DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Centers for Medicare & Medicaid Services 

[CMS-9075-N] 

Medicare and Medicaid Programs; Quarterly 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 instructions, substantive and interpretive 

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

2012, relating to the Medicare and Medicaid 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. Consequently, 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 Determinations 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 Facilities Sarah J. McClain (410) 786-2294 

VIII American College of Cardiology-National Cardiovascular Data Registry Sites JoAnna Baldwin, MS (410) 786-7205 

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

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

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

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

XIII Medicare-Approved Lung Volume Reduction 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 and Medicaid programs and coordination and oversight of private 

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

furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the 
 2 

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

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

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

Commissioners (NAIC), health insurers, 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 necessary 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 least every 3 months in the Federal Register. 

II. Revised Format for the Quarterly Issuance Notices 

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

no longer republish duplicative information that is available 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 2011entitled “Improving Regulation and Regulatory 

Review,” which promotes modifying and streamlining an agency’s regulatory program to be more 

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

to identify regulations that may be “outmoded, ineffective, 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 participation, and collaboration. 

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

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

appropriate data registries that are used as our resources. This information is the most current upto-date information and will be available earlier than we publish our quarterly notice. We believe 

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

believe the website offers a more convenient tool for the public to find the 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 subscriber as they occur. 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 that a reader may access the subjects published during 

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

notice to be used in concert with previously published notices. Those unfamiliar with a description 

of our Medicare manuals should view the manuals at http://www.cms.gov/manuals. 
 4 

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

Insurance, Program No. 93.774, Medicare--Supplementary 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-P 
 5 

Publication Dates for the Previous Four Quarterly Notices

We publish this notice at the end of each quarter reflecting 

information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: 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 the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional information. 

Addendum I: Medicare and Medicaid Manual Instructions 

(July through September 2012) 

The CMS Manual System is used by CMS program components, 

partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. How to Obtain Manuals

The Internet-only Manuals (IOMs) are a replica of the Agency’s 

official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (IOM) or retired. Pub 15-1, Pub 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the IOM, send a message via the CMS Feedback tool. 

Those wishing to subscribe to old versions of CMS manuals should 

contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: http://cms.gov/manuals. 

How to Review Transmittals or Program Memoranda

Those wishing to review transmittals and program memoranda can 

access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 

designated libraries throughout the United States. arrangements to transfer material to a local library FDL. Contact any library to locate the nearest FDavailable at http://www.gpo.gov/libraries/

In addition, individuals may contact regi

that receive and retain at least one copy of most fepublications, either in printed or microfilm form, public. These libraries provide reference services however, they are not sales outlets. Individuals mabout the location of the nearest regional depositolibrary. CMS publication and transmittal numberentitled Medicare and Medicaid Manual Instructiothe materials, use the CMS publication and transmexample, to find the Medicare National Coverage titled Transcutaneous Electrical Nerve Stimulation Low Back Pain (CLBP) use CMS-Pub. 100-03, T

Addendum I lists a unique CMS transmit

instruction in our manuals or program memoranda A transmittal may consist of a single or multiple inecessary to use information in a transmittal in coinformation currently in the manual. For the purpnotice, we list only the specific updates to the list that have occurred in the 3-month period. This in

our website at www.cms.gov/Manuals. 

Transmittal Number 

Manual/Subject/Publication Number

Medicare General Information (CMS-P

79 January 2013 Quarterly Updates to the CMS 

for the Fiscal Intermediary Shared System (F

Medicare Benefit Policy (CMS-Pub

00 None 

Medicare National Coverage Determination (

144 Transcutaneous Electrical Nerve Stimulation 

Pain (CLBP) 

145 National Coverage Determination (NCD) for 

Replacement (TAVR) 

146 Liver Transplantation for Patients with Malig

Valve Replacement (TAVR) Adult Liver Tra

Medicare Claims Processing (CMS-Pu

2494 Pharmacy Billing for Drugs Provided "Incide

Service This CR rescinds and fully replaces C

2495 Validation of Payment Group Codes for Pros
 6 

Based on Patient Assessments Systematic Validation of Claims Information Using Patient Assessments 

