Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2014, 5537-5551 [2015-01904]
Download as PDF
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2015–01856 Filed 1–27–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Meeting of the Community Preventive
Services Task Force
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)
announces the next meeting of the
Community Preventive Services Task
Force (Task Force). The Task Force is an
independent, nonpartisan, nonfederal,
and unpaid panel. Its members
represent a broad range of research,
practice, and policy expertise in
prevention, wellness, health promotion,
and public health, and are appointed by
the CDC Director. The Task Force was
convened in 1996 by the Department of
Health and Human Services (HHS) to
identify community preventive
programs, services, and policies that
increase healthy longevity, save lives
and dollars and improve Americans’
quality of life. CDC is mandated to
provide ongoing administrative,
research, and technical support for the
operations of the Task Force. During its
meetings, the Task Force considers the
findings of systematic reviews on
existing research and issues
recommendations. Task Force
recommendations provide information
about evidence-based options that
decision makers and stakeholders can
consider when determining what best
meets the specific needs, preferences,
available resources, and constraints of
their jurisdictions and constituents. The
Task Force’s recommendations, along
with the systematic reviews of the
scientific evidence on which they are
based, are compiled in The Guide to
Community Preventive Services
(Community Guide).
DATES: The meeting will be held on
Wednesday, February 25, 2015 from
8:30 a.m. to 6:00 p.m. EST and
Thursday, February 26, 2015 from 8:30
a.m. to 1:00 p.m. EST.
ADDRESSES: The Task Force Meeting
will be held at CDC Edward R. Roybal
Campus, Tom Harkin Global
Communications Center (Building 19),
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SUMMARY:
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1600 Clifton Road NE., Atlanta, GA
30333. You should be aware that the
meeting location is in a Federal
government building; therefore, Federal
security measures are applicable. For
additional information, please see
Roybal Campus Security Guidelines
under SUPPLEMENTARY INFORMATION.
Information regarding meeting logistics
will be available on the Community
Guide Web site
(www.thecommunityguide.org).
Meeting Accessibility: This meeting is
open to the public, limited only by
space availability in the meeting
location. All meeting attendees must
RSVP to ensure the required security
procedures are completed to gain access
to the CDC’s Global Communications
Center.
U.S. citizens must RSVP by 2/15/
2015.
Non U.S. citizens must RSVP by 2/9/
2015 due to additional security steps
that must be completed.
In addition to in-person participation,
individuals may view presentations via
live video stream on the Internet. Those
interested in accessing the live stream
must also RSVP, and additional
information will be sent to registrants
requesting connectivity via the Internet
in advance of the meeting. Failure to
RSVP by the dates identified could
result in an inability to attend the Task
Force meeting due to the strict security
regulations on federal facilities.
For Further Information and to RSVP
Contact: Terica Scott, The Community
Guide Branch; Division of
Epidemiology, Analysis, and Library
Services; Center for Surveillance,
Epidemiology and Laboratory Services;
Office of Public Health Scientific
Services; Centers for Disease Control
and Prevention, 1600 Clifton Road, MS–
E–69, Atlanta, GA 30333, phone: (404)
498–6360, email: CPSTF@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The purpose of the meeting
is for the Task Force to consider the
findings of systematic reviews and issue
findings and recommendations. Task
Force recommendations provide
information about evidence-based
options that decision makers and
stakeholders can consider when
determining what best meets the
specific needs, preferences, available
resources, and constraints of their
jurisdictions and constituents.
Matters To Be Discussed:
Vaccinations, Obesity, Cardiovascular
Disease, and Health Equity. Topics are
subject to change.
Roybal Campus Security Guidelines:
The Edward R. Roybal Campus is the
headquarters of the U.S. Centers for
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5537
Disease Control and Prevention and is
located at 1600 Clifton Road NE.,
Atlanta, Georgia. The meeting is being
held in a Federal government building;
therefore, Federal security measures are
applicable.
All meeting attendees must RSVP by
the dates outlined under Meeting
Accessability. In planning your arrival
time, please take into account the need
to park and clear security. All visitors
must enter the Roybal Campus through
the entrance on Clifton Road. Your car
may be searched, and the guard force
will then direct visitors to the
designated parking area. Upon arrival at
the facility, visitors must present
government issued photo identification
(e.g., a valid federal identification
badge, state driver’s license, state nondriver’s identification card, or passport).
Non-United States citizens must
complete the required security
paperwork prior to the meeting date and
must present a valid passport, visa,
Permanent Resident Card, or other type
of work authorization document upon
arrival at the facility. All persons
entering the building must pass through
a metal detector. Visitors will be issued
a visitor’s ID badge at the entrance to
Building 19 and may be escorted to the
meeting room. All items brought to
HHS/CDC are subject to inspection.
Dated: January 27, 2015.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2015–01875 Filed 1–30–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–9088–N]
Medicare and Medicaid Programs;
Quarterly Listing of Program
Issuances—October Through
December 2014
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice lists
CMS manual instructions, substantive
and interpretive regulations, and other
Federal Register notices that were
published from October through
December 2014, relating to the Medicare
and Medicaid programs and other
programs administered by CMS.
FOR FURTHER INFORMATION CONTACT: It is
possible that an interested party may
SUMMARY:
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Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
need specific information and not be
able to determine from the listed
information whether the issuance or
regulation would fulfill that need.
Consequently, we are providing contact
persons to answer general questions
concerning each of the addenda
published in this notice.
I. Background
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.
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.
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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’’
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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: January 23, 2015.
Kathleen Cantwell,
Director, Office of Strategic Operations and
Regulatory Affairs.
BILLING CODE 4120–01–P
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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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Addendum 1: Medicare and Medicaid Manual Instructions
(October through December 2014)
The CMS Manual System is used by CMS program components,
partners, providers, contractors, Medicare Advantage organizations, and
State Survey Agencies to administer CMS programs. It offers day-to-day
operating instructions, policies, and procedures based on statutes and
regulations, guidelines, models, and directives. In 2003, we transformed the
CMS Program Manuals into a web user-friendly presentation and renamed
it the CMS Online Manual System.
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How to Obtain Manuals
The Internet-only Manuals (IOMs) are a replica of the Agency's
official record copy. Paper-based manuals are CMS manuals that were
officially released in hardcopy. The majority of these manuals were
transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub
15-2 and Pub 45 are exceptions to this rule and are still active paper-based
manuals. The remaining paper-based manuals are for reference purposes
only. If you notice policy contained in the paper-based manuals that was
not transferred to the 10M, send a message via the CMS Feedback tool.
Those wishing to subscribe to old versions ofCMS manuals should
contact the National Technical Information Service, Department of
Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703605-6050). You can download copies of the listed material free of charge
at: !lliJQ.;LL9!!;~1Y!.Illi!Il!!illi1'.
