US Agency Issues New Billing Code for Nutritional Supplement Encala

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by Marisa Wexler MS |

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The federal agency that administers Medicare programs in the U.S. has just made it easier for people with cystic fibrosis (CF) to get the nutritional supplement Encala, designed to help CF patients better absorb fat in their digestion.

The Centers for Medicare and Medicaid Services, called CMS, has issued a new Healthcare Common Procedure Coding System code — a billing code — for Encala. Such codes represent procedures, supplies, products, and services that may be provided to Medicare beneficiaries and to people enrolled in private health insurance programs, according to the agency.

Having code S9432, “Medical Food for Non-Inborn Errors of Metabolism,” will make it easier for payers to cover the cost of Encala for people for whom the supplement is deemed medically necessary, manufacturer Envara Health said in a press release.

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The new code was welcomed by patients with CF — and by parents of children with the inheritable progressive disease.

“This is a game changer,” said Katie Derks, whose son was diagnosed with CF in 2019, when he was 1 month old.

Derks’ son was started on Encala in late 2020, and since then, his growth has increased by 47%, she said, noting that he is now in the above-average percentile of body weight for his age.

“Coding gives patients and their families access to important new treatments,” said Derks, who had advocated for the CMS to issue a new code for the nutritional supplement, speaking in its favor at a CMS public meeting.

“I’m so happy that many others will now have access to Encala,” she said.

Digestive problems are common in people with CF. In particular, the thick mucus that characterizes CF can build up in the ducts within the pancreas, the large gland behind the stomach that releases digestive enzymes. Mucus buildup prevents the pancreas from secreting such enzymes, which are needed for digestion.

That resulting lack of enzymes — termed pancreatic insufficiency — can make it hard for the body to properly digest certain nutrients, especially fats, which contributes to malabsorption. The result for patients is poor weight gain and growth, and many people with CF experience bouts of pain, constipation, or greasy stools.

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Encala is a plant-based, flavorless powder that contains various kinds of fats that are relatively easy for the body to absorb. Envara launched the supplement late last year.

Results from a Phase 2 clinical trial (NCT00406536) demonstrated that taking Encala led to improvements in fat levels, height, weight, and body mass index (a measure of body fat) for those with poor fat absorption. Specifically, the supplement aided individuals with a coefficient of fat absorption, or CFA, less than 88%.

The trial, completed in 2012, had enrolled 110 children and adolescents with CF and pancreatic insufficiency. An analysis found the supplement was safe and well-tolerated, and increased dietary fat absorption in patients.

“By issuing this code, CMS is recognizing the uniqueness of Encala and the strength of our National Institutes of Health sponsored clinical data in improving height, weight, and essential fatty acid status in patients with malabsorption,” said Linda Palczuk, chief operating officer at Envara.

Added Jim O’Connell, the company’s CEO: “As pioneers in the ‘food as medicine’ movement, we are committed to developing innovative solutions for the over 1.5 billion people suffering from malabsorption. We’ll continue our efforts to expand access and ensure treatment is available for patients in need.”


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