Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices 43475 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Improving 

Quality of Care in Medicaid and CHIP 

through Increased Access to Preventive 

Services State Survey; Use: The survey 

will be used to gain a better 

understanding of state efforts to increase 

the utilization of preventive services 

and to develop resources (including 

educational and outreach resources) to 

help states increase the utilization of 

these services. The results will provide 

a baseline regarding the coverage of 

preventive services and will help us 

identify ways to assist states with 

materials focusing on prevention and 

technical assistance. The survey has 

been revised subsequent to the 

publication of the 60-day Federal 

Register notice (79 FR 20211). 

Form Number: CMS–10521 (OMB 

control number: 0938—New); 

Frequency: Once; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 51; Total Annual 

Responses: 51; Total Annual Hours: 

128. (For policy questions regarding this 

collection contact Mary Beth Hance at 

410–786–4299.) 

2. Type of Information Collection 

Request: Revision to a currently 

approved collection; Title of 

Information Collection: Cooperative 

Agreement to Support Navigators in 

Federally-facilitated and State 

Partnership Exchanges; Use: Section 

1311(i) of the Affordable Care Act 

requires Exchanges (Marketplaces) to 

establish a Navigator grant program as 

part of its function to provide 

consumers with assistance when they 

need it. Navigators will assist 

consumers by providing education 

about and facilitating selection of 

qualified health plans (QHPs) within 

Marketplaces, as well as other required 

duties. Section 1311(i) requires that a 

Marketplace operating as of January 1, 

2014, must establish a Navigator 

Program under which it awards grants 

to eligible individuals or entities who 

satisfy the requirements to be Exchange 

Navigators. For Federally-facilitated 

Marketplaces (FFMs) and State 

Partnership Marketplaces (SPMs), we 

will be awarding these grants. Navigator 

awardees must provide weekly, 

monthly, quarterly, and annual progress 

reports to us on the activities performed 

during the grant period and any subawardees receiving funds. We have 

modified the data collection 

requirements for the weekly, monthly, 

quarterly, and annual reports that were 

provided in the 60-day Federal Register 

notice (79 FR 20211). 

Form Number: CMS–10463 (OMB 

control number: 0938–1215); Frequency: 

Annually; Quarterly, Monthly, Weekly; 

Affected Public: Private sector; Number 

of Respondents: 99; Total Annual 

Responses: 5,148; Total Annual Hours: 

49,512. (For policy questions regarding 

this collection contact Julia Dreier at 

301–492–4123.) 

Dated: July 22, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–17555 Filed 7–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9086–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—April Through June 2014 

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 April through June 

2014, 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. 

BILLING CODE 4120–01–C 

I. Background 

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 


emcdonald on DSK67QTVN1PROD with NOTICESEN25JY14.000</GPH>
43476 Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices 

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. Format for the Quarterly Issuance 

Notices 

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. 

Dated: July 18, 2014. 

Kathleen Cantwell, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 


emcdonald on DSK67QTVN1PROD with NOTICES

EN25JY14.001</GPH>emcdonald on DSK67QTVN1PROD 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: July 26,2013 (78 FR 45233), November 8, 2013 (78 FR 67153), 

January 31, 2014 (79 FR 5419), and April25, 2014 (79 FR 22976). 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 infonnation and a contact person for questions or 

additional information. 

Addendum 1: Medicare and Medicaid Manual Instructions 

(April through June 2014) 

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 (10M) 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 of the listed material free of charge 

at: ="'-'-'--'-"-'-'==-'-"-=""-'-="'· 

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 I ,400 

designated libraries throughout the United State

arrangements to transfer material to a local libr

FDL. Contact any library to locate the nearest 

available 

In addition, individuals may contact re

that receive and retain at least one copy of mos

publications, either in printed or microfilm fonnpublic. 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 Percutaneous Image-guide

(PILD) for Lumbar Spinal Stenosis (LSS)use C

Transmittal No. 167. 

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 l

that have occurred in the 3-month period. This 

our website at 

85 

86 

188 

Manual/Subject/Publ

Issued to a specific audience, not posted to 

Confidentiality of Instruction 

Contractor Implementation of Change Re

Technical Direction Letters 

Sample Cover Letter/Attestation Statemen

CR Implementation Report (CRlR) Temp

TDL Comoliance Renort ITCR) Temolate 

Update to the Medicare Benefit Policy Ma

Ambulance Definitions Air Ambulance Services 

Updates and Clarifications tn the Hospice 

Policy Manual 

Requirements- General 

Timing and Content ofCetiitication 

Election, Revocation, and Change of Hos

EN25JY14.002</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

189 

Hospice Discharge 

Election by Managed Care Enrollees 

Drugs and Biologicals Coinsurance 

Respite Care Coinsurance 

Benetit Coverage 

Nursing Care 

Physicians' Services 

Nurse Practitioners as Attending Physicians 

Short-Term Inpatient Care 

Medical Appliances and Supplies 

Other Items and Services 

Continuous Home Care (CHC 

Respite Care 

Other Issues 

Non-core Services 

Limitation on Liability for Certain Hospice Coverage Denials 

Documentation 

Limitations on Payments for Inpatient Care 

Counting Beneficiaries for Calculation 

Special Modalities 

Invalidation ofNational Coverage Determination 140.3- Transsexual Surgery 

Services Related to and Required as a Result of Services Which Are Not 

Covered Under Medicare 

Services Related to and Required as a Result of Services Which Are Not 

Covered Under Medicare 

166 I Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid 

Tumors (This CR rescinds and fully replaces CR8468/TR2873 

dated February 6, 2014) 

Positron Emission Tomography (FDG PET) for Oncologic Conditions 

167 I Percutaneous Image-guided I .umbar Decompression (PH D) for f .umbar 

Spinal Stenosis (LSS) 

Percutaneous image-guided lumbar decompression for lumbar spinal 

Stenosis 

16li I Fluorodcoxyglucosc (FDG) Positron Emission Tomography (PET) for Solid 

169 I 

2919 2920 2921 

Tumors (This CR rescinds and fully replaces CR8468/TR2873 dated 

Februmy 6, 2014) 

Positron Emission Tomography (FDG PET) for Oncologic Conditions 

Analysis and Implementation of Non-Medical Code Set Edit Bypass for 

Contractor Initiated Adjustment Claims in the Fiscal Intermediary Shared 

System (FISS) 

New Waived Tests 

Remittance Advice Remark and Claims Adjustment Reason Code and 

Medicare Remit Easy Print and PC Print Update 

Internet Only Manual Updates to Pub. 100-01, 100-02 and 100-04 to Correct 

Errors and Omissions 

2922 2923 2924 2925 2926 

Provider Charges to Beneficiaries 

Annual Updates to the SNF Pricer 

Other Excluded Services Beyond the Sco

Other Services Excluded from SNF PPS a

Ambulance Services 

Screening and Preventive Services 

Physician's Services and Other Profession

PPS Payment and the Consolidated Billin

Medicare Claims Processing Pub. I 00-04 

Uniform Bill- f'orm C.\t!S-1450 

Form Locators 43-81 Disposition of Copies of Completed Form

General Instructions for Completion of Fo

Form Locators l-15 

Form Locators 3 l-41 

Unitonn Billing with Form CMS-1450 

April Update to the CY 2014 Medicare Ph

(MPFSDB) 