2496 New Waived Tests 2497 Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and the 

Hospice Prices for FY 2013 

2498 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

2499 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2500 Clarification of the Use of the Electronic Claim Format to Indicate Where a 

Service Was Performed  Payment Jurisdiction Among Local B/MACs for Services Paid Under the Physician Fee Schedule and Anesthesia Claims Processing Instructions for 

Payment Jurisdiction  Conditional Data Element Requirements for A/B MACs and DMEMACs 

2501 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2502 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2503 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2504 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

2505 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2506 Extracorporeal Photopheresis (ICD-10) 2507 Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System 

(PPS) Pricer Update FY 2013 

2508 Claim Status Category and Claim Status Codes Update 2509 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2510 Payment of Global Surgical Split Care in a Method II Critical Access Hospital 

(CAH) Submitted with Modifier 54 and/or 55 

2511 Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back 

Pain (CLBP) 

2512 National Coverage Determination (NCD) for Transcatheter Aortic Valve 

Replacement (TAVR)  Transcatheter Aortic Valve Replacement (TAVR) Furnished on or After May 1, 2012  Coding Requirements for Requirements for Transcatheter Aortic Valve Replacement (TAVR) Services Furnished On or After May 1, 2012  Claims Processing Requirements for TAVR Services on Professional Claims  Claims Processing Requirements for TAVR Services on Inpatient Hospital Claim 

2513 Liver Transplantation for Patients with Malignancies Liver Transplants 2514 October 2012 Quarterly Average Sales Price (ASP) Medicare Part B Drug 

Pricing Files and Revisions to Prior Quarterly Pricing Files Notification for Beneficiaries Exceeding Financial Limitations 

2515 Handling Form CMS-1500 Hard Copy Claims Where an ICD-9-CM "E" 

Code or Where an ICD-10 V00-Y99 Code is on the Claim  Conditional Data Element Requirements for Consolidated Claims Crossover Process  Claims Crossover Disposition and CoordinaPass Indicators 

2516 New Non- Physician Specialty Code for Cen

Practitioner, Supplier, and Provider Specialty 

2517 Medicare Claims Processing Pub. 100-04 Ch

Requirements 

2518 Inpatient Rehabilitation Facility (IRF) Annua

System (PPS) Pricer Changes for FY 2013 PaPPS 

2519 New Fiscal Intermediary Shared System (FIS

Attending Physician NPI 

2520 Update-Inpatient Psychiatric Facilities Prosp

PPS) Fiscal Year (FY) 2013 Annual Update 

2521 Claim Adjustment Reason Code (CARC), Re

(RARC), and Medicare Remit Easy Print (M

2522 Issued to a specific audience, not posted to In

of Instruction 

2523 Revised Medicare Summary Notice (MSN) M

Therapy Caps 

2524 Issued to a specific audience, not posted to In

Confidentiality of Instruction 

2525 October 2012 Update of the Ambulatory Sur

(ASC) 

2526 Annual Update for the Health Professional S

Payments 

2527 Issued to a specific audience, not posted to In

of Instruction 

2528 Instructions for Downloading the Medicare Z2529 Healthcare Common Procedure Coding Syste

Reminder 

2530 October Update to the CY 2012 Medicare Ph

(MPFSDB) 

2531 October 2012 Update of the Hospital Outpati

(OPPS) Transitional Outpatient Payments (TOPs) for Fiscal Intermediary Billing Requirements 

2532 Issued to a specific audience, not posted to In

of Instruction 

2533 Issued to a specific audience, not posted to In

Confidentiality of Instruction 

2534 Healthcare Provider Taxonomy Codes (HPTC2535 Chapter 24 Update to Remove Outdated Info

A/B MACs, and CEDI HIPAA Claim Level Institutional Implementation Guide (IG) EditGuide and Direct Data Entry Edits 
 7 

