22976 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 

Medicare Integrity Contractor (NBI 

MEDIC). Developed by Health Integrity, 

LLC and licensed for one of its 

contracts—the NBI MEDIC—PLATOTM

utilizes a cutting-edge advanced 

analytics fraud detection process in 

conjunction with a state-of-the-art webbased user interface tool to present 

fraud and abuse lead information 

visually to Medicare Part D plan 

sponsors. Summary data, based on 

National Prescription Drug Event Data 

and actions from all Part D plan 

sponsors, is shared with law 

enforcement, CMS, NBI MEDIC, and 

Part D plan sponsors to review historic 

actions taken against providers who are 

enrolled in the Medicare Part D 

program, which will assist in detecting 

and preventing fraud, waste, and abuse. 

Form Number: CMS–10517 (OCN: 0938- 

New); Frequency: Monthly; Affected 

Public: Private sector—Business or other 

for-profits and Not-for-profit 

institutions; Number of Respondents: 

1,550; Total Annual Responses: 1,550; 

Total Annual Hours: 18,600. (For policy 

questions regarding this collection 

contact Delois Newkirk at 410–786– 

1247). 

Dated: April 22, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–09505 Filed 4–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–21 and CMS– 

21B] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by May 27, 2014. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Quarterly 

Children’s Health Insurance Program 

(CHIP) Statement of Expenditures for 

the Title XXI Program (CMS–21) and 

State Children’s Health Insurance 

Program Budget Report for the Title XXI 

Program State Plan Expenditures (CMS– 

21B); Use: Form CMS–21 and form 

CMS–21B provide CMS with the 

information necessary to issue quarterly 

grant awards, monitor current year 

expenditure levels, determine the 

allowability of state claims for 

reimbursement, develop Children’s 

Health Insurance Program (CHIP) 

financial management information, 

provide for state reporting of waiver 

expenditures, and ensure that the 

federally established allotment is not 

exceeded. Further, these forms are 

necessary in the redistribution and 

reallocation of unspent funds over the 

federally mandated timeframes. Form 

Number: CMS–21 and CMS–21B (OCN: 

0938–0731); Frequency: Quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 448; Total 

Annual Hours: 7,840. (For policy 

questions regarding this collection 

contact Abraham John at 410–786– 

4519). 

Dated: April 22, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–09507 Filed 4–25–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9085–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—January Through March 

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 January through March 

2014, relating to the Medicare and 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 22977 

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. 

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 

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. 

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: April 16, 2014. 

Kathleen Cantwell, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 


mstockstill on DSK4VPTVN1PROD with NOTICESEN25AP14.000</GPH>

EN25AP14.001</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Publication Dates for the Previous Four Quarterly Notices 

We publish this notice at the end of each quarter reflecting 

information released by eMS during the previous quarter. The publication 

dates of the previous four Quarterly Listing of Program Issuances notices 

are: May 3, 2013 (78 FR 26038) July 26, 2013 (78 FR 45233), November 8, 

2013 (78 FR 67153) and January 31, 2014 (79 FR 5419). For the purposes 

of this quarterly notice, we are providing only the specific updates that have 

occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional 

information. 

Addendum I: Medicare and Medicaid Manual Instructions 

(January through March 2014) 

The eMS Manual System is used by eMS program components, 

partners, providers, contractors, Medicare Advantage organizations, and 

State Survey Agencies to administer eMS 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 

eMS Program Manuals into a web user-friendly presentation and renamed 

it the eMS Online Manual System. 

How to Obtain Manuals 

The Internet-only Manuals (lOMs) are a replica of the Agency's 

official record copy. Paper-based manuals are eMS manuals that were 

officially rcleascd in hardcopy. Thc majority ofthesc manuals werc 

transfcrrcd into thc Intcrnct-only manual (10M) or retircd. Pub 15-1, Pub 

15-2 and Pub 45 arc cxccptions to this rulc and arc still active paper-based 

manuals. Thc remaining paper-bascd manuals arc for rcfcrencc purposes 

only. If you notice policy contained in the paper-based manuals that was 

not transferred to the 10M, send a message via the eMS Feedback tool. 

Those wishing to subscribe to old versions of eMS 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: =ct=-'-,===_-,-,-,,===, 

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 

designated libraries throughout the United State

arrangements to transfer material to a local libr

FDL. Contact any library to locate the nearest 

available at 

In addition, individuals may contact re

that receive and retain at least one copy of mos

publications, either in printed or microfilm form

public. These libraries provide reference servic

however, they are not sales outlets. Individuals 

about the location of the nearest regional depos

library. eMS publication and transmittal numb

entitled Medicare and Medicaid Manual Instruc

the materials, use the CMS publication and tran

example, to find the Changes to the Laboratory 

Detennination (NCD) Edit Software for April 2

eMS-pub. 100-04, Transmittal No. 2852. 

Addendum I lists a uniquc CMS transm

instruction in our manuals or program memoran

A transmittal may consist of a single or multipl

necessary to use infornlation in a transmittal in 

infonnation 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 

179 

180 

Manual/Subject/Publ

Update to Pub. 100-01, Chapter 7 for Lan

. "tandard 

Manual Updates to ClarifY Skilled Nursin

Rehabilitation Facility (lRF), Home Healt

Coverage Pursuant to Jimmo vs. Sebelius 

Aprepitant for Chemotherapy Induced Em

(Anti-Emetic) Drugs 

EN25AP14.002</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

181 Pub. 100-02 Language-Only Update for ICD-I 0 

Admission Requirements 

Partial Hospitalization Services 

Coverage oflntravenous Immune Globulin for Treatment of Primary 

Immune Deficiency Diseases in the Home Coverage of Outpatient 

Rehabilitation Therapy Services (Physical Therapy, 

Occupational Therapy, and Speech-Language Pathology Services) Under 

Medicallnsurallce 

Documentation Requirements for Therapy Services 

Glaucoma Screening 

Determining Whether or Not the Beneficiary is at High Risk for 

Developing Colorectal Cancer 

Screening Pap Smears Limitations for Coverage 

182 Implementing the Part B Inpatient Payment Policies from CMS-J599-F 

Medical and Other Health Services Furnished to Inpatients of Hospitals and 

Skilled Nursing Facilities 

Reasonable and Necessary Part A Hospital Inpatient Claim Denials 

Other Circumstances in Which Payment Cannot Be Madc Under Part A 

Hospital Inpatient Services Paid Only Under Part B 

Medical and Other Heahh Services Furnished to SNF Patients 

Medical and Other Health Services Furnishcd to Inpatients of Participating 

Ilospitals 

159 Pub 100-03, Chapter I, language-only update Foreword Purpose for 

National Coverage Determinations (NCD) Manual 

Routine COqts in Clinical Trials (Fffective .luly 9, 2007 

Transcutaneous Electrical Nerve Stimulation (TENS) for Acute PostOperative Pain 

Outpatient Hospital Pain Rehabilitation Programs 

Anesthesia in Cardiac Pacemaker Surgery 

Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates 

Below) 

