# DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9075-N]

Medicare and Medicaid Programs; Quarte rly Listing of Program Issuances—

July through September 2012

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice

SUMMARY: This quarterly notice lists CMS manual in structions, substantive and interpretive

regulations, and other Federal Register notices that were published from July through September

2012, relating to the Medicare and Me dicaid programs and other programs administered by CMS.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may need

specific information and not be able to determine from the listed information whether the issuance

or regulation would fulfill that need. Consequen tly, we are providing contact persons to answer

general questions concerning each of the addenda published in this notice.

Addenda Contact Phone Number

I CMS Manual Instructions Ismael Torres (410) 786-1864

II Regulation Documents Published in the Federal Register Terri Plumb (410) 786-4481

III CMS Rulings Tiffany Lafferty (410)786-7548

IV Medicare National Coverage Determ inations Wanda Belle (410) 786-7491

V FDA-Approved Category B IDEs John Manlove (410) 786-6877

VI Collections of Information Mitch Bryman (410) 786-5258

VII Medicare –Approved Carotid Stent F acilities Sarah J. Mc Clain (410) 786-2294

VIII American College of Cardiology-Nationa l Cardiovascular Data Registry Site s JoAnna Baldwin, MS (410) 786-7205

IX Medicare’s Active Coverage-Related Gu idance Documents Lori Ashby (410) 786-6322

X One-time Notices Regarding National Cove rage Provisions Lori Ashby (410) 786-6322

XI National Oncologic Positron Emission Tomography Regi stry Sites Stuart Caplan, RN, MAS (410) 786-8564

XII Medicare-Approved Ventricular Assist Device (Destinati on Therapy) Facilities JoAnna Baldwin, MS (410) 786-7205

XIII Medicare-Approved Lung Volume Re duction Surgery Facilities JoAnna Baldwin, MS (410) 786-7205

XIV Medicare-Approved Bariatric Surgery Facilities Kate Tillman, RN, MAS (410) 786-9252

XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials Stuart Caplan, RN, MAS (410) 786-8564

All Other Information Annette Brewer (410) 786-6580



# I. Background

Among other things, the Centers for Medicare & Medicaid Services (CMS) is responsible

for administering the Medicare a nd Medicaid programs and coordina tion and oversight of private

health insurance. Administration and oversight of these programs involves the following: (1)

furnishing information to Medicare and Medicaid benefi ciaries, health care providers, and the

# 2

public; and (2) maintaining effective communi cations with CMS regional offices, State

governments, State Medicaid agencies, State survey agencies, various providers of health care, all

Medicare contractors that process claims a nd pay bills, National Association of Insurance

Commissioners (NAIC), health insu rers, and other stakeholders. To implement the various statutes

on which the programs are based, we issue regulations under the authority granted to the Secretary

of the Department of Health and Human Services under sections 1102, 1871, 1902, and related

provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue

various manuals, memoranda, and statements nece ssary to administer and oversee the programs

efficiently.

Section 1871(c) of the Act requires that we publish a list of all Medicare manual

instructions, interpretive rules, statements of policy, and guidelines of general applicability not

issued as regulations at le ast every 3 months in the Federal Register

.

II. Revised Format for th e Quarterly Issuance Notices

While we are publishing the quarterly notice re quired by section 1871(c) of the Act, we will

no longer republish duplicative information that is av ailable to the public elsewhere. We believe

this approach is in alignment with CMS’ commitment to the general principles of the President’s

Executive Order 13563 released January 2011enti tled “Improving Regulation and Regulatory

Review,” which promotes modifying and streamlini ng an agency’s regulator y program to be more

effective in achieving regulatory objectives. Sec tion 6 of Executive Order 13563 requires agencies

to identify regulations that may be “outmoded, ine ffective, insufficient, or excessively burdensome,

and to modify, streamline, expand or repeal them in accordance with what has been learned.” This

approach is also in alignment with the President’s Open Government and Transparency Initiative

that establishes a system of transparency, public particip ation, and collaboration.

Therefore, this quarterly notice provides only th e specific updates that have occurred in the

3-month period along with a hyperlink to the full listi ng that is available on the CMS website or the

# 3

appropriate data registries that ar e used as our resources. This in formation is the most current upto-date information and will be available earlier th an we publish our quarterly notice. We believe

the website list provides more timely access for be neficiaries, providers, and suppliers. We also

believe the website offers a more convenient tool for the public to find th e full list of qualified

providers for these specific services and offers more flexibility and “real time” accessibility. In

addition, many of the websites have listservs; that is, the public can subscribe and receive

immediate notification of any updates to the website . These listservs avoid the need to check the

website, as notification of updates is automatic and sent to the subs criber as they occu r. If assessing

a Website proves to be difficult, the contact person listed can provide information.

III. How to Use the Notice

This notice is organized into 15 addenda so th at a reader may access the subjects published during

the quarter covered by the notice to determine whether any are of partic ular interest. We expect this

notice to be used in concert with previously pub lished notices. Those unf amiliar with a description

of our Medicare manuals should view the manuals at http://www.cms.gov/manuals

.

# 4

Authority : (Catalog of Federal Do mestic Assistance Program No. 93.773, Medicare--Hospital

Insurance, Program No. 93.774, Medicare--Supple mentary Medical Insurance Program, and

Program No. 93.714, Medical Assistance Program)

Dated: November 5, 2012

__________________________ Kathleen Cantwell,

Director,

Office of Strategic Operations and

Regulatory Affairs.

