Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2014, 43475-43491 [2014-17488]
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Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
part of its function to provide
consumers with assistance when they
need it. Navigators will assist
consumers by providing education
about and facilitating selection of
qualified health plans (QHPs) within
Marketplaces, as well as other required
duties. Section 1311(i) requires that a
Marketplace operating as of January 1,
2014, must establish a Navigator
Program under which it awards grants
to eligible individuals or entities who
satisfy the requirements to be Exchange
Navigators. For Federally-facilitated
Marketplaces (FFMs) and State
Partnership Marketplaces (SPMs), we
will be awarding these grants. Navigator
awardees must provide weekly,
monthly, quarterly, and annual progress
reports to us on the activities performed
during the grant period and any subawardees receiving funds. We have
modified the data collection
requirements for the weekly, monthly,
quarterly, and annual reports that were
provided in the 60-day Federal Register
notice (79 FR 20211).
Form Number: CMS–10463 (OMB
control number: 0938–1215); Frequency:
Annually; Quarterly, Monthly, Weekly;
Affected Public: Private sector; Number
of Respondents: 99; Total Annual
Responses: 5,148; Total Annual Hours:
49,512. (For policy questions regarding
this collection contact Julia Dreier at
301–492–4123.)
I. Background
Medicaid programs and coordination
and oversight of private health
insurance. Administration and oversight
of these programs involves the
following: (1) furnishing information to
The Centers for Medicare & Medicaid
Services (CMS) is responsible for
administering the Medicare and
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Dated: July 22, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–17555 Filed 7–24–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–9086–N]
Medicare and Medicaid Programs;
Quarterly Listing of Program
Issuances—April Through June 2014
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice lists
CMS manual instructions, substantive
and interpretive regulations, and other
Federal Register notices that were
published from April through June
2014, relating to the Medicare and
Medicaid programs and other programs
administered by CMS.
FOR FURTHER INFORMATION CONTACT: It is
possible that an interested party may
need specific information and not be
able to determine from the listed
information whether the issuance or
regulation would fulfill that need.
Consequently, we are providing contact
persons to answer general questions
concerning each of the addenda
published in this notice.
SUMMARY:
BILLING CODE 4120–01–C
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Medicare and Medicaid beneficiaries,
health care providers, and the public;
and (2) maintaining effective
communications with CMS regional
offices, state governments, state
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the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Improving
Quality of Care in Medicaid and CHIP
through Increased Access to Preventive
Services State Survey; Use: The survey
will be used to gain a better
understanding of state efforts to increase
the utilization of preventive services
and to develop resources (including
educational and outreach resources) to
help states increase the utilization of
these services. The results will provide
a baseline regarding the coverage of
preventive services and will help us
identify ways to assist states with
materials focusing on prevention and
technical assistance. The survey has
been revised subsequent to the
publication of the 60-day Federal
Register notice (79 FR 20211).
Form Number: CMS–10521 (OMB
control number: 0938—New);
Frequency: Once; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 51; Total Annual
Responses: 51; Total Annual Hours:
128. (For policy questions regarding this
collection contact Mary Beth Hance at
410–786–4299.)
2. Type of Information Collection
Request: Revision to a currently
approved collection; Title of
Information Collection: Cooperative
Agreement to Support Navigators in
Federally-facilitated and State
Partnership Exchanges; Use: Section
1311(i) of the Affordable Care Act
requires Exchanges (Marketplaces) to
establish a Navigator grant program as
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Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
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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.
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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
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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 https://
www.cms.gov/manuals.
Dated: July 18, 2014.
Kathleen Cantwell,
Director, Office of Strategic Operations and
Regulatory Affairs.
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Addendum 1: Medicare and Medicaid Manual Instructions
(April through June 2014)
The CMS Manual System is used by CMS program components,
partners, providers, contractors, Medicare Advantage organizations, and
State Survey Agencies to administer CMS programs. It offers day-to-day
operating instructions, policies, and procedures based on statutes and
regulations, guidelines, models, and directives. In 2003, we transformed the
CMS Program Manuals into a web user-friendly presentation and renamed
it the CMS Online Manual System.
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How to Obtain Manuals
The Internet-only Manuals (IOMs) are a replica of the Agency's
official record copy. Paper-based manuals are CMS manuals that were
officially released in hardcopy. The majority of these manuals were
transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub
15-2 and Pub 45 are exceptions to this rule and are still active paper-based
manuals. The remaining paper-based manuals are for reference purposes
only. If you notice policy contained in the paper-based manuals that was
not transferred to the 10M, send a message via the CMS Feedback tool.
Those wishing to subscribe to old versions of CMS manuals should
contact the National Technical Information Service, Department of
Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703605-6050 ). You can download copies of the listed material free of charge
at: ="'-'-'--'-"-'-'==-'-"-=""-'-="'·
How to Review Transmittals or Program Memoranda
Those wishing to review transmittals and program memoranda can
access this information at a local Federal Depository Library (FDL). Under
the FDL program, government publications are sent to approximately I ,400
designated libraries throughout the United States. Some FDLs may have
arrangements to transfer material to a local library not designated as an
FDL. Contact any library to locate the nearest FDL. This information is
available at=~'-'-'-'-'--"~~=~~!!!.!"-"'In addition, individuals may contact regional depository libraries
that receive and retain at least one copy of most federal government
publications, either in printed or microfilm fonn, for use by the general
public. These libraries provide reference services and interlibrary loans;
however, they are not sales outlets. Individuals may obtain information
about the location of the nearest regional depository library from any
library. CMS publication and transmittal numbers are shown in the listing
entitled Medicare and Medicaid Manual Instructions. To help FDLs locate
the materials, use the CMS publication and transmittal numbers. For
example, to find the Percutaneous Image-guided Lumbar Decompression
(PILD) for Lumbar Spinal Stenosis (LSS)use CMS-Pub. 100-03,
Transmittal No. 167.
Addendum I lists a unique CMS transmittal number for each
instruction in our manuals or program memoranda and its subject number.
A transmittal may consist of a single or multiple instruction(s). Often, it is
necessary to use information in a transmittal in conjunction with
information currently in the manual. For the purposes of this quarterly
notice, we list only the specific updates to the list of manual instructions
that have occurred in the 3-month period. This information is available on
our website at ..!!.2.!.2:!~~~~~~~·
Manual/Subject/Publication Number
85
86
188
Issued to a specific audience, not posted to Internet/ Intranet due to
Confidentiality of Instruction
Contractor Implementation of Change Requests and Compliance with
Technical Direction Letters
Sample Cover Letter/Attestation Statement
CR Implementation Report (CRlR) Template
TDL Comoliance Renort ITCR) Temolate
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
Publication Dates for the Previous Four Quarterly Notices
We publish this notice at the end of each quarter reflecting
information released by CMS during the previous quarter. The publication
dates of the previous four Quarterly Listing of Program Issuances notices
are: July 26,2013 (78 FR 45233), November 8, 2013 (78 FR 67153),
January 31, 2014 (79 FR 5419), and April25, 2014 (79 FR 22976). For the
purposes of this quarterly notice, we are providing only the specific updates
that have occurred in the 3-month period along with a hyperlink to the
website to access this infonnation and a contact person for questions or
additional information.
