CurrentHUSKY HealthPolicy N/A

Digestive Enzyme Cartridges

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This policy governs prior authorization and medical-necessity review for digestive enzyme cartridges used with enteral tube feedings for HUSKY Health members in Connecticut.

Policy Summary

PayerHUSKY Health

PolicyDigestive Enzyme Cartridges

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2026

Last ReviewSep 21, 2026

Next Review DateN/A

Key ActionObtain prior authorization before providing digestive enzyme cartridges.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization interval when criteria are met

2/dayInfants age 6 months or younger

6/dayOlder infants, children, and adults

3Initial criteria required

1Covered code

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CurrentHUSKY HealthPolicy N/A

Digestive Enzyme Cartridges

Customize your policy alerts

Sign up for all husky_health policy alerts

Know when husky_health releases new policies or updates existing guidance.

Monitor payer policy activity

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

This policy governs prior authorization and medical-necessity review for digestive enzyme cartridges used with enteral tube feedings for HUSKY Health members in Connecticut.

Policy Summary

PayerHUSKY Health

PolicyDigestive Enzyme Cartridges

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2026

Last ReviewSep 21, 2026

Next Review DateN/A

Key ActionObtain prior authorization before providing digestive enzyme cartridges.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization interval when criteria are met

2/dayInfants age 6 months or younger

6/dayOlder infants, children, and adults

3Initial criteria required

1Covered code

Coverage Criteria

Initial Therapy Criteria

Digestive enzyme cartridges are considered medically necessary when all of the following are met:

ALL of the following

Established exocrine pancreatic insufficiency condition: The individual has an established diagnosis of a condition leading to exocrine pancreatic insufficiency, such as cystic fibrosis.
Enteral tube feeding required: The individual requires enteral tube feeding to meet nutritional or caloric needs.
PERT failure or intolerance: The individual has documented failure to achieve feeding goals with pancreatic enzyme replacement therapy (PERT) or is unable to tolerate PERT.

Ongoing Therapy Criteria

Ongoing use is considered medically necessary when all of the following are met:

ALL of the following

Continued enteral feeding requirement: The individual continues to require enteral tube feeding to meet nutritional or caloric needs.
Continued PERT failure or intolerance: The individual continues to be unable to achieve feeding goals with PERT or is unable to tolerate PERT.

Coding and Supply Limits

Covered HCPCS CodesHCPCSCovered

B4105

In-line cartridge containing digestive enzyme(s) for enteral feeding, each

Maximum Supply

Applicable populationInfants 6 months of age or younger

Maximum authorized supply2 cartridges per day

Authorization intervalApproved at 12-month intervals when medical-necessity criteria are met

Maximum Supply

Applicable populationInfants older than 6 months, children, and adults

Maximum authorized supply6 cartridges per day

Authorization interval

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required before providing digestive enzyme cartridges. Coverage requests are reviewed under the procedures for medical supplies and based on submitted, case-specific information.

Step Therapy

PERT Is First-Line Therapy

Pancreatic enzyme replacement therapy (PERT) remains the recommended first-line treatment. Digestive enzyme cartridges may be medically necessary when an individual has difficulty breaking down and absorbing fats despite optimal PERT, or when the individual cannot tolerate PERT, and the applicable medical-necessity criteria are met.

Established diagnosis of a condition causing exocrine pancreatic insufficiency, such as cystic fibrosis.
Requires enteral tube feeding to meet nutritional or caloric needs.
Has documented failure to achieve feeding goals with PERT or is unable to tolerate PERT.

Background

Digestive enzyme cartridges connect inline with an existing enteral pump feed set and pump extension set during enteral tube feeding. They are designed to mimic the action of pancreatic lipase, supporting the digestion and absorption of fats for adults and pediatric patients who have difficulty breaking down and absorbing fats despite optimal pancreatic enzyme replacement therapy (PERT).

Definitions

Medically Necessary or Medical Necessity

PurposeHealth services required to prevent, identify, diagnose, treat, rehabilitate, or ameliorate an individual's medical condition or its effects

Clinical standardServices must be consistent with generally accepted medical practice, clinically appropriate, and considered effective for the individual's illness, injury, or disease

Additional requirementsServices must not be primarily for convenience, must not cost more than an equally effective alternative, and must be based on an assessment of the individual and medical condition

Prior Authorization

DefinitionA process for approving covered services before delivery of the service or initiation of the plan of care

Decision basisCHNCT determines whether the requested service is medically necessary

Medical Necessity

Coverage distinguishes between criteria for starting therapy and criteria for continuing therapy.