BILLING CODE 4120-01-P5Publication Dates for the Previous Four Quarterly NoticesWe publish this notice at theend of each quarter reflectinginformation released by CMS during the previous quarter. The publicationdates of the previous four Quarterly Listing of Program Issuances noticesare: December 16, 2011 (76 FR 78267),February 21, 2012(77 FR 9931),May 18, 2012 (77 FR 29648) and August 17, 2012 (77 FR 49799). For thepurposes of this quarterly notice, we are providing only the specific updatesthat have occurred in the 3-month period along with a hyperlink to thewebsite to access this information and a contact person for questions oradditional information.Addendum I: Medicare and Medicaid Manual Instructions(July through September 2012)The CMS Manual System is usedby CMS program components,partners, providers, contractors, Medicare Advantage organizations, andState Survey Agencies to administerCMS programs. It offers day-to-dayoperating instructions, policies, and procedures based on statutes andregulations, guidelines, models, and directives. In 2003, we transformed theCMS Program Manuals into a web user-friendly presentation and renamedit the CMS Online Manual System.How to Obtain ManualsThe Internet-only Manuals (IOMs)are a replica of the Agency’sofficial record copy. Paper-based manuals are CMS manuals that wereofficially released in hardcopy. The majority of these manuals weretransferred into the Internet-only manual (IOM) or retired. Pub 15-1, Pub15-2 and Pub 45 are exceptions to thisrule and are still active paper-basedmanuals. The remaining paper-based manuals are for reference purposesonly. If you notice policy contained in the paper-based manuals that wasnot transferred to the IOM, send a message via the CMS Feedback tool.Those wishing to subscribe to old versions of CMS manuals shouldcontact the National Technical Information Service, Department ofCommerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of chargeat:http://cms.gov/manuals.How to Review Transmittals or Program MemorandaThose wishing to review transmittals and program memoranda canaccess this information at a local Federal Depository Library (FDL). Underthe FDL program, government publications are sent to approximately 1,400designated libraries throughout the United States. Some FDLs may havearrangements to transfer material toa local library not designated as anFDL. Contact any library to locate the nearest FDL. This information isavailable athttp://www.gpo.gov/libraries/In addition, individuals may contact regional depository librariesthat receive and retain at least one copy of mostfederal governmentpublications, either in printed or microfilm form, for use by the generalpublic. These libraries provide reference services and interlibrary loans;however, they are not sales outlets. Individuals may obtain informationabout the location of the nearest regional depository library from anylibrary. CMS publication and transmittal numbers are shown in the listingentitled Medicare and Medicaid Manual Instructions. To help FDLs locatethe materials, use the CMS publication and transmittal numbers. Forexample, to find the Medicare National Coverage Determination publicationtitled Transcutaneous Electrical Nerve Stimulation (TENS) for ChronicLow Back Pain (CLBP) use CMS-Pub. 100-03, Transmittal No. 144.Addendum I lists a unique CMS transmittal number for eachinstruction in our manuals or program memoranda and its subject number.A transmittal may consist of a single ormultiple instruction(s). Often, it isnecessary to use information in a transmittal in conjunction withinformation currently in the manual. For the purposes of this quarterlynotice, we list only the specific updates to the list of manual instructionsthat have occurred in the 3-month period.This information is available onour website atwww.cms.gov/Manuals.TransmittalNumberManual/Subject/Publication NumberMedicare General Information (CMS-Pub. 100-01)79 January 2013 Quarterly Updates to theCMS Standard File for Reason Codesfor the Fiscal Intermediary Shared System (FISS)Medicare Benefit Policy (CMS-Pub. 100-02)00 NoneMedicare National CoverageDetermination (CMS-Pub. 100-03)144 Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low BackPain (CLBP)145 National Coverage Determination (NCD) for Transcatheter Aortic ValveReplacement (TAVR)146 Liver Transplantation for Patients with Malignancies Transcatheter AorticValve Replacement (TAVR) Adult Liver TransplantationMedicare Claims Processing (CMS-Pub. 100-04)2494 Pharmacy Billing for Drugs Provided "Incident To" a PhysicianService This CR rescinds and fully replaces CR 7109.2495 Validation of Payment Group Codes for Prospective Payment Systems (PPS)6Based on Patient Assessments SystematicValidation of Claims InformationUsing Patient Assessments2496 New Waived Tests2497 Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and theHospice Prices for FY 20132498 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction2499 Issued to a specific audience, notposted to Internet/Intranet/ due toConfidentiality of Instruction2500 Clarification of the Use of the Electronic Claim Format to Indicate Where aService Was PerformedPayment Jurisdiction Among Local B/MACs for Services Paid Under thePhysician Fee Schedule and AnesthesiaClaims Processing Instructions forPayment JurisdictionConditional Data Element Requirements for A/B MACs and DMEMACs2501 Issued to a specific audience, notposted to Internet/Intranet/ due toConfidentiality of Instruction2502 Issued to a specific audience, notposted to Internet/Intranet/ due toConfidentiality of Instruction2503 Issued to a specific audience, notposted to Internet/Intranet/ due toConfidentiality of Instruction2504 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction2505 Issued to a specific audience, notposted to Internet/Intranet/ due toConfidentiality of Instruction2506 Extracorporeal Photopheresis (ICD-10)2507 Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System(PPS) Pricer Update FY 20132508 Claim Status Category andClaim Status Codes Update2509 Issued to a specific audience, notposted to Internet/Intranet/ due toConfidentiality of Instruction2510 Payment of Global Surgical Split Carein a Method II Critical Access Hospital(CAH) Submitted with Modifier 54 and/or 552511 Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low BackPain (CLBP)2512 National Coverage Determination (NCD) for Transcatheter Aortic ValveReplacement (TAVR)Transcatheter Aortic Valve Replacement (TAVR) Furnished on or AfterMay 1, 2012Coding Requirements for Requirements for Transcatheter Aortic ValveReplacement (TAVR) Services Furnished On or After May 1, 2012Claims Processing Requirements for TAVR Services on Professional ClaimsClaims Processing Requirements for TAVR Services on Inpatient HospitalClaim2513 Liver Transplantation for Patientswith Malignancies Liver Transplants2514 October 2012 Quarterly Average Sales Price (ASP) Medicare Part B DrugPricing Files and Revisions to Prior Quarterly Pricing Files Notification forBeneficiaries Exceeding Financial Limitations2515 Handling Form CMS-1500 Hard Copy Claims Where an ICD-9-CM "E"Code or Where an ICD-10 V00-Y99 Codeis Reported as the First Diagnosison the ClaimConditional Data Element Requirements for A/B MACs and DMEMACsConsolidated Claims Crossover ProcessClaims Crossover Disposition and Coordination of Benefits Agreement ByPass Indicators2516 New Non- Physician Specialty Codefor Centralized Flu NonphysicianPractitioner, Supplier, and Provider Specialty Codes2517 Medicare Claims Processing Pub. 100-04 Chapter 24 Update for SecurityRequirements2518 Inpatient Rehabilitation Facility (IRF)Annual Update: Prospective PaymentSystem (PPS) Pricer Changes for FY 2013 Payment Provisions Under IRFPPS2519 New Fiscal Intermediary Shared System(FISS) Consistency Edit to ValidateAttending Physician NPI2520 Update-Inpatient Psychiatric Facilities Prospective Payment System (IPFPPS) Fiscal Year (FY) 2013 Annual Update2521 Claim Adjustment Reason Code (CARC), Remittance Advice Remark Code(RARC), and Medicare Remit Easy Print (MREP) and PC Print Update2522 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction2523 Revised Medicare Summary Notice (MSN) Message Regarding OutpatientTherapy Caps2524 Issued to a specific audience, notposted to Internet/Intranet/ due toConfidentiality of Instruction2525 October 2012 Update of the Ambulatory Surgical Center Payment System(ASC)2526 Annual Update for the Health Professional Shortage Area (HPSA) BonusPayments2527 Issued to a specific audience, not posted to Internet/Intranet/ due to Sensitivityof Instruction2528 Instructions for Downloading the Medicare ZIP Code File for January 20132529 Healthcare Common Procedure Coding System (HCPCS) Annual UpdateReminder2530 October Update to the CY 2012 Medicare Physician Fee Schedule Database(MPFSDB)2531 October 2012 Update of the Hospital Outpatient Prospective Payment System(OPPS)Transitional Outpatient Payments(TOPs) for CY 2010 through CY 2012Fiscal Intermediary Billing Requirements2532 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction2533 Issued to a specific audience, notposted to Internet/Intranet/ due toConfidentiality of Instruction2534 Healthcare Provider Taxonomy Codes (HPTC) Update, October 20122535 Chapter 24 Update to Remove OutdatedInformation FIs, Carriers, RHHIs,A/B MACs, and CEDI HIPAA Claim Level EditsInstitutional Implementation Guide (IG)Edits Institutional ImplementationGuide and Direct Data Entry Edits72536 Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 20122537 Expiration of 2012 Therapy Cap Revisions and User-Controlled Mechanismto Identify Legislative Effective Dates S2538 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction2539 Fiscal Year (FY) 2013 Inpatient Prospective Payment System (IPPS), LongTerm Care Hospital (LTCH) PPS Changes Medicare Code Editor (MCE)Disproportionate Share Hospital (DSH) Policy Changes Effective for CostReporting Periods beginningon or after October 1, 2009Disproportionate Share Hospital (DSH) Policy Changes Effective for CostReporting Periods beginningon or after October 1, 2012Repeat AdmissionsOutpatient Services Treated as Inpatient ServicesReplaced Devices Offered Without Cost or With a CreditAddenda A-Provider Specific File2540 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction2541 Issued to a specific, audience notposted to Internet/Intranet due toConfidentiality of Instruction2542 2013 Annual Update of Healthcare Common Procedure Coding System(HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing(CB) Update2543 Extracorporeal Photopheresis (ICD-10) Billing Requirements forExtracorporeal PhotopheresisHealthcare Common Procedural Coding System (HCPCS), ApplicableDiagnosis Codes and Procedure Code Medicare Summary Notices (MSNs),Remittance Advice Remark Codes (RAs) and Claim Adjustment ReasonCode2544 Contractor and Common Working File (CWF) Additional InstructionsRelated to Change Request (CR) 7633 -Screening and Behavioral CounselingInterventions in Primary Care to Reduce Alcohol Misuse2545 Issued to a specific audience, not posted to Internet/ Intranet due toConfidentiality of Instruction2546 Instructions for Retrieving the 2013Pricing and HCPCS Data Files throughCMS' Mainframe Telecommunications Systems2547 Claim Status Category andClaim Status Codes UpdateMedicare Secondary Payer (CMS-Pub. 100-05)87 Clarification of Medicare ConditionalPayment Policy and Billing Proceduresfor Liability, No-Fault and Workers’ Compensation Medicare SecondaryPayer (MSP) Claims.88 Expanding the Coordination of Benefits (COB) Contractor Numbers toinclude 11139 and 11142 for the Common Working File (CWF) Definition ofMSP/CWF Terms89 Expanding the Coordination of Benefits (COB) Contractor Numbers toinclude 11139 and 11142 for the Common Working File (CWF)Medicare Financial Management (CMS-Pub. 100-06)211 Notice of New Interest Rate for Medicare Overpayments and Underpayments– 4th Notification for FY 2011212 New Non- Physician Specialty Codefor Centralized Flu Claims ProcessingTimeliness - All ClaimsPart E/Interest Payment DataNon-Physician Practitioner/Supplier Specialty Codes210 Validation of Recovery Audit Program New IssuesMedicare State Operations Manual (CMS-Pub. 100-07)82 CMS Certification Numbers for Medicaid-Only Hospitals and New StateCode for Foreign CountriesMedicare Program Integrity (CMS-Pub. 100-08)00 NoneMedicare Contractor Beneficiary andProvider Communications (CMS-Pub. 100-09)00 NoneMedicare Quality Improvement Organization (CMS-Pub. 100-10)00 NoneMedicare End Stage Renal Disease Network Organizations (CMS Pub 100-14)00 NoneMedicare Managed Care (CMS-Pub. 100-16)108 This is the initial release of New Chapter 21, Compliance Program Guidelines109 This is the initial release of New Chapter 21, Compliance Program GuidelinesMedicare Business Partners Systems Security (CMS-Pub. 100-17)00 NoneDemonstrations (CMS-Pub. 100-19)84 Revisions to the Method of Cost Settlement for Inpatient Services for RuralHospitals Participating Under Demonstration Authorized by Section 410A ofthe Medicare Modernization Act. Sections 3123 and 10313 of the AffordableCare Act authorizes an expansion ofthe demonstration and an extension foran additional 5-year period. ThisCR makes revisions to CR 7505, whichgives instructions for the additional 5-year period.One Time Notification (CMS-Pub. 100-20)1101 Reporting of Recoupment for Overpayment on the Remittance Advice (RA)with Patient Control Number1102 Direction to Modify Institutional Reason Code 390121103 Health Insurance Portability andAccountability Act (HIPAA) 5010 and D.0Execution of the Annual Recertification Program1104 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction1105 Issued to a specific, audience notposted to Internet/Intranet due toConfidentiality of Instruction1106 Posting the Limiting Charge after Applying the e-Prescribing (eRx) NegativeAdjustment1107 The Medicare Secondary PayerPayment Module (MSPPAY) to beMaintained by the SharedSystem Maintainers for all Future Enhancements1108 Fee For Service Common Eligibility Services (FFS CES) - Common WorkingFile (CWF) Detail Analysis, Design and Requirements1109 Issued to a specific, audience notposted to Internet/Intranet due toConfidentiality of Instruction1110 Revision of Medicare Summary Notice (MSN) for Non-Competitive BidClaims1111 Expand Place of Service Address to Include Full Address81112 Health Insurance Portability and Accountability Act (HIPAA) 5010 837Institutional (8371) Edits and 5010 837 Professional (837P) EditsJanuary 20121113 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction1114 New Field Established within FISS and MCS1115 Implement Fraud Prevention Predictive Modeling Prepayment Edits forShared Systems (xref CR7787)1116 Implement Fraud Prevention Predictive Modeling Prepayment Edits forShared Systems (xref CR7787)1117 Manual Medical Review of Therapy Services1118 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivityof Instruction1119 Implementation of the Award for the Jurisdiction 5 Part A and Part BMedicare Administrative Contractor (J5 A/B MAC) Reprocurment Includinga New Workload Number for theRemaining WPS Legacy Workload1120 Issued to a specific, audience notposted to Internet/Intranet due toConfidentiality of Instruction1121 None1122 International Classification of Diseases (ICD)-10 Conversion from ICD-9 andRelated Code Infrastructure of the Medicare Shared Systems as They Relateto CMS National Coverage Determinations (NCDs) (CR 1 of 3) (ICD-10)Addendum II: Regulation Documents Publishedin the Federal Register (July through September 2012)Regulations and NoticesRegulations and notices are published in the dailyFederalRegister. To purchase individual copies or subscribe to theFederalRegister,contact GPO atwww.gpo.gov/fdsys. When ordering individualcopies, it is necessary to cite either the date of publication or the volumenumber and page number.TheFederal Registeris available as an online database throughGPO Access.The online database is updated by 6 a.m. each day theFederal Registeris published. The database includes both text andgraphics from Volume 59, Number 1 (January 2, 1994) through the presentdate and can be accessed athttp://www.gpoaccess.gov/fr/index.html. Thefollowing Websitehttp://www.archives.gov/federal-register/providesinformation on how to access electronic