Ear, nose and throat (ENT) specialist Intersect ENT®, Inc. tells us about a new Centers for Medicare and Medicaid Services (CMS) approval for the PROPEL family of sinus implants. The approval now separates PROPEL from the “therapeutically distinct” SINUVA® implant with which it previously shared coding.
The PROPEL® family of products are the first and only bioabsorbable steroid releasing sinus implants approved by the FDA to maintain patency and locally deliver steroid to the sinus mucosa in patients >18 years of age after sinus surgery. Clinically proven to improve outcomes for chronic sinusitis patients following sinus surgery, PROPEL sinus implants mechanically prop open the sinuses and release mometasone furoate, an advanced corticosteroid with anti-inflammatory properties, directly into the sinus lining then bioabsorb. PROPEL’s safety and effectiveness for use in ethmoid sinuses is supported by Level 1-A clinical evidence from multiple clinical trials, which demonstrates that PROPEL implants reduce inflammation and scarring after ethmoid sinus surgery, thereby lessening the need for post-operative oral steroids and surgical interventions. PROPEL is indicated for the ethmoid sinus; PROPEL Mini is indicated for the ethmoid and frontal sinuses; and PROPEL Contour is indicated for the frontal and maxillary sinuses.
Prior to this decision, PROPEL shared a billing code with the Company’s related but therapeutically distinct SINUVA® (mometasone furoate) sinus implant, used to reduce polyps and the need for revision sinus surgery. The approval of this new application establishes a separate code for PROPEL, S1091 “Stent, non-coronary, temporary, with delivery system (propel),” as well as updates the current SINUVA J-Code to, J7402 “Mometasone furoate sinus implant, (sinuva), 10 micrograms.”
The Company believes these specific coding assignments, will have a positive impact by improving the accuracy in claims adjudication for both PROPEL and SINUVA, support expanded use in multiple sites of service for both products, provide greater clarity for payers and providers and solidify the current reimbursement environment. CMS will discontinue the original shared Level II HCPCS code J7401 “Mometasone furoate sinus implant, 10 micrograms.” The new PROPEL and SINUVA codes are scheduled to take effect April 1, 2021.
Thomas A. West, President and Chief Executive Officer of Intersect ENT stated ;“We are pleased that CMS recognized the benefit to payers and providers of decoupling the previously shared, and therefore potentially confusing, single J-Code for both SINUVA and PROPEL. These are distinct offerings with different uses and benefits. In addition, SINUVA is classified by FDA as a drug and PROPEL as a device. With the dedicated and updated SINUVA code, J7402, and a specific PROPEL code, S1091, payers can now more accurately delineate and reimburse based upon the specific use of each product. Moreover, Payers can accurately align each product’s National Drug Code (NDC) to the product-specific, CMS-assigned, code and the product’s actual use.
“CMS’s agreement, at our request, to assign separate codes to SINUVA and PROPEL reflects and supports our deliberate strategy to leverage Intersect ENT’s proprietary drug eluting sinus stent technology platform while, at the same time, broadening our portfolio of therapeutic offerings, clinical indications and health economic data to support evidence-based and cost-effective care across the continuum of need in chronic rhinosinusitis.”
Source: Intersect ENT®, Inc.