New Bill Mandates Coverage of HIV Lipodystrophy Treatments

Ben Klein, a Senior Attorney from GLAD.org speaks about the new bill approved in the state of Massachusetts in Aug. 2016 that mandates several insurance carriers in that state to reimburse cost for HIV related lipodystrophy therapies and how activists can advocate for similar bills in other states.

California is also trying to get a similar bill approved.

California May Require Insurance Companies Cover Lipodystrophy for Poz People

Senator Scott Wiener (D-San Francisco) introduced an Equality California sponsored bill called HEAL (“Help End Antiretroviral-related Lipodystrophy”) that will require insurance companies and government programs to cover medical treatment for those suffering from the condition.

“The early generation of anti-retroviral medications saved thousands and thousands of HIV survivors’ lives, yet they scarred many survivors with the disfigurement caused by lipodystrophy,” Senator Wiener said in a statement. “Many long-term HIV survivors continue to struggle with this side effect, with both physical and psychological ramifications. The failure of our private insurance and public health programs to cover lipodystrophy correction surgeries for long-term HIV survivors is both unacceptable and discriminatory. It’s time to ensure that these long-term HIV survivors receive the healthcare they need, including correction of this debilitating health condition.”

 

Abdominal Fat Accumulation in HIV: Interview with Dr Grinspoon

Nelson Vergel from PowerUSA.org interviews Dr Steven Grinspoon from Harvard Medical School about what we know about HIV lipodystrophy associated fat accumulation. Dr Grinspoon covers potential causes and treatments. For more information please refer to the closing image at the end of the video.


QUESTIONS FOR DR GRINSPOON’S INTERVIEW:
1. Please give our audience background information on what HIV lipodystrophy is.
2. What causes HIV lipodystrophy? How is HIV lipodystrophy different than other lipodystrophies?
3. What types of fat tissue does the body have? What are their metabolic functions, if any?
4. Why is visceral fat and dorsocervical accumulation not just a cosmetic issue?
5. Talking specifically about visceral fat (VAT), have we learned about what makes someone more or less prone to having increased VAT before and after starting antiretrovirals? Is increased VAT driven by HIV as much as ART? Inflammation?
6. Are some antiretrovirals “better” than others when it comes to avoiding excessive VAT increase? Can switching HIV regimens improve VAT?
7. What kind of hormonal, lipids and glucose issues have you seen in your research with HIV+ patients experiencing increased VAT?
8. What is growth hormone pulsatile release and how does it differ in HIV lipodystrophy patients?
9. Are there any ways to predict who may have more increased VAT when starting HIV ARVs?
10. VAT then and now- Is increased VAT as common now as it was back in the 90’s and early 2000’s? If not, why? is current lipodystrophy being hidden by the aging of the HIV population? Is our perception of a decrease in prevalence being affected by the increase of fat tissue due to aging? Does current day LD look different and how?
11. What treatments are approved to manage adipose tissue accumulation in HIV? How effective is it?
12. How can we predict if someone will be a good responder to the therapy? When someone responds what should they expect? Does something happen metabolically before the response happens?
13. Can exercise and diet work in synergy with the adipose tissue treatment? How about any synergy with Metformin?
14. How does liver fat affect someone’s health? Do we experience more liver fat in HIV lipodystrophy?
15. Can you tell us how VAT can affect carotid intima thickness, coronary calcium, hypertension, neurocognitive, and mortality?
16. Follow up, will a reduction in VAT improve these? What about SAT?
17. Why has leptin not been studied further?
18. Your team recently published a puzzling study on DICER deficiency in HIV lipodystrophy patients. Can you elaborate on your findings and what they may mean clinically?
19. Why does it seem that a lot of the HIV lipodystrophy research interest has decreased in the last few years? What can patient advocates do to advance more research?

