Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40043 

Dated: August 8, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–17318 Filed 8–10–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9110–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—April through June 2018 

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 

2018, 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. 

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 website 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 website 

list provides more timely access for 

beneficiaries, providers, and suppliers. 

We also believe the website 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 

websites have listservs; that is, the 

public can subscribe and receive 

immediate notification of any updates to 

the website. These listservs avoid the 

need to check the website, as 

notification of updates is automatic and 

sent to the subscriber as they occur. If 

assessing a website 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: August 3, 2018. 

Olen D. Clybourn, 

Deputy Director, Office of Strategic 

Operations and Regulatory Affairs. 

BILLING CODE 4120–01–P 


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EN13AU18.021</GPH>sradovich on DSK3GMQ082PROD with NOTICES

Publication Dates for the Previous Four Quarterly Notices 

We publish this notice at the end of each quarter reflecting 

information released by CMS during the previous quarter. The publication 

dates of the previous four Quarterly Listing of Program Issuances notices 

are: August 4, 2017 (82 FR 36404), October 27, 2017 (82 FR 49819), 

January 26, 2018 (83 FR 3716) and May 4, 2018 (83 FR 19769). We are 

providing only the specific updates that have occurred in the 3-month 

period along with a hypcrlink to the website to access this information and a 

contact person for questions or additional information. 

Addendum 1: Medicare and Medicaid Manual Instructions 

(April through June 2018) 

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 transfmmed 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 tlris rule and are still active paper-based 

manuals. The remaining paper-based manuals are for reference purposes 

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

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

Those wishing to subscribe to old versions of CMS manuals should 

contact the National Technical Information Service, Department of 

Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone 

(703-605-6050). You can download copies of the listed material free of 

charge at: http://cms.gov/manuals. 

How to Review Transnrittals or Program Memoranda 

Those wishing to review transmittals and program memoranda can 

access this information at a local Federal Depository Library (FDL). Under 

the FDL program, government publications are sent to approximately 1,400 

designated libraries throughout the United States. Some FDLs may have 

arrangements to transfer material to a local libr

FDL. Contact any library to locate the nearest 

available at http://www.gpo.gov/libraries/ 

In addition, individuals may contact re

that receive and retain at least one copy of mos

publications, either in printed or nricrofilm formpublic. These libraries provide reference servic

however, they arc not sales outlets. Individuals 

about the location of the nearest regional depos

library. CMS publication and transnrittal numb

entitled Medicare and Medicaid Manual Instruc

the materials, use the CMS publication and tran

example, to find the manual for Bundled Payme

Advanced (BPCI Advanced Skilled Nursing Fa

(CMS-Pub. 100-01) Transnrittal No. 115. 

Addendum I lists a mrique CMS trans

instruction in our manuals or program memoran

A transnrittal may consist of a single or multipl

necessary to use information in a transnrittal 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 www.cms.gov/Manuals. 

Transmittal Manual/Subject/Publ

Issued to a specific audience, not posted to 

Confidentialit of Instruction 

4016 Supervised Exercise Therapy (SET) for S

Disease (PAD) 

EN13AU18.022</GPH>sradovich on DSK3GMQ082PROD with NOTICES

--Table ofContents/390-Supervised Exercise Therapy (SET) for Treatment of Confidentiality of Instruction 

Symptomatic Peripheral Artery Disease (PAD) 4034 Issued to a specific audience, not posted t

--General Billing Requirements Confidentiality of Instruction 

--Coding Requirements for SET 4015 Enhancements to Processing of Hospice R

--Special Billing Requirements for Professional Claims Payer Only Codes Utilized by Medicare 

--Special Billing Requirements for Institutional Claims Data Required on the Institutional Claim 

--Common Working File (CWF) Requirements Input/Output Record Layout 

--Applicable Medicare Summary Notice (MSN), Remittance Advice 4036 Quarterly Update for the Durable Medica

--Remark Codes (RARC) and Claim Adjustment Reason Code (CARC) and Supplies (DMEPOS) Competitive Bi

Messaging 4037 Removal of KH Modifier from Capped R

4017 Increased Ambulance Payment Reduction for Non-Emergency Basic Life Rented or Purchased 

Support (BLS) Transports to and from Renal Dialysis Facilities 

Payment for Non-Emergency BLS Trips to/from ESRD Facilities 

4018 New Waived Tests 4019 Issued to a specific audience, not posted to Intemet/Intranet due to a 

Confidentiality of Instruction 

4038 Notification of Change in Instructions for 

4039 New Physician Specialty Code for Medic4040 Revision to the Skilled Nursing Facility (

Based Purchasing (VBP) 

