FORMULA & SPECIALIZED FOOD

Transcription

1 FORMULA & SPECIALIZED FOOD ADMINISTRATIVE POLICY Policy Number: HOME T2 Effective Date: December 1, 2014 Table of Contents CONDITIONS OF COVERAGE... COVERAGE RATIONALE BENEFIT CONSIDERATIONS... BACKGROUND... DEFINITIONS. APPLICABLE CODES... REFERENCES... POLICY HISTORY/REVISION INFORMATION... Page Related Policies: None The services described in Oxford policies are subject to the terms, conditions limitations of the Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without prior written notice unless otherwise required by Oxford's administrative procedures or applicable state law. The term Oxford includes Oxford Health Plans, LLC all of its subsidiaries as appropriate for these policies. Certain policies may not be applicable to Self-Funded Members certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between any policy the Member s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of Coverage will govern. CONDITIONS OF COVERAGE Applicable Lines of Business/Products Benefit Type Referral Required (Does not apply to non-gatekeeper products) Authorization Required (Precertification always required for inpatient admission) Precertification with Medical Director Review Required Applicable Site(s) of Service (If site of service is not listed, Medical Director review is required) Special Considerations This policy applies to Oxford Commercial plan membership See state specific grid for benefit considerations 2 No Yes Yes 1,2 Home 1 Precertification with Medical Director review or their Designee is required. 2 For Self-Funded Plans, refer to Member s certificate of coverage/health benefits plan for specific benefit coverage guidelines. 1

2 COVERAGE RATIONALE Oxford will cover specialized formula specialized foods as outlined below. The intent of this policy is to pay for food/formula that is specially formulated for specific medical conditions is not normally consumed by generally healthy individuals. For children under one year of age, stard cow's milk or soy-based baby formula is also not covered since it is considered routine nutrition during this time period. Any one of these formulas that are able to support growth development would be considered a routine dietary adjustment. Exclusions: Nutritional supplements Nutritional products are considered supplements when they are non-essential or convenience additions or substitutions to a regular formula or adult solid or blenderized (liquefied) food diet Banked breast milk Connecticut New Jersey Plans Products Specialized Formula: Specialized formula will be covered when all of the following criteria one of the conditions, all of the documentation requirements are met: 1. Criteria: A physician prescribes the therapy; The condition is chronic is expected to last for an undetermined or prolonged period of time; Adequate nutrition is not possible by dietary adjustment; Nutritional therapy is provided as replacement therapy; The material used is specially formulated as a nutrition replacement; Individuals who will become malnourished or suffer from severe disorders such as physical disability, mental retardation or death if the medical nutritional therapy is not instituted; 2. Conditions (must meet 1 of 7): Inborn error of metabolism; or Inherited diseases of amino-acid or organic acid metabolism; or Crohn's Disease; or Disorders of gastrointestinal motility such as chronic intestinal pseudo-obstruction; or Severe malabsorptive syndrome; or Severe food allergies which if left untreated will cause malnourishment, chronic physical disability, mental retardation or death. (Note: see documentation required for severe food allergy); or GE Reflux with failure to thrive (Note: see documentation required for GE reflux with failure to thrive) 3. Documentation requirements: For Multiple Food Allergy: 2

3 a. Consultation with relevant specialist (Neonatologist, Gastroenterologist or Allergist); Note: For New Jersey Commercial plans - consultation by a specialist is not required, requests from the covered infant's physician is sufficient. b. Diagnosis of multiple food protein allergy; Note: New Jersey Commercial plans also accept multiple food protein intolerance. c. Office notes indicating: failure to tolerate due to severe allergic reaction, or contraindication to available stard cow milk based formula; failure to tolerate due to severe allergic reaction or contraindication to available stard non-cow milk based formula, (including soy-bean) For GE reflux with failure to thrive: a. Consultation with relevant specialist (gastroenterologist or neonatologist); Note: For New Jersey Commercial plans: consultation by a specialist is not required, requests from the covered infant's physician is sufficient.) b. Diagnosis of GE reflux WITH failure to thrive (defined as: a child growing below 3rd or 5th percentile; or A child whose decreased growth has crossed 2 major growth percentiles); c. Office notes indicating: Specialized Foods: failure to tolerate due to severe allergic reaction or contraindication to available stard cow milk based formula; failure to tolerate due to severe allergic reaction or contraindication to available stard non-cow milk based formula, (including soy-bean) Specialized foods (including low protein amino acid modified food or formula) are covered for inborn errors of metabolism, which may include Homocystinuria, Maple syrup urine disease, methylmalonic aciduria, phelylketonuria (PKU), Tyrosinemias, certain inherited diseases of amino acid organic acid metabolism, Cystic Fibrosis. Note: Specialized food for Members with a diagnosis of Cystic Fibrosis is covered for Connecticut Commercial plans only. New York Plans Products Enteral formulas which are medically necessary taken under written order from a physician for the treatment of specific diseases shall be distinguished from nutritional supplements taken electively. Enteral formula or modified solid food products will be approved based on all of the following: 1. Being used as part of disease specific treatment; 2. Treatment is for one of the following: a. Inherited diseases of amino acid /or organic acid metabolism b. Crohn s Disease c. Gastroesophageal reflux disease with failure to thrive d. Disorders of gastrointestinal motility such as chronic intestinal pseudo-obstruction 3