Update to the Medicare Benefit Policy Manual to Restore Missing Air
Ambulance Definitions
Air Ambulance Services
Updates and Clarifications tn the Hospice Policy Chapter ofthe Benefit
Policy Manual
Requirements- General
Timing and Content ofCetiitication
Election, Revocation, and Change of Hosnice
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I Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid
Tumors (This CR rescinds and fully replaces CR8468/TR2873
dated February 6, 2014)
Positron Emission Tomography (FDG PET) for Oncologic Conditions
I Percutaneous Image-guided I .umbar Decompression (PH D) for f .umbar
Spinal Stenosis (LSS)
Percutaneous image-guided lumbar decompression for lumbar spinal
Stenosis
I Fluorodcoxyglucosc (FDG) Positron Emission Tomography (PET) for Solid
Tumors (This CR rescinds and fully replaces CR8468/TR2873 dated
Februmy 6, 2014)
Positron Emission Tomography (FDG PET) for Oncologic Conditions
I
Analysis and Implementation of Non-Medical Code Set Edit Bypass for
Contractor Initiated Adjustment Claims in the Fiscal Intermediary Shared
System (FISS)
New Waived Tests
Remittance Advice Remark and Claims Adjustment Reason Code and
Medicare Remit Easy Print and PC Print Update
Internet Only Manual Updates to Pub. 100-01, 100-02 and 100-04 to Correct
Errors and Omissions
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Provider Charges to Beneficiaries
Annual Updates to the SNF Pricer
Other Excluded Services Beyond the Scope of a SNF Pmt A Benefit
Other Services Excluded from SNF PPS and Consolidated Billing
Ambulance Services
Screening and Preventive Services
Physician's Services and Other Professional Services Excluded Prom Part
PPS Payment and the Consolidated Billing Requirement
Medicare Claims Processing Pub. I 00-04 Chapter 25 Update
Uniform Bill- f'orm C.\t!S-1450
Form Locators 43-81
Disposition of Copies of Completed Forms
General Instructions for Completion of Form CMS-1450 for Billing
Form Locators l-15
Form Locators 3 l-41
Unitonn Billing with Form CMS-1450
April Update to the CY 2014 Medicare Physician Fee Schedule Database
(MPFSDB)
July 20131ntegrated Outpatient Code Editor (I/OCE) Specifications
Version 14.2
Corrections to the Medicare Claims Processing Manual
Foreword
Liability Considerations for Bundled Services
CWF General Instruction
Liability Considerations for Bundled Services
Line-Item Modifiers Related to Reporting of Non-covered Charges When
Covered and Non-covered Services Are on the Same Outpatient Claim
Claims Processing Requirements for Financial Limitations
Physician Fee Schedule Payment Policy Indicator File Record Layout
General Billing Requirements
Payment
Coding That Results from Processing Noncovered Charges
Chapter 29 Appeals Update (Includes Post-DOMA Guidance and Signature
Requirement for Appointment of Representatives and Assignment of
Appeal Rights
CMS Decisions Subject to the Administrative Appeals Process
Who May Appeal
Steps in the Appeals Process: Overview
Where to Appeal
Procedures to Follow When a Party Fails to Establish Good Cause
Amount in Controversy General Requirements
Principles tor Determining Amount in Controversy
Aggregation of Claims to Meet the Amount in Controversy
Appointment of Representative - Introduction
How to Make and Revoke an Appointment
When and Where to Submit the Appointment
Rights and Responsibilities of a Representative
Duration of Appointment
Curing a Defective Appointment of Representative
How to Make and Revoke a Transfer of Appeal Rights
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
Hospice Discharge
Election by Managed Care Enrollees
Drugs and Biologicals Coinsurance
Respite Care Coinsurance
Benetit Coverage
Nursing Care
Physicians' Services
Nurse Practitioners as Attending Physicians
Short-Term Inpatient Care
Medical Appliances and Supplies
Other Items and Services
Continuous Home Care (CHC
Respite Care
Other Issues
Non-core Services
Limitation on Liability for Certain Hospice Coverage Denials
Documentation
Limitations on Payments for Inpatient Care
Counting Beneficiaries for Calculation
Special Modalities
Invalidation ofNational Coverage Determination 140.3- Transsexual Surgery
Services Related to and Required as a Result of Services Which Are Not
Covered Under Medicare
Services Related to and Required as a Result of Services Which Are Not
Covered Under Medicare
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(MPFSDB)
Issued to a specitic audience, not posted to lnternet/lntranet due to Sensitivity
oflnstruction
July 2014 Quarterly Average Sales Price (ASP) Medicare Part B Drug
Pricing Files and Revisions to Prior Quarterly Pricing Files
Medicare Claims Processing Pub. I 00-04 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 276/277 Claim Status Request and Response
Transmission Requirements
Batch Transactions
Online Direct Data Entry
Interactive/Online (Non-DOE
Summary of the ASC Xl2 276/277 Claim Status Request and Response
Process for AlB Medicare Administrative Contractors, DME MACs,
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CEDI
Flat File
Translation Requirements
Transmission Mode
Claim Status Request/Response Transaction Standard
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to lnternet/lntranet due to
Confidentiality of Instmction
Update for the Durable Medical Equipment, Prosthetics, Orthotics and
Supplies (DMEPOS) Competitive Bidding Program (CBP)- July 2014
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Tnternet/Tntranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to lntcrnct/lntranet due to
Confidentiality of Instruction
Issued to a specitic audience, not posted to lnternet/lntranet due to Sensitivity
oflnstruction
Issued to a specific audience, not posted to Internet/Intranet due to
Contidentiality of Instruction
Tssued to a specific audience, not posted to lntcrnct/lntranct due to
Confidentiality ofTnstruction
Medicare System Updates to Include Splints, Casts and Cctiain Intraocular
Lenses Payment Category Indicators in the Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule File and
Alpha-Numeric HCPCS file
Calendar Year (CY) 2014 Annual Update for Clinical Laboratory Fee
Schedule and Laboratory Services Subject to Reasonable Charge Payment
-REVISION
Adjustment to Fiscal Intermediary Shared System (F!SS) Consistency Edit to
Implement J\'ational Uniform Billing Committee (NUBC)
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
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Curing a Defective Transfer of Appeal Rights
Medicare Secondary Payer (MSP) Specific Limitations or Additional
Requirements With Respect to the Appointment of Representatives Fraud and
Abuse- Authority
Appeals of Claims Involving Excluded Providers, Physicians, or Other
Suppliers
Required Elements in Appeals Correspondence
General Information
Appeal Decision Involving Multiple Beneficiaries
Filing a Request for Redetermination
The Redetermination
The Redetermination Decision
Dismissals
Dismissal Letters
Requests for U.S. District Court Review by a Party
Medicare Redetennination Notice (For Partly or Fully Unfavorable
Redeterminations)
Medicare Redetermination Notice (For Fully Favorable Redeterminations)