--Billing SNF PPS Services 

4020 Issued to a specific audience, not posted to Intemet/Intranet due to a --Input/Output Record Layout 

Confidentiality of Instruction --Billing in Benefits Exhaust and No-Pay

4021 Ambulance Transportation for a Skilled Nursing Facility (SNF) Resident in a 4041 Issued to a specific audience, not posted t

Stay Not Covered by Part A- Medicare Benefit Policy Manual, Confidentiality of Instruction 

--Chapter I 0 and Medicare Claims Processing Manual, Chapter 15 4042 Issued to a specific audience, not posted t

4022 Quarterly Update to the National Correct Coding Initiative (NCCI) Confidentiality of Instruction 

Procedure-to-Procedure (PTP) Edits, Version 24.2 Effective July I, 2018 4043 Issued to a specific audience, not posted t

4023 Update ofTntemet Only Manual (TOM), Medicare Claims Processing Manual, Confidentiality of Instruction 

Publication 100-04, Chapter 37- Department of Veterans Affairs (VA) 

Claims Adjudication Services Project 

4044 Issued to a specific audience, not posted t

Confidentiality of Instruction 

4024 File Conversions Related to the Spanish Translation of the Healthcare 

Common Procedure Coding Svstem (HCPCS) Descriptions 

4045 Quarterly Update for Clinical Laboratory 

Services Subject to Reasonable Charge P

4025 Quarterly Healthcare Common Procedure Coding System (HCPCS) 

Drug/Biological Code Changes- July 2018 Update 

4046 Inpatient Prospective Payment System (IP

(LTCH) PPS Extensions per the Advanci

4026 Revisions to the Telehealth Billing Requirements for Distant Site Services Social Services (ACCESS) Act Included 

4027 Inexpensive or Routinely Purchased Durable Medical Equipment (D.Y!E) 4047 Updates to Publication 100-04, Chapters 

--Payment Classification for Speech Generating Devices (SGD) and Advice Remark Code (RARC) MA61 wit

Accessories 4048 Quarterly Healthcare Common Procedure 

--Inexpensive or Other Routinely Purchased DME 

--Billing for Inexpensive or Other Routinely Purchased DME 

--Inexpensive or Other Routinely Purchased DME 

--Billing for Inexpensive or Other Routinely Purchased DME 

4028 Issued to a specific audience, not posted to Internet/Intranet due to a 

Confidentiality of Instruction 

4029 Issued to a specific audience, not posted to Intemet/Intranet due to a 

Drug/Rio logical Code Changes- July 201 

4049 Supervised Exercise Therapy (SET) for S

Disease (PAD) General Dilling Requirem

--Coding Requirements for SET 

--Special Billing Requirements for Institu

--Common Working File (CWF) Requirem

Summary Notice (MSN), Remittance Adv

Confidentiality of Instruction (RARC) and Claim Adjustment Reason C

4010 Issued to a specific audience, not posted to Tntemet/Tntranet due to a 4050 Issued to a specific audience, not posted t

Confidentiality of Instruction Confidentiality of Instruction 

4031 Issued to a specific audience, not posted to Internet/Intranet due to a 4051 Issued to a specific audience, not posted t

Confidentiality of Instruction Confidentiality of Instruction 

4032 Issued to a specific audience, not posted to Intemet/Intranet due to a 4052 Removal ofKH Modifier from Capped R

Confidentiality of Instruction 4053 Quarterly Update to the Medicare Physici

4013 Issued to a specific audience, not posted to Tntemet/Tntranet due to a (MPFSDB)- July 2018 Update 

EN13AU18.023</GPH>sradovich on DSK3GMQ082PROD with NOTICES

4054 Implement Operating Rules- Phase III Electronic Remittance Advice (ERA) 

Electronic Funds Transfer (EFT): Committee on Operating Rules for 

Information Exchange (CORE) 360 Uniform Use of Claim Adjustment 

Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and 

Claim Adjustment Group Code (CAGC) Rule - Update from Council for 

Affordable Quality Healthcare (CAQH) CORE 

4055 Atumal Updates to the Prior Authorization/Pre-Claim Review federal 

Holiday Schedule Tables for Generating Reports 

4056 Instructions for Downloading the Medicare ZIP Code File for October Files 

4057 Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code 

(CARC), Medicare Remit Easv Print (MREP) and PC Print Update 

4058 Common Edits and Enhancements Modules (CEM) Code Set Update 

4059 Issued to a specific audience, not posted to Intemel/Intrantl due to a 

Sensitivity 

4060 Issued to a specific audience, not posted to Intemet/Intranet due to a 

Sensitivity 

4061 July 2018 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing 

Files and Revisions to Prior Quarterly Pricing Files 

4062 Diagnosis Code Cpdate for Add-on Payments for Blood Clotting Factor 

Administered to Hemophilia Inpatients 

--Payment for Blood Clotting Factor Administered to Hemophilia Inpatients 

4063 New Q Code for In-Line Cartridge Containing Digestive Enzyme(s) 

4064 July 2018 Update of the Hospital Outpatient Prmpective Payment System 

COPPS) 

