Volume 63, No. 1 January 2007
LINKAGE: EBM, EMR, P4P
Physicians are not against science, or medicine based on
evidence. Nor do they oppose technology, progress, efficiency, or
knowledge of patients’ history and the medical literature.
The label “evidence-based” is de rigueur and as ubiquitous
as “low-carb,” note Earl Steinberg and Bryan Luce (Health
Affairs 2005;24:80-92) and perhaps as meaningful.
The RTI International University of North Carolina Evidence-
based Practice Center (EPC) found that only 19 of 121 different
approaches for rating the quality of individual studies met the
EPC’s own standards for such assessments.
Evidence-based clinical guidelines must link several bodies
of evidence, with opinion often filling in the gaps.
According to an expert committee of the Institute of
Medicine (IOM), only about 4% of all medical services are backed
by strong evidence, and more than half by weak evidence or none.
While there is great emphasis on internal validity, there is
strikingly little attention to the external validity of a study
or body of evidence when applied in practice. In other words,
there’s a lack of “medicine-based evidence” (ibid.), for all the
emphasis on EBM.
Nonetheless, EBM, as clinical decision-making “tools,” is to
be embedded in the electronic medical record (EMR). To be
distinguished from a customized digital personal health record
(PHR) that a patient controls, the EMR is standardized,
interoperable, and controlled by the System. A critical purpose
of the EMR is apparently to collect evidence of “provider” and
patient behavior, as well as, purportedly, of outcomes.
Physicians are notoriously slow to adopt change, even when
“educated” by its proponents. A stronger financial incentive is
needed. EBM is to determine the standards for pay for performance
(P4P), and data from the EMR can be used to assess, rank,
credential, and pay physicians.
“P4P is a outgrowth of the [EBM] movement,” writes Michael
Cannon in a Cato Institute Working Paper, to be published in 7
Yale J Health P Law & Ethics.
The Drive for Health Information Technology (HIT)
Although the Bush Administration and prominent Republicans
are pushing hard for implementation of HIT, the IOM has been
advocating the EMR since at least 1991. The Briefing Book on HIT
by the Clinton Taskforce on Health Care Reform spells out the
agenda. Savings of $78 billion by 2000 were projected, largely
through “elimination of inappropriate care.” Standardization and
uniformity were needed to compare performance. A “seamless
network” was required for sharing data nationwide. Clinicians
were expected to change their behavior based on cost data.
Incoming HIT czar Robert Kolodner is former director of
informatics with the Veterans Administration and served on the
Clinton Taskforce. At a meeting at the Institutes of Health on IT
on Sept 19, 1999, he stated: “Like it or not, when IT
comes in, there will be a fundamental change in
the whole process of care and who is delivering what
care.”
Big employers, including Wal-Mart, Intel, and British
Petroleum, are planning to provide digital records for their
employees, and store them in a multi-million-dollar data
warehouse. The goal: reduce benefits costs (Wall St J
11/29/06).
Independence Blue Cross and 19 other Blue plans nationwide
are joining to form a massive database of health records “to
enable employers, consumers and medical professionals to learn
better what kind of care works best” (Josh Goldstein,
Inquirer 8/7/06).
Barriers to the Adoption of HIT
After the Clinton Taskforce officially disbanded, one member
wrote, in June 1993: “I look forward to working with you further
during this unique window in history for developing the health
information infrastructure.”
The window closed; momentum slowed. Now, the biggest
obstacle to HIT is probably physicians in solo or small-group
practice. One hurdle is that costs must be borne by physicians
while most benefits will be realized by others, such as payers.
Only 13% of practices with fewer than 10 doctors had access
to IT for prescribing in 2004-2005. Such practices “appear to be
at risk of being left behind” (HITS 11/9/06).
According to the Medical Group Management Association, the
average cost per physician to buy and implement an EMR system is
$32,606. On average, implementation costs exceed vendor estimates
by 25%. P4P might bring compliant physicians an extra $10,000 per
year in revenue.
