Thursday, April 5, 2012

The Master Debaters

Recently that SHILL of a publication, OTW, ran an article entitled, "PODS, The Great Debate."  TSB thought our readers would be taken back in time when Wiley College debated Harvard.  No Denzel Washington on this set.  The Great Debate was centered on the following question; "Should physicians own their own means of implant or instrument distribution?" Hey Jimmy Olsen, why not pose a simpler question?  To call Doc Steinmann one of the most articulate and knowledgeable experts in this field is rather entertaining.  Though, TSB must admit, Steinmann's jab at Biomet regarding their recent run in with the OIG/DOJ must have cut like a knife through Jeff Binder.

Let just cut through the BS, rather than debating the issue, the question that should have been asked how does the industry enforce proper intent, structure, and conduct that would make everyone compliant with the laws?  Ever hear of checks and balances?  How does the industry ensure that it advocates and sustains free market enterprise without stacking the deck?  We do like to think of ourselves like our Wall Street Brethren based on our behavior.  How does the industry contain cost, when the industry is built on growth and profitability?  How does the industry play a role in delivering affordable healthcare in a fee for service model?  If proper intent is about demonstrating cost containment, why don't surgeons and hospital administrators allow everyone to compete in a closed bid system?  Talk about leveling the playing field.  If one's intent is to eliminate one intermediary to benefit by extracting profits out of the industry by developing another model, what is there to debate?

Whether our readers agree or dissent, PODS are nothing more than another entity based on insider trading with the objective of extracting as much profit as they can out of the industry.  If PODs truly believe that they are driving down the cost of delivering healthcare, why haven't surgeons agreed to take a decrease in reimbursements?  In a free market everyone should have the ability to compete. There will be an outcry. TSB you're a socialist.  How could you suggest a closed bidding system? As Steinmann states; "legally compliant structure for surgeon ownership of distribution is available based on the position of the Inspector General."  Bill Kolter of Biomet counters by challenging whether 60% of revenue generated by PODs comes from non-investors.  TSB's question to other surgeons would be why would you want to make the Dr. Steinmann's of the world richer than they already are without reaping your own profits.  Why not each individual surgeon in this country start their own POD?  Like this they could hire their girl friends, sons, or daughters and ensure that they have a job.  But then who would make the donuts?  As TSB loves to say, "if surgeons are so unhappy with how little money they make, why not become a plumber or carpenter?"

Kolter is correct when he states that PODs depend on surgeon investors, why else would anyone subsidize some other surgeons venture?  Self-referral?  Kick-back?  You be the Judge and the Jury. What Steinmann fails to understand is that it is not only Biomet that maintains that surgeons, hospitals, and manufacturers cannot be trusted to act honorably, the majority of us that have been in this business longer than Steinmann can definitely name the cast of characters that have had their hands out since day one.  If the Anti-Kickback Law's "One Purpose Rule" tests self-induced referrals in order for a surgeon to gainfully profit from their actions, then why doesn't the OIG put them to the test?  

Steinmann talks about Bill Kolter not providing solutions, but what does Steinmann provide as a solution when he cuts one middleman out only to be replaced by Steinmann and his cronies? Steinmann is the typical surgeon who complains about the escalating cost of healthcare and deflects the blame on the weakest link in the system, the distributor.  As companies decrease commissions to increase shareholder profits it is ironic that Steinmann himself has a need to be a distributor, hiding behind the AMA and AAOS Code of Ethics.

"It is unethical for an orthopedic surgeon to receive compensation from a manufacturer for using a particular device or product." Hey Doc, you ever hear of Blackstone Medical?  They were the poster child for surgeons receiving compensation from a manufacturer for using a product, and the rest is history.

But for arguments sake, isn't Steinmann himself "accepting payment of any kind" when he profits from his own company distributing and using products that he sells to the hospital, even at a cheaper price?  What the Steinmann's of the medical device world fail to understand is that there is a de facto absence of ethical standards.  The AMA nor the AAOS have any legal authority to enforce any actions upon its members because these organizations are lame duck at best.  So in closing, all one has to do is look in back of any AAOS, AANS, CNS, or NASS publication to see how stock investments, royalties, and consultancies affect a surgeons choice only to be determined by one's vested interest.  TSB wants to know what our readers think?

