Parenteral Nutrition Therapy in the Home - 91517 - Priority Health

MEDICAL POLICYNo. 91517-R4PARENTERAL NUTRITIONAL THERAPYEffective Date: February 26, 2015 Review Dates: 8/06, 8/07, 8/08, 8/09, 8/10, 8/11,12/11, 8/12, 8/13, 8/14Date of Origin: August 9, 2006Status: CurrentNote: This policy incorporates Intradialytic Parenteral Nutrition (IDPN) criteriaformerly part of the End Stage Renal Disease (ESRD) & Home Hemodialysis MedicalPolicy #91526 now known as “Home Hemodialysis”.Summary of ChangesClarifications:•Deletions:•Additions:• Pg 1, Section I, A, note added to reflect Botulinum toxin and TPN will not be authorized togetherfor the treatment of gastroparesis.I. POLICY/CRITERIAParenteral nutritional therapy in the home:A. Home parenteral nutrition may be considered medically necessary and acovered benefit when the patient has a structural or functional gastrointestinaltract disease or condition (see D below for examples) resulting in insufficientabsorption of nutrients to maintain adequate strength and weight that cannotbe corrected by modifying the nutrient composition of the enteral/oral diet(e.g., lactose-free) or utilizing pharmacologic means to treat the etiology (e.g.,pancreatic enzymes or botulinum toxin*) AND meets one of the following:1. > 10% loss of body weight over three-months or less,OR2. Serum albumin concentration less than 3.4 gm/dL,OR3. The clinical record demonstrates that the patient cannot be maintainedon enteral feedings.*Note: Botulinum toxin and TPN will not be authorized together for thetreatment of gastroparesis.B. Equipment - If the criteria for parenteral nutrition are met, medicallynecessary nutrients, administration supplies, and equipment are consideredmedically necessary.C. Preauthorization is required. Initial authorization will not exceed threemonths and continuing authorization is required at least every three months.D. Specific malabsorptive conditions include, but are not limited to, thefollowing:Page 1 of 9

MEDICAL POLICYNo. 91517-R4Parenteral Nutritional Therapy• Crohn's disease• Newborn infants with catastrophic gastrointestinal anomalies such astracheoesophageal fistula, gastroschisis, omphalocele, or massiveintestinal atresia• Infants and young children who fail to thrive due to short bowelsyndrome, malabsorption, or chronic idiopathic diarrhea• Short bowel syndrome secondary to massive small bowel resection• Prolonged paralytic ileus after major surgery or multiple injuries• Radiation enteritis• Chronic or severe acute pancreatitis when a feeding tube cannot beplaced or tube feeding is not tolerated• Hyperemesis Gravidarum (severe hyperemesis during pregnancy)when a feeding tube cannot be placed or tolerated.• Obstruction secondary to stricture or neoplasm of the esophagus orstomach, where a feeding tube cannot be placed beyond theobstruction• Small bowel obstruction that cannot be bypassed by a feeding tube• Malabsorption due to enterocolic, enterovesical, or enterocutaneousfistulas (parenteral nutrition being temporary until the fistula isrepaired)• Motility disorder (pseudo-obstruction)E. Home intravenous parenteral nutrition is considered not medically necessaryand not a covered benefit, including but not limited to the followingcircumstances:1. To increase protein or caloric intake in addition to the patient’s dailydiet2. For routine pre- and/or postoperative care3. Patients with functional GI tracts including but not limited to thefollowing:a. Disorders that induce anorexia including cancerb. Swallowing disordersc. A temporary defect in gastric emptying such as a metabolic orelectrolyte disorder.d. A psychological disorder impairing food intake such asdepression or anorexia nervosa.e. A physical disorder impairing food intake such as dyspnea ofsevere pulmonary or cardiac disease.f. A side effect of a medicationg. Renal failure or dialysis.F. Intradialytic Parenteral Nutrition (IDPN)1. Intradialytic parenteral nutrition (IDPN) will be covered for ESRD* ifmember has a serum albumin < 33.4 g/dl or protein < 6 g/dl and one ofthe following:Page 2 of 9

