83_FR_40199 83 FR 40043 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April through June 2018

83 FR 40043 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April through June 2018

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 156 (August 13, 2018)

Page Range40043-40054
FR Document2018-17316

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.

Federal Register, Volume 83 Issue 156 (Monday, August 13, 2018)
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40043-40054]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17316]


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

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.
[GRAPHIC] [TIFF OMITTED] TN13AU18.020

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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[FR Doc. 2018-17316 Filed 8-10-18; 8:45 am]
 BILLING CODE 4120-01-P



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

                                                   Dated: August 8, 2018.                               DEPARTMENT OF HEALTH AND                              and interpretive regulations, and other
                                                William N. Parham, III,                                 HUMAN SERVICES                                        Federal Register notices that were
                                                Director, Paperwork Reduction Staff, Office                                                                   published from April through June
                                                of Strategic Operations and Regulatory                  Centers for Medicare & Medicaid                       2018, relating to the Medicare and
                                                Affairs.                                                Services                                              Medicaid programs and other programs
                                                [FR Doc. 2018–17318 Filed 8–10–18; 8:45 am]             [CMS–9110–N]                                          administered by CMS.
                                                BILLING CODE 4120–01–P                                                                                        FOR FURTHER INFORMATION CONTACT: It is
                                                                                                        Medicare and Medicaid Programs;                       possible that an interested party may
                                                                                                        Quarterly Listing of Program                          need specific information and not be
                                                                                                        Issuances—April through June 2018                     able to determine from the listed
                                                                                                        AGENCY: Centers for Medicare &                        information whether the issuance or
                                                                                                        Medicaid Services (CMS), HHS.                         regulation would fulfill that need.
                                                                                                        ACTION: Notice                                        Consequently, we are providing contact
                                                                                                                                                              persons to answer general questions
                                                                                                               This quarterly notice lists
                                                                                                        SUMMARY:                                              concerning each of the addenda
                                                                                                        CMS manual instructions, substantive                  published in this notice.




                                                I. Background                                           various manuals, memoranda, and                       accessibility. In addition, many of the
                                                                                                        statements necessary to administer and                websites have listservs; that is, the
                                                  The Centers for Medicare & Medicaid                   oversee the programs efficiently.                     public can subscribe and receive
                                                Services (CMS) is responsible for                         Section 1871(c) of the Act requires                 immediate notification of any updates to
                                                administering the Medicare and                          that we publish a list of all Medicare                the website. These listservs avoid the
                                                Medicaid programs and coordination                      manual instructions, interpretive rules,              need to check the website, as
                                                and oversight of private health                         statements of policy, and guidelines of               notification of updates is automatic and
                                                insurance. Administration and oversight                 general applicability not issued as                   sent to the subscriber as they occur. If
                                                of these programs involves the                          regulations at least every 3 months in                assessing a website proves to be
                                                following: (1) Furnishing information to                the Federal Register.                                 difficult, the contact person listed can
                                                Medicare and Medicaid beneficiaries,                                                                          provide information.
                                                health care providers, and the public;                  II. Format for the Quarterly Issuance
                                                and (2) maintaining effective                           Notices                                               III. How To Use the Notice
                                                communications with CMS regional                           This quarterly notice provides only                  This notice is organized into 15
                                                offices, state governments, state                       the specific updates that have occurred               addenda so that a reader may access the
                                                Medicaid agencies, state survey                         in the 3-month period along with a                    subjects published during the quarter
                                                agencies, various providers of health                   hyperlink to the full listing that is
                                                                                                                                                              covered by the notice to determine
                                                care, all Medicare contractors that                     available on the CMS website or the
                                                                                                                                                              whether any are of particular interest.
                                                process claims and pay bills, National                  appropriate data registries that are used
                                                                                                                                                              We expect this notice to be used in
                                                Association of Insurance Commissioners                  as our resources. This is the most
                                                                                                                                                              concert with previously published
                                                (NAIC), health insurers, and other                      current up-to-date information and will
                                                                                                                                                              notices. Those unfamiliar with a
                                                stakeholders. To implement the various                  be available earlier than we publish our
                                                                                                                                                              description of our Medicare manuals
                                                statutes on which the programs are                      quarterly notice. We believe the website
                                                                                                                                                              should view the manuals at http://
                                                based, we issue regulations under the                   list provides more timely access for
                                                                                                                                                              www.cms.gov/manuals.
                                                authority granted to the Secretary of the               beneficiaries, providers, and suppliers.
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                                                Department of Health and Human                          We also believe the website offers a                    Dated: August 3, 2018.
                                                Services under sections 1102, 1871,                     more convenient tool for the public to                Olen D. Clybourn,
                                                1902, and related provisions of the                     find the full list of qualified providers             Deputy Director, Office of Strategic
                                                Social Security Act (the Act) and Public                for these specific services and offers                Operations and Regulatory Affairs.
                                                Health Service Act. We also issue                       more flexibility and ‘‘real time’’                    BILLING CODE 4120–01–P
                                                                                                                                                                                                             EN13AU18.020</GPH>




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                                                                                                                                                                                                  40044
                                 Publication Dates for the Previous Four Quarterly Notices                arrangements to transfer material to a local library not designated as an
                                    We publish this notice at the end of each quarter reflecting          FDL. Contact any library to locate the nearest FDL. This information is
20:42 Aug 10, 2018




                          information released by CMS during the previous quarter. The publication        available at http://www.gpo.gov/libraries/
                          dates of the previous four Quarterly Listing of Program Issuances notices                 In addition, individuals may contact regional depository libraries
                          are: August 4, 2017 (82 FR 36404), October 27, 2017 (82 FR 49819),              that receive and retain at least one copy of most federal government
                          January 26, 2018 (83 FR 3716) and May 4, 2018 (83 FR 19769). We are             publications, either in printed or nricrofilm form, for use by the general




