Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices 5537 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2015–01856 Filed 1–27–15; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Meeting of the Community Preventive 

Services Task Force 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) 

announces the next meeting of the 

Community Preventive Services Task 

Force (Task Force). The Task Force is an 

independent, nonpartisan, nonfederal, 

and unpaid panel. Its members 

represent a broad range of research, 

practice, and policy expertise in 

prevention, wellness, health promotion, 

and public health, and are appointed by 

the CDC Director. The Task Force was 

convened in 1996 by the Department of 

Health and Human Services (HHS) to 

identify community preventive 

programs, services, and policies that 

increase healthy longevity, save lives 

and dollars and improve Americans’ 

quality of life. CDC is mandated to 

provide ongoing administrative, 

research, and technical support for the 

operations of the Task Force. During its 

meetings, the Task Force considers the 

findings of systematic reviews on 

existing research and issues 

recommendations. Task Force 

recommendations provide information 

about evidence-based options that 

decision makers and stakeholders can 

consider when determining what best 

meets the specific needs, preferences, 

available resources, and constraints of 

their jurisdictions and constituents. The 

Task Force’s recommendations, along 

with the systematic reviews of the 

scientific evidence on which they are 

based, are compiled in The Guide to 

Community Preventive Services 

(Community Guide). 

DATES: The meeting will be held on 

Wednesday, February 25, 2015 from 

8:30 a.m. to 6:00 p.m. EST and 

Thursday, February 26, 2015 from 8:30 

a.m. to 1:00 p.m. EST. 

ADDRESSES: The Task Force Meeting 

will be held at CDC Edward R. Roybal 

Campus, Tom Harkin Global 

Communications Center (Building 19), 

1600 Clifton Road NE., Atlanta, GA 

30333. You should be aware that the 

meeting location is in a Federal 

government building; therefore, Federal 

security measures are applicable. For 

additional information, please see 

Roybal Campus Security Guidelines 

under SUPPLEMENTARY INFORMATION. 

Information regarding meeting logistics 

will be available on the Community 

Guide Web site 

(www.thecommunityguide.org). 

Meeting Accessibility: This meeting is 

open to the public, limited only by 

space availability in the meeting 

location. All meeting attendees must 

RSVP to ensure the required security 

procedures are completed to gain access 

to the CDC’s Global Communications 

Center. 

U.S. citizens must RSVP by 2/15/

2015. 

Non U.S. citizens must RSVP by 2/9/ 

2015 due to additional security steps 

that must be completed. 

In addition to in-person participation, 

individuals may view presentations via 

live video stream on the Internet. Those 

interested in accessing the live stream 

must also RSVP, and additional 

information will be sent to registrants 

requesting connectivity via the Internet 

in advance of the meeting. Failure to 

RSVP by the dates identified could 

result in an inability to attend the Task 

Force meeting due to the strict security 

regulations on federal facilities. 

For Further Information and to RSVP 

Contact: Terica Scott, The Community 

Guide Branch; Division of 

Epidemiology, Analysis, and Library 

Services; Center for Surveillance, 

Epidemiology and Laboratory Services; 

Office of Public Health Scientific 

Services; Centers for Disease Control 

and Prevention, 1600 Clifton Road, MS– 

E–69, Atlanta, GA 30333, phone: (404) 

498–6360, email: CPSTF@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: The purpose of the meeting 

is for the Task Force to consider the 

findings of systematic reviews and issue 

findings and recommendations. Task 

Force recommendations provide 

information about evidence-based 

options that decision makers and 

stakeholders can consider when 

determining what best meets the 

specific needs, preferences, available 

resources, and constraints of their 

jurisdictions and constituents. 

Matters To Be Discussed: 

Vaccinations, Obesity, Cardiovascular 

Disease, and Health Equity. Topics are 

subject to change. 

Roybal Campus Security Guidelines: 

The Edward R. Roybal Campus is the 

headquarters of the U.S. Centers for 

Disease Control and Prevention and is 

located at 1600 Clifton Road NE., 

Atlanta, Georgia. The meeting is being 

held in a Federal government building; 

therefore, Federal security measures are 

applicable. 

All meeting attendees must RSVP by 

the dates outlined under Meeting 

Accessability. In planning your arrival 

time, please take into account the need 

to park and clear security. All visitors 

must enter the Roybal Campus through 

the entrance on Clifton Road. Your car 

may be searched, and the guard force 

will then direct visitors to the 

designated parking area. Upon arrival at 

the facility, visitors must present 

government issued photo identification 

(e.g., a valid federal identification 

badge, state driver’s license, state nondriver’s identification card, or passport). 

Non-United States citizens must 

complete the required security 

paperwork prior to the meeting date and 

must present a valid passport, visa, 

Permanent Resident Card, or other type 

of work authorization document upon 

arrival at the facility. All persons 

entering the building must pass through 

a metal detector. Visitors will be issued 

a visitor’s ID badge at the entrance to 

Building 19 and may be escorted to the 

meeting room. All items brought to 

HHS/CDC are subject to inspection. 

Dated: January 27, 2015. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2015–01875 Filed 1–30–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9088–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—October Through 

December 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 October through 

December 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

5538 Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices 

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 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: January 23, 2015. 

Kathleen Cantwell, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 

BILLING CODE 4120–01–P 


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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: January 31,2014 (79 FR 5419), April25, 2014 (79 FR 22976), July 25, 

2014 (79 FR 43475) and November 14, 2014 (79 FR 68253). 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 1: Medicare and Medicaid Manual Instructions 

(October through December 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 ofCMS 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 1,400 

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 Medicare Coverage of Ultr

Abdominal Aortic Aneurysms (AAA) and Scre

Tests (FOBT) Coverage Criteria use CMS-Pub

Transmittal No. 196. 

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 usc 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 

Transmittal Manual/Subject/Publ

Number 

15,\' 

None 

If'>'' '+; .. 