July 20131ntegrated Outpatient Code Edi

Version 14.2 

Corrections to the Medicare Claims Proce

Foreword 

Liability Considerations for Bundled Serv

CWF General Instruction 

Liability Considerations for Bundled Serv

Line-Item Modifiers Related to Reporting 

Covered and Non-covered Services Are o

Claims Processing Requirements for Fina

Physician Fee Schedule Payment Policy I

General Billing Requirements 

Payment 

Coding That Results from Processing Non

Chapter 29 Appeals Update (Includes Pos

Requirement for Appointment of Represe

Appeal Rights 

CMS Decisions Subject to the Administra

Who May Appeal 

Steps in the Appeals Process: Overview 

Where to Appeal 

Procedures to Follow When a Party Fails 

Amount in Controversy General Requirem

Principles tor Determining Amount in Co

Aggregation of Claims to Meet the Amou

Appointment of Representative - Introdu

How to Make and Revoke an Appointmen

When and Where to Submit the Appointm

Rights and Responsibilities of a Represen

Duration of Appointment 

Curing a Defective Appointment of Repre

How to Make and Revoke a Transfer of A

EN25JY14.003</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Curing a Defective Transfer of Appeal Rights (MPFSDB) 

Medicare Secondary Payer (MSP) Specific Limitations or Additional 2935 Issued to a specitic audience, not posted t

Requirements With Respect to the Appointment of Representatives Fraud and oflnstruction 

Abuse- Authority 2936 July 2014 Quarterly Average Sales Price 

Appeals of Claims Involving Excluded Providers, Physicians, or Other Pricing Files and Revisions to Prior Quar

Suppliers 2937 Medicare Claims Processing Pub. I 00-04 

Required Elements in Appeals Correspondence Health Care Claim Status Category Code

General Information Codes for Use with the Health Care Claim 

Appeal Decision Involving Multiple Beneficiaries ASC X12 276/277 Claim Status Request 

Filing a Request for Redetermination Transmission Requirements 

The Redetermination Batch Transactions 

The Redetermination Decision Online Direct Data Entry 

Dismissals Interactive/Online (Non-DOE Dismissal Letters 

Requests for U.S. District Court Review by a Party Summary of the ASC Xl2 276/277 Claim 

Medicare Redetennination Notice (For Partly or Fully Unfavorable 

Redeterminations) Process for AlB Medicare Administrative 

Medicare Redetermination Notice (For Fully Favorable Redeterminations) 

System and Processing requirements for Use of Secure Internet 

Portal/ Application to Support Appeals Activities 

Reconsideration -The Second Level of Appeal 

Filing a Request for a Reconsideration 

Administrative Law Judge (ALl) Hearing- The Third Level of Appeal 

Departmental Appeals Board- Appeals Council- The Fourth Level of 

Appeal 

District Court Review - The Filth Level of Appeal 

Model Dismissal "Jotices 

2927 April2014 Update ofthe Ambulatory Surgical Center (ASC) Payment 

System 

2928 Enforcement of the 5 day Payment Limit for Respite Care Onder the Hospice 

Medicare Benefit 

2929 Update to Pub. I 00-04, Medicare Claims Processing Manual, Chapter II to 

Provide Language-Only Changes for Updating !CD-I 0 and ASC X 12 

Requirement for RNHCI Election 

2930 Update to Pub. I 00-04, Medicare Claims Processing Manual, Chapter II to 

Provide Language-Only Changes for Updating ICD-10 and ASC X12 

2931 Aprepitant for Chemotherapy-Induced Emesis 

Billing and Payment Instructions for A/B MAC 

IICPCS Codes for Oral Anti-Emetic Drugs 

Claims Processing Jurisdiction for Oral Anti-Emetic Drugs 

Oral Anti-Emetic Drugs Used as Full Replacement for Intravenous AntiEmetic Drugs as Part of a Cancer Chemotherapeutic Regimen 

2932 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for 

Solid Tumors (This CR rescinds and fully replaces CR8468/TR2873 dated 

February 6, 2014 

2933 Addition of New Fields and Expansion of Existing Model I Discount 

Percentage Field in the Inpatient Hospital Provider Specific File (PSF) and 

Addition of New Fields and Renaming Payment Fields in the Inpatient 

Prospective Payment System (IPPS) Pricer Output 

2934 April Update to the CY 2014 Medicare Physician Fee Schedule Database 

CEDI 

Flat File 

Translation Requirements Transmission Mode 

Claim Status Request/Response Transacti

2938 Issued to a specific audience, not posted t

Confidentiality of Instruction 

2939 Issued to a specific audience, not posted t

Confidentiality of Instmction 

2940 Update for the Durable Medical Equipme

Supplies (DMEPOS) Competitive Biddin

2941 Issued to a specific audience, not posted t

Confidentiality of Instruction 

2942 Issued to a specific audience, not posted t

Confidentiality of Instruction 

2943 Issued to a specific audience, not posted t

Confidentiality of Instruction 

2944 Issued to a specitic audience, not posted t

oflnstruction 

2945 Issued to a specific audience, not posted t

Contidentiality of Instruction 

2946 Tssued to a specific audience, not posted t

Confidentiality ofTnstruction 

2947 Medicare System Updates to Include Spli

Lenses Payment Category Indicators in th

Prosthetics, Orthotics, and Supplies (DME

Alpha-Numeric HCPCS file 

2948 Calendar Year (CY) 2014 Annual Update 

Schedule and Laboratory Services Subjec

-REVISION 

2949 Adjustment to Fiscal Intermediary Shared 

Implement J\'ational Uniform Billing Com

EN25JY14.004</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Revision to Occurrence Span Code (OSC) Definition for Code 72. F -Notice that determination reached that 

2950 Adjustment to Fiscal Intermedimy Shared System (FISS) Consistency Edit to submit paper claims 

Implement l\ational Uniform Billing Committee (NUBC) G- Notice from the Railroad Board Speci

Revision to Occurrence Span Code (OSC) Definition for Code 72. Contractor (RRB SMAC) to a Provider th