                                                                                                                                                                                                  Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                          providing only the specific updates that have occurred in the 3-month           public. These libraries provide reference services and interlibrary loans;
                          period along with a hypcrlink to the website to access this information and a   however, they arc not sales outlets. Individuals may obtain information
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                          contact person for questions or additional information.                         about the location of the nearest regional depository library from any
                                                                                                          library. CMS publication and transnrittal numbers arc shown in the listing
                                 Addendum 1: Medicare and Medicaid Manual Instructions                    entitled Medicare and Medicaid Manual Instructions. To help FDLs locate
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                                                   (April through June 2018)                              the materials, use the CMS publication and transnrittal numbers. For
                                    The CMS Manual System is used by CMS program components,              example, to find the manual for Bundled Payments for Care Improvement
                          partners, providers, contractors, Medicare Advantage organizations, and         Advanced (BPCI Advanced Skilled Nursing Facility (SNF) Waiver, use
                          State Survey Agencies to administer CMS programs. It offers day-to-day          (CMS-Pub. 100-01) Transnrittal No. 115.
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                          operating instructions, policies, and procedures based on statutes and                    Addendum I lists a mrique CMS transnrittalnumber for each
                          regulations, guidelines, models, and directives. In 2003, we transfmmed the     instruction in our manuals or program memoranda and its subject number.
                          CMS Program Manuals into a web user-friendly presentation and renamed           A transnrittal may consist of a single or multiple instruction(s). Often, it is
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                          it the CMS Online Manual System.                                                necessary to use information in a transnrittal in conjunction with
                                                                                                          information currently in the manual. For the purposes of this quarterly
                          How to Obtain Manuals                                                           notice, we list only the specific updates to the list of manual instructions
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                                    The Internet-only Manuals (IOMs) are a replica of the Agency's        that have occurred in the 3-month period. This information is available on
                          official record copy. Paper-based manuals are CMS manuals that were             our website at www.cms.gov/Manuals.
                          officially released in hardcopy. The majority of these manuals were
E:\FR\FM\13AUN1.SGM




                          transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub       Transmittal                      Manual/Subject/Publication Number
                          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
13AUN1




                          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                    Issued to a specific audience, not posted to Internet/Intranet due to a
                          the FDL program, government publications are sent to approximately 1,400                      Confidentialit of Instruction
                          designated libraries throughout the United States. Some FDLs may have           4016          Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery
                                                                                                                        Disease (PAD)




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                                           --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 to Intemet/Intranet due to a
20:42 Aug 10, 2018




                                           --General Billing Requirements                                                       Confidentiality of Instruction
                                           --Coding Requirements for SET                                                 4015   Enhancements to Processing of Hospice Routine Home Care Payments
                                           --Special Billing Requirements for Professional Claims                                Payer Only Codes Utilized by Medicare
                                           --Special Billing Requirements for Institutional Claims                              Data Required on the Institutional Claim to AlB MAC (HHH)
                                           --Common Working File (CWF) Requirements                                             Input/Output Record Layout




                                                                                                                                                                                                               Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                                           --Applicable Medicare Summary Notice (MSN), Remittance Advice                 4036   Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics
                                           --Remark Codes (RARC) and Claim Adjustment Reason Code (CARC)                        and Supplies (DMEPOS) Competitive Bidding Program (CBP)- July 2018
Jkt 244001




                                           Messaging                                                                     4037   Removal of KH Modifier from Capped Rental Claims Showing Whether
                             4017          Increased Ambulance Payment Reduction for Non-Emergency Basic Life                   Rented or Purchased
                                           Support (BLS) Transports to and from Renal Dialysis Facilities                4038   Notification of Change in Instructions for Handling IRF Active Provider List
                                            Payment for Non-Emergency BLS Trips to/from ESRD Facilities                  4039   New Physician Specialty Code for Medical Genetics and Genomics
                             4018          New Waived Tests
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                                                                                                                         4040   Revision to the Skilled Nursing Facility (SNF) Pricer to Support Value-
                             4019          Issued to a specific audience, not posted to Intemet/Intranet due to a               Based Purchasing (VBP)
                                           Confidentiality of Instruction                                                       --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
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                                                                                                                                --Billing in Benefits Exhaust and No-Payment Situations
                             4021          Ambulance Transportation for a Skilled Nursing Facility (SNF) Resident in a   4041   Issued to a specific audience, not posted to Intemet/Intrantl due to a
                                           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 to Intemet/Intranet due to a
                             4022          Quarterly Update to the National Correct Coding Initiative (NCCI)                    Confidentiality of Instruction
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                                           Procedure-to-Procedure (PTP) Edits, Version 24.2 Effective July I, 2018       4043   Issued to a specific audience, not posted to Internet/Intranet due to a
                             4023          Update ofTntemet Only Manual (TOM), Medicare Claims Processing Manual,               Confidentiality of Instruction
                                           Publication 100-04, Chapter 37- Department of Veterans Affairs (VA)           4044   Issued to a specific audience, not posted to Intemet/Intrantl due to a
                                           Claims Adjudication Services Project
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                                                                                                                                Confidentiality of Instruction
                             4024          File Conversions Related to the Spanish Translation of the Healthcare         4045   Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory
                                           Common Procedure Coding Svstem (HCPCS) Descriptions                                  Services Subject to Reasonable Charge Payment
                             4025          Quarterly Healthcare Common Procedure Coding System (HCPCS)                   4046   Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital
                                           Drug/Biological Code Changes- July 2018 Update
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                                                                                                                                (LTCH) PPS Extensions per the Advancing Chronic Care, E>.ienders, and
                             4026          Revisions to the Telehealth Billing Requirements for Distant Site Services           Social Services (ACCESS) Act Included in the Bipartisan Budget Act 2018
                             4027          Inexpensive or Routinely Purchased Durable Medical Equipment (D.Y!E)          4047   Updates to Publication 100-04, Chapters I and 27 to Replace Remittance
                                           --Payment Classification for Speech Generating Devices (SGD) and                     Advice Remark Code (RARC) MA61 with N382
                                           Accessories                                                                   4048   Quarterly Healthcare Common Procedure Coding System (HCPCS)
                                           --Inexpensive or Other Routinely Purchased DME                                       Drug/Rio logical Code Changes- July 201 S Update
                                           --Billing for Inexpensive or Other Routinely Purchased DME                    4049   Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery
                                           --Inexpensive or Other Routinely Purchased DME                                       Disease (PAD) General Dilling Requirements
                                           --Billing for Inexpensive or Other Routinely Purchased DME                           --Coding Requirements for SET
13AUN1




                             4028          Issued to a specific audience, not posted to Internet/Intranet due to a              --Special Billing Requirements for Institutional Claims
                                           Confidentiality of Instruction                                                       --Common Working File (CWF) Requirements Applicable Medicare
                             4029          Issued to a specific audience, not posted to Intemet/Intranet due to a               Summary Notice (MSN), Remittance Advice Remark                        Codes
                                           Confidentiality of Instruction                                                       (RARC) and Claim Adjustment Reason Code (CARC) Messaging
                             4010          Issued to a specific audience, not posted to Tntemet/Tntranet due to a        4050   Issued to a specific audience, not posted to Internet/Intranet due to a
                                           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 to Intemet/Intranet due to a
                                           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 Rental Claims Payment System (PPS)
                                           Confidentiality of Instruction                                                4053   Quarterly Update to the Medicare Physician Fee Schedule Database
                             4013          Issued to a specific audience, not posted to Tntemet/Tntranet due to a               (MPFSDB)- July 2018 Update




