67368 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 

the individual named within the FOR

FURTHER INFORMATION CONTACT section of 

this notice. 

Dated: September 24, 2012. 

Don Wright, 

Director, Office of Disease Prevention and 

Health Promotion. 

[FR Doc. 2012–27425 Filed 11–8–12; 8:45 am] 

BILLING CODE 4150–32–P 

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 No. 

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 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 Web site or 

the appropriate data registries that are 

used as our resources. This information 

is the most current up-to-date 

information and will be available earlier 

than we publish our quarterly notice. 

We believe the Web site list provides 

more timely access for beneficiaries, 

providers, and suppliers. We also 

believe the Web site 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 Web sites have 

listservs; that is, the public can 

subscribe and receive immediate 

notification of any updates to the Web 

site. These listservs avoid the need to 

check the Web site, as notification of 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 67369 

updates is automatic and sent to the 

subscriber as they occur. If assessing a 

Web site 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. 

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 


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EN09NO12.009</GPH>tkelley on DSK3SPTVN1PROD with NOTICES

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 (lOM) 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 10M, 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 ofthe 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 Statearrangements to transfer material to a local libr

FDL. Contact any library to locate the nearest 

available at http://www.gpo.gov/libraries/ 

In addition, individuals may contact re

that receive and retain at least one copy of mos

publications, either in printed or microfilm form

public. These libraries provide reference servic

however, they are not sales outlets. Individuals 

about the location of the nearest regional depos

library. CMS publication and transmittal numb

entitled Medicare and Medicaid Manual Instruc

the materials, use the CMS publication and tran

example, to find the Medicare National Covera

titled Transcutaneous Electrical Nerve Stimulat

Low Back Pain (CLBP) use CMS-Pub. 100-03, 

Addendum I lists a unique CMS transm

instruction in our manuals or program memoran

A transmittal may consist of a single or multipl

necessary to use information in a transmittal in 

information currently in the manual. For the pu

notice, we list only the specific updates to the li

that have occurred in the 3-month period. This 

our website at www.cms.govlManuals. 

Transmittal MannallSnbject/Pnblication Nnmber 

Nnmber 

79 January 2013 Quarterly Updates to the CM

for the Fiscal Intermediary Shared System 

I 00 I None 

144 Transcutaneous Electrical Nerve Stimulat

Pain (CLBP) 

145 National Coverage Determination (NCD) 

Replacement (TAVR) 

146 Liver Transplantation for Patients with M

Valve Replacement (T A VR) Adult Liver 

2494 Pharmacy Billing for Drugs Provided "Inc

Service This CR rescinds and fully replac

2495 Validation of Payment Group Codes for P

EN09NO12.010</GPH>tkelley on DSK3SPTVN1PROD with NOTICES

Based on Patient Assessments Systematic Validation of Claims Information Code or Where an ICD-lO VOO-Y99 Cod

Using Patient Assessments on the Claim 

2496 New Waived Tests Conditional Data Element Requirements 

2497 Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and the Consolidated Claims Crossover Process 

Hospice Prices for FY 2013 Claims Crossover Disposition and Coor

2498 Issued to a specific audience, not posted to Internetiintranet due to Sensitivity Pass Indicators 

ofInstruction 2516 New Non- Physician Specialty Code for C

2499 Issued to a specific audience, not posted to InternetiIntraneti due to Practitioner, Supplier, and Provider Speci

Confidentiality of Instruction 2517 Medicare Claims Processing Pub. 100-04 

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

Service Was Performed 2518 Inpatient Rehabilitation Facility (IRF) An

Payment Jurisdiction Among Local BIMACs for Services Paid Under the System (PPS) Pricer Changes for FY 201

Physician Fee Schedule and Anesthesia Claims Processing Instructions for PPS Payment Jurisdiction 2519 New Fiscal Intermediary Shared System 

Conditional Data Element Requirements for AlB MACs and DMEMACs Attending Physician NPI 

2501 Issued to a specific audience, not posted to Internetiintranetl due to 2520 Update-Inpatient Psychiatric Facilities Pr