2951 Issued to a specific audience, not posted to Internet! Intranet due to Sensitivity Claims that Paper Claims Submitted by th

oflnstruction Network Service Vendor (NSV) Agreeme

2952 Issued to a specific audience, not posted to lnternet/Intranet due to Sensitivity 2966 Instructions for Downloading the Medica

of Instruction 2967 Claim Status Categmy and Claim Status C

2953 Issued to a specific audience, not posted to Internet/Intranet due to 2968 Quarterly Update for the Durable Medica

Confidentiality ofTnstruction 01thotics and Supplies (DMEPOS) Comp

2954 Issued to a specific audience, not posted to lntcrnct/lntranct due to -October 2014 

Confidentiality of Instruction 2969 Quarterly Update to the Correct Coding I

2955 Mandatmy Rep011ing of an 8-Digit Clinical Trial Number on Claims Effective October l, 20 I 4 

General 2970 July 2014 Update of the Ambulatory Surg

2956 Issued to a specific audience, not posted to Internet/Intranet due to 2971 July 2014 Update of the Hospital Outpati

Confidentiality of lnstmction System (OPPS 

2957 July 2014 Integrated Outpatient Code Editor (IiOCE) Specifications Type of Bill 

Version 15.2 Method of Payment for Clinical Laborato

2958 Issued to a specific audience, not posted to lnternet/lntranct due to Service Variation 

Confidentiality of Instruction Hospital Billing Under Part B 

2959 Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Critical Access Hospital (CAH) Outpatie

Spinal Stenosis ( LSS) 2972 Issued to a specific audience, not posted t

2960 Issued to a specific audience, not posted to Intcrnct/Intranct due to Confidentiality of Instmction 

Confidentiality of Instruction 2973 Issued to a specific audience, not posted t

2Y61 Issued to a specific audience, not posted to lnternet/lntranet due to of Instruction 

Confidentiality of Instruction 2974 July Update to the CY 2014 Medicare Ph

2962 Issued to a specific audience, not posted to Internet/Intranct due to (MPFSDB) 

Confidentiality of Instruction 2975 Issued to a specific audience, not posted t

2963 Common Edits and Modules (CEM) Code Set Update Confidentiality of Instruction 

2964 Indian Health Services (HIS) Hospital Payment Rates for Calendar Year 2014 

2965 Medicare Claims Processing Pub. 1 00-04 Chapter 24 Update 

A - Response to a non - "unusual circumstance" waiver request 

Number of ASCS Enforcement Reviews to he Conducted by the RRB 

SMAC 

2976 Changes to the Laboratory National Cove

Soflware 

2977 Claritlcation of Billing Instructions Relat

Split Percentage Payment of Episodes 

Home health Consolidated Billing Edits i

EDI Enrollment and ED! Claim Record Retention More Than One Agency Furnished Home 

H- Notice from the Railroad Retirement Board Speciality MAC to a 

Provider with a Pre-Established Record in PES that Paper Claims Will 

be Denied as Result of the Requirements that a Provider Submit Claims 

to One or More 

Grouper Links Assessment and Payment 

Submission of Request for Anticipated Pa

Claim Submission and Processing 

Payment, Claim Adjustments and Cancell

Other Medicare Contractors Electronically 

B - Denial of an "unusual circumstance" waiver request 

C - Request for Documentation from Provider Selected for Review to 

Establish Entitlement to Submit Claims on Paper 

D -Notice that paper claims will be denied effective with the 9 I st 

calendar day after the original letter as result of non-response to that 

letter 

Adjustments of Episode Payment- Low U

Adjustments (LUP As) Adjustments of Episode Payment- Early 

Adjustments of Episode Payment- Outlie

Glossmy and Acronym List 

Home Health Prospective Payment System 

General Guidelines for Processing !lome 

E- Notice that paper claims will he denied effective with the 91st 

calendar day after the original letter as result of determination that they 

-- -----------------

provider is not cligiblcto sub!Tiit paper clain1s 

--------

Therapy Editing 

Nonroutine Supply Editing 

Other Editing Related to Home Health Co

Home Health Consolidated Billing and Su

EN25JY14.005</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Suppliers 

National Home Health Prospective Payment Episode History File 

Other Editing for HH PPS Episodes 

Coordination of I Ill PPS Claims Episodes With Inpatient Claim Types 

Request for Anticipated Payment (RAP 

HH PPS Claims 

Collection of Deductible and Coinsurance from Patient 

Billing for Nonvisit Charges 

Beneficiary-Driven Demand Billing Under HH PPS 

No Payment Billing 

General 

lnpuUOutput Record Layout 

Decision Logic Used by the Pricer on RAPs 

Decision Logic Used by the Pricer on Claims 

Medical and Other Health Services Not Covered Under the Plan of Care 

(Type of Bill 034x 

Osteoporosis Injections as HHA Benefit 

Billing and Payment Procedures Regarding Ownership and CMS Certification 

Numbers (CCl\s) 

Billing Procedures for an Agency Being Assigned Vlultiple CCNs or a 

Change in CCN 

Timeliness and Limitations ofCWF Response 

2978 I Issued to a specific audience, not posted to Internet/ Intranet due to 

101 

1 236 

115 

116 

Additional Electronic CoJTespondence Referral System (ECRS) Reason 

Codes COBC Electronic 

New to State Operations Manual (SOM) Appendix Y- Organ Procurement 

Organization (OPO) Interpretive Guidance 

Revised State Operations Manual (SOM), Appendix A, Survey Protocol, 

Regulations and Interpretive Guidelines for Hospitals 

Survey Protocol, Regulations and Interpretive Guidelines for Hospitals/A0957 /§482.51 (b)( 4 )!There must be adequate provisions for immediate postoperative care. 

Survey Protocol, Regulations and Interpretive Guidelines for Hospitals/ A0409/§482.23(e)(4)/Blood transfusions and intravenous medications must be 

administered in with State law and approved medical slaiT policies 

and procedures 

Survey Protocol, Regulations and Interpretive Guidelines for Hospitals/A0412/§482.23(c)(6)/The hospital may allow a patient (or his or her 

caregiver/support person where appropriate) to both hospitalissued medications and the patient's own medications brought into the 

hospitals defined and specified in the hospital's policies and procedures 

117 118 

Survey Protocol, Regulations and Interpre

0405/§482.23(c)Standard: Preparation an

Revision to Medicare State Operations M

37 Model Letter Announcing Validation S

Provider/Supplier 

162 Model Letter: Request for a Plan of 

Survey for Swing-bed Approval in a Hosp

196 Model Letter Announcing to Deemed 

Validation Survey that it does not Comply 

199 Model Letter Announcing to Deemed 

Substantial Allegation Survey that it will 

Authorization by Deemed Provider/Suppl

Report of a Hospital Death Associated wi

CMS-10455) 