                                                                                                                                                                                                               40045
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                                                                                                                                                                                                               40046
                             4054          Implement Operating Rules- Phase III Electronic Remittance Advice (ERA)               Publication I 00-04, Chapter 18- Preventive and Screening Services, and
                                           Electronic Funds Transfer (EFT): Committee on Operating Rules for                     Chapter 35 -Independent Diagnostic Testing Facility (IUTF)
20:42 Aug 10, 2018




                                           Information Exchange (CORE) 360 Uniform Use of Claim Adjustment              4072     July Quarterly Update for 2018 Durable Medical Equipment, Prosthetics,
                                           Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and                        Orthotics and Supplies (DMEPOS) Fee Schedule
                                           Claim Adjustment Group Code (CAGC) Rule - Update from Council for            4073   I Quarterly Update to the End-Stage Renal Disease (ESRD) Prospective
                                           Affordable Quality Healthcare (CAQH) CORE                                             Payment System (PPS)
                             4055          Atumal Updates to the Prior Authorization/Pre-Claim Review federal           4074   I July 2018 Integrated Outpatient Code Editor (I/OCE) Specifications




                                                                                                                                                                                                               Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                                           Holiday Schedule Tables for Generating Reports                               4075   I July 2018 Update of the Hospital Outpatient Prospective Payment System
                             4056          Instructions for Downloading the Medicare ZIP Code File for October Files
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                             4057          Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code
                                           (CARC), Medicare Remit Easv Print (MREP) and PC Print Update                 117     None Remote Identity Proofing (RIDP) and Multi-Factor Authentication
                             4058          Common Edits and Enhancements Modules (CEM) Code Set Update                          (Ml' A) for Electronic Correspondence Referral System (ECRS) Web Users
                             4059          Issued to a specific audience, not posted to Intemel/Intrantl due to a       118     Individuals Not Subject to the Limitation on Medicare Secondary Payment
                                           Sensitivity
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                                                                                                                                (MSP)
                             4060          Issued to a specific audience, not posted to Intemet/Intranet due to a       119     Implement the International Classification of Diseases, Tenth Revision (ICD-
                                           Sensitivity                                                                          10) 201S General Equivalence Mappings (GEMs) Tables in the Common
                             4061          July 2018 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing           Working File (CWF) for Purposes of Processing Non-Group Health Plan
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                                           Files and Revisions to Prior Quarterly Pricing Files                                 (NGHP) Medicare Secondary Payer (MSP) Records and Claims
                             4062          Diagnosis Code Cpdate for Add-on Payments for Blood Clotting Factor          120     Electronic Correspondence Referral System (ECRS) User Guide Medicare
                                           Administered to Hemophilia Inpatients                                                Beneficiary Identifier (MBI) Modifications including Updated Enterprise
                                           --Payment for Blood Clotting Factor Administered to Hemophilia Inpatients            Identity Management (EIDM) Multi-Factor Authentication (MF A)/Remote
                             4063          New Q Code for In-Line Cartridge Containing Digestive Enzyme(s)                      Identity Proofing (RIDP) Screen Shots
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                             4064          July 2018 Update of the Hospital Outpatient Prmpective Payment System        121     Update the International Classification of Diseases, Tenth Revision (ICD-10)
                                           COPPS)                                                                               2019 Tables in the Common Working File (CWF) for Purposes of Processing
                             4065          July 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version           Non- Group Ilealth Plan (NGIIP) Medicare Secondary Payer (MSP) Records
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                                           19.2                                                                                 and Claims
                             4066          Claim Status Category and Claim Status Codes Update
                             4067          July 2018 Update of the Ambulatory Surgical Center (ASC) Payment System      303     Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments
                             4068          ElM Service Documentation Provided by Students (Manual Update)                       3rd Qtr Notification for FY 2018
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                             4069          Alignment of Coordination of Benefits Agreement (COBA) Internet Only         304     New Physician Specialty Code for Medical Genetics and Genomics
                                           Manual References                                                                     Part D(1)- Claims Processing Timeliness- All Claims
                                           --Assignment of Claims and Transfer Policy                                            Part E - Interest Payment Data
                                           --MSN Messages                                                                        Classification of Claims for Counting
                                           --Returned Medigap Notices                                                            Physician/Limited License Physician Specialty Codes
                                           --Coordination of Medicare With Medigap and Other Complementary Health                Exhibit
                                           Insurance Policies
                                           --Standard Medicare Charges for COB Records                                  178    I Revisions to State Operations Manual (SOM) Appendix J, Part I Survey
                                           --Consolidation of the Claims Crossover Process                                      Protocol for Intermediate Care Facilities for Individuals with Intellectual
13AUN1




                                           --Coordination of Benefits Agreement (COBA) Full Claim File Repair                   Disabilities
                                           Process
                                           --Coordination of Benefits Agreement (COBA) Eligibility File Claims
                                           Recovery Process                                                             786    I Reimbursing Providers and Health Information Handlers (HIHs) for
                                           --Coordination of Benefits Agreement (COBA) Medigap Claim-Based                      Additional Documentation
                                           Crossover Process                                                            787     Issued to a specific audience, not posted to Intemel/Intrantl due to
                                           --Electronic Transmission- General Requirements                                      Confidentiality of Instruction
                             4070          Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics   788     Issued to a specific audience, not posted to Intemet/Intranet due to
                                           and Supplies (UMEPOS) Competitive Bidding Program (CBP)- October                     Confidentiality of Instruction
                                           2018                                                                         789     Issued to a specific audience, not posted to Intemet/Intranet due to
                             4071          Update oflntemet Only Manual (!OM), Medicare Claims Processing Manual,               Confidentiality of Instruction




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                              790                            Issued to a specific audience, not posted to Internet/Intranet due to                                                                 Wireless Access Monitoring
                                                             Coni!dentiality of Instruction                                                                                                        Malicious Software
20:42 Aug 10, 2018




                              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 Requirements-HIGH
                                                             Confidentiality of Instruction                                                                                                        Internet Security




                                                                                                                                                                                                                                                                                                            Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                              793                            Issued to a specific audience, not posted to Internet/Intranet due to                                                                Introduction
                                                             Confidentiality of Instruction                                                                                                       Safeguards against Employee Fraud
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                              794                            Issued to a specific audience, not posted to Internet/Intranet due to                                                                 Attachment 1/MAC ARS
                                                             Confidentiality of Instmction                                                                            .("i\. . ;':'";:~<;~;'"'"'' {,7.<'•2                                                    • t.zz•~;\•"c;i;;;;" {ii ,~\ii~§
                              795                            Issued to a specific audience, not posted to Internet/Intranet due to                                     193                        Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
                                                             Confidentiality of Instmction                                                                                                        of Instmction
                                                                                                                                                                       194                         Medicare Diabetes Prevention Program (MDPP) Model Expansion Medicare
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                              796                            Intent to Reopen
                              797                            Reviewing for Adverse Legal Actions (ALA)                                                                                             Beneficiary Database (MBD) File Data for the Health Insurance Portability
                              798                            Issued to a specific audience, not posted to Internet/Intranet due to                                                                and Accountability Act (HIP AA) Eligibility Transaction System (HETS)
                                                             Confidentiality of Instmction                                                                             195                        Update to CR9341 Oncology Care Model (OCM) Restricted Care
                                                                                                                                                                                                   Management Code List
Frm 00067




