7/28/2017. Disclaimer. AOA Practice Builder Session: Coding & Coverage of Drug eluting Sinus Implants. Introduction and Agenda

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1 AOA Practice Builder Session: Coding & Coverage of Drug eluting Sinus Implants Betsy Gross, RN, BSN, CPC, CENTC Vice President, Health Economics & Reimbursement DELIVERING INNOVATION. Intersect ENT WHERE IT S NEEDED. Disclaimer The information provided in this presentation is not legal advice nor is it advice about how to code, complete, or submit any particular claim for payment. The information is gathered from various sources and represents Intersect ENT s understanding of coding, coverage and reimbursement policies. It is the health care provider s responsibility to determine appropriate codes, charges, and modifiers, and submit bills for the services consistent with payor s requirements. Third party payors may have different policies and coding requirements. Such policies can change over time. Intersect ENT disclaims any responsibility for claims submitted by health care providers associated with the use of PROPEL products. The key in all coding and billing 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. 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. Safety and effectiveness of the implants in pregnant or nursing females have not been studies. 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. Introduction and Agenda DELIVERING INNOVATION. WHERE IT S NEEDED. 1

2 Review the burden of illness of Chronic Rhinosinusitis Describe the clinical and health economic benefits of steroid eluting sinus implants during the postoperative period following sinus surgery Examine the coding, coverage and payment associated with the use of drug eluting sinus implants Clinical Definition of Chronic Rhinosinusitis (CRS) Chronic inflammation of the sinus lining leading to: Blockage of the natural drainage passageways Chronic infections Nasal obstruction Lasts for more than 12 weeks Healthy Open Sinuses Diseased Inflamed Sinuses Classifications: CRSwNP (with nasal polyps) CRSsNP (without nasal polyps) Manes RP, Batra PS. Etiology, diagnosis and management of chronic rhinosinusitis. Expert Rev. Anti Infect. Ther. 11(1), (2013). Etiologies Driving Chronic Inflammatory Disease The inflammatory process is tightly regulated, involving mediators that initiate and maintain inflammation and mediators that shut the process down. In states of chronic inflammation, an imbalance between the two mediators leaves inflammation unchecked, resulting in cellular damage. 1 Manifestations of Common Chronic Inflammatory Conditions Rheumatoid Arthritis Psoriasis Crohn s Disease Chronic Rhinosinusitis 1 Choy, et al; New England Journal Med 2001; Vol.344; March 22,

3 The Clinical Burden of CRS is Profound CRS has a profound impact on QOL and productivity. The indirect impact on overall QOL rivals other well recognized conditions with significant clinical and health economic burden to society. SF 6D Utility Scores by Health State Death 0 HIV 0.52 Pre liver transplant 0.61 Pre hip replacement 0.61 ESRD with HD 0.64 Asthma (moderate) 0.64 Chronic Rhinosinusitis 0.65 CAD requiring PCI 0.67 Parkinsons Disease (Year 1) 0.67 Obesity 0.71 COPD (moderate) 0.73 Hearing Loss 0.77 US Norms 0.81 Perfect Health Refractory CRS Severe Asthma Chronic Migraine 1 Annual US Productivity Costs by Disease Heart Disease Diabetes $7,261 $5,755 $5,266 $3,920 $10,077 DeConde AS, Soler ZM. Chronic rhinosinusitis: Epidemiology and burden of disease. Am J Rhinol Allergy 30, , 2016; doi: /ajra as is the Health Economic Burden of CRS More prevalent than arthritis and hypertension. 1 One of top 10 most costly conditions for employers. 3,4 1 in 7 2 adults >$7B Annual spend in US 25 Mean work days lost per year 11 % Of all outpatient visits associated with antibiotic prescription 39 days lost to presenteeism and 21 household days lost related to daily sinus care requirements. 5 Most common reason for an adult antibiotic prescription. 6 1 National Health Interview Survey, DeConde AS, et.al. Chronic rhinosinusitis: epidemiology and burden of disease. AM J Rhinol Allergy Mar Apr;30(2): doi: /ajra Gross CW, Schlosser RJ. Prevalence and economic impact of rhinosinusitis. Curr Opin Otolaryngol Head Neck Surg. 2001;9 (1):8 10. ($5B in 2001, inflation adjusted to 2014). 4 Goetzel RZ, et.al. The health and productivity cost burden of the top 10 physical and mental health conditions affecting six large U.S. employers in Journal Occupational Environmental Medicine 2003: 45: Rudmik, et al, Productivity Costs in Patients with Refractory Chronic Rhinosinusitis. Laryngoscope, March Shintani Smith S, et. al. National burden of antibiotic use for adult rhinosinusitis. Journal of Allergy Clin Immunology. November The Journey of a CRS Patient At some point, most patients with CRS will undergo sinus surgery at least once. Surgical treatment is not considered curative for CRS. Evidence indicates that if persistent inflammation is adequately treated following surgery, the chance of revision surgical intervention is essentially eliminated over a nearly 8 year period. 1 The condition is considered chronic if symptoms last for more than 12 weeks. Underlying Inflammatory Etiology Post Surgical Healing Cascade 1 Senior BA,, Kennedy, DW, Tanabodee J, et al. Long term results of functional endoscopic sinus surgery. Laryngoscope 1998; 108:

