TEXAS-MAC - PART B-TRAILBLAZER TABLE OF CONTENTS
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1 TABLE OF CONTENTS CPT t LCD ID... 4 L Autmatic Implantable Cardiac Defibrillatr (AICD) - 4C-58AB L Cardiac Catheterizatin - 4C-50AB L Transthracic Echcardigraphy (TTE) - 4C-52AB L Interventinal Cardilgy - 4C-54AB L Cardivascular Stress Testing - 4C-55AB L Cardivascular Nuclear Medicine 4C-57AB L Bne Mass Measurement (BMM) - 4X-60AB L Barium Swallw Studies, Mdified - 4F-65AB L Crysurgical and Radifrequency Ablatin f Hepatic Tumrs - 4S- 152AB L Vertebrplasty, Kyphplasty; Percutaneus - 4S-153AB L Transesphageal Echcardigraphy (TEE) L Endvascular Repair fr Descending Thracic Aneurysm (DTA) - 4S-147AB L Thracic Artgraphy and Cartid, Vertebral and Subclavian Angigraphy - 4X-59AB L Nn-Crnary Vascular Stents - 4S-141AB L Treatment f Varicse Veins in Lwer Extremities - 4S-144AB L MRI and CT Scans f Thrax and Chest - 4X-58AB L MRI f a Jint - 4X-47AB L Vascular Access fr Hemdialysis - 4S-142AB L Upper Gastrintestinal Endscpy With/Withut Ultrasund - 4S- 133AB L D Interpretatin and Reprting f Imaging Studies - 4X-48AB L Radipharmaceuticals: Mnclnal Antibdies, Diagnstic - 4X- 50AB L Pain Management - 4S-149AB L Nn-Invasive Cerebrvascular Studies - 4U-19AB L Nn-Invasive Peripheral Arterial Studies - 4U-20AB L Nn-Invasive Venus Studies - 4U-21AB L Ultrasund, Abdminal and Retrperitneal - 4U-22AB L Psitrn Emissin Tmgraphy (PET) - 4X-54AB Cpyright 2008 CdeMap Page 1
2 TABLE OF CONTENTS L MRI and CT Scans f the Head and Brain - 4X-57AB L Diagnstic Abdminal Artgraphy and Renal Angigraphy - 4X- 55AB L Vertebral Fracture Assessment (VFA) - 4X-49AB L Magnetic Resnance Angigraphy (MRA) f the Head and Neck, Chest, Abdmen and Pelvis, Lwer Extremities - 4X-56AB L Mammgraphy, Diagnstic - 4X-61AB L MRI and CT Scans f the Spine - 4X-62AB L Thrmblytic Agents - 4I-91AB L Transcatheter Therapy Other Than Thrmblysis, Chemtherapy r Emblizatin - 4Y-24AB L Pachymetry - 4O-62AB L Ophthalmic A and B Scans - 4O 55AB L Nn-Cvered Services 4Z-18AB L Helicbacter Pylri Testing 4L-105AB L Grenz Ray Treatment - 4R-20AB L Intensity-Mdulated Radiatin Therapy (IMRT) - 4R-22AB L Brachytherapy: Nn-Intracrnary - 4R-21AB L Steretactic Bdy Radiatin Therapy - 4R 24AB L Steretactic Radisurgery - 4R 25AB L Radiatin Onclgy: External Beam/Teletherapy 4R-23AB Cpyright 2008 CdeMap Page 2
3 CPT t LCD ID CPT t LCD ID CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26772 Cpyright 2008 CdeMap Page 4
4 CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26763 Cpyright 2008 CdeMap Page 5
5 CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26763 Cpyright 2008 CdeMap Page 6
6 CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26806 Cpyright 2008 CdeMap Page 7
7 CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26833 Cpyright 2008 CdeMap Page 8
8 CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26839 Cpyright 2008 CdeMap Page 9
9 CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26583 Cpyright 2008 CdeMap Page 10
10 CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26723 Cpyright 2008 CdeMap Page 11
11 CPT...LCD ID L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L26747 Cpyright 2008 CdeMap Page 12
12 CPT...LCD ID L L L L L L L L L26737 G L26584 G L26764 G L26764 Cpyright 2008 CdeMap Page 13
13 L26500 L Autmatic Implantable Cardiac Defibrillatr (AICD) - 4C-58AB L26500 LCD ID Number: L26500 LCD Title: Autmatic Implantable Cardiac Defibrillatr (AICD) - 4C-58AB Cntractr's Determinatin Number: 4C-58 CMS Natinal Cverage Plicy: Medicare Benefit Plicy Manual Pub Medicare Natinal Cverage Determinatins Manual Pub Crrect Cding Initiative Medicare Cntractr Beneficiary and Prvider Cmmunicatins Manual Pub , Chapter 5. Scial Security Act (Title XVIII) Standard References, Sectins: 1862 (a)(1)(a) Medically Reasnable and Necessary (a)(1)(d) Investigatinal r Experimental (e) Incmplete Claim. Primary Gegraphic Jurisdictin: Texas Original Determinatin Effective Date: 03/01/2008 Revisin Effective Date: 03/01/2008 Indicatins and Limitatins f Cverage and/r Medical Necessity: Implantatin r replacement f autmatic implantable cardiac defibrillatr, with r withut sensing electrdes. The fllwing are the nly cvered indicatins as published CMS in the Natinal Cverage Determinatins (NCD) Manual, Publicatin 100-3, Sectin 20.4 (frmerly CIM 35-85) quted belw exactly and as amended by Change Request 3604 fr dates f service n r after January 27, 2005). Based n this, these are the nly circumstances under which prviders shuld submit claims fr Medicare payment (even thugh the ICD-9-CMs used fr cverage might therwise indicate ther cnditins): The implantable autmatic defibrillatr is an electrnic device designed t detect and treat life-threatening tachyarrhythmias. The device cnsists f a pulse generatr and electrdes fr sensing and defibrillating. A. Cvered Indicatins Cpyright 2008 CdeMap Page 14
14 L26500 Dcumented episde f cardiac arrest due t Ventricular Fibrillatin (VF), nt due t a transient r reversible cause (effective July 1, 1991). Dcumented sustained Ventricular Tachyarrhythmia (VT), either spntaneus r induced by an Electrphysilgy (EP) study, nt assciated with an acute Mycardial Infarctin (MI) and nt due t a transient r reversible cause (effective July 1, 1999). Dcumented familial r inherited cnditins with a high risk f life-threatening VT, such as lng QT syndrme r hypertrphic cardimypathy (effective July 1, 1999). Additinal indicatins effective fr services perfrmed n r after Octber 1, 2003 are: Crnary artery disease with a dcumented prir MI, a measured Left Ventricular Ejectin Fractin (LVEF) 0.35 and inducible, sustained VT r VF at EP study. (The MI must have ccurred mre than 40 days prir t defibrillatr insertin. The EP test must be perfrmed mre than fur weeks after the qualifying MI.) Dcumented prir MI and a measured LVEF 0.30 and a QRS duratin f > 120 millisecnds (the QRS restrictin des nt apply t services perfrmed n r after January 27, 2005). Patients must nt have: New Yrk Heart Assciatin (NYHA) classificatin IV. Cardigenic shck r symptmatic hyptensin while in a stable baseline rhythm. Had a Crnary Artery Bypass Graft (CABG) r Percutaneus Transluminal Crnary Angiplasty (PTCA) within the past three mnths. Had an enzyme-psitive MI within the past mnth. (Effective fr services n r after January 27, 2005, patients must nt have an acute MI in the past 40 days.) Clinical symptms r findings that wuld make them a candidate fr crnary revascularizatin. Any disease, ther than cardiac disease (e.g., cancer, uremia, liver failure), assciated with a likelihd f survival less than ne year. Additinal indicatins effective fr services perfrmed n r after January 27, 2005 are: Patients with ischemic dilated cardimypathy (IDCM), dcumented prir MI, NYHA Class II and III heart failure, and measured LVEF 35. Patients with nn-ischemic dilated cardimypathy (NIDCM) > 9 mnths, NYHA Class II and III heart failure, and measured LVEF 35 Cpyright 2008 CdeMap Page 15
15 L Patients wh meet all current Centers fr Medicare Medicaid Services (CMS) cverage requirements fr a cardiac resynchrnizatin therapy (CRT) device and have NYHA Class IV heart failure. All indicatins must meet the fllwing criteria: Patients must nt have irreversible brain damage frm preexisting cerebral disease. MIs must be dcumented and defined accrding t the cnsensus dcument f the Jint Eurpean Sciety f Cardilgy/American Cllege f Cardilgy Cmmittee fr the Redefinitin f Mycardial Infarctin. 