                              799                            Issued to a specific audience, not posted to Internet/Intranet due to
                                                             Confidentiality oflnstruclion                                                                             196                        Comprehensive ESRD Care (CEC) Model Telehealth- Implementation
                              800                            Comprehensive Error Rate Testing (CERT) Update to Chapter 12 of                                          \j:~·~-~~          ,.• ~¥~i'r,,                                                         \!~\i;c\i;~izi.;i)'zit;>\:>~(i3&0:";'1A' ~;
                                                             Publication (Pub.)l00-08                                                                                  2050                Modifications to the Implementation of the Paperwork (PWK) Segment ofthe
                           lt<~z''                                                                                                                                                         Electronic Submission of Medical Documentation (esMD) System
Fmt 4703




                                                             None                                                                                                      2051                Claims Processing Actions to Implement Certain Provisions ofthe Bipartisan
                           t,z,z~;,~,-,:;z,._;,.,;                                                                                                  ?i;<+o"z'•"                            Rudget Act of 20 1S
                                                             None                                                                                                      2052                Issued to a specific audience, not posted to Internet/ Intranet due to a
                                                                                                                                                                                           Sensitivity
Sfmt 4725




                                                                                                                                                    .2 ~{'\~:(zl'
                                                             None                                                                                                      2053                Issued to a specific audience, not posted to Internet/ Intranet due to a
                                                                                                                                                                                           Sensitivity
                           l''"i••'i'S
                                                             None                                                                                                      2054                Change in Type of Service (TOS) for Current Procedural Terminology (CPT)
                                                                                                                                                                                           Code 77067
E:\FR\FM\13AUN1.SGM




                           l.$;>i.•;•;.'£;<i ~'•'•!:;~;~:~·st ~~:~)                                                  ;,~'Ki   _;;7,;: .. z;;v ~78i';_r·: i:cz~~Fl"'
                                                                                                                                                                       2055                Update to the Hospital Transfer Policy for Early Discharges to Hospice Care
                                                             None
                                                                                                                                                                       2056                User CR: Develop Enhanced Claims Search Repmting in Fiscal Intennediary
                           II5~:n~;1'i'~tr~~.;                                                                        ·:t-:t•ll:";l'~~ ;~;;z;,;Z~,'/i •;~
                                                                                                                                                                                           Shared System (FISS)- Phase 1
                              14                             !OM 100-17 Updates
                                                                                                                                                                       2057                Common Working File (CWF) to Increase Next Eligible Date Occurrences to
                                                             Additional Requirements for MACs
                                                                                                                                                                                           99 for Preventative Services
                                                             Principal Systems Security Officer (SSO)
                                                             Control Components Reporting Requirements                                                                 2058                Issued to a specific audience, not posted to Internet/ Intranet due to a
                                                                                                                                                                                           Sensitivity
                                                             Risk Assessment (RAJ Certification
                                                             Annual FISMA Assessment (FA)                                                                              2059                Issued to a specific audience, not posted to Internet/ Intranet due to a
13AUN1




                                                             Plan of Action and Milestones                                                                                                 Sensitivity
                                                             Timing Requirements for Compliance Conditions                                                             2060                Issued to a specific audience, not posted to Internet/ Intranet due to a
                                                             Security Incident Reporting and Response                                                                                      Sensitivity
                                                             Patch Management                                                                                          2061                Issued to a specific audience, not posted to Internet/ Intranet due to a
                                                             Security Configuration Management                                                                                             Sensitivity
                                                             Security Technical Implementation Guides (STIG)                                                           2062                Updates to Peritoneal Dialysis Claims Processing, Provider Statistical and
                                                             National Institute of Standards and Technology (NIST)                                                                         Reimbursement Report (PSR) and Payment for Ultrafiltration for
                                                             End of Life Technology Components                                                                                             Beneficiaries with Acute Kidney Injury (AKI)
                                                             Cloud Computing                                                                                           2063                Processing Instructions to Update the Identification Code Qualifier Being
                                                             MAC ARS Control Tailoring                                                                                                     Used in the NM108 Data Element at the 2100 Loop, NMl- Patient Name
                                                             Data Loss Prevention                                                                                                          Segment in the 835 Guide




                                                                                                                                                                                                                                                                                                            40047
EN13AU18.024</GPH>


sradovich on DSK3GMQ082PROD with NOTICES
VerDate Sep<11>2014




                                                                                                                                                                                                                                               40048
                             2064          Part B Detail Line Expansion- Fiscal Intermediary Shared System (FISS)                              Sensitivity
                             2065          Part B Detail Line Expansion- Multi-Carrier System (MCS) Phase 9                 2088               Issued to a specific audience, not posted to Internet/ Intranet due to a
20:42 Aug 10, 2018




                             2066          Enhancement for Undeliverable Pay Medicare Summarv Notices (MSNs) for                               Sensitivity
                                           Multi-Carrier System (MCS) Users                                                 2089               Standardization of Case File Transmittal and Provider Information Processes,
                             2067          Shared System Enhancement 2014: Implementation of Fiscal Intermediary                               Bankruptcy, Payment Hold, and Cancellation Reporting Between the
                                           Shared System (I'ISS) Obsolete On-Request Jobs- Phase 2                                             Medicare Administrative Contractors (MAC) and the Recovery Audit
                             2068          Common Working File (CWF) Split Medicare Part A Claims to Carry 50                                  Contractor (RAC)




                                                                                                                                                                                                                                               Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                                           Lines per Segment Rather than I 00 Lines per Segment                             2090               Use the V\1AP/4D States Table in all VMS Address Processing
                             2069          Shared System Enhancement 2014: Implementation of Fiscal Intermediary            2091               Identifying and Eliminating Discrepancies between the Provider Enrollment,
Jkt 244001




