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 parenteral 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.

Parenteral nutrition is the provision of nutritional requirements intravenously and is covered for beneficiaries who qualify under the Prosthetic Device Benefit defined in the Medicare Benefit Policy Manual (CMS Pub. 100-02), Chapter 15, Section 120.

When nutritional support other than the oral route is necessary, enteral nutrition (EN) is usually initially preferable to parenteral nutrition for the following reasons: (1) In a fluid restricted beneficiary, EN permits delivery of all necessary nutrients in a more concentrated volume than parenteral nutrition; (2) EN allows for safer home delivery of nutrients; and (3) EN lowers the risk of Central Line-Associated Bloodstream Infections (CLABSI).

For parenteral nutrition to be considered reasonable and necessary, the treating practitioner must document that enteral nutrition has been considered and ruled out, tried and been found ineffective, or that EN exacerbates gastrointestinal tract dysfunction. The beneficiary must have (a) a condition involving the small intestine and/or its exocrine glands which significantly impairs the absorption of nutrients or (b) disease of the stomach and/or intestine which is a motility disorder and impairs the ability of nutrients to be transported through and absorbed by the gastrointestinal (GI) system. The beneficiary must have a permanent impairment. Please refer to the LCD-related Policy Article for further guidance regarding the test of permanence.  

The treating practitioner is required to evaluate the beneficiary within 30 days prior to initiation of parenteral nutrition. If the treating practitioner does not see the beneficiary within this timeframe, they must document the reason why and describe what other monitoring methods were used to evaluate the beneficiary's parenteral nutrition needs. There must be documentation in the medical record supporting the clinical diagnosis.

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.

If the coverage requirements for parenteral nutritional therapy are met under the prosthetic device benefit provision, related supplies, equipment and nutrients are also covered.

No more than one month's supply of parenteral nutrients, equipment or supplies is allowed for one month's prospective billing. Claims submitted retroactively, however, may include multiple months.

Services associated with the administration of parenteral nutrition in a beneficiary’s home are addressed in the Non-Medical Necessity Coverage and Payment Rules section located in the LCD-related Policy Article. 

NUTRIENTS:

A total caloric daily intake of 20-35 cal/kg/day is considered reasonable and necessary to achieve or maintain appropriate body weight. The treating practitioner must document the medical necessity for a caloric intake outside this range in an individual beneficiary.

The treating practitioner must document the medical necessity for protein orders outside of the range of 0.8-2.0 gm/kg/day (B4168, B4172, B4176, B4178), dextrose concentration less than 10% (B4164, B4180), or lipid use per month in excess of the product-specific, FDA-approved dosing recommendations (B4185, B4187).

Special nutrient formulas, HCPCS codes B5000, B5100, and B5200 are produced to meet the unique nutrient needs for specific disease conditions. The beneficiary’s medical record must adequately document the specific condition and the necessity for the special nutrient.

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 (B4220, B4222 and B4224) 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.