2536 Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2012 2537 Expiration of 2012 Therapy Cap Revisions and User-Controlled Mechanism 

to Identify Legislative Effective Dates S 

2538 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

2539 Fiscal Year (FY) 2013 Inpatient Prospective Payment System (IPPS), Long 

Term Care Hospital (LTCH) PPS Changes Medicare Code Editor (MCE)  Disproportionate Share Hospital (DSH) Policy Changes Effective for Cost Reporting Periods beginning on or after October 1, 2009  Disproportionate Share Hospital (DSH) Policy Changes Effective for Cost Reporting Periods beginning on or after October 1, 2012 Repeat Admissions  Outpatient Services Treated as Inpatient Services  Replaced Devices Offered Without Cost or With a Credit  Addenda A-Provider Specific File 

2540 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

2541 Issued to a specific, audience not posted to Internet/Intranet due to 

Confidentiality of Instruction 

2542 2013 Annual Update of Healthcare Common Procedure Coding System 

(HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Update 

2543 Extracorporeal Photopheresis (ICD-10) Billing Requirements for 

Extracorporeal Photopheresis  Healthcare Common Procedural Coding System (HCPCS), Applicable Diagnosis Codes and Procedure Code Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RAs) and Claim Adjustment Reason Code 

2544 Contractor and Common Working File (CWF) Additional Instructions 

Related to Change Request (CR) 7633 - Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse 

2545 Issued to a specific audience, not posted to Internet/ Intranet due to 

Confidentiality of Instruction 

2546 Instructions for Retrieving the 2013 Pricing and HCPCS Data Files through 

CMS' Mainframe Telecommunications Systems 

2547 Claim Status Category and Claim Status Codes Update 

Medicare Secondary Payer (CMS-Pub. 100-05)

87 Clarification of Medicare Conditional Payment Policy and Billing Procedures 

for Liability, No-Fault and Workers’ Compensation Medicare Secondary Payer (MSP) Claims. 

88 Expanding the Coordination of Benefits (COB) Contractor Numbers to 

include 11139 and 11142 for the Common Working File (CWF) Definition of MSP/CWF Terms 

89 Expanding the Coordination of Benefits (COB) Contractor Numbers to 

include 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 2011 

212 New Non- Physician Specialty Code for Centralized Flu Claims Processing 

Timeliness - All Claims  Part E/Interest Payment Data  Non-Physician Practitioner/Supplier Special

210 Validation of Recovery Audit Program New 

Medicare State Operations Manual (CMS

82 CMS Certification Numbers for Medicaid-On

Code for Foreign Countries 

Medicare Program Integrity (CMS-Pu

00 None 

Medicare Contractor Beneficiary and Provider Commu

00 None 

Medicare Quality Improvement Organization 

00 None 

Medicare End Stage Renal Disease Network Organiz

00 None 

Medicare Managed Care (CMS-Pub

108 This is the initial release of New Chapter 21, 109 This is the initial release of New Chapter 21, 

Medicare Business Partners Systems Security 

00 None 

Demonstrations (CMS-Pub. 100

84 Revisions to the Method of Cost Settlement f

Hospitals Participating Under Demonstration the Medicare Modernization Act. Sections 31Care Act authorizes an expansion of the deman additional 5-year period. This CR makes r

gives instructions for the additional 5-year pe

One Time Notification (CMS-Pub. 

