Dermal injections for the treatment of facial lipodystrophy syndrome (FLS)

Facial Wasting is a huge problem for people with AIDS. It causes people to be easily identified as AIDS victims. I have seen people with AIDS hide old photographs of themselves so that people can''t easily recognize how much facial wasting has occurred. I have talked with several AIDS patients are saving their grocery money to try and get facial injections. They have limited their outside activities because they feel like once someone looks at their sunken cheeks, they will know that they have AIDS. No amount of makeup can cover facial wasting. I have seen some AIDS victims who will avoid looking directly into a mirror because the sight of their sunken cheeks reminds them of the severity of their terminal illness.

I think Dermal injections are absolutely necessary to help AIDS victims deal with a horrible disease..

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Madeline Ulrich, MD
Lead Medical Officer
Madeline.Ulrich@cms.hhs.gov

JoAnna Baldwin, MS
Lead Analyst
JoAnna.Baldwin@cms.hhs.gov

Re: Proposed Decision Memo for Dermal injections for the treatment of facial lipodystrophy syndrome (FLS) (CAG-00412N)

Dear Dr. Ulrich and Ms Baldwin:

EMD Serono appreciates the opportunity to comment on the Proposed Decision Memorandum (PDM) for Dermal injections for the treatment of facial lipodystrophy syndrome (FLS). EMD Serono is a biopharmaceutical company dedicated to developing and delivering therapies that fight disease and improve the lives of patients. EMD Serono has been conducting research with respect to HIV associated metabolic conditions for more than 15 years and we commend CMS’ efforts to improve patient access to such therapies.

Based on the available clinical evidence, EMD Serono agrees that the use of therapies to treat FLS should be covered. Clinical experience has clearly identified the challenges facing HIV-patients impacted by FLS. The evidence demonstrates that treatment of FLS with an injectable dermal filler can result in clinically meaningful outcomes such as improvements in depressive symptoms. The potential impact of FLS on HIV patients’ adherence to their antiretroviral regimens also should also be considered. Optimal management of HIV, not only should aim at suppressing viral load, but also at alleviating co-existing conditions such as FLS.

EMD Serono supports CMS’ proposed decision finding dermal injections for FLS to be reasonable and necessary for HIV-infected beneficiaries. We believe the proposed decision will improve patient access to these important medicines. If you have any questions or would like to speak further about our comments, please do not hesitate to contact Dan Todd, Senior Director of Health Policy at (202) 626-2590 or though email at Daniel.todd@emdserono.com.

Sincerely,
Lynn Taylor
Vice President, Government Affairs

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Re the proposed national coverage determination for lipoatrophy secondary to HIV and/or its treatment, I would like to suggest that perhaps a better way to prioritize those for whom dermal injections should be medically necessary and reasonable is to measure the degree of the wasting condition itself. In the proposed coverage memorandum,a study is summarized that included measurements of thickness of peoples'' cheeks. A patient''s cheek deterioration can be measured and it can be determined when a lipoatrophy condition has reached an unacceptable level. Thus, it would also be a level that can be assumed to cause loss of self esteem and other symptoms of depression. This strikes me as a more objective measure of the severity of the condition and at the same time rules out patients whose conditions are mild. It also is more fair and consistent with what is medically necessary breast reconstruction. That is, it is the altered appearance of the body that triggers the necessity for covered medical intervention.

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The facial atrophy associated with some prescriptions subscribed and used in the treatment of HIV/AIDS is to many a debilitating side effect. It is a visual reminder to those affected, and and unfair sign to others that the affected person has an affliction, similar to that of the sores of a leper. This has to have a negative impact on the psyche and mental condition of the afflicted. I''m sure that the feeling of going about looking like a freak or monster certainly can send one into a mental tailspin. The reality of others not wanting to associate with you simply because of something beyond your control is at best depressing. The fact that lipoatrophy/lipodystropy is a result of having ones medical condition treated is reason enough that approved, corrective measures be made available and insurable so that the mental stability, physical appearance, and self confidence of those afflicted might be restored and maintained. This is my position. This is where I stand!

