UPMC Health Plan

MedStar Health, Inc. POLICY AND PROCEDURE MANUAL

POLICY NUMBER: MP.056.MH REVISION DATE: 03/15 ANNUAL APPROVAL DATE 03/15 PAGE NUMBER: 1 of 9

SUBJECT: Parenteral Nutrition INDEX TITLE: Medical Management ORIGINAL DATE: January 2013

This policy applies to the following lines of business: (Check those that apply.) COMMERCIAL [ ] HMO [ ] PPO [ ] Fully [ ] Individual [ ] Marketplace [ X ] All Insured Product (Exchange) GOVERNMENT [ ] MA HMO [ ] MA PPO [ ] MA C-SNP [ ] MA D-SNP [ X ] MA All PROGRAMS [ ] Medicaid OTHER [ X ] Self-funded/ASO

I. POLICY

It is the policy of MedStar Health, Inc. to cover parenteral nutrition when it is medically necessary and covered under the member’s specific benefit plan.

It is the policy of MedStar Health, Inc. to consider coverage of parenteral nutrition when appropriate and consistent with good medical practice, after review on an individual basis, for the specific indications detailed in this policy.

The coverage and payment of pumps and supplies is considered independent of nutritional product determinations.

All denials are based on medical necessity and appropriateness as determined by a MedStar Health Medical Director (Medical Director).

II. DEFINITIONS

Enteral Nutrition - the delivery of nutrition through a tube into the gastrointestinal tract, for the purpose of restoring or maintaining nutrition, weight, and both electrolyte and metabolic integrity.

Enteric Tube Trial - a temporary placement of a tube into the gastrointestinal track for the purpose of determining tolerance and efficacy of enteric delivery of nutrition. Adjustments in the enteral formulation selection, formula strength, and infusion rate must also be attempted to reduce stool output and improve tolerance before a tube feeding trial can be said to have failed.

POLICY NUMBER: MP.056.MH REVISION DATE: 01/15 ANNUAL APPROVAL DATE: 01/15 PAGE NUMBER: 2 of 9

Fat Malabsorption, Severe - fecal fat exceeds 50% of oral/enteral intake on a diet of at least 50 gm of fat/day as measured by a standard 72 hour fecal fat test.

Intradialytic Parenteral Therapy (IDPN) - parenteral nutrition delivered during hemodialysis or peritoneal dialysis. Infusing hyperalimentation fluids at the time of hemodialysis or peritoneal dialysis is used to treat protein calorie malnutrition.

Malnourished - 10% weight loss over 3 months or less and serum albumin less than or equal to 3.4 gm/dl or BMI less than 18.5.

Parenteral Nutrition - the administration of specially prepared intravenous fluid which typically includes one or more essential nutritional elements (calories, fat, protein, electrolytes, vitamins, and/or trace elements)

Prokinetic Medication - medication that increases or restores gastrointestinal motility

Special Parenteral Formulas - compounded parenteral formulas that are designed to meet the needs of individuals with unique and special nutritional deficiencies, inborn errors of metabolism, and/or uncompensated organ system failures, including but not limited to:  Renal insufficiency (i.e.,amirosyn rf, nephramine, renamine – premix)  Hepatic failure (freamine hbc, hepatamine – premix)  Stress (branch chain amino acids – premix)

Total Caloric Daily Intake to Maintain Appropriate Body Weight - (parenteral, enteral and oral) is considered to be approximately 20-35 cal/kg/day.

Total Parenteral Nutrition (TPN) - Parenteral nutrition administered as a complete maintenance or replacement for individuals who are unable to obtain any nutrition through oral consumption or enteric tube administration.

III. PURPOSE

The purpose of this policy is to define the indications for parenteral nutrition.

IV. SCOPE

This policy applies to various MedStar Health departments as indicated by the Benefit and Reimbursement Committee.

POLICY NUMBER: MP.056.MH REVISION DATE: 01/15 ANNUAL APPROVAL DATE: 01/15 PAGE NUMBER: 3 of 9

V. PROCEDURE

A. Medical Description

There are several reasons why the stomach or bowel may not be working normally, including motility disorders, obstructive anatomies, malabsorptive syndromes, and surgical removal of parts or whole of the digestive track. These conditions interrupt the normal process of digestion and require alternative methods for a person to receive vital nutrients. One alternative is parenteral nutrition, which is a special intravenous elemental nutritional solution, given into the blood directly through an intravenous catheter bypassing the normal digestive and absorption process. Parenteral nutrition is administered through a central line placed in a large vein of the chest or arm and is available in various combinations of proteins, carbohydrates, fats, vitamins, and minerals based on the individual needs of the patient. If a person is on dialysis, nutrition can be received in a similar way known as IDPN. Usually, IDPN is given in conjunction with a patient’s scheduled dialysis treatments.

B. Specific Indications

PARENTERAL NUTRITION/ TPN Parenteral nutrition/TPN is considered medically necessary when both criteria # 1 and # 2 is met:

1. Absorption of nutrients is impaired due to a condition involving the small intestine and/or its exocrine glands OR There is a motility disorder that impairs the ability of nutrients to be transported through the gastro intestinal (GI) system.

