for RPDs made with Ultaire AKP (Aryl Ketone Polymer) Make METAL-FREE Possible with Ultaire AKP Solvay Dental 360 Ultaire AKP Reimbursement Guide 1

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1 REIMBURSEMENT Dentivera Milling GUIDE Discs for RPDs made with Ultaire AKP (Aryl Ketone Polymer) Make METAL-FREE Possible with Ultaire AKP Solvay Dental 360 Ultaire AKP Reimbursement Guide 1

2 Introduction This guide was developed to help with the reimbursement submission process for removable partial dentures (RPDs) manufactured from Ultaire AKP (aryl ketone polymer). Because Ultaire AKP is so distinctly different from cast metal, conventional acrylic resins and other flexible resins for RPDs, the existing reimbursement codes for RPDs are not applicable. Using the Generic CDT code is recommended until a new code is obtained. This guide provides you with details on how to code and bill for the new material, intending to augment your current awareness of coding, coverage, and reimbursement for RPDs. Solvay Dental 360 is committed to not only supporting your efforts to provide patients with a premium alternative to metal and flexible partials but also help your practice navigate through the reimbursement process. Our goal is to equip you with what you ll need to enable dental reimbursement committees to make evidence-based decisions when selecting preferred treatment options for your patients. The Reimbursement Process It s critical to demonstrate why RPDs manufactured from Ultaire AKP do not fit within existing CDT codes. Evidence to help substantiate the clinical and material property advantages of Ultaire AKP can be found on subsequent pages. How to File a Dental Claim Form for an RPD Manufactured from Ultaire AKP 1. Complete an ADA Dental Claim Form for the patient receiving a removable partial denture made from Ultaire AKP. 2. In the procedure submission section of the form, use CDT Code D5899 for the designation of the prosthesis. 3. Attach a copy of pages 3-13 from this Reimbursement Guide when submitting the Form, which outlines why the other codes do not apply for RPDs manufactured with Ultaire AKP. Claim Outcome Approval or denial for each claim submitted is at the discretion of the indvidual payer. If a claim is initially denied, follow the typical appeal process for that payer and reinforce why the existing codes do not apply to Ultaire AKP. For further questions regarding reimbursement, please contact Solvay Dental 360 Customer Service at (844) Solvay Dental 360 Ultaire AKP Reimbursement Guide 2

3 Ultaire AKP Generic Name: Brand Name: High-Performance Polymer, Denture Resin Milling Blank Dentivera Milling Disc Manufacturer: Solvay Dental 360 (A Division of Solvay Specialty Polymers, USA, LLC) Reason for Review: Provide payers with scientific, clinically-relevant information regarding Ultaire AKP (aryl ketone polymer), a high-performance polymer option prescribed for removable partial dentures. Table of Contents Product...4 Ultaire AKP (Aryl Ketone Polymer)...4 Comparison of RPD Materials Economic Value...8 Clinical Data...9 Market Research...9 Clinical Trial...10 Scientific/Clinical Testing...10 Summary...11 Coding...12 Coverage...12 Current CDT Codes Do Not Apply to Ultaire AKP...12 A New CDT Code is Required...13 Recommendation...13 Solvay Dental 360 Ultaire AKP Reimbursement Guide 3