195 Issued to a specific audience, not posted to 

of Instruction 

196 Medicare Coverage of Ultrasound Screen

Aneurysms (AAA) and Screening Fecal-O

Coverage Criteria 

197 Issued to a specific audience, not posted to 

of Instruction 

198 Medicare Coverage ofltems and Services 

Investigational Device Exemption (IDE) S

Coverage of Medical Devices 

Food and Drug Administration (FDA)-A

Exemption (IDE) Studies 

EN02FE15.002</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Medicare Requirements for Coverage of Items and Services in FDA- RHCs and FQHCs Billing Under the AIR 

Approved Category A and B IDE Studies RHC Per-Visit Payment Limit and Excep

Payment for Items and Services in Categmy A and B IDE Studies FQHC Per-Visit Payment Limit 

FDA Withdrawal of IDE Approval or Change in Categorization FQHCs Billing Under the PPS Payment R

1611 0/General Exclusions from Coverage Payment Codes for FQHCs Billing Under 

Re-evaluation of FDA-approved IDE Device Categorization Decision Cost Reports 

Hospital Institutional Review Board (IRB) Approved Non-significant Risk Productivity Standards 

Devices RIIC and FQIIC Patient Charges, Coinsu

14/30.1/Payment for Hospital IRB Approved Non-significant Risk Devices Charges and Waivers 

Services Related to and Required as a Result of Services Which are Not Graduate Medical Education 

Covered Under Medicare Confidentiality of IDE Information Transitional Care Management (TCM) Se

199 Implementation of Changes in the End-Stage Renal Disease Prospective Services and Supplies Furnished Incident 

Payment System (ESR[) PPS) for Calendar Year (CY) 2015 Provision ofincident to Services and Sup

ESRD PPS Case-Mix Adjustments Payment for Incident to Services and Sup

Renal Dialysis Items and Services Nurse Practitioner, Physician Assistant, a

Laboratory Services Outpatient Mental Ilealth Treatment Lim

Drugs and Biologicals Physical and Occupational Therapy 

Definitions Relating to ESRD Description of Visiting Nursing Services 

Home Dialysis Items and Services Requirements of Visiting Nursing Service

Equipment and Supplies Home Health Agency Shortage Area 

Other Services Tclchcalth Services 

ESRD Prospective Payment System (PPS) Base Rate Preventive Health Services 

Home Dialvsis Training Preventive Health Services in RHCs 

200 Implementation of Changes in the End-Stage Renal Disease Prospective Copayment and Deductible for RliC Prev

Payment System (ESRD PPS) for Calendar Year (CY) 2015 Preventive Health Services in FQHCs 

Definitions Relating to ESRD FQHC General Information 

Renal Dialysis Items and Services 202 Modifications to Medicare Part B Covera

Laboratory Services Immunizations 

ESRD PPS Case-Mix Adjustments 

Equipment and Supplies 175 Intensive Cardiac Rehabilitation Program 

Home Dialysis Items and Services Wellness Program 

Home Dialysis Training 176 Medicare Coverage of Ultrasound 

Other Services Aneurysms (AAA) and Screening Fecal-O

ESRD Prospective Payment System (PPS) Base Rate Colorectal Cancer Screening Tests 

Drugs and Biologicals 177 Screening for Hepatitis C Virus (HCV) in 

201 Medicare Benefit Policy Manual- RHC and FQHC Update- Chapter 13 178 Issued to a specific audience, not posted t

RHC General Information of Instruction 

Copayment for FQHC Preventive Health Services ;;}:;::: \{'jt;.; '').;;;:; •• , i;· 

Requirements 3083 Form CMS-1500 Instructions: Revised fo

FQHC Staffing 

RHC and FQHC Visits 

Items 14-33 Provider of Service or Supp

Items l-11 Patient and Insured Informat

Location Items II a-13 Patient and Insured Inform

Hours of Operation Health Insurance Claim Form CMS-150

Multiple Visits on Same Day and Exceptions 

Global Billing 

RHC Services 

FQHC Services 

Non RHC/FQHC Services 

Description of Non RHC/FQHC Services 

RHC and FQHC Payment Rates, Exceptions, and Adjustments 

3084 Intensive Cardiac Rehabilitation Program 

Wellness Program 

Requirements for CR and ICR Services 

3085 Update to Pub. I 00-04, Chapter 17 to Pro

Updating ICD-10 and ASC Xl2 

Claims Processing Requirements -Gene

Billing Drugs Electronically- NCPDP 

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Adjustment Message Codes for Oral Cancer Drug Denials Consistency Edits for Institutional Claim

HCPCD Codes for Oral Anti-Emetic Urugs 3087 2015 Annual Update for the Health Profe

Submitting the Prescription Order Numbers and No Pay Modi tiers Bonus Payments 

Billing and Payment Instructions for AlB MACs (A) 3088 2015 Annual Update ofHealthcare Comm

Requirements for Billing A/B MAC (A) for Immunosuppressive Drugs (HCPCS) Codes for Skilled Nursing Faci

MSN/Remittance Messages for Immunosuppressive Drugs (CB) Update 

Intravenous Immune Globulin 3089 Issued to a specific audience, not posted t

Claims Processing Rules for ESAs Administered to Cancer Patients for Anti- Confidentiality of Instmction 

Anemia Therapy 

Hospital Outpatient Payment Under OPPS for New, Unclassified Drugs and 

Biologicals After FDA Approval But Before Assignment of a ProductSpecit1c Drug or Biological HCPCS Code 

Hospital Billing For Take-Home Drugs 

The Competitive Acquisition Program (CAP) for Drugs and Biologicals Not 

Paid on a Cost or Prospective Payment Basis 

Denial/Claim Adjustment and Remark Messages for Anti-Emetic Drugs 

3086 Update to Pub. l 00-04, Chapter l to Provide Language-Only Changes for 

Updating JCD-10 and ASC X12 

Foreword 

Formats for Submitting Claims to Medicare 

Electronic Submission Requirements 

Paper Formats for Institutional Claims 

3090 Ambulance Inflation Factor for CY 2015 

Ambulance Inflation Factor (AJF) 

3091 Update to Pub. 100-04 Chapter 13 to Prov

Updating ICD-10 and ASC Xl2 lCD Cod

AlB MAC (A)Payment for Low Osmola

(Radiology) 

Special Billing Instructions for RHCs Pa

Medicare Summary Notices (MSN), Rea

Billing Instructions 

Coverage for PET Scans for Dementia a

Payment Methodology and HCPCS CodBilling and Coverage Changes for PET S

Billing and Coverage Changes tor PET S

tor Services on or After November I 0, 20

Paper Formats for Professional and Supplier Claims 

Remittance Advices 

Billing and Coverage Changes for PET 

Metastasis of Cancer Effective for Claims 

Payment Jurisdiction Among Local A/B MACs tor Services Paid Onder the 

Physician Fee Schedule 

February 26,2010 

EMC Formats 

Claims Processing Instructions for Payment Jurisdiction 

Payment to Physician or Other Supplier for Diagnostic Tests Subject to the 

Anti-0 1/Markup Payment Limitation/ Claims Submitted to AlB MACs (B) 

