Health and Prescription Medicine Insurance Denials

Information and Resources for Appeals

The majority of people with hypersomnias in the U.S. will experience a denial of coverage by their health and/or prescription medicine insurer. According to the Hypersomnia Foundation’s 2019 Idiopathic Hypersomnia (IH) Drug Challenges Survey, almost 72% of respondents were denied coverage for a medicine during the previous two years. Of those who filed appeals, a little over half successfully overturned the denial and won coverage. We’ve gathered information and resources from those who have won their appeals to develop this web page. With the information in this section, you will be able to build a strong case and improve your chances of getting coverage. While coverage for prescription medicines is the most common insurance issue for our community, the information on handling denials can be applied to other health insurance claims for hypersomnias or other health conditions.

We strongly encourage everyone to use the appeals and formulary exception processes available to them. If you discover a new resource or argument that helped you win your appeal or formulary exception request which is not listed on this web page, please email us at . While the information on this page is geared towards the U.S. system of health insurance, we hope that those in other countries may find the information and references useful when filing appeals with their local insurance system.

Back Coverage for Cost of Medication During Appeal

If you choose to pay for your medication out of pocket while appealing for coverage, be sure to file for back coverage if you win your appeal. Keep receipts so that you may submit claims for reimbursement.

To find the lowest out-of-pocket cost while you are paying for the medications yourself, go to our webpage on Saving Money On Prescription Medications to find out about shopping strategies, discount programs, patient assistance programs and more.

Sources of Insurance Appeal Information and Support

While this web page provides a concise overview of the appeals process, there are a few important sources with more extensive information and step-by-step procedures for winning appeals. If you are appealing an insurance denial right now, here is a list of resources that members of our community have used to navigate the process and win their appeals: 

  1. One the most comprehensive resources describing the prescription medicine appeals process is authored and maintained by the non-profit organization the Patient Advocate Foundation. The PAF Guide to Navigating the Appeals Process provides a detailed overview of the appeals process. PAF also maintains a PAF Education Resource Library containing many resources on topics related to insurance and disability.
    In addition to written materials, the Patient Advocate Foundation (PAF) provides personal assistance to those with serious or chronic diseases. If you have questions about appeals that the Guide does not answer, you can call the Patient Advocate Foundation at 800-532-5274. If you need more than just an answer to a question, PAF also provides case managers who help patients navigate insurance appeals and financial challenges. PAF case management services are provided at no cost to patients.
  2. If you want to know how to win an insurance appeal, an excellent source is the book “APPROVED: Win Your Insurance Appeal in 5 Days” by Laurie Todd, an insurance appeals expert. Laurie won her first appeal for herself to get coverage for high dollar treatment which had been denied by her insurance plan. She has since helped hundreds of others in similar situations and wrote the book so that everyone can learn from her experience and methods. If you have filed an appeal and lost, it is likely time to read this brief and extremely helpful book. You can find out more and buy the book at Laurie’s website theinsurancewarrior.com. At least two Hypersomnia Foundation community members with idiopathic hypersomnia have used this book to win insurance coverage for Xyrem after having lost their initial appeals. For examples of appeals prepared using the methods in this book, see the Example Appeal Letters section below.

