October 3, 2006

Jo Anne B. Barnhart

Commissioner of Social Security

Social Security Administration

P.O. Box 17703

Baltimore, Maryland 21235-7703

Via email: regulations@ssa.gov

Via telefax: 410-966-2830

Re: Proposed Rules Revising Medical Criteria for Evaluating Immune
System Disorders Dear Commissioner Barnhart:

Set forth below are comments on the Proposed Rules revising the criteria
in the Listing of Impairments used by the Social Security Administration
(SSA) to evaluate claims involving immune system disorders. The
undersigned organizations submitting these comments have extensive
expertise in the area of HIV-related treatment and representation of
HIV-positive claimants at every stage of the Social Security
Administration\'s disability determination process.1 Through our many
years working in legal and medical programs and multidisciplinary
agencies specializing in the needs of people living with HIV, we have
learned the common difficulties faced by HIV-positive claimants and the
typical responses of disability examiners and adjudicators to claims of
disability based on HIV.

I. General Comments

Clearly the Social Security Administration has put a great deal of
thought and effort into revising the medical criteria for evaluating
immune system disorders. SSA is to be commended for soliciting comments
in 2003, before undertaking revision of those criteria, and for
carefully considering the comments that it received. We are very pleased
to see that important changes to 20 CFR Part 404, Subpart P proposed in
the revised criteria reflect concerns that many of us raised during that
earlier process. SSA has improved the rules by extensively rewording and
reorganizing Sections 14.00 and 114.00. In particular, the expanded
discussion of treatment-related topics \-- both in general and
specifically in the HIV infection context \-- is a significant
improvement over the current version of the rules. Importantly, the
Proposed Rules specifically mention the variability of individuals\'
responses to treatment, the difficulty of distinguishing side effects of
treatment from side effects of infection and the fact that side effects
of treatment themselves may result in functional limitations. These
changes are important, much needed improvements.

Despite many positive changes in the rules, we believe some additional
revisions are needed to remedy problems that we have seen in practice
and issues that we anticipate will arise during the years that the
revised rules will be in effect. The changes proposed by these comments
will more accurately reflect the nature, course and treatment of HIV at
this time and in the years ahead. Also, throughout the rules, it is
important to include language that makes it clear to those determining
claimants\' disability that each claimant is entitled to an
individualized assessment of his or her situation.

In finalizing the rules, the Social Security Administration should keep
in mind the following principles: (1) the rules should accurately and
comprehensively reflect the current understanding of HIV disease and
treatment; and (2) the rules should include enough general language to
accommodate the inevitable changes in understanding and treatment of the
disease that will occur during the anticipated eight year life of the
rules. Failure to include such general language will result in disabled
persons being unfairly denied a finding of disability, because, for
example, their medical records do not record the clinical markers
written into the listings. HIV disease is still a relatively new disease
and the standards for identifying it and its associated conditions, and
for treatment, will continue to change. If, over the life of the final
rules, the standards for identifying listed conditions change, claimants
need to be able to have evidence related to those new standards
credited, rather than be required to submit evidence of diagnostic
findings which no longer are typically used by the medical profession.

II\. Comments on Sections 14.00 (Part A) and 114.00 (Part B) of Appendix
1 A. Sections 14.00(F) & 114.00(F) and 14.08(K) & 114.08(L): The
interplay between HIV and mental health should be specifically
addressed.

Changes in mental and emotional functioning are often connected to HIV
infection. Mental illness may precede HIV infection, as mental illness
places people at risk of contracting HIV infection.2 Mental health
issues may accompany HIV infection, as the initial diagnosis of HIV
infection can trigger anxiety and depressive disorders. Reservoirs of
latent HIV virus accumulate in the brain and central nervous system,
unreachable by most HIV medications that are unable to cross the
blood-brain barrier. In this way, the HIV virus impairs the central
nervous system, leading to dementia and cognitive difficulties as the
disease progresses.3 Additionally, HIV medications can themselves cause
mental impairments such as significant memory loss, cognitive deficits,
depression, anxiety, paranoia and hypervigilance.4

For these and other reasons, mental illness frequently affects people
who are living with HIV, and becomes more pronounced as the HIV disease
progresses and becomes more severe. Mental health conditions can
interfere with self-care, activities of daily living, and adherence to
treatment regimens and appointment schedules.5 Stress, anxiety and
depression weaken the immune system and speed disease progression,
whether they stem from mental illness, the trauma of the diagnosis, or
the rigors of treatment.6 In evaluating the severity and level of
progression of HIV disease in a particular claimant, attention must be
paid to signs and limitations that stem from mental and emotional
deficits.