editions, printed editions, andreference copies.This information is available on our Website at:http://www.cms.gov/quarterlyproviderupdates/downloads/Regs3Q12QPU.pdfFor questions or additional information, contact Terri Plumb(410-786-4481).Addendum III: CMS RulingsCMS Rulings are decisions of the Administrator that serve asprecedent final opinions and orders and statements of policy andinterpretation. They provide clarification and interpretation of complex orambiguous provisions of the law or regulations relating to Medicare,Medicaid, Utilization and Quality Control Peer Review, private healthinsurance, and related matters.The rulings can be accessed athttp://www.cms.gov/Rulings/CMSR/list.asp#TopOfPage. For questions oradditional information, contact Tiffany Lafferty (410-786-7548).Addendum IV: Medicare National Coverage Determinations(July through September 2012)Addendum IV includes completed national coveragedeterminations (NCDs), or reconsiderations of completed NCDs, from thequarter covered by this notice. Completed decisions are identified by thesection of the NCD Manual (NCDM) inwhich the decision appears, thetitle, the date the publication was issued, and the effective date of thedecision. An NCD is a determinationby the Secretary for whether or not aparticular item or service is covered nationally under the Medicare Program(title XVIII of the Act), but does not include a determination of the code, ifany, that is assigned to a particular covered item or service, or paymentdetermination for a particular covereditem or service. The entries belowinclude information concerning completed decisions, as well as sections onprogram and decision memoranda, which also announce decisions or, insome cases, explain why it was not appropriate to issue an NCD.Information on completed decisions as well as pending decisions has alsobeen posted on the CMS website. For the purposes of this quarterly notice,we list only the specific updates that have occurred in the 3-month period.This information is available on our website at:www.cms.gov/medicarecoverage-database/. For questions or additional information, contactWanda Belle (410-786-7491).Title NCDMSectionTransmittalNumberIssue Date EffectiveDateLiver Transplantation forMalignanciesNCD260.1R146NCD 08/03/2012 07/13/2012Transcutaneous Electrical NerveStimulation (TENS) ChronicLow Back PainNCD160.27R144NCD 08/03/2012 06/08/20129Transcatheter Aortic ValveReplacement (TAVR)NCD20.32R145NCD 08/03/2012 05/01/2012Addendum V: FDA-Approved Category B Investigational DeviceExemptions (IDEs) (July through September 2012)Addendum V includes listings of the FDA-approvedinvestigational device exemption (IDE)numbers that the FDA assigns. Thelistings are organized according to the categories to which the devices areassigned (that is, Category A or Category B), and identified by the IDEnumber. For the purposes of this quarterly notice, we list only the specificupdates to the Category B IDEs as of the ending date of the period coveredby this notice and a contact person for questions or additional information.For questions or additional information, contact John Manlove (410-786-6877).Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devicesfall into one of three classes. To assist CMS under this categorizationprocess, the FDA assigns one of two categories to each FDA-approvedinvestigational device exemption (IDE). Category A refers to experimentalIDEs, and Category B refers to non-experimental IDEs. To obtain moreinformation about the classes or categories, please refer to the noticepublished in the April 21, 1997Federal Register(62 FR 19328).IDE Device Start DateBB15140 Magellan System 07/06/12G100021 Stentys Coronary Stent System 09/12/12G110112 Formula Balloon-Expandable Stent 07/18/12G110162 Solace Intra Vesical Bladder Control System 08/09/12G110186 Spinal Modulation Neurostimulator System 09/19/12G110217 Unify Quadra MP CRT-DS Device 08/08/12G110221 Siello S Pacing Leads 09/12/12G110223 Consulta CRT-P Device 09/12/12G110227 Ingevity Active Fixationand Passive Fixation Pace 07/13/12G110229 Surpass Intracranial Embolization System 07/11/12G120008 Pulmonx Zephyr Endobronchial Valve 07/19/12G120010 NEO Baroreflex Activation Therapy 08/24/12G120021 Intuitive Surgical Davinci 08/07/12G120030 Nucleus Cochlear Implant System 07/19/12G120075 Vercise Deep Brain Stimulation 07/25/12G120076 Samurai Clinical Study 08/16/12G120077 Reliance 4-Front Clinical Study 07/10/12G120092 Non-Invasive Reduction of Fat in the InnerThighs with the ZeltiqCool Sculpting System07/12/12G120104 Robot-Assisted MRI-Guided Prostate Biopsy 08/09/12G120133 Allegretto Wave Eye-QExcimer Laser System 07/03/12G120135 Deviate-AF 07/06/12G120136 Zenith P-Branch 07/11/12G120141 Embosphere Microspheres 09/11/12G120142 Solitaire FR Revascularization Device 07/18/12G120143 Michi Neuroprotection System 07/18/12G120144 Supera Veritas Peripheral Sten System 07/18/12G120146 Subqstim Study 07/20/12G120147 Rescue-VT 07/19/12G120149 Tria Beauty Fan Precision Device 07/18/12G120150 Implantable Myoelectric Sensors for Upper Extremity ProstheticControl in Transradial Amputees07/25/12G120151 Star S4 Excimer Laser System 07/24/12G120152 Lifevest Wearable Cardioverter Defibrillator (WDC) 07/25/12G120155 Prevent 07/26/12G120162 Star SR IR Excimer Laser System and IDesign AdvancedWavescan Studio for Wavefront-Guided Lasik Treatment ofMixed Astig08/08/12G120164 Star SR IR Excimer Laser System and IDesign