Cardiac Pacemakers (Various Effective Dates) 

Cardiac Pacemaker Evaluation Services 

Transtelephonic Monitoring of Cardiac Pacemakers 

Electrocardiographic Services 

Cardiac Output Monitoring By Thoracic Electrical Bioimpedance (TEB) 

Various Effective Dates Below 

Speech Generating Devices 

Cochlear Implantation (Effective April 4, 2005) 

Physician's Office Within an Imtitution - Coverage of Services and Supplies 

Incident to a Physician's Services 

Hospital and Skilled Nursing Facility Admission Diagnostic Procedures 

Hydrophilic Contact Lens for Corneal Bandage 

Photodynamic Therapy 

Ocular Photodynamic Therapy (OPT) - Eftective April 3, 2013 

Photosensitive Drugs 

Verteporfin - Effective April 3, 2013 

Hydrophilic Contact Lenses 

Laproscopic Cholecystectomy 

Certain Drugs Distributed by the Nation

Stem Cell Transplantation (Various Effe

Anticancer Chemotherapy for Colorecta

20(5) 

Aharelix for the Treatment of Prostate C

Erythropoiesis Stimulating Agents (ESA

Conditions 

Inpatient Hospital Stays for the Treatme

Chemical Aversion Therapy t()r Treatme

lese of Visual Tests Prior to and General 

Surgery 

Withdrawal Treatments for Narcotic Ad

Laser Procedures 

Diathermy Treatment 

Lumbar Artificial Disc Replacement (LA

Induced Lesions of Nerve Tracts 

Electrical Nerve Stimulators 

Supplies Used in the Delivery of Transc

Stimulation (TENS) and Neuromuscular E

Nutritional Therapy 

Nesiritide for Treatment of Heart Failure 

Nebulized Beta Adrenergic Agonist The

September 10, 2007 

Screening PAP Smears and Pelvic Exam

Cervical or Vaginal Cancer 

Computed Tomography (CT) 

Magnetic Resonance Imaging (MRl) (V

Ultrasound Diagnostic Procedures (Effe

FDG Positron Emission Tomography (P

Neurodegenerative Diseases (Effective S

Positron Emission Tomography (PET) (

(Various Effective Dates) 

Digital Subtraction Angiography (DSA 

Tomograph (SPECT) 

Percutaneous Image-Guided Breast Biop

Water Purification and Softening System

Dialysis 

Home Use of Oxygen 

Pulmonary Rehabilitation Services - (Ef

Treatment of Psoriasis 

Treatment of Drug Abuse (Chemical De

(Effective July 1,2004) 

Durahle Medical Equipment Reference L

Hospital Beds 

Infusion Pumps 

Obsolete or Unreliable Diagnostic Tcsts 

Intravenous Immune Globulin for the Tr

Mucocutaneous 

Blistering Diseases 

EN25AP14.003</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

160 Medicare National Coverage Detennination (NCD) for Beta Amyloid 115 percent Fee Schedule Payment for Pr

Positron Emission Tomography (PET) in Dementia and Neurodegenerative Billing and Payment in a Physician Scar

Disease for Outpatient Services: Cost-Based Facil

Beta Amyloid Positron Emission Tomography in Dementia and Schedule Payment for Professional Servic

Neurodegenerative Disease Identifying Primary Care Services Eligib

161 National Coverage Determination (NCD) for Single Chamber and Dual Partial Hospitalization Services Received 

Chamber Centers (CMIlC) 

Permanent Cardiac Pacemakers Line Item Dale of Service Reporting for 

Single and Dual Chamber Permanent Cardiac Pacemakers 2863 April 2014 Quarterly Average Sales Price 

162 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Pricing Files and Revisions to Prior Quar

Tumors 2864 Additional Data Reporting Requirements 

Positron Emission Tomography (FDG PET) for Oncologic Conditions on the Institutional Claim to Medicare Co

163 Aprepitant for Chemotherapy Induced Emesis 2865 Changes to the Laboratory National Cove

Oral Agents for Chemotherapy-Induced Emesis for ICD-IO Codes 

164 Medicare National Coverage lJetennination (NCO) for Beta Amyloid 2g66 Enforcement ofthe 5 day Payment Limit 

Positron Emission Tomography (PET) in Dementia and Neurodegenerative Medicare Renefit 

Disease 2867 Enforcement of the 5 day Payment Limit 

Beta Amyloid Positron Emission Tomography in Dementia and Medicare Benefit 

N, nmrlpopner'ltive Disease 2868 Therapy Modifier Consistency Edits 

;:(, 'e,'","",,',,: Application of Financial Limitations 

2850 Issued to a specific audience, not posted to Internet/Intranet due to Discipline Specific Outpatient Rehabilit

Confidentiality of Instruction Reporting of Service Units With HCPCS 

2851 Common Edits and Enhancements Modules (CEM) Code Set Update Rebilling Therapy Services for Hospital 

2852 Changes to the Laboratory National Coverage Determination (NCO) Edit 2869 Issued to a specific, audience not posted t

Software for April 2014 (ICD-IO) of Instruction 

2853 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics 2870 Addition of New Fields and Expansion o

and Supplies (DMEPOS) Competitive Bidding Program (CBP) - April 2014 Percentage Field in the Inpatient Hospital 

2854 New Waived Tests Addition of New Fields and Renaming Pa

2855 Remittance Advice Remark and Claims Adjustment Reason Code and Prospective Payment System (lPPS) Price

Medicare Remit Easy Print and PC Print Update 2871 Medicare National Coverage Determinati

2856 Issued to a specific audience, not posted to Internet/Intranet due to Positron Emission Tomography (PET) in 

Confidentiality of Instruction Disease Coverage for PET Scans for Dem

2857 Hcalthcare Common Procedure Coding System (HCPCS) Codes Subject to Diseases 

and Excluded from Clinical Laboratory Improvement Amendments (CLlA) 2872 National Coverage Determination (NCO) 

Edits Chamber Permanent Cardiac Pacemakers 

2858 Claim Status Category and Claim Status Codes Update 

2859 Applying the Therapy Caps to Critical Access Hospitals 2860 Part B Claims Submission under the Indirect Payment Procedure (lPP) 2861 2014 Durable Medical Equipment Prosthetics, Orthotics, and Supplies 

Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction 

List 

2862 2014 Durable Medical Equipment Prosthetics, Orthotics, and Supplies 

Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction 

List 

Billing Requirements for Cardiac Pacem

Cardiac Pacemakers: Single and Dual Ch

Healthcare Common Procedure Coding S

Cardiac Pacemaker Covered ICD-9/ICDCardiac Pacemaker Claims Require the 

Cardiac Pacemaker Claims Without the Cardiac Pacemaker Non Covered ICD-9Cardiac Pacemaker Claims Non Covered 

Denial Messages 

Where to Report Modifiers on the Hospital Part B Claim 

General Rules for Reporting Outpatient Hospital Services 

Billing of General Rules for Reporting Outpatient Hospital Services or 

Autologous Stem Cell Transplants 

Optional Method for Outpatient Services: Cost-Based Facility Services Plus 

EN25AP14.004</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

2873 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Billing and Payment Instructions for A/B 

Tumors HCPCS Codes for Oral Anti-Emetic Drug

Billing Requirements for CMS-Approved Clinical Trials and Coverage with Claims Processing Jurisdiction for Oral A

Evidence Development Claims for PET Scans for Neurodegenerative Oral Anti-Emetic Drugs Used as Full Rep

Diseases, Previously Specified Cancer Indications, and All Other Cancer Emetic Drugs as Part of a Cancer Chemot

Indications Not Previously Specified 2884 Claim Status Category and Claim Status C

Billing and Coverage Changes for PET Scans 2885 Issued to a specific audience, not posted t

2874 Medicare Claims Processing Pub. 100-04 Chapter 25 Update of Instruction 

Form Locators 43-81 2XX6 Issued to a specific audience, not posted t

l;niform Billing with Form CMS-1450 Confidentiality of Instruction 

Disposition of Copies of Completed Forms 2887 Issued to a specific audience, not posted t

General Instructions for Completion of Form CMS-1450 for Billing Form oflnstruction 

Locators 1-15 

Form Locators 31-41 

Uniform Bi11- Form CMS-1450 

2875 Issued to a specific audience, not posted to Internet/Intranet due to 

Contidentiality of Instruction 

2876 Update to Pub 100-04, Claims Processing Manual, Chapter One Section 

20.3/CMS No Longer Accepts Provider Requests For A Change of Fiscal 

Intermediary 

Solicitation of a Provider to Secure a Change of Fiscal Intermediary 

Communications 

CMS No Longer Accepts Provider Requests to Change Their Fiscal 

Intermediary 

2877 Implementing the Part B Inpatient Payment Policies from CMS-1599-F 

Payment of Part B Services in the Payment Window for Outpatient Services 

Treated as Inpatient Services when Part A Payment Cannot Be Made 

Inpatient Part B Hospital Services 

Editing Of Hospital Part B Inpatient Services: Reasonable and Necessary 

P31i A Ilospitallnpatient Denials 

Editing Of Hospital Part B Inpatient Services: Other Circumstances in 

Whieh Payment Cannot Be Made under Part A 

Implantable Prosthetic Devices 

Indian Health Service/Tribal Hospital Inpatient Social Admits Payment 

Window for Outpatient Services Treated as Inpatient Services 

2878 Correction CR - Advance Beneficiary Notice of None overage (ABN), Form 

CMS-R-131 

ABN Scope 

flome Health Agency Use ofthe ABN 

General Notice Preparation Requirements 

2879 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

2880 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

2881 Issued to a specific audience, not posted to InternellIntranet due to Sensitivity 

of Instruction 

2882 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

2883 Aprepitant for Chemotherapy Induced Emesis 

2888 Healthcare Provider Taxonomv Codes (H

2889 Common Edits and Enhancements Modul

2XYO Health Protessional Shortaae Area (HPSA

2891 Instructions for Downloading the Medica2892 Quarterly Update to the Correct Coding T

EfTective July 1,2014 

2893 Issued to a specific audience, not posted t

of Instruction 

2894 April 20 14 Update of the Hospital Outpat

(OPPS) 

2895 Update to Pub. 100-04. Chapter 19 to Pro

ICD-IO and ASC X12 

FI - Inpatient Acute Care - Medicare Par

FI Payment Policy and Claims Processin

2896 Indirect Payment Procedure (lPP) - Paym

Complementarv to Medicare Part J3 

2897 Indirect Payment Procedure (11'1') - Paym

Complementary to Medicare Part B 

2898 Update to Pub. 100-04 Chapter 13 to Prov

Updating ICD-IO and ASC XI2 

ICD Coding for Diagnostic Tests 

Place of Service (POS) Instructions for t

Interpretation) and the I'echnical Compon

Special Billing Instructions for RHCs an

Medicare Summary Notices (MSN), Rea

Billing Instructions 

Coverage for PET Scans for Dementia a

Billing Requirements for CMS - Approv

With Evidence Development Claims for P

Diseases, Previously Specified Cancer In

Indications Not Previously Specified 

Billing and Coverage Changes for PET 

After April 3, 2009 

Billing and Coverage Changes for PET S

for Services on or After November 10, 20

Billing and Coverage Changes for PET 

Metastasis of Cancer Effective for Claims 

Aprepitant for Chemotherapy Induced Emesis 

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february 26,20 10 Beginning January 1,2008 

EMC Formats Drugs, Biologicals, and Radiopharmaceu

Payment Methodology and HCPCS Coding Requirements When a Device is Furnishe

fI Payment for Low Osmolar Contrast \1aterial (LOCM) (Radiology) to January I, 2014 

2899 Pub 100-04, Language Only Update for Chapters Five and Six for Conversion 2904 Update to Pub. 100-04, Chapter 16 to Pro

toICD-IO Updating ICD-IO and ASC XI2 

Other Billing Situations 2905 Update to Pub. 100-04, Chapters 7 and 8 

of Financial Limitations for Updating ICD-I0 and ASC XI2 

Multiple Procedure Payment Reductions for Outpatient Rehabilitation Hilling Formats 

Services Data Elements Required on Claim for M

Reporting of Service Units With HCPCS Billing for Enteral and Parenteral Nutriti

Coding Guidance for Certain CPT Codes - All Claims Mammography Screening 

General Hospital Services Off-Site CORf Services Calculation of the Basic Case-Mix Adju

Notifying Patient of Service Denial Prospt:ctive Payment System Rale 

Billing for DME, Prosthetic and Orthotic Devices, and Surgical Dressings In-Facility Dialysis Bill Processing Proc

Addendum A - Chapter 5, Section 20.4 - Coding Guidance for Certain CPT Required Information tor In-Facility Cla

Codes - All Claims and the ESRD PPS 

Consolidated Billing Requirement for SNFs Payment for lIemodialysis Sessions 

Billing SNF PPS Services Ultrafiltration 

Billing Procedures for Periodic Interim Payment (PIP) Method of Payment Lab Services 

