{"id":452333,"date":"2021-03-08T07:03:17","date_gmt":"2021-03-08T12:03:17","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=452333"},"modified":"2021-03-08T07:03:17","modified_gmt":"2021-03-08T12:03:17","slug":"cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\/","title":{"rendered":"CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication<\/b><\/p>\n<p class=\"bwalignc\"><i>Pass-Through Status Will Continue Under the New Code Through June 30, 2023<\/i><\/p>\n<p>MENLO PARK, Calif.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nIntersect ENT\u00ae, Inc. (Nasdaq: XENT), a global ear, nose and throat (\u201cENT\u201d) medical technology leader dedicated to transforming patient care, today announced that the Centers for Medicare and Medicaid Services (CMS) published an average selling price (ASP) for the Company\u2019s SINUVA sinus implant, providing predictability, transparency, and confidence<b \/>of reimbursement for providers and payers going forward. In January 2021, CMS created separate and distinct codes for Intersect ENT\u2019s two bioabsorbable implant product lines PROPEL (S1091) and SINUVA (J7402). CMS has now attached an ASP to J7402, \u201cmometasone furoate sinus implant, (sinuva), 10 micrograms.\u201d Previously, a single code covered both products despite their substantial differences.\n<\/p>\n<p>\nAdditionally, CMS confirmed consolidation of all coding for SINUVA into the newly created Code, J7402. In so doing, CMS\u2019s action incorporates SINUVA \u201cpass-through\u201d status in ambulatory care settings with Medicare patients to the new J-Code, J7402, and eliminates the temporary sinus implant C-Code, C9122, issued in July 2020. These actions came as a result of the Company\u2019s application to CMS for clarification and simplification in coding of the products. The Company believes the separate and dedicated codes will have a positive impact on patient and physician access by improving accuracy in claims adjudication, supporting expanded use at multiple sites of service, and providing greater clarity of coverage for payers and providers.\n<\/p>\n<p>\n\u201cWe are pleased that CMS consolidated SINUVA coverage to a single code and published a SINUVA ASP. These actions will help better inform ENT surgeons of the amount of implant reimbursement they can expect regardless of setting of care, thereby greatly reducing the uncertainty that can come with claims submissions,\u201d stated Thomas A. West, President and Chief Executive Officer of Intersect ENT. \u201cCMS\u2019s recent decisions will also clearly differentiate coding for SINUVA and PROPEL, two very different products. This will serve to simplify and streamline coding and reimbursement across our portfolio and will support evidence-based and cost-effective care across the continuum of need in chronic rhinosinusitis.\u201d\n<\/p>\n<p><b>SINUVA<sup>\u00ae<\/sup> Steroid Releasing Sinus Implant<\/b><\/p>\n<p>\nSINUVA is a non-surgical, corticosteroid-eluting implant for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery. Its innovative 2-in-1 design incorporates a self-expanding, bioabsorbable implant structure along with the targeted delivery of an anti-inflammatory corticosteroid, mometasone furoate. It provides localized drug delivery for up to 90 days directly to the site of disease. By nature of its design as an office-administered implant with direct delivery of anti-inflammatory medication, SINUVA minimizes the reliance on patient compliance. SINUVA is clinically proven to reduce polyps and the need for revision nasal surgery, as well as improve the symptoms of nasal polyps, nasal obstruction, congestion and decreased sense of smell.\n<\/p>\n<p><b>About Intersect ENT\u00ae<\/b><\/p>\n<p>\nIntersect ENT is a global ear, nose and throat medical technology leader dedicated to transforming patient care. The Company\u2019s steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company\u2019s unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care. In October 2020, Intersect ENT acquired Fiagon AG Medical Technologies, a global leader in electromagnetic surgical navigation solutions with an expansive portfolio of ENT product offerings, including the VENSURE sinus dilation balloon, that complement the Company\u2019s PROPEL<sup>\u00ae<\/sup> and SINUVA<sup>\u00ae<\/sup> sinus implants and extend its geographic reach.