DOWNLOAD TRANSCRIPT HERE

Interview with Dr Luis Casavantes About Facial, Buttock and Penile Fillers

Nelson Vergel from the non-profit Program for Wellness Restoration ( www.PoWeRUSA.org ) interviews Dr Luis Casavantes about his experience with PMMA filler for HIV-related facial/buttock wasting reconstruction. He also shares his experience on the use of PMMA for penile girth enlargement. For more info visit www.AvantiDerma.com. You can also find more info on PoWeR’s site www.FacialWasting.org

 

Recent Studies Show Concerns With The Use of Tenofovir (Viread), Popular Drug in HIV Treatment

Tenofovir impairs enzyme that stops cells aging

This study let us know that NRTI drugs, already known for causing the damage to mitochondrial DNA that leads to peripheral neuropathy, fat loss and some other side-effects, also exert an effect on cellular DNA, and that in this case tenofovir may be the drug to keep an eye on.

Telomerase shortening is, by definition, a side-effect that won’t start causing symptoms for many years, and the study does provide a cautionary note in discussions about the possibility of very long-term side-effects associated with the use of tenofovir, both in HIV treatment and in pre-exposure prophylaxis.

More information here

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Changes in Fat Mitochondrial DNA and Function in Subjects Randomized to Abacavir+Lamivudine or Tenofovir DF+ Emtricitabine With Atazanavir-Ritonavir or Efavirenz: AIDS Clinical Trials Group Study A5224s, Substudy of A5202

“In conclusion, we have shown significant perturbation in mitochondrial indices after 96 weeks of nonthymidine NRTI containing regimens which were assigned randomly. In the TDF/FTC group, changes in oxidative phosphorylation complex I and complex IV activity levels consistently were inversely correlated with changes in several objective measures of body fat, including in both subcutaneous and visceral compartments”

  Patients with human immunodeficiency virus type 1 (HIV-1) infection receiving thymidine nucleoside reverse-transcriptase inhibitors (NRTIs) experience a high rate of metabolic abnormalities, including lipoatrophy. Depletion of adipose tissue mitochondrial DNA (mtDNA) and impairment of the oxidative phosphorylation system are associated with lipoatrophy induced by thymidine NRTI containing regimens. Mitochondrial oxidative phosphorylation enzymes nicotinamide adenine dinucleotide (reduced; NADH) dehydrogenase (complex I) and cytochrome c oxidase (complex IV) contain polypeptides of mtDNA-encoded subunits and so are affected by mtDNA depletion.
In the current era of nonthymidine NRTI containing regimens, lipoatrophy incidence has significantly decreased but has not been completely prevented . In addition, subjects who have established lipoatrophy while taking thymidine NRTI containing regimens experience only a slow and incomplete resolution of lipoatrophy after switching to nonthymidine NRTI based therapy , putting into question the mitochondrial toxicity.

More information here

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Fortunately, 10 year observational data on the use of TDF show encouraging results in stabilization of reduced creatinine clearance

Association Between Tenofovir Exposure and Reduced Kidney Function in a Cohort of HIV-Positive Patients: Results From 10 Years of Follow-up

 “In this cohort, TDF exposure was associated with reduced kidney function, but the loss in eGFR attributable to TDF is relatively mild in a long-term perspective.

There has been debate about the association between TDF exposure and renal dysfunction and about the clinical impact of the loss in eGFR due to TDF exposure. Our study shows that the association was not of a high magnitude and that the quantified loss in eGFR attributable to TDF is relatively modest after many years of exposure. Importantly, the loss attributable to TDF seems to occur during the first year of exposure and stabilizes after that. Although the loss is maintained, it does not seem to further deteriorate with additional years of exposure. The clinical impact of this association need to be analyzed, taking into account the efficacy of TDF, but it is highly plausible that TDF exposure, although associated with reduced kidney function, has no severe adverse effects over the long term for most HIV-positive patients.”

More information here

Sign-On to Support an Increase in Medicare Reimbursement for Facial Fillers

April 8, 2011
Sign-On to Support an Increase in Medicare Reimbursement for Facial Fillers

A prominent AIDS activist is asking people with HIV and the organizations that serve them to sign on to a letter asking the agency that sets reimbursement rates for Medicare to boost the rate it offers doctors to administer the facial fillers Sculptra (poly-L-lactic acid) and Radiesse (calcium hydroxylapatite).

Activists thought they’d won a major battle when the Center for Medicare and Medicaid Services (CMS) announced in March 2010 that the government health insurance program would begin covering the costs of Sculptra and Radiesse for people who have psychological trauma due to loss of fat in their faces, a condition known as lipoatrophy or facial wasting.

