Thursday, March 28, 2013

Here Comes The Rain Again!

Here comes the rain again, falling on my head like a memory, falling on my head like a new emotion
I want to walk in the open wind, I want to talk like lovers do, I want to dive into your ocean, Is it raining with you?

Yes fellow bloggers, here comes the rain again, it's the time of the season when love runs high at the OIG. That acronym stands for the Office of Inspector General. On March 26th, 2013 the OIG issued a special fraud alert for physician owned entities. Wah! Wah! Could the Federalis have finally come to their senses? I mean they have gone after Julian Assange, Pvt. Bradley Manning, internet wiz kid Aaron Swartz, while giving Wall Street a pass, claiming that they are TBTF but also too big too prosecute. Oh, who said crime doesn't pay?  Where's Vanilla Ice when you need him? As POD's and POC's continue to proliferate the medical device sector, while dividing companies against physicians, physicians against salespeople, the OIG's concerns focus on the strong potential for improper inducements between and among physician investors, the entities that they are involved with, device vendors, and device purchasers.

Essentially, the penultimate question remains; "do POD's and POC's violate anti-kickback statutes?" For years, this issue has been debated. Does this type of business model affect a surgeons decision making process? The last five years in spine has tarnished an industry that was once respectable. From the Wall Street Journal to the NY Times, from Long Beach, California (can I hear casino backed medicine?), to Tennessee, Mississippi, and Alabama (the birthplace of POD's?), to Florida, to The Spine Blogger, POD's and POC's have been subject to scrutiny. As TSB claims ever since private equity and orthopedic investment banks took hold of the opportunities to capitalize and profit in a healthcare market that had very little oversight provided by the government, everybody has partied like its 1999.  The foxes have been guarding the hen house. Yet, slow but surely all things must pass. As Glenn Frey once sang, "the heat is on!"

Systemic abuse in healthcare is rampant. From the hospital CEO's and facilities hiding behind "non-profit" tax exemptions, to the physician consultants, to the insurance industry, to device companies, to the hospital staff, to RapeTrax and VendorRape (that's the next scam that needs to be investigated), to salespeople, to investors, everyone needs to take responsibility for their actions and how those actions have contributed to the rise and fall of the American healthcare system. From patients who cannot control their vices, to greedy investors who cry about FDA oversight because time and money drive their thoughts, to greedy surgeons who probably hate their medical careers only to moonlight as fictitious entrepreneurs, to those whom complain about entitlements only to use their Medicare at every chance they get, everyone gets some blame. Anyone who denies that their personal and professional judgement is not tainted by having a vested financial interest in a POD or POC is higher that Hunter Thompson leaving Las Vegas.  

If a group of slimy surgeons start a POC and are the only customers using the product, or, are enticing other physicians to use their product by providing them with an inducement, isn't that illegal? The definition of inducement is something that motivates, stimulates, or creates an incentive, and what better way to incentivize a surgeon? The only way you make more money as a surgeon is by performing more surgeries. Let's take some examples. Say a start-up company that has plenty of cash decides to hand out equity in return for sales volume, is that an inducement? Wouldn't having a vested interest in the success or failure of a medical device company be construed as a inducement? Especially, if the surgeon had the ability to drive up the valuation of the company by implanting more product?  Let's try another example, let's say a company created a platform whereby they subsidized a Fellows or residents start-up practice in exchange for their loyalty meaning only using their product, could that be construed as an inducement?  Say ten surgeons invest one hundred thousand dollars each in a company and only use that specific company's products, regardless whether those products have the same quality or meet the safety standards of a competing product, is that good medical judgement? Let's say the implants break, or the rod reducer malfunctions every time the surgeon uses it, resulting in a fracture of the patient's pedicle, and the surgeon investors fail to report it to the FDA because they have a vested interest in the company, is that good medical judgement? Let say you have a pedicle screw head that splays in-vivo, you change the design without notifying the FDA, and the surgeons that are getting paid to use the product never report it to the FDA, is that legal?  Let alone do they have the incentive not to report it? These are the types of scenarios that patients and the government are not privy to until some individual risks his or her career and files a whistleblower complaint or a patient gets hurt or killed. There is no oversight.

Isn't it interesting that the states where activity has been rampant include, California (there's gold in 'em hills), Utah, Alabama, Texas, Mississippi, Florida, and Tennessee, just to name a few.  I mean, even Nuvasive has complained about POD's affecting their business. If you prey on the elderly (Medicare patients), the uneducated, the misinformed, the helpless, PODs and POCs have torn down a once respected profession and industry. As my granddaddy use to say; "if you hate your career, do something different." There will be complaints about big brother imposing more rules and restrictions. About tort reform, about Obamacare. That will be construed as nothing more than an irrational projection on who is to fault for the state of the U.S. healthcare system. There will be complaints and arguments made about how much it cost to get a medical education in the United States. Here's a clue, don't go to medical school. Yet, this isn't really about free markets, it's about patient safety, it's about the publics safety, it's about abusing the Medicare system whether our readers believe it or not. There have been more than one Dr. Makker's in the industry. Unfortunately, he was not only greedy but a terrible surgeon.  Where was the oversight?  When your own peers are not willing to condemn you and exile you until there is public outcry, what type of society have we become?  Just read some of our readers experiences while working in spine. We have become a society that the end (making a lot of money) justifies the means. Money obfuscates reality.

Corruption of medical judgement? Overuse to increase the cost of Federal healthcare programs? Unfair competition? Not in spine. No siree! When you control whose product you will use, how many times you use it, and where you will operate because you have a financial interest in an entity, is that a free market? After twenty-five years in the device industry, something is amiss. Those who are involved in POD's or POC's will wrap themselves in an outcry of "free markets." They will say that we are becoming a socialist society, but even free markets must have rules. That is why you can't drive at 120 miles an hour in a 55 speed zone, or yell "fire" in a crowded movie theater. Without rules we become a lawless society with no boundaries.  Just look at where we are today?  As Yogi Berra use to say, "when you come to the fork in the road, take it." TSB wants to know what our readers think?

Wednesday, March 6, 2013

Talk About Circling the Bowl - Spine Frontier

Word on the Street is that Spine Frontier, a company where no man has ever gone, traveling through multiple galaxies, light years ahead of its time beyond Mars, (isn't there some millionaire that wants to fund a trip to Mars) is lying in the spine industry's intensive care unit looking for another sucker, oops, TSB means another investor that can set up a  life line and infuse some capital into a hemorrhaging and dehydrated patient. Oh Kingsley (is it Ben), as George Harrison stated, sooner or later "all good things must pass." There's birth and then there's death. How many people have taken precious time to listen to the Spine Frontier story? It's a solution to a problem that really doesn't exist at least on a major scale.  This has been more theater than anything else. Like Trans 1 and Baxano, maybe SF can cut a deal with VTI, they know how to burn through cash. Who knows, maybe it would resurrect Touchdown Tommy's career? Is he still stuck in the Heisman pose? It would be entertaining witnessing the blind leading the blind. Anyway, TSB has alerted the coroner, the body bag is ready, unfortunately, we have been informed that before they pick up the body they would like prepayment.  Hi, Ho, Hi, Ho, it's off to play we go

Monday, March 4, 2013

Trans 1 Buys Baxano

Today's news flash pertains to the acquisition of Baxano by Trans 1.  As TSB would ask, where's the synergy, or is there any synergy?  You be the judge.  Could this be a strategic move to bolster their product portfolio.  How much has this deal diluted the stock? Is this a deal made in heaven or made out of desperation.  And who wins?  At least on the surface the people that started Baxano, at least on paper.  TSB wants to know what our readers think?