Reconstructive Treatments for Facial Lipodystrophy Syndrome

I strongly support coverage for reconstructive treatments for facial lipodystrophy and urge the government to institute this policy. [PHI Redacted]

The benefits from reconstructive treatments are significant and an important component in establishing well-being in HIV and AIDS survivors.

Thank you for your consideration, and I look forward to your great help in this matter.

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The treatment of lipodystrophy by various facial fillers should be approved. There is significant documentation in the community and medically that certain drugs in a HAART HIV cocktail cause lipodystrophy as well as lipoatrophy. The result is physical as well as mental. Breast reconstructions following mastectomy is covered as it enhances the patient''s overall mental health. Without such treatment, the possibility of severe clinical depression which can lead to expensive hospitalizations is quite evident. In more severe terms, without treatment, the possibility of suicide or other self-harm is prevalent. The same scenario applies without treatment of facial wasting caused by life-prolonging treatment/medications. The cost benefit of covering this treatment and promoting mental health and possibly a return to work from the secondary confidence can not be overlooked. The alternative is to deny coverage and people will continue to suffer the visual stigma of a well known appearance for advanced stages of HIV/AIDS. People with HIV/AIDS are living longer now and there must be the inclusion of adjunct treatments and procedures to help them live in society without fear of judgment and rejection by their peers and society in general.

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Affordable treatment to repair damage from facial lipoatrophy is greatly needed. I urge careful consideration and support reimbursement for reconstructive treatment.

Several individuals I know suffer with feelings of disfigurement, self-isolation and poor self-esteem due to changes in facial appearance as result of some anti-HIV medication.

Such trreatment is rehabilitative to pyshological health and would assist in those affected to feel complete, productive and healthful. This treatment is equivalent to reconstruction surgeries with cancers, skin grafts for burn victims, or prosthetic devices for amputees.

Thank you for soliciting comments and look forward to response.

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Adding approval of effective treatment procedures to Medicare & insurance coverage protocol would be extreamly benificial for the physical & emotional well being of people living with HIV. Treatments available now, are too expensive for most Patients to avail themselves of with the other expenses related to this disease & the limited income & resourses available to us. [PHI Redacted] This is one of the prime causes of depression for people dealing with long term HIV infection. Adding covered treatment protacols would allow many to avail themselves of treatment out of our finacial reach with current private practice costs. Please concider this for the benifit of countless patients in need of assistance. Thank you, Allan Austin

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Revised Comments re: Coverage for Reconstructive
Treatments for Facial Lipodystrophy Syndrome

Dear Dr. Hambrick:

The HIV Medicine Association (HIVMA) is pleased that the Centers for Medicare and Medicaid Services (CMS) has opened the National Coverage Determination (NCD) process to the question of whether or not Medicare will cover reconstructive treatment of facial lipodystrophy syndrome (LDS). We believe that CMS should cover this as a medically legitimate therapy for a disfiguring complication of HIV treatment.

I am offering these comments on behalf of our more than 3,600 clinician and scientist members that are devoted to the field of HIV medicine and that provide HIV care and treatment across the U.S.

Reconstructive treatments for facial LDS are reasonable, medically necessary, and appropriate for patients with HIV/AIDS who have or are undergoing antiretroviral therapy (ART). Facial lipoatrophy (lipodystrophy) among HIV-infected patients in the U.S. is mainly attributed to the wasting effects of prescribed antiretroviral therapy, which includes a combination of potent medications. The effect on patients can be profound, and can severely compromise the strict adherence that is vitally important to the success of combination antiretroviral therapy.

Facial LDS is an iatrogenic disease for which treatment is reasonable and necessary for patients to maintain functioning. In most cases, treatment requires a series of injections of poly-L-lactic acid by a trained practitioner in a medical office.

CMS should cover these treatments in patients with HIV/AIDS with appropriate physician documentation in the medical record.

The questions that you are considering to evaluate coverage as we understand it are:

1. Are these treatments statutorily excluded as “cosmetic surgery?”
2. Do these treatments fall into a benefit category?
3. Is the service “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member?” Sec. 1862. [42 U.S.C. 1395y]

We believe reconstructive treatment for facial LDS is not “cosmetic surgery” and that it meets the criteria outlined for coverage. We hope you find our comments compelling and that CMS will issue a national coverage payment policy for treatment of facial LDS in patients with HIV/AIDS.

Please contact us through our Executive Director, Andrea Weddle, aweddle@idsociety.org, 703.299.0915, should you require additional information or if we can assist you or CMS in any way.
Sincerely, Arlene D. Bardeguez, MD, MPH
Chair, HIV Medicine Association

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[PHI Redacted]

Allowing medicaid to pay for treatment for this condition will greatly improve the lives of those afflicted with this medical condition. I can unequivocally state that treatment for lipoatrophy/lipodystrophy is NOT cosmetic, it is a treatment for a medical condition similat to reconstructive surgery for breast cancer. I strongly urge HHS/CMS to authorize medicaid to pay for treatment for lipoatrophy/lipodystrophy. Thank you for your consideration of this matter.

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For once successful, divorced, middle aged women with HIV/AIDS it is hard enough to make friends, let alone meet a person of the opposite sex to date. The odds of ever getting married again are highly unlikely. Add to that the fact that many times they are completely alone, becoming estranged from their families due to the shame of having contracted this dreaded disease. Between the side effects of the meds, the complications of the disease, and the reactions of friends, family, and society, ending up on disability is almost inevitable. Trying to hold onto any semblance of the life they once lead, or any quality of life at all is nearly impossible. For a woman suffering from lipoatrophy, looking in the mirror can be devastating. Having lost all fat from her face, butt, arms and legs she resembles a person suffering from an extreme eating disorder on the verge of death, a walking skeleton. The skin just hangs there & no amount of exercise helps. People are constanly staring when they are in public because they look so hideous. There are many days when they contemplate discontinuing taking their medications that cause so many side effects, even though the only way for them to stay alive is to continue taking them. Reconstructive treatments for facial lipodystrophy syndrome should definitely be covered by Medicare.

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As a physician, I''ve observed facial lipodystrophy to be associated with depression and anxiety that has required long term treatment. Additionally, patients have become less compliant and adherant to their HIV antiretroviral agents and are thus at risk for resistance to current therapy and can also spread resistant virus. From my experience, after patients have corrective treatment for facial atrophy, they become more stable, improved quality of life, marked less depression and anxiety and are more apt to return to work from their dissabilities.

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[PHI Redacted] I am editor of a national HIV publication, Postively Aware, and in my line of work I recieve countless letters and emails from individuals all over the world who suffer from the same condition, many of them unable to even leave their house, look for a job or maintain friendships because of the crippling stigma attached to this condition. Please make these treatments affordable so that [they] can once again become contributing members of society, and not have to fear being seen in public.

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February 12, 2009

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed national benefit category analysis (NBCA), Reconstructive Treatments for Facial Lipodystrophy Syndrome. America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 health insurance plans providing coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
The determination of which benefit category is appropriate for reconstructive treatments for facial lipodystrophy syndrome (FLS) is a complex issue, as FLS is a direct result of an effective, life-saving treatment (anti-retroviral medication) for the treatment of Human Immunodeficiency Virus (HIV).

According to the Medicare Benefit Policy Manual, reconstructive treatments for FLS would be considered a cosmetic procedure by CMS. Reconstructive treatments for FLS are not permanent and will require multiple sessions/treatments after the condition develops, for the life of the patient. Before CMS should reconsider FLS under their reconstructive surgery policy, it would be helpful if CMS develop patient selection criteria to delineate which types of treatments (surgery or injectable fillers), how many and how often treatments should be covered per patient. This would help CMS determine if the side effects of this life-saving treatment negatively impacts a patient's health status and ability to function in society. At this time, AHIP is unable to comment on facial reconstructive treatments for FLS as a non-cosmetic procedure, without additional information as suggested above.

Thank you for the opportunity to provide comments on this issue.

Sincerely,

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I feel strongly that these treatments should be covered. I have worked with hundreds of HIV positive individuals in support groups over the last three years, many of whom have had to deal with facial lipodystrophy. Although this is a condition that casuse facial disfiguration, there is also another issue at stake. One''s right to disclose there HIV status is seriuosly jeopadized, being that having this condition is a dead give away of one''s positive status. It is also my professional opinion that facial lipodystrophy is associated with serious depression and anxiety, which tends to require long term treatment to correct.

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Reconstructive treatment for Facial Lipodystrophy Syndrome is not about cosmetics or vanity. Walking around in life with a sunken skeletal face covered only by a thin layer of skin hinders not only ones self esteem, but also ones ability to date, find employment, housing, and it is also a known visible sign of having Aids. This condition is caused by the very drugs that help save lives and in some cases manages this deadly disease.[PHI Redacted]

I urge you to visit Lipodystrophy sites and look at the pictures of those suffering from this condition and then ask yourself, if you could function in society, date, find employment ect in this very condition that your are refusing to help us pay for it''s treatment.

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As a psychiatrist, I have seen many HIV patients whose facial wasting was severe, disfiguring, and a cause of stigma, depression, agoraphobia and other anxiety disorders. To call such cases cosmetic rather than reconstructive is to misunderstand the severity of what many sufferers of this syndrome experience.The appearance of this disfigurement is such that it affects social relationships and employment potential. For employed individuals, their on-the-job experiences are affected by their coworkers reaction to their disfigurement, resulting in poor work satisfaction.The face represents who we are as no other part of the body does. When it is disfigured, the impact on one''s functioning can be profound.I urge you to cover treatment for facial wasting related to HIV disease as the reconstructive procedure it is. The alternative is to tell these sufferers that their life-changing disfigurement is something trivial a cruel topper to an already cruel disease.

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I am a primary care physician that has been active in the care of HIV patients since the mid-80''s and have seen many changes in the treatment of HIV disease. Unfortunately, the use of HAART or just the disease process itself casuses Facial Lipodystrophy Syndrome. This is a debilitating condition causing depression and anxiety, which at times needs to be treated with additional medications at additional cost. HIV/AIDS patients take enough medications without having to treat associated diseases (like depression and anxiety) caused by disfiguring side effects of the medicatons or HIV disease itself. I support CMS recognizing Facial Lipodystrophy Syndrome and reimbursing for reconstructive treatments for this DISEASE.

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I''m writing in response to an article in POZ/AIDSmed.com. Living in NYC, people are more used to seeing walking skeletons on the street. After reading the AIDSmeds.com article, I was brought to tears some of the comment from small-town AIDS survivors. Depression, suicidal thoughts, being homebound from low self-esteem, and the MOST importantly lack of getting any part time work (in this economy!) I''m in agreement with two other comments: Artefill is the only permanent solution for AIDS wasting, NOT Sculptra; secondly whoever said “try telling a women with breast cancer that her artificial boobs are “cosmetic” and not covered!

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With an HIV/AIDS diagnosis over a number of years, lipodystrophy can be severe and cause disfiguring facial fat loss. The condition can provoke people to stare in public and children point and ask their mothers to explain. Further, it leaves the patient wanting to seclude themselves. Self esteem all but disappears along with any connections to one''s local community and support networks. Treatment of this condition is an extreme financial burden but left untreated the patient is often discriminated against in housing, employment, restaurants and the ordinary activities most people take for granted. This is not simply a matter of cosmetics and vanity, it is also about the face we present to the world and the positive outlook that is so necessary in fighting the underlying disease.

