Prior authorization request form Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 06|01|2023 POLICY LAST UPDATED: 02|16|2023 OVERVIEW This policy describes the reimbursement for enteral and parenteral nutrition therapy. Enteral nutrition (EN) is used for individuals with a functioning intestinal tract, but with disorders of the pharynx, esophagus or stomach that prevent nutrients from reaching the absorbing surfaces in the small intestine. The individual is at risk of severe malnutrition. EN involves administering non-sterile liquids directly into the gastrointestinal tract through nasogastric, gastrostomy or jejunostomy tubes. An infusion pump may be used to assist the flow of liquids. Feedings may be either intermittent or continuous (infused 24 hours a day). Total parenteral nutrition (TPN), also known as parenteral hyperalimentation, is used for individuals with medical conditions that impair gastrointestinal absorption to a degree incompatible with life. It is also used for variable periods of time to bolster the nutritional status of severely malnourished patients with medical or surgical conditions. TPN involves percutaneous transvenous implantation of a central venous catheter into the vena cava or right atrium. 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. This policy does not describe coverage or reimbursement of donor breast milk therapy which is not a covered service under Blue Cross & Blue Shield of Rhode Island plans.
MEDICAL CRITERIA None PRIOR AUTHORIZATION Preauthorization is not required. POLICY STATEMENT Medicare Advantage Plans and Commercial Products • Enteral nutrition therapy as the sole source of nutrition delivered by means of a nasogastric (NG tube), nasoenteric (NE tube), gastrostomy (G tube), or jejunostomy (J tube) tube 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) unless provided by tube as sole source of nutrition. For Commercial products please refer to oral nutrition mandate policy. Payment Policy | Enteral/Parenteral Nutrition Therapy

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

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 (EN) Enteral nutrition, oral nutrition, and parenteral nutrition therapies are seen as valuable treatment in the management of select individuals requiring nutritional support to prevent the adverse effects of malnutrition. To determine the type of nutritional support and accurately calculate the individual’s nutritional needs review of the following data is necessary: patient age and gender; review of pre-existing medical conditions and history; and body mass index determination.

The National Institutes of Health (NIH) and the American Society for Parenteral and Enteral Nutrition (ASPEN) published a joint conference report that reviewed current literature concerning the importance of nutritional support. 5 The review included prospective, randomized, controlled trials where nutritional therapy was administered for a minimum of five days and provided satisfactory nutrients to meet daily requirements. In total, more than 2500 individuals were included in the studies reviewed. With one final statement, the report concluded that: • The use of nutritional therapy requires careful integration of data from pertinent clinical trials; • Clinical expertise is required in the illness or injury being treated; • Clinical input from nutritional therapy clinicians is required; • Input from the individual and family is required.

Parenteral Nutrition (PN) The American Gastroenterological Association (AGA) published a medical position on parenteral nutrition in 2001 that states: In general, parenteral nutrition is indicated to prevent the adverse effects of malnutrition in individuals who are unable to obtain adequate nutrients by oral or enteral routes. The decision to use parenteral nutrition requires an understanding of the individual’s clinical condition and anticipated outcome, judgment as to the individual's ability to tolerate undernutrition, knowledge of the clinical efficacy of parenteral nutrition and an appreciation of the individual’s desires and needs.

The American Society for Parenteral and Enteral Nutrition (ASPEN) (2002) published clinical guidelines as an update to the first published guidelines in 1993 as a result of new evidence. The ASPEN update included the following recommendations:

When specialized nutrition support (SNS) is indicated, PN should be used when gastrointestinal tract is not functional or cannot be accessed and in individuals who cannot be adequately nourished by oral diets or EN”. This was a grade B recommendation which provides fair research-based evidence to support the guideline (well- designed studies without randomization).

The nutritional requirements for adults who need SNS should be based on the results of the formal individualized nutrition assessment. The requirements for each nutrient may vary with nutrition status, disease, organ function, metabolic condition, medication use, and duration of nutrition support.

Per the ASPEN guidelines, common indications for home PN include inflammatory bowel disease, nonterminal cancer, ischemic bowel, and radiation enteritis, motility disorders of the bowel, bowel obstruction, high-output intestinal or pancreatic fistulae, celiac disease, hyperemesis gravidarum, and protein-losing enteropathy.

CODING Medicare Advantage Plans and Commercial Products The following codes are covered for Medicare Advantage Plans and Commercial products: B4034 Enteral feeding supply kit; syringe, per day

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

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
B9002 Enteral nutrition infusion pump, any type
B9004 Parenteral nutrition infusion pump, portable B9006 Parenteral nutrition infusion pump, stationary

The following codes for enteral and parenteral nutrition are covered Medicare Advantage Plans and Commercial products as the formula is administered via a feeding tube:
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 feeding tube, 100 calories = 1 unit B4159 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 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)

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

B4180 Parenteral nutrition solution; carbohydrates (dextrose), greater than 50% (500 ml=1 unit) – homemix B4185 Parenteral nutrition solution, per 10 grams lipids B4187 Omegaven, 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

The following codes are non-covered for Medicare Advantage Plans 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) RELATED POLICIES Oral Nutrition Mandate Coding and Payment Guidelines Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations PUBLISHED Provider Update, April 2023 Provider Update, April 2022 Provider Update, May 2021 Provider Update, September 2019 Provider Update, February 2019 REFERENCES

1. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD), 180.2, Enteral and Parenteral Nutrition.
2. Centers for Medicare and Medicaid Services, Local Coverage Determination (LCD), Noridian Healthcare Solutions, LLC, L38953, Parenteral Nutrition.
3. Centers for Medicare and Medicaid Services, Local Coverage Determination (LCD), Noridian Healthcare Solutions, LLC, L38955, Enteral Nutrition.
4. Centers for Medicare and Medicaid Services, Local Coverage Determination Article, Noridian Healthcare Solutions, LLC, A58836, Parenteral Nutrition.
5. Centers for Medicare and Medicaid Services, Local Coverage Determination Article, Noridian Healthcare Solutions, LLC, A58833, Enteral Nutrition.

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 5 (401) 274-4848 WWW.BCBSRI.COM

6. American Gastroenterological Association. American Gastroenterological Association medical position statement: Parenteral nutrition. Gastroenterology. 2001;121(4):966-969.
7. Klein, S., Kinney, J., Jeejeebhoy, K., Alpers, D., Hellerstein, M., Murray, M., & Twomey, P. (1997). Nutrition support in clinical practice: review of published data and recommendations for future research directions. Summary of a conference sponsored by the National Institutes of Health, American Society for Parenteral and Enteral Nutrition, and American Society for Clinical Nutrition. The American journal of clinical nutrition, 66(3), 683-706.
8. American Society for Parenteral and Enteral Nutrition (ASPEN) Board of Directors. Clinical Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients, 2009. JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):255-9. doi: 10.1177/0148607109333115. PMID: 19398611.
9. Nutrition support for adults: oral nutrition support, enteral tube feeding and parenteral nutrition. London: National Institute for Health and Care Excellence (NICE); 2017 Aug. PMID: 31999417.

10. Klein, S., Kinney, J., Jeejeebhoy, K., Alpers, D., Hellerstein, M., Murray, M., & Twomey, P. (1997). Nutrition support in clinical practice: review of published data and recommendations for future research directions. Summary of a conference sponsored by the National Institutes of Health, American Society for Parenteral and Enteral Nutrition, and American Society for Clinical Nutrition. The American journal of clinical nutrition, 66(3), 683-706. i

    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. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS