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.

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 parenteral
nutrition are reasonable and necessary.