Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April through June 2018, 40043-40054 [2018-17316]
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Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–17318 Filed 8–10–18; 8:45 am]
[CMS–9110–N]
Centers for Medicare & Medicaid
Services
BILLING CODE 4120–01–P
Medicare and Medicaid Programs;
Quarterly Listing of Program
Issuances—April through June 2018
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice
AGENCY:
This quarterly notice lists
CMS manual instructions, substantive
SUMMARY:
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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
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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’’
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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.
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 https://
www.cms.gov/manuals.
Dated: August 3, 2018.
Olen D. Clybourn,
Deputy Director, Office of Strategic
Operations and Regulatory Affairs.
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Dated: August 8, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
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Addendum 1: Medicare and Medicaid Manual Instructions
(April through June 2018)
The CMS Manual System is used by CMS program components,
partners, providers, contractors, Medicare Advantage organizations, and
State Survey Agencies to administer CMS programs. It offers day-to-day
operating instructions, policies, and procedures based on statutes and
regulations, guidelines, models, and directives. In 2003, we transfmmed the
CMS Program Manuals into a web user-friendly presentation and renamed
it the CMS Online Manual System.
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How to Obtain Manuals
The Internet-only Manuals (IOMs) are a replica of the Agency's
official record copy. Paper-based manuals are CMS manuals that were
officially released in hardcopy. The majority of these manuals were
transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub
15-2 and Pub 45 are exceptions to tlris rule and are still active paper-based
manuals. The remaining paper-based manuals are for reference purposes
only. If you notice policy contained in the paper-based manuals that was
not transferred to the 10M, send a message via the CMS Feedback tool.
Those wishing to subscribe to old versions of CMS manuals should
contact the National Technical Information Service, Department of
Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone
(703-605-6050). You can download copies of the listed material free of
charge at: https://cms.gov/manuals.
How to Review Transnrittals or Program Memoranda
Those wishing to review transmittals and program memoranda can
access this information at a local Federal Depository Library (FDL). Under
the FDL program, government publications are sent to approximately 1,400
designated libraries throughout the United States. Some FDLs may have
EN13AU18.021
arrangements to transfer material to a local library not designated as an
FDL. Contact any library to locate the nearest FDL. This information is
available at https://www.gpo.gov/libraries/
In addition, individuals may contact regional depository libraries
that receive and retain at least one copy of most federal government
publications, either in printed or nricrofilm form, for use by the general
public. These libraries provide reference services and interlibrary loans;
however, they arc not sales outlets. Individuals may obtain information
about the location of the nearest regional depository library from any
library. CMS publication and transnrittal numbers arc shown in the listing
entitled Medicare and Medicaid Manual Instructions. To help FDLs locate
the materials, use the CMS publication and transnrittal numbers. For
example, to find the manual for Bundled Payments for Care Improvement
Advanced (BPCI Advanced Skilled Nursing Facility (SNF) Waiver, use
(CMS-Pub. 100-01) Transnrittal No. 115.
Addendum I lists a mrique CMS transnrittalnumber for each
instruction in our manuals or program memoranda and its subject number.
A transnrittal may consist of a single or multiple instruction(s). Often, it is
necessary to use information in a transnrittal in conjunction with
information currently in the manual. For the purposes of this quarterly
notice, we list only the specific updates to the list of manual instructions
that have occurred in the 3-month period. This information is available on
our website at www.cms.gov/Manuals.
Transmittal
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Manual/Subject/Publication Number
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Confidentialit of Instruction
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery
Disease (PAD)
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20:42 Aug 10, 2018
Publication Dates for the Previous Four Quarterly Notices
We publish this notice at the end of each quarter reflecting
information released by CMS during the previous quarter. The publication
dates of the previous four Quarterly Listing of Program Issuances notices
are: August 4, 2017 (82 FR 36404), October 27, 2017 (82 FR 49819),
January 26, 2018 (83 FR 3716) and May 4, 2018 (83 FR 19769). We are
providing only the specific updates that have occurred in the 3-month
period along with a hypcrlink to the website to access this information and a
contact person for questions or additional information.
