[Med-privacy] The Loss of the Right of Consent (from Psychiatric Times)

Wed, 1 Oct 2003 13:09:13 EDT

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[Unable to display image]
Guest Editorial: The Loss of the Right of Consent

by Deborah C. Peel, M.D. 

Psychiatric Times [Unable to display image]September 2003 [Unable to display image]Vol. XX [Unable to display image]Issue 9 

The right of consent, which gives individuals the power to keep personal 
health information private, has always been recognized under state law and has 
always been strongly upheld by state and federal courts. When President Bush made 
the Health Insurance Portability and Accountability Act (HIPAA) the law of 
the land in April 2001, the Privacy Rule gave every American the federal right 
to consent to the release of their medical records.

Originally, the HIPAA Privacy Rule did in fact protect every citizen's right 
to medical privacy, and Bush was lauded as the Privacy President. But behind 
the scenes, powerful corporate interests worked to turn it into its polar 
opposite, a "disclosure rule." The Bush Administration opened the door so that the 
hospital and insurance industries could amend the privacy regulations. 
Distracted by war, we missed completely the elimination of our precious 
constitutional right to privacy, the right to be let alone, as the so-called Privacy Rule 
went into effect. 

A massive campaign of disinformation has led the media and public to blind 
acceptance of the Administration's claims that HIPAA will increase medical 
privacy protections. In actuality, the amendments to the HIPAA Privacy Rule 
surgically excised every citizen's right of consent to release their medical records 
and replaced it with a new doctrine of federal "regulatory permission" (67 
Fed. Reg. 53,182, Aug. 14, 2002). This new right of access given to over 600,000 
"covered entities" and their innumerable "business associates" allows them to 
access every American's cradle-to-grave medical records without consent, 
without notice and without recourse. It is unlikely that any identifiable health 
information, past or future, will be immune from use and disclosure under this 
new standard. This technical exception, embedded deep in the several-inch-thick 
Rule, created a loophole the size of Texas that insurers, employers, banks, 
state and federal agencies, and all their "business associates" can drive 
through with truckloads full of medical records. (Final modifications to the 
Privacy Rule, in the Aug. 14, 2002, Federal Register and the Complete Privacy Rule 
Text, as modified Oct. 10, 2002, are available at <
www.hhs.gov/ocr/hipaa/finalreg.html>.)

The loss of meaningful consent for patients will have far-reaching 
consequences for medical care in the United States. These consequences have yet to be 
understood by most physicians, not to mention the public, the media or arguably 
even the promulgators of this impending disaster. Even if treatment is paid 
for out-of-pocket or an individual never has another contact with the health 
care system, their personal health information may now be accessed. The 
amendments to the HIPAA Privacy Rule grant breathtakingly broad and unprecedented 
powers to both private corporations and government entities to collect and amass 
the individual medical data of every person in the United States. Never in 
history has such a crucial right been eliminated for every member of the 
population.

The loss of consent will insidiously yet radically alter the 
physician-patient relationship and destroy the trust that patients must feel to share 
sensitive and painful medical and mental health information with all health care 
professionals. 

Will there be a physician or patient or consumer-led uprising? Not 
necessarily. But there will inevitably be a profound shift in patient behavior. People 
refuse treatment when they believe their diagnosis or prescription records will 
be seen by employers, insurers and bankers and used to discriminate against 
them. When patients realize neither they nor their doctors have the right to 
stop the flow of sensitive medical information out of doctors' offices and other 
treatment sites, they will fight back. Patients will begin to avoid or leave 
doctors and hospitals that use their medical records without permission. They 
will avoid treatment for as long as possible, they will omit sensitive 
information, or they will provide false information to try and protect themselves. 

