Inspire Medical Systems Hospital Billing Guide 2020

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Inspire Medical SystemsHospital BillingGuide 2020

Inspire Medical Systems Hospital Billing GuideThis Hospital Billing Guide was developed to help centers correctly bill for Inspire Upper AirwayStimulation (UAS) therapy. This Guide provides background information on payer coverage forimplantable devices as well as proper coding and billing for Medicare and private payers. Thecontents are intended to augment the hospital’s current awareness of coding and coverage forimplantable devices.Inspire Medical Systems has made every effort to ensure that the information in this Guide issuitable, accurate, and appropriate to describe and code the services provided in the care andmanagement of patients undergoing a UAS implant procedure for obstructive sleep apnea. Thesample codes displayed should be used to facilitate appropriate coding and should not be construedas recommendations or guidelines in establishing policy, physician services or procedures, physicianpractice, or standards of care.For questions regarding reimbursement, please call the Inspire Reimbursement Hotline at1-833-897-0939 or email questions to reimbursement@inspiresleep.com.Inspire Medical Systems, Inc.1

Inspire Medical Systems Hospital Billing GuideDevice and Procedure Description. 3 Device DISE Procedure Implant Procedure Analysis & Programming ProceduresCoverage. 4 FDA Approval Medicare Coverage Private Payer Coverage Reimbursement DenialsUpper Airway Examination Coding. 5 Diagnosis Codes CPT Procedure CodesImplant Coding. 6 Diagnosis Codes CPT Procedure Codes Hospital Device Codes – Implant Procedure Hospital Inpatient Codes – Implant ProceduresRevision, Removal and Replacement Procedure Coding.10 CPT Procedure CodesAnalysis and Programming Coding.11 Diagnosis Codes CPT Procedure CodesBilling Requirements. 12 Hospital Outpatient Billing – Implant Procedure Hospital Inpatient Billing – Implant ProcedureSample Claims. 14-15Disclaimers and Appendices.16 Appendix A: Information on the Medicare Appeal Process Appendix B: ICD-10-PCS Code TableInspire Medical Systems, Inc.2

Device and Procedure DescriptionDeviceInspire Upper Airway Stimulation (UAS) therapy is a neurostimulation system for the treatment ofmoderate to severe obstructive sleep apnea. The system detects breathing patterns while the patientis sleeping and stimulates the hypoglossal nerve (cranial nerve XII) to move the tongue and soft palatefrom obstructing the airway.The system consists of three implantable components: Generator – Like all neurostimulators, the generator provides the electrical stimulation pulse. Stimulation Lead – The stimulation lead delivers the stimulation pulse to the hypoglossal nerve. reathing Sensor Lead – The breathing sensor lead detects breathing patterns and relays this Binformation to the generator.Upper Airway Examination CodingDISE (Drug Induced Sleep Endoscopy) is a required diagnostic procedure for evaluating palatialcollapse for Hypoglossal Nerve Stimulation. During the procedure, artificial sleep is induced bymidazolam and/or propofol, and the pharyngeal collapse patterns are visualized using a flexiblefiberoptic nasopharyngoscope. The level (palate, oropharynx, tongue base, hypopharynx/epiglottis),the direction (anteroposterior, concentric, lateral), and the degree of collapse (none, partial, orcomplete) are examined. Occasionally, a physician may choose to examine the upper airway while thepatient is awake using local anesthesia.Implant ProcedureThe generator is placed in a subcutaneous pocket created via blunt dissection, typically in theupper chest. Following surgical exposure, the stimulation lead is placed in the upper neck with thecuff wrapped around the hypoglossal nerve. It is tunneled subcutaneously to the upper chest andconnected to the generator. The breathing sensor lead is placed via incision into the plane betweenthe external and internal intercostal muscles in the lower chest. It is tunneled subcutaneously andconnected to the generator.Analysis and Programming ProceduresDuring electronic analysis of the implanted neurostimulator pulse generator/transmitter, settingssuch as electrode configuration, amplitude, pulse width, rate, start delay, burst, patient selectableparameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passiveparameters are analyzed.Programming includes adjusting parameters (e.g., current, frequency, pulse width, train duration,magnet mode, or sensing), based on respiratory obstructive apneas and/or swallowing difficulties. Thephysician or other qualified health care professional conducts multiple stimulation trials, adjusting theparameters until optimal therapeutic stimulation are achieved.Inspire Medical Systems, Inc.3

