Dear Members and Friends of VSI,

We have all experienced the tremendous frustration, or at least heard stories from others, about hitting a brick wall with insurance reimbursement for vitiligo treatments. Having vitiligo already places a high burden on patients, and adding the barriers patients face in obtaining reimbursement increases that burden greatly. Know that you are not alone! Vitiligo Support International is on the front lines, gauging the problems vitiligo patients face with reimbursement and offering you the tools to guide you through the maze of insurance reimbursement and increase your chances of success when requesting reimbursement and/or appealing denials for a claim.

VSI sent out a survey to its membership last fall to better understand the difficulties faced by vitiligo patients with insurance reimbursement, and we learned about some interesting trends. (See survey results below.) We also have been gathering information from many of you about your difficulties and your successes. This way, we can use your experiences to help others and better understand the insurance landscape so we can begin to strategize about how to change it.

Wouldn’t it be great to have all of the information you need for handling insurance claims at your fingertips? We wanted to offer you answers to your many questions that come in to our office and through our message boards, and provide you with top resources on insurance reimbursement. Even better, we wanted to make that information easily accessible by placing all the information in one location, that you need to make your quest for reimbursement. We have included tips on insurance and sample letters for appealing a denial.

VSI can provide you with the information you need, but YOU provide the key to your success. Be an empowered patient! Educate yourself, and be proactive. If you take charge of your care, your chances for success are increased significantly. VSI is here to help you do just that. We’re committed to increasing your access to insurance coverage and have provided the tools you need to get started.

Sincerely,

Jackie Gardner
Executive Director

Advocacy Update
Your Investment at Work!

VSI Director Jackie Gardner recently attended the 2014 American Academy of Dermatology Annual Meeting in Denver, Colorado. In addition to attending the vitiligo medical education sessions, she addressed the Vitiligo Working Group (VWG), an international panel of esteemed researchers and clinicians committed to improving current treatments, increasing research efforts, and perhaps most importantly, gaining a better understanding of what patients want and need.

The focus of Ms. Gardner’s presentation centered on the many challenges faced by vitiligo patients, including such topics as the lack of understanding by many in the medical field of the emotional impact of the disease; the inequality of access to treatment; the burden of the expense of treatments, coupled with problems presented by denial of insurance coverage; and the need for additional financial support of VSI to enable better representation of the needs of the vitiligo community.

While attending the VWG meeting, Ms. Gardner had the opportunity to hear an update on the clinical trial for Scenesse, developed by Clinuvel.

After the meeting, she took a moment to speak with Clinuvel’s CEO and Director, Philippe Wolgen.

Tackling Health Insurance
and Reimbursement for Vitiligo Treatments

Obtaining insurance coverage for the most basic and standard medical treatments for vitiligo can present a major challenge. The insurance industry often labels such treatments as being merely “cosmetic” rather than medically necessary, and they use this description to deny claims. Vitiligo patients face a much more difficult battle than those with similar diseases, because standard treatments for vitiligo are not FDA-approved for vitiligo. In comparison, those same treatments might be approved for psoriasis, psoriatic arthritis or alopecia areata. Ideally, companies would engage in randomized, placebo-controlled clinical trials for these treatments using vitiligo patients and request FDA-approval for those that demonstrate positive outcomes. Unfortunately, once a therapy is approved for a similar disease, companies have little incentive to spend the millions of dollars it would take to enter trials for vitiligo. This often leaves the vitiligo patient scrambling for insurance reimbursement for treatments that are considered off-label.

Denials for vitiligo patients most often are attributed to the insurance company designating a therapy as cosmetic, not medically necessary, and/or being experimental or investigational in vitiligo and prescribed as off-label use. Statistically, about 40% of appeals are successful, so VSI urges you to always appeal a denial.

2013 VSI Survey on Insurance Reimbursement

VSI surveyed vitiligo patients in the fall of 2013 about health insurance and reimbursement rates. Respondents cited a wide range of affiliation with specific insurance companies, and the insurance company did not appear to affect the outcome of coverage. Overall, the responses VSI received reveal some interesting trends:

• Astoundingly, all of those who appealed insurance denials reported receiving at least partial reimbursement.
  
  
• On average, 68% of those who applied for insurance for any vitiligo-related treatment were denied reimbursement on the first application.
  
  
• More than twice as many applicants were denied coverage than accepted for both home light therapy and topical non-steroidal immunomodulators such as Protopic® or Elidel®.
  
  
• Only 1 out of 5 applications for laser therapy reimbursement was accepted on the first try. More people were denied coverage for laser therapy than any other therapy (80% for initial applications).
  
  
• Topical steroids as well as light therapy provided in the office setting were the treatments most likely to be covered by health insurance.