The link between HIV infection and mental illness is so strong,
moreover, that often primary care providers and infectious disease
specialists prescribe compensatory medications such as anti-depressants
and anti-anxiety medications to their patients without referring them
for psychiatric care or counseling.7 In such cases, there is no
longitudinal history of psychiatric care or assessment as would be
expected in the ordinary claim where the principal disabling impairment
is a mental health condition. While such a patient may not have the
history of signs and symptoms that document the severity required by
SSA\'s mental health condition listings, these very real and often
severe conditions must be recognized by SSA as a manifestation of HIV
infection which contributes to the disabling nature of the disease.

Therefore, we recommend that Sections 14.08(K) and 114.08(L) be modified
to recognize specifically that mental health conditions can be a
manifestation of HIV infection which, even if they do not rise to the
level of severity required by the ordinary mental health condition
listings, such as 12.04 (affective disorders including depression) or
12.06 (anxiety disorders), can and should be rightfully considered as
repeated manifestations of HIV infection. Also, an additional subsection
should be added to Sections 14.08(F) and 114.08(F) to make the points
discussed above.

B. Sections 14.00(G) & 114.00(G): More specific discussions of some
issues related to treatment are needed.

In the discussion on \"variability of your response to treatment\"
(14.00(G)(2), 114.00(G)(2)), the Proposed Rules note generally various
important factors to be considered. Moreover, the Proposed Rules improve
upon the existing rules in that they more fully discuss side effects of
HIV medication. However, greater discussion of some of those general
factors in the specific context of HIV infection should be added to
14.00(G)(5) and 114.00(G)(5). Our experience reveals that the impact on
HIV infected persons of treatment failures and the difficulties of
adhering to treatment continue to be understood poorly by the Social
Security Administration\'s disability examiners, adjudicators, and even
medical consultants. These issues need to be addressed more fully in the
Rules, in part to aid adjudicators in fairly and properly handling these
issues.

1\. Sections 14.00(G)(5) and 114.00(G)(5) should directly address the
issue of a claimant\'s non-responsiveness to HIV treatments.

The Rules should specifically state that the mere fact that an
individual does not medically respond to highly active anti-retroviral
therapy (\"HAART\") does not indicate that he or she is not disabled or
is not credible. SSI and SSDI claimants and their representatives
continue to encounter medical \"experts\" who seemingly assume that for
every individual with HIV infection a treatment can be prescribed that
will, if adhered to, enable the individual to work. When reaching
conclusions about claimants\' functional limitations, these consultants
assume that the claimants are capable of responding positively to
treatment through a mix of adherence, lifestyle alteration and sheer
willpower. Such conclusions, however, fail to recognize that prescribed
treatments are not effective or suitable for every HIV infected person.
Although the general section on response to treatment acknowledges the
need to consider individual variability, this problem in the HIV context
is persistent enough to warrant specific reference in Sections
14.00(G)(5) and 114.00(G)(5).

In addition, the Rules should note the increasing fragility of persons
who do not respond to prescribed treatment and the impact on them of
reduced treatment options. If an individual fails to respond to a
particular combination of medications, either because he or she is
naturally resistant, because the virus mutates in the body or for some
other reason, that individual has fewer options for relief in the
future. With fewer available treatment options, the person is more
susceptible to complications, illness and disabling conditions. With
this increased susceptibility to opportunistic infection and other
medical complications come additional mental health implications, as
stress, fear, depression and anxiety compound the claimant\'s physical
fragility. In many such cases, physicians instruct their patients to
reduce their exposure to infection by limiting their contact with other
people, stress and adverse weather conditions. A claimant with few
treatment options is likely to have created a very structured
environment to reduce his or her risk of infection and illness. Whether
the claimant avoids subsequent infection at the expense of his or her
relationships, mobility, freedom and mental health is itself a
manifestation of HIV disease and the direct result of the damage to his
or her immune system caused by HIV. The discussion in sections
14.00(G)(5) and 114.00(G)(5) should specifically require that the
fragile and tenuous position of a claimant with HIV be taken into
account. We recommend that an additional subsection be added to each of
those sections, reading \"i. Whether you have exhausted most or all
treatment alternatives.\"

