Enteral nutrition is the provision of nutritional requirements through a tube into the stomach or small intestine. Enteral therapy may be given by nasogastric, jejunostomy or gastrostomy tubes and can be provided safely and effectively in the home by nonprofessional persons who have undergone special training.  

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.  For the items addressed in this policy, the criteria for "reasonable and necessary," based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted.  If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not reasonable and necessary.

Enterable nutrition is covered for a patient who has (a) permanent non-function or disease of the structures that normally permit food to reach the small bowel or (b) disease of the small bowel which impairs digestion and absorption of an oral diet, either of which requires tube feedings to provide sufficient nutrients to maintain weight and strength commensurate with the patient’s overall health status.

The patient must have a permanent impairment. Permanence does not require a determination that there is no possibility that the patient’s condition may improve sometime in the future.  If the judgment of the attending physician, substantiated in the medical record, is that the condition is of long and indefinite duration (ordinarily at least three months), the test of permanence is considered met.  Enteral nutrition will be denied as non-covered in situations involving temporary impairments.

The patient’s condition could be either anatomic (e.g., obstruction due to head and neck cancer or reconstructive surgery, etc.) or due to a motility disorder (e.g., severe dysphagia following a stroke, etc.).  Enteral nutrition is non-covered for patients with a functioning gastrointestinal tract whose need for enteral nutrition is due to reasons such as anorexia or nausea associated with mood disorder, end-stage disease, etc.

The patient must require tube feedings to maintain weight and strength commensurate with the patient’s overall health status.  Adequate nutrition must not be possible by dietary adjustment and/or oral supplements.  Coverage is possible for patients with partial impairments – e.g., a patient with dysphagia who can swallow small amounts of food or a patient with Crohn’s disease who requires prolonged infusion of enteral nutrients to overcome a problem with absorption.

If the coverage requirements for enteral nutrition are met, medically necessary nutrients, administration supplies and equipment are covered.

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

The supplier is responsible for assessing how much enteral nutrition and supplies the member is actually using.  The supplier must contact the member or caregiver prior to dispensing nutrients or supplies to determine the quantities that remain from previous delivery and modify the quantity delivered or delivery date accordingly.  The supplier must not automatically dispense a quantity of items on a predetermined regular basis, even if the member has "authorized" this in advance.  Contact with the member or designee regarding refills should take place no sooner than approximately 7 days prior to the delivery/shipping date.  For subsequent deliveries of refills, the supplier should deliver the product no sooner than approximately 5 days prior to the end of usage for the current product.  For patients in a nursing home, the delivery must be designated for each individual member, not as a general delivery to the nursing home.

Enteral nutrition provided to a patient in a Part A covered stay must be billed by the SNF to the fiscal intermediary.  No payment from Part B is available when enteral nutrition services are furnished to a member in a stay covered by Part A.  However, if a member is in a stay not covered by Part A, enteral nutrition is eligible for coverage under Part B and may be billed to the DME MAC by either the SNF or an outside supplier.

Nutrients

Enteral formulas consisting of semi-synthetic intact protein/protein isolates (B4150 or B4152) are appropriate for the majority of patients requiring enteral nutrition.

The medical necessity for special enteral formulas (B4149, B4153-B4157, B4161 and B4162) must be  justified in each patient.  If a special enteral nutrition formula is provided and if the medical record does not document why that item is medically necessary, it will be denied as not medically necessary.

Equipment and Supplies

Enteral nutrition may be administered by syringe, gravity or pump.  Some enteral patients may experience complications associated with syringe or gravity method of administration. 

If a pump (B9000-B9002) is ordered, there must be documentation in the patient’s medical record to justify its use (e.g., gravity feeding is not satisfactory due to reflux and/or aspiration, severe diarrhea, dumping syndrome, administration rate less than 100ml/hr, blood glucose fluctuations, circulatory overload, gastrostomy/jejunostomy tube used for feeding).  If the medical necessity of the pump is not documented, the pump will be denied as not medically necessary.  

The feeding supply kit (B4034-B4036) must correspond with the method of administration.  If it does not correspond with the method of administration, it will be denied as not medically necessary.

If a pump supply kit (B4035) is provided and if the medical necessity of the pump is not documented, it will be denied as not medically necessary.

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.

Payment for a catheter/tube anchoring device is considered included in the allowance for enteral feeding supply kits (B4034 – B4036).  Code A5200 should not be billed separately and is not paid in addition to the supplies for enteral nutrition.

The codes for 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.  The provider cannot bill the member for the denied service. 

A 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, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Reasons for Noncoverage

Enteral nutrition products that are administered orally and related supplies are non-covered.  The provider can bill the member for the denied service.

Food thickeners (B4100), baby food and other regular grocery products that can be blenderized and used with the enteral system will be denied as non-covered.  The provider can bill the member for the denied service.

Codes B4102 and B4103 describe electrolyte-containing fluids that are non-covered.  The provider can bill the member for the denied service.

Self-blenderized formulas are non-covered.  The provider can bill the member for the denied service.

Code B4104 is an enteral formula additive.  The enteral formula codes include all nutrient components, including vitamins, minerals and fiber.  Therefore, code B4104 will be denied as not separately payable.  The provider cannot bill the member for the denied service.

Documentation Requirements

It is expected that the patient’s medical records will reflect the need for the care provided.  The patient’s medical records include the physician’s written order or prescription, physician office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports.  This documentation must be available upon request.  The ordering physician must complete a certificate of medical necessity (CMN).

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request.  Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.  

Special nutrient formulas, procedure codes B4149, B4153-B4157, B4161 and B4162, are produced to meet unique nutrient needs for specific disease conditions.  The patient’s medical record must adequately document the specific condition and the need for the special nutrient.  This information must be available upon request. 

If two enteral nutrition products, which are described by the same procedure code, are being provided at the same time, they should be billed on a single claim line with the units of service reflecting the total calories of both nutrients.

A Certificate of Medical Necessity (CMN) should be completed, signed, dated, kept on file, and made available upon request.

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.

When an IV pole (E0776) is used for enteral nutrition administered by gravity or a pump, the BA modifier should be added to the code.  Code E0776 is the only code with which the BA modifier may be used.

When enteral nutrients (B4149-B4162) are administered by mouth, the BO modifier must be added to the code.

Code B4149 describes formulas containing natural foods that are blenderized and packaged by a manufacturer.  Code B4149 must not be used for foods that have been blenderized by the patient or caregiver for administration through a tube.

Suppliers should refer to the Enteral Nutrition Product Classification list on the Pricing, Data Analysis and Coding (PDAC) Contractor web site or contact the PDAC for guidance on the correct coding for these items.

Only those products included in the Product Classification List published by the PDAC may be billed using code B4149, B4153, B4154, B4155, B4157, B4161, or B4162.  If a manufacturer or supplier thinks that another product meets the definition of this code, they should contact the PDAC for a coding determination.

Provider News

02/2011, Elimination of least costly alternative for Medicare Advantage

CMS Online Manual Pub. 100-3, Chapter 1, Section 180.2