Effective June 20, 1997, enteral feeding solutions (enteral formulas, procedure codes B4157, B4162, B9998) administered by any method are eligible when necessary for the therapeutic treatment of the following hereditary genetic disorders as defined in Act 191 - 1996. Under this Act, benefits for medically necessary enteral formulas, such as PKU 1 or 2, Lofenalac, or Ketonex 1 or 2, administered under the direction of a physician for these specified conditions are exempt from any contract deductibles:

Phenylketonuria (PKU)
Branched-chain ketonuria
Galactosemia
Homocystinuria

Infant formulas, administered either by mouth or through a tube, may be considered eligible for coverage based on the content of the formula and the reason for use of a special formula as noted above. Lactose intolerance, milk protein intolerance, or other milk allergies are not indications for coverage. However, any hemorrhagic colitis secondary to these conditions is eligible. It will be necessary for the provider to submit medical records and/or additional documentation to determine coverage in this situation. Basic milk or soy formulas are not eligible.

Enteral feeding via nasogastric, jejunostomy, or gastrostomy tubes is an alternative to parenteral nutrition for the patient with a functioning gastrointestinal tract but for whom regular, oral feeding is impossible. Indications for enteral feeding solutions (enteral formulas, procedure codes B4149-B4155, B4158-B4161) via tube feeding include but are not limited to:

Catheter sepsis from hyperalimentation
Central nervous system diseases
Fistula
Gastrointestinal cancer
Granulomatous colitis
Head and neck cancer and reconstructive surgery
Infection, chronic
Intestinal atresia (infants)
Irradiated bowel
Ischemic bowel disease
Jaw fracture
Malabsorption syndrome
Obstruction of gastric outlet due to ulcer diathesis
Pancreatitis, acute or chronic
Partial obstruction
Renal failure
Short-gut syndrome
Stroke
Ulcerative colitis, acute

Food thickener, blenderized baby food or regular shelf food used with an enteral system, and nutritional supplements, are not covered.

Codes B4100, B4102, B4103, and B4104 are not covered. A network provider can bill the member for these non-covered services.

Prosthetic devices which are dispensed to a patient prior to performance of the procedure that will necessitate use of the device are not covered. Dispensing a prosthetic device in this manner would not be considered reasonable and necessary for the treatment of the patient's condition.

Enteral feeding by any method for any eligible condition is covered under the prosthetic benefit and, except as defined by Act 191, is subject to any contract deductibles.

Enteral Accessories and Supplies

Accessories and/or supplies that are used directly with enteral systems to achieve therapeutic benefit or assure proper functioning of the feeding system are eligible durable medical equipment (DME). They include:

Catheters
Concentrated nutrients
Dressings
Enteral nutrition preparation
Extension tubing
Filters
Infusion bottles
IV pole
Liquid diet (for catheter administration)
Needles
Pumps (food or infusion)
Tape

No more than one month's supply of enteral nutrients, equipment or supplies may be dispensed at one time.

The codes for feeding supply kits (B4034-B4036) are specific to the route of administration. Claims for more than one type of kit code delivered on the same date or provided on an ongoing basis will be denied as not medically necessary. The feeding supply kit must correspond to the method of administration.

More than three nasogastric tubes (B4081-B4083), or one gastrostomy/jejunostomy tube (B4087, B4088) every three months is not medically necessary. 

The codes for the enteral feeding supplies (B4034-B4036) include all supplies, other than the feeding tube itself, required for the administration of enteral nutrients to the patient for one day. Codes B4034-B4036 describe a daily supply fee rather than a specifically defined "kit." Some items are changed daily; others may be used for multiple days. Items included in these codes are not limited to pre-packaged "kits" bundled by manufacturers or distributors. These supplies include, but are not limited to, feeding bag/container, flushing solution bag/container, administration set tubing, extension tubing, feeding/flushing syringes, gastrostomy tube holder, dressings (any type) used for gastrostomy tube site, tape (to secure tube or dressings), Y connector, adapter, gastric pressure relief valve, declogging device, etc. These items must not be separately billed using the miscellaneous code (B9998)) or using specific codes for dressings or tape. The use of individual items may differ from patient to patient and from day to day. Only one unit of service may be billed for any one day. Units of service in excess of one per day will be denied as not separately payable.

A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Coverage for Durable Medical Equipment/Prosthetics is determined according to individual or group customer benefits.

Description

Enteral feeding is the provision of nutrition through the use of special enteral formulae either by mouth or through a tube placed into the gastrointestinal tract.