The elimination of the right of consent will provide fertile ground for a 
black market in private medical treatment for those who can afford it. The only 
other guarantee of medical privacy will be to get treatment under an alias. If 
the doctrine of federal "regulatory permission" is not reversed through 
litigation or legislation by the U.S. Congress, the currently existing stronger 
protections for medical records in the states will likely be eliminated in order 
to bring state laws into conformity with HIPAA. Powerful industries that profit 
from access to identifiable medical information will introduce legislation in 
every state to eliminate consent and conform with the limitless disclosures 
allowed under HIPAA. This has already happened in Texas and Oregon.

Understandably, physicians and patients have been focusing almost exclusively 
on the hassles and bureaucratic forms required to comply with HIPAA. But the 
loss of the right of consent in the new Privacy Rule imposes several subtle 
and several more obvious problems and potential conflicts on every part of the 
system. While the federal Privacy Rule requires "covered entities" to fully 
inform patients of their rights under state and common law, this is just not 
being done. The privacy notices being given to patients across the nation are not 
only defective, misleading and inadequate, but illegal. 

Federal regulations provide the floor for patient privacy, not the ceiling. 
The Rule still requires providers to give patients notice about how to utilize 
the greater medical privacy protections contained in state laws. It further 
specifies that health care professionals should continue to use and follow the 
longstanding professional codes of ethics for their field or specialty and 
should develop privacy policies and notices in accordance with these traditional 
ethical principles. Yet HIPAA legal experts have simply not advised providers 
of the full extent of their legal and ethical obligations under the Privacy 
Rule. 

Privacy notices typically imply that patients have lost the right of consent, 
in flagrant violation of the core ethical principle of every medical and 
health profession. What does your privacy notice say? Does it cite the American 
Psychiatric Association and American Medical Association (AMA) Codes of Medical 
Ethics on the right of consent? Most privacy notices do state that patients 
have the right to request a consent process; but under the federal Privacy Rule, 
providers have no obligation to provide one. Although privacy notices are 
required to inform patients that more stringent state laws and medical ethics 
governing the right of consent actually prevail over the federal Privacy Rule, I 
have yet to find a single privacy notice that does that. 

As a matter of record, defective privacy notices are part of the basis for a 
lawsuit filed against the U.S. Department Health and Human Services (HHS) on 
April 10, 2003, in federal district court in Philadelphia. The lawsuit was 
filed on behalf of the American Psychoanalytic Association and 15 other health and 
advocacy organizations and individuals. Its main purpose is to overturn the 
amendments to HIPAA and restore the right of consent (see Citizens for Health 
et al. v Tommy G. Thompson, Secretary, US Dept of HHS, CA No. 03-2267 [E.D. 
Pa.]). The lawsuit cites three typical "privacy notices" from national 
corporations that did not advise patients of the existence of more stringent state and 
common laws governing medical privacy, did not advise patients about ethics 
governing medical privacy, and also failed to inform them about how to exercise 
their rights under state laws. For example, a privacy notice that states 
"stricter state laws may provide greater protections for people with HIV or AIDS" is 
totally inadequate. Surely HHS did not intend for each citizen to be forced 
to become an expert on the medical privacy statutes in their state. 

Many hospitals and academic institutions view the right of consent as 
inefficient, or as a barrier or impediment to treatment or research, rather than 
viewing the body of laws and ethical principles as necessary and important 
conditions of effective treatment. But psychiatrists know from direct experience just 
how far many parents and patients will go to protect their children or their 
jobs, and to hide or omit information to keep others from knowing intimate 
personal or family secrets. Our patients will not share any sensitive information 
at all if they believe it can be accessed by anyone other than the person who 
is treating them. 

The U.S. Supreme Court recognized that effective psychotherapy cannot exist 
without the guarantee of absolute privacy. In Jaffee v Redmond (No. 95-266 
[1996]), the justices rejected any balancing test to weigh the needs of private 
individuals or entities against the right of patients to have privacy. The court 
noted that it was in the best interests of the nation to have effective 
psychotherapy available for citizens, so they affirmed the absolute right to 
privacy of the communications between patient and psychotherapist by recognizing a 
federal therapist-patient privilege.