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Dear CMS ,

Please let me introduce myself. My name is Gregg Cassin [PHI Redacted] I am the chairperson of the national AIDS service organization AIDS, Medicine and Miracles. (Please see the below websites for more information.)

My letter is regarding the issue of the thousands of people dealing with the horrible and disabling condition of lipoatrophy/lipodystrophy. A decade ago California State Assembly Bill AB 1621 was amended (in 1998) to give people with HIV who are suffering from facial wasting the same right to insurance paid reconstructive procedures as a woman having a mastectomy. The goal was mandating that insurance companies see facial wasting and other HIV disease and it''s medications side-effects as disfiguring, life-altering conditions that should be treated. As with breast reconstruction, insurance companies had seen facial wasting and other lipoatrophies/lipodystrophies as purely cosmetic. Years later we have come to understand the devastating effects of these conditions causing increased occurrences of depression, anxiety, isolation, and even suicidality.

My own personal experience living in San Francisco''s Castro district tells me that few people know about this bill and fewer are benefiting from it. I''ve asked several doctors, case-managers and social workers about insurance coverage of facial restoration treatments and almost all give the same response- ''Insurance won''t pay''. It''s troubling that few know about the bill, follow up with any questions, nor request more information from me. It seems that it is hard for most people to even believe that there is such a bill. It is troubling to me that this issue continues to not be addressed by doctors, HIV advocates/activists, the HIV/gay media nor ''filler'' companies. This makes this treatment only available to the wealthy few that can afford to pay out-of-pocket. Sadly, I know of only three people that have gotten it covered by insurance - one by Medi-care, one by Kaiser, and one by Blue Cross. All three were several years ago. I think this is incredibly unfair that there are so many truly suffering from real depression, anxiety and worse that results from this condition. I''m appealing to you for some assistance in getting this issue addressed so that the people that are surviving this epidemic can get some real help. I''m trying to build a coalition of supporters to move this issue forward and ensure insurance coverage of these necessary treatments. Please respond as soon as possible. Thank you very much.

www.aidsmedicineandmiracles.org
www.greggcassin.com

AB 1621

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Date of Hearing: February 25, 1998

AB 1621 (Figueroa and Leach) - As Amended: February 19, 1998

SUBJECT : Health care coverage: reconstructive surgery

SUMMARY : Requires health insurance and HMO contracts to cover reconstructive surgeries. Specifically, this bill :

1) Provides that health care service plans and disability insurers that cover hospital, medical or surgical benefits, including entities that provide Medi-Cal coverage, shall cover reconstructive surgeries.

2) Defines "reconstructive surgery" as surgery performed on abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease if the surgery will either improve function or give a patient a normal appearance.

EXISTING LAW :

1) By regulation promulgated by the Department of Corporations (DOC), requires health plans to cover all "medically necessary" services.

2) Requires health plans to cover reconstructive surgery following a woman''s mastectomy.

FISCAL EFFECT : Potentially modest increase in costs to Medi-Cal for coverage of cases falling within the bill''s parameters. May involve some additional, absorbable costs for enforcement.

COMMENTS :

1) Purpose of the bill : The authors introduced AB 1621 because managed care organizations have been refusing to cover surgeries that would have corrected serious physical deformities in patients, often children. The rationale used by the plans was that reconstructive surgery was not medically necessary because the person could continue to function without having the surgery.

2) Background : At an informational hearing, convened by the Assembly Insurance Committee, evidence showed that managed care organizations have been relying on a narrow interpretation of existing law, which requires them to cover only services that are "medically necessary." This term is undefined, and is thus subject to varying interpretations. While the DOC often reads this language broadly, some health plans argue that unless a surgical procedure is needed in order to restore a patient''s bodily function, it is not necessary in a medical sense.

AB 1621

Page 2

This "bodily function test" can have cruel repercussions. For example, a young child born without an outer ear was denied surgery that would have created a visible ear structure. Because the child was deaf, the HMO argued that surgery would have been "cosmetic" rather than medically necessary. The plan argued that the reconstructive surgery would not have

http://www.calhealthplans.com/4legislation/regulations_laws_1999_2005.pdf

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Lipodystrophy is a term that includes 2 conditions, one - lipoatrophy - caused by medication to treat the human immunodeficency virus infection (HIV), the other - lipohypertrophy - a result of a "return to health", caused by normal or over-nutrition, and not generally associated with any specific medications to treat patients with HIV.

Lipoatrophy causes gross disfigurement of the face by loss of subcutaneous fat. This almost always occurs in those patients who are very adherent to their medications that treats HIV infection. Lipoatrophy is a direct cause of taking antiretrovirals as directed. Lipoatrophy is an adverse event, such as nausea can be an adverse event caused by taking certain medications. The treatment of nausea may include using other medication to prevent nausea. This treatment would be covered by health insurance.

The treatment of lipoatrophy should be covered by health insurance, including medicare. Using facial fillers, etc., to treat lipoatrophy is no different from using other treatments to treat adverse events caused by approved, standard medications to treat other conditions.

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Reconstructive Treatment for Facial Lipodystrophy Syndrome is medically necessary. FDA approved treatment for AIDS causes facial disfigurement to the degree that reconstructive surgery is required to correct it. This is not cosmetic surgery to enhance your appearance or fill a wrinkle. It is the use a larger than normal volume of an FDA approved product to correct the sagging folds and cavernous indentations left behind due to loss of body fat in the face.

I see it as similar to a women who undergoes breast reconstruction after having mastectomy to treat cancer. The treatment of the disease causes a disfigurement that requires surgical correction.

Facial wasting is devastating to the individual in that it affects all aspects of life. People who previously knew you no longer recognize you. It affects self confidence, self worth, ability to interact, and can lead to isolation and depression.

Anything you can do to help individuals over come this terrible affliction would go a long way to enhancing their quality of life for which they are truly fighting a never ending battle.

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I feel very strongly that this is NOT a cosmetic but a health procedure just as reconstructive breast post-cancer surgery is. [PHI Redacted] went to Canada (Toronto) in June 2006 to have bio-alcamid injections performed by Dr. Francis [PHI Redacted]. This procedure was not yet FDA approved, or rather the product wasn''t. It still might not be for all I know but sculptra and other products are FDA approved and I believe PMMI is under active consideration. [PHI Redacted] This condition is disease and treatment caused so it seems that any treatment that can alleviate or correct it (as with cholesterol meds which [PHI Redacted] never had to take before becoming HIV+) should be covered as a matter of course because of its unhealthy side affects. [PHI Redacted] Please cover it for all who are afflicted by this devastating condition. There is only so much stigma a person can endure before s/he gives up.

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It is very important that the government provide financial assistance for individuals who physiologically as well as psychologically suffer as a result of lipoatrophy due to certain medications used for the treatment of HIV/AIDS. Simply having the virus is bad enough, but add to that the side effects of treatments, lipoatrophy being one of them, and the astronomical cost associated with treating the side effects, it''s enough to make a person sink into a deep depression. Many individuals who are currently dealing with this awful loss of fat have become reclusive and hopeless because they lack the resources needed to get appropriate treatment. One can only wonder why there haven''t been more suicides because of this dreaded condition. Financial coverage by governmental agencies to treat lipoatrophy for persons affected by it due to HIV medications would go a long way to restore to them a more decent quality of life. Perhaps then private insurance companies will follow suit. This is not merely a cosmetic correction, it is a matter of physical and mental health. Please forge ahead swiftly to make this available. Thank you!

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I''m a physician and I have interacted with HIV positive individuals both professionally and personally. The social stigma and the emotional toll and burden secondary to facial lipodystrophy could never be overstated. The anxiety, anguish and impact on self esteem are immense. It is imperative to facilitate access to available treatment in order to, amongst other things, reduce the greater risk of suicide associated with facial lipodystrophy. I would urge in the strongest possible terms to cover such treatments under Medicare and Medicaid.

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As a nurse working in a Ryan White funded HIV clinic, I have seen many patients who are living longer and healthier lives with HAART. We are all trying hard to diminish the stigma related to this disease. However, many patients suffer with the scarlet letter of this disease - facial lipodystrophy. They are still identifed with "the face of HIV". To make things worse, most of these patients have financial hardships. As such, the average patient is unable to pay for these reconstructive treatments out-of-pocket. These folks are not especially vane, but rather simply do not want to be stigmatized by the way they look. Please pay for this service!!

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The importance of treating facial fat loss as a side effect of antiretroviral drugs to control viral replication among the HIV+ population cannot be overstated.

[PHI Redacted] While the metabolic abnormalities associated with long- term drug use are common ([PHI Redacted] developed diabetes from long-term use of the blood thinner, Cummadin, what was new was the severe facial wasting associated with HIV-drug lipid changes. The body no longer burns fat as its source of energy. Instead, the body stores fat in obscure places (the back of the neck, under the chin, the gut) and the blood (thus the elevated cholesterol and triglycerides), and burns lean body mass as its source of energy.

This results in an emaciated face, stick-like arms and legs, and a deflated buttocks, and the loss of fat on the bottom of the feet. Walking becomes painful, even crippling without expensive inner soles. Sitting even for short periods becomes uncomfortable, without adequate cushion (forget about a long bus or train ride on plastic seats), and wearing shorts, t-shirts, or bathing suits becomes embarassing.

Most debilitating to the spirit and psyche is the loss of fat in the face. Deep crevises, dark shadows, long sunken valleys in places where the face would ordinarily be full, punctuate the face, making it painfully uncomfortable to look in the mirror or be in public. [PHI Redacted]

Who among long-term survivors, who, [PHI Redacted] are unable to work or have lost their jobs due to inability to perform, can afford to pay for fat replacement therapy to reconstruct the debilitating effects of this horrific side effect? [PHI Redacted]

In most cases, insurance companies and state- sponsored medical assistance programs coverthe costs of treating severe side effects of life- saving medication. It is only fair and logical to extend the same policy to those who suffer from facial wasting.

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[PHI Redacted] I strongly feel that this should be covered. This is not a cosmetic procedure but a procedure to restore what the disease and the harsh treatment regimens have taken away.

This problem is a very serious psychological and physiological issue that unless you are experiencing it then you have no clue as to the debilitation one suffers from this horrible syndrome.

I urge you to understand that this is a serious issue facing HIV/AIDS patients[PHI Redacted]. This is NOT about looking good but about LOOKING NORMAL AGAIN!

Please vote to include this in what medicare will approve for payment. This will significantly impact the lives of thousands of people living with this terrible disease and the effects such as Facial Lipodystrophy.

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In today''s society where other human being are so judge mental of other people, why wound you want to deny this procedure for facial lipodystrophy treatments and reconstructive surgery!... I strongly feel this treatment and surgery is necessary for a person healing process. People do not need more distress in their lives. Unhappiness, depression and low self esteem goes against a person trying to live a healthy life, whether you have HIV or not. I thought the idea is to provide a person with all the treatment and support they need.

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At my HMO there is a 6 month waitlist for Lipodystrophy treatment for patients who cannot afford the normal charge. The wait is worth it and patient is scheduled in on Plastic Surgeon "slow " days and just the usual co-pay is charged. 6 month follow-up visits for a tune-up with Sculptra may be required. Often no treatment is necessary. Results not only make the patient look better but also feel better thus minimizing depression and the inevitable non adherence to Rx especially important with HIV multi drug regimen.