System and Processing requirements for Use of Secure Internet
Portal/Application to Support Appeals Activities
Reconsideration -The Second Level of Appeal
Filing a Request for a Reconsideration
Administrative Law Judge (ALl) Hearing- The Third Level of Appeal
Departmental Appeals Board- Appeals Council- The Fourth Level of
Appeal
District Court Review - The Filth Level of Appeal
Model Dismissal "Jotices
April2014 Update ofthe Ambulatory Surgical Center (ASC) Payment
System
Enforcement of the 5 day Payment Limit for Respite Care Onder the Hospice
Medicare Benefit
Update to Pub. I 00-04, Medicare Claims Processing Manual, Chapter II to
Provide Language-Only Changes for Updating !CD-I 0 and ASC X 12
Requirement for RNHCI Election
Update to Pub. I 00-04, Medicare Claims Processing Manual, Chapter II to
Provide Language-Only Changes for Updating ICD-10 and ASC X12
Aprepitant for Chemotherapy-Induced Emesis
Billing and Payment Instructions for A/B MAC
IICPCS Codes for Oral Anti-Emetic Drugs
Claims Processing Jurisdiction for Oral Anti-Emetic Drugs
Oral Anti-Emetic Drugs Used as Full Replacement for Intravenous AntiEmetic Drugs as Part of a Cancer Chemotherapeutic Regimen
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for
Solid Tumors (This CR rescinds and fully replaces CR8468/TR2873 dated
February 6, 2014
Addition of New Fields and Expansion of Existing Model I Discount
Percentage Field in the Inpatient Hospital Provider Specific File (PSF) and
Addition of New Fields and Renaming Payment Fields in the Inpatient
Prospective Payment System (IPPS) Pricer Output
April Update to the CY 2014 Medicare Physician Fee Schedule Database
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F -Notice that determination reached that the provider is eligible to
submit paper claims
G- Notice from the Railroad Board Specialty Medicare Administrative
Contractor (RRB SMAC) to a Provider that Has Just Begun to Submit
Claims that Paper Claims Submitted by that Provider Will be Denied
Network Service Vendor (NSV) Agreement
Instructions for Downloading the Medicare ZIP Code File for October 2012
Claim Status Categmy and Claim Status Codes Update
Quarterly Update for the Durable Medical Equipment, Prosthetics,
01thotics and Supplies (DMEPOS) Competitive Bidding Program (CBP)
-October 2014
Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 20.3,
Effective October l, 20 I 4
July 2014 Update of the Ambulatory Surgical Center (ASC) Payment System
July 2014 Update of the Hospital Outpatient Prospective Payment
System (OPPS
Type of Bill
Method of Payment for Clinical Laboratory Tests - Place of
Service Variation
Hospital Billing Under Part B
Critical Access Hospital (CAH) Outpatient Laboratory Service
Issued to a specific audience, not posted to Internet/ Intranet due to
Confidentiality of Instmction
Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity
of Instruction
July Update to the CY 2014 Medicare Physician Fee Schedule Database
(MPFSDB)
Issued to a specific audience, not posted to Internet/ Intranet due to
Confidentiality of Instruction
Changes to the Laboratory National Coverage Determination (NCD)
Soflware
Claritlcation of Billing Instructions Related to the Home Health Benefit
Split Percentage Payment of Episodes
Home health Consolidated Billing Edits in Medicare Systems
More Than One Agency Furnished Home Health Services
Grouper Links Assessment and Payment
Submission of Request for Anticipated Payment (RAP)
Claim Submission and Processing
Payment, Claim Adjustments and Cancellations
Adjustments of Episode Payment- Low Utilization Payment
Adjustments (LUPAs)
Adjustments of Episode Payment- Early or Later Episodes
Adjustments of Episode Payment- Outlier Payments
Glossmy and Acronym List
Home Health Prospective Payment System (HH PPS) Consolidated Billing
General Guidelines for Processing !lome Health Agency (I UclA) Claims
Therapy Editing
Nonroutine Supply Editing
Other Editing Related to Home Health Consolidated Billing
Home Health Consolidated Billing and Supplies Provided by DMEPOS
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
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Revision to Occurrence Span Code (OSC) Definition for Code 72.
Adjustment to Fiscal Intermedimy Shared System (FISS) Consistency Edit to
Implement l\ational Uniform Billing Committee (NUBC)
Revision to Occurrence Span Code (OSC) Definition for Code 72.
Issued to a specific audience, not posted to Internet! Intranet due to Sensitivity
oflnstruction
Issued to a specific audience, not posted to lnternet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality ofTnstruction
Issued to a specific audience, not posted to lntcrnct/lntranct due to
Confidentiality of Instruction
Mandatmy Rep011ing of an 8-Digit Clinical Trial Number on Claims
General
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of lnstmction
July 2014 Integrated Outpatient Code Editor (IiOCE) Specifications
Version 15.2
Issued to a specific audience, not posted to lnternet/lntranct due to
Confidentiality of Instruction
Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar
Spinal Stenosis ( LSS)
Issued to a specific audience, not posted to Intcrnct/Intranct due to
Confidentiality of Instruction
Issued to a specific audience, not posted to lnternet/lntranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranct due to
Confidentiality of Instruction
Common Edits and Enhancem~nts Modules (CEM) Code Set Update
Indian Health Services (HIS) Hospital Payment Rates for Calendar Year 2014
Medicare Claims Processing Pub. 100-04 Chapter 24 Update
A - Response to a non - "unusual circumstance" waiver request
Number of ASCS Enforcement Reviews to he Conducted by the RRB
SMAC
EDI Enrollment and ED! Claim Record Retention
H- Notice from the Railroad Retirement Board Speciality MAC to a
Provider with a Pre-Established Record in PES that Paper Claims Will
be Denied as Result of the Requirements that a Provider Submit Claims
to One or More
Other Medicare Contractors Electronically
B - Denial of an "unusual circumstance" waiver request
C - Request for Documentation from Provider Selected for Review to
Establish Entitlement to Submit Claims on Paper
D -Notice that paper claims will be denied effective with the 9 I st
calendar day after the original letter as result of non-response to that
letter
E- Notice that paper claims will he denied effective with the 91st
calendar day after the original letter as result of determination that they
provider is not cligiblcto sub!Tiit paper clain1s
--------
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Additional Electronic CoJTespondence Referral System (ECRS) Reason
Codes
COBC Electronic
236
115
116
New to State Operations Manual (SOM) Appendix Y- Organ Procurement
Organization (OPO) Interpretive Guidance
Revised State Operations Manual (SOM), Appendix A, Survey Protocol,
Regulations and Interpretive Guidelines for Hospitals
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Survey Protocol, Regulations and Interpretive Guidelines for Hospitals/A0957 /§482.51 (b)( 4 )!There must be adequate provisions for immediate postoperative care.