CoverageFDA ApprovalInspire UAS therapy received PMA approval from the FDA on April 30, 2014.Medicare CoverageMedicare and other payers determine whether to cover the procedure or technology as a healthbenefit based on the published literature as well as business considerations. The first requirementis FDA approval.An FDA-regulated product must receive FDA approval or clearance (unless exempt from the FDApremarket review process) for at least one indication to be eligible for consideration of Medicarecoverage (except in specific circumstances). However, FDA approval or clearance alone does notentitle that technology to Medicare coverage.8.7.2013, Federal Register, Vol. 78, No. 152, page 48165Although not required, Medicare may develop national or local coverage policies specific to theprocedure or technology. These policies may extend coverage for the procedure or technology forcertain diagnoses or specific scenarios, or they may identify the procedure or technology as generallynon-covered. At this time, there is no Medicare national coverage policy on UAS, however someMedicare Administrative Contractors (MACs) have released policies and guidelines for UAS on the localor regional level.Traditional Medicare does not require or allow prior authorization or prior approval for procedures. Tolimit the risk of Medicare non-coverage, hospitals should contact their local MAC’s Medical Director inadvance. Hospitals may also contact Inspire Medical Systems for support in this process.Note: Medicare Advantage plans are managed by commercial payers. Those payers may require priorauthorization for Medicare Advantage patients.Private Payer CoveragePrivate payers also require FDA approval. Once approved, coverage is determined according to theframework of each patient’s specific plan, rather than on a geographic basis like Medicare.Also, unlike traditional Medicare, private payers often require prior authorization for an elective proceduresuch as UAS implantation. Before scheduling a patient’s UAS procedure, the hospital can contact InspireMedical Systems’ Prior Authorization program to determine the availability of coverage. Proceedingwithout a required prior authorization typically results in a denial and non-payment. Prior authorization isalso a good time to check for the payer’s billing requirements specific to implantable devices.Reimbursement DenialsPrivate payers sometime deny prior authorizations or a submitted claim. Medicare may also deny asubmitted claim. Hospitals may wish to appeal these denials. See Appendix A for information on theMedicare appeal process. For private payer denials, hospitals can contact Inspire Medical Systems forsupport. When doing so, it is helpful to provide the payer’s denial letter or the Explanation of Benefitsoutlining the reasons for denial.Inspire Medical Systems, Inc.4

Upper Airway Examination CodingDiagnosis CodesDiagnosis coding for endoscopic evaluation of the upper airway may involve the following code:ICD-10-CM Diagnosis CodeCode DescriptionG47.33Obstructive sleep apnea (adult), (pediatric)This code includes obstructive sleep apnea hypopnea.Procedure CodesPre-operative anatomical assessment of the upper airway is required for all Inspire patients. Theprocedure most performed is a Drug Induced Sleep Endoscopy (DISE), which is an evaluation of theupper airway after pharmacologic induction of unconscious sedation. Occasionally a physician maychoose to examine the upper airway while the patient is awake using local anesthesia. The followingcodes can be used for either asleep or awake endoscopic examinations.CPT 1ProcedureCodeCode DescriptionService92511Nasopharyngoscopy with endoscope (separate procedure)Asleep or awake, nasalapproach92502Otolaryngologic examination under general anesthesia*Asleep only31575Laryngoscopy, flexible fiberoptic; diagnosticAsleep or awake, nasalor oral approach* Cannot be reported with 31575 (Correct Coding Initiative (CCI) edits) If CPT 31575 is billed with 92511, most extensive procedure edit applies.1CPT Copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply toGovernment Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommendingtheir use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.APC CodesAs mentioned above, for hospital outpatient payments, Medicare assigns each CPT code to a specificAPC. Each APC has a fixed payment amount which includes the cost of any devices. The Upper AirwayExamination Coding procedures map to the following APCs:CPT ProcedureCodeAPCCode DescriptionSI925115151Level 1 Airway EndoscopyT925025162Level 2 ENT ProceduresT315755151Level 1 Airway EndoscopyTAPC is assigned ‘Status T’, meaning the procedure is paid at a reduced rate when performed withother procedures during the same visit. The “T” procedure with the highest relative weight will not bediscounted. The remaining “T” procedure(s) will be subject to a multiple procedure discount (50%).Inspire Medical Systems, Inc.5

