CMS Manual System Pub 100-03 Medicare Natinal Cverage Determinatins Department f Health & Human Services (DHHS) Centers fr Medicare & Medicaid Services (CMS) Transmittal 86 Date: July 3, 2008 Change Request 6048 SUBJECT: Cntinuus Psitive Airway Pressure (CPAP) Therapy fr Obstructive Sleep Apnea (OSA) I. SUMMARY OF CHANGES: After recnsideratin, cverage fr CPAP therapy fr OSA is expanded t include a psitive diagnsis f OSA made using a hme sleep test under specified criteria. This revisin is a natinal cverage determinatin (NCD). NCDs are binding n all carriers, fiscal intermediaries, quality imprvement rganizatins, qualified independent cntractrs, the Medicare appeals cuncil, and administrative law judges (ALJs) (see 42 CFR sectin 405.1060(a)(4) (2005)). An NCD that expands cverage is als binding n a Medicare advantage rganizatin. In additin, an ALJ may nt review an NCD. (See sectin 1869(f)(1)(A)(i) f the Scial Security Act.) NEW / REVISED MATERIAL EFFECTIVE DATE: March 13, 2008 IMPLEMENTATION DATE: August 4, 2008 Disclaimer fr manual changes nly: The revisin date and transmittal number apply nly t red italicized material. Any ther material was previusly published and remains unchanged. Hwever, if this revisin cntains a table f cntents, yu will receive the new/revised infrmatin nly, and nt the entire table f cntents. II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is nt updated) R=REVISED, N=NEW, D=DELETED R/N/D R CHAPTER / SECTION / SUBSECTION / TITLE 1/240.4/Cntinuus Psitive Airway Pressure (CPAP) Therapy fr Obstructive Sleep Apnea (OSA) (Effective March 13, 2008) III. FUNDING: SECTION A: Fr Fiscal Intermediaries and Carriers: N additinal funding will be prvided by CMS; cntractr activities are t be carried ut within their perating budgets. SECTION B: Fr Medicare Administrative Cntractrs (MACs): The Medicare administrative cntractr is hereby advised that this cnstitutes technical directin as defined in yur cntract. CMS des nt cnstrue this as a change t the MAC Statement f Wrk. The cntractr is nt bligated t incur csts in excess f the amunts alltted in yur cntract unless and until specifically authrized by the cntracting fficer. If the cntractr cnsiders anything prvided, as described abve, t be utside the current scpe f wrk, the cntractr shall withhld perfrmance n the part(s) in questin and immediately ntify the cntracting fficer, in writing r by e-mail, and request frmal directins regarding cntinued perfrmance requirements.
IV. ATTACHMENTS: Business Requirements Manual Instructin *Unless therwise specified, the effective date is the date f service.
Attachment - Business Requirements Pub. 100-03 Transmittal: 86 Date: July 3, 2008 Change Request: CR 6048 SUBJECT: Cntinuus Psitive Airway Pressure (CPAP) Therapy fr Obstructive Sleep Apnea (OSA) Effective Date: March 13, 2008 Implementatin Date: August 4, 2008 I. GENERAL INFORMATION A. Backgrund: The Centers fr Medicare & Medicaid Services (CMS) received a request frm the American Academy f Otlarynglgy-Head and Neck Surgery, t recnsider its 2005 Natinal Cverage Determinatin (NCD) fr CPAP Therapy fr OSA t allw fr cverage f CPAP based upn a diagnsis f OSA by hme sleep testing (HST). Medicare cvers the use f CPAP in beneficiaries wh have been diagnsed with mderate t severe OSA when rdered and prescribed by a licensed treating physician and cnfirmed by plysmngraphy (PSG) perfrmed in a sleep labratry in accrdance with sectin 240.4, f the NCD Manual. There are currently a number f prcedures used by physicians singly r in cmbinatin that cntribute t a diagnsis f OSA: clinical evaluatin, PSG perfrmed in a sleep labratry, HST using Type II, III, & IV devices, and ther services. After