    Author Laurie Todd, while assisting the Hypersomnia Foundation with the development of this web page, shared her passion for helping people win insurance appeals with these encouraging words:
    “The insurer doesn’t care if we need a treatment. They don’t care if the doctor says we need a treatment. There is only one question that any insurer cares about when deciding whether to approve a treatment: ‘Are we required to pay for this—per the terms of your contract?’
    You are the one who holds the contract. YOU—not the doctor, the employer or the insurance commissioner—are the only one who has power over the insurance plan. I encourage you to claim your power and win your appeal.
    I wrote APPROVED in 2018 so that all of the tips and tricks that I have developed over sixteen years of writing and fighting appeals would not be lost. All of the information is there if you need it. However, you could do one-tenth of what I do and probably still win your appeal. Take what you need and leave the rest.
    Go into the appeal process saying, ‘I will do my very best, according to my abilities. And I will win—because success is the only option.’
    At the time when we feel the most vulnerable—taking on the insurer and winning an appeal can restore our power and our dignity. I invite you to feel the joy that comes with winning your own appeal.”
  3. If your insurance coverage is provided by an employer, it may be a good choice to reach out to your manager or the HR department for assistance with prescription medicine coverage issues. If your appeals have been denied and the loss of access to medications is affecting your ability to work or causing the health of a family member to deteriorate, explain the situation and make the case that paying for the medication will benefit the company when their employee is able to be present and productive.
    A word of caution—while some members of our community have had a positive experience approaching HR or management at their employer, others have reported that their company was unwilling to assist with resolving an insurance denial. If the company is self-insured, any coverage approval means a direct and immediate increased cost to the company. If the company is not self-insured, coverage approval may still lead to increased insurance costs to the employer when their health insurance contracts are next updated. Another consideration is that management and/or HR will become aware of your or your family member’s diagnosis and the cost of your treatment.
  4. The Center for Medicare and Medicaid Services provides assistance for program participants.
    For Medicaid patients, state ombudsman programs can provide information about appealing claims denials. Find a link to your state’s Medicaid program here.
    Medicare.gov provides information for Medicare patients preparing appeals for medical care and medicine coverage appeals. Every state also provides a State Health Insurance Assistance Program, often referred to as SHIP offices. SHIP offices provide localized, personal counseling on all topics related to Medicare, including complaints and appeals. Find your SHIP office here or call 800-633-4227.

Basics of Appealing a Health Insurance or Prescription Medicine Denial

After receiving a denial letter, your first step is to quickly find the benefits book for your particular insurance policy (most insurers have numerous policies with different books/rules) and look up the section on the appeals process. The benefits book can be found by logging into your insurance company’s website or by an internet search. If your insurance is provided by an employer, HR should be able to help you obtain the correct specific benefits book. The appeals process section of the book will describe in detail the steps and timelines for appealing the denial.

The next step is to get organized! Start a folder to store all documentation. The first entry in the folder is your denial letter from the insurance company. Keep a copy of all correspondence in the folder, including emails and detailed notes of any phone conversations. Be sure to date all documents/notes and record the name and contact information for anyone involved in the appeal.

As soon as possible, contact your doctor to inform them of the denial and request their participation in the appeals process. Discuss with your doctor whether they intend to file an appeal or whether they will be supplying you with information for your own appeal. Information provided by your doctor that you will want to reference in your appeal may include relevant medical records, copies of medical journal articles supporting the treatment, and a Letter of Medical Necessity. A Letter of Medical Necessity is the formal medical judgement of a licensed physician as to why a patient needs a specific treatment and why other treatments are not appropriate. For more information on the format and contents of Letters of Medical Necessity, see this article.

One key strategy is to request urgent/expedited appeals, as this can help avoid the delay tactics often used by insurers. The process for requesting expedited/urgent appeals can be found in the benefits book. Typically, the insurer requires that the treating physician write a brief letter (see our Example Expedited Appeal Request letter) explaining that a delay will be harmful to the patient and requesting urgent/expedited appeal processing.

Your doctor may appeal a denial by submitting an appeal letter directly to your insurance company. You may choose to make it easier for your doctor by developing a draft for them to edit and submit. AppealTraining.com is an organization that provides education and example appeal letters for physicians, and they have developed a 5-part approach to physician appeals, which you may use as a guide for writing the draft.

If your doctor writes an appeal letter, some insurance companies may ask you to sign a form saying that the doctor is appealing on your behalf or as your authorized representative. Do not sign this form! If you do and the doctor’s appeal does not result in an approval, the insurance company may say that you may not appeal further because you have given your right to appeal to the doctor as your authorized representative. If you have not signed a form giving your appeal to your doctor, you will still have the right to file your own appeal as guaranteed by the Affordable Care Act.

