Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Enteral Nutritional Therapy
Policy #:MA08.003d

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

Enteral nutrition and administration supplies and equipment are considered medically necessary and, therefore, covered when the individual meets the following criteria:
  • The individual has one of the following indications which requires tube feedings to provide sufficient nutrients to maintain weight and strength commensurate with their overall health status:
    • *Permanent nonfunctional or disease of the structures that normally permit food to reach the small bowel (e.g., obstruction due to head and neck cancer or reconstructive surgery, or due to a motility disorder [e.g., severe dysphagia following a stroke, etc]); or
    • Disease of the small bowel which impairs digestion and absorption of an oral diet (e.g., Crohn's)

Adequate nutrition must not be possible by dietary adjustment and/or oral supplements. Coverage is possible for individuals with partial impairments (e.g., an individual with dysphagia who can swallow small amounts of food or a individual with Crohn's disease who requires prolonged infusion of enteral nutrients to overcome a problem with absorption).

*A permanent impairment is defined as a permanence that does not require a determination that there is no possibility that the individual'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 3 months), the test of permanence is considered met.

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

The medical necessity for special enteral formulas (B4149, B4153-B4155, B4157, B4161, and B4162) must be supported for each individual. If a special enteral nutrition formula is provided and the medical necessity is not supported and documented in the medical record, it will be considered not medically necessary and, therefore, not covered.

EQUIPMENT AND SUPPLIES
Enteral nutrition may be administered by syringe, gravity, or pump. Some individuals receiving enteral nutrition may experience complications associated with the syringe or gravity method of administration. Therefore, if a pump is ordered, there must be documentation in the individual’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 100 mL/hr, blood glucose fluctuations, circulatory overload, gastrostomy/jejunostomy tube used for feeding). If the medical necessity of the pump is not met, the pump will be considered not medically necessary and, therefore, not covered.

The feeding supply kit must correspond to the method of administration. If it does not correspond, it will be considered not medically necessary and, therefore, not covered.

If the medical necessity of the pump supply kit is not met, it will be considered not medically necessary and, therefore, not covered.

The codes for feeding supply kits are specific to the route of administration. The feeding supply kit must correspond to the method of administration.

The codes for enteral feeding supplies include all supplies, other than the feeding tube itself, required for the administration of enteral nutrients to the individual for one day.

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

NOT SEPARATELY REIMBURSABLE

Reimbursement for enteral formula additives (B4104) is considered included in the allowance for the enteral formula. Therefore, enteral formula additives are not separately reimbursable when billed with the enteral formula.

Reimbursement for a catheter/tube anchoring device (A5200) is considered included in the allowance for enteral feeding supply kits (B4034-B4036). Therefore, catheter/tube anchoring devices are not separately reimbursable when billed with the enteral feeding supply kits.

NOT COVERED

Enteral nutrition is not covered by the Company for any of the following indications, because these indications are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration:
  • For individuals 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.
  • For individuals with temporary impairments.
  • Enteral nutrition products and supplies, when the nutrition is administered orally.

Nutritional supplements (used as the mainstay of a daily nutritional plan, or in between meals to boost protein-caloric intake) are not covered by the Company because these items are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

Food thickeners (B4100), baby food, and other regular grocery products that can be blenderized and used with the enteral system are not covered by the Company because these items are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

Electrolyte-containing fluids (B4102 and B4103) are not covered by the Company because these items are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

Self-blenderized formulas are not covered by the Company because these items are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

EXPERIMENTAL/INVESTIGATIONAL

Although the US Food and Drug Administration (FDA) has approved the RELiZORB® device for digestive enzyme supplementation, the Company has determined that the safety and/or effectiveness of this device cannot be established by review of the available published peer-reviewed literature. Therefore, RELiZORB® is considered experimental/investigational by the Company and not covered.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include, but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, enteral nutrition is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not covered are not eligible for coverage or reimbursement by the Company.

Description

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 individuals who have undergone special training.

Enteral nutrition is appropriate for individuals who, because of chronic illness or trauma, cannot be sustained through oral feeding and must rely on enteral nutritional therapy to provide sufficient nutrients to maintain weight and strength.

The FDA approved the RELiZORB® device to hydrolyze fats in enteral formulas for adults and pediatric individuals ages 5 years and older. Based on available evidence to date, the safety and effectiveness cannot be established.
References

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual.Chapter 15: Covered medical and other health services. 120 - Prosthetic Devices (Rev. 1, 10-01-03). [CMS Web site]. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-Ioms-Items/Cms012673.html . Accessed June 21, 2018.

Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD). 180.2: Enteral and parenteral nutrition therapy. [CMS Web site]. 07/11/84.
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=242&ncdver=1&DocID=180.2&ncd_id=180.2&ncd_version=1&basket=ncd%25253A180%25252E2%25253A1%25253AEnteral+and+Parenteral+Nutritional+Therapy&bc=gAAAAAgAAAAAAA%3d%3d& . Accessed June 21, 2018.

Noridian Medicare Local Coverage Determination (LCD): L33783 & A52493: Enteral nutrition. Original: 10/01/2015. Revised 01/01/2017. Available at: https://med.noridianmedicare.com/web/jadme/policies/lcd/active . Accessed June 25, 2018.

RELiZORB®. Prescribing information. Alcresta Therapeutics, Inc. 2018. Available at: http://relizorb.com/hcp . Accessed July 10, 2018.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT ENTERAL SUPPLIES:

B4034 Enteral Feeding Supply Kit; Syringe fed, per day, includes, but not limited to feeding/flushing syringe, administration set tubing, dressings, tape.

B4035 Enteral Feeding Supply Kit; Pump fed, per day, includes, but not limited to feeding/flushing syringe, administration set tubing, dressings, tape

B4036 Enteral Feeding Supply Kit; gravity fed, per day, includes, but not limited to feeding/flushing syringe, administration set tubing, dressings, tape

B4081 Nasogastric tubing with stylet

B4082 Nasogastric tubing without stylet

B4083 Stomach tube Levine type

B4087 Gastrostomy/jejunostomy tube, standard, any material, any type, each

B4088 Gastrostomy/jejunostomy tube, low-profile, any material, any type, each

B9002 Enteral nutrition infusion pump, any type

B9998 NOC for enteral supplies

E0776 IV pole


THE FOLLOWING CODES ARE USED TO REPRESENT FORMULA:

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

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, includes proteins, fats, carbohydrates, vitamins and minerals, 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


NOT COVERED

B4100 Food thickener, administered orally, per ounce

B4102 Enteral formula, for adults, used to replace fluids and electrolytes (eg, clear liquids), 500 ml= 1 unit

B4103 Enteral formula for pediatrics, used to replace fluids and electrolytes (eg, clear liquids), 500 ml= 1 unit

S9433 Medical food nutritionally complete, administered orally, providing 100% of nutritional intake

S9434 Modified solid food supplements for inborn errors of metabolism


THE FOLLOWING CODE IS NOT SEPARATELY REIMBURSABLE:

B4104 Additive for enteral formula (eg, fiber)


THE FOLLOWING CODE IS NOT SEPARATELY PAYABLE WHEN REPORTED WITH B4034, B4035, B4036:

A5200 Percutaneous catheter/tube anchoring device, adhesive skin attachment


EXPERIMENTAL/INVESTIGATIONAL

B4105 In-line cartridge containing digestive enzyme(s) for enteral feeding, each



Revenue Code Number(s)

N/A

Coding and Billing Requirements

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

Reimbursement for a catheter/tube anchoring device is considered included in the reimbursement for the enteral feeding supply kits (B4034-B4036). Therefore, code A5200 is not separately reimbursable when billed with enteral feeding supply kits (B4034-B4036).


Cross References




Policy History

MA08.003d
10/23/2019This policy has been reissued in accordance with the Company's annual review process.
01/01/2019This policy has been updated to communicate the experimental/investigational coverage of Relizorb®.

MA08.003c
11/22/2017This policy has been reissued in accordance with the Company's annual review process.
01/01/2017This policy has been identified for the HCPCS code update, effective 01/01/2017.

The following HCPCS code has been deleted from this policy:
B9000 Enteral nutrition infusion pump - without alarm

The following HCPCS narrative has been revised in this policy:
    FROM: B9002 Enteral nutrition infusion pump - with alarm
    TO: B9002 Enteral nutrition infusion pump, any type

MA08.003b
09/28/2016This policy has been updated to reflect the coverage position of newly-added HCPCS codes:

Medically Necessary if criteria are met:
S9435 Medical foods for inborn errors of metabolism.

Non-covered, per Medicare rules:
  • S9433 - Medical food nutritionally complete, administered orally, providing 100% of nutritional intake
  • S9434 - Modified solid food supplements for inborn errors of metabolism

MA08.003a
03/11/2015The Company has clarified its position of Non-Coverage regarding nutritional supplements, as described in the Medicare National Coverage Determination (NCD):180.2: Enteral and parenteral nutrition therapy.

An error was identified and corrected in "Coding and Billing Requirements" Section: HCPCS code B5034 was changed to B4034.

MA08.003
01/01/2015This is a new policy.




Version Effective Date: 01/01/2019
Version Issued Date: 12/31/2018
Version Reissued Date: 10/23/2019