Volume 67, no. 4 April 2011
Whatever claims are made for them, or whatever advantages they may have, the real motive for pushing electronic health records (EHRs) is control. The EHR enables a chain of accountability in a monolithic, radically transformed, collectivist system.
Only 3 months after the passage of the Patient Protection and Affordable Care Act (PPACA, ACA, or “ObamaCare”), the 60th anniversary national symposium and concept paper by the National Committee on Vital and Health Statistics (NCVHS) was ready—to explore the “robust health information capacities needed to support the changes the ACA…set in motion.”
Work started long ago, of course, and three prior major pieces of legislation since 1996 “have positioned NCVHS to make mandated recommendations to support both administration and patient care activities” [emphasis added]: HIPAA, the Medicare Modernization and Improvement Act, and the American Recovery and Reinvestment Act (ARRA or “Stimulus” Act).
Construction of the Tower of Babel can proceed, as language is standardized, even internationally, enabling “harmonization of standards,” with quality measures and clinical decision support.
The “New” Paradigm
“Our health care system is not broken—it’s obsolete!” writes Jordan J. Cohen, M.D. of George Washington Univ. (Pharos, Winter 2011). In a bygone era, we could manage with doctors, working solo or in small groups, “in total control.” But these days we have chronic diseases, rising costs, too many medical errors, “inexplicable” variations in practice, and “wide disparities in health and health care.” In a re-design, we’d want “‘units of accountability’ big enough to be held responsible for delivering comprehensive, high-quality, cost-effective care to large groups of people.” They’d have to demonstrate “appropriate outcomes” and take on significant financial risk. “Modern information technology could stitch together the needed network….”
We need not just patient management (of both individuals and populations), but a “physician management infrastructure,” write Peter Provonost and Jill Marsteller (JAMA 2/2/11). We need quality improvement (QI) programs in which “health care leaders” hold physicians, who work in interdisciplinary teams, accountable for quality in their “product line.”
One barrier is physician leaders’ perceived lack of leverage over medical staff. But “hospital and physician managers have much greater authority over physicians than they exercise or believe they have”—as through peer review or credentialing (ibid.).
The Federation of State Medical Boards (FSMB) is working on a “template” for maintenance of licensure. The “performance in practice” (PIP) component will be EHR-dependent.
Costs and Liability
ARRA promises $44,000 to $66,000 to eligible physicians and up to $9 million for hospitals, over 5 years, for installing an EHR—if they meet all the requirements. Under the best-case scenario, however, average costs for the first year top $46,000 per physician. Maintenance costs alone totaled about $17,100 per physician for the first year (Modern Healthcare 3/11/11). Less than 10% of hospitals can meet meaningful use requirements (Modern Healthcare 11/16/10). According to an Arizona State Univ. study, EHR implementation was associated with a 6% to 10% increase in cost per discharge in medical-surgical acute units. In stage 2, the EHR increased R.N. time per patient by 15% to 26%.
About 50,000 new medical informaticians and health–information managers will be needed (Nature 2/17/11).
The typical practitioner does not have the knowledge to make informed decisions about the selection or use of EHRs, according to a panel at the 2011 American College of Legal Medicine meeting. He is, however, responsible for assuring that they are authentic, reliable, contemporaneous, usable, and unaltered. Failure to warn patients of the security risks inherent in EHRs constitutes professional misconduct. The doctor must also assure that any agents or contractors comply with all obligations. Encryption must meet standards that change every 6 months or so. If data are stored in a proprietary format, the practitioner can be held hostage if he does not continue paying support or the vendor goes bankrupt. Liability was called “daunting” and “terrifying.”
Errors and Quality
EHRs make the list of the Top 10 health technology hazards for 2011 (ECRI Institute, November 2010). Health information technology (HIT) has a “magnifying property”: the tendency to exchange a large number of small failures for a small number of large, potentially catastrophic failures. Currently, there are no regulatory requirements to demonstrate HIT safety, although no other hazardous industry employs safety critical IT without some form of independent hazard analysis. ARRA calls for rapid, semi-compulsory implementation of complex HIT systems by organizations with little previous experience with such products. Its fallacies and sober realities are now being discovered (J Am Med Inform Assoc. doi:10.1136/jamia.2010.005637).
“I would like to see some ability to evaluate, to cancel or to admit we made a mistake if it doesn’t work out,” said Mark Pauly of the Univ. of Pennsylvania Wharton School (Modern Healthcare, Dec 20/27, 2010). Apparently, however, the architects of a radical transformation of America deliberately intend to destroy existing institutions so that there is no going back.
HIT Aphorisms
HIT software has commonly been identified as among the least reliable. A National Academy of Science report said HIT should be considered “guilty until proven innocent.”
