This document is scheduled to be published in the

Federal Register on 02/21/2012 and available online at

http://federalregister.gov/a/2012-03967, and on FDsys.gov

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Centers for Medicare & Medicaid Services 

[CMS-9069-N] 

Medicare and Medicaid Programs; Quarterly Listing of Program 

Issuances—October through December 2011 

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 October through 

December 2011, 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 
 2 

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. 
 3 

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 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. 
 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: February 6, 2012. 

 

 __________________________ 

 Olen Clybourn,

Deputy 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: March 31, 2011 (76 FR 17873), August 8, 2011 (76 FR 48564), November 4, 2011 (76 FR 68467), and December 16, 2011 (76 FR 78267). 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 Web site to access this information and a contact person for questions or additional 

information. 

Addendum I: Medicare and Medicaid Manual Instructions 

(October through December 2011) 

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. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest 

FDL. This information is available at http://www.gpo.gov/libraries/

In addition, individuals may contact regional depository libraries that receive and 

retain at least one copy of most Federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled 

Medicare and Medicaid Manual Instructions. To hethe CMS publication and transmittal numbers. For eNational Coverage Determination publication titled Immunotherapy Treatment of Metastatic Prostate CaTransmittal No. 136. 

Addendum I lists a unique CMS transmittal num

manuals or program memoranda and its subject numsingle or multiple instruction(s). Often, it is necessatransmittal in conjunction with information currently of this quarterly notice, we list only the specific updinstructions that have occurred in the 3-month period

our Web site at www.cms.gov/Manuals. 

Transmittal 

Number 

Manual/Subjec

Medicare General Information 

71 January 2012 Quarterly Updates to th

the Fiscal Intermediary Shared System 

72 Update to Medicare Deductible, Coin73 April 2012 Quarterly Updates to the C

the Fiscal Intermediary Shared System 

74 Update to Medicare Deductible, Coin

for Determining the Part A Coinsuran

75 Contractor Implementation of Chang

Direction Letters CR Implementation Report (CRIR) TTDL Compliance Report (TCR) TemSample Cover Letter/Attestation Stat

Medicare Benefit Policy (C

148 Billing for Donor Post-Kidney Trans149 Implementation of Changes in End S

Calendar Year (CY) 2012 

150 Implementation of Changes in End S

Calendar Year (CY) 2012 

151 Expansion of Medicare Telehealth Se152 January 2012 Update of the Hospital 

(OPPS) 

Coverage of Outpatient Diagnostic S

January 1, 2010 

Coverage of Outpatient Therapeutic 

Furnished on or after January 1, 2

Medicare National Coverage Determ

136 Autologous Cellular Immunotherapy 137 Intensive Behavioral Therapy for Car138 Screening and Behavioral Counseling 

Alcohol Misuse 

139 Screening for Depression in Adults 

Medicare Claims Processing 

2315 Issued to a specific audience, not pos
 6 

Transmittal 

Number 

Manual/Subject/Publication Number 

Confidentiality of Instruction 

2316 Hospice Claims Processing Procedures When Required Face-to-Face Encounters 

Do Not Occur Timely 

2317 Annual Update of HCPCS Codes Used for Home Health Consolidated 

Billing Enforcement 

2318 Updates to the Internet Only Manual Pub.100-04, Chapter 15-Ambulance to 

include The Medicare and Medicaid Extenders Act of 2010 (MMEA) Provisions 

2319 Calendar Year (CY) 2012 Participation Enrollment and Medicare Participating 

Physicians and Suppliers Directory (MEDPARD) Procedures 

2320 Changes to the Laboratory National Coverage Determination (NCD) Edit 

Software for January 2012 

2321 New Waived Tests 2322 Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 18.0, 

Effective January 1, 2012 

2323 Inpatient Rehabilitation Facility (IRF) and Inpatient Psychiatric Facility (IPF) 

Cost-to-Charge Ratios (CCRs) 

2324 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2325 Annual Type of Service (TOS) Update 2326 Discontinuation of Hospice Late Charge Claims 2327 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction

2328 Claim Adjustment Reason Code (CARC) Used for Therapy Claims Subject to 

the Multiple Procedure Payment Reduction 

2329 Influenza Vaccine Payment Allowances - Annual Update for 2011-2012 Season 2330 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2331 January 2012 Quarterly Average Sales Price (ASP) Medicare Part B Drug 