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Confidentiality of Instruction
Issued to a specific audience, not posted to Intemet/Intranet due to a
Confidentiality of Instruction
Enhancements to Processing of Hospice Routine Home Care Payments
Payer Only Codes Utilized by Medicare
Data Required on the Institutional Claim to AlB MAC (HHH)
Input/Output Record Layout
Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics
and Supplies (DMEPOS) Competitive Bidding Program (CBP)- July 2018
Removal of KH Modifier from Capped Rental Claims Showing Whether
Rented or Purchased
Notification of Change in Instructions for Handling IRF Active Provider List
New Physician Specialty Code for Medical Genetics and Genomics
Revision to the Skilled Nursing Facility (SNF) Pricer to Support ValueBased Purchasing (VBP)
--Billing SNF PPS Services
--Input/Output Record Layout
--Billing in Benefits Exhaust and No-Payment Situations
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Confidentiality of Instruction
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Confidentiality of Instruction
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Confidentiality of Instruction
Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory
Services Subject to Reasonable Charge Payment
Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital
(LTCH) PPS Extensions per the Advancing Chronic Care, E>.ienders, and
Social Services (ACCESS) Act Included in the Bipartisan Budget Act 2018
Updates to Publication 100-04, Chapters I and 27 to Replace Remittance
Advice Remark Code (RARC) MA61 with N382
Quarterly Healthcare Common Procedure Coding System (HCPCS)
Drug/Rio logical Code Changes- July 201 S Update
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery
Disease (PAD) General Dilling Requirements
--Coding Requirements for SET
--Special Billing Requirements for Institutional Claims
--Common Working File (CWF) Requirements Applicable Medicare
Summary Notice (MSN), Remittance Advice Remark
Codes
(RARC) and Claim Adjustment Reason Code (CARC) Messaging
Issued to a specific audience, not posted to Internet/Intranet due to a
Confidentiality of Instruction
Issued to a specific audience, not posted to Intemet/Intranet due to a
Confidentiality of Instruction
Removal ofKH Modifier from Capped Rental Claims Payment System (PPS)
Quarterly Update to the Medicare Physician Fee Schedule Database
(MPFSDB)- July 2018 Update
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--Table ofContents/390-Supervised Exercise Therapy (SET) for Treatment of
Symptomatic Peripheral Artery Disease (PAD)
--General Billing Requirements
--Coding Requirements for SET
--Special Billing Requirements for Professional Claims
--Special Billing Requirements for Institutional Claims
--Common Working File (CWF) Requirements
--Applicable Medicare Summary Notice (MSN), Remittance Advice
--Remark Codes (RARC) and Claim Adjustment Reason Code (CARC)
Messaging
Increased Ambulance Payment Reduction for Non-Emergency Basic Life
Support (BLS) Transports to and from Renal Dialysis Facilities
Payment for Non-Emergency BLS Trips to/from ESRD Facilities
New Waived Tests
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Confidentiality of Instruction
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Confidentiality of Instruction
Ambulance Transportation for a Skilled Nursing Facility (SNF) Resident in a
Stay Not Covered by Part A- Medicare Benefit Policy Manual,
--Chapter I 0 and Medicare Claims Processing Manual, Chapter 15
Quarterly Update to the National Correct Coding Initiative (NCCI)
Procedure-to-Procedure (PTP) Edits, Version 24.2 Effective July I, 2018
Update ofTntemet Only Manual (TOM), Medicare Claims Processing Manual,
Publication 100-04, Chapter 37- Department of Veterans Affairs (VA)
Claims Adjudication Services Project
File Conversions Related to the Spanish Translation of the Healthcare
Common Procedure Coding Svstem (HCPCS) Descriptions
Quarterly Healthcare Common Procedure Coding System (HCPCS)
Drug/Biological Code Changes- July 2018 Update
Revisions to the Telehealth Billing Requirements for Distant Site Services
Inexpensive or Routinely Purchased Durable Medical Equipment (D.Y!E)
--Payment Classification for Speech Generating Devices (SGD) and
Accessories
--Inexpensive or Other Routinely Purchased DME
--Billing for Inexpensive or Other Routinely Purchased DME
--Inexpensive or Other Routinely Purchased DME
--Billing for Inexpensive or Other Routinely Purchased DME
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Confidentiality of Instruction
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Confidentiality of Instruction
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Confidentiality of Instruction
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Confidentiality of Instruction
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--Electronic Transmission- General Requirements
Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics
and Supplies (UMEPOS) Competitive Bidding Program (CBP)- October
2018
Update oflntemet Only Manual (!OM), Medicare Claims Processing Manual,
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Publication I 00-04, Chapter 18- Preventive and Screening Services, and
Chapter 35 -Independent Diagnostic Testing Facility (IUTF)
July Quarterly Update for 2018 Durable Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS) Fee Schedule
I Quarterly Update to the End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS)
I July 2018 Integrated Outpatient Code Editor (I/OCE) Specifications
I July 2018 Update of the Hospital Outpatient Prospective Payment System
None Remote Identity Proofing (RIDP) and Multi-Factor Authentication
(Ml' A) for Electronic Correspondence Referral System (ECRS) Web Users
Individuals Not Subject to the Limitation on Medicare Secondary Payment
(MSP)
Implement the International Classification of Diseases, Tenth Revision (ICD10) 201S General Equivalence Mappings (GEMs) Tables in the Common