AdvancedWavescan Studio for Wavefront-Guided Lasik Treatment ofHyperopia08/08/12G120166 Ulthera System Model 8850-0001 08/15/12G120169 Surtavi 08/15/12G120171 Medtronic Reveal XT Isertable Cardiac Monitor Model 9529 08/24/12G120175 Native Outflow Tract TPV System 08/30/12G120176 B-Tevar Device 08/24/12G120181 Intra-Articular Hyaluronan 08/29/12G120183 C-Met Immunohistochemistry 09/05/12G120188 Pulmonary Artery Repair withCovered Cheatham Platinum Stent 09/12/12G120191 The Lone AFIB Trial 09/19/12G120194 Nucleus 24 Auditory Brainstem Implant 09/21/12G120195 The Moe Plasma Treatment System 09/17/12Addendum VI: Approval Numbers for Collections of Information(July through September 2012)All approval numbers are available to the public at Reginfo.gov.Under the review process, approved information collection requests areassigned OMB control numbers. A single control number may apply toseveral related information collections. This information is available atwww.reginfo.gov/public/do/PRAMain. For questions or additionalinformation, contact Mitch Bryman (410-786-5258).Addendum VII: Medicare-ApprovedCarotid Stent Facilities,(July through September 2012)Addendum VII includes listings of Medicare-approved carotidstent facilities. All facilities listed meet CMS standards for performing10carotid artery stenting for high risk patients. On March 17, 2005, we issuedour decision memorandum on carotid artery stenting. We determined thatcarotid artery stenting with embolic protection is reasonable and necessaryonly if performed in facilities that have been determined to be competent inperforming the evaluation, procedure,and follow-up necessary to ensureoptimal patient outcomes. We have created a list of minimum standards forfacilities modeled in part on professional society statements on competency.All facilities must at least meet our standards in order to receive coveragefor carotid artery stenting for high risk patients. For the purposes of thisquarterly notice, we are providing only the specific updates that haveoccurred in the 3-month period. This information is available on ourwebsite at:http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPageFor questions or additional information, contact Sarah J. McClain(410-786-2294).FacilityProviderNumberEffectiveDateStateThe following facilities are new listings for this quarter.Carlsbad Medical Center2430 W. Pierce Street Carlsbad, NM 88220320065 07/11/2012 NMDenver Health Medical Center777 Bannock Street,MC0960 Denver, CO 80204060011 07/11/2012 COGalion Community Hospital269 Portland Way South Galion, OH 448331215907522 07/18/2012 OHBeaumont Health System – Troy44201 Dequindre Road Troy, MI 480851306825997 07/25/2012 MITexoma Medical Center5016 South US Hwy 75 Denison, TX 750201851390967 07/25/2012 TXMcLaren-Lapeer Region1375 North Main Street Lapeer, MI 48446-1350230193 08/06/2012 MILutheran Medical Center150 55th Street Brooklyn, NY 11220-2574330306 08/20/2012 NYSouthside Regional Medical Center200 Medical Park Boulevard Petersburg, VA 23805490067 08/29/2012 VASaint Agnes Hospital900 Caton Avenue Baltimore, MD 21229210011 09/10/2012 MDMercy Hospital Washington901 E 5th Street Washington, MO 63090260052 09/13/2012 MOSt. Joseph Regional Medical Center415 6th Street Lewiston, ID 835011225090954 09/24/2012 IDEditorial changes (shown in bold) were made to the facilities listed below.From: Dakota Specialty InstituteTo: Innovis Health dba Essentia Health3000 32nd Avenue SW Fargo, ND 5810435007006/05/2007 NDFacilityProviderNumberEffectiveDateStateFranciscan St. Anthony Health – Michigan City301 West Homer Street Michigan City, IN 4636015001507/06/2006INFrom: Kaleida Health, Millard Fillmore Hospital3 Gates Circle Buffalo, NY 14209To: Buffalo General Medical Center100 High Street Buffalo, NY 1420333000505/03/2005 NYGalichia Heart Hospital2610 N. Woodlawn BoulevardWichita, KS 67220-272917012305/16/2005 KSFrom: Saint Joseph Medical CenterTo: Alegent Creighton Health CreightonUniversity Medical Center601 North 30th Street Omaha, NE 68131-2197280030 06/27/2005 NEThe following facility has beenremoved from the listingsof Medicare-approved carotid stent facilities.Saint Anthony Memorial301 W. Homer Street Michigan City, IN 46360150015 07/06/2006 INAddendum VIII:American College of Cardiology’s NationalCardiovascular DataRegistry Sites (July through September 2012)Addendum VIII includes a list of the American College ofCardiology’s National Cardiovascular Data Registry Sites. We coverimplantable cardioverter defibrillators (ICDs) for certain clinicalindications, as long as information about the procedures is reported to acentral registry. Detailed descriptions of the covered indications areavailable in the NCD. In January 2005, CMS established the ICDAbstraction Tool through the Quality Network Exchange (QNet) as atemporary data collection mechanism. On October 27, 2005, CMSannounced that the American College of Cardiology’s NationalCardiovascular Data Registry (ACC-NCDR) ICD Registry satisfies the datareporting requirements in the NCD. Hospitals needed to transition to theACC-NCDR ICD Registry by April 2006.Effective January 27, 2005, to obtain reimbursement, MedicareNCD policy requires that providers implanting ICDs for primary preventionclinical indications (that is, patients without a history of cardiac arrest orspontaneous arrhythmia) report data on each primary prevention ICDprocedure. Details of the clinical indications that are covered by Medicareand their respective data reporting requirements are available in theMedicare NCD Manual, which is on the CMS Website athttp://www.cms.hhs.