Merrill Goozner’s piece on the FDA’s decision to pull a stent from the market after it was shown “2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%).” shows how science can – and should – be brought to what is all-too-often the “art” of medicine.
The stent was approved based on a rather limited study by manufacturer Stryker, but fortunately only approved for use if it that use was as part of an evaluative study.
That study was stopped early due to the higher death/repeat stroke rate; unfortunately it appears that use of the stent may have played a role in patients dying and/or having more strokes.
The good news is the stent is, or soon will be, off the market. The bad news – outside of that delivered to the families of those who died possibly as a result of the stent – is that this is actually “news”.
The reason this device was pulled from the market is because it was only approved on a limited basis by the FDA, who could pull that approval relatively easily. For devices and drugs and treatments already approved by, or not subject to approval by, the FDA (or any other regulatory authority) it is much more difficult to get them off the market. And it’s impossible for Medicare to factor effectiveness into payment.
If we are to gain any measure of control over health care costs, we have to start by paying for performance – not just for docs, but for drugs and devices as well. One wouldn’t think that would require the proverbial “Act of Congress’, but it does.
Perhaps the Super-Committee can decide that one way to attack the deficit is to stop paying for unproven treatments, or at least stop paying so much if the treatments aren’t proven to be effective. Can you imagine what that would do to health care? Actually paying for good stuff rather than paying for anything that gets prescribed for/inserted into/done to a patient?

Everyone seems convinced there’s a ton of fraud in Medicare. And they may be right. What there wasn’t, for far too long, was much emphasis on finding and prosecuting the criminals stealing from taxpayers by defrauding Medicare.
Well, looks like that’s changed. This ‘story’ was first broken a week ago by Merrill Goozner, one of the more insightful observers of the health care scene. Here’s a piece from an OIG release quoted in Merrill’s post:
“Since their inception in March 2007, [CMS anti-fraud] Strike Force operations in nine locations have charged more than 1,000 individuals who collectively have falsely billed the Medicare program for more than $2.3 billion.”
CMS’ anti-fraud efforts are finally getting some press. For instance, prosecutions are up 85% over last year. Compared to five years ago, there’s been a 71% increase. It takes quite a bit of time to develop a prosecute a health care fraud case, as laws and regulations are quite complex and often confusingly contradictory; following the paper trail is difficult at best; and company ownership and fiduciary responsibility usually hard to identify and even more difficult to prove; thus it’s no surprise it’s taken a couple years for the Obama Administration to start to produce major results.
According to the piece in FierceHealthcare;
“The government prosecuted 903 cases of healthcare fraud, up 24 percent from last year, reports USA Today. The increased numbers come from more investigations under the close attention of the Federal Bureau of Investigation (FBI) and the Medicare Fraud Task Force, as well as the participation of whistleblowers. The FBI recently changed their focus to target criminal enterprises, including hospitals. In 2010, the government paid out $300 million to whistleblowers.”
Health care geeks may recall that the PPACA was supposed to deliver $4.9 billion in savings over ten years due to better controls over fraud and abuse. Looks like that was a ‘gimme’, as the GAO reported savings in 2010 alone were $4 billion.
These prosecutions often netted criminals defrauding commercial insurers as well as we taxpayers – one case in Puerto Rico nailed hundreds of crooks who stole $7 million from AFLAC.
Another CMS-led effort earlier this year resulted in indictments of 111 individuals for allegedly defrauding Medicare of $225 million.
That’s all to the good – perhaps as much for the ‘Sentinel Effect’ as for catching these thieves. Others who may be tempted to steal from the Feds or commercial payers may be a bit de-motivated when they hear about prison terms and hefty fines levied against others with the same idea.
There’s no question Medicare is a prime target for crooks large and small. After all, it’s a program that pays out billions each year, so there’s bound to be fraud. Commercial health plans, workers comp insurers, and other payers are certainly vulnerable and often victimized as well. Here’s hoping the recent press attention leads to even more attention on fraud, and more convictions as well.
What does this mean for you?
Are your SIU people tied into the CMS Strike Forces, sharing information and collaborating on investigations?

In MCM’s ongoing effort to keep our loyal readers apprised of things that will affect their businesses, it’s time to remind one and all that the Super-Committee’s budget cuts are due in less than three months.
Yep, in 83 days or so, six Republicans and six Democrats are supposed to come up with (at least) $1.2 trillion in cuts. If they don’t, automatic cuts will be triggered beginning in 2013, including a two percent cut in Medicare (and that’s assuming the pending SGR cuts hit on January 1…)
Couple of key points that bear mentioning;
1. the $1.2 trillion is spread over the next decade. Cuts could be back-loaded to minimize political fallout – and probably will be (if the group reaches agreement)
2. the automatic cuts take effect January 2013 – a lifetime away in political terms. Congress could do something else to prevent some of the automatic, or Group of Twelve cuts from occurring, modify the cuts, or pass a “fooled you, we were just kidding” law.
Back to the committee. As we’ve noted, it’s difficult to see how they can hit their target unless health care is addressed.
There’s no consensus on whether the twelve will manage to reach consensus or not. With an election year coming up, it’s hard to see how the GOP’s folks will agree to any kind of revenue increases, while Dems have been quite public about their intent to prevent cuts to entitlements. And if they don’t, as Steve Davis noted in an online piece on AISHealth, “Across-the-board reductions in Medicare payment could translate to more cost shifting by providers, which could lead to higher premiums charged by commercial plans and/or increased cost shifting onto employee-based coverage”.
That said, there’s some hope that statesmen-like traits will somehow take hold in the group and we’ll actually see them arrive at a grand bargain. If such a happy event occurs, expect to see:
– subsidies for Medicare Advantage programs cut
– a potential increase in eligibility age for Medicare recipients
– decrease in hospital reimbursement under Medicare
– means testing premiums for Medicare
You’ll note these are all focused on Medicare. Medicaid is unlikely to be cut dramatically – but then again, we just don’t know.
This all supposes the SGR cuts to physician reimbursement actually take effect on January 1 2012 – which is about as likely as our house getting power this week (no chance at all). If it doesn’t, there’s another $300 million or so in cuts that will have to be made.
What does this mean for you?
Watch carefully what happens with the Super Committee…It WILL affect you.