Survey Protocol, Regulations and Interpretive Guidelines for Hospitals/A0409/§482.23(e)(4)/Blood transfusions and intravenous medications must be
administered in a~cordan~e with State law and approved medical slaiT policies
and procedures
Survey Protocol, Regulations and Interpretive Guidelines for Hospitals/A0412/§482.23(c)(6)/The hospital may allow a patient (or his or her
caregiver/support person where appropriate) to sell~administer both hospitalissued medications and the patient's own medications brought into the
hospitals defined and specified in the hospital's policies and procedures
117
118
Survey Protocol, Regulations and Interpretive Guidelines for Hospitals/A0405/§482.23(c)Standard: Preparation and Administration of Drugs
Revision to Medicare State Operations Manual (SOM), Chapter 9 Exhibits
37 Model Letter Announcing Validation Survey of Deemed Status
Provider/Supplier
162 Model Letter: Request for a Plan of Correction Following an Initial
Survey for Swing-bed Approval in a Hospital
196 Model Letter Announcing to Deemed Status Provider/Supplier afler a
Validation Survey that it does not Comply with all Medicare Conditions
199 Model Letter Announcing to Deemed Status Provider/Supplier atler a
Substantial Allegation Survey that it will Undergo a Full Survey
Authorization by Deemed Provider/Supplier Selected for Validation Survey
Report of a Hospital Death Associated with Restraint or Seclusion (Form
CMS-10455)
New Guidance Added to Chapter 7- Survey and Enforcement Process for
Skilled Nursing Facilities and Nursing Facilities
Definitions and Acronyms
Informal Dispute Resolution
After Request to Waive Hearing
Mandatory Elements of Informal Dispute Resolution
Independent Informal Dispute Resolution (Independent !DR)
Introduction
Purpose
Independent Informal Dispute Resolution Requirements
Applicability of the Independent Informal Dispute Resolution Process
Key F:lements oflndependent Informal Dispute Resolution
Qualifications of an Independent Informal Dispute Resolution Entity or
Pcrson(s
Approval of an Independent Informal Dispute Resolution process
State Budget and Payment for Expenses
Independent Informal Dispute Resolution Recommendation and
Final Decision
Additional Elements for Federal Independent Informal Dispute Resolution
process
Notice Requirements
When Immediate Jeopardy Exists
Reduction of a Civil Money Penalty by 50 Percent for Self-Reporting and
Prompt Correction ofNoncompliance
When Penalty Is Due and Payable
When a Civil Money Penalty Subject to Being Collected and Placed in an
Escrow Account is Imposed
After Final Administrative Decision
No Hearing Requested
MODEL LETTER TO INVOLVED RESIDENT, RESIDENT
REPRESENTATIVE AND/OR STATE OMBUDSMAN OPPORTUNITY
TO PROVIDE WRITTEN COMMENT (INDEPENDENT INFORMAL
DISPUTE
RESOLUTJON (!DR) HAS BEEN REQUESTED)
After Substantial Compliance is Achieved
After Effective Date ofTennination
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
2978
Suppliers
National Home Health Prospective Payment Episode History File
Other Editing for HH PPS Episodes
Coordination of I Ill PPS Claims Episodes With Inpatient Claim Types
Request for Anticipated Payment (RAP
HH PPS Claims
Collection of Deductible and Coinsurance from Patient
Billing for Nonvisit Charges
Beneficiary-Driven Demand Billing Under HH PPS
No Payment Billing
General
lnpuUOutput Record Layout
Decision Logic Used by the Pricer on RAPs
Decision Logic Used by the Pricer on Claims
Medical and Other Health Services Not Covered Under the Plan of Care
(Type of Bill 034x
Osteoporosis Injections as HHA Benefit
Billing and Payment Procedures Regarding Ownership and CMS Certification
Numbers (CCl\s)
Billing Procedures for an Agency Being Assigned Vlultiple CCNs or a
Change in CCN
Timeliness and Limitations ofCWF Response
I Issued to a specific audience, not posted to Internet/ Intranet due to
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1511
512
513
514
I Clarification to Pub. 100-02, Medicare Benefit Policy Manual Regarding
Antigens and Deletion of Section 13.14 from Chapter 13 of Pub. 100-08,
Medicare Program Integrity Manual
Evaluation of Local Coverage Determination (LCD) Topics for National
Coverage Determination (NCD) Consideration
I Issued to a specific audience not posted to lntemet/ Intranet due to
Confidentiality oflnstruction
I Revision to the Program Integrity Manual, Chapter 3, section 3.3
Policies and Guidelines Applied During Review
I Issued to a specific audience not posted to Intemeti Intranet due to
Confidentiality of lnstmction
I Update to CMS Publication 100-08, Chapter 15
Potential Changes of Ownership
Under the Principles of§ 489.18 Direct Referral to the Regional Office
Required
Radiation Therapy Centers
Practice Location lnformation
Form CMS-855A and Form CMS-855B Signatories
Delegated Officials
Submission of Registration Applications
Registration Letters
Certified Providers and Certified Suppliers
Temporary Moratoria
515
516
517
518
519
520
521
522
523
Model Approval Recommended Letters
Initial Enrollments Requiring Retimal to the State
Initial Enrollments Requiring Direct Referral to the Regional Office
(Including Federally Qualified Health Centers)
Changes oflnformation
Changes oflnformation Requiring Referral to the State
Changes oflnfonnation Requiring Direct Referral to the Regional Office
Potential Changes of Ownership Under the Principles of§ 489.18
Potential Changes of Ownership Under the Principles of§ 489.18Referral to the State Required
Federally Qualified Health Centers (FQHCs)
Issued to a specific audience not posted to Internet! Intranet due to
Conlidentiality of lnstmction
Issued to a specific audience not posted to Internet/ 1ntranet due to
Confidentiality of Instruction
Update to Surety Bond Collection Procedures
Model Letters tor Claims against Surety Bonds
Claims against Surety Bonds
Issued to a specific audience not posted to lntemetl Intranet due to
Confidentiality of Instruction\
Revision to CMS Publication 100-08, Chapter 15
Individual Practitioners
Speech Language Pathologists in Private Practice
Audiologists
Certified Nurse-Midwives
Certified Registered Nurse Anesthetists (CRNAs
Clinical Nurse Specialists
Clinical Psychologists
Clinical Social Workers
Nurse Praditioners
Occupational Therapists in Private Prac
Physical Therapists in Private Practice
Physicians
Physician Assistants (PAs)
Psychologists Practicing Independently
Registered Dietitians
Anesthesiology Assistants
Issued to a specific audience not posted to Internet/ Intranet due to
Confidentiality of Instruction
Submission of Community Mental Health Center (CMHC)
Certifications of Compliance with Section 485.918(b)(l)
Release of Information
CMHC 40 Percent Rule
Section 4 of the Form CMS-855I
Special Procedures for Physicians and Non-Physician Practitioners
Community 'v!ental Health Centers (CMHCs)
Issued to a specific audience not posted to Internet! Intranet due to
Confidentiality of Instruction
Update to CMS Pub. I 00-08, Chapter 3
Reimbursing Providers and HIHs for Additional Documentation
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
Disposition of Collected Civil Money Penalty
Collected From Medicare or Dually-Participating Facility
Entities Other Than Nursing Homes May Receive Collected Civil Money
Penalty Funds From the State
Entities Other Than Nursing Homes May Receive Collected Civil Money
Penalty Funds From the State
Collected Amounts From Dually-Participating Facility or Medicare Facility
and Held in Esc
Use of Civil Money Penalty Funds
MODEL LETTER TO PROVIDER (SEND WITH FORM CMS-2567)
(IMMEDIATE JEOPARDY DOES NOT EXIST)
MODEL LETTER NOTIFYING PROVIDER OF RESULTS OF REVISIT
MODEL LETTER TO PROVIDER (IMPOSITION OF REMEDIES)
(IMMEDIATE JEOPARDY DOES NOT EXIST)
MODEL LETTER TO PROVIDER (IMPOSITION OF REMEDIES)
(IMMEDIATE JEOPARDY EXISTS)
NOTICE OF IMPOSITION OF A CIVIL MONEY PENALTY (INSERT TO
FORMAL NOTICE)
NOTICE OF PAYMENT AMOUNT DUE AND PAY ABLE
NOTICE OF PAYMENT AMOUNT DUE FOR PLACEMENT IN
ESCROW
(IIDR COMPLETE OR NOT TJMEL Y REQUESTED-FACILITY IS
FILING
FORMAL APPEAL)
Purpose -To Provide Facilities an Opportunity To Informally Dispute Cited
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Revision of Pub. 100-09, Chapter 6, Medicare Contractor Beneficiary and
Provider Communications Manual; Clearance of MAC Internet-Based
Provider Portal Handbook; and Deletion of!OM Pub. 100-09, Chapter 3,
Provider Inquiries.