Advocacy for patients and protection of patient privacy are core ethical 
principles for physicians and most health professionals. Therein lies the moral 
and ethical guidance our nation needs. Section III in the Preamble of the AMA 
Principles of Medical Ethics (2001) affirms the physician's role as an advocate 
for patients, stating, "A physician shall respect the law and also recognize a 
responsibility to seek changes in those requirements which are contrary to 
the best interests of the patient." Section IV in the Preamble states, "A 
physician shall respect the rights of patients, colleagues, and other health 
professionals, and shall safeguard patient confidences and privacy within the 
constraints of the law." Both principles are incorporated into the Principles of 
Medical Ethics of the APA.

Here are some tangible steps you can take to safeguard patient privacy, 
advocate for the best interests of patients and inform the public:

1) Ask groups and individuals to support the federal lawsuit to restore the 
right to consent. Contributions can be made to help pay the costs of litigating 
the lawsuit. Tax-deductible checks can be sent directly to the Appeal for 
Privacy Foundation, P.O. Box 248, Austin, TX 78767.

2) Look at your own privacy notices. If they do not tell patients the steps 
they can take to protect their medical records under state laws and medical 
ethics, they are illegal. Ask your HIPAA expert to prepare privacy notices that 
follow the law.

3) Keep abreast of national efforts to protect medical privacy. See <
www.medicalprivacycoalition.org> and <www.patientprivacy.info> for more information 
about medical privacy.

4) Encourage your congressional delegation to co-sponsor or draft other 
legislation to fix the serious privacy defects in HIPAA. Restoring the right to 
consent is the centerpiece of the bipartisan Stop Taking Our Health Privacy Act, 
STOHP (HR 1709). Co-sponsors Reps. Edward J. Markey (D-Mass.) and Dana 
Rohrbacher (R-Calif.) stated:

The purpose of this Act is to restore patient privacy protections essential 
for the delivery of high-quality health care that were undermined when the 
medical privacy rule was modified in August 2002. STOHP will restore the core 
medical privacy protections of the December 2000 medical privacy rule by:

A) Reinstating the patient consent requirement for treatment, payment and 
health care operations. 

B) Returning to the 2000 definition of and thus ensuring that activities 
typically considered 'marketing,' such as drug companies paying pharmacies to send 
product recommendations to patients, fall under the rule's privacy 
protections governing marketing activities. 

C) Eliminating the broad 'public health' loophole created by the August 2002 
rule.

No single approach to medical privacy can preserve such an important 
individual right. When the privacy rights of individuals are pitted against 
corporations and governmental agencies that want unfettered access to the most valuable 
personal information that exists, eternal vigilance is the only effective 
response.

Dr. Peel is a past president of the Texas Society of Psychiatric Physicians 
and was recently appointed to the council of advisors of the Michael Tigar 
Human Rights Center for her expertise in medical privacy. 

References

American Medical Association (2001), Principles of Medical Ethics, Preamble, 
Section 3. Available at: www.ama-assn.org/ama/pub/category/4256.html. Accessed 
July 31, 2003.

Citizens for Health et al. v Tommy G. Thompson, Secretary, US Dept of HHS, CA 
No. 03-2267 (E.D. Pa.).

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Guest Editorial: Th=
e Loss of the Right of Consent 
 
by Deborah C. Peel, M.D. 
 
Psychiatric Times</=
I> <IMG SRC=3D"cid:X.MA2.1065028151@aol.com" ID=3D"MA2.1065028151" WIDTH=
=3D"7" HEIGHT=3D"7" BORDER=3D"0">September 2003 <IMG SRC=3D"cid:X.MA3.106502=
8151@aol.com" ID=3D"MA3.1065028151" WIDTH=3D"7" HEIGHT=3D"7" BORDER=3D"0">=
Vol. XX <IMG SRC=3D"cid:X.MA4.1065028151@aol.com" ID=3D"MA4.1065028151" WI=
DTH=3D"7" HEIGHT=3D"7" BORDER=3D"0">Issue 9 
 
The right of consent, which gives individuals the power to keep personal hea=
lth information private, has always been recognized under state law and has=20=
always been strongly upheld by state and federal courts. When President Bush=
 made the Health Insurance Portability and Accountability Act (HIPAA) the la=
w of the land in April 2001, the Privacy Rule gave every American the federa=
l right to consent to the release of their medical records. 
 
