Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2014, 22976-22991 [2014-09288]
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22976
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
Medicare Integrity Contractor (NBI
MEDIC). Developed by Health Integrity,
LLC and licensed for one of its
contracts—the NBI MEDIC—PLATOTM
utilizes a cutting-edge advanced
analytics fraud detection process in
conjunction with a state-of-the-art webbased user interface tool to present
fraud and abuse lead information
visually to Medicare Part D plan
sponsors. Summary data, based on
National Prescription Drug Event Data
and actions from all Part D plan
sponsors, is shared with law
enforcement, CMS, NBI MEDIC, and
Part D plan sponsors to review historic
actions taken against providers who are
enrolled in the Medicare Part D
program, which will assist in detecting
and preventing fraud, waste, and abuse.
Form Number: CMS–10517 (OCN: 0938New); Frequency: Monthly; Affected
Public: Private sector—Business or other
for-profits and Not-for-profit
institutions; Number of Respondents:
1,550; Total Annual Responses: 1,550;
Total Annual Hours: 18,600. (For policy
questions regarding this collection
contact Delois Newkirk at 410–786–
1247).
Dated: April 22, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–09505 Filed 4–24–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–21 and CMS–
21B]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
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
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SUMMARY:
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other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) 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 May 27, 2014.
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
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.
SUPPLEMENTARY INFORMATION: 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
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publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Quarterly
Children’s Health Insurance Program
(CHIP) Statement of Expenditures for
the Title XXI Program (CMS–21) and
State Children’s Health Insurance
Program Budget Report for the Title XXI
Program State Plan Expenditures (CMS–
21B); Use: Form CMS–21 and form
CMS–21B provide CMS with the
information necessary to issue quarterly
grant awards, monitor current year
expenditure levels, determine the
allowability of state claims for
reimbursement, develop Children’s
Health Insurance Program (CHIP)
financial management information,
provide for state reporting of waiver
expenditures, and ensure that the
federally established allotment is not
exceeded. Further, these forms are
necessary in the redistribution and
reallocation of unspent funds over the
federally mandated timeframes. Form
Number: CMS–21 and CMS–21B (OCN:
0938–0731); Frequency: Quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 448; Total
Annual Hours: 7,840. (For policy
questions regarding this collection
contact Abraham John at 410–786–
4519).
Dated: April 22, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–09507 Filed 4–25–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–9085–N]
Medicare and Medicaid Programs;
Quarterly Listing of Program
Issuances—January Through March
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 January through March
2014, relating to the Medicare and
SUMMARY:
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Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
22977
Medicaid programs and other programs
administered by CMS.
FOR FURTHER INFORMATION CONTACT: It is
possible that an interested party may
need specific information and not be
able to determine from the listed
information whether the issuance or
regulation would fulfill that need.
Consequently, we are providing contact
persons to answer general questions
concerning each of the addenda
published in this notice.
I. Background
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.
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 information 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
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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.
Authority: (Catalog of Federal Domestic
Assistance Program No. 93.773, Medicare—
Hospital Insurance, Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program, and Program No. 93.714,
Medical Assistance Program)
Dated: April 16, 2014.
Kathleen Cantwell,
Director, Office of Strategic Operations and
Regulatory Affairs.
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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
various manuals, memoranda, and
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Addendum I: Medicare and Medicaid Manual Instructions
(January through March 2014)
The eMS Manual System is used by eMS program components,
partners, providers, contractors, Medicare Advantage organizations, and
State Survey Agencies to administer eMS 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
eMS Program Manuals into a web user-friendly presentation and renamed
it the eMS Online Manual System.
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How to Obtain Manuals
The Internet-only Manuals (lOMs) are a replica of the Agency's
official record copy. Paper-based manuals are eMS manuals that were
officially rcleascd in hardcopy. Thc majority ofthesc manuals werc
transfcrrcd into thc Intcrnct-only manual (10M) or retircd. Pub 15-1, Pub
15-2 and Pub 45 arc cxccptions to this rulc and arc still active paper-based
manuals. Thc remaining paper-bascd manuals arc for rcfcrencc purposes
only. If you notice policy contained in the paper-based manuals that was
not transferred to the 10M, send a message via the eMS Feedback tool.
