Billing and Coding Support
Kabiven®(Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion), for intravenous use
The information and guidance within this document are intended for educational purposes related to Kabiven® only and is not a complete listing of all coding requirements for all insurance plans. Coverage and Coding requirements vary by insurance companies and by plans offered by insurance companies. These policies are constantly evolving by payers without notice and should be verified by the provider for each patient prior to treatment. Information provided by this document is not a guarantee of coverage or payment of Kabiven®. It is the sole responsibility of the provider to select proper codes and ensure the accuracy of all claims used in seeking reimbursement.
Brand Name: Kabiven®
Generic Name: amino acids, electrolytes, dextrose and lipid injectable emulsion
Kabiven® Indication and Selected Safety Information1
See full prescribing information for complete boxed warning
- Deaths in preterm infants have been reported in literature. (5.1, 8.4)
- Autopsy findings included intravascular fat accumulation in the lungs. (5.1, 8.4)
- Preterm and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. (5.1, 8.4)
Kabiven® is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN® may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.
- Kabiven® is indicated for intravenous infusion into a central vein.
- Ensure the vertical seals between chambers are broken and the contents of all three chambers for KABIVEN® and PERIKABIVEN® are mixed together prior to infusion.
Limitations of Use:
- Not recommended for use in pediatric patients < 2 years including preterm infants because the fixed content of the formulation does not meet nutritional requirements in this age group.
KABIVEN® is a sterile, hypertonic emulsion, for central venous administration, in a three-chamber bag. The product contains no added sulfites.
Chamber 1 contains Dextrose solution for fluid replenishment and caloric supply.
Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes.
Chamber 3 contains Intralipid®20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids.
To report suspected adverse reactions, contact Fresenius Kabi USA, LLC, at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Information that has been provided is not a guarantee of coverage of Kabiven®. Benefits, billing and coding requirements should always be verified with the specific patient’s insurance plan. Benefits and Coverage is typically unique to a patient’s insurance plan, not just the insurance company in general. Level of coverage varies by plan type within an insurance company. Coverage information provided within this document is subject to change without notice and is only as accurate as the information provided by the payers. It is the sole responsibility of the provider to select proper codes and ensure the accuracy of all claims used in seeking reimbursement.
1 Kabiven® Prescribing Information, Fresenius Kabi USA, LLC. 2016
- NDC (National Drug Code, assigned by the FDA to identify specific drugs)
- ICD-10-CM (International Classification of Diseases, 10th Revision, Clinical Modification, assigned by WHO, World Health Organization to classify diagnoses, used in all places of service)
- HCPCS (Healthcare Common Procedure Coding System assigned by CMS to identify products or procedures)
The NDC Codes below are assigned to “Kabiven®” (also known as: “Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine”), a human prescription drug labeled by “Fresenius Kabi USA, LLC”.
|63323-712-10||Three Chamber Bag/ Kabiven® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion) for Central Infusion||870 kcal||3.3% Amino Acids, 0.7% Electrolytes, 9.8% Dextrose and 3.9% Lipid Injectable Emulsion||1026 mL|
|63323-712-15||Three Chamber Bag/ Kabiven® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion) for Central Infusion||1310 kcal||3.3% Amino Acids, 0.7% Electrolytes, 9.8% Dextrose and 3.9% Lipid Injectable Emulsion||1540 mL|
|63323-712-20||Three Chamber Bag/ Kabiven® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion) for Central Infusion||1745 kcal||3.3% Amino Acids, 0.7% Electrolytes, 9.8% Dextrose and 3.9% Lipid Injectable Emulsion||2053 mL|
|63323-712-25||2380 kcal||3.3% Amino Acids, 0.7% Electrolytes, 9.8% Dextrose and 3.9% Lipid Injectable Emulsion||2566 mL|
For reimbursement purposes, some payers may require the Healthcare Provider (HCP) to include NDCs on the claim form. For claims-reporting purposes, some payers may also require HCPs to convert the 10-digit NDC to an 11-digit NDC by adding a “0” (zero) where appropriate to create a 5-4-2 configuration. The zero is added in front of the second segment of numbers when the 10-digit format is the 5-3-2 configuration.