Originally, the HIPAA Privacy Rule did in fact protect every citizen's right=
 to medical privacy, and Bush was lauded as the Privacy President. But behin=
d the scenes, powerful corporate interests worked to turn it into its polar=20=
opposite, a "disclosure rule." The Bush Administration opened the door so th=
at the hospital and insurance industries could amend the privacy regulations=
. Distracted by war, we missed completely the elimination of our precious co=
nstitutional right to privacy, the right to be let alone, as the so-called P=
rivacy Rule went into effect. 
 
A massive campaign of disinformation has led the media and public to blind a=
cceptance of the Administration's claims that HIPAA will increase medical pr=
ivacy protections. In actuality, the amendments to the HIPAA Privacy Rule su=
rgically excised every citizen's right of consent to release their medical r=
ecords and replaced it with a new doctrine of federal "regulatory permission=
" (67 Fed. Reg. 53,182, Aug. 14, 2002). This new right of access given to ov=
er 600,000 "covered entities" and their innumerable "business associates" al=
lows them to access every American's cradle-to-grave medical records without=
 consent, without notice and without recourse. It is unlikely that any ident=
ifiable health information, past or future, will be immune from use and disc=
losure under this new standard. This technical exception, embedded deep in t=
he several-inch-thick Rule, created a loophole the size of Texas that insure=
rs, employers, banks, state and federal agencies, and all their "business as=
sociates" can drive through with truckloads full of medical records. (Final=20=
modifications to the Privacy Rule, in the Aug. 14, 2002, Federal Register=
 and the Complete Privacy Rule Text, as modified Oct. 10, 2002, are avai=
lable at &lt;www.hhs.gov/ocr/hipaa/finalreg.html&gt;.) 
 
The loss of meaningful consent for patients will have far-reaching consequen=
ces for medical care in the United States. These consequences have yet to be=
 understood by most physicians, not to mention the public, the media or argu=
ably even the promulgators of this impending disaster. Even if treatment is=20=
paid for out-of-pocket or an individual never has another contact with the h=
ealth care system, their personal health information may now be accessed. Th=
e amendments to the HIPAA Privacy Rule grant breathtakingly broad and unprec=
edented powers to both private corporations and government entities to colle=
ct and amass the individual medical data of every person in the United State=
s. Never in history has such a crucial right been eliminated for every membe=
r of the population. 
 
The loss of consent will insidiously yet radically alter the physician-patie=
nt relationship and destroy the trust that patients must feel to share sensi=
tive and painful medical and mental health information with all health care=20=
professionals. 
 
Will there be a physician or patient or consumer-led uprising? Not necessari=
ly. But there will inevitably be a profound shift in patient behavior. Peopl=
e refuse treatment when they believe their diagnosis or prescription records=
 will be seen by employers, insurers and bankers and used to discriminate ag=
ainst them. When patients realize neither they nor their doctors have the ri=
ght to stop the flow of sensitive medical information out of doctors' office=
s and other treatment sites, they will fight back. Patients will begin to av=
oid or leave doctors and hospitals that use their medical records without pe=
rmission. They will avoid treatment for as long as possible, they will omit=20=
sensitive information, or they will provide false information to try and pro=
tect themselves. 
 
