Not a bad idea - this article is a good starting point. The editorial
coment at the end is interesting.
http://www.cdc.gov/mmwr/preview/mmwrhtml/00019855.htm

Also here
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1
501307&dopt=Abstract

This states the false positivity was of mean 75 day duration.

Crucial points
1. All these cases can be readily identified as false positives. There
should be no real risk of anyone recieving a label of HIV-positive.
2. Newer ELISAs are unlikely to be subject to the same phenomenon.
3. It was very unusual, and transient. The way some dissidents talk,
they expect everyone who has ever had a vaccination to become
"HIV-positive" and stay that way.

 I am going to post this Wall Street Journal report on Doctors using out
of state and or the cheapest labs for profit. Since the HIV test has
several steps a quality lab is important. As well as how long blood is in
transit if it's getting shipped out of state

After her mother was diagnosed with skin cancer, Lori Hansen went to a
local dermatologist in North Carolina to have her skin tested. When she
got the results-with a worrisome mention of "atypical" levels-she was
surprised to learn her doctor had sent the samples across the country to
California.

Even more surprising: Her doctor stood to make nearly $200 on the test,
she says. Ms. Hansen later learned her skin biopsies weren't abnormal.
Also, the California testing center's owner had once directed a lab that
the state called a threat to public health.

Arrangements such as the one between Ms. Hansen's North Carolina doctor
and the California operation --- sometimes called referral deals --- are
common in the more than $40 billion medical laboratory business.

It works like this: A doctor sends a patient sample to an outside lab for
testing. The lab charges the doctor a discounted price --- say, $30 for a
skin biopsy. The doctor then gets reimbursed by the patient's insurer for
a much higher amount, say $100. The difference, $70, is profit for the
doctor.

Typically the doctor doesn't tell the insurer that an outside lab did the
work for a steep discount. Insurers could put a stop to the practice by
refusing to pay the inflated reimbursement, but they are often unaware of
the arrangements.

Critics say referral deals are harmful because doctors have an incentive
to send work to the cheapest lab, not necessarily the best one, to
maximize their profit margins. Also, by enticing doctors to order many
tests, the arrangements drive up the nation's health-care bill.

"Patients should wonder if this dermatologist is doing this biopsy because
I need it or he is going to make money from it," says Lisa Lerner, a
Boston area dermatopathologist.

While referral deals aren't new, people in the industry say they have
grown rapidly in recent years as doctors seek new sources of income and
demand grows for expensive lab work to detect diseases such as prostate
cancer. "Five years ago, no one was interested in this," says Bernie Ness,
the owner of a laboratory industry consulting firm in Toledo, Ohio. "That
has changed dramatically. I get calls every week from people who want to
get in on the billing."

One of the few private insurers to block' doctors from profiting on
outside lab work is Blue Cross Blue Shield of Georgia. Starting Aug. 1, it
required those performing lab tests to do the billing themselves, a
practice known as direct billing. That eliminated deals where doctors bill
for work they didn't perform. It isn't clear why other insurers don't do
the same. Several of the biggest ones declined to comment.

Medicare requires direct billing, as do a few states. In some other
states, doctors and local medical societies upset at the prospect of
losing revenue have thwarted such legislation. Some doctors still bill
Medicare for lab work performed off-site by owning "condo" labs within a
larger facility.

The American Medical Association's code of ethics says under the heading
of laboratory services that a "physician should not charge a markup,
commission, or profit on the services rendered by others." It adds,
however, that doctors can levy a processing charge on such services. The
AMA code says that a doctor "who chooses a laboratory solely because it
provides low-cost laboratory services on which the patient is charged a
profit is not acting in the best interest of the patient."

Federal laws broadly prohibit doctors from receiving inducements for
referrals or engaging in "self-dealing" --- referring patients for
services in which they have a financial interest. Doctors and companies
involved in lab referrals say what they do is legal. Companies say they're
just offering a service for a price, and that doesn't add up to illegal
inducement. In general doctors don't own a stake in the outside labs,
which they say clears them of any charge of self-dealing. They say they're
entitled to mark up work farmed out to a contractor to cover costs such as
billing for the work and delivering results to patients.

