Summary Of Evidence

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.

Analysis of Evidence

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.

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.