The elimination of the right of consent will provide fertile ground for a bl=
ack market in private medical treatment for those who can afford it. The onl=
y other guarantee of medical privacy will be to get treatment under an alias=
. If the doctrine of federal "regulatory permission" is not reversed through=
 litigation or legislation by the U.S. Congress, the currently existing stro=
nger protections for medical records in the states will likely be eliminated=
 in order to bring state laws into conformity with HIPAA. Powerful industrie=
s that profit from access to identifiable medical information will introduce=
 legislation in every state to eliminate consent and conform with the limitl=
ess disclosures allowed under HIPAA. This has already happened in Texas and=20=
Oregon. 
 
Understandably, physicians and patients have been focusing almost exclusivel=
y on the hassles and bureaucratic forms required to comply with HIPAA. But t=
he loss of the right of consent in the new Privacy Rule imposes several subt=
le and several more obvious problems and potential conflicts on every part o=
f the system. While the federal Privacy Rule requires "covered entities" to=20=
fully inform patients of their rights under state and common law, this is ju=
st not being done. The privacy notices being given to patients across the na=
tion are not only defective, misleading and inadequate, but illegal. 
 
Federal regulations provide the floor for patient privacy, not the ceiling.=20=
The Rule still requires providers to give patients notice about how to utili=
ze the greater medical privacy protections contained in state laws. It furth=
er specifies that health care professionals should continue to use and follo=
w the longstanding professional codes of ethics for their field or specialty=
 and should develop privacy policies and notices in accordance with these tr=
aditional ethical principles. Yet HIPAA legal experts have simply not advise=
d providers of the full extent of their legal and ethical obligations under=20=
the Privacy Rule. 
 
Privacy notices typically imply that patients have lost the right of consent=
, in flagrant violation of the core ethical principle of every medical and h=
ealth profession. What does your privacy notice say? Does it cite the Americ=
an Psychiatric Association and American Medical Association (AMA) Codes of M=
edical Ethics on the right of consent? Most privacy notices do state that pa=
tients have the right to request a consent process; but under the federal Pr=
ivacy Rule, providers have no obligation to provide one. Although privacy no=
tices are required to inform patients that more stringent state laws and med=
ical ethics governing the right of consent actually prevail over the federal=
 Privacy Rule, I have yet to find a single privacy notice that does that. <B=
R>
 
As a matter of record, defective privacy notices are part of the basis for a=
 lawsuit filed against the U.S. Department Health and Human Services (HHS) o=
n April 10, 2003, in federal district court in Philadelphia. The lawsuit was=
 filed on behalf of the American Psychoanalytic Association and 15 other hea=
lth and advocacy organizations and individuals. Its main purpose is to overt=
urn the amendments to HIPAA and restore the right of consent (see Citizen=
s for Health et al. v Tommy G. Thompson, Secretary, US Dept of HHS, CA N=
o. 03-2267 [E.D. Pa.]). The lawsuit cites three typical "privacy notices" fr=
om national corporations that did not advise patients of the existence of mo=
re stringent state and common laws governing medical privacy, did not advise=
 patients about ethics governing medical privacy, and also failed to inform=20=
them about how to exercise their rights under state laws. For example, a pri=
vacy notice that states "stricter state laws may provide greater protections=
 for people with HIV or AIDS" is totally inadequate. Surely HHS did not inte=
nd for each citizen to be forced to become an expert on the medical privacy=20=
statutes in their state. 
 
Many hospitals and academic institutions view the right of consent as ineffi=
cient, or as a barrier or impediment to treatment or research, rather than v=
iewing the body of laws and ethical principles as necessary and important co=
nditions of effective treatment. But psychiatrists know from direct experien=
ce just how far many parents and patients will go to protect their children=20=
or their jobs, and to hide or omit information to keep others from knowing i=
ntimate personal or family secrets. Our patients will not share any sensitiv=
e information at all if they believe it can be accessed by anyone other than=
 the person who is treating them. 
 
