Medicare Fraud

Medicareless

Are we doing all we can to prevent Medicare fraud?

Last Friday, the Wall Street Journal[http://online.wsj.com/article/SB10001424052748704657704576150293189313156.html] reported that 114 doctors and other professionals have been arrested for fraudulent Medicare claims, ranging from “unbundling” procedures that should have been billed together for a lower cost, to charging for extensive and expensive procedures that were simply never performed. The FBI crackdown led to arrests in nine metropolitan areas across the US, uncovering roughly $240 million in fraud.

This series of arrests is an interesting development in the world of Medicare fraud—the doctors worked alone or with few accomplices, rather than in a network. Compare that to the 2010 arrest of a ring allegedly led by Armen Kazarian. In the Kazarian ring, the fraudulent claims are thought to have been submitted by non-doctors using the stolen identities of real doctors and patients. Authorities claim the network brought in $100 million in fraudulent revenue, according to MSNBC[http://www.msnbc.msn.com/id/39657964/ns/us_news-crime_and_courts/].

Neither of these enforcement crackdowns is even vaguely assumed to be a majority of, or even a major portion of the total Medicare fraud that exists in the country today, and the money recovered by both the 2010 and the 2011 operations combined would account for seven hundredths of a percent of the $452 billion dollars in federal spending on the program in 2010. But if Medicare is seen as a program that is easily gamed and poorly policed, it seems likely that in the long term, it will cease to perform its intended function. Indeed, in our politically turbulent time, it may one day disappear completely.

Dow Jones, last month, filed papers to obtain access to Medicare records. If Dow has its way, a 1979 ruling in favor of the American Medical Association will be overturned, allowing the public to see the records. The AMA’s concern, then, and most likely now, is privacy. And this is where it gets tricky. If the records are allowed to remain completely private, the Medicare Fraud Strike Force (consisting of FBI, Health and Human Services, and Department of Justice officials) will be only body that can provide Medicare oversight. If the records are opened, patients’ rights may be violated.

This appears to be an unresolvable situation, but if doctors and patients want programs like Medicare to continue, they’ll have to prove to a hostile crowd that the programs work, and that means both decreasing the amount of money billed and decreasing the amount of fraud that’s committed. It means moving beyond a perfunctory nod to the education of doctors and patients on identifying and reporting fraud, waste, and abuse.

Take, for example, the way to get teachers to stop cheating for their students on proctored exams. Early in the last decade, Steven Levitt and Brian Jacob, experts in behavioral economics, were hired by then-chair of Chicago Public Schools, Arne Duncan (now head of the US Department of Education), to find out which teachers were cheating. Having selected some suspicious and some non-suspicious teachers for the test, they allowed the teachers to proctor their exams like normal, then re-tested the students with different proctors. The results were predictable; suspicions were largely confirmed. The upshot, though, was that after the resulting wave of firings, cheating in the next year declined 30%.

Unfortunately, we're still left with the question: how do we beat Medicare fraud?

Hunting Demons

Originally posted in Feb 2011

Tuberculosis should be extinct, but it’s not.

An editorial in the most recent Lancet notes that in 1911, the journal’s editor wrote that he was looking forward to the day when “the demon of tuberculosis” would finally be eradicated. Though society and medicine have, of course, made great strides in the last 100 years, the “demon” still exists, especially among homeless populations in large cities.

The writer of this year’s Lancet editorial notes that in Toronto, the percentage of homeless people who die within after diagnosis has remained unchanged over the last ten years. Getting people diagnosed, and after diagnosis, getting them to follow medication dosing instructions are complicated tasks when patients are homeless. New York City’s approach is called “active case finding” and it involves going out into the streets and finding people who need treatment. Patients are admitted to an intermediate care facility, where their treatment is monitored.

Tuberculosis rates are declining in New York City, as reported in this New York Times blog, such that the vast majority of cases in the City now are immigrants from other countries. While such a decline could be due to a number of factors, it’s quite possible that this case finding program is responsible for the drop. What appears to be true in either case is that, as far as TB risk goes, you’re better off as a homeless New Yorker than an immigrant. What’s more, multi-drug resistant TB in New York is nearly gone, with only eight cases reported in 2009.

The Lancet editor notes that London uses a similar program that is in jeopardy. Find and Treat is the name of the organization that does case finding for London, and the British National Health Service is about to put the responsibility for “commissioning”, running the day-to-day treatment operations of NHS within communities, into the hands of general practitioners, who may choose to end the relationship between NHS and Find and Treat.

The editor’s fear may turn out to be unfounded. Let’s all hope this is the case.

The Long View

originally posted Feb 2011

A tribe in Ecuador is impervious to cancer and diabetes. How does that help us?