MEDICAL POLICYNo. 91517-R4Parenteral Nutritional Therapya. BMI < 18.5 kg/m2 orb. Unintentional weight loss > 10% within last 6 months orc. BMI < 20 kg/m2 and unintentional weight loss >5% within last3-6 months*clinical re-evaluation after six months for consideration of continuedtreatmentII.MEDICAL NECESSITY REVIEWRequiredNot RequiredNot ApplicableIII.APPLICATION TO PRODUCTSCoverage is subject to member’s specific benefits. Group specific policy willsupersede this policy when applicable. HMO/EPO: This policy applies to insured HMO/EPO plans. POS: This policy applies to insured POS plans. PPO: This policy applies to insured PPO plans. Consult individual plan documents asstate mandated benefits may apply. If there is a conflict between this policy and a plandocument, the provisions of the plan document will govern. ASO: For self-funded plans, consult individual plan documents. If there is a conflictbetween this policy and a self-funded plan document, the provisions of the plan documentwill govern. INDIVIDUAL: For individual policies, consult the individual insurance policy. If there isa conflict between this medical policy and the individual insurance policy document, theprovisions of the individual insurance policy will govern. MEDICARE: Coverage is determined by the Centers for Medicare and Medicaid Services(CMS); if a coverage determination has not been adopted by CMS, this policy applies. MEDICAID/HEALTHY MICHIGAN PLAN: For Medicaid/Healthy Michigan Planmembers, this policy will apply. Coverage is based on medical necessity criteria being metand the appropriate code(s) from the coding section of this policy being included on theMichigan Medicaid Fee Schedule located at: http://www.michigan.gov/mdch/0,1607,7-132-2945_42542_42543_42546_42551-159815--,00.html. If there is a discrepancy betweenthis policy and the Michigan Medicaid Provider Manual located at:http://www.michigan.gov/mdch/0,1607,7-132-2945_5100-87572--,00.html, the MichiganMedicaid Provider Manual will govern. For Medical Supplies/DME/Prosthetics andOrthotics, please refer to the Michigan Medicaid Fee Schedule to verify coverage. MICHILD: For MICHILD members, this policy will apply unless MICHILD certificate ofcoverage limits or extends coverage.Page 3 of 9

MEDICAL POLICYNo. 91517-R4Parenteral Nutritional TherapyIV.DESCRIPTIONParenteral Nutrition (PN)Parenteral nutrition (or PN) is the provision of nutritional requirementsintravenously, either through a central or peripheral vein. The purpose ofinitiating parenteral nutritional therapy is to prevent or correct specific nutrientdeficiencies and to prevent the adverse effects of malnutrition when thegastrointestinal tract cannot be used effectively or safely.Generally, the parenteral approach is considered medically necessary only ifadequate nutritional intake is not possible via the oral or tube-feeding route.A daily caloric intake for adults of 20-40kcal/kg is generally sufficient to maintainbody weight. If less than 20-30kcal/kg per day it may be consideredsupplemental.Parenteral nutritional therapy is covered as defined above for patients with severepathology of the alimentary tract that does not allow absorption of sufficientnutrients to maintain weight and strength commensurate with the patient's generalcondition.Intradialytic Parenteral Nutrition (IDPN) for ESRDIn use since the 1970s, intradialytic parenteral nutrition (IDPN) is a convenientmethod of administering nutritional supplements to patients undergoinghemodialysis for end-stage renal disease (ESRD). Malnutrition is common inpatients with ESRD due to factors such as poor eating habits and loss of nutrientsduring dialysis. Maintaining adequate nutrition in patients undergoinghemodialysis is vital, as a number of nutritional parameters are associated withincreased mortality, including low body fat, fat loss over time, low body massindex (BMI) (< 20 kg/m2), reduced serum albumin levels, and reduced creatininelevels. In the 1980s, a trend began in which decisions regarding the use of IDPNin the United States were empirically based, and, although this was controversial,IPDN gained approval through the Centers for Medicaid & Medicare Services asa Medicare-covered benefit. As IDPN use expanded, the increasing use andassociated costs attracted scrutiny, due to the limited evidence base that supportedIDPN use. Accordingly, in 1994, Medicare coverage of IDPN was tightened andthen further restricted in 1996, which resulted in a decline in its use. Severalmanufacturers produce premixed bags for IDPN, or components of a formulationcan be made up on site from previously prepared ingredients. IDPN formulasgenerally contain a mix of amino acids, carbohydrate (usually dextrose), andlipids. Trace elements and multivitamins may also be included. IDPN may beconsidered for hemodialysis patients who show physical wasting and significantweight loss; have serum hypoalbuminemia (low albumin) and/or other markers ofmalnutrition; have failed to respond to oral nutrition supplements; have failed, orPage 4 of 9