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
arrangements to transfer material to a local library not designated as an
FDL. Contact any library to locate the nearest FDL. This information is
available at=~'-'-'-~'-'-"'"==~==:.=In addition, individuals may contact regional depository libraries
that receive and retain at least one copy of most federal government
publications, either in printed or microfilm fonn, for use by the general
public. These libraries provide reference services and interlibrary loans;
however, they are not sales outlets. Individuals may obtain information
about the location of the nearest regional depository library from any
library. CMS publication and transmittal numbers are shown in the listing
entitled Medicare and Medicaid Manual Instructions. To help FDLs locate
the materials, use the CMS publication and transmittal numbers. For
example, to find the Medicare Coverage of Ultrasound Screening for
Abdominal Aortic Aneurysms (AAA) and Screening Fecal-Occult Blood
Tests (FOBT) Coverage Criteria use CMS-Pub. 100-02,
Transmittal No. 196.
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 usc 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 YJ.J~~~~!_!!_~~~~·
Transmittal
Number
Manual/Subject/Publication Number
15,\' ~;;~j ~\'~ 1:''~: ;\;\~;~\'~,
<•.· \;\ ''\\".
\c\\ii:c'.~!i,
None
If'>'' c;~~~,, '+;. ;•i'\Fi~'~''~l')•?
195
196
197
198
\\,~\\(; ~':i:~.i. •;;, ~~ '[\i\\;
Issued to a specific audience, not posted to Internetllntranet due to Sensitivity
of Instruction
Medicare Coverage of Ultrasound Screening for Ahdominal Aortic
Aneurysms (AAA) and Screening Fecal-Occult Blood Tests (FOBT)
Coverage Criteria
Issued to a specific audience, not posted to lnternetllntranet due to Sensitivity
of Instruction
Medicare Coverage ofltems and Services in Category A and B
Investigational Device Exemption (IDE) Studies
Coverage of Medical Devices
Food and Drug Administration (FDA)-Approved Investigational Device
Exemption (IDE) Studies
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
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: January 31,2014 (79 FR 5419), April25, 2014 (79 FR 22976), July 25,
2014 (79 FR 43475) and November 14, 2014 (79 FR 68253). For the
purposes of this quarterly notice, we are providing only the specific updates
that have occurred in the 3-month period along with a hyperlink to the
website to access this information and a contact person for questions or
additional information.
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202
i~'[\ii;i\
175
176
177
178
RHCs and FQHCs Billing Under the AIR
RHC Per-Visit Payment Limit and Exceptions
FQHC Per-Visit Payment Limit
FQHCs Billing Under the PPS Payment Rate and Adjustments
Payment Codes for FQHCs Billing Under the PPS
Cost Reports
Productivity Standards
RIIC and FQIIC Patient Charges, Coinsurance, Deductible and Waivers
Charges and Waivers
Graduate Medical Education
Transitional Care Management (TCM) Services
Services and Supplies Furnished Incident to Physician's Services
Provision ofincident to Services and Supplies
Payment for Incident to Services and Supplies
Nurse Practitioner, Physician Assistant, and Certified Nurse Midwife Services
Outpatient Mental Ilealth Treatment Limitation
Physical and Occupational Therapy
Description of Visiting Nursing Services
Requirements of Visiting Nursing Services
Home Health Agency Shortage Area
Tclchcalth Services
Preventive Health Services
Preventive Health Services in RHCs
Copayment and Deductible for RliC Preventive I Icalth Services
Preventive Health Services in FQHCs
FQHC General Information
Modifications to Medicare Part B Coverage of Pneumococcal Vaccinations
Immunizations
;: ;';\',}:;!,~~i!i~i:.t.
Intensive Cardiac Rehabilitation Program - Benson-Henry Institute Cardiac
Wellness Program
Medicare Coverage of Ultrasound ~crcening for Abdominal Aortic
Aneurysms (AAA) and Screening Fecal-Occult Blood Tests (FOBT)
Colorectal Cancer Screening Tests
Screening for Hepatitis C Virus (HCV) in Adults
Issued to a specific audience, not posted to lnternet/Intranet due to Sensitivity
of Instruction
,i;;;t;; :::~;·.~~~~t~'g.j
;;}:;::: \{'jt;.; •;:·t~:tt.'"'').;;;:; • ,i;·
3083
Form CMS-1500 Instructions: Revised for Form Version 02/12
Items 14-33 Provider of Service or Supplier Information
Items l-11 Patient and Insured Information
Items II a-13 Patient and Insured Information
Health Insurance Claim Form CMS-1500
3084
Intensive Cardiac Rehabilitation Program - Benson-Henry Institute Cardiac
Wellness Program
Requirements for CR and ICR Services on Institutional Claims
3085
Update to Pub. I 00-04, Chapter 17 to Provide Language-Only Changes for
Updating ICD-10 and ASC Xl2
Claims Processing Requirements -General
Billing Drugs Electronically- NCPDP
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
199
Medicare Requirements for Coverage of Items and Services in FDAApproved Category A and B IDE Studies
Payment for Items and Services in Categmy A and B IDE Studies
FDA Withdrawal of IDE Approval or Change in Categorization
1611 0/General Exclusions from Coverage
Re-evaluation of FDA-approved IDE Device Categorization Decision
Hospital Institutional Review Board (IRB) Approved Non-significant Risk
Devices
14/30.1/Payment for Hospital IRB Approved Non-significant Risk Devices
Services Related to and Required as a Result of Services Which are Not
Covered Under Medicare Confidentiality of IDE Information
Implementation of Changes in the End-Stage Renal Disease Prospective
Payment System (ESR[) PPS) for Calendar Year (CY) 2015
ESRD PPS Case-Mix Adjustments
Renal Dialysis Items and Services
Laboratory Services
Drugs and Biologicals
Definitions Relating to ESRD
Home Dialysis Items and Services
Equipment and Supplies
Other Services
ESRD Prospective Payment System (PPS) Base Rate
Home Dialvsis Training
Implementation of Changes in the End-Stage Renal Disease Prospective
Payment System (ESRD PPS) for Calendar Year (CY) 2015
Definitions Relating to ESRD
Renal Dialysis Items and Services
Laboratory Services
ESRD PPS Case-Mix Adjustments
Equipment and Supplies
Home Dialysis Items and Services
Home Dialysis Training
Other Services
ESRD Prospective Payment System (PPS) Base Rate
Drugs and Biologicals
Medicare Benefit Policy Manual- RHC and FQHC Update- Chapter 13
RHC General Information
Copayment for FQHC Preventive Health Services
Requirements
FQHC Staffing
RHC and FQHC Visits
Location
Hours of Operation
Multiple Visits on Same Day and Exceptions
Global Billing
RHC Services