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The effects of lipoatrophy are frequently high impact on patient''s lives. Sequelae include major depression, altered self-image and extremely negative reactions from the public and co-workers as these patients look gravely ill. Current treatment regimens to treat facial lipoatropy in particular can often reduce or alleviate depression as well as increase positive reactions from the public and co-workers saving the government large sums of money currently used for counseling, antidepressants and unemployment(due to negative workplace reactions to lipoatrophy). Treatments can provide long acting results with substantial benefit. Patients seeking lipoatrophy treatment are beyond simple enhancements to appear youthful.. they are seeking reconstruction(facial) to treat the appearance of the gravely ill or dying.

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To whom it may concern:

[PHI Redacted]

I know of several people, however, who gave up on their life-saving medications because of the unnatural changes in their appearance. They are all gone now. I also know that additional people have done and are now doing the same thing. They have made choices that I would not have made for myself, but I can understand their motivation.

Treating facial wasting is not simply a matter of cosmetics. For many, it is a lifesaver. For others, it is a ticket out of clinical depression. And for still others, who work in the many areas of our economy where appearance is important, it can be a ticket to a productive and meaningful job. Simply put, Medicare should cover the costs of these treatments.

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[PHI Redacted] has been diagnosed with HIV Aids since the late 1980s. He has Lipodystrophy Syndrome and has benefited from treatment. Prior to treatment he was extremely self conscience and now does not exhibit the visual symptoms of the syndrome. Fortunately he was covered by government agencies for the cost of the medication (he had to pay the physician for each treatment to date over 10 spanning a multi-year period).

This treatment is as important as the daily medications that HIV Aids patients must take. It is my opinion that, like the daily medications, this drug be offered at deeply discounted prices (or free for those who cannot afford it).

Self esteem is as important as physical health and this treatment can greatly magnify self esteem.

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I feel that their should definitely be medicare coverage for those with AIDS-related facial wasting pursuing procedures to reduce or eliminate facial wasting.

The rationale is that many people that are afflicted with this sypmptom may be able to perform in normal work life, etc. but are shunned or turned away due to the fact that colleagues may brand them as "sick" or "on death''s door" because of the way they look based upon cause & effects of the disease.

Since this is a cause & effect of the disease and does not happen unless the disease causes the sympton, I say that individuals should have this covered under medicare or Federal assistance.

Greg Foote

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Please consider coverage for lipoatrophy for individuals with Aids. Aids is stygmatizing and lipoatrophy is a dead give away to others that a person has Aids.

People just want their faces back. AIDS has gouged out their cheeks and it is obvious to everyone what they are suffering from. The treatment is usually beyond what an average American has to spend on reconstructive procedures.

[PHI Redacted]. People just want their faces back so they can try to lead a normal life.

Thank you for your time and consideration.

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I am writing on behalf of [PHI Redacted].He has been HIV positive for about 15 years or so and has been through more than most people go through in a lifetime.[PHI Redacted] I can see how this affects him in alot of different ways.It is not just something that you see in the mirror every time you look but something you are aware of 24/7,or at least every waking moment.Since his face is getting thinner I have noticed how he doesn''t look at him-self the same as before this started.He does get depressed because a dis-ability check will not cover even something minor to correct this problem.[PHI Redacted] These things affect a person alot more than anyone realizes.He is not the type of person who wants to look 20 again,he just wants to be able to look in a mirror again and see what he is used to seeing,and that is not a thin face.He is 6 ft.and weighs 220 so he would just like to be able to have a face that matches the body in a manner of speaking.This means it is somewhat about looks, but alot more about the state of mind he is in now.He doesn''t think of him-self the way he used to.We both hope than one day soon it will be possible to rid himself of some of the "belly" that is also caused by this disease.He eats as healthy as possible but it''s one of those things that comes with this disease.I and We are asking you to PLEASE consider this and a health problem and not something people want just to make themselves more attractive like cosmectic surgery is.

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I am very much in favor of having treatment for facial wasting covered by medicare/medicaid. [PHI Redacted]

[PHI Redacted] Most of the people I''ve known that have had to deal with wasting are moderate to low income and do not have the ability to pay for the treatments out of their own pockets. Since it is such a marker of HIV infection it may as well be the new scarlet letter "A" for aids. Leading to all kinds of social and psychological issues for the person affected.

I hope that the treatments will be covered and will allow many people to continue with as normal a life as they can with this disease.

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The fact that there is an FDA approved treatment for HIV facial wasting, but the procedures to administer it are not covered my Medicare is unconscionable. There is no doubt in my mind that certain anti HIV/AIDS medications cause lipoatrophy. The condition itself is very depressing and a strong psychological deterrent to adhering to medication regimens. With all the advances in anti-HIV medications, it is a shame that people struggle to rebuild their immune systems only to be scarred for life as a person who looks like they have AIDS.

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People living with HIV continue to face privacy violations, stigma and discrimination in their day to day lives. Our AIDS Law Project receives calls from people with HIV-related legal concerns, and we’re aware that people want to protect the disclosure of their HIV status from people they do not trust. Lipodystrophy, however, visibly discloses a person’s HIV status without their consent. We receive a number of calls from people struggling to have treatment for lipodystrophy covered by their insurance companies.

Privacy and disclosure are not the only reasons for people to seek out coverage for lipodystrophy; in our experience these procedures are medically necessary for people with HIV. We represented a young girl in Massachusetts when MassHealth refused to cover the removal of a buffalo hump. MassHealth claimed the procedure was cosmetic, even though it was recommended by her doctor as medically necessary. The buffalo hump grew on the back of the young girl’s neck to the point where she lived in constant pain and could not engage in many activities. Our AIDS Law Project represented mother and child in their fight for MassHealth to cover the surgery, and prevailed. In the end, MassHealth agreed to pay for the surgery.

Coverage for lipodystrophy treatment is a step toward providing equal access to health care coverage for people living with HIV. Children growing up with HIV and people living with HIV are living longer and longer with the virus. The additional medical complications that can result deserve to be treated like any other condition that requires a medically necessary procedure.

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Just like women can get reconstructive surgery paid for by their public or private insurance providers, so too should HIV-infected people receive coverage for payment to reconstruct their face or body after they take HIV medications that cause disfiguring changes in their face and torso. All these people did was take a medicine to help save their life. As a result they are thankfully alive but now must deal with the stigma that comes with facial disfiguration. Look at the photographs and witness for yourself the drastic changes that many people with HIV have had to deal with.

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Persons living with HIV or AIDS are dealing daily with medicatons that, although prolonging their lives, have marked and often extreme side effects among which is facial lipodystrophy syndrome. The appearance of facial lipodystrophy, as a result of depending on life saving medications, adds yet another stress factor into the lives of these individuals. This stress factor is the stigma of living with an HIV infection. Unfortunately, too many of our public are poorly informed about HIV infection, even this long into the epidemic, and facial lipodystrophy is a clear marker of the presence of this disease. In dealing with a disease that necessitates reaching out to others for support and healing, many with facial lipodystrophy instead withdraw from contact. Good mental health and personal interaction are vital aspects of a holistic approach to living well with HIV infection (or any disease), and any concern that may limit a person''s ability to cope daily with a disease needs to be addressed and treated. It is my opinion, shared by many medical providers, that it is imperative that we add facial lipodystrophy treatment as an essential part of the HIV treatment regimen.

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To those in charge of decision-making, especially the ones who are not closely affected by Facial Lipodystrophy Syndrome, Please consider the fact that this horrific disease is not an enhancement to one''s appearance. It is, at best, a procedure that helps one with getting back to what they looked like before, as much as possible. Thus, making this procedure a very neccesary one in the over-all care that all Humans are entitled. Please, before you make your vote, ask yourselves what your decision would be if you were poverty poor, and this was happening to your child. If we, as One Nation, deemed ALL our citizens as One, imagine what affect that would have on the lesser advanced societies. Signed, Citizen of One Planet
P.S. Please, if possible, do not remove content of message before posting!

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As a clinical pharmacist working with HIV-infected patients on a daily basis I am often involved in the management of HIV medication related side-effects. Unfortunately, Facial lipodystrophy is a side effect that most clinicians have been unable to manage despite the FDA approval if a few new therapies. Many of the patients we serve at Boston Medical Center are unable financially to afford such treatment and procedures. It is extremely frustrating as a clinician to know that patients developing Facial lipodystrophy are typically extremely adherent to their regimen, yet no options are available to help them manage this clearly demonstrated HIV medication-related side effect whcih typically occur in patients with excellent medication taking behavior. Facial LD is clearly associated with the unwilling disclosure of an HIV/AIDS diagnosis in our commmunities and the stigma associated with it is overwhelming for all patients affected by it.

As you may know, minorities in the US are at the fore front of the HIV/AIDS epidemic in this country. Yet, equity of care is far to be achieved. The lack of Medicare treatment coverage for Facial LD is yet another example of this inequality, yet its physical presentation and the stigma associated with it are ones that no human being should have to endure.

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I support coverage for these reconstructive treatments. I have known individuals with HIV-related facial wasting who have been stigmatized because others assume the facial wasting is a result of abusing illegal drugs. Let''s face it pardon the pun if we do not support facial reconstruction for long-term HIV survivors we are actually discouraging individuals living with HIV from adhering to their antiretroviral therapy. Any public policy that encourages treatment adherence is step forward in the quest to end the HIV pandemic.

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Please! consider covering treatment for facial lipo. There are numerous reasons as to why this should be done, which none of them have to do with vanity or cosmetic reasons. One''s quality of life improves, ex. going back to work, medication adherence, reduction of isolation, removing depression/sucidial thoughts. etc....If the CMS wants some physical proof of what facial lipo syndrome looks like, walk into any HIV or Internal medicine clinic and sit for ten minutes and one will be able to see this debilitating syndrome.

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[PHI Redacted] Part of our well being is how we see ourselves not just vainity but for self- esteem. When one can have a touch of surgery to help improve his/her look means a lot and can help with the healing process. It is another form of giving one HOPE. When they look in the mirror and see that their face looks so much better than before it definetly adds to that person''s self esteem.

I hope that CMS will go along with this part of the healing process so that an indiviual can have the self confidence to meet the public. The stigma of having this disease is very difficult to deal with and to add to that the "sunken in withdrawn cheeks" doesn''t help self esteem. [PHI Redacted]

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While I know how grateful one is to be alive and be reasonably healthy, having facial wasting can be the unfortunate, result of the bittersweet success of many HIV drugs all of which have side effects.

Sometimes side-effects subside or become tolerable over time which is a blessing. However; facial wasting is one extremely visible side- effect which doesn''t seem to go away or really become more tolerable. When one sees their face in a mirror or reflection, it''s literally like a kick in the face and dreaded reminder that "oh yea, just in case I forgot for one second, I have HIV". Not to mention when people seem to stare just a little longer, are they thinking, hmmm, I wonder why his face looks so hollow? Is it some type of illness? hereditary? cancer or god forbid, AIDS? Sometimes they ask, "have you been sick?" then motion with their hands to their cheeks indicating your loss of normal fat. [PHI Redacted] isn''t facial disfigurement important enough to have some help with reversing. if possible? I''m sure most folks would agree that always "looking sick", while it may not physically kill you, emotionally takes quite a toll. Thank you for considering offering help with this terrible side-effect, I''m sure I speak for all who share it and bare it.

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Thank your for allowing this discussion. Yes, Facial Reconstruction should be allowed when caused by Lipodystrophy Syndrome. Just as important, Liposuction needs to be allowed for Lipodystrophy Syndrome Fat Deposits.Usually at the base of the neck and sometimes around the organs. The procedure can be done through full surgery, however the cost is more than 100% of the cost of lyposuction. Why should a person have to pay $10,000.00 or more and spend several days in a hospital for a procedure that can be done as an out patient for about $4,000.00 or less?Thank you again, for listening and considering Lipodystrophy Syndrome as a covered illness.