Introduction to Provider Customer Service Program (PCSP)
PCSP Electronic Mailing Lists (Listservs)
Provider Customer Service Program User Group (PCUG) Calls
PCSP Contractor Sharing and Collaboration Team Room
Integration of POE, PCC and PSS Activities in the PCSP
Provider Outreach and Education (POE)
Internal Development of Provider Issues
Partnering with External Entities
Data Analysis
Error Rate Reduction Data
Inquiry Analysis
Medical Review Referrals
Provider Education
Provider Bulletins/Newsletters
Direct Mailings for the PCSP
rraining for New Medicare Providers
Training Tailored for Small Medicare Providers
Educational Topics
Local Coverage Determinations (LCDs)
Education Resulting from Medical Review Referrals
Medicare Preventive Service Benefits
Electronic Claims Submissions
Remittance Advice (RA
POE Materials
POE Advisory Groups (POE AGs)
Ask-the-Contractor" Teleconferences (ACTs
POE Reporting
Provider Service Plan (PSP)
Provider Customer Service Program Activity Repott (PAR)
Error Rate Reduction Plan (ERRP
Additional Reporting
charging Fees to Providers for Medicare Education and Training
No Charge
Fair and Reasonable Fees
Fees for Materials Available on Contractors' Provider Education Websites
Fees for Education and Training Activities
Fees for Videotapes or Recordings of Education and Training Activities
Prohibitions
Reimbursement Jrom Providers for POE Staff Attendance at Provider
Meetings
Excess Revenues from Provider Participant Fees
Refunds/Credits for Cancellation of Education and Training Activities
Considerations and Recordkeeping for Fee Collection
Provider Contact Center (PCC)
Inquiry Triage Process
Responding to Coding Questions
Provider Telephone Inquiries
General Inquiries Line
Teletypewriter (TTY) Lines
Inbound Calls
Troubleshooting Problems
Requesting Changes to Telephone Configurations
!lours of Operation
PCC Closures
Pre-Approved PCC Closures
Planned PCC Closures that are not Pre-Approved Closures
Emergency PCC Closures
Providing Busy Signals
Queue Message
PCC Staffing
CSR Equipment Requirements
CSR Identilieation to Callers
Remote Monitoring Access
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
525
Issued to a specific audience not posted to Internet/ Intranet due to
Conlidentiality oflnstruction
Update to Form CMS-855 Application Processing Sections ofCMS
Pub. 100-08, Chapter 15
Sections of the Forms CMS-855A, CMS-855B, and CMS-855[
Medicare Contractor Duties
Changes ofinformation and Complete l'orm CMS-855 Applications
Correspondence Address and E-mail Addn:sscs
Contact Persons
Application Review and Verification Activities
Receipt/Review of Application and Verification ofData
Receipt/Review of Paper Applications
Receipt/Review of Internet-Based PECOS Applications
Verification of Data
Requesting Missing/Clarifying Data/Documentation
Paper Applications
Internet-Based PECOS Applications
General Principles Paper and Internet-Based PECOS Applications
Receiving Missing/ClarifYing Data/Documentation
Failure to Submit Requested Data/Documentation
Paper Applications
Internet-Based PECOS Applications
Reserved for Future Use
Reserved for Future Usc
Requesting and Receiving ClarifYing lnforn1ation
Basic Information (Section I of the Form CMS-855)
Issued to a specific audience not posted to Internet/ Intranet due to
Confidentialitv of Instruction
Provider Notice on MAC Web Sites
Provider Notice
Proof of Delivery
Supplier Documentation
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lntemet-based Provider Educational Offerings
Provider Edncation Website Promotion
Electronic Mailing List (Listserv)
Targeted Electronic Mailing Lists (Listservs)
Electronic Mailing List (Listserv) Promotion
Social Media
Contractor Intcmct-bascd Provider Portals
PCSP PerJormance Management
POE- Electronic Mailing List (Listserv) Subscribership
Telephone Standards
Customer Service Representative (CSR) Callback Rate
Call Completion
Average Speed of Answer (ASA)
Callbacks
QCM Performance Standards
Written Inquiries
QWCM Pertormance Standards
General Inquiries Timeliness
PRRS Timeliness- Provider Inquiries
PRRS Timeliness-- Complex Bene11ciary Inquiries
Congressional Inquiries Timeliness
PCSP Data Reporting
Provider Inquiries Evaluation System (PIES
Access to PIES
Due Date for Data Submission
Data to be Repmied Monthly
Provider Customer Service Program Contractor Information Database
(PCID)
Access to PCID
Contract Data tD be Reported in PCID
Other Data to be Reported in PCID
Inquiry Tracking Data to be Reported in PCID
Disclosure of Information
POE Data to be Reported in PCID
Provider Electronic Mailing List (Listserv) Subscriber Data to be Reported
in PCID
Special Initiatives to be Reported in PCID
Emergency PCC Closure Data to Be Reported in PCID
lclecommunications Service Interruptions to be Reported in PCIU
QCM Data Reporting
QWCM Data Reporting
Reporting Provider and Beneficiary Inquiry Workload Data in the Contractor
Reporting of Operational Workload Data (CROWD
PCC Training Closure Information to be Reported in PCID
Revision of Pub. 100-09, Chapter 6, Medicare Contractor Benet1cimy and
Provider Inquiries.
Introduction to Provider Customer Service Program (PCSP)
PCSP Electronic Mailing Lists (Listservs)
Provider Customer Service Program User Group (PCUG) Calls
PCSP Contractor Sharing and Collaboration Team Room
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
EN25JY14.008
Contingency Plans
Guidelines for High Quality Responses to Telephone Inquiries
Telephone Response Quality Monitoring Program
Telephone Responses -- Quality Call Monitoring (QCM) Program Minimum
Requirements
Recording Calls
QCM Calibration
CMS Monitoring
Provider Written Inquiries
Controlling Wri!ten Inquiries
Telephone Responses to Written Inquiries
E-mail and Fax Responses to Written Inquiries
Guidelines for High Quality Responses to Written Inquiries
Stock Language/Form Letters
Written Response Quality Monitoring Program
Written Responses-- Quality Written Correspondence Monitoring (QWCM)
Program Minimum Requirements
QWCM Calibration
Replying to Correspondence from Members of Congress
Walk-In Inquiries
Guidelines for Walk-In Service
Complex Provider Inquiries
Complex Bene11ciary Inquiries
Inquiry Tracking
Updates for the CMS Standardized Provider Inquiry Chart
Fraud and Abuse
Surveys
Provider Satisfaction Survey
Telephone Satisfaction Survey
Provider Edu<.:atiun Website Satisfaction Survey
PCSP Staff Development and Education
POE Staff Training
PCC Staff Development and Training
Required Training
PCC Training Program
Training Schedule
Training Closures of More Than Four Hours
Provider Noti11cations
!raining Closure Information Reporting
PRRS StaffTraining
Provider Self-Service (PSS) Technology
Interactive Voice Response System (IVR)
Provider Education Website
General Requirements
Webmastcr and Attestation Requirements
Feedback Mechanism
Contents
Dissemination oflnformation from CMS to Providers
Frequently Asked Questions (FAQs)
Quarterly Provider Update (QPU
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Pre-Approved PCC Closures
Planned PCC Closures that are not Pre-Approved Closures
Emergency PCC Closures
Providing Busy Signals
Queue Message
PCC Staffing
CSR Equipment Requirements
CSR Identification to Callers
Remote Monitoring Access
Contingency Plans
Guidelines for High Quality Responses to Telephone Inquiries
Telephone Response Quality Monitoring Program
Telephone Responses-- Quality Call Monitoring (QCM) Program Minimum
Requirements
Recording Calls
QCM Calibration
CMS Monitoring
Provider Written Inquiries
Controlling Written Inquiries
Telephone Responses to Written Inquiries
E-mail and Fax Responses to Written Inquiries
Guidelines for lligh Quality Responses to Written Inquiries
Stock Language/Form Letters
Written Response Quality Monitoring Program
Written Responses-- Quality Written Correspondence Monitoring (QWCM)
Program Minimum Requirements
QWCM Calibration
Replying to Correspondence from Members of Congress
Walk-In Inquiries
Guidelines for Walk-In Service
Complex Provider Inquiries
Complex Beneficiary Inquiries
Inquiry Tracking