Peer-to-peer reviews, in which your doctor talks with an insurance company “peer” to make verbal arguments for your case, may or may not be offered by your insurance company. Unfortunately, the doctors hired by insurance companies are almost never expert in your particular medical condition, making it difficult to have a truly peer-to-peer discussion with a qualified doctor representing the insurance company. Unless this review is specifically mandated by your insurer (which is not usually the case), don’t worry if your doctor prefers not to participate in a peer-to-peer review or does not feel comfortable doing so.

If your doctor chooses not to appeal or their efforts are denied, then it is time for you to exercise your right to appeal. There are typically two or three levels of patient appeals:

  1. The first level of appeal is an internal review by the insurer and is guaranteed to you as a right under the Affordable Care Act. Appeal forms and letters provided by you and your healthcare provider are reviewed by coverage decision panels or first-level decision makers.
  2. If you are denied coverage in the first appeal, there is sometimes an opportunity for a second internal appeal by the insurance company. (Second internal appeals are not guaranteed as a right under the Affordable Care Act.) While second internal appeals used to be common, many insurers no longer offer a second appeal. Regardless of whether a second internal appeal is offered, at this point it is likely best to consider proceeding to the process outlined in Laurie Todd’s book “APPROVED” (referenced above). Laurie’s book tells you how to take your case to the top decision-makers, instead of the lower-level appeal panels or decision-makers. Even if you think you have used up your appeals, there are almost always ways to make another appeal.
  3. If one or both internal appeals are denied, you have the right to appeal by external review. At this level, your appeal is reviewed by a third-party reviewer, not by employees or contractors of the insurance company. However, this process is often not as “independent” as it seems, as the third-party reviewers are hired and paid by the insurance company. It is very likely that the reviewers will not have any training or experience in sleep medicine or follow current medical practices. Instead of pursuing an external appeal, it is likely best to proceed to the appeal process outlined in Laurie Todd’s book “APPROVED”. If you do decide to file for external review, know that the process for external reviews is different for each state. For basic information on external reviews and how the process works in your state, see this web page at healthcare.gov.

Appeals for Specific Denial Reasons

Denial letters from insurers are required to state the reason that coverage was denied for the medication or procedure. There may be multiple reasons for a single denial of coverage. In the following sections, we will list common reasons for denial of coverage for hypersomnia medications and provide information and resources that you and your doctor may use as evidence or arguments in your appeal.

Insurers use step therapy programs to reduce the costs of medicine coverage by offering to cover cheaper medicines instead of a more expensive medicine. Step therapy programs require patients to try cheaper medicines first, before “stepping up” to more expensive medications.

If you have already tried the cheaper medication and it has not worked for you in the past, you may appeal the original decision to try and avoid step therapy. In some cases, cheaper medications may lead to health risks or exacerbate other health conditions. Make sure your doctor is informed of any previous experience you have had with the medication or similar medications so that they may have enough evidence to write a strong appeal.

If you do not have a record of trying the cheaper medicine, you will likely have to participate in the step therapy program. In the Hypersomnia Foundation’s 2019 IH Drug Challenges Survey, about 10% of people who experienced step therapy found that the less-expensive medicine worked well for them. For those that do need to step up to the originally-prescribed medicine, your doctor will need to make a case that you have “failed” treatment on the cheaper medicine and that the more expensive medicine is medically necessary for your treatment. If you complete step therapy and the cheaper medicine does not work for you but your insurance company continues to deny coverage of the originally-prescribed medicine, then the regular appeals process is available to you. If you have tried and failed the cheaper medicine, then the denial letter should provide a new reason for denying coverage.

