Modifiedselect_healthPolicy CCP.1524

Specialized infant formula

Customize your policy alerts

Sign up for select_health Policy CCP.1524 alerts

Get alerted when Policy CCP.1524 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Coverage rules for oral specialized infant formula for home use in infants aged 12 months or younger, including medical necessity criteria, covered conditions, contraindications, and limitations. Applies to Select Health of South Carolina plan determinations.

Policy Summary

Payerselect_health

PolicySpecialized infant formula

Policy CodePolicy CCP.1524

Change TypeClarified coverage and added exclusions

Effective DateDec 1, 2021

Last ReviewDec 1, 2025

Next Review DateApr 1, 2027

Key ActionObtain prior authorization and document that breast milk or standard formula is insufficient and that a physician deems a hypoallergenic or indicated specialized formula medically necessary.

SourceLink

POLICY UPDATE CHANGES

Coverage for cow's milk allergy now requires hypoallergenic formulas and explicitly excludes partially hydrolyzed products.

Physiologic regurgitation (Rome IV) is separated from gastroesophageal reflux disease; anti-regurgitation formulas are allowed for Rome IV regurgitation after failure of non-nutritional measures.

Explicit absolute contraindications were added for formulas marketed for infant colic, combined multi-claim GI disorders, and older infant/toddler follow-on milks.

Coverage for phenylalanine hydroxylase deficiency terminology was aligned with ACMG guidance.

12 monthsmaximum infant age

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

Modifiedselect_healthPolicy CCP.1524

Specialized infant formula

Customize your policy alerts

Sign up for select_health Policy CCP.1524 alerts

Get alerted when Policy CCP.1524 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

Payerselect_health

PolicySpecialized infant formula

Policy CodePolicy CCP.1524

Change TypeClarified coverage and added exclusions

Effective DateDec 1, 2021

Last ReviewDec 1, 2025

Next Review DateApr 1, 2027

SourceLink

POLICY UPDATE CHANGES

Coverage for cow's milk allergy now requires hypoallergenic formulas and explicitly excludes partially hydrolyzed products.

Physiologic regurgitation (Rome IV) is separated from gastroesophageal reflux disease; anti-regurgitation formulas are allowed for Rome IV regurgitation after failure of non-nutritional measures.

Explicit absolute contraindications were added for formulas marketed for infant colic, combined multi-claim GI disorders, and older infant/toddler follow-on milks.

Coverage for phenylalanine hydroxylase deficiency terminology was aligned with ACMG guidance.

12 monthsmaximum infant age

6 monthsmedical review timepoint

hypoallergenic requiredcow's milk allergy requirement

colic / toddler milksexcluded product types

Rome IVregurgitation criteria

Coverage criteria for specialized infant formula

Initial coverage

Covered when ALL of the following are met

Initial coverage criteria: (1) Infant is age 12 months or younger; (2) Breast milk or standard infant formula is insufficient, not tolerated, or contraindicated; (3) A physician or licensed health care provider deems the oral specialized formula medically necessary and will supervise its use; (4) The formula is exempt from standard FDA nutrient labeling requirements and is labeled for the indicated medical condition.

Covered medical conditions

Documentation must support one of the following diagnoses

Covered conditions list: Immunoglobulin E (IgE)-mediated or Non-IgE-mediated cow's milk allergy (requires hypoallergenic formula such as extensively hydrolyzed, amino acid, or hydrolyzed rice formulas; partially hydrolyzed 'gentle' or 'comfort' products are contraindicated); Galactosemia; Phenylalanine hydroxylase deficiency (including phenylketonuria); Congenital/primary lactase deficiency; Non-IgE-mediated food protein allergy; Short bowel syndrome; Inborn errors of metabolism; Homocystinuria; Maple syrup urine disease; Documented gastroesophageal reflux disease unresponsive to standard management techniques (pathological reflux with symptoms negatively impacting health or wellbeing).

For cow's milk allergy, hypoallergenic formulas (extensively hydrolyzed, amino acid–based, or hydrolyzed rice formulas) are required; partially hydrolyzed formulas are excluded.