Updates for the CMS Standardized Provider Inquiry Chart
Fraud and Abuse
Surveys
Provider Satisfaction Survey
Telephone Satisfaction Survey
Provider Education Website Satisfaction Survey
PCSP Staff Development and Education
POE Stall Training
PCC Staff Development and Training
Required Training
PCC Training Program
!'raining Schedule
rraining Closures of More Than Four Hours
Provider Notifications
Training Closure Information Reporting
PRRS StaffTraining
Provider Seli:Service (PSS) Technology
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
Integration of POE, PCC and PSS Activities in the PCSP
Provider Outreach and Education (POE)
Internal Development of Provider Issues
Partnering with External Entities
Data Analysis
Error Rate Reduction Data
Inquiry Analysis
Medical Review Referrals
Provider Education
Provider Bulletins/Newsletters
Direct Mailings for the PCSP
Training for New Medicare Providers
Training Tailored for Small Medicare Providers
Educational Topics
Local Coverage Determinations (LCDs)
Education Resulting from Medical Review Referrals
Medicare Preventive Service Benelils
Electronic Claims Submissions
Remittance Advice (RA
POE Materials
POE Advisory Groups (POE AGs)
Ask-the-Contractor" Teleconferences (ACTs
POE Reporting
Provider Service Plan (PSP)
Provider Customer Service Program Activity Report (PAR)
Error Rate Reduction Plan (ERRP
Additional Reporting
charging Fees to Providers for Medicare Education and Training
No Charge
Fair and Reasonable Fees
Fees for Materials Available on Contractors' Provider Education Websites
Fees for Education and Training Activities
Fees for Videotapes or Recordings of Education and Training Activities
Prohibitions
Reimbursement from Providers for POE Staff Attendance at Provider
Meetings
Excess Revenues from Provider Participant Fees
Refunds/Credits for Cancellation of Education and Training Activities
Considerations and Recordkceping for Fee Collection
Provider Contact Center (PCC)
Inquiry Triage Process
Responding to Coding Questions
Provider Telephone Inquiries
General Inquiries Line
Teletype\vriter (TTY) Lines
Inbound Calls
Troubleshooting Problems
Requesting Changes to Telephone Configurations
Hours of Operation
PCC Closures
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Reporting of Operational Workload Data (CROWD
PCC Training Closure Information to be Reported in PCID
None
2
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Confidentiality of Instruction
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Affordable Care Act Bundled Payments for Care Improvement Initiative-
B-~~~~J!J.g_F_i_l~_{JJl.~!~~-M_o_cl~l~-~-
Interactive Voice Response System (!VR)
Provider Education Website
Genera 1 Requirements
Webmaster and Attestation Requirements
Feedback Mechanism
Contents
Dissemination ofinformation from CMS to Providers
Frequently Asked Questions (FAQs)
Quarterly Provider Update (QPU
Internet-based Provider Educational Offerings
Provider Education Website Promotion
Electronic Mailing List (Listscrv)
Targeted Electronic Mailing Lists (Listservs)
Electronic Mailing List (Listserv) Promotion
Social Media
Contractor Intemet-based Provider Portals
PCSP Performance Management
POE- Electronic Mailing List (Listserv) Subscribership
Telephone Standards
Customer Service Representative (CSR) Callback Rate
Call Completion
Average Speed of Answer (ASA)
Callbacks
QCM Performance Standards
Written Inquiries
QWCM Perfonnance Standards
General Inquiries Timeliness
PRRS Timeliness - Provider Inquiries
PRRS Timeliness-- Complex Beneficiary Inquiries
Congressional Inquiries Timeliness
PCSP Data Reporting
Provider Inyuiries Evaluation System (PIES
Access to PIES
Due Date for Data Submission
Data to be Reported Monthly
Provider Customer Service Program Contractor Information Database (PCID)
Access to PCID
Contract Data to be Repmied in PCID
Other Data to be Reported in PCID
Inquiry Tracking Data to be Reported in PCID
Disclosure of Information
POE Data to be Repmied in PCID
Provider Electronic Mailing List (Listserv) Subscriber Data to be Reported
in PClD
Special Initiatives to be Reported in PCID
Emergency PCC Closure Data to Be Reported in PCID
Telecommunications Service Interruptions to be Reported in PCID
QCM Data Reporting
QWCM Data Reporting
Reporting Provider and Beneficiary Inquiry Workload Data in the Contractor
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Periodic Financial Transactions
CWF Editing for Vaccines Furnished at Hospice- Correction
Health Insurance Portability and Accountability Act (HIPAA) EDI Front End
Updates for October 2014
Adding New MSP Data Fields to the CWF Daily File
Return Maintenance of the ANSILIST to the Durable Medical Equipment
(DME) Medicare Administrative Contractors (MACs).
Hewlett Packard Enterprise Services, LLC (HPES) Shared Systems
Maintainer (SSM) support for Medicare Administrator Contractors (MACs)
testing and inquiries for the Combined Common Edits/Enhancements Module
(CCEM) for Part A and Part B
Implement Operating Rules- Phase III ERA EFT: CORE 360 Uniform Use of
Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark
Codes (RARC) Rule- Update from CAQH CORE- June 1, 2014 version
3.0.5
Anesthesiologist/Certified Registered Nurse Anesthetist (CRNA) Related
Services in a Method II Critical Access Hospital (CAH)
Present on Admission (POA) Indicator Editing for Maryland Waiver
Hospitals
CEM Zip Code Analysis and Design
Analysis and Design ofthe ASC X12 278 Transactions
Implementation of a Prospective Payment System (PPS) for Federally
Qualified Health Centers (FQHCs)
Posting the Limiting Charge after Applying the Electronic Health Record
(EHR)
and Physician Quality Reporting System (PQRS) Negative Adjustments
Additional States Requiring Payment Edits for DMEPOS Suppliers of
Prosthetics and Certain Custom-Fabricated Orthotics. Update to CR 3959 and
CR 8390
ModifYing the Daily Common Working File (CWF) to Medicare Bcncficiaty
Database (MBD) File to Include Diagnosis Codes on the Health Insurance
Portability and Accountability Act Eligibility Transaction System (HETS)
270/271 Transactions
Clarification of Remittance Advice Code Combination Reports Generated by
Shared Systems
ICD-I 0 Conversion/Coding Infrastructure Revisions/ICD-9 Updates to
National Coverage Determinations (NCDs)--Maintenance CR
CWF, MCS and VMS Date of Birth (DOB) Analysis
Addendum II: Regulation Documents Published
in the Federal Register (April through June 2014)
Regulations and Notices
Regulations and notices are published in the daily Federal
Register. To purchase individual copies or subscribe to the Federal
Register, contact GPO at
When ordering individual
copies, it is necessary to cite either the date of publication or the volume
number and page number.
The Federal Register is available as an online database through
GPO Access. The online database is updated by 6 a.m. each day the
Federal Register is published. The database includes both text and
graphics from Volume 59, Number 1 (January 2, 1994) through the present
date and can be accessed at
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 final 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 nup:llwww.cms.gov/Kcgumuu!l::;£!!.!'~~~~~~~~~~~· For questions or additional infonnation,
contact Tiffany Lafferty (410-786-7548).
Addendum IV: Medicare National Coverage Determinations
(April through June 2014)
Addendrun IV includes completed national coverage
determinations (NCDs ), or reconsiderations of completed NCDs, from the
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 Secretary for whether or not a
particular item or service is covered nationally under the Medicare Program
(title XVIII ofthe Act), but does not include a determination of the code, if
any, that is assigned to a particular covered item or service, or payment
determination for a particular covered item or service. The entries below
include information concerning completed decisions, as well as sections on
program and decision memoranda, which also announce decisions or, in
some cases, explain why it was not appropriate to issue an NCD.
