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Date Printed: December 19, 2014: 01:27 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2014, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J0000-61

Original Effective Date: 07/15/02

Reviewed: 07/23/09

Revised: 05/11/14

Subject: Enteral Formulas

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates

DESCRIPTION:

Enteral formulas are liquid food products that are specially formulated and designed to increase the amount of various food elements and nutrients that will maintain proper physiological function of the body process. They may also be used to correct an existing deficiency.

Enteral formulas may be administered intermittently or continuously through nasogastric, gastrostomy, or jejunostomy tubes directly into the gastrointestinal tract with or without the assistance of an infusion pump, or they may be administered orally.

Florida state statutes mandate that coverage for prescription and nonprescription enteral formulas for home use, be made available, at an appropriate additional premium, to policyholders when the below criteria is met. For mandate language, please refer to the section of this MCG entitled OTHER.

POSITION STATEMENT:

Prescription and nonprescription enteral formulas meet the definition of medical necessity when prescribed by the physician as being medically necessary and there is an inherited disease of amino acid, organic acid, carbohydrate, or fat metabolism, or malabsorption originating from congenital defects present at birth or acquired during the neonatal period.

Products for inherited diseases of amino acid and organic acid may also include food products modified to be low protein such as those manufactured by Dietary Specialties, Inc., Med Diet, or Energy Food, Inc.

The $2,500 limitation, as noted below in the state mandate, applies to both congenital and inherited diseases for members through the age of 24 years. These services that have been provided to individuals prior to 03/15/05 will be reviewed on an individual basis.

Although the criteria for coverage of enteral formula may not be met in some cases, the associated surgery, durable medical equipment and supplies meet the definition of medical necessity. (NOTE: Enteral formula is considered food rather than a supply.)

BILLING/CODING INFORMATION:

The following codes may be used to report enteral formulas:

HCPCS Coding:

B4102

Enteral formula, for adults, used to replace fluids and electrolytes (e.g., clear liquids), 50 ml = 1 unit (non-covered)

B4103

Enteral formula, for pediatrics, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit (non-covered)

B4104

Additive for enteral formula (e.g., fiber) (non-covered)

B4149

Enteral formula, manufactured blenderized natural foods with intact nutrients, includes proteins, fats, carbohydrates, vitamins, and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit (non-covered)

B4150

Enteral formula, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins, and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit

B4152

Enteral formula, nutritionally complete, calorically dense (equal to or greater than 1.5 KCAL/ML) with intact nutrients, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit

B4153

Enteral formula, nutritionally complete, hydrolyzed proteins (amino acids and peptide chain), includes fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit

B4154

Enteral formula, nutritionally complete, for special metabolic needs, excludes inherited disease of metabolism, includes altered composition of proteins, fats, carbohydrates, vitamins and/or minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit

B4155

Enteral formula, nutritionally incomplete/modular nutrients, includes specific nutrients, carbohydrates (e.g., glucose polymers), proteins/amino acids (e.g., glutamine, arginine), fat (e.g., medium chain triglycerides) or combination, administered through an enteral feeding tube, 100 calories = 1 unit

B4157

Enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit

B4158

Enteral formula, for pediatrics, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber and/or iron, administered through an enteral feeding tube, 100 calories = 1 unit

B4159

Enteral formula, for pediatrics, nutritionally complete soy based with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber and/or iron, administered through an enteral feeding tube, 100 calories = 1 unit

B4160

Enteral formula, for pediatrics, nutritionally complete calorically dense (equal to or greater than 0.7 KCAL/ML with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit

B4161

Enteral formula, for pediatrics, hydrolyzed/amino acids and peptide chain proteins, includes fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit

B4162

Enteral formula, for pediatrics, special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit

S9435

Medical foods for inborn errors of metabolism

ICD-9 Diagnoses Codes That Support Medical Necessity:

270.0 – 270.9

Disorders of amino-acid transport and metabolism

271.0 – 271.9

Disorders of carbohydrate transport and metabolism

272.5 – 272.9

Disorders of lipoid metabolism

775.0 – 775.7

Endocrine and metabolic disturbances specific to the fetus and newborn

775.81, 775.89

Other neonatal endocrine and metabolic disturbances

775.9

Unspecified endocrine and metabolic disturbances specific to the fetus and newborn

