Parenteral nutrition products are considered drugs; only a pharmacy may dispense these solutions. Refer to the Pharmacy Services section of the Minnesota Health Care Programs (MHCP) Provider Manual for information about parenteral nutrition.

Nasogastric tubes, gastrostomy, or jejunostomy tubes (feeding tubes), enteral supply kits and enteral nutrition infusion pumps are supplies used to administer enteral nutrition products to individuals who are unable to take enteral nutrition products orally.

Eligible Providers

The following providers may provide enteral nutrition products and related supplies:

· Federally qualified health centers

· Home health agencies

· Indian health services

· Medical suppliers

· Pharmacies

· Rural health clinics

TPL and Medicare
Providers must meet any provider criteria, including accreditation, for third-party insurance or for Medicare to assist members for whom Minnesota Health Care Programs (MHCP) is not the primary payer.

MHCP quantity limits and thresholds apply to all members unless only Medicare coinsurance or deductible is requested.

Refer to the Medicare and Other Insurance section of the MHCP Provider Manual for more information.

Eligible Members

Enteral nutrition is covered for eligible Medical Assistance and MinnesotaCare members who need nutritional supplementation and meet criteria under Covered Services.

Program HH members are eligible for crucial medications and care services for members living with HIV. Refer to the HIV/AIDS Services section of the MHCP Provider Manual.

Program HH members also enrolled in MinnesotaCare or who are on Medical Assistance are eligible for benefits if they meet criteria under Covered Services.

Covered Services

Codes: B4034-B4036, B4081-B4083, B4087, B4088, B4100, B4102, B4103, B4105, B4148-B4150, B4152-B4155, B4157-B4162, B9002, B9004, B9006, B9998, B9999, E0791, T2101
Enteral nutrition products are covered for members who need nutritional supplementation due to a medical condition and require nutrition supplements to improve their condition or illness.

MHCP covers the following products and supplies:

· Enteral formula (B4149, B4150, B4152 to B4155, B4157 to B4162)

· Enteral feeding supply kits (B4034 to B4036, B4148)

· Feeding tubes (B4081 to B4083, B4087, B4088)

· Feeding pumps (B9002, B9004, B9006, E0791)

· Food thickeners (B4100)

· Electrolyte-containing fluids (B4102, B4103)

· In-line cartridge containing enzymes (B4105)

· Human donor milk (T2101)

Only products classified by the Centers for Medicare and Medicaid Services’ (CMS) Pricing, Data Analysis and Coding (PDAC) contractor are covered. Refer to the DMECS Product Classification List to determine the correct HCPCS code.

Refer to the Equipment and supplies resources webpage for enteral nutrition lists by HCPCS ranges B4149 to B4155 and B4157 to B4162. MHCP assigns 4-character codes. Nutrition products do not need to be listed on the MHCP lists for coverage. Products must be classified by PDAC.

Refer to Medical Supply Coverage Guide (PDF) for information about items not specified in this section of the MHCP Provider Manual.

Enteral Nutrition for Feeding Tubes

Enteral nutrition products are covered for members with feeding tubes. MHCP covers up to 1,050 units of enteral nutrition per month for members who meet criteria. Authorization is required for any amount over 1,050 units. Documentation must support the medical necessity of the amount requested.

Oral Enteral Nutrition

Codes: B4149-B4150, B4152-B4155, B4157-B4162 (1 unit = 100 calories)
Authorization is not required for the initial 1,050 units per month for the following diagnoses:

· Hyperlysinemia

· Maple syrup urine disease

· Phenylketonuria

The applicable diagnosis must be billed on the claim.

Providers may dispense up to 400 units initially to meet the member’s need while requesting authorization for all other medically necessary oral enteral nutrition. This is a one-time allowance when the enteral nutrition is initially requested by a licensed health care prescriber. Quantities beyond the intial dispensing require authorization.

Members who receive more than 75% of their daily nutrition from oral enteral nutrition products must have a detailed plan for decreasing their dependence. The plan must be written by a nutritionist, speech-language pathologist, or other provider working within their scope of practice.

Nutrition for pediatric members
Enteral nutrition products are covered when documentation indicates the medical necessity that enteral nutrition will improve a member’s physical condition or illness .

