Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2016, 11456-11470 [2017-03559]
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Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
Dated: February 21, 2017.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2017–03604 Filed 2–21–17; 4:15 pm]
BILLING CODE P
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
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The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
I. Background
The Centers for Medicare & Medicaid
Services (CMS) is responsible for
administering the Medicare and
Medicaid programs and coordination
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bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than March 20,
2017.
A. Federal Reserve Bank of St. Louis
(David L. Hubbard, Senior Manager)
P.O. Box 442, St. Louis, Missouri
63166–2034. Comments can also be sent
electronically to
Comments.applications@stls.frb.org:
1. Connections Bancshares, Inc.,
Ashland, Missouri; to acquire 80 percent
of the voting shares of Kirksville
Bancorp, Inc., Kirksville, Missouri, and
thereby indirectly acquire shares of
American Trust Bank, Kirksville,
Missouri.
Board of Governors of the Federal Reserve
System, February 17, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
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
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[FR Doc. 2017–03500 Filed 2–22–17; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–9100–N]
Medicare and Medicaid Programs;
Quarterly Listing of Program
Issuances—October Through
December 2016
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice lists
CMS manual instructions, substantive
and interpretive regulations, and other
Federal Register notices that were
published from October through
December 2016, relating to the Medicare
and Medicaid programs and other
programs administered by CMS.
FOR FURTHER INFORMATION CONTACT: It is
possible that an interested party may
need specific information and not be
able to determine from the listed
information whether the issuance or
regulation would fulfill that need.
Consequently, we are providing contact
persons to answer general questions
concerning each of the addenda
published in this notice.
SUMMARY:
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concurred in by Director Richard
Cordray (Director, Consumer Financial
Protection Bureau), and Chairman
Martin J. Gruenberg, that Corporation
business required its consideration of
the matters which were to be the subject
of this meeting on less than seven days’
notice to the public; that no earlier
notice of the meeting was practicable;
that the public interest did not require
consideration of the matters in a
meeting open to public observation; and
that the matters could be considered in
a closed meeting by authority of
subsections (c)(4), (c)(6), (c)(8),
(c)(9)(A)(ii), (c)(9)(B), and (c)(10) of the
‘‘Government in the Sunshine Act’’ (5
U.S.C. 552b(c)(4), (c)(6), (c)(8),
(c)(9)(A)(ii), (c)(9)(B), and (c)(10).
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
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agencies, various providers of health
care, all Medicare contractors that
process claims and pay bills, National
Association of Insurance Commissioners
(NAIC), health insurers, and other
stakeholders. To implement the various
statutes on which the programs are
based, we issue regulations under the
authority granted to the Secretary of the
Department of Health and Human
Services under sections 1102, 1871,
1902, and related provisions of the
Social Security Act (the Act) and Public
Health Service Act. We also issue
various manuals, memoranda, and
statements necessary to administer and
oversee the programs efficiently.
Section 1871(c) of the Act requires
that we publish a list of all Medicare
manual instructions, interpretive rules,
statements of policy, and guidelines of
general applicability not issued as
regulations at least every 3 months in
the Federal Register.
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II. Format for the Quarterly Issuance
Notices
This quarterly notice provides only
the specific updates that have occurred
in the 3-month period along with a
hyperlink to the full listing that is
available on the CMS Web site or the
appropriate data registries that are used
as our resources. This is the most
current up-to-date information and will
be available earlier than we publish our
quarterly notice. We believe the Web
site list provides more timely access for
beneficiaries, providers, and suppliers.
We also believe the Web site offers a
more convenient tool for the public to
find the full list of qualified providers
for these specific services and offers
more flexibility and ‘‘real time’’
accessibility. In addition, many of the
Web sites have listservs; that is, the
public can subscribe and receive
immediate notification of any updates to
the Web site. These listservs avoid the
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need to check the Web site, as
notification of updates is automatic and
sent to the subscriber as they occur. If
assessing a Web site proves to be
difficult, the contact person listed can
provide information.
III. How To Use the Notice
This notice is organized into 15
addenda so that a reader may access the
subjects published during the quarter
covered by the notice to determine
whether any are of particular interest.
We expect this notice to be used in
concert with previously published
notices. Those unfamiliar with a
description of our Medicare manuals
should view the manuals at https://
www.cms.gov/manuals.
Dated: February 16, 2017.
Kathleen Cantwell,
Director, Office of Strategic Operations and
Regulatory Affairs.
BILLING CODE 4120–01–P
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Addendum 1: Medicare and Medicaid Manual Instructions
(October through December 2016)
The CMS Manual System is used by CMS program components,
partners, providers, contractors, Medicare Advantage organizations, and
State Survey Agencies to administer CMS programs. It offers day-to-day
operating instructions, policies, and procedures based on statutes and
regulations, guidelines, models, and directives. In 2003, we transformed the
CMS Program Manuals into a web user-friendly presentation and renamed
it the CMS Online Manual System.
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How to Obtain Manuals
The Internet-only Manuals (IOMs) are a replica of the Agency's
official record copy. Paper-based manuals are CMS manuals that were
officially released in hardcopy. The majority of these manuals were
transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub
15-2 and Pub 45 are exceptions to 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 Transmittals or Program Memoranda
Those wishing to review transmittals and program memoranda can
access this information at a local Federal Depository Library (FDL). Under
the FDL program, government publications are sent to approximately 1,400
designated libraries throughout the United States. Some FDLs may have
EN23FE17.001
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 microfilm form, for use by the general
public. These libraries provide reference services and interlibrary loans;
however, they are not sales outlets. Individuals may obtain information
about the location of the nearest regional depository library from any
library. CMS publication and transmittal numbers are shown in the listing
entitled Medicare and Medicaid Manual Instructions. To help FDLs locate
the materials, use the CMS publication and transmittal numbers. For
example, to find the manual for Medicare Internet Only Manual Publication
Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 22.3,
Effective October 1, 2016 use (CMS-Pub. 100-04) Transmittal No. 3561.
Addendum I lists a unique CMS transmittal number for each
instruction in our manuals or program memoranda and its subject number.
A transmittal may consist of a single or multiple instruction(s). Often, it is
necessary to use information in a transmittal in conjunction with
information currently in the manual. For the purposes of this quarterly
notice, we list only the specific updates to the list of manual instructions
that have occurred in the 3-month period. This information is available on
our website at www.cms.gov/Manuals.