Working File (CWF) for Purposes of Processing Non-Group Health Plan
(NGHP) Medicare Secondary Payer (MSP) Records and Claims
Electronic Correspondence Referral System (ECRS) User Guide Medicare
Beneficiary Identifier (MBI) Modifications including Updated Enterprise
Identity Management (EIDM) Multi-Factor Authentication (MF A)/Remote
Identity Proofing (RIDP) Screen Shots
Update the International Classification of Diseases, Tenth Revision (ICD-10)
2019 Tables in the Common Working File (CWF) for Purposes of Processing
Non- Group Ilealth Plan (NGIIP) Medicare Secondary Payer (MSP) Records
and Claims
Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments
3rd Qtr Notification for FY 2018
New Physician Specialty Code for Medical Genetics and Genomics
Part D(1)- Claims Processing Timeliness- All Claims
Part E - Interest Payment Data
Classification of Claims for Counting
Physician/Limited License Physician Specialty Codes
Exhibit
I Revisions to State Operations Manual (SOM) Appendix J, Part I Survey
Protocol for Intermediate Care Facilities for Individuals with Intellectual
Disabilities
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787
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789
I Reimbursing Providers and Health Information Handlers (HIHs) for
Additional Documentation
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Confidentiality of Instruction
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Confidentiality of Instruction
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Implement Operating Rules- Phase III Electronic Remittance Advice (ERA)
Electronic Funds Transfer (EFT): Committee on Operating Rules for
Information Exchange (CORE) 360 Uniform Use of Claim Adjustment
Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and
Claim Adjustment Group Code (CAGC) Rule - Update from Council for
Affordable Quality Healthcare (CAQH) CORE
Atumal Updates to the Prior Authorization/Pre-Claim Review federal
Holiday Schedule Tables for Generating Reports
Instructions for Downloading the Medicare ZIP Code File for October Files
Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code
(CARC), Medicare Remit Easv Print (MREP) and PC Print Update
Common Edits and Enhancements Modules (CEM) Code Set Update
Issued to a specific audience, not posted to Intemel/Intrantl due to a
Sensitivity
Issued to a specific audience, not posted to Intemet/Intranet due to a
Sensitivity
July 2018 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing
Files and Revisions to Prior Quarterly Pricing Files
Diagnosis Code Cpdate for Add-on Payments for Blood Clotting Factor
Administered to Hemophilia Inpatients
--Payment for Blood Clotting Factor Administered to Hemophilia Inpatients
New Q Code for In-Line Cartridge Containing Digestive Enzyme(s)
July 2018 Update of the Hospital Outpatient Prmpective Payment System
COPPS)
July 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version
19.2
Claim Status Category and Claim Status Codes Update
July 2018 Update of the Ambulatory Surgical Center (ASC) Payment System
ElM Service Documentation Provided by Students (Manual Update)
Alignment of Coordination of Benefits Agreement (COBA) Internet Only
Manual References
--Assignment of Claims and Transfer Policy
--MSN Messages
--Returned Medigap Notices
--Coordination of Medicare With Medigap and Other Complementary Health
Insurance Policies
--Standard Medicare Charges for COB Records
--Consolidation of the Claims Crossover Process
--Coordination of Benefits Agreement (COBA) Full Claim File Repair
Process
--Coordination of Benefits Agreement (COBA) Eligibility File Claims
Recovery Process
--Coordination of Benefits Agreement (COBA) Medigap Claim-Based
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Wireless Access Monitoring
Malicious Software
White listing
Data Encryption
Security Level by Information Type
Minimum System Security Requirements-HIGH
Internet Security
Introduction
Safeguards against Employee Fraud
Attachment 1/MAC ARS
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193
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instmction
194
Medicare Diabetes Prevention Program (MDPP) Model Expansion Medicare
Beneficiary Database (MBD) File Data for the Health Insurance Portability
and Accountability Act (HIP AA) Eligibility Transaction System (HETS)
195
Update to CR9341 Oncology Care Model (OCM) Restricted Care
Management Code List
Comprehensive ESRD Care (CEC) Model Telehealth- Implementation
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Modifications to the Implementation of the Paperwork (PWK) Segment ofthe
Electronic Submission of Medical Documentation (esMD) System
Claims Processing Actions to Implement Certain Provisions ofthe Bipartisan
Rudget Act of 20 1S
Issued to a specific audience, not posted to Internet/ Intranet due to a
Sensitivity
Issued to a specific audience, not posted to Internet/ Intranet due to a
Sensitivity
Change in Type of Service (TOS) for Current Procedural Terminology (CPT)
Code 77067
Update to the Hospital Transfer Policy for Early Discharges to Hospice Care
User CR: Develop Enhanced Claims Search Repmting in Fiscal Intennediary
Shared System (FISS)- Phase 1
Common Working File (CWF) to Increase Next Eligible Date Occurrences to
99 for Preventative Services
Issued to a specific audience, not posted to Internet/ Intranet due to a
Sensitivity
Issued to a specific audience, not posted to Internet/ Intranet due to a
Sensitivity
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Sensitivity
Issued to a specific audience, not posted to Internet/ Intranet due to a
Sensitivity
Updates to Peritoneal Dialysis Claims Processing, Provider Statistical and
Reimbursement Report (PSR) and Payment for Ultrafiltration for
Beneficiaries with Acute Kidney Injury (AKI)
Processing Instructions to Update the Identification Code Qualifier Being