If hospitals are permitted to buy IT for their stable of
referring physicians, the picture could change.
Physicians also care about a degradation in efficiency one
reason why IT systems such as computerized order entry are not
always used (iHealthBeat 11/20/06).
Then there’s the risk of IT-related litigation: such as
diagnostic errors related to inaccurate PHRs or flawed decision-
support programs (modernhealthcare.com 9/20/06).
Although 97% of Americans say it’s important for doctors to
be able to access all their medical records, only 34% believe
that an EMR would improve the quality of their care
(HITS 12/7/06). They are very concerned about secondary
uses of their medical data as to deny employment, insurance, or
loans.
Physicians will be paid to accept P4P. A House bill to stave
off Medicare fee cuts provides a 1.5% P4P bonus.
To win over the public, the National Committee on Vital and
Health Statistics recommends using the NHIN exclusively for
patient care for 5 years. Once trust has been established, the
system can be expanded to secondary uses, such as “syndromic
surveillance,” outcomes research, and quality assurance.
Frighten; Build Confidence
The strategy for gaining public acceptance of the NHIN
resembles that of Cold War arms controllers. First, persuade the
public that the threat is apocalyptic and defense impossible.
Then build trust in the adversary that controls the weapons.
The IOM’s alleged 100,000 deaths from medical errors,
pandemic flu, loss of records in a hurricane, undetected fraud,
unaffordable costs all are ways in which paper medical records
can supposedly cause death and bankruptcy.
“We have to recognize that the quality of healthcare that we
have in this country is poor,” said John Lumpkin, senior vice
president and director of the Robert Wood Johnson Foundation’s
healthcare group. “If we are going to reduce errors, working
harder is not going to work” (HITS 10/11/06).
We must have data for cost-effectiveness analysis, for “the
day may be dawning when the Medicare system will face a severe
financial crisis, and the available alternatives will be far
worse” (N Engl J Med 2005;353:1516-1522).
The public fears the consequences of data sharing. “NCVHS
finds that the one benefit that will win over public support is
better health care.” Individuals will absorb some risk to privacy
for identifiable personal benefit but not for societal gain.
“Public participation” in the design of the NHIN will also
increase public trust and “level of comfort.”
Ownership
The Clinton Taskforce raised the question of ownership of
health data. According to a proposed statement of principles
from Heritage Foundation WebMemo 1131 by Edmund Haislmaier,
submitted to the American Legislative Exchange Council, data
generated in a “patient-provider” interaction belongs jointly to
both parties. And “if other parties, such as a payer, are
involved, then they too have a reasonable claim to ownership of
that portion of the information that is generated by their
involvement.” This would mean that payers had the right to use
and disseminate the data.
Healthcare Chernobyl?
In 2001, William Winkenwerder, who was about to become
assistant secretary of defense for health affairs, told attendees
at an HIT convention that “privacy and security are the Chernobyl
that is waiting to happen to the healthcare industry.” Through
2005, nearly 18,000 cases of medical identity theft had been
reported to the Federal Trade Commission. Organized crime is
becoming involved. Damages to hospitals and physician practices
could easily total billions of dollars annually (HITS
10/16/06).
The street value of medical data is now $50 per record.
When fraud is discovered, the victim may be denied access to
his own records, which have become commingled with others,
because of the HIPAA Privacy Rule. Dangerously incorrect medical
information, disseminated nationwide, may be virtually impossible
to amend (HITS 10/17/06).
JCAHO may soon require hospitals to adopt new patient
identification technology to prevent delivery of the wrong
medical treatment to a misidentified patient. Even biometric
identifiers, however, can be counterfeited or stolen. The
Frauhofer Research Institute in Darmstadt, Germany, demonstrated
its ability to fool fingerprint, facial scan, and retinal scan
technology (DeWeese Report, November 2006).