Total and 1'oncovered Charges Separately Billable ESRD Drugs 

Services in Excess of Covered Services Physician Billing Requirements to the C

Reporting Accommodations on Claims Other Information Required on the Form 

Bills with Covered and Noncovered Days Other Infonnation Required on the Form 

Billing in Benefits Exhaust and No-Payment Situations (Aranesp) 

Part B Outpatient Rehabilitation and Comprehensive Outpatient (Jeneral Intermediary Rill Processing Pr

Rehabilitation Facility (CORF) Services General Dialysis Services 

2900 April 2014 Integrated Outpatient Code Editor (VOCE) Specifications Version Physician'S Services Furnished to a Dial

15.1 Usual Facility Physicians and Supplier (N

2901 April 2014 Update of the Ambulatory Surgical Center (ASC) Payment Services/General 

System Hilling tor Durable Medical Equipment 

2902 April 20 14 Update of the Ambulatory Surgical Center (ASC) Payment and Supplies (including Surgical Dressing

System 2906 Pub 100-04, Chapter 28 language-only up

2903 April 2014 Update of the Hospital Outpatient Prospective Payment System implementation ofMACs, and MAC coor

(OPPS) and Other Complementary Insurers. 

Composite APCs Medigap! Definition and Scope 

HCPCS Codes Replacements Assignment of Claims and Transfer Poli

Reporting and Charging Requirements When the Hospital Receives Full Requirements as of.luly 2012 

Credit lor the Replaced Device against the Cost of a More Expensive Completion of the Claim Form 

Replacement Device Prior to January I, 2014 Form CMS-ISOO/ ASC X 12 837 Professi

Reporting Requirements When the Hospital Receives Partial Credit for the Form CMS-1450/ASC XI2 837 Instituti

Replacement Device Prior to January I, 2014 MSN Messages 

Medicare Payment Adjustment Prior to January 1,2014 Remittance Notice Mcssages 

Reporting and Charging Requirements When a Device is furnished Without Returned Mcdigap Notices 

Cost to the Hospital or When the Hospital Receives a Full or Partial Credit tor Coordination of Medicare With Medigap 

the Replacement Device Beginning January I, 2014 Insurance Policies 

Medicare Payment Adjustment Beginning January I, 2014 Requests for Additional Information 

Billing and Payment for Observation Services Beginning January I. 2008 Release of Title XVIII Claims Informati

Billing and Payment for Direct Referral for Observation Care Furnished by Providers 

EN25AP14.006</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Standard Medicare Charges for COB Records Summary of the ASC XI2 276/277 Claim 

General Guidelines for A/13 MAC (A, 13, or HH) or DME MAC Transfer of Process for A/I3 Medicare Administrative 

Claims Information to Mcdigap Insurers Flat File 

Consolidation of the Claims Crossover Process Translation Requirements 

Coordination of Benefits Agreement (COBA) Detailed Error Report Transmission Mode 

Notification Process Health Care Eligibility Benefit Inquiry a

Coordination of Benetits Agreement (COBA) ASC X12 837 5010 2910 Update to Pub. 100-04. Medicare Claims 

Coordination of Benefits (COB) Flat File Errors Provide Language-Only Changes for Upd

Coordination of Bcncfits Agreement (COBA) Full Claim File Repair Completing the Uniform \Institutional P

Process Hospice Election 

Coordination of Benefits Agreement (COBA) Eligibility File Claims Data Required on the Institutional Claim 

Recovery Process Medicare Summary Notice (MSN) Mess

Coordination of Benefits Agreement (COB A) Medigap Claim-Based Adjustment Reason and Remark Codes 

Crossover Process 2911 Manual Updates to Clarify Skilled Nursin

Coordination ofI3enefits Agreement (COI3A) ASC Xl2 837 Coordination of Notice (SNF ABN) Requirements Pursua

Benefits (COB) Mapping Proper Denial Paragraphs 

National Council for Prescription Drug Programs (NCPDP) Version D.O 2912 April Update to the CY 2014 Medicare P

Coordination of Benefits (COB) Mapping Requirements (MPFSDB) 

Electronic Transmission/ General Requirements 

Reserved 

Reserved 

Bencficiary Insurance Assignment Selection 

AlB MAC (A) Crossover Claim Requirements 

B MAC/DME MAC Crossover Claim Requirements 

Reserved 

2913 Issued to a specitic audience, not posted t

Confidentiality oflnstruction 

2914 Health Professional Shortage Area (I IPSA

Post-payment Review 

2915 Medicare National Coverage Determinati

Positron Emission Tomography (PET) in Disease 

Medigap Insurers Fraud Refen'al 

Outline of Complaint Referral Process 

Medigap Electronic Claims Transfer Agreements 

2907 Clinical Laboratory Fee Schedule - Medicare Travel Allowance Fees for 

Coverage for PET Scans for Dementia a

2916 Calendar Year (CY) 2014 Annual Update 

Schedule and Laboratory Services Subjec

REVISION 

Collection of Specimens Travel Allowance 

2908 Update to Pub. 100-04. Chapter 15 to Provide Language-Only Changes for 

2917 Issued to a specific audience, not posted t

of Instruction 

Updating [CD-IO and ASC XI2 

Medical Conditions List and Instructions 

General Billing Guidelines 

Coding Instructions for Paper and Electronic Claim Forms 

Fiscal Intermediary Shared System (FISS) Guidelines 

A/MAC Bill Processing Guidelines Effective April 1,2002, as a Result of 

Fee Schedule Implementation Detinition 

2909 Medicare Claims Processing Pub. 100-04 Chapter 31 Update 

Health Care Claim Status Category Codes and Health Care Claim Status 

Codes for Use with the Health Care Claim Status Request and Response ASC 

X12 

Claim Status Request and Response 

Background 

Eligihility Connectivity Workflow 

Claim Status Request/Response Transaction Standard 

Transmission Requirements 

Batch Transactions 

Online Direct Data Entry 

Interactive/Online (Non-DDE) 

;:,11:< 

99 Apply Front-End Edits to Electronic Corr

(ECRS) Files Submitted Via ECRS Web 

Code J3N 

COBC Electronic Correspondence Refer

100 The Medicare Contractors and the Shared 

Cost Avoided Indicator and Special Proje

File (CWF) so the Correct Savings is app

Payer (MSP) Savings Report and the Orig

230 Notice of :--Jew Interest Rate for Medicare 

Underpayments-2nd qtr Notification for 

231 Issued to a specific audience, not posted t

Confidentiality of Instruction 

232 Issued to a specific audience, not posted t

Confidentiality of Instruction '\:," 