Sculptra and Radiesse are both temporary facial fillers that require touch-ups at least once per year for most people. The retail cost of a vial of Sculptra or Radiesse usually tops $500. As most people need a minimum of four to six treatments, and as doctors charge about $500 to $900 to inject the filler, a full course of treatment can easily exceed $4,000.

It’s the latter point, reimbursement for the physician’s fee, that has Nelson Vergel, a longtime AIDS activist from Houston, and other activists up in arms. Though doctors typically got $500 or more per treatment from their cash-paying patients to inject the facial fillers, Medicare is typically reimbursing only about $80. Obviously, the math doesn’t add up.

“The cost of acquiring and administering the product is higher than the payment amount set by Medicare,” he explains in the letter he’s asking people to sign on to. “As a result, physicians are not accepting Medicare payments for this service, and patient access to these effective therapies remains quite limited at the current reimbursement rates.”

To sign on to a letter demanding that Medicare increase its reimbursement rate for Sculptra and Radiesse treatment, click herebefore April 18.

Second Bioplasty Congress in Mexico- PMMA for facial and buttock lipoatrophy

I  attended the second International Congress on Bioplasty in Guadalajara last week. Here is the program in Spanish: http://www.bioplastia.org.mx/es/programa.php
Cosmetic and dermatology physicians from Mexico, Spain, Argentina, Brazil, and Colombia  came to share experiences on the use of PMMA (polymethylacrylate) to treat HIV related facial and buttock lipoatrophy and other non HIV related physical abnormalities.
Bioplasty is a technique of  inyectable implantation  done  under local anesthesia for facial and buttock lipoatrophy and for reshaping other body parts. The product usually used is PMMA (polymethylmethacrylate microspheres) and it is  usually  (but not always) injected using a micro-canula (gun like device that enables faster and smooth dispersion of the product under the skin) .  Two brands used overseas are Metacryl and Newplastic.  In the States, Artefill is the only PMMA based product approved (for cosmetic use, not lipoatrophy). 
It was confusing for me to find out that Bioplasty really is a brand name for the specific use of NewPlastic which was created by Dr Nagul in Brazil (he wrote a book on the procedure and trains doctors in Porto Alegre, Brazil).   But Bioplastic is only one of the several PMMA options available worldwide but it seems to be spreading fast around the world. More on Bioplasty here : http://www.bioplastia.med.br/bioplasty.htm 
I presented  the current status of facial lipoatrophy solutions in the United States and the challenges we still face with access and the lack of an economical permanent solution to facial and buttock lipoatrophy.  I presented the results of the 1500 people survey that people subscribed to my pozhealth yahoo group ( http://health.groups.yahoo.com/group/PozHealth/ ) helped me gather about the impact on lipodystrophy on quality of life.  They were surprised that almost half of the respondents with lipoatrophy have not done anything to treat it and that  25 percent of respondents had  suicidal thoughts in the past due to body changes ( http://bit.ly/fg4ODN )

Dr Luis Casavantes reviewed the different options available for facial and buttock lipoatrophy. Dr Gottfried Lemperle from the US reviewed management techniques for potential complications like granulomas.  Dr Marcio Serra from Brazil reviewed his experiences during the past 12 years of work. He and colleges from Brazil also described their national free assistance program for people with facial lipotrophy. Physicians in Mexico want to use Brazil’s model to provide economical access to patients in Mexico with facial wasting.
The most interesting part of the conference for me was the 3 hours in which all of us got to watch 5 doctors apply PMMA (Metacryl or NewPlastic) to patients in the operating room from a giant screen. Some use a gun-like canula to inject the product and others using insulin syringes.  It was great for me to see the different techniques in person.   It was a true eye opener for me !
I was impressed with the work on Dr Suzana Barreto from  Sao Paulo, Brazil. She does a MRI on patients before she injects them with PMMA and a few months later to see how the implant behaves in people. She showed great slides on MRI results of the face and buttocks. She also compared MRIs done in patients that have had silicone injected to show how silicone migrates and shifts in tissue. I would love for her to present in the United States since I had never seen anyone who has MRI data on patients with any injectable implants.