AND

2. Any one of the following criteria is met:  The member has undergone massive small bowel resection leaving less than or equal to 5 feet of small bowel beyond the ligament of Treitz OR  The member has a short bowel syndrome, or other intestinal malabsorptive disorder, where on an oral/enteral intake of 2.5-3 liters/day results in enteral losses which exceed 50% of the oral/enteral intake and the urine output is less than 1 liter/day OR

POLICY NUMBER: MP.056.MH REVISION DATE: 01/15 ANNUAL APPROVAL DATE: 01/15 PAGE NUMBER: 4 of 9

 The member has complete mechanical small bowel obstruction where surgery is not an option OR  The member requires bowel rest and is receiving 20-35 cal/kg/day intravenously for treatment of certain medical conditions OR  All of the following criteria are met: o The member is severely malnourished

And

o There is documented evidence that a disease and clinical condition is present and modifying the nutrient composition of the enteral diet and use of pharmacologic means to treat the etiology has failed

And

o An enteric tube trial of nutrition was attempted and failed.

IDPN IDPN is considered medically necessary when both criteria # 1 and # 2 is met:

1. The individual is on chronic hemodialysis or peritoneal dialysis And 2. The individual’s nutritional status cannot be adequately maintained on oral or enteral feedings/supplements.

Requests for Parenteral Nutrition, TPN, or IDPN will be evaluated on a case by case basis with special consideration given to the information provided by the prescribing physician in the decision.

Review Period 1. Parenteral nutrition/TPN is reviewed and authorized for two (2) week periods. 2. Documented requests to continue or renew parenteral nutrition must be submitted by the treating physician prior to expiration of the authorization. 3. A review is done when there is a request to change the nutrients and/or when increasing/decreasing the number of days administered. 4. In the case of special chronic conditions, a request for a nutritional product will be authorized, at the Medical Director’s or Nurse Reviewer’s discretion, for duration commensurate with the chronicity and stability of the member’s clinical circumstance. No request will be approved for duration of greater than 180 days.

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D. Limitations/Exclusions

1. TPN is not covered for members with a functioning gastrointestinal tract and the need is due to any of the following:  Swallowing disorder  A side effect of a medication  Renal failure and/or dialysis as a sole diagnosis  A psychological disorder impairing food intake such as depression  A metabolic disorder inducing anorexia, such as cancer  A disorder that causes a temporary defect in gastric emptying  A physical disorder that impairs food intake, i.e., dyspnea from severe cardiac or pulmonary disease  For routine pre- and/or postoperative care  When used to increase protein or caloric intake in addition to the member’s daily diet. 2. The medical necessity for special parenteral formulas must be justified and documented for each member or it will be denied as not medically necessary. 3. The ordering physician must document the medical necessity for protein orders outside of the range of 0.8-1.5 gm/kg/day, dextrose concentration less than 10%, or lipid use greater than 1500 grams per month or it will be denied as not medically necessary. 4. The ordering physician is expected to see the member within 30 days prior to the initial certification or required recertification (but not revised certifications). If the physician does not see the member within this timeframe, they must document the reason why and describe what other monitoring methods were used to evaluate the member’s nutrition needs. 5. One (1) pump (stationary or portable) will be covered at any one time. Additional pumps will be denied as not medically necessary. 6. One (1) supply kit and one (1) administration kit will be covered for each day that parenteral nutrition is administered.

E. Information Required for Review

In order to assess medical necessity for parenteral nutrition, adequate information must be furnished by the treating physician. Necessary documentation includes but not limited to the following: 1. An attending physician’s order or prescription which includes the product, the administration rate, the route of administration and need for special equipment, such as a pump. 2. An account of the member’s current nutritional status, including height and weight, and if pediatric- current percentiles. 3. Diagnosis and description of functional impairment. 4. Estimated duration of therapy, including frequency.

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5. Certificate of Medical Necessity (CMN) form and sufficient documentation (e.g., hospital records, clinical findings, lab values, etc. from the attending) to justify that the requirements of medical necessity are met. 6. A Durable Medical Equipment (DME) Information Form (DIF) should be completed, signed, and dated by the supplier. It must be kept on file by the supplier and made available on request. 7. Upon request of a nurse or medical director, a detailed account of the member’s oral or enteric intake (calorie count) may be required in those cases where parenteral nutrition is ordered as a necessary supplement to oral or tube feeding.

E. Review Process

1. The Medical Management staff assigned to review obtains the clinical information, to determine if there is adequate clinical information. If the case does not meet the established criteria, it is referred to a MedStar Health, Inc. Medical Director. 2. If referred, the Medical Director determines if the requested service is medically necessary and appropriate. 3. The Medical Management staff completes the review process and communicates the review decision according to the Timeliness of UM Decisions policy for the member’s benefit plan.