1101 Reporting of Recoupment for Overpayment o

with Patient Control Number 

1102 Direction to Modify Institutional Reason Cod1103 Health Insurance Portability and Accountabil

Execution of the Annual Recertification Prog

1104 Issued to a specific audience, not posted to In

of Instruction 

1105 Issued to a specific, audience not posted to In

Confidentiality of Instruction 

1106 Posting the Limiting Charge after Applying t

Adjustment 

1107 The Medicare Secondary Payer Payment Mo

Maintained by the Shared System Maintainer

1108 Fee For Service Common Eligibility Service

File (CWF) Detail Analysis, Design and Req

1109 Issued to a specific, audience not posted to In

Confidentiality of Instruction 

1110 Revision of Medicare Summary Notice (MSN

Claims 

1111 Expand Place of Service Address to Include F
 8 

1112 Health Insurance Portability and Accountability Act (HIPAA) 5010 837 

Institutional (8371) Edits and 5010 837 Professional (837P) Edits January 2012 

1113 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

1114 New Field Established within FISS and MCS 1115 Implement Fraud Prevention Predictive Modeling Prepayment Edits for 

Shared Systems (xref CR7787) 

1116 Implement Fraud Prevention Predictive Modeling Prepayment Edits for 

Shared Systems (xref CR7787) 

1117 Manual Medical Review of Therapy Services 1118 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

1119 Implementation of the Award for the Jurisdiction 5 Part A and Part B 

Medicare Administrative Contractor (J5 A/B MAC) Reprocurment Including a New Workload Number for the Remaining WPS Legacy Workload 

1120 Issued to a specific, audience not posted to Internet/Intranet due to 

Confidentiality of Instruction 

1121 None 1122 International Classification of Diseases (ICD)-10 Conversion from ICD-9 and 

Related Code Infrastructure of the Medicare Shared Systems as They Relate 

to CMS National Coverage Determinations (NCDs) (CR 1 of 3) (ICD-10) 

Addendum II: Regulation Documents Published 

in the Federal Register (July through September 2012) 

Regulations and Notices

Regulations and notices are published in the daily Federal 

Register. To purchase individual copies or subscribe to the Federal 

Register, contact GPO at www.gpo.gov/fdsys. When ordering individual 

copies, it is necessary to cite either the date of publication or the volume number and page number. 

The Federal Register is available as an online database through 

GPO Access. The online database is updated by 6 a.m. each day the 

Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at http://www.gpoaccess.gov/fr/index.html. The 

following Website http://www.archives.gov/federal-register/ provides 

information on how to access electronic editions, printed editions, and reference copies. 

This information is available on our Website at:

http://www.cms.gov/quarterlyproviderupdates/downloads/Regs3Q12QPU.pdf

For questions or additional information, contact Terri Plumb 

(410-786-4481). 

Addendum III: CMS Rul

CMS Rulings are decisions of the Admin

precedent final opinions and orders and statementinterpretation. They provide clarification and inteambiguous provisions of the law or regulations reMedicaid, Utilization and Quality Control Peer Reinsurance, and related matters. 

The rulings can be accessed at 

http://www.cms.gov/Rulings/CMSR/list.asp#Top

additional information, contact Tiffany Lafferty (4

Addendum IV: Medicare National Cover

(July through September 2

Addendum IV includes completed nation

determinations (NCDs), or reconsiderations of comquarter covered by this notice. Completed decisiosection of the NCD Manual (NCDM) in which the title, the date the publication was issued, and the edecision. An NCD is a determination by the Secrparticular item or service is covered nationally un(title XVIII of the Act), but does not include a detany, that is assigned to a particular covered item odetermination for a particular covered item or servinclude information concerning completed decisioprogram and decision memoranda, which also annsome cases, explain why it was not appropriate to Information on completed decisions as well as penbeen posted on the CMS website. For the purposewe list only the specific updates that have occurreThis information is available on our website at: w

coverage-database/. For questions or additional in

Wanda Belle (410-786-7491). 

