Improving Patient Safety In The EU: HIT Should Be Classified As Medical Devices. And, Can We Drop the "Massive Cost Savings" Fable?

Here is some sense on healthcare IT from the European Union, echoing a number of themes I've written about at Healthcare Renewal and my academic site on HIT difficulties and failures.

These themes revolve around the consideration of healthcare information systems (increasingly used to mediate many aspects of medical care delivery) as medical devices requiring regulation by transparent and impartial authorities - i.e., without conflicts of interest; the importance of regulation due to the adverse consequences caused by ill designed and/or poorly implemented HIT; the need for validation and postmarketing surveillance of the performance of these systems; and vendor accountability.

From the Swedish Medical Products Agency:

Improving patient safety in the EU: Many Medical Information Systems should be classified as Medical Devices

Thursday, June 18, 2009

Correctly functioning Information Technology (IT) systems for health care is a prerequisite for ensuring patient safety. However, applicable regulation is rarely applied, mainly due to the lack of useful guidelines on how to classify the IT-systems [guidelines whose formulation has been resisted for many years by the HIT industry, I might add - ed.] A national working group in Sweden has prepared a guidance report that will help increase compliance with the Medical Device regulation in the EU, thus improving patient safety.

An increasing number of serious incidents, with IT-systems involved, have been reported from the health care sector in recent years [but largely covered up in part due to contractual gag clauses on HIT sales and resultant violations of healthcare leadership fiduciary responsibilities - see this link - ed.] In most of these cases, existing regulatory regimes have not been applied, either by manufacturers or by health care providers. As a result, the assessment of safety issues has become unclear because the manufacturer’s responsibility is vague. [It's not vague; it's contractually absent - ed.]

For this reason, in 2008 the Swedish Medical Products Agency (MPA) initiated a national working group with the aim of providing guidelines for the classification of IT-systems intended to be used in health care. The working group has now prepared a report, intended to serve as guidance for both manufacturers and end-users. At present, there are no guidelines of this kind in Sweden, or the rest of Europe.

“Many parties, including the European Commission, have expressed interest in our work. We believe that it will improve the quality and safety of medical information systems. [Finally -ed.] A common approach to product classification is key” says Lennart Philipson, Scientific Director.

One important conclusion from the working group is that the Medical Device Directives is the most suitable regulation to be applied.

“Our market surveillance of medical information systems will be based on the conclusions in the report from now on. If a system falls within the definition of a medical device, the requirements for CE-marking [Conformité Européene, a branding mark - ed.] shall be applied” says Mats Ohlson, Chairman of the working group.

Manufacturers need to adapt to applicable standards when it comes to quality systems, risk management and usability. They will also need to establish post-market surveillance routines to regularly assess products on the market.

The working group consisted of members from the Swedish Medical Products Agency, the National Board of Health and Welfare, the Swedish Association of Local Authorities and Regions, Swedish Medtech, the Swedish Standards Institute, Swedish Electrical Standardization and notified bodies through Intertek Semko.

A report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" is available in English translation at this link (PDF).

Download and read the entire report.

Highlights:

A general opinion of the health care providers represented in this Working group is that from a patient safety point of view, it is desirable that stand alone software and systems intended to, directly or indirectly, affect diagnosis, health care and treatment of an individual patient [what I have referred to a "mediating aspects of care" - ed.] shall be regulated under a Product Safety Regulation.

The Working group has not been able to define any other appropriate regulation than the Medical Device Directive when it comes to the definition of such systems. Adherence to the Medical Device Directive is important so that manufacturers and clients can work with the same intentions. [I would add that the intentions are not exactly the same; the manufacturers' intentions are, by necessity, to maximize profits - ed.] This project report serves as one step towards the clarification regarding which conditions that shall apply.

The Working group believes that software intended for a medical purpose must be regarded as a "device" [indeed - ed.] and expressions such as "project", "service" and similar must be avoided describing a Medical Information System. This approach has advantages since a product safety regulation, such as the Medical Device Directive, can be applied and the product will have:

• a defined intended use
• defined and documented specifications
• a manufacturer with a clear responsibility until the delivery is accepted
• a controlled ”Post Market” surveillance

Furthermore, the Working group believes:

• that the Medical Device Directive shall be applicable for software and systems that fulfills the definition of a medical device
• that the manufacturer of the intended systems shall follow the appropriate validation method [e.g., as in the pharma industry's IT - ed.] in the Medical Device Directive
• that the level of risk shall be assessed, motivated and control the classification and verification method
• that applicable standards shall be followed for design, verification and validation regarding software and information systems that are medical devices
• that there is no legal requirement that manufacturers of devices in the lowest device classes must have certification for their operational processes to fulfill the Medical Device Directive. The Medical Products Agency has in these cases no mandate to formally demand certification, such as for instance ISO 13485. However, in reality it is still necessary to have some form of a functional quality management system to manage a proper design process for software systems [due to the fact that patients, ethical issues, and human rights issues are involved - ed.] as well as the necessity to fulfill the Post Market Requirements including Vigilance reporting.
• that the prerequisite for a successful and fair application of the regulation assumes that health care providers demands that such systems shall be CE‐marked and be regarded as medical devices
• that a controlled and standardised verification method when performing installation work in a user’s network, supported by the manufacturer, is an essential supplement to the manufacturer’s CE‐marking and a prerequisite for an acceptable safety level when using the device.

This section gets to the heart of the matter regarding electronic medical records:

8.2.3 Electronic patient records

Electronic patient record systems are more than an archive for just documents, they also have features for compiling and transferring information to be used for decision making. Patient records are the basis for documentation and planning of diagnosis, therapy and follow‐up, especially when it comes to drug prescriptions and recommendations. [These caveats include CPOE systems as well - ed.]

It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.

Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents that has been reported to the Swedish National Board of Health and Welfare. [It would be interesting to know more about this "series of incidents" - ed.]

Finally, in the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:

... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.

HIT can be a facilitator (not a replacement or revolutionary tool) to physicians, if done well, and not overdone to the point of costing far more than entire new hospitals or hospital wings. There is no replacement for a physician with a strong background in the preclinical and clinical sciences, ethics, critical thinking, and the scientific method. Computers are not a miracle. They can help provide facts, but cannot fundamentally turn a poor physician into a Marcus Welby. Verghese on that issue:

To come back to my favorite painting: a computer cannot take the place of the doctor in Fildes’s painting ["The Doctor", 1891, see below - ed.]; an electronic medical record (EMR) may or may not save money (it won’t be anywhere as much as is projected) but what it will do is ensure that we doctors, nurses, therapists, particularly in hospitals will be spending more and more time focused on the computer, communicating with each other, ordering and getting tests, buffing and caring for our virtual patient—the iPatient is my term for this phenomenon—while the patient in the bed wonders where everybody is. Having worked exclusively for the last seven years or so in hospitals that have electronic medical records (EMR), I have felt for some time that the patient in the bed has become an icon for the real focus of our attention, the iPatient. Yes, electronic medical records help prevent medication errors [only when done well, see Koppel - ed.] and are a blessing in so many ways, but they won’t hold the patient’s hand for you, they won’t explain to the family what is going on.

"The Doctor", 1891 (Sir Luke Fildes, 1843-1927)

I will go a step further. It is now clear that the promises of massive savings from electronic medical records, usually originating from vendors based on hearsay or cherry-picked, favorable but flawed studies that dismiss a growing body of other literature (such as in Cerner CEO Neil Patterson's hyper-ebullient piece here), have been deliberately manufactured by a lobby of industry pundits.