Potential diagnoses include, but are not limited to:

· A combined allergy to human milk, cow milk, or soy formula

· Ankyloglossia

· Congenital anomalies

· Feeding intolerance

· Growth faltering or failure to thrive in newborns

· Heart, kidney, and pulmonary diseases

· High risk of necrotizing enterocolitis

· Hyperlysinemia

· Hypoglycemia

· Immunologic deficiency

· Impaired gastrointestinal function

· Intrauterine growth restriction

· Issues related to dehydration

· Malabsorption

· Maple syrup urine disease

· Metabolic conditions

· Neonatal jaundice

· Phenylketonuria

· Prematurity (less than 37 weeks gestational age)

· Sensory issues related to medical conditions or maternal substance use

· Sepsis

· Very low birth weight (less than 1,500 grams or 3.3 pounds)

Oral nutrition for malabsorption or malnutrition
Enteral nutrition products may be medically necessary for medical conditions related to malabsorption or malnutrition. The condition must have resulted in weight loss or difficulty maintaining a healthy weight. Medical necessity for enteral nutrition must demonstrate that if the member were left untreated by oral enteral nutrition they would risk harmful effects to their health.

Potential diagnoses include, but are not limited to:

· An oral aversion which significantly limits the ability to get adequate nutrients

· Inborn errors of metabolism

· Malabsorption due to disease or infection

· Mechanical inability to chew or swallow blended, pureed, or solid foods

· Weaning from total parenteral nutrition or feeding tube

Oral nutrition for members with nonhealing wounds
High-protein enteral nutrition products are covered for up to six months with authorization if the member has one or more wounds that have not responded to treatment for at least 30 days, and a dietary assessment has determined that the member has a nutritional deficit which may be impeding healing. Documentation must include a nutrition plan written by a nutritionist, physician or other health care provider.

Human Donor Milk

Code: T2101 (1 unit = 1 ounce)
Human donor milk is covered for eligible members from birth up to 12 months old who meet nutrition criteria for pediatric members.

MHCP covers up to 16 units per day. Additional units may be approved through authorization.

Authorization is always required, except when the member is discharged from a hospital. Authorization is not required for the initial 30-day supply.

Documentation must include:

· Medical necessity by the ordering physician, including applicable diagnoses and length of need; and

· The provider must discuss with the infant’s parent or guardian and document in the medical record the benefits and risks of donor human milk and other feeding alternatives.

Human donor milk must be obtained from a milk bank and adhere to quality guidelines consistent with the Human Milk Bank Association of North America. When receiving human donor milk, the milk bank screens and approves all donor mothers and monitors and tests all donated milk. The milk is commercially formulated and undergoes pasteurization. Pasteurization removes bacteria and other harmful organisms from the human donor milk. The entire process ensures the milk is completely safe to be consumed by infants in need.

Providers must address the benefits and risks of using donor human milk such as the effects of pasteurization, immune properties, nutrients, and growth factors to the parent. Providers must also address the milk banking process including donor screening, pasteurization, milk storage, and transport of the milk. The physician may procure this information from the donor milk bank.

Food Thickeners

B4100 (1 unit = 1 ounce)
Food thickeners are covered for individuals at risk of choking or aspirating liquids. The member must have a history of aspiration to qualify. Authorization is always required.

Documentation must include:

· Medical necessity by the ordering physician, including applicable diagnoses and length of need; and

· An explanation that the member has a history or is at risk of choking or aspirating liquids; and

· A swallow study performed by a speech-language pathologist; and

· A plan of care, including annual follow ups.

Requests for food thickeners for members younger than 12 months old must include gestational age at birth.

Electrolyte-Containing Fluids

Codes: B4102 and B4103 (1 unit = 500 milliliters)
Electrolyte-containing fluids may be medically necessary for medical conditions related to malabsorption or malnutrition. Authorization is always required.

Documentation must include:

· Medical necessity by the ordering physician, including applicable diagnoses and length of need; and

· An explanation that the member cannot absorb adequate nutrients or requires fluids. Fluids for members only requiring electrolytes are not covered; and

· An explanation in the medical record the benefits of these fluids and why other nutritional products do not satisfy the needs of the member. The provider must discuss these fluids and nutritional products with the member.

In-Line Cartridge Containing Digestive Enzymes

Code: B4105 (1 unit = 1 cartridge)
Member must meet the criteria for enteral feeding and have a diagnosis of exocrine pancreatic insufficiency or fat malabsorption as shown in clinical documentation, not just a letter of medical necessity. Coverage is indicated for use with members ages 2 years and older who require the delivery of absorable fatty acids and monoglycerides. This device has 510(k) clearance by the Food and Drug Administration (FDA), and therefore does not need a full review for safety and effectiveness. Authorization is always required.

Amino-Acid Based Elemental Formula

Amino-acid based elemental formula is covered for medically necessary conditions including, but not limited to:

· Cystic fibrosis

· Eosinophilic colitis

· Eosinophilic esophagitis

· Eosinophilic gastroenteritis

· Foot protein-induced enterocolitis syndrome

· Immunoglobulin E mediated allergies to food proteins

· Mast cell activation syndrome

· Metabolic and malabsorption disorders for amino acids, organic acids, and fatty acids

Authorization is required for members older than five years.

Supplies for Enteral or Parenteral Nutrition

Enteral feeding supply kits
Codes: B4034-B4036, B4148 (1 unit = 1 kit)
Thirty-one enteral feeding supply kits per month are medically necessary for members receiving enteral nutrition products through a feeding tube. The feeding supply kit must correspond with the method of administration, and must contain all supplies necessary for feeding using that method of administration for one day. For members who use the same or a different method of administration at work or school, up to 20 additional enteral feeding supply kits per month are covered. Documentation on file at the provider’s office must support the need for additional feeding supply kits. MHCP will cover only 51 enteral feeding supply kits per month without authorization.

Feeding tubes
Codes: B4081-B4083, B4087, B4088 (1 unit = 1 tube)
Most people who use a feeding tube require only one tube every two to three months. Up to two tubes per month may be medically necessary for people with more than one tube site or for those with highly acidic gastrointestinal tracts. Low-profile feeding tubes are medically necessary for infants, children and adults with cognitive impairments who are at risk of dislodging a standard feeding tube or those determined by a physician to need this type of feeding tube. The provider must maintain documentation to support the quantity and type of feeding tubes supplied. When billing B4088 for a kit, not a single tube, use modifier U3. Review the Pricing for enteral nutrition products information under Billing for more information.

MHCP covers feeding tubes for purposes of hydration and medication for members who cannot consume medications or meet hydration needs due to a behavioral or medical diagnosis. Documentation must demonstrate that the diagnosis severely restricts the member’s ability to effectively maintain hydration or consume medications. Authorization is always required for purposes of hydration and medication.

Documentation must include:

· Medical necessity from the ordering physician, including applicable diagnoses and length of need; and

· An explanation that the member cannot maintain hydration or medication needs without the use of a feeding tube. Documentation must clearly articulate why needs cannot be met by other methods. Feeding tubes for purposes of convenience are noncovered; and

· Consideration of less costly alternatives; and

· An explanation in the medical record the benefits of the tube and medications and nutritional products consumed by the member.

Feeding pumps
Codes: B9002, B9004, B9006, E0791 (1 unit = 1 pump)
A parenteral infusion pump is medically necessary for members for whom parenteral nutrition is required. An enteral infusion pump is medically necessary for members with feeding tubes for whom gravity or syringe feeding is not appropriate. Authorization is required only for maintenance service or for repairs when parts and labor exceed $400. One pump is covered every five years. Consider the member’s current and expected lifestyle when selecting a stationary versus portable pump. If a pump must be replaced due to theft or damage, providers must submit a claim with an attachment explaining the circumstances. Authorization is required for maintenance service contracts or for repairs to patient-owned pumps where parts and labor exceed $400. Refer to Non-Mobility Equipment Repairs section of the MHCP Provider Manual for more information.

Supplies not otherwise classified
Codes: B9998–B9999 (For Enteral/Parenteral Supplies)
Up to 31 extension sets per month are medically necessary for members with low-profile feeding tubes. Up to thirty 35 ml or 60 ml syringes per month are medically necessary for people receiving medication through a feeding tube. One carrying case per year is covered for members with portable feeding pumps.

Noncovered Services

MHCP does not cover the following:

· Electrolytes for members who only require fluids

· Energy drinks

· Enteral formula additives (B4104)

· Food thickeners for infants younger than age 1 who were born at less than 37 weeks gestation due to FDA caution

· Nutrition products for healthy newborns

· Nutrition products for people living in long-term care (LTC) facilities

· Nutrition products for which coverage is requested because of an inability to afford regular foods or supplements

· Nutrition products for which the need is nutritional rather than medical or is related to an unwillingness to consume solid or pureed foods

· Nutrition products that are requested as a convenient alternative to preparing or consuming regular foods

· SimplyThick brand thickener for infants younger than age 1 regardless of gestational age at birth is not covered due to FDA caution

· Sport shakes

Members who are unable to afford regular foods should be refered to county human services.

Authorization

Submit authorization requests and required documentation to the Medical Review Agent. Review the Equipment and Supplies section of the MHCP Provider Manual for general authorization requirements.

When authorization is required, the claim must match HCPCS code, modifiers and product code as noted on the authorization letter.

