Volume 62, No. 8 August 2006

DATA MINING

The problems bedeviling American medicine are well understood, writes the general manager of health care and life services for IBM. Costs are growing faster than revenues, and in the U.S. more people are dying of medical errors than of AIDS, homicide, and car crashes put together, she states.

"This has become quite literally a matter of life and death." Fortunately, we have "reached a consensus on at least one solution: We need to wire our entire health-care infrastructure into an intelligent national network. Doing so will transform the quality of care, while streamlining and automating the economics of health care to produce dramatic cost savings...." The vision is shared by Hillary Clinton and Bill Frist (Carol Kovac, "Toward a Digital Health-Care Ecosystem," Wall St J 10/25/05). And by Newt Gingrich and many others AAPS News, September 2003, December 2004).

Virtual Reality

"The potential for third-party geniuses to extract data and figure out what it all means is almost limitless," writes Richard B. Warner, M.D., President of the Kansas Medical Society. "It may hold as much promise as x-ray vision."

In wartime or "extreme disasters" like Hurricane Katrina, "advanced expert systems" could track patients' symptoms; determine possible causes of an outbreak; assess response effectiveness; and direct scarce resources to where they are most needed. "Intuitively we know," Gingrich says, that evacuees of M.D. Anderson died of lack of information, not just cancer. All we need is a President Eisenhower, who "forced the country to act" to build the interstate highway system (Newt Gingrich, Center for Health Transformation, June 29, 2006).

For peacetime and chronic diseases, there's the Archimedes system invented by heart surgeon and mathematical genius David Eddy, M.D., to overcome the limitations of the human mind. It seeks to model human biology in equations, make treatment recommendations, and figure out what each approach costs. Its mathematical lever moves vast amounts of data in virtual trials on virtual patients. It works at least ten times "better than the current model, which is called thinking," according to Dr. Richard Kahn, chief scientific officer at the American Diabetes Association. Real trials, in contrast, cost millions of dollars and may be obsolete by the time the results come in years later: Up to one-third of them lead to conclusions that are later overturned (BusinessWeek online 5/29/06).

System Must Be Universal, Interoperable

As Linda Gorman points out, we can already have instant electronic records no Congress required. Everybody can buy a USB flashstick, tested for ruggedness and reliability by millions of teenagers. Doctors and hospitals can put your medical records on it using the national document interchange standard: Adobe Acrobat. Moreover, we already have Wal-Mart and Home Depot with their telephones and network of contacts to divert supplies to a distressed region, rather than a "dumb, bug-ridden hunk of software."

Nevertheless, writes James Knight, M.D., CEO of Consumer Directed Health Care, the government wants doctors to spend tens of thousands of dollars on new, unproven technology; learn how to spend time entering data they already know; and be responsible for the security of that data at the risk of going to jail all without additional pay.

Without interoperability, "the government can't rummage through everyone's records at will," Gorman explains.

Interoperability enables data mining, which has already proved its potential. It made UnitedHealthcare Group what it is today. Only 25% of United's profits come from its HMO business. In 1993, it sold its Diversified Pharmaceutical Services to Smith Kline Beecham for $2.3 billion, agreeing to provide access to its pharmaceutical data mining operation data.

Data mining enables organizations to create reports of quality indicators, which they can use to drive practice changes (Richard Reece, HealthLeaders Media 6/27/06).

If public report cards are to work, "participation must be mandatory and quality measurements...must be universally adopted," write Rachel Werner and David Asch. Otherwise, "the sickest patients will be shifted from rated to unrated providers" (JAMA 2005;293:1239-1243) as shown in New York.

Despite attempts at risk adjustment, public reporting of hospital outcomes for coronary artery bypass and angioplasty in New York has resulted in denial of services to high-risk patients, according to 83% of practitioners participating in a survey. Additionally, there is evidence that high-risk patients are being referred to nonreporting states. Cleveland Clinic, for example, demonstrated a significantly higher-risk population referred from New York than from any other state, beginning at the time the reporting requirement went into effect (Zoltan Turi, JACC 2005:45:1766-1768).