Last year, the U.S. attorney in Oklahoma City indicted three former
executives of a lab, UroCor Inc. The indictment says UroCor charged
discount prices to doctors who turned around and billed private insurance
companies at a much higher rate for the lab work. Doctors were charged as
little as $2.75 for a common analysis to detect prostate cancer, called
the PSA test, and got reimbursement of $25 and up, the indictment says. It
says the discount was a kickback to induce the doctors to also refer work
covered by Medicare, which was billed directly by the lab.

UroCor is now a division of Laboratory Corp. of America Holdings, known as
LabCorp. The illegal activity alleged in the indictment occurred before
UroCor was sold and none of the three executives named in the indictment
still work for UroCor, according to LabCorp. The case is scheduled for
trial next June. The executives have denied wrongdoing.

The Oklahoma case is an exception. Most of the referral arrangements never
get authorities' attention.

In 2004 LabCorp gave a Tennessee dermatologist a document marked
"confidential special client fees." It said Lab Corp would charge the
doctor $30 to analyze a skin biopsy. Blue Cross Blue Shield of Tennessee
says it reimburse an average of $109 per biopsy interpretation. That would
allow the doctor to realize a profit of 263%. Fees for other lab services
on the document allowed for a markup of m re ban 700%.

LabCorp Executive Vice President Bradford T. Smith says the company has a
policy of not discussing specific billing arrangements. He says another
case in which a Nashville doctor group was charged only $17 for a biopsy
analysis appears to be an "outlier." That doctor group could yield a
profit of more than $90. About 10% of LabCorp's business comes from
"client billing," or arrangements in which LabCorp bills the doctor and
the doctor then bills the patient or an insurer, Mr. Smith says.

LabCorp, with sales of $3 billion last year, is the country's second
largest tab company. The biggest is Quest Diagnostics Inc. of Lyndhurst,
N.J., with revenue of $5.1 billion last year. Quest says client billing
accounts for 6% to 7% of its revenue.

No Choice

At a recent conference of the American Urological Association in San
Antonio, doctors took seats at the exhibition booth of Lakewood Pathology
Associates of Lakewood, N.J., as the firm touted its "revenue share"
model. If urologists send their tests to Lakewood, the company's marketing
director said they could generate up to $35,000 per year. Lake wood's
chief executive, Raza Bokhari, says the lab is careful to obey federal
laws barring kickbacks to doctors, in part by making sure that doctors
don't get a discount based on the volume of referrals.

Some of the labs engaged in client billing say they have no choice. "A lot
of labs do it and if you got out of it the other guys will take you to the
cleaners," says Clay Cockerell, a Dallas dermatopathologist who is on the
board of Ameripath Inc., a national lab based in Palm Beach Gardens, Fla,

Dr. Cockerell, who is also the president of the American Academy of
Dermatology concedes the practice raises ethical issues. "Is the physician
billing for it the one looking at the slide? No," he says. "From that
perspective, does it totally pass the smell test? Maybe not."

Several studies have shown physicians are more likely to order services
for patients if they have a financial incentive. A 1993 study compared
states where doctors are allowed to bill for outside lab work and states
where they aren't It found doctors in the former ordered 28% more tests.
The study was conducted by the Center for Health Policy Studies, a
consulting group, for the American Clinical Laboratory Association, an
industry group.

The study's author, economist Zachary Dyckman, says he would expect the
same results today. The extra testing, he says, "appears to be done
exclusively to earn more revenue and increase profits."

Ms. Hansen, the North Carolinian who was worried about skin cancer, had
her skin biopsies analyzed by National Dermatopathology Laboratory of Lake
Balboa, Calif. Ms. Hansen of Cary, N.C., says she asked a local
pathologist, Keith Nance, to review her biopsies after hearing that they
were "atypical." Dr. Nance found no abnormalities.

