Healthcare IT Timing "Cemented in Law?" A Healthcare Renewal Contest

I am quoted in the article "Liability an issue with health care software" in today's online edition of NextGov.com (link to article).

Nextgov.com is part of the National Journal Group Inc. and the Atlantic Media Company. It is a spin off of Government Executive.com and provides coverage and commentary on the management of information technology in the federal government.

Read the whole article. I reproduce a part of it below for the purposes of sponsoring the first ever Healthcare Renewal contest.

The rules are simple. Add to the blog comments section your best explanation of the interesting phrase in the last sentence of the excerpt, bolded below. The best comment will get an honorable mention appended to the text of this posting.

Keep in mind that the laws regarding health IT appeared in H.R. 1 EH, a.k.a. the Economic Recovery Act of 2009, with little or no public discussion regarding incentives, penalties or timing. See Div. B Title IV, Health Information Technology (Word file extract of a version of the bill from a few months ago) to review the Act's text on HIT.

With that in mind, here is the excerpt:

... Health IT provisions in the economic stimulus package are integral to Obama's overall health care agenda, and give doctors and hospitals incentives to adopt certified electronic records by 2014. The Recovery Act appropriates about $20 billion in Medicare and Medicaid incentives to meet that goal.

Professionals who deploy certified electronic health records between 2011 and 2014 will be eligible for Medicare bonus payments, while hospitals that implement certified e-records by 2015 also will get bonuses.

Scot M. Silverstein, a medical informatics consultant, adjunct professor at Drexel University and former director of Drexel's Institute for Healthcare Informatics, said the timeline for adoption should be extended. Starting in 2015, the administration plans to dock Medicare payments for professionals and hospitals that fail to use certified e-records.

"I think the punitive aspects that kick in need to be eliminated," Silverstein said. "I think the government needs to re-examine its justifications for shoving IT down doctors' throats by 2014."

David Blumenthal, Obama's national coordinator for health information technology, said the government will tighten oversight of the certification process to address such concerns.

"Right now, we are reviewing that process to see how it can provide stronger guarantees that [products] will perform as they are promised to perform," he said. But the timelines for rollout of health IT are cemented in law, he noted.

"Cemented in law?" Your comments, please.

-- SS

Novo Nordisk Accepts Deferred Prosecution Agreement, Settles, Pays Fine

Back in early 2007, we noted that several large drug companies were under investigation for possible involvement in the Iraq oil-for-food sanctions scandal. More than two years later, a US Department of Justice press release from last week includes the following:

Novo Nordisk A/S (Novo), a Danish corporation based in Bagsvaerd, Denmark, has agreed to pay a $9 million penalty for illegal kickbacks paid to the former Iraqi government. Novo agreed to pay the fine as part of a deferred prosecution agreement with the Department. The matter is part of the Justice Department’s ongoing investigation into the U.N. Oil-for-Food program.

A criminal information was filed today against Novo in U.S. District Court for the District of Columbia charging Novo with one count of conspiracy to commit wire fraud and to violate the books and records provisions of the Foreign Corrupt Practices Act (FCPA). Novo, an international manufacturer of insulin, medicines and other pharmaceutical supplies, has acknowledged responsibility for improper payments made by its agents to the former Iraqi government in order to obtain contracts with the Iraqi ministry of health to provide insulin and other medicines. The agreement requires the company and its subsidiaries to cooperate fully with the Justice Department’s ongoing Oil-for-Food investigation.

According to the agreement and the information filed today, between 2001 and 2003, Novo paid approximately $1.4 million to the former Iraqi government by inflating the price of contracts by 10 percent before submitting the contracts to the United Nations for approval and concealed from the United Nations the fact that the price contained a kickback to the former Iraqi government. Novo also admitted it inaccurately recorded the kickback payments as 'commissions' in its books and records.

In recognition of Novo’s thorough review of the illicit payments and its implementation of enhanced compliance policies and procedures, the Department has agreed to defer prosecution of criminal charges against Novo for a period of three years.