FQHC Services
Non RHC/FQHC Services
Description of Non RHC/FQHC Services
RHC and FQHC Payment Rates, Exceptions, and Adjustments
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Consistency Edits for Institutional Claims
2015 Annual Update for the Health Professional Sh01tage Area (HPSA)
Bonus Payments
2015 Annual Update ofHealthcare Common Procedure Coding System
(HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing
(CB) Update
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instmction
Ambulance Inflation Factor for CY 2015 and Productivity Adjustment
Ambulance Inflation Factor (AJF)
Update to Pub. 100-04 Chapter 13 to Provide Language-Only Changes for
Updating ICD-10 and ASC Xl2 lCD Coding for Diagnostic Tests
AlB MAC (A)Payment for Low Osmolar Contrast Material (LOCM)
(Radiology)
Special Billing Instructions for RHCs Payment Requirements
Medicare Summary Notices (MSN), Reason Codes, and Remark Codes
Billing Instructions
Coverage for PET Scans for Dementia and Neurodegenerative Diseases
Payment Methodology and HCPCS Coding
Billing and Coverage Changes for PET Scans
Billing and Coverage Changes tor PET Scans tor Cervical Cancer Effective
tor Services on or After November I 0, 2009
Billing and Coverage Changes for PET (l\'aF-18) Scans to IdentifY Bone
Metastasis of Cancer Effective for Claims With Dates of Services on or After
February 26,2010
EMC Formats
Billing Requirements for CMS - Approved Clinical Trials and Coverage
With Evidence Development Claims tor PET Scans tor Neurodegcnerative
Diseases,
Previously Specitied Cancer Indications, and All Other Cancer Indications
Not Previously Specified
Annual Medicare Physician Fcc Schedule (MPFS) Files Delivery and
Implementation
Issued to a specific audience, not posted to lnternet/lntranet due to Sensitivity
oflnstruction
Issued to a specific audience, not posted to Internet/lntranet due to Sensitivity
of Instruction
Issued to a specitic audience, not posted to Internet/Intranet due to Sensitivity
ofinstruction
Medicare Coverage of Ultrasound Screening for Abdominal Aortic
Aneurysms (AAA) and Screening Fecal-Occult Blood Tests (FOBT)
Coverage
Initial Preventive Physical Examination (IPPE) and Annual Wellness Visit
(AWV)
Initial Preventive Physical Examination (IPPE)
Ultrasound Screening for Abdominal Aortic Aneurysm (AAA)
Detinitions
HCPCS Codes, Frequency Requirements, and Age Requirements (lf
Applicable)
October Update to the CY 2014 Medicare Physician Fee Schedule Database
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
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MS~/Claim Adjustment Message Codes for Oral Cancer Drug Denials
HCPCD Codes for Oral Anti-Emetic Urugs
Submitting the Prescription Order Numbers and No Pay Modi tiers
Billing and Payment Instructions for AlB MACs (A)
Requirements for Billing A/B MAC (A) for Immunosuppressive Drugs
MSN/Remittance Messages for Immunosuppressive Drugs
Intravenous Immune Globulin
Claims Processing Rules for ESAs Administered to Cancer Patients for AntiAnemia Therapy
Hospital Outpatient Payment Under OPPS for New, Unclassified Drugs and
Biologicals After FDA Approval But Before Assignment of a ProductSpecit1c Drug or Biological HCPCS Code
Hospital Billing For Take-Home Drugs
The Competitive Acquisition Program (CAP) for Drugs and Biologicals Not
Paid on a Cost or Prospective Payment Basis
Denial/Claim Adjustment and Remark Messages for Anti-Emetic Drugs
Update to Pub. l 00-04, Chapter l to Provide Language-Only Changes for
Updating JCD-10 and ASC X12
Foreword
Formats for Submitting Claims to Medicare
Electronic Submission Requirements
Paper Formats for Institutional Claims
Paper Formats for Professional and Supplier Claims
Remittance Advices
Payment Jurisdiction Among Local A/B MACs tor Services Paid Onder the
Physician Fee Schedule
Claims Processing Instructions for Payment Jurisdiction
Payment to Physician or Other Supplier for Diagnostic Tests Subject to the
Anti-0 1/Markup Payment Limitation/ Claims Submitted to AlB MACs (B)
Billing Procedures for Entities Qualified to Receive Payment on Basis of
Reassignment/ for A/B MACs(B) Processed Claims
Rilling for Diagnostic Tests (Other Than Clinical Diagnostic Lahoratory
Tests) Subject to the Anti-Markup Payment Limitation/ Claims Submitted to
AB/MACs(B)
Billing Form as Request for Payment
Beneficiary Request for Payment on Provider Record Institutional Claims
ASC Xl2 837 Institutional Claim Format and Form CMS 1450
Definition of a Claim for Payment
Policy and Billing Instructions for Condition Code 44
General Information on Non-covered Charges on Institutional Claims
Determining Start Date of Timely Filing Period-- Date of Service
Form Prcscrib~:d by CMS
In Accordance with CMS Instructions
Handling Incomplete or Invalid Submissions
Claims Forms C'viS 1490S and CMS-1450
Conditional Data Element Requirements for AlB MACs (B) and DME
MACs
B MAC(B) Specific Requirements for Certain Specialties/ Services
Payer Only Codes Utilized by Medicare
Inpatient Pmt A Hospital Adjustment Bills
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Billing Requirements for Providers Billing for Routine Care Items and
Services in Category A IDE Studies
Investigational Device Exemption (IDE) Studies
Implementing the Payment Policies related to Patient Status fi·mn
CMS-1599-F
Inpatient Part B Hospital Services
Medicare Shared Systems Modifications Necessary to Capture various
HIP AA compliant fields
Payments on the MPFS for Providers With Multiple Service Locations
Issued to a speci fie 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 lo a sped lie audience, not posted to Intcrnclllnlranet uuc to
Conlidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of lnstmction
Issued to a specific audience, not posted to lnternet/Intranet due to
Confidentiality of Instruction
Issued to a specilic audience, not posted to Internet/lntranet due to
Conlidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Moditlcations to the National Coordination of Benefits Agreement (CORA)
Crossover Process
Claims Crossover Disposition and Coordination of Benefits Agreement ByPass Indicators
Elimination of the 50/50 Payment Rule for Laboratory Services on End Stage
Renal Disease (ESRD) Claims Lab Services
Automated Multi-Channel Chemistry (AMCC) Tests for ESRD
Beneliciaries
Issued to a specilic audience, not posted to Internet/Intranet due to
Confidentiality of lnstmction
Correction to Remittance Messages When Hospice Claims are Reduced Due
to Late Filing of the Notice of Election.