Functional infant regurgitation

Anti-regurgitation (thickened) formulas may be considered when ALL of the following are met

Functional regurgitation criteria: (1) Infant meets Rome IV criteria for regurgitation (physiologic reflux without signs of GERD); AND (2) Documentation shows failure of non-nutritional interventions (reassurance, feeding adjustments); AND (3) Significant parental distress persists despite reassurance.

Anti-regurgitation/thickened formulas are for physiologic regurgitation (Rome IV) and are not indicated for GERD, which requires documented pathological reflux unresponsive to standard management.

The policy lists absolute contraindications for several product types that will not be covered. These include formulas marketed for infant colic (often labeled "comfort," "sensitive," or "anti-colic") and products marketed for combined functional gastrointestinal disorders (multi-claim). The policy also excludes coverage for older infant/young child follow-on or toddler milks, which the evidence and guidance state offer no nutritional advantage for healthy children. Continued coverage of any specialized infant formula is subject to medical review at six months of use or sooner if requested.

These exclusions are based on evidence and guideline updates cited in the policy noting limited or low-quality support for efficacy of colic- or multi-claim formulas and guidance that toddler/follow-on milks do not provide additional nutrition for healthy children. The 2025 policy revision explicitly added these contraindications to clarify coverage expectations and align with recent guideline reports.

The policy explicitly states that partially hydrolyzed formulas — commonly marketed as "gentle" or "comfort" — are not hypoallergenic and are contraindicated for treatment of cow's milk allergy. For confirmed cow's milk allergy the policy requires use of hypoallergenic formulas such as extensively hydrolyzed, amino acid–based, or hydrolyzed rice formulas.

Where the policy identifies excluded products and contraindications it frames these as coverage limits rather than clinical recommendations; absent explicit wording elsewhere, requests for excluded product types will be denied as unsupported or contraindicated. The policy also requires documentation and physician supervision for covered specialized formulas and subjects continued coverage to periodic medical review.

Provider responsibilities, prior authorization, and documentation

Prior Authorization

Prior authorization required for home-use specialized infant formula

Prior authorization is required for home-use specialized infant formula; continued coverage is subject to medical review at six months of use or earlier if requested.

Note

No additional prior authorization details in excerpt

The provided excerpt of the policy does not specify additional prior authorization metadata or different prior authorization processes beyond the main requirement and review timing noted elsewhere in the policy text.

Step Therapy

Fail conservative measures before anti-regurgitation formula

Before anti-regurgitation (thickened) formulas will be approved, documentation must show failure of non-nutritional interventions such as reassurance and feeding adjustments.

Key definitions and formula types

Hypoallergenic formula — extensively hydrolyzed, amino acid, or hydrolyzed rice formulas definition

DefinitionFormulas intended to minimize antigenicity for cow's milk allergy that contain extensively hydrolyzed proteins, amino acid–based formulations, or hydrolyzed rice protein formulations.

ExamplesExtensively hydrolyzed formula; Amino acid–based (elemental) formula; Hydrolyzed rice formula.

Clinical roleUsed when breast milk or standard infant formula is insufficient, not tolerated, or contraindicated for infants with confirmed cow's milk allergy.

ExclusionsPartially hydrolyzed formulas (often labeled 'gentle' or 'comfort') are not hypoallergenic and are contraindicated for treatment of cow's milk allergy.

Rome IV regurgitation — definition and criteria for physiologic infant regurgitation

Definition

Background and scope

Specialized infant formulas are designed to meet the needs of infants with distinct medical or metabolic conditions when breast milk or standard formula is insufficient, not tolerated, or contraindicated. Indications include inborn errors of metabolism, cow's milk protein allergy, congenital lactase deficiency, short bowel syndrome, and documented pathologic gastroesophageal reflux disease unresponsive to standard management. These products may provide therapeutic protein modification (e.g., extensively hydrolyzed or amino acid–based formulas) or altered nutrient composition required for specific diagnoses.

Policy revision history and changes

2025-12-01reference_updateLatest

Policy references updated.

2024-11-01reference_update

Policy reference updated.

2023-11-01reference_update

Policy references updated.

Policy Summary

Payerselect_health

PolicySpecialized infant formula

Policy CodePolicy CCP.1524

Change TypeClarified coverage and added exclusions

Effective DateDec 1, 2021

Last ReviewDec 1, 2025

Next Review DateApr 1, 2027

SourceLink

On This Page

Anti-regurgitation formulas are considered only after non-nutritional measures fail.

