Continuous Positive Airway Pressure (CPAP) and Respiratory Assist Devices (RADs) including Bi-Level PAP

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1 Cntinuus Psitive Airway Pressure (CPAP) and Respiratry Assist Devices (RADs), Including Bi-Level PAP Benefit Criteria t Change fr Texas Medicaid Effective March 1, 2017 Overview f Benefit Changes Benefit criteria fr CPAP and RADs have been expanded and are based n Centers fr Medicare & Medicaid Services (CMS) cverage determinatins. The Hme Health Services (Title XIX) DME/Medical Supplies Physician Order Frm is n lnger required fr CPAP r RAD prir authrizatin requests. All CPAP and RAD prir authrizatin (Fee-Fr-Service) requests must be submitted using the Texas Medicaid Prir Authrizatin Request fr CPAP r RAD (BI-level PAP) frm. Prescribing prviders must maintain the riginal, cmpleted, signed and dated Texas Medicaid Prir Authrizatin Request fr CPAP r RAD (BI-level PAP) in the client s medical recrd. The DME prvider needs t maintain a cpy f the cmpleted, signed, and dated frm in the client's recrd. Chinstrap (prcedure cde A7036) will be a new benefit. Related supplies (prcedure cdes A7027 thrugh A7036) d nt require prir authrizatin when requested within the defined limits except when used with prcedure cde E0472, as supplies are included in the rental f a RAD with backup rate when used with an invasive interface. Prviders are encuraged t read the CPAP and RADs benefit limitatins and reimbursement utlined in the Cvered Prcedure Cdes and Benefit Limitatins table which can be fund in the article titled Benefit Criteria t Change fr Respiratry Equipment and Supplies Effective March 1, 2017 Cntinuus Psitive Airway Pressure (CPAP) and Respiratry Assist Devices (RADs) including Bi-Level PAP CPAP and RAD criteria are based n Centers fr Medicare & Medicaid Services (CMS) cverage determinatins. Cntinuus psitive airway pressure (CPAP) (prcedure cde E0601) and respiratry assist devices (RADS) (prcedure cdes E0470, E0471, E0472), which include bi-level psitive airway pressure (PAP) with r withut a set backup respiratry rate are a benefit when medically necessary and may be cnsidered fr rental r purchase with prir authrizatin (Fee-Fr-Service) fr clients requiring: Treatment f bstructive sleep apnea Restrictive thracic disrders Severe chrnic bstructive pulmnary disease Central sleep apnea Cmplex sleep apnea

2 Hypventilatin syndrme. Only when medically necessary are RADs with a set backup respiratry rate available fr rental. Other cnditins may be cnsidered based n medical necessity. Humidificatin devices (heated and nn-heated) may be a benefit with prir authrizatin (Fee-Fr-Service) when medically necessary fr rental r purchase fr use with CPAP devices and RADs. CPAP devices deliver a single, fixed pressure t the client during the night while sleeping. Sme sleep breathing disrders d nt benefit frm CPAP and require treatment with RADs that are able t recgnize the client's breathing patterns and adjust pressure during the respiratry cycle during sleep. Headgear, chinstraps, face masks, nasal pillws, cushins, nasal interfaces, tubing, and filters fr CPAP and RADs within the maximum allwed limits d nt require prir authrizatin. Exceptin: RAD with backup rate used with an invasive interface (prcedure cde E0472) des require prir authrizatin (Fee-Fr-Service) and supplies will nt be authrized separately as they are included in the rental. Prviders may refer t the table titled Respiratry Assist Device (RAD) & CPAP Prcedure Cde Billing Relatinships, which can be fund in the article titled Benefit Criteria t Change fr Respiratry Equipment and Supplies Effective March 1, 2017, fr a cmplete list f related supplies that will deny as part f a prcedure cde E0472 rental. With a fee-fr-service histry f a client-wned CPAP and RAD accessries (prcedure cdes A7027 thrugh A7036), d nt require prir authrizatin within the maximum allwed limits. In the case f a client-wned RAD with backup rate that is used with an invasive interface (prcedure cde E0472) that was purchased as a result f a rental r purchased thrugh anther payer surce, prf f wnership f the device is required fr cnsideratin f reimbursement f assciated supplies and accessries. A statement frm the treating physician prviding the make and mdel f the client-wned device, submitted with the claims appeal, will meet this requirement when a claims histry is nt available. A CPAP device r a RAD withut a set backup rate may be cnsidered fr an initial three-mnth rental perid with prir authrizatin (Fee-Fr-Service). Fllwing the initial three-mnth rental perid, if the CPAP r RAD withut a set backup rate is effective the device may be cnsidered fr purchase. Bth devices may als be cnsidered fr cntinued rental with renewal at 3 mnth intervals up t 12 mnths. A CPAP device and a RAD withut a set backup rate will be cnsidered purchased after 12 mnths f rental thrugh the same prvider and a request fr purchase r further rental will nt be cnsidered. A RAD with a set backup respiratry rate requires prir authrizatin (Fee-Fr-Service) and may be cnsidered nly fr rental. Humidificatin devices (heated r nn-heated) fr use with a CPAP r RAD device may be a benefit with prir authrizatin (Fee-Fr-Service) when medically necessary. Dcumentatin submitted must supprt why humidificatin is medically necessary fr use with psitive pressure ventilatin. Prir Authrizatin (Fee-Fr-Service)