Title NCDM 

Section 

Transmittal Number 

Liver Transplantation for Malignancies 

NCD 260.1 R146NCD 

Transcutaneous Electrical Nerve Stimulation (TENS) Chronic Low Back Pain 

NCD 160.27 R144NCD 
 9 

Transcatheter Aortic Valve Replacement (TAVR) 

NCD 20.32 R145NCD 08/03/2012 05/01/2012 

Addendum V: FDA-Approved Category B Investigational Device 

Exemptions (IDEs) (July through September 2012) 

Addendum V includes listings of the FDA-approved 

investigational device exemption (IDE) numbers that the FDA assigns. The 

listings are organized according to the categories to which the devices are assigned (that is, Category A or Category B), and identified by the IDE number. For the purposes of this quarterly notice, we list only the specific updates to the Category B IDEs as of the ending date of the period covered by 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) devices 

fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved investigational device exemption (IDE). Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the notice published in the April 21, 1997 Federal Register (62 FR 19328). IDE Device Start Date BB15140 Magellan System 07/06/12 G100021 Stentys Coronary Stent System 09/12/12 G110112 Formula Balloon-Expandable Stent 07/18/12 G110162 Solace Intra Vesical Bladder Control System 08/09/12 G110186 Spinal Modulation Neurostimulator System 09/19/12 G110217 Unify Quadra MP CRT-DS Device 08/08/12 G110221 Siello S Pacing Leads 09/12/12 G110223 Consulta CRT-P Device 09/12/12 G110227 Ingevity Active Fixation and Passive Fixation Pace 07/13/12 G110229 Surpass Intracranial Embolization System 07/11/12 G120008 Pulmonx Zephyr Endobronchial Valve 07/19/12 G120010 NEO Baroreflex Activation Therapy 08/24/12 G120021 Intuitive Surgical Davinci 08/07/12 G120030 Nucleus Cochlear Implant System 07/19/12 G120075 Vercise Deep Brain Stimulation 07/25/12 G120076 Samurai Clinical Study 08/16/12 G120077 Reliance 4-Front Clinical Study 07/10/12 G120092 Non-Invasive Reduction of Fat in the Inner Thighs with the Zeltiq 

Cool Sculpting System 

07/12/12 

G120104 Robot-Assisted MRI-Guided Prostate Biopsy 08/09/12 G120133 Allegretto Wave Eye-Q Excimer Laser System 07/03/12 

G120135 Deviate-AF G120136 Zenith P-Branch G120141 Embosphere Microspheres G120142 Solitaire FR Revascularization Device G120143 Michi Neuroprotection System G120144 Supera Veritas Peripheral Sten System G120146 Subqstim Study G120147 Rescue-VT G120149 Tria Beauty Fan Precision Device G120150 Implantable Myoelectric Sensors for Upper Extr

Control in Transradial Amputees 

G120151 Star S4 Excimer Laser System G120152 Lifevest Wearable Cardioverter Defibrillator (WG120155 Prevent G120162 Star SR IR Excimer Laser System and IDesign A

Wavescan Studio for Wavefront-Guided Lasik TMixed Astig 

G120164 Star SR IR Excimer Laser System and IDesign A

Wavescan Studio for Wavefront-Guided Lasik THyperopia 

G120166 Ulthera System Model 8850-0001 G120169 Surtavi G120171 Medtronic Reveal XT Isertable Cardiac Monitor G120175 Native Outflow Tract TPV System G120176 B-Tevar Device G120181 Intra-Articular Hyaluronan G120183 C-Met Immunohistochemistry G120188 Pulmonary Artery Repair with Covered CheathaG120191 The Lone AFIB Trial G120194 Nucleus 24 Auditory Brainstem Implant G120195 The Moe Plasma Treatment System Addendum VI: Approval Numbers for Collect

(July through Septemb

All approval numbers are available to the 

Under the review process, approved information cassigned OMB control numbers. A single control several related information collections. This inforwww.reginfo.gov/public/do/PRAMain. For quest

information, contact Mitch Bryman (410-786-525

Addendum VII: Medicare-Approved Car

(July through September 2

Addendum VII includes listings of Medi

stent facilities. All facilities listed meet CMS stan
 10 

carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available on our website at: http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage

For questions or additional information, contact Sarah J. McClain (410-786-2294). 

Facility Provider 

Number

Effective Date

State 

The following facilities are new listings for this quarter. 

