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Volume 62, No. 9 September 2006
British patients with coronary artery disease or diabetes
and blood pressure greater than 150/90 or 145/85, respectively,
or with a stroke or TIAs and cholesterol greater than 193 mg/dL,
may be a threat to their doctor's financial well-being.
These are some of the 146 quality indicators in 10 clinical
domains in the British National Health Service (NHS) pay-for-
performance (P4P) contracts with family practitioners. Such
contracts were introduced in 2004 after a series of national
initiatives said to be "associated with marked improvement in the
quality of care" (N Engl J Med 2006;355:375-384).
The program was intended to increase family physicians'
incomes by up to 25%. Physicians hired more administrators and
nurses, established chronic-disease clinics, increased use of
electronic medical records (EMRs) and quadrupled prescriptions
for lipid-regulating drugs. A study of data from 8,105 family
practices in England showed an unexpectedly high rate of
achievement (83.4%) in the first year. There were significant
costs, and authors noted that "[b]udget neutral programs would
face greater resistance from family practitioners" (ibid.).
The attempt to transform the NHS comes with a sustained
annual increase in cost of 7.3% above inflation more than double
the average in previous decades and unprecedented for the NHS.
After 5 years of tightening the command-and-control structure,
the Labour government is trying to use incentives in a "mimic
market." One new regulator, the Monitor, is intended to insulate
ministers from exposure to political pressures. Another, the
National Institute for Clinical Excellence (NICE), is supposed to
substitute technical criteria for political decisions about
rationing. It is hoped that payment by results will spur
efficiencies. So far, the outcome is a budget "hiccup" of more
than $1 billion, and a doctors' sense that "their status and
autonomy [are] threatened by a regime of inspection and
regulation" (N Engl J Med 2006;355:409-415).
It is feared that a "focus on efficiency may raise
skepticism among providers that saving money is the real goal of
government" (N Engl J Med 2006;355:406-408).
Of course, in the U.S. saving money is an explicit
goal of P4P, and negative incentives are already in place.
This fall, hospitals participating in the Centers for
Medicare and Medicaid Services (CMS) P4P program will incur a 1
to 2% penalty if they fall below the baseline for 34 "quality"
measures. While the penalty may not sound like much, "if you're
the hospital where half your revenue is [derived from] people
with those conditions, then this can come out to huge amounts of
money," stated Susan L. Freeman, chief medical officer at Temple
University Hospital in Philadelphia (Healthcare Strategic
Management 8/11/06).
The CMS grand plan for restructuring physician payments was
announced by Administrator Mark McClellan, M.D., Ph.D., in July
27 congressional testimony. The goal is to "realign Medicare's
physician payment system" to achieve high quality "without
increasing overall Medicare costs" instead of increasing
expenditures as volume of services grows.
"Performance payment may be earned if actual
Medicare spending for the population assigned to the physician
group is below the annual target," McClellan said [emphasis
added].
CMS anticipates a minus 5.1% physician fee "update" in 2007
under the sustained growth rate (SGR). Citing a need to get out
of the "vicious cycle of rapid growth in utilization and
spending," McClellan did not propose a change in the SGR.
It seems doubtful that the AMA anticipated this outcome when
it cut a secret deal with Congress last December (see News of the
Day 2/21/06). Instead of a trade-off, it is likely to get both
cuts and P4P.
P4P needs interoperable EMRs to support the "automated
collection and reporting of consensus measures." Additionally,
the American Health Information Community (AHIC) is discussing
how crucial it is to embed Clinical Decision Support (CDS)
software in health information technology (IT), reports AAPS
Public Affairs counsel Kathryn Serkes.
Insurers are already using a computerized decision system
called Colossus, she reports, to guide adjustors through options
and come up with a low-ball settlement offer.
Physician resistance is the biggest barrier to P4P. To
overcome doctors' fear that they will be rated on measures over
which they have no control, because of team management or patient
variables, hospitals must collect data on process rather than
outcome, suggests Robert Marder, M.D., vice president of The
Greeley Company (HC Strategic Mgt 7/17/06).
Physician "leaders" must help overcome their colleagues'
pushback against the change from self-directed practice to "an
industry model with increased standardization" (ibid.).
The process is to use federal buying power to force the
desired outcome, which appears to be central control of medicine:
"Playing for the test" is not only expected, but is "the entire
point of the exercise" (JAMA 2006;295:2780-2783). The
level of improvement called for by the Institute of Medicine
report on medical error (see p. 2) is but a pretext; there is no
evidence that it could be achieved in this way. Process measures
in acute myocardial infarction, for example, explain only 6% of
variations in hospital mortality (JAMA 2006;295:1912-
1920), notes David McKalip, M.D., of Florida.
Stakeholders include government and insurers, who hope to
save, and vendors of IT, professional standards, and recommended
drugs and devices, who hope to profit.
