In April of 2011, the Wall Street Journal wrote an article about one V. James Makker, formerly a practicing neurosurgeon in Oregon. The article identified that the former doctor had performed multiple spine fusions on patients, 10 times the national average, at that time Makker was being investigated by the FBI and the Medical Board for the state. At a meeting on September 24th, 2012, the Board and Makker have agreed that it was time for the former neurosurgeon to leave the medical profession. What is fascinating with the pomp and circumstance of stripping away his right to practice medicine is that the deal includes Mr. Makker denying he has done anything wrong. So why didn't he fight the Board's demands?
In 2006, the laissez-faire Oregon Medical Board had investigated Makker and accused him of inappropriate and unnecessary billing, unnecessary surgeries, misleading statements, and "gross or repeated negligence." His punishment? New training and an audit of his billing to settle the case. In retrospect, the patients that have been harmed should probably consider suing the Oregon Medical Board that handed down this decision for negligence. If the foxes are protecting the hen house, how is John Q. Public protected? Makker has agreed to provisions in the settlement that he can never reapply for the privilege to practice medicine in Oregon, and that this finding will be reported to every state in the union making it unlikely that he will ever practice medicine legally in the United States.
Mr. Makker's response on his LinkedIn page was even more troubling, to paraphrase, "my success generated jealousy, I was slandered, etc., etc. So here is TSB's suggestion to the Board of Directors at NASS, rather than toast yourselves at this years meeting, patting one another on the back, telling each other how great you are, or about the next big deal you signed with some POD or some desperate company, a moment of silence and reflection may be needed on why you really entered the art of medicine. You are "entitled" to be compensated commensurate for your skill sets, but at the same time, somewhere back in time you took an oath to practice medicine ethically and honestly, who knows, it might do some of you some good. But then, it may not. You should be thankful that you have a career that other people envy, but at the same time, as a member of that exclusive club, it doesn't give you the right to do whatever you can within the confines of the law to potentially make someone worse at the expense of padding your personal wallet.
In closing, maybe Mr. Makker will take the time to come to grips with his own realities. He had the world and the health of his patients in the palm of his hands, only to have it taken away by the type of behavior that gives a great profession a very bad name. Does a man or an industry have the ability to change its innate nature? Rather than be critical of the current environment and the debate that surrounds all Americans regarding healthcare, we should be asking ourselves questions, whether the actions of the few permeate and delude our perceptions of what is right and what is wrong? Do we justify our behaviors by income rationalization? TSB wants to know what our readers think?
I hear he is opening a Chiropractic clinic.
ReplyDeleteAny repercussions for his Phygen POD hottie girlfriend? A case study in slimy PODs.
ReplyDeleteWas Makker a Phygen member?
DeletePhygen & Stabel Spine are examples of the slimest PODs out there. They need a bight light shined upone them & we can all watch the cockroaches run for cover!
DeleteDear Anonymous,
DeleteI'm a journalist interested in Phygen. It doesn't describe itself as a POD, but rather a device manufacturer with 100 "member surgeons." Phygen was purchased in 2012 by Alphatec Spine, and helped Alphatec's sales performance for that year. Here is the news release: http://investors.alphatecspine.com/releasedetail.cfm?ReleaseID=719283
Alphatec's 8K filed with the SEC says it wanted access to Phygen's "proprietary Autolok set screw locking technology," among other technology developed by Phygen.
My question is what evidence is there that Phgen was a PODS? You can email me at ragraham@sandiegobiotechnology.com
Thanks,
Rex Graham
Of WSJ fame, Dr. Adam Lewis was promoted to Chief of Surgery at ST Dominic's Hospital in Jackson, MS. He is not the only surgeon at ST Dominics with ownership "interests" in Spinal USA and Precision Spine.
ReplyDeleteAll three hospitals in Chattanooga have agreed to fines for anti-kickback payments to cardiologists. Not one cardiologists has paid a fine.
DeleteThe regulators in the SE need to be fired without pensions.