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=99&sortByDID=1&sortOrder=ascending&itemID=CMS01496111A provider can use either of two mechanisms to satisfy the datareporting requirement. Patients may be enrolled either in an InvestigationalDevice Exemption trial studying ICDs asidentified by the FDA or in theACC-NCDR ICD registry. Therefore,for a beneficiary to receive aMedicare-covered ICD implantation for primary prevention, the beneficiarymust receive the scan in a facility that participates in the ACC-NCDR ICDregistry. The entire list of facilities that participate in the ACC-NCDR ICDregistry can be found atwww.ncdr.com/webncdr/commonFor the purposes of this quarterly notice, we are providing only thespecific updates that have occurred in the 3-month period. This informationis available by accessing our websiteand clicking on the link for theAmerican College of Cardiology’s National Cardiovascular Data Registryat:www.ncdr.com/webncdr/common.For questions or additionalinformation, contact Joanna Baldwin, MS (410-786-7205).Facility Name City StateThe following facilities are new listings for this quarter.Children’s Mercy Hospital Kansas City MONorwegian American Hospital Chicago ILLake Wales Medical Center Lake Wales FLThomas Hospital Fairhope ALEphraim McDowell Regional Medical Center Danville KYPonca City Medical Center Ponca City OKNorthwestern Lake Forest Hospital Lake Forest ILWentworth-Douglass Hospital Dover NHOro Valley Hospital Ora Valley AZSeton Medical Center Harker Heights Harker Heights TXJupiter Medical Center Jupiter FLHendricks Regional Health Danville INSt. Anthony’s Hospital Houston TXMaine General Medical Center Augusta MESoutheast Georgia Health System Brunswick GACentral Vermont Medical Center Inc Berlin VTOpelousas General Health System Opelousas LALodi Memorial Hospital Lodi CAMemorial Hospital of Tampa Tampa FLSan Francisco Heart and Vascular Institute Daly City CAFeather River Hospital Paradise CAMercy Memorial Hospital Monroe MIPalestine Regional Medical Center Palestine TXUniversity Medical Center Lubbock TXAddendum IX: Active CMS Coverage-Related Guidance Documents(July through September 2012)There were no CMS coverage-related guidance documentspublished in the July through September 2012 quarter. To obtain full-textcopies of these documents, visit the CMS Coverage website athttp://www.cms.gov/mcd/index_list.asp?list_type=mcd_1and click on thearchives link. For questions or additional information, contact Lori Ashby(410-786-6322).Addendum X:List of Special One-Time NoticesRegarding National CoverageProvisions (July through September 2012)There were no special one-time notices regarding nationalcoverage provisions published in the July through September 2012 quarter.This information is available atwww.cms.hhs.gov/coverage. For questionsor additional information, contact Lori Ashby (410-786-6322).Addendum XI: National Oncologic PET Registry (NOPR)(July through September 2012)Addendum XI includes a listing of National Oncologic PositronEmission Tomography Registry (NOPR) sites. We cover positron emissiontomography (PET) scans for particularoncologic indications when they areperformed in a facility that participates in the NOPR.In January 2005, we issued our decision memorandum onpositronemission tomography(PET) scans, which stated that CMS would coverPET scans for particular oncologic indications, as long as they wereperformed in the context of a clinical study. We have since recognized theNational Oncologic PET Registry asone of these clinical studies.Therefore, in order for a beneficiary to receive a Medicare-covered PETscan, the beneficiary must receive the scan in a facility that participates inthe registry. There were no updates to the listing of National OncologicPositron Emission Tomography Registry (NOPR) in the July throughSeptember 2012 quarter. This information is available athttp://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage.For questions or additional information, contact Stuart Caplan, RN, MAS(410-786-8564)12Addendum XII: Medicare-Approved Ventricular Assist Device(Destination Therapy) Facilities(July through September 2012)Addendum XII includes a listingof Medicare-approved facilitiesthat receive coverage for ventricular assist devices (VADs) used asdestination therapy. All facilities were required to meet our standards inorder to receive coverage for VADs implanted as destination therapy. OnOctober 1, 2003, we issued our decision memorandum on VADs for theclinical indication of destination therapy. We determined that VADs usedas destination therapy are reasonable and necessary only if performed infacilities that have been determined to have the experience andinfrastructure to ensure optimal patient outcomes. We established facilitystandards and an application process.All facilities were required to meetour standards in order to receive coverage for VADs implanted asdestination therapy.For the purposes of this quarterly notice, we are providing only thespecific updates that have occurred to the list of Medicare-approvedfacilities that meet our standards in the 3-month period. This information isavailable on our website athttp://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage.For questions or additional information, contact JoAnna Baldwin, MS(410-786-7205).Facility