99 Revised State Operations Manual (SOM) 

EN25AP14.007</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

100 State Operations Manual (SOM) Appendix AA revisions for Intermediate Disputing/Disagreeing With a CERT De

Care Facilities for Individuals with Intellectual Disabilities (lCFIIIDJ. Voluntary Refunds 

Psychiatric Hospitals-Interpretive Guidelines and Survey Procedures/Title Handling Appeals Resulting From CERT 

AA-Psychiatric Hospitals-Interpretive Guidelines and Survey CERT Appeal Results 

Procedures/BI12/§482.61(b)(2) Include a Medical History Disseminating CERT Information 

101 State Operations Manual (SOM) Appendix I revisions for Intermediate Care Error Rate Reduction Plans (ERRPs) 

Facilities tor Individuals with Intellectual Disabilities (ICFIlID) Contacting Non-Responders & Docume

II-Survey Procedures and Interpretive Guidelines for Life Safety Code Late Documentation Received by the CE

Surveys/Part [I-Interpretive Guidelines/ll. The Survey Tasks/Task 4- Overpayments and Underpayments Resul

Infonnation Gathering 505 Removing Prohibition Requesting Additi

I-Survey Procedures and Interpretive Guidelines for Life Safety Code Prepayment and Postpayment Review 

Surveys/Part II-Interpretive Guidelines/II. The Survey Tasks/Task 2- 506 Issued to a specific audience, not posted t

Entrance Conference/On site Preparatory Activities Confidentiality oflnstruction 

I-Survey Procedures and Interpretive Guidelines for Life Safety Code 507 Issued to a specific audience, not posted t

102 State Operations Manual (SOM) Appendix Q revisions for Intermediate Care of Instruction 

Facilities lor Individuals with Intellectual Disabilities (ICF/IID). 508 Supplemental Medical Review Contracto

Q-Guidelines for Determining Immediate Jeopardy/Attachment C-Overview Overview of Program Integrity and Prov

Recommended Key Components of Systemic Approach to Prevent Abuse Medicare Improper Payment Reduction 

and Neglect Types of Contractors 

Q-Guidelines for Determining Immediate Jeopardy/Attachment A Improper Payment Prevention Goals 

Q-Guidelines f1.Jr Determining Immediate JeopardyIVIII-Enforcement! A- Applicable Program Integrity Manual Se

Termination for Title XIX-Only NFs, ICFs!lID Performance Metrics 

103 Revised State Operations Manllal (SOM) Hospital Appendix A Types of Claims for Which Contractors 

Facilities, supplies, and equipment must be maintained to ensure an Quality Issues and Potential Frau

acceptable level of safety and quality. The MAC and SMRC Medical Review P

104 State Operations Manual (SOM) Appendix M revisions for Intermediate Care Goal of MAC and SMRC MR Program 

Facilities tor Individuals with Intellectual Disabilities (lCFIIID) Provider Self Audits 

105 Revised Annpnri;y A, Interpretive Guidelines lor Hospitals, Condition of 

Participatioll: Quality Assessment and Performance 

Coordination Among Contractors 

Maintaining the Confidentiality of MR M

it!;(\ i.Vi ·,;1, ':,;,;: \R';C':" Medical Review Manager 

501 Complex Medical Review Contractor Medical Director (CMD) 

502 Registration o[Entities Using the Indired Payment Procedure (lPP) 509 Issued to a specific audience, not posted t

Registration Letters oflnstruction 

Indirect Payment Procedure Background 

Submission of Registration Applications 00 None 

Processing of Registration Applications 

Disposition of Registration Applications 00 None 

Revocation of Registration :\Y i .• '; 

Changes of Information and Other Registration Transactions 116 Conversion from ICD-9 to ICD-IO and fr

Indirect Payment Procedure Expanded Alternative Verification Meth

503 Inter-Jurisdictional Reassignments Calibration ofthe CMS-HCC Risk Adju

504 Revision to Chapter 12 of the Medicare Program Integrity Manual- The Model Similarities 

Comprehensive Error Rate Testing Program. Operations 

The Comprehensive Error Rate Testing (CERT) Program Sources of Data 

MAC Communication with the CERT Program Format 

Overview of the CERT Process Diagnosis Cluster 

Providing Sample Information to the CERT Review Contractor Valid Diagnosis Codes 

Providing Review Information to the CERT Review Contractor Health Insurance Portability and Accoun

MAC Responsibility After Workload Transition Providing Feedback Glossary of Terms 

Information to the CERT Review Contractor Rules for Payment of"Signific3nt Cost" 

EN25AP14.008</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Special Rules for the September 2000 NCD on Clinical Trials 

Category B Investigational Device Exemption (IDE) Trials Adjustment to 

MA Payments Under the CMS-HCC Risk Adjustment Models 

Role and Responsibilities of Plan Sponsors 

.. 

00 None 

rRi .• 

94 Affordable Care Act Bundled Payments for Care Improvement Initiative -

Recurring File Updates Models 2 and 4 April 2014 Update 

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

oflnstruction 

96 Issued to a speciJic audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

97 MAPCP Demonstration - Update for ICD-IO 

',.' .' ,.,{./jiL.!l'll¥ < :i:;\\);.\';' •• ":: 

1332 Rescind and Replace of CR 8409: Reclassification of Certain Durable 

Medical Equipment from the Inexpensive and Routinely Purchased Payment 

Category to the Capped Rental Payment Category 

1333 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

1334 Occurrence Span Code 72; Identification of Outpatient Time Associated with 

an Inpatient Hospital Admission lmd Inpatient Claim for Payment 

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

of Instruction 

1336 Modifying the Daily Common Working File (CWF) to Medicare Beneficimy 

Database (MBD) File to Include Diagnosis Codes 011 the Health Insurance 

Portability and Accountabi[ity Act Eligibility Transaction System (HErS) 

270/271 Transactions 

1337 Encounter Data System Payer 10: Payer ID Creation for the Financial 

Alignment Demonstration for Medicare Medicaid Plans (MMPsJ 

1338 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

1339 CWF Editing for Vaccines Furnished at Hospice - Correction 

[340 Health lllsurance Portability and Accountability Act (HIP AA) EDI Front End 

Updates for July 2014 

1341 Changing Fiscal Intennediary Shared System (FfSS) Action on Informational 

Unsolicited Responses (I U Rs) From Canceled Claims to Adjustments 

1342 Reporting principal and inkrest amounts when refunding previously recouped 

money on the Remittance Advice (RAJ 

1343 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

1344 Fee for Service Beneficiary Data Streamlining (FFS BDS) 

[345 Implementing Operating Rule (OR)-Phase 1Il ERA Or Dual Delivery of ERA 

and Paper Remittance 

1346 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

1347 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

1348 Handling Bankrupt Suppliers within VMS 

1349 

1350 

1351 

1352 1353 

1354 1355 1356 

1357 

1358 1359 

13()O 

1361 

1362 1363 

Implementation ofNACHA Operating Ru

Funds Transfers (EFT) 

