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FACIAL WASTING
Oct 31, 2007

is there any progress in the move to make "facial fillers" less expensive or payable by insurance companies ,medicare medicais?..thanks tony

Response from Dr. Frascino

Hi,

The price for facial fillers has not dropped significantly; however, with new products beginning to come online, we can hope at least some of the older products may eventually lower their markup. (I'll reprint below some information about Radiesse, the newest synthetic facial filler to be FDA approved for facial lipoatrophy.)

As for insurance companies paying for facial reconstructive procedures resulting from lipoatrophy, this continues to be a tug-of-war between the unreasonable insurance giants and the individual HIV-positive patient suffering the consequences of facial deformity. We have won some cases; many more are on appeal. See Michael Moore's movie SICKO to gain a better understanding of how insurance companies deny very reasonable claims for all types of health problems. It's unconscionable and immoral! I'm sure there is a special place in hell for these insurance adjustors. I'll reprint some information from our Lipodystrophy Resource Center that may help folks get their procedures covered.

Finally, I should mention that recently I've seen some impressive results in the treatment of facial lipoatrophy using a surgical procedure called "nasolabial fold reduction," which can permanently remove the redundant cheek folds. This procedure is performed by plastic surgeons.

Good luck!

Dr. Bob

U.S. Food and Drug Administration FDA Approves Radiesse for Treating Facial Lipoatrophy

December 29, 2006

On December 22, 2006, the Food and Drug Administration approved Radiesse, an injectable (under the skin) implant to restore or correct signs of facial lipidatrophy, or fat loss, in people with human immunodeficiency virus (HIV). Radiesse, a sterile, semi-solid cohesive implant consisting of synthetic calcium hydroxylapatite suspended in a gel carrier, is a medical device. It is already approved for use as a tissue marker, for treatment of vocal fold insufficiency, and to correct certain dental defects.

The safety and effectiveness of Radiesse for the treatment of facial lipoatrophy was evaluated in a prospective, open-label, multi-center study of 100 patients with human immunodeficiency virus and facial lipoatrophy. Study subjects were at least 18 years of age, HIV positive, with a CD4 count = 250/mm3 and viral load = 5000 copies/mL, had been receiving HAART therapy for a minimum of 3 years, and had HIV-associated facial lipoatrophy that was a grade 2, 3, or 4 on the Facial Lipoatrophy Severity Scale. The study population consisted predominantly of multi-ethnic, non-smoking males (94% male) with a mean age of 48 years. Forty-four (44) percent of patients were Black, Hispanic or Asian. Fifty-six (56) percent were Caucasian.

Patients received an initial treatment (initial injection and an additional injection at 1 month as needed). Six months later, all patients were assessed for the need for a touch up injection. Effectiveness was assessed at 3, 6 and 12 months from initial treatment by means of a Global Aesthetic Improvement Scale (GAIS) rating, cheek skin thickness measurements, and patient satisfaction assessment. Safety was assessed by the recording of adverse events through 12 months.

All treatments were performed with a 25 gauge, 1.5 inch needle. Mean initial treatment volumes were 4.8 mL for the initial treatment and 1.8 mL at 1 month if necessary (85% of patients were treated at 1 month). At 6 months, the mean touch up volume was 2.4 mL (89% of patients). Four (4) percent of patients received only one treatment, 18% of patients received a total of two treatments and 78% of patients received a total of three treatments. No patient received more than three treatments.

Mean left cheek thickness measurements at baseline was 4.7 mm (N=100). At 3 months, the mean thickness was 7.3 mm (N=100), representing an increase of 2. 6 mm from baseline, with p-value = 0.0001. At 6 months the mean thickness was 7.1 mm (N=97), representing an increase of 2.4 mm from baseline, with a p-value = 0.0001.

Mean cheek thickness at baseline for the right cheek was 4.9 mm (N=100). At 3 months, the mean thickness was 8.0 mm (N=100), representing an increase of 2.1 mm from baseline, with a p-value of 0.0001. At 6 months the mean thickness was 7.5 mm (N=97), representing an increase of 2.7 mm from baseline, with a p-value of 0.0001.

The most common adverse events reported were temporary edema (swelling), ecchymosis (bruising), erythema (reddening) and/or pain at the injection site.

The calcium hydroxylapatite (CaHA) particles in Radiesse can be seen in X-rays and CT Scans. It is important that patients inform their doctor and other health care professionals that they have had Radiesse injected in the face. In a radiographic study of 58 patients, there was no indication that Radiesse potentially masked abnormal tissues or was interpreted as tumors in CT Scans.

Radiesse is a product of BioForm Medical Inc., of Franksville, WI.

INSURANCE TIPS

Your health insurance company (otherwise known as a health maintenance organization or HMO) will do everything in its power to deny you coverage for Sculptra (poly-L-lactic acid, New-Fill) treatments. Here's how one HIVer beat them at their own game.