Benefits of current HIT systems accrue upstream to patient care processes. The mismatch between who benefits and who pays leads to “garbage in, garbage out,” inefficiency, workarounds, and poor adoption. As Grudin’s Law: “When those who benefit from a technology are not those who do the work, then the technology is likely to fail or be subverted.”
Healthcare does not exist to create documentation or generate revenue, [but]…to help the sick and injured.
HIT must support and extend the work of users, not try to replace human intelligence.
Paper continues to be used extensively because paper forms are not simple data repositories that can be eliminated, once computerized. “Scraps” of paper are sophisticated cognitive artifacts that support memory, planning, communication, etc.
Just as a single carbon atom can make the difference between a miracle cure and a toxin, the details of HIT design and implementation are hugely important (AMIA, op cit.)
The Evidence Base
Some conclusions of “meta-researcher” John Ionnides, summarized by David H. Freedman in “Lies, Damned Lies, and Medical Science, The Atlantic, November 2010:
As much as 90% of published medical information that doctors rely on is flawed.
“There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded.”
Of 45 super-cited studies, only 11 had been re-tested.
There is too much complexity in patient treatment to pin down every situation with a great study. “Doctors need to rely on instinct and judgment to make choices.”
The Data Deluge
While physicians are pressured to enter all patient information into a vast data network to facilitate research on “what works,” scientists warn that with data, sometimes “more is less.”
For example, “Can scientific conclusions be trusted when the raw experimental data are lost and the data triage or compression algorithm might be suspect?” asks Richard A. Baraniuk. “Can we resist the temptation to equate correlation with causation when mining massive data sets?” (Science 2011;331:717-719).
Too much collaboration and resource sharing may result in unstated assumptions or paradigms that shape the type of reasoning and evidence deemed acceptable. The reliability of a result increases, write James A. Evans and Jacob G. Foster, if it is produced in several disparate labs (Science 2011;331:721-725). Decentralization (“fragmentation”) in science might be good.
“Making progress in the value framework means capturing data in different parts of the delivery system, which means we all have to use the exact same terminology” (NEJM 12/23/10).
Third-Party Waste and Abuse
The health care system spends as much as $210 billion each year on claims processing, estimates the AMA. According to a TMA survey, 37% of physicians experience a 20% rejection rate on first-time preauthorizations for tests and procedures, and 57% such a rate on first-time preauthorizations for drugs. Navigating the managed-care maze costs physicians up to $31 billion every year. More than 70% of Texas physicians reported at least one instance in the past year in which private-sector utilization practices had an adverse effect on patient care. And 17% report cases in which a physician lost employment, contracts, or hospital privileges because he raised issues about hospital regulatory compliance or patient care quality (Texas Medicine, January 2011).
Impossible Entitlement Arithmetic
With 43% of the U.S. federal budget going to entitlements, such as Social Security and Medicare, the $1.3 trillion cut needed to balance the budget would have to come from the remaining $660 billion (Nature 2/17/11). Some claim that the entitlements have already been “paid for.” A couple retiring last year paid $109,000 into Medicare but can expect $343,000 back (WSJ 2/26-27/11). Government’s share of personal health expenditures has increased from 20% in 1970 to almost 50% in 2007. While the average American spent five times as much, in inflation-adjusted dollars, on private medical care in 2008 as in 1967, he contributed almost 15 times as much toward Medicaid (PRI 8/10/10).
In other countries, national health insurance plays a more important role in wealth redistribution than in the U.S., writes Victor Fuchs, Ph.D. “If spending in these countries were at U.S. levels, the taxation required to accomplish their redistribution goals would probably wreck the economy.” Hence the need to limit the number of physicians and facilities (NEJM 12/2/10).
ObamaCare Destruction Proceeds
After the HHS ruling requiring insurers to write policies for children under 19, regardless of pre-existing conditions, 20 states have no carriers selling children-only policies to new enrollees. In 2011, there will be a 13% decline in Medicare Advantage plans. Carriers offering small group and individual plans are also exiting the market (Galen Institute 2/25/11). Meanwhile, 10 health insurance carriers have received HHS waivers from ObamaCare requirements—for their own employees (CNSNews.com 2/22/11).
AAPS Calendar
May 15. Brunch in Manhattan.
May 20-21, workshop, board meeting, Omaha, NE.
Sep 28-Oct 1, 2011. 68th annual meeting, Atlanta, GA.
ACTION OF THE MONTH
Visit our state chapter websites: http://www.azaaps.org, http://www.caaaps.org, http://www.njaaps.org, http://www.nvaaps.org, http://www.paaaps.org, http://www.tnaaps.org.
None in your state? Volunteer to be a state coordinator!