Those wishing to subscribe to old versions of eMS 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: =ct=-'-,===_-,-,-,,===,
Those wishing to review transmittals and program memoranda can
access this information at a local Federal Depository Library (FDL). Under
EN25AP14.001
Manual/Subject/Publication Number
Update to Pub. 100-01, Chapter 7 for Language-Only Changes for ICD-IO
. "tandard
179
180
Manual Updates to ClarifY Skilled Nursing Facility (SNF), Inpatient
Rehabilitation Facility (lRF), Home Health (HH), and Outpatient (OPT)
Coverage Pursuant to Jimmo vs. Sebelius
Aprepitant for Chemotherapy Induced Emesis Oral Anti-Nausea
(Anti-Emetic) Drugs
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
We publish this notice at the end of each quarter reflecting
information released by eMS during the previous quarter. The publication
dates of the previous four Quarterly Listing of Program Issuances notices
are: May 3, 2013 (78 FR 26038) July 26, 2013 (78 FR 45233), November 8,
2013 (78 FR 67153) and January 31, 2014 (79 FR 5419). 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.
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 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. eMS 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 Changes to the Laboratory National Coverage
Detennination (NCD) Edit Software for April 2014 (lCD-lO) use
eMS-pub. 100-04, Transmittal No. 2852.
Addendum I lists a uniquc 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 infornlation in a transmittal in conjunction with
infonnation 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 ..:.:...::.:...:.:-'-"-'==~"'-"'==~.
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Pub 100-03, Chapter I, language-only update Foreword Purpose for
National Coverage Determinations (NCD) Manual
Routine COqts in Clinical Trials (Fffective .luly 9, 2007
Transcutaneous Electrical Nerve Stimulation (TENS) for Acute PostOperative Pain
Outpatient Hospital Pain Rehabilitation Programs
Anesthesia in Cardiac Pacemaker Surgery
Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates
Below)
Cardiac Pacemakers (Various Effective Dates)
Cardiac Pacemaker Evaluation Services
Transtelephonic Monitoring of Cardiac Pacemakers
Electrocardiographic Services
Cardiac Output Monitoring By Thoracic Electrical Bioimpedance (TEB)
Various Effective Dates Below
Speech Generating Devices
Cochlear Implantation (Effective April 4, 2005)
Physician's Office Within an Imtitution - Coverage of Services and Supplies
Incident to a Physician's Services
Hospital and Skilled Nursing Facility Admission Diagnostic Procedures
Hydrophilic Contact Lens for Corneal Bandage
Photodynamic Therapy
Ocular Photodynamic Therapy (OPT) - Eftective April 3, 2013
Photosensitive Drugs
Verteporfin - Effective April 3, 2013
Hydrophilic Contact Lenses
Laproscopic Cholecystectomy
Certain Drugs Distributed by the National Cancer Institute
Stem Cell Transplantation (Various Effective Dates Below
Anticancer Chemotherapy for Colorectal Cancer (Effective JanualY 28,
20(5)
Aharelix for the Treatment of Prostate Cancer (Effective March 15,2005)
Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic
Conditions
Inpatient Hospital Stays for the Treatment of Alcoholism
Chemical Aversion Therapy t()r Treatment of Alcoholism
lese of Visual Tests Prior to and General Anesthesia During Cataract
Surgery
Withdrawal Treatments for Narcotic Addictions
Laser Procedures
Diathermy Treatment
Lumbar Artificial Disc Replacement (LADR) (Effective August 14, 2007)
Induced Lesions of Nerve Tracts
Electrical Nerve Stimulators
Supplies Used in the Delivery of Transcutaneous Electrical Nerve
Stimulation (TENS) and Neuromuscular Electrical Enteral and Parenteral
Nutritional Therapy
Nesiritide for Treatment of Heart Failure Patients (Effective March 2, 2006)
Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases - (Effective
September 10, 2007
Screening PAP Smears and Pelvic Examinations for Early Detection of
Cervical or Vaginal Cancer
Computed Tomography (CT)
Magnetic Resonance Imaging (MRl) (Various Effective Dates Below)
Ultrasound Diagnostic Procedures (Effective May 22, 2007)
FDG Positron Emission Tomography (PET) for Dementia and
Neurodegenerative Diseases (Effective September 15, 2004)
Positron Emission Tomography (PET) (FDG) for Oncologic Conditions (Various Effective Dates)
Digital Subtraction Angiography (DSA Single Photon Emission Computed
Tomograph (SPECT)
Percutaneous Image-Guided Breast Biopsy Sterilization
Water Purification and Softening Systems Used in Conjunction with Home
Dialysis
Home Use of Oxygen
Pulmonary Rehabilitation Services - (Effective September 25, 2007)
Treatment of Psoriasis
Treatment of Drug Abuse (Chemical Dependency) Wounds(Effective July 1,2004)
Durahle Medical Equipment Reference List (Effective May 5, 2005)