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

E70.0

Classic phenylketonuria

E70.20 – E70.29

Disorders of tyrosine metabolism

E70.30

Albinism, unspecified

E70.40 – E70.49

Disorders of histidine metabolism

E70.8

Other disorders of aromatic amino-acid metabolism

E71.0

Maple-syrup-urine disease

E71.19

Other disorders of branched-chain amino-acid metabolism

E71.2

Disorder of branched-chain amino-acid metabolism, unspecified

E72.00 – E72.19

Other disorders of amino-acid metabolism

E72.8, E72.9

Other specified and unspecified disorders of amino-acid metabolism

E74.00 – E74.39

Other disorders of carbohydrate metabolism

E74.8, E74.9

Other specified and unspecified disorders of carbohydrate metabolism

E78.6

Lipoprotein deficiency

E78.9

Disorder of lipoprotein metabolism, unspecified

P70.0 – P70.9

Transitory disorders of carbohydrate metabolism specific to newborn

P71.0 – P71.9

Transitory neonatal disorders of calcium and magnesium metabolism

P72.1

Transitory neonatal hyperthyroidism

P72.8, P72.9

Other specified and unspecified transitory neonatal endocrine disorders

P74.0

Late metabolic acidosis of newborn

P74.1

Dehydration of newborn

P74.4

Other transitory electrolyte disturbances of newborn

P74.8, P74.9

Other specified and unspecified transitory metabolic disturbances of newborn

P94.0

Transient neonatal myasthenia gravis

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical notes, physician treatment and progress notes.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note or treatment notes

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Clinical notes and chart section

28650-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline revised date: Enteral and Parenteral Nutritional Therapy (180.2) located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Enteral Nutrition (L11553) located at cgsmedicare.com.

DEFINITIONS:

Malabsorption: inability of the intestines to absorb nutrition from food, leading to malnutrition.

RELATED GUIDELINES:

External Infusion Pumps (non-insulin), 09-E0000-10

OTHER:

Florida Statute 627.42395 –

Coverage for certain prescription and nonprescription enteral formulas – Notwithstanding any other provision of law, any health insurance policy delivered or issued for delivery, to any person in this state or any group, blanket, or franchise health insurance policy delivered or issued for delivery in this state shall make available to the policyholder as part of the application, for an appropriate additional premium, coverage for prescription and nonprescription enteral formulas for home use which are physician prescribed as medically necessary for the treatment of inherited diseases of amino acid, organic acid, carbohydrate, or fat metabolism as well as malabsorption originating from congenital defects present at birth or acquired during the neonatal period. Coverage for inherited diseases of amino acids and organic acids shall include food products modified to be low protein, in an amount not to exceed $2,500 annually for any insured individual, through the age of 24. This section applies to any person or family notwithstanding the existence of any preexisting condition.

REFERENCES:

  1. American Academy of Pediatrics Committee on Nutrition. Reimbursement for Medical Foods for Inborn Errors of Metabolism. Pediatrics 1994; 93; 860.
  2. American Academy of Pediatrics Policy Statement. Reimbursement for Foods for Special Dietary Use. PEDIATRICS Vol. 111 No. 5 May 2003, pp. 1117-1119; reaffirmed 05/01/06.
  3. American Medical Association CPT (current edition).
  4. Blue Cross Blue Shield Association Medical Policy Reference Manual, 1.02.01 Total Parenteral Nutrition and Enteral Nutrition in the Home, (04/29/03).
  5. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for Enteral and Parenteral Nutritional Therapy; Publication 100-3, Section 180.2, 07/11/84.
  6. Centers for Medicare and Medicaid Services (CMS) Region C DMERC Local Coverage Determination (LCD) and Policy Article for Enteral Nutrition (L11553), 01/01/08.
  7. Florida State Statute 627.42395.
  8. St. Anthony’s ICD-9-CM Code Book (current edition).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 07/23/09.

GUIDELINE UPDATE INFORMATION:

07/15/02

MCG Reformatted; revised to remove information relating to supplies and parenteral nutrition.

03/15/03

Added S9435.

07/15/04

Scheduled review with revisions to coverage statement regarding state mandate language; added Program Exception for Medicare+Choice.

01/01/05

HCPCS coding update: added new codes B4102 – B4104, B4149, B4157 – B4162, revised descriptors for B4150, B4152 – B4155, and removed deleted codes B4151 and B4156.

03/15/05

Revision to guideline consisting of adding clarification of coverage criteria regarding state mandate.

01/01/06

Annual HCPCS coding update: revise B4149.

07/01/06

Updated MCG number from 09-A4000-08 to 09-J0000-61.

08/15/06

Biennial review, no changes, updated references.

10/15/07

Reviewed and reformatted guideline; no change in coverage statement.

08/15/09

Scheduled review; revise position statement for clarification; add fifth-digit specificity to ICD-9 diagnosis code list; update references.

12/15/10

Revisions; related ICD-10 codes added; formatting changes.

09/15/11

Revision; formatting changes.

05/11/14

Revision: Program Exceptions section updated.

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Date Printed: December 19, 2014: 01:27 AM