4065 July 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version 

19.2 

4066 Claim Status Category and Claim Status Codes Update 4067 July 2018 Update of the Ambulatory Surgical Center (ASC) Payment System 

4068 ElM Service Documentation Provided by Students (Manual Update) 

4069 Alignment of Coordination of Benefits Agreement (COBA) Internet Only 

Manual References 

--Assignment of Claims and Transfer Policy 

--MSN Messages --Returned Medigap Notices --Coordination of Medicare With Medigap and Other Complementary Health 

Insurance Policies 

--Standard Medicare Charges for COB Records 

--Consolidation of the Claims Crossover Process 

--Coordination of Benefits Agreement (COBA) Full Claim File Repair 

Process 

--Coordination of Benefits Agreement (COBA) Eligibility File Claims 

Recovery Process 

--Coordination of Benefits Agreement (COBA) Medigap Claim-Based 

Crossover Process --Electronic Transmission- General Requirements 

4070 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics 

and Supplies (UMEPOS) Competitive Bidding Program (CBP)- October 

2018 

4071 Update oflntemet Only Manual (!OM), Medicare Claims Processing Manual, 

4072 

Publication I 00-04, Chapter 18- Preventiv

Chapter 35 -Independent Diagnostic Test

July Quarterly Update for 2018 Durable M

Orthotics and Supplies (DMEPOS) Fee S

4073 I Quarterly Update to the End-Stage Renal 

Payment System (PPS) 

4074 I July 2018 Integrated Outpatient Code Edi

4075 I July 2018 Update of the Hospital Outpati

117 118 119 120 

121 

303 304 

None Remote Identity Proofing (RIDP) a

(Ml' A) for Electronic Correspondence Re

Individuals Not Subject to the Limitation 

(MSP) 

Implement the International Classification 

10) 201S General Equivalence Mappings 

Working File (CWF) for Purposes of Pro

(NGHP) Medicare Secondary Payer (MSP

Electronic Correspondence Referral Syste

Beneficiary Identifier (MBI) Modification

Identity Management (EIDM) Multi-Fact

Identity Proofing (RIDP) Screen Shots 

Update the International Classification of 

2019 Tables in the Common Working Fil

Non- Group Ilealth Plan (NGIIP) Medica

and Claims 

Notice of 'lew Interest Rate for Medicare 

3rd Qtr Notification for FY 2018 

New Physician Specialty Code for Medic

Part D(1)- Claims Processing Timeline

Part E - Interest Payment Data 

Classification of Claims for Counting 

Physician/Limited License Physician Sp

Exhibit 

178 I Revisions to State Operations Manual (SO

Protocol for Intermediate Care Facilities f

Disabilities 

786 I Reimbursing Providers and Health Inform

787 788 789 

Additional Documentation 

Issued to a specific audience, not posted t

Confidentiality of Instruction 

Issued to a specific audience, not posted t

Confidentiality of Instruction 

Issued to a specific audience, not posted t

Confidentiality of Instruction 

EN13AU18.024</GPH>sradovich on DSK3GMQ082PROD with NOTICES

790 Issued to a specific audience, not posted to Internet/Intranet due to Wireless Access Monitoring 

Coni!dentiality of Instruction Malicious Software 

791 Restoring Section 3.2.3 B. and Section 3.2.3 C. to Chapter 3 of Publication White listing 

(Pub.) 100-08 in the Internet Only Manual (IOM Requesting Additional Data Encryption 

Documentation During Prepayment and Postpayment Review Security Level by Information Type 

792 Issued to a specific audience, not posted to Intcrnct/Intranct due to Minimum System Security Requirement

Confidentiality of Instruction Internet Security 

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

Confidentiality of Instruction Safeguards against Employee Fraud 

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

Confidentiality of Instmction 

Attachment 1/MAC ARS 

.("i\ . . {,7.<'•2 

795 Issued to a specific audience, not posted to Internet/Intranet due to 193 Issued to a specific audience, not posted t