57 comments:

  1. Expect there to be considerable debate over the issue. What I have never understood is how the gov can give a positive opinion about PODs when it is not allowing surgeons to refer their patients to their own radiology centers and similar. It appears as though it's a point the good doctor does not want to address. Irrespective of the intent to save healthcare dollars, that's a question still to answered, and if it turns out in the PODs favor, I would expect interested parties to go back to the gov and say, if you allow this, why not allow me to refer to the radiology center, surgery center, etc. that I have ownership.

    While I read the article in OTW, I don't recall seeing the doctor saying they have saved anyone any money; they have just not shown an increase. I find that interesting in the every device company has taken a serious ASP hit. Most are selling devices well below where they were a few years ago. How is it the PODs have not seen the same.

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    1. How can a hospital negotiate with a POD? The owners are their customers. Surgeons would move their class across town in a blink if the hospital dared "take money out my pocket". It's anti competitive. PODs don't eliminate the middleman, they replace him with an entity that doesn't have to provide any service or quality to win.

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  2. I wonder if another company came into a POD hospital and offered a cheaper solution, would they be allowed to compete? If so, how much would that influence the product choice of the POD physicians? My guess is that it would be business as usual for the POD Surgeons, if they even allow another company in (which I would highly doubt). If it is about cost savings the easiest solution is defining a pricing matrix, whoever wants to provide their products at that price point can participate. The hospitals limiting choice and further defining what products a physician can use is not ethical at best. I would enjoy hearing from Sales Representatives that compete against POD's. What's involved with getting in to those facilities? If you do get in, what is the general acceptance of products outside the physician distributors products?

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    1. Don't you understand? There is no competing with a POD. The hospital can't open it up for a bid because the POD supplier is also their customer. The competing suppliers can't compete because their customer is their competition

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    2. Been there. Done that.

      You could give your implants away for free and you still couldn't get the business.

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    3. @9:13 that is what I figured. Those are the things that need to be pointed out about this debate.

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  3. Most of the major health systems in California have kicked them out.

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    1. They have pretended to kick them out. The POD just reorganizes and comes in under another name or entity. The hospital then turns a blind eye to it or is truly ingnorant.

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  4. I still marvel at the entire POD phenomenon that is currently underway. These entities are what make me feel like I need a shower when I speak to surgeons these days. I got into this business because I wanted to try and create products to help people and their debilitating conditions, and now I just feel like a cheap used car salesman.

    In response to the good Dr. SteinMAN and the entire debate over healthcare costs in general, I'm interested to know if anyone has actually looked into the astronomical upcharge that hospitals place on implantable products. I've seen some invoices as high as a 600% markup. I just find it interesting.

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    1. Oh yes. I think you will find that hospital administrators are some of the most unscrupulous bastards anywhere. Second only to insurance company CEO's.

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    2. 3:52: great point, one constantly overlooked in the POD debate. We can beat each other up on the price of a screw to the hospital all day long. Unfortunately, whether we charge them $1,000 or $500 each, the hospital still sticks the patient at $5,000 a piece. We're not "saving healthcare dollars", but rather improving hospital profitability when we lower prices.

      Remember that next time somebody gets all egalitarian on you about your pricing. Maybe if they let us sell direct to the patient or payor, it would be different.

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  5. So I guess POD surgeons income decrease as they help lower the price of healthcare? The #1 reason to be in business is to generate revenue. Non-profit PODs will be Plan-B.

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    1. No. The POD is a new career on top of their surgery practice. They don't lower cost in the long run. They might lower cost to the hospital in the beginning but the hospital can never renegotiate. Non-profit PODs do not, and will never, exist. They exist for one purpose only, to make money based on the bastardized dynamics of the surgeons being the product choice decision makers, but having the luxury of someone else paying the bill for said products.