Carlsbad Medical Center 2430 W. Pierce Street Carlsbad, NM 88220 

320065 07/11/2012 NM 

Denver Health Medical Center 777 Bannock Street, MC0960 Denver, CO 80204 

060011 07/11/2012 CO 

Galion Community Hospital 269 Portland Way South Galion, OH 44833 

1215907522 07/18/2012 OH 

Beaumont Health System – Troy 44201 Dequindre Road Troy, MI 48085 

1306825997 07/25/2012 MI 

Texoma Medical Center 5016 South US Hwy 75 Denison, TX 75020 

1851390967 07/25/2012 TX 

McLaren-Lapeer Region 1375 North Main Street Lapeer, MI 48446-1350 

230193 08/06/2012 MI 

Lutheran Medical Center 150 55th Street Brooklyn, NY 11220-2574 

330306 08/20/2012 NY 

Southside Regional Medical Center 200 Medical Park Boulevard Petersburg, VA 23805 

490067 08/29/2012 VA 

Saint Agnes Hospital 900 Caton Avenue Baltimore, MD 21229 

210011 09/10/2012 MD 

Mercy Hospital Washington 901 E 5th Street Washington, MO 63090 

260052 09/13/2012 MO 

St. Joseph Regional Medical Center 415 6th Street Lewiston, ID 83501 

1225090954 09/24/2012 ID 

Editorial changes (shown in bold) were made to the facilities listed below.

From: Dakota Specialty Institute To: Innovis Health dba Essentia Health 3000 32nd Avenue SW Fargo, ND 58104 

350070 06/05/2007 ND 

Facility Pro

Num

Franciscan St. Anthony Health – Michigan City 301 West Homer Street Michigan City, IN 46360 

150

From: Kaleida Health, Millard Fillmore Hospital 3 Gates Circle Buffalo, NY 14209 To: Buffalo General Medical Center 100 High Street Buffalo, NY 14203 

330

Galichia Heart Hospital 2610 N. Woodlawn Boulevard Wichita, KS 67220-2729

170

From: Saint Joseph Medical Center To: Alegent Creighton Health Creighton University Medical Center 601 North 30th Street Omaha, NE 68131-2197

280

The following facility has been removed f

of Medicare-approved carotid stent 

Saint Anthony Memorial 301 W. Homer Street Michigan City, IN 46360 

150

Addendum VIII: 

American College of Cardiology’s National 

Registry Sites (July through Septe

Addendum VIII includes a list of the Am

Cardiology’s National Cardiovascular Data Regisimplantable cardioverter defibrillators (ICDs) for indications, as long as information about the proccentral registry. Detailed descriptions of the coveavailable in the NCD. In January 2005, CMS estaAbstraction Tool through the Quality Network Extemporary data collection mechanism. On Octobeannounced that the American College of CardioloCardiovascular Data Registry (ACC-NCDR) ICD reporting requirements in the NCD. Hospitals neeACC-NCDR ICD Registry by April 2006. 

Effective January 27, 2005, to obtain reim

NCD policy requires that providers implanting ICclinical indications (that is, patients without a histspontaneous arrhythmia) report data on each primprocedure. Details of the clinical indications that and their respective data reporting requirements aMedicare NCD Manual, which is on the CMS Wehttp://www.cms.hhs.gov/Manuals/IOM/itemdetail

erByDID=99&sortByDID=1&sortOrder=ascendin
 11 

A provider can use either of two mechanisms to satisfy the data 

reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the 

ACC-NCDR ICD registry. Therefore, for a beneficiary to receive a Medicare-covered ICD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR ICD registry. The entire list of facilities that participate in the ACC-NCDR ICD registry can be found at www.ncdr.com/webncdr/common

For the purposes of this quarterly notice, we are providing only the 

specific updates that have occurred in the 3-month period. This information is available by accessing our website and clicking on the link for the American College of Cardiology’s National Cardiovascular Data Registry at: www.ncdr.com/webncdr/common. For questions or additional 

information, contact Joanna Baldwin, MS (410-786-7205). 

