ModifiedMass General Brigham Health PlanPolicy N/A

Medical Policy Enteral Nutrition Formulas and Supplements

Defines medical necessity criteria, prior authorization and documentation requirements, exclusions, and coding guidance for coverage of enteral nutrition formulas, supplements, and digestive enzyme cartridges (e.g., RELiZORB) for Mass General Brigham Health Plan across Commercial, MassHealth, and Medicare Advantage members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Policy Enteral Nutrition Formulas and Supplements

Policy CodePolicy N/A

Change TypeMODIFIED — multiple updates including RELiZORB age reduction and MassHealth alignment

Effective DateJanuary 2025 (RELiZORB age change)

Next Review DateJan 1, 2025

Key ActionAuthorization is required for enteral nutrition formulas and supplements; include supporting diagnosis, condition, and medical necessity in the PA request using the MCO Combined Form and required documentation.

SourceLink

POLICY UPDATE CHANGES

Lowered eligibility age for RELiZORB from five to two (effective January 2025 ad-hoc review).

Added MassHealth Variation (October 2024 annual review).

Added Medicare Advantage to authorization table and Medicare variation language (October 2023).

Coverage criteria updated to align with revised MassHealth guidelines (July 2022 ad-hoc review).

Added coverage criteria language for RELiZORB (December 2021 ad-hoc review).

Exclusion: Authorization for enteral formulas and supplements that are not requested through a certified DME provider (October 2022).

2+RELiZORB minimum age lowered

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$5,000Commercial annual limit for low-protein foods

Coverage Summary

This policy defines medical necessity, prior authorization, documentation, and coding guidance for coverage of enteral formulas, nutritional supplements, and digestive enzyme cartridges (e.g., RELiZORB) for Mass General Brigham Health Plan members. It applies across Commercial, MassHealth, and Medicare Advantage populations and requires prior authorization with supporting clinical documentation. High-level exclusions include use of enteral products for non-medical purposes (e.g., as regular food or for weight loss), coverage does not extend to standard commercial infant formulas when not medically necessary, and requests submitted through a non-certified DME provider will not be authorized.

Quick thresholds and facts

RELiZORB minimum age>= 2 years

RELiZORB continuous feed duration>= 6 hours continuous and requires overnight enteral feeds

RELiZORB initial authorization duration6 months

Prematurity gestational age<= 36 weeks gestation (formulas may be covered up to 3 months of age)

Adult weight loss threshold>= 10% involuntary weight loss over 3–6 months

Adult BMI thresholdBMI < 18.5 kg/m2

Commercial annual low‑protein foods limitUp to $5,000 per year for low‑protein food products (Commercial accounts only)

Medically Necessary Criteria

Medical necessity for nutritional formula or supplements administered orally or via enteral tube is established when ONE of the following conditions is met:

ANY of the following

General therapeutic enteral nutrition: Enteral nutrition, orally or by tube feeding, when used as a therapeutic regimen to prevent serious disability or death in a member with a medically diagnosed condition that precludes the full use of regular food or precludes adequate ingestion of calories to achieve sufficient growth.
Prematurity: Formulas formulated for premature infants born at less than or equal to 36 weeks gestation; may be covered for up to 3 months of age. Documentation required includes gestational age.<= 36 weeks gestation; coverage up to 3 months of age
Clinical signs and symptoms / nutritional risk

Not Covered / Exclusions

Excluded/not-covered scenarios include enteral products used for non-medical purposes or as supplementation to a normal diet when nutritional needs can be met with regular food or store-bought supplements; standard commercial or WIC infant formulas for Commercial members (unless medically necessary quantities beyond WIC allowance are documented); and the explicit policy exclusion that authorizations will not be provided for requests submitted through a non-certified DME provider. Prior authorization and adequate clinical documentation are required; absence of a medical history/physical or documentation supporting need is a basis for noncoverage.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Authorization is required for enteral nutrition formulas and supplements for Commercial, Qualified Health Plans, MassHealth, and Medicare Advantage members; the treating provider must include supporting diagnosis, condition, and medical necessity in the PA request. Affected member types: - Commercial - Qualified Health Plans (QHP) - MassHealth - Medicare Advantage Required PA elements: - Supporting diagnosis - Description of the condition - Statement of medical necessity