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Having worked with a skin specialist and running a programme in New Zealand for people living with HIV and using fillers to correct the effects of lipoatrophy from either the medication or the disease itself.

I would be in support of the use of fillers,the advantages that the patient/s feel once they recieve the injections. For example one client said "Now that I have my sense of self worth back help me find a job...and this was only after the first treatment.

I do however question the reasoning behind using a temporary filler as this,would in the long run be of a much greater expence to the health system. As top ups are required because of the longitivity of the product itself only being at the most a year.

Here in New Zealand we use Aquamid which is permanent lasting up to 25-30 years. Which would be considered to last the duration of a normal life span, if someone was diagnosed in their 30''s/40''s and lived till they were 60 and beyond....

Aquamid is safe providing the conditions of its use are followed. ie: Sterile enviroment and the clients also follow the recommendations from the specialist for example not subjecting oneself to extreme hot or cold for the first 24hrs nor touching the area treated following the procedure for 6 hrs....

We have some medical company''s that sponsor the treatment for those that connot afford it, a wellness fund setup by the (New Zealand Aids Foundation). etc... all these services are means tested and are partly paid for by funding....

If you would like more information let me know!!!

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I believe it would be a very good idea. I know that my friend has paid for 4 injections at 300.00 a syrings and his confidence went up and depression down. He no longer sees a wasting HIV infected face when he looks in the mirror. Problem is after 9 months it will be needed again and he has no income to divert to this particular need due to the need for home, food, other meds, etc. I believe CMS and other Healthcare plans need to cover this side effect of the treatment medications. Self confidence and less depression make for a more productive member of society. thanks for your time.

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Facial wasting caused by some HIV medications can have serious psychological consequences on an individual who is already under severe mental stress from having an HIV diagnosis. It can lessen one''s self-esteem, make one appear much older than one''s actual age, and elicit from others unwarranted accusations of illegal drug use, such as crystal meth, which can cause similar appearance. This in turn can affect an individual''s ability to find employment or advancement in their job, which is also detrimental psychologically. It''s a very serious condition that needs to be addressed.

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I believe this is a great initiative as many people at some level (especially gay men) are quite conscious of their appearance as well as are judged on such and therefore are likely to feel some level of discomfort at this marker of being HIV+ and will most likely have resulting depression. While psychotherapy and proper nutrition can help address the many challenges of being HIV+ that ultimately touch on one''s self- esteem, being able to address this purely physical condition is a great addition. [PHI Redacted]

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Please support funding/access to this treatment. The stigma associated with HIV/AIDS can be debilitating and that stigma is enhanced by outward manifestations of the disease process. The psychosocial realities of PLWHA are vast and varied. The shifts toward medical outcomes (reduced viral load, higher cd4 counts) fails to recognize and value the real effects the psychosocial stressors that PLWHA experience daily while attempting to manage their disease process. Surely there must be a database that supports that most people living with HIV/AIDS indeed experience depression as a result of the real or perceived stigma endured on a daily basis. (Even those with little or no outward manifestations.) Access to these dermal injections has the potential to ease some of the stigma / psychosocial stress/ and depression encountered by this population and should be affordable and accessible.

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As facial wasting is irreversible disfigurement due to treatment with life saving medications, it seems only logical that providing ameliorative treatment for the disfigurement ought to be a recognized insurable medical expense - just as when a woman has a mastectomy or when someone has a cancerous lesion removed from their face - in those instances there is not question about providing restoration. Making proof of co-occurring depression a requirement seems to be based on bias against those who are most likely to have this condition Gay men and drug addicts- this facial wasting contributes to lowered self-esteem; social isolation, and being shunned by others. It makes confidentiaility about the diagnosis a joke. Depression is just one kind of negative consequence. It seems that the only just course of action is provide payment for restoring a disfigured face that occurred due to the medications used to treat HIV disease without further qualification.

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I am concerned about having to prove that in order to receive funds for this treatment, one has to prove that it caused depression. It goes without saying that our face is what we present to the world, and one would be depressed because of this. I don''t think there should be a criteria such as this. One should be able to access this regardless of depression. I know I would be very depressed if my face was a wasteland because of anti-retro-viral treatments, and I would be the first in line for the treatments for facial wasting.