4 Common Complications & Interventions Following ESS The most common reasons for surgical failure include scarring of the sinus ostia, adhesion formation, and middle turbinate lateralization. 1 Other common causes of failure that should be considered include poor post operative care and patient non compliance. 2 Adhesion Lysis Polypectomy Sinus Balloon Dilation Revision Surgery Setting Cost Office ASC $912 1 ($613 $1,099) Office ASC $501 1 ($344 $601) Office ASC ASC HOPD $2,800 $3,200 2 $6,563 1 ($5,672 $11,136) 1 Otto KJ, DelGaudio JM. Operative findings in the frontal recess at time of revision surgery. American Journal of Otolaryngology 2010;31(3): Goldstein GH and Kennedy DK. Long term Success of Various Sinus Surgeries: A Comprehensive Analysis. Curr Allergy Asthma Rep. April 2013, Volume 13, Issue 2, pp Rizzo J, Rudmik L, Mallow P, Palli S. Budget impact analysis of bioabsorbable drug eluting sinus implants following endoscopic sinus surgery. Journal of Medical Economics, DOI: / Medicare National Average Facility and Non facility Payment for CPT (Frontal sinus dilation) Post Operative Standard of Care Recommendations Practice guidelines recommend patient tailored clinical strategies of multiple approaches to maintain sinus patency, reduce mucosal inflammation, and reduce infection. 1 Debridement Can prevent potential synechiae and sinus ostial stenosis, Schedule and frequency are based on physician discretion. Antibiotics Recommended as needed based on patient symptoms consistent with potential infection. Nasal Saline Irrigation Benefit is most evident during the early post op period, not long term, but highly dependent on patient compliance. 3,4 Topical Steroids Topical nasal steroid spray may be initiated between the first 2 and 6 weeks following ESS to reduce mucosal inflammation. 1,2 1 Rudmik L and Smith T. Evidence Based Practice: Postoperative Care in Endoscopic Sinus Surgery. Otolaryngol Clin N Am 45 (2012) Rudmik L, et al. Early postoperative care following endoscopic sinus surgery: an evidence based review with recommendations. Int Forum Allergy Rhinol, 2011; 1: Freeman SR, et al. A preliminary randomized controlled trial evaluating the efficacy of saline douching following endoscopic sinus surgery. Clin Otolaryngol. 2008;33: Liang KL, Su MC, Tseng HC, et al. Impact of pulsatile nasal irrigation on the prognosis of functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg. 2008;37: Limitations of Topical Steroids Post operatively, persistent inflammation of the frontal recess can lead to scarring and long term stenosis with clinical sequelae. 1 Only 2% of the active drug in topical nasal sprays actually reaches the sinus cavity due to post operative inflammation. 2 MRI slices of a healthy subject 5, 20, and 60 minutes after administration of radiolabeled Mometasone Furoate. ~60% of the active drug in a metered dose nasal steroid spray is removed by mucociliary clearance within 15 minutes. 3 1 Möller W, et al. Topical Drug Delivery in Chronic Rhinosinusitis Patients before and after Sinus Surgery Using Pulsating Aerosols. PLoS ONE 8(9); Sean Bury and Ameet Singh (2017) Evaluation of a Steroid Releasing Sinus Implant for the Treatment of Patients Undergoing Frontal Sinus Surgery for Chronic Rhinosinusitis, Expert Review of Medical Devices, DOI: / Shah SA et al. Deposition of mometasone furoate nasal spray suspension in humans. Allergy Asthma Proc 36:48 57,