Dr. Nance, who considers client billing unethical and pushed an
unsuccessful effort to ban the practice in North Carolina, urged her to
report the situation to the state medical board and helped write a
complaint. He helped her find out how much the California lab was charging
doctors by contacting the lab and pretending to be a potential customer.

In her October 2003 complaint to the medical board, Ms. Hansen cites an
email in which National Dermatopathology quoted Dr. Nance a rate of $35 to
analyze a biopsy. Ms. Hansen, who had four biopsies analyzed, says in the
complaint that the lab must have charged her dermatologist, William
Ketcham, no more than $140 for her lab work. Insurance records show Dr.
Ketcham was paid $328 for the work by her insurance company.

Dr. Ketcham declined to discuss dollar figures but says his deals with
labs are appropriate and don't cost patients anything. He says paperwork
is easier when he doesn't have to exchange patient information with the
lab. The North Carolina Medical Society has said that "markups are a
legitimate business practice" for lab services.

Dr. Ketcham says he has stopped using National Dermatopathology because
the state medical board told him he must send his biopsies to pathologists
licensed by North Carolina. The board took no disciplinary action against
Dr. Ketcham. He now sends his lab work to Dermatopathology Laboratory of
Central States in Dayton, Ohio.

Central States won't say what it charges doctors for lab work. But a 2003
fee schedule from the lab states that doctors were charged $25 for the
first biopsy and $15 for each additional specimen. The same fee schedule
indicates that when Central States billed insurers directly for biopsy
interpretations it charged a rate of $95.

The owner of National Dermatopathology Laboratory, Cyrus Milani, was
banned from performing certain laboratory work by the state of California
in 1989 after state officials accused a lab he directed of operating "in a
manner which poses a threat of injury to public health." The state said
the lab had an error rate of 21.2%.

Dr. Milani says the charges were "totally false." He acknowledged a
settlement barred him from serving as medical director of any lab
conducting pap smear tests "for a year or two." California authorities
couldn't find a copy of the settlement.

For several years after the ban, Dr. Milani says he had "a very meager
income." Even now, he says, his life is one of "simple living." Los
Angeles County real-estate records show him as the owner of a home
assessed at $4.1 million on the same street in Bel Air where the actress
Elizabeth Taylor lives.

According to a court filing, the pathologist who analyzed Ms. Hansen's
biopsies was Hong Li, who worked at National Dermatopathology between July
and December 2003. Dr. Milani is suing Dr. Li, accusing her of breaking a
one year employment contract. In the court filing, Dr. Li says her daily
volume "far exceeded the generally accepted workload" in her specialty and
"directly affected the quality of patient care." She says she quit from
fatigue. Dr. Milani says Dr. Li's allegations are false.

Getting Around Medicare Ban

Although Medicare refuses to pay doctors for work performed by others,
some companies have figured out a way to let doctors bill Medicare for
offsite lab work. It involves doctor groups creating a "condo" or "pod"
lab within a building that also houses labs for many other practices.
Since the doctors own their "condo" lab, they believe they can bill
Medicare for work performed there.

One such facility is operated by Uropath LLC at a medical office building
in San Antonio. The door of the building lists the names of 15 urology
practices from as far away as Missouri. Inside, there is a long hallway
with a series of doors that open into small rooms with labels such as "Lab
F --- Urologic Associates of South Texas." Technicians and pathologists in
white flab coats move in and out of the small rooms conducting tests.

Each doctor group buys the microscope and other supplies used in its lab.
Uropath is paid a management fee by the doctor groups and is reimbursed
for rent, personnel costs and other expenses. The doctor groups pay
pathologists for their work on a per-case basis. The doctor group does all
of the insurance billing, including for patients on Medicare.

The inspector general for the U.S. Department of Health and Human Services
evaluated a somewhat different condo arrangement last December. In that
case, the lab company provided the pathologists and equipment while
receiving a monthly management fee from the referring doctors, who did the
billing and kept any profit. The inspector general said the deal could
constitute a violation of antikickback laws since the lab company was
giving the doctors an opportunity for near-certain profits in exchange for
the business.