Confidentiality of Instmction of Instmction 

796 Intent to Reopen 194 Medicare Diabetes Prevention Program (M

797 Reviewing for Adverse Legal Actions (ALA) 

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

Confidentiality of Instmction 

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

Confidentiality oflnstruclion 

Beneficiary Database (MBD) File Data fo

and Accountability Act (HIP AA) Eligibil

195 Update to CR9341 Oncology Care Model 

Management Code List 

196 Comprehensive ESRD Care (CEC) Mode

800 Comprehensive Error Rate Testing (CERT) Update to Chapter 12 of , .• 

Publication (Pub.)l00-08 2050 Modifications to the Implementation of th

Electronic Submission of Medical Docum

None 2051 Claims Processing Actions to Implement 

?i;<+o"z'•" Rudget Act of 20 1 S 

None 2052 Issued to a specific audience, not posted t

None 

Sensitivity 

2053 Issued to a specific audience, not posted t

l''"i••'i'S 

None 

Sensitivity 

2054 Change in Type of Service (TOS) for Cur

l.$;>i.•;•;.'£;<i _;;7,;: .. z;;v 

None 

Code 77067 

2055 Update to the Hospital Transfer Policy fo

14 !OM 100-17 Updates 

Additional Requirements for MACs 

Principal Systems Security Officer (SSO) 

Control Components Reporting Requirements 

Risk Assessment (RAJ Certification 

Annual FISMA Assessment (FA) 

Plan of Action and Milestones 

2056 User CR: Develop Enhanced Claims Sear

Shared System (FISS)- Phase 1 

2057 Common Working File (CWF) to Increas

99 for Preventative Services 

2058 Issued to a specific audience, not posted t

Sensitivity 

2059 Issued to a specific audience, not posted t

Sensitivity 

Timing Requirements for Compliance Conditions 

Security Incident Reporting and Response 

Patch Management 

Security Configuration Management 

2060 Issued to a specific audience, not posted t

Sensitivity 

2061 Issued to a specific audience, not posted t

Sensitivity 

Security Technical Implementation Guides (STIG) 2062 Updates to Peritoneal Dialysis Claims Pro

National Institute of Standards and Technology (NIST) Reimbursement Report (PSR) and Payme

End of Life Technology Components Beneficiaries with Acute Kidney Injury (A

Cloud Computing 2063 Processing Instructions to Update the Ide

MAC ARS Control Tailoring Used in the NM108 Data Element at the 2

Data Loss Prevention Segment in the 835 Guide 

EN13AU18.025</GPH>sradovich on DSK3GMQ082PROD with NOTICES

2064 Part B Detail Line Expansion- Fiscal Intermediary Shared System (FISS) 

2065 Part B Detail Line Expansion- Multi-Carrier System (MCS) Phase 9 

2066 Enhancement for Undeliverable Pay Medicare Summarv Notices (MSNs) for 

Multi-Carrier System (MCS) Users 

2067 Shared System Enhancement 2014: Implementation of Fiscal Intermediary 

Shared System (I'ISS) Obsolete On-Request Jobs- Phase 2 

2068 Common Working File (CWF) Split Medicare Part A Claims to Carry 50 

Lines per Segment Rather than I 00 Lines per Segment 

2069 Shared System Enhancement 2014: Implementation of Fiscal Intermediary 

Shared System (FISS) Obsolete On-Request Jobs- Phase 3 

2070 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration 

Projects within the Fiscal Intermediary Shared System -

(Removing/ Archiving Demonstration Codes 51 and 56) 

2071 Phase 4- Updating the Fiscal Intermediary Shared System (FISS) to Make 

Payment for Drugs and Biologicals Services for Outpatient Prospective 

Payment System (OPPS) Providers 

2072 Implementation of Business Requirements to Increase Claim Counter 

Maximum and Create Auto-Deletion Utility 

2073 Use the V\1AP/4D States Table in all VMS Address Processing 

2074 Modifying FISS Part B Claims Overlap Edits 

2075 Medicare Cost Report E-Filing (MCReF) 

2076 International Code of Diseases_ Tenth Revision (ICD-10) and Other Coding 

Revisions to National Coverage Determinations (NCDs) 

2077 Clean-up of Fiscal Intermediary Shared System (FISS) Reason Codes and 

Quarter! y Reports 

2on Issued to a specitlc audience, not posted to Internet/ Intranet due to a 

Sensitivity 

2079 Identifying and Eliminating Discrepancies between the Provider Enrollment, 

Chain and Ownership System (PECOS) and the Fiscal Intermediary Shared 

System (FISS) 

2080 Fee-For-Service (FFS) Shared System Maintainers (SSMs) Standardized 

Release Identification (!D) Format 

2081 Transition Letter Writing from Client Letter Software to the Durable Medical 

Equipment (DME) Medicare Administrative Contractors (MACs) 