It amazes me that in the US  we are so far behind  of all of these countries when it comes to dealing with facial and buttock lipoatrophy   in a permanent way. As I said before, the PMMA product in the US is Artefill, which is not approved for HIV lipoatrophy (only for cosmetic purposes- wrinkles, etc)  and was priced horribly high for it to be cost effective for us in HIV. Luckily, its patent expires next year, which will open the door for Brazilians to bring their cheaper option to the US. I had a meeting with a few doctors to discuss how  feasible it would be to do a study  in the United States in 2011 so that we HIV+ patients can have access to a more cost effective permanent correction.  
The two options approved by the FDA (Sculptra and Radiesse) are non permanent and not cost effective for those  with more advanced facial lipoatrophy. They both require yearly touch ups in most patients. Currently, Medicare pays for both but the reimbursement amounts are too low to entice doctors to use it for HIV patients.  Both products have patient assistance programs that are decreasing in scope with time.
The other two products  that can be used in the US for facial lipoatrophy but that are not approved for that use are Silicone 1000 micro droplets and Artefill, and both are permanent. Neither gets reimbursed and there are no patient assistance programs for them. It would be interesting to see an economic analysis of the total cost for each for a facial wasting grade 2-4 in  a 5 year period.  I would not be surprised that permanent solutions will be cheaper in the long run for some patients.  
We have a lot of activist work to do to try to get something permanent approved for lipoatrophy that is not outrageously expensive and that has a good patient assistance program for those with no insurance (ADAP patients).  Most people with facial lipoatrophy still have no access to treatments for that condition.  Let’s see what happens in the long run with Medicare and insurance rates for the two FDA approved options we have now.  Unless something changes with a petition from the community, Medicare approval may actually hurt us more now since both companies are already reducing their patient assistance programs considerably after they assumed that Medicare would pick up a lot of the patients in their programs. If Medicare does not reimburse doctors properly, we will actually lose ground in this field.  Tim Murphy from POZ is writing an article on this problem after he interviewed a few doctors who are having problems with Medicare right now.
I am encouraging companies from other countries that have cheaper PMMA to start studies on facial and buttock lipoatrophy in the US soon to get ready for the time when the patent of the expensive Artefill expires next year.
I will try to post some videos I took of several presentations from the conference. I am still traveling a lot and have not had much time to download and process them.
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Background on PMMA- From www.FacialWasting.org
(collaboration with Al Benson)