Billing Requirements for CMS - Approv

With Evidence Development Claims tor P

Diseases, 

Billing Procedures for Entities Qualified to Receive Payment on Basis of 

Reassignment/ for A/B MACs(B) Processed Claims 

Rilling for Diagnostic Tests (Other Than Clinical Diagnostic Lahoratory 

Tests) Subject to the Anti-Markup Payment Limitation/ Claims Submitted to 

AB/MACs(B) 

Billing Form as Request for Payment 

Previously Specitied Cancer Indications

Not Previously Specified 

3092 Annual Medicare Physician Fcc Schedule 

Implementation 

3093 Issued to a specific audience, not posted t

oflnstruction 

Beneficiary Request for Payment on Provider Record Institutional Claims 

ASC Xl2 837 Institutional Claim Format and Form CMS 1450 

Definition of a Claim for Payment 

Policy and Billing Instructions for Condition Code 44 

General Information on Non-covered Charges on Institutional Claims 

Determining Start Date of Timely Filing Period-- Date of Service 

Form by CMS 

In Accordance with CMS Instructions 

Handling Incomplete or Invalid Submissions 

Claims Forms C'viS 1490S and CMS-1450 

Conditional Data Element Requirements for AlB MACs (B) and DME 

MACs 

B MAC(B) Specific Requirements for Certain Specialties/ Services 

Payer Only Codes Utilized by Medicare 

Inpatient Pmt A Hospital Adjustment Bills 

3094 Issued to a specific audience, not posted t

of Instruction 

3095 Issued to a specitic audience, not posted t

ofinstruction 

3096 Medicare Coverage of Ultrasound Screen

Aneurysms (AAA) and Screening Fecal-O

Coverage 

Initial Preventive Physical Examination 

(AWV) 

Initial Preventive Physical Examination 

Ultrasound Screening for Abdominal Ao

Detinitions 

HCPCS Codes, Frequency Requirement

Applicable) 

3097 October Update to the CY 2014 Medicare 

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(MPFSDB) Billing Requirements for Providers Billin

3Q<;g Reporting the Service Location National Provider ldentitier (NPl) on Anti- Services in Category A IDE Studies 

Markup and Reference Laboratory Claims Investigational Device Exemption (IDE) 

3099Payment Jurisdiction for Services Subject to the Anti-Markup Payment 3106 Implementing the Payment Policies relate

Limitation CMS-1599-F 

Diagnostic Tests Subject to the Anti-Markup Payment Limitation Inpatient Part B Hospital Services 

Billing for Diagnostic Tests (Other Than Clinical Diagnostic Laboratory 3107 Medicare Shared Systems Modifications N

Tests) Subject to the Anti-Markup Pa)ment Limitation/Claims Submitted to HIP AA compliant fields 

A/B MACs (B) Payments on the MPFS for Providers W

Conditional Data Element Requirements lor AlB MACs (B) and 3108 Issued to a speci fie audience, not posted t

DMEMACs Confidentiality of Instruction 

Carrier Specific Requirements for Certain Specialties/Services 3109 Issued to a specific audience, not posted t

Paper Claim Submission To Can·iers/B MACs (B) Confidentiality of Instruction 

Electronic Claim Submission to Carriers/B MACs B) 

Items 14-33 -Provider of Service or Supplier Information 

Payment to Physician or Other Supplier fur Diagnostic Tests Subject to the 

Anti-Markup Payment Limitation - Claims Submitted to AlB MACs (B) 

3099 Instructions for Retrieving the 2015 Pricing and HCPCS Data Files through 

CMS' Mainframe Telecommunications Systems 

3100 Issued to a specific audience, not posted to lnternet/lntranet due to Sensitivity 

oflnstruction 

3101 Issued to a specilic audience, not posted to lnternet/Intranet due to Sensitivity 

of Instruction 

3102 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

3110 Issued lo a sped lie audience, not posted t

Conlidentiality of Instruction 

3111 Issued to a specific audience, not posted t

Confidentiality of lnstmction 

3112 Issued to a specific audience, not posted t

Confidentiality of Instruction 

3113 Issued to a specilic audience, not posted t

Conlidentiality of Instruction 

3114 Issued to a specific audience, not posted t

Confidentiality of Instruction 

3115 Moditlcations to the National Coordinatio

Crossover Process 

1103 Reporting the Service I "ocation National Provider ldentitler (NPI) on AntiMarkup and Reference Laboratmy Claims Claims Crossover Disposition and Coord

Pass Indicators 

Payment Jurisdiction for Services Subject to the Anti-Markup Payment 

Limitation 

Diagnostic Tests Subject to the Anti-Markup Payment Limitation 

Billing tor Diagnostic Tests (Other Than Clinical Diagnostic Laboratory 

3116 Elimination of the 50/50 Payment Rule fo

Renal Disease (ESRD) Claims Lab Servic

Automated Multi-Channel Chemistry (A

Beneliciaries 

Tests) 

Subject to the Anti-Markup Payment Limitation/Claims Submitted to A/B 

MACs(B) 

Conditional Data Element Requirements for A/B MACs (B) and 

DMEMACs 

Carrier Specific Requirements for Certain Specialties/Services 

Paper Claim Submission To Carricrs/B MACs (B) 

Electronic Claim Submission to Carriers/B MACs B) 

Items 14-33- Provider of Service or Supplier Information 

Payment to Physician or Other Supplier for Diagnostic Tests Subject to the 

Anti- Markup Payment Limitation- Claims Submitted to AlB MACs (B) 

3104 Correction to Remittance Information When HIPPS Codes are Re-ceded by 

Medicare Systems 

Decision Logic Used by the Pricer on Claims HI-I PPS Claims 

Adjustments of Episode Payment - Contirming OASl S Assessment Items 

3105 Medicare Coverage of Items and Services in Category A and B 

Investigational Device Exemption (IDE) Studies 

Billing Requirements for Providers Billing for Category BIDE Devices and 

Routine Care Items and Services in Category B IDE Studies 

3117 Issued to a specilic audience, not posted t

Confidentiality of lnstmction 

3118 Correction to Remittance Messages When 

to Late Filing of the Notice of Election. 

