Coverage Policy Manual
Policy #: 2017029
Category: DME
Initiated: August 2017
Last Review: June 2023
  Immobilized lipase cartridge for enteral feedings (Relizorb)
Description:
Immobilized lipase cartridge (RELiZORB) is a single-use, point-of-care digestive enzyme cartridge that connects in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes. This product is designed to hydrolyze (digest) fats contained in enteral formulas, mimicking the function of the digestive enzyme lipase that is normally secreted by the pancreas, the body’s digestive organ.  This device proposes delivery of absorbable fatty acids and monoglycerides to patients by hydrolyzing fats from enteral formulas. This product is indicated for use in pediatric patients (ages 5 years and above) and adult patients to hydrolyzefats in enteral formula.
 
Immobilized lipase cartridges (RELiZORB) contain the digestive enzyme lipase bound to beads (iLipase)   designed to hydrolyze fats contained in enteral formulas. Relizorb is a single-use product and re-use may result in contamination of the product. Not all enteral tube feeding formulas are compatible with Relizorb.
 
Regulatory
On January 02, 2015, Relizorb received 513(f)(2)(de novo) classification from the U.S. Food and Drug Administration for use in adults to hydrozlyze fats in enteral formula.
 
Coding
See CPT/HCPCS Code section below.
 
Policy/
Coverage:
Prior approval is required for Immobilized lipase cartridge for enteral feedings (e.g., Relizorb).
 
EFFECTIVE April 1, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
INITIAL APPROVAL for up to 12 months:
 
Immobilized lipase cartridge for enteral feedings (e.g., Relizorb) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
    1. Individual has an established diagnosis for cystic fibrosis and requires enteral feeding for nutrition; and
    2. Individual has a diagnosis of cystic fibrosis with pancreatic insufficiency as evidenced by malabsorption of fats (as evidenced by insufficient weight gain or weight loss) from enteral feeding which is refractory to standard care despite optimizing therapy with pancreatic enzyme replacement therapy (PERT) tablets or capsules administered orally or via feeding tube (capsules only) (Pertzye 2020, Ferrie 2011, Shileout 2011); AND
    3. Individual requires enteral feedings for continuous durations of 6 hours or more with use of 1 cartridge per 500ml of formula and no more than 2 cartridges per 24 hours,   
 
CONTINUED APPROVAL for 1 year:
 
Continuation requests for Immobilized lipase cartridge for enteral feedings (e.g., Relizorb) may be approved if the following criteria are met:
 
    1. Individual meets criteria for initial approval based on criteria above; and
    2. Individual has evidence of stable or increased weight gain from use of Immobilized lipase cartridge for enteral feedings (e.g., Relizorb); and
    3. Individual continues to require enteral feedings nutrition for continuous durations of 6 hours or more.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of digestive enzymes added to enteral formula via a cartridge device attached to the tubing used for enteral feeding (e.g., Immobilized lipase cartridge for enteral feedings (e.g.,  Relizorb) or any similar device) not meeting the above criteria does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For member with contracts without primary coverage criteria, the use of digestive enzymes added to enteral formula via a cartridge device attached to the tubing used for enteral feeding (e.g., Immobilized lipase cartridge for enteral feedings (e.g.,  Relizorb) or any similar device) not meeting the above criteria is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
All other indications and conditions, including but not limited to, inpatient use outside of the above criteria do not meet primary coverage criteria that there be scientific evidence of effectiveness and are not covered.
 
For member with contracts without primary coverage criteria, all other indications and conditions, including but not limited to, inpatient use outside of the above criteria, are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EFFECTIVE June 2021 through March 2023
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of digestive enzymes added to enteral formula via a cartridge device attached to the tubing used for enteral feeding (i.e., Relizorb or any similar device) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For member with contracts without primary coverage criteria, the use of digestive enzymes added to enteral formula via a cartridge device attached to the tubing used for enteral feeding (i.e., Relizorb or any similar device) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EFFECTIVE PRIOR TO June 2021
 
The use of digestive enzymes added to enteral formula via a cartridge device attached to the tubing used for enteral feeding (i.e., Relizorb or any similar device) does not meet primary coverage criteria.
 
For members with contracts without primary coverage criteria, the use of digestive enzymes added to enteral formula via a cartridge device attached to the tubing used for enteral feeding (i.e., Relizorb or any similar device) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
Although Relizorb has received 513(f)(2)(de novo) classification from the FDA, there is no evidence in published, peer-reviewed, randomized, placebo controlled studies comparing Relizorb to established therapeutic alternatives. Additionally, there are no published studies assessing the clinical utility or long-term safety of the use of Relizorb. Therefore, there is insufficient evidence to support the use of Relizorb for any indication at this time.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
B4105In line cartridge containing digestive enzyme(s) for enteral feeding, each
B9998Noc for enteral supplies
B9999Noc for parenteral supplies
References: U.S. Food and Drug Administration.(2017) Device Classification under Section 513(f)(2)(de novo). Ezyme Packed Cartridge. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN150001. Accessed Aug. 25, 2017.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.