It is only now that I more fully comprehend the origins of and motivations behind the "we will revolutionize medicine" fervor exhibited by HIT company CEO's, such as I experienced and wrote about starting back in the 1990's. From my 1999 essay "What is Medical Informatics, and Why is it an Important Specialty":

... A letter I had written [in Feb. 1999 - ed.], "Broken Chord" published in the journal Healthcare Informatics, further amplifies the skills and experience issue. The letter addressed issues of skills, insights, and roles of MIS personnel in healthcare settings. I described a Microsoft Healthcare Users Group conference attended predominantly by healthcare MIS staff and vendors, where I observed a panel discussion moderated by the CEO of HBOC [before he was found to be cooking the books - ed.] and composed of several other industry CEO's. The panel was discussing how they would revolutionize healthcare through their leadership in information technology.

During the Q&A period I asked the audience how many really felt they would revolutionize medicine through their leadership in IT. Several hundred--almost all in the audience--raised their hands. I then asked how many had ever taken care of patients or examined any textbook of medicine, such as Harrison's Textbook of Internal Medicine or the Merck Manual. A minority of hands went up. This suggested, in my view, a striking deficiency of knowledge, experience and insight on the part of the de facto clinical information technology leadership, complicated by rather cavalier attitudes regarding the essential role of clinical expertise.

I believed what I was hearing to be irrational exuberance, not manufactured exuberance.

Quality improvements are possible under the most controlled of environments, such as here (such projects are not easily portable, unfortunately). Massive cost savings? When organizations are spending upwards of $100 million just for system implementation, not including ongoing lifecycle costs, massive savings projections from HIT are risible.

One would think that after Madoff, Stanford and other recent financial confidence scandals, that bright people would be more skeptical of "massive returns, always and forever" promises, but that does not appear to be the case. With regard to mass savings, I make the prediction that in 2014, as in the UK today, our government, healthcare management, and medical professionals will realize, Madoff style, that they've been had.

So, Health IT Industry executives, pundits, and consultants, can we drop the grandiose "we will revolutionize medicine!" and "massive savings" myths, and focus on facilitating clinicians and on quality improvement, please?

-- SS

6/22/09 Addendum

The U.S. Food and Drug Administration (FDA) and Sweden's Medical Products Agency are no strangers.

Scrushy Owes $2.88 Billion for Damages

As reported by the Wall Street Journal, here is another reminder about just how bad the leadership of health care can be,

Richard Scrushy was hit with a staggering $2.88 billion civil judgment in a suit brought by HealthSouth Corp. shareholders, one of the largest findings ever from the era of massive corporate scandals.

The plaintiffs said that the former chairman and chief executive helped artificially inflate HealthSouth's earnings for at least six years through an accounting scam uncovered in 2003.

Lawyers said Thursday's judgment appears to be the largest financial penalty ever levied against a single executive.

Mr. Scrushy was once the poster child of highflying CEOs. He was paid salary and perks of as much as $40 million a year, performed at company events in his country band and traveled on one of a fleet of corporate jets.

Mr. Scrushy hosted parties on the Chez Soiree, his 92-foot yacht, and arranged to pay for breast augmentation for a member of a company-sponsored singing group.

Judge Horn said Mr. Scrushy either knew or should have known about the fraud, giving no credence to Mr. Scrushy's repeated insistence that subordinates perpetrated the scheme without his knowledge.

Note that Scrushy had is already a convicted felon, "as he is two years into a seven-year sentence in federal prison on the bribery conviction." He has gone from being a "poster-child" for the high-flying health care corporate CEO to being a poster-child for liars and criminals fraudulently leading health care organizations.

So I get to say it again: instead of focusing on the reform of health care finance, we should be focused on the reform of health care leadership. We have set up a system that rewards imperial health care CEOs with the the lavish life-style and power that used to be reserved for the aristocracy. We have attracted health care leaders who value their own wealth and power ahead of patients' welfare and safety. To improve health care, we need responsible, ethical, honest stewardship of health care organizations. If we do not improve health care's leadership, it will not matter whether we finance it via private insurance, public options, or single-payers.

Synthes Indicted

Last month, we posted about a legal settlement in which device manufacturer Synthes agreed to stop creating conflicts of interests by paying physicians who performed its trials with company stock. Synthes is back in the news, and not in favorable terms. As reported by the Philadelphia Inquirer,

A Swiss company with major operations in West Chester illegally tested its bone cement on about 200 people, three of whom died, according to a 52-count indictment issued yesterday by the U.S. attorney in Philadelphia.

Synthes Inc., a producer of orthopedic products that employs about 1,400 in Chester County, did not tell any of the patients that they were participating in experimental surgeries, the indictment said.

Federal prosecutors also accused Synthes executives of lying to the U.S. Food and Drug Administration about whether they had tested the product for uses that the agency had not approved.

Particularly striking were allegations that the company's CEO was directly involved in the decisions.

The FDA had approved Norian XR to fill bony voids or defects in some parts of the body, but not in the spine. The agency insisted that Synthes conduct clinical trials, which are lengthy and expensive and require FDA oversight, if it wanted to expand the uses of Norian XR to treat spinal fractures.

But, a company executive identified in the indictment as 'Person No. 7' decided not to conduct clinical trials. Instead, the person said the company should 'get a few sites to perform 60-80 procedures and help them publish their clinical results,' according to the indictment.

The report never explicitly identifies 'Person No. 7,' but says he was the chief executive officer and a large shareholder. A company spokesman identified Hansjörg Wyss as the CEO while the tests occurred.

Forbes Magazine lists Wyss, a Swiss citizen, as a West Chester resident and the Philadelphia area's wealthiest person, with a net worth of $5.7 billion. Last year, Wyss gave the largest amount from a single source in Harvard University's history when he donated $125 million to create a bio-engineering institute.

Wyss owns about 40 percent of outstanding Synthes stock. The company, which had about $805 million in first-quarter sales this year, specializes in orthopedic devices, including plates and screws.

The Inquirer article included more detail about how the company allegedly disregarded risks to patients as it pushed the surgeons to try Norian XR on them, without disclosing that its use was experimental,

Instead of conducting trials with FDA oversight, Synthes executives convinced about 50 surgeons to test Norian XR in people with spinal fractures. Synthes sales representatives often were in the operating room during the surgeries, including those where patients died, prosecutors said.

When company executives began these surgical tests in 2002, they knew that Norian XR caused blood clots in test tubes and that clots became lodged in the lungs in tests with pigs, the indictment said.

Synthes continued the experimental surgeries even after two patients died on the operating table, prosecutors said. The company stopped the tests after a third patient died in January 2004.

Again, it seems that the current leaders of health care all too often put more priority on personal profits than on protecting patients' health and safety. So instead of all the talk about reforming how health care is financed, maybe the conversation should be about reforming how health care is lead, and finding ethical, honest leaders who put patients' welfare ahead of their own wealth.

Managed Care Executives Will Not Limit Rescissions

We have posted before about how certain health care insurance companies/ managed care organizations in California were found to have cancelled individual health insurance policies after the people holding them made substantial claims, supposedly rationalized by minor errors or omissions in the information the people supplied to the companies on their individual applications found after the claims were made. Several companies were subsequently disciplined by the state government for these "rescissions." See posts on rescissions by WellPoint here, here, and here, and by Health Net here.

Executives of several such companies testified before a US congressional committee recently, with remarkable results, as reported by Lisa Girion writing in the Los Angeles Times. First, by way of background, the article suggested that rescissions are widespread:

An investigation by the House Subcommittee on Oversight and Investigations showed that health insurers WellPoint Inc., UnitedHealth Group and Assurant Inc. canceled the coverage of more than 20,000 people, allowing the companies to avoid paying more than $300 million in medical claims over a five-year period.