I recently left the spine business after 20 plus years and am now working with other surgical specialties, including general surgeons. It is a tremendous relief to experience that there are still many surgeons who put the well-being of their patients first. In adult spine they have become the rare exception, and Makker is just the tip of the arrogant self serving iceberg. That many may follow in his footsteps, out the door.
ReplyDeleteWhere did you go . What you selling
DeleteWhat is going on with Mazor?
ReplyDeleteA beer can device that thinks its a robot. Whatever they can con patients to thinking they are doing robotic surgery, thinking they are a real robot like Intuitive. Patients don't know any better. They think Robot = Better Outcomes. Even docs that use it agree its a joke, but hospitals market the heck out of it, and their practice.
DeleteTip of the iceberg.
ReplyDeleteThis illustrates that state medical boards are a joke and not truly governmental agencies. This is more reason for why the entire industry need proper regulation the same as every other industry.
Look at the recent deaths and injuries caused by the contaminated ESI injectables -- another example of the danger of non regulation.
This sort of thing needs to be prevented long before the FDA gets involved. Now it looks like this guy is going to run a scam as a DC.
My God, I thought the thing about him becoming a chiropractor was a joke.
DeleteHard to tell the difference between jokes and reality, these days.
It was a joke.
DeleteI remember a high brow spine MD at HSS;NYC(FC) telling me years ago that the spine company I worked for should be embarrassed that we let a certain physician use our implants. I was proud of the fact that I told him it was his repsonsibility and the responsibility of spine surgeons to kick the bad ones out. I told him the review board at hospitals are the ones who should be monitoring their MD's. (Frankly)I told him it was he and TE,HY,KF,HM,GA,EB.....and all the leaders of the spine industry that should monitor the bad hands. Needless to say........(white shirt) never used our products again. BTW....he was always concerned about infection in his O.R.; when I pointed out that he should stop wearing clogs that exposed his cracked and fissured heels; with years of callous and absolute decay he turned red faced. I did notice after a few months that he started to wear closed shoes. I'm glad I monitored him.
ReplyDeleteLove it!
DeleteI agree that Hospital CEO's should do more, considering many of them have not for profit status and anti-trust exemption based on "community benefit".
ReplyDeleteBut these hospital CEO's were hired by Boards that are appointed by the previous CEO based on the Board members not having experience in healthcare.
And the Hospital CEO in my community fired his experienced Compliance department and has continued the "STUPID BOARD" recruitment, so unless the state and federal regulatory authorities do something, nothing is going to happen, except more inurement, more stark, more anti-kickbacks and another dozen affiliations with the smaller hospitals in Alabama and more purchases of Spinal USA implants.
I sure hope Spinal USA has a good product, because if not, my community is going to have alot of "redo" exposure.
It makes me sick that our justice department and congress fail to do their duty to enforce the laws. They should all resign, especially Obama!! If they were concerned more with doing their duty to this nation rather than their own re-election, we would be far better off.
ReplyDeleteWhat you're calling for is more government regulation. Perhaps you've been asleep for the last 30 years while most government regulation in the US has been pilloried, disassembled, and thrown away.
DeleteCarter actually started it, Reagan accelerated it, Clinton approved of it. We're all too blame.
Can anyone name the federal agency that oversees and regulates doctors and hospitals? Hint...There is none.
DeleteIf the guy agreed voluntarily to give up the extremely lucrative practice of neurosurgery, I'd have to guess some heavy pressure was brought to bear on him.
ReplyDeleteDoes this mean the system worked?
Just throwing it out there.
Very boring topic - can we move to something with some meat on it like what will happen at NASS?
ReplyDeleteBoring? This guy is just 1 example of an epidemic infecting our entire industry. Companies pay to play, Surgeons looking for handouts, many Patients suffer as a result. We all have surgeons just like this guy in our territories. Don't believe me, just come to Texas...You'd be surprised what a few of these docs get away with. Patients come and go, some get better, some code... Arguably the worst surgeon in my area (who many would consider a menace to society) has some of the highest ratings and gradings from his patients. It's sad, and this stuff goes on everywhere, the only difference is that Makker got caught.
ReplyDeleteA lot of bad doctors are hooked up with a service called Medical Justice which write glowing reviews on the doctor rating sites.