The use of PMMA for medical uses dates to 1936 in as a bone cement.  PMMA has presented a good degree of bio-compatibility and as a result it has been extensively used as a soft tissue filler, bone cement, component of denture materials and tooth bond, housing for pacemakers and intra-ocular and contact lenses. The material itself was chemically synthesized in 1904.
Dr. Gottfried Lemperle developed the concept of using PMMA micro-spheres for tissue augmentation in Germany in 1989. PMMA has been available in Germany since as sub-dermal injections used to reduce wrinkles, scars and for certain larger soft tissue deficits.  
PMMA as a tissue filler was first introduced to Europe in 1991 as Arteplast and marketed as a non absorbable injected material. It was composed of microspheres suspended in a gelatin solution. It was observed that the gelatin material was reabsorbed and replaced by native collagen. Not fully recognized at the time was that PMMA itself was stimulating the deposition of new healthy collagen around the individual microspheres without causing fibrotic reactions seen in the implant of foreign materials such as siloxane. Arteplast has since been superseded by newer generations of PMMA of greater consistency in granule size and surface smoothness.  Dr Lemperle said: “because of the extensive fibrous network associated with PMMA related granulomas, intralesional corticosteroid injections are considered the best treatment. We saw an Arteplast® granuloma develop as late as 10 years after injection, which responded well to high doses of local steroids and a pulse light therapy.  After sieving and washing, the second generation Artecoll in Europe caused a significant lower number of foreign body granuloma.” 
There are several PMMA injectable products available. Among the approved and registered PMMA based products are Artecoll and Artesense®, manufactured in Holland and approved in Mexico and Canada since 1998.  Both are formulated with 20% PMMA in a vehicle composed of 79.7% bovine collagen and 0.3% lidocaine. Metracryl and BioPlastic are two other PMMA products widely used in Mexico, Brazil, Argentina and Europe.
Published safety and efficacy studies of PMMA in the United States done for FDA review dealt with PMMA use for the cosmetic correction of nasolabial deficits and concluded that “PMMA is the first soft tissue filler that demonstrates continued improvement and persistence of correction over a 5-year period post-treatment”. PMMA is now manufactured in the United States and was approved by the FDA in October 2006; marketed as ArteFill® (a new formulation of Artecoll), a compound of 20% PMMA in 80% bovine collagen and a small amount of lidocaine.
However, Artefill is extremely expensive for facial or buttock lipoatrophy correction.  ArteFill® costs medical providers $720.00 per ml prepackaged in a box containing 4 syringes of 0.8 ml of product. The professional services of the provider are often sold to the patient for double the cost of the product, thus making it impractical as a corrective for large volume tissue loss. Calculations for the cost-of-treatment climbs astronomically since quite common in the faces or buttocks of people with HIV tissue loss are deficits which can require from 30 ml to 400 ml of filler to correct. A severely atrophied buttock requiring 300 to 400 ml of ArteFill® would cost in the range of $ 200,000 to $ 300,000.
Dr Lemperle has shown that the reported complication appearing in clinical trial results of Arte-Fill has been a small number of tiny palpable nodules. The clinical experience suggests that nodules tend to develop in thin skin areas or when the product is dermally injected in a too superficial manner. These nodules often respond to treatment with Kenalog 40, a cortico-steroid and in many cases also spontaneously remiss.  ArteFill was developed and purified over several generations from the original Arteplast, the appearance of granuloma have decreased dramatically after the micro sphere surface was cleaned up of any imperfections that may have caused macrophages to attack them as foreign objects.
Dr. Luis Casavantes said that based on his experience in the past 5 years of experience with NewPlastic, a PMMA product produced in Brazil and widely used in Mexico and worldwide, does not appear to produce either palpable nodules or true foreign body granuloma, when grafted underneath the muscle fascia.  NewPlastic seems to be a lot cheaper than Artefill.  A moderate to severe facial lipoatrophy correction would cost from 2500 to 3500 depending on the volume needed.  Buttocks require a lot more volume, with costs running from $4000 to $8000 depending on the severity of wasting. Of course, no one knows how much this product would cost in the US if it gets studied and approved here.
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Codes to get Medicare to pay doctors for injection Sculptra or Radiesse in faces of people living with HIV-related facial lipoatrophy

Wellcare put together a great summary of all codes used for reimbursement.  Medicare decided in January 2010 to cover HIV facial lipoatrophy products as long as the patient has depression induced by this condition.

http://www.wellcare.com/WCAssets/corporate/assets/HS134_Dermal_Injections_for_Facial_Lipodystrophy_Syndrome.pdf

MEDICARE EXPANDS COVERAGE FOR TREATING FACIAL LIPODYSTROPHY SYNDROME IN PEOPLE LIVING WITH HIV

MEDICARE NEWS

For Immediate release Contact: CMS Office of Media RelationsMarch 23, 2010 (202) 690-6145 MEDICARE EXPANDS COVERAGE FOR TREATING FACIAL LIPODYSTROPHY SYNDROME IN PEOPLE LIVING WITH HIV The Centers for Medicare & Medicaid Services (CMS) today announced its decision to cover facial injections for Medicare beneficiaries who experience symptoms of depression due to the stigmatizing appearance of severely hollowed cheeks resulting from the drug treatment for Human Immunodeficiency Virus (HIV). Today’s decision is effective immediately. Facial lipodystrophy (LDS) is a localized loss of fat from the face, causing an excessively thin appearance in the cheeks. In some cases, facial LDS may be a side effect of certain kinds of medications (antiretroviral therapies) that individuals receive as part of an HIV infection treatment regimen. The facial LDS can leave people living with HIV looking gaunt and seriously ill, which may stigmatize them as part of their HIV-infection status. Individuals who take these medications and experience facial LDS side effects may suffer psychological effects related to a negative self-image. These effects may lead people living with HIV to discontinue their antiretroviral therapies. The new decision allows for treatment of individuals who experience symptoms of depression due to the appearance changes from facial LDS. The injections included in today’s coverage decision are “fillers” that have been approved by the U.S. Food & Drug Administration (FDA) to be injected under the skin in the face to help fill out its appearance specifically for treatment of facial LDS. Data show that these injections can improve patient self-image, relieve symptoms of depression, and may lead to improved compliance with anti-HIV treatment. “Today’s decision marks an important milestone in Medicare’s coverage for HIV-infection therapies,” said Barry M. Straube, M.D., CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards & Quality. “Helping people living with HIV improve their self-image and comply with anti-HIV treatment can lead to better quality of life and, ultimately, improve the quality of care that beneficiaries receive.” The final decision is posted on the CMS Web site athttp://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=234.