Transmittal
Manual/Subject/Publication Number
Dasis for Determining the Part A Coinsurance Amounts
Part B Annual Deductible
Part B Premium
Internet Only Manual Updates to Pub. 100-01, 100-02 and 100-04 to Correct
Errors and Omissions (SNF)
Requirements - General
Medicare SNF PPS Overview
Medicare SNF Coverage Guidelines Under PPS
Hospital Providers of Extended Care Services
Three-Day Prior Hospitalization
Three-Day Prior Hospitalization - Foreign Hospital
Effect on Spell of Illness
Medical Service of an Intern or Resident-in-Training
Medical and Other Health Services Furnished to SNF Patients
Services Furnished Under Arrangements With Providers
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
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: February 4, 2016 (81 FR 6009), May 9, 2016 (81 FR 28072),
August 5, 2016 (81 FR 51901) and November 2016 (81 FR 79489. We are
providing only the specific updates that have occurred in the 3-month
period along with a hyperlink to the website to access this information and a
contact person for questions or additional information.
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Definition of Durable Medical Equipment
Implementation of Changes in the End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS) and Payment for Dialysis Furnished for
Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2017
Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC)
Updates
Index of Acronyms
RHC General Information
FQHC General Information
RHC Staffing Requirements
RHC Temporary Staffing Waivers
RHC and FQHC Visits
Multiple Visits on Same Day
Day Payment Window
RHC Services
FQHC Services
Emergency Services
Non RHC/FQHC Services
Description of Non RHC/FQHC Services
RHC Payment Rate
Payment Codes for FQHCs Billing Under the PPS
FQHC PPS Payment Rate and Adjustments
FQHC Payment Codes
RHC and FQHC Cost Report Requirements
RHC and FQHC Cost Report Forms
RHC and FQHC Charges, Coinsurance, Deductible, and Waivers
Commingling
Dental, Podiatry, Optometry, and Chiropractic Services
Graduate Medical Education
Transitional Care Management (TCM) Services
Chronic Care Management (CCM) Services
Services and Supplies Furnished "Incident to" Physician's Services
Provision oflncident to Services and Supplies Incident to Services and
Supplies Furnished in the Patient's Home or Location Other than the RHC or
FQHC
Payment to Physician Assistants
Services and Supplies Furnished Incident to NP, P A, and CNM Services
Services and Supplies Incident to CP Services
Mental Health Visits
Physical Therapy, Occupational Therapy, and Speech Language Pathology
Services
Requirements for Visiting l\ursing Services
Treatment Plans
231
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None
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Hospice Services
Hospice Attending Practitioner
Provision of Services to Hospice Patients in a RHC or FQHC
Preventive Health Services
Preventive Health Services in RHCs
Preventive Health Services in FQHCs
Copayment for FQHC Preventive Health Services
Implementation of Changes in the End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS) and Payment for Dialysis Furnished for
Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2017
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~s;:,z ::1t~;•;i:'t:}'.~21\~
Annual Update of HCPCS Codes Used for Home Health Consolidated Billing
Enforcement
Table of Chemistry Panels
Organ or Disease Oriented Panels
Update to Pub 100-04, Medicare Claims Processing Manual, Chapter 15:
Ambulance
SNF Billing
Billing of Vaccine Services on Hospice Claims
Hospice Claims for Vaccine Services
Billing Requirements
Claims Submitted to MACs Using Institutional Formats
Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis
D Virus Vaccines and T11eir Administration on Institutional Claims
Institutional Claims Submitted by Home Health Agencies and Hospices
Payment Procedures for Renal Dialysis Facilities (RDF)
Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of
Instruction
Issued to a specific audience, not posted to Internet/ Intranet to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of
Instruction
Ambulance Inflation Factor for CY 2017 and Productivity Adjustment
Ambulance Inflation Factor (AIF)
Fiscal Year (FY) 2017 Inpatient Prospective Payment System (IPPS) and
Long Term Care Hospital (LTCH) PPS Changes
Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of
Instruction
Changes to the Laboratory National Coverage Determination (NCD) Edit
Software for January 2017
Denial of Home Health Payments When Required Patient Assessment Is Not
Received
Correcting Editing for Condition Code 54 and Updating Remittance Advice
Messages on Home Health Claims
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Intemet/Intrant! due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity
of Instruction
Instmctions to Process Services Not Authorized by the Veterans
Administration (VA) in a Non-VA Facility Reported With Value Code (VC)
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Applicable Messages for ASC 2008 Payment Changes Effective January 1,
2008
Applicable ASC Messages for Certain Payment Indicators Effective for
Services Performed on or after January I, 2009
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instmction
Implementation of the Restmctured Clinical Lab Fee Schedule
2017 Annual Update to the Therapy Code List
Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
Competitive Didding Implementation of Policy Changes for the CY 2017
Home Health Prospective
Adjustments of Episode Payment- Outlier Payments
Therapy Editing
HH PPS Claims
Beneficiary-Driven Demand Billing Under HH PPS
Input/Output Record Layout
Decision Logic Used by the Pricer on Claims
Annual Updates to the HH Pricer
Medical and Other Health Services Submitted Using Type of Bill 034x
Billing Instmctions for Disposable Negative Pressure Wound Therapy
Services Payment System
Changes to the Laboratory National Coverage Determination (NCD) Edit
Software for January 2017
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instmction
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instmction
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instruction
Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code
(CARC), Medicare Remit Easy Print (MREP) and PC Print Update
Claim Status Category and Claim Status Codes Update