Give first-time gift memberships free when you pay your dues.
Fraud Strike Force Deploys
In what it called the “largest-ever federal health care fraud takedown” on Feb 17, more than 700 agents charged 111 defendants in nine cities for about $225 million in alleged false Medicare billings. The “schemes” involved providing “medically unnecessary” items or services, violations of antikickback laws, upcoding, or allegedly billing for services not provided.
The Administration’s 2012 budget proposes expanding the strike force to a total of 20 cities. Funding for Health Care Fraud and Abuse Control (HCFAC) will nearly double, to $1.9 billion.
“We want health care providers to know that we are paying attention to billing records, and that abuses will be aggressively prosecuted,” stated U.S. Attorney Barbara McQuade. Whether a clinic owner or solo practitioner, violators will be prosecuted to the fullest extent of the law.
More information technology to detect potential fraud before payments are made is also being deployed.
Attorney Laurence Freedman said that new proposals might put enormous pressures on regulators to “find savings.” There could be over-review of legitimate claims. The “layers of contractors and heaps of new requirements and prepayment reviews could seriously drag down the whole payment system.”
Amendments to sentencing guidelines in the Patient Protection and Affordable Care Act (PPACA), which are based on aggregate total billing, mean that minor upcoding that brings in $100,000 extra on $900,000 worth of services will be punished with as much prison time as billing $100,000 and providing no services at all (BNA’s HCFR 2/23/11).
HITECH Increases HIPAA Penalties
The Health Information Technology for Economic and Clinical Health Act (HITECH), part of ARRA, will “strengthen the civil and criminal enforcement of the HIPAA rules,” according to the Federal Register Vol, 74, No. 209, pp 56124 ff, Oct 30, 2009. It strikes the affirmative defense for violations in which the covered entity did not know, or by reasonable diligence would not have known, of the violation. Instead of maximum penalties of $100 for certain violations, there are minimum penalties, which are as high as $50,000 for each violation involving “willful neglect—not corrected.” The maximum penalty for all violations of an identical provision is $1.5 million/year, even “did not know” violations—up from $25,000. HHS exempts itself from Executive Order 12866 because it does not expect these penalties to adversely effect the economy, productivity, jobs, public health, etc.
HITECH’s unprecedented $27 billion investment will dovetail with comparative effectiveness research.
I Meant What I Said: Judge Vinson
In response to the Administration’s request for “clarification” of his opinion in the challenge to ObamaCare by Florida and other states, Judge Vinson writes: “While I believe my order was as clear and unambiguous as it could be, it is possible that the defendants may have perhaps been confused or misunderstood its import.” He reiterated that the entire act is “void.”
Moreover, “the defendants had acknowledged in their summary judgment opposition brief that, if I were to find for the plaintiffs, separate injunctive relief would be superfluous.” Now the defendants claim it is confusing that the Judge would apply the long-standing presumption “that they themselves had identified and specifically insisted that they would honor.”
To suggest that a declaratory judgment will only be effective and binding after the appeals process has fully run its course is “manifestly incorrect and inconsistent with well established statutory and case law.” The assertion that the ruling required “careful analysis” also “seems contrary to media reports that the White House declared within hours after entry of my order that ‘implementation will proceed apace’ regardless of the ruling.”
Noting that halting implementation would be “extremely disruptive and cause significant uncertainty,” yet that plaintiffs complain of substantial harm now, the Judge decided to treat the motion to clarify as also a motion to stay, and granted it on condition that the defendants would file their anticipated appeal with 7 days and seek an expedited process.
The Judge noted that reversing what has already been implemented may prove enormously difficult. “Indeed, one could argue that that was the entire point in front-loading certain of the Act’s provisions in the first place.”
AAPS Files Amicus in Virginia Case
In an amicus brief joined by Doctors 4 Patient Care, AAPS makes a number of notable arguments about the unconstitutionality of ObamaCare. Congress has power to regulate only certain types of commerce—and commerce always involves a transaction between parties. There can be no commerce involving only a single individual. Moreover, the argument that individual decisions not to purchase insurance have a “substantial” effect on the economy are based on numerous assumptions and extrapolations, some of which contradict each other.
Mark Twain expounded on the dangers of extrapolation, as from the statement that over 176 years the Mississippi River had shortened itself by an average of about 1.3 miles per year. Obviously, a million years ago the Mississippi was 1.3 million miles long, and 742 years hence will be only 1.75 miles long, he wrote.
Congress violated the Presentment Clause repeatedly by simultaneously enacting and amending many ACA provisions. Two provisions contain incompatible definitions of “penalty amount.” The law is too incoherent to be understood.