There Is No Anonymous Information
While marketing firms, researchers, financial institutions,
pharmaceutical companies, and others may claim to use de-
identified information, industry experts told the National
Committee on Vital and Health Statistics (NCVHS) that such
information can easily be re-identified, reports Kathryn Serkes.
Secondary uses of data are far more widespread than most
realize. Physicians’ staff members may be selling “anonymized”
information from EMRs for up to $100,000 per practice, without
the knowledge of patients or physicians.
The CDC is already collecting information from emergency
rooms for biosurveillance.
Security Lacking
According to an August 2006 report of the Government
Accountability Office, Medicare computers have numerous
vulnerabilities in user identification and authorization,
cryptography, system boundary protection, and monitoring of
security-related events. These could allow access to personally
identifiable information and lead to interruptions in claims
processing (www.gao.gov/new.item
s/d06750.pdf).
Providers and payers have made little progress in complying
with HIPAA security requirements. By October, 56% of providers
(up from 50% in January) and 80% of payers claimed to be
compliant (HITS 10/17/06).
Introducing New Errors
Introducing new technology into complex systems can create
new pathways to adverse drug events. Bar-code medication
administration systems reduced some types of errors but degraded
nurse-physician coordination, caused nurses to drop activities
during heavy workloads, increased prioritization of monitored
activities during goal conflicts, and decreased flexibility
(J Am Med Inform Assoc 2002;9:540-553).
The EBM Agenda
According to Bernardine Healy, M.D., “the autonomy and
authority of the doctor, and the subsequent variability in care,
are the problems that EBM wants to cure.” EBM “breaks the lock-
hold” of the medical profession over how medicine is practiced
and compensated. Through a “microfascist” process of “sift and
sliver,” EBM discards physician judgment and more than 90% of the
medical literature (US News 9/11/06).
AAPS Calendar
Feb 9, 2007. Thrive, Not Just Survive V,
Dallas, TX
Feb 10, 2007. Winter Board meeting, Dallas, TX
Oct 10-13, 2007. 64th annual meeting, Cherry Hill, NJ.
NPI Update
The unanswered questions on the NPI, posted in the AAPS FAQ
on our website, remain unanswered. Please send us copies of
communications you receive from hospitals or pharmacies regarding
the NPI!
To access the official government FAQs, go to
http://questions.cms.hhs.gov, and enter “NPI” in the
search field.
Items of special interest include :
ID 2623: “NPIs may also be used to
identify…providers on prescriptions, in internal files to link
proprietary provider identification numbers and other
information, in coordination of benefits between health plans, in
patient medical record systems, in program integrity files, and
in other ways.”
ID 6147: “The NPI will eventually be the standard identifier
for e-prescribing under Part D.”
ID 8063: “All CMS education on the NPI is also free.” A
company that offers a $110 manual is not CMS.
ID 7298: If you get an NPI, you need to keep a copy
of the notification from the Enumerator as you will need
it “when you enroll or make a change to your Medicare enrollment
information.”
Tip of the Month: The decision in Stowers v.
Clinton Cent. School Corp. (Ind. App.) upheld the
admissibility of a release form signed by an athlete. The student
football player and his mother acknowledged the inherent
potential for injuries. This was relevant to the school’s defense
in the wrongful death action brought by the parents. Medical
release of liability forms should be admissible also.
Government Keeps Data Secret
Despite the 1999 Shelby Amendment requiring that all data
from federally funded trials be made available to the public
through the Freedom of Information Act, no data have actually
been released, despite numerous requests. All are considered to
fall under exemptions. The secrecy is costing lives.
With great fanfare, the NIH announced guidelines for using
high-dose steroids in patients with spinal cord injuries, 6 weeks
before the study was published in the New England Journal of
Medicine. Physicians were skeptical because they were seeing
more deaths in patients treated in this way a concern that was
borne out in a subsequent study. But the raw data underlying the
new “standard of care” are still under wraps.