It's About the Money

A federal advisory panel is "spending summer cooking up standards" for utilization and lab data transmission. They are boiling down 570 standards to 92 sets of "cookbooklike instructions" (modernhealt hcare.com 7/3/06).

Such standards will support a new mode for provider payment: evidence-based case rates (ECRs). One model is called PROMETHEUS, which is designed to work both for integrated delivery networks and individual practitioners (www.bridgestoexcellence.org).

The process will surely reduce errors defined as "undesired variations in practice" as well as costs. And all through "rationalizing" care, not rationing it.

Statistical Malpractice

The current trend is to look for answers to medical problems in information technology rather than an understanding of disease and its causes. Bruce Charlton of the University of Newcastle upon Tyne calls it "statistical malpractice": it is "brilliantly clever" but "fundamentally wrong-headed."

Big databases, Charlton writes, are a sign "not of rigour but of poor control." Basic scientists quip that if statistics are needed, you need to go back and do a better experiment.

The perils of statistics include averaging qualitatively different instances to produce nonexistent artefacts. The root of most statistical malpractice is the breaking of mathematical neutrality and introducing causal assumptions without scientific justification: "science by sleight of hand."

Medicine is deluged, Charlton writes, with "more or less uninterpretable `answers' generated by heavyweight statistics operating on big databases of dubious validity" (J R Coll Phys London 1996;30:112-114).

While physicians voluntarily adopt evidence-based medicine (EBM) standards when convinced that they are an improvement, changes in practice are slow. EBM experts seek to streamline the process "by having the law empower a handful of experts to dictate which sources of information clinical practitioners must revere and which can be safely ignored," writes Linda Gorman (Independence Institute Issue Backgrounder IB-2004-F).

The gold standard is the randomized controlled trial. But one study of RCTs for surgery showed that only half of them had sample sizes large enough to detect treatment differences as great as 50%. Underpowered RCTs, Gorman notes, are "an attractive justification for arbitrary rationing decisions."

RCTs can do harm. If physicians were forced to follow the guidelines from the ALLHAT study, nonblack men would be placed on a regimen that increased their risk of death by 3 to 6% in the study, Gorman points out.

It's about money and power, she concludes. Physicians deviating from EBMs would be prime targets for trial lawyers. "EBM shifts the power to determine medical practice from clinicians who deliver care to patients to people in government and academia who manage to get appointed to the right committees." Moreover, the developers of guidelines stand to make considerable money by selling them.

Digitomania

The compulsion to digitize all human activity mirrors the "tulipomania" of the 17th century, writes Marian Chester Coombs. Prolonged suspension of disbelief can spring up periodically even among the most enlightened of peoples.

"The worship of Information and other forms of digitalia is as superstitious as any form of idolatry. But misinformation is worse than no information, and disinformation is worse still; and digitomania unfortunately lends itself equally well to all three" (Chronicles, June 2005).

"The evidence-based medicine initiative involves a technocratic takeover of the practice of medicine through data collection, guideline creation, clinical surveillance, pay-for-performance strategies, and centralized decision-making. In short, EBM is aimed at stopping the heart of health care the compassionate, first-do-no-harm, to-my-own-patient be true ethics of medicine."

Twila Brase, R.N., quoted in Health Care News 2/1/05

Nominating and Resolutions Committee Reports

The Nominating Committee, chaired by Chester Danehower, M.D., presents the following slate:

President Elect: Tamzin Rosenwasser, M.D., Venice, FL;

Secretary: Charles McDowell, Jr., M.D., Alpharetta, GA;

Treasurer: R. Lowell Campbell, M.D., Corsicana, TX;

Directors: John H. (Tim) Boyles, Jr., M.D., Centerville, OH; Curtis Caine, M.D., Brandon, MS; James F. Coy, M.D., Cape Coral, FL; Lawrence R. Huntoon, M.D., Lake View, NY; James L. Pendleton, M.D., Bryn Athyn, PA; Mark Schiller, M.D., San Francisco, CA.