When Kaiser Permanente, the behemoth health care provider for Californians, announced earlier this year that it would do the right thing by HIVers with lipoatrophy and start reimbursing for Sculptra treatments, it was a hard-won battle by the state's HIVers and their doctors, advocates and lobbyists. If activists like Jim Shea, of Gay Men's Health Crisis (GMHC), have their way, Kaiser is but the first of many HMO dominoes that will fall in the cold war over facial-filler coverage. And you can help heat things up by fighting for your own face. "People shy away from fighting with insurance companies," Shea says. "They think the companies are the be-all and end-all: If they say no, you just say, 'Oh, it's a hassle,' and go away. That's exactly what they depend on you doing."

Shea is the first to admit that it's a hassle: The New Yorker spent the better part of six months on the phone, writing letters, doing research, filing appeals and generally twisting Oxford Health Plans' arm until the HMO said uncle. He got them to agree that his Sculptra treatments were not "cosmetic" -- i.e., an elective surgery to enhance his looks -- but in fact "reconstructive" -- i.e., a medical necessity to restore his normal appearance. "I was determined that if I did nothing else in my life, this was one thing that I was going to prove," he recalls. "Because it wasn't just me -- it was everybody else, too." Oxford, for its part, begs to differ: The insurer made an exception for Shea, but the no-coverage rule still stands, so every Oxford HIVer has to get in the ring. The trick, according to Shea, is to never say die.

"People shy away from fighting with insurance companies," Shea says. "They think the companies are the be-all and end-all: If they say no, you just say, 'Oh, it's a hassle,' and go away. That's exactly what they depend on you doing."Diagnosed in 1986 and on disability for a decade, Shea couldn't afford $10,000 for facial filler, so fighting back was his only option. As soon as the U.S. Food and Drug Administration (FDA) approved Dermik Laboratories' Sculptra for HIV-related lipoatrophy in 2004, making it a legitimate product for medical coverage, Shea launched his campaign. "I needed prior authorization to have this done," he says. "I knew from my experience with dealing with Oxford that if I just went ahead and had it done, chances are I would have wound up never getting reimbursed for it." With the kind of tooth-gritting determination that defines "medical necessity," Shea was primed to jump through Oxford's every last administrative hoop. In fact, the long-term survivor was no stranger to insurance insurrections. In 1999, when the industry was lobbying the state of New York for a 70 percent increase on the premiums of direct payers who, like Shea, have private disability benefits after being employed for decades and therefore don't qualify for Medicaid or an AIDS Drug Assistance Program (ADAP), he testified against the staggering hike at a public hearing.

"A woman from GMHC contacted me. At that point I wouldn't speak before more than two people [because of my lipoatrophy], but she convinced me that yes, in fact, you can beat an insurance company," he says. "A group of us from GMHC spoke that day. After the hearing was over, the rate was rolled back from [a] 70 percent increase to 10 percent." His response? "That was the biggest high I ever had in my life. It just, like, blew my head off!" Call him the Erin Brockovich of lipoatrophy.

Shea went on to become GMHC's resident expert in insurance issues, applying his own knowledge of the appeals process to other cases. Unfortunately, with the advent of Medicare Part D, which allows insurance companies to deny more and more medications to people with HIV, this particular expertise is in increasing demand. Shea's patient and painstaking, even relentless, persistence is the model for any Sculptra coverage claim. "The insurance company at first said they had never heard of the treatment. Then they said it was not approved. We went back and forth on phone calls for a couple of weeks, until I sent them the FDA-approval notice from the Internet," Shea recalls. "At that point, they came back and said that the procedure was considered 'cosmetic,' not medically necessary, and therefore it was not covered." Shea asked what other options he had, and Oxford told him to write a letter -- the old heave-ho. Then he remembered a little thing called an appeal. "They don't bring it to your attention, but there is a standard appeals process when you're denied coverage from an insurance company, and [in New York] it is monitored by the New York State Insurance Department," he says. "The first step is to get a written denial from the insurance company, which is not always easy. They'll say, 'Call this department.' 'Call that department.' They'll give you the runaround." After many frustrating phone calls, Shea finally wrote to Oxford's clinical appeals department that he had been denied Sculptra and wanted to appeal the decision. That got him what he wanted -- the denial in writing.

The goal is to get off the phone and onto paper as fast as possible. And be sure to send a copy to the state. "I automatically sent a carbon copy of all correspondence to the New York State Insurance Department," Shea says. "They write a letter to the insurance company, and the insurance company has to answer them as well as you. It prevents anything from falling through the cracks."

Once you have entered the appeals process' courtroom, your strategy should be to gather as much evidence as possible in support of your argument. In Shea's case, this file ultimately ran to more than 50 pages, including the mandatory letter of medical necessity from his doctor, an additional letter from his longtime psychotherapist detailing the profoundly negative effects facial lipoatrophy had on Shea's mental health and his own personal account. He also included a wide-ranging package of articles he had downloaded from the Internet explaining what causes HIV-related lipoatrophy, how the Sculptra procedure works and how effective it is at improving people's quality of life. "In one article, a parallel was drawn between Sculptra for facial lipoatrophy and breast reconstructive surgery following mastectomies [which is covered by insurance] -- I put that into my appeal," Shea says. "And of course I always referred to the procedure as 'reconstructive' rather than 'cosmetic' surgery."

