The Centers for Medicare and Medicaid Services (CMS) has issued a permanent billing code (B4105) to Alcresta Therapeutics’ in-line digestive enzyme cartridge Relizorb, making it easier for insurance payers and potentially more accessible to patients.
The code, effective on Jan. 1, should now enable coverage for Relizorb that can be separately reimbursed without
any technical billing issues, like coding concerns.
Patients with cystic fibrosis (CF) often don’t produce enough lipase, a digestive enzyme that catalyzes the breakdown of fats, resulting in insufficient absorption of fat which hinders weight gain and causes other gastrointestinal problems.
Relizorb is an in-line digestive enzyme cartridge that contains lipase immobilized on beads (iLipase). As the enteral tube-feeding formula passes through the cartridge, iLipase acts on complex fats and hydrolyzes them into a simple absorbable form, which is readily used by the body. The system allows patients to absorb 90 percent of the fats present in most enteral tube-feeding formulas.
The treatment is approved by the U.S. Food and Drug Administration (FDA) for use in adults and children (5 years and up).
“RELiZORB is already used by approximately 50% of all enterally fed [tube-fed] cystic fibrosis patients in the U.S.,” Tasos Konidaris, chief financial officer of Alcresta Therapeutics, said in a press release. “This reimbursement milestone makes RELiZORB accessible to many patients who had previously been denied access, due to coding issues.”
A multi-center clinical study, ASSURE (NCT02750501) has shown that Relizorb helps improve the absorption of healthy omega-3 fats in tube-fed CF patients who maintain their body mass index for over 90 days.
Other studies have shown that Relizorb lowers the frequency and severity of gastrointestinal symptoms, thus improving patients’ nutrition. Its use was also reported to be safe and well-tolerated.
“In clinical trials and published reports, RELiZORB has been shown to normalize absorption of key fatty acids, decrease gastrointestinal adverse events like diarrhea, and increase weight in patients suffering from fat malabsorption as a consequence of cystic fibrosis and other serious diseases,” Konidaris said.
“RELiZORB can be an important option for these patients, as there is no other drug or medical device approved by the FDA to do what RELiZORB does,” he added.
As per the CMS’ healthcare common procedure coding system (HCPCS), the ‘B’ code was given to RELiZORB — B4105, “In-Line Cartridge Containing Digestive Enzymes(s) for Enteral Feeding, Each.” It is grouped under the medical procedure or service code for parenteral and enteral nutrition (category 39), and can be paid for at the insurance contractor’s discretion (category “C”).
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