Clarification of Remittance Advice Code 

Shared Systems 

[mplementation ofHIPAA Standards and 

Electronic Funds Transfers 

Issued to a specific audience, not posted t

ofInstruction 

Interuational Classification of Diseases, l

Providers through the Common Edits and 

Common Electronic Data Interchange (CE

Issued to a speciJic audience, not posted t

of Instruction 

Issued to a specific audience, not posted t

oflnstruction 

ModifYing the Daily Common Working F

Database (MBD) File to Include Diagnos

Portability and Accountability Act Eligib

270/271 Transaction 

[nternational Classification of Diseases, 1

Providers through the Common Edits and 

Common Electronic Data Interchange (CE

Implement Operating Rules-Phase !II ER

Claim Adjustment Reason Codes (CARC

Codes (RARC) Rule-Update from CAQH 

The Coordination of Benefits Contractor 

Apply Federal Tax Information (FTf) Rec

Service (IRS), Social Security Administra

and Medicaid Services (eMS) Medicare S

Program 011 the Common Working File (C

Implement Operating Rules-Phase 1II ER

Claim Adjustment Reason Codes (CARC

Codes (RARC) Rule-Update from CAQH 

Implementation ofNACHA Operating Ru

Funds Transfers (EfT) 

Rescind and Replace ofCR 8409: Reclas

Medical Equipment from the Inexpensive 

Category to the Capped Renla I Payment C

Implement Operating Rules-Phase III ER

Claim Adjustment Reason Codes (CARC

Codes (RARC) Rule-Update from CAQH 

Issued to a specitic audience, not posted t

ofInstruction 

EN25AP14.009</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Addendum II: Regulation Documents Published 

in the Federal Register (January through March 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 

numbcr and pagc numbcr. 

The Federal Register is available as an onlinc database through 

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

Federal Register is published. The database includes both text and 

graphics from Volume 59, Number 1 (January 2, 1994) through the present 

date and can be accessed at The 

following website provides 

information on how to access electronic editions, printed editions, and 

reference copies. 

This information is available on our website at: 

For questions or additional information, contact Terri Plumb 

(410-786-4481). 

Addendum III: CMS Rulings 

CMS Rulings are decisions of the Administrator that serve as 

precedent tinal opinions and orders and statements of policy and 

interpretation. They provide clarification and interpretation of complex or 

ambiguous provisions of the law or regulations relating to Medicare, 

Medicaid, Utilization and Quality Control Peer Review, private health 

insurance, and related matters. 

The rulings can be accessed at Ull/J.IIWWW'\';"''''!:fUV;r\.''!bUIdUUU:SFor questions or additional information, 

contact Tiffany Lafferty (410-786-7 548). 

Addendum IV: Medicare National Coverage Determinations 

(January through March 2014) 

Addendum IV includes completed national coverage 

dctcrminations (NCDs), or rcconsidcrations of completcd NCDs, from thc 

quarter covered by this notice. Completed decisions are identified by the 

section of the NCD Manual (NCDM) in which the decision appears, the 

title, the date the publication was issued, and the effective date of the 

decision. An NCD is a determination by the Se

particular item or service is covered nationally 

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

any, that is assigned to a particular covered item 

determination for a particular covered item or s

include information concerning completed deci

program and decision memoranda, which also a

somc cascs, cxplain why it was not appropriatc 

Infornlation on completed decisions as well as 

been posted on the CMS website. For the purp

we list only the specific updates that have occu

This information is available at: 

For questions or additional informat

(4lO-786-7491). 

Title NCDM Transmit

Section Number 

PET (FOG) for Solid NCD220.6.17 TRI62 

Tumors 

Beta Amyloid PET in NCO Dementia! Neurodenerative 220.6.18 TN160 

Disease 

Single-Chamber/DualChamber Permanent NCD20.8 TN 161 

Cardiac Pacemakers 

Aprepitant tor 

Chemotherapy-Induced NCDllO.18 TNI63 

Emesis , 

Addendum V: FDA-Approved Category 

Exemptions (IDEs) (January thro

Addendum V includes listings ofthe F

investigational device exemption (IDE) number

listings are organized according to the categorie

assigned (that is, Category A or Category B), an

number. For the purposes ofthis quarterly noti

updates to the Category B IDEs as of the endin

by this notice and a contact person for question

For questions or additional information, contac

6877). 

Under the Food, Drug, and Cosmetic A

fall into one of three classes. To assist CMS un

EN25AP14.010</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

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 

0130288 Medtronic Activa PC+S System Cook Custom Aortic Endograft 01/03/2014 

and Zenith t-Branch Endovascular Graft 

0130292 EXOGEN Ultrasound Bone Healing System 01108/2014 0130300 Fucused Ultrasuund Stimulatur Fur Aesthetic Use 01/22/2014 

UI30132 lherapy Cool Flex Ablation Catheter 01/22/2014 

0130237 Embosphere Microspheres 01/24/2014 0110303 Concert Implant 01/30/2014 0140003 Essure System for Permanent Birth Control 0113112014 0130248 SIR-Spere Microspheres Oli3112014 

SIR-Spheres :viicrospheres Brachytherapy Device Plus Delivery 01/3112014 

0130127 VIOl ICV Filter System 02/04/2014 0140006 Medtronic Tined Leads (Models 3889 and 3093) and the 02/04/2014 

Medtronic Restoreprime Neurostimulatory (Model 37701) 

0130244 LUTONIX 035 Drug Coated Balloon PTA Catheter 02106/2014 

GI40001 Nucleus 24 Auditory Brainstem Implant (ABI) 02/07/2014 

0130245 Micra Transcatheter Pacemaker System Model MCI VROI 02110/2014 0130278 Embozene Microspheres 02/11/2014 

G130290 BrainSonix BX Pulsar 1001 Focused Ultrasonic 02112/2014 G130276 Sentinel Cerebral Protection System 02114/2014 GI30205 Embospherc 02/14/2014 

0130172 

________ 

02/2112014 

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

0140014 RMY Contact Lens 02/2112014 

0140013 FAME 3 02/2112014 

GI30190 Vascular Embolization Device 02/26/2014 

BB15909 Emergency Use - Treatment of using Haploidcntical Parental 02/27/2014 

Adenovirus Specific I-Cells using the CliniMACS System 

(Cytokine Capture Reagent, Interferon-gamma) 

0130213 Vascular Sealing System 02/28/2014 

GI40019 lmplany, Cochlear 03/05/2014 GI40020 Dako PD-L! IHC pharmDx kit 03/06/2014 