Data Required on the Institutional Claim to Medicare Contractor Notice of
Election (NOE)- Form CMS 1450
Issued to a specific audience, not posted to Internet/lntranet due to
Confidentiality of lnstmction
Therapy Cap Values for Calendar Year (CY) 2015
20 15 Annual Update to the Therapy Code List
Issued to a specific audience, not posted to Internet/lntranet due to
Confidentiality of lnstmction
October Quarterly Update for 2014 Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS) Fee Schedule
2015 Healthcare Common Procedure Coding System (HCPCS) Annual
Update Reminder
Implementation of Changes in the End-Stage Renal Disease Prospective
Payment System (ESRD PPS) tor Calendar Year (CY) 2015
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
3099
(MPFSDB)
Reporting the Service Location National Provider ldentitier (NPl) on AntiMarkup and Reference Laboratory Claims
3099Payment Jurisdiction for Services Subject to the Anti-Markup Payment
Limitation
Diagnostic Tests Subject to the Anti-Markup Payment Limitation
Billing for Diagnostic Tests (Other Than Clinical Diagnostic Laboratory
Tests) Subject to the Anti-Markup Pa)ment Limitation/Claims Submitted to
A/B MACs (B)
Conditional Data Element Requirements lor AlB MACs (B) and
DMEMACs
Carrier Specific Requirements for Certain Specialties/Services
Paper Claim Submission To Can·iers/B MACs (B)
Electronic Claim Submission to Carriers/B MACs B)
Items 14-33 -Provider of Service or Supplier Information
Payment to Physician or Other Supplier fur Diagnostic Tests Subject to the
Anti-Markup Payment Limitation - Claims Submitted to AlB MACs (B)
Instructions for Retrieving the 2015 Pricing and HCPCS Data Files through
CMS' Mainframe Telecommunications Systems
Issued to a specific audience, not posted to lnternet/lntranet due to Sensitivity
oflnstruction
Issued to a specilic audience, not posted to lnternet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Reporting the Service I "ocation National Provider ldentitler (NPI) on AntiMarkup and Reference Laboratmy Claims
Payment Jurisdiction for Services Subject to the Anti-Markup Payment
Limitation
Diagnostic Tests Subject to the Anti-Markup Payment Limitation
Billing tor Diagnostic Tests (Other Than Clinical Diagnostic Laboratory
Tests)
Subject to the Anti-Markup Payment Limitation/Claims Submitted to A/B
MACs(B)
Conditional Data Element Requirements for A/B MACs (B) and
DMEMACs
Carrier Specific Requirements for Certain Specialties/Services
Paper Claim Submission To Carricrs/B MACs (B)
Electronic Claim Submission to Carriers/B MACs B)
Items 14-33- Provider of Service or Supplier Information
Payment to Physician or Other Supplier for Diagnostic Tests Subject to the
Anti- Markup Payment Limitation- Claims Submitted to AlB MACs (B)
Correction to Remittance Information When HIPPS Codes are Re-ceded by
Medicare Systems
Decision Logic Used by the Pricer on Claims HI-I PPS Claims
Adjustments of Episode Payment - Contirming OASl S Assessment Items
Medicare Coverage of Items and Services in Category A and B
Investigational Device Exemption (IDE) Studies
Billing Requirements for Providers Billing for Category BIDE Devices and
Routine Care Items and Services in Category B IDE Studies
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3140
3141
3142
3143
3144
3145
3146
for Obesity, Screening Digital Tomosynthesis Mammography, and Anesthesia
Associated with Screening Colonoscopy
3147
Calendar Year (CY) 2015 Rural Health Clinic (RHC) and Federally Qualified
Health Centers (FQHC) Updates: Payment Rate Increases for RHCs and
FQHCs Billing Under the All-Inclusive Rate System (AIR) and Urban and
Rural Designations for FQHCs Billing Under the AIR
2015 Durable Medical Equipment Prosthetics, Orthotics, and Supplies
3148
Hcalthcare Common Procedure Coding System (HCPCS) Code Jurisdiction
List
3149
New Waived Tests
3150
January 2015 Update of the Hospital Outpatient Prospective Payment System
(OPPS) Billing tor "Sometimes Therapy" Services that May be Paid as NonTherapy Services for ll ospital Outpatients Packaging
Billing for Linear Accelerator (Robotic Image-Guided and Non-Robotic
!mage-Guided) SRS Planning and Delivery Comprehensive APCs
3151
Correction to Remittance Information When HIPPS Codes are Re-coded by
Medicare Systems
Adjustments of Episode Payment- Confirming OASIS Assessment Items
HH PPS Claims
Decision Logic Used by the Pricer on Claims
Calendar Year (CY) 2015 Annual Update for Clinical Laboratory Fee
3152
Schedule and Laboratory Services Subject to Reasonable Charge Payment
January 2015 Integrated Outpatient Code Editor (l!OCE) Specifications
3153
Version 16.0
3154
Automation ofthe Request tor Reopening Claims Process Application to
Special Claim Types
3155
Issued to a specific audience not posted to Internet/ Intranet due to
Confidentiality of lnstmction
January 2015 Update of the Hospital Outpatient Prospective Payment System
3156
(OPPS)
Billing for "Sometimes Therapy" Services that May be Paid as Non-Therapy
Services for Hospital Outpatients Packaging
Billing for Linear Accelerator (Robotic Image-Guided and Non-Robotic
Image-Guided) SRS Planning and Delivery Comprehensive APCs
3157
Summary ofPolicies in the CY 2015 Medicare Physician Fee Schedule
(MPFS) Final Rule and Telehealth Originating Site Facility Fee Payment
Amount
January 2015 Update of the Ambulatory Surgical Center (ASC) Payment
3158
System
Modifications to Medicare Part B Coverage of Pneumococcal Vaccinations
3159
Roster Claims Submitted to Carriers/ AH MACs tor Mass Immunization
Pneumococcal Vaccine
'~> .,,,,,,,,;:,;,!,:~; S~il'~;i:l
•.• ••;v; .•''i\ •• !c<:;;; . . '.~ ~ ;\i~,~~;• .:
105
Electronic Correspondence Referral System (ECRS) notification regarding
Defense of Marriage Act (DOMA) and ICD-10 changes COBC Electronic
Correspondence Referral System (ECRS)
Medicare Secondary Payer (MSP) Uroup Health Plan (UHP) Working Aged
106
Policy-- Definition of"Spouse"; Same-Sex Marriages
Delinitions Working Aged
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
3126
Required Information for In-Facility Claims Paid Under the Composite Rate
and the ESRD PPS
Issued to a specific audience, not posted to lnternet/Intranct due to
Conlidentiality of Instruction
Screening for Hepatitis C Virus (HCV) in Adults
Common Working File (CWF) Edits
Institutional Billing Requirements
Professional Billing Requirements
Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark
Codes (RARCs), Group Codes, and Medicare Summary Notice (MS\f)
Messages
Screening for Hepatitis C Virus (HCV
Issued to a specitic audience, not posted to Internetllntranet due to
Confidentiality oflnstmction
CY 2015 Update for Durable Medical Equipment, Prosthetics, Orthotics and
Supplies (DMEPOS) Fee Schedule
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
ofTnstruction
Common Edits and Enhancements Modules (CEM) Code Set Update
Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 21.1,
Ellective April!, 2015
Issued to a specific audience, not posted to Internet/ Intranet due to