4 PRODUCT Ultaire AKP (Aryl Ketone Polymer) High-performance polymer materials provide many beneficial properties not currently satisfied by traditional cast metal, flexible and resin based materials in the denture space of the dental market. Solvay Dental 360 developed a new high-performance polymer specifically for use in RPDs. This aryl ketone polymer, called Ultaire AKP, is sold to dental labs in a disc form called the Dentivera Milling Disc. It produces an RPD that is bone-like in its rigidity and flexibility and will not wear on the abutment teeth as metal partials do. The elastic modulus of the Ultaire AKP material is closer to that of cortical bone than metal options. Flexible ~ GPa Aryl Ketone 3.5 GPa Cortical Bone GPa Elastic Modulus An object s resistance to being deformed when stress is applied CoCr (cobalt-chrome/metal) ~220 GPa GPa The Ultaire AKP RPD will have a long lifetime 1 (over ten years with normal insertion and removal). It is designed to be supportive yet lightweight, delivering a comfortable, natural-looking partial which may improve overall patient compliance. Due to the fully biocompatible nature of this material, Ultaire AKP is non-allergenic which is not the case with conventional flexible, acrylic resin based or metal partials. Ultaire AKP is monomer, BPA and nickel-free, as well as non-irritant, non-pyrogenic, non-mutagenic, and non-cytotoxic. Comparison of RPD Materials Ultaire AKP bridges the gap between metal RPDs and those made with polymers that merely meet minimum requirements. Typical Properties ASTM Test Methods Units Cobalt-Chrome (CoCr) D5213, D5214, D5282, D5283 Acrylics/Resin (PMMA), (Flexible/Acetal) D5211, D5212, D5225, D5226 Ultaire AKP (Aryl Ketone Polymer) CODE TBD Tensile Strength MPa Elastic Modulus (Cortical Bone GPa) GPa PMMA Acetal Flexural Strength MPa ~2600 PMMA Acetal Charpy Impact, notched kj/m 2 N/A PMMA 1.1 Acetal Specific Gravity g/cm PMMA ~1.17 Acetal Specific Strength MPa / g/cm Solvay Dental 360 Ultaire AKP Reimbursement Guide 4

5 RPDs need the right combination of flexural strength and tensile strength. Flexural Strength: (MPa) At what point does the material yield or break? The flexural strength needs to be high enough to withstand loading and not break and to avoid permanent deformation during mastication. RPDs made with Ultaire AKP are designed to have the most effective flexural strength Flexural Strength Too Stiff Flexural Modulus (MPa) Too Flexible 0.00 Valplast Duracetal Ultaire AKP Juvora Bredent Pekkton Trinia BioHPP Ivory Trinia Pink Tensile Strength: (GPa) How resistant is the material to breaking under tension or deformation? An RPD needs an appropriate tensile strength to ensure that stresses encountered during normal biting forces and insertion/removal of the prosthesis do not cause permanent RPD deformation. The tensile strength cannot be so high (or stiff) that it becomes difficult to insert or remove the denture Tensile Strength Too Stiff Elastic Modulus (GPa) Too Flexible 0.00 Valplast Duracetal Ultaire AKP Juvora Bredent Pekkton Trinia BioHPP Ivory Trinia Pink Note: Too Flexible and Too Stiff are not clinical claims based on evidence. Solvay Dental 360 Ultaire AKP Reimbursement Guide 5