1 When Autmatic Implantable Cardiac Defibrillatr (AICD) is used fr primary preventin f sudden cardiac death, the fllwing criteria must als be met: Patients must be able t give infrmed cnsent. Patients must nt have: Cardigenic shck r symptmatic hyptensin while in a stable baseline rhythm. Had a CABG r PTCA within the past three mnths. Had an acute MI within the past 40 days. Clinical symptms r findings that wuld make them a candidate fr crnary revascularizatin. Any disease, ther than cardiac disease (e.g., cancer, uremia, liver failure), assciated with a likelihd f survival less than ne year. Ejectin fractins must be measured by angigraphy, radinuclide scanning r echcardigraphy. The beneficiary receiving the defibrillatr implantatin fr primary preventin is enrlled in either a Fd and Drug Administratin (FDA)- apprved categry B Investigatinal Device Exemptin (IDE) clinical trial (42 CFR Sectin ), a trial under the CMS Clinical Trial Plicy (NCD, Sectin 310.1) r a qualifying data cllectin system including apprved clinical trials and registries. Initially, an Implantable Cardiac Defibrillatr (ICD) database will be maintained using a data submissin mechanism that is already in use by Medicare-participating hspitals t submit data t the Iwa Fundatin fr Medical Care (IFMC) a Quality Imprvement Organizatin (QIO) cntractr fr determinatin f Cpyright 2008 CdeMap Page 16
16 L26500 reasnableness and necessity and quality imprvement. Initial hypthesis and data elements are specified in this decisin (Appendix VI) and are the minimum necessary t ensure that the device is reasnable and necessary. Data cllectin will be cmpleted using the ICDA (ICD Abstractin Tl) and transmitted via Quality Netwrk Exchange (QNet) t the IFMC, which will cllect and maintain the database. Additinal stakehlderdevelped data cllectin systems t augment r replace the initial QNet system, addressing at a minimum the hyptheses specified in this decisin, must meet the fllwing basic criteria: Written prtcl n file. Institutinal review bard review and apprval. Scientific review and apprval by tw r mre qualified individuals wh are nt part f the research team. Certificatin that investigatrs have nt been disqualified. Fr purpses f this cverage decisin, CMS will determine whether specific registries r clinical trials meet these criteria. Prviders must be able t justify the medical necessity f devices ther than single lead devices. This justificatin shuld be available in the patient s medical recrd. Patients with NIDCM > three mnths, NYHA Class II r III heart failure and measured LVEF 35, nly if the fllwing additinal criteria are als met: Patients must be able t give infrmed cnsent. Patients must nt have: Cardigenic shck r symptmatic hyptensin while in a stable baseline rhythm. Had a CABG r PTCA within the past three mnths. Had an acute MI within the past 40 days. Clinical symptms r findings that wuld make them a candidate fr crnary revascularizatin. Irreversible brain damage frm preexisting cerebral disease. Any disease, ther than cardiac disease (e.g. cancer, uremia, liver failure), assciated with a likelihd f survival less than ne year. Cpyright 2008 CdeMap Page 17
17 L26500 Ejectin fractins must be measured by angigraphy, radinuclide scanning r echcardigraphy. MIs must be dcumented and defined accrding t the cnsensus dcument f the Jint Eurpean Sciety f Cardilgy/American Cllege f Cardilgy Cmmittee fr the Redefinitin f Mycardial Infarctin. 2 ) The beneficiary receiving the defibrillatr implantatin fr this indicatin is enrlled in either an FDA-apprved categry B IDE clinical trial (42 CFR Sectin ), a trial under the CMS Clinical Trial Plicy (NCD, Sectin 310.1) r a prspective data cllectin system meeting the fllwing basic criteria: Written prtcl n file. Institutinal Review Bard review and apprval. Scientific review and apprval by tw r mre qualified individuals wh are nt part f the research team. Certificatin that investigatrs have nt been disqualified. Fr purpses f this cverage decisin, CMS will determine whether specific registries r clinical trials meet these criteria. Prviders must be able t justify the medical necessity f devices ther than single-lead devices. This justificatin shuld be available in the patient's medical recrd. B. Other Indicatins All ther indicatins fr implantable autmatic defibrillatrs nt currently