2082 Analysis for Mandatory Support of Review Contractors to Send Electronic 

Medical Documentation Requests (eMDR)to Participating Providers via the 

Electronic Submission of Medical Documentation (esMD) System 

2083 Implementation of Changes to the Pre-Payment Additional Documentation 

Request (AIJR) Letters for Medical Review 

2084 Analysis and Design for Fiscal Intermediary Shared System (FISS), \1ultiCarrier System (MCS), and Viable Information Processing System (VIPS) 

Medicare System (VMS) Prepayment Review Report 

2085 Implementation of Procedures for Undeliverable Medicare Summary Notices 

(uMSNs) and Summary MSNs for Previously Undeliverable MSNs for FISS 

and MCS (No-Pav onlv) 

2086 Combined Common Edits/Enhancements Module (CCEM) Cpdates for 

Apache POI (version 3.14.0) to Apache POI (version 3.17) and Analysis from 

.TAV A (version 6) to .TA VA (version 7) 

2087 Issued to a specific audience, not posted to Internet/ Intranet due to a 

Sensitivity 

2088 Issued to a specific audience, not posted t

Sensitivity 

2089 Standardization of Case File Transmittal 

Bankruptcy, Payment Hold, and Cancella

Medicare Administrative Contractors (MA

Contractor (RAC) 

2090 Use the V\1AP/4D States Table in all VM

2091 Identifying and Eliminating Discrepancie

Chain and Ownership System (PECOS) a

System (FISS) 

2092 Analysis for First Coast Service Options 

Asse1tion Markup Language 2.0 (SAML 

76 Issued to a specific audience, not posted t

Confidentiality of Instruction 

:.:"iJ<;: 

5 Issued to a specific audience, not posted t

Confidentiality of Instmction 

Addendum II: Regulation Doc

in the Federal Register (April th

Regulations and Notices 

Regulations and notices are published 

Register. To purchase individual copies or sub

Register, contact GPO at www.gpo.gov/fdsys. 

copies, it is necessary to cite either the date of p

number and page number. 

The Federal Register is available as a

GPO Access. The online database is updated b

Federal Register is published. The database i

graphics from Volume 59, Number l (January 

date and can be accessed at http://www.gpoacc

following website http://www.archives.gov/fed

information on how to access electronic edition

reference copies. 

This information is available on our w

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

2Ql8QPU.pdf 

For questions or additional informatio

( 410-786-4481 ). 

EN13AU18.026</GPH>sradovich on DSK3GMQ082PROD with NOTICES

Addendum III: CMS Rulings 

(April through June 2018) 

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 ""P·" "" "·'"""·&v" ,,._...,5 cum,vu"-

For questions or additional information, 

contact Tiffany Lafferty (410-786-7548). 

Addendum IV: Medicare National Coverage Determinations 

(April through June 2018) 

Addendum 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 of the 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 

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

we are providing only the specific updates that have occurred in the 3-

month period. There were no national coverage determinations (NCDs), or 

reconsiderations of completed NCDs published in the 3-month period. This 

information is available at: www.cms.gov/medicare-coverage-database/. 

For questions or additional information, contact Wanda Belle, MP A 

(410-786-7491). 

Addendum V: FDA-Approved Category B Investigational Device 

Exemptions (IDEs) (April through June 2018) 

Addendum V includes listings of the FDA -approved 

investigational device exemption (IDE) numbers that the FDA assigns. The 

listings are organized according to the categor

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

number. For the purposes of this quarterly no

updates to the Category BIDEs as of the endi

by this notice and a contact person for questio

For questions or additional information, conta

6877). 

Under the Food, Drug, and Cosmetic 

fall into one of three classes. To assist CMS u

process, the FDA assigns one of two categorie

investigational device exemption (IDE). Cate

IDEs, and Category B refers to non-experime

information about the classes or categories, pl

published in the April21, 1997 Federal Regi

IDE Device 

BB18107 Miltenyi CliniMACS System BB18136 Miltenyi CliniMACS TCRalpha/beta, CD1

System 

BB18220 Magnetic-Activated Cell Sorter (CliniMAC

CD45RA+ Depletion; Allogeneic Unrelate

Matched Related, G-CSF Mobiized Periphe

Cell Addback with TCRab+ and CD19 De

Chemotherapy 

Gl60220 Stellarex 0.014" OTW Drug-coated AngiopGl70030 MiStent Sirolimus Eluting Absorbable Poly