The following is an example of converting a 10-digit NDC to an 11-digit NDC for Kabiven®: NDC 63323-712-20 would become NDC 63323-0712-20
NDC – National Drug Code (The NDC, or National Drug Code, is a unique 10-digit or 11—digit, 3 segment number, and a universal product identifier for human drugs in the United States.
The 3 segments of the NDC identify:
- The labeler (Segment #1)
- The product (Segment #2)
- The commercial package sizes (Segment #3)
ICD-10-CM – International Classification of Diseases, 10th Revision, Clinical Modification
Daily parenteral nutrition is considered reasonable and necessary for a patient with severe pathology of the alimentary tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient’s general condition.
Below is a table of common diagnosis codes that may be covered by an insurance company. Patient specific diagnosis should be validated with the patient’s insurance company. This list is not all inclusive, but only a small list of possibilities:
|Malabsorption due to intolerance, not elsewhere classified||K90.48|
|Complete intestinal obstruction, unspecified as to cause||K56.601|
|Acute Infarction of intestine, part and extent unspecified||K55.069|
|Postsurgical malabsorption, not elsewhere classified||K91.2|
|Acquired absence of other specified parts of digestive tract||Z90.49|
|Fistula of Stomach and duodenum||K31.6|
|Gastroenteritis and colitis due to radiation||K52.0|
|Irritable Bowel Syndrome||K58.1|
Medicare – a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities. Medicare coverage is categorized into four groups:
Part A – Hospital Inpatient
Part B – Durable Medical Equipment, prosthetics/orthotics and Enteral/Parenteral Nutrition
Part C – Medicare Advantage plans
Part D – Prescription Drug Coverage
Kabiven® is considered a parenteral nutrition and therefore covered by Part B, Medicare. Medicare coverage is administered by commercial insurance companies that contract with Medicare. Commercial insurers that have been awarded the Part B contracts are called DME-MACs (Durable Medical Equipment Medicare Administrative Contractors).
Below is a table that provides the names of the commercial insurers that have been awarded the DME-MAC contracts for 2020 by state:
2020 Medicare Administrative Carrier Contracts for DME-MAC Coverage
|Jurisdiction||States Covered||Medicare Administrative Carrier (MAC)|
|Jurisdiction A||CT DE DC MD ME ML NH NJ NY PA RI VT||Noridian Healthcare Solutions|
|Jurisdiction B||IL ID KY MI MN OH WI||CGS, A Celerian Group Company|
|Jurisdiction C||AL AK CO FL GA LA MS NM NC OK PR SC TN TX U.S. VIRGIN ISLANDS VA WV||CGS, A Celerian Group Company|
|Jurisdiction D||AK AMERICAN SAMOA AZ CA GUAM HW ID IA KS MO MT NB NV ND NORTHERN MARIANA ISLANDS OR SD UT WA WY||Noridian Healthcare Solutions|
Medicare Advantage – Medicare beneficiaries are offered Medicare coverage via commercial insurance companies that at a minimum Medicare coverage, but often enhanced benefits. These plans are also referred to as Part C.
Medicaid – A federal/state system of health insurance for those patients requiring financial assistance.
Commercial – Health insurance that is typically offered via an employer or purchased by the patient directly from a for-profit insurance company.
The following is a brief summary of Medicare’s coverage of parenteral nutrition. Medicare’s coverage policy is particularly important due to the fact that other insurance types (Medicare Advantage, Medicaid and Commercial) often follow Medicare’s coverage policy.
Medicare’s coverage of Parenteral Nutrition is standardized by implementation of a National Coverage Determination (NCD) for Enteral and Parenteral Nutritional Therapy (180.2). This means that all Medicare patients across the U.S. have the same benefits and are held by the same coverage criteria.