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PLEASE include coverage for the reconstructive treatment of facial lipoatrophy/lipodystrophy in the treatment of HIV disease.

I am a licensed psychotherapist in California, [PHI Redacted]. I specialize in working with people with HIV. I was the Chair of the Los Angeles County HIV Mental Health Task Force for 10 years, including co-chairing their annual conference. I wrote a mental health column for Art & Understanding, America''s AIDS magazine, for 2 years. My website is full of articles at www.PozTherapist.com. I have treated hundreds of HIV-positive patients.

I can say for certain that lipoatrophy treatment is "reconstructive", not "cosmetic". It is vital to restoring the functioning, occupationally and functionally, of HIV-positive patients with lipoatrophy. It is vital to restoring self- esteem and a normal appearance. The productivity that is gained by helping these patients return to work and be functional in society far outweighs the cost of treatment with facial fillers.

[PHI Redacted]

I urge you, on behalf of everyone living with HIV, to cover these procedures in full.

Please contact me if you need additional testimony.

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As a Nurse Practitioner trained in Dermatology and HIV Medicine who has performed over 450 treatments of facial fillers ie) Sculptra, I can say without question that the psychological benefit of these treatments has changed my patients'' lives. For the first time many of them are getting out of the house and socializing; some are even re-entering the work force!

Since this disfigurement is a known result of the antiviral medications these patients took for years, I feel that the cost of correcting it should be a covered medical expense. Many of the patients qualify for the patient assistance program through the manufacturer of the product, but the cost of the procedure can be significant. This should be re-imbursed by the insurance company or covered by MediCare/MediCaid.

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As a health care professional I have too many times witnessed the devastating effect that lipodystrophy can have on an individual with a long term condition such as AIDS. Such effects are often a result of the progression of the disease as well as the very medications the patient is taking to manage the condition and its sequallae.

I personally feel that the injections for lipodystrophy; should be in some respect covered by medicare, if not entirely, in part; of course, some criteria should be put in place as to when it is necessary, what degree must it reach before injections are considered ...ect. In fact, it should be instituted as part of the treatment regiment to some extent on the basis I have suggested above.

Remember:that (side effects of some of the drugs do cause it) so like breast implants after mastectomy re:cancer or limb enhancement or prosthesis due to accident or cancer to name a few; the whole idea is to bring functionallity and create independent human being with self esteem that are a productive part of our society and not dependent of it. I personally wouldn''t fire a person whom look emaciated due to wasting if I were his or her employer; but I only represent a very small sample of the population; thus not statistically significant when it comes to popular beliefs.

Yes we need to make our law makers understand the impact that long term, chronic, debilitating diseases and their medications have on people who live with them day to day so they can bring about changes in the health care system.

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[PHI Redacted] It is absolutely clear that the disfiguring effects of facial wasting on on individuals already struggling with health complications and societal pressures, contributes to remarkably poor self esteem. Depression, and in some casessuicide . I know several individuals that have plenty of t cells and no viral load but have skeletal looking facial stucture due to the devastating effects of meds and virus.There is no doubt that it affects many aspects of "normal" life. People stare at them on buses, they often become agoraphobic, or struggle to get the exhorbitant amounts of money together needed to try and repair the facial damage.Also the current treatments are not all permanent so it becomes a constant challenge to find resources to keep up the treatments. It becomes a case of medications, food , and last of all , self esteem and appearances.For too long it has been consider merely "cosmetic"This is NOT simply a a matter of cosmetic appearance, there is far more at stake for the individuals suffering the disfiguring effects of Facial Wasting. often whether or not it is worth staying well.

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Please see www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1640

Department of Veterans Affairs VHA DIRECTIVE 2008-003

Veterans Health Administration

January 22, 2008

TREATMENT OF ANTIRETROVIRAL-INDUCED FACIAL LIPOATROPHY IN HUMAN IMMUNODEFICIENCY VIRUS (HIV)-INFECTED PATIENTS

on page 2 of this directive the following is a policy statement: "3. POLICY: It is VHA policy that eligible veterans with AIFL [antiretroviral-induced facial lipoatrophy] may undergo treatment for this disorder at VHA facilities, or be referred by VHA on a cost basis to outside facilities for such treatment, if it would improve the patient's mental health."

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It''s obvious from various studies that facial lipodystrophy is a side effect of various HIV medications and is in no way superficial or narcissistic cosmetic surgery. It can be horribly disfiguring and can be the cause of significant distress to the person affected. One of the most devastating effects is the depression caused by often blatant social stigmatism and ostracism, and the decline in self-esteem resulting from looking like you’re on death’s door. If a woman with breast cancer gets reconstructive surgery after a mastectomy then people with facial lipodystrophy should have access to its remedy.

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The changes of the facial lipodystrophy syndrome are, in large part, a side effect of medications used to suppress HIV. At the time when most cases developed, their occurence was unavoidable, as non-toxic medications were not available. Unfortunately, reversal of the changes is slow and incomplete. However, when they occur, they are a source of significant distress, which subtracts from the clinical benefit of treatment. While the problem may disappear in the future, currently affected patients would greatly benefit from reconstructive treatments.

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Reconstructive treatment for facial lipodystrophy syndrome as well as excessive dorsocervical fat accumulation (bufflo hump)should be covered by Medicare. These treatment are not "merely cosmetic," rather they alleviate conditions that contribute to isolation, poor self image, poor mental health, and opportunities for gainful employment.

As my plastic surgeon explained to me, facial lipoatrophy in the presence of central adiposity creates a discordant image to which people respond negatively, often on an unconscious level. Any attempt to reintegrate in the work force will be hindered by conscious or unconscious stimatization due to unusual, often freakish, appearance.

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I believe all treatment for Aids care should be cover by the government the sooner we get people into care the happier and healthy they will. People must stop using this illness as a barrier. Take good care of yourself and get , back To work you can do it if not, I will highly remind people get involved with they local Planning Body and let your voice be heard. Your silence will be your DEATH!!!! I am getting sick and tired people telling me that they don''t want people know they have AIDS. get over it .this is why we have the STIGMA!!!!!!!

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Recontructive treatments for facial lipodystophy syndrone in my opinion should be cover under our governments medicare program. Lets face it, plastic surgury is very exspensive and is noted to be a proceedure that is reserved primarily for the finantialy endowed social class. And,what we look like is important, right? "Face-in-point, these proceedures and treatments are done with the intentions of correcting what is an ideal image of impressions plus expressions''. More so when the canvous is the artist all in one. This may sound a little weird, but take notice of how things really work with approval and exceptence. Lets all look at this with a paint brush in mind and say to ourselves," how would I altimately wanna look when cremation make-up and special foundations are applied to make you your look". lastly and respectfully, she looked good, very peaceful.

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I am retired plastic surgeon and an expert on dermal fillers. Before the era of injectables, facial lipodystrophy was treated surgically with malar implants or custom made small silicone gel prostheses. Both methods were insufficient because the implants became visible during chewing.

Autologous fat grafting would be the ideal treatment. However, it will take another 2 - 5 years until it will be a reliable methodand can be recommended.

Therefore, the only treatment option today are semi-permanent or permanent dermal fillers. Satisfactory results can be achieved with Radiesse and Sculptra over a period of 9 - 18 months, only. The ideal filler will be ArteFill: it is permanent and FDA-approved but so far, no HIV-patient assisting program has been established.

In the eyes of a plastic surgeon, facial LDS is clearly a medical disease, caused by live-saving drugs, which cannot be avoided. These unfortunate men and women carry a stigma in their faces, which may be repulsive to others. Often, the psychological burden is unbearable. THis deformity has nothing to do with vanity and patients fly to Europe and Brazil to find affordable relief.

Facial LDS needs a reconstructive procedure with 10 - 20 mL of a filler substance, and often needs a second and third intervention. I am a strong promotor of the involvement of Health Insurers and our social network. Facial LDS is not the fault of the patient concerned; it is a problem of our society !

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Persons suffering from facial lipodystrophy are unable to put their "best face forward" to the world around them. The "D" class drugs caused this injury to occur. While these medications did save lives, the lives they left behind were left to deal with the disfigurement of ravaged faces. These faces, devoid of the natural fat pads that support the contours of the face appear to be old beyond their years, or horribly shriveled. Misery, heartache and shame are endured daily by these individuals.

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If anyone would consider this treatment as necessary for a child whether their own or not; then the obviously this treatment should be covered by Medicare & Medicaid. A sickly and skeletal face must be considered a complete detrimental health crisis. How can a sick person maintain a positive outlook with their illness. It is scientifically proven that a positive attitude and body image keeps a sickly person alive longer.

This must be approved and otherwise we are condemning all who may be afflicted with this catastrophic illness to more depression and a speedier demise.

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Dear Sir/Madame: Thank you for the chance to urge coverage for the treatment of HIV associated lipodystrophy. This condition is documented in our medical literature to be the cause of depression and great unhappiness. Any discussion with patients afflicted with this facial disfigurement will convince the listener of just how negatively it affects the sufferer. Disfigured patients withdraw; they do not work and they do not participate in society. This removes them from our economy and deprives them of lives worth living.

The treatment is very simple and effective. The condition is clearly disease related. Yes, it does make a person look better, but so does reconstructive surgery for congenital defects like cleft lip, and surgery for facial reconstruction after cancer removal and trauma. The benefits of these latter treatments are real and well acknowledged. How can we persist in denying medical care insuring a simple correction to facial lipodystrophy patients with disfiguring disease-caused deformity?

Please correct this injustice.
Dr. Ernie Manders
Professor of Surgery
The University of Pittsburgh Medical Center

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[PHI Redacted] It''''s very difficult to get by on a fixed income and to pay off these charges for the facial filler. I feel that this is a direct side effect from a medication/illness and that it should be covered. It affects your quality of life to have a freakisly wasted face. [PHI Redacted] I really think that this should be covered by medicare and medicaid. It''''s a matter of human dignity to have your face restored to a somewhat healty, non freakish appearance. Looking hideously wasted in the face has such a negative impact on the persons physcial and mental health. We need the helping hand of our government health system to correct this devastating condition.

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I feel the treatments for LDS should be covered by Medicare as well as all commercial/managed care insurances in this country. This consideration should not be based on the assumption that these corrective procedures are "cosmetic" but that they are a "quality of life" issue.

The medication a person takes to treat HIV/AIDS was approved by the FDA. They were told the drugs were safe and they have indeed slowed the progression of the disease and prolonged the life of users. However the now understood side affects of these medications, LDS, is causing tremendous psychosocial burdens and barriers to those living with the disease and the side effects of treatments. Avoiding looking in the mirror, refusing to be photographed and the isolation they feel causes nothing but fear and depression which eventually progresses to self-loathing.

They debate sometimes if stopping the medication and at least looking normal, although knowing they''ll pay the price in the end, is possibly the better way to manage their disease. Developing the "look" of LDS and the labeling society put on them already has severely affected job performances, friendships, relationships with family and their will to simply survive.

If insurances cover the cost of a double mastectomy AND reconstructive breast surgery, even though a woman has not developed breast cancer, and they don’t consider this “cosmetic” then it astounds me that treatment of LDS would be considered anything else.

