Reimbursement Guide 2017 - Intersect ENT

1 Reimbursement Guide 2017 For more info rmation, call 8 66-242-4638 or email Reimbursement @interse MPM 00030 Rev. M For more information, call 866-242-4638 or email: MPM 00030 Rev. M; Last updated: March 2017 SEE DISCLAIMER ON PAGE 2 1 | Page Table of Contents Section 1: Discl aimer .. 2 Section 2: Introduction Technology Overview .. 3 Section 3: Physician coding and Payment ICD-10-CM Diagnosis Codes .. 5 CPT Codes/Physician Services .. 5 Modifi ers .. 8 Section 4: Physician Office Billing .. 9 Section 5: Category III and Unlisted Procedure Code Billing .. 11 Section 6: Outpatient Surgery coding and Payment Hospital Outpatient Prospective Payment System (HOPPS) .. 13 Ambulatory Surgery Center (ASC) Payment Methodology .. 1 3 Section 7: Facility Reporting for Supplie s, Disposables and implants .. 17 Section 8: Hospital Inpatient coding and Payment Overview.

2 18 ICD-10-CM Diagnosis Codes .. 19 ICD-10-PCS Procedure Codes .. 19 Medicare Severity Diagnosis- Related Groups (MS-DRGs) .. 20 Other Payment Methodologies .. 21 Section 9: Place of Service and Revenue Codes .. 22 Section 10: Coverage Benefits Verification .. 24 Prior Authorization Process .. 24 Section 11: Denial s Overview .. 28 Recommendations .. 28 Section 12: Payor Contracting .. 30 Section 13: Bibliography .. 32 Section 14: Appendix / Resourc es .. 34 For more information, call 866-242-4638 or email: MPM 00030 Rev. M; Last updated: March 2017 SEE DISCLAIMER ON PAGE 2 2 | Page Section 1 Disclaimer The information in this guid e is provided for the benefit of Intersect ENT customers and offers general coverage, coding and payment information for procedures as sociated with the use of PROPEL, PROPEL Mini and PROPEL Contour sinus implants , hereinafter generally referred to as PROPEL sinus implants except where coding differentiation is required.

3 The information provided is intended to facilit ate appropri ate coverage and Reimbursement for providers in vari ous sites of serv ice. This Guide includes coding information for the PROPEL family of products (PROPEL, PROPEL Mini, and PROPEL Contour sinus implants ) for informational purposes only. PROPEL and PROPEL Mini sinus implants are approved by the FDA for use in the ethmoid sinuses following sinus surgery. PROPEL Mini sinus implants are approved by the FDA for use in the frontal sinuses following sinus surgery. PROPEL Contour sinus implants are approved by the FDA for use in the frontal and maxillary sinuses following sinus surgery. Codes that apply to procedures performed in other sinuses or nasal anatomy are not applicable to PROPEL, PROPEL Mini and PROPEL Contour sinus implants . Such codes are presented for informational purposes only because sinus surgery procedures often involve concurrent procedures on other nasal and sinus anatomy.

4 Users of this Guide should understand that this is general information, not legal guidance and is not advice about how to code, complete, or submit any particular cl aim for payment. Information provided is not intended to incr ease or maximize Reimbursement by any payor. The information provided represents Intersect ENT s understanding of current Reimbursement policies. The suggested codes are to be used only to faci litate appropri ate coding and should not be construed as recommended guidelines in the establishment of poli cy or prac tice. Any descriptions of services contained in this Guide are for the purpose of illustrating typical clinical services and not intended to represent practice guidelines or standards of care. Intersect ENT makes no representations or warranties with respect to the contents of this Guide and disclaims any implied guarantee or warr anty of fitness for any partic ular purpose. Intersect ENT will not be li able to any individual or entity for any losses or damages that may be in curr ed by the use of this Guide .

5 Furthermore, Intersect ENT specifical ly discl ai ms any liability or responsibility for the results or consequences of any actions taken in reliance on the statements, opinions, or suggestions in this Guide . It is always the provider s responsibility to determine coverage and submit appropri ate codes and charg es for services re ndered. Providers should check and veri fy curr ent polici es and requirements with the payor for any particular patient. It is important to verify coverage for each patient as policies and guidelines can vary by payor and plan. The key in all coding and bill ing to payors is to be truthful and not misleading and make full disclosures to the payor about how the product has been used and the procedures necessary to implant the product when seeking Reimbursement for any product or procedure. Information in this Guide was last reviewed on March 31, 2017 . For more information, call 866-242-4638 or email: MPM 00030 Rev.