Strive To Thrive While Growing Older With HIV

By Dennis McMillan
Published: February 11, 2010

Nelson Vergel. Photo by Rink.

Positive Force will present “Survivor Health Wisdom: Strive to Thrive While Growing Older with HIV” on Wednesday, Feb. 17, 6:30-9:30 p.m. at the San Francisco LGBT Community Center, 1800 Market and Octavia Streets. Join Nelson Vergel, author of Built to Survive, for the latest information on lipoatrophy, combating premature aging, and much more. A light dinner will be provided. To take advantage of the fact that Vergel will be in the Bay Area for a conference, Positive Force scheduled this event on the third Wednesday of the month. Twice annually, Positive Force produces a community health forum on a hot button issue. “Survivor Health Wisdom…” is a Positive Force community health forum.In this instance, they decided to do a forum on HIV and aging. The face of HIV changes with each passing day. For example, thanks to treatment advances, many people living with HIV today are living longer lives. Along with longer lives come the usual health concerns: increased risks for heart disease, non-HIV related cancers, bone loss, decreased mental function, etc.
However, a plethora of recent research has clearly demonstrated that people living with HIV are suffering from accelerated aging; sometimes their minds and bodies manifest problems decades earlier than their HIV-negative counterparts. Consequentially, researchers, medical providers, treatment advocates, and HIV-positive people alike are trying to figure out how to conquer this new phase of living with HIV.Many community forums on HIV and aging involve doctors and other socio-medical professionals speaking clinically, and providing the same information, from the same point of view, time and time again. Positive Force decided to move in a different direction. They invited Vergel, a man who has lived with HIV for more than two decades and who is an internationally renowned treatment advocate, to discuss HIV and aging concerns from a peer perspective. Vergel has traveled the world talking about living and thriving with HIV; has written books on the topic; and has been featured in numerous publications for his expertise and perspective.
Participants who attend the forum will benefit from Vergel’s unique perspective, presentation style, and lots of information. He will present the latest treatment information, both clinical and practical, for a range of subjects, including but not limited to lipodystrophy/ lipoatrophy, accelerated aging of both mind and body, and sexual health. Forum attendees will walk away with a better handle on how to deal with problems they may already be facing and how to prevent new problems associated with HIV and aging.Vergel is a 27-year HIV survivor, Venezuelan, retired chemical engineer, lecturer and author of Built to Survive, founder of the Body Positive Wellness Clinic in Houston, and treatment activist involved in research advocacy. Bay Times interviewed him recently. “I am the founder of pozhealth at yahoogroups.com, the largest online health discussion group, and serve as an expert at thebody.com, the HIV web site with the largest reach in HIV related health issues,” he said. “I have provided over 600 lectures since 1994 in English and Spanish. I am a member of the DHHS HIV Treatment Guidelines Panel. I have presented in many conferences about issues related to living with HIV.”What is different about what he does is his being able to lecture in layman terms by blending the latest research data with a patient perspective.
He spoke of the hot topics in HIV in the next five years. “The search for a cure using stem cell and immune based therapy research will become more important as well as how to deal with long term effects of HIV medications on aging, frailty, cognitive function, bone density, frailty, body changes, and others,” said Vergel. “Combating stigma and dealing with challenges in funding will be essential to controlling the spread of this epidemic.”Vergel provides a unique angle to patients. He speaks in their language about the latest research findings on facial lipoatrophy options, cardiovascular health, sexual dysfunction, hormonal balance, exercise and nutrition, latest HIV medications for those with limited treatment options, side effect management, and many other issues that are important to patients.