New Guidance Added to Chapter 7- Sur

Skilled Nursing Facilities and Nursing Fa

Definitions and Acronyms 

Informal Dispute Resolution 

After Request to Waive Hearing 

Mandatory Elements of Informal Dispute 

Independent Informal Dispute Resolution Introduction 

Purpose 

Independent Informal Dispute Resolution 

Applicability of the Independent Informal 

Key F:lements oflndependent Informal D

Qualifications of an Independent Informa

Pcrson(s 

Approval of an Independent Informal Dis

State Budget and Payment for Expenses 

Independent Informal Dispute Resolution 

Final Decision 

Additional Elements for Federal Independ

process 

Notice Requirements 

When Immediate Jeopardy Exists 

Reduction of a Civil Money Penalty by 50 

Prompt Correction ofNoncompliance 

When Penalty Is Due and Payable 

When a Civil Money Penalty Subject to B

Escrow Account is Imposed 

After Final Administrative Decision 

No Hearing Requested 

MODEL LETTER TO INVOLVED RESREPRESENTATIVE AND/OR STATE O

TO PROVIDE WRITTEN COMMENT (

DISPUTE 

RESOLUTJON (!DR) HAS BEEN REQU

After Substantial Compliance is Achieved 

After Effective Date ofTennination 

EN25JY14.006</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Disposition of Collected Civil Money Penalty 

Collected From Medicare or Dually-Participating Facility 

Entities Other Than Nursing Homes May Receive Collected Civil Money 

Penalty Funds From the State 

Entities Other Than Nursing Homes May Receive Collected Civil Money 

Penalty Funds From the State 

Collected Amounts From Dually-Participating Facility or Medicare Facility 

and Held in Esc 

Use of Civil Money Penalty Funds 

MODEL LETTER TO PROVIDER (SEND WITH FORM CMS-2567) 

(IMMEDIATE JEOPARDY DOES NOT EXIST) 

MODEL LETTER NOTIFYING PROVIDER OF RESULTS OF REVISIT 

MODEL LETTER TO PROVIDER (IMPOSITION OF REMEDIES) 

(IMMEDIATE JEOPARDY DOES NOT EXIST) 

MODEL LETTER TO PROVIDER (IMPOSITION OF REMEDIES) 

(IMMEDIATE JEOPARDY EXISTS) 

NOTICE OF IMPOSITION OF A CIVIL MONEY PENALTY (INSERT TO 

FORMAL NOTICE) 

NOTICE OF PAYMENT AMOUNT DUE AND PAY ABLE 

NOTICE OF PAYMENT AMOUNT DUE FOR PLACEMENT IN 

ESCROW 

(IIDR COMPLETE OR NOT TJMEL Y REQUESTED-FACILITY IS 

FILING FORMAL APPEAL) 

Purpose -To Provide Facilities an Opportunity To Informally Dispute Cited 

510 I Clarification to Pub. 1 00-02, Medicare Benefit Policy Manual Regarding 

Antigens and Deletion of Section 13.14 from Chapter 13 of Pub. 100-08, 

Medicare Program Integrity Manual 

Evaluation of Local Coverage Determination (LCD) Topics for National 

Coverage Determination (NCD) Consideration 

1511 I Issued to a specific audience not posted to lntemet/ Intranet due to 

Confidentiality oflnstruction 

512 I Revision to the Program Integrity Manual, Chapter 3, section 3.3 

Policies and Guidelines Applied During Review 

513 I Issued to a specific audience not posted to Intemeti Intranet due to 

Confidentiality of lnstmction 

514 I Update to CMS Publication 100-08, Chapter 15 

Potential Changes of Ownership 

Under the Principles of§ 489.18 Direct Referral to the Regional Office 

Required Radiation Therapy Centers 

Practice Location lnformation 

Form CMS-855A and Form CMS-855B Signatories 

Delegated Officials 

Submission of Registration Applications 

Registration Letters 

Certified Providers and Certified Suppliers 

Temporary Moratoria 

515 516 517 518 519 

520 

521 522 523 

Model Approval Recommended Letters 

Initial Enrollments Requiring Retimal to 

Initial Enrollments Requiring Direct Refe

(Including Federally Qualified Health Ce

Changes oflnformation Changes oflnformation Requiring Referr

Changes oflnfonnation Requiring Direct 

Potential Changes of Ownership Under th

Potential Changes of Ownership Under th

Referral to the State Required 

Federally Qualified Health Centers (FQH

Issued to a specific audience not posted to 

Conlidentiality of lnstmction 

Issued to a specific audience not posted to 

Confidentiality of Instruction 

Update to Surety Bond Collection Proced

Model Letters tor Claims against Surety B

Claims against Surety Bonds 

Issued to a specific audience not posted to 

Confidentiality of Instruction\ 

Revision to CMS Publication 100-08, Ch

Individual Practitioners 

Speech Language Pathologists in Private 

Audiologists 

Certified Nurse-Midwives 

Certified Registered Nurse Anesthetists (C

Clinical Nurse Specialists Clinical Psychologists Clinical Social Workers 

Nurse Praditioners 

Occupational Therapists in Private Prac 

Physical Therapists in Private Practice 

Physicians 

Physician Assistants (PAs) Psychologists Practicing Independently Registered Dietitians 

Anesthesiology Assistants 

Issued to a specific audience not posted to 

Confidentiality of Instruction 

Submission of Community Mental Health 

Certifications of Compliance with Section 

Release of Information 

CMHC 40 Percent Rule 

Section 4 of the Form CMS-855I 

Special Procedures for Physicians and No

Community 'v!ental Health Centers (CMH

Issued to a specific audience not posted to 

Confidentiality of Instruction 

Update to CMS Pub. I 00-08, Chapter 3 

Reimbursing Providers and HIHs for Add

EN25JY14.007</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

524 Issued to a specific audience not posted to Internet/ Intranet due to 

Conlidentiality oflnstruction 

525 Update to Form CMS-855 Application Processing Sections ofCMS 

Pub. 100-08, Chapter 15 

Sections of the Forms CMS-855A, CMS-855B, and CMS-855[ 

Medicare Contractor Duties 

Changes ofinformation and Complete l'orm CMS-855 Applications Correspondence Address and E-mail Addn:sscs 

Contact Persons 

Application Review and Verification Activities 

Receipt/Review of Application and Verification ofData 

Receipt/Review of Paper Applications 

Receipt/Review of Internet-Based PECOS Applications 

Verification of Data 

Requesting Missing/Clarifying Data/Documentation 

Paper Applications 

Internet-Based PECOS Applications 

General Principles Paper and Internet-Based PECOS Applications 

Receiving Missing/ClarifYing Data/Documentation 

Failure to Submit Requested Data/Documentation 

Paper Applications 

Internet-Based PECOS Applications 

Reserved for Future Use 

Reserved for Future Usc 

Requesting and Receiving ClarifYing lnforn1ation 

Basic Information (Section I of the Form CMS-855) 

526 Issued to a specific audience not posted to Internet/ Intranet due to 

Confidentialitv of Instruction 

527 Provider Notice on MAC Web Sites 

Provider Notice 

528 Proof of Delivery 

Supplier Documentation 

28 Revision of Pub. 100-09, Chapter 6, Medicare Contractor Beneficiary and 

Provider Communications Manual; Clearance of MAC Internet-Based 

Provider Portal Handbook; and Deletion of!OM Pub. 100-09, Chapter 3, 

Provider Inquiries. 