Authorization is required for the following:

· Oral enteral nutrition, unless it is the initial 400 units or the member has a diagnosis of hypoglycemia, maple syrup urine disease, or phenylketonuria

· Quantities over 1,050 units per month for oral enteral nutrition or enteral nutrition for feeding tubes for any diagnosis

· Food thickeners (B4100)

· Electrolyte-containing fluids (B4102 and B4103)

· In-line cartridge-containing digestive enzymes (B4105)

· Human donor milk (T2101), unless it is the initial 30-day supply

· Amino-acid based elemental formula for members older than 5 years

Documentation must include:

· Member’s diagnosis and clinical history; and

· What is preventing adequate nutritional intake or consumption; and

· Weight history and concerns; and

· Documentation that includes a care plan from a speech-language pathologist, nutritionist, or other provider in their scope of practice; and

· The specific enteral nutrition product requested; and

· The average number of calories to be obtained per day from the enteral nutrition product; and

· The average number of calories to be obtained per day from other sources; and

· The medical condition that requires an enteral nutrition product; and

· Manufacturer’s suggested retail price (MSRP) or invoice as pricing documentation.

Billing

Providers are responsible to coordinate services. Refer to the Billing Policy Overview section in the Provider Basics of the MHCP Provider Manual for general billing information.

Bill nutritional products using MN–ITS 837P Professional. Refer to the Billing for Durable Medical Equipment, Medical Supplies, Prosthetics and Orthotics, and Augmentative Devices MN–ITS user guide for general billing requirements and guidance when submitting claims.

Use modifier U3 if you are a home infusion therapy (HIT) pharmacy billing enteral nutrition supplies (B4034, B4035, B4036, B4081, B4082, B4083, B4087, B4088, B9002, E0776) not related to the HIT services.

All claims for enteral nutrition products
Enter the following information on all claims for enteral nutrition products:

· Modifier BO for members taking their enteral nutrition orally

· A valid diagnosis code to the greatest specificity indicating the medical condition that requires the product

· The date of service is the date the item was dispensed to the member; do not use a date span

· The appropriate HCPCS code for the product dispensed

· The appropriate number of units dispensed

· The product name in the service line level notes field when product-specific pricing is requested

· The type of product billed must match what was on the prior authorization request for name and price

Enteral nutrition products when authorization is not required
A valid diagnosis of phenylketonuria, hyperlysinemia, maple syrup urine disease or tube-feeding must be on the claim or the claim will deny for needing authorization.

Enteral nutrition products when authorization is required
HCPCS codes and modifiers on submitted claims must be identical to the approved authorization to prevent a denial.

Pricing for enteral nutrition products
Use these guidelines:

· Bill B4149 to B4150, B4152 to B4155, and B4157 to B4162 with modifier NU, with or without modifier BO, requires by-report or product-specific pricing

· B4088 with modifier U3, billing for a kit, requires by-report or product-specific pricing

· Pricing documentation must include the following:

· Product name

· Product code (the UPC or NDC)

· Package size (amount per case or individual)

· Total calories per can or packet

· Information that identifies whether pricing attachment is manufacturer’s suggested retail price or invoice

Gastrostomy or jejunostomy tubes and supplies not otherwise classified
Use these guidelines:

· Bill B4087 and B4088 only for the feeding tubes

· Bill B9998 for all related supplies including extension sets

· Include a valid diagnosis code to the greatest specificity indicating the medical condition that requires the tube feeding

· The date of service is the date the item was dispensed to the member; do not use a date span

· Enter the item name in the comments or description field

· Do not use B9998 for feeding supply kits or for syringes smaller than 35 ml

Enteral feeding kits
Use these guidelines:

· Use the HCPCS code that is appropriate to the ordered method of feeding

· The date of service is the date the item was dispensed to the member; do not use a date span

Billing units of nutritional products
Refer to the Quantity descriptions for nutritional products table to review HCPCS code descriptions based on the amount per unit by HCPCS code.

Quantity descriptions for nutritional products

HCPCS Code(s)	Quantity Description
B4149 to B4150, B4152 to B4155, B4157 to B4162	1 unit = 100 calories
B4034 to B4036, B4148	1 unit = 1 kit
B4081 to B4083, B4087, B4088	1 unit = 1 tube
B9002, B9004, B9006, E0791	1 unit = 1 pump
B4100, T2101	1 unit = 1 ounce
B4102, B4103	1 unit = 500 milliliters
B4105	1 unit = 1 cartridge

Legal References

Minnesota Statutes, 62Q.531 (Amino-Acid Based Elemental Formula)
Minnesota Statutes, 256B.0625, subdivision 32 (Nutrition Products)
Minnesota Statutes, 256B.766 (i) (Reimbursement for Basic Care Services)
Minnesota Rules, 9505.0325 (Nutrition Products)
Code of Federal Regulations, title 42, section 414.104 (PEN Items and Services)

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