It’s time we, as a society, did the right thing for this ever-growing population of sufferers, be they gay/straight, old/young, male/female, adult/child, black/white or brown. It’s the disease we should be fighting not the stereotypes those with the disease fight every day.

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I have never acted on public comments before but this one hits so close to home that I felt I have to. Medications in the fight of HIV/AIDS have come so far in the last 20 years that it has extended the life expectancy of individuals with this disease trememdously. I know many who have this disease and are living otherwise normal and healthy lives. Most I have talked to fear the day when Lipotrophy will begin and then it will significantly change the way they can live their lives. It is so much more than a treatment but also goes to the mental health of the individual, self esteem and quality of life for those living with this disease. I do hope and strongly urge you to include this as a covered treatment option for individuals with this and allow them to continue to lead a quality of life that all deserve to have until the end comes. Thank you for your consideration and trust for a favorable outcome for all that desperately need this treatment but cannot afford it otherwise.

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I have been treating patients for HIV-Associated Facial Lipodystrophy syndrome since 2001. I was the principal investigator of 1 of 2 US trials whose data was used in the approval process of the first FDA approved treatment for this condition. I testified before the FDA advisory panel and it was clear from that meeting that the treatment of this condition was intended to be reconstructive (restorative) rather than cosmetic. It is also my experience and opinion that the treatment of HIV-Associated Facial Lipodystrophy is NOT cosmetic in nature as these patients merely want their normal faces back and are not trying to look younger. Therefore, the treatments are not statutorily excluded by 1862(a)(10). As further evidence, the following information, including references, are added for your review in regards to the medical necessity of restorative treatment for the facial deformities that patients suffer from secondary to HIV-Associated Lipodystrophy: Facial fat loss is the most devastating aspect of this condition as it can not be disguised by clothing or other means. Although the exact underlying mechanism of HIV-Associated Lipoatrophy is unknown (1), the devastating effects of this condition are known (2,3). Patients suffering from this condition are at an increased risk of depression, socially withdrawn and potentially suicidal. Furthermore, patients have even stopped their life saving HAART therapy without consultation with their physician in an attempt to stop this side effect. The implications for mutations and worsening of patients underlying condition requiring more expensive treatments cannot be stressed enough. Treatment of HIV-Associated Lipoatrophy with Sculptra™(Poly-L-Lactic Acid) has been shown to improve anxiety and depression scores (4) as well as improve patient’s quality of life as measured by visual analogue scale (5).

1) Montessori, V. CMAJ. 2004;170:229-238.
2) James J, Carruthers, A. Dermatol Surg. 2002;28:979-986.
3) Martinez, E. Drug Saf. 2001;24:157-166.
4) Moyle, GJ. HIV Medicine. 2004;5:82-87.
5) Valantin, M. AIDS. 2003;17:2471-2477.
6) FDA Scientific Advisory Panel 3/25/2004 Washington DC

As for the statutory benefit, treatment of this condition clearly has been shown to improve the mental functioning for the malformed body member. Since mental and physical disease should be treated equally, this treatment qualifies as a covered benefit.

However, if CMS does determine that the statutory issues have been met and that treatment of HIV-Associated Facial Lipodystorphy is a covered benefit, then a new, more accurate CPT procedure code will need to be introduced. Otherwise, patients may not be able to access, qualified physician injectors as the reimbursement for the current codes do not either accurately address how these procedures are performed or do not adequately address the amount of physician work that is involved in doing these procedures.

Specifically, CPT code 21138, injection prosthetic material, is the closest current code. However, this code may only be used every 90 days and both FDA approved treatment options for this condition are performed at 30-45 days during the treatment series. The other code 11952-11954, injection of subcutaneous material, was developed for other conditions and again, does not adequately represent the amount of physician work that is involved in reconstructing the normal facial contours for these patients.

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I feel strongly that reconstructive treatments for facial lipodystrophy should be covered. This is a disfiguring condition that cannot be hidden. It is obvious to any onlooker. It causes emotional distress as well as physical problems. Also, it can lead to loss of employment. If breast reconstruction is covered - a condition which is not immediately obvious, and for which there are other solutions - it seems grossly unfair that women and men suffering fom facial lipodystrophy should not have access to reconstructive treatments.

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I am submitting this comment on behalf of the Disability Rights Network of Pennsylvania (DRN). DRN is a statewide, non-profit corporation designated as the federally-mandated organization in Pennsylvania to advance and protect the civil rights of adults and children with disabilities. Among other things, DRN works to ensure that people with disabilities have equal and unhindered access to government services and benefits.

DRN supports Medicare coverage for reconstructive treatments for AIDS-related Facial LDS because these treatments are not done for "cosmetic" reasons, but instead are necessary to make a positive impact on the quality of life for individuals with facial deformities or disfigurement caused by HIV and/or the medications they are using to treat it. Without reconstructive treatments for Facial LDS, individuals with AIDS are very likely to experience intense psychological distress that will affect their mental, emotional, and physical health. Consequently, these treatments should be considered, on the whole, a non-cosmetic procedure that is reasonable and necessary to ameliorate a condition caused by disease. Moreover, a lack of treatment for individuals with AIDS may lead to greater stigma and discrimination and ultimately prevent them from being fully included in all aspects of community life this is a societal cost that we cannot tolerate or afford.

Mark J. Murphy
Legal Director, Disability Rights Network of PA

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I think Dr. Cathcart states it very well and Irepeat his comments here adding that the effectsof Lipoatrophy are disfiguring and contributegreatly to intensifying psychological conditionssuch as depression, anxiety, social phobias andthis can increase isolation which re-intensifiesthe above. This lipoatrophy is directly caused byconscientious adherence to prescribed HIV medicaltreatments recommended and provided by Medicareand Medi-CAL. Covering this treatment may in factresult in SAVINGS to Medicare and Medi-CAL as thisvery effective treatment may directly reduce theneed for certain psychological treatments and willvastly improve the quality of life for thousands.

"Lipoatrophy causes gross disfigurement of theface by loss of subcutaneous fat. This almostalways occurs in those patients who are veryadherent to their medications that treats HIVinfection. Lipoatrophy is a direct cause oftaking antiretrovirals as directed. Lipoatrophyis an adverse event, such as nausea can be anadverse event caused by taking certainmedications. The treatment of nausea may includeusing other medication to prevent nausea. Thistreatment would be covered by health insurance.

The treatment of lipoatrophy should be covered byhealth insurance, including medicare. Usingfacial fillers, etc., to treat lipoatrophy is nodifferent from using other treatments to treatadverse events caused by approved, standardmedications to treat other conditions."

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Two [PHI Redacted] are in great need of reconstructive treatment for FLSyndrome. The process is not cosmetic, as it is replacing what was taken away, and helps the patients self esteem, psychology, and mental ability to face the challenges of their illness. Without it, mental anguish and stress increase, as well the symptoms visibly announce their illness, and exposes them to prejudice, isolation, and mistreatment in their daily lives- especially the workplace.

I highly support that it be covered in healthcare insurance, albeit carefully monitored, fairly and frugally administered. It will help prolong lives.

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Health care treatment should be as equal as possible. If a woman has breast cancer and medicare pays for reconstrutive surgery because the woman has been disfigured by a disease.

With aids, the same logic is true. One face is disfigured because of HIV or the drugs used to keep that person alive. A breast is always covered with clothing which allows the woman to mingle with people without everyone knowing she is disfigured. Not so with aids patients. Unless they wear a ski mask, it is very apparent that they are HIV positive.

The cost to inject facial fillers is much less than the cost of major surgery to reconstruct the breast. I believe medicare should pay for both or not pay for either.

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Please post. This revises HIV Medicine Comments posted on 2/9/09. February 10, 2009

E.L. Hambrick, MD
Lead Medical Officer
ReconstructionNCD@cms.hhs.gov

Re: Coverage for Reconstructive Treatments for Facial Lipodystrophy Syndrome

Dear Dr. Hambrick:

The HIV Medicine Association (HIVMA) is pleased that the Centers for Medicare and Medicaid Services (CMS) has opened the National Coverage Determination (NCD) process to the question of whether or not Medicare will cover reconstructive treatment of facial lipodystrophy syndrome (LDS). We believe that CMS should cover this as a medically legitimate therapy for a disfiguring complication of HIV treatment.

I am offering these comments on behalf of our more than 3,600 clinician and scientist members that are devoted to the field of HIV medicine and that provide HIV care and treatment across the U.S.

Reconstructive treatments for facial LDS are reasonable, medically necessary, and appropriate for patients with HIV/AIDS who have or are undergoing antiretroviral therapy (ART). Facial lipoatrophy (lipodystrophy) among HIV-infected patients in the U.S. is mainly attributed to the wasting effects of prescribed antiretroviral therapy, which includes a combination of potent medications. The effect on patients can be profound, and can severely compromise the strict adherence that is vitally important to the success of combination antiretroviral therapy.

Facial LDS is an iatrogenic disease for which treatment is reasonable and necessary for patients to maintain functioning. In most cases, treatment requires a series of injections of poly-L-lactic acid by a trained practitioner in a medical office. CMS should cover these treatments in patients with HIV/AIDS with appropriate physician documentation in the medical record.

The questions that you are considering to evaluate coverage as we understand it are:

1. Are these treatments statutorily excluded as “cosmetic surgery?”
2. Do these treatments fall into a benefit category?
3. Is the service “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member?” Sec. 1862. [42 U.S.C. 1395y]

We believe reconstructive treatment for facial LDS is not “cosmetic surgery” and that it meets the criteria outlined for coverage. We hope you find our comments compelling and that CMS will issue a national coverage payment policy for treatment of facial LDS in patients with HIV/AIDS.

Please contact us through our Executive Director, Andrea Weddle, aweddle@idsociety.org, 703.299.0915, should you require additional information or if we can assist you or CMS in any way.

Sincerely,

Arlene D. Bardeguez, MD, MPH
Chair, HIV Medicine Association

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I would like to thank the Centers for Medicare and Medicaid Services (CMS) for opening the National Coverage Determination (NCD) process to the question of whether or not Medicare will cover reconstructive treatment of facial lipodystrophy syndrome (LDS). It is essential that CMS should cover this as a medically legitimate therapy for a disfiguring complication of HIV treatment.

Nearly every medical organization that has examined the language of the governing regulation, including the American Medical Association, and the American Society of Plastic Surgeons, essentially defines “cosmetic” procedures as those that enhance a normal appearance, and “reconstructive” procedures as those that are intended to correct a deformity or disfigurement caused by injury or disease. By these definitions, surgery, including injections, for AIDS-related facial lipodystrophy is clearly reconstructive and not cosmetic (bearing in mind, of course, that surgery that is clearly reconstructive, such as breast reconstruction following cancer surgery, may confer a cosmetic benefit).

[PHI Redacted] I urge the CMS to approve the treatments for this condition as medically required and approve the treatment for payment by authorized medical providers.

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Dear Medicare Admin,

[PHI Redacted] I am writing to first thank you for all you do and have done for my medical coverage. Without YOU I would be in the streets for sure. My love of country, retiring from the Department of Veterans Affairs Medical Center in San Francisco is indeed the light of my life. Of my entire career, and three places I worked for 30+ years (I miss and a great loss to my self esteem and purpose, truly the last place at the VA was absolutely wonderful and the most rewarding of all my years in health care working with death and dying.

I would like to offer input on Reconstructive Treatment for Facial Lipodystrophy Syndome. [PHI Redacted] I personally receive and distribute all medical lab tests to other doctors as appropriate so as NOT to waste valueable resources that Medicare so ably offers. It is to my extreme gratitude to YOU and everyone who makes it possible.