Introduction to Provider Customer Service Program (PCSP) 

PCSP Electronic Mailing Lists (Listservs) 

Provider Customer Service Program User Group (PCUG) Calls 

PCSP Contractor Sharing and Collaboration Team Room 

Integration of POE, PCC and PSS Activities in the PCSP 

Provider Outreach and Education (POE) 

Internal Development of Provider Issues 

Partnering with External Entities 

Data Analysis 

Error Rate Reduction Data 

Inquiry Analysis 

Medical Review Referrals Provider Education 

1\\'t 

Provider Bulletins/Newsletters Direct Mailings for the PCSP 

rraining for New Medicare Providers 

Training Tailored for Small Medicare Pro

Educational Topics 

Local Coverage Determinations (LCDs) 

Education Resulting from Medical Revie

Medicare Preventive Service Benefits 

Electronic Claims Submissions 

Remittance Advice (RA 

POE Materials 

POE Advisory Groups (POE AGs) 

Ask-the-Contractor" Teleconferences (AC

POE Reporting 

Provider Service Plan (PSP) 

Provider Customer Service Program Acti

Error Rate Reduction Plan (ERRP 

Additional Reporting 

charging Fees to Providers for Medicare E

No Charge 

Fair and Reasonable Fees Fees for Materials Available on Contracto

Fees for Education and Training Activitie

Fees for Videotapes or Recordings of Edu

Prohibitions 

Reimbursement Jrom Providers for POE S

Meetings 

Excess Revenues from Provider Participa

Refunds/Credits for Cancellation of Educ

Considerations and Recordkeeping for Fe

Provider Contact Center (PCC) 

Inquiry Triage Process 

Responding to Coding Questions 

Provider Telephone Inquiries 

General Inquiries Line 

Teletypewriter (TTY) Lines 

Inbound Calls 

Troubleshooting Problems 

Requesting Changes to Telephone Config

!lours of Operation 

PCC Closures 

Pre-Approved PCC Closures 

Planned PCC Closures that are not Pre-Ap

Emergency PCC Closures 

Providing Busy Signals 

Queue Message 

PCC Staffing 

CSR Equipment Requirements 

CSR Identilieation to Callers 

Remote Monitoring Access 

EN25JY14.008</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Contingency Plans 

Guidelines for High Quality Responses to Telephone Inquiries 

Telephone Response Quality Monitoring Program Telephone Responses -- Quality Call Monitoring (QCM) Program Minimum 

Requirements Recording Calls 

QCM Calibration 

CMS Monitoring 

Provider Written Inquiries 

Controlling Wri!ten Inquiries 

Telephone Responses to Written Inquiries 

E-mail and Fax Responses to Written Inquiries 

Guidelines for High Quality Responses to Written Inquiries 

Stock Language/Form Letters 

Written Response Quality Monitoring Program 

Written Responses-- Quality Written Correspondence Monitoring (QWCM) 

Program Minimum Requirements 

QWCM Calibration 

Replying to Correspondence from Members of Congress 

Walk-In Inquiries 

Guidelines for Walk-In Service 

Complex Provider Inquiries Complex Bene11ciary Inquiries 

Inquiry Tracking 

Updates for the CMS Standardized Provider Inquiry Chart 

Fraud and Abuse 

Surveys 

Provider Satisfaction Survey 

Telephone Satisfaction Survey 

Provider Edu<.:atiun Website Satisfaction Survey 

PCSP Staff Development and Education POE Staff Training 

PCC Staff Development and Training 

Required Training 

PCC Training Program 

Training Schedule Training Closures of More Than Four Hours 

Provider Noti11cations 

!raining Closure Information Reporting 

PRRS StaffTraining Provider Self-Service (PSS) Technology 

Interactive Voice Response System (IVR) 

Provider Education Website 

General Requirements 

Webmastcr and Attestation Requirements 

Feedback Mechanism 

Contents 

Dissemination oflnformation from CMS to Providers 

Frequently Asked Questions (FAQs) 

Quarterly Provider Update (QPU 

29 

lntemet-based Provider Educational Offe

Provider Edncation Website Promotion 

Electronic Mailing List (Listserv) 

Targeted Electronic Mailing Lists (Listse

Electronic Mailing List (Listserv) Promot

Social Media 

Contractor Intcmct-bascd Provider Portal

PCSP PerJormance Management 

POE- Electronic Mailing List (Listserv) 

Telephone Standards 

Customer Service Representative (CSR) C

Call Completion 

Average Speed of Answer (ASA) 

Callbacks 

QCM Performance Standards 

Written Inquiries 

QWCM Pertormance Standards General Inquiries Timeliness 

PRRS Timeliness- Provider Inquiries 

PRRS Timeliness-- Complex Bene11ciary 

Congressional Inquiries Timeliness 

PCSP Data Reporting 

Provider Inquiries Evaluation System (PI

Access to PIES 

Due Date for Data Submission 

Data to be Repmied Monthly 

Provider Customer Service Program Cont

(PCID) 

Access to PCID 

Contract Data tD be Reported in PCID 

Other Data to be Reported in PCID 

Inquiry Tracking Data to be Reported in P

Disclosure of Information 

POE Data to be Reported in PCID 

Provider Electronic Mailing List (Listserv

in PCID 

Special Initiatives to be Reported in PCID 

Emergency PCC Closure Data to Be Repo

lclecommunications Service Interruption

QCM Data Reporting 

QWCM Data Reporting 

Reporting Provider and Beneficiary Inqui

Reporting of Operational Workload Data 

PCC Training Closure Information to be 

Revision of Pub. 100-09, Chapter 6, Med

Provider Inquiries. 

Introduction to Provider Customer Servic

PCSP Electronic Mailing Lists (Listservs

Provider Customer Service Program User 

PCSP Contractor Sharing and Collaborati

EN25JY14.009</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Integration of POE, PCC and PSS Activities in the PCSP 

Provider Outreach and Education (POE) 

Internal Development of Provider Issues 

Partnering with External Entities 

Data Analysis 

Error Rate Reduction Data 

Inquiry Analysis 

Medical Review Referrals 

Provider Education 

Provider Bulletins/Newsletters 

Direct Mailings for the PCSP 

Training for New Medicare Providers Training Tailored for Small Medicare Providers 

Educational Topics Local Coverage Determinations (LCDs) Education Resulting from Medical Review Referrals 

Medicare Preventive Service Benelils 

Electronic Claims Submissions 

Remittance Advice (RA 

POE Materials 

POE Advisory Groups (POE AGs) 

Ask-the-Contractor" Teleconferences (ACTs 

POE Reporting 

Provider Service Plan (PSP) 

Provider Customer Service Program Activity Report (PAR) 

Error Rate Reduction Plan (ERRP 

Additional Reporting 

charging Fees to Providers for Medicare Education and Training 

No Charge 

Fair and Reasonable Fees 

Fees for Materials Available on Contractors' Provider Education Websites Fees for Education and Training Activities 