4 e. Multiple, severe food allergies 3. One of the following: a. Patient is malnourished b. Patient will become malnourished without treatment c. If patient s condition is left untreated it will cause one of the following: Chronic physical disability Mental retardation Death Authorization will be issued for one year. State Product Benefit Type Specialized food General benefit package: Refer to the summary of benefits for applicable copayment, 1, 2, 3 Pharmacy benefit: New Jersey Non-stard infant formula New York Connecticut Specialized food Non-stard infant formula Specialized food Non-stard infant formula 1 Refer to the summary of benefits for applicable copayment, Pharmacy benefit are Tier 3. 3 Infant is to age 1 year (12 months). Pharmacy benefit: 1, 2 1 Refer to the summary of benefits for applicable copayment, Pharmacy benefit are Tier 3. Pharmacy benefit: 1, 2 1 Refer to the summary of benefits for applicable copayment, Pharmacy benefit are Tier 3. 1, 2,3,4 Pharmacy benefit: 1 Refer to the summary of benefits for applicable copayment, Pharmacy benefit are Tier 3 3 CT requires coverage of specialized infant formula to age 12 if medically necessary. 4 CT requires coverage under the general benefit package if plan does not have pharmacy coverage. 1, 2,3,4 Pharmacy benefit: 1 Refer to the summary of benefits for applicable copayment, Pharmacy benefit are Tier 3 3 CT requires coverage of specialized infant formula to age 12 if medically necessary. 4 CT requires coverage under the general benefit package if plan does not have pharmacy coverage. 4

5 BENEFIT CONSIDERATIONS Note: All bred nutritional therapies covered under the Pharmacy benefit are Tier 3 for commercial Members who have a three tier Pharmacy benefit. For Self-Funded Plans, refer to Member s certificate of coverage/health benefits plan for specific benefit coverage guidelines BACKGROUND Nutrition is a term describing all the processes involved in the taking in utilization of essential food substances necessary to sustain bodily functions. These processes include ingestion, digestion, absorption, metabolism. There are conditions that inhibit any one or combination of these processes. In these cases medical nutritional therapy intervention may be required; a specific formula may be necessary to sustain life, or to prevent, delay, or reduce medical complications or sequelae when an inborn error of metabolism or a severe food allergy exists. Routes of medical nutritional therapy include enteral (enteral therapy may be given orally or by tube feeding may be liquefied food preparations or medically formulated foods) parenteral (intravenous). Specialized Foods include Low Protein Modified Food Products, Amino Acid Food Preparations, Specialized Formula for infants. Low Protein Modified Foods are products formulated to have less than one gram of protein per serving, intended for dietary treatment of an inherited metabolic disease under the direction of a physician. Amino Acid Food Preparations are products intended for use under the direction of a physician for the dietary treatment of an inherited metabolic disease. Specialized Formula is intended for use solely under medical supervision in the dietary management of specific diseases. Examples of specialized formulas for medical conditions are listed in the table below (not all inclusive): Formula Name Alimentum MJ3232A Neocate Nutramigen Portagen Pregestimil RCF Elecare Neocate One Peptamen ProPeptide for Kids Vivonex Phenalcate, MSU D.powder CaminoPro Suggested Use Infants with food allergies, protein or fat malabsorption Infants with severe carbohydrate (CHO) intolerance (CHO must be added) Infants with food allergies Infants with fat malabsorption Infants with food allergies, protein or fat malabsorption Infants with severe CHO intolerance (CHO must be added) Modified for ketogenic diet Children with malabsorption Children with malabsorption Children with Phenylketonuria (PKU) Children with Phenylketonuria (PKU) 5