[PHI Redacted]

I''''m fortunate to live in an area and have worked with many of my physicians in the past, that are highly trained, skilled, caring, and stay in close connection with practice at the University of California Medical Center (my first place of employment) even though we are in Marin County north of the Golden Gate Bridge. [PHI Redacted]

I urge you to consider this matter when deciding on Medicare coverage. [PHI Redacted]

Please consider this matter with compassion as well as budgetary restraints. It is important to me, YOU are important to me, and I will never stop singing your praises or expressing my gratituded from the very bottom of my heart.

Thank you in advance for your time and assistance.

Sincerely Yours,

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I believe the title that you chose to give this issue answers the very question at hand, ÒReconstructive Treatments for Facial Lipodystrophy SyndromeÓ. It is reconstruction of something taken away by disease, not a cosmetic surgery for vanities sake. Facial Lipodystrophy not only effects ones face, it effects your health physically and mentally. It also effects how you are treated by the outside world every day.I strongly believe that the Centers for Medicare and Medicaid Services should cover this as a medically legitimate therapy for a disfiguring complication of HIV.

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I am an infectious disease physician specializing in the treatment of HIV infection. For the last four years, I have been treating patients with HIV related facial lipoatrophy with facial fillers and have witnessed first-hand the dramatic improvement in quality-of-life that result from this treatment.

Facial lipoatrophy is a known metabolic complication of antiretroviral therapy.This medication related side effect has been clearly linked to decreased quality of life and its presence leads to a greater risk for nonadherence to life saving medication.Treatment with facial fillers, including FDA approved options such as Radiesse and Sculptra, has been shown to reverse the effects of HIV related facial lipoatrophy. There should be no question that coverage is warranted for this effective reconstructive procedure.

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[PHI Redacted]

When you look like a living corpse, it is very difficult to continue taking the very medications which cause the condition. Living with this condition becomes very much a nightmarish catch- 22 in which you take the meds to live, but taking the meds makes you want to die. [PHI Redacted]

I pray that the many thousands of Americans living with this condition will receive relief by receiving coverage for treatment. The cost savings to the country will be astronomical, and it is the right thing to do for humanitarian reasons. Please help end the suffering.

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February 12, 2009

The Honorable Kerry Weems
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1403-FC
P.O. Box 8013
Baltimore, MD 21244-8013

Re: Reconstructive Treatments for Facial Lipodystrophy Syndrome

Dear Acting Administrator Weems:

As President of the American Society for Dermatologic Surgery Association (ASDSA), a medical specialty organization representing over 5,000 physician members across the nation, I am writing to urge the Center for Medicare & Medicaid Services to cover reconstructive treatments for facial lipodystrophy syndrome under Medicare parts A and B. Clear precedence exists for the coverage of reconstruction when resulting from a medically necessary treatment of disease.

According to 1862(a)(10) of the Social Security Act, no payment may be made under Medicare part A or part B for any expenses incurred for items or services which are “not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” Likewise, 42 CFR 411.15(h) stipulates that among those services excluded from coverage are, “cosmetic surgery and related services, except as required for the prompt repair of accidental injury or to improve the functioning of a malformed body member.”

However, according to Medicare National Coverage Determinations Manual (CMS Pub. 100-03)§140.2 - Breast Reconstruction Following Mastectomy (formerly CIM 35-47), “While extirpation of the disease remains of primary importance, the quality of life following initial treatment is increasingly recognized as of great concern… The increased use of breast reconstruction procedures is due to…increasing awareness by physicians of the importance of postsurgical psychological adjustment. Reconstruction of the affected and the contralateral unaffected breast following a medically necessary mastectomy is considered a relatively safe and effective non-cosmetic procedure. Accordingly, program payment may be made for breast reconstruction surgery following removal of a breast for any medical reason.”

In the case of facial lipodystrophy syndrome, reconstructive treatment should be considered medically necessary and therefore covered by Medicare based on the precedent for breast reconstruction following mastectomy cited above. Facial lipodystrophy syndrome, which occurs in HIV-positive patients taking highly active antiretroviral therapy, refers to abnormal fat distribution including both lipohypertrophy (fat accumulation) and lipoatrophy (fat wasting or loss). As stated in the enclosed article, “Facial lipoatrophy can be a physically and emotionally disturbing consequence of HIV associated lipodystrophy syndrome. Patients experiencing facial lipoatrophy report low self-esteem, depression, and stopping their [highly active antiretroviral therapy] HAART to avoid fat wasting and its psychosocial consequences.” (Mest, D; Humble, G; “Retreatment with Injectable Poly-L-Lactic Acid for HIV-Associated Facial Lipoatrophy: 24-Month Extension of the Blue Pacific Study,” Dermatol Surg 2009;35:350–359)

The psychological implications inherent to disfigurement due to medically necessary treatment also pertain to HIV patients suffering from facial lipodystrophy syndrome due to HAART. “The long-term psychological effects of injectable PLLA in the management of HIV-associated facial lipoatrophy were recently demonstrated in a followup study that used visual analog scales to record patient satisfaction approximately 2 years after initial participation in an open-label, single-center study. Results from the original study demonstrated improvements in patient self-perception, anxiety, and depression after treatment with injectable [Poly-L-lactic acid] PLLA that persisted and increased through the recall visit.” (Mest, D; Humble, G.)

There are several different approaches to reconstructive treatments for facial lipodystrophy syndrome, which may be considered under Medicare part A (such as surgical facelifts) or part B depending on the treatment provided. Because treatment of facial lipodystrophy syndrome using dermal fillers can be done safety and cost effectively in an outpatient setting, it would be appropriate to cover this type of treatment under Medicare part B.

Thank you for your consideration. Should you have any questions, or wish to discuss this issue further, please do not hesitate to contact Director of Advocacy and Public Policy Lisle Poulsen at (847) 956-9126 or lpoulsen@asds.net.

Sincerely,

Robert A. Weiss, MD
President

cc: Jeffrey Dover, MD, FRCPC, President-Elect
Richard G. Bennett, MD, Vice President
David Goldberg, MD, JD, Secretary
Christopher J. Arpey, MD, Treasurer
Darrell S. Rigel, Immediate Past President
Katherine J. Svedman, CAE, Executive Director
Lisle Poulsen, Director of Advocacy and Public Policy

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[PHI Redacted] NOT for cosmetic reasons AT ALL. This is about SELF-ESTEEM, this is about not looking like a skeleton with skin stretched over your bones. Because of the meds, many people are affected, feeling OK about how one looks is KEY to moving the patient off of themselves and enabling them to spend their energies on prevention, adherence and regaining a quality of life that can learned to enjoy once again. [PHI Redacted]

It is NOT just the face that suffers. MEDICAID, MEDICARE AND PRIVATE INSURANCE SHOULD COVER THE COSTS OF THESE TREATMENTS. THEY ARE IMPERIATIVE FOR MANY PEOPLE TO HAVE A CHANCE AT LIVING AND NOT JUST EXISTING IN A SMALL CUBILE SOMEWHERE ALONE. Thank you.

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[PHI Redacted] I work as the Prevention for Positives worker at my local ASO and have spoken to numerous of clients who have expressed self-esteem issues regarding wasting caused by the medications that they either have taken in the past or are currently still taking. I’ve spoken with a new client earlier this week who has informed me that he did not want to start ARV medications because of the wasting associated with them. Funding by the Federal government and/or Pharmaceutical companies and coverage by insurance companies for this as a reconstructive procedure would make a direct and tremendous impact on the self-esteem issue, which in turn greatly affects a person’s medication adherence, quality of life, and a future outlook for anyone who is HIV Positive or an AIDS Diagnosis.

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From 2004-2008 I was the regional Part B medical director in California. We received occasional claims for repair or restoration of lipofacial dystrophy and I believe on a case by case basic we found them to be primarily within a cosmetic category and therefore unavailable for coverage as medically necessary to a body part''s function. There are a number of parallels to puzzle through.

(A) Facial aging may be disfiguring and cause psychological distress, but procedures like eyelid surgery are covered only when a sagging eyelid occludes vision, a clear functional disability. Numerous Medicare LCDs and private payor LCDs use this standard for eyelid surgery. (B) On the other hand, amelioration of some abnormal disfiguring conditions clearly qualify for medical coverage, such as facial reconstructive prostheses after cancer surgery of the jaw or side of face. (B) A brief NCD deals with breast reconstructive surgery, which may also be linked to psychological distress but not a direct functional disability. The NCD rules this is a non-cosmetic benefit by the direct statement that post-mastectomy, or contralateral, reconstructive surgery "is considered a noncosmetic procedure." (NCD 140.2) The NCD suggests the determinative feature in practice is less a reference to the statutory phrase, a malfunctioning body part, but rather whether on the whole a surgery is "considered a noncosmetic procedure," a viewpoint which could change depending on circumstances or the decade.

Therefore, the decision for lipofacial dystrophy becomes whether it is more like (A) facial aging - distressing but non-covered without a clearcut functional impairment - or more like (C) mastectomy reconstruction, a service to ameliorate a change caused by disease which is "considered a noncosmetic procedure."

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I believe that each person deserves to look as normal as they can. The present system with sculptra works for a year at best. In America you are only allowed to use sculptra as a filler for places on your face and body that need reconstruction from the Hiv virus and the meds [PHI Redacted]

In most cases I have seen it starts disolving away from your face in less than a month.Then you have to go through this process again to get similar results.

In Mexico you can get at a higher initial expense, a treatment with pmma which is a permanent filler to put in areas that need reconstruction where your body has been affected by the virus and medicine [PHI Redacted]. There are pictures i have seen where you can not even recognize the person before and after the treatment.

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As I Am Board-Certified in Internal Medicine, Infectious Disease, and a specialist in the care of HIV From the American Academy of HIV Medicine approximately 1200 patients with HIV disease. Lipodystrophy of the face, neck, and upper back( Buffalo Hump) is in no way cosmetic. I have at least 6 patients on the verge of Respiratory Obstruction. In Many Cases, is extremely dense adipose tissue that needs to be removed as a large mass. In no way is surgery to correct lipodystrophy in HIV cosmetic in any way. In some, it will become a surgical necessity. These patients, otherwise, lead productive lives working, contributing to Society, and do not ask for anything. It is about time that they receive proper treatment, that is not cosmetic but necessary to prevent long term disability in order to continue to function.

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Reconstructive treatments for facial lipoatrophy syndrome should be considered reconstructive in nature and consequently covered by Medicare. Although Medicare reasonably excludes coverage for cosmetic procedures, this exclusion is deemed not to apply to reconstructive procedures such as "surgery in connection with treatment of severe burns or repair of the face following a serious automobile accident, or to surgery for therapeutic purposes which coincidentally also serves some cosmetic purpose." (quotes are from the Medicare Benefit Policy Manuel.) Clearly, facial lipodystrophy syndrome is caused by a disease process and is as disfiguring and distressing to the person affected by it as a burn scar or the loss of a breast are to persons affected by those conditions. A survey of people affected by facial lipodystrophy syndrome has found that it restricts them in all areas of life, from socializing to employment, and many have in fact considered suicide. As a benefits advocate for people with HIV for more than 10 years, I can attest to the profound psychological effect facial lipodystrophy syndrome has on people affected by the condition, many of whom have withdrawn from most social interactions. Medicare ought to cover reconstructive treatments for facial lipoatrophy syndrome just as it does for breast reconstruction and for surgery to restore normal appearance after a burn.