6 Detailed Comparison of RPD Materials This table compares the properties of the different materials used to fabricate RPDs along with the impact to the patient or clinician. Non-Favorable Caution Favorable Trait Why is it important? Metal CoCr D5213, D5214 D5282, D4283 Acrylics/Resin (PMMA), (Flexible/Acetal) D5211, D5212, D5225, D5226 Ultaire AKP (Aryl Ketone Polymer) CODE TBD Aesthetics Patients care about appearance Visible metal clasps, conduct heat/cold, oral galvanism Can be tooth/gingival colored or translucent, lightweight Can be tooth/gingival colored and is lightweight UNFAVORABLE EXCELLENT EXCELLENT Stain Resistance Patients don t want their RPD to stain Does not stain E from pre- to post-soak after 30 d Curry: 27.7 Wine: 2.2 E from pre- to post-soak after 30 d Curry: 7.9 Wine: 0.5 EXCELLENT LOW VERY HIGH Water Sorption and Solubility Per ISO 20795: Min water sorption requirement is < 32 µg/mm; Solubility is < 1.6 µg/mm Any swelling or leaching influencing flexural strength, fatigue, and color Solubility: None LOW Sorption: 21 µg/mm 3 Solubility: µg/mm 3 HIGH Sorption: 8 µg/mm 3 Solubility: 0 µg/mm 3 LOW Flexural Strength (MPa) Elastic Modulus (GPa) Able to withstand loading and avoid permanent deformation during mastication Ease of denture insertion and removal ~2500 MPa TOO HIGH GPa TOO HIGH Reported acrylics ~77 to >100 MPa GPa HIGH - VERY HIGH HIGH 148 MPa 3.5 GPa VERY HIGH HIGH Impact Strength Withstand impact without fracturing N/A 0.44±0.15 kn Charpy impact dry and conditioned in water at 37 ºC for 7 days Charpy impact dry and conditioned in water at 37 ºC for 7 days As molded: 1.1 kj/m 2 Post-conditioning: 1.5 kj/m 2 As molded: 9 kj/m 2 Post-conditioning: 10.2 kj/m 2 (ASSUMED) HIGH LOW HIGH Repair Chairside capability for dentists Soldering is typically required and repairs often increase risk of corrosion leading to reactions in the soft tissue Easy to adjust, polish, and handle is relineable/repairable at chairside Easy to polish using same procedures as for acrylics; relineable repairs can be challenging; Solvay Dental 360 has a recommended approach DIFFICULT EASY MODERATE Resistance to Cleaners Maintenance of surface quality and color stability of dentures (durability) 45ºC no significant changes before and after cleanser Roughness: (Ra, µm) Polident: (3 min): % NaOCl (10 min): 0.07 Some dark tarnishing 7 days at 50 ºC for 15 min/day Roughness: (Ra, µm) Polident: 0.56 Efferdent: % NaOCl: 0.93 (+54%) Noticeable color difference ( E < 2) 7 days at 50 ºC for 15 min/day Roughness: (Ra, µm) Polident: 0.03 Efferdent: % NaOCl: 0.03 No color difference ( E < 0.2) HIGH (SOME PITTING) HIGH (COLOR EFFECT) HIGH Resistance to Heat Maintain mechanical properties when subjected to common high temperature items (e.g., boiling water, hot coffee, humidity) Extreme resistance to heat HIGH - VERY HIGH May melt if exposed to temperatures 130 o C or greater MODERATE Thermal analysis demonstrated aryl ketone has high resistance to heat (up to 300 C) HIGH - VERY HIGH Fatigue and Creep Resistance Retention of shape to maintain position, comfort and strength over time More durability CoCr has a -2.44N change in retention force and shows a ~300micron deformation of the active clasp arm over 15,000 cycles Aryl ketone materials show superior creep performance versus the acetal resin systems, as it shows about a ~3-11x lower strain (over all stresses tested) compared to Acetal over 1,000 hr experiment Fatigue improved over CoCr by undergoing just a -0.06N change in retention force and no measurable macroscopic deformation in a clasp fatigue test over 15,000 cycles MODERATE MODERATE VERY HIGH Solvay Dental 360 Ultaire AKP Reimbursement Guide 6

7 Detailed Comparison of RPD Materials (Continued) This table compares the properties of the different materials used to fabricate RPDs along with the impact to the patient or clinician. Non-Favorable Caution Favorable Trait Why is it important? Metal CoCr D5213, D5214 D5282, D4283 Acrylics/Resin (PMMA), (Flexible/Acetal) D5211, D5212, D5225, D5226 Ultaire AKP (Aryl Ketone Polymer) CODE TBD Biofilm Resistance Superior biofilm resistance enables better overall oral health Aryl ketone shows a 51% drop in candida albicans (yeast strain often responsible for denture stomatitis biofilm build up) This is a significantly better performance than CoCr (95% confidence interval) Aryl ketone has demonstrated 90% significantly better performance than acetal resin against biofilms of candida albicans, ctrep mutans and dtrep sanguinis (the bacterial strains primarily responsible for dental caries) Aryl ketone has demonstrated better resistance to biofilms compared to CoCr and acetal MODERATE MODERATE HIGH Toxicity Toxic chemicals can lead to adverse health effects Sensitization to nickel and possibly cobalt Possible leaching of 0.1-5% of residual monomer and additives Generally no cytotoxicity, possible carcinogenic and embryotoxic potential of monomer, rare severe allergic reactions reported No cell lysis or systemic toxicity and does not leach in water, ethanol, or hexane; aryl ketones are monomer and nickel free Biocompatibility Less Time to Manufacture Only safe, biocompatible materials can be used within the body Turnaround time to the patient LOW Increase in chromium levels in blood and plasma Small amounts of chromium found in saliva of partial denture wearers ( ppm) 8-15% of population has dermal contact sensitization to Ni, Cr, or Co Inhibited gingival cell growth with cobalt Cobalt alloys should be avoided due to carcinogenicity risks 188 minutes SENSITIZATION LOW 45 mg MMA release per ml of saliva over 1 week of denture use (non-heat polymerized) Release of PMMA in heat polymerized in much less quantity Possible leaching of 0.1-5% of residual monomer & additives No reported effects on organs (kidneys, spleen, pancreas, lungs, gut) Possible carcinogenic and embryotoxic potential of monomer Rare severe allergic reactions reported 176 minutes MONOMER LEACH NO RISK No delayed dermal contact sensitization Non-irritant, nonmuta-genic to multiple strains of salmonella, e coli Non-mutagenic in mouse lymphoma forward gene mutation assay Does not induce micronuclei No cell lysis or systemic toxicity, non-pyrogenic; does not leach in water, ethanol, or hexane SAFE 98 minutes to manufacture No waxing and no casting Perception Patient compliance may improve if they perceive it well LONG Patients do not like the look of metal in the mouth: the rigidity and hot/cold conduction can be uncomfortable MEDIUM Flexibles tend to get too loose too fast: typically used as a temporary solution FASTER The tooth color and ability to shade the clasp is favorable: the strength is perceived well NEGATIVE MEDIUM POSITIVE Solvay Dental 360 Ultaire AKP Reimbursement Guide 7