Pricing Files and Revisions to Prior Quarterly Pricing Files 

2332 Diagnosis Code Update for Add-on Payments for Blood Clotting Factor 

Administered to Hemophilia Inpatients 

2333 Payment for Multiple Surgeries in a Method II Critical Access Hospital (CAH) 2334 Billing for Donor Post-Kidney Transplant Complication Services 2335 Clarification and Revisions for Claims Submitted for End Stage Renal Disease 

(ESRD) Patients 

2336 FISS Claims Processing Updates for Ambulance Services 2337 New Influenza Virus Vaccine Code y 2338 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction 

2339 Autologous Cellular Immunotherapy Treatment of Metastatic Prostate 

Cancer 

2340 CY 2012 Update for Durable Medical Equipment, Prosthetics, Orthotics and 

Supplies (DMEPOS) Fee Schedule 

2341 January 2012 Quarterly Update for the DMEPOS Competitive Bidding Program 2342 Annual Medicare Physician Fee Schedule Files Delivery and Implementation 

Manualization 

2343 Announcement of Medicare Rural Health Clinic (RHC) and Federally Qualified 

Health Centers (FQHC) Payment Rate Increases 

2344 Changes to the Laboratory National Coverage Determination (NCD) Edit 

Software for January 2012 

Transmittal 

Number 

Manual/Subjec

2345 Influenza Vaccine Payment Allowan2346 Medicare Claims Processing Pub. 10

and EDI Enhancements 

2347 Recoupment of Incorrect Payments M

(ESRD) Prospective Payment System Adjustment 

2348 Instructions for Retrieving the 2012 P

CMS Mainframe Telecommunication

2349 Reasonable Charge Update for 2012 

Lenses 

2350 Annual Update to the Therapy Code 2351 Therapy Cap Values for Calendar Ye2352 Issued to a specific audience, not pos

Confidentiality of Instruction 

2353 Instructions for Downloading the Me2354 Expansion of Medicare Telehealth Se

List of Medicare Telehealth ServicTelehealth Consultation Services, E

versus Inpatient Evaluation and M

Telehealth Consultation Services, E

Defined 

Originating Site Facility Fee Paym

2355 Issued to a specific audience, not pos

Confidentiality of Instruction 

2356 Home Health Prospective Payment S

Year (CY) 2012 

2357 Intensive Behavioral Therapy for Car

Table of Contents Intensive Behavioral Therapy for CClaims Processing Requirements foCorrect Place of Services (POS) Co

Claims 

Provider Specialty Edits for IBT foCorrect Types of Bill (TOB) for IB

Frequency Edits for IBT for CVD CCommon Working File (CWF) Edi

2358 Screening and Behavioral Counseling 

Alcohol Misuse Alcohol Screening and Behavioral CReduce Alcohol Misuse Policy Institutional Billing Requirements Claim Adjustment Reason Codes, ReCodes and Medicare Summary Common Working File (CWF) Requ

2359 Screening for Depression in Adults 

Table of Contents Screening for Depression in Adults A/B Medicare Administrative Cont

Requirements Frequency 

Place of Service (POS) Common Working File (CWF) Edi
 7 

Transmittal 

Number 

Manual/Subject/Publication Number 

Professional Billing Requirements Institutional Billing Requirements CARCs, RARCs, Group Codes, and MSN Messages

2360 Instructions for Retrieving the 2012 Pricing and HCPCS Data Files through 

CMS Mainframe Telecommunications Systems 

2361 Clarification and Revisions for Claims Submitted for End Stage Renal Disease 

(ESRD) Patients 

Emergency Room (ER) Services That Span Multiple Service Dates Calculation of the Basic Case-Mix Adjusted Composite Rate and the ESRD 

Prospective Payment System Rate 

Laboratory Services Performed During Emergency Room Service Coding for Adequacy of Dialysis, Vascular Access and Infection Separately Billable ESRD Drugs Epoetin Alfa (EPO) Darbepoetin Alfa (Aranesp) for ESRD Patients 

2362 Home Health Advance Beneficiary Notice, (HHABN), Form CMS-R-2962363 Table of Contents 

Form CMS-R-296 Home Health Advance Beneficiary Notice (HHABN) Background on the HHABN Scope of the HHABN Triggering Events for HHABN/ Written Notice Completing the HHABN HHABN Delivery Effective HHABNs Defective HHABNs Collection of Funds and Liability Related to the HHABN Special Issues Associated with the HHABN 

2364 April 2012 Quarterly Update for the DMEPOS Competitive Bidding Program 2365 Issued to a specific audience, not posted to Internet/Intranet/ due to 