Confidentiality of Instruction PPS) Fiscal Year (FY) 2013 Annual Upda

2502 Issued to a specific audience, not posted to Internetiintranetl due to 2521 Claim Adjustment Reason Code (CARC)

Confidentiality of Instruction (RARC), and Medicare Remit Easy Print 

2503 Issued to a specific audience, not posted to InternetiIntraneti due to 2522 Issued to a specific audience, not posted t

Confidentiality of Instruction of Instruction 

2504 Issued to a specific audience, not posted to Internetiintranet due to Sensitivity 2523 Revised Medicare Summary Notice (MSN

ofInstruction Therapy Caps 

2505 Issued to a specific audience, not posted to Internetiintranetl due to 2524 Issued to a specific audience, not posted t

Confidentiality of Instruction Confidentiality of Instruction 

2506 Extracorporeal Photopheresis (ICD-l 0) 2525 October 2012 Update of the Ambulatory 

2507 Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (ASC) 

(PPS) Pricer Update FY 2013 2526 Annual Update for the Health Professiona

2508 Claim Status Category and Claim Status Codes Update Payments 

2509 Issued to a specific audience, not posted to Internetiintranetl due to 2527 Issued to a specific audience, not posted t

Confidentiality of Instruction of Instruction 

2510 Payment of Global Surgical Split Care in a Method II Critical Access Hospital 2528 Instructions for Downloading the Medica

(CAH) Submitted with Modifier 54 and/or 55 2529 Healthcare Common Procedure Coding S

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

Pain (CLBP) 2530 October Update to the CY 2012 Medicare 

2512 National Coverage Determination (NCD) for Transcatheter Aortic Valve (MPFSDB) 

Replacement (TAVR) 2531 October 2012 Update of the Hospital Out

Transcatheter Aortic Valve Replacement (TA VR) Furnished on or After (OPPS) 

May 1,2012 Transitional Outpatient Payments (TOPs) 

Coding Requirements for Requirements for Transcatheter Aortic Valve Fiscal Intermediary Billing Requirements 

Replacement (TAVR) Services Furnished On or After May 1,2012 2532 Issued to a specific audience, not posted t

Claims Processing Requirements for TAVR Services on Professional Claims of Instruction 

Claims Processing Requirements for TA VR Services on Inpatient Hospital 2533 Issued to a specific audience, not posted t

Claim Confidentiality of Instruction 

2513 Liver Transplantation for Patients with Malignancies Liver Transplants 2534 Healthcare Provider Taxonomy Codes (H2514 October 2012 Quarterly Average Sales Price (ASP) Medicare Part B Drug 2535 Chapter 24 Update to Remove Outdated I

Pricing Files and Revisions to Prior Quarterly Pricing Files Notification for AlB MACs, and CEDI HIP AA Claim Lev

Beneficiaries Exceeding Financial Limitations Institutional Implementation Guide (IG) E

2515 Handling Form CMS-1500 Hard Copy Claims Where an ICD-9-CM "E" Guide and Direct Data Entry Edits 

EN09NO12.011</GPH>tkelley on DSK3SPTVN1PROD with NOTICES

2536 Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2012 Timeliness - All Claims 

2537 Expiration of2012 Therapy Cap Revisions and User-Controlled Mechanism Part ElInterest Payment Data 

to Identify Legislative Effective Dates S Non-Physician Practitioner/Supplier Spe

2538 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 210 Validation of Recovery Audit Program N

of Instruction 

2539 Fiscal Year (FY) 2013 Inpatient Prospective Payment System (IPPS), Long 82 CMS Certification Numbers for Medicaid

Term Care Hospital (LTCH) PPS Changes Medicare Code Editor (MCE) Code for Foreign Countries 

Disproportionate Share Hospital (DSH) Policy Changes Effective for Cost 

Reporting Periods beginning on or after October 1, 2009 00 None 

Disproportionate Share Hospital (DSH) Policy Changes Effective for Cost 

Reporting Periods beginning on or after October 1, 2012 I 00 None 

Repeat Admissions 

Outpatient Services Treated as Inpatient Services 

Replaced Devices Offered Without Cost or With a Credit 

I 00 None 

Addenda A-Provider Specific File 

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

00 None 

ofInstruction 

2541 Issued to a specific, audience not posted to InternetlIntranet due to 

Confidentiality of Instruction 

I 108 This is the initial release of New Chapter I 109 This is the initial release of New Chapter 