Confidentiality of Instruction
Instmctions for Downloading the Medicare ZIP Code File for April 2015
Implement Operating Rules- Phase Ill ERA EFT: CORE 360 Uniform Usc of
Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark
Codes (RARC) Rule- Update from CAQH CORE
Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics
and Supplies (DMEPOS) Competitive Biddin<> Program (CBP)- April 2015
Issued to a specific audience, not posted to Internet/ Intranet due to
Conlidentiality oflnstmction
Fiscal Year (FY) 2015 Inpatient Prospective Payment System (lPPS) and
Long Term Care Hospital (LTCH) PPS Changes
Implementation of Changes in the End-Stage Renal Disease Prospective
Payment System (ESRD PPS) for Calendar Year (CY) 2015
Required Information for In-Facility Claims Paid Under the Composite Rate
and the ESRD PPS
Home Health Prospective Payment System (HH PPS) Rate Update for
Calendar Year (CY) 2015
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 Sensitivity
of Instruction
Claim Status Category and Claim Status Codes Update
Medicare Physician Fee Schedule Database (MPFSDB) 2015 File Layout
Manual Addendum
Home Health Prospective Payment System (HH PPS) Rate Update tor
Calendar Year (CY) 201 S
Preventive and Screening Services · ·· Update- Intensive Behavioral Therapy
5543
EN02FE15.005
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123
124
EN02FE15.006
:::,,;;J::; 't;');;:,;;•,;,
125
126
127
128
129
130
~~>%~~;\\!:;
Notice of :--Jew Interest Rate for Medicare Overpayments and Underpayments
-1st Qtr Notfication for FY 2015
Revisions to State Operations Manual (SOM), Appendix W, Interpretive
Guidelines for Critical Access Hospitals
559
560
Revisions to State Operations Manual (SOM) Chapter 2
Revisions to State Operations Manual (SOM), Chapter 4- "Program
Administration and Fiscal Management"
Revisions to State Operations Manual (SOM), Chapter 4- "Program
Administration and Fiscal Management"
Revisions to State Operations Manual (SOM) Table of Contents Appendix J
and Appendix Table of Contents Letter J Description
State Operations Manual (SOM) Appendix Y- Organ Procurement
Organization (OPO) Interpretive Guidance Revisions to §486.318 Condition:
Outcome Measures
Revisions to State Operations Manual (SOM). Appendix PP "Guidance to
Surveyors for Long Term Care Facilities"
/i>'c:;:~>i;>l\2:~::~\
;t>
Documentation for Durable Medical Equipment Prosthetics, Orthotics and
Supplies (DMEPOS) Repair Claims. This CR rescinds and fully replaces
CR 8843.
Suppliers Documentation for DMEPOS Repair Claims
Review Timeliness Requirements for Complex Review Complex Medical
Review Requesting Additional Documentation During Prepayment and
Postpayment Review
Deletion of Program Integrity Manual Exhibit 34
Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity
of Instruction
One on One Education
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 Internet/ Intranet due to
Confidentiality of lnstrudion
New Timeframe for Response to Additional Documentation Requests TimeFrames for Submission
Issued to a specific audience, not posted to Internet/ Intranet due to
Confidentialitv oflnstruction
Revisions to Pub. 100-08, Program Integrity Manual (PIM), Chapter IS
Background
Owning and Managing Organizations
End-Stage Renal Disease Facilities (ESRDs)
Update to CMS Publication 100-08. Chapter 3, Section 3.2.3,4 (Additional
Documentation Request Required and Optional l:Ciements)
Additional Documentation Request Required and Optional Elements
Update to the Program Integrity Manual (Pub. I 00-08) Exhibit 36 Overview of the Comprehensive Error Rate Testing (CERT) Process
CERT Formats for A/B MACs (B) and DME MACs and Shared Systems
CERT Formats for AlB MAC (A) MACS and Shared Systems
Overview of the CERT Process
Issued to a specific audience not, to lnternet/Intranet due to Confidentiality of
Instruction
Program Integrity Manual Chapter 12 Revision
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
Update to Pub. I 00-05. Chapters 05 and 06 to Provide Language-Only
Changes for Updating ICD-10 and ASC Xl2
Medicare Sccondmy Payment Pm1 A Claims Determination for Services
Received on ASC X12 837 Institutional Electronic or Hard Copy Claim
Formats
Identification of Liability and No-Fault Situations
Conditional Medicare Payment
Medicare Secondary Payment Part B Claims Determination for Services
Received on ASC X 12 837 Professional Electronic Claims
Sources That May Identify Other Insurance Coverage
Inpatient Hospital Claims and Medicare Secondaty Payer (MSP) Claims with
108
Medicare Coinsurance Days and/or Medicare Lifetime Reserve
Days Occurring in the Seventh to Fifteenth Years
Return Codes
Payment Calculation for Inpatient Bills (MSPPA YAI Module)
Electronic Correspondence Referral System (ECRS) notification regarding
109
Defense of Marriage Act (DOMA) and ICD-10 changes
,, (\1:;~2/;;\}.',,;,~\
fi;.·;\; >''(,~)· ~~~i'l;:J2014
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02FEN1
562
563
564
565
;tr
•I";
None Revision of Pub. I 00-06 - Medicare Financial Management Manual,
Chapter 6 Intermediary and Carrier Financial Reports, and Pub. 100-09 Medicare Contractor Beneficiary and Provider Communications, Chapter 6Provider Customer Service Program
Reporting Provider and Beneficiary Inquiry Workload Data in the
Contractor Reporting of Operational Workload Data (CROWD)
30
lt~i.
·~~;;:'(.~ §"''\;'~,~
lJ;.\ri(!\;/;i\2.}~2'••
None
'
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1437
1439
1440
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1443
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1446
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1447
E:\FR\FM\02FEN1.SGM
1448
1449
~~~'x:~~,~~i
35
36
02FEN1
37
38
?.~~;t(•'~\!;
Issued to a specific audience not posted to
Confidentiality oflnstructions
Issued to a specific audience not posted to
Confidentiality of Instructions
Issued to a specific audience not posted to
Confidentiality oflnstructions
Issued to a specific audience not posted to
Confidentiality of Instructions
Internet/ Intranet due to
Internet/ Intranet due to
Internet/ Intranet due to
Internet/ Intranet due to
Addendum II: Regulation Documents Published
in the Federal Register (October through December 2014)
Regulations and Notices
Regulations and notices are published in the daily Federal
Register. To purchase individual copies or subscribe to the Federal
When ordering individual
Register, contact GPO at
EN02FE15.008
copies, it is necessary to cite either the date of publication or the volume
number and page number.
The Federal Register is available as an online database through
GPO Access. The online database is updated by 6 a.m. each day the
Federal Register is published. The database includes both text and
graphics from Volume 59, Number 1 (January 2, 1994) through the present
date and can be accessed at
The
following website
provides
information on how to access electronic editions, printed editions, and
reference copies.
