Severe protein allergies are rare, and you may need to educate your insurer about why you are entitled to reimbursement. Below are some tools that will help you make your case.
Exempt Infant Formula:
Food and Drug Administration, HHS
21 CFR Ch. 1 (4-1-97 Edition)
Subpart C - Exempt Infant Formulas
(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.
Food and Drug Administration, HHS
21 CFR Ch. 1 (4-1-95 Edition)
(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 enterally under the supervision of a physician and which is intended for the specific dietary management of a 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
“Reimbursement codes” are terms you will hear referenced often. The codes are part of a system created by insurance companies to identify the nutritional product or category and process claims. Some states legally require that reimbursement be provided based on the patient’s diagnosis. Your doctor’s office may have more information regarding reimbursement in your state.
Claims are usually processed in one of two ways:
In addition, there are diagnostic codes, also called ICD-9 codes, that identify the disease of the patient and may further help in getting reimbursement.
By supplying as much information as possible to your insurance company and providing accurate and complete information according to the guidelines of your insurance company, you greatly increase your chance of success.
As we explained above, some insurance companies and state programs that cover our products require a reimbursement or Healthcare Common Procedure Code (HCPCS). We’ve listed these codes here for your convenience.
|Product||Nutricia Item||Reimbursement Code||HCPCS Code|
|Neocate Infant DHA and ARA||12595||49735-0125-95||B4161|
|Neocate Junior (Unflavored)||11790-USA||49735-0117-90||B4161|
|Neocate Junior with Prebiotics||12912||49735-012912||B4161|
|Neocate Junior with Prebiotics (Vanilla)||60627||49735-010627||B4161|
|Neocate Junior (Tropical Fruit)||12124-USA||49735-0121-24||B4161|
|Neocate Junior (Chocolate)||12690||49735-0126-90||B4161|
|EO28 Splash (Grape)||12670||49735-0126-70||B4161|
|EO28 Splash (Tropical Fruit)||12666||49735-0126-66||B4161|
|EO28 Splash (Orange-Pineapple)||11050||49735-0110-50||B4161|
|Pepdite Junior (Unflavored)||11766||49735-0117-66||B4161|
|Super Soluble Duocal||10280||49735-0102-80||B4155|
*US Reimbursement codes listed above have been submitted by Nutricia North America to US data warehouses based on the format establised by NDC data warehouses. These codes are not NDC numbers.
As we explained above, some insurance companies and state programs that cover our products require a diagnosis code from your doctor. For your convenience, we’ve listed these codes here.
|Diagnosis||ICD – 9 Code|
|Multiple food protein allergy||558.1|
|Atopic dermatitis due to food allergy||693.1|
|Allergic rhinitis due to food allergy||477.1|
|Gastroesophageal reflux disease||530.81|
|Failure to thrive/Underweight||783.22|
We created the following sample reimbursement letters to help you get insurance coverage for Neocate. Please contact your physician to complete the missing information and individualize the letters to suit your child’s needs.
Simply click the appropriate product below to download the Word file of each sample letter: