Nutrition Therapy. Medical Coverage Policy Enteral/Parenteral EFFECTIVE DATE: POLICY LAST UPDATED: 11/20/2018 OVERVIEW

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Medical Coverage Policy Enteral/Parenteral Nutrition Therapy EFFECTIVE DATE: 01 20 2007 POLICY LAST UPDATED: 11/20/2018 OVERVIEW This policy describes the reimbursement for enteral and parenteral nutrition therapy. Enteral nutrition therapy (commonly called tube feeding) is a form of nutrition administered into the gastrointestinal tract through a small catheter that may be temporary or permanent. Parenteral nutrition involves the delivery of micronutrients and macronutrients through catheters in central or peripheral veins when adequate nutritional intake is not possible via the oral or tube-feeding route because the gastrointestinal tract is non-functioning. MEDICAL CRITERIA None PRIOR AUTHORIZATION Preauthorization is not required POLICY STATEMENT BlueCHiP for Medicare and Commercial Products Enteral nutrition therapy as the sole source of nutrition delivered by means of a nasogastric (NG), nasoenteric (NE), gastrostomy (G), or jejunostomy (J) tubefeeding tube or through a vein is covered. Parenteral nutrition therapy as the sole source of nutrition delivered through a catheter through a central or peripheral vein is covered. Enteral or parenteral formulas must be prescribed by a physician for use and administered by a Home Infusion Therapy provider. The following enteral products are not covered: Enteral products that are administered orally and related supplies Enteral products used as supplements to the patient's daily diet Baby food and other grocery items/products that can be pureed in a blender and used with the enteral system Over-the-counter products (e.g., Boost, Ensure, Pediasure, Sustacal) COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage, Subscriber agreement for the applicable "Medical Equipment, Medical Supplies and Prosthetic Devices" coverage. BACKGROUND Enteral nutrition therapy (commonly called tube feeding) is a form of nutrition administered into the gastrointestinal tract through a small catheter that may be temporary or permanent. The liquid nutritional formula may be may be delivered via a nasogastric, nasoenteric, jejunostomy, or gastrostomy infusion tube. The American Gastroenterological Association states that tube feeding should be considered for patients who cannot or will not eat, who have a functional digestive tract, and for whom a safe method of access is possible. The use of enteral therapy may be on a short-term basis for acute conditions, or long-term for chronic conditions. The nutrient mixture is a diet that provides essential nutrients in a readily assimilated form requiring little or no active 500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY 1

digestion and minimal residue. The standard formula selected for most patients is the isotonic polymeric formula, which meets the nutritional needs of most people. Enteral nutrition is typically for a patient with a functioning gastrointestinal tract who cannot maintain weight and strength commensurate with his/her general condition due to an anatomical or motility disorder that prevents food from reaching the digestive tract. Examples of anatomical conditions include obstructions due to head and neck cancer, tumors, reconstructive surgery, or stricture of the esophagus or stomach. Examples of motility disorders include dysphagia following a stroke and neuromuscular diseases that interfere with the normal ability to chew and swallow. It is also for patients with partial impairments such as Crohn's disease resulting with absorption problems, or a patient who can only swallow small amounts of food due to dysphagia where the gastrointestinal tract function is adequate and the enteral nutrition is the sole source. Sole source is defined as the primary source of sufficient caloric/nutrient intake to achieve or maintain appropriate body weight. For most adults, a total caloric intake of 20-35 calories per kilogram per day is considered sufficient to achieve or maintain appropriate body weight adults. Sufficient caloric intake is essential in pediatric patients to ensure proper growth and maintenance of body metabolism. Estimated energy needs of a pediatric patient's caloric intake ranges vary. Infants 0-1 years of age require 90-120 calories per kilogram per day; 1-7 years, 75-90 calories per kilogram per day; 7-12 years, 60-75 calories per kilogram per day; 12-18 years, 30-60 calories per kilogram per day; older than 18 years should follow the adult recommendations of 20-35 calories per kilogram per day. Parenteral nutrition involves the delivery of micronutrients and macronutrients through catheters in central or peripheral veins when adequate nutritional intake is not possible via the oral or tube-feeding route because the gastrointestinal tract is non-functioning. In most instances, the central venous route is utilized, and for long-term total parenteral nutrition a central catheter is burrowed through a subcutaneous tunnel on the anterior chest. It is also used for variable periods of time to bolster the nutritional status of severely malnourished patients with medical or surgical conditions. A nutritionally adequate hypertonic solution consisting of glucose (sugar), amino acids (protein), electrolytes (sodium, potassium), vitamins and minerals, and sometimes fats is administered daily. An infusion pump is generally used to assure a steady flow of the solution either on a continuous (24-hour) or intermittent schedule. If intermittent, a heparin lock device and diluted heparin are used to prevent clotting inside the catheter Relizorb is considered a first of it's kind enzyme cartridge. It is designed to mimic the action of pancreatic lipase for use in adults receiving enteral tube feedings. Relizorb is a digestive enzyme cartridge that is used in adults to helps break down (digest) the fats in enteral tube feeding formula into an absorbable form the body can use. It was approved by the FDA for this indication. However, large scale studies in human subjects are still lacking. Therefore, there is an insufficient evidence to determine that the technology results in a meaningful improvement in the net health outcome. CODING The following codes are covered for BlueCHiP for Medicare and Commercial products: B4034 Enteral feeding supply kit; syringe, per day B4035 Enteral feeding supply kit; pump fed, per day B4036 Enteral feeding supply kit; gravity fed, per day B4081 Nasogastric tubing with stylet B4082 Nasogastric tubing without stylet B4083 Stomach tube-levine type B4087 Gastrostomy/jejunostomy tube, standard, any material, any type, each B4088 Gastrostomy/jejunostomy tube, low-profile, any material, any type, each The following enzyme cartridge, Relizorb is covered but not separately reimbursed for for BlueCHiP for Medicare and Commercial products 500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY 2