3 Prir authrizatin may be cnsidered fr initial and renewal requests fr CPAP and RADs, with submissin f all f the fllwing: A Texas Medicaid Prir Authrizatin Request fr CPAP r RAD (Bi-level PAP) frm (new with each request) cmpleted, signed, and dated by the treating physician Sectins A and B must be cmpleted fr initial requests Sectins A and C must be cmpleted fr renewal requests Additinal dcumentatin (e.g., titratin sleep studies) as necessary t supprt the medical necessity f the service required as utlined belw fr the initial and renewal requests Initial Request fr a Cntinuus Psitive Airway Pressure (CPAP) System The American Academy f Sleep Medicine (AASM) Guidelines state that it is clinically apprpriate t treat clients wh are 18 thrugh 20 years f age using adult criteria. A CPAP device (prcedure cde E0601) may be cnsidered fr an initial three-mnth rental perid based n dcumentatin supprting the medical necessity and apprpriateness f the device when all f the fllwing cnditins are met: Dcumentatin that the client has had a sleep study, lasting a minimum f tw hurs, and meeting at least ne f the fllwing criteria: Fr clients wh are 17 years f age and yunger, plysmngraphy results dcumenting an apnea-hyppnea index (AHI) greater than ne event per hur may be used t establish medical necessity. Fr clients wh are 18 years f age and lder, plysmngraphy results dcumenting an AHI r a respiratry disturbance index (RDI) greater than r equal t 15 events per hur Fr clients wh are 18 years f age and lder, an AHI r RDI greater than five events per hur with dcumentatin f at least ne f the fllwing: Excessive daytime sleepiness assessed by either the Epwrth Sleepiness Scale (ESS) with a result greater than 10 r the Multiple Sleep Latency Test (MSLT) with a result less than 6 Symptms f impaired cgnitin, md disrders, r insmnia Hypertensin (systlic bld pressure greater than 140 mm Hg r diastlic bld pressure greater than 90 mm Hg) Ischemic heart disease r previus mycardial infarctin Histry f strke Greater than 20 episdes f xygen desaturatin t less than 85 percent during a full night sleep study Any ne episde f xygen desaturatin f less than 70 percent Pulmnary hypertensin CPAP may be medically necessary fr the treatment f bstructive sleep apnea (OSA) in clients wh are 18 years f age and yunger when ne f the fllwing criteria are dcumented:

4 Adenidectmy r tnsillectmy is cntraindicated Adenidectmy r tnsillectmy is delayed Adenidectmy r tnsillectmy has been unsuccessful in relieving symptms f OSA Dcumentatin must be maintained by the prvider in the client's medical recrd that the client r respnsible caregiver has received instructin frm the DME prvider n the prper use and care f the device and supplies. Renewal Request fr a CPAP System Prir authrizatin (Fee-Fr-Service) fr purchase r an additinal three mnths CPAP rental after the initial three-mnth rental perid will be cnsidered with all f the fllwing dcumentatin cmpleted, signed, and dated by the client s treating physician: A new Texas Medicaid Prir Authrizatin Request fr CPAP r RAD (Bi-level PAP) frm. Dcumentatin f medical necessity supprting: The client s cntinuus use f the equipment fr a minimum f 4 hurs per 24-hur perid The client s symptms as dcumented by the treating physician are imprved with use f the CPAP Cntinued rental f CPAP may be cnsidered fr up t 12 mnths f cntinuus renewal at 3-mnth intervals. A CPAP device will be cnsidered purchased after 12 mnths f cntinuus rental thrugh the same prvider. Initial Request fr Respiratry Assist Devices (RADs), including BiPAP with and withut a Set Backup Respiratry Rate A RAD with r withut a set backup rate may be cnsidered fr prir authrizatin (Fee- Fr-Service) when the client has ne f the fllwing medical cnditins as dcumented by a sleep study and meets criteria fr medical necessity fr the specific medical cnditin: Obstructive sleep apnea (OSA) Restrictive thracic disrders (e.g., neurmuscular diseases r severe thracic cage abnrmalities) Severe Chrnic Obstructive Pulmnary Disease (COPD) Central sleep apnea (CSA), cmplex sleep apnea (CmpSA) Hypventilatin syndrme Initial Request fr RAD fr the Treatment f Obstructive Sleep Apnea (OSA) A RAD withut backup may be cnsidered fr an initial three-mnth trial perid, with prir authrizatin (Fee-Fr-Service), fr the treatment f OSA with prir authrizatin and submissin f all f the fllwing:

5 All the required dcumentatin delineated n the Texas Medicaid Prir Authrizatin Request fr CPAP r RAD (Bi-level PAP) frm The client meets the criteria fr the initial CPAP rental The dcumentatin supprts that CPAP has been tried and ne f the fllwing is dcumented: The client's treating physician verifies that a therapeutic trial f CPAP was cnducted in the hme r a facility setting and failed t be effective in treating the client's OSA. A CPAP device was fund t be ineffective during the initial facility based r sleep labratry titratin trial testing. If a CPAP device is tried and fund ineffective during the initial facility-based titratin r hme trial, substitutin f a RAD des nt require a new face-t-face clinical evaluatin r a new sleep test. Initial Request fr RAD fr the Treatment f Restrictive Thracic Medical Cnditins A RAD withut a set backup rate requires prir authrizatin (Fee-Fr-Service) and may be cnsidered fr the treatment f thracic medical cnditins when all f the fllwing are met: The client is diagnsed with a neurmuscular disrder (e.g., Duchenne muscular dystrphy, ALS, spinal crd injuries) r the client has a diagnsis f a severe thracic cage abnrmality (e.g., severe chest wall defrmities) negatively impacting the client's respiratry effrt. Significant respiratry insufficiency is dcumented by ne f the fllwing: An arterial bld gas (ABG) PaCO 2 greater than r equal t 45 mm Hg, btained while awake and breathing the client's rutinely prescribed FIO 2 Sleep ximetry demnstrates xygen saturatin less than r equal t 88 percent fr 5 minutes r lnger f cntinuus ncturnal recrding time (minimum recrding time f 2 hurs), btained while client is breathing his r her rutinely prescribed FiO 2 NOTE: FIO 2 (fractin f inspired xygen cncentratin) is the cncentratin f xygen prescribed fr rutine use by the client. Fr example, if the client des nt nrmally use supplemental xygen, their prescribed xygen is rm air (FiO 2 f 21 percent). Fr clients wh have been diagnsed with a neurmuscular disrder nly, dcumentatin must supprt ne f the fllwing: Maximal inspiratry pressure less than 60 cm H 20 Frced vital capacity less than 50 percent f predicted A RAD with a set backup rate requires prir authrizatin (Fee-Fr-Service) and may be cnsidered fr the treatment f thracic medical cnditins when all f the fllwing are met: The client meets the criteria fr use f the RAD withut a backup rate fr the treatment f a thracic medical cnditin.

6 The rdering physician certifies t all f the fllwing: Client has tried a RAD withut a backup rate fr at least 60 days. The client was cmpliant in the use f the device (using n average 4 r mre hurs in a 24-hur day). The desired therapeutic respiratry respnse was nt achieved with the RAD withut a set backup rate. Initial Request fr RAD fr the Treatment f Severe Chrnic Obstructive Pulmnary Disease (COPD) A RAD withut a backup rate may be cnsidered fr the treatment f severe COPD, with prir authrizatin (Fee-Fr-Service), when all f the fllwing criteria are met: An arterial bld gas PaCO 2 less than 52 mm Hg, btained while awake and when the client is either using 2 LPM f xygen r the client's prescribed FIO 2 (the bld gas shuld be drawn while the client is using whichever cncentratin f xygen is the higher f the tw). Sleep ximetry demnstrates xygen saturatin less than r equal t 88 percent fr 5 minutes r lnger f cntinuus ncturnal recrding time (minimum recrding time f 2 hurs), btained while breathing xygen at 2 LPM r the client's prescribed FIO 2 (whichever is higher). Prir t initiating therapy, dcumentatin f sleep apnea and that treatment with CPAP has been cnsidered with an explanatin f why it was ruled ut. T rule ut the use f a CPAP, frmal sleep testing is nt required if there is sufficient infrmatin in the medical recrd submitted with the request t demnstrate that the client des nt suffer frm sme frm f sleep apnea (bstructive sleep apnea (OSA), CSA, r CmpSA) as the predminant cause f awake hypercapnia r ncturnal arterial xygen desaturatin. A RAD with a backup feature will be cnsidered with prir authrizatin (Fee-Fr- Service) fr severe COPD when the all f the fllwing criteria are met: The client meets the criteria fr use f the RAD withut a backup rate fr COPD The rdering physician certifies t all f the fllwing: Client has tried a RAD withut a backup rate fr at least 60 days The client was cmpliant in the use f the device (using n average 4 r mre hurs in a 24-hur day) The desired therapeutic respiratry respnse was nt achieved with the RAD withut a set backup rate Initial Request fr RAD fr the Treatment f Central Sleep Apnea (CSA) r Cmplex Sleep Apnea (CmpSA) CSA r CmpSA is characterized by the develpment f central apneas r central hyppneas during pressure titratins perfrmed in a sleep lab titratin study fr CPAP r RAD withut a backup rate.