Confidentiality of Instruction

2366 Off-Cycle Release of the Inpatient Prospective Payment System (IPPS) Fiscal 

Year (FY) 2012 Pricer 

2367 Verification of Status for all Hospitals Qualifying for Disproportionate Share 

Hospital (DSH) Payments under 42 CFR Section 412.106(c)(2), also known as the “Pickle Amendment” 

2368 Additional Payment Amounts for Hospitals with Disproportionate Share of 

Low-Income Patients 

2369 Summary of Policies in the CY 2012 Medicare Physician Fee Schedule (MPFS) 

Final Rule and the Telehealth Originating Site Facility Fee Payment Amount 

2370 January 2012 Integrated Outpatient Code Editor (I/OCE) Specifications Version 

13.0 

2371 Claim Status Category and Claim Status Codes Update 2372 Claim Adjustment Reason Code (CARC), Remittance Advice Remark Code 

(RARC), and Medicare Remit Easy Print (MREP) and PC Print Update 

2373 Bundling of Payments for Services Provided to Outpatients Who Later Are 

Admitted as Inpatients: 3-Day Payment Window Policy and the Impact on Wholly Owned or Wholly Operated Physician Practices 

2374 Additional Instructions Regarding Demand Bills Under the Home Health 

Prospective Payment System 

2375 Annual Type of Service (TOS) Update 2376 January 2012 Update of the Hospital Outpatient Prospective Payment System 

Transmittal 

Number 

Manual/Subjec

(OPPS) Policy and Billing Instructions for Co

Table of Contents Cardiac Resynchronization TherapPayment Window for Outpatient SeUse of Modifiers for Discontinued 

2377 Manual Revision to Chapter 6, Sectio

Professional Services Excluded From 

Billing Requirement Physician’s Services and Other ProfePPS Payment and the Consolidated B

2378 January 2012 Update of the Ambulat

Medicare Secondary Payer (

00 None 

Medicare Financial Manageme

196 Notice of New Interest Rate for Medi

First Notification for FY 2012 

197 Notice of New Interest Rate for Medi

Underpayments - 1st Notification for 

198 Medicare Financial Management Ma

(RTA) by Treasury 

Table of Contents Debts Returned to Agency (RTA) b

Treasury (Treasury) 

Debts RTA by Treasury Due to BaDebts RTA By Treasury as UncolleDebts RTA by Treasury as Dispute Debts RTA by Treasury as a Misce

Complaint or as Recall Approved 

Debts RTA by Treasury as paid in 

(RS) or Satisfied Compromise (R

199 Instructions for Processing Physician

Confirmed as Identity Theft 

Table of Contents Confirmed Identity Theft 1 IRS Form 1099 MISC 2 Seized Monies Received from La

200 Recovery Audit Program Tracking A

Table of Contents Tracking Appeals and Reopenings 

201 Issued to a specific audience, not pos

Confidentiality of Instruction 

Medicare State Operations Man

72 Revised Appendix A: Conditions of P

Hospitals Standard: Respiratory Services Standard: Nursing Services Standard: Rehabilitation Services Standard: Rehabilitation Services Standard: Rehabilitation Services Standard: Respiratory Services 
 8 

Transmittal 

Number 

Manual/Subject/Publication Number 

Standard: Pharmaceutical Services 

73 74 Revised Appendix A, Interpretive Guidelines for Hospitals 

Standard: Post-anesthesia Evaluation Standard: Pre-anesthesia Evaluation Condition of Participation: Anesthesia Services 

75 Revised Appendix A, Interpretive Guidelines for Hospitals, and Appendix W, 

Interpretive Guidelines for Critical Access Hospitals (CAHs) Standard: Notice of Rights/A-0117 Standard: Exercise of Rights/A-0130 Standard: Exercise of Rights/A-0131 Standard: Exercise of Rights/A-0132 Standard: Patient Visitation Rights/C-1002 Standard: Patient Visitation Rights/A-0215 Standard: Patient Visitation Rights/A-0216 Standard: Patient Visitation Rights/A-0217 Standard: Compliance With Federal Laws and Regulations/A-0151 Standard: Patient Visitation Rights/C-1000 Standard: Patient Visitation Rights/C-1001 Standard: Exercise of Rights/A-0133 