\n<\/p>\n<p>\nFor additional information on the Company or the products including risks and benefits please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.IntersectENT.com&amp;esheet=52392009&amp;newsitemid=20210308005289&amp;lan=en-US&amp;anchor=www.IntersectENT.com&amp;index=1&amp;md5=77daab9e642f8633cdfcea89ab71dc6a\">www.IntersectENT.com<\/a>. For more information about PROPEL\u00ae (mometasone furoate) sinus implants and SINUVA\u00ae (mometasone furoate) sinus implant, please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.PROPELOPENS.com&amp;esheet=52392009&amp;newsitemid=20210308005289&amp;lan=en-US&amp;anchor=www.PROPELOPENS.com&amp;index=2&amp;md5=038ec13e509a2817d768bd9359b708e8\">www.PROPELOPENS.com<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.SINUVA.com&amp;esheet=52392009&amp;newsitemid=20210308005289&amp;lan=en-US&amp;anchor=www.SINUVA.com&amp;index=3&amp;md5=a530d8c6e5db4a54bc3955a1d163603c\">www.SINUVA.com<\/a>.\n<\/p>\n<p>\nIntersect ENT\u00ae, PROPEL\u00ae and SINUVA\u00ae are registered trademarks of Intersect ENT, Inc.\n<\/p>\n<p><b>SINUVA Indication &amp; Important Safety Information<\/b><\/p>\n<p>\nINDICATION\n<\/p>\n<p>\nSINUVA Sinus Implant is a prescription steroid-releasing (mometasone furoate) implant indicated for the treatment of nasal polyps in patients 18 years or older who have had ethmoid sinus surgery.\n<\/p>\n<p>\nIMPORTANT SAFETY INFORMATION\n<\/p>\n<p>\nWho should not use SINUVA?\n<\/p>\n<p>\nDo not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.\n<\/p>\n<p>\nWhat should I tell my doctor before receiving SINUVA?\n<\/p>\n<p>\nBefore you receive SINUVA, tell your doctor about all medical conditions you have including nasal\/sinus problems (such as nasal ulcers or trauma), eye problems (such as glaucoma or cataracts), or any untreated fungal, bacterial, or viral infections.\n<\/p>\n<p>\nWhat are the possible side effects of SINUVA?\n<\/p>\n<p>\nSerious side effects of SINUVA can include:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nLocal reactions including nosebleed and injury to nerves or blood vessels in the nose\/sinus.\n<\/li>\n<li>\nSerious allergic reactions have happened in patients using mometasone furoate including rash, itching or swelling of the lips, face, tongue, and throat, and breathing problems. Call your doctor right away if you have any of these reactions.\n<\/li>\n<li>\nWeakened immune system that may increase your risk of infections. Avoid contact with people who have contagious diseases such as chickenpox or measles. Call your doctor right away if you have been near someone with chickenpox or measles.\n<\/li>\n<li>\nAdrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones and can cause tiredness, weakness, nausea and vomiting and low blood pressure. Talk to your doctor if steroid effects such as Cushing Syndrome and adrenal suppression appear.\n<\/li>\n<\/ul>\n<p>\nThe most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. The following adverse reactions have been identified during post-approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, and nosebleeds.\n<\/p>\n<p>\nTell your doctor if you have any side effects that bother you or don\u2019t go away.\n<\/p>\n<p>\nRisks related with the insertion and removal of SINUVA are similar to other endoscopic sinus procedures.\n<\/p>\n<p>\nSINUVA is made from materials designed to soften over time and may fall out of the nose on its own as polyps decrease or if you sneeze or blow your nose forcefully. The implant will be removed 90 days after placement or earlier at your doctor\u2019s discretion.\n<\/p>\n<p>\nContact your doctor immediately if you have any changes in vision, excessive nasal bleeding, symptoms of infection or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat.\n<\/p>\n<p>\nYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&amp;esheet=52392009&amp;newsitemid=20210308005289&amp;lan=en-US&amp;anchor=www.fda.gov%2Fmedwatch&amp;index=4&amp;md5=8b5c0d5bee262dfe6274bd5db0bd84da\">www.fda.gov\/medwatch<\/a>, or call 1-800-FDA-1088. For important risk and use information, please see Full Prescribing Information for SINUVA (<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.SINUVA.com%2FPI&amp;esheet=52392009&amp;newsitemid=20210308005289&amp;lan=en-US&amp;anchor=www.SINUVA.com%2FPI&amp;index=5&amp;md5=762a1b69a7e944436716dc85e75f85cb\">www.SINUVA.com\/PI<\/a>).\n<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>\nThis release contains forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as \u201clook forward,\u201d confident,\u201d \u201cpromises,\u201d \u201cpredicts,\u201d \u201cbelieve,\u201d \u201cpotential,\u201d \u201canticipates,\u201d \u201cexpects,\u201d \u201cplans,\u201d \u201cintends,\u201d \u201cmay,\u201d \u201ccould,\u201d \u201cmight,\u201d \u201cwill,\u201d \u201cshould,\u201d or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Intersect ENT\u2019s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the company\u2019s products and therapies, the ability to obtain and maintain reimbursement codes for its products, the company\u2019s ability to procure and maintain required regulatory approvals for our products, the company\u2019s ability to grow and expand its business, as well as other risks detailed from time to time in Intersect ENT\u2019s filings with the Securities and Exchange Commission (SEC), including Intersect ENT\u2019s filings on Form 10-K and Form 10-Q available at the SEC&#8217;s Internet site (<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sec.gov&amp;esheet=52392009&amp;newsitemid=20210308005289&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=6&amp;md5=9f4ddb4ecb6377ea537a59f16b6482b9\">www.sec.gov<\/a>). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210308005289r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20210308005289\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20210308005289\/en\/<\/a><\/span><\/p>\n<p><b>IR Contact:<br \/>\n<br \/><\/b>Randy Meier, 650-641-2105<br \/>\n<br \/>Executive Vice-President &amp; CFO<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:ir@intersectENT.com\">ir@intersectENT.com<\/a><\/p>\n<p><b>Media Contact:<br \/>\n<br \/><\/b>Erich Sandoval, 917-497-2867<br \/>\n<br \/>Finn Partners\u00a0for\u00a0Intersect ENT<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:IntersectENT@finnpartners.com\">IntersectENT@finnpartners.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> United States North America California<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> General Health Health Medical Devices<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20210308005289\/en\/788056\/3\/XENT_Logo.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication Pass-Through Status Will Continue Under the New Code Through June 30, 2023 MENLO PARK, Calif.&#8211;(BUSINESS WIRE)&#8211; Intersect ENT\u00ae, Inc. (Nasdaq: XENT), a global ear, nose and throat (\u201cENT\u201d) medical technology leader dedicated to transforming patient care, today announced that the Centers for Medicare and Medicaid Services (CMS) published an average selling price (ASP) for the Company\u2019s SINUVA sinus implant, providing predictability, transparency, and confidenceof reimbursement for providers and payers going forward. In January 2021, CMS created separate and distinct codes for Intersect ENT\u2019s two bioabsorbable implant product lines PROPEL (S1091) and SINUVA (J7402). CMS has now attached an &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-452333","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication Pass-Through Status Will Continue Under the New Code Through June 30, 2023 MENLO PARK, Calif.&#8211;(BUSINESS WIRE)&#8211; Intersect ENT\u00ae, Inc. (Nasdaq: XENT), a global ear, nose and throat (\u201cENT\u201d) medical technology leader dedicated to transforming patient care, today announced that the Centers for Medicare and Medicaid Services (CMS) published an average selling price (ASP) for the Company\u2019s SINUVA sinus implant, providing predictability, transparency, and confidenceof reimbursement for providers and payers going forward. In January 2021, CMS created separate and distinct codes for Intersect ENT\u2019s two bioabsorbable implant product lines PROPEL (S1091) and SINUVA (J7402). CMS has now attached an &hellip; Continue reading &quot;CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-03-08T12:03:17+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20210308005289r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication\",\"datePublished\":\"2021-03-08T12:03:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\\\/\"},\"wordCount\":1471,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20210308005289r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cms-consolidates-sinuva-sinus-implant-coverage-under-a-distinct-code-j7402-and-publishes-an-asp-clarifying-payment-and-easing-payer-coverage-adjudication\\\/\",\"name\":\"CMS Consolidates SINUVA Sinus Implant Coverage Under a Distinct Code, J7402, and Publishes an ASP Clarifying Payment and Easing Payer Coverage Adjudication - 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(Nasdaq: XENT), a global ear, nose and throat (\u201cENT\u201d) medical technology leader dedicated to transforming patient care, today announced that the Centers for Medicare and Medicaid Services (CMS) published an average selling price (ASP) for the Company\u2019s SINUVA sinus implant, providing predictability, transparency, and confidenceof reimbursement for providers and payers going forward. In January 2021, CMS created separate and distinct codes for Intersect ENT\u2019s two bioabsorbable implant product lines PROPEL (S1091) and SINUVA (J7402). 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