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    2. Also, once they get a good taste of double dipping, they generally start to get greedy so their volumes go up. But even if they don't, the inducement is there and that makes the arrangement illegal according to OIG. Steinmanns whole "study" was trying to prove volumes didn't go up, but he missed the point that it is still illegal if the inducement was there all along. If the inducement wasn't there, why do a study proving you didn't succumb to the inducement and over utilize? Now that's a good question!

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  6. Stomach turning as usual. There is no real way to compete against the POD model, the only thing you can do is try to affect the referral market and sway it to benefit your customers that do not participate in them.

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    1. Exactly right. They refuse to make the surgeons state their financial interests, and instead ask manufacturers to state that the surgeons are not being paid. This covers up the truth. What is wrong with transparency? If there is nothing wrong with it, then tell the world. Hospitals are afraid to lose the referral, so they turn a blind eye. Fortunately Medicare/Medicaid will not find that exceptable. I am sure some money will be paid back by MANY hospitals.

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    2. The comment about moving the PCP referral base away from surgeons in a POD is an effective strategy. However, laws prohibit a manufacturer from doing just that. Does Kyphon ring any bells? Unfortunately a manufacturer may only promote on-lable utilization, not directly solicit the direction of referrals, other than through providing the demonstration of credentials.

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  7. Dr. Steinmann an expert on distribution? Come on Wally Eisner have some balls, do you and the caterpillar mustachioed boss of yours ever take a position on anything in the industry? Anyone can be an expert when the hospital that you work for panders to your scheme. If that hospital wants to lower the cost of implants lets go back to closed bids as TSB says and lets get it on.

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  8. Dr. Steinman is driving down the cost of healthcare, LOLATWTTB.

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  9. Steinmann claims the reps AND their distributors make millions. I can assure you that he makes more per implant than any rep that ever called on him. Knowing that, do you really think saving the hospital money is his primary motivation?

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  10. Spinal USA? An owner that was previously appointed to the Mississippi's Hospital Equipment Facilities Authority. Scary.

    http://www.governorbarbour.com/appointments/archive/appointments/2005/mar/apptHospitalEquipment.htm

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  11. All of us in Texas love the smoke and mirrors going on at TBI. They use PDP which spins their story to state that they are not a POD. Instead of one company's products, they will have 2 or 3 "negotiated" product lines, but still surgeons invested in the company and benefiting from the implanting of negotiated products

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    1. If it looks like a duck and quacks like a duck... TBI, why am I not surprised.

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    2. Let me guess, none of the negotiated lines are ones they used prior to being in the POD? And they probably wouldn't have given the reps selling those lines the time of day prior to having a financial interest. Am I right? I knew it! I love it when I'm right!!

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  12. Give it time in good ole Texas...the true colors of who TBI has partnered with will end up in a lawsuit just like prior business arrangements when the profits start getting divided! Watch out Hochshuler and Friends!

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    1. Nice foreshadowing!......

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    2. Ever watch the Alphatec management team kiss Hochshuler's ass when he walks into their booth? "Oh Dr. Hochshuler, so great to see you." Disgusting! The Hymen Roth of the industry. A real scammer! If the OIG/DOJ would like to learn about how its done, pay a visit to TBI, the teacher has schooled his pupils well.

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    3. Like Lenke walking into MDT's booth?