2\. Sections 14.00(G)(5) and 114.00(G)(5) should directly address the
difficulty of adhering to treatment regimen.

For many people with HIV disease, their prescribed treatment regimens
are very complicated and difficult to follow. They may be required to
take numerous pills each day at several different times of the day and
night, to keep certain medications refrigerated, to take some on an
empty stomach and to take others with food. The requirements of HAART
can be dizzying, difficult to follow, and potentially embarrassing. In
addition, the often-debilitating side effects of the medications \--
e.g., diarrhea, nausea, vomiting, neuropathy, fatigue \-- make it
difficult for some individuals to take each of their prescribed
medications at every prescribed time.8 Unfortunately, patients are often
punished severely by their own bodies for the most minor transgressions;
even brief interruptions in treatment may lead to virus mutation and
resistance.9

Many people living with HIV experience these adherence problems, but,
for obvious reasons, perfect adherence is especially difficult for some
populations. In particular, people who experience mental illness have
difficulties adhering to their treatment regimen because of their mental
health conditions. Persons who are homeless or who lack Medicaid or
other insurance coverage are also likely to have great difficulty
accessing their medications and adhering exactly to prescribed
treatment. In addition, HIV-positive children are particularly subject
to adherence problems. For children, the bad taste of the medications,
the repetition of the regimen, the appearance of being different at
school, and an inherent lack of maturity and full understanding of the
need for the medications all affect a medical provider\'s and a
parent\'s ability to maintain compliance in an HIV-positive child.10

At present, some claimants are penalized by adjudicators for their
inability to adhere to a strict and sometimes overwhelming regimen of
medications. Therefore, Sections 14.00(G)(5) and 114.00(G)(5) of the
Rules need to directly address this issue. Those sections should include
a discussion of the difficulty of adhering to HIV treatment regimen and
directly acknowledge that there are many valid reasons why individuals
with HIV disease do not perfectly adhere to their prescribed treatment
regimen, such as the individual\'s mental illness or young age;
logistical difficulties (e.g., lack of access to refrigeration)
precluding exact compliance; debilitating side effects from the
medication; and inability to afford the prescribed treatment. The Rules
also should state that a claimant\'s admitted lack of adherence to HAART
should neither reflect on the claimant\'s credibility nor indicate that
his or her functional capacity is artificially low. The individual\'s
reasons for non-perfect adherence need to be taken into account, and we
are concerned that the subsections of 14.00(G) do not provide sufficient
guidance to adjudicators. Because adherence to HAART is particularly
difficult, and because individuals who have not adhered may no longer
have the option of resuming a particular treatment, claimants should not
be penalized for their failure to adhere to complicated medication
regimens.

III\. Comments on Sections 14.08 (Part A) and 114.08 (Part B) of
Appendix 1

The Proposed Rules properly recognize that an individual does not have
to satisfy the specific listings set forth in Sections 14.08 and 114.08
to be found to suffer an impairment that is severe enough for him or her
to be disabled for purposes of Title II and Title XVI. For example,
Sections 14.00(G) and 114.00(G) state that a person may be disabled due
to the effects of treatment \-- including the interactive and cumulative
effects of treatments \-- without meeting the \"stand-alone\" listings
and that the effects of treatment must be considered on an individual
basis. As another example, 14.08(K) clearly states that repeated
manifestations of HIV infection that are not listed in 14.08(A)-(J)11
can be the basis for a disability finding, as can repeated
manifestations of conditions that are listed in 14.08(A)-(J) but lack
the required findings of those listings.