8 Economic Value For Labs: An Ultaire AKP RPD is produced digitally in a dental lab using CAD/CAM technology. The manufacturing process is shorter eliminating the need for waxing and casting saving time and money for the lab. From CAD to Finish in 1 Day No in-house waxing or casting necessary 1.5 hours savings to manufacture each case Increases workflow efficiency Reduces labor costs For Dentists: The shorter manufacturing time at the lab may lead to a faster turnaround time for the dentist to receive the RPD. After dentists send an impression for a metal RPD to the lab, the average turnaround time is days. 3 With an RPD made from Ultaire AKP, the CAD to finish turnaround time may be as little as one day. 2 In addition, Ultaire AKP RPDs are designed to provide a custom fit that requires minimal adjusting. This means fewer visits to the dentist to adjust the fit of the RPD. A recent market study conducted focus groups of 400 dentists and hygienists to get feedback on RPDs produced from three different materials (metal, flexible, and Ultaire AKP). The study found that: 3 Dentists see an average of six patients monthly for RPD adjustments Hygienists see 20 patients monthly for RPD adjustments The average time investment (chairtime) for patient adjustments is around 25 minutes Dentists Were Nearly Unanimous 96% said it would be of value to eliminate adjustments 71% said it would be VERY valuable to eliminate adjustments Prescribing RPDs produced with Ultaire AKP could potentially save dentists 2.5 hours/ month of chairtime on adjustments, freeing them up to provide other cost beneficial work. For Patients: An Ultaire AKP RPD is custom-designed for each patient and fits the first time requiring fewer dental visits for adjustments. The reduced fabrication time (CAD to finish in one day), combined with the precise fit, provides a significantly quicker turnaround time for patients to get their prosthesis. The clasps do not loosen over time, which may mean fewer re-visits for tightening. The bone-like properties of Ultaire AKP are less likely to cause harm to abutment teeth. Ultaire AKP delivers premier aesthetics and comfort which may improve patient compliance. Solvay Dental 360 Ultaire AKP Reimbursement Guide 8

9 CLINICAL DATA Market Research Patients Prefer Ultaire AKP 1 In August 2018, market research was conducted with six focus groups in Atlanta, Georgia to collect in-depth insights from dentists, hygienists and consumers about their attitudes regarding metal versus Ultaire AKP partial dentures. 1 Male and female patients were vocal on their dissatisfaction with their current metal RPDs. Hygienists reiterated receiving similar feedback from patients. Metal RPD Ultaire AKP RPD Patients complained that their metal RPD was uncomfortable, made speech and eating difficult, caused a negative taste while eating, broke easily, caused tooth decay around the clasps, slipped, was hard to clean, and was not aesthetically pleasing which makes them self-conscious and embarrassed. On a 5-point scale, each group rated what was most important to them when it came to RPDs. Patients liked the Ultaire AKP RPDs better than the metal RPDs, describing them as: All three groups felt Comfort Flexibility Easier to smile were some of the most critical attributes. More comfortable Better aesthetics Cosmetic the clasps don t show like the metal clasps Flexible Light and thin but still strong Blends with the gums Easy to adjust if needed Solvay Dental 360 Ultaire AKP Reimbursement Guide 9