lnstmctions for Downloading the Medicare ZIP Code File for April 2017
Common Edits and Enhancements Modules (CEM) Code Set Update
Issued to a specific audience, not posted to Intemel/Intrantl due to
Confidentiality of Instmction
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
New Waived Tests
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instmction
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
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Requirements for Processing Non Veterans Administration (VA) Authorized
Inpatient Claims
Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics
and Supplies (DMEPOS) Competitive Bidding Program (CBP) - January
2017
New Physician Specialty Code for Hospitalist Physician Specialty Codes
Update to the Federally Qualified Health Centers (FQHC) Prospective
Payment System (PPS)- Recurring File Updates
Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity
Instruction
January 2017 Quarterly Average Sales Price (ASP) Medicare Part D Drug
Pricing Files and Revisions to Prior Quarterly Pricing Files
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instruction
Instructions for Retrieving the 2017 Pricing and HCPCS Data Files through
CMS's Mainframe Telecommunications Systems
Therapy Cap Values for Calendar Year (CY) 2017
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instmction
Quarterly Update to the Correct Coding Initiative (CCI) Edits, Vcrsion 23,0,
EITeclive January 1, 2017
Issued to a specific audience, not posted to Intemet/Intranet due to
Confidentiality of Instmction
Calendar Year (CY) 2017 Participation Enrollment and Medicare
Participating Physicians and Suppliers Directory (MEDP ARD) Procedures
Payment for Ox')'gen Volume Adjustments and Portable Oxygen Equipment
Billing for Oxygen and Oxygen Equipment
Updates to Pub. 100-04, Chapters S, l3 and 14 to Correct Remittance Advice
Messages
Physician Billing Requirements to the AlB MAC (B)
l\oninvasive Studies for ESRD Patients- Facility and Physician Services
Medicare Summary Notices (MSN), Reason Codes, and Remark Codes
Messages for Noncovered PET Services
Coverage for PET Scans for Dementia and Neurodegenerative Diseases
Billing and Coverage Changes for PET Scans Effective for Services on or
After April 3, 2009
Billing and Coverage Changes for PET Scans for Cervical Cancer Effective
for Services on or After November 10, 2009
Metastasis of Cancer Effective for Claims With Dates of Services on or
After February 26, 2010
Local Coverage Determination for PET Using New, Proprietary
Radiopharmaceuticals for their FDA-Approved Labeled Indications for
Oncologic Imaging Only
Denial Messages for Noncovered Bone Mass Measurements
Ambulatory Surgical Center Services on ASC List
Applicable Messages for NTIOLs
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Electronic Correspondence Referral System (ECRS) Web Updates to Claims
Processing Medicare Secondary Payer (MSP) Policy and Procedures
Regarding Ongoing Responsibility for Medicals (ORM)
Instructions on Using the Claim Adjustment Segment (CAS) for Medicare
Secondary Payer (MSP) Part A CMS-1450 Paper Claims, Direct Data Entry
(DDE), and 837 Institutional Claims Transactions
.'.';,;k~~\>'\J;';~t(A;';i
Notice of .\Jew Interest Rate for Medicare Overpayments and Underpayments
~:~~J)3i>} !~'~; ··;,;;iy~
162
163
-1 ~ Qtr N otfication for FY 2017
New Physician Specialty Code for Hospitalist
Pub. 100-06, Chapter 3, Section 90 (Provider Liability) Revision
Claims Processing Timeliness - All Claims
Part E - Interest Payment Data
Classification of Claims for Counting
Physician/Limited License Physician Specialty Codes
New Physician Specialty Code for Hospitalist
Part D(1)- Claims Processing Timeliness- All Claims
Part E - Interest Payment Data
Classification of Claims for Counting
Physician/Limited License Physician Specialty Codes
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Medicare Financial Management Manual, Chapter 7, Internal Control
Requirements
OMB Circular A-123
GAO Standards for Internal Controls in the Federal Government
Definition and Objectives
Contractor Internal Control Review Process and Time line
Risk Assessment
Risk Analysis Chart
Certification Package for Internal Controls (CPIC) Requirements
OMB Circular A-123, Appendix A; Internal Controls Over Financial
Reporting (ICOFR)
Certification Statement
CPIC- Report of Material Weaknesses
CPIC- Report oflnternal Control Deficiencies
Statement on Standards for Attestation Engagements (SSAE) Number 18
(SSAE 18), Reporting on Controls at Service Providers
Corrective Action Plans
Submission, Review, and Approval of Corrective Action Plans
Corrective Action Plan (CAP) Reports
CMS Finding Numbers
Initial CAP Report
Quarterly CAP Report
CMS CAP Report Template
List of CMS Contractor Control Objectives
Instructions to Hospitals on the Election of a Medicare-Supplemental Security
Income (SSI) Component of the Disproportionate Share (DSH) Payment
Adjustment for Cost Reports that Involve SSI Ratios for Fiscal Year (FY)
2004 and Earlier, or SST Ratios for Hospital Cost-Reporting Periods for
Patient Dischar<>es Occurrina Before October 1 2004
..,.,,,;;;;;;
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14:10 Feb 22, 2017
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Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics
and Supplies (UMEPOS) Competitive Bidding Program (CBP)- January
2017
HCPCS Code Update for Preventive Services
Table of Preventive and Screening Services
Rural Health Clinic (RHC)/Federally Qualified Health Center (FQHC)
Special Billing Instructions
Deductible and Coinsurance
HCPCS Code
Advance Beneficiary Notice
RHCs/FQHCs Special Billing Instructions
RHCs/FQHCs Special Billing Instructions
Update to Editing of T11erapy Services to Reflect Coding Changes
CY 2017 Update for Durable Medical Equipment, Prosthetics, Orthotics and
Supplies (DMEPOS) Fee Schedule
Gap-filling DMEPOS Fees
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
January 2017 Integrated Outpatient Code Editor (IIOCE) Specifications
Version 18.0
2017 Healthcare Common Procedure Coding System (HCPCS) Annual
Update Reminder
Summary of Policies in the Calendar Year (CY) 2017 Medicare Physician Fee
Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee
Payment Amount and Telehealth Services List, and CT Modifier Reduction
List