Also,

In a related matter, Novo reached a settlement today with the U.S. Securities and Exchange Commission (SEC) on a complaint and agreed to pay $3,025,066 in civil penalties and $6,005,079 in disgorgement of profits, including pre-judgment interest, in connection with contracts for which it paid kickbacks to the former Iraqi government.

Note that so far I can only find coverage of this story in this brief piece from Reuters.

So here we go again. Yet another big health care corporation, in this case, an international pharmaceutical company, admits to criminal conduct, and agrees to operate under a deferred prosecution agreement, while also paying additional millions in a civil settlement. In this case, the amounts of money paid were not particularly large, but the nature of the conduct involved, involving paying to play with a particularly notorious dictator, was striking.

Like most cases involving settlements for unethical behavior, or even deferred prosecutions or convictions for criminal behavior, this one has attracted almost no attention. Have such stories become like "dog bite man" stories, so commonplace that they deserve no notice from a public that has become cynical?

As we have said before, while human beings authorized or committed the acts that got the organization in trouble, rarely do these people seem to suffer any negative consequences. At most, the organization may pay a fine. In this case, the fine was, in corporate terms, tiny. However, even a large fine, however, may come out of dividends or the stock price, dispersing the cost to stock-holders, or out of salaries across the board. Thus, those who got the organization into trouble are unlikely to feel pain from it. Perhaps because of reverence for all organizations related to health care, and fear that the bankruptcy of any health care organization, even a health care insurance company, will leave patients in the lurch, prosecutors do not seem inclined to actually prosecute such organizations. The net effect, though, seems to be that dishonest executives of health care organizations can continue to act with impunity.Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.

Hat Tip to the White Collar Crime Prof Blog.

Dangerous Games and Health IT Feudalism

I am reposting a provocative open letter from Ignacio Valdes, MD, MSc (a proponent of Open Software and proprietor of the LinuxMedNews blog) on the revelations about Health IT by Penn sociology professor Ross Koppel and by Washington Post reporter Robert O'Harrow, Jr.

While I am not predicting nor recommending the elimination of the commercial HIT sector (just its major reformation!), Dr. Valdes makes many valid points about the current state of health IT and the value of open source solutions. VistA/CPRS and its derivatives are one example of an open source EHR. (Note: Dr. Valdes is an acquaintance from informatics meetings; I have no commercial connections or financial interests in his business affairs).

I cannot add much more to the letter's sentiments:

Dangerous Games and Health IT Feudalism.

From: LinuxMedNews announce -- breaking news of Free/Open Source in medicine.
To: linuxmednews-announce
Date: Mon, 18 May 2009 12:43 pm

Dr. Koppel,

This is an open letter that I plan to publish on Linux Medical News and elsewhere. As you probably know, your JAMA 'Hold Harmless' article presents just the tip of the iceberg. Your article and more data from the Washington Post article (link) make it abundantly clear that proprietary vendors are intent on establishing private property rights for something that private property rights are clearly not appropriate for.

It leads to the logical absurdities, expense, and moral hazards we are experiencing now. The obvious dangers, enormous conflict of interest, as well as highly practical considerations such as simple non-performance of proprietary Electronic Medical Record software is manifest. What the proprietary industry could not achieve with vendor lock-in, legislative help like Stark exceptions, trade secrets, and inadequate products they are attempting to achieve by pure politics. Politicians, proprietary vendors and its lobby are playing 'heads we win, tails you lose, we are king, it is good to be king' games with our safety, our privacy, taxpayer money, and our lives. This may well succeed in ushering in a kind of digital feudalism with the most intimate details of our lives. Such landlord type games are entirely inappropriate for the practice of medicine. They are antithetical to American history and values. A generous and virtuous society should not allow this to occur.

The medical profession no longer condones even 15 cent pens with pharmaceutical company logos on them because of the moral hazard and the perception of untoward financial coercion. Yet we are now by law embarking on a program of essentially bribing physicians with approximately $40,000 each of taxpayer money and then punishing them if they cannot be bribed in order to implement problematic proprietary health IT loaded with legal, financial, and practical minefields. Have we as a nation taken leave of our senses?