Furthermore,

The committee's investigation found that WellPoint's Blue Cross targeted individuals with more than 1,400 conditions, including breast cancer, lymphoma, pregnancy and high blood pressure. And the committee obtained documents that showed Blue Cross supervisors praised employees in performance reviews for rescinding policies.

One employee, for instance, received a perfect 5 for 'exceptional performance' on an evaluation that noted the employee's role in dropping thousands of policyholders and avoiding nearly $10 million worth of medical care.

Nonetheless, the executives were not prepared to abandon rescissions:

Executives of three of the nation's largest health insurers told federal lawmakers in Washington on Tuesday that they would continue canceling medical coverage for some sick policyholders, despite withering criticism from Republican and Democratic members of Congress who decried the practice as unfair and abusive.

The executives -- Richard A. Collins, chief executive of UnitedHealth's Golden Rule Insurance Co.; Don Hamm, chief executive of Assurant Health and Brian Sassi, president of consumer business for WellPoint Inc., parent of Blue Cross of California -- were courteous and matter-of-fact in their testimony.

But they would not commit to limiting rescissions to only policyholders who intentionally lie or commit fraud to obtain coverage, a refusal that met with dismay from legislators on both sides of the political aisle.

Sassi said rescissions are necessary to prevent people who lie about preexisting conditions from obtaining coverage and driving up costs for others.

'I want to emphasize that rescission is about stopping fraud and material misrepresentations that contribute to spiraling healthcare costs,' Sassi told the committee.

But rescission victims testified that their policies were canceled for inadvertent omissions or honest mistakes about medical history on their applications. Rescission, they said, was about improving corporate profits rather than rooting out fraud.

Also,

Late in the hearing, Stupak, the committee chairman, put the executives on the spot. Stupak asked each of them whether he would at least commit his company to immediately stop rescissions except where they could show 'intentional fraud.'

The answer from all three executives:

'No.'

This is just amazing. Here are executives of three of the country's largest for-profit health care insurance companies/ managed care organizations asserting they will continue cancelling peoples' policies after they make claims, simply because of minor errors or omissions in the application documents that have no bearing on the particular claims, or on discrepancies between information provided by patients and doctors, given that patients may not have full access to or understanding of what is in their charts. What good is an insurance policy that is liable to be cancelled as soon as one makes a claim on it?

Whatever these companies are selling, it is not insurance. Basing our health care system on their products is foolish, but that is what we are doing, and what many political leaders would continue to do.

In my humble opinion, if we are going to have a system based on privately provided insurance, that insurance has to be honest, unlike what some of our largest insurance companies seem to be peddling.

A Clear-Headed Defense of Comparative Effectiveness Research

We have tried to argue why comparative effectiveness research is a good idea. To cut and paste what I wrote in a previous post,

Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When the only studies done compared individual treatments to placebos, and when even those were restricted to narrow patient populations unlike those patient usually seen in daily practice, physicians are left juggling oranges, tomatoes, and carburetors.

Comparative effectiveness studies are simply studies that compare plausible treatments that could be used for patients with particular problems, and which are designed to be generalizable to the sorts of patients usually seen in practice. As a physician, I welcome such studies, because they may provide very useful information that could help me select the optimal treatments for individual patients.

Because I believe that comparative effectiveness studies could be very useful to improve patient care, it upsets me to see this particular kind of clinical study get caught in political, ideological, and economic battles.

In particular, we have discussed a number of high profile attacks on comparative effectiveness research, which often have featured arguments based on logical fallacies. While some of the people making the attacks have assumed a conservative or libertarian ideological mantle, one wonders whether the attacks were more driven by personal financial interests. For example, see our blog posts here, here, here, and here.

Therefore, it was refreshing to see this defense of comparative effectiveness research in the opinion pages of the New York Times, which demonstrated that the issues here are really not ideological.

Drawing upon the ideas of the Harvard economist David Cutler, the Obama administration talks of empowering an independent board of experts to judge the comparative effectiveness of health care expenditures; the goal is to limit or withdraw Medicare support for ineffective ones. This idea is long overdue, and the critics who contend that it amounts to 'rationing' or 'the government telling you which medical treatments you can have' are missing the point. The motivating idea is the old conservative chestnut that not every private-sector expenditure deserves a government subsidy.

This was written by Tyler Cowen, a well known academic economist, a Professor in that department at George Mason University with impeccable libertarian credentials. (Prof Cowen also blogs on Marginal Revolution.) Prof Cowen reminded us how the current health care reform debate could benefit from some clear thinking that eschews ideological posturing.

Pharmacy Benefit Managers as Pharmaceutical Marketers

We posted a number of times about questionable practices Eli Lilly used to market its atypical anti-psychotic drug Zyprexa (olanzapine). A post from 2007, with links backward, is here, and our most recent post is here. The company remains entangled in litigation over its marketing of this drug. That litigation has lead to the release of numerous internal documents that provide quite a view of Lilly's marketing practices. Bloomberg continued its reporting on these documents, with its latest effort here via the Boston Globe, describing yet another surprising way this drug was sold:

A unit of CVS Caremark Corp. used its access to doctors to market Eli Lilly & Co.'s Zyprexa antipsychotic while it was under contract to bargain with the drug maker on behalf of health insurers, internal Lilly files disclosed in a multibillion-dollar lawsuit by insurers show.

The subsidiary of CVS, the largest US drugstore chain, touted Zyprexa starting in 2003, according to e-mails made public by lawyers suing Lilly for overpayment. CVS's AdvancePCS, a pharmacy benefit manager, or PBM, offered to send 120,000 letters to doctors promoting the drug, Lilly's top-seller with $4.7 billion in sales last year, according to a confidential 2004 proposal. The CVS unit said it would charge $5 per letter.

AdvancePCS, acquired by Woonsocket, R.I.-based CVS in 2007, said in the documents that the direct-mail campaign was 'designed to influence key prescribers' as part of a 'tactical plan for Zyprexa.'

Furthermore,

In AdvancePCS's 2004 pitch to Lilly offering to send out letters promoting Zyprexa, Kevin Aholt, the company's assistant vice president in charge of strategic alliances, said he could target physicians based 'on the most recent AdvancePCS claims data,' according to the unsealed documents.

Aholt also said that one of the 'key issues' in the market for antipsychotic drugs was finding ways to 'accelerate the growth of new patient starts,' according to the proposal.

Also,

Steven Fuchs, an official at the PBM, asked Lilly officials in an April 2004 e-mail whether he should include information about Zyprexa's ability to calm agitated patients in the next round of letters to doctors.

'Would a discussion of that be something you would want to include?' Fuchs asked, according to the document.

Lilly marketing executive Scott Dell responded in an e-mail that officials at the drug maker had discussed asking AdvancePCS to include material highlighting 'the new bipolar maintenance indication for Zyprexa.'

AdvancePCS was not the only pharmacy benefits manager (PBM) that offered to help sell Zyprexa.

CVS rival Express Scripts Inc. also sent out Zyprexa marketing letters, according to the unsealed documents and also isn't named as a defendant in the suits.

So here we have at least two pharmacy benefit managers (PBMs) offering to help market a particular drug, for money, of course. What is the problem here?

CVS's contracts with insurers and pensions meanwhile place it in an adversarial posture with Lilly, requiring it to use its buying power as leverage in drug-price negotiations.