F. Variations For Commercial Members in the State of Maryland

Coverage for amino acid-based elemental formula, regardless of delivery method, for the diagnosis and treatment of: (I) Immunoglobulin E and non-immunoglobulin E mediated allergies to multiple food proteins; (II) Severe food protein induced Enterocolitis Syndrome; (III) Eosinophilic disorders, as evidenced by the results of a biopsy; and (IV) Impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract.

Provided that the ordering physician issues a written order that states the amino acid-based elemental formula is medically necessary for treatment of one of the above listed diseases or disorders

G. Records Retention

POLICY NUMBER: MP.056.MH REVISION DATE: 01/15 ANNUAL APPROVAL DATE: 01/15 PAGE NUMBER: 7 of 9

Records Retention for documents, regardless of medium, are provided within the MedStar Health Policy and Procedure CORP.028 Records Retention.

H. Codes

The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Applicable HCPCS Coding: HCPS Code: Description: B4164 Parenteral nutrition solution: carbohydrates (dextrose), 50% or less (500 ml=1 unit), home mix B4168 Parenteral nutrition solution: amino acid, 3.5% (500 ml=1 unit), home mix B4172 Parenteral nutrition solution: amino acid, 5.5% through 7% (500 ml= 1unit), home mix B4176 Parenteral nutrition solution: amino acid, 7% through 8.5% (500 ml= 1unit), home mix B4178 Parenteral nutrition solution: amino acid, greater than 8.5% (500 ml= 1unit), home mix B4180 Parenteral nutrition solution: carbohydrates (dextrose) greater than 50%(500 ml= 1unit), home mix B4189 Parental nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 10 to 51 g of protein, premix B4193 Parental nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 52 to 73 g of protein, premix B4197 Parental nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, 74 to 100 g of protein, premix B4199 Parental nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and

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vitamins, including preparation, any strength, over 100 g of protein, premix B4216 Parenteral nutritional; additives (vitamins, trace elements, Heparin, electrolytes), home mix, per day B4220 Parenteral nutrition supply kit; premix, per day B4222 Parenteral nutrition supple 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- Amirosyn RF, NephrAmine, RenAmine-premix B5100 Parenteral nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, hepatic- FreAmine HBC, HepatAmine,- premix

B5200 Parental nutrition solution: compounded amino acid and carbohydrates with electrolytes, trace elements, and vitamins, including preparation, any strength, stress- branch chain amino acids- premix

I. References Medical Literature/Government Source: 1. American Society for Parenteral and Enteral Nutrition: What is Parenteral Nutrition? ©2014, American Society of Parenteral and Enteral Nutrition (A.S.P.E.N) https://www.nutritioncare.org/About_Clinical_Nutrition/What_is_Parenteral_N utrition/ 2. Heyland DK. Nutritional support in the critically ill patient. A critical review of the evidence. Crit Care Clin 1998 Jul; 14(3):423-440. http://www.mdconsult.com/das/article/body/431732251- 3/jorg=journal&source=&sp=10322761&sid=0/N/116369/1.html?issn=074907 04&_returnURL=http%3A//linkinghub.elsevier.com/retrieve/pii/S07490704057 00099%3Fshowall%3Dtrue 3. Reilly H. Parenteral nutrition: an overview of current practice. Br J Nurse 1998 Apr 23-May 13:7(8):461-467. http://www.ncbi.nlm.nih.gov/pubmed/?term=Reilly+H+%5Bau%5D+AND+pare nteral+%5Bti%5D 4. The Veterans Affairs Total Parenteral Nutrition Cooperative Study Group. Perioperative total parenteral nutrition in surgical patients. N Engl J Med.

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1991 Aug; 325(8):525-532. http://www.nejm.org/doi/pdf/10.1056/NEJM199108223250801

Regulatory/Government Source: 1. Centers for Medicare and Medicaid Services: Local Coverage Determination (L5063) - Parenteral Nutrition (Contractor: NHIC,Corp). Revision Effective Date: February 4, 2011. http://www.cms.gov/medicare-coverage- database/details/lcd- details.aspx?LCDId=5063&ContrId=137&ver=34&ContrVer=1&CntrctrSelecte d=137*1&Cntrctr=137&name=NHIC%2c+Corp.+(16003%2c+DME+MAC)&s= 45&DocType=All&bc=AggAAAIAAAAAAA%3d%3d& 2. Centers for Medicare and Medicaid Services: Medicare National Coverage Determinations Manual, Chapter 1, (Sections 170-190.34) Coverage Determinations, Section 180.2, Rev. 173, 09/04/2014. http://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads/ncd103c1_Part3.pdf 3. Centers for Medicare and Medicaid Services: National Coverage Determination (180.2) for Enteral and Parenteral Nutrition, Effective July 11, 1984. http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=242&ncdver=1&bc=AgAAgAAAAAAAAA%3d%3d& 4. Maryland State Mandate Benefits: Amino Acid Based Elemental Formula: Maryland Code of law Insurance Article §15-843. http://www.mdinsurance.state.md.us/sa/docs/documents/consumer/publicnew /mandatedbenefits.pdf