Cutaquig 16.5% Part B Approval for Infusions with Electric and Mechanical Pumps Started September 6th


Octapharma USA announces medicare part b approval of cutaquig 16.5% for adult PI patients. (Credit:)

Octapharma USA today announced the Centers for Medicare & Medicaid Services (CMS) has modified the External Infusion Pump Local Coverage Determination to include cutaquig 16.5%, the company’s subcutaneous immunoglobulin (SCIg), for use with electric and mechanical pumps. The Medicare Part B coverage determination is effective September 6, 2020.

“Cutaquig is an important CMS-approved addition to the available supply of SCIg products for adult primary immune disease patients,” said Octapharma USA President Flemming Nielsen. “As the supply of immunoglobulin products faces challenges in the near future, the addition of cutaquig® to the list of products available for Medicare patients comes at the right time. Octapharma has increased its production of cutaquig by more than 45 percent over the last year so we have strong supply to meet patient needs.”

For any item to be covered by Medicare Part B, it must be eligible for a Medicare benefit category, and meet all other applicable Medicare statutory and regulatory requirements. Since cutaquig is administered through an external infusion pump, an item of durable medical equipment, it is covered for Medicare beneficiaries with Primary Immune Deficiency under the Part B, Durable Medical Equipment (DME) benefit of the Social Security Act.

“As skyrocketing demand looms on the horizon and more geriatric patients and others on Medicare are being treated independently at home, it is essential that this group have access to an SCIg product which has been demonstrated in clinical studies to be well-tolerated, safe and effective,” said Roger H. Kobayashi, M.D., Clinical Professor UCLA School of Medicine and National Consultant, Immune Deficiency Foundation.

Source: Company Press Release