Deletehttp://arstechnica.com/tech-policy/2011/05/medical-justice-caught-impersonating-happy-patients-on-yelp-ratemds/
Think about it. A good doctor who fixes the problem right the first time will not make and much $$$ a charlatan.
Here in the Show Me State, we have our fair share of Pay 2 Play and Black Disc Disease Surgeons. I am wondering if the extra scrutiny that some states are receiving based on procedural volume will make a difference. Let us face the fact that most patients would be better off with physical therapy or a simple decompression... no LIF. When Surgeons start to get payed on results... re-operative, infection, ADD, we may see the tide shift.... Who is holding their breath for that one? I see some of the new Surgeons take a stand on these matters, but they are few and far between.
Deletep.s. I have seen a lot of companies and reps/distributors pay for services that augment negative patient comments. If you want to see a good example check out Lasik Surgeons....
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DeleteWhen is Nuvasive going private?
ReplyDeleteNuvasive, private? Doesn't Alex already run the company as if it's his won anyway?
DeleteWhen they complete the scrub tech shock collar attachment for their surgeon directed monitoring. :)
DeleteWhen is Hans Joerg Wyss going to jail?
ReplyDeleteGreat question. That article in Forbes was scathing.
DeleteZimmer is on the move!
ReplyDeleteYawn.
Deleteorthoimplantcompany.com will certainly put them on the downward move
DeleteMonday night football more interesting
ReplyDeleteLet's move on to NASS - Will Coflex be approved before NASS? - Will NuVasive's booth be smaller this year, Let talk about some important stuff
DeleteCoflex - NASS 2014 you mean?
ReplyDeleteMSM: Any comment on this?
ReplyDeleteThe original patent for Coflex was applied in 1994.
It will be public domain in 2014.
What Patent are you referring to?
DeleteIF, a patent had been filed in 1994 then it would be entitled to a term equal to the longer of 17 years from the date of issue or 20 years from the date of US filing! Which is it?
You can stop asking now, Coflex has been approved!
ReplyDeleteWOW Big News - the market will change. This is good news for spine market. Something new to talk about and less high priced pedicle screws will be used.
DeleteSo Paradigm did all these trials for one year patent protection?
DeleteYes. The PMA will protect the coflex for a few more years but the market will be flooded with copies
DeleteDon't understand your comment. Many PMA products go "off-patent" but copies can't enter the market because they don't have an FDA issued PMA Approval Order. It doesn't matter if you can make exact copies, you need the government-issued license. LCS Knee, Electrical stimulation devices, InFuse (off-patent in 2013/2014), etc.
DeleteBy the way, study coflex patent timing - it isn't 2014... It will be more like 2020 with the clinical trial exemption. But, my point is even then it won't matter - the PMA is a several decade barrier to entry.
Copies don't need PMA approval; but they need the 510k, which is a much shorter and easier process than PMA.
DeleteSeveral decade barrier to entry is very optimistic.
stupidist thing I have ever heard. a PMA does not mean that every company now copy the PMA device and get 510ks.
Deletelooks like the Paradigm marketing team is out in full force trying to get noticed again.
DeleteThe PMA is NOT a several decade (??) barrier to entry (haha). At best the company will have a few years of decent sales prior to competition.
I've been waiting 9 years for something to be invented as simple as the u. Still nothing invented. Once it is need to wait for either motion preservation reclassification or start an IDE. Have fun.
DeleteIn the U.S., does a patent matter when you have a PMA Approval? The answer is NO.
ReplyDeleteSo when will the ip coverage end?
Delete2014
DeleteI'm sure they applied for the clinical study exception prolonging ip coverage
ReplyDeleteyou're right, that's about the only reason a patent can be extended when it's not the uspto's fault. they will have many more years added to the patent in the USA; specifically only the embodiment approved via the PMA, anything else in that patent will keep the original term.
Deletehttp://www.uspto.gov/web/offices/pac/mpep/s2750.html
Coflex is simple which means "only the embodiment" is everything
DeleteThis is interesting: I had a hospital group email me this morning that they are going to "repless" pricing caps in 18 months. Then just an hour ago, another GPO emailed me an RFP specifically with a column for "repless" pricing.