Table Showing Results of 2013
VSI Survey on Insurance Reimbursement

Tips on Applying for Insurance Reimbursement

1. Know your insurance policy and what it covers.

• Diagnosis is billed using the International Classification of Diseases (ICD) coding system. The diagnostic code for vitiligo is 709.01.
  
  
• Investigate how your policy handles a specific treatment. For example, for a home light unit, the policy needs to include Durable Medical Equipment (DME) coverage.
  
  
• Note whether prior authorization is needed for a therapy.
  
  
• Understand any co-pays and how much you will be expected to contribute to the cost of a therapy.
  
  
• Know whether your insurance company requires “step therapy,” which means you must try and fail one therapy before the next level of therapy can be covered.

2. Do your homework before submitting a claim.

• Some treatments require pre-authorization. Be aware whether this is the case with your therapy.
  
  
• Many light companies recommend that you let them file the claim.

3. Make sure your medical records are accurate.

• Maintain copies of your medical records. You have the right to receive copies of all of your medical records. Note that you can be charged a copy fee.

4. Include a Letter of Medical Necessity.

• See sample “Letter of Medical Necessity for Home Light Therapy” below. Sample language for alternate therapies for vitiligo patients can be taken from the sample appeal letters below.

5. Always appeal denials!

• Appeal a denial at every level. Most vitiligo patients receive at least partial reimbursement upon appealing a negative decision from their insurance company.
  
  
  • When appealing a denial:
    
    
• Be persistent! Don’t give up!
  
  
• Involve your doctor in helping you respond to a denial.
  
  
• Documentation is crucial! In addition to making sure you have the necessary documentation showing that your case meets the insurance provider’s guidelines and demonstrates medical need, maintain records of your communication with the insurance company. Document every time you speak or hear from a company representative; Record the person’s name, date, time and key messages from the conversation.
  
  
• Familiarize yourself with your insurance company’s guidelines and deadlines for appeal. This information is usually included in the denial letter.
  
  
• Understand why you were denied, so you can address the insurance company’s reason(s) directly.
  
  
• If you are communicating with the Customer Service office of the insurance company and are dissatisfied with the response, ask for a Nurse Case Manager or a Supervisor who might be more understanding of your situation.
  
  
• If you did not previously include a Letter of Medical Necessity, make sure you include one for the appeals process.
  
  
• When possible, demonstrate that treatment is more cost-effective than alternatives or non-treatment. See sample language in the information provided on the Letter of Medical Necessity.
  
  
• If you are still denied following the final round of appeals for a prescription treatment, contact the advocacy or patient assistance program for the company that produces the treatment. Most companies have divisions that take applications for financial assistance for their therapies.
  
  
• If you are unsuccessful with the appeal process, consider contacting your state insurance commission. Information can be found at www.kff.org/consumerguide/7359.cfm.

How to Draft an Appeal Letter

Include the following information and documentation:

1. Your policy and claim numbers, employer name if your policy is through an employer, and the full name of the insured
   
   
2. The therapy or procedure for which you were denied and why the denial letter stated you were denied
   
   
3. Medical records that back up your diagnosis and medical problem that relates to the therapy in question
   
   
4. A cost-benefit analysis when relevant - For example, you can compare the cost savings of purchasing home light therapy equipment compared to the higher cost of receiving light therapy in an office setting. If your office light therapy costs, for example, about $50 per treatment, the annual cost at three times a week would be $7,500. Compare the $7,500 cost for office light therapy to the home equipment cost of about $2,200, and you have demonstrated a savings to the insurance company of more than $5,000.
   
   
5. Letter of Medical Necessity:
   Click Here to View Sample Letter of Medical Necessity for Home Light Therapy
   
   
6. If the Letter of Medical Necessity is not signed by your physician, have your physician provide a letter of support that includes the reason for recommending or prescribing your therapy.
   
   
7. Quotes from your health insurance policy that are helpful to your case – For example, one VSI member stated that her policy cited that coverage was provided for laser treatment in psoriasis patients because the treatment is coded for inflammatory skin disease. By quoting this back to the insurance company and providing documentation that vitiligo involves a similar inflammatory response, the chance for success of an appeal is much greater.
   
   
8. Two or more articles from respected medical journals backing your claim of medical necessity
   
   
9. Refer to the VSI website as an authoritative source of medical information on vitiligo.
   
   

Response to denial designation that a treatment is “cosmetic”:

1. Breast reconstructive surgery is also cosmetic, but usually covered. We recognize the importance of how loss of a breast affects a person’s psychological and social well-being. This is true of the depigmentation that occurs in vitiligo as well.
   