Stent System (MiStent II) in the CRYSTAL 

Gl70190 AXIOS Stent and Electrocautery Enhanced 

lOmmxlOmm; AXIOS Stent and Electroca

Delivery System 15mmxl0mm 

Gl70209 WVEDERM VOLUX XC Gl70274 AtriCure Synergy Ablation System 

Gl80001 iStent infinite Model iS3 

Gl80033 Edwards Transcatheter Atrial Shunt System Gl80045 CENTERA Transcatheter Heart Valve Sys

Gl80048 Boston Scientific Embozene Color-Advanc

for Embolization 

Gl80049 Exablate Model4000 Type-2 for Blood-Br

Disruption (BBBD) 

Gl80052 XIE'ICE Alpine Everolimus Eluting Coron

XIE'ICE Xpedition Everolimus Coronary S

Gl80053 t:slim X2 with Control-IQ Technology 

Gl80057 Effectiveness of spinal cord stimulation for 

of freezing of gait and locomotion in Parkin

Gl80058 SYNCHRONY Cochlear Implant 

EN13AU18.027</GPH>sradovich on DSK3GMQ082PROD with NOTICES

IDE Device Start Date 

Gl80059 VENT ANA PATHWAY HER-2/neu ( 4B5) Rabbit 04/20/2018 

Monoclonal Primary Antibody Assay 

G180063 Restylane Defyne 04/27/2018 

Gl80064 Juvederm Volite XC 04/27/2018 Gl80068 Guardant360 CDx Test 05/02/2018 Gl80070 Slit Stent II Lacrimal Stent 05/04/2018 

G180071 PN40082 (with lidocaine) for Lip Augmentation 05/04/2018 

Gl80073 DES BTK Dmg-Eluting Vascular Stent System 05/11/2018 Gl80074 Next-Generation Sequencing Minimal Residual Disease 05/16/2018 

Assay (NGS MRD Assay) 

G180085 Mag Venture MagPro R30 transcranial stimulator 06/13/2018 

Gl80090 Synergy Disc 06/06/2018 

Gl80091 Abbott Laboratories Infinity implantable deep brain 06/18/2018 

stimulation system 

Gl80092 Celcuity CELx HER2 Signaling Function Test 06/07/2018 Gl80093 NovoTTF-100\1 System 06/09/2018 Gl80094 NeVa VS 06/10/2018 Gl80096 SERF (Saline Enhanced Radio-Frequency) Ablation System 06/14/2018 

Gl80097 Medtronic Summit RC+S System 06/14/2018 

Gl80100 Easytech Reversed Shoulder System 06/14/2018 Gl80102 Accelerated rTMS as a treatment for post-stroke depression in 06/28/2018 

the subacute phase: an open label pilot study 

Gl80109 LUM Imaging System 06/29/2018 Gl80110 Boston Scientific Precision Spectra Spinal Cord Stimulator 06/01/2018 

and Cover Edge X32 Surgical Leads 

Gl80113 Pneumatic Vitreolysis on Vitreomacular Traction (Protocol 06/29/2018 

AG); Pneumatic Vitreolysis for Macular Hole (Protocol AH) 

Gl80115 HydroPearl Microspheres 06/29/2018 

Addendum VI: Approval Numbers for Collections of Information 

(April through June 2018) 

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 

www.reginfo.gov/public/do/PRAMain. For questions or additional 

information, contact William Parham ( 410-786-4669). 

Addendum VII: Medicare-Approved Carotid Stent Facilities, 

(April through June 2018) 

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 stcnting with embolic protectio

only if performed in facilities that have been d

performing the evaluation, procedure, and fol

optimal patient outcomes. We have created a 

facilities modeled in part on professional soci

All facilities must at least meet our standards 

for carotid artery stenting for high risk patient

quarterly notice, we are providing only the spoccurred in the 3-month period. This informa

http://www. ems. gov /MedicareApprovedFacil

For questions or additional information, conta

(410-786-2749). 

Facility 

Western Maryland Health System 

12500 Willowbrook Road 

Cumberland, MD 21 502 

Methodist Health Centers 

17201 Interstate 45 South 

The Woodlands, TX 77385 

Other Information: d/b/a Houston Methodist- The 

Woodlands Hospital 

Garden City Hospital 

6425 Inkster Road 

Garden City, MI 48136 

Provider 

Number 

1609831247 1184179194 1578550174 

Christ Hospital, CarePoint Health I 310016 

System 

176 Palisade Avenue 

Jersey City, NJ 07306 

Other Locations: Bayonne Medical 

Center 29th Street at A venue E 

Bayonne, NJ 07002 Hoboken 

University Medical Center 308 

Willow Avenue Hoboken, NJ 07030 

lf:;'i' 0 

Froedtert South Inc. I 520021 

6308 Eighth Avenue 

Kenosha, WI 53143-5082\1ichigan 

City, IN 46360 

Dba Kenosha Medical Center and St. 