Enteral feeding is provided when because of trauma or illness, a patient cannot ingest enough food orally to support healing and maintain activities of daily life. It is also provided when the body cannot properly process normal food taken orally, as in rare hereditary genetic disorders. In the presence of such disorders, severe mental retardation and chronic physical disabilities may occur without proper therapeutic management.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

CMS Pub. 100-03, Medicare National Determination Manual, Chapter 1, Section 180.2

Region A DMERC PSC Bulletin, Bul 20041201 ENT Nutrition, December 2004

SUBJECT:  ENTERAL NUTRITION (Mandated and Expanded Benefit)

POLICY #: O-6

DESCRIPTION:
Enteral feeding is the provision of nutrition through the use of special enteral formulae provided either by mouth or through a feeding tube placed into the gastrointestinal tract. It is an alternative to hyperalimentation for individuals who cannot take adequate nutrition through regular diet but who have adequate gastrointestinal tract function to absorb the enteral formulae.

PATIENT SELECTION:

1. State-mandated conditions for use of enteral feeding:
   
   
   • congenital metabolic disorders (phenylketonuria, galactosemia, homocystinuria, branched-chain ketonuria) requiring limitation of certain nutrients
     
     
2. Expanded benefit conditions for use of enteral feeding may include but are not limited to:
   
   
   • neurologic deficits which make oral feeding difficult (cerebral palsy, coma)
   • difficulty swallowing (stroke, cerebral palsy, head and neck cancer following surgery, jaw fractures)
   • congenital metabolic disorders (phenylketonuria, galactosemia, homocystinuria, etc.) requiring limitation of certain nutrients
   • gastric reflux with risk of aspiration
   • digestive problems with difficulty absorbing normal nutrients (pancreatic insufficiency, malabsorption, short bowel syndrome, inflammatory bowel diseases, etc.)
   • acquired metabolic disorders (hepatic insufficiency, pulmonary insufficiency, renal failure) requiring limitation of certain nutrients  

MEDICAL POLICY:

1. State Mandate - Act 191

   Effective June 20, 1997, enteral feeding solutions (enteral formulas, procedure code B4157, B4162, B9998) administered by any method are eligible when necessary for the therapeutic treatment of the following hereditary genetic disorders as defined in Act 191 - 1996. Under this Act, benefits for medically necessary enteral formulas, such as PKU 1 or 2, Lofenalac, or Ketonex 1 or 2, administered under the direction of a physician for these specified conditions are exempt from any contract deductibles.

   Phenylketonuria (PKU)

   Branched-chain ketonuria

   Galactosemia

   Homocystinuria

    

    

   
    

2. Expanded Benefit

   Enteral feeding solutions are eligible for coverage when they are provided via tube (nasogastric, gastrostomy, jejunostomy, etc.) and are the sole source of nutrition for any condition listed in Patient Selection, II. Program deductibles are applied for the Expanded Benefit and are subject to all benefit limits and coinsurance.

   In addition, enteral feeding solutions are eligible for coverage when they are provided orally and they are the sole source of nutrition for:

   • individuals who require a hydrolyzed protein predigested or amino acid-based formula (B4153), formula for special metabolic needs (B4154), modular components formula (B4155) or standardized nutrient formula
   • individuals who require a defined formula with specialized contents for specific metabolic needs (B4154)
   • individuals who require a modular component formula (B4155)

   Once eligible for coverage, they will remain eligible until an individual is able to take at least 50% of their daily caloric requirement in regular foods.

   Enteral formulae provided due to inability to take adequate calories by regular diet is not eligible for coverage, unless the enteral formulae is the sole source of nutrition and is a formulae included in B4153 to B4155.

   Infant formulas, administered either by mouth or through a tube, may be considered eligible for coverage based on the content of the formula and the reasons for use of a special formula as noted above (B4158 to B4161). Lactose intolerance, milk protein intolerance, or other milk allergies are not indications for coverage. However, hemorrhagic colitis secondary to these conditions is eligible. Basic milk or soy formulas are not eligible.

RATIONALE:
These solutions when used under the circumstances noted under Medical Policy are medically necessary and appropriate for the health of the individual due to the presence of a medical condition as outlined under Patient Selection.

BENEFIT ADMINISTRATION
Benefits are payable for enteral feeding solution under the enteral formula benefit. When provided for one of the state mandated conditions in Patient Selection I, enteral feeding solutions are exempt from any contract deductibles.

Enteral Accessories and Supplies

Accessories and/or supplies that are used directly with enteral systems to achieve therapeutic benefit or assure proper functioning of the feeding system are eligible under the Durable Medical Equipment (DME) benefit. They include:

Catheters
Concentrated nutrients
Dressings
Enteral nutrition preparation
Extension tubing
Filters
Infusion bottles
IV pole
Liquid diet (for catheter administration)
Needles
Pumps (food or infusion)
Tape