NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES
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. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).
Enteral nutrition is covered under the Prosthetic Device benefit (Social Security Act § 1861(s)(8)). In order for a beneficiary’s nutrition to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met). In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.
Enteral nutrition is the provision of nutritional requirements through a tube into the stomach or small intestine.
Enteral nutrition is covered for a beneficiary 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 beneficiary's overall health status.
The beneficiary must have a permanent impairment. Permanence does not require a determination that there is no possibility that the beneficiary's condition may improve sometime in the future. If the judgment of the treating practitioner, 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. Enteral nutrition will be denied as non-covered in situations involving temporary impairments.
The beneficiary'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 beneficiaries 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 beneficiary must require tube feedings to maintain weight and strength commensurate with the beneficiary's overall health status. Adequate nutrition must not be possible by dietary adjustment and/or oral supplements. Coverage is possible for beneficiaries with partial impairments - e.g., a beneficiary with dysphagia who can swallow small amounts of food or a beneficiary with Crohn's disease who requires prolonged infusion of enteral nutrients to overcome a problem with absorption.
Enteral nutrition products that are administered orally and related supplies are noncovered, no benefit.
If the coverage requirements for enteral nutrition are met, medically necessary nutrients, administration supplies, and equipment are covered.
Enteral nutrition provided to a beneficiary 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 beneficiary in a stay covered by Part A. However, if a beneficiary 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.
Food thickeners (B4100), baby food, and other regular grocery products that can be blenderized and used with the enteral system will be denied as noncovered.
Codes B4102 and B4103 describe electrolyte-containing fluids that are noncovered by Medicare.
Self-blenderized formulas are noncovered by Medicare.
Code B4104 is an enteral formula additive. The enteral formula codes include all nutrient components, including vitamins, mineral, and fiber. Therefore, code B4104 will be denied as not separately payable.
The unit of service (UOS) for the supply allowance (B4034, B4035, or B4036) is one (1) UOS per day. Claims that are submitted for more than one UOS per day for HCPCS codes B4034, B4035, or B4036 will be rejected.
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)
Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The link will be located here once it is available.
Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.
If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS
In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.
Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.
The supplier must enter a diagnosis code corresponding to the beneficiary's diagnosis on each claim.
DME INFORMATION FORM (DIF)
A DME Information Form (DIF) which has been completed, signed, and dated by the supplier, must be kept on file by the supplier and made available upon request.
The DIF for Enteral Nutrition is CMS Form 10126. The initial claim must include an electronic copy of the DIF.
A new Initial DIF for enteral nutrients is required when:
- A formula billed with a different code, which has not been previously certified, is ordered, or
- Enteral nutrition services are resumed after they have not been required for two consecutive months.
A new Initial DIF for a pump (B9002) is required when:
- Enteral nutrition services involving use of a pump are resumed after they have not been required for two consecutive months, or
- A beneficiary receiving enteral nutrition by the syringe or gravity method is changed to administration using a pump.
A revised DIF for enteral nutrients is required when:
- The number of calories per day is changed, or
- The number of days per week administered is changed, or
- The method of administration (syringe, gravity, pump) changes, or
- The route of administration is changed from tube feedings to oral feedings (if billing for denial), or
- The HCPCS code for the current nutrient changes
A revised DIF must be submitted when the length of need previously entered on the DIF has expired and the treating practitioner is extending the length of need for the item(s).
Special nutrient formulas, HCPCS codes B4149, B4153, B4154, B4155, B4157, B4161, and B4162, are produced to meet unique nutrient needs for specific disease conditions. The beneficiary's medical record must adequately document the specific condition and the need for the special nutrient. This information shall be available upon request.
If two enteral nutrition products, which are described by the same HCPCS 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.
Enteral feeding supply allowances (B4034, B4035, and B4036) include all supplies, other than the feeding tube and nutrients, required for the administration of enteral nutrients to the beneficiary for one day. Only one unit of service may be billed for any one day. Codes B4034, B4035, and B4036 describe a daily supply fee rather than a specifically defined “kit”. The use of individual items may differ from beneficiary to beneficiary, and from day to day. Items included in these codes are not limited to pre-packaged “kits” bundled by manufacturers or distributors. These supply allowances include, but are not limited to, a catheter/tube anchoring device, 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 a specific code for any individual item, should a unique HCPCS code for item exist (for examples dressing, tape, etc.).
The following Coding Guidelines apply for billing of In-Line Cartridges for enteral feeding:
Effective for dates of service on or after July 1, 2018 through July 12, 2018, code Q9994 (IN-LINE CARTRIDGE CONTAINING DIGESTIVE ENZYME(S) FOR ENTERAL FEEDING, EACH) is the code used to bill for in-line digestive enzyme cartridges. For these dates of service, code Q9994 is not payable by Medicare.
Effective for dates of service on or after July 13, 2018 through December 2, 2018, code Q9994 (IN-LINE CARTRIDGE CONTAINING DIGESTIVE ENZYME(S) FOR ENTERAL FEEDING, EACH) is the code used to bill for in-line digestive enzyme cartridges. For these dates of service, code Q9994 is not separately billable and is included in the supply allowance for enteral feeding supplies (see section 30.7.2 of the Medicare Claim Processing Manual (Internet Only Manual (IOM) 100-4), Chapter 20, "Payment for Parenteral and Enteral Nutrition (PEN) Items and Services.")
Effective for dates of service on or after December 3, 2018 through December 31, 2018, claims for code Q9994 are eligible for separate payment.
Effective for dates of service on or after January 1, 2019, code Q9994 is crosswalked to code B4105 (IN-LINE CARTRIDGE CONTAINING DIGESTIVE ENZYME(S) FOR ENTERAL FEEDING, EACH). Claims for code B4105 are eligible for separate payment.
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, B4150, B4152, B4153, B4154, B4155, B4157, B4158, B4159, B4160, B4161, and B4162) are administered by mouth, the BO modifier must be added to the code. Products that are only administered orally should be coded as A9270.
Code B4149 describes formulas containing natural foods that are blenderized and packaged by a manufacturer. B4149 formulas are classified based upon this manufacturer requirement, not on the composition of the enteral formula. Code B4149 must not be used for foods that have been blenderized by the beneficiary or caregiver for administration through a tube.
The only products which may be billed using codes B4149, B4153, B4154, B4155, B4157, B4161, or B4162 are those for which a written Coding Verification Review has been made by the Pricing, Data Analysis and Coding (PDAC) Contractor and subsequently published on the appropriate Product Classification List.
Suppliers should refer to the Enteral Nutrition Product Classification list on the PDAC Contractor web site or contact the PDAC for guidance on the correct coding for these items.