   
2. Wigs for those with alopecia areata require prior authorization as DME but are then covered as a legislatively mandated benefit. Wigs would fall under the “cosmetic” category, but our government recognizes the devastating mental and social consequences of dealing with hair loss. This is true of the depigmentation that occurs in vitiligo as well.
   
   
3. Disease-modifying treatments such as photochemotherapy – psoralen plus UVA therapy or PUVA – are covered for alopecia areata and that and other light therapies are covered for psoriasis and psoriatic arthritis when provided by a physician in a clinic or other outpatient setting. While co-pays might be high, broad acceptance exists for these treatments as medically necessary in closely related diseases. Light therapy is a disease-modifying treatment that is scientifically proven effective, widely accepted in the medical community for treating and managing vitiligo, and access to coverage should not be any different for vitiligo than for psoriasis and alopecia areata.

Click Below for Individual Sample Appeal Letters

1. Home Light Therapy
   
   
2. Office Light Therapy
   
   
3. Laser Treatment
   
   
4. Topical Immunomodulatory Ointment (Protopic, Elidel)
   
   

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What's On Your Mind?

Q. Is it OK to put the topical ointments around the eyes?

1. If you are trying to treat depigmented areas around the eyes, you need to be careful not to get the ointment or cream too close to the eye where it could get warm and possibly leach into the eye. If you are worried, you might ask your doctor about sparingly applying the ointment or cream just below the eyebrow. Many VSI members have reported that after blinking a few times, it seems to spread onto the lower part of the eyelid without getting into the eye.

Q. I am using NB-UVB light, but wearing goggles.  Is it safe to remove the goggles to expose my eyelids to the light?

1. Research has shown that NB-UVB light does not penetrate the eyelid. As long as no psoralen is being used (as with PUVA), the patient is old enough to understand they must keep their eyes closed at all times, and has an annual eye exam, it should be safe to expose the eyelid to NB-UVB light.

Source: Amit G. Pandya, MD, Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas)

Q. Is it true that you can treat vitiligo with dandruff shampoo?

1. Unfortunately, this is not true. There are various skin conditions that can cause “hypo-pigmentation,” or loss of pigment. One of the more common, known as tinea versicolor, is caused by a yeast-type fungus, and as such, is treated with antifungal medications. Because (anti) dandruff shampoos contain antifungal ingredients, many times this type of “over-the-counter” product will clear up a condition like tinea versicolor. Vitiligo is not a skin fungus, and cannot be treated with antifungal medications.

Read more about vitiligo treatments on VSI’s Treatment page

Medical News Updates

Scenesse Found Beneficial for Darker Complexions
Phase 2 to be held in Singapore

Vitiligo patients with darker skin complexions demonstrated the most pronounced benefit in Phase I trials for Scenesse combined with NB-UVB light therapy. This announcement marks a potential breakthrough for vitiligo patients with darker complexions and is especially exciting because of the hope it brings to those with darker complexions and who live in countries in which the negative social stigma of vitiligo is especially devastating. As a result of the Phase 1 results, Phase 2 for the use of Scenesse combined with NB-UVB light therapy will be launched this year in Singapore to more closely observe the results of those with a darker complexion.

Clinuvel Pharmaceuticals Limited announced the launch of the CUV103 trial this winter. The CUV103 trial tests the use of afamelanotide (Scenesse), a repigmentation therapy. The latest trials hope to confirm earlier results showing that a combination of Scenesse and NB-UVB light therapy provides repigmentation at a greater and faster rate than NB-UVB light therapy alone.

The randomized placebo-controlled clinical trial (the gold standard in clinical trials) plans to enroll about 60 patients over a three-month period, and the trial itself is expected to run for seven months with patients followed for an additional 3 months. As in earlier trials, patients in the Phase II trial will receive narrowband ultraviolet B (NB-UVB) light therapy twice weekly in addition to the new therapy, Scenesse. The study will be carried out at the National Skin Centre in Singapore. Assessment will include the use of two prevalent scoring systems for vitiligo and vitiligo repigmentation - the Vitiligo Area Scoring Index or VASI and the Vitiligo European Task Force or VETF, the length of time it takes for repigmentation to occur, digital photography, questionnaires on quality of life, and investigator statements and patient surveys.

The new trial builds on initial CUV102 trials for which results were released in December 2012 and follow-up results published in July 2013. Primary and secondary objectives were met in the initial trial and focused primarily on the extent of repigmentation and, secondly, on the time it took to repigment. No significant safety issues were reported.