NPR reports on the existence of a tribe in Ecuador that never gets diabetes and very rarely gets cancer. Valter Longo, gerontologist at the University of Southern California, was studying genes responsible for the development of cancer, and had already increased the lifespan of a yeast colony tenfold by disabling genes and feeding the colony fewer calories. The two genes he was researching, RAS2 and SCH9, have mutated in a population of Ecuadorian dwarfs, giving them nigh-immunity to cancer, and apparently complete immunity to diabetes.

The Ecuadoreans affected are a very limited population, as anyone who has one or the other of the two genes in a normal state lives a normal life, both with regards to height and susceptibility to cancer and diabetes. The obvious question then is: Are we going to have to shorten the height of the human race in order to lengthen its lifespan? “No,” says Dr. Longo, “the results suggest that after we grow to normal size we could either use dietary or pharmacological interventions to decrease specific growth factors, to divert energy from cellular growth and reproduction to protective systems. This switch could be reversed when needed,” for reproduction, to fight disease, or to heal physical damage. Essentially, this would mean that our bodies would run on lower power, diverting energy from non-essential functions to avoid the possibility of cancer.

As you’ll recall, Longo’s experiment with the yeast had two parts: knocking out genes, and lowering caloric intake. It appears that if humans want to use a similar method, a decrease in caloric intake is not optional. A breakthrough of this magnitude would have serious implications for agriculture, foodservice, and pharmaceuticals, and would likely receive a lot of resistance from groups that stand to lose a lot of money in a post-cancer, low-calorie world. And maybe that’s not actually as nasty as it sounds—don’t we want a treatment that could change the entirety of human existence to undergo serious scrutiny?

Here’s a thought, though, on the matter of surviving on fewer calories for longer times: It might also have a seriously positive unintended consequence. That is, ending world hunger.

What do you think? Is this something we’ll see in our lifetimes? Valter Longo guesses that twenty or thirty years from now we might be able to knock out these genes. Is that too optimistic?

Attribution Error

Originally posted Mar 2011

Q: What happens when a professor visits a corporation and devises a groundbreaking AIDS test? A: Chaos.

On Monday, the Supreme Court of the United States head arguments in Stanford v. Roche, a case that will likely lay the first significant amount of case law regarding the transfer of patents from universities to corporations. The dispute centers on a patented method of testing patients for AIDS, developed by Stanford professor Mark Holodniy while working with Cetus, which later sold the patents to Roche. Dr. Holodniy apparently signed a document that assigned rights for any of his discoveries to Cetus before beginning a collaborative effort with them.

It seems open and shut from here—the man signed a contract. However, the collaboration was federally-funded, it appears, and that changes everything. The 1980 Bayh-Dole Act allows universities to retain (and sell) rights to discoveries they make as a result of federally-funded projects, and has no provision for individuals to waive those rights on behalf of the university. In fact, the Bayh in Bayh-Dole, former Indiana senator Birch Bayh, sides with Stanford, as does the Department of Justice.

What’s interesting about this case is that Dr. Holodniy actually learned some of the essential process from Cetus. According to the Silicon Valley Mercury News, Holodniy learned the process of polymerase chain reactions (PCR) at the Cetus facility, according to the Mercury News report. As the AIDS test Holodniy developed requires PCR as part of the procedure, it seems that no matter who wins this case, justice will not be served.

Let me explain why I say that. Dr. Holodniy clearly joined Stanford University first, and signed away all of his inventions to the university, then joined the visiting scientist program at Cetus as a representative of Stanford. Clearly holding in favor of Roche would be unfair to Stanford, as Holodniy’s contracts with the university are clear. However, the test was designed at the Cetus facility, using equipment and expertise that originated with the company, so finding for Stanford would be unfair to Roche, and to Cetus, who made money by selling the testing products.

Catherine Fisk, law professor at Duke University wrote a paper on attribution of inventions, which points to the way to fix this problem: “The criteria for granting credit should be relatively transparent or publicly known. Transparency motivates people to do the work to earn credit and enables people to conform their conduct so as to avoid blame.” In this case, the criteria for assigning rights to inventions produced during the collaboration should have been made clear beforehand, and any companies and universities engaging in visiting scientist programs should have the foresight to put it in writing before that professor crosses the threshold of that company.

What do you think? Is that even reasonable, or should universities rely on Bayh-Dole to maintain their intellectual property? Whose side do you take? Let me know in the comments.

Cliff Diving

Originally posted Feb 2011

With drug patents expiring left and right, Big Pharma stares into the abyss.