Used in the NM108 Data Element at the 2100 Loop, NMl- Patient Name
Segment in the 835 Guide
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
20:42 Aug 10, 2018
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Issued to a specific audience, not posted to Internet/Intranet due to
Coni!dentiality of Instruction
Restoring Section 3.2.3 B. and Section 3.2.3 C. to Chapter 3 of Publication
(Pub.) 100-08 in the Internet Only Manual (IOM Requesting Additional
Documentation During Prepayment and Postpayment Review
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Confidentiality of Instruction
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Confidentiality of Instruction
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Confidentiality of Instmction
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Confidentiality of Instmction
Intent to Reopen
Reviewing for Adverse Legal Actions (ALA)
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instmction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality oflnstruclion
Comprehensive Error Rate Testing (CERT) Update to Chapter 12 of
Publication (Pub.)l00-08
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Part B Detail Line Expansion- Fiscal Intermediary Shared System (FISS)
Part B Detail Line Expansion- Multi-Carrier System (MCS) Phase 9
Enhancement for Undeliverable Pay Medicare Summarv Notices (MSNs) for
Multi-Carrier System (MCS) Users
Shared System Enhancement 2014: Implementation of Fiscal Intermediary
Shared System (I'ISS) Obsolete On-Request Jobs- Phase 2
Common Working File (CWF) Split Medicare Part A Claims to Carry 50
Lines per Segment Rather than I 00 Lines per Segment
Shared System Enhancement 2014: Implementation of Fiscal Intermediary
Shared System (FISS) Obsolete On-Request Jobs- Phase 3
Shared System Enhancement 2015: Identify Inactive Medicare Demonstration
Projects within the Fiscal Intermediary Shared System (Removing/Archiving Demonstration Codes 51 and 56)
Phase 4- Updating the Fiscal Intermediary Shared System (FISS) to Make
Payment for Drugs and Biologicals Services for Outpatient Prospective
Payment System (OPPS) Providers
Implementation of Business Requirements to Increase Claim Counter
Maximum and Create Auto-Deletion Utility
Use the V\1AP/4D States Table in all VMS Address Processing
Modifying FISS Part B Claims Overlap Edits
Medicare Cost Report E-Filing (MCReF)
International Code of Diseases_ Tenth Revision (ICD-10) and Other Coding
Revisions to National Coverage Determinations (NCDs)
Clean-up of Fiscal Intermediary Shared System (FISS) Reason Codes and
Quarter! y Reports
Issued to a specitlc audience, not posted to Internet/ Intranet due to a
Sensitivity
Identifying and Eliminating Discrepancies between the Provider Enrollment,
Chain and Ownership System (PECOS) and the Fiscal Intermediary Shared
System (FISS)
Fee-For-Service (FFS) Shared System Maintainers (SSMs) Standardized
Release Identification (!D) Format
Transition Letter Writing from Client Letter Software to the Durable Medical
Equipment (DME) Medicare Administrative Contractors (MACs)
Analysis for Mandatory Support of Review Contractors to Send Electronic
Medical Documentation Requests (eMDR)to Participating Providers via the
Electronic Submission of Medical Documentation (esMD) System
Implementation of Changes to the Pre-Payment Additional Documentation
Request (AIJR) Letters for Medical Review
Analysis and Design for Fiscal Intermediary Shared System (FISS), \1ultiCarrier System (MCS), and Viable Information Processing System (VIPS)
Medicare System (VMS) Prepayment Review Report
Implementation of Procedures for Undeliverable Medicare Summary Notices
(uMSNs) and Summary MSNs for Previously Undeliverable MSNs for FISS
and MCS (No-Pav onlv)
Combined Common Edits/Enhancements Module (CCEM) Cpdates for
Apache POI (version 3.14.0) to Apache POI (version 3.17) and Analysis from
.TAV A (version 6) to .TA VA (version 7)
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2092
Sensitivity
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Sensitivity
Standardization of Case File Transmittal and Provider Information Processes,
Bankruptcy, Payment Hold, and Cancellation Reporting Between the
Medicare Administrative Contractors (MAC) and the Recovery Audit
Contractor (RAC)
Use the V\1AP/4D States Table in all VMS Address Processing
Identifying and Eliminating Discrepancies between the Provider Enrollment,
Chain and Ownership System (PECOS) and the Fiscal Intermediary Shared
System (FISS)
Analysis for First Coast Service Options (FCSO) and Novitas for the Security
Asse1tion Markup Language 2.0 (SAML 2.0) Migration
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Confidentiality of Instruction
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Issued to a specific audience, not posted to Intcrnct/Intranct due to
Confidentiality of Instmction
Addendum II: Regulation Documents Published
in the Federal Register (April through June 2018)
Regulations and Notices
Regulations and notices are published in the daily Federal
Register. To purchase individual copies or subscribe to the Federal
Register, contact GPO at www.gpo.gov/fdsys. When ordering individual
copies, it is necessary to cite either the date of publication or the volume
number and page number.
The Federal Register is available as an online database through
GPO Access. The online database is updated by 6 a.m. each day the
Federal Register is published. The database includes both text and
graphics from Volume 59, Number l (January 2, 1994) through the present
date and can be accessed at https://www.gpoaccess.gov/fr/. The
following website https://www.archives.gov/federal-register/ provides
information on how to access electronic editions, printed editions, and
reference copies.
This information is available on our website at:
https://www.cms.gov/quarterlyproviderupdates/downloads/Regs2Ql8QPU.pdf
For questions or additional information, contact Terri Plumb
(410-786-4481 ).