0140021 Toronto EVLP System 03/06/2014 0140025 COST A TUS SYSTEM 03/12/2014 

G130223 Concentric Medical, Inc 03/20/2014 

0130287 Microtransponder, Inc 03/20/2014 

GI30034 BIOFREEDOM Drug Couted Coronary Sten! System 03/25/2014 

0140028 Teosyal RHA 010bal Action (TP30L), Teosyal RHA Deep Lines 03/26/2014 

(TP27L) 

GI40030 Bcst-CLI 03/27/2014 

Gl40032 MolecularMD MRDX BCR-ABL TEST 03/27/2014 

Addendum VI: Approval Numbers for Coll

(January through M

All approval numbers are available to 

Under the review process, approved informatio

assigned OMB control numbers. A single cont

several related inf0l11lation collections. This in

For qu

information, contact Mitch Bryman (410-786-5

Addendum VII: Medicare-Approved C

(January through Marc

Addendum VII includes listings of Me

stent facilities. All facilities listed meet CMS s

carotid artery stenting for high risk patients. O

our decision memorandum on carotid artery stecarotid artery stenting with embolic protection 

only if performed in facilities that have been de

performing the evaluation, procedure, and follo

optimal patient outcomes. We have created a l

facilities modeled in part on professional societ

All facilities must at least meet our standards in 

for carotid artery stenting for high risk patients

quarterly notice, we are providing only the spe

occurred in the 3-month period. This infonnati

For questions or additional information, contac

(410-786-6322). 

P

N

. 

Capital Regional Medical Centcr 

2626 Capital Medical Boulevard 

Tallahassee, FL 32308 

Berwick Hospital Center 

701 E. 16th Street Berwick, PA 18603 

Texas Heart Health and Vascular Hospital Arlington 6

811 Wright Street Arlington, TX 76012 

Doctors Hospital 

3651 Wheeler Road Augusta, GA 30909 

Baylor Medical Center at McKinney 6

5252 W. University Drive. Hwy 380 

At Lake Forest Drive McKinney, TX 75071 

EN25AP14.011</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Facility Provider Effective State 

Number Date 

FROM: Southwest Wasbington Medical Center 500050 05/26/2005 WA 

TO: Peace Health Southwest Medical Center 

400 N.E. Mother Joseph Place 

Vancouver, WA 98668 

P.O. Box 1600 

Covenant Healthcare 230070 06/22/2006 MI 

900 Cooper Avenue 

Saginaw, :\,11 48602 

Addendum VIII: 

American College of Cardiology's National Cardiovascular Data 

Registry Sites (January through March 2014) 

Addendum Vlll includes a list ofthe 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 collection 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 website at 

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 TCDs 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 offacilities that particip

registry can be found at 

For the purposes of this quarterly notic

specific updates that have occurred in the 3-mo

is available by accessing our website and clicki

American College of Cardiology's National Ca

at: For ques

information, contact Marie Casey, BSN, MPH 

Facility 

Carolina Pines Regional Medical Center 

Charlotte Regional Medical Center 

& Country Hospital 

Crossgates River Oaks Hospital 

St. Cloud Regional Center 

Summit Medical Center Saint Mary's Mercy Medical Center 

Fisher-Titus Medical Center 

University Medical Center 

Geisinger Community Medical Center 

Tulare District Hospital 

Lake "lorman Regional Medical Center 

Methodist Mansfield Medical Center 

University of Texas Health Science Center at Tyler 

Mercy Hospital Ada 

Hospital total Cor 

St. Luke's Warren Campus 

Castle Rock Adventist 

New York Presbyterian - Weill Cornell Medical Center 

Santa Rosa Medical Center Shands Lake Shore Regional Medical Center 

Bayfront Health Spring Hill 

Williamson Memorial Hospital 

Pine Creek Medical Center 

New York Presbyterian Hospital-Columbia 

Central Carolina (TENET) 

Saint Vincent Medical Center North 

Children's Hospital of Los Angeles 

Northbank Surgical Center 

Children's Hospital of Philadelphia 

Mary Lanning Healthcare 

Mercy Tiffin Hospital 

Wilson Medical Center 

Signature Healthcare Brockton Hospital 

Norton Brownsboro Hospital 

EN25AP14.012</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Facility City State 

Walnut Hill Medical Center Dallas IX 

Coronado SurgerY Center Henderson NV 

Eastern New Mexico Medical Center Roswell NM 

Valley View Hospital Glenwood Springs CO 

[he Heart Hospital Baylor Denton Denton IX 

Baylor Medical Cenler Carrollton Carrollton TX 

Temecula Valley Hospital Temecula CA 

St Mary's Medical Center Blue Springs MO 

,;\i. 

Oconee Regional Medical Center Milledgeville GA 

Charlotte Regional Medical Center Punta Gorda FL 

Crossgates River Oaks Hospital Brandon MS 

Shands Lake Shore Regional Medical Center Lake City FL 

Addendum IX: Active CMS Coverage-Related Guidance Documents 

(January through March 2014) 

'Ihere were no CMS coverage-related guidance documents 

published in the January through March 2014 quarter. To obtain the 

document, visit the eMS coverage website at 

For questions or additional 

information, contact Lori Ashby (410-786-6322). 

Addendum X: 

List of Special One-Time Notices Regarding National Coverage 

Provisions (January through March 2014) 

There were no special one-time notices regarding national 

coverage provisions published in the January through March 2014 quarter. 

This information is available at For questions 

or additional information, contact Lori Ashby (410-786-6322). 

Addendum XI: National Oncologic PET Registry (NOPR) 

(January through March 2014) 

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 

perfonued in the context of a clinical study. W

National Oncologic PET Registry as one of the

Therefore, in order for a beneficiary to receive 

scan, the beneficiary must receive the scan in a 

the registry. There were no additions, deletions

listing of National Oncologic Positron Emissio

(NOPR) in the January through March 2014 qu

available at 

For questions or additional information, contac

(410-786-8564). 

Addendum XII: Medicare-Approved 

(Destination Therapy) Facilities (Januar

Addendum XII includes a listing of M

that receive coverage for ventricular assist devi

destination therapy. All facilities were required 

order to receive coverage for V ADs implanted 

October I, 2003, we issued our decision memo

clinical indication of destination therapy. We d

as destination therapy are reasonable and neces

facilities that have been determined to have the 

infrastmchlre to ensure optimal patient outcom

standards and an application process. All facili

our standards in order to receive coverage for V 

destination therapy. 

For the purposes of this quarterly notic

specific updates that have occurred to the list o

facilities that meet our standards in the 3-month 

available at 

For questions or additional information, contac

(410-786-7861). 