                                           Shared System (FISS) Obsolete On-Request Jobs- Phase 3                                              Chain and Ownership System (PECOS) and the Fiscal Intermediary Shared
                             2070          Shared System Enhancement 2015: Identify Inactive Medicare Demonstration                            System (FISS)
                                           Projects within the Fiscal Intermediary Shared System -                          2092               Analysis for First Coast Service Options (FCSO) and Novitas for the Security
                                           (Removing/Archiving Demonstration Codes 51 and 56)                                                  Asse1tion Markup Language 2.0 (SAML 2.0) Migration
                                                                                                                          ~,·,; iX~~:~;~:·•·
                                                                                                                                                                                                                       ··~·······'···;~;.~)*
PO 00000




                             2071          Phase 4- Updating the Fiscal Intermediary Shared System (FISS) to Make
                                           Payment for Drugs and Biologicals Services for Outpatient Prospective            76                 Issued to a specific audience, not posted to Internet/Intranet due to
                                           Payment System (OPPS) Providers                                                                     Confidentiality of Instruction
                             2072          Implementation of Business Requirements to Increase Claim Counter              :.:"iJ<;:                                                                                         {S/i.•;\\7'3
Frm 00068




                                           Maximum and Create Auto-Deletion Utility                                         5                  Issued to a specific audience, not posted to Intcrnct/Intranct due to
                             2073          Use the V\1AP/4D States Table in all VMS Address Processing                                         Confidentiality of Instmction
                             2074          Modifying FISS Part B Claims Overlap Edits
                             2075          Medicare Cost Report E-Filing (MCReF)
                                                                                                                                            Addendum II: Regulation Documents Published
                             2076          International Code of Diseases_ Tenth Revision (ICD-10) and Other Coding
Fmt 4703




                                           Revisions to National Coverage Determinations (NCDs)                                            in the Federal Register (April through June 2018)
                             2077          Clean-up of Fiscal Intermediary Shared System (FISS) Reason Codes and            Regulations and Notices
                                           Quarter! y Reports                                                                         Regulations and notices are published in the daily Federal
Sfmt 4725




                             2on           Issued to a specitlc audience, not posted to Internet/ Intranet due to a         Register. To purchase individual copies or subscribe to the Federal
                                           Sensitivity
                                                                                                                            Register, contact GPO at www.gpo.gov/fdsys. When ordering individual
                             2079          Identifying and Eliminating Discrepancies between the Provider Enrollment,
                                           Chain and Ownership System (PECOS) and the Fiscal Intermediary Shared            copies, it is necessary to cite either the date of publication or the volume
                                                                                                                            number and page number.
E:\FR\FM\13AUN1.SGM




                                           System (FISS)
                             2080          Fee-For-Service (FFS) Shared System Maintainers (SSMs) Standardized                        The Federal Register is available as an online database through
                                           Release Identification (!D) Format                                               GPO Access. The online database is updated by 6 a.m. each day the
                             2081          Transition Letter Writing from Client Letter Software to the Durable Medical
                                           Equipment (DME) Medicare Administrative Contractors (MACs)
                                                                                                                            Federal Register is published. The database includes both text and
                             2082          Analysis for Mandatory Support of Review Contractors to Send Electronic          graphics from Volume 59, Number l (January 2, 1994) through the present
                                           Medical Documentation Requests (eMDR)to Participating Providers via the          date and can be accessed at http://www.gpoaccess.gov/fr/index.html. The
                                           Electronic Submission of Medical Documentation (esMD) System                     following website http://www.archives.gov/federal-register/ provides
                             2083          Implementation of Changes to the Pre-Payment Additional Documentation
                                                                                                                            information on how to access electronic editions, printed editions, and
13AUN1




                                           Request (AIJR) Letters for Medical Review
                             2084          Analysis and Design for Fiscal Intermediary Shared System (FISS), \1ulti-        reference copies.
                                           Carrier System (MCS), and Viable Information Processing System (VIPS)                      This information is available on our website at:
                                           Medicare System (VMS) Prepayment Review Report                                   http://www.cms.gov/quarterlyproviderupdates/downloads/Regs-
                             2085          Implementation of Procedures for Undeliverable Medicare Summary Notices          2Ql8QPU.pdf
                                           (uMSNs) and Summary MSNs for Previously Undeliverable MSNs for FISS
                                           and MCS (No-Pav onlv)                                                                      For questions or additional information, contact Terri Plumb
                             2086          Combined Common Edits/Enhancements Module (CCEM) Cpdates for                     (410-786-4481 ).
                                           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




EN13AU18.025</GPH>


sradovich on DSK3GMQ082PROD with NOTICES
VerDate Sep<11>2014




                                                  Addendum III: CMS Rulings                                    listings are organized according to the categories to which the devices are
                                                    (April through June 2018)                                  assigned (that is, Category A or Category B), and identified by the IDE
20:42 Aug 10, 2018




                                     CMS Rulings are decisions of the Administrator that serve as              number. For the purposes of this quarterly notice, we list only the specific
                           precedent final opinions and orders and statements of policy and                    updates to the Category BIDEs as of the ending date of the period covered
                           interpretation. They provide clarification and interpretation of complex or         by this notice and a contact person for questions or additional information.
                           ambiguous provisions of the law or regulations relating to Medicare,                For questions or additional information, contact John Manlove (410-786-




                                                                                                                                                                                                      Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                           Medicaid, Utilization and Quality Control Peer Review, private health               6877).
                           insurance. and related matters.                                                               Under the Food, Drug, and Cosmetic Act (21 U.S. C. 360c) devices
Jkt 244001




                                     The rulings can be accessed at ""P·" " " "·'"""·&v" ,,._..., 5 cum,vu"-   fall into one of three classes. To assist CMS under this categorization
                                                              For questions or additional information,         process, the FDA assigns one of two categories to each FDA-approved
                           contact Tiffany Lafferty (410-786-7548).                                            investigational device exemption (IDE). Category A refers to experimental
PO 00000




                                                                                                               IDEs, and Category B refers to non-experimental IDEs. To obtain more
                                  Addendum IV: Medicare National Coverage Determinations                       information about the classes or categories, please refer to the notice
                                                     (April through June 2018)                                 published in the April21, 1997 Federal Register (62 FR 19328).
Frm 00069




                                     Addendum IV includes completed national coverage
                          determinations (NCDs), or reconsiderations of completed NCDs, from the               IDE        Device                                                        Start Date
                          quarter covered by this notice. Completed decisions are identified by the            BB18107    Miltenyi CliniMACS System                                     04/12/2018
                                                                                                               BB18136    Miltenyi CliniMACS TCRalpha/beta, CD19, CD45RA                05/01/2018
                          section of the NCD Manual (NCDM) in which the decision appears, the
Fmt 4703




                                                                                                                          System
                          title, the date the publication was issued, and the effective date of the            BB18220    Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) for      06/08/2018
                          decision. An NCD is a determination by the Secretary for whether or not a                       CD45RA+ Depletion; Allogeneic Unrelated and Partially
                          particular item or service is covered nationally under the Medicare Program                     Matched Related, G-CSF Mobiized Peripheral Blood Stem
Sfmt 4725