As for patients, the process of giving statin drugs might
might not achieve the U.S. national outcome of an LDL < 100 and
BP < 140/80 perhaps while killing cells in the left ventricle
(BioFactors 2005;25:146-152). But it's not the life of
the patient, but the death of medicine that is the ultimate end.
"The IOM study was a trumped-up mess designed to stir up
public panic and pave the way for yet more government
regulation," writes Linda Gorman. "It should have been killed in
the cradle and in more responsible times would not have made it
past review, let alone into the media canon as received truth."
Even the author of the original study said that the 173 deaths in
the Harvard Medical Practice Study extrapolated to 44,000 to
98,000 deaths per year were used inappropriately by the IOM. It
was not determined whether these deaths were actually caused by
medical error (see AAPS News, April
2000).
Uncritically accepted by the AMA and other influential
groups, the IOM report has "profoundly changed" thinking. One
effect was to give new life to the "decades-old stalled
discussions" on the EMR. Also, write Lucian Leape and Donald
Berwick of Harvard, it showed the need to "change the culture" in
ways that "professionals easily perceive as threats to their
authority and autonomy." Instead of a "professional fragmentation
and a tradition of individualism," we need a systems-oriented
approach, in their view. We need something stronger than the
threat of decertification, which can produce "evanescent,
compliant behavior." P4P might work in conjunction with "strict,
ambitious, quantitative, well-tracked national goals"
(JAMA 2005;293:2384-2390).
Will the safety movement make patients safer? Computer
systems may improve practitioner performance (or compliance with
guidelines), but cost-effectiveness or effect on patient health
are still unknown (JAMA 2005;293:1223-1238).
New York City has taken the unprecedented step of requiring
laboratories with electronic reporting capabilities to report all
hemoglobin A1c measurements within 24 hours. Health officials
plan to use the information to intervene directly in patient care
by contacting physicians and patients (N Engl J Med
2006;354:545-548).
"This is really a recipe for the invasion of privacy,"
stated Sue Blevins, president of the Institute for Health
Freedom. "Under the law, personal health information can be
shared without consent for many purposes. All it takes is the
click of a mouse" (Wash Post 1/11/06).
Gov. Robert Ehrlich, Jr., vetoed Senate Bill 333
Prescription Drug Monitoring Program, which would have required a
central program to electronically collect and store data on
prescriptions for controlled drugs.
In a letter to the Senate, Gov. Ehrlich wrote: "The
provisions of this bill may exacerbate untreated or inadequately
treated pain management. Unfortunately, even after numerous
amendments, this bill focuses on law enforcement, not treatment."
He also referred to an argument presented by AAPS member James E.
Kelly, D.O., of Easton, MD, a psychiatrist: "Although the
Legislature removed the prescriber's diagnosis code from the
database, many prescription medications are commonly linked to
certain ailments. Unfortunately, there are stigmas associated
with certain diseases." The bill would have opened confidential
patient-physician information to nonmedical individuals, as it
did not specifically state who was an authorized recipient.
According to Linda Gorman's reading of the legislation, "the
state is in complete control of the plans that will be
offered.... The plan is structured so people mostly have group
plans or Medicaid clones." Employers who sign up with the
Connector are prohibited from simultaneously offering competing
plans with similar benefits.
She notes out that the plan ignores the contribution of
illegal aliens to uncompensated care and Medicaid: "In a
particularly dishonest move, the law prohibits reimbursements to
hospitals for `health services provided to residents of other
states and foreign countries.' Hospitals have to treat everyone,
but the state isn't going to pay."
State Rep. Harriett L. Stanley, one of the Legislature's
foremost authorities on health and fiscal policy, told a Boston
newspaper: "We don't yet know what it's going to cost us or where
we're going to get the money from. To some extent you might call
it a Hail Mary pass" (CURE Bulletin, July 2006).
According to a Cato analysis by Michael Tanner, "the
Connector will eventually squeeze out any outside market,"
eventually becoming a monopsony purchaser like the community
pools envisioned in the Clinton health care plan of 1993.
Additionally, inability to price products by risk will result in
"an overprovision of services to the healthy and an
underprovision to the sick" (Cato Briefing Papers No.
97, June 6, 2006, www.cato.org).
One of the 370,000 uninsured working adults in Mass., Ryan
Crosby is thinking of moving away. "What if I get a job and I
start having to pay several hundreds of dollars for health
insurance just because I come out of making a low income.
Sometimes I think the state does things that encourages
[sic.] people to stay poor" (Boston Business
Journal 6/12/06).
The Connector is already talking about how to restrict
access to care by defining provider networks that mandate which
hospitals patients can use (Consumer Power Report #37).
A serious flaw in evidence-based medicine is reliance on
drug trials: "They answer only questions they want to answer.