'The problem is that PBMs are negotiating these hidden deals while at the same time telling employers that they represent them at the negotiating table,' said Gerry Purcell, a former PBM executive who advises companies on their drug plans. 'These documents will add fuel to the perception that the companies and the PBMs are in cahoots with each other.'

Also,

While PBMs negotiate on behalf of insurers, most states don't designate them as agents of the benefit plans, said Robert Garis, a pharmacy professor at Creighton University in Omaha who studies the industry. As a result, they aren't legally required to act only in the best interest of their clients, he said. Maine is one of a few states that have specified PBMs as fiduciaries, or agents, he noted.

'The companies have gotten around that by adding language to their contracts that exclude them from having to meet those fiduciary duties,' Garis said.

Apparently, in this case, one PBM said it disclosed its relationship to the drug company to physicians, but it is not clear whether it was disclosed to the health care insurers and managed care organizations which paid the PBM to reduce the costs of drugs:

CVS, which isn't a defendant in the Lilly suit, said that it tells doctors when it has 'financial relationships' with drug makers and that they are free to opt out of mailings.

'To engage in a point/counterpoint in a media outlet rather than in court would not be productive,' said Lilly spokeswoman Marni Lemons.

Lemons declined to answer specific queries about the CVS or Express Scripts letters, whether Lilly paid for the practice, or other questions raised by the unsealed documents....

CVS said in its e-mailed statement that it has 'no active educational programs' related to Zyprexa.

'CVS Caremark discloses to its PBM clients that it may have financial relationships with pharmaceutical manufacturers in connection with these educational programs,' said Christine Cramer, a spokeswoman for the chain. 'CVS Caremark's PBM clients are aware of these programs and have the opportunity to opt out.'

Maria Palumbo, a spokeswoman for Express Scripts, didn't respond to eight telephone and e-mail requests seeking comment.

CVS covers 82 million people, with a market share of 12 percent, and is the largest pharmacy benefit manager, according to Atlantic Information Services. Express Scripts, which covers 55 million people, is the fifth largest. PBMs process about 75 percent of the retail prescriptions written annually in the United States, according to the insurance plans.

The insurance plans sued the drug maker in 2005, contending it used researchers, pharmacy benefit managers, advocacy groups, and public agencies to promote Zyprexa.

Whether or not the PBMs disclosed their relationships to the pharmaceutical company to everyone who might be interested, it does seem that having PBMs who are supposed to help insurers and managed care organizations control drug costs be paid by pharmaceutical companies to market drugs is yet another new species of institutional conflict of interest. Like the many other conflicts of interest, individual and institutional, we have discussed, this one appears to be mutually advantageous to the parties involved. However, it could have adverse consequences for physicians, patients, and the health care system. If the organizations that are supposed to be controlling drug costs are also promoting expensive drugs, the likely result would be excess prescription of expensive drugs to patients who may not derive benefits from the drugs outweighing their harms.

This is another reminder how much we need more sunshine shone on the multitudinous conflicts of interest affecting just about every type of actor within the current US health care system.

A Handbook for Ghost-Writing

We posted a number of times about questionable practices Eli Lilly used to market its atypical anti-psychotic drug Zyprexa (olanzapine). A post from 2007, with links backward, is here, and our most recent post is here. The company remains entangled in litigation over its marketing of this drug. That litigation has lead to the release of numerous internal documents that provide quite a view of Lilly's marketing practices. In particular, a Bloomberg news article discussed how the company used ghost-writers:

Ensuring that medical journal articles presented Zyprexa study results in a positive light was one way for Lilly to reach its sales goal, company officials said in its plan, according to the documents.

To do that, Lilly officials hired ghostwriters to prepare submissions to journals such as Progress in Neurology and Psychiatry, according to the unsealed documents.

The article then described how Lilly marketers set up a ghost-written article.

'The paper for the Progress in Neurology and Psychiatry supplement has been completed and sent to the journal for peer review,' Kerrie Mitchell, an employee of the public relations agency Cohn & Wolfe, wrote in a Feb. 23, 2001, e-mail to Michael Sale, a Lilly marketing official. The message was among the unsealed files.

'We ‘ghost’ wrote this article and then worked with author Dr. Haddad to work up the final copy,' Mitchell said in the e- mail. Eric Litchfield, a spokesman for Cohn & Wolfe, didn’t immediately return a call seeking comment.

Peter Haddad, a researcher at Greater Manchester West Mental Health NHS Foundation Trust in the U.K., was listed as the article’s lead author. Haddad didn’t respond to requests for comment.

The global Lilly team approved a draft of Haddad’s ghost- written paper in 2000, according to the unsealed documents.

Lilly marketers, rather than articles' putative authors, sometimes exerted pressure to get ghost-written articles published. For example,

Lilly officials e-mailed journal editors to complain about delays in publishing favorable Zyprexa articles, according to the unsealed documents.

In one instance, Lilly employees contacted the Journal of Clinical Epidemiology about delays of an article criticizing a previously published piece linking Zyprexa, as well as the class of atypical antipsychotics, to diabetes.

After Suraja Roychowdhury, Lilly’s senior scientific communications coordinator, wrote to the journal in November 2002, its editor, Andre Knottnerus, replied in an e-mail that it was 'a bit strange to be contacted via the Lilly product team. Dr. Buse and coauthors can contact us directly next time.'

Knottnerus was referring to the manuscript’s lead author, John Buse, a former president of the American Diabetes Association. A copy of the Nov. 22, 2002, e-mail was included in the unsealed documents.

Patrizia Cavazzoni, a Lilly staffer who co-wrote the article, e-mailed Buse on Jan. 9, 2003, seeking permission to send a separate e-mail asking to expedite publication. She also asked Buse if he would prefer 'to send it in your name?'

It isn’t clear from the e-mail chain whether the e-mail was sent by Buse or Cavazzoni.

Finally, Lilly developed a handbook for ghost-writers:

To ensure that ghostwritten Zyprexa articles met Lilly’s standards, company officials issued a guide to preparing them, according to the unsealed files.

The guide, 'Medical Press: Pre-Launch Feature Outline,' was undated. It’s unclear from the documents which teams in Lilly’s top 10 markets for the drug received it.

The primer provided a how-to for writing articles, such as instructing the author to use Zyprexa’s generic name, olanzapine, instead of its brand moniker, according to the documents. Scientists in medical research traditionally refer to a drug’s chemical name.

The guide also offered tips on how to find authors by identifying a 'key opinion leader' and providing them either an outline of the article or a finished copy. Authors could include a study investigator, an advisory board member or “Lilly-friendly” doctor, according to the documents.

A sample article laid out how a Lilly employee may find a doctor to ghostwrite a submission that would 'prepare the market' for the launch of an intramuscular injectable version of the drug. It also offered an outline for the contents of the article, beginning with background on another drug, droperidol, which had been withdrawn from several countries.

The article, with the suggested title 'Filling the Droperidol Gap,' noted that an anti-anxiety drug could be used, before going on to say, 'more advanced IM treatments may soon be available to provide a superior alternative.' The article explained that injectable Zyprexa had just received approval from the FDA, and recounted its clinical trial history.

'The anticipated forthcoming availability of atypical antipsychotics in an IM formulation could be a major step forward in the treatment of acute agitation associated with schizophrenia,' the sample article concluded.

We addressed ghost-writing frequently when we started Health Care Renewal, and have returned to the topic periodically (see these more recent links, from 2008, here and here). The most striking feature of this newest case is the use of a "ghost-writers' handbook" denoting how systematized the practice has become. With each new case, it becomes clearer how common the practice may be. Since the parties involved seem ashamed enough of the practice to try to keep it well hidden, it may be that ghost-writing is even more common than we now realize.