Data Required on the Institutional Claim 

Election (NOE)- Form CMS 1450 

3119 Issued to a specific audience, not posted t

Confidentiality of lnstmction 

3120 Therapy Cap Values for Calendar Year (C3121 20 15 Annual Update to the Therapy Code 

3122 Issued to a specific audience, not posted t

Confidentiality of lnstmction 

3123 October Quarterly Update for 2014 Durab

Orthotics, and Supplies (DMEPOS) Fee S

3124 2015 Healthcare Common Procedure Cod

Update Reminder 

3125 Implementation of Changes in the End-St

Payment System (ESRD PPS) tor Calend

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Required Information for In-Facility Claims Paid Under the Composite Rate for Obesity, Screening Digital Tomosynth

and the ESRD PPS Associated with Screening Colonoscopy 

3126 Issued to a specific audience, not posted to lnternet/Intranct due to 3147 Calendar Year (CY) 2015 Rural Health C

Conlidentiality of Instruction Health Centers (FQHC) Updates: Paymen

3127 Screening for Hepatitis C Virus (HCV) in Adults FQHCs Billing Under the All-Inclusive R

Common Working File (CWF) Edits Rural Designations for FQHCs Billing Un

Institutional Billing Requirements 3148 2015 Durable Medical Equipment Prosthe

Professional Billing Requirements Hcalthcare Common Procedure Coding S

Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark List 

Codes (RARCs), Group Codes, and Medicare Summary Notice (MS\f) 3149 New Waived Tests 

Messages 3150 January 2015 Update of the Hospital Outp

Screening for Hepatitis C Virus (HCV (OPPS) Billing tor "Sometimes Therapy" 

3128 Issued to a specitic audience, not posted to Internetllntranet due to Therapy Services for ll ospital Outpatient

Confidentiality oflnstmction Billing for Linear Accelerator (Robotic 

3129 CY 2015 Update for Durable Medical Equipment, Prosthetics, Orthotics and !mage-Guided) SRS Planning and Delive

Supplies (DMEPOS) Fee Schedule 3151 Correction to Remittance Information Wh

3130 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Medicare Systems 

ofTnstruction Adjustments of Episode Payment- Conf

3131 Common Edits and Enhancements Modules (CEM) Code Set Update HH PPS Claims 

3132 Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 21.1, Decision Logic Used by the Pricer on Cl

Ellective April!, 2015 3152 Calendar Year (CY) 2015 Annual Update 

3133 Issued to a specific audience, not posted to Internet/ Intranet due to Schedule and Laboratory Services Subjec

Confidentiality of Instruction 3153 January 2015 Integrated Outpatient Code 

3134 Instmctions for Downloading the Medicare ZIP Code File for April 2015 Version 16.0 

3135 Implement Operating Rules- Phase Ill ERA EFT: CORE 360 Uniform Usc of 3154 Automation ofthe Request tor Reopening 

Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Special Claim Types 

Codes (RARC) Rule- Update from CAQH CORE 3155 Issued to a specific audience not posted to 

3136 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics Confidentiality of lnstmction 

and Supplies (DMEPOS) Competitive Biddin<> Program (CBP)- April 2015 3156 January 2015 Update of the Hospital Outp

3137 Issued to a specific audience, not posted to Internet/ Intranet due to (OPPS) 

Conlidentiality oflnstmction Billing for "Sometimes Therapy" Servic

3138 Fiscal Year (FY) 2015 Inpatient Prospective Payment System (lPPS) and Services for Hospital Outpatients Packagi

Long Term Care Hospital (LTCH) PPS Changes Billing for Linear Accelerator (Robotic 

3139 Implementation of Changes in the End-Stage Renal Disease Prospective 

Payment System (ESRD PPS) for Calendar Year (CY) 2015 

Image-Guided) SRS Planning and Delive

3157 Summary ofPolicies in the CY 2015 Med

Required Information for In-Facility Claims Paid Under the Composite Rate (MPFS) Final Rule and Telehealth Origin

and the ESRD PPS Amount 

3140 Home Health Prospective Payment System (HH PPS) Rate Update for 3158 January 2015 Update of the Ambulatory S

Calendar Year (CY) 2015 System 

3141 Issued to a specific audience, not posted to Internet! Intranet due to 3159 Modifications to Medicare Part B Covera

Confidentiality of Instruction Roster Claims Submitted to Carriers/ AH 

3142 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instruction 

Pneumococcal Vaccine 

3143 Claim Status Category and Claim Status Codes Update 105 Electronic Correspondence Referral Syste

3144 Medicare Physician Fee Schedule Database (MPFSDB) 2015 File Layout 

Manual Addendum 

Defense of Marriage Act (DOMA) and IC

Correspondence Referral System (ECRS) 

3145 Home Health Prospective Payment System (HH PPS) Rate Update tor 

Calendar Year (CY) 201 S 

3146 Preventive and Screening Services · ·· Update- Intensive Behavioral Therapy 

106 Medicare Secondary Payer (MSP) Uroup 

Policy-- Definition of"Spouse"; Same-S

Delinitions Working Aged 

EN02FE15.006</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

107 Update to Pub. I 00-05. Chapters 05 and 06 to Provide Language-Only 125 Revisions to State Operations Manual (SO

Changes for Updating ICD-10 and ASC Xl2 126 Revisions to State Operations Manual (SO

Medicare Sccondmy Payment Pm1 A Claims Determination for Services Administration and Fiscal Management" 

Received on ASC X12 837 Institutional Electronic or Hard Copy Claim 127 Revisions to State Operations Manual (SO

Formats Administration and Fiscal Management" 

Identification of Liability and No-Fault Situations 128 Revisions to State Operations Manual (SO

Conditional Medicare Payment and Appendix Table of Contents Letter J 

Medicare Secondary Payment Part B Claims Determination for Services 

Received on ASC X 12 837 Professional Electronic Claims 

Sources That May Identify Other Insurance Coverage 

129 State Operations Manual (SOM) Appendi

Organization (OPO) Interpretive Guidanc

Outcome Measures 

108 Inpatient Hospital Claims and Medicare Secondaty Payer (MSP) Claims with 

Medicare Coinsurance Days and/or Medicare Lifetime Reserve 

130 Revisions to State Operations Manual (SO

Surveyors for Long Term Care Facilities" 

Days Occurring in the Seventh to Fifteenth Years 

Return Codes 

Payment Calculation for Inpatient Bills (MSPPA YAI Module) 

109 Electronic Correspondence Referral System (ECRS) notification regarding 

/i>'c:<t 

546 Documentation for Durable Medical Equi

Supplies (DMEPOS) Repair Claims. This 

CR 8843. 

Defense of Marriage Act (DOMA) and ICD-10 changes 

fi;.·;\; ;., .. ,, 

242 Medicare Financial Management Manual, Chapter 7, Internal Controls 

Certification Package for Internal Controls (CPIC) Requirements 

List of CMS Contractor Control Objectives 

Certification Statement 

CPIC - Report oflnternal Control Deficiencies 

Suppliers Documentation for DMEPOS 

547 Review Timeliness Requirements for Com

Review Requesting Additional Document

Postpayment Review 

548 Deletion of Program Integrity Manual Ex

549 Issued to a specific audience, not posted t

of Instruction 

Statement on Standards for Attestation Engagements (SSAE) Number 16, 

Reporting on Controls at Service Providers 

Submission, Review, and Approval of Corrective Action Plans 

Corrective Action Plan (CAP) Reports 

CMS Finding Numbers 

Quarterly CAP Report 

OMB Circular A-123, Appendix A: Internal Controls Over Financial 

Reporting (ICOFR) 

243 Notice of :'-Jew Interest Rate for Medicare Overpayments and Cnderpayments 

-1st Qtr Notlication for FY 2015 

244 l'reasury Report on Receivables ('l'ROR) Reporting Debts RTA, Pending 

Final Disposition 

245 Required Changes to the Company Entry Description Value in the Batch 

Header Record for Backup Withholding Files 

246 Recovery Auditor Appeal Adjustments with "Rl" Indicator Tracking Appeals 

and Reopenings 

247 Issued to a specific audience, not posted to IntcrneV Intranet due to 

Confidentiality of Instruction 

248 Revision of Pub. I 00-06 - Medicare Financial Management Manual, Chapter 

f)- Intermediary and Carrier Financial Reports, and Puh. 100-09 Medicare 

Contractor Beneficiary and Provider Communications, Chapter 6 - Provider 

Customer Service Program Part B - Inquiries Body of Report 

•. :::,,;;J::; 't;');;:,;;•,;, .;x> 

123 Notice of :--Jew Interest Rate for Medicare Overpayments and Underpayments 

-1st Qtr Notfication for FY 2015 

124 Revisions to State Operations Manual (SOM), Appendix W, Interpretive 

Guidelines for Critical Access Hospitals 

550 One on One Education 

55! Issued to a specific audience, not posted t

Confidentiality of Instruction 

552 Issued to a specific audience, not posted t

Confidentiality of Instruction 

553 Issued to a specific audience, not posted t

Confidentiality of lnstrudion 

554 New Timeframe for Response to Addition

Frames for Submission 

555 Issued to a specific audience, not posted t

Confidentialitv oflnstruction 

556 Revisions to Pub. 100-08, Program Integr

Background 

Owning and Managing Organizations 

End-Stage Renal Disease Facilities (ESR

557 Update to CMS Publication 100-08. Chap

Documentation Request Required and Op

Additional Documentation Request Req

558 Update to the Program Integrity Manual (

Overview of the Comprehensive Error R

CERT Formats for A/B MACs (B) and DCERT Formats for AlB MAC (A) MAC

Overview of the CERT Process 

559 Issued to a specific audience not, to lntern

Instruction 

560 Program Integrity Manual Chapter 12 Re

EN02FE15.007</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

Contacting Non-Responders and Documentation Requests •I"; 

MAC Communication with the CERT Program 30 None Revision of Pub. I 00-06 - Medicare 

Overview of the CERT Process Chapter 6 Intermediary and Carrier Fina

Providing Sample Information to the CERT Review Contractor Medicare Contractor Beneficiary and Pro

MAC Responsibility After Workload Transition Provider Customer Service Program 

Providing Feedback Information to the CERT Review Contractor Reporting Provider and Beneficiary Inqu

Disputing/Disagreeing with a CERT Decision Contractor Reporting of Operational Wor

Handling Overpayments and Underpayments Resulting From the CERT 

Findings None 

Disseminating CERT Information 

MAC Error Rate Reduction Plan (ERRPs) 

00 None 

The Comprehensive Error Rate Testing (CERT) Program 

561 Incorporation of Certain Provider Enrollment Policies in CMS-4159-F into Nunc 

Pub. 100-08, Program Integrity Manual (PIM), Chapter 15 

Indian Health Services (IHS) Facilities 

Skilled Nursing Fadlilies (SNFs) 

Ambulatory Surgical Centers (ASCs) 

CLIALabs 

Mammography Screening Centers Pharmacies 

21Revocations 

;•;' ,';;/;r,';'r;;)'f;';:;; 

119 Chapter 16b: Special Needs Plans 

The majority of sections of the chapter w

Additionallv there are several sections wi

,iJ!; < · 

t\',\ l'J)\;)';'1,!\ 'Xl''':ll't';···.··••· 

Radiation Therapy Centers 

Suppliers of Ambulance Services 

Intensive Cardiac Rehabilitation (ICR) 

Diabetes Self-Management Training (DSMT) 

Mass Immunizers Who Roster Bill 

109 Updates to the Model4 Bundled Paymen

Calculation to Include Uncompensated C

in Payment Due to Sequestration 

110 Termination of Multi-Payer Advance Prim

Demonstration in Minnesota and Pennsyl

Inter-Jurisdictional Reassignments 

Receiving Missing/Claritying Data/Documentation 

Ill Issued to a specific audience, not posted t

of Instruction 

Documentation 112 Issued to a specific audience, not posted t

Denials of Instruction 

Non-Certified Suppliers and Individual Practitioners 113 Issued to a specific audience, not posted t

Certitied Providers and Certified Suppliers of Instruction 

Establishing an Effective lJate of Medicare Billing Privileges 114 Affordable Care Act Bundled Payments f

Application Fees Recurring File Updates Models 2 and 4 A

Claims against Surety Bonds i 

Release of Information 1429 Fee for Service Beneficiary Data Streaml

Deactivations Operational Issues Reactivations 1430 Issued to a specific audience not posted to Reactivations -Deactivation for Reasons Other Than Non-Submission of a ofinstruction 

Claim/Reactivations- Deactivation for Non-Submission of a Claim Portable 1431 Issued to a specific audience not posted to 

X-Ray Suppliers (PXRSs) of Instruction 

562 Issued to a specific audience not, to Internet/Intranet due to Confidentiality of 1432 Issued to a specific audience not posted to 

Instruction of Instruction 

563 Issued to a specific audience not, to lnternet/Intranet due to Confidentiality of 1433 Additional Instruction on the Use of Claim