6 DEFINITIONS Failure to Thrive: Failure to thrive in childhood is a state of undernutrition due to inadequate caloric intake, inadequate caloric absorption, or excessive caloric expenditure. Although failure to thrive is often defined as a weight for age that falls below the 5th percentile on multiple occasions or weight deceleration that crosses two major percentile lines on a growth chart, use of any single indicator has a low positive predictive value. 11 Malnutrition: Malnutrition is a broad term commonly used as an alternative to undernutrition but technically it also refers to overnutrition. People are malnourished if their diet does not provide adequate calories protein for growth maintenance or they are unable to fully utilize the food they eat due to illness (undernutrition). 13 Severe malnutrition can further be defined by a very low weight for height (below -3z scores of the median WHO growth stards), by visible severe wasting, or by the presence of nutritional edema. 12 APPLICABLE CODES The codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the Member s plan of benefits or Certificate of Coverage. This list of codes may not be all inclusive. Applicable HCPCS Codes HCPCS Code B4104 B4149 B4150 B4152 B4153 B4154 B4155 B4157 B4158 B4159 Description Additive for enteral formula (e.g., fiber) Enteral formula, manufactured blenderized natural foods with intact nutrients, includes proteins, fats, carbohydrates, vitamins minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit Enteral formula, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit Enteral formula, nutritionally complete, calorically dense (equal to or greater than 1.5 kcal/ml) with intact nutrients, includes proteins, fats, carbohydrates, vitamins minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit Enteral formula, nutritionally complete, hydrolyzed proteins (amino acids peptide chain), includes fats, carbohydrates, vitamins minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit Enteral formula, nutritionally complete, for special metabolic needs, excludes inherited disease of metabolism, includes altered composition of proteins, fats, carbohydrates, vitamins /or minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit 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 Enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit Enteral formula, for pediatrics, nutritionally complete with intact nutrients, includes proteins, fats, carbohydrates, vitamins minerals, may include fiber /or iron, administered through an enteral feeding tube, 100 calories = 1 unit Enteral formula, for pediatrics, nutritionally complete soy based with intact nutrients, includes proteins, fats, carbohydrates, vitamins minerals, may include fiber /or iron, administered through an enteral feeding tube, 100 calories = 1 unit 6

7 HCPCS Code B4160 B4161 B4162 S9433 S9435 Description 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 minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit Enteral formula, for pediatrics, hydrolyzed/amino acids peptide chain proteins, includes fats, carbohydrates, vitamins minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit Enteral formula, for pediatrics, special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins minerals, may include fiber, administered through an enteral feeding tube, 100 calories = 1 unit Medical food nutritionally complete, administered orally, providing 100% of nutritional intake Medical foods for inborn errors of metabolism REFERENCES 1. CGSA 38a-492c 38a-518c. State of Connecticut, Insurance Department, Bulletin HC- 60. September 24, Oxford Certificate of Coverage Member Hbook. 3. Connecticut Insurance Code: 38a-492c. 4. Connecticut Insurance Code: 38a-518c. 5. New York Insurance Laws: 4303 (y); 3216 (c)(21); 3221 (k)(11). 6. New York OGC Opinion no New Jersey; Group Health Blanket Insurance: 17B: r, 17B: z. 8. New Jersey; Individual Health Insurance Reform: 17B:27A-19.6; 17B:27A-7; 17B:27A American Medical Association. Healthcare Common Procedure Coding System, Medicare's National Level II Codes: HCPCS. 10. N.Y. ISC. LAW 3221(k)(11) Group or blanket accident health insurance policies; stard provisions 11. American Academy of Family Physicians (AAFP). Failure to Thrive: An Update. S. Cole, J. Lanham. Am Fam Physician Apr 1;83(7): Available at: World Health Organization (WHO) Available at: UNICEF. POLICY HISTORY/REVISION INFORMATION Date 12/01/2014 Action/Description Changed policy type classification from Clinical to Administrative (no change in content/guidelines) Archived previous policy version HOME T2 7