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Prolonged Services Without Direct Face-to-Face Patient Contact Separately
Payable Under the Physician Fee Schedule (Manual Update)
Prolonged Services Without Direct Face-to-Face Patient Contact Service
(Codes 99358- 99359)
Payment for Oxygen Volume Adjustments and Portable Oxygen Equipment
Billing for Oxygen and Oxygen Equipment
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Revisions to State Operations Manual (SOM) Appendix J, Part IIInterpretive Guidelines -Responsibilities of Intermediate Care Facilities for
Individuals with Intellectual Disabilities
Revisions to State Operations Manual (SOM) Appendix W - Survey Protocol,
Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs)
and Swing-Beds in CAHs
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Revisions to the State Operations Manual (SOM) Chapter 2 Numbering
System for CMS Certification Numbers (CCN)
CCN for Medicare Providers
165
Revisions to State Operations Manual (SOM) Appendix W - Survey Protocol,
Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs)
and Swing-Beds in CAHs
tl.,c~·:
tc~c1
164
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690
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){';;
33
Intemet-based PECOS Applications
Release of Information
Model Letter Guidance
Reactivations -Deactivation for Non-Submission of a Claim
Reactivations -Miscellaneous Policies
Issued to a specific audience, not posted to Intcmct/ Intranet Confidentiality
of Instmction
Contacting Non-Responders and Documentation Requests
>.f'i/
PO 00000
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Medicare Contractor Beneficiary and Provider Communications Manual
Beneficiary Customer Services Pub. 100-09 Chapter 2- Update Beneficiary
Customer Services
Escalation of Complex Beneficiary Inquiries to the MACs by the Beneficiary
Contact Center ( BCC)
Next Generation Desktop (NGD) Training
Disclosure of Information (Adherence to the Privacy Act and the Health
Insurance Portability and Accountability Act (HIP AA) Privacy Rule)
Screening of Beneficiary Complaints Alleging Fraud or Abuse
Medicare Customer Service- Nex-t Generation Desk-top (MCSC-NGD) Client
Installation and Configuration Requirements
Call Center User Group (CCUG
Complex Beneficiary Inquiries
Handling Complex Beneficiary Inquiries
Controlling Complex Beneficiary Inquiries
E-mail and Fax Responses to Complex Written Beneficiary Inquiries
Telephone Responses to Complex Beneficiary Inquiries
Written Responses to Complex Beneficiary Inquiries
l"imeliness of Responses to Complex Benetlciary Inquiries
Congressional Beneficiary Inquiries
Surveys
Urgent Need Regional Offices Casework
''\'' t~~~~.Yi-~!'ti
~~~¥~;;\1e 1 ~1~·~~
28
29
23FEN1
QIO Manual Chapter 5 -"Quality of Care Review
QIO Manual Chapter 3 "Memoranda of Agreement for Case Review
Authority and Scope for Memoranda of Agreement (MOA)
MEMORANDA OF AGREEMENT (MOA) WITH PROVIDERS OF
SERVICES
Agreements with Providers of Services
Hospital Memorandum of Agreement (MOA)
Home Health Agencies (HHAs) and Skilled Nursing Facilities (SNFs)
Memoranda of Agreement (MOA)
AGREEMENTS WITH PAYERS OF HEALTHCARE SERVICES
Medicare Administrative Contractor (MAC) Joint Operating Agreements
(JOA)
Memorandum Of Agreement (MOA) with State Agencies Responsible for
Licensing and Certification of Providers and Practitioners
;j;i 1 :n:•·~
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
689
Estimation and Recoupment of Projected Overpayment by Contractors
Update to Pub. 100-08, Chapter 15 Medicaid State Agencies
Correspondence Address and E-mail Addresses
Form CMS-855A and Form CMS-855B Signatories
Delegated Officials
Supporting Documents
Processing Alternatives- Form CMS-855B and Form CMS-855I
Processing Alternatives- Form CMS-8550
Processing Alternatives- Form CMS-855R
Special Program Integrity Procedures
Model Revocation T.etter for Part R Suppliers and Certified Providers and
Suppliers
Favorable Corrective Action Plan/Reconsideration Decision -Denials
Corrective Action Plans (CAPs
Reconsideration Requests -Non-Certified Providers/Suppliers
Additional Appeal Levels
Appeals Involving Certified Providers and Certified Suppliers
Corrective Action Plans (CAPs)
Reconsideration Requests -Certified Providers and Certified Suppliers
Additional Appeal Levels
HHA Ownership Changes
Revocations
Medicare Contractor Duties
Correspondence Address and E-mail Addresses
Contact Persons
Certification Statement Signature Requirements
I'om1 CMS-855I and CMS-8550 Signatories
Form CMS-855R Signatories
Form CMS-S55A. Form Clv!S-S55B and Form Clv!S-S55S Signatories
Authorized Officials
Delegated Officials
Submission of Paper and Intemet-based PECOS Certification Statements
Certification Statement Development
Reserved for Future Use
Reserved for Future Use
Receipt/Review of Paper Applications
Receipt/Review oflnternet-Based PECOS Applications
Processing Alternatives- Form Clv!S-855B and Form CMS-855I
Processing Alternatives- Form CMS-855A
Processing Alternatives- Form CMSPaper Applications
Intemet-Based PECOS Applications
General Principles- Paper and lntemet-Based PECOS Applications
Receiving Missing/Clarifying Data/Documentation
Paper Applications
Intemet-Based PECOS Applications
Special Program Integrity Procedures
Rejections
Changes oflnformation - General Procedures
Electronic Fund Transfers (EFT)
1\·fi
None
;~~~;, i~~;.;;;]
.c:.
None
11463
EN23FE17.006
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1737
:::<;~;:.,;;;,;;.•:\;;•
t~?.;\;Ji;.'\'
1738
None
l','tc: '::t~:; i
Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity
Instruction
Common Working File (CWF) Reorganization of Daily Beneficiary Extract
Files
Changes to the End-Stage Renal Disease (ESRD) Facility Claim (Type of Bill
72X) to Accommodate Dialysis Furnished to Beneficiaries with Acute Kidney
Injury ( AKI)
Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of
Instruction
Section 504: Adding a Qualified Reader Preference in Alternate Formats
Part B Detail Line Expansion- MCS Phase 6
Analysis Only - Populate MCS PE Screens from PECOS (Phased Approach)
Part B Detail Line Expansion- MCS Phase 5
Fiscal Intermediary Shared System (FISS) Heath Information Technology for
Economic and Clinical Health (HITECH) Quatterly Repmt
Phase Three: Changing Fiscal Intennediary Shared System (FISS) Action on
Informational Unsolicited Responses (ICRs) From Canceled Claims to