Note

No additional step therapy sequences specified

No step therapy sequences beyond the requirement to fail non-nutritional interventions for anti-regurgitation formulas are described in the provided policy excerpt.

Documentation Required

Physician documentation and supervisory determination required

Physician or licensed health care provider must document that breast milk or standard infant formula is insufficient, not tolerated, or contraindicated, and must deem the specialized formula medically necessary and supervise its use.

Formula must be exempt from standard FDA nutrient labeling and labeled for the indicated medical condition.

Documentation Required

Regurgitation documentation: Rome IV and failed conservative care

For anti-regurgitation formulas, documentation must confirm the infant meets Rome IV criteria for regurgitation and demonstrate failure of non-nutritional interventions, with persistent significant parental distress.

Rome IV = physiologic reflux without signs of GERD.
Failure of reassurance and feeding adjustments must be documented.

Note

No other documentation requirements in excerpt

The provided portion of the policy contains no additional documentation requirements beyond those specified for physician determination and for anti-regurgitation formulas.

Denial Risk

Do not request formulas marketed for colic, multi-claim GI, or toddler milks

Requests for formulas marketed for infant colic (e.g., 'comfort' or 'sensitive' formulas), formulas marketed for combined functional gastrointestinal disorders (multi-claim), or older infant/young child follow-on or toddler milks will be denied as contraindicated or unsupported by evidence.

Partially hydrolyzed 'gentle' or 'comfort' products are not hypoallergenic and are contraindicated for cow's milk allergy.

Note

No other denial triggers specified in excerpt

No specific denial triggers beyond the explicit contraindications listed (colic-marketed, multi-claim GI products, and follow-on/toddler milks) are identified in the provided excerpt.

Physiologic infant regurgitation that meets Rome IV criteria (regurgitation without signs of gastroesophageal reflux disease).

Required criteria for considering anti‑regurgitation formula(1) Infant meets Rome IV regurgitation criteria; (2) Documentation of failed non‑nutritional interventions (reassurance, feeding adjustments); (3) Persistent significant parental distress despite reassurance.

ScopeAnti‑regurgitation (thickened) formulas are for physiologic regurgitation only and are not indicated for GERD with pathologic signs such as esophagitis or failure to thrive.

FPIES — referenced via international consensus guidelines as a serious non-IgE-mediated allergy

DesignationFood protein–induced enterocolitis syndrome (FPIES) is referenced via international consensus guidelines as a serious non‑IgE‑mediated food allergy affecting infants.

Guideline sourceInternational consensus guidelines (NowakWęgrzyn et al., J Allergy Clin Immunol. 2017) referenced in policy.

Clinical implicationRecognized as a separate, serious non‑IgE‑mediated allergic condition that may warrant specialized formula management and specialist involvement.

Hydrolyzed and amino acid formulas — referenced in guidelines and systematic reviews for cow's milk protein allergy management

Guideline and review citationsSystematic reviews and guidelines (Cochrane review; clinical trials and guideline literature cited in references) discuss hydrolyzed and amino acid formulas for prevention and management of cow's milk protein allergy.

Clinical useHydrolyzed protein formulas and amino acid–based formulas are discussed as treatment options for cow's milk protein allergy and related conditions in guideline and systematic review evidence cited by the policy.

Supporting evidence examplesOsborn et al. Cochrane review on hydrolysed formulas; Stróżyk et al. systematic review on efficacy and safety of hydrolyzed formulas; Sorensen et al. meta‑analysis on amino acid formula with synbiotics cited in references.

2022-11-01reference_update

Policy references updated.

2021-11-01initial_review

Initial review date and clinical policy effective date set (policy effective 2021-12-01).

The 2025 revisions introduced material operational expectations: prior authorization is required for home-use specialized infant formula with continued coverage medical review at six months; coverage for cow's milk allergy must be limited to hypoallergenic formulas (extensively hydrolyzed, amino acid, or hydrolyzed rice), excluding partially hydrolyzed 'gentle' products; anti-regurgitation (thickened) formulas are allowed only for infants meeting Rome IV regurgitation criteria after failed non-nutritional measures; and requests for formulas marketed for colic, multi-claim GI symptoms, or toddler/follow-on milks should be denied as contraindicated or unsupported.