5 Poor Compliance with Oral Medication Reduces Therapeutic Effect Typical adherence rates for prescribed medications are about 50%. 1 In the primary care setting, a prospective cohort of 15,961 patients in a primary care network was identified. The overall rate of non adherence was 31.3%. The incidence of not filling prescriptions for treatment of rhinitis was nearly 40%. 2 When primary adherence was assessed by pharmacologic class, rates were as follows: Hormones/Synthetics 36.3% Cardiovascular Drugs 34.7% Ear/Nose/Throat Preparations 34.2% 1 Brown MT and Bussell JK. Medication Adherence: WHO Cares? Mayo Foundation for Medical Education and Research, Tamblyn R, Eguale T, Huang A et al. The Incidence and Determinants of Primary Nonadherence with Prescribed Medication and Primary Care, Ann Int. Med. 2014: 160, Patients whose cavities become normal on endoscopic inspection after surgery are much less likely to require revision surgery. 1 1 Kennedy DW, Wright ED, Goldberg AN. Objective and subjective outcomes in surgery for chronic sinusitis. Laryngoscope Mar;110 sinus surgery. Laryngoscope 1998; 108: MPM Rev. A The Solution: Drug eluting Sinus Implants DELIVERING INNOVATION. WHERE IT S NEEDED. 5

6 PROPEL (Mometasone Furoate Sinus Implant) FDA Approval Type FDA Approval Path FDA Approval Date Bioabsorbable Device PMA Ethmoid Sinus 2011 Frontal Sinus (PROPEL Mini) 2016 Frontal and Maxillary Sinuses (PROPEL Contour) 2017 Yes, days FDA INDICATION: 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. Drug Component Mometasone furoate, 370 µg 1 Parikh A, et al. Drug Eluting Nasal Implants: Formulation, Characterization, Clinical Applications and Challenges. Pharmaceutics 2014, 6, Technology Differentiation; Predictable Local Drug Delivery The steroid chosen in the development process for the PROPEL sinus implant was deliberate based on characteristics to ensure optimal local drug delivery. PROPEL reliably delivers a slow and predictable dose of mometasone furoate directly to sinus mucosa. 4 Note: Receptor binding affinity is a measure of the tendency of the drug to bind to the glucocorticoid receptor. The higher the number, the more likely the drug will be bound. Relative receptor binding affinity is measured relative to Dexamethasone, which is set to a value of Lemke L. Foye s Principles of Medicinal Chemistry Winkler J et al. Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aquous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open label, single dose three period crossover study in healthv volunteers. Clinical Therapeutics, Volume 31, Issue 12. pp December Sastre J. Local and systemic safety of intranasal corticosteroids. J Investig Allergol Clin Immunol. 2012; 22(1): Parikh A, et al. Drug Eluting Nasal Implants: Formulation, Characterization, Clinical Applications and Challenges. Pharmaceutics 2014, 6, MPM Rev. A PROPEL Sinus Implant: 3 Clinical Trials, 386 Subjects Pilot Study 1 n=38, 4 sites Randomized Controlled Double Blind Intra patient Control ADVANCE Study 2 n=50, 7 sites Non Randomized Single Arm Safety / Symptoms to 6 months ADVANCE II Pivotal Trial 3 n=105, 11 sites Randomized Controlled Double Blind Intra patient Control Meta Analysis 4 n=143 Level 1 A Evidence 1 Murr AH, Smith TL, Hwang PH, et al. Int Forum Allergy Rhinol. 2011;1: Forwith KD, Chandra RK, Yun PT, Miller SK, Jampel HD. Laryngoscope. 2011;121: Marple BF, Smith TL, Han JK et al. Otolaryngol Head Neck Surg. 2012; 146(6) Han JK, Marple BF, Smith TL et al. Int Forum Allergy Rhinol. 2012; 2:

7 PROPEL Ethmoid Sinus Meta analysis Data ETHMOID SINUS A combined level 1 A meta analysis of efficacy results from the two randomized controlled studies of PROPEL sinus implants (Pilot and ADVANCE II) demonstrated statistically significant improvements in clinically meaningful endpoints. META ANALYSIS 143 combined patients (280 sinuses) from 2 RCTs at 15 US sites POSTOPERATIVE INTERVENTION NEED FOR ORAL STEROIDS INFLAMMATION (POLYPOSIS) SCARRING (ADHESIONS) MIDDLE TURBINATE LATERALIZATION 35% 40% 46% 70% p= p= p< p= % p= Han JK, et. al., Meta Analysis: Effect of Steroid Releasing Sinus Implants on Post Operative Medical and Surgical Interventions. Intl Forum Allergy & Rhinology; May Clinical Program Overview Frontal Sinus Two RCTs using an intra patient control design were conducted to evaluate whether the ADDITION of local steroid delivery provided a superior benefit to traditional postoperative care alone in the frontal sinus. EXCEED PROGRESS Mini PROGRESS Contour Non Randomized Open Label (PROPEL Contour; frontal and maxillary sinuses) Randomized Double Blind Intra patient Control (PROPEL Mini plus SOC vs. SOC alone) Randomized Double Blind Intra patient Control (PROPEL Contour plus SOC vs. SOC alone) Follow up: n = 15 2 sites 3 months n = sites 3 months n = sites 3 months PROGRESS Contour and EXCEED study data on file. All numbers indicate relative reduction 30 days following treatment. PROGRESS Frontal Sinus Study Data FRONTAL SINUS An RCT confirms the use of PROPEL Mini sinus implant in the frontal sinus provides improved outcomes over surgery alone. 1 FDA approval was expanded to the frontal sinus in March PROGRESS STUDY 160 Patient (320 sinuses) Prospective, Randomized, Blinded, Multi Center Trial POST OPERATIVE INTERVENTION OCCLUSION/ RESTENOSIS NEED FOR ORAL STEROIDS SURGICAL RE INTERVENTION 38% 54% 56% 75% p= p= p= p= 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 All numbers indicate relative reduction 30 days following treatment. *Judged by clinical investigators. The p values for the secondary endpoints were not adjusted for multiplicity. 7

8 QOL Scores Significantly Better at Six Months An independent clinical study of 136 patients demonstrated improvement in patientreported QOL and endoscopic appearance six months after placement of a steroideluting implant following ESS, irrespective of the presence of polyposis or eosinophilia SNOT 22 scores before and after endoscopic sinus surgery Serum Serum Tissue Tissue Polyps Present Polyps Absent Lund Mackay Lund Mackay Eosinophilia Eosinophilia Eosinophilia Eosinophilia Score > 6 Score < 6 Present Absent Present Absent Pre Op 3 Month Post Op 6 Month Post Op 1 Pou JD, Riley CA, Tipirneni KE, Bareiss AK, McCoul ED. Eosinophilia and Quality of Life in Patients Receiving a Bioabsorbable Steroid Eluting Implant during Endoscopic Sinus Surgery. Sinusitis. 2017, 2, 3; doi: /sinusitis Drug eluting Sinus Implants: Coding, Coverage & Payment DELIVERING INNOVATION. WHERE IT S NEEDED. General Concepts Coding Codes exist to report the work of placement of a drugeluting sinus implant whether performed during of immediately following ESS or performed as a stand alone procedure. Regardless of procedure codes reported, a HCPCS code for drug eluting sinus implant should also be listed separately. Coverage Payors commonly create investigational policies for new technology which can create barriers to access. Negative coverage does not impact access under all contractual arrangements (e.g. PMPM, ACO, bundled payment). Payment Whether PROPEL sinus implants are paid separately is dependent on the site of service and the provider s (facility and physician) contractual arrangement. 8