Every prescription medicine program has a list of medicines covered by the policy, called a formulary. It is possible that your prescription medicine insurance company does not include the medicine on the formulary. If this is the case, your application for coverage will be denied and the reason given will be that the medicine is not covered by the policy formulary. To check whether a prescription medicine insurance plan covers your medicine, see “Is My Medication Covered? Checking if Your Medicine Is on the Formulary” on the Health and Prescription Medicine Insurance web page.

In this case, you may apply for a formulary exception. A formulary exception request is filed by your doctor with the insurance company. The request explains why you cannot take the medications on the formulary and why the requested medication is medically necessary. For more information visit the PAF Education Resource Library, choose the category “Health Insurance: Learning and Exploring”, then choose the Educational Topic “Affording Medications & Your Formulary”.

Before writing your request, we recommend that you find a copy of your insurance policy and look up the section that covers formulary exception requests. Find out what you need to prove in your request. Your request should provide ample evidence that this medicine is medically necessary (more details in further appeal arguments below) and covered under the terms of the insurance contract.
 

The Medication Is Not FDA-Approved for the Diagnosis or Is Stated to Be Not Medically Necessary

When writing an appeal for a medicine not FDA-approved for the diagnosis, it is important to provide evidence that this medicine is:

  1. Commonly used to treat this diagnosis on an off-label basis
  2. Appropriate for the patient given their medical history, comorbidities, and/or problems with other types of medications
  3. Safe and effective when used to treat this condition

In addition to providing medical records, you and your doctor may need to refer to medical literature that relates to the appropriate use of a medicine for the treatment of your diagnosis. The insurance company may require one or two medical journal articles demonstrating that the medicine is safe and effective in treating your diagnosis. Following is a list of literature that supports the use of specific medications to treat IH and related disorders. While most of these links access the full-text version of the article, some link to a summary version of the article called an “abstract”. If your appeal only requires you to list articles supporting the use of your medication for your diagnosis, the abstract may be all you need to provide a reference or relevant quote. If you need the full-text version, you can access the full-text article through your doctor’s office, through the library at a nearby hospital or university, or by purchasing a copy outright. 

Overviews of Medications for IH and Other Central Hypersomnias (each covers the use of multiple medications)

Pitolisant

Modafinil

Methylphenidate and Modafinil

Sodium Oxybate

Amphetamines

Clarithromycin

Flumazenil

Mazindol

Levothyroxine

Transcranial Direct Current Stimulation

When writing an appeal letter asking for approval for an off-label prescription that is FDA-approved for narcolepsy, you and your doctor may choose to point out that IH and narcolepsy type 2 are thought by many experts to be the same disorder. By demonstrating the overlap between diagnoses and that standard clinical practice is to prescribe the same medications for IH that are used to treat NT2, the appeal may then argue that coverage for IH medications should be approved as they would be for narcolepsy patients.

In the Example Appeal Letters section below, the letters include examples of this argument and several relevant journal article references.

Your own sleep diary and at-home monitoring of symptoms and side effects can be very useful information during an appeal. If you are taking a medicine and can collect personal health data on either positive or negative effects of a medicine, this can provide important evidence supporting your need to stay on a medicine or switch to a new medicine. We recommend submitting any collected data to your doctor, who can then include it in your official health record. The insurance company is much more likely to consider data from your official health record than data submitted by a patient outside of their medical records. Once the data is in your health record, then both you and your doctor may refer to it in official statements to the insurance company.