This information is available on our website at:
For questions or additional information, contact Terri Plumb
( 410-786-4481 ).
Addendum III: CMS Rulings
CMS Rulings are decisions of the Administrator that serve as
precedent final opinions and orders and statements of policy and
interpretation. They provide clarification and interpretation of complex or
ambiguous provisions of the law or regulations relating to Medicare,
Medicaid, Utilization and Quality Control Peer Review, private health
insurance, and related matters.
The rulings can be accessed at ""f!·! 1 vv vv vv ·"!!'"·!:'", 1 """tsuu2014
Jkt 235001
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PO 00000
Frm 00046
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Medicare Coverage of
Ultrasound Screening for
Abdominal Aortic
Aneurysms (AAA) and
Screening Fecal-Occult
Blood Tests (FOBT)
Screening Hepatitis C
Virus in Adults
Transcatheter Mitral Valve
Repair (TMVR)-National
Coverage Determination
(NCD)
NCDM
Section
Transmittal
Number
Issue Date
Effective
Date
NCD210.3
R176
10/17/2014
01/24/2014
NCD210.13
Rl77
11/19/2014
06/02/2014
NCD20.33
Rl78
12/05/2014
08/07/2014
Sfmt 4725
E:\FR\FM\02FEN1.SGM
02FEN1
Addendum V: FDA-Approved Category B Investigational Device
Exemptions (IDEs) (October through December 2014)
Addendum V includes listings of the FDA-approved
investigational device exemption (IDE) numbers that the FDA assigns. The
listings are organized according to the categories to which the devices are
assigned (that is, Category A or Category B), and identified by the IDE
number. For the purposes of this quarterly notice, we list only the specific
updates to the Category 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
Ul40170
Ul40120
Gl40171
G140174
Gl40175
Ul40177
G140172
Gl30249
G140055
Gl40104
Ul40173
Device
Start Date
Syncardia Temporary Total Aliiticial Heart (TAH-T) System
10/03/2014
10/08/2014
Revanesse Ultra
10/08/2014
Juvederm Voluma XC Gel Implant
10/08/2014
Spiration Valve System Model PIV-C26N
IlluminOss Bone Stabilization System
10/08/2014
10/08/2014
Tiara Valve; Tiara Delivery System
10/09/2014
AMICUS Separator System
Rodo Abutment Svstem
10/15/2014
Oncozene Microspheres
10116/2014
Celotres
10/17/2014
A Randomize Trial Comparing Usc of Continuous Glucose
10/20/2014
Monitoring with and without Routine Blood Glucose Monitoring
in Adults with Type I Diabetes
Mcdtronic Activa PC+S
10/29/2014
U140181
TriGuard IIDII Embolic Deflection Device
10/29/2014
G140074
NovoTTF-100A System
10/30/2014
G140184
Gl40185
CompuFio Epidural Computer Controlled Anesthesia System
10/3112014
EPI 6000
G140187
Mcdtronic Activa PC+S
10/31/2014
G140189
ThermoCool SmartT ouch SF Catheter D-1347-XX-SI And D10/31/2014
1348-XX-SI
Vcntana PD-Ll (SP263) Rabbit Monoclonal Primary Antibody
Gl40188
10/31/2014
aura6000 Targeted Hypoglossal Neurostimulation (THN) System
lli06/2014
Gl40158
(y140194
11/07/2014
Lumifi With Crux Vena Cava Filter System Model 7070
Gl40198
11/07/2014
Vysis Egfr CDx Fish Kit (LISZT NO. 08N75)
Gl40199
11/07/2014
Brainsway Deep TMS Device For The Treatment of PostTraumatic Stress Disorder (PTSD)
11/13/2014
G L_4()2Q()__ L}\_c_ti_va_P_C:::-i' ]'J~ur_osti !llu!ation_System
Activa PC-S Ncurostimulation System and Ncurosiim~tlation- --rli;1472o14-G140203
Systems for DBS
G140201
11/14/2014
Pediatric Cystoscope For Use in Fetal Neural Tube Defect Repair
G140207
11!20/2014
TAAA Dcbranching Stent Graft System
G140107
11/21/2014
Bionir Ridatorolimus Eluting Coronary Stent System
G140190
11/24/2014
EXALE)JZ BREATHID LF System 13C-Mcthacetin Breath Test
U140212
11!25/2014
Self Expanding Mitral Transcatheter Heart Valve System, Model
9800
11/28/2014
Magnap (Magnetic Apnea Prevention) Device
Gl30285
XprESS Device for Eustachian Tube Dilation
12/03/2014
Gl40214
Ventana PD-Ll (SP263) Rabbit Monoclonal Primary Antibody
12/03/2014
Gl40215
Cervical Pessary
12/04/2014
G140219
12/10/2014
Med-El Maestro Cochlear Implant System
G140226
0140223
12/11/2014
Acell Matristem SurgicalMatrix PSMX-6 Layers-IOcm x !Scm
(Acell, Inc.); Boston Scientilic Walll1ex Fully Covered
Esophageal Stent
Alfapump
12/12/2014
G140126
Early Feasibility Study ofThe Networked J\europrosthesis for
Gl40225
12/12/2014
Grasp and Trunk Function in Spinal Cord Injury
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
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 list only the specific updates that have occurred in the 3-month period.
This information is available at: -~-~~--~Y..~;:-"!!.~c!O~..!.L'-!.~.~'-'-~''~-"-~-;,_'C::::!-'!l:"-".:
For questions or additional information, contact Wanda Belle
(410-786-7491).
5547
EN02FE15.009
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5548
VerDate Sep<11>2014
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Device
Gore Tag Thoracic Branch Endoprosthesis
Exalenz BreathiD For Use With C-Laeled Palmitate
Juvederm Voluma (AIIergan)
2008K(a)homc Noctumal Hemodialysis Indication
1.5T And 3.0T MRI Scanners
Bioprosthetic Mitral Valve System
Starflo Glaucoma lmplantMode192101
Doctormate Renqiao Remote Ischemic Conditioning Device
Type: IPC-906X
PO 00000
Addendum VI: Approval Numbers for Collections of Information
(October through December 2014)
Frm 00047
Fmt 4703
All approval numbers are available to the public at Reginfo.gov.
Under the review process, approved information collection requests are
assigned OMB control numbers. A single control number may apply to
several related information collections. This information is available at
For questions or additional
information, contact Mitch Bryrnan (41 0-786-5258).
Sfmt 4725
Addendum VII: Medicare-Approved Carotid Stent Facilities,
(October through December 2014)
E:\FR\FM\02FEN1.SGM
02FEN1
Addendum VII includes listings of Medicare-approved carotid
stent facilities. All facilities listed meet CMS standards for performing
carotid artery stenting for high risk patients. On March 17, 2005, we issued
our decision memorandum on carotid artery stenting. We determined that
carotid artery stenting with embolic protection is reasonable and necessary
only if performed in facilities that have been determined to be competent in
perfonning 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 infom1ation is available at:
For questions or additional information, contact Lori Ashby
( 41 0-786-6322).