careful cnsideratin, CMS is revising its NCD n CPAP therapy fr OSA t mdify certain elements as well as allwing fr the cverage f CPAP based n a psitive diagnsis f OSA by HST as cntained in sectin 240.4, f Pub. 100-03, f the NCD Manual. Als refer t chapter 20, sectin 30.5, f Pub. 100-04, f the Medicare Claims Prcessing Manual, fr billing guidelines fr capped rental items, including CPAP. B. Plicy: Effective fr claims with dates f service n and after March 13, 2008, Medicare will allw fr cverage f CPAP therapy based upn a psitive diagnsis f OSA by HST. Refer t sectin 240.4, f Pub. 100-03, f the NCD Manual. 1. Cverage f CPAP is initially limited t a 12-week perid fr beneficiaries diagnsed with OSA as subsequently described. CPAP is subsequently cvered fr thse beneficiaries diagnsed with OSA whse OSA imprved as a result f CPAP during this 12-week perid. NOTE: The CMS reminds the reader that durable medical equipment, prsthetics, rthtics, and supplies (DMEPOS) suppliers are required t prvide beneficiaries with necessary infrmatin and instructins n hw t use Medicare-cvered items safely and effectively. 42 CFR 424.57(c)(12). Failure t meet this standard may result in revcatin f the DMEPOS supplier s billing privileges. 42 CFR 424.57(d). 2. The CPAP fr adults is cvered when diagnsed using a clinical evaluatin and a psitive: a. plysmngraphy (PSG) perfrmed in a sleep labratry; r b. unattended hme sleep mnitring device f Type II; r c. unattended hme sleep mnitring device f Type III; r d. unattended hme sleep mnitring device f Type IV, measuring at least 3 channels
NOTE: The CMS reminds the reader that, in general, pursuant t 42 CFR 410.32(a) diagnstic tests that are nt rdered by the beneficiary s treating physician are nt cnsidered reasnable and necessary. Pursuant t 42 CFR 410.32(b) diagnstic tests payable under the physician fee schedule that are furnished withut the required level f supervisin by a physician are nt reasnable and necessary. 3. A psitive test fr OSA is established if either f the fllwing criterin using the Apnea-Hyppnea Index (AHI) r Respiratry Disturbance Index (RDI) are met: AHI r RDI greater than r equal t 15 events per hur, r AHI r RDI greater than r equal t 5 and less than r equal t 14 events per hur with dcumented symptms f excessive daytime sleepiness, impaired cgnitin, md disrders r insmnia, r dcumented hypertensin, ischemic heart disease, r histry f strke. The AHI is equal t the average number f episdes f apnea and hyppnea per hur. The RDI is equal t the average number f respiratry disturbances per hur. 4. If the AHI r RDI is calculated based n less than 2 hurs f cntinuus recrded sleep, the ttal number f recrded events t calculate the AHI r RDI during sleep testing is at least the number f events that wuld have been required in a 2-hur perid. 5. The CMS is deleting the distinct requirements that an individual have mderate t severe OSA and that surgery is a likely alternative. 6. The CPAP based n clinical diagnsis alne r using a diagnstic prcedure ther than PSG r Type II, Type III, r a Type IV HST measuring at least three channels is cvered nly when prvided in the cntext f a clinical study as specified in sectin 310.1, f Pub. 100-03, f the NCD Manual. New HST Prtable Mnitring G Cdes Effective March 13, 2008: G0398: Hme sleep study test (HST) with type II prtable mnitr, unattended; minimum f 7 channels: EEG, EOG, EMG, ECG/heart rate, airflw, respiratry effrt and xygen saturatin. G0398 Shrt Descriptr: Hme sleep test/type 2 Prta G0399: Hme sleep test (HST) with type III prtable mnitr, unattended; minimum f 4 channels: 2 respiratry mvement/airflw, 1 ECG/heart rate and 1 xygen saturatin G0399 Shrt Descriptr: Hme sleep test/type 3 Prta G0400: Hme sleep test (HST) with type IV prtable mnitr, unattended; minimum f 3 channels G0400 Shrt Descriptr: Hme sleep test/type 4 Prta II. BUSINESS REQUIREMENTS TABLE Use Shall" t dente a mandatry requirement Number Requirement Respnsibility (place an X in each applicable clumn) 6048.1 Effective fr claims with dates f X X X X A/B DME FI CARRIER RHHI Shared-System Maintainers FISS MCS VMS CWF MAC MAC OTHER