                                                                                                                          Cell Addback with TCRab+ and CD19 Depletion following
                          (title XVIII of the Act), but does not include a determination of the code, if                  Chemotherapy
                          any, that is assigned to a particular covered item or service, or payment            Gl60220    Stellarex 0.014" OTW Drug-coated Angioplasty Balloon          05/03/2018
                          determination for a particular covered item or service. The entries below            Gl70030    MiStent Sirolimus Eluting Absorbable Polymer Coronary         06/15/2018
E:\FR\FM\13AUN1.SGM




                          include information concerning completed decisions, as well as sections on                      Stent System (MiStent II) in the CRYSTAL Clinical Study
                          program and decision memoranda, which also announce decisions or, in                 Gl70190    AXIOS Stent and Electrocautery Enhanced Delivery System       04/10/2018
                                                                                                                           lOmmxlOmm; AXIOS Stent and Electrocautery Enhanced
                          some cases, explain why it was not appropriate to issue an NCD.                                 Delivery System 15mmxl0mm
                          Information on completed decisions as well as pending decisions has also             Gl70209    WVEDERM VOLUX XC                                              04/26/2018
                          been posted on the CMS website. For the purposes of this quarterly notice,           Gl70274    AtriCure Synergy Ablation System                              04/27//2018
                          we are providing only the specific updates that have occurred in the 3-              Gl80001    iStent infinite Model iS3                                     04/1112018
                          month period. There were no national coverage determinations (NCDs), or              Gl80033    Edwards Transcatheter Atrial Shunt System                     05/24/2018
13AUN1




                                                                                                               Gl80045    CENTERA Transcatheter Heart Valve System                      04/04/2018
                          reconsiderations of completed NCDs published in the 3-month period. This             Gl80048    Boston Scientific Embozene Color-Advanced Microspheres        04/05/2018
                          information is available at: www.cms.gov/medicare-coverage-database/.                           for Embolization
                          For questions or additional information, contact Wanda Belle, MP A                   Gl80049    Exablate Model4000 Type-2 for Blood-Brain Barrier             04/04/2018
                          (410-786-7491).                                                                                 Disruption (BBBD)
                                                                                                               Gl80052    XIE'ICE Alpine Everolimus Eluting Coronary Stent System,      04/13/2018
                                                                                                                          XIE'ICE Xpedition Everolimus Coronary Stent System
                              Addendum V: FDA-Approved Category B Investigational Device                       Gl80053    t:slim X2 with Control-IQ Technology                          04/13/2018
                                         Exemptions (IDEs) (April through June 2018)                           Gl80057    Effectiveness of spinal cord stimulation for the management   04/19/2018
                                    Addendum V includes listings of the FDA-approved                                      of freezing of gait and locomotion in Parkinson's disease
                           investigational device exemption (IDE) numbers that the FDA assigns. The            Gl80058    SYNCHRONY Cochlear Implant                                    04/13/2018




                                                                                                                                                                                                      40049
EN13AU18.026</GPH>


sradovich on DSK3GMQ082PROD with NOTICES
VerDate Sep<11>2014




                                                                                                                                                                                                          40050
                             IDE           Device                                                          Start Date   carotid artery stcnting with embolic protection is reasonable and necessary
                             Gl80059       VENT ANA PATHWAY HER-2/neu ( 4B5) Rabbit                        04/20/2018   only if performed in facilities that have been determined to be competent in
                                           Monoclonal Primary Antibody Assay
20:42 Aug 10, 2018




                             G180063       Restylane Defyne                                                04/27/2018
                                                                                                                        performing the evaluation, procedure, and follow-up necessary to ensure
                             Gl80064       Juvederm Volite XC                                              04/27/2018   optimal patient outcomes. We have created a list of minimum standards for
                             Gl80068       Guardant360 CDx Test                                            05/02/2018   facilities modeled in part on professional society statements on competency.
                             Gl80070       Slit Stent II Lacrimal Stent                                    05/04/2018   All facilities must at least meet our standards in order to receive coverage




                                                                                                                                                                                                          Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                             G180071       PN40082 (with lidocaine) for Lip Augmentation                   05/04/2018   for carotid artery stenting for high risk patients. For the purposes of this
                             Gl80073       DES BTK Dmg-Eluting Vascular Stent System                       05/11/2018
                                                                                                                        quarterly notice, we are providing only the specific updates that have
Jkt 244001




                             Gl80074       Next-Generation Sequencing Minimal Residual Disease             05/16/2018
                                           Assay (NGS MRD Assay)                                                        occurred in the 3-month period. This information is available at:
                             G180085       Mag Venture MagPro R30 transcranial stimulator                  06/13/2018   http://www. ems. gov/MedicareApprovedFacilitie/CASF/list. asp#TopO:lPage
                             Gl80090       Synergy Disc                                                    06/06/2018   For questions or additional information, contact Sarah Fulton, MHS
                             Gl80091       Abbott Laboratories Infinity implantable deep brain             06/18/2018
PO 00000




                                                                                                                        (410-786-2749).
                                           stimulation system
                             Gl80092       Celcuity CELx HER2 Signaling Function Test                      06/07/2018
                                                                                                                          Facility                                 Provider     Effective Date    State
                             Gl80093       NovoTTF-100\1 System                                            06/09/2018
                                                                                                                                                                   Number
Frm 00070




                             Gl80094       NeVa VS                                                         06/10/2018
                             Gl80096       SERF (Saline Enhanced Radio-Frequency) Ablation System          06/14/2018
                                                                                                                          Western Maryland Health System           1609831247   04/10/2018       I MD
                             Gl80097       Medtronic Summit RC+S System                                    06/14/2018
                                                                                                                          12500 Willowbrook Road
                             Gl80100       Easytech Reversed Shoulder System                               06/14/2018
                                                                                                                          Cumberland, MD 21 502
Fmt 4703




                             Gl80102       Accelerated rTMS as a treatment for post-stroke depression in   06/28/2018     Methodist Health Centers                 1184179194   04/23/2018        TX
                                           the subacute phase: an open label pilot study
                                                                                                                          17201 Interstate 45 South
                             Gl80109       LUM Imaging System                                              06/29/2018     The Woodlands, TX 77385
                             Gl80110       Boston Scientific Precision Spectra Spinal Cord Stimulator      06/01/2018
Sfmt 4725