Adjustments
Modifications to the National Coordination of Benefits Agreement (CORA)
1748
Crossover Process
1723
1758
Phase 3- Updating the fiscal Intern1ediary Shared System (l'ISS) to Make
Payment for Drugs and Biologicals Services for Outpatient Prospective
Payment System (OPPS) Providers
System Specific Enhancement 2014: Retaining Most Recent Update for
Auxiliary (Aux) File Data in Common Working File (CWF)
Shared System Enhancement 2014- Identification of Fiscal Intermediary
Shared System (FISS) Obsolete On-Request Jobs -Analysis Only File
1749
1750
1751
1752
1753
1754
1755
1756
1757
1759
1760
1761
(CWF)1693
Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity
Instruction
Network Fee Reduction for Acute Kidney Injury (AKI) services submitted on
Type of Bill 72x
Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity
Instruction
Shared System Enhancement 2015: National Coverage Determination (NCO)
Fiscal Intermediary Shared System (FISS) Implementation
Issued to a specific audience, not posted to Internet/ Intranet Confidentiality
of Instruction
Issued to a specific audience, not posted to Internet/ Intranet Confidentiality
of Instruction
Modifications to the National Coordination of Benefits Agreement (COBA)
Crossover Process
Audit Trail for Reason Code Edit Changes
Part B Detail Line Expansion - Checkpoint Discussion Meetings
Medicare Electronic Health Record (EHR) Incentive Program- Analysis of
Meaningful Use Hospital Transition into Hospital Quality Reporting System
Issuing Compliance Letters to Specific Providers and Suppliers Regarding
Inappropriate Billing of Qualified Medicare Beneficiaries (Q'v!Bs) for
Medicare Cost-Sharing
Adding a Foreign Language Tagline Sheet to Medicare Summary Notices
(MSNs)
Issued to a specific audience, not posted to Intcrnct/Intranct due to Sensitivity
oflnstruclion
Increasing the Number of Address Fields in MCS to Match the Address Fields
in CWF in Order to Improve the Undeliverable Medicare Summary Notices
(uMSNs) Situation: Phase One oflmproving FFS9372
Adding a Foreign Language Tagline Sheet to Medicare Summary Notices
(MSNs)
System Specific Enhancement 2014: String Testing Automation
Coding Revisions to National Coverage Determination (NCDs)
Common Working File and Fraud Prevention System 2.0 Predictive Modeling
and Edits, Data Feed Migration
ICD-1 0 Coding Revisions to National Coverage Determination (NCDs)
Analysis Only - Modification of Process for Handling the Provider
Enrollment Chain Ownership System (PECOS) Exiract Pile
Issuing Compliance Letters to Specific Providers and Suppliers Regarding
Inappropriate Billing of Qualified Medicare Beneficiaries (Q'v!Bs) for
Medicare Cost-Sharing
Updates for the Shared System lvlaintainers to implement the Social Security
Number Removal Initiative (SSJ\Rl)
Changes to the End-Stage Renal Disease (ESRD) Facility Claim (Type of Bill
72X) to Accommodate Dialysis Fumished to Beneficiaries with Acute Kidney
Injury ( AKI)
Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity
Instruction
Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
I\> ~ ~:~ :\;Itx.·~~ ~:·z·,: i'.·\;'N:t\!2',
123
Chapter 16b, Special Needs Plans
124
Update ot Chat tel 1 of the Managed Care Manual
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.··.•:',:\:l•'"·.i.sz·
·:<:.·.'•'····"''•<::•··\
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.: •:.: ;:t\•~ ~,,~~
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Addendum II: Regulation Documents Published
in the Federal Register (October through December 2016)
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 1 (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/Regs3Ql6QPU.pdf
For questions or additional information, contact Terri Plumb
(410-786-4481).
23FEN1
Addendum III: CMS Rulings
(October through December 2016)
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 mlp:!iWW\1 .~,;m::;.gvvl "'"'!:'lwmvu;,For questions or additional information,
contact Tiffany Lafferty (410-786-7548).
Addendum IV: Medicare National Coverage Determinations
(October through December 2016)
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. There were no updates that occurred in
the 3-month period. This information is available at:
www.cms.gov/medicare-coverage-database/. For questions or additional
information, contact Wanda Belle, MP A (410-786-7491).
Addendum V: FDA-Approved Category B Investigational Device
Exemptions (IDEs) (October through December 2016)
Addendum V includes listings of the FDA-approved
investigational device exemption (IDE) numbers that the FDA assigns. The
listings are organized according to the categories to which the devices are
assigned (that is, Category A or Category B), and identified by the IDE
number. For the purposes of this quarterly notice, we list only the specific
updates to the Category BIDEs as of the ending date of the period covered
by this notice and a contact person for questions or additional information.
For questions or additional information, contact John Manlove (410-786
6877).
Under the Food, Drug, and Cosmetic Act (21 U.S. C. 360c) devices
fall into one of three classes. To assist CMS under this categorization
process, the FDA assigns one of two categories to each FDA-approved
investigational device exemption (IDE). Category A refers to experimental
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
1763
Instruction
Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity
Instruction
Shared Savings Program (SSP) Accountable Care Organization (ACO)
Qualifying Stay Edits
11465
EN23FE17.008
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IDE
Gl60189
Gl60131
Gl60191
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Gl60149
Gl60200
Gl60197
Gl60205
Gl60203
G160168
G040175
Gl60136
Gl60206
Gl60207
Fmt 4703
Gl60211
Sfmt 4725
Gl60212
Gl60208
Gl60213
E:\FR\FM\23FEN1.SGM
G160214
Gl60216
Gl60218
Gl60219
23FEN1
Gl60223
Gl60226
Gl60229
Gl60234
Gl60233
Gl00108
Gl60238
Gl60106
G160232
Gl60243
Gl60242
EN23FE17.009
Device
Exablate Model 4000 Type 1
EMBOSPHERE MICROSPHERE
RETINOIC ACID RECEPTOR ALPHA- INTERFERON
RESPONSE FACTOR 8(RARA-IRF8)
E-QURE Bioelectrical Signal Therapy (BST) Device
FE NIX Plus Continence Restoration System
IMPELLA CP SYSTEM
Agili-C
BREATHID HP SYSTEM, BREATHID HP LAB SYSTEM
TOPS Svstem
Relay Thoracic Stend Graft with Transport Delivery System
for treatment of thoracic aortic aneurysms.
Medtronic Spinal Cord Stimulation Systems
Restylane Silk Injectables
Cook Zenith TX2 Proximal Component, Cook Zenith TX2
Proximal Extension, Cook Zenith TX2 Proximal Taper
BEAT AML MASTER TRIAL CLINICAL TRIAL ASSAY
(BEAT AML GENOMIC PROFILING ASSAY)
SENSE BRAIN INWRY MONITOR (SDX1)
STARS TIM
ARTISSE INTRASACCULAR DEVICE, ARTISSE
DETACHMENT DEVICE
EMBOSPHERE MICROSPHERES
Morphology Recurrence Plot Mapping
The GORE Cardioform ASD Occuluder
ARTIC FRONT ADVANCE CARDIAC CRYOABLATION
CATHETER
Carillon Mitral Contour System
Ovation Alto Abdominal Stent Graft System
Custom bipolar electrode based on PermaLoc Electrode
Embosphere (R) Microspheres
Activa Deep Brain Stimulation Therapy System
Exablate Model2100 Type 3.0
ALUVRA
FemBLOC Permanent Contraceptive System; Component 1)
FemBLOC Biopolymer; Component 2) FemBLOC Delivery
System; Component 3) FemBLOC FemChec Tubal Occlusion
Confirmation Device
Zilver Vascular Stent
Lynparza HRR Assay
IN.PACT AV Access Paclitaxel-Coated PTA Balloon
Catheter
Start Date
10/0112016
10/04/2016
10/07/2016
10/14/2016
10/18/2016
10/19/2016
10/20/2016
10/2112016
10/26/2016
10/27/2016
10/28/2016
10/28/2016
10/28/2016
1110112016
11102/2016
11104/2016
11104/2016
11104/2016
11109/2016
11110/2016
11110/2016
11117/2016
11117/2016
11118/2016
1112112016
11123/2016
12/02/2016
12/06/2016
12/07/2016
12/09/2016
12/13/2016
12/14/2016
IDE
Gl60250
Gl60172
Gl60180
Gl60209
Gl60247
Gl60248
Gl60249
Gl60251
G160265
Gl60253
Gl60259
Device
tRISTAN 624 biOMAGNETOMETER
Ranger Paclitaxel-Coated PTA Balloon Catheter
OPTUKE (NovoTTF 100A System)
LOTUS Edge Valve System, 23 mm; LOTUS Edge Valve
System, 25 mm, LOTUS Edge Valve System, 27 mm
Proclaim Elite Implantable Pulse Generator; Triple 16 Paddle
Leads
A Prospective Pilot Trial for PFO CLOSURE at the Time of
ENDOCASCULAR Cardiac Electronic Device Implantation
Hydrus Microstent
da Vinci SP Surgical System, EndoWrist SP Instruments, and
Accessories
In Press Technologies Post Pactum Hemorrhage Device
PERIODONTAL STRUCTURE REPAIR DEVICE
Edwards SAPIEN 3 Transcatheter Heart Valve and
Start Date
12115/2016
12116/2016
12116/2016
12116/2016
12116/2016
12116/2016
12116/2016
12116/2016
12/20/2016
12/20/2016
12/20/2016
Accessories
Gl00322
Gl30034
Gl60256
Gl60263
GlG02G5
Gl60121
TheraSphere
BIOFREEDOM Drug Coated Coronary Stent System
NUCLEUS C1532 COCHLEAR IMPLANT
EXTRACORPOREAL CPR FOR REFRACTORY OUT-OFHOSPITAL CARDIAC ARREST (EROCA)
EMBOZENE MICROSPHERES
Implantable Miniature Telescope (IMT) Models Wide Angle
2.2X and Wide Angle 2.7X
12/2112016
12/2112016
12/2112016
12/2112016
12/23/2016
12/29/2016
Addendum VI: Approval Numbers for Collections of Information
(October through December 2016)
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,
(October through December 2016)
Addendum VII includes listings of Medicare-approved carotid
stent facilities. All facilities listed meet CMS standards for performing
carotid artery stenting for high risk patients. On March 17, 2005, we issued
our decision memorandum on carotid artery stenting. We determined that
carotid artery stenting with embolic protection is reasonable and necessary
only if perfonned in facilities that have been determined to be competent in
perfonning the evaluation, procedure, and follow-up necessary to ensure
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
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).
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Baxter Regional Medical Center
624 Hospital Drive
Mountain Home, AR 72653
Wellington Regional Medical Center
10101 Forest Hill Boulevard
Wellington, FL 33414
St Mark's Hospital
1100 East 3900 South
Salt Lake City, UT 84124
Sfmt 4725
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Provider
Number
Effective
Date
1033147921
10/26/2016
AR
1720078702
11108/2016
FL
470046
11130/2016
NE
100077
08/24/2009
FL
15-0074
08/04/2005
IN
\\;.(!:i;,·\ .•,•''"'"~··>'~<
.
:\'li\~\~fi\-J, .';i
i.''''''''"····•·;·;~'·''''
FROM: Peace River Regional Medical Center
TO: Bayfront Health Port Charlotte
2500 Harbor Boulevard
Port Charlotte, FL 33952
FROM: Community Heart and Vascular
Hospital
TO: Community Health Network, Inc
1500 N. Ritter Avenue
Indianapolis, IN 46219
State
announced that the American College of Cardiology's National
Cardiovascular Data Registry (ACC-NCDR) ICD Registry satisfies the data
reporting requirements in the NCD. Hospitals needed to transition to the
ACC-NCDR ICD Registry by April2006.
Effective January 27, 2005, to obtain reimbursement, Medicare
NCD policy requires that providers implanting ICDs for primary prevention
clinical indications (that is, patients without a history of cardiac arrest or
spontaneous arrhythmia) report data on each primary prevention ICD
procedure. Details of the clinical indications that are covered by Medicare
and their respective data reporting requirements are available in the
Medicare NCD Manual, which is on the CMS website at
A provider can use either of two mechanisms to satisfy the data
reporting requirement. Patients may be enrolled either in an Investigational
Device Exemption trial studying ICDs as identified by the FDA or in the
ACC-NCDR ICD registry. Therefore, for a beneficiary to receive a
Medicare-covered ICD implantation for primary prevention, the beneficiary
must receive the scan in a facility that participates in the ACC-NCDR lCD
registry. The entire list of facilities that participate in the ACC-NCDR ICD
registry can be found at www.ncdr.com/webncdr/conunon
For the purposes of this quarterly notice, we are providing only the
specific updates that have occurred in the 3-month period. This information
is available by accessing our website and clicking on the link for the
American College of Cardiology's National Cardiovascular Data
Registry at: www.ncdr.com/webncdr/common. For questions or additional
information, contact Sarah Fulton, MHS (410 786 2749).
Facility
23FEN1
Addendum VIII:
American College of Cardiology's National Cardiovascular Data
Registry Sites (October through December 2016)
Addendum VIII includes a list of the American College of
Cardiology's National Cardiovascular Data Registry Sites. We cover
implantable cardioverter defibrillators (ICDs) for certain clinical
indications, as long as information about the procedures is reported to a
central registry. Detailed descriptions of the covered indications are
available in the NCD. In January 2005, CMS established the ICD
Abstraction Tool through the Quality Network Exchange (QNet) as a
temporary data collection mechanism. On October 27, 2005, CMS
City
r ~:li~;.i '*'l;c:•'0s'·:·~r>'
Sarah Bush Lincoln Health Center
Kaiser Permanente - Vacaville Medical Center
Jersey Community Hospital District
Roane Medical Center
1:1 \'Yi•·~··.···:o'.\;i'~i~i
Unity Hospital
St. Mary's Medical Center
Wheaton Franciscan Inc. -Wisconsin Heart
Hospital
Vaughan Regional Medical Center
Northshore Regional Medical Center
TriStar Southern Hills Medical Center
St. Elizabeth Boardman
Mattoon
Vacaville
Jerseyville
Harriman
Fridley
West Palm Beach
Milwaukee
Selma
Slidell
Nashville
Boardman
State
··•····•···•·
IL
..,., ..