What could Oxford do but bow before such a display of proof, right? Wrong. "I sent the appeal in, and it came back within a week and a half -- which anybody familiar with insurance companies knows never happens -- and, of course, it was denied again," Shea says. Now it was time to call in the authorities -- by terminating the internal appeals process and initiating the external appeals process. Shea explains: "The state insurance department handles it. They send it to an outside -- I don't want to say 'uninterested party' because, of course, it's people in health care -- but there's nobody from your insurance company involved in that process."

Bingo! This panel of more objective experts ruled, not surprisingly, in Shea's favor, agreeing with him that getting his face (read: life) back was not a cosmetic enhancement after all but a medical necessity. Written by a dermatologist, the decision repeatedly referenced the letter from Shea's psychotherapist.

"They don't bring it to your attention, but there is a standard appeals process when you're denied coverage from an insurance company, and [in New York] it is monitored by the New York State Insurance Department."By any standard, this letter contains some strong stuff, but that is the reality of facial lipoatrophy. "My therapist said I was becoming very withdrawn," Shea recalls. "She also stated -- and when I read it, I was upset until she explained it to me -- that I was starting to have paranoid delusions. About people looking at me, and not sitting next to me on the subway, saying I had AIDS and not wanting to come near me. When I thought about it afterward, I said, 'You know, she's right. Lipoatrophy can have very strong effects that just snowball.'"

Shea advises everyone who is appealing a Sculptra case to come clean about every piece of dirty laundry in their emotional closet. "I have a strong suspicion that people don't put [in] enough about the mental health issues," he says. "I think all of us, when it comes to that stuff, don't really want to share it with other people. But it's key to getting the approval." In other words, it's all well and good for your physician to write that "making this person's face look the way it used to is a medical necessity," but only you can serve up the complete and uncensored five-course meal of misery, panic, humiliation, paranoia, etc., that will drive the point home -- through the heart of your insurance company if need be.

In any event, the external appeals panel's ruling was a partial victory for Shea because it approved only four treatments in the first year, not the full eight his doctor had requested. Still, he's pleased -- to put it mildly -- with the results. "My face looks absolutely 200 percent better than it did before," he says. "I'm able to do a lot more. I had been avoiding anything that required speaking in front of groups, but at the AIDS Walk last year I was able to address the entire crowd. I was only in the middle of the Sculptra process, but I already felt that good about myself."

And when he finished all four treatments, he felt that his face had come back. And more than that. "All of a sudden, it was like, 'I'm back! I felt like myself again,'" Shea says. "That has had such far-reaching effects on me that I still don't understand." Cosmetic? We don't think so. Enhance this, HMO.

FIVE TIPS TO A BETTER APPEAL

Start early. It's likely that you stand a better chance of getting your insurance company to cover Sculptra as a prior authorization (before the treatments) rather than a reimbursement (after the treatments). Plus, your desire to fix your face may make you a more determined opponent than your desire to get your cash back.

Work late. Leave no stone unturned in making your medical-necessity case. Jim Shea's six-month appeal ran to 50-plus pages, including many downloaded articles (start with The Body's entire Lipoatrophy Resource Center) from the Internet and ample documentation of lipoatrophy's costs, psychological and otherwise, by his primary-care physician, his psychotherapist and himself. Be sure that your own account of the negative mental-health effects of facial lipoatrophy is unsparing in its details. Shea's shrink used the phrase "paranoid delusions." It doesn't get much worse than that. Now, does that ring any bells?

Get it in writing. Since your endless phone calls for even routine information are likely to meet with the runaround, save yourself the frustration by preempting the process: Write directly to the HMO's clinical appeals department requesting documentation of their reasons for denying you coverage. Once you have that in writing, the appeals-process curtain rises!

Copy the state. Make it a habit to send a carbon copy ("c.c.") of every written communication you have with your HMO to your state's department of insurance, which is authorized to monitor every step of the process. And since your appeal will probably go all the way to a (state-monitored) external panel of experts, you might as well get on the official radar as early as possible. This is one time when you do want Big Brother watching. Click here for a listing of state insurance departments.

Provide a precedent. An insurance appeals process is not a lawsuit, but showing that your HMO has covered treatment for other HIVers with lipoatrophy shifts the burden of proof, compelling them to make the case against you. According to Shea, Oxford did a 180 on a fellow HIVer's appeal when he included mention of Shea's prior approval. Finding precedent-setting cases may present a bit of a problem, but you can start by posting a query on PWA (person with AIDS) activist Nelson Vergel's e-mail list, http://health.groups.yahoo.com/group/pozhealth/, and contacting your local AIDS organization's insurance department. The news about Kaiser Permanente's pioneering policy of covering Sculptra for facial lipoatrophy should at least send a chill down the spine of your own HMO. Download? You bet.


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