Commercial
Qualified Health Plans (QHP)
MassHealth
Medicare Advantage
Supporting diagnosis
Condition description
Medical necessity

Documentation Required

Coding

Background & Definitions

Background: the policy references Massachusetts state mandates for coverage of formulas for inborn errors of amino/organic acid metabolism (including a Commercial $5,000 annual limit for low-protein food products) and notes authorization durations and annual review requirements for state‑mandated conditions. Medicare Advantage determinations follow CMS LCDs/LCAs where applicable. The policy excludes standard commercial formulas and non-medical uses and specifies detailed documentation and prior authorization requirements for enteral products and digestive enzyme cartridges.

Term	Definition
Enteral Formula	Liquid nourishment, which may be given through a feeding tube.
Supplements	Liquid nourishment taken by mouth and usually not associated with regular store-bought food, such as instant breakfast drinks or protein powder drinks.
Malabsorption	A problem properly absorbing nutrition from food, potentially or actually leading to malnutrition.
Malnutrition	A pathologic state caused by deficiency, excess or imbalance of essential nutrients; primary or secondary causes.
Combined MCO Medical Necessity Review Form for Enteral Nutrition Products	Standardized form completed by the prescriber for establishing medical necessity for prior authorization.
Digestive enzyme cartridge	A cartridge containing lipase designed to mimic pancreatic lipase action to increase fat absorption from enteral nutrition (e.g., RELiZORB).

Medicare Determinations

Type	Number	Name	Effective Date
LCD	L38955	Enteral Nutrition
LCA	A58833	Enteral Nutrition Policy Article
LCD	L38953	Parenteral Nutrition
LCA	A58836	Parenteral Nutrition - Article	2023-07-02

Evidence & References

Evidence Source	Identifier/Notes
Medicare LCDs referenced	L38955 (Enteral Nutrition); L38953 (Parenteral Nutrition)
Medicare LCAs referenced	A58833 (Enteral Nutrition Policy Article); A58836 (Parenteral Nutrition - Article; effective 07/02/2023)

Revision History

January 2025material (ad-hoc)Latest

Lowered eligibility age for RELiZORB from five to two; effective January 2025 ad-hoc review. (change detail: RELiZORB criteria now specify minimum age 2 years and initial authorization for 6 months.)

October 2024non-material (annual)

Added MassHealth Variation (October 2024 annual review). (change detail: Policy includes MassHealth guidance and references MassHealth medical necessity guidelines.)

October 2023

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Policy Enteral Nutrition Formulas and Supplements

Policy CodePolicy N/A

Change TypeMODIFIED — multiple updates including RELiZORB age reduction and MassHealth alignment

Effective DateJanuary 2025 (RELiZORB age change)

Next Review DateJan 1, 2025

SourceLink

On This Page

Inability to ingest regular food / swallowing impairment: The member cannot ingest regular food because of a medical condition or has a medical condition causing difficulty with swallowing and inability to take nutrition by mouth.

Evidence of weight loss (adults/post-pubertal)

Adult weight/BMI thresholds: Adults and post-pubertal adolescents: involuntary or acute weight loss >= 10% of usual body weight during a 3- to 6-month period, or BMI below 18.5 kg/m2; for members with chronic immobility where height is difficult to measure, another anthropometric method (e.g., arm span) may be used.>= 10% weight loss; BMI < 18.5 kg/m2

Pediatric growth criteria

VLBW: Very low birth weight (VLBW <1500 g) within the first three months of life corrected for prematurity even in the absence of gastrointestinal, pulmonary, or cardiac disorders.VLBW <1500 g within first 3 months corrected age
Sustained decrease in weight percentiles: Sustained decrease in weight or weight-for-height-for-age-and-gender across two or more major percentiles after previously stable growth (growth velocity).two or more major percentiles decrease
Lack of weight gain - infants: Lack of weight gain, or weight <2 standard deviations below the age-appropriate mean, and not growing at a rate parallel to the growth curve in a three-month period for children under six months or four-month period for children six to 12 months, not reversed with appropriate diet instruction.< -2 SD or not gaining in specified period
No weight gain - older children: No weight gain or slow rate of gain for six months for children older than one year, and/or documented weight loss not reversed promptly with appropriate diet instruction.6 months no/slow gain
Weight-for-age threshold: Weight or weight-for-height <2 standard deviations below mean for age and gender and not growing at a rate parallel to the growth curve.< -2 SD
Syndrome-specific charts: For individuals with genetic or other syndromes with syndrome-specific growth charts, weight and growth abnormally slow for that condition using the condition-specific chart.condition-specific abnormal growth
Abnormal labs: Abnormal laboratory tests pertinent to the diagnosis.