Following are some examples of how to collect personal health data to use in an appeal:

  • If you are taking a medication as part of a step therapy program and experiencing side effects, start a daily medication and side effect log. For example, if you are on a stimulant and you believe it is affecting your heart rate and blood pressure, buy a blood pressure cuff at the pharmacy and record your vitals before and after taking the stimulants. You may want to discuss this plan with your doctor to find out the best times for testing your vital signs. This data should be included in your medical record as evidence that the medication has negative impacts on your health.
  • If you are on a medication currently but are concerned that you may be denied coverage or may have to change insurance companies in the future, think of a way to capture data on the benefits provided by the medicine. For example, if you are currently taking a medicine that allows you to wake up earlier in the day or take shorter naps, create a sleep diary and collect 30-60 days of data on your sleep and wake times while on the medication. If you do lose coverage for the medicine in the future, collect another 30-60 days of data of your sleep and wake times while you are not on the medicine. By comparing the sleep patterns of the time periods on and off the medication, you will demonstrate the benefits of the medication.
  • Since Xyrem may improve sleep consolidation and increase NREM3 (deep) sleep, it may be worthwhile to invest in sleep tracking technology in order to demonstrate the benefits of this medication. A few wearable devices such as certain models of Apple watch and Fitbit include sleep tracking that provides total sleep time and the amount of time in NREM3 sleep. If you are already taking Xyrem and are concerned about losing coverage in the future, proactively purchasing a device and collecting data does require an investment in time and money, but it may pay off if you lose coverage and are able to appeal successfully by demonstrating the benefit of the medicine.

While it is true that most medications used to treat IH are not FDA-approved for the diagnosis, Xyrem is a special case in that it has been given an “FDA Orphan Drug Designation” specifically for the treatment of IH. Some insurance policies specify that the use of an orphan medicine is considered to be medically necessary to treat a rare disease for which the medicine has received an FDA orphan designation. Look in your policy for a section describing coverage for off-label prescriptions, orphan medicine use, or rare diseases. If you find your policy does cover FDA orphan designated medications for rare diseases, quote this policy in your appeal and include a link to the FDA Orphan Drug Designation database, which is at Search Orphan Drug Designations and Approvals (fda.gov). In the search field “Generic name”, type in the generic chemical name for Xyrem, which is gamma-hydroxybutyric acid. A screenshot of the search result is shown below:

Many insurance companies will not pay for flumazenil to treat IH; however, a few will do so, often as part of their coverage for compounded medications. A first step is to review your insurance policy to determine if compounded medications are covered. Given that there are very few pharmacies in the U.S. that compound flumazenil, we understand from some patients that they have successfully argued with their insurance companies that they must cover the available compounding pharmacies as in-network, on the grounds that the insurance company can provide no in-network options for coverage.

If your claim is denied because the insurance company claims that flumazenil is experimental (i.e., not FDA-approved or medically necessary for your disorder), you may argue that flumazenil is used in current clinical practice, especially for treatment-refractory patients (i.e., patients in which many medications have been tried without success). The two journal articles below include flumazenil as a treatment option for IH. Only the abstract for each article is available on-line, so you will need to access the full-text article through your doctor’s office, through the library at a nearby hospital or university, or by purchasing a copy outright.

You may also argue that there are two specific journal articles demonstrating the effectiveness of this medication for IH:

You may also argue that flumazenil is less expensive than many other current therapies for IH and therefore less expensive for your insurer to cover. You may be able to find further information on appealing successfully via support groups, such as Facebook’s Flumazenil for Hypersomnia.

General Appeal Argument: Outdated Treatment Guidelines and Inexperienced Reviewers

Insurance companies employ doctors to make coverage decisions using treatment guidelines which describe the first- and second-line medications that doctors recommend for the treatment of a specific disease. When reviewing claims for rare diseases, the doctor making the decision is often from a different medical field and has little knowledge of the rare disease or current treatments. The treatment guidelines used in the decision-making process may be years out of date and fail to include recently approved medications or current clinical recommendations.

If your appeal is denied, you have the right to obtain information about the credentials of the doctor(s) who made the decision and the treatment guidelines used. It is your right to obtain this information, along with any other information in your claim file. If your initial requests for information about the doctors conducting the reviews and treatment guidelines are not very quickly answered, immediately send a letter formally requesting the information (see our Example Claim File Request letter). By sending the letter via registered mail with return receipt, you will have documentation that your request was received.

