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Coverage criteria policies

Formula - amino acid-based elemental – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for amino acid-based elemental formula (AABF) taken orally or via feeding tube.

Prior authorization is not required for:

  • Amino acid-based elemental formula when used as nutritional support for inborn errors of metabolism such as Phenylketonuria (PKU), Hyperlysinemia, or Maple Syrup Urine Disease (MSUD). See definition below.
  • Supplies related to the administration of covered nutritional therapy given via tube feeding.


Amino acid-based elemental formulas (AABF) are generally covered subject to the indications listed below and per your plan documents

Indications that are covered

  1. Amino acid-based elemental formula given via tube feeding is covered.
  2. Amino acid-based elemental formula taken orally is covered when all of the following criteria are met:
    1. The formula contains 100% free amino acids as the protein source.
    2. The member is five years of age or younger
    3. Amino acid-based elemental formula is ordered by a physician for a member who has a definitive diagnosis of any of the following conditions:
      1. IgE mediated allergies to food proteins
      2. Food protein induced enterocolitis syndrome
      3. Eosinophilic esophagitis (EE)
      4. Eosinophilic gastroenteritis (EG)
      5. Eosinophilic colitis
      6. Amino acid, organic acid and fatty acid metabolic and malabsorption disorders
      7. Cystic fibrosis
    4. The condition must be diagnosed by an allergist, gastroenterologist, or pediatrician
    5. Documentation must include a description of the member’s symptoms, diagnosis (supported by lab and/or diagnostic test results), and the expected course of treatment with AABF
    6. Interim coverage may be provided for up to 90 days when requested by a physician while actively seeking diagnosis.
    7. Requests for coverage of oral AABF in members greater than 5 years of age will be reviewed by a medical director to determine medical necessity. Documentation must clearly explain why the member remains at nutritional risk due to inability to tolerate or adequately absorb food.

Indications that are not covered

  1. Oral amino acid-based formula for conditions not listed under Indications that are covered is considered not medically necessary.
  2. For the treatment of conditions listed above, other formulas which do not provide 100% free amino acids as the protein source, including, but not limited to: Casein Hydrolysate formulas with added Amino Acids, (examples include Nutramigen LGG, Enfamil Pregestimil, Similac Alimentum Advance,and Similac Alimentum) ,Hydrolyzed Whey-based formulas (examples include Carnation Good Start and Nestle Peptamen), Modified amino acid formulas, (examples include formulas such as I-Valex and Glutarex), and semi-elemental formulas (such as Vital Jr.).


Amino acid-based elemental formulas (AABFs) are one of four main classes of oral formula. AABFs contain proteins which are broken down into their simplest and purest form, making them easier for the body to absorb and digest. This is in contrast to regular dairy (milk or soy based) formulas that contain many complete proteins. An infant or child may be placed on an AABF if he/she is unable to digest or tolerate whole proteins found in other formulas, due to certain allergies or gastrointestinal conditions.

‘Vivonex’ and ‘Tolerex’ manufactured by Novartis Nutrition, ‘Neocate’ manufactured by Nutricia North America, ‘Elecare’ by Abbott, ‘Nutramigen AA’ and ‘Nutramigen AA LIPIL’ manufactured by Mead Johnson and ‘E028 Splash’ manufactured by SHS International are examples of 100% amino acid based elemental formulas.

Inborn errors of metabolism are genetic disorders in which the body cannot properly turn food into energy. The disorders are usually caused by defects in specific proteins (enzymes) that help break down (metabolize) parts of food

Oral Formula refers to a commercially formulated substance, ingested through the mouth, that provides nourishment, and affects the nutritive and metabolic processes of the body; nourishment that is required to provide sufficient nutrients to maintain weight and strength related to the persons overall health status.


This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy contact Member Services at 952-883-7979 or 1-800-233-9645.


  • Items must be received from a contracted vendor or pharmacy for in-network benefits to apply.
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  1. Minnesota Health Care Provider Manual- Nutritional Products and Related Supplies- Revised 6/1/2018