9 Site of Service & Associated Coding O.R. ASC or HOPD OFFICE IMMEDIATELY IMMEDIATELY EARLY INTERVENTION FOLLOWING SINUS FOLLOWING SINUS STAGED DELAYED IN OFFICE DURING SURGERY PROCEDURE SURGERY PROCEDURE PLACEMENT IN OFFICE POST OP VISIT IN O.R. IN OFFICE SETTING Coding/Reporting Procedure 31254, 31255, 31256, 31267, Product S1090/C2625 The work associated with drug eluting implant placement is integral to the sinus surgery procedure performed. Coding/Reporting Coding/Reporting Coding/Reporting Procedure 31237, 31254, Procedure 31231, 31237, Procedure 30560, 31237, 31295, T, 0407T 0406T, 0407T Product S1090/J3490 Product S1090/J3490 Product S1090/J T Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant; 0407T Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant; with polypectomy, biopsy or debridement These codes cannot be reported in addition to an ethmoid surgery procedure. Use of Category III Codes & HCPCS Codes for Drugeluting Sinus Implants 0406T and 0407T describe the use of drug eluting sinus implants, specifically when the implants are placed in a separate encounter, not at the time of endoscopic sinus surgery. When using the Category III CPT codes (or the endoscopic sinus surgery codes during which the implant is placed concurrently), you must report a HCPCS code for the implant itself. Source: The Coding Institute. Otolaryngology Coding Alert. September 2015, Vol. 17, No. 9 (Pages 65 72) Disclaimer: Example Only. Please consult payor for specific coding guidelines. Reimbursement Overview Coding & Payment O.R. ASC or HOPD OFFICE PHYSICIAN PAYMENT The work associated with implant placement is integral to the sinus surgery procedure performed. There is NO separate payment to physicians for implant placement, therefore no overuse potential. Placement of a drug eluting sinus implant is NOT separately reportable when performed following an endoscopic sinus procedure in the office. The Category III codes can only be reported when implant placement is the only procedure performed in the ethmoid sinus during the encounter, and cannot be reported for frontal or maxillary placement. IMPLANT PAYMENT Separate payment for PROPEL sinus implants is dependent upon facility CONTRACT DESIGN. For most facilities, the implant is not paid separately. When covered, payors establish a physician fee schedule rate for drug eluting sinus implants tied to HCPCS S1090 and pay similar to other physician administered drugs and drug implants (i.e. typically ASP plus 6%). This minimizes potential for inappropriate use. 9

10 CPT Codes Modifiers What do I use and when do I use it? Payor Preference HCPCS Codes Case Studies Bilateral Ethmoid Debridement CPT Description Nasal/sinus endoscopy, surgical; with biopsy, polypectomy or debridement (separate procedure) Disclaimer: Example Only. Please consult payor for specific coding guidelines. 10