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  13. Dr. Steinman claims that since Hooper, Lundy, Bookman healthcare attorneys in California have a 19 point compliance issue that makes them legal. It doesn’t!. Even HLB’s own authors on the subject have made comments that even though they may try to make a POD as legal as may be possible, they still can’t guarantee that the set up is legal. Dr. Steinman and their group try to make the impression they come close to satisfying the Safe Harbors laws, but they don’t. His set up is one of mini-pods where a non-utilizer becomes his own POD. Thus, the non-utilizer does not make money even though they can invest in the company. The company does not have a bunch of investors who have a equal share and split the proceeds evenly among the investors. Their model is again a mini-pods where a small group of docs become their own POD, put in the implants and get 80% of the proceeds; Dr. Steinman gets 20% for setting up the POD. It may be that Dr. Steinman’s implants are supplied to the hospital at a cheaper cost, but where are they made and what is the quality? As well, it’s not the cost of the individual implants it’s the number of levels of fused and number of implants implanted that escalates the cost. Until the behavior of greedy physicians can be changed and those greedy docs do only what is necessary and what makes sense (eg a 10 level fusion in a 85 year old to treat back pain does not make sense) then this abuse will continue.
    The California States Attorney General claim that a POD might be a legal entity or could be legal. However, the California States Attorney General does not have authority to make them legal for any federally funded patient. The OIG has that authority!
    What about the Healthcare West Hospital system (40 hospitals in the Western US), the Providence Health and Services hospital system (28 hospitals in the Western US), not to mention a smattering of hospitals who no longer use PODs (Loma Linda University, UC Irvine Medical Center, The Scripps Hospital System)? More and more individual hospitals are abandoning PODs once they figure out they are being ripped off by these greed surgeons doing egregious procedures.
    Unfortunately, the OIG has not taken a firm stance to make PODs entirely illegal. Instead, Dan Levinson of the OIG stated on 9/13/11 that they would keep an eye on PODs, investigate when appropriate and take a better look at their use for possible violators. Who are they kidding? For the OIG to investigate each “suspect” POD would take EONS and the POD investors realize this. It then becomes a joke with these groups. Who cares? No one is doing anything? The only advocate against PODs that has been very is the Wall Street Journal. The Wall Street Journal has been very informative as far as individual abuses but unfortunately the patients don’t know about this and most hospital administrators don’t know what a POD is or how they operate or why it would be a bad idea to get in bed with a POD. The Senate Finance Committee is trying to get the OIG to eliminate PODs, but until the OIG say “yes” or “no” there will be no changes.
    So, we are left with the crooks making more money than the honest physicians. In addition, these crooks can get cheaper insurance contracts, will do work for far less on capitated and IPA groups contracts with no oversight on indication for extensive fusion procedures. The losers in these POD models are the patients, generally the hospitals as the hospitals have to foot the bill for the implants and the honest surgeons who just can’t bring themselves to whore themselves. Meanwhile, the honest physicians are left to fend for ourselves and are effectively pushed out of practice as we cannot compete.

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  14. You can set up a POD that "might be legal", but unless the surgeons behave within the bylaws of the POD then it becomes highly unlikely that it is legal. You mention that the surgeon have 80% ownership and Steinman has 20%. That violates a safe harbor right from the start. I'm not sure I understand the role of the non-utilizer you described if he makes no money.
    I would ask Dr. Steinmann if the manufacturer whose implants he buys we're to hire a rep in the area where he practices, and the pricing offered to the hospital was lower, would he switch suppliers to save money? I would but my first born his verbal answer would be "yes" but he wouldn't agree to it in practice. Just like te POD structure might be legal, but not practicing within the rules of the POD makes it illegal.

    Read the safe harbors for yourself, it is virtually impossible for a POD to fall within them all and still be able to provide the owners an incentive to participate.

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    1. It is impossible with the way PODs are set up to get Safe Harbor protection. That's not what the Steinmans are after. They are after the appearance of seeming as though they qualify for Safe Harbor. There is a gray zone of kickback issues then that follows if Safe Harbor is not possible and that is where the OIG is hedging on the model perhaps being illegal. Illegal or not the bottom line is that PODs are just too much of a enticement for docs to perform unnecessary surgery for the sake of making money. All other legal arguments just don't even matter.

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    2. Its not impossible to set them up on paper to fall within the Safe Harbors, but not the single purpose rule. You can state in the by laws that no more than 40% of sales can be derived from investors who are capable of prescribing the products, but to actually pull that off is not realistic (at least I've never seen one with ANY non-investor customers). You can state that non-investor customers and investor customers are marketed to in the same fashion, but we all know those 2 require a very different marketing approach. You can state that the surgeons shall not use their inpatient referrals as leverage to force the hospital to do business with the POD, but that threat doesn't even have to be verbalized to be realized.