They ignore evidence that does not fit with their story. They set
up and knock down straw men" (Nature 2006;440:270-272).
While outright deception is said to be rare, "finances and
career motives decide what gets published," stated Peter
G tzsche, director of the Nordic Cochrane Centre.
"Phantom papers," showing ambiguous results, may languish in
filing cabinets. GlaxoSmithKline paid $2.5 million to avoid the
cost of litigation on allegations that it had suppressed data
showing an increased suicide risk in young patients taking the
antidepressant Paxil.
Sep 13-16. 63rd annual meeting, Embassy Suites,
Scottsdale, AZ.
AAPS members are receiving threatening communications, as
from HealthCare Compliance Solutions, Inc., stating that "federal
law requires your practice to have an NPI number," and that they
will be unable to refer patients or have claims paid or
prescriptions filled unless they have an NPI and know how to use
it. The company helpfully offers to send an NPI Implementation
Guide for $110.
In fact, according to the CMS web site, federal law only
requires HIPAA-covered entities to use the NPI for
HIPAA standard transactions. Medicare will start requiring
an NPI on both paper and electronic claims after April 2007.
It is possible that private entities such as hospitals or
pharmacies may demand your NPI as a condition for having staff
privileges or doing business. Private insurers may require it in
order to reimburse your patients. Simply obtaining an NPI does
not make you a HIPAA-covered entity.
If you decide to obtain an NPI, you can download an
application free from www.cms.hhs.gov (search on "NPI"). You can
print or type the information and send it by mail to: NPI
Enumerator, PO Box 6059, Fargo, ND 58108-6059. You must certify
that you are aware of a 5-year prison term and fines of up to
$500,000 for falsifying information, and you must notify the NPI
Enumerator of changes in information, such as a change of
address, within 30 days. You can also submit on-line, but AAPS
members may feel more comfortable having the entire form in front
of them in black and white at once.
If you work for a professional corporation, both you and the
organization may need an NPI. Your group practice may also need
one.
At present, a fee is not required to obtain a number. CMS
has considered charging physicians a "maintenance fee" to help
defray the cost of what will be a huge government database.
69 Federal Register 3434 (Jan 23, 2004):
Tip of the Month: Electronic medical records can never
be destroyed or fully erased, as there are always backup copies.
Electronic records last forever and are always vulnerable to
subpoenas, leaks, theft, and misuse. People are already careful
about what they say in email for this reason. In contrast, paper
records can easily be returned to the patient or destroyed
without any backup copies. Access is limited and well-defined.
Patients who care about their privacy are more comfortable with
paper records, for good reason, despite probably self-interested
claims that electronic records are more secure.
Reporting Requirements. Failure to report operational
changes, such as pivotal personnel changes, on Medicare
enrollment form 855 can trigger extra audits or a site visit from
the Office of the Inspector General (OIG). Of 218 independent
diagnostic testing facilities (IDTFs) that it audited, the OIG
found that 191 had not fulfilled reporting requirements, raising
suspicions that they were "billing mills" (MCA 8/7/06).
Pain Management. Despite its claims to prosecute only a
small fraction of its registrants, the Drug Enforcement
Administration has hired hundreds of new drug diversion
investigators. In fiscal year 2004, 737 prescribers were
investigated by federal agents; this threat alone chills
prescribing: "All it takes is one investigation for your
livelihood to go down the drain," stated Will Rowe, executive
director of the American Pain Foundation. Actual convictions from
DEA investigations totaled 24 in FY 2004 and 39 in FY 2005
(Medical Economics 6/4/06).
Identity Theft Victims May Be Guilty. Physicians need
to carefully protect their identification number. Even if a
physician wrongfully suspected of fraud is cleared because he is
a victim of identity theft, he may be guilty of a HIPAA
violation. Additionally, physicians who have a legitimate
relationship with a patient whose number was compromised could be
implicated in a billing fraud investigation. Doctors are warned
to have patients review EOBs carefully, and also to compare their
1099s with the office ledger, looking for evidence that their
number is being misused, with improper checks being sent to
another location (MCA 6/12/06).
Off-Label Drug Use. Psychiatrist Peter Gleason was
surrounded by six agents, handcuffed, and arrested in a Long
Island train station for giving seminars in which he advised that
a narcolepsy drug (Xyrem) could be used to treat pain or
depression. He was accused of conspiring with the drug
manufacturer, which paid his speaking fees, to circumvent rules
against promoting a drug for non-FDA-approved indications. Jazz
Pharmaceuticals is leaving him to face the indictment on his own
(NY Times 7/22/06).
Prosecutors Focus on Quality Data. The new quality
reporting standards in the Medicare Modernization Act of 2003
provide new data for law enforcers about hospitals' compliance
with federal health requirements. Reporting inaccurate quality
data can give rise to False Claims Act liability. This is a new
area of interest for federal prosecutors, said Associate U.S.