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
20:42 Aug 10, 2018
2064
2065
2066
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13AUN1
Addendum IV: Medicare National Coverage Determinations
(April through June 2018)
Addendum IV includes completed national coverage
determinations (NCDs), or reconsiderations of completed NCDs, from the
quarter covered by this notice. Completed decisions are identified by the
section of the NCD Manual (NCDM) in which the decision appears, the
title, the date the publication was issued, and the effective date of the
decision. An NCD is a determination by the Secretary for whether or not a
particular item or service is covered nationally under the Medicare Program
(title XVIII of the Act), but does not include a determination of the code, if
any, that is assigned to a particular covered item or service, or payment
determination for a particular covered item or service. The entries below
include information concerning completed decisions, as well as sections on
program and decision memoranda, which also announce decisions or, in
some cases, explain why it was not appropriate to issue an NCD.
Information on completed decisions as well as pending decisions has also
been posted on the CMS website. For the purposes of this quarterly notice,
we are providing only the specific updates that have occurred in the 3month period. There were no national coverage determinations (NCDs), or
reconsiderations of completed NCDs published in the 3-month period. This
information is available at: www.cms.gov/medicare-coverage-database/.
For questions or additional information, contact Wanda Belle, MP A
(410-786-7491).
listings are organized according to the categories to which the devices are
assigned (that is, Category A or Category B), and identified by the IDE
number. For the purposes of this quarterly notice, we list only the specific
updates to the Category BIDEs as of the ending date of the period covered
by this notice and a contact person for questions or additional information.
For questions or additional information, contact John Manlove (410-7866877).
Under the Food, Drug, and Cosmetic Act (21 U.S. C. 360c) devices
fall into one of three classes. To assist CMS under this categorization
process, the FDA assigns one of two categories to each FDA-approved
investigational device exemption (IDE). Category A refers to experimental
IDEs, and Category B refers to non-experimental IDEs. To obtain more
information about the classes or categories, please refer to the notice
published in the April21, 1997 Federal Register (62 FR 19328).
IDE
BB18107
BB18136
BB18220
Gl60220
Gl70030
Gl70190
Gl70209
Gl70274
Gl80001
Gl80033
Gl80045
Gl80048
Gl80049
Gl80052
Addendum V: FDA-Approved Category B Investigational Device
Exemptions (IDEs) (April through June 2018)
Addendum V includes listings of the FDA-approved
investigational device exemption (IDE) numbers that the FDA assigns. The
Gl80053
Gl80057
Gl80058
Device
Miltenyi CliniMACS System
Miltenyi CliniMACS TCRalpha/beta, CD19, CD45RA
System
Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) for
CD45RA+ Depletion; Allogeneic Unrelated and Partially
Matched Related, G-CSF Mobiized Peripheral Blood Stem
Cell Addback with TCRab+ and CD19 Depletion following
Chemotherapy
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon
MiStent Sirolimus Eluting Absorbable Polymer Coronary
Stent System (MiStent II) in the CRYSTAL Clinical Study
AXIOS Stent and Electrocautery Enhanced Delivery System
lOmmxlOmm; AXIOS Stent and Electrocautery Enhanced
Delivery System 15mmxl0mm
WVEDERM VOLUX XC
AtriCure Synergy Ablation System
iStent infinite Model iS3
Edwards Transcatheter Atrial Shunt System
CENTERA Transcatheter Heart Valve System
Boston Scientific Embozene Color-Advanced Microspheres
for Embolization
Exablate Model4000 Type-2 for Blood-Brain Barrier
Disruption (BBBD)
XIE'ICE Alpine Everolimus Eluting Coronary Stent System,
XIE'ICE Xpedition Everolimus Coronary Stent System
t:slim X2 with Control-IQ Technology
Effectiveness of spinal cord stimulation for the management
of freezing of gait and locomotion in Parkinson's disease
SYNCHRONY Cochlear Implant
Start Date
04/12/2018
05/01/2018
06/08/2018
05/03/2018
06/15/2018
04/10/2018
04/26/2018
04/27//2018
04/1112018
05/24/2018
04/04/2018
04/05/2018
04/04/2018
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
20:42 Aug 10, 2018
Addendum III: CMS Rulings
(April through June 2018)
CMS Rulings are decisions of the Administrator that serve as
precedent final opinions and orders and statements of policy and
interpretation. They provide clarification and interpretation of complex or
ambiguous provisions of the law or regulations relating to Medicare,
Medicaid, Utilization and Quality Control Peer Review, private health
insurance. and related matters.
The rulings can be accessed at ""P·" " " "·'"""·&v" ,,._..., 5 cum,vu"For questions or additional information,
contact Tiffany Lafferty (410-786-7548).