      I agree that they are not trying to fall within the Safe Harbors, but they very much want to appear to comply. AKS violations are felonies and surgeons have very soft hands that are highly sought after in prison. You can bet they want to give the appearance that they are in it solely to save the system money, to do whats best for the patients and to abide by the law. And being surgeons, they are too accustomed to never having their judgement questioned or second guessed, until now.

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  15. Check out aasdonline.org. American association of Sugeon Dustributors. A new industry association for PODs.

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  16. www.renovis-surgical.com

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  17. Is Renovis Dr. Steinmann's POD or is it his implant company for his POD?
    Either way, this is unreal

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  18. Dr.Steinmann VP of Sales and Marketing LMAO, another genius.

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    1. Thats his son or something. John Steinman, DO is the Prez and CEO, John Steinman, MBA is his son or just a coincidental name. At least he's following the business model of most PODs and douchebag distributors with surgeon nepotism.

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  19. Good and innovative products should drive surgeons what is best for their patients. Not their involvement in PODs and distribution. That belongs to distributors.

    1. Surgeon=Perform Surgery & Design Product
    2. Manufacturer=Put products on the market
    3. Distributors=Distribute products
    4. Governmant=Support all the above, support all of us

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  20. All this activity does is spark innovation which will kill their business model.

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  21. Isn't it amazing that a surgeon can collect payments for implanting spinal devices in which he has a financial interest in and its considered "legal but maybe unethical" ....and yet if we spend $150.01 on a dinner with that same surgeon. WE are in violation of a federal mandate and looked at as unscrupulous business people. Talk about contradiction. This industry has become a joke. I'd rather sell diapers than deal with the BS spine offers me nowadays. If a surgeon has a problem with the money I make, I'd be more than happy to compare W2's

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  22. You gotta love surgeons that complain about big government. This is an ideal situation that the government should come in and scrutinize this biz model. But no, as usual they sit on the sidelines with excuses. Let's just fry the bastards, and name names. Until then nothing will get done. The first scam to be outed should be the TEXAS BACK INSTITUTE.

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  23. In spite of the current occupants in the White House....Happy Easter all you Spineophils!!!!

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  24. Wasn't the big bad FBI and DOJ going too prosecute the Lyons Brothers, so typical all tal no action, does anyone have b*@ls to follow thru, until the Steinmann's of the world are led away in Orange Jumpsuits this insanity continues Happy Holidays to all

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  25. I'd like everyone to document any PODs that you are aware. I'd welcome any commentary. Let's do our own market assessment via blog.

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    1. Mobile Infirmary. More $$$ = more implanted screws!

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    2. Anyone that wants to look at PODS should start in the SF East Bay. Look at the John Muir Med Center doc's in Walnut Creek, the San Ramon Med Center doc's in San Ramon, and worst of all, the Valley Care doc's in Pleasanton. My guess is that an investigation into the surgeons and distributors in these systems would yield enough evidence, that the DOJ, OIG, FDA, FBI, IRS, ATF, DEA, CIA and any other government agencies would be forced to take action.

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    3. See TBI's disclosure on their website for a complete list.

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    4. Exactly 60 companies listed as financial "partners". The title of their disclosure page is "Invested in Your Care" Wholly shit!

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  26. Also,

    Anonymous April 5, 12:25; as you will note above, we have saved $4.8 million dollars in our community alone. Our study across all distributorships demonstrates an average of 37% first year reduction in the implant costs for the items distributed. With regard to referrals to radiology centers and surgery centers, there exist many circumstances where the government has found these arrangements to be compliant and in societies best interest, and has either structured safe harbors or rule exceptions to protect them.

    Anonymous April 5 1:12; if another distributor comes into a hospital with a better product for the same price or the same product for a lower price then they will get the business.