Number Requirement Respnsibility (place an X in each applicable clumn) service n and after March 13, 2008, Medicare will allw fr cverage f CPAP therapy fr adult beneficiaries based upn clinical evaluatin and a psitive diagnsis f OSA by HST. Refer t sectin 240.4, f Pub.100-03, f the NCD Manual. 6048.2 Fr cverage f rutine items/services prvided in the cntext f a clinical study, claims shall be prcessed accrding t CED/clinical trials criteria at sectin 310.1, f Pub.100-03, f the NCD Manual, sectin 240.4, f the NCD Manual, and chapter 32, sectins 69.6-69.7, f Pub.100-04 f the Claims Prcessing Manual. 6048.3 Cntractrs shall nt search files t adjust claims but shall adjust claims brught t their attentin. A/B MAC DME MAC X X X X X X X X FI CARRIER RHHI Shared-System Maintainers FISS MCS VMS CWF OTHER III. PROVIDER EDUCATION TABLE Number Requirement Respnsibility (place an X in each applicable clumn) 6048.4 A prvider educatin article related t this instructin will be available at http://www.cms.hhs.gv/mlnmattersarticles/ shrtly after the CR is released. Yu will receive ntificatin f the article release via the established "MLN Matters" listserv. Cntractrs shall pst this article, r a direct link t this article, n their Web site and include infrmatin abut it in a listserv message within ne week f the availability f the prvider educatin article. In additin, the prvider educatin article shall be included in yur next regularly scheduled bulletin. Cntractrs are free t supplement MLN Matters articles with lcalized infrmatin that wuld benefit their prvider cmmunity in billing and administering the Medicare prgram crrectly. A/B MAC DME MAC X X X X FI CARRIER RHHI Shared-System Maintainers FISS MCS VMS CWF OTHER
IV. SUPPORTING INFORMATION Sectin A: Fr any recmmendatins and supprting infrmatin assciated with listed requirements, use the bx belw: N/A Use "Shuld" t dente a recmmendatin. X-Ref Requirement Number Recmmendatins r ther supprting infrmatin: Sectin B: Fr all ther recmmendatins and supprting infrmatin, use this space: N/A V. CONTACTS Pre-Implementatin Cntact(s): Jean Stiller (cverage), 410-786-0708, jean.stiller@cms.hhs.gv, Pat Brcat-Simns (cverage), 410-786-0261, patricia.brcatsimns@cms.hhs.gv Pst-Implementatin Cntact(s): Apprpriate RO. VI. FUNDING Sectin A: Fr Fiscal Intermediaries (FIs), Carriers, and Reginal Hme Health Carriers (RHHIs) use nly ne f the fllwing statements: N additinal funding will be prvided by CMS; cntractr activities are t be carried ut within their perating budgets. Sectin B: Fr Medicare Administrative Cntractrs (MACs), use the fllwing statement: The Medicare administrative cntractr is hereby advised that this cnstitutes technical directin as defined in yur cntract. CMS des nt cnstrue this as a change t the MAC Statement f Wrk. The cntractr is nt bligated t incur csts in excess f the amunts alltted in yur cntract unless and until specifically authrized by the cntracting fficer. If the cntractr cnsiders anything prvided, as described abve, t be utside the current scpe f wrk, the cntractr shall withhld perfrmance n the part(s) in questin and immediately ntify the cntracting fficer, in writing r by e-mail, and request frmal directins regarding cntinued perfrmance requirements.