Instruction (CARCs) and Remittance Advice Remark 

564 Issued to a specitic audience not, to Internet/Intranet due to Confidentiality of Operating Rule: 360 Compliance 

Instruction 1434 Issued to a specific audience not posted to 

565 Update to CMS Publication 100-08, Chapter 3, Section 3.2.3.2 (Time Frames of Instruction 

for Submission) 1435 New Informational Unsolicited Response 

Equipment (DME) Items Furnished durin

EN02FE15.008</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

1436 Fee for Service Beneficiary Data Streamlining (FFS BDS) Phase II Analysis 1437 Data Quality Between the Multi Carrier System (MCS) and YiPS Medicare 

System (VMS) and the Common Working File (CWF) 

1438 Data Quality between the Fiscal Intermediary Shared System (FISS) and the 

Common Working File (CWF) 

1439 Issued to a specific audience not posted to Internet/ Intranet due to Sensitivity 

of Instruction 

1440 Health Insurance Portability and Accountability Act (HIPAA) ED! Front End 

Updates for April20I5 

1441 Implementation Instructions for the A/B and DME Medicare Administrative 

Contractors (MACs) and their Designated Shared Systems to Send the Correct 

Cost A voided Indicator and Special Project Type to the Common Working 

File (CWF) To Ensure Correct Savings is Applied Both to the Medicare 

Secondary Payer (MSP) Savings Report and the Originating Contractor 

1442 Issued to a specitlc audience not posted to Internet! Intranet due to Sensitivity 

of Instruction 

1443 Issued to a specific audience not posted to Internet/ Intranet due to Sensitivity 

of Instruction 

1444 Analysis and Design to Automate Adjustments That Arc Completed In The 

Common Working File (CWF) When Inpatient (INP) Or Skilled Nursing 

Facility (SNF) Claims Are Processed Out Of Sequence 

1445 Rescind and Replace of CR l\409: Reclassification of Certain Durable 

Medical Equipment from the Inexpensive and Routinely Purchased Payment 

Category to the Capped Rental Payment Category 

1446 !DR Shared Systems Daily Claims Feeds Expansion to Accommodate 

Medical Review Data Elements 

1447 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 

1448 Fee for Service Beneficiary Data Streamlining (FFS BDS) Updates to 

Operational Issues 

1449 20 15 Electronic Health Record System Payment A Letter 

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

Confidentiality oflnstructions 

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

Confidentiality of Instructions 

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

Confidentiality oflnstructions 

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

Confidentiality of Instructions 

Addendum II: Regulation Documents Published 

in the Federal Register (October through December 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 o

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 ""f!·! 

For questio

contact Tiffany Lafferty ( 41 0-786-7548). 

Addendum IV: Medicare National C

(October through Decem

Addendum 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 detennination by the 

particular item or service is covered nationall

(title XVIII of the 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 

EN02FE15.009</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

some cases, explain why it was not appropriate to issue an NCD. 

Information on completed decisions as well as pending decisions has also 

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 information, contact Wanda Belle 

(410-786-7491). 

Title NCDM Transmittal Issue Date Effective 

Section Number Date 

Medicare Coverage of 

Ultrasound Screening for 

Abdominal Aortic NCD210.3 R176 10/17/2014 01/24/2014 Aneurysms (AAA) and 

Screening Fecal-Occult 

Blood Tests (FOBT) 

Screening Hepatitis C NCD210.13 Rl77 11/19/2014 06/02/2014 Virus in Adults 

Transcatheter Mitral Valve 

Repair (TMVR)-National NCD20.33 Rl78 12/05/2014 08/07/2014 Coverage Determination 

(NCD) 

Addendum V: FDA-Approved Category B Investigational Device 

Exemptions (IDEs) (October through December 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 BIDEs 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 

Ul40170 Ul40120 

Gl40171 G140174 Gl40175 

Ul40177 

G140172 Gl30249 G140055 Gl40104 

Ul40173 U140181 

G140074 G140184 

Gl40185 G140187 G140189 Gl40188 Gl40158 

(y140194 

Gl40198 Gl40199 

Device 

Syncardia Temporary Total Aliiticial Heart (

Revanesse Ultra 

Juvederm Voluma XC Gel Implant 

Spiration Valve System Model PIV-C26N 

IlluminOss Bone Stabilization System 

Tiara Valve; Tiara Delivery System 

AMICUS Separator System 

Rodo Abutment Svstem 

Oncozene Microspheres 

Celotres 

A Randomize Trial Comparing Usc of Conti

Monitoring with and without Routine Blood 

in Adults with Type I Diabetes 

Mcdtronic Activa PC+S 

TriGuard IIDII Embolic Deflection Device 

NovoTTF-100A System 

CompuFio Epidural Computer Controlled An

EPI 6000 

Mcdtronic Activa PC+S 

ThermoCool SmartT ouch SF Catheter D-134

1348-XX-SI 

Vcntana PD-Ll (SP263) Rabbit Monoclonal 

aura6000 Targeted Hypoglossal Neurostimul

Lumifi With Crux Vena Cava Filter System 

Vysis Egfr CDx Fish Kit (LISZT NO. 08N75

Brainsway Deep TMS Device For The Treat

Traumatic Stress Disorder (PTSD) 

G L_4()2Q()__ L }\_c_ti_va_P_C:::-i' !llu!ation_System 

Activa PC-S Ncurostimulation System and 

Systems for DBS 

G140203 G140201 G140207 G140107 G140190 

U140212 

Gl30285 Gl40214 Gl40215 G140219 G140226 

0140223 

G140126 Gl40225 

Pediatric Cystoscope For Use in Fetal Neura

TAAA Dcbranching Stent Graft System 

Bionir Ridatorolimus Eluting Coronary Sten

EXALE)JZ BREATHID LF System 13C-Mc

Self Expanding Mitral Transcatheter Heart V

9800 

Magnap (Magnetic Apnea Prevention) Devic

XprESS Device for Eustachian Tube Dilation 

Ventana PD-Ll (SP263) Rabbit Monoclonal 

Cervical Pessary 

Med-El Maestro Cochlear Implant System 

Acell Matristem SurgicalMatrix PSMX-6 La

(Acell, Inc.); Boston Scientilic Walll1ex Full

Esophageal Stent 

Alfapump 

Early Feasibility Study ofThe Networked J\e

Grasp and Trunk Function in Spinal Cord Inj

EN02FE15.010</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

IDE Device Start Date 

Gl40230 Gore Tag Thoracic Branch Endoprosthesis 12/17/2014 Gl40235 Exalenz BreathiD For Use With C-Laeled Palmitate 12/18/2014 

Gl40229 Juvederm Voluma (AIIergan) 12/19/2014 

Gl40233 2008K(a)homc Noctumal Hemodialysis Indication 12/19/2014 

Gl40234 1.5T And 3.0T MRI Scanners 12/19/2014 

Gl40240 Bioprosthetic Mitral Valve System 12/19/2014 

G140193 Starflo Glaucoma lmplantMode192101 12/19/2014 

GJ40239 Doctormate Renqiao Remote Ischemic Conditioning Device 12/21/2014 

Type: IPC-906X 

Addendum VI: Approval Numbers for Collections of Information 

(October through December 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 Bryrnan ( 41 0-786-5258). 