Catherine's Medical Center 

EN13AU18.028</GPH>sradovich on DSK3GMQ082PROD with NOTICES

Facility Provider Effective Date State 

Number 

St. Catherine's Medical Center 

Address: 9555 S 76th St 

Pleasant Prairie, WI 53158 

Provider# 520021 

FROM: Community Health 360172 05/23/2005 OH Partners 

TO: Mercy Health- Regional 

Medical Center LLC 

3700 Kolbe Road 

Lorain, OH 44053-1697 

;

0;} \,, Si;' .. ·. i 

Mercy Hospital Ardmore, Inc 370047 09/06/2006 OK 

1011 4th Avenue NW 1386741635 

Ardmore, OK 734010klahoma City, 

OK 73120 

Addendum VIII: 

American College of Cardiology's National Cardiovascular Data 

Registry Sites (April through June 2018) 

The initial data collection requirement through the American 

College of Cardiology's National Cardiovascular Data Registry (ACCNCDR) has served to develop and improve the evidence base for the use of 

ICDs in certain Medicare beneficiaries. The data collection requirement 

ended with the posting of the final decision memo for Implantable 

Cardioverter Defibrillators on February 15, 2018. 

For questions or additional information, contact Sarah Fulton, 

MHS (410-786-2749). 

Addendum IX: Active CMS Coverage-Related Guidance Documents 

(April through June 2018) 

CMS issued a guidance document on November 20, 2014 titled 

"Guidance for the Public, Industry, and CMS Staff: Coverage with 

Evidence Development Document". Although CMS has several policy 

vehicles relating to evidence development activities including the 

investigational device exemption (IDE), the clinical trial policy, national 

coverage determinations and local coverage determinations, this guidance 

document is principally intended to help the public understand CMS' s 

implementation of coverage with evidence development (CED) through the 

national coverage determination process. The document is available at 

http://www. ems. gov /medicare-coverage-database/ details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional 

Active CMS Coverage-Related Guidance Doc

period. For questions or additional informatio

JoAnna Baldwin, MS ( 410-786-7205). 

Addendum X: 

List of Special One-Time Notices Rega

Provisions (April through 

There were no special one-time notic

coverage provisions published in the 3-month 

available at www.cms.hhs.gov/coverage. For 

information, contact JoAnna Baldwin, MS ( 41

Addendum XI: National Oncologic 

(April through June 

Addendum XI includes a listing of N

Emission Tomography Registry (NOPR) sites

tomography (PET) scans for particular oncolo

performed in a facility that participates in the 

In January 2005, we issued our decis

emission tomography (PET) scans, which sta

PET scans for particular oncologic indications

performed in the context of a clinical study. W

National Oncologic PET Registry as one of th

Therefore, in order for a beneficiary to receive 

scan, the beneficiary must receive the scan in 

the registry. There were no additions, deletion

listing of National Oncologic Positron Emissi

(NOPR) in the 3-month period. This informa

http/ /WW\v. ems. gov ll\tledicareApprovedF acilitie

For questions or additional infonnation, conta

(410-786-8564). 

Addendum XII: Medicare-Approved 

(Destination Therapy) Facilities (Ap

Addendum XII includes a listing of M

that receive coverage for ventricular assist dev

destination therapy. All facilities were requir

order to receive coverage for V ADs implanted 

October 1, 2003, we issued our decision mem

clinical indication of destination therapy. We 

EN13AU18.029</GPH>sradovich on DSK3GMQ082PROD with NOTICES

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 to the list of Medicare-approved facilities that meet our 

standards that have occurred in the 3-month period. This information is 

available at 

http://www. ems. gov /MedicareApprovedF acilitie/V AD/list.asp#TopOfPage. 

For questions or additional information, contact Linda Gousis, JD, 

(410-786-8616). 

Facility Provider Date of Date of State 

Number Initial Recertification 

Certification 

.. :•.:.·· :;s;: .·; . 