Even though evaluation of an individual situation cannot be limited to
consideration of the disabling impairments specified in Sections 14.08
and 114.08, those \"stand-alone\" diagnoses of opportunistic infections
are an important part of the rules. Diagnosis with a condition listed in
those sections demonstrates that an individual has a severely
compromised immune system and serves as a useful and sensible indicator
of the inability to work. Therefore, the specific listings of
impairments facilitate determinations of disability where an individual
does meet one of the \"stand-alone\" listings. To more accurately
reflect the current medical understanding of the disabling impairments
experienced by people living with HIV and to allow for changes in that
understanding over the next several years, some additional language
should be added to Sections 14.08 and 114.08.12

A. The \"stand-alone\" listings should include general language
anticipating changed understanding over the life of the rules.

As recognition that medical knowledge regarding the effects of HIV
disease and HIV treatments will change over the anticipated eight year
life of the rules, we recommend that the following language be added as
a final subcategory for listings 14.08(A) through (F) and 114.08(A)
through (F): \"an infection or condition that is systemic or
disseminated.\"

B. The descriptions of some conditions currently listed in Sections
14.08 and 114.08 should be modified to better account for the variety of
disabling impairments experienced by people living with HIV.

1\. Sections 14.08(D) and 114.08(D): Viral infections

Sections 14.08(D) and 114.08(D) both currently state that a person with
HIV meets a Step 3 listing if he or she meets the criteria for hepatitis
set out in Section 5.05. We recognize that SSA has decided to remove all
reference listings in the Proposed Rules. However, when removing the
reference listing to Section 5.05, the Proposed Rules should have
retained a reference to hepatitis. The current references to hepatitis
in the HIV listings do not adequately address the complicated medical
realities faced by people who are infected with both HIV and Hepatitis C
(\"HCV\") or Hepatitis B (\"HBV\").

The Proposed Rules recognize generally that the interactive and
cumulative effects of treatment for both HIV and hepatitis must be
evaluated when an individual suffers from both. (Section
14.00(G)(1)(f).) However, the complicated interplay between HIV and
hepatitis warrant greater recognition in the listings. Although
simultaneous treatment of both HIV and hepatitis is critical for people
who experience co-infection, the two treatment regimens can work against
one another. Moreover, drugs used to treat HIV can undercut the benefits
sought through treatment for HCV because the HIV drugs are toxic to the
liver.13 And HCV-related liver disease has been found to accelerate
among people infected with HIV.14 Such complications are common to
HIV-positive people with either HCV or HBV.15

In short, people who are infected with both HIV and hepatitis are more
prone to illness, more difficult to treat, and less able to function
than people who are only infected with a hepatitis virus. This
compounding effect means that it is not sufficient to allow such persons
to be separately evaluated under the listing for hepatitis as well as
the listing for HIV. The liver listings themselves do not contemplate
overall suppression of the immune system, the necessity of taking
medications that damage the liver or the other complications of
HIV/AIDS. Nor is it sufficient to allow for consideration of the
interactive and cumulative effects of treatment and to reference
\"hepatitis\" in Section 14.08(K). To adequately reflect the extent of
functional impairment of a person with both HIV and hepatitis, Sections
14.08(D) and 114.08(D) should reference hepatitis, where co-infection
with both HIV and HCV or HCB complicates treatment of both conditions.

2\. Section 14.08(H): HIV wasting syndrome

Section 14.08(H)\'s listing of HIV wasting syndrome should be revised to
reflect more current medical knowledge about this condition. As
currently written, this listing is too restrictive in its documentation
requirements. The listing should note that body mass index (BMI) and
body cell mass (BCM) can be relied upon as accurate indicators of the
severity of wasting in a given individual.16 Involuntary weight loss as
low as 5% have been associated with increased risk of death.17 The
requirements with regard to diarrhea are too restrictive: a person with
HIV who experiences wasting is typically functionally unable to work if
he or she experiences diarrhea for two weeks and experiences protein
deficiency. Although a documented fever is a useful clinical indicator
of wasting syndrome, it should not be necessary that the claimant have
many temperature readings throughout a month or longer period. Moreover,
wasting can be disabling even in the absence of the listed
manifestations when it is accompanied by constitutional symptoms such as
weakness, lack of muscle strength, fatigue, malaise, or inability to
lift. As an alternative to evidence of diarrhea or fever, the listing
should specify that it can be satisfied by documentation of other
objective evidence of significant involuntary weight loss. To do so,
wording comparable to that used in Section 14.00(F) regarding
documentation of HIV infection could be added: \"OR Documented by other
generally acceptable methods consistent with the prevailing state of
medical knowledge or clinical practice.\"