Fees for Videotapes or Recordings of Education and Training Activities 

Prohibitions 

Reimbursement from Providers for POE Staff Attendance at Provider 

Meetings 

Excess Revenues from Provider Participant Fees 

Refunds/Credits for Cancellation of Education and Training Activities 

Considerations and Recordkceping for Fee Collection 

Provider Contact Center (PCC) 

Inquiry Triage Process 

Responding to Coding Questions 

Provider Telephone Inquiries 

General Inquiries Line 

Teletype\vriter (TTY) Lines 

Inbound Calls 

Troubleshooting Problems 

Requesting Changes to Telephone Configurations Hours of Operation 

PCC Closures 

Pre-Approved PCC Closures Planned PCC Closures that are not Pre-A

Emergency PCC Closures 

Providing Busy Signals 

Queue Message 

PCC Staffing 

CSR Equipment Requirements CSR Identification to Callers 

Remote Monitoring Access 

Contingency Plans 

Guidelines for High Quality Responses to 

Telephone Response Quality Monitoring 

Telephone Responses-- Quality Call Mon

Requirements 

Recording Calls 

QCM Calibration 

CMS Monitoring 

Provider Written Inquiries 

Controlling Written Inquiries 

Telephone Responses to Written Inquiries 

E-mail and Fax Responses to Written Inq

Guidelines for lligh Quality Responses to 

Stock Language/Form Letters 

Written Response Quality Monitoring Pro

Written Responses-- Quality Written Cor

Program Minimum Requirements 

QWCM Calibration 

Replying to Correspondence from Membe

Walk-In Inquiries 

Guidelines for Walk-In Service 

Complex Provider Inquiries 

Complex Beneficiary Inquiries 

Inquiry Tracking 

Updates for the CMS Standardized Provid

Fraud and Abuse 

Surveys 

Provider Satisfaction Survey 

Telephone Satisfaction Survey 

Provider Education Website Satisfaction 

PCSP Staff Development and Education 

POE Stall Training 

PCC Staff Development and Training 

Required Training 

PCC Training Program 

!'raining Schedule 

rraining Closures of More Than Four Ho

Provider Notifications 

Training Closure Information Reporting 

PRRS StaffTraining Provider Seli:Service (PSS) Technology 

EN25JY14.010</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Interactive Voice Response System (!VR) 

Provider Education Website 

Genera 1 Requirements 

Webmaster and Attestation Requirements 

Feedback Mechanism 

Contents 

Dissemination ofinformation from CMS to Providers 

Frequently Asked Questions (FAQs) 

Quarterly Provider Update (QPU 

Internet-based Provider Educational Offerings 

Provider Education Website Promotion 

Electronic Mailing List (Listscrv) 

Targeted Electronic Mailing Lists (Listservs) 

Electronic Mailing List (Listserv) Promotion 

Social Media 

Contractor Intemet-based Provider Portals 

PCSP Performance Management 

POE- Electronic Mailing List (Listserv) Subscribership 

Telephone Standards 

Customer Service Representative (CSR) Callback Rate 

Call Completion 

Average Speed of Answer (ASA) 

Callbacks 

QCM Performance Standards 

Written Inquiries 

QWCM Perfonnance Standards 

General Inquiries Timeliness 

PRRS Timeliness - Provider Inquiries 

PRRS Timeliness-- Complex Beneficiary Inquiries 

Congressional Inquiries Timeliness 

PCSP Data Reporting 

Provider Inyuiries Evaluation System (PIES 

Access to PIES 

Due Date for Data Submission 

Data to be Reported Monthly 

Provider Customer Service Program Contractor Information Database (PCID) 

Access to PCID 

Contract Data to be Repmied in PCID Other Data to be Reported in PCID 

Inquiry Tracking Data to be Reported in PCID 

Disclosure of Information POE Data to be Repmied in PCID Provider Electronic Mailing List (Listserv) Subscriber Data to be Reported 

in PClD 

Special Initiatives to be Reported in PCID 

Emergency PCC Closure Data to Be Reported in PCID 

Telecommunications Service Interruptions to be Reported in PCID 

QCM Data Reporting QWCM Data Reporting 

Reporting Provider and Beneficiary Inquiry Workload Data in the Contractor 

2 

98 

100 

101 

102 

103 

104 

105 1366 1367 

1368 

1369 

1370 

1371 1372 

Reporting of Operational Workload Data 

PCC Training Closure Information to be 

None 

Issued to a specific audience not posted to 

Confidentiality of Instruction 

None 

Affordable Care Act Bundled Payments f

4 Ju

lssued to a specific audience not posted to 

oflnstruction 

Issued to a specific audience not posted to 

of Instruction 

Correction to CR 8599-Implementation o

(IVIG) demonstration 

Issued to a specific audience not posted to 

oflnstruction 

Issued to a specific audience not posted to 

Confidentiality oflnstruction 

Implementing Payment Changes for FCH

Integration Project), Mandated by section 

amended by section 3126 of the ACA of2

Affordable Care Act Bundled Payments f

Recurring File Models 2 and 4 O

Reporting principal and interest amounts 

money on the Remittance Advice (RA) 

Termination of the Common Working Fil

HUQA Part A Provider Queries 

Implementation ofNACIIA Operating Ru

Funds Transfers (EFT) 

Classifi"ation I 

Providers through the Common Edits and 

Common Electronic Data Interchange (C

Clarification of Remittance Advice Code 

Shared Systems 

Implement Operating Rules- Phase lll ER

Claim Adjustment Reason Codes (CARCCodes (RARC) Rule- Update li·om CAQ

3.0.4 

Instructions to Contractors for Implement

Care Act (ACA)- Preservation of Reside

Teaching Hospitals Rounds l, 2, 3 and 

Affordable Care Act (ACA) Bundled Pay

EN25JY14.011</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Periodic Financial Transactions 

1373 CWF Editing for Vaccines Furnished at Hospice- Correction 

1374 Health Insurance Portability and Accountability Act (HIPAA) EDI Front End 

Updates for October 2014 

1375 Adding New MSP Data Fields to the CWF Daily File 

1376 Return Maintenance of the ANSILIST to the Durable Medical Equipment 

(DME) Medicare Administrative Contractors (MACs). 