Novant Health Forsyth Medical 340014 04/20/2018 NC 

Center 3333 Silas Creek Parkway 

Winston Salem, NC 27103 

Other information: DNV GL 

Certified on 2018-04-20 

Northeast Georgia Medical 110029 04/26/2018 GA 

Center 743 Spring Street 

Gainesville, GA 30501 

Other Information: 

Joint Commission# 6711 

:•; l •• z' ,:,., ..... ; •. ;.,·;:,·,, ..•. :;: 

FROM: NYU Hospitals 330214 02114/2012 03/28/2018 NY 

Center 

TO: NYU Medical Center, Tisch Hospital 

550 1ST Avenue 

New York, NY 10016 

Joint Commission ID # 5820 

Previous Re-certification Dates: 2014-01-14; 2016-03-08 FROM: York Hospital 390046 11119/2013 01/24/2018 PA 

TO: WellSpan York Hospital 

1001 S. Georee St. 

Facility Pro">ider Date of 

Number Initial 

Certific

York, PA 17403 

Other Information: 

Joint Commission ID # 6228 

Previous Re-certification Dates: 2015-12-15 

University of California, Davis 050599 10/06/2

Medical Center (UCDMC) 

2315 Stockton Boulevard 

Sacramento, CA 95817 

Other Information: 

Joint Commission# 7030 

Newark Beth Israel Medical 310002 02/06/2

Center 

201 Lyons Avenue 

Newark, NJ 07112 

Joint Commission ID # 5965 

Previous Re-certification Dates: 2011-09-20; 2013-10-

01; 2015-12-15 

Moses H. Cone Memorial 340091 01/08/2

Hospital 

1200 North Elm Street 

Greensboro NC 27401-1020 

Joint Commission ID # 

6504Joint Commission ID # 

6504 

Previous Re-certification 

Dates: 2016-02-09 FROM: University Hospitals 360137 02/09/2

- Case Medical Center 

TO: University Hospitals 

Cleveland Medical Center 

11100 Euclid A venue 

Cleveland. OH 44106 

Joint Commission ID # 7017 

Previous Re-certification Dates: 2012-01-24; 2014-01-

30; 2016-02-23 

Providence St Vincent Medical 380004 12/06/2

Center 9205 Southwest Barnes Road 

Portland, OR 

EN13AU18.030</GPH>sradovich on DSK3GMQ082PROD with NOTICES

Facility Provider Date of Date of State Facility Pro">ider Date of 

Number Initial Recertification Number Initial 

Certification Certific

Joint Connnission ID # 9705 FROM: The University of 17-0040 03/08/2

Previous Re-certification Kansas Hospital Authority Dates: 2013-12-10; 2016-01-26 TO: University of Kansas 

Other Infonnation: Health System 

Joint Connnission # 7315 4000 Cambridge Street 

FROM: Bon Secours - St. 490059 1211112007 02/22/2018 VA Kansas City, KS 66160 Mary's Hospital 

TO: Bon Secours St. Mary's Joint Connnission ID # 8567 

Hospital The Christ Hospital 360163 02/17/2

5801 Bremo Road 2139 Auburn Avenue 

Richmond, VA 23226 Cincinnati, Oil 45219 

Joint Connnission ID # 6387 Joint Connnission ID # 6987 

Previous Re-certification Previous Re-certification 

Dates: 2013-12-17; 2016-01-26 Dates: 2014-02-20; 2016-04-05 

Jolms Hopkins Hospital 210009/1 1211112007 02/14/2018 MD UPMC Presb;terian 390164 06/10/2

600 N Wolfe Street 79070090 200 Lothrop Street 

Baltimore, MD 21287 4 Pittsburgh, PA 15213 

Joint Connnission ID #6252 Joint Connnission ID # 6169 

Previous Re-certification Previous Re-certification 

Dates: 2009-12-15; 2011-11- Dates: 2010-05-21; 2012-04-

29; 2013-12-03; 2016-01-12 12; 2014-03-25; 2016-04-13 

TO: University Cincinnati 360003 12113/2011 03/14/2018 OH Saint Cloud Hospital 240036 04/13/2

Medical Center 1406 Sixth Avenue North FROM: University of Saint Cloud, MN 56303 

Cincinnati Medical Center 

234 Goodman Street Joint Connnission ID # 8183 

Cincinnati, OH 45219 FROM: University of Utah 460009 01/13/2

Hospital 

Joint Connnission ID # 6988 TO: University of Utah 

Previous Re-certification Health Care - Hospitals and Dates: 2014-01-07; 2016-02-23 Clinics Mercy General Hospital 050017 02112/2014 03/14/2018 CA 50 N Medical Drive 

4001 J Street Salt Lake City, UT 84132 

Sacramento, CA 95819 

DNV GL Certificate#: 

Joint Connnission ID # 10053 264328-2018-V AD 

Previous Re-certification Previous Re-certification 

Dates: 2016-03-08 Dates: 2011-07-13; 2013-06-

18; 2015-06-23; 2017-08-08 
40054 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 

[FR Doc. 2018–17316 Filed 8–10–18; 8:45 am] 

BILLING CODE 4120–01–P 


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