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.  
  
The purpose of a Local Coverage Determination (LCD) is to provide information
regarding "reasonable and necessary" criteria based on Social Security Act 
1862(a)(1)(A) provisions.  
  
In addition to the "reasonable and necessary" criteria contained in this LCD
there are other payment rules, which are discussed in the following documents,
that must also be met prior to Medicare reimbursement:

  * The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  * The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.
  * Refer to the Supplier Manual for additional information on documentation requirements.
  * Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria,
based on Social Security Act  1862(a)(1)(A) provisions, are defined by the
following coverage indications, limitations and/or medical necessity.

Enteral nutrition is covered for a beneficiary who requires feedings via an
enteral access device to provide sufficient nutrients to maintain weight and
strength commensurate with the beneficiary's overall health status and has a
permanent:

  1. full or partial non-function or disease of the structures that normally permit food to reach the small bowel; OR,
  2. disease that impairs digestion and/or absorption of an oral diet, directly or indirectly, by the small bowel.

Refer to the LCD-related Policy Article for the definition of test of
permanence.

Adequate nutrition must not be possible by dietary adjustment and/or oral
supplements.

Typical examples of conditions associated with non-function or disease of the
structures that permit food from reaching the small bowel that qualify for
coverage are head and neck cancer with reconstructive surgery and central
nervous system disease leading to interference with the neuromuscular
mechanisms of ingestion of such severity that the beneficiary cannot be
maintained with oral feeding (not all inclusive).

Typical examples of conditions associated with impaired digestion and/or
absorption of an oral diet by the small bowel that may qualify for coverage
include inflammatory bowel disease, surgical resection of small bowel, cystic
fibrosis, chronic pancreatitis, and advanced liver disease (not all
inclusive).

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

For coverage of the following scenarios, see the LCD-related Policy Article:

  * Enteral nutrition for temporary impairments
  * Enteral nutrition for beneficiaries with a functioning gastrointestinal tract whose need for enteral nutrition is not due to reasons related to the non-function or disease of the structures that normally permit food to reach the small bowel
  * Orally administered enteral nutrition products, related supplies and equipment

NUTRIENTS

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

The medical necessity for special enteral formulas (B4149, B4153, B4154,
B4155, B4157, B4161, and B4162) must be justified in each beneficiary. 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
reasonable and necessary. (Refer to the LCD-related Policy Article for policy
specific documentation requirements.)

EQUIPMENT AND SUPPLIES

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

If a pump (B9002) is ordered, there must be documentation in the beneficiary'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 documented, the pump will be denied as
not reasonable and necessary.

In-line digestive enzyme cartridges (B4105) are reasonable and necessary for
beneficiaries who:

  1. meet the coverage criteria for enteral nutrition; AND,
  2. have a diagnosis of Exocrine Pancreatic Insufficiency (EPI) (refer to the Group 1 Codes in the LCD-related Policy Article for applicable diagnoses).

More than two in-line digestive enzyme cartridges (B4105) per day will be
denied as not reasonable and necessary.

The feeding supply allowance (B4034, B4035, and B4036) must correspond with
the method of enteral nutrition administration (syringe, pump, gravity). If a
feeding supply kit does not correspond with the method in which the enteral
nutrition is being administered, then the feeding supply kit will be denied as
not reasonable and necessary.

For dates of service prior to January 1, 2023, the feeding supply allowance
(B4034, B4035, and B4036) must correspond to the method of administration
indicated in question 5 of the DME Information Form (DIF). If it does not
correspond, it will be denied as not reasonable and necessary.

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

The codes for feeding supply allowances (B4034, B4035, and 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 reasonable and necessary.

Enteral feeding supply kit allowances (B4034, B4035, and B4036), are all-
inclusive, with the exception of B4105 in-line digestive enzyme cartridge.
Separate billing for any item including an item using a specific HCPCS code,
if one exists, or B9998 (ENTERAL SUPPLIES, NOT OTHERWISE CLASSIFIED) will be
denied as unbundling.

Refer to the LCD-related Policy Article CODING GUIDELINES section for
additional information about enteral feeding supply allowances.

More than three nasogastric tubes (B4081, B4082, and B4083), or one
gastrostomy/jejunostomy tube (B4087 or B4088) every three months is not
reasonable and necessary.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a
claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving a completed SWO, the claim shall be denied as not
reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
base items that require a Written Order Prior to Delivery (WOPD), the supplier
must have received a signed SWO before the DMEPOS item is delivered to a
beneficiary. If a supplier delivers a DMEPOS item without first receiving a
WOPD, the claim shall be denied as not reasonable and necessary. Refer to the
LCD-related Policy Article, located at the bottom of this policy under the
Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed
associated options, accessories, and/or supplies, the supplier must have
received a WOPD which lists the base item and which may list all the
associated options, accessories, and/or supplies that are separately billed
prior to the delivery of the items. In this scenario, if the supplier
separately bills for associated options, accessories, and/or supplies without
first receiving a completed and signed WOPD of the base item prior to
delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines
listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC
articles. Claims that do not meet coding guidelines shall be denied as not
reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be
based on prospective, not retrospective use. For DMEPOS products that are
supplied as refills to the original order, suppliers must contact the
beneficiary prior to dispensing the refill and not automatically ship on a
pre-determined basis, even if authorized by the beneficiary. This shall be
done to ensure that the refilled item remains reasonable and necessary,
existing supplies are approaching exhaustion, and to confirm any changes or
modifications to the order. Contact with the beneficiary or designee regarding
refills must take place no sooner than 14 calendar days prior to the
delivery/shipping date. For delivery of refills, the supplier must deliver the
DMEPOS product no sooner than 10 calendar days prior to the end of usage for
the current product. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are
required to have contact with the beneficiary or caregiver/designee prior to
dispensing a new supply of items. Suppliers must not deliver refills without a
refill request from a beneficiary. Items delivered without a valid, documented
refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's
expected utilization. Suppliers must stay attuned to changed or atypical
utilization patterns on the part of their clients. Suppliers must verify with
the treating practitioner that any changed or atypical utilization is
warranted.

Regardless of utilization, a supplier must not dispense more than a 1-month
quantity at a time.

Supply allowance HCPCS codes (B4034, B4035, and B4036) are daily allowances
which are considered all-inclusive and therefore refill requirements are not
applicable to these HCPCS codes. Refer to the Coding Guidelines section in the
LCD-related Policy Article for further clarification.

Per the 2022 Medicare Fee-for Service Supplemental Improper Payment Data, the
overall CERT error rate for DMEPOS claims is 25.2%. Claims for items which
have recently had Certificates of Medical Necessity (CMNs) or Durable Medical
Equipment Information Forms (DIFs) eliminated represent an area of potential
vulnerability that may increase the CERT error rate.

As outlined in the CMS _Program Integrity Manual_ (Pub. 100-08) Chapter 1,
Section 1.3.8, the DME MACs are responsible for reducing the payment error
rate by preventing initial payment of claims that do not comply with
Medicare's coverage, coding, payment, and billing policies. The DME MACs are
continually looking to identify any potential vulnerabilities that may
increase the CERT error rate and have recognized that claims for items which
have recently had the CMNs or DIFs eliminated may represent one such
vulnerability. Therefore, the DME MACs are proposing the addition of the KX,
GA, GY, and GZ modifiers to properly indicate when claims for enteral
nutrition are reasonable and necessary.