7 A RAD withut a backup rate will be cnsidered with prir authrizatin (Fee-Fr- Service) fr the treatment f CSA r CmpSA when a facility based plysmngram is perfrmed and supprts all f the fllwing: The client has a diagnsis f CSA r CmpSA. The sleep study dcuments ne f the fllwing: The sum ttal f central hyppneas plus central apneas is greater than 50 percent f the ttal apneas and hyppneas rate. A central hyppnea/apnea rate index greater than five events per hur; and significant imprvement f the sleep-assciated hypventilatin while breathing the clients prescribed FiO 2. Dcumentatin ruling ut CPAP as effective therapy if either OSA r CSA is a cmpnent f the initially bserved sleep assciated hypventilatin. A RAD with a backup rate will be cnsidered with prir authrizatin (Fee-Fr-Service) fr the treatment f CSA r CmpSA when all f the fllwing are met: The client meets the criteria fr use f the RAD withut a backup rate fr the treatment f CSA r CmpSA. The rdering physician certifies t all f the fllwing: The client as tried a RAD withut a backup rate fr at least 60 days. The client was cmpliant in the use f the device (using n average 4 r mre hurs in a 24-hur day). The desired therapeutic respiratry respnse was nt achieved with the RAD withut a set backup rate. Initial Request fr RAD fr the Treatment f Hypventilatin Syndrme A RAD withut a backup rate may be cnsidered fr treatment f hypventilatin syndrme with prir authrizatin (Fee-Fr-Service) when all f the fllwing criteria are met: An initial arterial bld gas PaCO 2, btained while awake with the client breathing their prescribed FIO 2, greater than r equal t 45 mm Hg Spirmetry shws a frced expired vlume in 1 sec (FEV1) r the frced vital capacity (FVC) greater than r equal t 70 percent A facility-based plysmngram demnstrates xygen saturatin less than r equal t 88 percent fr 5 minutes r lnger f cntinuus ncturnal recrding time (minimum recrding time f 2 hurs) nt caused by bstructive upper airway events. A RAD with a set backup respiratry rate may be cnsidered with prir authrizatin (Fee-Fr-Service) fr the treatment f hypventilatin syndrme when ne f the fllwing are met: The client has hypventilatin syndrme as determined by a facility-based plysmngram that demnstrates the desired respiratry therapeutic effects were nt achieved with a RAD withut a backup rate.

8 The client meets the criteria fr RAD withut a backup rate fr hypventilatin syndrme, and the physician dcuments the desired respiratry therapeutic effects were nt achieved with the RAD withut a backup rate. Renewal Request fr RAD with r withut a Backup Rate Prir Authrizatin (Fee-Fr-Service) is required fr renewal f a RAD with r withut a backup rate. Prir authrizatin (Fee-Fr-Service) fr purchase f RAD withut a set backup rate r cntinued rental f a RAD with r withut a backup rate, after cmpletin f the initial three-mnth rental perid, may be cnsidered with all f the fllwing dcumentatin cmpleted, signed, and dated by the client's treating physician: A new Texas Medicaid Prir Authrizatin Request fr CPAP r RAD (Bi-level PAP) frm Attestatin frm the treating physician that states the client is cntinuing t use the equipment at a minimum f 4 hurs in a 24 hur perid Client symptms are imprved as dcumented by the client's treating physician. When recertifying a RAD with r withut a set backup rate fr significant respiratry insufficiency, dcumentatin f a capillary bld gas (CBG) demnstrating a PaCO 2 greater than r equal t 45 mm Hg, btained while awake and breathing the client's rutinely prescribed FiO 2 may be submitted in lieu f an ABG. Prviders may refer t the Cvered Prcedure Cdes and Benefit Limitatins table which can be fund in the article titled Benefit Criteria t Change fr Respiratry Equipment and Supplies Effective March 1, 2017, fr additinal details fr each prcedure cde. These details include maximum quantity limitatins, rental versus purchase ptins and prir authrizatin requirements.

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