2542 2013 Annual Update of Health care Common Procedure Coding System 

(HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing 00 None 

(CB) Update 

2543 Extracorporeal Photopheresis (ICD-l 0) 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 

84 Revisions to the Method of Cost Settleme

Hospitals Participating Under Demonstra

the Medicare Modernization Act. Section

Care Act authorizes an expansion of the d

an additional 5-year period. This CR mak

gives instructions for the additional 5-yea

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 

1101 Reporting of Recoupment for Overpayme

with Patient Control Number 

1102 Direction to Modify Institutional Reason 

ll03 Health Insurance Portability and Account

Execution of the Annual Recertification P

1104 Issued to a specific audience, not posted t

of Instruction 

ll05 Issued to a specific, audience not posted t

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 

Confidentiality of Instruction 

1106 Posting the Limiting Charge after Applyi

Adjustment 

1107 The Medicare Secondary Payer Payment 

Maintained by the Shared System Mainta

1108 Fee For Service Common Eligibility Serv

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

include 11139 and 11142 for the Common Working File (CWF) 

File (CWF) Detail Analysis, Design and R

1109 Issued to a specific, audience not posted t

Confidentiality of Instruction 

211 Notice of New Interest Rate for Medicare Overpayments and Underpayments 

- 4th Notification for FY 2011 

1110 Revision of Medicare Summary Notice (M

Claims 

212 New Non- Physician Specialty Code for Centralized Flu Claims Processing 1111 Expand Place of Service Address to Inclu

EN09NO12.012</GPH>tkelley on DSK3SPTVN1PROD with NOTICES

1112 Health Insurance Portability and Accountability Act (HIP AA) 5010 837 

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

January 2012 

1113 Issued to a specific audience, not posted to InternetlIntranet due to Sensitivity 

of Instruction 

1114 New Field Established within FISS and MCS 

1115 Implement Fraud Prevention Predictive Modeling Prepayment Edits for 

Shared Systems (xrefCR7787) 

1116 Implement Fraud Prevention Predictive Modeling Prepayment Edits for 

Shared Systems (xrefCR7787) 

1117 Manual Medical Review of Therapy Services 

1118 Issued to a specific audience, not posted to InternetlIntranet due to Sensitivity 

of Instruction 

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

Medicare Administrative Contractor (J5 AlB MAC) Reprocurment Including 

a New Workload Number for the Remaining WPS Legacy Workload 

1120 Issued to a specific, audience not posted to InternetlIntranet due to 

Confidentiality of Instruction 

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

Related Code Infrastructure of the Medicare Shared Systems as They Relate 

to CMS National Coverage Determinations (NCDs) (CR 1 of3) (TCD-IO) 

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! guarterlyproviderupdates! downloads/Regs3Q12QPU.pdf 

For questions or additional information, contact Terri Plumb 

(410-786-4481). 

Addendum III: CMS R

CMS Rulings are decisions of the Adm

precedent final opinions and orders and stateme

interpretation. They provide clarification and i

ambiguous provisions of the law or regulations 

Medicaid, Utilization and Quality Control Peer 

insurance, and related matters. 

The rulings can be accessed at 

http://www .cms. gov /Rulings!CMSRllist.asp#T

additional information, contact Tiffany Lafferty 

Addendum IV: Medicare National Cov

(July through Septembe

Addendum IV includes completed nat

determinations (NCDs), or reconsiderations of 

quarter covered by this notice. Completed deci

section of the NCD Manual (NCDM) in which 

title, the date the publication was issued, and th

decision. An NCD is a determination by the Se

particular item or service is covered nationally 

(title XVIII ofthe Act), but does not include a d

any, that is assigned to a particular covered item determination for a particular covered item or s

include information concerning completed deci

program and decision memoranda, which also 

some cases, explain why it was not appropriate 

Information on completed decisions as well as 

been posted on the CMS website. For the purp

we list only the specific updates that have occu

This information is available on our website at: 

coverage-database!. For questions or additiona

Wanda BelleJ41O-786-7491). 