Medicare Natinal Cverage Determinatins Manual Chapter 1, Part 4 (Sectins 200 310.1) Cverage Determinatins Table f Cntents (Rev.86, 07-03-08) 240.4 Cntinuus Psitive Airway Pressure (CPAP) Therapy fr Obstructive Sleep Apnea (OSA) (Effective March 13, 2008)
240.4 - Cntinuus Psitive Airway Pressure (CPAP) Therapy Fr Obstructive Sleep Apnea (OSA) (Effective March 13, 2008) (Rev.86, Issued: 07-03-08, Effective: 03-13-08, Implementatin: 08-04-08) A. General Cntinuus Psitive Airway Pressure (CPAP) is a nn-invasive technique fr prviding single levels f air pressure frm a flw generatr, via a nse mask, thrugh the nares. The purpse is t prevent the cllapse f the rpharyngeal walls and the bstructin f airflw during sleep, which ccurs in bstructive sleep apnea (OSA). The apnea hyppnea index (AHI) is equal t the average number f episdes f apnea and hyppnea per hur. The respiratry disturbance index (RDI) is equal t the average number f respiratry disturbances per hur. Apnea is defined as a cessatin f airflw fr at least 10 secnds. Hyppnea is defined as an abnrmal respiratry event lasting at least 10 secnds with at least a 30% reductin in thracabdminal mvement r airflw as cmpared t baseline, and with at least a 4% xygen desaturatin. The AHI and/r RDI may be measured by plysmngraphy (PSG) in a facility-based sleep study labratry, r by a Type II hme sleep test (HST) mnitr, a Type III HST mnitr, r a Type IV HST mnitr measuring at least 3 channels. B. Natinally Cvered Indicatins Effective fr claims with dates f service n and after March 13, 2008, the Centers fr Medicare & Medicaid Services (CMS) determines that CPAP therapy when used in adult patients with OSA is cnsidered reasnable and necessary under the fllwing situatins: 1. The use f CPAP is cvered under Medicare when used in adult patients with OSA. Cverage f CPAP is initially limited t a 12-week perid t identify beneficiaries diagnsed with OSA as subsequently described wh benefit frm CPAP. CPAP is subsequently cvered nly fr thse beneficiaries diagnsed with OSA wh benefit frm CPAP during this 12-week perid. 2. The prvider f CPAP must cnduct educatin f the beneficiary prir t the use f the CPAP device t ensure that the beneficiary has been educated in the prper use f the device. A caregiver, fr example a family member, may be cmpensatry, if cnsistently available in the beneficiary's hme and willing and able t safely perate the CPAP device. 3. A psitive diagnsis f OSA fr the cverage f CPAP must include a clinical evaluatin and a psitive: a. attended PSG perfrmed in a sleep labratry; r
b. unattended HST with a Type II hme sleep mnitring device; r c. unattended HST with a Type III hme sleep mnitring device; r d. unattended HST with a Type IV hme sleep mnitring device that measures at least 3 channels. 4. The sleep test must have been previusly rdered by the beneficiary s treating physician and furnished under apprpriate physician supervisin. 5. An initial 12-week perid f CPAP is cvered in adult patients with OSA if either f the fllwing criterin using the AHI r RDI are met: a. AHI r RDI greater than r equal t 15 events per hur, r b. AHI r RDI greater than r equal t 5 events and less than r equal t 14 events per hur with dcumented symptms f excessive daytime sleepiness, impaired cgnitin, md disrders r insmnia, r dcumented hypertensin, ischemic heart disease, r histry f strke. 6. The AHI r RDI is calculated n the average number f events f per hur. If the AHI r RDI is calculated based n less than 2 hurs f cntinuus recrded sleep, the ttal number f recrded events t calculate the AHI r RDI during sleep testing must be at a minimum the number f events that wuld have been required in a 2-hur perid. 7. Apnea is defined as a cessatin f airflw fr at least 10 secnds. Hyppnea is defined as an abnrmal respiratry event lasting at least 10 secnds with at least a 30% reductin in thracabdminal mvement r airflw as cmpared t baseline, and with at least a 4% xygen desaturatin. 