Addendum VII: Medicare-Approved Carotid Stent Facilities, 

(October through December 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 

perfonning 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 infom1ation is available at: 

For questions or additional information, contact Lori Ashby 

( 41 0-786-6322). 

Facility P

N

··•• • '' 

Los Alamitos Medical Center 0

3751 Katella Avenue Los Alamitos, CA 90720 

Walnut Hill Medical Center 6

7502 Greenville Avenue Dallas, TX 75231 

Einstein Medical Center Montgomery 3

559 West Germantown Pike 

East Norriton. PA 19403 

,,::'A'''\'"' 0 :z;,'( .• 

Physicians Regional Health care System, Collier Boulevard 

8300 Collier Boulevard Naples, FL 34114 

Physicians Regional Healthcare System, Pine 

Ridge 

610 I Pine Ridge Road Naples, FL 34119 

FROM: Heart Hospital of New Mexico 3

TO: Heart Hospital of New Mexico at Lovelace 

Medical Center 

504 Elm StreetN.E. Albuquerque, NM 87102 

FROM: Swedish Medical Center-Providence 5

Campus 

TO: Swedish Medical Center- Cherry Hill 

500 17th Avenue Seattle WA 98122 

FROM: The Indiana Heart Hospital, LLC 

TO: Community Heart and Vascular Hospital 

1500 N. Ritter Indianapolis, IN 46219 

Addendum VIII: 

American College of Cardiology's Nation

Registry Sites (October through 

Addendum VIII includes a list of the A

Cardiology's National Cardiovascular Data Re

implantable cardioverter defibrillators (ICDs) f

indications, as long as information about the pr

central registry. Detailed descriptions of the co

available in the NCD. In January 2005, CMS e

Abstraction Tool through the Quality Network temporary data collection mechanism. On Oct

announced that the American College of Cardi

Cardiovascular Data Registry (ACC-NCDR) lC

reporting requirements in the NCD. Hospitals 

ACC-NCDR lCD Registry by April 2006. 

EN02FE15.011</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

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 ICDs as identified by the FDA or in the 

ACC-NCDR ICD registry. Therefore, for a beneficiary to receive a 

Medicare-covered ICD implantation for primary prevention, the beneficiary 

must receive the scan in a facility that participates in the ACC-NCDR ICD 

registry. The entire list of facilities that participate in the ACC-NCDR lCD 

registry can be found 

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

specific updates that have occurred in the 3-month period. This information 

is available by accessing our website and clicking on the link for the 

American College of Cardiology's National Cardiovascular Data Registry 

at: For questions or additional 

infonnation, contact Marie Casey, BSN, MPH (410-786-7861). 

Facility City State >>'. :·,'." ; '.;l'> 

University of Arkansas Medical Sciences Physician Little Rock AR 

Verdugo Hills Hospital Glendale CA 

Morris Hospital Morris lL 

Truman Medical Centers Kansas City MO 

Great Plains Health North Platte NE 

St. Vincent Blount Oneonta AL 

Citizens Medical Center Victoria TX 

Ililo Medical Center llilo Ill 

Seton Medical Center Hays Kyle TX 

.. 

.. ,,.,,,,, ;,{ .. . \\';/•.:',;; 

Watsonville Community Hospital Watsonville CA 

Owensboro Health Regional Hospital Owensboro KY 

Bartow Regional Medical Center Bartow FL 

Camden Clark Medical Center-St Joseph Campus Parkersburg wv 

Carlsbad Medical Center Carlsbad NM 

Bayfront Health Spring Hill Spring Hill FL 

Addendum IX: Active CMS Coverage-Re

(October through Decem

CMS issued a guidance document on 

"Guidance for the Public, Industry, and CMS 

Evidence Development Document". Althoug

vehicles relating to evidence development act

investigational device exemption (IDE), the c

coverage detenninations and local coverage ddocument is principally intended to help the p

implementation of coverage with evidence de

national coverage detennination process. The 

information, contact JoAnna Baldwin ( 41 0-78

Addendum X: 

List of Special One-Time Notices Rega

Provisions (October through D

There were no special one-time notic

coverage provisions published in the October quarter. This infom1ation is available at 

questions or additional information, contact Jo

7205). 

Addendum XI: National Oncologic 

(October through Decem

Addendum XI includes a listing of N

Emission Tomography Registry (NOPR) sites

tomography (PET) scans for particular oncolo

perfom1ed 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

perfonned 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 ofNational Oncologic Positron Emissi

(NOPR) in the October through December 20

EN02FE15.012</GPH>mstockstill on DSK4VPTVN1PROD with NOTICES

available at 

For questions or additional information, contact Stuart Caplan, RN, MAS 

( 41 0-786-8564). 

Addendum XII: Medicare-Approved Ventricular Assist Device 

(Destination Therapy) Facilities (October through December 2014) 

Addendum XII includes a listing of Medicare-approved facilities 

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

destination therapy. All facilities were required to meet our standards in 

order to receive coverage for V ADs implanted as destination therapy. On 

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

clinical indication of destination therapy. We determined that VADs used 

as destination therapy are reasonable and necessary only if performed in 

facilities that have been determined to have the experience and 

infrastructure to ensure optimal patient outcomes. We established facility 

standards and an application process. All facilities were required to meet 

our standards in order to receive coverage for V ADs implanted as 

destination therapy. 

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

specific updates that have occurred to the list of Medicare-approved 

facilities that meet our standards in the 3-month period. This information is 

available at 

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

( 410-786-7861 ). 

Provider Number 

Rush University Medical Center 140119 

1653 West Congress Parkway 

Chicago, IL 60612 

Addendum XIII: Lung Volume Reduction Surgery (LVRS) 

(October through December 2014) 

Addendum XIII includes a listing of Medicare-approved facilities 

that are eligible to receive coverage for lung volume reduction surgery. 