10 Clinical Trial 4 Initial studies conducted by Solvay Dental 360 included seventeen patients enrolled in a patient satisfaction trial to evaluate overall satisfaction and preference between the standard metal frame and then their satisfaction wearing a high-performance polymer frame (Ultaire AKP). Results demonstrated an increase in satisfaction scores when wearing the Ultaire AKP frame as shown in the table below. Satisfaction with RPD Satisfaction Metal Frame Ultaire AKP Frame Comfort 76.5% 81.3% Weight 82.4% 93.8% Aesthetics 58.8% 87.5% Color 76.5% 81.3% Scientific/Clinical Testing 5 An ongoing clinical trial of forty patients is under way at the University of Chicago, Illinois and the University of Leeds, United Kingdom. The intended objective of the trial is to evaluate the change in patient oral health and related quality of life while wearing the Ultaire AKP RPD. Expected report completion is targeted for Quarter 2 of Retention of aryl ketone based RPDs (specifically Ultaire AKP) is improved over cobalt-chrome (CoCr) by undergoing just a -0.06N change in retention force and no measurable macroscopic deformation in a clasp fatigue test over 15,000 cycles. The aryl ketone clasps had a significantly lower average distortion than CoCr at both ideal and non-ideal (10 degrees off vertical) angles of clasp removal. The aryl ketone polymer showed overall lower retention forces than CoCr, but displayed much more stability over the 15,000 cycle lifetime. Aryl ketone materials show superior creep performance versus the acetal resin systems, as it shows about a ~3-11x lower strain (over all stresses tested) compared to acetal over 1,000 hr experiment. In biofilm testing, aryl ketone shows a 51% drop in Candida albicans (yeast strain primarily responsible for denture stomatitis biofilm build up on surface). This value indicates a statistically significant better performance (95% confidence interval) than CoCr. Aryl ketone based RPDs are CAD/CAM compatible, therefore reducing the overall time to manufacture (from CoCr prosthesis) by 50% and getting the patient the prosthesis they need in a more timely fashion. Solvay Dental 360 Ultaire AKP Reimbursement Guide 10

11 Summary: Ultaire AKP RPDs are Different RPDs made with Ultaire AKP meet multiple patient and clinical requirements that are not present in metal replacement technologies currently on the market hitting the sweet spot between metal and flexible materials. Ultaire AKP is the only solution that provides rigidity and toughness combined with: Excellent fatigue and creep resistance High machinability Stain-resistance Coatability and repairability Precision fit through processing via CAD/CAM technology Fully biocompatible Non-allergenic Bone-like characteristics Solvay Dental 360 Ultaire AKP Reimbursement Guide 11

12 CODING Coverage The Dentivera milling disc, made from Ultaire AKP, received FDA approval on June 15, It is available in North America and has 510k clearance. It is also available in the United Kingdom, Germany, Austria, Switzerland, and Belgium and has been granted CMDCAS, EU regulatory approvals and CE mark. Ultaire AKP is made in the U.S. under FDA and International Organization for Standardization (ISO) guidelines. Current CDT Codes Don t Apply to Ultaire AKP The current CDT reimbursement codes used for RPD frameworks are listed below. These codes do not describe Ultaire AKP or the techniques required for manufacturing Ultaire AKP frames. RPD Material Existing Dental Codes Why Existing Dental Codes Don t Apply to Ultaire AKP Cast Metal Flexible Resin Based New Manufacturing Process for RPDs made with Ultaire AKP D5213 Maxillary partial denture: cast metal framework with resin denture bases (incl. any conventional clasps, rests and teeth) D5214 Mandibular partial denture: cast metal framework with resin denture bases (incl. any conventional clasps, rests and teeth) D5282 Removable unilateral partial denture: one-piece cast metal (incl. clasps and teeth), maxillary (New in 2019) D5283 Removable unilateral partial denture: one-piece cast metal (incl. clasps and teeth), mandibular (New in 2019) D5225 Maxillary partial denture: flexible base (incl. any clasps, rests and teeth) D5226 Mandibular partial denture: flexible base (incl. any clasps, rests and teeth) D5211 Maxillary partial denture: resin base (incl. conventional clasps, rests and teeth) D5212 Mandibular partial denture: resin base (incl. conventional clasps, rests and teeth) New Code Required Ultaire AKP (an aryl ketone RPD material) is metal-free. The codes used for cast metals are not applicable to Ultaire AKP. Ultaire AKP demonstrates low deformation through fatigue testing, therefore presenting superior performance over flexible materials such as acetal in both fatigue and creep resistance, which typically lend the flexible material better for a temporary solution. The codes used for flexibles are not applicable to the properties established by Ultaire AKP. The biocompatibility and non-allergenic properties of the Ultaire AKP RPD differentiate it from conventional acrylic resin methyl methacrylate (MMA) based materials, which have been proven to be allergenic in nature. The codes used for conventional acrylic resin are not applicable to Ultaire AKP. The fitting and manufacturing process for Ultaire AKP requires that a disc, made of the high-performance polymer, is milled into the design of the RPD framework via CAD/CAM technology. Utilizing this technology provides a more precision fit for the patient, but also requires a different workflow in the clinical setting and how they interact with the dental laboratory manufacturing the RPD. There are fewer manufacturing steps using the CAD/CAM technology and the interaction between the dentist and the laboratory is more integrative. Manipulation of the RPD chairside is much more limited (i.e. the claps can t be bent to fit like one can do with a metal RPD nor heated and manipulated as can be done with acrylic). The existing codes do not describe the new techniques required for manufacturing. Solvay Dental 360 Ultaire AKP Reimbursement Guide 12