                                           and CoverEdge X32 Surgical Leads                                               Other Information:
                             Gl80113       Pneumatic Vitreolysis on Vitreomacular Traction (Protocol       06/29/2018     d/b/a Houston Methodist- The
                                           AG); Pneumatic Vitreolysis for Macular Hole (Protocol AH)                      Woodlands Hospital
                             Gl80115       HydroPearl Microspheres                                         06/29/2018     Garden City Hospital                     1578550174   05/09/2018        MI
E:\FR\FM\13AUN1.SGM




                                                                                                                          6425 Inkster Road
                                Addendum VI: Approval Numbers for Collections of Information                              Garden City, MI 48136
                                                                                                                          Christ Hospital, CarePoint Health    I 310016         05/25/2018       I NJ
                                                      (April through June 2018)
                                                                                                                          System
                                      All approval numbers are available to the public at Reginfo.gov.                    176 Palisade Avenue
                             Under the review process, approved information collection requests are                       Jersey City, NJ 07306
                             assigned OMB control numbers. A single control number may apply to
                             several related information collections. This information is available at                    Other Locations: Bayonne Medical
13AUN1




                                                                                                                          Center 29th Street at Avenue E
                             www.reginfo.gov/public/do/PRAMain. For questions or additional                               Bayonne, NJ 07002 Hoboken
                             information, contact William Parham (410-786-4669).                                          University Medical Center 308
                                                                                                                          Willow Avenue Hoboken, NJ 07030
                                   Addendum VII: Medicare-Approved Carotid Stent Facilities,                            lf:;'i' 0
                                                        (April through June 2018)
                                                                                                                          Froedtert South Inc.                 I   520021       12/2112007       I IN
                                                                                                                          6308 Eighth Avenue
                                       Addendum VII includes listings of Medicare-approved carotid                        Kenosha, WI 53143-5082\1ichigan
                             stent facilities. All facilities listed meet CMS standards for performing                    City, IN 46360
                             carotid artery stenting for high risk patients. On March 17, 2005, we issued
                                                                                                                          Dba Kenosha Medical Center and St.
                             our decision memorandum on carotid artery stenting. We determined that                       Catherine's Medical Center




EN13AU18.027</GPH>


sradovich on DSK3GMQ082PROD with NOTICES
VerDate Sep<11>2014




                             Facility                                Provider     Effective Date          State               Active CMS Coverage-Related Guidance Documents for the 3-month
                                                                     Number                                                   period. For questions or additional information, contact
20:42 Aug 10, 2018




                             St. Catherine's Medical Center
                             Address: 9555 S 76th St                                                                          JoAnna Baldwin, MS (410-786-7205).
                              Pleasant Prairie, WI 53158
                             Provider# 520021                                                                                                               Addendum X:
                             FROM: Community Health                  360172       05/23/2005              OH                       List of Special One-Time Notices Regarding National Coverage




                                                                                                                                                                                                               Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                             Partners
                             TO: Mercy Health- Regional
                                                                                                                                                Provisions (April through June 2018)
                                                                                                                                        There were no special one-time notices regarding national
Jkt 244001




                             Medical Center LLC
                             3700 Kolbe Road                                                                                  coverage provisions published in the 3-month period. This information is
                             Lorain, OH 44053-1697                                                                            available at www.cms.hhs.gov/coverage. For questions or additional
                           H~ ;0;} :~~~ \,, Si;' ..·. ~~~(7~2.\:•·                                          i
                                                                                          ;.,;l\z'•,~~:• ;~}' ~~:~~~;.l~it;
                                                                                                                              information, contact JoAnna Baldwin, MS (410-786 7205).
                             Mercy Hospital Ardmore, Inc             370047       09/06/2006              OK
PO 00000




                             1011 4th Avenue NW                      1386741635
                             Ardmore, OK 734010klahoma City,                                                                          Addendum XI: National Oncologic PET Registry (NOPR)
                             OK 73120                                                                                                                  (April through June 2018)
Frm 00071




                                                                                                                                        Addendum XI includes a listing of National Oncologic Positron
                                                        Addendum VIII:                                                        Emission Tomography Registry (NOPR) sites. We cover positron emission
                              American College of Cardiology's National Cardiovascular Data                                   tomography (PET) scans for particular oncologic indications when they are
                                           Registry Sites (April through June 2018)                                           performed in a facility that participates in the NOPR.
Fmt 4703




                                   The initial data collection requirement through the American                                         In January 2005, we issued our decision memorandum on positron
                           College of Cardiology's National Cardiovascular Data Registry (ACC-                                emission tomography (PET) scans, which stated that CMS would cover
                           NCDR) has served to develop and improve the evidence base for the use of                           PET scans for particular oncologic indications, as long as they were
Sfmt 4725




                           ICDs in certain Medicare beneficiaries. The data collection requirement                            performed in the context of a clinical study. We have since recognized the
                           ended with the posting of the final decision memo for Implantable                                  National Oncologic PET Registry as one of these clinical studies.
                           Cardioverter Defibrillators on February 15, 2018.                                                  Therefore, in order for a beneficiary to receive a Medicare-covered PET
E:\FR\FM\13AUN1.SGM




                                   For questions or additional information, contact Sarah Fulton,                             scan, the beneficiary must receive the scan in a facility that participates in
                           MHS (410-786-2749).                                                                                the registry. There were no additions, deletions, or editorial changes to the
                                                                                                                              listing of National Oncologic Positron Emission Tomography Registry
                            Addendum IX: Active CMS Coverage-Related Guidance Documents                                       (NOPR) in the 3-month period. This information is available at
                                                   (April through June 2018)                                                  http//WW\v. ems. govll\tledicareApprovedF acilitie/NOPR/list. asp#T opOfPage.
                                   CMS issued a guidance document on November 20, 2014 titled                                 For questions or additional infonnation, contact Stuart Caplan, RN, MAS
                          "Guidance for the Public, Industry, and CMS Staff: Coverage with                                    (410-786-8564).
13AUN1




                          Evidence Development Document". Although CMS has several policy
                          vehicles relating to evidence development activities including the                                         Addendum XII: Medicare-Approved Ventricular Assist Device
                          investigational device exemption (IDE), the clinical trial policy, national                                 (Destination Therapy) Facilities (April through June 2018)
                          coverage determinations and local coverage determinations, this guidance                                      Addendum XII includes a listing of Medicare-approved facilities
                          document is principally intended to help the public understand CMS' s                               that receive coverage for ventricular assist devices (VADs) used as
                          implementation of coverage with evidence development (CED) through the                              destination therapy. All facilities were required to meet our standards in
                          national coverage determination process. The document is available at                               order to receive coverage for VADs implanted as destination therapy. On
                          http://www. ems. gov/medicare-coverage-database/details/medicare-                                   October 1, 2003, we issued our decision memorandum on VADs for the
                          coverage-document-details.aspx?MCDid=27. There are no additional                                    clinical indication of destination therapy. We determined that VADs used