A lawyer for Uropath, Greg Cardenas, says the company has carefully
constructed its dealings with doctor groups to comply with federal laws
including the antikickback law.

Another company offering doctors a chance to profit from lab work for both
Medicare and privately insured patients is PathOptions of Hollywood, Fla.
It solicited business from Edward Coles, a gastroenterologist in New
Braunfels, Texas, saying he could bill insurance companies for four times
what tests cost him. A financial "snapshot" attached to the letter claimed
Dr. Coles could boost revenue for his small practice by a quarter million
dollars. Dr. Coles says the proposal "didn't sound kosher" and he declined
to participate.

But dozens of other doctors have signed up with PathOptions, says company
co-founder Daniel Karten. Mr. Karten says lawyers have reviewed the
company's model to make sure it is legal.

Getting a cut of lab revenue is attractive to gastroenterologists, who
specialize in stomach and intestinal diseases. One of their cash cows used
to be endoscopy, in which the doctor puts a tube down the patient's throat
to examine the digestive tract, but Medicare reimbursement for that
procedure fell more than 50% in the five-year period ended in 2002,
according to a government study.

At an April 2004 seminar in Knoxville, Tenn., sponsored by the American
Society for Gastrointestinal Endoscopy, gastroenterologist Bergein
Overholt began with a review of reimbursement cuts before dangling some
big numbers in front of the audience.

Dr. Overholt showed how his practice of 12 doctors, Gastrointestinal
Associates in Knoxville, netted $643,000 by sending its lab work to GI
Pathology Partners in Memphis, Tenn. According to information presented at
the seminar, Dr. Overholt's group paid $52.55 to GI Pathology Partners for
each biopsy the lab examined and then billed insurance companies an
average of $94.55 for the work.

Dr. Overholt has presented the material at similar seminars, including
some underwritten by GI Pathology Partners. He says he typically receives
a $1,000 honorarium for such talks. Dr. Overholt was among those who
fought a bill in Tennessee last year to ban client billing. The
Legislature eventually approved a watered-down measure.

In an interview, Dr. Overholt says the $643,000 figure he cited at the
2004 meeting doesn't include "significant administrative" costs in billing
patients and losses from patients who don't pay. He says the profit to his
practice from billing on lab work is about 10% to 20%.

GI Pathology Partners says it does work for doctors in 14 states. Pat
Dean, a pathologist and lab co-founder, says his company has a "business
model of focused, factory efficiency," which along with client billing has
"been a real boon for us. "

Some doctors who send lab work to Dr. Dean, however, eschew client
billing.

"We are a little old-fashioned," says one of them, Michael Freeman of Cape
Girardeau, Mo. "It's one of those ethical things. Pat is doing the work.
We just assume that Pat does the billing."





Notice: Microsoft has no responsibility for the content featured in this
group. Click here for more info.
 Try MSN Internet Software for FREE!     MSN Home  |  My MSN  |  Hotmail

 ©2005 Microsoft Corporation. All rights reserved.  Terms of Use
Advertise  TRUSTe Approved Privacy  

"Fondoo" <dale601@hotmail.com> wrote...

I don't think a false positive on an HIV test is a bad thing.  The tests
SHOULD be 100.0% accurate but since they're not, it is better to have
false positives than false negatives, because a false negative gives a
person a false sense of security and he WILL go out and infect others
(of course many do this with real positive results, but the legal system
can deal with that).  It seems your concern with people's feelings is
more important than stopping the transmission of HIV.

The Western Blot is not used as a screening tool because…it yields an
unacceptably high percentage of indeterminate results.” (Archives of
Family Medicine, Sept/Oct 2000)

At present there are about six dozen reasons given in the literature why
the tests come up positive. In fact, the medical literature states that
there is simply no way of knowing if any HIV test is truly positive or
negative:

“[F]alse-positive reactions have been observed with every single HIV-1
protein, recombinant or authentic.” (Clinical Chemistry. 37; 1991). “Thus,
it may be impossible to relate an antibody response specifically to HIV-1
infection.” (Medicine International, 1988)

And even if you believe the reaction is not a false positive, “the test
does not indicate whether the person currently harbors the virus.”
(Science, November, 1999).