Nonetheless, while the practice may be common, and mutually advantageous for ghost-writers, the academics who front for them, and the marketers who hire them all, as we and others have said before, ghost-writing is dangerous to health. It deludes physicians and patients into thinking health care products are more beneficial and less risky than they really are. Ghost-writing also undermines science by shifting the agenda away from interesting and important questions to questions whose answers may mainly benefit vested interests. Finally, on a personal note, ghost-writing demoralizes honest academics who must run their own studies, write their own papers, and manage the logistics of paper submission in competition with fake authors backed by corporate money and corporate staff. Scientists and academics who allow and front for ghost-writers ought to be ashamed of themselves.

See also comments in the Clinical Psychology and Psychiatry blog, and discussion of some of the other recent revelations about Zyprexa marketing in the Hooked: Ethics, Medicine and Pharma blog.

ADDENDUM (14 June, 2009) - Also see comments by Prof Margaret Soltan on the University Diary blog on the "Stockholm Syndrome" as manifested by "key opinion leaders" in the pay of health care corporations.

ADDENDUM (15 June, 2009) - Furthermore, see comments by Dr Howard Brody in the Hooked: Ethics, Medicine and Pharma Blog.

Wharton on Healthcare IT: Can I Go Home Now?

Professors at the Wharton School of the University of Pennsylvania (one of the most prestigious business colleges in the world) had some very interesting observations about healthcare IT yesterday in an article entitled:

"Information Technology: Not a Cure for the High Cost of Health Care."

I have been writing on these same themes - irrational exuberance, HIT not being a panacea or cybernetic miracle, HIT as a facilitating tool in medicine, not a revolutionary one (but only if "done right"), inadequate research to back up the often grandiose claims, and so forth for over a decade ("Contemporary Issues in Medical Informatics: Common Examples of Healthcare IT Failure", link). I penned such sacrilege, often at risk to my career due the unpopularity of these ideas, itself due to the irrational exuberance of the HIT community (these attitudes were perhaps in part manufactured by a healthcare IT lobby).

Here are excerpts of what Wharton professors observed. Do read the entire article at the link above:

President Obama made information technology a linchpin in his plan to reform health care when he included $19 billion in computerized medical record funding in the $787 billion American Recovery and Reinvestment Act of 2009. The goal: Use technology to reduce costs and improve the quality of care. The reality: Technology could increase health care costs without markedly improving quality, according to experts at Wharton [except perhaps in very highly specialized projects, not easily portable, such as here - and not without its own set of problems - ed.]

... "No one has done the careful research to indicate that if one health care system has information technology and the other doesn't, then the care is different. There are no controlled trials," says Mark Pauly, a health care management professor at Wharton. All that technology is no panacea, he warns. In fact, he believes IT could actually raise costs because of culture clashes, training, the implementation of the systems [I would say "the mayhem that often goes on during the implementation" - ed.] and the labor required to maintain the new technology.

"The best-case scenario is that information technology will improve quality but not lower costs. The worst case is that there's no difference at all." [I believe if HIT is "done well", we can achieve best case, and lower costs as well to an extent, but there is enormous complexity behind the two simple words "done well" that I'm not sure we've fully mastered as a society yet - ed.]

... That opinion is echoed by other experts at Wharton and the University of Pennsylvania. "The focus on IT in health care is a good thing, but there's way too much hype about it [an understatement - ed.] and misunderstanding about what the benefits will be and how quickly they will come," says Peter Gabriel, medical director of clinical information systems at the University of Pennsylvania Health System.

[Kevin Volpp, professor of medicine and health care management] agrees that tracking real cost savings from health care IT is a difficult task, but he expects there to be some benefits from spotting and eliminating redundant care. [Agree - ed.] But those benefits aren't likely to add up to big savings, says Lawton R. Burns, director of the Wharton Center for Health Management and Economics. "I agree that information technology is important, but it's not the slam dunk it's portrayed to be," he says. The chase to reduce costs, improve quality and expand coverage is deemed the "iron triangle of health care. A lot of us wince [at that goal]," Burns notes. "It's arguable that we can't do any of those things well."

David A. Asch, a Wharton health care management and economics professor, agrees that technology is a big part of reform. "No one is arguing against it, but that doesn't mean that it's not oversold," he says. Gabriel likens the fascination over IT in health care to a shiny new object that's easier to focus on relative to more daunting issues.

... In addition, it's unclear what cultural issues [a big theme in my writings - ed.] will emerge as information technology is adopted. These cultural issues are in the forefront of primary care physician relationships. Experts at Wharton and Penn say physicians are generally skeptical of the technology movement. How much will a technology overhaul add to operating costs? How much will it cost to retrain workers? What's the electronic record learning curve? And what happens when a doctor has a laptop between him and the patient?

"Individual physicians just don't know where the money is going to come from," says Pauly. "If IT is tied to reimbursements it could work, but [many] are skeptical." Burns adds that the physician-patient relationship can also be altered. "Technology adoption changes the way you practice. What happens when your primary care physician is looking at his screen instead of you?"

All themes obvious to me after an informatics fellowship and term as CMIO at a major hospital, and to a number of my like minded colleagues as well. However, these themes were as hard to get published and recognized (i.e., turned into "memes") as a book against Global Warming ...

The Wharton article concludes with this pithy wisdom:

Experts say these projects are worth the effort, but the industry should keep its expectations in check [i.e., ditch the irrational exuberance - ed.] and closely scrutinize investments. "To the extent [that] these technologies improve the quality of care and get the patient more involved, I'm all for them," says [Richard Neill, residency director and vice chair at the University of Pennsylvania's Department of Family Medicine and Community Health]. "But the technology is not a sea change -- just a chance to change."

Anyone in Washington listening?

Finally, after a decade of writing on these same observations to a public apparently inclined to believe the myths and promised cybernetic miracles nourished by the IT industry, and getting nowhere until some very serious organizations caught on this year and joined in (the Joint Commission, the National Research Council, UK House of Commons, JAMA, AMIA, Wharton, etc.) I ask: can I go home now?

-- SS

Public CCHIT response to NJ "CCHIT or else" Health IT Bill

In my June 7 post Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT I asked CCHIT's chair pointed questions about a remarkable NJ Bill to make non-CCHIT-certified health IT forbidden for sale or use, with civil penalties, in the state of NJ. His response is posted in the link.

I've just become aware of a June 8 public response to the Bill at CCHIT's site "EHR Decisions" entitled Legislating Health IT: Beware of Land Mines:

... A number of people contacted me this weekend about a bill on the floor of the New Jersey legislature which proposes to make the purchase of non-CCHIT Certified products illegal. I want to make a few facts clear, then share some news about our plans going forward in the new environment created by ARRA.

First, I do not believe this is an appropriate use of health IT certification. Our goal, stated in almost every presentation I’ve given, and to which I’ve adhered in my leadership of the Commission, has always been to unlock positive incentives for health IT adoption. Bridges to Excellence provides a role model for integrating health IT into outcome-based, pay for performance incentives. Successfully executed, ARRA might too. But the New Jersey bill is nowhere near that. Making software purchases illegal, like dangerous substances? Let’s “just say no” to that idea.

Second, neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill. We were unaware of it until it started showing up on listserves Friday. The bill has never been mentioned in any of our Trustee, Commission, or staff meetings ...

A fine answer. Read the whole thing.