Facility Name City State 

The following facilities are new listings for this quarter. 

Children’s Mercy Hospital Kansas City MO Norwegian American Hospital Chicago IL Lake Wales Medical Center Lake Wales FL Thomas Hospital Fairhope AL Ephraim McDowell Regional Medical Center Danville KY Ponca City Medical Center Ponca City OK Northwestern Lake Forest Hospital Lake Forest IL Wentworth-Douglass Hospital Dover NH Oro Valley Hospital Ora Valley AZ Seton Medical Center Harker Heights Harker Heights TX Jupiter Medical Center Jupiter FL Hendricks Regional Health Danville IN St. Anthony’s Hospital Houston TX Maine General Medical Center Augusta ME Southeast Georgia Health System Brunswick GA Central Vermont Medical Center Inc Berlin VT Opelousas General Health System Opelousas LA Lodi Memorial Hospital Lodi CA Memorial Hospital of Tampa Tampa FL San Francisco Heart and Vascular Institute Daly City CA Feather River Hospital Paradise CA Mercy Memorial Hospital Monroe MI Palestine Regional Medical Center Palestine TX University Medical Center Lubbock TX 

Addendum IX: Active CMS Coverage-Relate

(July through September 2

There were no CMS coverage-related gu

published in the July through September 2012 quacopies of these documents, visit the CMS Coveraghttp://www.cms.gov/mcd/index_list.asp?list_type

archives link. For questions or additional informa(410-786-6322). 

Addendum X: 

List of Special One-Time Notices Regardin

Provisions (July through Septem

There were no special one-time notices r

coverage provisions published in the July through This information is available at www.cms.hhs.gov

or additional information, contact Lori Ashby (41

Addendum XI: National Oncologic 

(July through September 2

Addendum XI includes a listing of Natio

Emission Tomography Registry (NOPR) sites. Wtomography (PET) scans for particular oncologic performed in a facility that participates in the NO

In January 2005, we issued our decision 

emission tomography (PET) scans, which stated PET scans for particular oncologic indications, as performed in the context of a clinical study. We hNational Oncologic PET Registry as one of these Therefore, in order for a beneficiary to receive a Mscan, the beneficiary must receive the scan in a fathe registry. There were no updates to the listing Positron Emission Tomography Registry (NOPR) September 2012 quarter. This information is availhttp://www.cms.gov/MedicareApprovedFacilitie/N

e. 

For questions or additional information, contact S(410-786-8564) 
 12 

Addendum XII: Medicare-Approved Ventricular Assist Device 

(Destination Therapy) Facilities (July through September 2012) 

Addendum XII includes a listing of Medicare-approved facilities 

that receive coverage for ventricular assist devices (VADs) used as 

destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. 

For the purposes of this quarterly notice, we are providing only the 

specific updates that have occurred to the list of Medicare-approved facilities that meet our standards in the 3-month period. This information is available on our website at http://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 State 

The following facilities are new listings for this quarter. 

Abington Memorial Hospital 1200 Old York Road Abington, PA 19001 

390231 07/10/2012 PA 

Froedtert Memorial Lutheran Hospital 9200 West Wisconsin Avenue Milwaukee, WI 53226 

520177 08/01/2012 Wi 

Maimonides Medical Center 4802 Tenth Avenue Brooklyn, NY 11219 

330194 08/24/2012 NY 

Addendum XIII: Lung Volume Reduction Surgery (LVRS) 

(July through September 2012) 

Addendum XIII includes a listing of Medicare-approved facilities 

that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): 

● National Emphysema Treatment Trial (NE

05/07/2007, these will no longer automatically quwith the other programs); 

● Credentialed by the Joint Commission (for

Commision on Accreditation of Healthcare Organtheir Disease Specific Certification Program for L

● Medicare approved for lung transplants. 