cvered in accrdance with this decisin will cntinue t be cvered under Categry B IDE trials (42 CFR Sectin ) and the CMS Rutine Clinical Trials Plicy (NCD, Sectin 310.1). Either ne f the fllwing criteria satisfies the diagnsis fr an acute, evlving r recent MI: Typical rise and gradual fall (trpnin) r mre rapid rise and fall (CK-MB) f bichemical markers f mycardial necrsis with at least ne f the fllwing: Ischemic symptms. Develpment f pathlgic Q waves n the ECG. ECG changes indicative f ischemia (ST segment elevatin r depressin). Crnary artery interventin (e.g., crnary angiplasty). Pathlgic findings f an acute MI. Cpyright 2008 CdeMap Page 18
18 L26500 C. Criteria fr Established MI Any ne f the fllwing criteria satisfies the diagnsis fr established MI: 1 Alpert and Thygesen et al., Criteria fr acute, evlving r recent MI. 2 Ibid Develpment f new pathlgic Q waves n serial ECGs. The patient may r may nt remember previus symptms. Bichemical markers f mycardial necrsis may have nrmalized, depending n the length f time that has passed since the infarctin develped. Pathlgic findings f a healed r healing MI. Nte: Type f Bill and Revenue Cdes DO NOT apply t Part B. Cverage Tpic: Surgical Services Bill Type Cdes: Cntractrs may specify Bill Types t help prviders identify thse Bill Types typically used t reprt this service. Absence f a Bill Type des nt guarantee that the plicy des nt apply t that Bill Type. Cmplete absence f all Bill Types indicates that cverage is nt influenced by Bill Type and the plicy shuld be assumed t apply equally t all claims. Revenue Cdes: Cntractrs may specify Revenue Cdes t help prviders identify thse Revenue Cdes typically used t reprt this service. In mst instances Revenue Cdes are purely advisry; unless specified in the plicy services reprted under ther Revenue Cdes are equally subject t this cverage determinatin. Cmplete absence f all Revenue Cdes indicates that cverage is nt influenced by Revenue Cde and the plicy shuld be assumed t apply equally t all Revenue Cdes. CPT/HCPCS Cdes: Nte: Prviders are reminded t refer t the lng descriptrs f the CPT cdes in their CPT bk. The American Medical Assciatin (AMA) and the Centers fr Medicare and Medicaid Services (CMS) require the use f shrt CPT descriptrs in plicies published n the Web INSERTION OF SINGLE OR DUAL CHAMBER PACING CARDIOVERTER- DEFIBRILLATOR PULSE GENERATOR SUBCUTANEOUS REMOVAL OF SINGLE OR DUAL CHAMBER PACING CARDIOVERTER- DEFIBRILLATOR PULSE GENERATOR REMOVAL OF SINGLE OR DUAL CHAMBER PACING CARDIOVERTER- DEFIBRILLATOR ELECTRODE(S); BY THORACOTOMY Cpyright 2008 CdeMap Page 19
19 L REMOVAL OF SINGLE OR DUAL CHAMBER PACING CARDIOVERTER- DEFIBRILLATOR ELECTRODE(S); BY TRANSVENOUS EXTRACTION INSERTION OR REPOSITIONING OF ELECTRODE LEAD(S) FOR SINGLE OR DUAL CHAMBER PACING CARDIOVERTER-DEFIBRILLATOR AND INSERTION OF PULSE GENERATOR ICD-9 Cdes that Supprt Medical Necessity: The CPT/HCPCS cdes included in this LCD will be subjected t prcedure t diagnsis editing. The fllwing lists include nly thse diagnses fr which the identified CPT/HCPCS prcedures are cvered. If a cvered diagnsis is nt n the claim, the edit will autmatically deny the service as nt medically necessary. Nte: Prviders shuld cntinue t submit ICD-9-CM diagnsis cdes withut decimals n their claim frms and electrnic claims. Medicare is establishing the fllwing limited cverage fr CPT/HCPCS cdes 33240, 33241, 33243, and 33249: Cvered fr: Malignant hypertensin with cngestive heart failure Benign hypertensin with cngestive heart failure Unspecified hypertensin with cngestive heart failure Hypertensive heart and chrnic kidney disease, malignant, with heart failure and with chrnic kidney disease stage I thrugh stage IV, r unspecified Hypertensive heart and chrnic kidney disease, benign, with heart failure and with chrnic kidney disease stage I thrugh stage IV, r unspecified Hypertensive heart and chrnic kidney disease, benign, with heart failure and chrnic