04/13/2018
04/13/2018
04/19/2018
04/13/2018
40049
EN13AU18.026
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Gl80059
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G180085
Gl80090
Gl80091
Frm 00070
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Gl80092
Gl80093
Gl80094
Gl80096
Gl80097
Gl80100
Gl80102
Sfmt 4725
Gl80109
Gl80110
Gl80113
E:\FR\FM\13AUN1.SGM
Gl80115
Start Date
04/20/2018
04/27/2018
04/27/2018
05/02/2018
05/04/2018
05/04/2018
05/11/2018
05/16/2018
06/13/2018
06/06/2018
06/18/2018
06/07/2018
06/09/2018
06/10/2018
06/14/2018
06/14/2018
06/14/2018
06/28/2018
06/29/2018
06/01/2018
06/29/2018
06/29/2018
13AUN1
Addendum VI: Approval Numbers for Collections of Information
(April through June 2018)
All approval numbers are available to the public at Reginfo.gov.
Under the review process, approved information collection requests are
assigned OMB control numbers. A single control number may apply to
several related information collections. This information is available at
www.reginfo.gov/public/do/PRAMain. For questions or additional
information, contact William Parham (410-786-4669).
Addendum VII: Medicare-Approved Carotid Stent Facilities,
(April through June 2018)
Addendum VII includes listings of Medicare-approved carotid
stent facilities. All facilities listed meet CMS standards for performing
carotid artery stenting for high risk patients. On March 17, 2005, we issued
our decision memorandum on carotid artery stenting. We determined that
EN13AU18.027
carotid artery stcnting with embolic protection is reasonable and necessary
only if performed in facilities that have been determined to be competent in
performing the evaluation, procedure, and follow-up necessary to ensure
optimal patient outcomes. We have created a list of minimum standards for
facilities modeled in part on professional society statements on competency.
All facilities must at least meet our standards in order to receive coverage
for carotid artery stenting for high risk patients. For the purposes of this
quarterly notice, we are providing only the specific updates that have
occurred in the 3-month period. This information is available at:
https://www. ems. gov/MedicareApprovedFacilitie/CASF/list. asp#TopO:lPage
For questions or additional information, contact Sarah Fulton, MHS
(410-786-2749).
Facility
Provider
Number
Effective Date
Western Maryland Health System
12500 Willowbrook Road
Cumberland, MD 21 502
Methodist Health Centers
17201 Interstate 45 South
The Woodlands, TX 77385
1609831247
04/10/2018
I MD
1184179194
04/23/2018
TX
1578550174
05/09/2018
MI
I 310016
05/25/2018
I NJ
I
12/2112007
I IN
Other Information:
d/b/a Houston Methodist- The
Woodlands Hospital
Garden City Hospital
6425 Inkster Road
Garden City, MI 48136
Christ Hospital, CarePoint Health
System
176 Palisade Avenue
Jersey City, NJ 07306
State
Other Locations: Bayonne Medical
Center 29th Street at Avenue E
Bayonne, NJ 07002 Hoboken
University Medical Center 308
Willow Avenue Hoboken, NJ 07030
lf:;'i' 0
Froedtert South Inc.
6308 Eighth Avenue
Kenosha, WI 53143-5082\1ichigan
City, IN 46360
Dba Kenosha Medical Center and St.
Catherine's Medical Center
520021
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
20:42 Aug 10, 2018
G180063
Gl80064
Gl80068
Gl80070
G180071
Gl80073
Gl80074
Device
VENT ANA PATHWAY HER-2/neu ( 4B5) Rabbit
Monoclonal Primary Antibody Assay
Restylane Defyne
Juvederm Volite XC
Guardant360 CDx Test
Slit Stent II Lacrimal Stent
PN40082 (with lidocaine) for Lip Augmentation
DES BTK Dmg-Eluting Vascular Stent System
Next-Generation Sequencing Minimal Residual Disease
Assay (NGS MRD Assay)
Mag Venture MagPro R30 transcranial stimulator
Synergy Disc
Abbott Laboratories Infinity implantable deep brain
stimulation system
Celcuity CELx HER2 Signaling Function Test
NovoTTF-100\1 System
NeVa VS
SERF (Saline Enhanced Radio-Frequency) Ablation System
Medtronic Summit RC+S System
Easytech Reversed Shoulder System
Accelerated rTMS as a treatment for post-stroke depression in
the subacute phase: an open label pilot study
LUM Imaging System
Boston Scientific Precision Spectra Spinal Cord Stimulator
and CoverEdge X32 Surgical Leads
Pneumatic Vitreolysis on Vitreomacular Traction (Protocol
AG); Pneumatic Vitreolysis for Macular Hole (Protocol AH)
HydroPearl Microspheres
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State
360172
05/23/2005
OH
370047
1386741635
09/06/2006
i
;.,;l\z'•,~~:• ;~}' ~~:~~~;.l~it;
OK
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Addendum VIII:
American College of Cardiology's National Cardiovascular Data
Registry Sites (April through June 2018)
The initial data collection requirement through the American
College of Cardiology's National Cardiovascular Data Registry (ACCNCDR) has served to develop and improve the evidence base for the use of
ICDs in certain Medicare beneficiaries. The data collection requirement
ended with the posting of the final decision memo for Implantable
Cardioverter Defibrillators on February 15, 2018.
For questions or additional information, contact Sarah Fulton,
MHS (410-786-2749).
