How to write a Synagis appeal letter (Part 2)

I have already received a lot of feedback from people who have received their first denial letter wondering if they should use my template to appeal. My answer is always appeal. Did you know that some insurance companies automatically deny Synagis (and other drugs) with the first applications. Yes, an automatic denial never mind how sick your baby is or how many criteria they satisfy. They do this because they know launching an appeal will just be too difficult for some parents. It is just evil.

In the last post I covered Synagis appeals, but left out a few special situations as there is only so much information I can put in one post!

Here are some special situations:

My baby has Medicaid:

In many states Medicaid uses the AAP guidelines (from the 2009 Redbook) so an appeal may also be needed. The big advantage of Medicaid? There should be no automatic denial if your baby meetings the AAP guidelines. However, as MEdicaid varies state to state, what they cover and what they don’t can vary significantly.  Use the same wording as the letter from yesterday that best suits your baby’s situation (recap: the 1rst letter is for a baby that meets the AAP guidelines and the second letter is for a baby who does not meet the AAP guidelines) but instead of ccing the State Insurance Commissioner send a copy of the appeal letter to the State Medicaid Director (use the link to find the name and address for your state).

What if your baby was approved for 1-2 shots and you want the full 5? This is most likely to happen for babies 32-35 weeks.

Following the same instructions from the previous post on meeting all the appeal deadlines and sending a cc to the State Insurance Commissioner (or State Medicaid Director) and use this wording for the body of your letter:

Dear Sir/Madam,

Thank you for approving 2 doses of Synagis for my son John Doe. As you know he was born prematurely at 33 weeks gestation. He spent 3 weeks in the NICU and is now 7 weeks old. His older brother attends day care.

I am appealing the decision to only given him 2 doses of Synagis. An article by Boyce TG et. al. (from the Mayo Clinic), published in the Journal of Pediatrics in 2000, indicates that all premature  infants born at 36 weeks or less are at increased risk for hospitalization due to RSV in the first year of life. The risk of hospitalization is 57/1,000 for babies born at 33 to < 36 weeks, which is almost double the rate for children born at term (30/1,000). The two year prospective PICNIC study (Wang EL, et. al. Journal of Pediatrics 1995) also confirms that relative to infants born at term, in the first year of life, babies born at 36 weeks or less are at increased risk for hospitalization related to RSV and premature babies born between between 33 and 36 weeks are two and half times more likely to need mechanical ventilation compared with a baby born at term.

In addition, the practice of limiting Synagis to less than 5 monthly injections is completely untested in prospective clinical studies and is not supported by the pharmacokinetics and therapeutic efficacy of the drug (IMpact-RSV Study Group trial, Pediatrics 1998 and Saez-Llorens et al. Pediatric Infectious Diseases 1998).

RSV season is here and so I expect to receive your approval for an addition 2 doses of Synagis within 5 business days,


One final point. Some parents are worried about launching an appeal and having the already 1-3 vials of Synagis retracted or denied. I have never heard of that happening, but you never know with insurance companies. Obviously you have to make your own decision about when and if you file an appeal. If your original vials are based on the AAP 2009 Redbook Guidelines then the chance of those being retracted should be zero, but of course I can’t make any guarantees. That, of course, highlights the problem with insurance companies – you pay your money and you still don’t get guarantees.

Best of luck. Please post success stories or problems!

Remember, this blog is not direct medical advice

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6 Responses to How to write a Synagis appeal letter (Part 2)

  1. PAS says:

    I’ve dealt with a fair bit of Synagis, so perhaps can offer some additional information here.

    The majority of insurance coverage determination follows a basic mode: Prior Authorization, then 1st level Appeals (by the plan), then 2nd level Appeals (independent medical review vendor). The first step in getting this covered is to submit a Prior Authorization request. Most plans only permit Synagis claims to be processed during RSV season, so a PA should be sent in about 30 days before the normal start of RSV season in your state.

    Prior Authorization generally has a very rapid turn around time: 24-72 hours, varying by plan and state law. Some plans do not permit PA to review Synagis, viewing it as too complex a drug for this level of review. They may require PA to decline to review it, or issue a denial, accompanied by contact information for Appeals for more sophisticated review – this is particularly common on very small plans, and far less so on very large insurance providers.

    It’s very important to include complete and accurate information in a PA request. In terms of Synagis, this would include:

    Infant’s name, date of birth, and ID number if available
    Mother’s name, date of birth and ID if available (if processed her insurance)
    Primary Prescriber’s Name, DEA/NPI, Phone and Fax *
    The requested quantity and dosing schedule for Synagis
    Gestational time at birth, if premature
    Age at the start of RSV season
    ANY significant comorbid medical conditions, especially the following:
    Chronic Lung Disease (including Type/Tx)
    Major Risk factors (siblings >5, child care)
    Congenital Heart Disease (type, Tx in use)
    Immunodeficiency (Type and severity)
    Abnormalities of airway (eg, Cystic Fibrosis, be specific)
    Neuromuscular disease (Type, be specific)
    The prescriber’s signature.