Medical necessity requirements

Initial therapy: Initial coverage requires an established condition leading to exocrine pancreatic insufficiency, a need for enteral tube feeding to meet nutritional or caloric needs, and documented failure to achieve feeding goals with PERT or inability to tolerate PERT.
Ongoing therapy: Continued coverage requires continued need for enteral tube feeding to meet nutritional or caloric needs and continued inability to achieve feeding goals with PERT or inability to tolerate PERT.

Prior Authorization Documentation

Documentation Required

Assemble the complete authorization packet

For prior authorization and reauthorization, submit the completed Outpatient Prior Authorization Request Form, a current prescription, timely treating-provider clinical documentation supporting the medical need, and pricing information required under the DSS Pricing Policy for MEDS Items.

Submit the request by fax or through the online web portal.
Include a prescription signed and dated within the past 6 months by the treating physician, APRN, or PA.
Use documentation written within the past 6 months for initial authorization and within the past 12 months for reauthorization.

Policy Summary

PayerHUSKY Health

PolicyDigestive Enzyme Cartridges

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2026

Last ReviewSep 21, 2026

Next Review DateN/A

Key ActionObtain prior authorization before providing digestive enzyme cartridges.

SourceLink

On This Page

Approved at 12-month intervals when medical-necessity criteria are met

Denial Risk

Failure to Meet Medical-Necessity Criteria

A request may be denied when the medical-necessity requirements are not established. Ongoing use also requires continued need for enteral tube feeding and continued inability to achieve feeding goals with PERT or inability to tolerate PERT.

No established qualifying condition leading to exocrine pancreatic insufficiency.
No ongoing requirement for enteral tube feeding to meet nutritional or caloric needs.
No documented failure to achieve feeding goals with PERT and no documented inability to tolerate PERT.

Documentation Required

Completed Prior Authorization Request

Submit a fully completed Outpatient Prior Authorization Request Form by fax or a fully completed authorization request through the online web portal. Coverage determinations are case-specific; missing required information or a prescription can delay review or prevent authorization.

Fax: fully completed Outpatient Prior Authorization Request Form.
Online: fully completed authorization request through the web portal.
Incomplete submissions are subject to case-specific review and may not support approval.

Documentation Required

Current Prescription Required

Include a current prescription from the treating physician, advanced practice registered nurse (APRN), or physician assistant (PA). The prescription must be signed and dated within the past 6 months.

Prescriber: treating physician, APRN, or PA.
Prescription must include the prescriber’s signature and date.
Prescription must be no more than 6 months old at submission.

Documentation Required

Clinical-Support Documentation

Provide documentation from the treating provider supporting the medical need for digestive enzyme cartridges as outlined in the Clinical Guideline section. Documentation must be written within the applicable recency period.

Initial authorization: documentation written within the past 6 months.
Reauthorization: documentation written within the past 12 months.
Support the qualifying pancreatic insufficiency, enteral feeding need, and PERT failure or intolerance.

Billing Rule

Pricing Information

Include the pricing information required for review, as outlined in the DSS Pricing Policy for MEDS Items.

Submit applicable pricing information with the authorization request.
Reference: DSS Pricing Policy for MEDS Items.

Denial Risk

Incomplete Authorization Submission

Failure to submit all required materials—including the completed authorization request, current prescription, clinical-support documentation, and pricing information—may delay review or prevent a favorable coverage determination. Requests are evaluated using case-specific information under the medical-supply review procedures.

Missing information may require additional review or follow-up.
A missing or outdated prescription does not meet the submission requirement.
Approval depends on satisfying applicable medical-necessity criteria.

TimingApproval must be obtained prior to service delivery or initiation of the plan of care

EPSDT Special Provision

ProgramEarly and Periodic Screening, Diagnosis, and Treatment (EPSDT) is a federal Medicaid requirement

Eligible membersMedicaid enrollees under 21 years of age

Coverage implicationCMAP must cover medically necessary services, products, or procedures needed to correct or ameliorate a defect, physical or mental illness, or condition identified through a screening examination