13AUN1
Addendum IX: Active CMS Coverage-Related Guidance Documents
(April through June 2018)
CMS issued a guidance document on November 20, 2014 titled
"Guidance for the Public, Industry, and CMS Staff: Coverage with
Evidence Development Document". Although CMS has several policy
vehicles relating to evidence development activities including the
investigational device exemption (IDE), the clinical trial policy, national
coverage determinations and local coverage determinations, this guidance
document is principally intended to help the public understand CMS' s
implementation of coverage with evidence development (CED) through the
national coverage determination process. The document is available at
https://www. ems. gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional
Active CMS Coverage-Related Guidance Documents for the 3-month
period. For questions or additional information, contact
JoAnna Baldwin, MS (410-786-7205).
Addendum X:
List of Special One-Time Notices Regarding National Coverage
Provisions (April through June 2018)
There were no special one-time notices regarding national
coverage provisions published in the 3-month period. This information is
available at www.cms.hhs.gov/coverage. For questions or additional
information, contact JoAnna Baldwin, MS (410-786 7205).
Addendum XI: National Oncologic PET Registry (NOPR)
(April through June 2018)
Addendum XI includes a listing of National Oncologic Positron
Emission Tomography Registry (NOPR) sites. We cover positron emission
tomography (PET) scans for particular oncologic indications when they are
performed in a facility that participates in the NOPR.
In January 2005, we issued our decision memorandum on positron
emission tomography (PET) scans, which stated that CMS would cover
PET scans for particular oncologic indications, as long as they were
performed in the context of a clinical study. We have since recognized the
National Oncologic PET Registry as one of these clinical studies.
Therefore, in order for a beneficiary to receive a Medicare-covered PET
scan, the beneficiary must receive the scan in a facility that participates in
the registry. There were no additions, deletions, or editorial changes to the
listing of National Oncologic Positron Emission Tomography Registry
(NOPR) in the 3-month period. This information is available at
http//WW\v. ems. govll\tledicareApprovedF acilitie/NOPR/list. asp#T opOfPage.
For questions or additional infonnation, contact Stuart Caplan, RN, MAS
(410-786-8564).
Addendum XII: Medicare-Approved Ventricular Assist Device
(Destination Therapy) Facilities (April through June 2018)
Addendum XII includes a listing of Medicare-approved facilities
that receive coverage for ventricular assist devices (VADs) used as
destination therapy. All facilities were required to meet our standards in
order to receive coverage for VADs implanted as destination therapy. On
October 1, 2003, we issued our decision memorandum on VADs for the
clinical indication of destination therapy. We determined that VADs used
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
20:42 Aug 10, 2018
St. Catherine's Medical Center
Address: 9555 S 76th St
Pleasant Prairie, WI 53158
Provider# 520021
FROM: Community Health
Partners
TO: Mercy Health- Regional
Medical Center LLC
3700 Kolbe Road
Lorain, OH 44053-1697
0
H~ ;;} :~~~ \,, Si;' ..·. ~~~(7~2.\:•·
Mercy Hospital Ardmore, Inc
1011 4th Avenue NW
Ardmore, OK 734010klahoma City,
OK 73120
Provider
Number
40051
EN13AU18.028
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Facility
..:•.:.··
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Provider
Number
:;s;:
340014
Date of
Recertification
04/20/2018
.·; .
i0~i:''iS
Novant Health Forsyth Medical
Center
3333 Silas Creek Parkway
Winston Salem, NC 27103
Sfmt 4725
E:\FR\FM\13AUN1.SGM
Other information: DNV GL
Certified on 2018-04-20
Northeast Georgia Medical
Center
743 Spring Street
Gainesville, GA 30501
Other Information:
Joint Commission# 6711
z'
r~·~i~·~;;:': '':\I:~~ :•; l ~••
110029
,:,.,
13AUN1
FROM: NYU Hospitals
Center
TO: NYU Medical Center,
Tisch Hospital
550 1ST Avenue
New York, NY 10016
Joint Commission ID # 5820
Previous Re-certification
Dates: 2014-01-14; 2016-03-08
FROM: York Hospital
TO: WellSpan York Hospital
1001 S. Georee St.
EN13AU18.029
Date of
Initial
Certification
390046
GA
•.;.,·;:,·,, . •.:;: ;)~:{,1*;~
;
330214
····~';:;
NC
04/26/2018
.....