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As a psychotherapist working in San Francisco I have the opportunity to see the impact of "facial filling" first hand. I do work with a support network of about 400 persons with HIV. Because one of our larger local HMO''s has chosen to cover facial filling in their plans, there is a visible distinction between those who have access to Sculptra and those who don''t (Of course there are those few who can pay several thousand dollars out of pocket to obtain it).

The difference is enormous. I believe a very simple study would demonstrate how the deep furrows that mark the faces of those who don''t have access to this medication enhance isolation, negative self talk, depression, lower self esteem - all things I have noticed firsthand. Rare is the person who can continue to go about their daily activities and feel good about him or herself with a face damaged by a disease that continues to terrify people.

In our case nearly all of the people I see are gay people for whom disproportionately higher incidences of anxious/depressive symptoms (insomnia, alcoholism, migraines, suicidal ideation) have already been well documented. It is clear to me that the financing of facial filling can only have a positive impact on the quality of life of people living with AIDS. From a public health perspective the improvement in self image that it engenders can mean better compliance to other medications, better self-care, less damaging behaviors.

Also I encourage the panel to investigate another procedure which is the use of the patient''s centrifuged belly fat as filler. The down side of the artificial fillers is the need to re-inject them as they get metabolized by the subject. This need tends to slow down over time. The use of the patient''s own belly fat has been used with very good results which are far more long lasting than the artificial fillers.

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I say all insurances should absolutely cover the costs of Facial Lipodystrophy, especially of the facial area. [PHI Redacted] experienced severe facial wasting due to anti-retroviral therapy. He finally paid to have several rounds of Sculptra at a cost of over $5,000.00 out of pocket which luckily he could afford. He previously refused to even allow his picture to be taken for years. Besides turning you into a sitting duck for te prejudice of individuals out there, it is obvious to even the general public at some point you are infected with HIV and/or AIDS. This can lead to bodily harm and severe depression, low self esteem just to name a few. To anyone who indicates it is purely cosmetic, I can assure you while I don''t see how you can say it is not part cosmetic, it is also very necessary to avoid many other problems associated with HIV and AIDS. We are not talking about some 65 year old woman who would like higher cheek bones or less wrinkles around her eyes. It is a recognized side effect of the drug therapies currently offered not simple aging ! I would further suggest a portion be charged to the drug companies since we need to hold them accountable, perhaps they can provide it from some of the many billions of dollars they are raking in from profits from these same drugs.

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Reconstructive Treatments absolutely must be covered by insurers and Medicaid/Medicare. FAcial Lipodystrophy Syndrome is a debilitating side effect of HIV/AIDS. Would you deny reconstructive surgery to women who is living with the aftermath of breast removal due to cancer? I think not. Try telling a women after breast removal that her reconstructive surgery is merely "cosmetic" and therefore is not covered. Wasting syndrome/Facial Lipodystrophy Syndrome as a result of HIV/AIDS is disfiguring both mentally and physically. Morally is should be covered by health care insurance.

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[PHI Redacted] This effect of the drugs he has to take has been one of the most mentally debilitating for him. He gets very depressed the more and more his face seems to sink in. He would do just about anything to be able to have some type of treatment done that would bring him back to even a semi-normal looking face for him. He is simply crushed every time he looks in the mirror and the more time wears on and the more his face sinks in the worse he gets depressed about it. He feels like every one on the streets can tell he has this disease and that they are judging him because of it. I believe these depressions weaken people almost as much as the physical affects of this disease. I think the quality of life would be so much greater for anyone who has this if this type of coverage were available for them.

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[PHI Redacted]

The main issue was whether the drugs, particularly Protease Inhibiters were the reason for the lipoatrophy or whether having HIV caused the condition. There is overwhelming evidence that such HIV medicatons do cause fat loss and such fat loss in the face can result in social stigma, rejection, depression, anxiety, and the inability to work in certain professions that require a "normal appearance".

It''s my hope that Medicare incorporates treatment for lipoatrophy facial wasting as covered procedures, primarily based on the fact that California''s health and safety code authorizes such treatment. Medicare''s policy to deny coverage is in direct conflict with state law, and most HMOs violate this law by having willful disregard for a patient''s wellbeing by denying coverage by insisting it''s cosmetic when evidence shows that PIs cause fat redistribution.

By having Medicare authorize procedures for Lipoatrophy, many long-term survivors with HIV and covered under Medicare, and now in Medicare Advantage Plans - which are required in many states for patients to receive ADAP (Ryan White) Funding - can get the treatments they need beyond begging companies or doctors to co-share costs.

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I believe that the costs should be covered because facial lipodystrophy causes discrimination and low self esteem which lead to depression. I have known many people who have suffered from degradation and have even seen anecdotal discrimination occur in the workplace. Facial lipodystrophy increases bigotry and causes many people more shame and public humiliation. This often leads to depression and antisocial behavior which in turn could be acted out sexually. Other people may be put at risk.

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Facial lipodystrophy for HIV positive individuals is a life changing experience. You are no longer the person you were months prior to the obvious changes and you feel the mark of Cain upon you. Your concern becomes that everyone will know just by looking at you and then you face the discrimination , shunning, possible job lose, or inability to change jobs due to the "mark". If not out to families, then you worry on the lost "chocice" to come out to family as it is now so visible and no longer your option to tell or not tell family or for that matter anyone. If this is not a mental health issue, then I do not know what is. Facial restoration for the victim is a mental health necessity but typically not affordable and not covered by insurance. So you live with it. [PHI Redacted] Please consider funding facial restoration for lipodystrophy victims.

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People who need facial fillers due to lipodystrophy have endured a terrible stigma for a very long time now. In this day and age we should be very inlightened about the ill effects of previous treatment and not turn our back on those who can''t afford this life altering procedure. [PHI Redacted] It restores your life and dignity and shouldn''t we all be entitled to that. For the many who do not understand the discrimination because of how one looks with a diformity should make every effort to become informed. And base any dicision on the facts and not on old policies. Please do all possible to reevaluate and change the current policies regarding this proceedure.

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[PHI Redacted] Living with HIV is difficult enough without advertising it with the physical signs of HIV.

Denial of treatment for Lipodystrophy is the equivalent of denying a woman reconstructive surgery after breast cancer. Despite all the information to the contrary out their, people with HIV and particularly facial wasting are discriminated against everyday. Wasting treatments at least allow a person with HIV to go about ones daily life without feeling being judged, stared at, or scorned, whether these reactions are real or imaginary, the pain that these reactions cause a person with HIV are real to them. I believe that the mental health benefits of treatment for wasting alone would make coverage of treatment $$ justified, if quality of life benefits are not a strong enough reason for coverage.

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As a physician caring for patients with HIV/AIDS since 1984, I have an interest in this issue. Facial lipodystrophy syndrome is not a cosmetic problem. It is a medical problem the unfortunate consequence of certain anti-retroviral agents. The patient is severely disfigured, with an appearance not unlike that of a concentration camp prisoner. The cheeks are sunken, the bony structure beneath is visible, the skin is seemingly prematurely aged. The condition is not reversible. Even if a patient switches to a regimen not known to cause the syndrome, the symptoms do not reverse.

I would compare a patient with facial lipodystrophy to a woman who has undergone a mastectomy for breast cancer. Once upon a time reconstructive surgery for breast cancer was not covered because the condition was considered to be cosmetic. Facial lipodystrophy should be viewed in a similar way. Facial fat loss has significant psychological consequences for a patient. It is a stigma of HIV disease no other condition has similar manifestations. Patients are often embarrassed by their appearance and many suffer from depression as a result.

In recent years, a number of modalities have been developed to improve the appearance of patients with facial lipodystrophy. Most are safe and remarkably effective.

I hope that Medicare will recognize that Facial Lipodystrophy Syndrome is a real disease. Such recognition will lead to an improvement in the quality of life of patients with HIV/AIDS.

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CMS should approve a new benefit category for AIDS related lipodystrophy for three reasons:
1. LDS has profound physical, psychological and socially stigmatizing effects;
2. No safe alternative treatments exist to remedy LDS; and
3. Private insurers have recognized the medical necessity for, and are covering, the reconstructive treatment for facial LDS.

The drastic change in facial features, and ultimately mental state, can easily be corrected by safe, effective FDA approved treatments which are realtively inexpensive. Individuals can then lead "normal" lives and resume daily activities, free of the stigma of their appearance.

The only recourse for individuals who suffer from facial LDS is to refrain from taking their life-sustaining medications. This is not acceptable.

Several private insurers, especially on the West Coast, do cover reconstructive LDS treatments. Medicare should do the same, as restoring individuals with this condition to a healthy-looking visage will, in many cases, renew their confidence and ability to become productive citizens.

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[PHI Redacted] Facial wasting identifies you as having HIV and exacerbates the social stigma that the disease has with many in our society. It has been unclear whether the facial wasting is due to the disease or some of the drugs given to treat it or a combination of both.

I think that treatment for facial wasting ought to be treated as a reconstuctive procedure rather than a cosmetic one. It is a result of the disease and/or the some of the drugs used to treat the disease. If you are burned in a fire, your skin replacement is considered reconstructive, not cosmetic although it has some cosmetic effects. You are not doing it simply because of your looks, you are doing it because a disease has changed your looks. Would reconstructive work for the effects of leprosy be considered cosmetic?

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Gentlemen:

[PHI Redacted]

People whose appearance has been ruined by HIV will turn to anything that promises them a glimmer of hope to restore their face. [PHI Redacted]. HIV is a large enough burden to deal with health-wise, but the social stigma it brings makes it worse. [PHI Redacted] fortunate enough to be able to afford these costly treatments, but many people are not so lucky. Their finances doom them to a sickly appearance which negatively impacts their self-esteem and so their quality of life. [PHI Redacted].

Although everyone likes to think they judge people by "what''s inside", we know they don''t. People judge on appearances. Job offers are extended based on all kinds of subjective causes, and appearances are a major part. Thus, an otherwise-healthy person who suffers from facial wasting is at a competitive disadvantage when job hunting nobody wants towill hire someone they think is sick. This increases the likelihood that an HIV+ person will be unemployed, without support, and dependent on government assistance. It''s bad for society, but it''s also bad for self-esteem. Everyone wants to be self-supporting and feel productive.

Restoring someone''s face to approximate its pre-wasting appearance is not cosmetic. It is RESTORATIVE. Nobody expects to be more beautiful from facial filler injections, they just hope to look more "normal" again. HIV disease ruins faces. People just want it undone, not cosmetic improvements.

People who look sick don''t get job offers. People without jobs drain the system. People who look "normal" get jobs. People who get jobs can pay taxes. People who pay taxes can support themselves and contribute to society.

People with HIV-associated facial wasting who are unemployed or unemployable don''t help support themselves and don''t help society.

Please help people restore their appearance and their chances at a more normal life again.

Medicare should pay for facial restoration for people suffering from HIV-associated facial wasting.