kidney disease stage V r end stage renal disease Hypertensive heart and chrnic kidney disease, unspecified, with heart failure and with chrnic kidney disease stage I thrugh stage IV, r unspecified Hypertensive heart and chrnic kidney disease, unspecified, with heart failure and chrnic kidney disease stage V r end stage renal disease Infarctin f anterlateral wall, episde f care unspecified - Infarctin f anterlateral wall, subsequent episde f care Infarctin f ther anterir wall, episde f care unspecified - Infarctin f ther anterir wall, subsequent episde f care Infarctin f inferlateral wall, episde f care unspecified - Infarctin f inferlateral wall, subsequent episde f care Infarctin f inferpsterir wall, episde f care unspecified - Infarctin f inferpsterir wall,subsequent episde f care Infarctin f ther inferir wall, episde f care unspecified - Infarctin f ther inferir wall, subsequent episde f care Infarctin f ther lateral wall, episde f care unspecified - Infarctin f ther lateral wall, subsequent episde f care True psterir wall infarctin, episde f care unspecified - True psterir wall infarctin, subsequent episde f care Subendcardial infarctin, episde f care unspecified - Subendcardial infarctin, subsequent episde f care Cpyright 2008 CdeMap Page 20
20 L Infarctin f ther specified sites, episde f care unspecified - Infarctin f ther specified sites, subsequent episde f care Infarctin, unspecified site, episde f care unspecified - Infarctin, unspecified site, subsequent episde f care 412 Old mycardial infarctin Other specified frms f chrnic ischemic heart disease Hypertrphic bstructive cardimypathy Other primary cardimypathies Lng QT syndrme Parxysmal ventricular tachycardia Ventricular fibrillatin Cardiac arrest Other nde dysfunctin Cngestive heart failure Left heart failure Systlic heart failure, unspecified - Systlic heart failure, acute n chrnic Diastlic heart failure, unspecified - Diastlic heart failure, acute n chrnic Cmbined systlic and diastlic heart failure, unspecified - Cmbined systlic and diastlic heart failure, acute n chrnic Heart failure, unspecified Other heart anmalies Other cmplicatins due t ther cardiac device, implant, and graft Diagnsis that supprt medical necessity. N/A ICD-9 Cdes that DO NOT Supprt Medical Necessity Asterisk Explanatin N/A Diagnses that DO NOT Supprt Medical Necessity All diagnses nt listed in the ICD-9-CM Cdes That Supprt Medical Necessity sectin f this LCD. Dcumentatin Requirements Dcumentatin supprting medical necessity shuld be legible, maintained in the patient s medical recrd and made available t Medicare upn request. Only ne f the diagnses listed abve is required, but the criteria listed in the Indicatins and Limitatins f Cverage and/r Medical Necessity sectin must be fulfilled t bill Medicare. The medical recrd must specify explicitly hw the criteria have been fulfilled. Appendices N/A Utilizatin Guideline N/A Surces f Infrmatin and Basis fr Decisin J4 (CO, NM, OK, TX) MAC Integratin TrailBlazer adpted the Nridian Administrative Services, LLC LCD, Autmatic Cpyright 2008 CdeMap Page 21
21 L26500 Implantable Cardiac Defibrillatr (AICD), fr the Jurisdictin 4 (J4) MAC transitin. Full disclsure f surces f infrmatin is fund with riginal cntractr LCD. Other Cntractr Lcal Cverage Determinatins Autmatic Implantable Cardiac Defibrillatr (AICD), Nridian Administrative Services, LLC LCD, (CO) L Advisry Cmmittee Meeting Ntes Start Date f Cmment Perid: End Date f Cmment Perid: Start Date f Ntice Perid: 12/20/2007 Revisin Histry Number: J4 Revisin Histry Explanatin N/A 06/13/2008 LCD effective in TX Part A and Part B and Part A CO and NM 06/13/2008 N/A 03/21/2008 LCD effective in CO Part B 03/21/2008 N/A 03/01/2008 LCD effective in NM Part B and OK Part A and Part B 03/01/ /20/2007 Cnslidated LCD psted fr ntice effective: 12/20/2007 Last Reviewed On Date: 06/12/2008 Cpyright 2008 CdeMap Page 22
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