FOIA requests have also been denied for data related to the
finding of smaller brains in children diagnosed with attention
deficit/hyperactivity disorder. Critics questioned whether this
might be an effect of drug treatment. Likewise, data withheld by
researchers might show that Prozac, the only antidepressant
approved by the FDA for use in children, is unsafe (Jeanne Lenz,
New Republic 10/30/06).
Non-Consented Research
The FDA’s Emergency Consent Rule provides for waiver of
consent only if “the human subjects are in a life-threatening
situation, available treatments are unproven or unsatisfactory…
[and] randomized placebo-controlled investigations [are]
necessary to determine the safety and effectiveness of particular
interventions” (21 CFR 50.24).
The FDA approved an exception in the case of an experiment
with PolyHeme, an artificial blood product despite unanimous
agreement that human blood is proven safe and effective. The
concept of “community consent” was used, although communities
were not informed that in a previous trial conducted on surgery
patients, 10 of 81 persons who received PolyHeme suffered heart
attacks and died, compared with zero heart attacks in 71 persons
receiving blood.
A test focusing on situations in which blood was out of
reach for hours wasn’t conducted because assembling patients for
such a trial would be “too difficult and time consuming.”
Linda Gorman asks: “Are they increasing risk for these
patients unnecessarily just because the FDA is demanding an RCT
and won’t accept observational evidence?… It is always so easy
to cite the good of the many from the losses of a few. Taking
private property is OK as long as tax revenues increase. Now it
appears to be OK to risk lives to get data faster.”
“Special Duty”
When physicians prescribe pain management, they incur the
risk that the patient will misuse the medication, leading to
criminal prosecution of the physician.
There is a similar legal theory that is spreading in the
area of civil litigation. Dr. Peter McConarty prescribed an oral
hypoglycemic medication for a patient. About 45 minutes after
discharge from the hospital, the patient lost consciousness while
driving (allegedly because of low blood sugar) and hit a
motorcyclist. The injured motorcyclist sued the doctor under the
theory that the doctor had a “special relationship” with him and
a “special duty” not to expose him to unreasonable risk of harm.
The lawsuit alleges that the doctor should have warned the
patient not to drive. Massachusetts Judge Peter W. Agnes, Jr.,
recently refused to dismiss the suit.
Three states that currently recognize this “special duty”
are California, Michigan, and Delaware. Five states that do not
recognize it are Missouri, Iowa, Texas, Kansas, and Florida.
Worker Fired for Smoking Off the Job
Scott Rodrigues has sued The Scotts Co., the lawn-care
giant, for terminating him because it found nicotine in his
urine. The company has a new policy of not hiring workers who
smoke, in order to reduce its benefits costs.
The Supreme Judicial Court has upheld a Massachusetts law
that makes smokers ineligible to be hired as police officers or
firefighters (Boston Globe 11/30/06).
Florida Pain Patient Loses Appeal
Richard Paey, a pain patient who has a morphine pump
prescribed for him in jail, was sentenced to 25 years because of
his doctor’s testimony that he was forging prescriptions. He
received the mandatory minimum sentence for “trafficking”
although he had not sold any drugs.
The majority in the District Court of Appeal of Florida,
Second District, held that it lacked the authority to mitigate
Paey’s harsh sentence. Dissenting Judge James Seals wrote: “It is
illogical, absurd, cruel, and unusual for the government to put
Mr. Paey in prison for twenty-five years for foolishly and
desperately pursuing his self-help solution to his medical
management problems, and then go to prison only to find out that
the prison medical staff is prescribing the same… medication he
had sought on the outside but could not legitimately obtain.”
Correspondence
Performance Standards for Hospital CEOs? According to
the Buffalo News, the median compensation in the U.S.
for hospital CEOs is $806,000. And while some doctors are
cheering a 1% fee increase as a “great victory,” hospital CEO
salaries went up 7.2%! Even at Erie County Medical Center, which
is $17.5 million in the red, the CEO makes nearly $400,000 per
year.
About 75% of hospital CEO compensation packages have
“incentives” accounting for 25% of the total. These incentives
are probably tied in some manner to cost containment. The reason
we are seeing so many sham peer reviews nationwide may be that
the CEO’s compensation depends on removing expensive doctors from
the medical staff.