Section 

Title I NCDM I Transmitt

Number 

Liver Transplantation for 

Malignancies 

Transcutaneous Electrical Nerve 

Stimulation (TENS) Chronic 

Low Back Pain 

NCD 

260.1 

NCD 

160.27 

R146NCD 

R144NCD 

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05/0112012 

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 ofthree 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 

GI00021 Stentys Coronary Stent System 09/12/12 

Gl101l2 Formula Balloon-Expandable Stent 07/18112 GII0162 Solace Intra Vesical Bladder Control System 08/09/12 

Gl10186 Spinal Modulation Neurostimulator System 09/19/12 

Gll0217 Unify Quadra MP CRT-DS Device 08/08/12 Gll0221 Siello S Pacing Leads 09/12/12 Gll0223 Consulta CRT-P Device 09/12/12 Gll0227 Ingevity Active Fixation and Passive Fixation Pace 07/13/12 GII0229 Surpass Intracranial Embolization System 07/11112 

G120008 Pulmonx Zephyr Endobronchial Valve 07/19/12 

G120010 NEO Baroreflex Activation Therapy 08/24/12 G120021 Intuitive Surgical Davinci 08/07/12 

Gl20030 Nucleus Cochlear Implant System 07/19/12 

G120075 Vercise Deep Brain Stimulation 07/25/12 

G120076 Samurai Clinical Study 08/16/12 

Gl20077 Reliance 4-Front Clinical Study 07/10/12 

G120092 Non-Invasive Reduction of Fat in the Inner Thighs with the Zeltiq 07/12/12 

Cool Sculpting System 

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

Gl20135 Deviate-AF 

Gl20136 Zenith P-Branch 

Gl20141 Embosphere Microspheres Gl20142 Solitaire FR Revascularization Device 

Gl20143 Michi Neuroprotection System 

Gl20144 Supera Veritas Peripheral Sten System Gl20146 Subqstim Study Gl20147 Rescue-VT Gl20149 Tria Beauty Fan Precision Device Gl20150 Implantable Myoelectric Sensors for Upper E

Control in Transradial Amputees 

Gl20151 Star S4 Excimer Laser System 

Gl20152 Lifevest Wearable Cardioverter Defibrillator 

Gl20155 Prevent 

Gl20162 Star SR IR Excimer Laser System and IDesig

Wavescan Studio for Wavefront-Guided Las

Mixed Astig 

Gl20164 Star SR IR Excimer Laser System and IDesig

Wavescan Studio for Wavefront-Guided Las

Hyperopia 

Gl20166 U1thera System Model 8850-0001 Gl20169 Surtavi Gl20171 Medtronic Reveal XT Isertable Cardiac MonGl20175 Native Outflow Tract TPV System Gl20176 B-Tevar Device Gl20181 Intra-Articular Hyaluronan Gl20183 C-Met Immunohistochemistry 

Gl20188 Pulmonary Artery Repair with Covered Chea

Gl20191 The Lone AFIB Trial 

Gl20194 Nucleus 24 Auditory Brainstem Implant Gl20195 The Moe Plasma Treatment System 

Addendum VI: Approval Numbers for Coll

(July through Septe

All approval numbers are available to 

Under the review process, approved informatio

assigned OMB control numbers. A single cont

several related information collections. This in

www.reginfo.gov/publicldo/PRAMain. For qu

information, contact Mitch Bryman (410-786-5

Addendum VII: Medicare-Approved C

(July through Septembe

Addendum VII includes listings of Me

stent facilities. All facilities listed meet CMS s

EN09NO12.014</GPH>tkelley on DSK3SPTVN1PROD with NOTICES

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 lMedicareApprovedF acilitie/CASF Ilist.asp#TopOfPage 

For questions or additional information, contact Sarah J. McClain 

(410-786-2294). 