6 M; Last updated: March 2017 SEE DISCLAIMER ON PAGE 2 3 | Page Section 2 Technology Overview The PROPEL sinus implant is a first of its kind product that provides controlled localized delivery of steroids directly to the sinus cavity. Currently, there is no other technology that provides localized steroid delivery, sustained over 30 days, to the sinuses while also providing mechanical support without obstructing the cavity. The PROPEL Mini sinus implant is a smaller version designed for smaller sinus anatomy and the frontal sinus recess. The PROPEL Contour sinus implant is an hourglass-shaped implant designed to conform to the sinus ostium (opening). Safety and efficacy of the PROPEL mometasone furoate sinus implants have been studied in five rigorous prospective clinical trials conducted in the United States enrolling a total of 365 patients: The CONSENSUS II randomized, controlled double-blind pilot study The ADVANCE single cohort safety study The ADVANCE II randomized, controlled double-blind clinical trial The PROGRESS Study: Mini cohort randomized, controlled blinded clinical study The PROGRESS Study: Contour cohort randomized, controlled blinded clinical study The PROPEL sinus implant clinical studies assessed the safety and efficacy of PROPEL sinus implants in chronic rhinosinusitis (CRS) patients post functional endoscopic sinus surgery (FESS).

7 A meta-analysis of data from CONSENSUS II and ADVANCE II provides the first Level 1-A evidence demonstrating clinically and statistically significant benefits of localized steroid delivery in the post-FESS period, including:1 35% reduction in post-FESS medical/surgical therapies, including adhesion lysis and oral steroid therapy (p= ) 40% reduction in need for oral steroids (p= ) 46% reduction in frank polyposis (p < ) 75% reduction in middle turbinate lateralization (p = ) 1 Han JK, Marple BF, Smith TL et al. Effect of Steroid-Releasing Sinus implants on Post-Operative Medical and Surgical Interventions. Int Forum Allergy Rhinol. 2012; 2:271 279. For more information, call 866-242-4638 or email: MPM 00030 Rev. M; Last updated: March 2017 SEE DISCLAIMER ON PAGE 2 4 | Page The PROGRESS study: Mini cohort evaluated the use of PROPEL Mini sinus implants when placed in the frontal sinus opening following sinus surgery.

8 This randomized controlled blinded study demonstrated statistically significant improvement in outcomes when added to standard postoperative care when compared to surgery with standard postoperative care alone. These outcomes include:2 38% reduction in need for post-operative medical or surgical intervention (p= ) 54% reduction in frontal sinus restenosis/occlusion (p= ) 56% reduction in the need for oral steroids (p= ) 75% reduction in need post-operative surgical intervention (p= ) The PROGRESS study: Contour cohort evaluated the use of PROPEL Contour sinus implants when placed in the frontal sinus ostium following sinus surgery. This randomized controlled blinded study demonstrated statistically significant improvement in outcomes when added to standard postoperative care when compared to surgery with standard postoperative care alone. These outcomes include:3 65% reduction in need for post-operative medical or surgical intervention (p= ) 63% reduction in frontal sinus restenosis/occlusion (p=< ) 73% reduction in need post-operative surgical intervention (p= ) The safety of PROPEL sinus implants has been well-documented in these studies.

9 There have been no clinically significant changes from baseline in intraocular pressure or lens opacities and no evidence of systemic steroid absorption or adrenal-pituitary axis suppression. Reducing scarring and inflammation is essential to improve long-term outcomes and reduce the need for revision ,5 Therefore, the value of PROPEL sinus implants in reducing postoperative complications translates to long-term clinical value for patients and payors. The PROPEL sinus implants are intended for use after sinus surgery to maintain patency and to locally deliver steroid to the sinus mucosa: PROPEL for use in the ethmoid sinus, PROPEL Mini for use in the ethmoid sinus and frontal sinus opening, and PROPEL Contour for use in the frontal and maxillary sinus ostia. The implants are intended for use in patients 18 years of age. Contraindications include patients with intolerance to mometasone furoate (MF) or a hypersensitivity to bioabsorbable polymers.

10 Safety and effectiveness of the implants in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For complete prescribing information see IFU at Rx only. Caution: Federal law (USA) restricts this product to sale by or on the order of a physician. 2 Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016; 126:2659-2664. 3 Data on file. N=80 in ITT population, with N=61 evaluable patients where both sinuses available for composite endpoint. Primary endpoint results judged by independent reviewer. Secondary efficacy results were judged by Clinical Investigators (Implanting Physician) and adjusted for Holm s step-down method to control for familywise type 1 error.