EN02FE15.010
Start Date
12/17/2014
12/18/2014
12/19/2014
12/19/2014
12/19/2014
12/19/2014
12/19/2014
12/21/2014
Facility
Provider
Number
Effective
Date
050551
10/10/2014
CA
670092
10/30/2014
TX
390329
12/15/2014
PA
•,·~~;:i%•
· • •~c'';;<';!;,i>'~ ''
Los Alamitos Medical Center
3751 Katella Avenue Los Alamitos, CA 90720
Walnut Hill Medical Center
7502 Greenville Avenue Dallas, TX 75231
Einstein Medical Center Montgomery
559 West Germantown Pike
East Norriton. PA 19403
~0~'~;'t':~;,>s ,,::'A'''\'"' 0 ( .•,~,
:z;,'
Physicians Regional Health care System, Collier
Boulevard
8300 Collier Boulevard Naples, FL 34114
Physicians Regional Healthcare System, Pine
Ridge
610 I Pine Ridge Road Naples, FL 34119
FROM: Heart Hospital of New Mexico
TO: Heart Hospital of New Mexico at Lovelace
Medical Center
504 Elm StreetN.E. Albuquerque, NM 87102
FROM: Swedish Medical Center-Providence
Campus
TO: Swedish Medical Center- Cherry Hill
500 17th Avenue Seattle WA 98122
FROM: The Indiana Heart Hospital, LLC
TO: Community Heart and Vascular Hospital
1500 N. Ritter Indianapolis, IN 46219
State
,.
;•~;;:~'11~~~! ~~'~\ ;t;;,E~;,;:.
100286
04/12/2012
FL
100286
11116/2006
FL
32009
06/20/2005
NM
500025
05/23/2005
WA
15-0074
08/04/2005
I~
Addendum VIII:
American College of Cardiology's National Cardiovascular Data
Registry Sites (October through December 2014)
Addendum VIII includes a list of the American College of
Cardiology's National Cardiovascular Data Registry Sites. We cover
implantable cardioverter defibrillators (ICDs) for certain clinical
indications, as long as 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
announced that the American College of Cardiology's National
Cardiovascular Data Registry (ACC-NCDR) lCD Registry satisfies the data
reporting requirements in the NCD. Hospitals needed to transition to the
ACC-NCDR lCD Registry by April 2006.
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
IDE
Gl40230
Gl40235
Gl40229
Gl40233
Gl40234
Gl40240
G140193
GJ40239
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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 ICD
registry. The entire list of facilities that participate in the ACC-NCDR lCD
registry can be found at~'-'-'-===-=~-'-===~==
For the purposes of this quarterly notice, we are providing only the
specific updates that have occurred in the 3-month period. This information
is available by accessing our website and clicking on the link for the
American College of Cardiology's National Cardiovascular Data Registry
at:
For questions or additional
infonnation, contact Marie Casey, BSN, MPH (410-786-7861).
E:\FR\FM\02FEN1.SGM
Facility
>>'. ;,;:~; :;~';,'zf :·,'." ;
02FEN1
University of Arkansas Medical Sciences Physician
Verdugo Hills Hospital
Morris Hospital
Truman Medical Centers
Great Plains Health
St. Vincent Blount
Citizens Medical Center
Ililo Medical Center
Seton Medical Center Hays
City
Little Rock
Glendale
Morris
Kansas City
North Platte
Oneonta
Victoria
llilo
Kyle
;,~~',''iJ.;,;ii;~~;: ..i}~'i\cJ
Watsonville Community Hospital
Owensboro Health Regional Hospital
Bartow Regional Medical Center
Camden Clark Medical Center-St Joseph Campus
Carlsbad Medical Center
Bayfront Health Spring Hill
State
'.;l'> ll''~.Li;\\';i~
Watsonville
Owensboro
Bartow
Parkersburg
Carlsbad
Spring Hill
..,,.,,,,,
AR
CA
lL
MO
NE
AL
TX
Ill
TX
;,{. .\\';/•.:',;;
CA
KY
FL
wv
NM
FL
Addendum IX: Active CMS Coverage-Related Guidance Documents
(October through December 2014)
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 detenninations 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 detennination process. The document is available at
For questions or additional
information, contact JoAnna Baldwin (41 0-786-7205).
Addendum X:
List of Special One-Time Notices Regarding National Coverage
Provisions (October through December 2014)
There were no special one-time notices regarding national
coverage provisions published in the October through December 2014
quarter. This infom1ation is available at
For
questions or additional information, contact JoAnna Baldwin (410-786
7205).
Addendum XI: National Oncologic PET Registry (NOPR)
(October through December 2014)
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
perfom1ed 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
perfonned 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 ofNational Oncologic Positron Emission Tomography Registry
(NOPR) in the October through December 2014 quarter. This information is
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
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
5549
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For questions or additional information, contact Stuart Caplan, RN, MAS
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Addendum XII: Medicare-Approved Ventricular Assist Device
(Destination Therapy) Facilities (October through December 2014)
Addendum XII includes a listing of Medicare-approved facilities
that receive coverage for ventricular assist devices (VADs) used as
destination therapy. All facilities were required to meet our standards in
order to receive coverage for VADs implanted as destination therapy. On
October 1, 2003, we issued our decision memorandum on VADs for the
clinical indication of destination therapy. We determined that VADs used
as destination therapy are reasonable and necessary only if performed in
facilities that have been determined to have the experience and
infrastructure to ensure optimal patient outcomes. We established facility
standards and an application process. All facilities were required to meet
our standards in order to receive coverage for VADs implanted as
destination therapy.
For the purposes of this quarterly notice, we are providing only the
specific updates that have occurred to the list of Medicare-approved
facilities that meet our standards in the 3-month period. This information is
available at
E:\FR\FM\02FEN1.SGM
For questions or additional information, contact Marie Casey, BSN, MPH
(410-786-7861 ).
Provider Number
02FEN1
Rush University Medical Center
1653 West Congress Parkway
Chicago, IL 60612
140119
Addendum XIII: Lung Volume Reduction Surgery (LVRS)
(October through December 2014)
Addendum XIII includes a listing of Medicare-approved facilities
that are eligible to receive coverage for lung volume reduction surgery.
Until May 17, 2007, facilities that participated in the National Emphysema
Treatment Trial were also eligible to receive coverage. The following three
types of facilities are eligible for reimbursement for Lung Volume
Reduction Surgery (LVRS):
• National Emphysema Treatment Trial (NETT) approved (Beginning
05/07/2007, these will no longer automatically qualify and can qualify only
with the other programs);
• Credentialed by the Joint Commission (formerly, the Joint
Commision on Accreditation ofHealthcare Organizations (JCAHO)) under
their Disease Specific Certification Program for LVRS; and
• Medicare approved for lung transplants.