Parenteral Nutrition Coverage Criteria:
Parenteral Nutrition Therapy is considered reasonable and necessary for a patient with severe pathology of the alimentary tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient’s general condition. Coverage of nutritional therapy as a Part B benefit is provided under the prosthetic device benefit provision, which requires that the patient must have a permanently inoperative internal body organ or function thereof. Therefore, parenteral nutritional therapy is normally not covered in situations involving temporary impairments.
Parenteral nutrition therapy claims must be as a result of a physician’s written order or prescription to prove medical necessity. DME MACs will only reimburse for 30-day supplies at a time.
To qualify for coverage of Parenteral Nutrition, the following requirements must be met:
- To qualify for Medicare coverage of Parenteral Nutrition the patient is required to have severe pathology of the alimentary tract that does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient’s general condition. PN must be administered 7 days per week and PN is required for a minimum of 90 days.
- A total caloric daily intake (parenteral, enteral, and oral) of 20-35 cal/kg/day is considered sufficient to achieve or maintain appropriate body weight. The ordering physician must document in the medical record the medical necessity for a caloric intake outside this range in an individual patient.
- The ordering physician must document the medical necessity for protein orders outside of the range of 0.8-1.5 gm/kg/day, dextrose concentration less than 10%, or lipid use greater than 1500 grams (150 units of service of code B4185) per month.
- Prescription/Orders – Medicare requires a DME Information Form (DIF) be 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. CMS 10126 – ENTERAL AND PARENTERAL NUTRITION
- Medical Records – Physician prescription documenting continued need/use if applicable. The patient’s diagnosis must be severe pathology of the alimentary tract, which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient’s general condition.
- Correct Coding – HCPCS codes correct to the product administered, ICD-10 diagnosis codes to document qualifying diagnosis
- Proof of Delivery – Signed delivery slip or proof of delivery via shipping
Medicare requires precertification/prior authorization for Parenteral Nutrition. A precertification number should be placed in Box 23 of the DMS 1500 claim form.
Most insurance plans require a Prior Authorization be submitted prior to provision of Kabiven® to a patient. Please contact the patient’s insurance company to identify required forms and how/where to submit the Prior Authorization.
HCPCS codes (Healthcare Common Procedure Coding System) identify a specific product. Below is a table that demonstrates what codes have been suggested by payers. Note there are two HCPCS codes to bill for each of the package type of Kabiven®. Provision of these codes is not a guarantee that the codes will be accepted by every payer. Check with each patient’s insurance company for coverage of these codes.
(Three Chamber Bag/ Kabiven® (Amino Acids, Electrolytes, Dextrose, and Lipid Injectable Emulsion) for Central Infusion)
|NDC||Fill Volume||Description||Concentration||HCPCS Code Options||HCPCS Code Options – Lipids|
|63323-712-10||1026 mL||34g Amino Acid
|870 kcal||*B4189 – Parenteral nutrition; compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 10 – 51g of protein, premix||**B4185 – Parenteral Nutrition Solution, Not Otherwise Specified, 10 Grams Lipids|
|63323-712-15||1540 mL||51g Amino Acid
|1310 kcal||*B4189 – Parenteral nutrition; compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 10 – 51g of protein, premix||**B4185 – Parenteral Nutrition Solution, Not Otherwise Specified, 10 Grams Lipids|
|63323-712-20||2053 mL||68g Amino Acid
|1745 kcal||*B4193 – Parenteral nutrition; compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 52 – 73g of protein, premix||**B4185 – Parenteral Nutrition Solution, Not Otherwise Specified, 10 Grams Lipids|
|63323-712-25||2566 mL||85g Amino Acid
|2380 kcal||*B4197 – Parenteral nutrition; compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 74 – 100g of protein, premix||**B4185 – Parenteral Nutrition Solution, Not Otherwise Specified, 10 Grams Lipids|
*Billing Units: HCPCS codes B4189, B4193 and B5197 should be billed with a billing unit of “1” for each of the days in the month that is being billed for. For example, June has 30 days in it, therefore the billing unit when billing for the month of June should be “30”. This number should be in box 24G on the CMS 1500 claim form.