Implant CodingDiagnosis CodesInspire Upper Airway Stimulation (UAS) therapy is used to treat a subset of patients with moderate tosevere Obstructive Sleep Apnea (OSA) (apnea-hypopnea index [AHI] of greater than or equal to 15 andless than or equal to 65).Diagnosis coding for UAS implantation may involve the following code:ICD-10-CM Diagnosis CodeCode DescriptionG47.33Obstructive sleep apnea (adult), (pediatric)This code includes obstructive sleep apnea hypopnea.For Medicare there is a dual diagnosis requirement Coverage for hypoglossal nerve stimulationprocedures on patients who meet coverage criteria must include both a primary ICD-10-CM diagnosiscode indicating the reason for the procedure and a secondary ICD-10-CM diagnosis code indicatingthe Body Mass Index (BMI) is less than 35 kg/m2. as set forth in the LCD Covered Indications. Report aprimary diagnosis code of OSA and a secondary diagnosis code from Group below:ICD-10-CM Diagnosis CodeCode DescriptionZ68.1Body mass index (BMI) 19.9 or less, adultZ68.20Body mass index (BMI) 20.0-20.9, adultZ68.21Body mass index (BMI) 21.0-21.9, adultZ68.22Body mass index (BMI) 22.0-22.9, adultZ68.23Body mass index (BMI) 23.0-23.9, adultZ68.24Body mass index (BMI) 24.0-24.9, adultZ68.25Body mass index (BMI) 25.0-25.9, adultZ68.26Body mass index (BMI) 26.0-26.9, adultZ68.27Body mass index (BMI) 27.0-27.9, adultZ68.28Body mass index (BMI) 28.0-28.9, adultZ68.29Body mass index (BMI) 29.0-29.9, adultZ68.30Body mass index (BMI) 30.0-30.9, adultZ68.31Body mass index (BMI) 31.0-31.9, adultZ68.32Body mass index (BMI) 32.0-32.9, adultZ68.33Body mass index (BMI) 33.0-33.9, adultZ68.34Body mass index (BMI) 34.0-34.9, adultInspire Medical Systems, Inc.6

Hospital Outpatient Codes – Implant ProcedureCPT Procedure CodesHospitals report outpatient procedures using CPT codes. Procedures involving UAS may involve thefollowing codes:CPT Procedure CodeCode DescriptionComponent64568Incision for implantation of cranial nerve (eg, vagus nerve)neurostimulator electrode array and pulse generatorGenerator andstimulation lead 0466TInsertion of chest wall respiratory sensor electrode or electrode array,including connection to a pulse generator (List separately in addition tocode for primary procedure) (Use 0466T in conjunction with 64568)Breathing sensorleadNote that a regular Category I CPT code is assigned for the placement of the generator and thestimulation lead. Because UAS stimulates the hypoglossal nerve, the system qualifies as a cranial nerveneurostimulator. The breathing sensor lead is a distinct component and is represented by Category IIICPT code 0466T. As indicated by the symbol, this is an add-on code and cannot be assigned byitself. Code 0466T for the breathing sensor lead must always be assigned together with code 64568for the generator and stimulation lead.APCFor hospital outpatient payments, Medicare assigns each CPT code to a specific Ambulatory PaymentClassification (APC). Each APC has a fixed payment amount which includes the cost of any devices. TheUAS implantation procedure may involve the following APCs:CPT CodeAPC CodeAPC DescriptionSI645685464Level 4 Neurostimulator and Related ProceduresJ1 0466T——NThe Status Indicator (SI) of J1 denotes a complexity-adjusted procedure with which other procedureswith a Status Indicator J1 may be complexity adjusted. Refer to CMS CY2020 OPPS 1717-FR AddendumJ for complexity adjustments. Procedures with Status Indicator N are packaged into the payment forother procedures reported on the same hospital outpatient claim. Therefore, the payment for primarycode 64568 is calculated to include the adjunctive procedure (i.e. 0466T) as well as the cost of alldevices, drugs and ancillary services for which separate payment is not made.Although some code combinations are eligible for an APC “complexity adjustment” that increasespayment to the next level, the combination of 64568 and 0466T does not qualify for an APCcomplexity adjustment.Inspire Medical Systems, Inc.7