76 Clarifications to Appendix L, Ambulatory Surgical Center Interpretive 

Guidelines – Obtaining Consent before Observing Surgical Procedures 

77 Revised Appendix A, Interpretive Guidelines for Hospitals 78 Revised Appendix A, Interpretive Guidelines for Hospitals, and Revised 

Appendix W, Interpretive Guidelines for Critical Access Hospitals (CAHs) 

Medicare Program Integrity (CMS-Pub. 100-08) 

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

Confidentiality of Instruction 

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

Confidentiality of Instruction 

392 Update to Notifications Sent to State Medicaid Agencies and Child Health Plans 

of Medicare Terminations for Certified Providers and Suppliers and Medicare 

Revocations for Providers and Suppliers. This CR rescinds and fully replaces 

CR 7017, 7074 and 7334. Contractor Issued Revocations 

Medicare Contractor Beneficiary and Provider Communications (CMS-Pub. 100-09) 

00 None 

Medicare End-Stage Renal Disease Network Organizations (CMS Pub 100-14)

00 None 

Medicare Managed Care (CMS-Pub. 100-16) 

00 None 

Medicare Business Partners Systems Security (CMS-Pub. 100-17) 

00 None 

Demonstrations (CMS-Pub. 100-19)

00 None 

One Time Notification (CMS-Pub. 100-20)

963 Expansion of the Current Scope of Editing for Ordering/Referring Providers for 

Durable Medical Equipment, Prosthetics, Orthotics, and Supplier (DMEPOS) Suppliers Claims Process by Durable Medical Equipment Medicare Administrative Contractors (DMEMACs) 

Transmittal 

Number 

Manual/Subjec

964 Expansion of the Current Scope of E

claims processed by Medicare CarrieContractors (MACs) 

965 Issued to specific audience, not poste

Confidentiality of Instruction 

966 Health Insurance Portability and Acc

Institutional (837I) Edits and 5010 83Version 

967 Issued to specific audience, not poste

Confidentiality of Instruction 

968 Automated Tracking and Reporting o

and Appeals 

969 Issued to specific audience, not poste

Confidentiality of Instruction 

970 VMS Modifications to Oxygen CMN 971 Instructions for the Fiscal Intermedia

Workers Compensation Set Aside (WAmount Medicare would have paid wchange request also updates the MSP Savings Total on the Savings Report 

972 Common Edits and Enhancements M973 Revisions to Common Working File 

Prosthetics, Orthotics, and Supplies (Skilled Nursing Facility (SNF) Stay 

974 Issued to specific audience, not poste

Confidentiality of Instruction 

975 Format Revisions to the Special Incen

Quarterly Incentive Payments for He

the Primary Care Incentive Payment 

Incentive Payment Program (HSIP) 

976 Determining Claims Processing Time

Subject to an Additional Documentat

977 Enhancements to the Recovery Audit 

Fiscal Intermediary Shared System (F

978 Modify the Interchange Control Num

Encounters 

979 Processing Multiple Home Health Un980 Modify the Interchange Control Num

Encounters 

981 Issued to specific audience, not poste

Confidentiality of Instruction 

982 Issued to specific audience, not poste

Confidentiality of Instruction 

983 Health Insurance Portability and Acc

April 2012 

984 Issued to specific audience, not poste

Confidentiality of Instruction 

985 Fee for Service Common Eligibility S986 Issued to specific audience, not poste

Confidentiality of Instruction 

987 Issued to specific audience, not poste
 9 

Transmittal 

Number 

Manual/Subject/Publication Number 

Confidentiality of Instruction 

988 Enhancements to the Recovery Audit Mass Adjustment/Reporting Process in the 

Multi-Carrier System (MCS) 

989 Change Management Process -- Enterprise Electronic Change Information 

Management Portal (ECHIMP) 

990 CMS Standard Edit 009H is Obsolete 991 Expansion of the Current Scope of Editing for Ordering/Referring Providers for 

Claims processed by Medicare Carriers and Part B Medicare Administrative Contractors (MACs)

992 Issued to specific audience, not posted to Internet/ Intranet due to 

Confidentiality of Instruction E 

993 Reporting of Recoupment for Overpayment on the Remittance Advice (RA) 

with Patient Control Number

994 Issued to a specific audience, not posted to Intranet/Intranet due to 

Confidentiality of Instruction 

995 Multiple Procedure Payment Reduction (MPPR) on Certain Diagnostic Imaging 

Procedures 

996 Creating Payor ID for Medicare Advantage Encounter Data Submission 997 Creating Payor ID for Medicare Advantage Encounter Data Submission 998 HIPAA 5010 Outbound File Compliance Check 999 MCS ICD-10 Changes 1000 Issued to a specific audience, not posted to Intranet/Intranet due to 