The Free/Open Source licensing in medicine crowd has been discussing these issues and showing demonstrable results for years but has received little attention and practically no funding. We have the legal, practical, and licensing means for achieving the transparency and rights guarantees that nearly everyone says that they want, solving many practical as well as moral issues. The AMIA Open Source working group white paper can be found here
http://www.amia.org/files/Final-OS-WG White Paper_11_19_08.pdf

Unfortunately, it was rejected from entering into the scientific literature by JAMIA on a technicality and voted down by the AMIA board of directors as AMIA policy on methodology and 'ideological' grounds. Such a stance and public declarations by AMIA's leaders seems to be in direct conflict with AMIA's mission.

Relying on government bureaucrats, proprietary vendor lobbies, and marketing representatives giving "trust us" type guarantees versus legally enforceable Free/Open Source licenses is a recipe for national disaster. Again, a generous and virtuous society should not allow this to occur. A practical solution is a law that only allows taxpayer money to be expended only for Electronic Medical Record software that is licensed only with Free Software Foundation approved licenses. Preferably the Affero General Public License which closes the software as a service loophole. The nations health, privacy, safety, finances and destiny are at stake.

Sincerely,

-- Ignacio Valdes, MD, MSc

-- SS

Wall Street Journal Letter Revisited

I believe yesterday's Washington Post article The Machinery Behind Health-Care Reform confirms that my Feb. 18, 2009 letter to the editor published in the Wall Street Journal was on the money (yes, that is a pun):

I wrote:

Dear Wall Street Journal:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Lobbyists do tend to present the rosiest picture possible to those with the gold. It appears the myths surrounding health IT have been deliberately engineered.

I believe it now essential and indeed socially responsible for our medical professional societies to ensure the administration is aware of the difficulties and potential downsides of health IT.

If the industry lobbyists have only presented one side of the story (and I believe that likely to be the case), then our government has been making critical social re-engineering decisions based on a dangerously and deceptively incomplete picture.

I for one would like an accounting from HIMSS and other lobbyists of exactly what literature and viewpoints they presented to our government officials, especially in recent years, that led to the massive inclusion of funds and the use of government power to enforce rapid timelines (via economic sanctions for non-meaningful users) in H.R. 1 EH , a.k.a. the Economic Recovery Act of 2009 .

I would also like to know what literature was not presented.

-- SS

The Coronary Heart Disease Epidemic: Possible Culprits Part I

In the last post, I reviewed two studies that suggested heart attacks were rare in the U.K. until the 1920s -1930s. In this post, I'll be discussing some of the diet and lifestyle factors that preceded and associated with the coronary heart disease epidemic in the U.K and U.S. I've cherry picked factors that I believe could have played a causal role. Many things changed during that time period, and I don't want to give the impression that I have "the answer". I'm simply presenting ideas for thought and discussion.

First on the list: sugar. Here's a graph of refined sugar consumption in the U.K. from 1815 to 1955, from the book The Saccharine Disease, by Dr. T. L. Cleave. Sugar consumption increased dramatically in the U.K. over this time period, reaching near-modern levels by the turn of the century, and continuing to increase after that except during the wars: Here's a graph of total sweetener consumption in the U.S. from 1909 to 2005 (source: USDA food supply database). Between 1909 and 1922, sweetener consumption increased by 40%:

If we assume a 10 to 20 year lag period, sugar is well placed to play a role in the CHD epidemic. Sugar is easy to pick on. An excess causes a number of detrimental changes in animal models and human subjects, including fatty liver, the metabolic syndrome, and small, oxidized low-density lipoprotein particles (LDL). Small and oxidized LDL associate strongly with cardiovascular disease risk and may be involved in causing it. These effects seem to be mostly attributable to the fructose portion of sugar, which is 50% of table sugar (sucrose), about 50% of most naturally sweet foods, and 55% of the most common form of high-fructose corn syrup. That explains why starches, which break down into glucose (another type of sugar), don't have the same negative effects as table sugar and HFCS.