Until May 17, 2007, facilities that participated in the National Emphysema 

Treatment Trial were also eligible to receive coverage. The following three 

types of facilities are eligible for reimbursement for Lung Volume 

Reduction Surgery (L VRS): 

• National Emphysema Treatment Trial 

05/07/2007, these will no longer automaticall

with the other programs); 

• Credentialed by the Joint Commission 

Commision on Accreditation ofHealthcare O

their Disease Specific Certification Program f

• Medicare approved for lung transplant

Only the first two types are in the lis

the listing offacilities for lung volume reduct

October through December 2014 quarter. Th

questions or additional infonnation, contact M

(410-786-7861). 

Addendum XIV: Medicare-Approved B

(October through Decem

Addendum XIV includes a listing of 

that meet minimum standards for facilities mo

society statements on competency. All facilit

order to receive coverage for bariatric surgery 

2006, we issued our decision memorandum o

We determined that bariatric surgical procedu

necessary for Medicare beneficiaries who hav

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

and have been previously unsuccessful with m

This decision also stipulated that covered bar

reasonable and necessary only when perform

certified by the American College of Surgeon

Surgery Center (program standards and requi

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

(ASBS) as a Bariatric Surgery Center of Exce

standards and requirements in effect on Febru

There were no additions, deletions, o

Medicare-approved facilities that meet CMS '

for bariatric surgery that have been certified b

October through December 2014 period. Thi

questions or additional information, contact J

( 410-786-2064). 
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices 5551 

[FR Doc. 2015–01904 Filed 1–30–15; 8:45 am] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6059–N2] 

Medicare, Medicaid, and Children’s 

Health Insurance Programs: 

Announcement of the Extended 

Temporary Moratoria on Enrollment of 

Ambulance Suppliers and Home Health 

Agencies in Designated Geographic 

Locations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Extension of temporary 

moratoria. 

SUMMARY: This document announces the 

extension of temporary moratoria on the 

enrollment of new ambulance suppliers 

and home health agencies (HHAs) in 

specific locations within designated 

metropolitan areas in Florida, Illinois, 

Michigan, Texas, Pennsylvania, and 

New Jersey to prevent and combat fraud, 

waste, and abuse. 

DATES: Effective Dates: January 29, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Belinda Gravel, (410) 786–8934. 

News media representatives must 

contact CMS’ Public Affairs Office at 

(202) 690–6145 or email them at press@

cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. CMS’ Imposition of Temporary 

Enrollment Moratoria 

Section 6401(a) of the Affordable Care 

Act added a new section 1866(j)(7) to 

the Social Security Act (the Act) to 

provide the Secretary with authority to 

impose a temporary moratorium on the 

enrollment of new Medicare, Medicaid 

or CHIP providers and suppliers, 

including categories of providers and 

suppliers, if the Secretary determines a 

moratorium is necessary to prevent or 

combat fraud, waste, or abuse under 

these programs. For a more detailed 

explanation of these authorities, please 

see the July 31, 2013 notice (78 FR 

46339) or February 4, 2014 extension 

and establishment of a temporary 

moratoria document (hereinafter 

referred to as the February 4, 2014 

moratoria document or notice) (79 FR 

6475). 

Based on this authority and our 

regulations at § 424.570, we have 

implemented three phases of the 

moratoria to date. In the notice issued 

on July 31, 2013 (78 FR 46339), we 

imposed moratoria on the enrollment of 

home health agencies in Miami-Dade 

County, Florida and Cook County, 

Illinois and surrounding counties and 

on the enrollment of ground ambulance 

suppliers in the Harris County, Texas 

area and surrounding counties. Then, in 

the notice published on February 4, 

2014 (79 FR 6475), we extended the 

initial moratoria and imposed moratoria 

on the enrollment of home health 

agencies in Broward County, Florida, 

Dallas County, Texas, Harris County, 

Texas and Wayne County, Michigan and 

surrounding counties and on the 

enrollment of ground ambulance 

suppliers in Philadelphia, PA and 

surrounding counties. In the notice 

published on August 1, 2014 (79 FR 

44702), CMS extended all of the abovementioned moratoria. 

B. Determination of the Need for 

Extending a Moratorium 

In extending these enrollment 

moratoria, CMS considered both 

qualitative and quantitative factors 

suggesting a high risk of fraud, waste, or 

abuse. CMS relied on law enforcement’s 

longstanding experience with ongoing 

and emerging fraud trends and activities 

through civil, criminal, and 

administrative investigations and 

prosecutions. CMS’ determination of a 

high risk of fraud, waste, or abuse in 

these provider and supplier types 

within these geographic locations was 

then confirmed by CMS’ data analysis, 

which relied on factors the agency 

identified as strong indicators of risk. 

(For a more detailed explanation of this 

determination process and of these 

authorities, see the July 31, 2013 notice 

(78 FR 46339) or February 4, 2014 

moratoria document (79 FR 6475)). 

1. Consultation With Law Enforcement 

In consultation with the HHS-Office 

of Inspector General (OIG) and the 

Department of Justice (DOJ), CMS 

identified two provider and supplier 

types in nine geographic locations that 

warrant a temporary enrollment 

moratorium. For a more detailed 

discussion of this consultation process, 

see the July 31, 2013 notice (78 FR 

46339) or February 4, 2014 moratoria 

document (79 FR 6475). 

2. Beneficiary Access to Care 

Beneficiary access to care in 

Medicare, Medicaid, and CHIP is of 

critical importance to CMS and its state 

partners, and CMS carefully evaluated 

access for the target moratorium 

locations. Prior to imposing and 

extending these moratoria, CMS 

consulted with the appropriate State 

Medicaid Agencies and with the 

appropriate State Department of 

Emergency Medical Services to 

determine if the moratoria would create 

an access to care issue for Medicaid and 

CHIP beneficiaries in the targeted 

locations and surrounding counties. All 

of CMS’ state partners were supportive 

of CMS analysis and proposals, and 

together with CMS, determined that 

these moratoria will not create access to 

care issues for Medicaid or CHIP 

beneficiaries. CMS also reviewed 

Medicare data for these areas and found 

there are no current problems with 

access to HHAs or ground ambulance 

suppliers. 

3. Lifting a Temporary Moratorium 

In accordance with § 424.570(b), a 

temporary enrollment moratorium 

imposed by CMS will remain in effect 

for 6 months. (For a more detailed 

explanation of how CMS can lift a 

temporary moratorium, see the July 31, 

2013 notice (78 FR 46339) or February 

4, 2014 moratoria document (79 FR 

6475)). If CMS deems it necessary, the 

moratorium may be extended in 6- 

month increments. CMS will evaluate 

whether to extend or lift the moratorium 

before any subsequent moratorium 

periods. If one or more of the moratoria 


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