Adult Enteral Nutritional Supplement Drug Class Monograph

Transcription

1 Adult Enteral Nutritional Supplement Drug Class Monograph Line of Business: Medi-Cal Effective Date: May 18, 2016 Renewal Date: May 17, 2017 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Policy/Criteria: Nutritional supplements are a Medi-Cal covered benefit when they are used in a therapeutic regimen to prevent serious disability or death in patients with medically diagnosed conditions that preclude the full use of regular food. Physicians must provide medical justification for nutritional supplementation on the IEHP Prescription Prior Authorization Request Form (RX PA). For information that may be necessary for nutritional supplementation justification, please review our Nutritional Evaluation Form (NEF). 1. Standard Enteral Nutrition Products (e.g. Ensure, Jevity, Osmolite, Boost) a. Enteral feeding tube (e.g. nasogastric, gastrostomy, jejunostomy) or transitioning from parenteral or enteral feeding tube to oral diet b. For oral administration, must meet one of the following: i. Have a documented chronic medical diagnosis and unable to meet their nutritional needs with dietary adjustment of regular or alteredconsistency (soft or pureed) foods AND one of the following: Involuntary weight loss of 10% or more within past 6 months Involuntary weight loss of 7.5% or more within past 3 months Involuntary weight loss of 5% or more within past one month Body mass index less than 18.5 kg/m 2 ii. Severe swallowing or chewing difficulty due to one of the following:

2 Cancer in the mouth, throat or esophagus Injury, trauma, surgery or radiation therapy involving the head or neck Chronic neurological disorders Severe craniofacial anomalies iii. Transitioning from parenteral or enteral tube feeding to an oral diet 2. Specialized Enteral Nutrition Products a. Diabetic Products (e.g. Glucerna, Boost Glucose Control, Diabetisource,) ii. Must have a documented diagnosis of diabetes or hyperglycemia b. Renal Products (e.g. Nepro, Novasource Renal, Renalcal) ii. Must have a documented diagnosis of kidney disease (e.g. chronic kidney disease) c. Hepatic Products (e.g. Nutrihep) ii. Must have a documented diagnosis of liver disorder (e.g. liver fibrosis, cirrhosis) d. Pulmonary Products (e.g. Pulmocare, Nutren Pulmonary) ii. Must have a documented diagnosis of Respiratory disease (e.g. COPD, cystic fibrosis) Note: Check CCS eligibility for cystic fibrosis member e. Lipid Modular Products (e.g. MCT oil, Liquigen MCT) i. Have a documented diagnosis of inability to digest or absorb conventional fats ii. OR Have a documented diagnosis of uncontrolled seizure disorder that cannot otherwise be medically managed f. Protein Modular Products (e.g. Proteinex, Pro-Stat Sugar Free) i. Documentation that member is unable to meet protein requirement 3. Elemental and Semi-Elemental Enteral Nutrition Products (e.g. Peptamen, Perative, Vital, Vivonex RTF) a. If member < 21 years of age, please check CCS eligibility. b. For age 21 or CCS ineligible, must meet one of the following: i. Have an intestinal malabsorption diagnosis (ICD-10-CM codes K90.0- K90.9 and K91.2) ii. Have a chronic medical diagnosis and present clinical signs and symptoms of inability to absorb nutrients or to tolerate intact protein

3 4. Metabolic Enteral Nutrition Products (e.g. Ketonex, Phenex, PhenylAde, PKU) a. If member < 21 years of age, please check CCS eligibility. b. For age 21 or not CCS eligible, authorization is restricted to members with a diagnosis of inborn errors of metabolism i. E.g. ICD-10-CM codes: E70.0, E70.1, E70.2-E70.29, E70.30-E70.39, E70.40-E70.49, E70.5, E70.8, E70.9, E71.0, E E71.19, E71.2, E71.30, E E71.318, E71.32, E71.39, E71.40, E71.42, E E71.548, E72.00-E72.09, E72.10-E72.19, E72.20-E72.29, E72.3, E72.4, E , E72.8, E72.9, E74.00-E74.9, E75.00-E75.6, E76.01-E76.9, E77.0-E77.9, E84.0-E84.9, E88.40-E88.49 Exemptions may be determined on a case-by-case basis for members who do not meet criteria but have exceptional needs. Standard Product, including but not limited to: Ensure Complete Jevity Ensure Fiber Osmolite Ensure High Protein Promote Fiber Ensure Plus Promote Fibersource TwoCal HN Isosource Nutren Specialized Product, including but not limited to: Diabetic: Glucerna Boost Glucose Control Diabetisource Glytrol Pulmonary: Pulmocare Nutren Pulmonary Modular Lipid: MCT Oil Microlipid Duocal powd Liquigen MCT Lipistart Powder Modular Protein: Promod liquid Proteinex Beneprotein Pro-Stat Sugar Free Boost Energy Drink Boost High Protein Boost Plus Carnation Breakfast Compleat Replete Fiber Renal: Nepro Suplena Novasource Renal Renalcal Renastart Elemental and Semi Elemental Product, including but not limited to: Optimental RTF Perative Pivot Vital Vital AF Vital HN Crucial Impact Glutamine Impact Peptide Peptamen Peptamen AF Peptamen Bariatric Peptamen with Prebio Tolerex Vivonex Plus Vivonex RTF EO28 Splash

4 Metabolic Product, including but not limited to: 3232A powd Acerflex Powd Add-Ins powder Arginine BCAD powd Calcilo XD Citrulline Complete Amino Acid Complex MSUD Creatine Cyclinex 1 powd Cystine Duocal powd EAA Supplement Essential Amino Acid Flavor Pac GA powd GlutarAde GA-1 Amino Acid Glutarex powd Glycine powder Glycosade powder HCU Cooler Milupa MSUD2 Milupa OS2 Milupa PKU2 HCY powd Hominex powd Isoleucine I-Valex powd 400g Ketocal Ketonex Lanaflex powd L-Arginine powder Leucine100 Lipistart powder Liquigen MCT L-Isoleucine powder L-Leucine powder LMD powd Lophlex L-Tyrosine powder L-Valine powder Lysine4000 MCT OIL MCT Procal Methionaid powd Methionine100 MICROLIPID Milupa HOM2 Milupa PKU3 Milupa UCD2 MMA/PA Express15 MMA/PA Gel Monogen, 400g MSUD Aid powd MSUD Analog powd MSUD Cooler OA 1 powd OA 2 powd Periflex PFD 2 powd Phenex PhenylAde Phenylalanine50 Amino Acid Supplement powder Phenyl-Free Phlexy-10 Drink Mix Powd PKU Portagen powd Pro-Phree powd vanilla Propimex 1 powd Propimex 2 powd ProViMin powd Clinical Justification: Department of Health Care Services Policy Letter : Enteral Nutrition Products MCPs shall develop and implement written policies and procedures for providing enteral nutrition products for outpatient beneficiaries who meet the new Medi-Cal enteral nutrition service policy outlined in the Enteral Nutrition Products sections of the Medi- Cal Part 2 Pharmacy Provider Manual MCPs are required to provide or arrange for all medically necessary Medi-Cal covered services, and to ensure that these services are provided in an amount no less than what is offered to beneficiaries under Medi-Cal fee-for-services. References:

5 1. 22 California Code of Regulations (CCR) (e)(2) 2. Medi-Cal Enteral Nutrition Service Policy. Available at: Accessed on March 23, Department of Health Care Services Policy, Medi-Cal Managed Care Health Plans Policy Letter April 11, 2014 Change Control Date Change 05/17/2017 Renewed with no new updates/changes