Parenteral Nutrition

**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").

Parenteral Nutrition is covered under the Prosthetic Device benefit (Social
Security Act  1861(s)(8)). In order for a beneficiary's equipment 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 non-medical necessity coverage and payment rules, discussed below,
that also must be met.

TEST OF PERMANENCE

As stipulated in the Medicare _Benefit Policy Manual_ (CMS Pub. 100-02),
Chapter 15 Section 120, coverage of parenteral nutrition requires that a
beneficiary must have a permanent impairment. However, this does not require a
determination that there is no possibility that the beneficiary's condition
may improve sometime in the future. If the medical record, including the
judgment of the treating practitioner, indicates that the impairment will be
of long and indefinite duration, the test of permanence is considered met.

EQUIPMENT AND SUPPLIES:

Only one infusion pump is covered for beneficiaries in whom parenteral
nutrition is required.

Additionally, only one supply kit and one administration kit is covered for
each day that parenteral nutrition is administered.

When parenteral nutrition is administered in an outpatient facility, the pump
used for its administration and IV pole will be denied as not separately
payable. The pump and pole are not considered as rentals to a single
beneficiary, but rather, as items of equipment used for multiple
beneficiaries.

Services associated with the administration of parenteral nutrition in a
beneficiary's home are not a covered benefit administered by the DME MACs.

**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 required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

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**

The beneficiary's medical record must contain sufficient documentation of the
beneficiary's medical condition to substantiate the necessity for the type and
quantity of items ordered and for the frequency of use or replacement (if
applicable). The information should include the beneficiary's diagnosis and
other pertinent information including, but not limited to, duration of the
beneficiary's condition, clinical course (worsening or improvement),
prognosis, nature and extent of functional limitations, other therapeutic
interventions and results, past experience with related items, etc.

Information describing the medical necessity for parenteral nutrition must be
available upon request. In order to satisfy the test of permanence, there must
be documentation to reflect that in the treating practitioner's judgement, the
impairment will be of long and indefinite duration.

Documentation in the medical record shall reflect that the beneficiary has (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.

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 (A55426),
located at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS.

MISCELLANEOUS:

Suppliers are required to monitor the beneficiary's medical condition to
confirm that the coverage criteria for parenteral nutrition continue to be
met.

Parenteral 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 parenteral 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, parenteral nutrition is eligible for coverage under Part B and may
be billed to the DME MAC by either the SNF or an outside supplier.

**DME INFORMATION FORM (DIF)**

Providers and suppliers no longer need to submit a DME Information Form (DIF)
for services rendered on or after January 1, 2023.

  * For claims with dates of service on or after January 1, 2023 - Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.
  * For claims with dates of service prior to January 1, 2023 - If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.

For dates of service for which a DIF is required, a 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 parenteral nutrition is CMS Form 10126. The initial claim must
include an electronic copy of the DIF.

For claims with dates of service prior to January 1, 2023 the following
requirements for new initial and revised DIFs remain in effect:

A new Initial DIF is required when parenteral nutrition services are resumed
when they are not required for two consecutive months.

A revised DIF must be submitted if:

  * Change in HCPCS code for the current nutrient provided.
  * Change (increase or decrease) in the calories prescribed for any HCPCS codes other than B4189, B4193, B4197, B4199, B5000, B5100, B5200.
  * Change in the number of days per week of administration.
  * Change in route of administration.
  * 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).

**MODIFIERS**

BA, GA, GY, GZ, and KX MODIFIERS:

When an IV pole (E0776) is used in conjunction with parenteral nutrition, the
BA modifier should be added to the code. Code E0776 is the only code with
which the BA modifier may be used.  
  
Suppliers must add the KX modifier to claim lines billed for parenteral
nutrition, parenteral pump, and supplies only if all of the coverage criteria
in the "Coverage Indications, Limitations, and/or Medical Necessity" section
in the related LCD have been met and evidence of such is retained in the
supplier's files and available to the DME MAC upon request.  
  
If all of the criteria in the "Coverage Indications, Limitations, and/or
Medical Necessity" section of the related LCD have not been met, the GA, GY or
GZ modifier must be added to the code. When there is an expectation of a
medical necessity denial, suppliers must enter the GA modifier on the claim
line if they have obtained a properly executed Advance Beneficiary Notice
(ABN) or the GZ modifier if they have not obtained a valid ABN. When there is
an expectation of a non-covered (no benefit) denial, suppliers must enter the
GY modifier on the claim line.

As of January 1, 2023, suppliers must calculate the units of service (UOS) for
each parenteral product billed to Medicare, based on the treating
practitioner's order. When billing for medically necessary parenteral
nutrition, units in excess of the treating practitioner's order must not be
billed with a KX (as these units are not reasonable and necessary). Instead,
these excess units must be billed with a GA or GZ modifier.

Claim lines billed with codes without a KX, GY, GA or GZ modifier will be
rejected as missing information.

**CODING GUIDELINES:**

When homemix parenteral nutrition solutions are used, the component
carbohydrates (B4164, B4180), amino acids (B4168, B4172, B4176, B4178),
additives (B4216), and lipids (B4185 or B4187) are all separately billable.
When premix parenteral nutrition solutions are used (B4189, B4193, B4197,
B4199, B5000, B5100, B5200) there must be no separate billing for the
carbohydrates, amino acids or additives (vitamins, trace elements, heparin,
electrolytes). However, lipids (B4185 or B4187) are separately billable with
premix solutions.

For lipids, one unit of service of code B4185 or B4187 is billed for each 10
grams of lipids provided. 500 ml of 10% lipids contains 50 grams of lipids (5
units of service); 500 ml of 20% lipids contains 100 grams (10 units of
service); 500 ml of 30% lipids contains 150 grams (15 units of service).

For codes B4189, B4193, B4197, B4199, one unit of service represents one day's
supply of protein and carbohydrate regardless of the fluid volume and/or the
number of bags. For example, if 60 grams of protein are administered per day
in two bags of a premix solution each containing 30 grams of amino acids,
correct coding is one (1) unit of B4193, not two units of B4189.

For codes B5000, B5100, B5200, one unit of service is one gram of amino acid.

Parenteral nutrition solutions containing less than 10 grams of protein per
day are coded using the miscellaneous code B9999.

Parenteral nutrition supply allowances (HCPCS codes B4220, B4222 and B4224)
describe a daily supply fee rather than a specifically defined "kit" and
include all supplies required for the administration of parenteral nutrition
to the beneficiary for one day. The use of individual items may differ from
beneficiary to beneficiary, and from day to day. Daily allowances are
considered all-inclusive and therefore refill requirements are not applicable
to HCPCS codes B4220, B4222 and B4224. Only one unit of service may be billed
for any one day.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)
Contractor for guidance on the correct coding of these items.