Information on completed decisions as well as pending decisions has also
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
1373
1374
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Percutaneous Image-guided
Lumbar Decompression for
Lumbar Spinal Stenosis
ICD-10 Conversion/Coding
Infrastructure
Revisions/lCD-9 Updates
to National Coverage
Determinations (NCDs)
Transmittal
Number
Issue Date
Effective
Date
NCD150.13
Rl67
05/16/2014
01/09/2013
N/A
R133
05/23/2014
07/0]/2014
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Addendum V: FDA-Approved Category B Investigational Device
Exemptions (IDEs) (April through June 2014)
Addendum V includes listings of the FDA-approved
investigational device exemption (IDE) numbers that the FDA assigns. The
listings are organized according to the categories to which the devices are
assigned (that is, Category A or Category B), and identified by the IDE
number. For the purposes of this quarterly notice, we list only the specific
updates to the Category B lDEs as of the ending date of the period covered
by this notice and a contact person for questions or additional information.
For questions or additional information, contact John Manlove (410-7866877).
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).
G140054
Gl40040
Gl30286
Gl30072
0140043
Gl40046
BB15998
()140048
G140049
G\40050
BBI5978
BB\5983
Gl40056
G140058
Gl40059
Gl40060
Gl40065
0130264
()140024
Gl40018
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Gl40083
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(l] 40091
G140092
IDE
G140034
!3!315945
Gl40035
Gl40039
Gl30185
BBI5963
EN25JY14.012
Device
ROCHE COBAS EGFR MUTATION TEST
ReCell Autologous Cell Harvesting Device (ReCell)
Strattice Reconstructive Tissue Matrix
EVERA MRI SURESCAN lCD SYSTEM CLINICAL STUDY
BARREL VASCULAR RECONSTRUCTION DEVICE
Dermagraft, Human Fibroblast-Derived Dermal Replacement
Start Date
04/03/2014
04/03/2014
04/04/2014
04/09/2014
041!0/2014
04/11/2014
G\40027
Gl30256
G 140093
G140099
Medtronic Specify 5-6-5 I \1edtronic Restore Advance
Blanketrollll
WEB Aneurysm Embolization System
Ovinium DH Hip System
Transcava1 Access For Transcathctcr Ortic Valve Replacement in
Patients With No Good Options For Aortic Access
PerMIT:Warfarin
Magnetic-Activated Cell Sorter(CliniMACS, Miltenyi) for
CD34 Selection, Allogeneic, Matched-related PBPC
Inferior Vcna Cava Filters
EON Implantable Pulse Generator (lPG) System (Model3688),
Libra Implantable Deep Brain Stimulation (DI3S) Electrodes
(Model 6145), Swift-Lock Anchor (Model 1192)
Mi 1000 Med-FI, Concert Cochlear Implant
Nstride APS Kit
Magnetic Activated Cell Sorter (CiiniMACS, Miltenyi) for
CD34+ Selected Allogeneic Mismatched/Haplocompatible
Related, 0-CSF Mobilized Hematopoietic Stem Cells(HSCs);
following Fludarbine and rATG, with or without Radiation
Model400 Aotiic Valve Bioprothesis
Thcrascrccn BRAF V600E RGQ PCR Kit
Corevalve Evolut R System
Gore Tag Thoracic Branch Endoprothesis
VENT ANA anti-ALK (D5F3) Rabbit Monoclonal Primary
Antibody
!lot Axios Stend And Delivery System (With I Omm x 1Omm
Stent) HXS-10-10, Hot Axios Stend And Delivery System (With
15mmx lOmm Stent)HXS-15-10
Saluda Medical External Trial System
Saluda Medical External Trial System
Liposorber LA-40S Adsorption Column
Zeltiq Coolsculpting System
XpreESS Multi-Sinus Dilation Tool, PathAssist LED Light
Fiber, PathAssist Light Fiber, PathAssist Light Seeker
Sinopsys Lacrimal Stent
Pipeline Embolization Device Model FA-772XX-XX-FA775XX-XX, Pipeline Embolization Device Model FA-712XXXX-FA-715XX-XX
ExAblate 4000 Typer 1.0 Tnmscranial magnetic resonance image
Read/Read Block Compressible Microspheres (ReadRiock)
Cardiac Resynchronization Therapy Efficacy Enhancements
(CRTee) Clinical Study
Transarterial embolization to avoid open prostatectomy in
patients with severe benign prostatic hyperplasia (Embosphere
Microspheres)
SCULPTRA-20 13-01
Custom-Made, Non-Biodegradable, Antibiotic Cement Spacer
VenaCure EVL T 400um Procedure Kit - - - - - --------- --- - - - - - - - - -
04/11/2014
04/17/2014
04/17/2014
04/22/2014
04/23/2014
04/23/2014
04/24/2014
04/25/2014
04/25/2014
04/25/2014
04/27/2014
04/30/2014
05/01/2014
05/01/2014
05/02/2014
05/02/2014
05/07/2014
05/08/2014
05/16/2014
05/16/2014
05/22/2014
05/30/2014
05/30/2014
06/03/2014
06/04/2014
06/04/2014
06113/2014
06/13/2014
06/13/2014
06/20/2014
06/26/2014
06/27/2014
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
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: .!Y.!~_,_£!:!lli.:£Q~i!l,;£!1.£l~::£~~m~
For questions or additional infom1ation, contact Wanda Belle
(410-786-7491).
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Addendum VII: Medicare-Approved Carotid Stent Facilities,
(April through June 2014)
Addendum VII includes listings of Medicare-approved carotid
stent facilities. All facilities listed meet CMS standards for performing
carotid artery stenting for high risk patients. On March 17, 2005, we issued
our decision memorandum on carotid artery stenting. We determined that
carotid artery stenting with embolic protection is reasonable and necessary
only if performed in facilities that have been determined to be competent in
performing the evaluation, procedure, and follow-up necessary to ensure
optimal patient outcomes. We have created a list of minimum standards for
facilities modeled in part on professional society statements on competency.
All facilities must at least meet our standards in order to receive coverage
for carotid artery stenting for high risk patients. For the purposes of this
quarterly notice, we are providing only the specific updates that have
occurred in the 3-month period. This information is available at:
For questions or additional information, contact Lori Ashby
(41 0-786-6322).
25JYN1
Facility
Provider
Number
Penrose-St. Francis Health Services
2222 N. Nevada A venue
Colorado Sprin s, CO 80907
The Heart Hospital Baylor Denton
2809 S. Mayhill Road
Denton, TX 76208
060031
1194753590
06/02/2014
TX
Addendum VIII:
American College of Cardiology's National Cardiovascular Data
Registry Sites (April through June 2014)
Addendum VIII includes a list of the American College of
Cardiology's National Cardiovascular Data Registry Sites. We cover
implantable cardioverter defibrillators (ICDs) for certain clinical
indications, as long as infonnation about the procedures is reported to a
central registry. Detailed descriptions of the covered indications are
available in the NCO. 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 April2006.
Effective January 27, 2005, to obtain reimbursement, Medicare
NCO policy requires that providers implanting lCDs tor 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 I COs 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 participate in the ACC-NCDR lCD
registry can be found at -'-'-'-'-'-'-=~=='-'-'-="-""=--"--"-==
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
information, contact Marie Casey, BSN, MPH (410-786-7861 ).
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
Addendum VI: Approval Numbers for Collections oflnformation
(April through June 2014)
All approval numbers are available to the public at Reginfo.gov.
Under the review process, approved information collection requests are
assigned OMB control numbers. A single control number may apply to
several related information collections. This information is available at
-""-'"-"'.'-'-"'~~~~~~~'-'-'-~'-'-'-"'-'-'-'' For questions or additional
information, contact Mitch Btyman (41 0-786-5258).