To be considered, Resolutions must be submitted to AAPS in writing no later than August 15.

Hacking Nightmares

After Orthopaedics Northeast of Wayne, IN, notified its local vendor that it was changing its software, the vendor unilaterally cancelled its support contract. Soon, the clinic's system started crashing on a daily basis and was once inoperable for a week. After the system went down for good, it was found that someone had entered through a "back door" left by system designers.

At the University of Washington, a hacker penetrated hundreds of servers, gaining access to medical records, financial data, passwords, and more. He roamed the system for 18 months before being detected. Repairing the breach required wiping the hard drives of more than 200 PCs, among other laborious measures. The team also had to notify authorities, employees, and outside affiliates. It decided not to notify individual patients since the hacker apparently hadn't used or disclosed their records (HIPAA Compliance Alert 3/13/06).

"No. 2 Preventable Killer" Debunked

After announcing that "obesity" had killed 400,000 people in 2000, a 33% increase since 1990, the CDC had to admit to a "methodologic flaw." There were actually only 26,000 obesity-related deaths annually, an error of about 1,400%. Most interestingly, the new study found that 86,000 "overweight" people lived longer than people of normal weight. And one study found that weight- related risks declined with age, disappearing at age 74.

Public policy, however, such as launching the Fat Police, admits of no error. We claim to know while in fact we rarely do. The CDC director called the error a "lesson in humility."

Will "the people in Washington with the power to impose solutions to the problems of life on all of us [make] their new watchword `humility'?" asks Donald Henninger.

"Fat chance," he says (Wall St J 5/6/05).

AAPS Calendar

Sep 13-16. 63rd annual meeting, Embassy Suites, Scottsdale, AZ.

AHIC Imbalance Doesn't Matter, Gov't Says

In its motion to enter judgment against the AAPS challenge to the American Health Information Community (AHIC), the government does not dispute the AAPS claim that AHIC lacks balance. Rather, it asserts that the issue is "not justiciable." AAPS v. U.S. Dept of HHS, Civil Action No. 1:06cv00319(ESH).

In the Federal Advisory Committee Act (FACA), Congress requires that committees be balanced, but does not define "fairly balanced," nor does it specify how such a membership is to be achieved. It would first have to determine which of a myriad of potential views have to be included.

As the Court has no principles to apply to resolve the issue, HHS asks the Court to rule against AAPS as a matter of law. Additionally, it does not argue that the AHIC subcommittees comply with FACA, simply that they shouldn't have to. After the fact, probably in response to the lawsuit, AHIC identified a privacy expert (see FAQs at www.hhs.gov/healthit). Documents pertaining to the lawsuit are posted at www .aapsonline.org/judicial/ahic.php.

AAPS thanks the American Health Legal Foundation for financial support for the litigation.

Dr. Nucklos Released on Bail Pending Appeal

Convicted for opioid treatment of three patients who claimed to have chronic pain, William Nucklos, M.D., age 58, was sentenced to serve 20 years in prison. The trial court having failed to act on his application for bail pending appeal, the Court of Appeals for the 2nd District of Ohio granted it.

The appeals brief, posted under "Judiciary" in the AAPS Hall of Shame, points to numerous shocking injustices in this case. AAPS President Kenneth Christman, M.D., introduced a resolution asking the Ohio State Medical Association to investigate the criteria and methods used by prosecutors in charging physicians who treat chronic pain, and also to write or join an amicus brief in support of overturning the Nucklos verdict. OSMA declined to act. Rev. Jesse Jackson wrote letters to members of the Court, expressing concerns about racial discrimination (Dr. Nucklos is black, and not a single black person sat on the jury), among other issues.