    Anonymous April 5, 3:52; seems like you are talking to the wrong surgeons. You do bring up a very good point though, a point that has not adequately been discussed, which is the role some hospital systems play in extorting money from the system by up charging implants up to 1000%. This creates a clear conflict of interest whereby a hospital can profit more by allowing the purchase of higher priced products. Selling direct to the payor or patient is a reasonable thought. So would be price transparency.

    Anonymous Reply April 5, 8:55; Review the definition of inducement. This requires an action that occurs that otherwise would not have occurred. An inducement is different from an incentive. It should be clear why the paper was written.

    Anonymous April 5 5:55; Be careful! Swaying the “referral market” would not be seen as legal.

    Anonymous April 6, 10:12pm, we set our distributorships up fully compliant with the law and are very comfortable with the legality of our structure and, hence, find no need to seek safe harbor protection. You grossly mischaracterize our model and I find it unprofessional of you to hide behind an anonymous and make slanderous and false statements about the quality of the products we use and the “number of fused levels” we perform. Possibly, I should assume you are speaking of someone else because there is not an ounce of truth to anything you state if you are addressing our model. The Wall Street Journal has presented a very biased and unbalanced view on this subject – failing to do anything other than sensationalize a few instances of bad behavior and to draw grossly inappropriate conclusions. I think I have an idea of who you are and I would implore you to spend your time shining a light on those specific individuals to whom you are referring to instead of making slanderous comments to the many of us that have adopted this model for the right reason and operate with proper intent.

    Anonymous April 7, 5:49am; once again, the model that we propose does not seek safe harbor protection and does not try in any way to appear as though we do. We are nonetheless fully compliant with existing law. It is not required that an arrangement fit within a safe harbor to comply with the law.

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    1. Dr. Steinmann, you started your post with "Also," was there another post? I'm interested to read your comments, so please re-post as it is no longer visible.

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    2. The fundamental issue I have with your comment, "we have saved $4.8 million dollars in our community alone. Our study across all distributorships demonstrates an average of 37% first year reduction in the implant costs for the items distributed." The number 37% and further 4.8 million dollars is relative to your starting point. Example if the price the hospital pays for a Perc Pedicle Screw is 2000.00 and you bring them to 1200.00, it would be very easy to demonstrate a decrease in cost. Although, the number 2000.00 for a Perc Pedicle Screw is considerably high in the market and thus easily attainable. This scenario is similar to the "fire sales" you see at many retail stores 50% off means nothing unless you know the starting points. In my territory we have a hospital that was paying 2000.00 for a perc pedicle screw and now they are paying 1100.00, perhaps the purchasing manager should be a distributor too. Your numbers need more clarification to justify the involvement you have made in the distribution of implants. I would suggest opening the prices payed previous to your involvement and the pricing paid now.
      Also, is this savings continued after one year relative to the market? Would it not also be a fundamental flaw in your study of involvement vs. procedure volume, given the fact you knew about the study and have financial benefit for showing positive outcome numbers? This is similar to a payed consultant speaking on the benefits of company X's pedicle screw.

      I would be interested in hearing about the process of the Dr's involvement in negotiating with the purchasing director of said hospitals. Would you think that a Physician negotiating the pricing of the implants he/she uses with the hospital would be a HUGE conflict of interest?

      Would it not have been more clear regarding inducement and patient care, if you would have considered involving yourself more in Value Analysis, instead of distribution? If the ultimate goal is lower priced implants, you could have easily accomplished this by encouraging product pricing negotiation at the hospital w/ capitated pricing and/or procedural contract matrix pricing. This would accomplish your goal of lower implant costs, while eliminating your perceived conflict of interest in implant choice.
      I do not see any legitimate argument why your involvement in the distribution of implants would be the catalyst to lower pricing, compared to what normally is a value process established in hospitals across the country.
      Your involvement is an obvious conflict of interest in your patients care.

      As always all within my humble opinion.