1377 Hewlett Packard Enterprise Services, LLC (HPES) Shared Systems 

Maintainer (SSM) support for Medicare Administrator Contractors (MACs) 

testing and inquiries for the Combined Common Edits/Enhancements Module 

(CCEM) for Part A and Part B 

1378 Implement Operating Rules- Phase III ERA EFT: CORE 360 Uniform Use of 

Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark 

Codes (RARC) Rule- Update from CAQH CORE- June 1, 2014 version 

3.0.5 

1379 Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Related 

Services in a Method II Critical Access Hospital (CAH) 

1380 Present on Admission (POA) Indicator Editing for Maryland Waiver 

Hospitals 

1381 CEM Zip Code Analysis and Design 

1382 Analysis and Design ofthe ASC X12 278 Transactions 

1383 Implementation of a Prospective Payment System (PPS) for Federally 

Qualified Health Centers (FQHCs) 

1384 Posting the Limiting Charge after Applying the Electronic Health Record 

(EHR) 

and Physician Quality Reporting System (PQRS) Negative Adjustments 

1385 Additional States Requiring Payment Edits for DMEPOS Suppliers of 

Prosthetics and Certain Custom-Fabricated Orthotics. Update to CR 3959 and 

CR 8390 

1386 ModifYing the Daily Common Working File (CWF) to Medicare Bcncficiaty 

Database (MBD) File to Include Diagnosis Codes on the Health Insurance 

Portability and Accountability Act Eligibility Transaction System (HETS) 

270/271 Transactions 

1387 Clarification of Remittance Advice Code Combination Reports Generated by 

Shared Systems 

1388 I CD-I 0 Conversion/Coding Infrastructure Revisions/ICD-9 Updates to 

National Coverage Determinations (NCDs)--Maintenance CR 

1389 CWF, MCS and VMS Date of Birth (DOB) Analysis 

Addendum II: Regulation Documents Published 

in the Federal Register (April through June 2014) 

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 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 

GPO Access. The online database is updated 

Federal Register is published. The database 

graphics from Volume 59, Number 1 (Januar

date and can be accessed at 

following website 

information on how to access electronic editi

reference copies. 

This information is available on our 

For questions or additional informat

( 410-786-4481 ). 

Addendum III: CMS 

CMS Rulings are decisions of the A

precedent final opinions and orders and statem

interpretation. They provide clarification and 

ambiguous provisions of the law or regulation

Medicaid, Utilization and Quality Control Pe

insurance, and related matters. 

The rulings can be accessed at nup:l

For questio

contact Tiffany Lafferty (410-786-7548). 

Addendum IV: Medicare National C

(April through June 

Addendrun IV includes completed n

determinations (NCDs ), or reconsiderations o

quarter covered by this notice. Completed de

section of the NCD Manual (NCDM) in whic

title, the date the publication was issued, and 

decision. An NCD is a determination by the 

particular item or service is covered nationall

(title XVIII ofthe Act), but does not include 

any, that is assigned to a particular covered it

determination for a particular covered item or 

include information concerning completed de

program and decision memoranda, which also 

some cases, explain why it was not appropria

Information on completed decisions as well a

EN25JY14.012</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

been posted on the CMS website. For the purposes of this quarterly notice, 

we list only the specific updates that have occurred in the 3-month period. 

This information is available at: 

For questions or additional infom1ation, contact Wanda Belle 

(410-786-7491). 

Title NCDM Transmittal Issue Date Effective 

Section Number Date 

Percutaneous Image-guided 

Lumbar Decompression for NCD150.13 Rl67 05/16/2014 01/09/2013 

Lumbar Spinal Stenosis 

ICD-10 Conversion/Coding Infrastructure 

Revisions/lCD-9 Updates N/A R133 05/23/2014 07/0]/2014 

to National Coverage 

Determinations (NCDs) 

Addendum V: FDA-Approved Category B Investigational Device 

Exemptions (IDEs) (April through June 2014) 

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 lDEs 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 April21, 1997 Federal Register (62 FR 19328). 

IDE Device Start Date 

G140034 ROCHE CO BAS EGFR MUTATION TEST 04/03/2014 

!3!315945 ReCell Autologous Cell Harvesting Device (ReCell) 04/03/2014 

Gl40035 Strattice Reconstructive Tissue Matrix 04/04/2014 Gl40039 EVERA MRI SURESCAN lCD SYSTEM CLINICAL STUDY 04/09/2014 Gl30185 BARREL VASCULAR RECONSTRUCTION DEVICE 041!0/2014 

BBI5963 Dermagraft, Human Fibroblast-Derived Dermal Replacement 04/11/2014 

G140054 

Gl40040 Gl30286 Gl30072 

0140043 

Gl40046 

BB15998 

()140048 

G140049 

G\40050 

BBI5978 

BB\5983 

Gl40056 G140058 Gl40059 Gl40060 Gl40065 

0130264 

()140024 

Gl40018 

()140077 

Gl40083 Gl40080 G140087 G140084 Gl40082 

(l] 40091 

G140092 

G\40027 Gl30256 G 140093 G140099 

Medtronic Specify 5-6-5 I \1edtronic Restore 

Blanketrollll 

WEB Aneurysm Embolization System 

Ovinium DH Hip System 

Transcava1 Access For Transcathctcr Ortic V

Patients With No Good Options For Aortic A

PerMIT:Warfarin 

Magnetic-Activated Cell Sorter(CliniMACS

CD34 Selection, Allogeneic, Matched-relate

Inferior V cna Cava Filters 

EON Implantable Pulse Generator (lPG) Sys

Libra Implantable Deep Brain Stimulation (D

(Model 6145), Swift-Lock Anchor (Model 1

Mi 1000 Med-FI, Concert Cochlear Implant 

Nstride APS Kit 

Magnetic Activated Cell Sorter (CiiniMACS

CD34+ Selected Allogeneic Mismatched/Ha

Related, 0-CSF Mobilized Hematopoietic St

following Fludarbine and rA TG, with or with

Model400 Aotiic Valve Bioprothesis 

Thcrascrccn BRAF V600E RGQ PCR Kit 

Corevalve Evolut R System 

Gore Tag Thoracic Branch Endoprothesis 

VENT ANA anti-ALK (D5F3) Rabbit Monoc

Antibody 

!lot Axios Stend And Delivery System (With 

Stent) HXS-10-10, Hot Axios Stend And De

15mmx lOmm Stent)HXS-15-10 

Saluda Medical External Trial System 

Saluda Medical External Trial System 

Liposorber LA-40S Adsorption Column 

Zeltiq Coolsculpting System 

XpreESS Multi-Sinus Dilation Tool, PathAs

Fiber, PathAssist Light Fiber, PathAssist Lig

Sinopsys Lacrimal Stent 

Pipeline Embolization Device Model FA-772

775XX-XX, Pipeline Embolization Device M

XX-FA-715XX-XX 

ExAblate 4000 Typer 1.0 Tnmscranial magn

Read/Read Block Compressible Microsphere

Cardiac Resynchronization Therapy Efficacy 

(CRTee) Clinical Study 

Transarterial embolization to avoid open pro

patients with severe benign prostatic hyperpl

Microspheres) 

SCULPTRA-20 13-01 

Custom-Made, Non-Biodegradable, Antibiot

VenaCure EVL T 400um Procedure Kit 

----- 

EN25JY14.013</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Addendum VI: Approval Numbers for Collections oflnformation 

(April through June 2014) 

All approval numbers are available to the public at Reginfo.gov. 

Under the review process, approved information collection requests are 

assigned OMB control numbers. A single control number may apply to 

several related information collections. This information is available at 

For questions or additional 

information, contact Mitch Btyman ( 41 0-786-5258). 