    *Bad contact info is a major source of problems. Triple check the fax#.
    Remember, if it’s not included, it’s not there. Likewise. Any appeal should contain the above information, as well as a copy of a denial issued by Prior Authorization.

    Likewise, many state laws and individual plans require that an appeal be submitted by the MD. Commercial insurance tends to be more lenient. Many Medicaid programs are particularly strict about this: they want it from the MD’s office, on office letterhead, with a non-stamped signature.

    Another common issue is sending Appeals to the wrong place. Synagis is usually handled via the Prescription Drug benefit of a plan, and should be sent to the appropriate Appeals department. Member Services, the PA department, or a denial letter should be checked before sending it out.

    In terms of turn around time, the sample letter specifies five days. From experience, I can say that the turn around time is usually specified by state law, and varies substantially state to state. Colorado, Oklahoma and Texas for instance have a very large number of state laws that substantially muck about with how insurance may process these. Three business days, five business days and ten business days are common, as are seven calendar days and fourteen calendar days. Insurance companies will do, at the minimum, what state law requires, often faster.

    As for threats of Medicaid Director involvement: be very, very careful with this – it may backfire. While a plan that is out of compliance with state directives may face fines, or difficult reorganizations, a reviewer found out of compliance will lose their job. Even if they’re an MD with twenty years of experience reviewing appeals, they’re gone. Under such circumstances, it would be difficult to find employment again in the industry. Faced with such a threat, especially under Medicaid, a reviewer is far more likely to be conservative, and review with a strict interpretation of medical literature – less than ideal.

    The other side of that is this can be very justified with certain Medicaids or plans. Especially plans that are extremely fragmented, and incoherent or disorganized. California’s MediCal, Arizona’s AHCCCS, and most BCBS come to mind. Legal and historical issues have left certain plans on the verge of inoperable, incoherent messes. A threat that induces CYA can be a good thing.

    On the subject of Appeals, it’s unfortunate that this needs mentioning, but from experience, it does. Some things have no place in either Appeals, or PAs: incoherent scribbled rants, swearing, insults, death threats or legal threats. These are reviewed by medical professionals, usually an MD or Clinical RPh. They should be addressed appropriately.

    In terms of losing an existing approval on appeal, even for a limited quantity? I’ve never, ever heard of this happening in a very large number of Synagis cases. I know in Medicare land, once an approval is issued by an RPh or Criteria, it’s ironclad, even if it’s done in error. The only circumstance I could imagine this happening was if fraudulent information was sent in to get the original approval, and this comes to light in an appeal. In that case, 1-3 vials of Synagis will be a very small concern.

    Lastly, one final bit. Second Level Appeals. Every plan I have ever dealt with has had a second level of appeals. This is invariably a confidential, independent medical review company. A denial on a 1st appeal (which is rare) can be sent to 2nd. Plans absolutely hate using 2nd level. Their turn around time is longer, and plans are charged a fee of several hundred dollars per review (which they get to pay). A 2nd level appeal concludes with an exhaustive review of medical literature on a case, generally drops 30+ pages of written material onto a plan, along with a nice bill. An approval at 2nd level can often result in significant plan reorganization according to the provided literature.

    To date, I have seen extremely few denials from 1st Appeals. From 2nd Appeals, I have only seen a small handful of denials, all of which involve either controlled substances or nonsensical demands for particular evergreened brand name drugs.

  2. Pingback: An Ounce of Prevention: Coverage Battles Rage Over the Biologic Synagis : HEALTH REFORM WATCH

  3. Kara says:

    I submitted a 1st appeal from my pediatrician, then a 2nd appeal leveraging your suggested facts above and quite a bit of additional supporting medical literature, cdc charts as well. It came back denied again. Its pretty clear to me that no matter the case, CIGNA will find a way to deny this. Do you think its crazy for us to consider purchasing the Synagis on our own from Canada? The insurance company told me today that my cost for the shot from them would be $2156. There are other online resources from Canada that are less expensive for the same 100ml vial that he needs.

  4. Jennifer Gunter says:

    I have consulted a pediatric infectious diseases expert and am working on a blog to cover this topic. In the mean time, I would talk with your pediatrician and even consider asking for a pediatric infectious diseases consult to get another opinion.

  5. Pingback: Our Synagis was denied, should we pay out of pocket? | The Preemie Primer Guide from Dr. Jen Gunter

  6. Diane Diaz says:

    This is a very nice sample,tips and guidelines on how to write a appeal letter .Thanks for sharing it with us.I’m pretty sure a lot of people out there will find this blog of yours very helpful.

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