MEDICAL POLICYNo. 91517-R4Parenteral Nutritional Therapyare contraindicated, for enteral feeding; and whose caloric and/or protein intake isinsufficient to meet recommended daily requirements. IDPN is given at the sametime as hemodialysis by a dialysis nurse or other licensed healthcare practitioner,at an outpatient center. IDPN is infused through an existing dialysis accesscatheter or site, via an infusion pump; no additional needle stick or line isnecessary.The results of three comparative retrospective studies suggest that IDPN forup to 1 year in duration may reduce mortality in malnourished patientsundergoing hemodialysis. In contrast, the results of the single prospectiverandomized study conducted in France, provide strong evidence that there is noreduction inmortality for 1 year of IDPN plus oral nutritional supplementationcompared with oral nutritional supplementation alone. Despite the lack of strongevidence, IDPN is an established therapy and it is possible that it offers potentialadvantages to a subset of malnourished patients in ESRD; however, prospectivestudies are needed to define these subpopulations.V. CODINGICD-9 Diagnosis Codes:These diagnoses may support medical necessity (for dates of service on or beforeSeptember 30, 2015):263.9 Unspecified Protein-Calorie Malnutrition536.3 Gastroparesis537.4 Fistula of stomach or duodenum555.0 – 555.9 Regional enteritis560.1 Paralytic ileus560.2 Volvulus560.81 Intestinal or peritoneal adhesions with obstruction(postoperative) (postinfection)560.89 Intestinal or peritoneal adhesions with obstruction, other560.9 Unspecified intestinal obstruction565.1 Anal fistula569.69 Other complication of colostomy or enterostomy569.71 Pouchitis569.79 Other complications of intestinal pouch569.81 Fistula of intestine, excluding rectum and anus569.83 Perforation of Intestine569.9 Unspecified Disorder of Intestine579.3 Other and Unspecified Postsurgical Nonabsorption579.8 Other specified intestinal malabsorption579.9 Unspecified intestinal malabsorption643.10 – 643.13 Hyperemesis gravidarum with metabolic disturbance751.5 Other congenital anomalies of intestine777.50 – 777.53 Necrotizing enterocolitis in newbornPage 5 of 9

MEDICAL POLICYNo. 91517-R4Parenteral Nutritional Therapy998.6 Persistent postoperative fistula, not elsewhere classifiedICD-10 Codes that may apply (for dates of service on or after October 1, 2015):E08.43 Diabetes mellitus due to underlying condition with diabeticautonomic (poly) neuropathyE09.43 Drug or chemical induced diabetes mellitus with neurologicalcomplications with diabetic autonomic (poly)neuropathyE10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathyE11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathyE13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathyE46Unspecified protein-calorie malnutritionE64.0 Sequelae of protein-calorie malnutritionK31.6 Fistula of stomach and duodenumK31.84 GastroparesisK31.89 Other diseases of stomach and duodenumK50.00 - K50.919 Crohn's diseaseK51.0012 - K51.919 Ulcerative colitisK56.0 Paralytic ileusK56.2 VolvulusK56.5 Intestinal adhesions [bands] with obstruction (postprocedural)(postinfection)K56.60 Unspecified intestinal obstructionK56.69 Other intestinal obstructionK56.7 Ileus, unspecifiedK60.3 Anal fistulaK60.4 Rectal fistulaK60.5 Anorectal fistulaK63.1 Perforation of intestine (nontraumatic)K63.2 Fistula of intestineK63.9 Disease of intestine, unspecifiedK90.4 Malabsorption due to intolerance, not elsewhere classifiedK90.89 Other intestinal malabsorptionK90.9 Intestinal malabsorption, unspecifiedK91.2 Postsurgical malabsorption, not elsewhere classifiedK91.850 PouchitisK91.858 Other complications of intestinal pouchK92.9 Disease of digestive system, unspecifiedK94.01 Colostomy hemorrhageK94.09 Other complications of colostomyK94.11 Enterostomy hemorrhageK94.19 Other complications of enterostomyO21.1 Hyperemesis gravidarum with metabolic disturbanceP77.1 – P77.9 Necrotizing enterocolitis in newbornQ43.0 – Q43.9 Q43.4 Other congenital malformations of intestineT81.83xA - T81.83xS Persistent postprocedural fistulaPage 6 of 9

