Download EDITABLE appeal letter - Experiences from Life

DATE
Via Facsimile to ________
NAME OF INSURANCE COMPANY
ADDRESS
Re:
DEEMBED MEDICAL NECESSITY
Subscriber’s Name: ________________
Group Number: __________________
ID Number: ____________
DOB: ___________
Patient Name and DOB: ___________________
Dear Sir or Madam:
This is an appeal to the written denial we received from _______ with regard to the
referenced patient (copy attached).
We are writing to explain that ____ has Gastroesophageal Reflux Disease (ICD – 9 Code
530.81), and has not been able to tolerate any formula other than Neocate. We tried every type of
formula on the market, but she was unable to digest all the other formulas (Similac Soy, Similac
Alimentum, etc.) and therefore screamed in pain for 2 to 3 hours immediately after every
feeding. She was also prescribed Zantac and Prevacid by her Pediatrician but neither worked.
After beginning Neocate, her digestive system settled down, she began to have normal bowel
movements, and the screaming stopped (with no medication). She is now a healthy, happy infant
and growing strong. This is why Neocate is her sole source of nutrition at this time.
Neocate formula is unique in that it is the only formula available in The United States
that is not plant or animal protein based. Neocate Infant formula is an amino acid based
nutritionally complete elemental formula. It is specifically designed to meet the nutritional needs
of children from newborn to one year who are unable to digest a normal diet or other
hypoallergenic products. Neocate is formulated with 100% free amino acids. It is milk free,
gluten free, and soy protein free. It provides complete nutrition, and is _____’s sole source of
nutrition.
Please see the below Texas House Bill:
Texas Bill Name: HB 2000
Effective date of the law: January 2010
Your coverage:
Insurance reimbursement of amino acid-based formula for children diagnosed by a physical with
milk protein allergy, eosinophilic esophagitis (EoE), short bowel syndrome (SBS) and
enterocolitis.
Insurance covers formula administered orally or by a feeding tube.
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Product
Neocate Infant DHA
and ARA
Nutricia
Item
12595
Pediatric GI/Allergy
NDC Reimbursement
Code
49735-0125-95
Diagnosis
Gastroesophageal reflux disease
HCPCS Code
B4161
ICD – 9 Code
530.81
Cause of acid reflux:
At the entrance to your stomach is a valve, which is a ring of muscle, called the lower
esophageal sphincter (LES). Normally, the LES closes as soon as food passes through it. If the
LES does not close all the way or if it opens too often, acid produced by your stomach can
move up into your esophagus. This causes the symptom known as acid reflux disease, also
known as gastroesophageal reflux disease (GERD). Source: WebMD
Attached please find two letters from ____’s pediatrician with regard to the necessity of her
being on Neocate formula.
Neocate formula is “to be used under the direction of a physician.” Neocate is not a drug,
but is classified by the FDA as a “medical food,” which requires usage under strict medical
supervision. Please see the below from the Food and Drug Administration:
Exempt Infant Formula:
Food and Drug Administration, HHS
21 CFR Ch. 1 (4-1-97 Edition)
§ 107.50
(c) Infant formulas not generally available at the retail level. (1) These exempt infant formulas
are not generally found on retail shelves for general consumer purchase. Such formulas typically
are prescribed by a physician and must be requested from a pharmacist, or are distributed directly
to institutions such as hospitals, clinics, and state or federal agencies. Such formulas are also
generally represented and labeled solely to provide dietary management for specific diseases or
conditions that are clinically serious or life threatening and generally are required for prolonged
periods of time.
Medical Food:
Food and Drug Administration, HHS
21 CFR C. 1 (4-1-95 Edition)
§ 101.9
(8) Medical foods as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3). A
medical food is a food which is formulated to be consumed or administered externally under the
supervision of a physician and which is intended for the specific dietary management of a
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disease or condition for which distinctive nutritional requirements, based on recognized scientific
principles, are established by medical evaluation. A food is subject to this exemption only if:
It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff
used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake
or feeding by tube;
It is intended for the dietary management of a patient who, because of therapeutic or chronic
medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary
foodstuffs or certain nutrients, or who has other special medically determined nutrient
requirements, the dietary management of which cannot be achieved by the modification of the
normal diet alone;
It provides nutritional support specifically modified for the management of the unique nutrient
needs that result from the specific disease or condition, as determined by medical evaluation;
It is intended to be used under medical supervision; and
It is intended only for a patient receiving active and ongoing medical supervision wherein the
patient requires medical care on a recurring basis for, among other things, instructions on the use
of the medical food.
From the Office of the Federal Register, National Archives and Records Administration
Without this formula our child most likely will end up in the hospital and possibly require
GI tube feeding. Our daughter’s health and well-being depends on her ability to receive Neocate
formula as her sole source of nutrition.
We are appealing to you in the hopes that you will approve this request for insurance
coverage of Neocate Infant formula. This would make a significant positive impact on _______’s
health.
Thank you for your time and efforts in considering this appeal.
Sincerely,
_________________________
NAME (Mother)
ADDRESS
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