43489
EN25JY14.013
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43490
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Facility
City
;;'.\>.l:'t,:l
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Houston Medical Center
Tahlequah City Hospital
South County Hospital
Wolfson Children's Hospital
West Park Hospital
MaryVale Hospital
Parkland Medical Center
Sentara Northern Virginia Medical Center
Lovelace Regional Hospital
Wheaton Franciscan ? Elm brook Memorial Campus
Kaiser Foundation Hospital
Prairie Ridge Hospital and Health Services
Hanover Hospital
St. Barnabas Hospital
Wellington Regional Medical Center
Carilion \few River Valley Medical Center
Warner Robins
Tahlequah
Waleficld
Jackonsville
Cody
Phoenix
Derry
Woodbridge
Roswell
Brookticld
Fontana
Elbow Lake
Hanover
Bronx
Wellington
\,!•:!~\!;;.;;,:;:,;,'\\.
Fmt 4703
Summit Medical Center (6/16/14)
Yakima Valley Memorial Hospital (6/30/14)
State
.~'t' ;':'\;~\\\;)!'~/{
GA
OK
RI
FL
WY
AZ
NH
VA
NM
WI
CA
MN
PA
NY
FL
VA
:\);>!i.~;,i>) :'~\(!i~\'\i:
Van Buren
Yakima
AR
WA
Sfmt 4725
E:\FR\FM\25JYN1.SGM
Addendum IX: Active CMS Coverage-Related Guidance Documents
(April through June 2014)
There were no CMS coverage-related guidance documents
published in the April through June 2014 quarter. To obtain the document,
visit the CMS coverage website at lli!!l;Lt~~:.&Iillh@:\:L.!l~l_\g!I.Q::£QYS
tomography (PET) scans for particular oncologic indications when they are
performed in a facility that participates in the NOPR.
In January 2005, we issued our decision memorandum on positron
emission tomography (PET) scans, which stated that CMS would cover
PET scans for particular oncologic indications, as long as they were
performed in the context of a clinical study. We have since recognized the
National Oncologic PET Registry as one of these clinical studies.
Therefore, in order for a beneficiary to receive a Medicare-covered PET
scan, the beneficiary must receive the scan in a facility that participates in
the registry. There were no additions, deletions, or editorial changes to the
listing of National Oncologic Positron Emission Tomography Registry
(NOPR) in the April through June 2014 quarter. This information is
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 (April through June 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 VADs implanted as destination therapy. On
October 1, 2003, we issued our decision memorandum on VADs for the
clinical indication of destination therapy. We determined that VADs used
as destination therapy are reasonable and necessary only if performed in
facilities that have been determined to have the experience and
infrastructure to ensure optimal patient outcomes. We established facility
standards and an application process. All facilities were required to meet
our standards in order to receive coverage for VADs implanted as
destination therapy.
For the purposes of this quarterly notice, we are 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 ).
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
18:34 Jul 24, 2014
;\\\j.~l.l!;,
emcdonald on DSK67QTVN1PROD with NOTICES
I
Provider Number
Date Approved
State
,~';''"'"''
New York-Presbyterian/Weill Cornell
133-0101
Medical Center
525 East 68th Street New York, NY I 0065
08/22/2013
NY
PO 00000
Frm 00104
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Addendum XIII: Lung Volume Reduction Surgery (LVRS)
(April through June 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 (LVRS):
• National Emphysema Treatment Trial (NETT) approved (Beginning
05/07/2007, these will no longer automatically qualifY and can qualify only
with the other programs);
• Credentialed by the Joint Commission (formerly, the Joint
Commision on Accreditation ofHealthcare Organizations (JCAHO)) under
their Disease Specific Certification Program for L VRS; and
• Medicare approved for lung transplants.
Only the first two types are in the list. There were no updates to
the listing of facilities for lung volume reduction surgery published in the
April through June 2014 quarter. This information is available at
For
questions or additional infonnation, contact Marie Casey, BSN, MPH
(410-786-7861).
25JYN1
Addendum XIV: Medicare-Approved Bariatric Surgery Facilities
(April through June 2014)
Addendum XIV includes a listing of Medicare-approved facilities
that meet minimum standards for facilities modeled in part on professional
society statements on competency. All facilities must meet our standards in
order to receive coverage for bariatric surgery procedures. On February 21,
2006, we issued our decision memorandum on bariatric surgery procedures.
We determined that bariatric surgical procedures are reasonable and
necessary for Medicare beneficiaries who have a body-mass index (BMI)
greater than or equal to 35, have at least one co-morbidity related to obesity
and have been previously unsuccessful with medical treatment for obesity.
This decision also stipulated that covered bariatric surgery procedures are
reasonable and necessary only when performed at facilities that are: (1)
certified by the American College of Surgeons (ACS) as a Level 1 Bariatric
Surgery Center (program standards and requirements in effect on February
15, 2006); or (2) certified by the American Society for Bariatric Surgery
(ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program
standards and requirements in effect on February 15, 2006).
There were no additions, deletions, or editorial changes to
Medicare-approved facilities that meet CMS 's minimum facility standards
for bariatric surgery that have been certified by ACS and/or ASMBS in the
April through June 2014 period. This information is available at
For
questions or additional information, contact Jamie Hermansen
( 41 0-786-2064).
Addendum XV: FDG-PET for Dementia and Neurodegenerative
Diseases Clinical Trials (April through June 2014)
There were no FDG-PET for Dementia and Neurodegenerative
Diseases Clinical Trials published in the April through June 2014 quarter.
This information is available on our website at
For questions or additional information, contact Stua1t Caplan, RN, MAS
( 41 0-786-8564).
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
Jkt 232001
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18:34 Jul 24, 2014
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43491
EN25JY14.015
Agencies
[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Notices]
[Pages 43475-43491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17488]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9086-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--April Through June 2014
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This quarterly notice lists CMS manual instructions,
substantive and interpretive regulations, and other Federal Register
notices that were published from April through June 2014, relating to
the Medicare and Medicaid programs and other programs administered by
CMS.
FOR FURTHER INFORMATION CONTACT: It is possible that an interested
party may need specific information and not be able to determine from
the listed information whether the issuance or regulation would fulfill
that need. Consequently, we are providing contact persons to answer
general questions concerning each of the addenda published in this
notice.
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[GRAPHIC] [TIFF OMITTED] TN25JY14.000
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
[[Page 43476]]
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 https://www.cms.gov/manuals.
Dated: July 18, 2014.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
[[Page 43477]]
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[GRAPHIC] [TIFF OMITTED] TN25JY14.002
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[GRAPHIC] [TIFF OMITTED] TN25JY14.004
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[GRAPHIC] [TIFF OMITTED] TN25JY14.005
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[GRAPHIC] [TIFF OMITTED] TN25JY14.006
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[GRAPHIC] [TIFF OMITTED] TN25JY14.007
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[GRAPHIC] [TIFF OMITTED] TN25JY14.008
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[GRAPHIC] [TIFF OMITTED] TN25JY14.009
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[GRAPHIC] [TIFF OMITTED] TN25JY14.010
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[GRAPHIC] [TIFF OMITTED] TN25JY14.011
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[GRAPHIC] [TIFF OMITTED] TN25JY14.012
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[GRAPHIC] [TIFF OMITTED] TN25JY14.013
[[Page 43490]]
[GRAPHIC] [TIFF OMITTED] TN25JY14.014
[[Page 43491]]
[GRAPHIC] [TIFF OMITTED] TN25JY14.015
[FR Doc. 2014-17488 Filed 7-24-14; 8:45 am]
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