                                                                                                                                                                                                               40051
EN13AU18.028</GPH>


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VerDate Sep<11>2014




                                                                                                                                                                                                                                       40052
                             as destination therapy are reasonable and necessary only if performed in                                          Facility                          Pro">ider   Date of         Date of           State
                             facilities that have been determined to have the experience and                                                                                     Number      Initial         Recertification
                                                                                                                                                                                             Certification
20:42 Aug 10, 2018




                             infrastructure to ensure optimal patient outcomes. We established facility                                        York, PA 17403
                             standards and an application process. All facilities were required to meet
                             our standards in order to receive coverage for V ADs implanted as                                                 Other Information:
                             destination therapy.                                                                                              Joint Commission ID # 6228




                                                                                                                                                                                                                                       Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                                                                                                                                               Previous Re-certification
                                        For the purposes of this quarterly notice, we are providing only the                                   Dates: 2015-12-15
                             specific updates to the list of Medicare-approved facilities that meet our                                        University of California, Davis   050599      10/06/2015      02/07/2018        CA
Jkt 244001




                             standards that have occurred in the 3-month period. This information is                                           Medical Center (UCDMC)
                             available at                                                                                                      2315 Stockton Boulevard
                                                                                                                                               Sacramento, CA 95817
                             http://www. ems. gov/MedicareApprovedF acilitie/VAD/list.asp#TopOfPage.
PO 00000




                             For questions or additional information, contact Linda Gousis, JD,                                                Other Information:
                             (410-786-8616).                                                                                                   Joint Commission# 7030
                                                                                                                                               Newark Beth Israel Medical        310002      02/06/2009      02/07/2018        NJ
                                                                                                                                               Center
Frm 00072




                              Facility                                    Provider   Date of         Date of                   State
                                                                          Number     Initial         Recertification                           201 Lyons Avenue
                                                                                     Certification                                             Newark, NJ 07112
                            ..:•.:.··          :;s;:    .·; .                                                    i0~i:''iS    ····~';:;
                                                                                                                                               Joint Commission ID # 5965
                             Novant Health Forsyth Medical                340014     04/20/2018                                NC
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                                                                                                                                               Previous Re-certification
                             Center
                                                                                                                                               Dates: 2011-09-20; 2013-10-
                             3333 Silas Creek Parkway
                                                                                                                                               01; 2015-12-15
                             Winston Salem, NC 27103
                                                                                                                                               Moses H. Cone Memorial            340091      01/08/2014      02/14/2018        NC
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                             Other information: DNV GL                                                                                         Hospital
                             Certified on 2018-04-20                                                                                           1200 North Elm Street
                                                                                                                                               Greensboro NC 27401-1020
                             Northeast Georgia Medical                     110029    04/26/2018                                GA
                             Center
E:\FR\FM\13AUN1.SGM




                                                                                                                                               Joint Commission ID #
                             743 Spring Street
                                                                                                                                               6504Joint Commission ID #
                             Gainesville, GA 30501
                                                                                                                                               6504
                                                                                                                                                Previous Re-certification
                              Other Information:
                                                                                                                                               Dates: 2016-02-09
                              Joint Commission# 6711
                           r~·~i~·~;;:': '':\I:~~ :•; l ~•• z'   ,:,.,     .....
                                                                         ;.~   ;                             •.;.,·;:,·,, . •.:;: ;)~:{,1*;~
                                                                                                      .:~.a:~:                                 FROM: University Hospitals
                                                                                                                                               - Case Medical Center
                                                                                                                                                                                 360137      02/09/2010      02/10/2018        OH
                              FROM: NYU Hospitals                         330214     02114/2012      03/28/2018                NY
                                                                                                                                               TO: University Hospitals
                              Center
13AUN1




                                                                                                                                               Cleveland Medical Center
                              TO: NYU Medical Center,
                                                                                                                                               11100 Euclid Avenue
                              Tisch Hospital
                                                                                                                                               Cleveland. OH 44106
                              550 1ST Avenue
                              New York, NY 10016
                                                                                                                                               Joint Commission ID # 7017
                                                                                                                                               Previous Re-certification
                             Joint Commission ID # 5820
                                                                                                                                               Dates: 2012-01-24; 2014-01-
                             Previous Re-certification
                                                                                                                                               30; 2016-02-23
                             Dates: 2014-01-14; 2016-03-08
                                                                                                                                               Providence St Vincent Medical     380004      12/06/2011      02/14/2018        OR
                             FROM: York Hospital                          390046     11119/2013      01/24/2018                PA
                                                                                                                                               Center
                             TO: WellSpan York Hospital
                                                                                                                                               9205 Southwest Barnes Road
                             1001 S. Georee St.
                                                                                                                                               Portland, OR




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                             Facility                        Provider   Date of         Date of           State   Facility                        Pro">ider   Date of         Date of           State
                                                             Number     Initial         Recertification                                           Number      Initial         Recertification
                                                                        Certification                                                                         Certification
                             Joint Connnission ID # 9705                                                          FROM: The University of         17-0040     03/08/2016      03/07/2018        KS




                                                                                                                                                                                                        Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
                             Previous Re-certification                                                            Kansas Hospital Authority
                             Dates: 2013-12-10; 2016-01-26                                                        TO: University of Kansas
                             Other Infonnation:                                                                   Health System
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                             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
PO 00000




                             Hospital                                                                             The Christ Hospital             360163      02/17/2012      03/21/2018        OH
                             5801 Bremo Road                                                                      2139 Auburn Avenue
                             Richmond, VA 23226                                                                   Cincinnati, Oil 45219
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                             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      06/10/2008      03/21/2018        PA
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                             600 N Wolfe Street              79070090                                             200 Lothrop Street
                             Baltimore, MD 21287             4                                                    Pittsburgh, PA 15213

                             Joint Connnission ID #6252                                                           Joint Connnission ID # 6169
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                             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      04/13/2016      04/04/2018        MN
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                             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      01/13/2009      05/25/2018        UT
                                                                                                                  Hospital
                             Joint Connnission ID # 6988                                                          TO: University of Utah
                             Previous Re-certification                                                            Health Care - Hospitals and
                             Dates: 2014-01-07; 2016-02-23
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                                                                                                                  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-VAD
                             Previous Re-certification                                                            Previous Re-certification
                             Dates: 2016-03-08                                                                    Dates: 2011-07-13; 2013-06-
                                                                                                                  18; 2015-06-23; 2017-08-08




                                                                                                                                                                                                        40053
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                                                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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Document Created: 2018-08-11 00:28:30
Document Modified: 2018-08-11 00:28:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice
ContactIt 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. [GRAPHIC] [TIFF OMITTED] TN13AU18.020
FR Citation83 FR 40043 

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