Confidentiality of Instruction 

1001 Request to Require Hours for Research and Conference Calls with Maintainers, 

MACs, and EDCs and Additional Requirements for IDR Shared Systems 

1002 Automated Tracking and Reporting of Recovery Audit-Associated Reopenings 

And Appeals 

1003 Instructions to Accept and Process All Ambulance Transportation Healthcare 

Common Procedure Coding System (HCPCS) Codes 

1004 Requirement to Report Medicare Fee for Service Rendering Provider Place of 

Service Address Information to the Common Working File 

1005 Implementation of the Award for the Jurisdiction F (J-F) Part A and Part B 

Medicare Administrative Contractor (A/B MAC) including New Workload Numbers for Alaska, Idaho, Oregon and Washington

1006 Issued to specific audience, not posted to Internet/ Intranet due to 

Confidentiality of Instruction 

1007 Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 

(DMEPOS) Competitive Bidding Program: Allowing Contract or Non-Contract Suppliers to Maintain and Service the Enteral Nutrition Equipment That They 

Provided in the 15th Continuous Month of Rental 

1008 Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 

(DMEPOS) Competitive Bidding Program: Allowing Contract or Non-contract Suppliers to Maintain and Service the Enteral Nutrition Equipment that They 

Provided in the 15th Continuous Month of Rental 

1009 Issued to specific audience, not posted to Internet/ Intranet due to Sensitivity of 

Instruction 

1010 Instructions to Teaching Hospitals for Reporting the Internal Revenue Service 

(IRS) Refund of Medical Resident FICA Taxes 

1011 Review and Analysis of Draft Accredited Standards Committee X12 Technical 

Report 3s 

Addendum II: Regulation Documents Pub

(October through Decem

Regulations and Notices

Regulations and notices are published in the dai

individual copies or subscribe to the Federal Registwww.gpo.gov/fdsys. When ordering individual cop

date of publication or the volume number and page n

The Federal Register is available as an online d

The online database is updated by 6 a.m. each day thThe database includes both text and graphics from V(January 2, 1994) through the present date and can bhttp://www.gpoaccess.gov/fr/index.html. The follow

http://www.archives.gov/federal-register/ provides in

electronic editions, printed editions, and reference co

This information is available on our Web site at

http://www.cms.gov/quarterlyproviderupdates/down

For questions or additional information, contact Terr

Addendum III: CMS R

CMS Rulings are decisions of the Administrator 

opinions and orders and statements of policy and intclarification and interpretation of complex or ambiguregulations relating to Medicare, Medicaid, UtilizatiReview, private health insurance, and related matter

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

information, contact Tiffany Lafferty (410-786-7548

Addendum IV: Medicare National Co

(October through Decem

Addendum IV includes completed national cove

reconsiderations of completed NCDs, from the quartCompleted decisions are identified by the section of which the decision appears, the title, the date the pubeffective date of the decision. An NCD is a determinor not a particular item or service is covered nationa(title XVIII of the Act), but does not include a determassigned to a particular covered item or service, or pparticular covered item or service. The entries below completed decisions, as well as sections on program also announce decisions or, in some cases, explain wan NCD. Information on completed decisions as webeen posted on the CMS Web site. For the purposes 
 10 

only the specific updates that have occurred in the 3-month period. This information is available on our Web site at: www.cms.gov/medicare-coverage-database/. For 

questions or additional information, contact Wanda Belle (410-786-7491). 

Title NCDM 

Section 

Transmittal 

Number 

Issue Date Effective Date 

Screening for Depression in Adults 210.10 R139NCD 11/23/2011 10/14/2011 Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse 

210.9 R138NCD 11/23/2011 10/14/2011 

Intensive Behavioral Therapy for Cardiovascular Disease 210.11 R137NCD 11/23/2011 11/08/2011 October Clinical Lab Edits 190 R2344CP 11/04/2011 10/01/2011 Autologous Cellular Immunotherapy for Prostate Cancer 110.22 R136NCD 11/02/2011 06/30/2011 

Addendum V: FDA-Approved Category B Investigational Device Exemptions 

(IDEs) (October through December 2011) 