**HCPCS Code B4185 should be billed with a billing unit of “1” for each 10 Grams. When administered for a 30-day period at 40g per day, the total billing units would be 120.
If an IV Pole and infusion pump are also used, the coding used could be:
|Parenteral Nutrition Infusion Pump, Stationary||B9006|
|Parenteral Nutrition Supply Kit; Premix, Per Day||B4220|
|Parenteral Nutrition Administration Kit, Per Day||B4224|
If the coverage requirements for parenteral nutrition are met, one supply kit (B4220) and one administration kit (B4224) will be covered for each day that parenteral nutrition is administered. For example, June has 30 days in it, therefore the billing unit when billing for the month of June should be “30”. This number should be in box 24G on the CMS 1500 claim form.
A Modifier that apply to the IV Pole or ambulatory infusion pump is “RR” – Rental. Append to appropriate code when billing rental items (inexpensive, capped rental, items that require servicing. Modifiers are to be placed in Box 24D of the CMS-1500. Up to 4 modifiers can be attached to each HCPCS code.
Place of Service Codes
Place of Service Codes tell the insurance company where Kabiven® is administered. The Place of Service code should be placed in Box 24B of the CMS-1500. Coverage of Parenteral Nutrition is based on the patient’s place of service. Products are either paid for using HCPCS codes and payment amounts on the payer’s fee schedule or on a “Per Diem” rate. Per Diem means the facility is paid a daily or monthly amount to provide all services to the patient, which includes their daily nutritional needs. Per Diem rates apply to hospital inpatient or Skilled Nursing Facilities.
|Place of Service Code||Place of Service Name||Place of
|12||Home||Location, other than hospital or other facility, where the patient receives care in a private residence||Billed with HCPCS codes|
|13||Assisted Living Facility||Congregate residential facility with self-contained living units providing assessment of each resident’s needs and on-site support 24 hrs. per day, 7 days a week||Billed with HCPCS codes|
|21||Inpatient Hospital||A facility, that primarily provides diagnostic, therapeutic and rehab services by supervision of physicians admitted due to medical condition||Considered a “Per Diem” situation. Hospitals are paid a fixed rate that includes parenteral nutrition|
|24||Ambulatory Surgical Center||A freestanding facility other than a physician’s office, where surgical and diagnostic services are provided on an ambulatory basis||Billed with HCPCS codes|
|31||Skilled Nursing Facility||A facility that provides inpatient skilled nursing to patients but does not provide level of care available in a hospital||Considered a “Per Diem” situation. Skilled facilities are paid a fixed rate that includes parenteral nutrition|
Performing a Benefit Verification
Coverage criteria for each individual patient should be validated by contacting the patient’s insurance company directly. This process is called a “Benefit Verification”. The phone number for the Benefits or Customer Service department at the patient’s insurance company should be on the back side of the patient’s insurance card.
Some of the information to be gathered from the insurance company during a Benefit Verification can include:
Benefit Verification Questions to Patient Insurance:
- Is Prior Authorization Required?
- What is the insurer’s Prior Authorization process?
- What is the fax or telephone number to the Prior Authorization unit within the insurer?
- What information will the Prior Authorization unit request?
- How long does the Prior Authorization process take?
- What is the patient’s out of pocket cost?
- Has the patient met their annual or lifetime benefit max?
- What amount has been paid to date?
- Annual Deductible
- Lifetime Benefit
- Out of pocket maximum
- What is the telephone number to your Claims Inquiry department?
- What is the address to submit claims to?
- Do you have any documentation requirements? (e.g. Statement of Medical Necessity