Coverage Policy Manual
Policy #: 2017029
Category: DME
Initiated: August 2017
Last Review: June 2022
  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
There is no specific HCPCS code for Relizorb. It is expected that it would be billed with B9998 or B9999.
 

Policy/
Coverage:
EFFECTIVE June 2021
 
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.

CPT/HCPCS:
B4105In line cartridge containing digestive enzyme(s) for enteral feeding, each
B9998Noc for enteral supplies
B9999Noc for parenteral supplies
Q9994In line cartridge containing digestive enzyme(s) for enteral feeding, each

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.
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