\,\';\•;':
CA
IL
TN
;s;''!i•'0~:•':iR\ ~:\',
MN
FL
WI
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
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/MedicareApprovedF acilitie/CASF/list.asp#TopOfPage
For questions or additional information, contact Sarah Fulton, MHS
(410-786-27 49).
AL
LA
TN
OH
11467
EN23FE17.010
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11468
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City
Dickson
Lihue
Tiffin
Coming
Livingston
State
TN
HI
OH
NY
TX
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Addendum IX: Active CMS Coverage-Related Guidance Documents
(October through December 2016)
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 (October through December 2016)
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, contactJoAnna Baldwin, MS (410-786 7205).
23FEN1
Addendum XI: National Oncologic PET Registry (NOPR)
(October through December 2016)
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
https://www.cms.gov/MedicareApprovedJ:iacilitie/NOPR!list.asp#'l'opOtPage.
For questions or additional information, contact Stuart Caplan, RN, MAS
(410-786-8564 ).
Addendum XII: Medicare-Approved Ventricular Assist Device
(Destination Therapy) Facilities (October through December 2016)
Addendum XII includes a listing of Medicare-approved facilities
that receive coverage for ventricular assist devices (VADs) used as
destination therapy. All facilities were required to meet our standards in
order to receive coverage for VADs implanted as destination therapy. On
October 1, 2003, we issued our decision memorandum on VADs for the
clinical indication of destination therapy. We determined that VADs used
as destination therapy are reasonable and necessary only if performed in
facilities that have been determined to have the experience and
infrastructure to ensure optimal patient outcomes. We established facility
standards and an application process. All facilities were required to meet
our standards in order to receive coverage for VADs implanted as
destination therapy.
We are providing only the specific updates to the list of Medicareapproved 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).
Facility
.. ~~;,~: .!i
NorthShore University Health System
130 1 Central Street, Suite 300
Evanston, IL 6020 1
St. Francis Hospital
100 Port Washington Boulevard
Roslyn, NY 11576
Swedish Medical Center Cherry Hill
500 17th Avenue Seattle, W A 98122
Provider
Number
Date Approved
State
14-0010
10/26/2016
IL
33-0182
11/09/2016
NY
500025
11/09/2016
WA
.
(,:~~E:~;;. ;·,~· :\'~~
[<:&:,~,,,,;
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
EN23FE17.011
Facility
Tristar Horizon Medical Center
Wilcox Memorial Hospital (Hawai'i Pacific)
Mercy Tiffin Hospital
Guthrie Corning Hospital
CHI St. Luke's Health Memorial Livingston
rmajette on DSK2TPTVN1PROD with NOTICES
VerDate Sep<11>2014
Facility
Date Approved
450044
12/10/2003
)\'~~~,:;
1'•·\~:;:: ;~1,>(', 1;',
Jkt 241001
PO 00000
Frm 00044
Fmt 4703
Sfmt 9990
FROM: UT Southwestern University
Hospital
TO: UT Southwestern Medical
Center
6201 Harry Hines Rlvd.
Dallas, TX 75390
Other information:
Joint Commission certified on 2/3/09.
Hospital previously listed as St. Paul
Medical Center.
FROM: Methodist Hospital, The
TO: Houston Methodist Hospital
6565 Fatmin Street
Houston, TX 77030
Other information:
DNV GL certified 12/6/16; JCAHO
certified 10/29/08
FROM: Community Heart and
Vascular
TO: Community Health Network,
Inc.
8075 N Shadeland Avenue
Indianapolis, IN 46250
Other information:
Joint Commission Certified
State
'·s•\i''>i.z'''
TX
450358
12/06/2016
TX
150074
10/01/2014
IN
E:\FR\FM\23FEN1.SGM
23FEN1
Addendum XIII: Lung Volume Reduction Surgery (LVRS)
(October through December 2016)
Addendum XIII includes a listing of Medicare-approved facilities
that are eligible to receive coverage for lung volume reduction surgery.
Until May 17, 2007, facilities that participated in the National Emphysema
Treatment Trial were also eligible to receive coverage. The following three
types of facilities are eligible for reimbursement for Lung Volume
Reduction Surgery (L VRS):
• National Emphysema Treatment Trial (NETT) approved (Beginning
05/07/2007, these will no longer automatically qualify and can qualify only
with the other programs);
• Credentialed by the Joint Col1llllission (formerly, the Joint
Col1llllision on Accreditation of Healthcare Organizations (JCAHO)) under
their Disease Specific Certification Program for L VRS; and
• Medicare approved for lung transplants.
Only the first two types are in the list. There were no updates to
the listing of facilities for lung volume reduction surgery published in the
3-month period. This infonnation is available at
www.cms.gov/MedicareApprovedFacilitie/L VRS/list.asp#TopOfPage. For
questions or additional information, contact Sarah Fulton, MHS
(410-786-27 49).
Addendum XIV: Medicare-Approved Bariatric Surgery Facilities
(October through December 2016)
Addendum XIV includes a listing of Medicare-approved facilities
that meet minimum standards for facilities modeled in part on professional
society statements on competency. All facilities must meet our standards in
order to receive coverage for bariatric surgery procedures. On February 21,
2006, we issued our decision memorandum on bariatric surgery procedures.
We detennined that bariatric surgical procedures are reasonable and
necessary for Medicare beneficiaries who have a body-mass index (BMI)
greater than or equal to 35, have at least one co-morbidity related to obesity
and have been previously unsuccessful with medical treatment for obesity.
This decision also stipulated that covered bariatric surgery procedures are
reasonable and necessary only when performed at facilities that are: (1)
certified by the American College of Surgeons (ACS) as a Levell Bariatric
Surgery Center (program standards and requirements in effect on February
15, 2006); or (2) certified by the American Society for Bariatric Surgery
(ASBS) as a Bariatric Surgery Center of Excellence (ESCOE) (program
standards and requirements in effect on February 15, 2006).
There were no additions, deletions, or editorial changes to
Medicare-approved facilities that meet CMS' s Ininimum facility standards
for bariatric surgery that have been certified by ACS and/or ASMBS in the
3-month period. This infonnation is available at
www. ems. gov/MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For
questions or additional information, contact Saral1 Fulton, MHS
(410-786-2749).
Addendum XV: FDG-PET for Dementia and Neurodegenerative
Diseases Clinical Trials (October through December 2016)
There were no FDG-PET for Dementia and Neurodegenerative
Diseases Clinical Trials published in the 3-month period.