Only the first two types are in the list. There were no updates to
the listing offacilities for lung volume reduction surgery published in the
October through December 2014 quarter. This infonnation is available at
~~~~~~~~~~£W~~~~~~Ull~~~- For
questions or additional infonnation, contact Marie Casey, BSN, MPH
(410-786-7861).
Addendum XIV: Medicare-Approved Bariatric Surgery Facilities
(October through December 2014)
Addendum XIV includes a listing of Medicare-approved facilities
that meet minimum standards for facilities modeled in part on professional
society statements on competency. All facilities must meet our standards in
order to receive coverage for bariatric surgery procedures. On Fcbruary 21,
2006, we issued our decision memorandum on bariatric surgery procedures.
We determined that bariatric surgical procedures are reasonable and
necessary for Medicare beneficiaries who have a body-mass index (BMI)
greater than or equal to 35, have at least one co-morbidity related to obesity
and have been previously unsuccessful with medical treatment for obesity.
This decision also stipulated that covered barialric 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 (BSCOE) (program
standards and requirements in effect on February 15, 2006).
There were no additions, deletions, or editorial changes to
Medicare-approved facilities that meet CMS 's minimum facility standards
for bariatric surgery that have been certified by ACS and/or ASMBS in the
October through December 2014 period. This information is available at
For
questions or additional information, contact Jamie Hermansen
(410-786-2064).
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
19:24 Jan 30, 2015
EN02FE15.012
available at
Federal Register / Vol. 80, No. 21 / Monday, February 2, 2015 / Notices
Belinda Gravel, (410) 786–8934.
News media representatives must
contact CMS’ Public Affairs Office at
(202) 690–6145 or email them at press@
cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Extension of temporary
moratoria.
A. CMS’ Imposition of Temporary
Enrollment Moratoria
Section 6401(a) of the Affordable Care
Act added a new section 1866(j)(7) to
the Social Security Act (the Act) to
provide the Secretary with authority to
impose a temporary moratorium on the
enrollment of new Medicare, Medicaid
or CHIP providers and suppliers,
including categories of providers and
suppliers, if the Secretary determines a
moratorium is necessary to prevent or
combat fraud, waste, or abuse under
these programs. For a more detailed
explanation of these authorities, please
see the July 31, 2013 notice (78 FR
46339) or February 4, 2014 extension
and establishment of a temporary
moratoria document (hereinafter
referred to as the February 4, 2014
moratoria document or notice) (79 FR
6475).
Based on this authority and our
regulations at § 424.570, we have
implemented three phases of the
moratoria to date. In the notice issued
on July 31, 2013 (78 FR 46339), we
imposed moratoria on the enrollment of
home health agencies in Miami-Dade
County, Florida and Cook County,
Illinois and surrounding counties and
on the enrollment of ground ambulance
suppliers in the Harris County, Texas
area and surrounding counties. Then, in
the notice published on February 4,
2014 (79 FR 6475), we extended the
initial moratoria and imposed moratoria
on the enrollment of home health
agencies in Broward County, Florida,
Dallas County, Texas, Harris County,
Texas and Wayne County, Michigan and
surrounding counties and on the
enrollment of ground ambulance
suppliers in Philadelphia, PA and
surrounding counties. In the notice
published on August 1, 2014 (79 FR
44702), CMS extended all of the abovementioned moratoria.
This document announces the
extension of temporary moratoria on the
enrollment of new ambulance suppliers
and home health agencies (HHAs) in
specific locations within designated
metropolitan areas in Florida, Illinois,
Michigan, Texas, Pennsylvania, and
New Jersey to prevent and combat fraud,
waste, and abuse.
DATES: Effective Dates: January 29, 2015.
B. Determination of the Need for
Extending a Moratorium
In extending these enrollment
moratoria, CMS considered both
qualitative and quantitative factors
suggesting a high risk of fraud, waste, or
abuse. CMS relied on law enforcement’s
longstanding experience with ongoing
and emerging fraud trends and activities
through civil, criminal, and
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–6059–N2]
Medicare, Medicaid, and Children’s
Health Insurance Programs:
Announcement of the Extended
Temporary Moratoria on Enrollment of
Ambulance Suppliers and Home Health
Agencies in Designated Geographic
Locations
AGENCY:
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administrative investigations and
prosecutions. CMS’ determination of a
high risk of fraud, waste, or abuse in
these provider and supplier types
within these geographic locations was
then confirmed by CMS’ data analysis,
which relied on factors the agency
identified as strong indicators of risk.
(For a more detailed explanation of this
determination process and of these
authorities, see the July 31, 2013 notice
(78 FR 46339) or February 4, 2014
moratoria document (79 FR 6475)).
1. Consultation With Law Enforcement
In consultation with the HHS-Office
of Inspector General (OIG) and the
Department of Justice (DOJ), CMS
identified two provider and supplier
types in nine geographic locations that
warrant a temporary enrollment
moratorium. For a more detailed
discussion of this consultation process,
see the July 31, 2013 notice (78 FR
46339) or February 4, 2014 moratoria
document (79 FR 6475).
2. Beneficiary Access to Care
Beneficiary access to care in
Medicare, Medicaid, and CHIP is of
critical importance to CMS and its state
partners, and CMS carefully evaluated
access for the target moratorium
locations. Prior to imposing and
extending these moratoria, CMS
consulted with the appropriate State
Medicaid Agencies and with the
appropriate State Department of
Emergency Medical Services to
determine if the moratoria would create
an access to care issue for Medicaid and
CHIP beneficiaries in the targeted
locations and surrounding counties. All
of CMS’ state partners were supportive
of CMS analysis and proposals, and
together with CMS, determined that
these moratoria will not create access to
care issues for Medicaid or CHIP
beneficiaries. CMS also reviewed
Medicare data for these areas and found
there are no current problems with
access to HHAs or ground ambulance
suppliers.
3. Lifting a Temporary Moratorium
In accordance with § 424.570(b), a
temporary enrollment moratorium
imposed by CMS will remain in effect
for 6 months. (For a more detailed
explanation of how CMS can lift a
temporary moratorium, see the July 31,
2013 notice (78 FR 46339) or February
4, 2014 moratoria document (79 FR
6475)). If CMS deems it necessary, the
moratorium may be extended in 6month increments. CMS will evaluate
whether to extend or lift the moratorium
before any subsequent moratorium
periods. If one or more of the moratoria
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FOR FURTHER INFORMATION CONTACT:
5551
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[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Pages 5537-5551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9088-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--October Through December 2014
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This quarterly notice lists CMS manual instructions,
substantive and interpretive regulations, and other Federal Register
notices that were published from October through December 2014,
relating to the Medicare and Medicaid programs and other programs
administered by CMS.
FOR FURTHER INFORMATION CONTACT: It is possible that an interested
party may
[[Page 5538]]
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] TN02FE15.000
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
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: January 23, 2015.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
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