MPNforum Magazine

How not to take NO for an answer…

by Samantha Trahan

Doctors write prescriptions every day, but insurance companies decide who actually pays for the drugs. Prescription co-pays are bad enough. The price of uninsured drugs can be insurmountable. So when an insurance company denies your prescription, how do you fight back? Appeal!

Find out who is running the show. Private insurance companies can run their own prescription drug program under their own rules or they can farm out the prescription side of your insurance plan to a third-party that will apply its own rules. If you’re not sure whose prescription drug rules apply, call the help number on the back of your insurance card and ask.

Watch your deadlines closely. Your right to appeal is a process with important deadlines. Your denial letters will have a deadline by which you must file your appeal. Mark those deadlines on your calendar! You want the fight to be about the prescription – not whether you missed a deadline.

Learn about the process. There can be multiple levels of appeals. Your first appeal will be reviewed by someone within the prescription drug program. If that review results in a second denial, then appeal it again. Your second appeal typically goes to someone higher in the organization. If that review results in a third denial, then appeal it again. It usually takes two, three or even four appeals before your case will be evaluated by an outside third party.

The specific rules governing the Medicare prescription drug plan can be found at: http://www.medicare.gov/claims-and-appeals/file-an-appeal/prescription-plan/prescription-drug-coverage-appeals.html.

Know your last resort. Once you exhaust the appeals process, you typically have the right to file a lawsuit and ask a federal judge to review the prescription denial. The court’s review is limited, however, to the information you submitted during the appeals process. The court will only rule for you if you can prove that the denial was arbitrary and unreasonable.

Ask your doctor’s office for help. Some doctors’ offices have a staff to appeal for you or provide you with help in writing an appeal. No matter who sends in the official appeal letter, you will need a letter from your doctor explaining the medical necessity of the particular prescribed drug for your individual treatment. The more specific, the better.

Write simple, clear letters with backup. Your goal is to convince every person reviewing your appeal that this drug is “reasonable” and “necessary” for your treatment. The internet has a wealth of information. Groups such as MPNForum, MPNresearchfoundation, MPNinfo and Facebook communities have examples that you can copy and articles that you can use as back-up support.

Include an express statement of appeal: I am appealing your decision to deny the prescription drug XXX.

List your diagnosis, the specific drug prescribed and the reason for its necessity.

Attach your doctor’s letter of medical necessity. If you don’t have this letter in time to meet your appeal deadline, state in your letter that the drug is medically necessary and send in your doctor’s letter whenever it’s signed.

If the drug was denied as “experimental” or “investigational,” explain why this is incorrect. If you are unsure how to do this, ask your doctor or a MPN community member for help.

More is better! The higher up you are in the appeal process, the more information you should submit. Attach medical articles that support the use of the prescription for your treatment. Include any state laws that may apply. Many states prevent a prescription drug company from denying a prescription for “off-label” use so long as the drug has been approved by the FDA for at least one other disorder and the drug is substantially accepted by peer-reviewed literature.

Most importantly, don’t give up! You are fighting for your life. The appeal process is as important as every other step in your medical care.

Here,　as a sample template, is a copy of　the letter Samantha sent to Caremark to protest its denial of claim for　her Pegasys prescription. She prevailed.

[date]

[insurance company]

[address]

[address]

[address]

Re:　　　　　　 Plan Participant Name:　　　　　 [name]

Plan Participant ID:　　　　　　　　　　 [ID / or other identifying number from denial]

Please accept this letter as my appeal to Caremark’s decision to deny coverage for the prescription Pegasys for the treatment of Polycythemia Vera.

I was diagnosed with Polycythemia Vera many years ago.　 Polycythemia Vera is a Myeloproliferative Neoplasm (MPN)—a rare bone marrow disease that leads to an abnormal increase in the number of blood cells.　 The goal of treatment is to reduce the thickness of the blood and prevent bleeding and clotting.

From 2005 to present, I have been under the care of Dr. Srdan Verstovsek, Chief of the Section of Myeloproliferative Neoplasms at MD Anderson.　 MD Anderson has become the largest center in the world for MPN research and treatment. Their work has been recognized both nationally and internationally, and Dr. Verstovsek is frequently an invited speaker at most significant hematology meetings worldwide, including annual meetings for the American Society for Hematology, American Society for Clinical Oncology, and European Hematology Association.　 In addition, Dr. Verstovsek has been first or corresponding author on many important publications in the MPN field.

At my most recent appointments at MD Anderson, Dr. Verstovsek suggested I change my medication from Hydroxuyrea to Pegasys due to an increase in uncontrolled disease-related symptoms.　 The requisite prescription was issued and MD Anderson submitted the prescription for pre-approval.

Caremark denied the Pegasys prescription stating that

Polycythemia Vera is not an approvable diagnosis.

Caremark’s position is arbitrary and unreasonable.　 Currently, there are no drugs approved by the Food and Drug Administration (FDA) specifically to treat Polycythemia Vera.　 However, some medicines approved for other diseases are used off-label to treat the signs and symptoms of this condition.　 One such medicine is Hydroxyurea, which I’ve been taking since 2005 without ever being denied by Caremark, UnitedHealthcare or any other insurer or pharmacy agent.　 It is an inexpensive medication, however, with a 90 capsule supply available by prescription for approximately $40-50.

Pegasys is another medication prescribed for off-label use in the treatment of Polycythemia Vera.　 Pegasys is a semi-synthetic form of long lasting interferon-alpha.　 The drug is conveniently given at home once a week by self-injection of a pre-filled syringe. Toxicities are less pronounced and happen less often than with regular interferon-alpha. MD Anderson notes that patient compliance is enhanced due to convenience and better tolerance of side effects than traditional interferon-alpha.　 Pegasys was evaluated in a phase II study at MD Anderson for Essential Thrombocythemia and Polycythemia Vera patients.　 Forty Polycythemia Vera patients participated and 80% achieved complete response, making Pegasys the best medication on the market that can be used off-label as therapy.　 While Pegasys is reportedly the best medication for treatment of Polycythemia Vera, it is not inexpensive.　 A four syringe kit of 180 mcg is approximately $3,000.

Dr. Verstovsek is not alone in recognizing the treatment value of Pegasys and interferon-alpha. United Healthcare has accepted that Pegasys evidence supports the use of Pegasys in patients with MPNs including Polycythemia Vera.　 Numerous MPN specialists have published professional articles showing that Pegasys is effective in normalizing blood counts, reducing the mutant JAK2 allele burden and, in some cases, reversing disease progression.　 Please review the following partial listing.

Note:　 This link to　Dr. John Crispino’s article in the MPN Research Foundation’s newsletter, provides documentation you can use in your drug reimbursement appeal.

Samantha, an attorney who focuses on commercial insurance matters, went on to cite applicable Texas insurance law, something she believes is not critical at this first stage but should be researched for more advanced appeals. She concluded:

“Pegasys meets the requirements of Texas Ins. Code § 1369.004.　 It is FDA approved for at least one indication, has been recognized for the treatment of Polycythemia Vera in substantially accepted peer-reviewed medical literature and is neither experimental nor contraindicated.

Based on this information, please reconsider your previous decision and allow coverage for the prescription drug Pegasys in the immediate treatment of Polycythemia Vera.　 Should you require additional information, please do not hesitate to contact me.　 I look forward to your prompt response.

Very truly yours,

[patient name]

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