Moses H. Cone Memorial Hospital 

1200 North Elm Street 

Greensboro NC 27401-1020 

Mercy General Hospital 

4UUl .J Street 

Sacramento. CA 95819 

Provider N

340091 

050071 

EN25AP14.013</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Geisinger Wyoming Valley 39-0270 02/26/2014 

Medical Center 

1000 East Mountain Drive 

Wilkes Barre, PA 18711 

Tulane University Hospital and Clinic 190176 03/15/2013 

14 J 5 Tulane Avenue 

New Orleans, LA 70112 

FROM: Clarian Health Partners, Inc. 150056 11125/2003 

(Methodist Hospital) 

TO: Indiana University Health, Inc. 

1701 N. Senate Boulevard 

Indianapolis. IN 46206 

Addendum XIII: Lung Volume Reduction Surgery (LVRS) 

(January through March 2014) 

PA 

LA 

'\',;\\,}i': 

IN 

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 offacilities 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 L VRS; and 

• Medicare approved for lung transplants. 

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

the listing offacilities for lung volume reduction surgery published in the 

January through March 2014 quarter. This information is available at 

For 

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

(410-786-7861 ). 

Addendum XIV: Medicare-Approved Bariatric Surgery Facilities 

(January through March 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 procedu

necessary for Medicare beneficiaries who hav

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

and have been previously unsuccessful with m

This decision also stipulated that covered bar

reasonable and necessary only when perform

certified by the American College of Surgeon

Surgery Center (program standards and requi

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

(ASBS) as a Bariatric Surgery Center of Exce

standards and requirements in effect on Febru

There were no additions, deletions, o

Medicare-approved facilities that meet CMS

for bariatric surgery that have been certified b

January through March 2014 period. This in

questions or additional information, contact K

(410-786-9252). 

Addendum XV: FDG-PET for Dement

Diseases Clinical Trials (January t

There were no FOG-PET for Demen

Diseases Clinical Trials published in the Janu

quarter. 

This intormation is available on our 

For questions or additional infonnation, cont

(410-786-8564). 
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 22991 

[FR Doc. 2014–09288 Filed 4–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1466–N] 

Medicare Program: Notice of Two 

Membership Appointments to the 

Advisory Panel on Hospital Outpatient 

Payment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces two 

new membership appointments to the 

Advisory Panel on Hospital Outpatient 

Payment (the Panel). The two new 

appointments to the Panel will each 

serve a 4-year period. The new members 

will have terms that begin on February 

16, 2014 and continue through February 

15, 2018. The purpose of the Panel is to 

advise the Secretary of the Department 

of Health and Human Services and the 

Administrator of the Centers for 

Medicare & Medicaid Services 

concerning the clinical integrity of the 

Ambulatory Payment Classification 

groups and their relative payment 

weights. The Panel also addresses and 

makes recommendations regarding 

supervision of hospital outpatient 

services. The advice provided by the 

Panel will be considered as we prepare 

the annual updates for the hospital 

outpatient prospective payment system. 

FOR FURTHER INFORMATION CONTACT: For 

additional information on the Panel 

meeting dates, agenda topics, copy of 

the charter, as well as updates to the 

Panel’s activities, search our Internet 

Web site: https://www.cms.gov/

Regulations-and-Guidance/Guidance/

FACA/AdvisoryPanelonAmbulatory

PaymentClassificationGroups.html. For 

other information regarding the Panel, 

contact Carol Schwartz, the Designated 

Federal Officer (DFO) at CMS, Center for 

Medicare, Hospital and Ambulatory 

Policy Group, Division of Outpatient 

Care, 7500 Security Boulevard, Mail 

Stop C4–05–17, Baltimore, MD 21244– 

1850, phone (410) 786–3985. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Department of Health and Human 

Services (the Secretary) is required by 

section 1833(t)(9)(A) of the Social 

Security Act (the Act) (42 U.S.C. 

1395l(t)(9)(A)) and section 222 of the 

Public Health Service Act (PHS Act) (42 

U.S.C. 217a) to consult with an expert 

outside advisory panel on the clinical 

integrity of the Ambulatory Payment 

Classification groups and relative 

payment weights, which are major 

elements of the Medicare Hospital 

Outpatient Prospective Payment System 

(OPPS), and the appropriate supervision 

level for hospital outpatient services. 

The Panel is governed by the provisions 

of the Federal Advisory Committee Act 

(FACA) (Pub. L. 92–463), as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

advisory panels. The Panel Charter 

provides that the Panel shall meet up to 

3 times annually. We consider the 

technical advice provided by the Panel 

as we prepare the proposed and final 

rules to update the OPPS for the 

following calendar year. 

The Panel shall consist of a chair and 

up to 19 members who are full-time 

employees of hospitals, hospital 

systems, or other Medicare providers. 

The Secretary or a designee selects the 

Panel membership based upon either 

self-nominations or nominations 

submitted by Medicare providers and 

other interested organizations. New 

appointments are made in a manner that 

ensures a balanced membership under 

the FACA guidelines. 

The Panel presently consists of the 

following members and a Chair. 

• Edith Hambrick, M.D., J.D., Chair, 

CMS Medical Officer. 

• Karen Borman, M.D., FACS. 

• Kari S. Cornicelli, C.P.A., FHFMA. 

• Brian D. Kavanagh, M.D., MPH. 

• Scott Manaker, M.D., Ph.D. 

• John Marshall, CRA, RCC, CIRCC, 

RT(R), FAHRA. 

• Jim Nelson, M.B.A., C.P.A., FHFMA. 

• Leah Osbahr, M.A., MPH. 

• Jacqueline Phillips. 

• Traci Rabine. 

• Michael Rabovsky, M.D. 

• Marianna V. Spanaki-Varela, MD, 

Ph.D., M.B.A. 

• Gale Walker. 

• Kris Zimmer. 

II. Provisions of the Notice 

We published a notice in the Federal 

Register on November 1, 2013, entitled 

‘‘Medicare Program; Solicitation of Five 

Nominations to the Advisory Panel on 

Hospital Outpatient Payment (HOP, the 

Panel)’’ (78 FR 65660). The notice 

solicited nominations for five new 

members to fill the vacancies on the 

Panel beginning September 30, 2013. As 

a result of that notice, we are 

announcing two new members to the 

Panel. The Panel currently consists of 

15 members. The two new Panel 

members appointments are for 4-year 

terms beginning on February 16, 2014. 

New Appointments to the Panel 

The two new members of the Panel 

with terms beginning on February 16, 

2014 and continuing through February 

15, 2018 are as follows: 

• Wendy Resnick, FHFMA. 

• Johnathan Pregler, M.D. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

Dated: April 17, 2014. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2014–09289 Filed 4–24–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0555] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Device Tracking 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

information collection requirements for 

the tracking of medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 24, 2014. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

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