

I'm sure John will argue that it's not necessarily something you can EXPECT from your wife.

Re: wives and women (off topic)

Carole C in NOLA on 7/29/02 at 21:13 (090946)

(grin) I'm sure a good looking guy like John can! :)

But then, come to think of it, Frank is a pretty good looking guy too, and look what it got him when he took this girlfriend of his to dinner... nothing much except a lighter wallet. :)

We had a great time, though, all kidding aside. Things don't have to get physical to have fun.

Carole C

Re: Future of ESWT in North America

Sunny Jacob - Bayshore on 7/29/02 at 21:16 (090947)

Dr. Z.:
Regarding your point of ESWT as a first line of treatment for tendinopathies:
One has to go back about 7 years when ESWT was introduced in Germany.
During that time the early researchers and users of ESWT were orthopedic surgeons. However, the major opposition to ESWT treatment at that time in Germany, Austria and Switzerland, came from other orthopedic surgeons and physicians who earned part of their income from conventional treatment of tendinopathies.
Therefore it was cleverly stated by the manufacturers (who needed the orthopods on their side) to use 'six months chronic' as their critierion for treatment with ESWT.
Apart from that, and due to the high cost of ESWT, the physicians wanted the patients with early stage of tendinopathy to undergo the conventional cheaper treatments, i.e. rest, pain killers, physiotherapy, cortisone, etc., which of course, was a reasonable advice, especially since approx. 97% of early tendonitis can be successfully treated with conventional methods.
I do not know of any peer-reviewed clinical studies with statistically significant results that state 6 months chronic tendinopathies will achieve better results than patients with less than 6 months chronic tendinopathy.
With some embarrassment I have to admit that Bayshore in the past also generally accepted mostly only 6 months chronic patients when referred by physicians and specialists. Here in Canada we call it health care politics.
Do we treat acute patients with ESWT? Yes.
One group of patients we treat are athletes from major North American teams. Many of them are acute cases and are treated with the same success as chronic patients.
As I have stated in my previous message, I am sure that in the future ESWT will be accepted as a first line of treatment.

North-American common currency:
A very recent survey revealed that only 23% of Canadians and 14% of U.S. citizens were in favour of a common currency.

Other:
Fee splitting or surcharge, whatever it may be called to make it legal, the ultimate result is the same.

Re: Future of ESWT in North America

Sunny Jacob - Bayshore on 7/29/02 at 21:20 (090951)

Cost recovery of medical equipment
Pauline,
It usually takes 5 years to depreciate an equipment (based on generally accepted accounting principles). From our experience, most of the medical equipments are obsolete by that time, example kidney dialysis machines, MRI, ESWT machines, etc.
Moreover, advances in medical technology usually outpace the 5-year period. There is also pressure from patients who want to be treated in a clinic with the latest machines/technology.
You mentioned MRI. Actually the magnet, a major component of an MRI equipment, will last forever. But the expensive servicing, preventive maintenance and parts for most medical equipment make it uneconomical to retain equipment for a long period of time as repair costs increase substantially. Therefore it is also usually a business decision to replace equipment every 5 to 7 years. Reducing the service after recovering equipment cost in this way will therefore not work. Moreover, insurance companies do understand very well the costs related to the various medical procedures.

Re: Future of ESWT in North America

john h on 7/30/02 at 09:04 (090976)

Sunny: I am supprised that the high tech equipment you talk about can last for 5-7 years. Computers go obsolete about every 3 years. There is some equipment that seem to have gone on and on such as the 50 year old B-52 Bomber. It is still the most potent long range bomber in the world. Of course, the upgrades to this old aircraft have exceeded it's original cost by 400-500 percent. Everyone is now wanting the new GE MRI equipment that does not require you to be intombed in close quarters. The hospitals that have them heavily advertise them in our local papers.

Re: To Carole wives and women (off topic)

Pauline on 7/30/02 at 11:16 (090990)

Really cute post. We've got to teach women to continue the same approach after marriage. Rule # 1. Never let the gifts slide and always expect more. Yea!

Re: To Carole wives and women (off topic)

Carole C in NOLA on 7/30/02 at 11:45 (090997)

You are right! There are so many changes that would need to be made. Rule #2, everyone is responsible for their own laundry! Rule #3, if the guy doesn't open doors for you and pull out your chair at dinner, he's toast. There are about a million more rules, too.

Now that I'm single again, I get the roses but not the dirty laundry. I get taken to fine restaurants and don't have to pack the guy's lunches at 5 AM. I can offer emotional commitment without a lot of strings attached, and expect the same.

Carole C

Re: To Carole wives and women (off topic)

Tammie on 7/30/02 at 12:06 (090999)

That is so true ! I found a laugh today thank u!

Re: To Carole wives and women (off topic)

john h on 7/31/02 at 09:51 (091128)

Hey Carole I have always done my own laundry. Want a well trained husband then marry a military guy. he will do the yard, vacume, do the laundry, make the beds, mop, take out the garbage, empty the kitty litter box and put up the dishes and then go to work/

Re: To Carole wives and women (off topic)

Carole C in NOLA on 7/31/02 at 18:55 (091199)

In your dreams! My ex was career Navy. He was a heck of a mopper, but he didn't do any of those other things at all!

But wait! You are talking about marriage. But now I'm opting for the fine dining, show, and dozen red roses, not for the slaving away over a hot stove, watching the end of a TV show, and growing my own flowers. LOL

Carole

Re: To Carole wives and women (off topic)

john h on 7/31/02 at 19:06 (091203)

Carole: the Navy guys march to their own drum. I do all those things and always have. not because my wife want do them but because i am a bit hyper. i climb mountains because they are there.

Re: To Carole wives and women (off topic)

Carole C in NOLA on 7/31/02 at 19:08 (091205)

John, Mary is a lucky woman. :)

Carole C