Facility Provider Effective State 

Number Date 

Carlsbad Medical Center 320065 07/1112012 NM 

2430 W. Pierce Street Carlsbad, NM 88220 

Denver Health Medical Center 060011 07/1112012 CO 

777 Bannock Street, MC0960 Denver, CO 80204 

Galion Community Hospital 1215907522 07/18/2012 OH 

269 Portland Way South Galion, OH 44833 

Beaumont Health System - Troy 1306825997 07/25/2012 MI 

44201 Dequindre Road Troy, MI 48085 

Texoma Medical Center 1851390967 07/25/2012 TX 

5016 South US Hwy 75 Denison, TX 75020 

McLaren-Lapeer Region 230193 08/06/2012 MI 

1375 North Main Street Lapeer, MI 48446-1350 

Lutheran Medical Center 330306 08/20/2012 NY 

150 55th Street Brooklyn, NY 11220-2574 

Southside Regional Medical Center 490067 08/29/2012 VA 

200 Medical Park Boulevard Petersburg, VA 23805 

Saint Agnes Hospital 210011 09/10/2012 MD 

900 Caton Avenue Baltimore, MD 21229 

Mercy Hospital Washington 260052 09113/2012 MO 

901 E 5th Street Washington, MO 63090 

St. Joseph Regional Medical Center 1225090954 09/24/2012 ill 

415 6th Street Lewiston, ill 83501 From: Dakota Specialty Institute 350070 06105/2007 ND 

To: Innovis Health dba Essentia Health 

3000 32nd Avenue SW Fargo, ND 58104 

Facility I P

3

1

2

Addendum Vill: 

American College of Cardiology's Nation

Registry Sites (July through Se

Addendum VIII includes a list of the A

Cardiology's National Cardiovascular Data Reg

implantable cardioverter defibrillators (ICDs) f

indications, as long as information about the pr

central registry. Detailed descriptions ofthe co

available in the NCD. In January 2005, CMS e

Abstraction Tool through the Quality Network 

temporary data collection mechanism. On Octo

announced that the American College of Cardio

Cardiovascular Data Registry (ACC-NCDR) IC

reporting requirements in the NCD. Hospitals n

ACC-NCDR ICD Registry by April 2006. 

Effective January 27,2005, to obtain r

NCD policy requires that providers implanting 

clinical indications (that is, patients without a h

spontaneous arrhythmia) report data on each pr

procedure. Details of the clinical indications th

and their respective data reporting requirements 

Medicare NCD Manual, which is on the CMS W

htlp:llwww.cms.hhs.govlManuals/IOMIitemdet

erByDID=99&sortByDID= 1 &sortOrder=ascen

EN09NO12.015</GPH>tkelley on DSK3SPTVN1PROD with NOTICES

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.comlwebncdr/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.comlwebncdr/common. For questions or additional 

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

Facility Name City State 

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 

W entworth-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-Re

(July through Septemb

There were no CMS coverage-related 

published in the July through September 2012 

copies of these documents, visit the CMS Cov

http://www.cms.gov/mcd/index list.asp?list t

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

Addendum X: 

List of Special One-Time Notices Rega

Provisions (July through Sep

There were no special one-time notic

coverage provisions published in the July throThis information is available at www.cms.hhsor additional information, contact Lori Ashby 

Addendum XI: National Oncolo

(July through Septemb

Addendum XI includes a listing of N

Emission Tomography Registry (NOPR) sites

tomography (PET) scans for particular oncolo

performed in a facility that participates in the 

In January 2005, we issued our decis

emission tomography (PET) scans, which sta

PET scans for particular oncologic indications

performed in the context of a clinical study. W

National Oncologic PET Registry as one of th

Therefore, in order for a beneficiary to receive 

scan, the beneficiary must receive the scan in 

the registry. There were no updates to the list

Positron Emission Tomography Registry (NO

September 2012 quarter. This information is a

http://www.cms.govlMedicareApprovedFacili

s;. 