;.~
State
.:~.a:~:
02114/2012
11119/2013
03/28/2018
01/24/2018
NY
PA
Facility
Pro">ider
Number
Date of
Initial
Certification
Date of
Recertification
State
050599
10/06/2015
02/07/2018
CA
310002
02/06/2009
02/07/2018
NJ
340091
01/08/2014
02/14/2018
NC
360137
02/09/2010
02/10/2018
OH
380004
12/06/2011
02/14/2018
OR
York, PA 17403
Other Information:
Joint Commission ID # 6228
Previous Re-certification
Dates: 2015-12-15
University of California, Davis
Medical Center (UCDMC)
2315 Stockton Boulevard
Sacramento, CA 95817
Other Information:
Joint Commission# 7030
Newark Beth Israel Medical
Center
201 Lyons Avenue
Newark, NJ 07112
Joint Commission ID # 5965
Previous Re-certification
Dates: 2011-09-20; 2013-1001; 2015-12-15
Moses H. Cone Memorial
Hospital
1200 North Elm Street
Greensboro NC 27401-1020
Joint Commission ID #
6504Joint Commission ID #
6504
Previous Re-certification
Dates: 2016-02-09
FROM: University Hospitals
- Case Medical Center
TO: University Hospitals
Cleveland Medical Center
11100 Euclid Avenue
Cleveland. OH 44106
Joint Commission ID # 7017
Previous Re-certification
Dates: 2012-01-24; 2014-0130; 2016-02-23
Providence St Vincent Medical
Center
9205 Southwest Barnes Road
Portland, OR
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
20:42 Aug 10, 2018
as destination therapy are reasonable and necessary only if performed in
facilities that have been determined to have the experience and
infrastructure to ensure optimal patient outcomes. We established facility
standards and an application process. All facilities were required to meet
our standards in order to receive coverage for V ADs implanted as
destination therapy.
For the purposes of this quarterly notice, we are providing only the
specific updates to the list of Medicare-approved facilities that meet our
standards that have occurred in the 3-month period. This information is
available at
https://www. ems. gov/MedicareApprovedF acilitie/VAD/list.asp#TopOfPage.
For questions or additional information, contact Linda Gousis, JD,
(410-786-8616).
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Joint Connnission ID # 9705
Previous Re-certification
Dates: 2013-12-10; 2016-01-26
Other Infonnation:
Joint Connnission # 7315
FROM: Bon Secours - St.
Mary's Hospital
TO: Bon Secours St. Mary's
Hospital
5801 Bremo Road
Richmond, VA 23226
Frm 00073
Fmt 4703
Joint Connnission ID # 6387
Previous Re-certification
Dates: 2013-12-17; 2016-01-26
Jolms Hopkins Hospital
600 N Wolfe Street
Baltimore, MD 21287
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E:\FR\FM\13AUN1.SGM
Joint Connnission ID #6252
Previous Re-certification
Dates: 2009-12-15; 2011-1129; 2013-12-03; 2016-01-12
TO: University Cincinnati
Medical Center
FROM: University of
Cincinnati Medical Center
234 Goodman Street
Cincinnati, OH 45219
13AUN1
Joint Connnission ID # 6988
Previous Re-certification
Dates: 2014-01-07; 2016-02-23
Mercy General Hospital
4001 J Street
Sacramento, CA 95819
Joint Connnission ID # 10053
Previous Re-certification
Dates: 2016-03-08
Provider
Number
490059
Date of
Initial
Certification
1211112007
Date of
Recertification
02/22/2018
State
Facility
Pro">ider
Number
VA
FROM: The University of
Kansas Hospital Authority
TO: University of Kansas
Health System
4000 Cambridge Street
Kansas City, KS 66160
Joint Connnission ID # 8567
The Christ Hospital
2139 Auburn Avenue
Cincinnati, Oil 45219
210009/1
79070090
4
360003
050017
1211112007
12113/2011
02112/2014
02/14/2018
03/14/2018
03/14/2018
MD
OH
CA
Joint Connnission ID # 6987
Previous Re-certification
Dates: 2014-02-20; 2016-04-05
UPMC Presb;terian
200 Lothrop Street
Pittsburgh, PA 15213
Joint Connnission ID # 6169
Previous Re-certification
Dates: 2010-05-21; 2012-0412; 2014-03-25; 2016-04-13
Saint Cloud Hospital
1406 Sixth Avenue North
Saint Cloud, MN 56303
Joint Connnission ID # 8183
FROM: University of Utah
Hospital
TO: University of Utah
Health Care - Hospitals and
Clinics
50 N Medical Drive
Salt Lake City, UT 84132
DNV GL Certificate#:
264328-2018-VAD
Previous Re-certification
Dates: 2011-07-13; 2013-0618; 2015-06-23; 2017-08-08
Date of
Recertification
State
17-0040
Date of
Initial
Certification
03/08/2016
03/07/2018
KS
360163
02/17/2012
03/21/2018
OH
390164
06/10/2008
03/21/2018
PA
240036
04/13/2016
04/04/2018
MN
460009
01/13/2009
05/25/2018
UT
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
20:42 Aug 10, 2018
Facility
40053
EN13AU18.030
40054
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[FR Doc. 2018–17316 Filed 8–10–18; 8:45 am]
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13AUN1
EN13AU18.031
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4120–01–P
Agencies
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40043-40054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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
[[Page 40044]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.021
[[Page 40045]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.022
[[Page 40046]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.023
[[Page 40047]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.024
[[Page 40048]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.025
[[Page 40049]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.026
[[Page 40050]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.027
[[Page 40051]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.028
[[Page 40052]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.029
[[Page 40053]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.030
[[Page 40054]]
[GRAPHIC] [TIFF OMITTED] TN13AU18.031
[FR Doc. 2018-17316 Filed 8-10-18; 8:45 am]
BILLING CODE 4120-01-P