Only the first two types are in the list. T

the listing of facilities for lung volume reduction sJuly through September 2012 quarter. This informwebsite at www.cms.gov/MedicareApprovedFacilitie/LVRS

questions or additional information, contact JoAn(410-786-7205). 

Addendum XIV: Medicare-Approved Baria

(July through September 2

Addendum XIV includes a listing of Med

that meet minimum standards for facilities modelesociety statements on competency. All facilities morder to receive coverage for bariatric surgery pro2006, we issued our decision memorandum on baWe determined that bariatric surgical procedures necessary for Medicare beneficiaries who have a bgreater than or equal to 35, have at least one co-mand have been previously unsuccessful with medi

This decision also stipulated that covered bariatric reasonable and necessary only when performed at certified by the American College of Surgeons (ASurgery Center (program standards and requireme15, 2006); or (2) certified by the American Societ(ASBS) as a Bariatric Surgery Center of Excellenstandards and requirements in effect on February 

For the purposes of this quarterly notice, 

updates to Medicare-approved facilities that meet standards for bariatric surgery and have been certiASMBS in the 3-month period. This information website at www.cms.gov/MedicareApprovedFacilitie/BSF/li
 13 

questions or additional information, contact Kate Tillman, RN, MAS (410-786-9252). Facility Provider 

Number 

Date Approved 

State 

The following facilities are new listings for this quarter. 

Greater Baltimore Medical Center (GBMC) Comprehensive Obesity Management Program 6535 North Charles Street Physicians Pavilion North, Suite 125 Baltimore, MD 21204

1396774238 06/07/12 MD 

The Bryn Mawr Hospital 130 South Bryan Mawr Avenue Bryn Mawr, PA 19010

24371 03/16/12 PA 

Hurley Medical Center One Hurley Plaza Flint, MI 48503-5993 

230132 04/14/12 MI 

Surgical Weight Loss Program at Eastern Maine Medical Center 905 Union Street, Suite 11 Bangor, ME 4401 

1790789147 06/10/12 ME 

Saint Vincent Hospital 123 Summer Street Worcester, MA 01608 

220176 06/10/10 MA 

Mount Sinai Hospital 5 East 98th Street, 15th Floor New York, NY 10029 

1932103413 07/15/11 NY 

Editorial changes (shown in bold) were made to the facilities listed below.

St. Francis Hospital & Health Centers 1600 Albany Street Beech Grove, IN 46107 

1386749893 05/30/2007 IN 

MetroWest Medical Center, Leonard Morse Hospital 67 Union Street, Fair 4 Natick, MA01760 

220175 07/14/2010 MA 

SSM DePaul Health Center 12266 DePaul Drive, Suite 310 Bridgeton, MO 63044 

260104 02/24/2006 MO 

Silver Cross Hospital and Medical Centers 1900 Silver Cross Boulevard New Lenox, IL. 60451-9508 

140213 03/10/2006 IL 

Brigham and Women's Hospital 75 Francis Street ASBII-3 Boston, MA 02115-619 

MPI1790717650; PI-220110 

08/14/2012 MA 

Albany Medical Center 47 New Scotland Avenue Albany, NY 12208 

330013 06/02/2012 NY 

The following facilities are no longer participants as of this notice.

Northeast Alabama Regional Medical Center 400 East 10th Street Anniston, AL 36207 

010078 07/30/2007 AL 

Parkway Medical Center 1854 Beltline Road SW Decatur, AL 35601 

01-0054 12/18/2009 AL 

Allegheny General Hospital 320 East North Avenue Pittsburgh, PA 15212 

390050 11/21/2006 PA 

Addendum XV: FDG-PET for Dementia an

Diseases Clinical Trials (July through 

There were no FDG-PET for Dementia a

Diseases Clinical Trials published in the July throquarter. 

This information is available on our web

www.cms.gov/MedicareApprovedFacilitie/PETD

For questions or additional information, contact S(410-786-8564). [FR Doc. 2012-27422 Filed 11/08/2012 at 8:45 am11/09/2012]