The test manufacturers state that after the antibody reaction occurs, the
tests have to be “interpreted.” There is no strict or clear definition of
HIV positive or negative. There’s just the antibody reaction. The reaction
is colored by an enzyme, and read by a machine called a spectrophotometer.

The machine grades the reactions according to their strength (but not
specificity), above and below a cut-off. If you test above the cut-off,
you’re positive; if you test below it, you’re negative.

So what determines the all-important cut-off? From The CDC’s instructional
material: “Establishing the cutoff value to define a positive test result
from a negative one is somewhat arbitrary.” (CDC-EIS, “Screening For HIV,”
2003 )

The University of Vermont Medical School agrees: “Where a cutoff is drawn
to determine a diagnostic test result may be somewhat arbitrary….Where
would the director of the Blood Bank who is screening donated blood for
HIV antibody want to put the cut-off?...Where would an investigator
enrolling high-risk patients in a clinical trial for an experimental,
potentially toxic antiretroviral draw the cutoff?” (University of Vermont
School of Medicine teaching module: Diagnostic Testing for HIV Infection)

A 1995 study comparing four major brands of HIV tests found that they all
had different cut-off points, and as a result, gave different test results
for the same sample: “[C]ut-off ratios do not correlate for any of the
investigated ELISA pairs,” and one test’s cut-off point had “no predictive
value” for any other. (INCQS-DSH, Brazil 1995).

I’ve never heard of a person being asked where they would “want to put the
cut-off” for determining their HIV test result, or if they felt that
testing positive was a “somewhat arbitrary” experience.

In the UK, if you get through two ELISA tests, you’re positive. In
America, you get a third and final test to confirm the first two. The test
is called the Western Blot. It uses the same proteins, laid out
differently. Same proteins, same nonspecific reactions. But this time it’s
read as lines on a page, not a color change. Which lines are HIV positive?
That depends on where you are, what lab you’re in and what kit they’re
using.

The Mayo Clinic reported that “the Western blot method lacks
standardization, is cumbersome, and is subjective in interpretation of
banding patterns.” (Mayo Clinic Procedural, 1988)

A 1988 study in the Journal of the American Medical Association reported
that 19 different labs, testing one blood sample, got 19 different Western
Blot results. (JAMA, 260, 1988)

A 1993 review in Bio/Technology reported that the FDA, the CDC/Department
of Defense and the Red Cross all interpret WB’s differently, and further
noted, “All the other major USA laboratories for HIV testing have their
own criteria.” (Bio/Technology, June 1993)

In the early 1990s, perhaps in response to growing discontent in the
medical community with the lack of precision of the tests, Roche
Laboratories introduced a new genetic test, called Viral Load, based on a
technology called PCR. How good is the new genetic marvel?

An early review of the technology in the 1991 Journal of AIDS reported
that “a true positive PCR test cannot be distinguished from a false
positive.” (J.AIDS, 1991)

A 1992 study “identified a disturbingly high rate of nonspecific
positivity,” saying 18% antibody-negative (under the cut-off) patients
tested Viral Load positive. (J. AIDS, 1992)

A 2001 study showed that the tests gave wildly different results from a
single blood sample, as well as different results with different test
brands. (CDC MMWR, November 16, 2001)

A 2002 African study showed that Viral Load was high in patients who had
intestinal worms, but went down when they were treated for the problem.
The title of the article really said it all. “Treatment of Intestinal
Worms Is Associated With Decreased HIV Plasma Viral Load.” (J.AIDS,
September, 2002)

Roche laboratories, the company that manufactures the PCR tests, puts this
warning on the label:

“The AMPLICOR HIV-1 MONITOR Test….is not intended to be used as a
screening test for HIV or as a diagnostic test to confirm the presence of
HIV infection.”

But that’s exactly how it is used – to convince pregnant mothers to take
AZT and Nevirapine and to urge patients to start the drugs.