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[PHI Redacted] That said, what IS the proper way to deal with facial lipodystrophy? If medicaid, medicare, or other healthcare suppliers for the non-insured are not going to fund reconstructive treatments for facial lipodystrophy, and if these agencies are going to continue to consider these procedures "cosmetic," then I feel that our government has AT LEAST an obligation to discover why facial lipodystrophy occurs and how to treat or prevent it in a non-cosmetic manner. People with HIV suffer on a daily basis from MANY debilitating ailments, yet many of our doctors fail to acknowledge these ailments as a direct result of HIV or antiretroviral treatment, and are still expected to be upstanding, hard-working citizens in our communities, and are expected to work and pay taxes. [PHI Redacted] The HIV-positive community DEMANDS better and dignified assistance for a better QUALITY of life [PHI Redacted]

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I have been a nurse (RN) in an HIV clinic for 18 years. I have seen alot. Most importantly I witnessed a dramatic drop in the death rate among my patients when better medications were introduced in 1995. Along with better medications came not only a chance to live, but many times disfiguring side effects. Treatment for facial lipodystrphy syndrome is no more a cosmetic procedure than breast augmentation following a mastectomy. I would not want a client to choose illness and potential death over taking meds that may cause disfigurement ssimply because their insurance company will not pay for proper treatment. Brian L. Taylor R.N.

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It is crucial that reimbursement be provided for facial reconstruction. Patients suffering from facial wasting lose motivation to comply with therapy putting them at risk for resistance and vastly more expensive treatment options. Depression and other psychosocial issues also further burden the healthcare system, in addition to worsening patient quality of life. Reconstructive surgery is provided without question to mastectomy patients, and the same standard should apply to AIDS patients with facial lipodystrophy.

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I believe Medicare/Medicaid SHOULD pay for the treatments for facial lipodystrophy in patients living with HIV/AIDS.

When a person living with HIV maintains "good" health, has bloodwork numbers that are excellent, yet is reduced to walking around with hollow, sunken cheeks...."the face of death" as it''s sometimes called, it takes a HUGE mental toll on the person living with HIV/AIDS. Some go into seclusion, some develop social disorders that require psychological treatment such as a fear of going out in public or severe depression, and others take the drastic measure of not taking their medicines because of the medicines inducing the lipo.

It should NOT be considered cosmetic surgery. People with HIV/AIDS are not asking to look younger, or more beautiful. Just normal. Without the attached stigma of living their daily lives outside the house with people pointing, staring and whispering.

I ask that the government PLEASE get involved and find a way to help those living with HIV/AIDS to pay for reconstructive treatments for facial lipodystrophy through Medicare AND Medicaid.

Most of those living with lipodystrophy are on full disability and have limited incomes and cannot afford to even see a qualified doctor, let alone afford the medication (facial fillers), OR even the cost for the treatment.

Please get involved and help.

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I am [PHI Redacted] the founder of FacialWasting.org and one of the founding members of the AIDS Treatment Activists Coalition (ATAC). I moderate the largest HIV health online group (pozhealth at yahoogroups.com), where I get a sense of what the main complaints of patients are around the world. [PHI Redacted]

1-Lipoatrophy- in the form of facial wasting - is a well confirmed medical condition and illness resulting either/and or from both HIV infection itself and the drugs used to treat infection. It may affect over 100,000 patients in the US, regardless of age or gender. In a 1100 people survey done recently by my non profit and which was presented at the latest HIV Lipodystrophy Conference, 25% of patients reported thoughts of suicide due to their HIV related body changes. Most patients were spending their own money to pay for the disfiguration caused by Zerit and AZT. The cost is over $5000, plus $1000 a year for touch ups. More on this survey at :http://www.surveymonkey.com/sr.aspx?sm=LYbzfgoEFlmgc1vkr3v_2bEWfscAbBPrjpRbaywPjqMqI_3 d

2- The expert medical community recognizes that FDA approved medical devices, not cosmetics, are standards of care to treat this condition

3- FDA''s formal approval history under the CDRH division for two such medical devices- among others- clearly establishes that these interventions are treatments not mere cosmetic procedures. The FDA, a coordinated agency within HHS like CMS- has verified that these treatments address reimburseable conditions and are necessary.

3- It is also important to be aware in extending coverage- that continued maintenance is necessary for effectiveness and that coverage should not be suspended or withheld based on temporary mitigation and subjective evaluation of a patient''s nominal appearance. Coverage need should be guided by the decisions of a board certified practitioner under whose care the patient receives best medical judgement

4- Facial lipoatrophy reimbursement issues are a lot similar to the hurdle that breast reconstruction following radical mastectomy, which was regarded as "cosmetic" surgery, had to overcome. It took several months, and a lot of testimony before Congress, culminating in passage of the Women''s Health and Cancer Rights Act of 1998 (introduced in Congress in February, 1997) to put an end to these denials. The reconstruction of a disease-related side effect like Zerit/AZT- related facial wasting should be also reimbursed by Medicare just like breast reconstruction is covered in the present for women with breast cancer.

I would be happy to serve as a volunteer expert on costs and community related needs assesment.

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[PHI Redacted]

What is the point of taking antiretroviral treatments at all when this insane deformity is the end result? The burden of this disfigurement is too much to bear, and far too expensive for those living on disability with AIDS to afford.

I beg the Centers for Medicare and Medicaid Services to approve treatments for Reconstructive Treatments for Facial Lipodystrophy Syndrome. Without this approval, many living with HIV/AIDS will have no reason to live. I thank you for your kind consideration on my behalf.

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I am a mental health professional who has worked with people experiencing facial and other lipodystrophy and I completely support reconstructive treatment coverage from Medicaid and Medicare. [PHI Redacted] The individuals living with this traumatic side effect of the disease and the meds are profoundly impacted. This condition can cause severe depression in people and increase mental health issues and increase liklihood of abusing substances to cope. There is nothing cosmetic about this.

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Hi, I know of people that are hiv positive and have seen their faces change dramatically for the worse due to Lipodystropy. It seems the fat or normalness leaves from their face and and they start to look sickly or disfigued; their cheeks get hollow and deformed looking. I''ve also noted how it affects the way they feel about themselves. Extreme poor self images develop from feeling "disfigured", verbal abuse by coworkers, peers etc. I believe coverage should be provided for reconstruction to their faces to undo what Lipodystrophy has done. Thank you for your consideration

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I have treated HIV+ patients for 12 years and have seen the physical and emotional devastation caused by lipodystrophy. Patient''s wanting to return to work but are unable to because of the physical changes that cause physical disfigurement and embarrasment. Patient''s wanting to be social but isolate because of poor self esteem and patient''s with such large buffalo humps and big bellys that they are unable to hold their head up or walk with stability. These are NOT cosmetic needs - these are necessary surgeries to correct the metaboloc changes caused by the HIV that prevent patients from living their lives. These are surgeries that presently patients with Medicare cannot afford and yet are physically warranted. Medicare needs to cover these surgeries as the HIV+ population gets older and require these services.

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i support the coverage of treatment in this document.

1) the proximate cause of the Syndrome is that the patent followed a doctor''s recommendation for treatment.

2) this was an unknown side effect of one or more drugs that were approved by the FDA and shown to be "safe and effective" for treatment of the medical condition they were prescribed for.

3) therefore there could be no informed consent to the side effect since it was unknown to the maker of the drug, the government which approved its use, the doctor who prescribed it, and above all the patient who consented to this course of treatment.

4) the person suffering from this disfigurement can no longer communicate with medical staff, friends, family, or members of the public without the condition adversely affecting the relationship, no matter how caring or loving.

5) the reconstructive treatment is not for "cosmetic surgery" to beautify the patient''s original appearance, but to ameliorate an unintended consequence of what was percieved as beneficial medical treatment.

for these reasons, the Center should support the coverage decribed in this Document.

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I am pleased that CMS has opened a benefit category NCD for AIDS-related facial lipodystrophy, and am grateful for the opportunity to provide comments. It is important to remember that AIDS-related lipodystrophy is a systemic disease, and may affect other parts of the body. As an example, individuals have been denied coverage for treatment of marked enlargement and/or deformity of the neck, based on the argument that it is “cosmetic,” even when there has been significant pain and aggravation of other conditions.

It is acknowledged by CMS that the fact that a procedure provides a cosmetic benefit does not mean it is not fundamentally reconstructive in nature. While it may seem obvious to us today that breast reconstruction after surgery for breast cancer should be covered, in the past, coverage was being denied because the procedure was deemed to be cosmetic in nature. It required an Act of Congress before coverage became available (Women''s Health and Cancer Rights Act of 1998, introduced in Congress in February, 1997).

To the extent that the relevant statutory provision, Section 1862(a)(10) of the Social Security Act (the Act) contains a definition of “cosmetic,” if it does at all, it is vague and subject to arbitrary interpretation, and clearly inadequate for purposes of something so important as coverage for health care.

Nowhere in the Act is there language that explicitly defines cosmetic surgery and reconstructive surgery. The words “define(d)” and “definition” do not appear in connection with those terms. Other Federal legislation does provide an explicit and sensible definition of cosmetic surgery (See, for example, Internal Revenue Code, 26 USCS §213 (d)(9)(B). Virtually every medical organization that has done so, including the American Medical Association, and the American Society of Plastic Surgeons, essentially defines “cosmetic” procedures as those that enhance a normal appearance, and “reconstructive” procedures as those that are intended to correct a deformity or disfigurement caused by injury or disease. By these definitions, surgery, including injections, for AIDS-related facial lipodystrophy is clearly reconstructive and not cosmetic (bearing in mind, of course, that surgery that is clearly reconstructive, such as breast reconstruction following cancer surgery, may confer a cosmetic benefit).

AIDS-related facial lipodystrophy produces a specific, recognizable facial deformity that is characteristic of the condition, and for which medically-accepted and FDA-approved treatments are available. Its presence, for the individual, commonly results in withdrawal and depression, thereby significantly increasing the morbidity of AIDS. Additionally, in some individuals, it may result in failure to continue highly active anti-retroviral (HAART) treatment– believed by many to be a significant cause of lipodystrophy. HAART treatment for AIDS has changed the face of the disease, and has resulted in prolonging life and maintaining quality of life in the patient with AIDS. Yet, for some, the embarrassment that comes from facial, or other manifestations of, lipodystrophy, may be severe enough to result in their self-discontinuing HAART therapy, resulting in increased AIDS-related morbidity.

For the reasons indicated above, I strongly urge CMS to establish the NCD to cover medically-accepted treatment, including reconstructive surgery (as defined by professional medical organizations), for AIDS-related facial lipodystrophy and to expand the scope of the NCD to include coverage for medically-accepted, including reconstructive surgery, treatment for lipodystrophy affecting other areas of the body.

By way of disclosure, I affirm that neither I nor any members of my immediate family have any economic or financial interest in the result of the NCD, nor do any of us have any ownership interest in any entity that has an economic or financial interest in the result of the NCD. I do not perform procedures for lipodystrophy.

Bruce L. Wilder, MD MPH JD
Pittsburgh, PA

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I personally have spent more than 20 thousand dollars on facial injection treatments. These dollars could have been better spent supporting my family and our economy. The same products that were injected were at a much lower cost prior to FDA approval (Sculptra specifically), if Medicare was to get involved, I believe that the price gouging practice for these treatments as well as others (such as Artefill) would benefit those living with HIV. I know people who won''t take medicine until they are hospitalized (at higher expense) and have NO choice about starting medicine, since they would rather wait as long as possible to stave off any negative physical side effects of medication.

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Aloha awakea!

[PHI Redacted]

I hope that CMS will seriously consider allowing reimbursement for facial reconstructive treatments and procedures. These reconstructive procedures can make a positive impact to mental health and quality of life, much like breast reconstruction procedures after mastectomy.

Please consider my plea to change policy to give countless Americans their faces back.

Thank you for considering my request.

Respectfully Submitted,

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