Addendum VII: Medicare-Approved Carotid Stent Facilities, 

(April through June 2014) 

Addendum VII includes listings of Medicare-approved carotid 

stent facilities. All facilities listed meet CMS standards for performing 

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 at: 

For questions or additional information, contact Lori Ashby 

( 41 0-786-6322). 

Facility Provider 

Number 

Penrose-St. Francis Health Services 060031 

2222 N. Nevada A venue 

Colorado Sprin s, CO 80907 

The Heart Hospital Baylor Denton 1194753590 06/02/2014 

2809 S. Mayhill Road 

Denton, TX 76208 

TX 

Addendum VIII

American College of Cardiology's Natio

Registry Sites (April throug

Addendum VIII includes a list of the 

Cardiology's National Cardiovascular Data R

implantable cardioverter defibrillators (ICDs) 

indications, as long as infonnation about the p

central registry. Detailed descriptions of the c

available in the NCO. In January 2005, CMS 

Abstraction Tool through the Quality Network 

temporary data collection mechanism. On Oc

announced that the American College of Card

Cardiovascular Data Registry (ACC-NCDR) I

reporting requirements in the NCD. Hospitals 

ACC-NCDR ICD Registry by April2006. 

Effective January 27, 2005, to obtain 

NCO policy requires that providers implanting 

clinical indications (that is, patients without a 

spontaneous arrhythmia) report data on each p

procedure. Details of the clinical indications 

and their respective data reporting requiremen

Medicare NCD Manual, which is on the CMS 

A provider can use either of two mec

reporting requirement. Patients may be enroll

Device Exemption trial studying I COs as iden

ACC-NCDR ICD registry. Therefore, for a b

Medicare-covered ICD implantation for prima

must receive the scan in a facility that participregistry. The entire list offacilities that particregistry can be found at 

For the purposes of this quarterly not

specific updates that have occurred in the 3-m

is available by accessing our website and click

American College of Cardiology's National C

at: For que

information, contact Marie Casey, BSN, MPH 

EN25JY14.014</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Facility City State 

;;'.\>.l:'t,:l 

Houston Medical Center Warner Robins GA 

Tahlequah City Hospital Tahlequah OK 

South County Hospital Waleficld RI 

Wolfson Children's Hospital Jackonsville FL 

West Park Hospital Cody WY 

MaryVale Hospital Phoenix AZ 

Parkland Medical Center Derry NH 

Sentara Northern Virginia Medical Center Woodbridge VA 

Lovelace Regional Hospital Roswell NM 

Wheaton Franciscan ? Elm brook Memorial Campus Brookticld WI 

Kaiser Foundation Hospital Fontana CA 

Prairie Ridge Hospital and Health Services Elbow Lake MN 

Hanover Hospital Hanover PA 

St. Barnabas Hospital Bronx NY 

Wellington Regional Medical Center Wellington FL 

Carilion \few River Valley Medical Center VA 

:\);>! 

Summit Medical Center (6/16/14) Van Buren AR 

Yakima Valley Memorial Hospital (6/30/14) Yakima WA 

Addendum IX: Active CMS Coverage-Related Guidance Documents 

(April through June 2014) 

There were no CMS coverage-related guidance documents 

published in the April through June 2014 quarter. To obtain the document, 

visit the CMS coverage website at 

For questions or additional information, contact JoAnna Baldwin 

( 41 0-786-7205). 

Addendum X: 

List of Special One-Time Notices Regarding National Coverage 

Provisions (April through June 2014) 

There were no special one-time notices regarding national 

coverage provisions published in the April through June 2014 quarter. This 

information is available at For questions or 

additional information, contact JoAnna Baldwin (410 786 7205). 

Addendum XI: National Oncologic PET Registry (NOPR) 

(April through June 2014) 

Addendum XI includes a listing of National Oncologic Positron 

Emission Tomography Registry (NOPR) sites. We cover positron emission 

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 additions, deletion

listing of National Oncologic Positron Emissi

(NOPR) in the April through June 2014 quarte

available at 

For questions or additional information, conta

( 41 0-786-8564). 

Addendum XII: Medicare-Approved 

(Destination Therapy) Facilities (Ap

Addendum XII includes a listing of M

that receive coverage for ventricular assist dev

destination therapy. All facilities were requirorder to receive coverage for V ADs implanted 

October 1, 2003, we issued our decision mem

clinical indication of destination therapy. We 

as destination therapy are reasonable and nece

facilities that have been determined to have th

infrastructure to ensure optimal patient outcom

standards and an application process. All faci

our standards in order to receive coverage for 

destination therapy. 

For the purposes of this quarterly not

specific updates that have occurred to the list 

facilities that meet our standards in the 3-mon

available at 

For questions or additional information, conta

( 410-786-7861 ). 
BILLING CODE 4120–01–C 

[FR Doc. 2014–17488 Filed 7–24–14; 8:45 am] 


EN25JY14.015</GPH>emcdonald on DSK67QTVN1PROD with NOTICES

Facility I Provider Number Date Approved 

New York-Presbyterian/Weill Cornell 133-0101 08/22/2013 

Medical Center 

525 East 68th Street New York, NY I 0065 

Addendum XIII: Lung Volume Reduction Surgery (L VRS) 

(April through June 2014) 

State 

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 (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 ofHealthcare Organizations (JCAHO)) under 

their Disease Specific Certification Program for L VRS; and 

• Medicare approved for lung transplants. 

Only the first two types are in the list. There were no updates to 

the listing of facilities for lung volume reduction surgery published in the 

April through June 2014 quarter. This information is available at 

questions or additional infonnation, contact Marie Casey, BSN, MPH 

(410-786-7861). 

For 

Addendum XIV: Medicare-Approved Bariatric Surgery Facilities 

(April through June 2014) 

Addendum XIV includes a listing of Medicare-approved facilities 

that meet minimum standards for facilities modeled in part on professional 

society statements on competency. All facilities must meet our standards in 

order to receive coverage for bariatric surgery procedures. On February 21, 

2006, we issued our decision memorandum on bariatric surgery procedures. 

We determined that bariatric surgical procedures are reasonable and 

necessary for Medicare beneficiaries who have a body-mass index (BMI) 

greater than or equal to 35, have at least one co-morbidity related to obesity 

and have been previously unsuccessful with medical treatment for obesity. 

This decision also stipulated that covered bariatric surgery procedures are 

reasonable and necessary only when performed at facilities that are: (1) 

certified by the American College of Surgeo

Surgery Center (program standards and requ

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

(ASBS) as a Bariatric Surgery Center of Ex

standards and requirements in effect on Feb

There were no additions, deletions

Medicare-approved facilities that meet CMS 

for bariatric surgery that have been certified 

April through June 2014 period. This inform

questions or additional information, contact 

( 41 0-786-2064). 

Addendum XV: FDG-PET for Demen

Diseases Clinical Trials (April 

There were no FDG-PET for Deme

Diseases Clinical Trials published in the Ap

This information is available on ou

For questions or additional information, con

( 41 0-786-8564).