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I am commenting in support of Dermal injections for the treatment of facial lipodystrophy syndrome (FLS). I know how facial wasting caused by HIV and/or HAART causes depression in HIV+ patients. I think it can be compared to breast cancer mastectomy survivors that get implants to improve their self esteem and self worth. The disfiguration that results from any medical condition and the depression it causes is the same that which is caused by lipoatrophy.Please help patients get the procedures covered that are needed to make their lives better.

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I am a clinical psychologist who has treated several persons with HIV who also had facial wasting. The stigma of facial wasting led these persons to suffer from depression partly as a result of cutting of social ties and limiting outside activities. Social support is important in the management of HIV. More importantly, facial wasting can lead to depression by making the person feel as facial wasting is a ''marker'', identifying them as being HIV positive. Negative self image and lack of social support are but two aspects of depression that can lead to non-adherence to HIV medications, which can hasten the progress of HIV. I urge the approval of Medicare funds to cover treatment of facial lypodystrophy. It is NOT a cosmetic issue, it can be a matter of life and death where HIV is concerned.

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From 1996 to 2003, I worked as a psychologist for a large clinic serving over 900 HIV+ adults. I worked with clients who experienced considerable lipodystrophies related to their ARV treatment, and support the proposed policy regarding dermal injections for treatment of FLS. Reconstruction of FLS-related changes is quite similar to breast reconstruction after mastectomy in breast cancer patients - to survive a deadly disease, patients must be treated, but the treatment can be disfiguring in a way that can cause social difficulties and personal shame. This can then lead to social withdrawal, depression, and even suicidality in some patients. Treatment is crucial to support not only quality of life in these patients, but their continued engagement in social activities, including work and family in some cases.

Obviously, it is reasonable to require documentation of the psychological and social impact experienced by the patient with FLS. Allowing such patients to receive an assessment from a qualified mental health provider would be an important aspect of this policy.

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I have a friend who suffers from facial wasting due to HIV. Prior to his use of Sculptra his face was skeletal, hollowed out from the lower temple, through his cheeks to his chin. It would be extraordinary if he were not depressed by his appearance. And he was. Sculptra filled in these hollows and reasonably restored his appearance. The cost however has prevented him from receiving a sufficient course of injections to more fully plump his features toward normal. Nevertheless, the gain was palpable and rewarding. To the extent that we can jointly afford it he receives maintenance injections to maintain his appearance. The restoration of his face and the knowledge that he can receive maintenance injections (assuming we can afford them) has been a boon. He no longer looks nor feels like a living skeleton. He no longer receives stares. While he still lives with the complications of HIV at least in this one area he is neither freak nor victim. His spirit is recovered.

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Given the vast amount of documented evidence that HIV, the antiretrovirals used to treat it and the diagnosis itself can cause depression and PTSD-like symptoms, how would one "prove" that their FLS lead to depression that they were already experiencing? Isn''t it common sense that a 20 y.o. who looks 70 y.o. due to FLS could very well be experiencing depression around their fear that others find them unattractive or may suspect that they are HIV-positive? Does Medicare require that a heterosexual 65+ y.o. male who has a long history of depression prove that their impotence caused the depression before they approve penile implants? No. Medicare just requires that impotence be caused by a medical condition. Isn''t it already well-documented that HIV (a medical condition) causes FLS? Although it''s possible, I doubt that a 65 y.o. male would want a penile implant to procreate. More likely, he wants the procedure to improve his quality of life. Medicare already allows for this - as it should. This increased quality of life is exactly what Dermal injections provide for young HIV+ men and women for whom appearance, understandably, is important in a culture that values aesthetic beauty. Furthermore, to deny a HIV+ person the opportunity to increase their quality of life through dermal injections because they can''t prove that it is the FLS that is causing their depression could very well exacerbate those symptoms of depression, putting them at increased risk of non-compliance with their antiretroviral regimen. This non-compliance would cost Medicare more in hospital readmissions and home health care services in the long-term than the cost of simply approving dermal injections for someone seeking to improve their quality of life without having to "prove" that FLS caused their depression.