Attorney James G. Sheehan (BNA's HCFR 8/2/06).
In the first court decision ever to criticize the U.S.
Department of Justice for overly broad and draconian
prosecutorial techniques, New York Federal District Judge Lewis
Kaplan ruled it was unconstitutional to threaten to indict an
entire health care organization if it covers the legal bills of
an employee accused of fraud. He explained that prosecutors
forced KPMG, one of the world's largest accounting firms, to
choose between going out of business or declining to pay
employees' legal bills. Without company support, employees often
cannot afford to defend themselves, Judge Kaplan said
(MCA 7/24/06; BNA's HCFR 7/5/06).
High-Velocity Practice. In certain specialties,
"churning" has become so pervasive that we may need a board-
certification examination for it. Some of the highest volume
churners I met worked in a hospital emergency room. The ER
doctors frequently did a cursory exam and ordered a totally
inappropriate neurologic consultation. For example, in one
patient referred to me at 2 a.m. for "altered mental status," I
found the blood sugar to be 30. One ER doc admitted that because
payment was the same regardless of the time spent, the goal was
"throughput." In the third-party game, patients are hot potatoes
that must be tossed along as quickly as possible lest the doctor
who touches them get burned. The loser in the game is the doctor
who ends up having to provide the care.
The best patients in managed care are the worried well who
have a diagnosed but nonexistent medical problem. One
"successful" doctor touted the advantages of managed care at a
medical staff meeting: "They actually pay us for doing nothing!"
The successful operator of a volume fraud mill (VFM) must think
in terms of a Reverse Emperor's New Clothes: He must convince
people that they are really naked and need the high-priced duds
he is selling.
The P4P Pretext. If ophthalmology is any guide, the
"leaders" in managed care gain access to a patient pool by being
the low-cost provider (I doubt that we should call them
physicians) per diagnosis. After gaining control of the patient
pool, the provider hires an aggressive stable of diagnosticians
(e.g. optometrists), who exaggerate diagnoses. Each such
diagnosis triggers mandatory fees under P4P. Each fee may be
small, but collecting a large number of fees, say 10,000, for
exaggerated diagnoses is better than collecting 100 big fees for
taking care of the truly sick. Canada has a similar system.
Doctors "see" 80 patients a day, most of whom don't need care.
Doctors go home refreshed after churning well patients and
referring sick ones to the emergency room.
Insurers play games with doctors, who, in turn, play games
with insurers. Whatever happened to patient care?
The New Standard. The "standard of care" is becoming
whatever is reimbursed. So physicians bring insured patients back
to their office more often than is warranted to churn their
insurance. One of my patients sees her cardiologist every 3
months to check her cholesterol, even though her level is good on
no treatment. Medicare pays, so why not? If the patient had to
pay, I suspect she would never have it checked again the course
that I recommended to her.
But lots of insured patients don't get the kind of care they
want, or can't get it in a timely fashion so they come to see
me. I think that as long as it is still legal to serve patients
and not sign contracts with the Beast, physicians will always
have work. No country with universal health coverage has ever
been able to guarantee prompt, high quality care.
Quality. The quality issue is constantly being
addressed in medicine. It is the reason that quality has improved
so much over the last 300 years. But most improvements take place
in small steps out of the public eye: hospital designs that make
infection control easier; lighter casts; surgical staples that
reduce time under anesthesia; disposable needles. The problem is
that regulatory walls often prevent changes by distorting
incentives or imposing ridiculous costs for small changes.
I'm hoping someone can tell me of a de novo quality diktat,
as opposed to a regulation ratifying already existing practice,
imposed from on high, that has ever unambiguously improved
medical quality. Regulations to correct messes created by
previous regs don't count. I'll even take regs from foreign
governments, such as the U.S. Supreme Court.
Insurance and Rationing. Will we ever recognize that
health insurance is the problem, not the solution, except for
catastrophic events? Care is rationed by whoever pays for it.
Public and private insurance deprives patients of the important
privilege of rationing their own medical care. Ironically, the
care is still paid for by the insured, directly or indirectly.
A Profitable Myth. The generally accepted myth, no
doubt generated by the single-payer crowd as well as the
insurance industry, is that people are incapable of making
medical purchase decisions themselves (not smart enough, not
enough information, etc.). Moreover, they couldn't possibly
afford to purchase care on their own. Thus, the only way is to
give the money, plus overhead and profit, to the government or
insurers and let them buy all the care.
Let People Talk. How much better informed will people
be with P4P generated by providers or consumers, or by media
advertising? Let people talk to their neighbors, workmates,
friends, church members, PTA acquaintances, 6-pack buddies. I
believe it will work out just as well. We are all becoming slaves
to systems that profess accuracy and promise utopia. Can people
handle HSAs, or do they need paternalism?
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