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 G110172 Small Particle Hyaluronic Acid with Lidocaine (SPHAL) 10/06/11 G110071 SpaceOAR System 10/14/11 G110096 Becton Dickinson Continuous Glucose Monitor Generation 2 10/14/11 G110177 DAKO EGFRVIII IHC Pharmdx Kit 10/18/11 G110048 Hydrus Aqueous Implant 10/20/11 BB14861 Cell Isolation System (CIS) 10/26/11 G100310 TransMedics Organ Care System (OCS) - Lung 10/26/11 G110191 Real-Time RT-PCR EGFRVIII Companion Diagnostics Assay 11/10/11 G110195 PTA Dilatation Catheter 11/10/11 G110198 Small Molecule Functional Kinase Inhibitor Screen 11/16/11 G110199 Deep Brain Stimulation 11/16/11 G110201 ISOMETRIC HANDGRIP THERAPY DEVICE 11/18/11 G110204 ACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS 11/22/11 G110206 COSTATUS SYETEM 11/23/11 

G110209 ZIMMER MAXERA ACETABULAR SYSTEM G110213 ANTI-MUC1 (H23) MOUSE MONOCLONAL ANG110215 AURORA ENDOMETRIAL ABLATION SYSTEM BB14923 Magnetic-Activated Cell Sorter (CliniMACS, MilteG110235 TAQMAN BASED REAL TIME RT-PCR EGFRV

DIAGNOSTIC ASSAY 

Addendum VI: Approval Numbers for C

(October through De

All approval numbers are available to the public 

process, approved information collection requests arA single control number may apply to several related information is available at www.reginfo.gov/public/

additional information, contact Mitch Bryman (410-

Addendum VII: Medicare-Approved C

(October through Decem

Addendum VII includes listings of Medicare-ap

facilities listed meet CMS standards for performing patients. On March 17, 2005, we issued our decision stenting. We determined that carotid artery stenting reasonable and necessary only if performed in facilitcompetent in performing the evaluation, procedure, optimal patient outcomes. We have created a list of modeled in part on professional society statements oat least meet our standards in order to receive coverahigh risk patients. For the purposes of this quarterly specific updates that have occurred in the 3-month pavailable on our Web site at: http://www.cms.gov/MedicareApprovedFacilitie/CA

questions or additional information, contact Sarah J. 

Facility Provid

Numb

The following facilities are new listings for 

Davis Hospital and Medical Center 1600 West Antelope Drive, Layton, UT 84041 

46004

The Jewish Hospital Mercy Health Partners 4777 E. Galbraith Road, Cincinnati, OH 45236 

13364

St. Francis Medical Center 601 Hamilton Avenue, Trenton, NJ 08629-1986 

31-002

Editorial changes (shown in bold) were made to the 

Saint Joseph Regional Medical Center 5215 Holy Cross Pkwy Mishawaka, IN 46545-1469

15001

Arizona Heart Hospital 1930 E. Thomas Road, Phoenix, AZ 85016 

03003
 11 

Facility Provider 

Number

Effective Date

State 

From: Medical Center East To: St. Vincent’s East 50 Medical Park East Drive, Birmingham, AL 35235 

010011 11/21/2005 AL 

From: Methodist Le Bonheur Germantown Hospital To: Methodist Hospital Germantown 7691 Poplar Avenue, Germantown, TN 38138

440049 11/14/2005 TN 

From: Methodist North Hospital To: Methodist Hospital North 3960 New Covington Pike, Memphis, TN 38128

440049 11/14/2005 TN 

From: Methodist University Hospital To: Methodist Hospital University 1211 Union Avenue, Memphis, TN 38104

440049 11/14/2005 TN 

Addendum VIII: 

American College of Cardiology’s National Cardiovascular Data Registry Sites 

(October through December 2011) 

Addendum VIII includes a list of the American College of Cardiology’s National 

Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the ICD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collecton mechanism. On October 27, 2005, CMS announced that the American College of Cardiology’s National Cardiovascular Data Registry (ACC-NCDR) ICD Registry 

satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR ICD Registry by April 2006. 

Effective January 27, 2005, to obtain reimbursement, Medicare NCD policy 

requires that providers implanting ICDs for primary prevention clinical indications (that is, patients without a history of cardiac arrest or spontaneous arrhythmia) report data on each primary prevention ICD procedure. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements are available in the Medicare NCD Manual, which is on the CMS Web site at http://www.cms.hhs.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=

99&sortByDID=1&sortOrder=ascending&itemID=CMS014961. 