MEDICAL POLICYNo. 91517-R4Parenteral Nutritional TherapyCPT/HCPCS Codes:Presence of codes on this list does not guarantee coverage.B4164 Parenteral nutrition solution: carbohydrates (dextrose), 50% or less (500 ml =1 unit), home mixB4168 Parenteral nutrition solution; amino acid, 3.5%, (500 ml = 1 unit) - home mixB4172 Parenteral nutrition solution; amino acid, 5.5% through 7%, (500 ml = 1 unit)- home mixB4176 Parenteral nutrition solution; amino acid, 7% through 8.5%, (500 ml = 1 unit)- home mixB4178 Parenteral nutrition solution: amino acid, greater than 8.5% (500 ml = 1 unit),home mixB4180 Parenteral nutrition solution: carbohydrates (dextrose), greater than 50% (500ml = 1 unit), home mixB4185B4189B4193B4197B4199B4216B4220B4222B4224B5000B5100B5200Parenteral nutrition solution, per 10 grams lipidsParenteral nutrition solution: compounded amino acid and carbohydrateswith electrolytes, trace elements, and vitamins, including preparation, anystrength, 10 to 51 g of protein, premixParenteral nutrition solution: compounded amino acid and carbohydrateswith electrolytes, trace elements, and vitamins, including preparation, anystrength, 52 to 73 g of protein, premixParenteral nutrition solution; compounded amino acid and carbohydrateswith electrolytes, trace elements and vitamins, including preparation, anystrength, 74 to 100 grams of protein - premixParenteral nutrition solution; compounded amino acid and carbohydrateswith electrolytes, trace elements and vitamins, including preparation, anystrength, over 100 grams of protein - premixParenteral nutrition; additives (vitamins, trace elements, Heparin,electrolytes), home mix, per dayParenteral nutrition supply kit; premix, per dayParenteral nutrition supply kit; home mix, per dayParenteral nutrition administration kit, per dayParenteral nutrition solution: compounded amino acid and carbohydrateswith electrolytes, trace elements, and vitamins, including preparation, anystrength, renal - Amirosyn RF, NephrAmine, RenAmine - premixParenteral nutrition solution: compounded amino acid and carbohydrateswith electrolytes, trace elements, and vitamins, including preparation, anystrength, hepatic - FreAmine HBC, HepatAmine - premixParenteral nutrition solution: compounded amino acid and carbohydrateswith electrolytes, trace elements, and vitamins, including preparation, anystrength, stress - branch chain amino acids - premixB9004B9006E0791A4211Parenteral Nutrition Infusion Pump, PortableParenteral Nutrition Infusion Pump, StationaryParenteral infusion pump, stationary, single or multichannelSupplies for self-administered injections(Per diem “S” codes include payment for TPN solution, standard additives, supplies andequipment)Page 7 of 9