Hydrogenated fat is the next suspect. I don't have any graphs to present, because no one has systematically tracked hydrogenated fat consumption in the U.S. or U.K. to my knowledge. However, it was first marketed in the U.S. by Procter & Gamble under the brand name Crisco in 1911. Crisco stands for "crystallized cottonseed oil", and involves taking an industrial waste oil (from cotton seeds) and chemically treating it using high temperature, a nickel catalyst and hydrogen gas (see this post for more information). Hydrogenated fats for human consumption hit markets in the U.K. around 1920. Here's what Dr. Robert Finlayson had to say about margarine in his paper "Ischaemic Heart Disease, Aortic Aneurysms, and Atherosclerosis in the City of London, 1868-1982":

...between 1909-13 and 1924-28, margarine consumption showed the highest percentage increase, whilst that of eggs only increased slightly and that of butter remained unchanged. Between 1928 and 1934, margarine consumption fell by one-third, while butter consumption increased by 57 percent: and increase that coincided with a fall of 48 percent in its price. Subsequently, margarine sales have burgeoned, and if one is correct in stating that the coronary heart disease epidemic started in the second decade of this century, then the concept of hydrogenated margarines as an important aetiological factor, so strongly advocated by Martin, may merit more consideration than hitherto.

Partially hydrogenated oils contain trans fat, which is truly new to the human diet, with the exception of small amounts found in ruminant fats including butter. But for the most part, natural trans fats are not the same as industrial trans fats, and in fact some of them, such as conjugated linoleic acid (CLA), may be beneficial. To my knowledge, no one has discovered health benefits of industrial trans fats. To the contrary, compared to butter, they shrink LDL size. They also inhibit enzymes that the body uses to make a diverse class of signaling compounds known as eicosanoids. Trans fat consumption associates very strongly with the risk of heart attack in observational studies. Which is ironic, because hydrogenated fats were originally marketed as a healthier alternative to animal fats. The Center for Science in the Public Interest shamed McDonald's into switching the beef tallow in their deep friers for hydrogenated vegetable fats in the 1990s. In 2009, even the staunchest opponents of animal fats have to admit that they're healthier than hydrogenated fat.

The next factor is vitamin D. When the industrial revolution became widespread in the late 19th century, people moved into crowded, polluted cities and vitamin D deficiency became rampant. Rickets was a scourge that affected more than half of children in some places. Dr. Edward Mellanby discovered that it's caused by severe vitamin D deficiency, milk was fortified with vitamin D2, and rickets was all but eliminated. However, it only takes a very small amount of vitamin D to avoid rickets, an amount that will not contribute significantly to optimum vitamin D status. Vitamin D modulates the body's inflammatory response, it's ability to resist calcium deposition in the arteries, and seems to be important for so many things I had to include it.

The rise of cigarettes was a major change that probably contributed massively to the CHD epidemic. They were introduced just after the turn of the century in the U.S. and U.K., and rapidly became fashionable (source):
If you look at the second to last graph from the previous post, you can see that there's a striking correspondence between cigarette consumption and CHD deaths in the U.K. In fact, if you moved the line representing cigarette consumption to the right by about 20 years, it would overlap almost perfectly with CHD deaths. The risk of heart attack is so strongly associated with smoking in observational studies that even I believe it probably represents a causal relationship. There's no doubt in my mind that smoking cigarettes contributes to the risk of heart attack and various other health problems.

Smoking is a powerful factor, but it doesn't explain everything. How is it that the Kitavans of Papua New Guinea, more than 3/4 of whom smoke cigarettes, have an undetectable incidence of heart attack and stroke? Why do the French and the Japanese, who smoke like chimneys (at least until recently), have the two lowest heart attack death rates of all the affluent nations? There's clearly another factor involved that trumps cigarette smoke. I have a guess, which I'll expand on in the next few posts.