For questions or additional information, conta

(410-786-8564) 

EN09NO12.016</GPH>tkelley on DSK3SPTVN1PROD with NOTICES

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 (V ADs) used as 

destination therapy. All facilities were required to meet our standards in order to receive coverage for V ADs implanted as destination therapy. On 

October 1, 2003, we issued our decision memorandum on V ADs for the 

clinical indication of destination therapy. We determined that V ADs 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 V ADs 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 

htip:llwww.cms.gov/MedicareApprovedFacilitieN AD/list.asp#TopOtPage. 

For questions or additional information, contact JoAnna Baldwin, MS 

(410-786-7205). 

Facility Provider Number Date Approved 

Abington Memorial Hospital 390231 07/10/2012 

1200 Old York Road 

Abington, PA 19001 

Froedtert Memorial Lutheran Hospital 520177 08/0112012 

9200 West Wisconsin Avenue 

Milwaukee, WI 53226 Maimonides Medical Center 330194 08/24/2012 

4802 Tenth Avenue 

Brooklyn, NY 11219 

Addendum XIII: Lung Volume Reduction Surgery (L VRS) 

(July through September 2012) 

State 

PA 

Wi 

NY 

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 (L VRS): 

• National Emphysema Treatment Trial 

05/07/2007, these will no longer automaticall

with the other programs); 

• Credentialed by the Joint Commission 

Commision on Accreditation of Healthcare O

their Disease Specific Certification Program f

• Medicare approved for lung transplant

Only the first two types are in the lis

the listing of facilities for lung volume reduct

July through September 2012 quarter. This in

website at 

www.cms.govlMedicareApprovedF acilitielL V

questions or additional information, contact J

(410-786-7205). 

Addendum XIV: Medicare-Approved B

(July through Septem

Addendum XIV includes a listing of 

that meet minimum standards for facilities m

society statements on competency. All facilit

order to receive coverage for bariatric surgery 

2006, we issued our decision memorandum o

We determined that bariatric surgical procedu

necessary for Medicare beneficiaries who hav

greater than or equal to 35, have at least one c

and have been previously unsuccessful with m

This decision also stipulated that covered bar

reasonable and necessary only when perform

certified by the American College of Surgeon

Surgery Center (program standards and requi

15,2006); or (2) certified by the American So

(ASBS) as a Bariatric Surgery Center of Exce

standards and requirements in effect on Febru

For the purposes of this quarterly no

updates to Medicare-approved facilities that m

standards for bariatric surgery and have been 

ASMBS in the 3-month period. This informa

website at 

www.cms.govlMedicareApprovedFacilitielB 

EN09NO12.017</GPH>tkelley on DSK3SPTVN1PROD with NOTICES

questions or additional information, contact Kate Tillman, RN, MAS 

(410-786-9252). 

Facility Provider Date 

Number Approved 

Greater Baltimore Medical Center (GBMC) 1396774238 06/07/12 Comprehensive Obesity Management Program 