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 to the list of Medicare-approved ICD facilities in the 3-

month period. This information is available by acce

the link for the American College of Cardiology’s NRegistry at: www.ncdr.com/webncdr/common. For q

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

Facility Name Address 1 

The following facilities are new listing

Barnes Jewish St. Peters Hospital 

10 Hospital Drive, MO 

Children's Healthcare of Atlanta 

1405 Clifton Road, NE 

Fairbanks Memorial Hospital 

1650 Cowles Street 

Highlands Regional Medical 

 3600 S Highlands Avenue 

Franciscan Healthcare Jackson Memorial Hospital (JACKSON HEALTH SYSTEM) 

1611 NW 12th Avenue 

Nacogdoches Memorial Hospital 

1204 Mound Street 

Pampa Regional Medical Center 

One Medical Plaza 

Parker Adventist Hospital 9395 Crown Crest 

Boulevard 

Providence Hospital 1150 Varnum Street, N.E. Riley Hospital for Children Indiana University Health 

705 Riley Drive 

Tanner Medical Center 705 Dixie Street Viera Hospital 8745 North Wickham Road 

The following facility is no longer a participant in 

as of this notice.

East Cooper Medical Center 2000 Hospital Drive 

Addendum IX: Active CMS Coverage-Re

(October through Decem

There were no CMS coverage-related guidance 

October through December 2011 quarter. To obtain documents, visit the CMS Coverage Web site at http://www.cms.gov/mcd/index_list.asp?list_type=m

link. For questions or additional information, contac

Addendum X: 

List of Special One-Time Notices Regarding N

(October through Decem

 There were no special one-time notices reg

published in the October through December 2011 
 12 

available at www.cms.hhs.gov/coverage. For questions or additional information, 

contact Lori Ashby (410-786-6322).

Addendum XI: National Oncologic PET Registry (NOPR) 

(October through December 2011) 

Addendum XI includes a listing of National Oncologic Positron Emission 

Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. 

In January 2005, we issued our decision memorandum on positron emission 

tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no new facilities that meet CMS’s requirements for performing PET scans under National Coverage Determination CAG-00181N published in the July through September 2011 quarter. This information is available at http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. 

For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564) 

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

Facility Name Address 1 City State Zip Code Capital Health System 1 Capital Way Pennington NJ 08534 Old name: Positron Imaging Of Austin New name: Texas Oncology Cancer Center 

6101 Balcones Drive Austin, TX 78731 

Addendum XII: Medicare-Approved Ventricular Assist Device (Destination 

Therapy) Facilities (October through December 2011) 

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 

updates that have occurred to the list of Medicare-apstandards in the 3-month period. This information is http://www.cms.gov/MedicareApprovedFacilitie/VA

questions or additional information, contact JoAnna 

Facility Provider 

Number 

Date App

The following are new listings for th

University of California San Diego Medical Center 9300 Campus Point Drive La Jolla, CA 92037 

050025 11/18/201

Providence St. Vincent Medical Center 9205 Southwest Barnes Road Portland, OR 97225 

380004 12/08/201

Scott & White Memorial Hospital 2401 South 31st Street Temple, TX 76508 

450054 12/08/201

Bon Secours – St. Mary’s Hospital 5801 Bremo Road Richmond, VA 23226 

490059 12/22/201

Facility Name Provider 

Number 

Date Approved 

Editorial changes (shown in bold) were made to t

Maine Medical Center 22 Bramhall Street Portland, ME 

060024 02/03/200

Joint Comcertified o02/03/09. 

OSF St Francis Medical Center 530 NE Glen Oak Avenue Peoria, Illinois 61637 

140067 08/31/200
 13 

Addendum XIII: Lung Volume Reduction Surgery (LVRS) 

(October through December 2011) 

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 (NETT) approved (Beginning 

05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); 

● Credentialed by the Joint Commission (formerly, the Joint Commision on 

Accreditation of Healthcare Organizations (JCAHO)) under their 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 to the listing of facilities for lung volume reduction surgery published in the October through 

December 2011 quarter.This information is available 

www.cms.gov/MedicareApprovedFacilitie/LVRS/lis

or additional information, contact JoAnna Baldwin, 

Addendum XIV: Medicare-Approved Ba

(October through Decem

Addendum XIV includes a listing of Medicare-a

minimum standards for facilities modeled in part on competency. All facilities must meet our standards ibariatric surgery procedures. On February 21, 2006memorandum on bariatric surgery procedures. We dprocedures are reasonable and necessary for Medicamass index (BMI) greater than or equal to 35, have aobesity and have been previously unsuccessful with This decision also stipulated that covered bariatric su

and 

necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006). 