13 A New CDT Code is Required The Ultaire AKP distinction in materials, properties, and manufacturing identify the need for a discrete code that accurately reports an RPD or overdenture that is constructed with a framework fabricated in the lab from a high-performance polymer material through the CAD/CAM process. Solvay Dental 360 has submitted the CDT Code Application to the ADA for a distinct code for Ultaire AKP and expects a response in early If the ruling is in favor of a new code, the code should be available for use in RECOMMENDATION Because Ultaire AKP is so distinctly different from metal or other flexible RPD materials, properties and processes the existing dental codes for RPDs (D5213, D5214, D5282, D5283, D5211, D5212, D5225, D5226) are not applicable. D5899 The recommendation is to use CDT Code D5899 (Unspecified removable prosthodontic procedure). A value commensurate to the improved properties of Ultaire AKP should be applied to the reimbursement strategy chosen. References 1. Market research. Conducted Aug Solvay Dental 360 data on file. 2. Solvay Dental 360 data on file. 3. Market research. Conducted Oct 2018 by Prost Marketing Inc. Solvay Dental 360 data on file. 4. Cooper, Lyndon. Clinical study: REFRAME RPD study on aryl ketone polymer (AKP) removable partial dentures. Univ of IL, Chicago. July 6, Marie A, Keeling A, Hyde P, et al. Deformation and retentive force following in vitro cyclic fatigue of cobalt-chrome and aryl ketone polymer (AKP) clasps. School of Dentistry, University of Leeds UK. Document DCR-DENT Disclaimer Solvay Dental 360 has authorized the completion of this guide for the benefit of dental practices prescribing Ultaire AKP RPDs for patients. Readers of this guide are advised that the contents of this publication are to be used as guidelines and are not construed as policies of Solvay Dental 360. Solvay Dental 360 specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on the statements, opinions, or suggestions in this guide. Solvay Dental 360 makes no representations or warranties with respect to the contents of the guide and disclaims any implied guarantee or warranty of fitness for any particular purpose. Solvay Dental 360 will not be liable to any individual or entity for any losses or damages that may be occasioned by the use of this guide. Solvay Dental 360 Ultaire AKP Reimbursement Guide 13

14 Worldwide Headquarters Solvay Specialty Polymers Italy S.p.A Viale Lombardia, Bollate (MI), Italy Americas Headquarters Solvay Specialty Polymers USA, LLC 4500 McGinnis Ferry Road Alpharetta, GA 30005, USA Solvay.com SolvayDental360.com Facebook.com/SolvayDental360 Twitter.com/SolvayDental360 Linkedin.com/company/SolvayDental360 Solvay Dental 360, a division of Solvay Specialty Polymers USA, LLC. All trademarks and registered trademarks are property of the companies that comprise the Solvay Group or their respective owners. 2018, Solvay Specialty Polymers. All rights reserved. SD-DENT v1.0 Caution: Federal law restricts this device to sale by or on the order of a dentist or other authorized dental professional.