One of the most egregious injustices was failure to reveal exculpatory evidence: Dr. David Romano, a prosecution witness, had also been deceived by one of the three patients.

Of the several physicians who had all prescribed for these patients, only Dr. Nucklos was charged. One of the patients had been discharged by Dr. Nucklos when he received word of "doctor shopping." All had plausible histories of pain.

About 95% of the trial transcript had nothing to do with the charges, but rather with highly prejudicial uncharged "bad acts." The prosecution alleged that there was a civil judgment against Dr. Nucklos for $600,000 of fraudulent charges. In fact, this dispute, still unresolved, concerns correct charges entered by Dr. Nucklos that his billing service increased on its own. The amount involved is about one-tenth the amount stated.

The judge who permitted the character assassination to proceed had a disqualifying conflict, having recently served as an assistant to the prosecutor. The evidence was insufficient to support a conviction. The jury instructions were improper. Sentencing was based on inadmissible "bad act" evidence introduced to inflame the jury. For all these and other reasons, justice demands a new trial before an impartial tribunal.

Medical Staff Bylaws Alert

One set of medical staff bylaws that came to our attention has a clause specifically saying that the bylaws do not constitute a contract. There is simply a vague statement that both the board of directors and medical staff are obligated by law to use "fairness" in dealing with persons bound by the bylaws but no specific procedures are spelled out.

There seems to be a growing trend for hospitals to try to exempt themselves from following the bylaws, while enforcing them against physicians, but the above is the most blatant example of a power grab that we have seen to date.

Final Rule on Medicare Enrollment

On Apr 21, CMS published a Final Rule establishing new enrollment procedures for all providers and suppliers except those who opt out of the Medicare program.

The period that would result in deactivation of billing privileges because of failure to submit a Medicare claim was lengthened from 6 to 12 months.

Applicants must already furnish a National Provider Identifier (NPI) on CMS form 855, even though the deadline for obtaining an NPI is not until May 23, 2007. Applicants will have to enclose a copy of the NPI notification.

One of the most controversial provisions is the need to validate enrollment information every 5 years. This will be phased in, recognizing that a large number of physicians who bill Medicare have never completed an application. Enrollees who never before submitted a form 855 will have to do so now, along with a vast amount of information. CMS asserts the right to do a site visit to validate the information.

The CMS 855 requires the applicant to agree to recoupment of Medicare overpayments, which could preempt subsequent legal arguments about the obligation to return a particular payment.

The Final Rule expands CMS authority to deny enrollment. "The possible reasons for denial are so broad that CMS could find grounds for denial in nearly any situation," state Karen Lovitch and Sarah Whipple (BNA's HCFR 6/21/06).

AAPS has helped many physicians opt out of Medicare. See www.aapsonline.org/medicare/m-optout.php .

To view CMS form 855i, see www.cms.hhs.gov .

Court Limits Protected Speech for Whistleblowers

The First Amendment does not protect public employees from being disciplined for statements made in the course of their official duties, ruled the U.S. Supreme Court in Garcetti v. Ceballos, U.S., No. 04- 473, 5/30/06.

Richard Ceballos argued that his comments to his supervisor about whether a deputy sheriff had lied to obtain a search warrant constituted protected free speech. A 5-to-4 majority held that the Constitution protects neither public nor private employees from employer discipline. A decision for Ceballos would commit the judiciary to permanent interventions in the conduct of government operations, the Court said.

Tom Devine of the Government Accountability Project said that the decision has the effect that a govern- ment worker could be protected if he talked to journalists, but fired if he talked to his boss. Justice Kennedy stated that legislation, such as whistleblower protection and labor codes, is available to those who seek to expose wrongdoing (HCFR 6/21/06).