I was probably one of the first to call this NJ Bill to his attention, under the assumption the leader of CCHIT would know about a bill calling for CCHIT exclusivity and "or else" civil penalties in a major state. (CCHIT's founder HIMSS certainly has been cheerleading for all health IT that receives ARRA support to be CCHIT certified. Is it reasonable to assume CCHIT's leader had knowledge of that?)

Instead of thanks for my calling the NJ Bill to Mark Leavitt's attention, potentially saving him from far worse troubles over it than my questions (I am, after all, a political nobody!), I got ... well, embellishments ... decide for yourself at the "Open Letter" link above.

You're welcome, Mark.

Hope you're equally as charitable to the NJ Assembly members who actually made this trouble for you.

p.s. the exact wording of a question I asked him on Jun. 7:

"Did you, or anyone in a governance or leadership position at CCHIT, play a role in sponsorhip of this bill, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?"

His June 8 post says:

Second, neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill

It even looks like I gave him the language for the public response. Again, Mark, you're welcome.

And your apology for the embellished section of your response to my simple questions is accepted.

Oh wait...

Haven't gotten that yet.

-- SS

Lessons From Aviation Heroes Towards Healthcare IT

One of my largest concerns about the state of health IT is its safety, and the effects the irrational exuberance about health IT, including coming use/misuse of EHR data, may have on physicians' ability to exercise judgment borne of experience. For more on this, see my essay "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" in the Journal of the Association of American Physicians and Surgeons (AAPS), Summer 2009, at this link (PDF).

I believe there is a strong lesson to be learned that is applicable to healthcare and HIT from the aviation industry. Namely, the wisdom of Captain Chesley Sullenberger, who guided a damaged and unpowered jet safely into the Hudson River on Jan. 15, 2009, saving all aboard.

The lessons are so obvious, I will not comment on the parallels between Capt. Sullenberger's observations and the issues in healthcare and healthcare IT:

Excerpts from:

Wall Street Journal
June 10, 2009

Hero Pilot 'Sully' Stars at Safety Hearing
Transcript Reveals Details From Hudson Splashdown

By Andy Pasztor

WASHINGTON -- US Airways Capt. Chesley "Sully" Sullenberger, the much-heralded hero of the January airliner ditching on New York's Hudson River, told federal investigators Tuesday that in a matter of seconds he determined only the river was "long enough, wide enough and smooth enough" to put down his crippled jetliner.

... At a time when many commercial airline pilots say they are frustrated by dwindling pay, longer work weeks and eroded pensions, the testimony of the captain recalled the golden age of aviators exuding confidence and sangfroid. [self-possession or imperturbability especially under strain - ed.]

Many of the flight attendants and passengers thought the Airbus was headed for land. But Capt. Sullenberger, who started flying at the age of 16 and has been at the controls of everything from gliders to three different jetliners, told the safety board he picked his landing spot with care.

The airline's training instructed pilots that if they ever had to ditch, they should "land near vessels to try to facilitate rescue."

Responding to questions about the lessons to be learned from the extraordinary landing, Capt. Sullenberger mentioned training to help pilots work together as a team and additional efforts to improve emergency evacuations. But his comments repeatedly swung back to the notion of an airline culture that stresses safety and respects the judgment of experienced pilots. US Airways pilots received classroom instruction in ditching procedures, but Capt. Sullenberger testified that they never practiced any ditching scenarios in simulators.

In a pointed remark on the cost-cutting and heightened corporate regimentation that currently drive many airlines, Capt. Sullenberger considered the intangibles of safe airmanship. "The captain's authority is a precious commodity that cannot be denigrated," [see all too typical IT attitudes about physicians in this post - ed.] he said.

The captain's testimony also highlighted the importance of relying on experience and memory, rather than rigidly using written checklists to deal with unexpected emergencies. With both pilots in the cockpit boasting about 20,000 hours of total flight time, Capt. Sullenberger said that teamwork and experience "allowed us to focus on the high priorities without referring to written" checklists.

Cybernetic miracles would not help here and might in fact have caused a different outcome than this, especially if they malfunctioned, caused cognitive overload, or otherwise impeded the pilots' abilities to utilize their expertise:

Billy Campbell, one of the passengers on the plane, testified about seeing the left engine engulfed in flames as though it were "a bonfire," and then scampering out of the aircraft as water was seeping in near the tail. "We were so fortunate to have an unbelievable pilot, an unbelievable copilot" and a highly experienced cabin crew, he told the board. [Note not a mention of "great computers", which in fact might be implicated due to faulty speed data in a recent and unfortunate Air France crash with no survivors - ed.]

The parallels between Capt. Sullenberger's observations and the observations of those concerned with ever growing exuberance about HIT should be obvious. (If not, spend some time here.) The lesson can be summarized through a line from another aviation hero:

"It's the man, not the machine."

That hero was Chuck Yaeger:

The most famous Mustang pilot and ace is Chuck Yeager. Yeager was the ultimate fighter pilot. As a young Mustang pilot he once downed five German fighters in one mission. He downed two much faster Me-262 jet fighters, escaped captivity after being shot down over occupied France, and when the war ended, it was still just the beginning of his amazing career. After the war Yeager became a test pilot, and in 1947 he earned his place in the history books as the first man who "broke the sound barrier" in the daring first supersonic flight.

The WSJ article concludes:

Robert Sumwalt, the safety board member chairing the hearing, said that after listening to the cockpit voice recorder after the ditching of US Airways Flight 1549, he was impressed by the actions of the pilots. "I've never walked out of a flight recorder lab with a smile."

I wish I could walk with a smile about the state of health IT, but lately that just has not seemed possible.

-- SS

A Letter from the RUC, and My Reply

The vast amounts spent in the US on health care have not translated into access for many patients, consistently excellent quality of care, and signiticantly improved outcomes. While we spend all this money, the primary care and generalist practitioners on the front lines are increasingly embattled and disgruntled, and their numbers are rapidly thinning. One problem may be the pattern of fees paid to physicians. Fees paid to physicians not only influence costs directly, but provide incentives for physician decision making about what tests and treatments patients receive. We have posted several times, most recently in February, 2009, here, about how the US Medicare system sets fees paid to physicians.

Since health care reform is now a hot topic in the US, there has been increasing discussion of the plight of primary care and generalist practitioners, but little consideration of how it arose. What we wrote in February was (with updated links):

As we have discussed, the US Medicare system determines what it pays physicians using the Resource Based Relative Value System (RBRVS). This system determines the pay for every kind of medical encounter according to a complex formula that is supposed to account for physicians' time and effort, physicians' practice expense, and the cost of malpractice insurance. The components of physicians' effort assessed are, in turn, technical skill and physical effort; the required mental effort and judgment; and stress due to the potential risk to the patient.

To keep the system, which was started in 1990, current, requires addition of new kinds of encounters, which means encounters involving new kinds of procedures, and updating of the estimates of various components, including physicians' time and effort. To do so, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee (RUC). The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are secret, as are the proceedings of the group.

This opaque and unaccountable process has resulted in increases outstripping inflation in fees paid for procedures, while fees paid for "cognitive" medicine, i.e., for primary care, and for services that involve diagnosis, management of acute and chronic disease, counseling, coordination of care, etc, but not procedures, have lagged inflation. The effects of the RUC have been amplified by the unexplained tendency of commercial managed care and health insurance to track the RBRVS system when making their own payments to physicians.

For further details about the RUC, see these posts on Health Care Renewal (here, here, here, here, and here) and important articles by Bodenheimer et al,(1) and Goodson.(2) By the way, why the US Center for Medicare and Medicaid Services (CMS) relies de facto exclusively on the RUC to control the RBRVS system, and why the AMA made the RUC into a secret organization apparently beholden only to the organization's proceduralist members are unanswered questions.