The patent cliff: Market watchers have been talking about it for years (as this Reuters article shows) and it’s finally here. This is the year that a huge number of patents on big-money drugs start running out, and, deprived of their cash cows, major pharmaceutical companies start to have serious cash flow difficulties. Among the drugs with patents expiring in the next 24 months are cholesterol drug Lipitor, the anti-clotting drug Plavix, asthma drug Singulair, and, well, Viagra.

In the US, drug patents are good for 17 to 20 years, after that anyone can create a generic version. Generic drugs are usually far less expensive than the original, of course. One such case is the sleep drug Ambien, which costs $159 per 30-day prescription. Generic zolpidem tartrate (the drug's chemical name) costs $3 for the same amount.

Cheap generic drugs for patients mean big losses for pharmaceutical companies. The drugs that are going off patent have been major sources of revenue for these companies. And at least thirteen of the biggest money-maker drugs are going off the market by 2012, taking millions of dollars of profit with them. Decreasing revenues for pharmaceutical companies may mean decreasing spending on R&D which translates into fewer new drugs. Already these companies are finding it difficult to get new drugs approved by the FDA, and its just going to get worse.

The facts are pretty stark, and everybody knows it. Here is an (almost) random sample of the headlines: “Patent Cliff Means Panic Time For Big Pharma”, “Big Pharma Hits the Panic Button...”, “Big Pharma Patent Expirations to Sock 2012 US Drug Sales.”

I don’t want to be a party-pooper here, but I have an impolite question for you: Is the apocalypse really such a bad thing?

Think about it. Why don’t those headlines say, “Lives to Be Improved By Cheaper Medication!”, “Generics Increase to Make Treatment Easier for Patients and Doctors”, and the like. (Full Disclosure: There was one “10 Biggest Selling Drugs Could Become Cheaper” from a CBS affiliate in Pennsylvania). Because if you take the broad view, society will probably be better off after Patent Armageddon. Life will be better for the sick and underfunded, and the doctors that treat them, and the taxpayer in general -- which includes all of us. So, here’s to the cliff...it can’t come fast enough.

The Truth About Potassium Iodide

originally posted Mar 2011

Fact-checking stories about radiation sickness and the potassium iodide prophylactic.

Since the March 11 earthquake in Japan and the subsequent failures of nuclear reactors at the Fukushima Daiichi power plant, there has been an impenetrable cyclone of news coverage about the effects of the reactor failures, including stories of a radiation plume billowing across the Pacific Ocean and into the United States. The Guardian reports that reserves of potassium iodide are low in the Western US, depleted by fears of contamination from Japanese fallout. Potassium iodide is often included in survival kits for its ability to prevent thyroid cancer in case of airborne radioactive iodine, a common byproduct of a large-scale radiation leak.

The media coverage to the upsurge in potassium iodide sales has been largely negative, with two major emerging complaints against potassium iodide buyers. The first is that they are running the risk of major side effects by taking the compound in doses recommended for cancer prevention, and the second is that the pills are in such limited supply that buying them depletes the reserves for those in Japan who may need them. (You can find these two opinions are laid out very well in this article from Boing Boing.)

Digging a little deeper, though, we find that a number of factors appear to invalidate these claims. Let’s look at them one by one.

First, that those who take potassium iodide at levels effective for the prevention of cancer run the risk of serious complications. The major problem here is allergic reactions, which for this compound are linked with shellfish allergies. So, while the pills could have serious effects for those who are allergic, less than 2% of Americans have shellfish allergies.

There are some much worse effects that can occur due to constant excessive ingestion of potassium iodide, but that doesn’t seem to be the issue here. The prophylactic dose is lower (100 vs. 150 mg) than the dosage that has been implicated in the worst of these complications: neck swelling, lack of appetite, lethargy, vomiting, and irregular heartbeat. And even that high dosage, these symptoms are only considered possible side effects. Much less scary than your average pharmaceutical TV ad.

As far as there not being enough potassium iodide to go around, there is a certain amount of truth to that claim: the three major American suppliers of potassium iodide are out of pills (due to have them again in mid-April). Indian distributors, however, are not at all difficult to find—a quick Google search unearths a number of them. Certainly there are Russian and European distributors as well, not as heavily depleted by the scare, as they are predicted to receive an even smaller dosage of Fukushima radiation, even later.

In sum, the side effects from anti-radiation pills are largely overblown, and the the shortage is mostly bogus.

Lost in this particular debate is the fact that levels levels of radiation that have reached the United States are small enough that EPA monitoring stations are not consistently able to find an increase in radioactive particles. So go ahead and take your potassium idodine if it makes you feel better. Or your sugar pills, for that matter. Because at this point, what we are talking about is a placebo cure for a non-existent illness.