For the purposes of this quarterly notice, we list only the specific updates to 

Medicare-approved facilities that meet CMS’s minimum facility standards for bariatric surgery and have been certified by ACS and/or ASMBS in the 3-month period. This information is available on our Web site at www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For questions or 

additional information, contact Kate Tillman, RN, MAS (410-786-9252). 

Facility Name Provider Number Date 

Approved

State 

The following facilities are new listings for this quarter.

University of California San Francisco Medical Center 500 Parnassus Avenue San Francisco, CA 94143-0790 1689772592 05/13/2011 CA Baylor Regional Medical Center at Grapevine 2020 West Highway 114 Grapevine, TX 76051 45-0563 11/18/2011 TX Metropolitan Methodist Hospital 1310 McCullough Avenue San Antonio, TX 78212 450388 11/18/2011 TX Lafayette General Medical Center 1214 Coolidge Boulevard Lafayette, LA 70503 190002 11/29/2011 LA Orlando Health 1414 Kuhl Avenue Orlando, FL 32806 100006 11/30/2011 FL Lawrence Hospital Center 55 Palmer Avenue Bronxville, NY 10708 330061 11/05/2011 NY Thomas Jefferson University Hospital 125 S. 11th Street Philadelphia, PA 19107 39-0174 11/18/2011 PA 

The following facilities are deletions for this quarter. 

The Regional Medical Center of Acadiana 2810 Ambassador Caffery Parkway Lafayette, LA 70506 190205 09/23/2005 LA Mount Sinai Hospital One Gustave L. Levy Place, 1190 5th Avenue New York, NY 10029 330024 07/06/2006 NY 

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

St. Anthony's Hospital 2807 Little York Road Houston, TX 77093 450795 03/18/2009 TX Aurora Sinai Medical Center 945 North 12 Street Milwaukee, WI53233 520138 09/30/2005 WI Centennial Center for the Treatment of Obesity 2200 Murphy Avenue Nashville, TN 37203 440161 08/22/2005 TN Abbott Northwestern Hospital 800 East 28th Street Minneapolis, MN 55407 240057 08/10/2005 MN 
 14 

Facility Name Provider Number Date 

Approved

State 

St. Mary's Hospital 5801 Bremo Road Richmond, VA 23226 490059 11/4/2005 VA Northwestern Memorial Hospital 251 East Huron Street Chicago, IL 60611 140281 09/25/2005 IL From: Southwest Washington Medical Center To: PeaceHealth Southwest 400 NE Mother Joseph Place Vancouver, WA 98664 

500050 09/08/2008 WA 

From: St. Mary’s Medical Center To: Essentia Health 400 East 3rd Street Duluth, MN 55805 1457393035 11/03/2011 MN Sacred Heart Hospital 421 Chew Street Allentown, PA 18102 390197 02/01/2007 PA Frye Regional Medical Center 420 N Center Street Hickory, NC 28601 340116 8/31/2005 NC From: St. John Providence Weight Loss To: St. John Hospital and Medical Center 21101 Moross Road Detroit, MI 48236

230165 05/14/2011 MI 

York Hospital 1001 South George Street York, PA 17405-7198 390046 9/30/2005 PA Spectrum Health Hospital 1840 Wealthy Street, SE Grand Rapids, MI 49506 23-0038 8/10/2005 MI Was: Gratiot Medical Center Now: MidMichigan Medical Center-Gratiot 300 E. Warwick Drive Alma, MI 48801 

23-0030 07/30/2007 MI 

Bon Secours Mary Immaculate Hospital 2 Bernardine Drive Newport News, VA 23602

49-0041 08/30/2011 VA 

Was: USC University Hospital Now: Keck Medical Center of USC 1500 San Pablo Street Los Angeles, CA 90033 

05-0696 01/30/2008 CA 

Methodist Dallas Medical Center P.O. Box 655999 Dallas, TX 75265-5999 

45-0051 05/15/2005 TX 

Virginia Commonwealth University Medical Center 1200 East Marshall Street Richmond, VA 23298-5049 

Kellum: 20000094; Maher: 004732m98 

10/14/2005 VA 

Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (October through Decembe

There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the October through December 2011 q

This information is available on our Web site at www.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. 

For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564) [FR Doc. 2012-3967 Filed 02/17/2012 at 8:45 am; Publication Date: 02/21/2012]