The next month, Dr William L Rich III, and Dr Barbary Levy, the Chair and Chair-Elect of the RUC, wrote me a letter to "point out several blatant inaccuracies within your blog entry that severely misrepresent the nature and work of the AMA / Specialty Society RVS Update Committee (RUC)." They then asked me to "retract or correct the inaccurate statements within the aforementioned blog immediately." However, the letter did not specify the supposedly inaccurate statements within the blog post. So, my email response noted that "the letter contains no detail about the alleged 'inaccurate statements.' If you define them, we will certainly consider your views." I never got a reply to this message, therefore thinking the matter to be closed, and I saw at that time no reason to make the exchange public.

Apparently, the matter was not closed. A few days ago, two anonymous comments were appended to the post. They stated that my letter had appeared on the AMA web-site, here. So it is now public. The comments did not say, and I have so far not been able to find out when the letter was posted, and what its context is within the AMA web-site, including any indication that I had already replied to it in private.

Despite these irregularities, however, given that the AMA apparently has chosen to make the letter public, I believe I ought to respond publicly.

"Blatant Inaccuracies?"

Dr Rich and Dr Levy wrote:

We would like to take this opportunity to point out several blatant inaccuracies within your blog entry that severely misrepresent the nature and work of the AMA / Specialty Society RBRVS Update Committee (RUC). We request you retract or correct the inaccurate statements within the aforementioned blog immediately.

First, as I noted above, the letter never specified which of my statements the letter writers considered "blatant inaccuracies." If there are any specific statements of fact in the post above (or any other post I write) that can be shown to be inaccurate, I will correct or retract them. However, I do not believe the letter by Dr Rich and Dr Levy demonstrated any particular statements of mine to be blatantly inaccurate.

The Obscurity of the RUC Membership

The letter stated:

The RUC does not operate in the shadows.

One of my major criticisms of the RUC was that it is opaque. Before I wrote my first post on the RUC, I tried to determine its membership by searching the AMA web-site, easily available AMA publications, and the web. I could find lists of past members, but no current list. In addition, I asked RUC staff by email whether they could provide me the list, or an easy way to access it. They would or could not do so, and the highest ranking staffer I contacted wrote, "we do not give out the RUC members' contact information. We attempt to shield the RUC from lobbying by industry or others." Only after these inquiries did I dub the RUC membership "secret."

Dr Rich and Dr Levy suggested that it is not quite secret. It stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95. However, the book is not on the web, or in my local or university library, and I have no other way to easily access it.

Additionally, although the letter stated, "any individual may solicit AMA staff directly or a specialty society to learn the names of the members of the RUC," the letter was not accompanied by any communication from AMA staff containing this information.

Thus, to date, I still do not know who the members of the RUC are. If the letter authors had wanted to show that the membership of the RUC was not meant to be obscure, they could easily have sent me the list with their letter, appended a copy of the pages of the book which contained the list, or asked their staff to provide this information. They chose not to do so. So, while the RUC membership may not be exactly secret, it remains obscure, only barely public, and relatively inaccessible.

The Secrecy of RUC Proceedings

Furthermore, to support its contention that "the RUC does not operate in the shadows," the letter stated that

any individual may attend a RUC meeting upon: (1) the invitation of and notification by a relevant specialty society; (2) an express invitation by the chair of the RUC; or (3) the approval of a written request to attend; and a review of conflicts and potential conflicts of interest.

This does not mean that RUC meetings are open, or that their proceedings are public. Instead, as Goodson(2) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."

The letter also personally invited me to attend "the next meeting of the RUC, which will take place April 23-26, 2009 in Chicago." In retrospect, this invitation did not appear serious, since it was never repeated or expanded after my email reply to the March letter.

Nor did the invitation include any assurance that I could make anything about this meeting public. I had learned from a previous RUC attendee who will remain anonymous that attendees are obligated to sign non-disclosure agreements. Signing such an agreement might jeopardize my further ability to write anything of substance about the RUC. Furthermore, making all meeting attendees sign non-disclosure agreements effectively makes the meeting secret.

The RUC and Primary Care

Dr Rich and Dr Levy asserted that:

Your publication irrationally and unreasonably paints the RUC as the perpetrator of all physician payment policies that have negatively affected primary care.

Furthermore, they argued that the RUC has been good for primary care and cognitive practice:

The RUC has made several recommendations that positively benefit cognitive and non-procedural physician specialties.

My opinions about the RUC's influence on payments to physicians, and the decline of primary care and generalist and cognitive practice are hardly original. My previous posts were clearly based on evidence and discussion from references 1-4. Let me summarize these arguments, using direct quotes from these references, which perusal of the original articles would reveal are not taken out of context.

Primary and generalist practice is threatened by the current payment system.

From Bodenheimer et al(1):

Incomes of primary care physicians are well below those of many specialists, and the primary care–specialty income gap is widening.

... the lower income of primary care physicians is a major factor leading U.S. medical students to reject primary care careers.

Primary care practice is not viable without a substantial increase in the resources available to primary care physicians.

From Goodson(2):

Medicine's generalist base is disappearing as a consequence of the reimbursement system crafted to save it—the resource-based relative value scale.

Current reimbursement incentives substantially favor procedures and technical interventions and offer financial advantages for expensive care, thereby encouraging specialty services.

The continued and sustained incentives for medical graduates to choose higher-paying specialty careers and for those physicians in specialty careers to increase income through highly compensated professional activities have been associated with the dwindling of the generalist workforce. The lack of incentives for medical graduates to choose generalist careers in internal medicine, family medicine, and pediatrics has had a profound effect on the workforce mix and, ultimately, US health care expenditures.

The RUC has been the major influence on the physician payment system leading to these problems.

From Bodenheimer et al(1):

In summary, the RUC process favors increases in procedural and imaging reimbursement for 3 reasons: specialty society influence in proposing RVU increases, the specialist-heavy RUC membership, and the desire of RUC specialists to avoid increases in evaluation and management RVUs. With their ability to create new codes and influence RVU updates, many procedural specialists can influence fees in a way that observers find to substantially overvalue procedural and imaging services. Moreover, high fees may encourage physicians to increase the volume of profitable services, leading to even higher income gains and greater spending growth.

From Goodson(2):

The RUC has powerfully influenced CMS decision making and, as a result, is a powerful force in the US medical economy. Furthermore, by creating and maintaining incentives for more and more specialty care and by failing to accurately and continuously assess the practice expense RVUs, the decisions of CMS have fueled health care inflation. Doing so has affected the competitiveness of US corporations in the global market by contributing to years of double-digit health care inflation that have consistently increased the costs of manufacturing and business in the United States over the last decades.

The current mechanism fails to provide sufficient checks and balances and is skewed and dysfunctional.

The resource-based relative value scale system originally developed to achieve full value for cognitive services currently threatens the sustainability of the generalist base. As a result, a large portion of the population will lose access to the continuous and personalized care provided by generalist physicians whose repertoire of clinical skills and interventions coupled with access to specialty and diagnostic services are essential for ensuring efficient and effective health care delivery.

Dr Rich and Dr Levy are entitled to their opinions, but I would argue that there is considerable evidence and opinion suggesting that the current dysfunctional physician payment system is a major cause of the decline of primary care and cognitive practice, and simultaneous rise in health care costs and decline in health care access in the US. Furthermore, there is also considerable evidence and opinion suggesting that the RUC has singular responsbility for the dysfunctionality of the payment system and how it is skewed in favor of procedures as opposed to cognitive services and primary care.