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    3. Oddly, the "study" on over utilization is no longer posted on the Alliance website and I can't find it anywhere on google, google scholar or pubmed. Whats the deal. If I remember correctly, the "study" stated that the savings were compared to the "then current pricing" of competitors. But since the POD had been going on for the length of the study, it is possible that whatever pricing contracts were in place with competitors had since been cancelled or lapsed since those companies were probably shut out. Anybody know the story on pricing at these hospitals pre and post POD?

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  27. Inducement does not require that any action occur. Here is the definition of "inducement" as it pertains to the AKS per "FUNDAMENTALS OF THE ANTI-KICKBACK LAW" by
    D. McCarty Thornton

    C. Inducement
    The term “inducement” also has been interpreted broadly to cover virtually any act that is intended “to exercise influence over the reason or judgment of another in an effort to cause the referral of program-related business.”9 The fact that there are legitimate reasons for the remuneration at issue is irrelevant. The government takes the position that as long as “one of the purposes” of the payment is to induce the referral of program-related business, the Anti-Kickback law is implicated.10

    9. Hanlester Network v. Shalala. 51 F.3d at 1398.
    10. OIG Advisory Opinion No. 99-14 (December 28, 1999); United States v. Kats, 971 F.2d 105, 108 (9th Cir. 1989).

    That clearly does not require an action that would not have otherwise occurred. The simple influence of the potential remuneration is enough.

    Dr. Steinmann, we reps have to remain anonymous because if we are exposed as trying to take down surgeons who, we believe, are benefitting financially for the referral of certain products for their patients, we would be black balled even by surgeons with no ties to PODs.

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  28. According to the same article referenced above, the primary policy objectives of the AKS are:
    (1) preventing the corruption of medical judgment, (2) preventing the overutilization of items or services covered by a federal health program (and the concomitant increase in program costs), and (3) preventing unfair competition.

    The fact that you make a margin on each implant that is used in your patients clearly has the potential to corrupt your judgement. Not because you are evil, but because you are human and we all have become pros at justifying the things that we do that are imperfect.

    You did a "study" attempting to prove that over utilization did not occur after your POD was established. I'm glad that the number of cases did not escalate and you are to be credited for that. However, knowing that this model is a attempted work around of the AKS, how are we to know that after the "study" was complete that over utilization did not begin. Also, how are we to know from the study that the utilization of implants PER PATIENT didn't increase? Your "study" only looked at the number of cases.

    The last policy objective is to prevent unfair competition. I would like for you to honestly answer a few questions since you have engaged TSB nation on this issue.
    1) How do you know how much you have saved the hospitals unless you are privy to your competitor's prices?
    2) Would you publish your prices to provide that same advantage to your competitors that you had so that they might bid on your business?
    3) Who gets to decide if the quality of a competing implant is the same or greater than the ones you sell? You, I presume, so what are the chances that you would accept any other product as superior if it was the same price or lower? Does that seem like fair competition to you? I would love to be able to make final decisions on whether or not my competitor's products are used in a hospital.
    4) What percentage of your business converted to products you distribute within one month of them being available to market?
    5) Do you imply that the products you distribute, all of them, offer a better value proposition (cost+ features+service) than every other product available on the market?
    6) How many surgeons that are not financially tied to your POD feel the same way about your products?

    I could go on and on with common sense questions that all point to the anti competitive nature of an arrangement like yours. And while you are correct that compliance within safe harbors is voluntary, if your entity does NOT fall within the safe harbors, it should be analyzed on a case by case basis for compliance with the AKS in general. Just reading the first paragraph, it seems impossible for you to make money on the sale of a product that you control, that is paid for by the federal government and it not be in violation.

    Respectfully, how do you respond?

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  29. Swaying the referral market is completely legal, unless you pay the docs to refer to a certain place. Otherwise its simple sales. Many reps have called on GP and Chiropracters to "sell" them on a particular doctor. You just can't provide any remuneration as inducement

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  30. Isn't Bimet looking into starting a POD as a company, that is what I have heard?

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