Afamelanotide (Scenesse) activates eumelanin in the skin, which is the dark pigment known to provide protective properties against light and UV radiation. The drug is delivered via a dissolvable implant injected underneath the skin. Study design was executed in the U.S. by Henry W. Lim, MD, Pearl Grimes, MD (VSI Medical Board Chair), and Mark G. Lebwohl, MD (President Elect of the American Academy of Dermatology), and in Singapore by Steven Thng, MD. Singapore announced last fall that the Ministry of Health was committing about $100 million for skin research.

VSI has been monitoring this new therapy and keeping you informed about progress via the VSI website and past newsletters. Readers can review the Fall 2013, Summer 2013 and Winter 2012 issues for past reports on Scenesse. Watch for the latest information on clinical trial recruitment in future VSI newsletters.

Potential Target for Vitiligo Treatment Identified

A new potential target for vitiligo treatment has been identified by a team of researchers led by John E. Harris, MD, PhD at the University of Massachusetts Medical School in Worcester, Massachusetts. The target involves a chemokine, which is a protein that is active in the communication between cells and is involved in immune function. The chemokine, called CXCL10, is elevated in the skin and blood of vitiligo patients and has been found to play a critical role in the progression and maintenance of depigmentation in a mouse model of vitiligo. In their study, Harris and colleagues found that mice lacking CXCL10 or that were treated with an antibody neutralizing their CXCL10 had minimal depigmentation. This discovery points to CXCL as a potential target for developing an effective therapy for vitiligo. 

Are Vitiligo Patients More Susceptible
to Developing Additional Autoimmune Disorders?

VSI previously reported on other autoimmune conditions that tend to occur in vitiligo patients in its Summer 2011 newsletter. Now, two studies just out concur with previous investigations showing that vitiligo patients can have additional autoimmune disorders.

The first study, an Italian study published in March 2014, looked at 175 vitiligo patients and found that autoimmune thyroid disease was the most prevalent autoimmune disorder that occurred in vitiligo patients, with 37% of those with vitiligo also having autoimmune thyroiditis. Nearly 42% of all subjects those who underwent laboratory tests had at least one type of autoantibody, or antibody directed against one’s own tissues and help a physician diagnose a specific autoimmune disease. The most common autoantibodies found were two that are involved in thyroid disease, anti-thyroperoxidase (25.6%) and anti-thyroglobulin (23.4%). The next most common were antinuclear antibodies (ANA), which were found in 16.8% of patients and can indicate the existence of other autoimmune diseases such as rheumatoid arthritis or lupus. A smaller percentage of patients (nearly 8%) were found to have anti-gastric parietal cell antibodies which target the stomach and lead to difficulty absorbing B12 and can cause pernicious anemia.

The second study, an eleven year retrospective review of the vitiligo patient population at Henry Ford Health Systems (HFHS) in Detroit MI, was presented at the American Academy of Dermatology conference in March 2014 and examined 1,098 vitiligo patients in the U.S. Similar to the other study, the most common autoantibodies targeted the thyroid, with 12.3% being diagnosed with thyroid disease, 27.1% testing positive for anti-thyroid peroxidase (TPO) and 10.4% testing positive for anti-thyroglobulin (Tg). Antinuclear antibodies (ANA) were found in 18.5% of the vitiligo patients, which is close to the rate of the earlier study. Among those who were tested, autoimmune diseases diseases found with greater frequency were, in order of prevalence, autoimmune thyroid, alopecia areata, inflammatory bowel disease, type 1 diabetes mellitus, pernicious anemia, systemic lupus erythematosus, myasthenia gravis and multiple sclerosis.

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Research & Clinical Trials

Clinical Trial In Arizona for Novel Topical Treatment

Melanocyte-Keratinocyte Transplant Procedure
Opportunity in Detroit!

Clinical Trial in Canada

Editors Note: UVA1 is a relatively new form of phototherapy that has been found to be effective in treating several skin disorders, including atopic dermatitis, localized scleroderma, systemic sclerosis, cutaneous T-cell lymphoma, lupus erythematosus, and others. Side effects (burning, hyperpigmentation, redness, itch, etc.) appear less frequently compared to conventional phototherapy, and none serious that can be traced directly to UVA1 treatment, though long-term studies are not yet available. Instances of UV-induced burning were actually less than with broadband UVB or PUVA treatments. UVA1 is reported to induce immediate tanning and pigment darkening. Responses from UVA1 treatments continue even months after the treatment is completed therefore generally requiring fewer overall treatments. UVA1 units consist of metal halide lamps equipped with special optical filters, which emit longer, more penetrating wavelengths than the fluorescent UVA tubes used with PUVA. Both smaller units to treat localized areas and larger cabinets to treat the whole body are available. Use of UVA1 light units are limited in the U.S., due most likely to the high cost of the equipment, which can be 2-3 times more expensive than conventional whole-body light units.

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