8. Cverage with Evidence Develpment (CED): Medicare prvides the fllwing limited cverage fr CPAP in adult beneficiaries wh d nt qualify fr CPAP cverage based n criteria 1-7 abve. A clinical study seeking Medicare payment fr CPAP prvided t a beneficiary wh is an enrlled subject in that study must address ne r mre f the fllwing questins a. In Medicare-aged subjects with clinically identified risk factrs fr OSA, hw des the diagnstic accuracy f a clinical trial f CPAP cmpare with PSG and Type II, III & IV HST in identifying subjects with OSA wh will respnd t CPAP? b. In Medicare-aged subjects with clinically identified risk factrs fr OSA wh have nt undergne cnfirmatry testing with PSG r Type II, III & IV HST, des CPAP cause clinically meaningful harm? The study must meet the fllwing additinal standards:
c. The principal purpse f the research study is t test whether a particular interventin ptentially imprves the participants health utcmes. d. The research study is well-supprted by available scientific and medical infrmatin r it is intended t clarify r establish the health utcmes f interventins already in cmmn clinical use. e. The research study des nt unjustifiably duplicate existing studies. f. The research study design is apprpriate t answer the research questin being asked in the study. g. The research study is spnsred by an rganizatin r individual capable f executing the prpsed study successfully. h. The research study is in cmpliance with all applicable Federal regulatins cncerning the prtectin f human subjects fund at 45 CFR Part 46. If a study is Fd and Drug Administratin-regulated, it als must be in cmpliance with 21 CFR Parts 50 and 56. i. All aspects f the research study are cnducted accrding t the apprpriate standards f scientific integrity. j. The research study has a written prtcl that clearly addresses, r incrprates by reference, the Medicare standards. k. The clinical research study is nt designed t exclusively test txicity r disease pathphysilgy in healthy individuals. Trials f all medical technlgies measuring therapeutic utcmes as ne f the bjectives meet this standard nly if the disease r cnditin being studied is life-threatening as defined in 21 CFR 312.81(a) and the patient has n ther viable treatment ptins. l. The clinical research study is registered n the ClinicalTrials.gv Web site by the principal spnsr/investigatr prir t the enrllment f the first study subject. m. The research study prtcl specifies the methd and timing f public release f all pre-specified utcmes t be measured, including release f utcmes if utcmes are negative r study is terminated early. The results must be made public within 24 mnths f the end f data cllectin. If a reprt is planned fr publicatin in a peer-reviewed jurnal, then that initial release may be an abstract that meets the requirements f the Internatinal Cmmittee f Medical Jurnal Editrs. Hwever, a full reprt f the utcmes must be made public n later than 3 years after the end f data cllectin. n. The research study prtcl must explicitly discuss subppulatins affected by the treatment under investigatin, particularly traditinally underrepresented grups in clinical studies, hw the inclusin and exclusin criteria affect enrllment f these
ppulatins, and a plan fr the retentin and reprting f said ppulatins in the trial. If the inclusin and exclusin criteria are expected t have a negative effect n the recruitment r retentin f underrepresented ppulatins, the prtcl must discuss why these criteria are necessary.. The research study prtcl explicitly discusses hw the results are r are nt expected t be generalizable t the Medicare ppulatin t infer whether Medicare patients may benefit frm the interventin. Separate discussins in the prtcl may be necessary fr ppulatins eligible fr Medicare due t age, disability, r Medicaid eligibility. C. Natinally Nn-cvered Indicatins Effective fr claims with dates f services n and after March 13, 2008, ther diagnstic tests fr the diagnsis f OSA ther than thse nted abve fr prescribing CPAP are nt cvered. D. Other N/A (This NCD last reviewed March 2008.)