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Facial and body wasting not only make you look sick, but also make you feel that you are not healthy! This does cause alot of anxiety, worry, depression, and not feeling very optomistic about your disease, or your future. It decreases hope that one day you will be back in good health and look and feel that you are healthy. It also affects your social life and prospects for employement, in that people immeadiatley know something is wrong with you. Finally, a great percentage of people can not afford the Doctors fees, much less the cost of the drug, in which many bottles of the drug may be needed and total treatment may be well over $3500, or more. Please consider this carefully and realize the chances of employment and discrimination are greatley affected when you look sick!! Thank you for you consideration. M.F.

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The proposed coverage decision limits the treatment to individuals "who manifest depression secondary to the physical stigma of HIV treatment." This proposal suggests that individuals must be clinically depressed in order to be eligible for coverage rather than simply be victims of the stigma. There needs to be clarification regarding the relationship between the stigma and depression. The stigma is the cause of depression. Individuals with this syndrome should receive coverage to avoid this stigma that would lead to depression. Coverage should be determined by whether the person has Facial Lipodystrophy and not whether the person has become depressed because of Facial Lipodystrophy.

As stated in the proposal, there are individuals who have ceased taking their HIV medications because they lead to Facial Lipodystrophy, a condition that requires treatments that many individuals will not be able to afford without Medicare assistance. Covering the dermal injections will promote greater HIV treatment compliance and improve HIV related health outcomes.

Coverage for these dermal injections will endow individuals with greater self confidence so they may reenter mainstream society and become productive once again.

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Firstly, I have concerns about use of the phrase“improving a patient''s physical appearance,” onpage 3 of the Proposed Decision Memorandum. Thelanguage should be more specific, i.e., it shouldrefer to correcting or ameliorating a deformitythat is distinctive and specific to AIDS and/or HAART.

Secondly, a requirement that individuals withAIDS-related facial lipodystrophy “manifestdepression” to qualify for coverage for dermalinjections is unacceptably vague. It provides anincentive for over-diagnosis or over-treatment fordepression. It provides a wide-open opportunityfor private Medicare contractors to deny treatmentbased on arbitrary requirements, and it willrequire potential beneficiaries to incur legalexpenses in pursuing claims. Potentialbeneficiaries may have to incur out-of-pocketexpenses for diagnosis and treatment ofdepression, that they might not otherwise need,before qualifying for coverage of reconstructivedermal fillers.

Additionally, the requirement that individuals“manifest depression” does not address anotherconcern in these patients, i.e. non-compliance,which might constitute, in some sense, a form ofself-treatment for depression.

CMS, in approving payment for screening fordepression (See http://www.ahrq.gov/clinic/uspstf09/adultdepression/addeprrs.htm#clinical See also Lesser,LI and Bazemore, AW, Improvingthe Delivery of Preventive Services to MedicareBeneficiaries, JAMA 2009;302(24): 2699) hasrecognized the need for, and importance of,preventing depression. A “Welcome to Medicare”visit (see http://www.cancer.org/docroot/PED/content/PED_2_3x_Cancer_Screening_-_Medicare_Coverage.asp) includes a review of risk factors fordepression. The Proposed Decision Memorandumacknowledges that depression is a commoncomplication of facial lipodystrophy, and thatfacial deformity due to facial lipodystrophy is arisk factor for depression. It is a widelyacknowledged, and a time-honored principle ofmedical practice and public health that removal ofa risk factor or factors for disease isfundamental to preventing the disease. Moreover,it is recognized that depression itself is adisease with its own set of complications,including suicide, the development of depressionon the children of adults who are depressed,side-effects of medication used to treatdepression, among them. Thus, an ounce ofprevention of depression is preferable to a poundof treatment of depression and its complications.

Moreover, it makes no sense to require thatindividuals with one condition develop ananticipated complication before treatment iseligible for coverage. Doing so is a bit likerequiring a diabetic to develop diabetic coma orperipheral neuropathy before providing coveragefor treatment of the diabetes.

Imagine what the uproar would be if people in needof reconstructive surgery following radical breastsurgery or radical surgery for head and neckcancer were required to “manifest depression”before coverage for that surgery would beprovided.