MEDICAL POLICYNo. 91517-R4Parenteral Nutritional TherapyS9364S9365S9366S9367S9368Home infusion therapy, total parenteral nutrition (TPN); administrativeservices, professional pharmacy services, care coordination, and all necessarysupplies and equipment including standard TPN formula (lipids, specialtyamino acid formulas, drugs other than in standard formula and nursing visitscoded separately), per diemHome infusion therapy, total parenteral nutrition (TPN); 1 liter per day,administrative services, professional pharmacy services, care coordination,and all necessary supplies and equipment including standard TPN formula(lipids, specialty amino acid formulas, drugs other than in standard formulaand nursing visits coded separately), per diemHome infusion therapy, total parenteral nutrition (TPN); more than 1 liter butno more than 2 liters per day, administrative services, professional pharmacyservices, care coordination, and all necessary supplies and equipmentincluding standard TPN formula (lipids, specialty amino acid formulas, drugsother than in standard formula and nursing visits coded separately), per diemHome infusion therapy, total parenteral nutrition (TPN); more than 2 litersbut no more than 3 liters per day, administrative services, professionalpharmacy services, care coordination, and all necessary supplies andequipment including standard TPN formula (lipids, specialty amino acidformulas, drugs other than in standard formula and nursing visits codedseparately), per diemHome infusion therapy, total parenteral nutrition (TPN); more than 3 litersper day, administrative services, professional pharmacy services, carecoordination, and all necessary supplies and equipment including standardTPN formula (lipids, specialty amino acid formulas, drugs other than instandard formula and nursing visits coded separately), per diemVI.REFERENCES1. “Nutritional Support”, Aetna Clinical Policy Bulletin, February 2005.Available on the World Wide Web @http://www.aetna.com/cpb/data/CPBA0061.html (Retrieved December 15,2005)2. “Parenteral Nutrition; Home and Intradialytic” Regence Blue Cross GroupMedical Policy December 2003. Available on the World Wide Web @http://www.regence.com/trgmedpol/alliedHealth/ah06.html (RetrievedDecember 15, 2005)3. “Home Total Parenteral Nutrition” Blue Cross Blue Shield of MassachusettsMedical Policy, May 2005. Available on the World Wide Web @http://www.bluecrossma.com/common/en_US/medical_policies/fs296.htm(Retrieved December 15, 2005)4. “Enteral and Parenteral Nutrition Therapy”, Medicare National CoverageDecision. Available on the World Wide Web @http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=180.2&ncd_version=1&basket=ncd%3A180%2E2%3A1%3AEnteral+and+Parenteral+Nutritional+Therapy (Retrieved December 15, 2005Page 8 of 9

MEDICAL POLICYNo. 91517-R4Parenteral Nutritional Therapy5. AdminaStar Federal, Inc (Region B), Local coverage Determination (LCD#L5063), Parenteral Nutrition, CMS Pub. 100-3 (National CoverageDeterminations Manual), chapter 1, section 180.2, Original determinationeffective date: 10/01/1993, Revision effective date 01/01/2007.6. Hayes Brief, Hayes, Inc. Intradialytic Parenteral Nutrition (IDPN) for End-StageRenal Disease in Adults, August 2008.AMA CPT Copyright Statement:All Current Procedure Terminology (CPT) codes, descriptions, and other data are copyrighted by theAmerican Medical Association.This document is for informational purposes only. It is not an authorization, certification, explanation ofbenefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage.Eligibility and benefit coverage are determined in accordance with the terms of the member’s plan in effectas of the date services are rendered. Priority Health’s medical policies are developed with the assistanceof medical professionals and are based upon a review of published and unpublished information including,but not limited to, current medical literature, guidelines published by public health and health researchagencies, and community medical practices in the treatment and diagnosis of disease. Because medicalpractice, information, and technology are constantly changing, Priority Health reserves the right to reviewand update its medical policies at its discretion...Priority Health’s medical policies are intended to serve as a resource to the plan. They are not intended tolimit the plan’s ability to interpret plan language as deemed appropriate. Physicians and other providersare solely responsible for all aspects of medical care and treatment, including the type, quality, and levelsof care and treatment they choose to provide.The name “Priority Health” and the term “plan” mean Priority Health, Priority Health Managed Benefits,Inc., Priority Health Insurance Company and Priority Health Government Programs, Inc.Page 9 of 9