If the doctor is not experienced in sleep medicine and/or the treatment guidelines are out of date, include this information in your next appeal along with information on the current treatment guidelines and a request for review by a doctor with training and experience in neurological sleep disorders. Journal articles covering current treatment for idiopathic hypersomnia and related sleep disorders are listed above in the section titled “Appeal Argument: Demonstrating Medication Is Safe and Effective for the Diagnosis.”

Example Appeal Letters

Both you and your doctor may submit letters in the appeals process. While the Patient Advocate Foundation resource A Patient’s Guide to Navigating the Insurance Appeals Process includes tips on writing effective appeal letters and example letters, we’ve provided some example appeal letters written by people with IH and their doctors. The Xyrem Example Appeals B and C were written using the process outlined in Laurie Todd’s book “Approved”. These letters include several examples of arguments to overcome insurer reasons for denial and include numerous references to relevant journal articles. While these appeal letters are long and exhaustive, a shorter letter may very well be sufficient for your particular situation. We’re including these longer letters to make it easier for you to choose those arguments that will work best for you.

Please keep in mind that because these letters are real examples, they are specific to the individuals who wrote them, including their specific diagnoses, health information, medication, gender, age, etc. As you craft your letter, you will of course make it specific to your personal health and insurance situation, but you may choose to use some of the arguments, language, structure, references, etc. from these examples. Many of the arguments are not specific to the medication, so we recommend reviewing these example appeal letters regardless of the medication or treatment you are appealing.

Xyrem Example Appeal ATwo brief letters written by a physician, an initial appeal and a followup appeal
Xyrem Example Appeal BWritten by a patient using the process outlined in the book “APPROVED: Win Your Insurance Appeal in 5 Days”
Xyrem Example Appeal CWritten by a patient using the process outlined in the book “APPROVED: Win Your Insurance Appeal in 5 Days”

We are looking for more example letters to share on this page, especially letters covering medications other than Xyrem. If you have a letter that was used to win an appeal and you think it may be appropriate to share on this page, please email .

Your Options If All Your Appeals Are Lost

If you’ve exhausted all of your appeals and are unable to obtain insurance coverage for your medication, your first concern will be finding ways to access the medication at an affordable price without insurance. For information on the many programs available to you to find the lowest out-of-pocket cost, go to our web page on Saving Money On Prescription Medications to find out about shopping strategies, discount programs, patient assistance programs and more.

Another strategy is to switch to a new insurance company at the next opportunity (either during annual enrollment or if you experience a qualifying life event), then immediately submit your prescription for coverage to this new company. If possible, consider choosing an insurer that has covered your medicines in the past, as this will give you a good argument for precedence if your coverage is denied. Hopefully it will not be denied, but if it is, use the resources and example appeal letters on this web page to prepare a strong appeal. If you haven’t already, consider reading Laurie Todd’s book “APPROVED: Win Your Insurance Appeal in 5 Days” to learn the strategies for preparing the strongest possible appeal.

Additional Resources

  • The Global Genes RARE Toolkit, Navigating Health Insurance, covers all aspects of health insurance, including selecting a policy, appealing denials, and accessing medications at an affordable price.
  • The Global Genes RARE Toolkit, Financial Advocacy in Rare: Navigating the U.S. Health System for Young Adults, includes basic information on finding health care and insurance coverage with a special focus on the needs of young adults with rare diagnoses. The Toolkit also includes sections on dealing with insurance company denials, plus tips on accessing and saving money on treatments.
  • The National Organization for Rare Disorders (NORD) created the webinar “How to Make Your Health Insurance Work for You.” The webinar includes information on working with your insurance company through an appeal. See this HF article for links to the webinar and related resources.
  • GoodRx has published an article on what to do if your insurance doesn’t cover your medicine.
  • Disability Rights Legal Center is a non-profit, public interest advocacy organization that champions the civil rights of people with disabilities as well as those affected by cancer and serious illness.