ReplyDeleteWhat is repless pricing?
DeletePricing without using O.R. sales reps therefore not having to pay them commission.
DeleteYes, this is great. Tell the hospital that they can buy the screws for $500 each. Then they need to buy all the instruments and trays and all the stocking inventory. One set of instruments cost $100K plus all the implants needed will need to be purchased in advance. After all, if the rep cant drop off and pick up the trays, the hospital must buy them.
DeleteGood luck with that.
Lol u don't even see problem. $100k instruments? Are you NASA? Cost is coming out of system. 1st the rep then the inventory or vice versa. Lol
Delete5:49 You're obviously not a salesman or even a good businessman.
DeleteIt only takes 4-6 surgeries to capture the cost of instruments in a pedicle screw system. The majority of spine fusion procedures are 1-2 levels. Hospitals realize that it is ridiculous to keep paying hundreds or thousands per case to have someone drop off sets and attend the surgery to simply fill out an order sheet for routine 1-2 level procedures.
DeleteSurgeons want reps all of the time because there is no cost involved out of their pocket. Also, who strokes their ego better than a rep (or picks up lunch and dry cleaning). Certianly not the OR staff! If surgeons were footing the cost to have a rep in the room for non-complicated procedures, the rep would be long gone!
Any smart company will give the hospital those instruments to get that Pedicle screw business.
DeleteWe, industry, have ourselves to blame. By inviting uneducated, unprofessional, unethical people represent our industry to our customers, we have diminished our value. The hospital CAN and will go to a "No rep for every case" model, and everyone will be just fine. The surgeons too... I know, hard to believe. Reps will still have a key role with the account, but not nearly as many (reps). It will be contract driven. Upon conversion, rep will help with delivery and system for stocking instruments/implant reordering. Then will be called upon to do a few inservices... and again as new products launch. These reps can still have a great living if they provide value, and all of the worthless order taking will be gone. Markets do have a way of correcting themselves.... and it sounds pretty good to me... I'll be hangin with my kids... can we get to this repless thing soon!
DeleteIf I were a patient, I would want a rep in the room
ReplyDeleteSunday Op Ed Piece? Still?
ReplyDeleteYup cause MSM SB is jealous of the VBs and wont acknowledge any success.
Deletenot much else worth reporting since Sunday
Delete3:02 pm, I agree having reps in the room does provide an additional level of expertise. But who is going to tell the patient that? Many hospitals have an ever changing staff in the OR and they aren't always familiar with the spine instrumentation. However, when it comes to the bottom line, the hospitals only see reps as one more layer of cost. Interesting that the hospitals will go the direct route but my guess is that it won't have any effect on the patient's charges. First its capitated pricing, now direct buy. Those upcharges to the patient from the hospital were 3,4, or 5 times what the PO to the hospital is and although going direct brings their prices down, yet again, I would think they will still reap these multiples when charging to the insurance companies. Can you say "NONPROFIT"? For years the manufacturers got the "black eye" from the public about rising health care costs, it has been my contention that comes more from inside the institutions rather than outside.
ReplyDelete^^ von Clausewitz
DeleteWe are working on selling directly to the payers. Hospital cuts out the reps, we cut out the hospitals. They're charging multiples of 3 to 5 times the invoice from the vendor. At 50 - 60 % discount that we already have at the hospitals, we propose to charge the payor a small discount off list and we are blowing the doors off what the hospital charges. Helps put a ding in POD's too. If the surgeon really wants to push for his "preferred/cost saving option", he can pay for it, take on the receivable and try and get reimbursed from the payor. Not impossible, but certainly tougher for the POD's. Simple plan, right? When the the fedex or ups ground shipment shows up at the dock, they can double check that everything the surgeon prefers is in the set, the set isn't all jumbled from shipping, and take it over to CSP. If the shipment is lost, delayed or any errors arise, the hospital is responsible to make sure the equipment is there. We can courier another set, but they will pay the freight. Once the surgery is done, the sets need to be cleaned repacked and sent back. If there are missing pieces a bill will follow as well as any additional cleaning fees. Oh yeah, loaner fees apply. The hospital now has their repless scenario they are asking for. It's coming, be ready for it, but we will still survive.