Q9994 In-line cartridge containing digestive enzyme(s) for enteral feeding, each (Effective 07/01/2018 and deleted as of 12/31/2018) B4105 In-line cartridge containing digestive enzyme(s) for enteral feeding, each (Effective 1/1/2019) For claims with an effective time before the above code effective date, There is not a specific code and claims must be submitted with the unlisted code below following the unlisted process. B9998 NOC for enteral supplies The following codes are non-covered for BlueCHiP for Medicare and Commercial products as the formula is not administered via a feeding tube: B4102 Enteral formula, for adults, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit B4103 Enteral formula, for pediatrics, used to replace fluids and electrolytes (e.g., clear liquids), 500 ml = 1 unit B4104 Additive for enteral formula (e.g., fiber) The following codes for enteral and parenteral nutrition are covered BlueCHiP for Medicare and Commercial products as the formula is administered via a feeding tube for institutional and professional providers: B4149 Enteral formula, blended natural foods with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit B4150 Enteral formula, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit B4152 Enteral formula, nutritionally complete, calorically dense (equal to or greater than 1.5 kcal/ml) with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit B4153 Enteral formula, nutritionally complete, hydrolyzed proteins (amino acids and peptide chain), includes fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit B4154 Enteral formula, nutritionally complete, for special metabolic needs, excludes inherited disease of metabolism, includes altered composition of proteins, fats, carbohydrates, vitamins and/or minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit B4155 Enteral formula, nutritionally incomplete/modular nutrients, includes specific nutrients, carbohydrates (e.g. glucose polymers), proteins/amino acids (e.g., glutamine, arginine), fat (e.g. medium chain triglycerides) or combination, administered through an enteral feeding tube, 100 calories = 1 unit B4157 Enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube,100 calories = 1 unit B4158 Enteral formula, for pediatrics, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber and/or iron, administered through an enteral B4159 feeding tube, 100 calories = 1 unit Enteral formula, for pediatrics, nutritionally complete soy based with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber and/or iron, administered through an enteral feeding tube, 100 calories = 1 unit B4160 Enteral formula, for pediatrics, nutritionally complete calorically dense (equal to or greater than 0.7 kcal/ml) with intact nutrients, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit B4161 Enteral formula, for pediatrics, hydrolyzed/amino acids and peptide chain proteins, includes fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit 500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY 3

B4162 Enteral formula, for pediatrics, special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit B4164 Parenteral nutrition solution: carbohydrates (dextrose), 50% or less (500 ml =1 unit) - homemix B4168 Parenteral nutrition solution; amino acid, 3. 5%, (500 ml = 1 unit) - homemix B4172 Parenteral nutrition solution; amino acid, 5. 5% through 7%, (500 ml = 1 unit) B4176 Parenteral nutrition solution; amino acid, 7% through 8. 5%, (500 ml = 1 unit) B4178 Parenteral nutrition solution: amino acid, greater than 8. 5% (500 ml = 1 unit) B4180 Parenteral nutrition solution; carbohydrates (dextrose), greater than 50% (500 ml=1 unit) - homemix B4185 Parenteral nutrition solution, per 10 grams lipids B4189 Parenteral nutrition solution; compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 10 to 51 grams of protein - premix B4193 Parenteral nutrition solution; compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 52 to 73 grams of protein - premix B4197 Parenteral nutrition solution; compounded amino acid and carbohydrates with electrolytes, trace elements and vitamins, including preparation, any strength, 74 to 100 grams of protein - premix B4199 Parenteral nutrition solution; compounded amino acid and carbohydrates with electrolytes, trace elements and vitamins, including preparation, any strength, over 100 grams of protein - premix B4216 Parenteral nutrition; additives (vitamins, trace elements, heparin, electrolytes) homemix per day B4220 Parenteral nutrition supply kit; premix, per day B4222 Parenteral nutrition supply kit; home mix, per day B4224 Parenteral nutrition administration kit, per day B5000 Parenteral nutrition solution compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, renal-aminosyn-rf, nephramine, renamine-premix B5100 Parenteral nutrition solution compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, hepatic, hepatamine-premix B5200 Parenteral nutrition solution compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, stress-branch chain amino acids-freamine-hbc-premix Pumps: The following codes are covered for BlueCHiP for Medicare and Commercial products: B9002 Enteral nutrition infusion pump, any type B9004 Parenteral nutrition infusion pump, portable B9006 Parenteral nutrition infusion pump, stationary RELATED POLICIES Oral Enteral Nutrition Mandate Coding and Payment Guideline PUBLISHED Provider Update, February 2019 Provider Update, January 2018 Provider Update, January 2017 Provider Update, August 2015 Provider Update, September 2013 Provider Update, February 2009 Policy Update, March 2008 REFERENCES 500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY 4

1. https://www.bcbsri.com/sites/default/files/polices/oral%20nutrition%20mandate.pdf 2.http://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?NCDId=242&ncdver=1&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCA %257CCAL%257CNCD%257CME 3. http://www.medicarenhic.com/viewdoc.aspx?id=1635 i CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. 500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY 5