Risk factors for malnutrition

Anatomic GI obstruction: Anatomic GI structures preventing food reaching the stomach (e.g., esophageal cancer) impairing digestion/absorption.
Neurological swallowing disorders: Neurological disorders that impair swallowing or chewing.
Inborn errors of metabolism requiring low-protein foods: Diagnosis of inborn errors of metabolism requiring low-protein modified food products (e.g., PKU, tyrosinemia, homocystinuria, MSUD, propionic/methylmalonic acidemia).
Cow's milk/soy allergy and protein intolerance: Documented allergy to cow's milk protein and soy infant formulas evidenced by improvement with elimination of dairy, AND documented multiple protein intolerance with successful trial of extensively hydrolyzed formula or, if failed, elemental amino acid-based formula; hydrolyzed/elemental formulas for infants up to 12 months may be initially prescribed by primary care pending specialist consult; for infants >12 months must be prescribed by pediatric allergist or pediatric gastroenterologist.
Prolonged nutrient losses / malabsorption syndromes: Prolonged nutrient losses due to malabsorption syndromes or short-bowel syndrome, diabetes, celiac disease, cystic fibrosis, chronic pancreatitis, renal dialysis, draining abscess or wounds.
Weight loss during catabolic therapy: Evidence of weight loss during treatment with anti-nutrient or catabolic therapies (e.g., anti-tumor treatments, corticosteroids, immunosuppressants).
Increased metabolic needs: Increased metabolic/caloric needs due to excessive burns, infection, trauma, prolonged fever, hyperthyroidism, or illnesses impairing caloric intake/retention.
Failure-to-thrive diagnosis that increases caloric needs while impairing caloric intake/retention.

Enteral nutrition as primary source: Enteral nutrition indicated as primary source of nutritional support essential for management of digestion/malabsorption risk factors or for surgical preparation/postoperative care.

Re-evaluation for children >1 year: For children >1 year, retrial of commercial food and re-evaluation should demonstrate continued evidence of need for specialized formula.

Digestive enzyme cartridges (RELiZORB)

Diagnosis of pancreatic insufficiency: Member is diagnosed with CF or other pancreatic insufficiency.
Continuous/overnight tube feeds: Member requires tube-fed enteral nutrition for continuous durations of 6 hours or more and requires overnight enteral feeds.>= 6 hours continuous and requires overnight feeds
PERT failure: Member has documented history of exocrine pancreatic insufficiency and documented failure of pancreatic enzyme replacement therapy (PERT).
Proven response to cartridge: Member has proven response to digestive enzyme cartridge (e.g., increased weight/BMI; significant improvement in GI symptoms such as bloating/flatulence; decreased diarrhea, dehydration, or GI-related hospitalizations).
Prescriber qualifications: Digestive enzyme cartridge is prescribed by a licensed pulmonologist or gastroenterologist, advanced practitioner registered nurse, or physician assistant working within scope of license (for CF members: pulmonologist, gastroenterologist, or endocrinologist specializing in CF).
Use per FDA/manufacturer: Digestive enzyme cartridge will be used according to FDA-cleared guidelines and manufacturer's instructions.
Initial authorization duration: Initial authorization for digestive enzyme cartridges will be approved for 6 months.6 months