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY
Flawed Standards. P4P has been the goal of the left for
more than a decade. Groups like the Robert Wood Johnson
Foundation funded the Leapfrog Group, staffed the federal
agencies, and pushed for federal departments. If an executive
agency controls the standards, and payment depends on adherence
to them, then the agency controls medical care, with no need for
federal legislation.
The standards are based on fundamentally flawed premises.
Meta-analyses of randomized controlled trials (RCTs) are
considered the most reliable form of information, but there is a
substantial body of literature showing that meta-analyses are
statistical nonsense. The group average shows little about the
effects of treatment in an individual: P4P standards for tight
blood sugar control have increased problems with fainting.
The experts pushing P4P have never seen an extension of
government control they didn’t like. No one knows whether P4P
will lead to better health. We have no measure of the value of
the medical dollar unless consumers are spending their own money.
But getting consumers and doctors out of the business of making
medical decisions is the whole point of P4P.
Linda Gorman, Independence Institute, Golden, CO
Where the Money Is. According to Modern
Healthcare, JCAHO’s 2005 form 990 reveals that it took in
more than $106 million while spending out almost $101 million. It
paid President Dennis O’Leary total compensation and benefits of
$1,972,598, up from $875,231 in 2004. Russell Massaro, executive
vice president of accreditation and certification operations, was
paid $635,857. JCAHO’s publishing division is giving the AMA a
run for its money: it took in $40 million, up from $33.9 million
in 2004, and paid its CEO $515,285.
It seems there’s more money in regulating medicine than in
practicing medicine.
Kathryn A. Serkes, Washington, D.C.
Objective Standards. The subjective/objective line is
grey. Finding objectivity in P4P is more difficult than locating
electrons within an atom.
Steven Bassett, Oak Park, IL
Comparative Fees. In 1986, a woman had a hip
replacement. Medicare paid the orthopedic surgeon $4,500. In 2006
she came back for the other hip. The Medicare fee is now $1,200.
The same woman said her golden retriever was also having a
hip replacement. The fee was $10,000: $3,000 up front for the
prosthesis, $7,000 for the surgeon.
Alieta Eck, M.D., Somerset, NJ
Non-Participation. P4P and other government
interventions would collapse if physicians would refuse to
participate. Bureaucrats cannot function without physician input.
But doctors are afraid of a free market. Some would experience a
huge bust if churning ceased. Borderline eye examinations,
glaucoma exams, lid surgeries, treatments for macular
degeneration many of these would probably stop.
Robert P. Gervais, M.D., Mesa, AZ
Opted Out. [From a letter to Sen. Murkowski] …I opted
out of Medicare when it first became possible to do so in 1998
and have been out ever since. My primary motivation was that
Medicare seemed to want to get in the middle of the patient-
doctor relationship and interfere with patient care. One example
was the permitted schedule of tests and the cross-linking coding
to justify them. Exceptions required a great hassle. I concluded
Medicare really didn’t want physicians to find things because
then government would have to pay for them. There was an
interminable wait to discuss any issue with Medicare personnel.
My staff was unhappy with the myriad regulations, which no one
seemed to understand….
Alex Baskous, M.D., M.P.H., Anchorage, AK
Standards. I don’t want “standardized” medicine. I want
customized medicine. I want each and every one of us to get the
best treatment for our unique needs and preferences. The best
treatment is determined by a host of factors: genetics, history,
environmental exposures, comorbidities, moral values, lifestyle
choices, and available resources.
Greg Scandlen, Consumers for Health Care Choices
Evidence. While meta-analysis is conceptually
attractive, no evidence supports overriding the treating
physician’s decisions with an RCT-based guidelines issued by a
third party who has never seen the patient. HHS found only nine
RCTs on EBM-based compensation: little data support this
approach.
Richard Dolinar, M.D., Phoenix, AZ