The U.S. Supreme Court recognized that effective psychotherapy cannot exist=20=
without the guarantee of absolute privacy. In Jaffee v Redmond (No. 9=
5-266 [1996]), the justices rejected any balancing test to weigh the needs o=
f private individuals or entities against the right of patients to have priv=
acy. The court noted that it was in the best interests of the nation to have=
 effective psychotherapy available for citizens, so they affirmed the absolu=
te right to privacy of the communications between patient and psychotherapis=
t by recognizing a federal therapist-patient privilege. 
 
Advocacy for patients and protection of patient privacy are core ethical pri=
nciples for physicians and most health professionals. Therein lies the moral=
 and ethical guidance our nation needs. Section III in the Preamble of the A=
MA Principles of Medical Ethics (2001) affirms the physician's role as an ad=
vocate for patients, stating, "A physician shall respect the law and also re=
cognize a responsibility to seek changes in those requirements which are con=
trary to the best interests of the patient." Section IV in the Preamble stat=
es, "A physician shall respect the rights of patients, colleagues, and other=
 health professionals, and shall safeguard patient confidences and privacy w=
ithin the constraints of the law." Both principles are incorporated into the=
 Principles of Medical Ethics of the APA. 
 
Here are some tangible steps you can take to safeguard patient privacy, advo=
cate for the best interests of patients and inform the public: 
 
1) Ask groups and individuals to support the federal lawsuit to restore t=
he right to consent. Contributions can be made to help pay the costs of=20=
litigating the lawsuit. Tax-deductible checks can be sent directly to the Ap=
peal for Privacy Foundation, P.O. Box 248, Austin, TX 78767. 
 
2) Look at your own privacy notices. If they do not tell patients the=
 steps they can take to protect their medical records under state laws and m=
edical ethics, they are illegal. Ask your HIPAA expert to prepare privacy no=
tices that follow the law. 
 
3) Keep abreast of national efforts to protect medical privacy. See &=
lt;www.medicalprivacycoalition.org&gt; and &lt;www.patientprivacy.info&gt; f=
or more information about medical privacy. 
 
4) Encourage your congressional delegation to co-sponsor or draft other l=
egislation to fix the serious privacy defects in HIPAA. Restoring the ri=
ght to consent is the centerpiece of the bipartisan Stop Taking Our Health P=
rivacy Act, STOHP (HR 1709). Co-sponsors Reps. Edward J. Markey (D-Mass.) an=
d Dana Rohrbacher (R-Calif.) stated: 
 
The purpose of this Act is to restore patient privacy protections essential=20=
for the delivery of high-quality health care that were undermined when the m=
edical privacy rule was modified in August 2002. STOHP will restore the core=
 medical privacy protections of the December 2000 medical privacy rule by:<B=
R>
 
A) Reinstating the patient consent requirement for treatment, payment and he=
alth care operations. 
 
B) Returning to the 2000 definition of and thus ensuring that activities typ=
ically considered 'marketing,' such as drug companies paying pharmacies to s=
end product recommendations to patients, fall under the rule's privacy prote=
ctions governing marketing activities. 
 
C) Eliminating the broad 'public health' loophole created by the August 2002=
 rule. 
 
No single approach to medical privacy can preserve such an important individ=
ual right. When the privacy rights of individuals are pitted against corpora=
tions and governmental agencies that want unfettered access to the most valu=
able personal information that exists, eternal vigilance is the only effecti=
ve response. 
 
Dr. Peel is a past president of the Texas Society of Psychiatric Physicia=
ns and was recently appointed to the council of advisors of the Michael Tiga=
r Human Rights Center for her expertise in medical privacy. 
 
References 
 
American Medical Association (2001), Principles of Medical Ethics, Preamble,=
 Section 3. Available at: www.ama-assn.org/ama/pub/category/4256.html. Acces=
sed July 31, 2003. 
 
Citizens for Health et al. v Tommy G. Thompson, Secretary, US Dept of HHS, C=
A No. 03-2267 (E.D. Pa.). 
 
 
 
 
 
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