3\. Sections 14.08(I) and 114.08(I): Diarrhea

Sections 14.08(I) and 114.08(I) (unchanged from their predecessor
sections in the current rules, adopted in 1993) need to be modified to
reflect current medical views regarding diarrhea and its treatment.
These sections now should include those HIV/AIDS claimants who suffer
from diarrhea, lasting over one month, with multiple loose stools per
day and/or bowel incontinence, despite modifications in HAART therapy
and antidiarrheals. Moreover, many patients with disabling diarrhea do
not require hydration and therefore are not treated with intravenous
hydration, and \"tube feeding\" is rarely used now to treat diarrhea.
Thus, diarrhea can rise to the level of being disabling without the
objective findings in the current listing being met. The listing should
be changed to allow documentation by other objective evidence, such as
reports of a rectal exam, stool culture, or fecal occult blood test. As
with wasting syndrome, general language should be added, comparable to
that used in Section 14.00(F) regarding documentation of HIV infection:
\"OR Documented by other generally acceptable methods consistent with
the prevailing state of medical knowledge or clinical practice.\"

C. Chronic or severe acute pancreatitis should be added as a
\"stand-alone\" listing in Sections 14.08 and 114.08.

Although pancreatitis is now referenced in 14.00(G)(5)(a) (as a side
effect of antiretroviral drugs) and in 14.08(K), the Proposed Rules fail
to acknowledge the seriousness and prevalence of pancreatitis among
people with HIV disease. Chronic or severe acute pancreatitis occurs at
a high rate among people with HIV disease and severely impairs those
individuals\' abilities to function.18 Pancreatitis is a potentially
disabling \-- and sometimes fatal \-- condition that can be caused by
either HIV or certain HIV medications. Most commonly, pancreatitis in
people with HIV is caused by medications taken to treat the HIV
disease.19 The condition may cause severe abdominal pain, nausea,
vomiting, fever, chills, and shortness of breath, and can result in
admission to a hospital\'s intensive care unit for two to three weeks at
a time. Also, it may result in profound weight loss and long-term food
intolerance. These manifestations may recur continually when the cause
of the pancreatitis persists or when lasting damage has been done to the
pancreas. The affected individual may suffer numerous painful and
debilitating relapses. Unfortunately, there is no cure for the
condition. Because pancreatitis is frequently associated with HIV
infection and nucleoside reverse transcriptase inhibitors, we recommend
that Sections 14.08 and 114.08 specifically indicate that a person with
HIV is disabled if he or she requires hospitalization for pancreatitis
twice in a one-year period.

D. Sections 14.08(K) and 114.08(L) should be revised to anticipate
changes in medical understanding and treatment of HIV disease.

Of course, over the anticipated eight year life of the new rules,
changes in the understanding of HIV disease and its treatment will
inevitably result in the recognition of new manifestations of the
disease and its treatment that should be considered in determining
disability. To take that into account and to reflect the non-exhaustive
listing of manifestations in Sections 14.08(K) and 114.08(L), the
following general language should be added to those sections: \"Special
consideration should be given to other conditions, signs and symptoms
deemed by the primary care provider as contributing to substantial
functional limitations.\"20

If you have any questions or wish for clarification regarding any of the
above comments, please contact, on behalf of the undersigned, Bebe J.
Anderson, HIV Project Director, Lambda Legal, 120 Wall Street, Suite
1500, New York, New York, 10005, telephone (212) 809-8585, email
banderson@lambdalegal.org.

Sincerely,

Rick Stoller

Clinical Manager

The Partnership Project

5525 SE Milwaukie

Portland, OR 97202

503-230-1202

Rick Stoller

OHSU

Partnership Project

503-230-1202