Coverage for State-Mandated Conditions

Inborn diseases list: Formulas for the treatment of inborn diseases of metabolism of amino acids and organic acids such as PKU, tyrosinemia, homocystinuria, MSUD, propionic or methylmalonic acidemia.
Nonprescription enteral formulas for malabsorption disorders: Nonprescription enteral formulas for home use for physician-ordered and medically necessary treatment of malabsorption caused by disorders affecting absorptive surface, functional length, or GI motility (e.g., Crohn's, ulcerative colitis, GERD, GI dysmotility, chronic intestinal pseudo-obstruction).
Low-protein food annual limit: State-mandated coverage includes food products modified to be low protein up to $5,000 annually for Commercial accounts (annual limit applies only to low protein food products for Commercial accounts).$5,000 annual limit (Commercial only)
Authorization duration for mandated conditions: Under State Mandate, formulas for above conditions may be authorized for one year and require annual review for renewal.1 year authorization; annual review

Required documentation

Submit the MCO Combined Form for Enteral Products Authorization Requests. Include a recent (within the past year) comprehensive history and physical, relevant laboratory tests, growth charts, heights/weights/BMI, and any other evidence supporting the clinical criteria.

MCO Combined Form for Enteral Products Authorization Requests
Recent (within past year) comprehensive history and physical
Relevant laboratory tests
Growth charts
Heights, weights, and BMI

Documentation Required

Documentation for special cases

For digestive enzyme cartridges and special cases, provide documentation of pancreatic insufficiency and related evidence; include pre- and during-use weights/BMI and GI symptom tracking. Prescribing provider specialty requirements apply for CF and non-CF malabsorption syndromes.

Documentation of pancreatic insufficiency and PERT failure
Proof of pancreatic insufficiency (relevant labs)
Prescribing provider specialty: for CF — pulmonologist, gastroenterologist, or endocrinologist specializing in CF; for non-CF malabsorption — gastroenterologist
Heights, weights, and BMI for the previous year
Pre- and during-use weight/BMI and GI symptom documentation (including 6 months prior if previously received cartridges)

Billing Rule

State-mandate annual limit for low-protein foods (Commercial)

State mandate coverage includes food products modified to be low protein for inborn amino/organic acid disorders with a Commercial annual dollar limit; formulas for state-mandated conditions may be authorized for one year and require annual review for renewal.

$5,000 annual limit for low-protein food products for Commercial accounts; formulas may be authorized for one year with annual review required for renewal

Denial Risk

Denial risk for noncertified DME provider

Authorizations will not be provided for enteral formulas and supplements requested through a non-certified DME provider; requests submitted via non-certified DME providers risk denial.

Authorizations will be denied if requested through a non-certified DME provider

non-material (annual)

Added Medicare Advantage to authorization table and Medicare variation language; references updated. (change detail: Medicare guidance (LCDs/LCAs) referenced for Medicare Advantage members.)

July 2022material (ad-hoc)

Coverage criteria updated to align with revised MassHealth guidelines (July 2022 ad-hoc review). (change detail: Substantive alignment with MassHealth guidelines; codes updated previously in Oct 2022.)

October 2022material (annual)

Exclusion added: Authorization for enteral formulas and supplements that are not requested through a certified DME provider. (change detail: Non-certified DME provider requests excluded.)

December 2021material (ad-hoc)

Added coverage criteria language for RELiZORB (digestive enzyme cartridges) including clinical prerequisites and documentation requirements; definitions and codes updated. (change detail: Defined clinical prerequisites and documentation requirements for digestive enzyme cartridges.)

October 2021non-material (annual)

Annual review performed. (change detail: October 2021: Annual review.)

December 2020non-material (annual)

Annual review; revised risk factor criteria on page 2. (change detail: December 2020: Annual review. Revised risk factor criteria.)

March 2020non-material (ad-hoc)

Ad-hoc review reflecting new MassHealth guidelines; removed requirement that child be seen by pediatric gastroenterologist/allergist/pulmonologist under certain criteria. (change detail: March 2020: Ad-hoc review reflecting new MassHealth guidelines.)

October 2018non-material (annual)

Added $5,000 annual limit under Coverage for State-Mandated Conditions and clarified exclusions. (change detail: October 2018: Added $5,000 annual limit; clarified exclusion #7 and added exclusion #8.)

October 2019non-material (annual)

Added Prematurity to list of conditions for coverage of nutritional formulas and supplements. (change detail: October 2019: Annual review. Added Prematurity.)

September 2017non-material (annual)

Added HCPCS codes to policy. (change detail: September 2017: Annual review. Added HCPCS codes.)