This information is available on our website at
www. ems. gov/MedicareApprovedF acilitie/PETDT/list.asp#TopOfPage.
For questions or additional information, contact Stuart Caplan, RN, MAS
(410-786-8564 ).
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
14:10 Feb 22, 2017
Provider
Number
11469
EN23FE17.012
11470
Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
[FR Doc. 2017–03559 Filed 2–22–17; 8:45 am]
BILLING CODE 4120–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10282]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; the accuracy of
the estimated burden; ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by March 27, 2017.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806, or Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
rmajette on DSK2TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:10 Feb 22, 2017
Jkt 241001
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Conditions of
Participation for Comprehensive
Outpatient Rehabilitation Facilities
(CORFs) and Supporting Regulations;
Use: The Conditions of Participation
(CoPs) and accompanying requirements
specified in the regulations are used by
our surveyors as a basis for determining
whether a comprehensive outpatient
rehabilitation facility (CORF) qualifies
to be awarded a Medicare provider
agreement. We believe the health care
industry practice demonstrates that the
patient clinical records and general
content of records are necessary to
ensure the well-being and safety of
patients and that professional treatment
and accountability are a normal part of
industry practice. Form Number: CMS–
10282 (OMB control number: 0938–
1091); Frequency: Yearly; Affected
Public: Business or other for-profit and
Not-for-profit institutions; Number of
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Respondents: 509; Total Annual
Responses: 509 Total Annual Hours:
6,815. (For policy questions regarding
this collection contact Jacqueline Leach
at 410–786–4282.)
Dated: February 16, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–03453 Filed 2–22–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: National Survey of Child and
Adolescent Well-Being-Third Cohort
(NSCAW III): Data Collection.
OMB No.: 0970–0202.
Description: The Administration for
Children and Families (ACF) within the
U.S. Department of Health and Human
Services (HHS) intends to collect data
on a third cohort of children and
families for the National Survey of Child
and Adolescent Well-Being (NSCAW
III). NSCAW is the only source of
nationally representative, longitudinal,
firsthand information about the
functioning and well-being, service
needs, and service utilization of
children and families who come to the
attention of the child welfare system.
Information is collected about children’s
cognitive, social, emotional, behavioral,
and adaptive functioning, as well as
family and community factors that are
likely to influence their functioning.
Family service needs and service
utilization also are addressed in the data
collection.
A previous notice provided the
opportunity for public comment on the
proposed Phase 1 recruitment and
sampling process (FR V.81, 4/8/2016).
This notice is specific to the Phase 2
data collection activities: (1) Baseline
and (2) 18-month follow-up data
collection. Data collection includes
child interviews and direct assessments,
as well as caregiver and caseworker
interviews. The overall goal is to
maintain the strengths and continuity of
the prior surveys while better
positioning the study to address changes
in the child welfare population.
Respondents: Children, and their
associated caregivers and caseworkers.
E:\FR\FM\23FEN1.SGM
23FEN1
Agencies
[Federal Register Volume 82, Number 35 (Thursday, February 23, 2017)]
[Notices]
[Pages 11456-11470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03559]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9100-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--October Through December 2016
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This quarterly notice lists CMS manual instructions,
substantive and interpretive regulations, and other Federal Register
notices that were published from October through December 2016,
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] TN23FE17.000
I. Background
The Centers for Medicare & Medicaid Services (CMS) is responsible
for administering the Medicare and Medicaid programs and coordination
and oversight of private health insurance. Administration and oversight
of these programs involves the following: (1) Furnishing information to
Medicare and Medicaid beneficiaries, health care providers, and the
public; and (2) maintaining effective communications with CMS regional
offices, state governments, state Medicaid agencies, state survey
[[Page 11457]]
agencies, various providers of health care, all Medicare contractors
that process claims and pay bills, National Association of Insurance
Commissioners (NAIC), health insurers, and other stakeholders. To
implement the various statutes on which the programs are based, we
issue regulations under the authority granted to the Secretary of the
Department of Health and Human Services under sections 1102, 1871,
1902, and related provisions of the Social Security Act (the Act) and
Public Health Service Act. We also issue various manuals, memoranda,
and statements necessary to administer and oversee the programs
efficiently.
Section 1871(c) of the Act requires that we publish a list of all
Medicare manual instructions, interpretive rules, statements of policy,
and guidelines of general applicability not issued as regulations at
least every 3 months in the Federal Register.
II. Format for the Quarterly Issuance Notices
This quarterly notice provides only the specific updates that have
occurred in the 3-month period along with a hyperlink to the full
listing that is available on the CMS Web site or the appropriate data
registries that are used as our resources. This is the most current up-
to-date information and will be available earlier than we publish our
quarterly notice. We believe the Web site list provides more timely
access for beneficiaries, providers, and suppliers. We also believe the
Web site offers a more convenient tool for the public to find the full
list of qualified providers for these specific services and offers more
flexibility and ``real time'' accessibility. In addition, many of the
Web sites have listservs; that is, the public can subscribe and receive
immediate notification of any updates to the Web site. These listservs
avoid the need to check the Web site, as notification of updates is
automatic and sent to the subscriber as they occur. If assessing a Web
site proves to be difficult, the contact person listed can provide
information.
III. How To Use the Notice
This notice is organized into 15 addenda so that a reader may
access the subjects published during the quarter covered by the notice
to determine whether any are of particular interest. We expect this
notice to be used in concert with previously published notices. Those
unfamiliar with a description of our Medicare manuals should view the
manuals at https://www.cms.gov/manuals.
Dated: February 16, 2017.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P
[[Page 11458]]
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[[Page 11459]]
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[[Page 11460]]
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[[Page 11461]]
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[[Page 11462]]
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[[Page 11463]]
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[[Page 11464]]
[GRAPHIC] [TIFF OMITTED] TN23FE17.007
[[Page 11465]]
[GRAPHIC] [TIFF OMITTED] TN23FE17.008
[[Page 11466]]
[GRAPHIC] [TIFF OMITTED] TN23FE17.009
[[Page 11467]]
[GRAPHIC] [TIFF OMITTED] TN23FE17.010
[[Page 11468]]
[GRAPHIC] [TIFF OMITTED] TN23FE17.011
[[Page 11469]]
[GRAPHIC] [TIFF OMITTED] TN23FE17.012
[[Page 11470]]
[FR Doc. 2017-03559 Filed 2-22-17; 8:45 am]
BILLING CODE 4120-01-C