State of Vermont Agency of Human Services

Department of Vermont Health Access

280 State Drive, NOB 1 South [Phone] 802-879-5903
Waterbury, VT 05671-1010 [Fax] 802-879-5963
www.dvha.vermont.gov

The Department of Vermont Health Access Clinical Criteria

Subject: Pediatric Liquid Oral Supplementation Clinical Criteria
Last Review: September 28, 2020

*Please note: This is a new criteria.

Description of Service or Procedure_______________________________________________

In some pediatric patients, additional supplementation to a standard diet with high-caloric density and/or
high nutrient supplementation may be necessary to avoid hospitalization and/or a significant weight
loss/decline in growth trend. In all cases of nutrient and calorie deficiency, a consultation with a registered
dietitian is recommended.

All liquid supplements are subject to the FDA definition of medical foods as defined in section 5(b)(3) of
the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). Please note that medical foods, per the FDA, “are
distinguished from the broader category of foods for special dietary use by the requirement that medical
foods be intended to meet distinctive nutritional requirements of a disease or condition, used under
medical supervision, and intended for the specific dietary management of a disease or condition. Medical
foods are not those simply recommended by a physician as part of an overall diet to manage the
symptoms or reduce the risk of a disease or condition.”

This policy is not intended to address standard infant formula or infant formulas found over-the-counter.

For infant formula or food assistance, see the website for Women, Infants and Children at
HealthVermont.gov.

The prior authorization form, Nutritionals Request Form, for pediatric liquid oral supplementation
nutritional products can be found at the Pharmacy Prior Authorization Request Forms and Order Forms
page at: https://dvha.vermont.gov/forms-manuals/forms/pharmacy-prior-authorization-request-forms-and-
order-forms

Disclaimer____________________________________________________________________

Coverage is limited to that outlined in Medicaid Rule or Health Care Administrative Rules that pertains to
the beneficiary’s aid category. Prior Authorization (PA) is only valid if the beneficiary is eligible for the
applicable item or service on the date of service.

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Medicaid Rule_________________________________________________________________

Medicaid Rules can be found at http://humanservices.vermont.gov/on-line-rules/dvha

7102.2 Prior Authorization Determination
4.101 Medical Necessity for Covered Services
4.106 Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Services

Coverage Position_____________________________________________________________

Pediatric liquid oral supplementation nutritional products may be covered for under the age of 21when:
• When the product is prescribed by a licensed medical provider, enrolled in the Vermont Medicaid
program, operating within their scope of practice as described in their Vermont State Practice Act,
who is knowledgeable regarding the use of nutritional support and who provides medical care to
the beneficiary AND
• When the clinical criteria below are met.

Coverage Criteria____________________________________________________________

Pediatric liquid oral supplementation nutritional products may be covered for beneficiaries under the age
of 21 for the shortest medically necessary period when:
• There is a functioning gastrointestinal tract. AND
• Anatomic causes for malnutrition have been evaluated and treated (ex.: gastro-esophageal reflux
disease, etc.); AND
• Social causes for malnutrition have been evaluated and treated (ex.: child neglect, etc.); AND
• The clinical documentation supports the need for enteral nutrition (lab measurements
demonstrating malnutrition, height, weight, BMI, past treatments and estimated duration of need).
AND ONE OF THE BELOW
• A chronic medical condition exists resulting in nutritional deficiencies, and a three-month trial is
required to prevent gastric tube placement, OR
• Supplementation to regular diet or meal replacement is required, and the beneficiary's weight-to-
height ratio has fallen below the 5th percentile or growth curve has fallen by 2 major percentiles
(as defined by the World Health Organization for children less than 2 years of age and defined by
the Centers for Disease Control for children greater than 2 years of age); OR
• The member has a documented diagnosis of an inborn error of metabolism that cannot be
accommodated by standard foods with a modified diet, OR
• Weaning from TPN or feeding tube

For supplementation related to errors of inborn metabolism, please see the Metabolic Nutrition criteria.
This can be found at: https://dvha.vermont.gov/providers/pharmacy/drug-coverage-lists

Early and Periodic Screening, Diagnostic and Treatment (EPSDT): Vermont Medicaid will provide
comprehensive services and furnish all Medicaid coverable, appropriate, and medically necessary services
needed to correct and ameliorate health conditions for Medicaid members under age 21.

Clinical criteria for repeat service or procedure___________________________________

Beneficiary must meet criteria above.

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Type of service or procedure not covered (this list may not be all inclusive)______________

Liquid oral supplementation for food allergies that can be accommodated by alternative foods and
supplements commonly available at retail grocers.

A child that qualifies for Women, Infants and Children (WIC) Program must receive supplementation
directly from WIC program unless:
• The child’s medical need for a product exceeds WIC’s allowed amount, OR
• A medically necessary product is not available through WIC

For resources related to standard infant formula or infant formulas found over-the-counter. For infant
formula or food assistance, see the website for Women, Infants and Children at HealthVermont.gov.

References____________________________________________________________________

Camp, K., Lloyd-Puryear, M., & Huntington, K. (2012). Nutritional treatment for inborn errors of
metabolism: Indications, regulations, and availability of medical foods and dietary supplements using
phenylketonuria as an example. National Institute of Health. NIH Public Assess, September 2012.
Retrieved September 24, 2020.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3444638/pdf/nihms394682.pdf

Center for Medicare and Medicaid Services. Early and Periodic Screening, Diagnostic, and Treatment.
Retrieved August 22, 2019, from: https://www.medicaid.gov/medicaid/benefits/epsdt/index.html

Food and Drug Administration. (2016). Frequently asked questions about medical foods; second edition.
Guidance for industry. FDA. Center for Food Safety and Applied Nutrition, May 2016. Retrieved
September 24, 2020. https://www.fda.gov/media/97726/download

Homan. G. (2016) Failure to thrive: A practical guide. American Academy of Family Physicians, 94(4).
Retrieved September 24, 2020. https://www.aafp.org/afp/2016/0815/p295.html

This document has been classified as public information.

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