6535 North Charles Street Physicians Pavilion North, 

Suite 125 Baltimore, MD 21204 

The Bryn Mawr Hospital 24371 03/16112 

130 South Bryan Mawr Avenue Bryn Mawr, PA 

19010 

Hurley Medical Center 230132 04/14/12 

One Hurley Plaza Flint, MI 48503-5993 

Surgical Weight Loss Program at Eastern Maine 1790789147 06/10/12 

Medical Center 

905 Union Street, Suite II Bangor, ME 4401 

Saint Vincent Hospital 220176 06/10/10 

123 Summer Street Worcester, MA 01608 

Mount Sinai Hospital 1932103413 07/15/11 

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

St. Francis Hospital & Health Centers 1386749893 05/30/2007 

1600 Albany Street Beech Grove, IN 46107 

MetroWest Medical Center, Leonard Morse Hospital 220175 07/14/2010 

67 Union Street, Fair 4 Natick, MAOl760 

SSM DePaul Health Center 260104 02/24/2006 

12266 DePaul Drive, Suite 310 Bridgeton, MO 63044 

Silver Cross Hospital and Medical Centers 140213 03/1012006 

1900 Silver Cross Boulevard 

New Lenox, IL. 60451-9508 

Brigham and Women's Hospital MPI- 08/14/2012 

75 Francis Street ASBII-3 1790717650; 

Boston, MA 02115-619 PI-220 11 0 

Albany Medical Center 330013 06/02/2012 

47 New Scotland Avenue Albany, NY 12208 

Northeast Alabama Regional Medical Center 010078 07/30/2007 

400 East 10th Street Anniston, AL 36207 

Parkway Medical Center 01-0054 12/18/2009 

1854 Beltline Road SW Decatur, AL 35601 

Allegheny General Hospital 390050 1112112006 

320 East North Avenue Pittsburgh, PA 15212 

State 

MD PA MI ME MA 

NY 

IN 

MA MO 

IL 

MA 

NY 

AL AL 

PA 

Addendum XV: FDG-PET for Deme

Diseases Clinical Trials (July thr

There were no FDG-PET for Dem

Diseases Clinical Trials published in the Ju

quarter. 

This information is available on ou

www.cms.govlMedicareApprovedFacilitieI

For questions or additional information, con

(410-786-8564). 
Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 67379 

[FR Doc. 2012–27422 Filed 11–08–12; 8:45 am] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–1057] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Highly 

Multiplexed Microbiological/Medical 

Countermeasure In Vitro Nucleic Acid 

Based Diagnostic Devices; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Highly Multiplexed 

Microbiological/Medical 

Countermeasure In Vitro Nucleic Acid 

Based Diagnostic Devices.’’ This draft 

guidance is to provide industry and 

Agency staff with recommendations for 

studies to establish the analytical and 

clinical performance of highly 

multiplexed microbiological/medical 

countermeasures in vitro nucleic acid 

based diagnostic devices (HMMDs) 

intended to simultaneously detect and 

identify multiple pathogen nucleic acids 

extracted from a single appropriate 

human specimen or culture. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 7, 

2013. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Highly Multiplexed 

Microbiological/Medical 

Countermeasure In Vitro Nucleic Acid 

Based Diagnostic Devices’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: John 

Hobson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5555, Silver Spring, 

MD 20993–0002, 301–796–5892. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance is to provide 

industry and Agency staff with 

recommendations for studies to 

establish the analytical and clinical 

performance of HMMDs intended to 

simultaneously detect and identify 

multiple pathogen nucleic acids 

extracted from a single appropriate 

human specimen or culture. For the 

purposes of this draft guidance 

document the multiplex level that is 

used to define HMMDs is the capability 

to detect ≥20 different organisms/ 

targets, in a single reaction, using a 

nucleic acid based technology and 

involves testing multiple targets through 

a common process of specimen 

preparation, amplification and/or 

detection, and result interpretation. 

HMMDs are used to aid in the diagnosis 

of infection. 

The scope of this draft guidance 

includes nucleic acid based devices that 

employ technologies such as 

polymerase chain reaction, reversetranscriptase polymerase chain reaction, 

bead-based liquid arrays, microarrays, 

re-sequencing approaches as well as the 

measurement of individual targets 

determined by ≥20 separate assays that 

are reported out simultaneously through 

the use of a diagnostic algorithm. This 

draft guidance is not intended to 

address devices that utilize detection 

mechanisms other than nucleic acid 

based approaches. The document does 

not apply to devices that are intended 

to screen donors of blood and blood 

components, and donors of human cells, 

tissues, and cellular and tissue-based 

products for communicable diseases. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on highly multiplexed microbiological/ 

medical countermeasure in vitro nucleic 

acid based diagnostic devices. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Highly Multiplexed 

Microbiological/Medical 

Countermeasure In Vitro Nucleic Acid 

Based Diagnostic Devices,’’ you may 

either send an email request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1803 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to currently 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR parts 801 and 809 have been 

approved under OMB control number 

0910–0485; the collections of 

information in 21 CFR part 807, subpart 

E, have been approved under OMB 

control number 0910–0120; and the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073. 

V. Comments 

Interested persons may submit either 

written comments regarding this 

document to the Division of Dockets 

Management (see ADDRESSES) or 

electronic comments to http:// 

www.regulations.gov. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http:// 

www.regulations.gov. 


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