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Disfigurement seen in many diseases should, and mostly are, covered for the well-being of the disfigured patient. If an ear or nose is lost due to disease, Medicare will cover reconstructive surgery or a prosthetic.Replacement of a lost physcial eye and bodily limbs are also considered necessary treatments. If a breast is lost due to cancer or some other problem, Medicare will cover reconstructive surgery or a prosthetic. Facial wasting due to AIDS or another medical condition is no different. Easing the stigma related to obvious wasting, as seen in the face, is vital to the self image and, therefore, the peace and tranquility of the patient. In the battle against AIDS within oneself, and other diseases, it is most important to relieve the stress of a patient in any way possible. Outcomes for treatment and survival improve dramatically as the self image of a patient improves.

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Since severe lipodystrophy most certainly announces the stigma of AIDS to the entire world. [PHI Redacted] Treatment with facial fillers eliminated this stigma. This treatment is as valid for the AIDS patient as breast reconstruction is to a cancer patient. It follows that since coverage for reconstruction of the breast is a covered benefit for the cancer patient then a corresponding tx be a covered benefit for the AIDS pt. The cosmetic objectives in both cases are the same, i.e., to restore what has been lost due to disease.

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I wholeheartedly support coverage for dermal injections for facial lipodystrophy. [PHI Redacted] I understand the stigma and debilitating effects from this condition, both physically and psychologically. [PHI Redacted] Please consider removing the depression qualification from coverage under Medicare, as once someone''s condition improves after treatment, they may no longer qualify to receive the once-a-year "touch-ups" it requires.
Sincerely,
Jeff Berry
Editor, Positively Aware

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Thank you so much for updating us. Many of my constituents from facialwasting.org and pozhealth at yahoogroups.com sent comments. I am a key advocate for facial lipoatrophy and really appreciate what your group has done.

I have a few questions:

Is this effective immediately or are we still in a comment period? Do you have plans for a separate codes for the device charge for these products and for physician''s labor? Do we know the answer whether patients need to be on antidepressants or is it merely enough to document in the chart?

As you can tell, these are many related questions are coming from the community.

As it stands today,most people need 4-8 sessions of Sculptra or 3-6 sessions of Radiesse, with a touch up a year since these two FDA approved options are not permanent. Physicians are charging around $350-$600 for labor per session, Product cost is around $1200 per session, give or take. So, what is Medicare covering? Will these devices become part of Medicare Part D formularies?

Thanks again for gathering all comments, research data, and for coming up with a compassionate system that can change people''s lives dramatically.

Regards,

Nelson Vergel
Director
FacialWasting.org

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In my experience, most People with AIDS who suffer from facial lipodystrophy who seek out facial reconstruction are doing so because the change in their appearance hollow cheeks, sometimes horrible indentations is making them depressed. Their freakishly gaunt appearance is an announcement to the world that they are sick with AIDS, and that is depressing! Why else would they consider facial reconstruction? What is even more depressing, is being on limited income and not being able to afford facial reconstruction, when Medicare won''t pay for it! It is cruel and uncaring to not pay for facial reconstruction for an AIDS patient with facial lipodystrophy, especially considering that Breast Reconstruction is paid for when a woman''s breasts are removed due to breast cancer, even though breasts are parts of the body that, in public, are covered by clothing! The face is bare for all to see! Facial deformity cannot be hidden, can it? This, to pay for breast reconstruction after breast cancer surgery, and not to cover facial reconstruction for AIDS related facial lipodystrophy, is a double standard, and, arguably, discriminatory!

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I agree with the conclusion that the current language regarding approved covered treatment is vague and woefully insufficient. Such language limits patient''s who experience a decline in quality of life due to the physical symptoms of lipodystrophy and facial wasting to cover only those patients with a clinical diagnosis of depression. Regardless of an individuals ability to cope with these symptoms, which can potentially result in discrimination in addition to emotional and psychological distress, the terms in which such treatment grants coverage should apply to all those who have been dianosed by physicians and showing signs of facial wasting due to medications and chronic illness.Let us remember that these symptoms are not a result of choice, but of a medically crucial treatment and side effects from a chronic and incurrable disease.

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