Provider Number Date Approved StateThe following facilities are new listings for this quarter.Abington Memorial Hospital1200 Old York RoadAbington, PA 19001390231 07/10/2012 PAFroedtert Memorial Lutheran Hospital9200 West Wisconsin AvenueMilwaukee, WI 53226520177 08/01/2012 WiMaimonides Medical Center4802 Tenth AvenueBrooklyn, NY 11219330194 08/24/2012 NYAddendum XIII: Lung Volume Reduction Surgery (LVRS)(July through September 2012)Addendum XIII includes a listing of Medicare-approved facilitiesthat are eligible to receive coveragefor lung volume reduction surgery.Until May 17, 2007, facilities that participated in the National EmphysemaTreatment Trial were also eligible toreceive coverage. The following threetypes of facilities are eligible for reimbursement for Lung VolumeReduction Surgery (LVRS):●National Emphysema Treatment Trial (NETT) approved (Beginning05/07/2007, these will no longer automatically qualify and can qualify onlywith the other programs);●Credentialed by the Joint Commission (formerly, the JointCommision on Accreditation of Healthcare Organizations (JCAHO)) undertheir Disease Specific Certification Program for LVRS; and●Medicare approved for lung transplants.Only the first two types are in the list. There were no additions tothe listing of facilities for lung volume reduction surgery published in theJuly through September 2012 quarter. This information is available on ourwebsite atwww.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage. Forquestions or additional information, contact JoAnna Baldwin, MS(410-786-7205).Addendum XIV: Medicare-ApprovedBariatric Surgery Facilities(July through September 2012)Addendum XIV includes a listing of Medicare-approved facilitiesthat meet minimum standards for facilities modeled in part on professionalsociety statements on competency. All facilities must meet our standards inorder to receive coverage for bariatricsurgery procedures. On February 21,2006, we issued our decision memorandum on bariatric surgery procedures.We determined that bariatric surgical procedures are reasonable andnecessary for Medicare beneficiarieswho have a body-mass index (BMI)greater than or equal to 35, have at least one co-morbidity related to obesityand have been previously unsuccessfulwith medical treatment for obesity.This decision also stipulated that covered bariatric surgery procedures arereasonable and necessary only when performed at facilities that are: (1)certified by the American College of Surgeons (ACS) as a Level 1 BariatricSurgery Center (program standards and requirements in effect on February15, 2006); or (2) certified by the American Society forBariatric Surgery(ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (programstandards and requirements in effect on February 15, 2006).For the purposes of this quarterly notice, we list only the specificupdates to Medicare-approved facilitiesthat meet CMS’s minimum facilitystandards for bariatric surgery and have been certified by ACS and/orASMBS in the 3-month period. This information is available on ourwebsite atwww.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For13questions or additional information, contact Kate Tillman, RN, MAS(410-786-9252).Facility ProviderNumberDateApprovedStateThe following facilities are new listings for this quarter.Greater Baltimore Medical Center (GBMC)Comprehensive Obesity Management Program6535 North Charles Street Physicians Pavilion North,Suite 125 Baltimore, MD 212041396774238 06/07/12 MDThe Bryn Mawr Hospital130 South Bryan Mawr Avenue Bryn Mawr, PA1901024371 03/16/12 PAHurley Medical CenterOne Hurley Plaza Flint, MI 48503-5993230132 04/14/12 MISurgical Weight Loss Program at Eastern MaineMedical Center905 Union Street, Suite 11 Bangor, ME 44011790789147 06/10/12 MESaint Vincent Hospital123 Summer Street Worcester, MA 01608220176 06/10/10 MAMount Sinai Hospital5 East 98th Street, 15th Floor New York, NY 100291932103413 07/15/11 NYEditorial changes (shown in bold) were made to the facilities listed below.St. Francis Hospital & Health Centers1600 Albany Street Beech Grove, IN 46107138674989305/30/2007 INMetroWest Medical Center, Leonard Morse Hospital67 Union Street, Fair 4 Natick, MA0176022017507/14/2010 MASSM DePaul Health Center12266 DePaul Drive, Suite 310 Bridgeton, MO 6304426010402/24/2006 MOSilver Cross Hospital and Medical Centers1900 Silver Cross BoulevardNew Lenox, IL. 60451-9508140213 03/10/2006 ILBrigham and Women's Hospital75 Francis Street ASBII-3Boston, MA 02115-619MPI1790717650;PI-22011008/14/2012MAAlbany Medical Center47 New Scotland Avenue Albany, NY 1220833001306/02/2012NYThe following facilities are no longer participants as of this notice.Northeast Alabama Regional Medical Center400 East 10th Street Anniston, AL 36207010078 07/30/2007 ALParkway Medical Center1854 Beltline Road SW Decatur, AL 3560101-0054 12/18/2009 ALAllegheny General Hospital320 East North Avenue Pittsburgh, PA 15212390050 11/21/2006 PAAddendum XV: FDG-PET for Dementia and NeurodegenerativeDiseases Clinical Trials (July through September 2012)There were no FDG-PET for Dementia and NeurodegenerativeDiseases Clinical Trials published in the July through September 2012quarter.This information is available on our website atwww.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage.For questions or additional information, contact Stuart Caplan, RN, MAS(410-786-8564).[FR Doc. 2012-27422 Filed 11/08/2012 at 8:45 am; Publication Date:11/09/2012]