11 Bilateral Ethmoid Debridement with Bilateral Placement of Drug eluting Sinus Implants in the Ethmoid Sinuses CPT Description 0407T 0407T 0407T Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant; with polypectomy, biopsy or debridement S1090 S1090 HCPCS Description S1090 Mometasone furoate sinus implant, 370 micrograms Disclaimer: Example Only. Please consult payor for specific coding guidelines. Bilateral Frontal Balloon Dilation with Bilateral Insertion of Drug eluting Sinus Implants in the Frontal Sinuses S S1090 CPT Description Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (e.g. balloon dilation) HCPCS S1090 Description Mometasone furoate sinus implant, 370 micrograms CPT codes 0406T/0407T are NOT used in this scenario. Those codes apply to standalone placement of drug eluting sinus implants in the ethmoid sinuses only Disclaimer: Example Only. Please consult payor for specific coding guidelines. The Path to Payor Acceptance of New Technology Even the most intuitive medical innovation is not always readily accepted by payors due to up-front costs, uncertain return-on-investment, or potential over-utilization. What Patients & Providers See What Payors See Improved clinical outcomes Reduced complications Reduced length of stay Reduced pain Reduced absenteeism Increased cost Increased number of patients Potential for abuse/overuse Lack of ROI 11

12 Payor Education Opportunities There are several key messages related to use of drug eluting sinus implants which resonate with payors and are unique from other technologies: Reducing complications benefits the payor. Not needed in all my patients, but of great value in patients at high risk for complications. FDA approval is to reduce adhesions and inflammation, not treat disease No direct economic benefit to me or my practice Alternative is to take patient to the O.R. for a surgical intervention. MPM REV A CONFIDENTIAL. INTERNAL USE ONLY. DO NOT COPY OR DISTRIBUTE. Factors Driving Payor Coverage of New Technology Not only do payors need to evaluate the clinical evidence to support new technology, they need to hear from physicians who want to use it. Peer reviewed publications of welldesigned clinical trials Compelling unmet clinical need Cost effectiveness and affordability data Local physician outreach Claims burden Specialty society support Cost Savings for Payors Results from an ICER based cost effectiveness study reveal placement of a steroid eluting sinus implant following ESS for refractory CRS is a cost effective intervention for preventing a postoperative intervention after surgery. 1 A budget impact analysis indicates the upfront cost of PROPEL sinus implant is offset by savings associated with reduced probability for post ESS intervention. The budget impact to a payor is therefore negligible. 2 Intervention needed during 6 months post ESS PROPEL sinus implant Other Products Revision Surgery 2.2% 4.7% Lysis of Adhesions 15.4% 39.8% Severe Polyp Recurrence 7.1% 23.5% 1 Rudmik L and Smith TL. Economic Evaluation of a Steroid Eluting Sinus Implant following Endoscopic Sinus Surgery for Chronic Rhinosinusitis. Otolaryngol Head Neck Surg May 5;151(2): Rizzo J, Rudmik L, Mallow P, Palli S. Budget impact analysis of bioabsorbable drug eluting sinus implants following endoscopic sinus surgery. Journal of Medical Economics, DOI: /

13 Cost Savings with Care Migration The absence of additional payment for new technology commonly used in sinus surgery often drives more cases to the HOPD setting, where higher payment rates create more viability. $10,731 The cost is less, EVEN if an additional payment for new technology such as PROPEL is provided. Potential Savings: $1,600 $3,128 $6,003 $6,003 HOPD ASC ASC *2016 National Medicare Payment based on a six sinus surgery encounter.; includes facility payment only. Payors Benefit from Reducing Complications following ESS Coverage by various managed care organizations that benefit from reductions in overall cost of care. Favorable coverage posted by independent BCBS plans covering ~23 Million lives in: 41 hospitals 11.3 million members TX IL NM OK MT HI MD DC VA NC SC Drug eluting sinus implants are considered a covered benefit. Separate payment varies by place of service. Summary For use of drug eluting sinus implants in the OR setting, like other technology, the product cost is typically accommodated in the facility payment. For clinically appropriate use of drug eluting sinus implants in the office setting, CPT and HCPCS codes are in place. Coverage and payment are possible if providers are willing to advocate to payors based on medical necessity and the documented clinical and health economic benefits. Payor coverage/payment resistance is a normal part of the medical technology evolution process. Payor adoption is dependent upon persistent provider demand. 13

14 Thank You! Q&A DELIVERING INNOVATION. WHERE IT S NEEDED. 14