Correspondence

Double Standard. The AMA has been issuing proclamations about the ethics of physicians' accepting gifts from pharmaceutical companies. Meanwhile, last year the AMA earned $44.5 million (16% of its total revenue) from sales of its database products, including the "AMA Masterfile," which contains information on all physicians, including non-AMA members, from medical school onward. The AMA sells information to entities like IMS Health (operating revenue $1.75 billion), which sells to pharmaceutical companies and others. Drug companies track physicians' prescriptions, and sometimes confront physicians with their history to pressure them to order more of a particular drug.

If the AMA were to stop licensing the Masterfile for this purpose, "it would separate itself from the practice, but its revenue would decline" and data would be purchased from others (N Engl J Med 2006;354:2745-2747).
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY

Danger! If someone would please explain to me why data mining my bank transactions or international telephone numbers called is a Bad Thing Dangerous to My Constitutionally Protected Privacy, while mining my medical records is a Good Thing, I could finally get a good night's sleep.

Apparently some people really believe that my physician is more dangerous to me than my local terrorist cell.
Linda Gorman, Independence Institute, Golden, CO

VA Electronic Medical Records. The VA's vaunted EMR system may be wonderful, but the VA won't allow anyone on the outside to verify this claim. The VA never provides medical information on its patients when we fax a signed release-of-information request. Never. When I need records from the VA, I have the patient collect them, and many times it is very difficult for him to do so. Because of the VA's secrecy, I do not believe the glowing reports on its chronic disease management system even though published in reputable journals. Also, what the VA will care for, based on the veteran's service- connectedness, is ever diminishing and longer delayed.
Robert S. Berry, M.D., Greeneville, TN

Error Free. People in Washington, D.C., never admit that they don't know something, nor do they ask questions. To find something out, they make a statement and wait to be contradicted. If they are at a bus stop and don't know whether it's the right one, they may say, "The C bus stops here." Someone else will pipe up and say, "No, the C bus stops over there." The first speaker says, "Well, yes, that's what I meant."
Greg Scandlen, Consumers for Health Care Choices

Government Tries to Recall Information. In a letter from the Department of the Army, we were notified that personal information was inadvertently provided in an abstract table and published. The information was removed from the internet, and we were asked to remove p 130S from the October 2005 supplement to Chest and mail it back in a self- addressed stamped envelope: "you may have a legal and/or ethical duty of confidentiality with respect to this information." Where does the buck stop, if merely receiving a journal creates a duty?
Debi Carey, Lexington, KY

Eavesdropping. One night I met with a computer consultant in the education building next door to a hospital, on the issue of security. He turned on his scanning equipment to monitor the hospital's broad band. Encrypted data and messages started popping up. He described his encryption busting program, saying that in a few hours of monitoring he could easily crack the whole system. He could also have done it from a parking lot 50 feet away. There is no such thing as computer security if it is on broad band.
Thomas W. LaGrelius, M.D., Torrance, CA

Funding Medical Care. There are three types of housing: government (possibly nice at first, but soon substandard); rental (no down payment, but no equity, and subject to inflation); and ownership. Medical care is similar. Health insurance is like a rental. Once you stop paying your premium, perhaps because you are too sick to work, you are out and you have nothing to show for it. Ownership is the American ideal; you build up equity, have an inflation hedge, and what you fix up you keep. Health Savings Accounts are a start. The new paradigm will be medical timeshares; you own part of the hospital. It will have to begin offshore because of government roadblocks in the U.S.
Alieta Eck, M.D., Somerset, NJ

No Guarantees. Even with the power to print money, govern-ments bankrupt their nations. There is no guarantee that health insurers will be around to fulfill their obligations. We need less reliance on financing mechanisms that make promises that they cannot keep or private practice could be destroyed.
Joseph Lee Pugh, Diamondhead, MS

U.S. Socialized Medicine. Group health insurance in the U.S. today is quasi-socialism because the government gives it a tax preference over other forms of risk sharing, such as associations. This allows redistribution of wealth from young to old. In a free- market system, unless a member of a group that agrees to share wealth (family, clan, or faith), no young person would ever agree to share health risk with an old person.
Steven Bassett, Oak Park, IL