Also, the individual mandate is an assault on patient privacy as it requires all Americans to submit their complete medical history to an insurance company.
AAPS Defends Privacy in Sorrell Case
AAPS filed an amicus brief defending the confidentiality of prescription records before the U.S. Supreme Court in Sorrell v. IMS Health (No. 10-779). The case involves the sale of aggregated prescription information to data mining companies for use as a marketing tool by pharmaceutical manufacturers. IMS Health challenged, on First Amendment grounds, the constitutionality of a Vermont statute that limits exploitation of pharmacy data.
“Data mining does not facilitate discourse or the exchange of ideas,” AAPS argues, “and in fact inhibits what people say and do for fear their privacy will be invaded.”
Correspondence
Beware the EHR. One of my patients saw a physicians assistant in a local emergency room, and told her she had headaches. The PA erroneously recorded, in the interoperable electronic health record, that the patient has a brain tumor. The patient contacted the hospital in an effort to correct this false information. It is, however, probably already disseminated widely. I hope she has life insurance already, because she probably won’t be able to get it now. The patient also never got to see a doctor.
I just returned from a presentation by two attorneys at the county medical society’s economics committee meeting, where physicians were told that EHRs are “more accurate.”
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY
Fractional-Reserve Systems. The 45-page disclosure statement that my bank gives to new depositors says nothing about fractional-reserve banking, or the practice of banks’ loaning out a depositor’s money nine times over. This would be akin to the long-term airport parking garage’s failure to tell you that it would lend your car to nine people while you were away. That’s a hypothetical example; the best real-world example is Social Security. The government takes your FICA deposits during your working life, without telling you that it is giving the money to other people and not holding it in reserve in your own account. Like banking. Social Security is a fractional-reserve system.
Craig Cantoni, Scottsdale, AZ
Accountability. Economics literature suggests that for-profit firms have lower costs than non-profits at the same level of service. The difference seems to be that managers of a for-profit firm, one with stockholders, have their noses kept to the cost-minimization grindstone. They can’t systematically rip off customers because customers can go elsewhere. Non-profit management doesn’t answer to anyone and typically has higher costs because managers opt for better working conditions—less pressure, longer vacations, etc. Profit-making businesses have far more accountability than most other forms of organization, e.g. government.
Linda Gorman Ph.D., Independence Institute, Golden, CO
Free Screening. Screening an entire population to find a few who need treatment is enormously wasteful. Moreover, people who feel a need to be screened will not be deterred by cost sharing. People who do not feel a need won’t bother even if it is free. Free care mostly allows people who feel a need to receive more expensive care. It is a boon to hypochondriacs.
Greg Scandlen, Hagerstown, MD
Report from the AMA. At the national conference in June 2010, most of the time for debate was spent on the election of officers. The rest was spent on how doctors would work with the new financing mechanisms: who we are going to throw under the bus as the money is divided among specialties and demographics. And, we sat around in a romper room and were instructed to write a note to the Senate on a paper “white coat,” begging them not to allow the 21% cut. Who’s asking why anyone would want to work for a bankrupt company? The AMA has disintegrated into an organization that exists only to exist.
Marcy Zwelling, M.D., Los Alamitos, CA
Pilot Programs. Before there was a modern welfare state, the federal government did a test run: the Seattle-Denver Income Maintenance Experiment (SIME/DIME). Participants were guaranteed a minimum income, regardless of wages or marital stability. Researchers were stunned by the results: couples split up, and people worked less. Before the welfare state created all the tragedy and social pathology that we are living with today, federal planners knew exactly what would happen! This shows that (1) it is possible to spend extraordinary amounts of money to learn something that ordinary people with common sense (people without Ph.D.s) could have told us anyway and (2) politicians are likely to do whatever is expedient for them no matter what we learn.
John Goodman, National Center for Policy Analysis
Soft Coercion. Do you ever notice that we are rarely directly mandated to do something, so as not to infringe our rights (the individual mandate being an exception), but we are pushed or nudged into doing something because otherwise we have to make serious changes to spin ourselves out of the system?
Karen Radley, M.D., Price, UT
“Time Out” Needed for PPACA. In medicine and in the operating room, we may need to call a time out, when everything is stopped and checked and re-checked. That’s what we need for “health care reform.” The more we find out, the less we like. The only people I see benefiting from PPACA [“ObamaCare”] are policy wonks, government bureaucrats, lawyers, and consultants. Already I see infighting among physicians.
Leah McCormack, M.D., President, MSSNY
Heading for the Exit. In 2014, one of the largest orthopedic practices in North Texas is planning to go cash only. They predict retention of current revenue levels with half the patients and much less administration related to claims filing.
Jay Huminsky, R.H.U., R.E.B.C., Dallas, TX