Summarizing: the Opacity of the RUC, and its Negative Effects on Primary Care and Cognitive Services

So, I stand by my statement that the RUC process is opaque. Instead of saying "the identities of RUC members are secret, as are the proceedings of the group," I would be willing to now say, "the identities of the RUC members are obscure and difficult to ascertain, and the proceedings of the group are secret." That is not much of an improvement.

If the RUC leadership wants to make its membership transparent, all it needs to do is post it on the web. If it wishes to make its proceedings transparent, all it needs to do is publish them as well. If it makes such changes, I would happily and publicly applaud them.

If the RUC leadership wants to show that their members are not influenced by individual conflicts of interest, transparency about the committee's membership would inspire more trust than making the information as obscure as possible.

Furthermore, there may be more reason to be concerned about the effects of institutional rather than individual conflicts of interest on the RUC. Most RUC members appear to represent specialty societies. Rothman et al claimed that industry funding of professional medical societies is "pervasive."(5) If the RUC leadership wants to show that their committee as a whole is not affected by institutional conflicts of interest of its specialty societies, it ought at least to disclose the relationships of those societies and their leaders with companies that stand to profit from increasing utilization of the specific services whose use is influenced by the incentives which the RUC largely determines.

Finally, if there is a "wedge between cognitive and procedural specialties" it was driven a long time ago, particularly by a payment system that progressively favored the latter over the former, and by a bureaucratic burden that fell disproportionately on the former. But blaming the messenger is a time-honored, if not necessarily honorable tactic.

References

1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link here.
3. Ginsburg PB, Berenson RA. Revising Medicare's physician fee schedule - much activity, little change. N Engl J Med 2007; 356: 1201-1203.
4. Newhouse JP. Medicare spending on physicians - no easy fix in sight. N Engl J Med 2007; 356: 1883-1884.
5. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA 2009; 301: 1367-1372. Link here.

Mr. HISTalk has a pair

I've been somewhat concerned about the HISTalk blog site becoming HIT ad revenue-beholden in recent years, perhaps diluting its critique of HIT industry dysfunction.

However, after seeing these posts today, I am reconsidering that impression (comments in red are mine).

On why physicians are ignored in HIT decisions:

... Because that’s what IT executives do (no offense to those CIOs who really do give physicians a strong voice in decision-making). I’ve been on that IT side and the working assumptions where I’ve been were that doctors and nurses (a) don’t understand organizational strategy; (b) are too easily swayed by demo eye candy and insincere vendor promises; (c) understand only products themselves and not the big picture IT world of vendor stability, product positioning, and integration; and (d) don’t appreciate IT’s technology, support, and organizational challenges. [In other words, are basically stupid; see my 1999-ish piece on doctor stereotypes here - ed.] I’ve worked in three places where users were invited to review and recommend clinical systems. In every one, the first choice of doctors and nurses wasn’t the one that was purchased because we IT folks (some of whom were held in very high regard, mostly by themselves and their easily influenced peers) were so much more knowledgeable that we had the right … no, the obligation … to override them to buy what we thought was the best system. Their resulting adoption was about what you would expect. CIOs are often fixated on buying whatever will cause them the fewest headaches or that carries the lowest organization risk. [I would not dismiss the potential influence of conflict of interest as well - ed.]

on CCHIT:

Some anonymous blog commenters (not here) are demanding that Mark Leavitt step down from his role as CCHIT chairman, claiming his history with HIMSS will always taint CCHIT. My thoughts: I agree. HIMSS wisely used its clout to create CCHIT in its image and nurture it through general acceptance to advance its own agenda, but the strings need to be cut now (including replacing Steve Lieber as CCHIT board chair). I predicted when CCHIT was created that it wouldn’t really change the industry because the interoperability changes CCHIT was supposed to certify (and nothing more) weren’t capabilities customers cared about anyway. That’s what has happened, at least from my cheap seat. Now that CCHIT indirectly affects billions in stimulus dollars, I’d rather see it run by people with no trade group or vendor connections. If it isn’t willing to do that, I’d say choose or form another group to run the certification program. Some of what CCHIT wants to measure, report, or certify (functionality, security, specialty capabilities) is going way beyond what the government should be mandating anyway, although this particular government seems to enjoy telling carmakers and banks how to run their affairs (kind of like letting the Mafia buy into your business). It’s funny that the industry has fought tooth and nail to avoid FDA oversight that it couldn’t control, but seems to like CCHIT because it removes some competitors and sends innovation to the back of the line. [I largely agree with the caveat that the #1 issue for me is clinical IT safety -- primum non nocerum -- and also recently found part of CCHIT leader Mark Leavitt's response to my pointed questions patronizing and a bit hysterical. Sign of a leader who can't handle the pressure of public scrutiny and controversy without blowing up? My early mentor, cardiovascular surgeon Dr. Victor P. Satinsky, had a rule in medicine - "If you don't like it, don't come" - i.e., if you can't take the heat, get out of the kitchen - ed.]

Regarding Mr. HisTalk's comments: wow.

-- SS

Wind Cripples Hospital's EHR Systems - But These Things "Just Happen"

I would like to pretend these incidents don't occur, but alas, they do. Of course, we only know about the ones that are reported.

At "Indiana Power Surge" I wrote about the dangers of EHR "glitches" that do, but should not, cause catastrophic failure of clinical IT systems that clinicians are increasingly dependent upon to deliver healthcare.

At "Another Episode in the Series: HIT Failure" I wrote about yet another hospital whose clinical IT suffered a "glitch" that caused the hospital to struggle for a week with computer failures.

Here we go again, this seems almost daily now. Wait until hospitals and offices really try to push the envelope to get onboard the ARRA EHR gravy train by 2014:

Strong winds damage Indian Hospital systems

Posted: June 8, 2009 05:48 PM

LAWTON Okla. - The Lawton Indian Hospital is trying to recover from damaging winds that came with a severe storm Sunday night, leaving the hospital without air-conditioning and severely crippled in their computer systems.

The storm damaged a coil to a $200,000 cooler that provides air conditioning for the hospital. The power went off for a short time around 8:30.

The power outage affected all their medical records, charts, everything that held patients' information. The only way to overcome the glitch was to resort to an old filing system. A system that used colors to match up what kind of care a patient needed.

And with 55,000 files to pour through, the hospital has severely slowed down. Rows and rows of thousands of files. Each one containing a patient's history.

Of course, there is the traditional disclaimer about how such outages NEVER, EVER jeopardize patient safety (see "Health IT Failure Never Puts Patients at Risk"):

Despite this setback hospital officials remain optimistic.

"The staff knows a lot of the folks, they know what's going on with them," said hospital Chief Executive Officer Hickory Starr.

I can attest to memory not being an optimal way to practice medicine ...

The outage has repercussions beyond inpatients:

Even if the hospital could call all of the existing patients to let them know the hospital's system is down, he says that would not solve everything.

"We have a lot of folks that show up here. Some that have appointments and a lot that do not."

Then there are those who need refills on their prescriptions.

"And we can not do refills because we can not pull up that electronic chart."

Finally, the prevailing attitude that safety is an Act of Providence (in reality, safety is not an accident):

Despite it all, most people remain pretty cheery.

"Generally they are. There is always some frustration but this is one of those situations that just happens."

One of those situations that "just happens" is days of EHR failure due to a power outage?

It'll all be fixed soon:

Hospital officials expect the computer systems back online late Monday or early Tuesday morning.

Real soon.

I repeat my oft-stated observation that IT culture will need to be reformed before IT will be able to "reform medicine."

-- SS