DeleteI used to live in a small town there there were only two super markets. One closed for renovations. The other one raised the price of milk and formula by 100%. As a result the state attorney general arrested the lowly manager for price gouging. He was taken out in handcuffs and it was on the front page of the local paper.
DeletePOD are also illegal. The simple solution is to enforce the law and put criminals is jail.
...and they burned the bad witch at the stake, and the good little spine reps got their income back and lived happily ever after.
DeleteHey 2:41, good luck with going straight to the payers. Yeah the hospitals upcharge, but the payers only pay one lump sum to the hospital for the operation, and that includes the implants. Why do you think the hospitals are pushing for lower prices from us? If they were making multiples on our invoices they'd be asking for us to charge more, not less.
DeleteSo what's the story with Tim Bram from Biodlogics joining forces with of all people, Kyle Webb? Does that make sense?
ReplyDeleteNASS pre-blog? What are the rumors heading into the meeting? Will anything new be debuted at the conference? What will be the big rumblings coming out of the meeting?
ReplyDeleteTSB, c'mon brother, step your game up!! lol
So much going on in spine and MSM is silent.
ReplyDeleteAnyone know if LDR is up for sale? Seems like they are ripe for the picking for one of the big boys...
ReplyDeleteNo future in medical sales......the goverment and hospitals are going to take us out...
ReplyDeleteI hear Stryker interested in LDR
ReplyDeleteWho is having the best party at NASS, and I can I get in?
ReplyDeleteAtec keeps bleeding people, heard the only person that knows spine at that place resigned, great before nass
DeleteCare to share who resigned at ATEC?
DeleteI call BS! Read their reports and news. They unfortunatly just hired in more talent. Oh, and took over two more of our accounts!! Don't under estimate these folks or their reps. It's like watching karate kid. Got beat a couple times and did some serious training..unless you're one of the guys :) lol
DeleteHoly shit they took over two accounts? Call in the horses and bayonets! The only people they should hire is a new plumbing crew because last time I was at headquarters in the Southland I took a monster screamer and it destroyed their piping.
DeleteWhats up with Kyle Webb and Tim Bram from BioD? Sounds like a dangerous combo....
ReplyDeleteDangerous combo like Dirk Diggler and Chest Rockwell from Boogie Nights. Exactly like that in fact.
DeleteKyle Webb? Mr. Champagne Wishes and Caviar Dreams. A recipe for disaster. Promises the world and then delivers bupkiss.
ReplyDeleteAny new updates from the NASS Meeting
ReplyDeleteHave you not heard? They cancelled NASS this year because attendance was going to be way down this year.
DeleteCertainly...everyone there is a corporate dildo and wasting the companies money or if independent wasting their own. You are all trolls.
ReplyDeleteMM must be dead or else she better be working on the October Surprise.
ReplyDeleteIn a case today with the doc. The daughter is the PA and the PA's husband, the doc's son in law, is the rep. Life is good........
ReplyDeleteMakker should be thrown in jail. Loss of his license is almost as bad as the Oregon Medical Board punishing him with having to take a billing course. The only justice would be for this guy to not be able to make a buck from this point on.
ReplyDeleteI know this is a couple of weeks old but after coming across it I really had to comment. I formally worked for the health care system that Dr. Makker worked at and they were made aware of concerns with Makker long before the WSJ got a hold of the information. Only after the article came out did they make a move to do something about it and attempt to disassociate themselves. In my opinion the hospital is very much responsible for monitoring the activities of their physicians and respond appropriately when the need arises. I heard a physician say that no one wants to speak out about the practice of another physician because everyone starts to "lawyer up"....... so what. Lawyer up and do the right thing. It sickening that patient morbidity and mortality at the hands of a physician and a hospital system that are more concerned about financial gain then actual quality care can write it off as collateral damage or being within "national averages".
ReplyDelete