HCPCS II Device CodesCPT codes are assigned for the UAS implant procedure. HCPCS II codes are assigned to identify thedevice itself.Coding for the UAS device may involve the following HCPCS II codes. In general, C-codes are used forbilling Medicare and L-codes are used for billing private payers, although some private payers may alsoaccept C-codes.HCPCS II CodeCode DescriptionC1767Generator, neurostimulator (implantable), non-rechargeableC1778Lead, neurostimulator (implantable)C1787Patient programmer, neurostimulatorL8688Implantable neurostimulator pulse generator, dual array, non-rechargeable, includesextensionL8680Implantable neurostimulator electrode, eachL8681Patient programmer (external) for use with implantable programmable neurostimulatorpulse generator, replacement onlyOn an outpatient basis, Medicare uses code C1778 for both the stimulation lead and the breathingsensor lead. Some payers may use L8680 for both. Prior authorization is a good time to check forprivate payer’s device-coding requirements.Hospital Inpatient Codes – Implant ProcedureICD-10-PCS Procedure CodesICD-10-PCS codes are used by hospitals to report inpatient procedures. Each major component ofthe procedure is coded separately. Procedures involving the UAS implant procedure may involve thefollowing codes:ICD-10-PCSProcedure CodeCode DescriptionComponent0JH60DZInsertion of multiple array stimulator generator into chestsubcutaneous tissue and fascia, open approachGenerator00HE0MZInsertion of neurostimulator lead into cranial nerve, open approachStimulation lead0KHX0YZInsertion of other device into upper muscle, open approachBreathing sensor leadSee Appendix B for the code tables from which these specific codes were constructed.The sixth character of an ICD-10-PCS code is the device value. A device value for the stimulation leadis available in code table 0KH but is not appropriate for the breathing sensor lead. In ICD-10-PCS, asensing lead for a phrenic neurostimulator is assigned to the device value for a monitoring deviceand, by inference, the UAS breathing sensor lead should also use the value for a monitoring device.However, because the value for a monitoring device is not available in code table 0KH, the default valueY - Other Device is assigned. See Appendix B for code table 0KH which displays this.Inspire Medical Systems, Inc.8

MS-DRG CodesMedicare uses MS-DRG codes to reimburse hospitals for inpatient admissions. Each inpatient stay isassigned to a specific diagnosis-related group (DRG) based on the ICD-10-CM diagnosis codes andICD-10-PCS procedure codes. Only one MS-DRG is assigned for each inpatient stay, regardless ofthe number of procedures performed. When more than one procedure is coded, DRG assignmentis based on the highest-ranked code. Each MS-DRG has a fixed payment amount which includes thecost of any devices.The UAS implant procedure for obstructive sleep apnea may involve the following DRGs:DRG CodeDRG Description040Peripheral/Cranial Nerve and Other Nervous System Procedures W/MCC041Peripheral/Cranial Nerve and Other Nervous System Procedures W/CC orPeripheral Neurostimulator042Peripheral/Cranial Nerve and Other Nervous System Procedures WO/CC/MCCThe distinction between DRG 040, 041 and 042 is the presence or absence of secondary diagnosiscodes designated by Medicare as MCCs or CCs. MCC refers to secondary diagnosis codes designatedas major complications or comorbidities. CC refers to secondary diagnosis codes designated as other(non-major) complications or comorbidities. A DRG defined as W CC/MCC means that at least one ofthe secondary diagnosis codes is a CC or an MCC. If none of the secondary diagnosis codes is a CC orMCC, then the DRG WO CC/MCC is assigned.Inspire Medical Systems, Inc.9

Revision, Removal, and Replacement Procedure CodingCPT Procedure CodesIn addition to implantation, the UAS device may require revision, removal, or replacement at some timeduring its life cycle. Hospital outpatient procedures may involve the following codes:CPT ProcedureCodeCode DescriptionComponent61886Insertion or replacement of cranial neurostimulator pulse generatoror receiver, direct or inductive coupling; with connection to 2 or moreelectrode arraysGenerator61888Revision or removal of cranial neurostimulator pulse generator or receiverGenerator64569Revision or replacement of cranial nerve (e.g., vagus nerve)neurostimulator electrode array, including connection toexisting pulse generatorStimulation lead64570Removal of cranial nerve neurostimulator electrode arrayand pulse generatorGenerator andStimulation lead64585Revision or removal of peripheral neurostimulator electrode arrayStimulation lead0467TRevision or replacement of chest wall respiratory sensor electrode orelectrode array, including connection to existing p

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