Hospital Beds
Infusion Pumps
Obsolete or Unreliable Diagnostic Tcsts
Intravenous Immune Globulin for the Treatment of Autoimmune
Mucocutaneous
Blistering Diseases
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
182
Pub. 100-02 Language-Only Update for ICD-I 0
Admission Requirements
Partial Hospitalization Services
Coverage oflntravenous Immune Globulin for Treatment of Primary
Immune Deficiency Diseases in the Home Coverage of Outpatient
Rehabilitation Therapy Services (Physical Therapy,
Occupational Therapy, and Speech-Language Pathology Services) Under
Medicallnsurallce
Documentation Requirements for Therapy Services
Glaucoma Screening
Determining Whether or Not the Beneficiary is at High Risk for
Developing Colorectal Cancer
Screening Pap Smears Limitations for Coverage
Implementing the Part B Inpatient Payment Policies from CMS-J599-F
Medical and Other Health Services Furnished to Inpatients of Hospitals and
Skilled Nursing Facilities
Reasonable and Necessary Part A Hospital Inpatient Claim Denials
Other Circumstances in Which Payment Cannot Be Madc Under Part A
Hospital Inpatient Services Paid Only Under Part B
Medical and Other Heahh Services Furnished to SNF Patients
Medical and Other Health Services Furnishcd to Inpatients of Participating
Ilospitals
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Medicare National Coverage Detennination (NCD) for Beta Amyloid
Positron Emission Tomography (PET) in Dementia and Neurodegenerative
Disease
Beta Amyloid Positron Emission Tomography in Dementia and
Neurodegenerative Disease
National Coverage Determination (NCD) for Single Chamber and Dual
Chamber
Permanent Cardiac Pacemakers
Single and Dual Chamber Permanent Cardiac Pacemakers
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid
Tumors
Positron Emission Tomography (FDG PET) for Oncologic Conditions
Aprepitant for Chemotherapy Induced Emesis
Oral Agents for Chemotherapy-Induced Emesis
Medicare National Coverage lJetennination (NCO) for Beta Amyloid
Positron Emission Tomography (PET) in Dementia and Neurodegenerative
Disease
Beta Amyloid Positron Emission Tomography in Dementia and
N, nmrlpopner'ltive Disease
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Billing and Payment Instructions for A/B MAC or Fls
HCPCS Codes for Oral Anti-Emetic Drugs
Claims Processing Jurisdiction for Oral Anti-Emetic Drugs
Oral Anti-Emetic Drugs Used as Full Replacement for Intravenous AntiEmetic Drugs as Part of a Cancer Chemotherapeutic Regimen
Claim Status Category and Claim Status Codes Update
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to InterneVlntranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
oflnstruction
Healthcare Provider Taxonomv Codes (HPTC) Update, April 2014
Common Edits and Enhancements Modules (CEM) Code Set Update
Health Protessional Shortaae Area (HPSA) Post-payment Review Process
Instructions for Downloading the Medicare ZIP Code File for July 2014
Quarterly Update to the Correct Coding Tnitiative (CCI) Edits, Version 20.2,
EfTective July 1,2014
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
April 20 14 Update of the Hospital Outpatient Prospective Payment System
(OPPS)
Update to Pub. 100-04. Chapter 19 to Provide Language-Only Changes for
ICD-IO and ASC X12
FI - Inpatient Acute Care - Medicare Part A - Claims Processing
FI Payment Policy and Claims Processing
Indirect Payment Procedure (lPP) - Payment to Entities that Provide Coverage
Complementarv to Medicare Part J3
Indirect Payment Procedure (11'1') - Payment to Entities that Provide Coverage
Complementary to Medicare Part B
Update to Pub. 100-04 Chapter 13 to Provide Language-Only Changes for
Updating ICD-IO and ASC XI2
ICD Coding for Diagnostic Tests
Place of Service (POS) Instructions for the Professional Component (PC or
Interpretation) and the I'echnical Component (TC) of Diagnostic Tests
Special Billing Instructions for RHCs and FQHCs Payment Requirements
Medicare Summary Notices (MSN), Reason Codes, and Remark Codes
Billing Instructions
Coverage for PET Scans for Dementia and Neurodegenerative Diseases
Billing Requirements for CMS - Approved Clinical Trials and Coverage
With Evidence Development Claims for PET Scans for Neurodegenerative
Diseases, Previously Specified Cancer Indications, and All Other Cancer
Indications Not Previously Specified
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
Billing and Coverage Changes for PET (KaF-18) Scans to IdentifY Bone
Metastasis of Cancer Effective for Claims With Dates of Services on or After
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
2874
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid
Tumors
Billing Requirements for CMS-Approved Clinical Trials and Coverage with
Evidence Development Claims for PET Scans for Neurodegenerative
Diseases, Previously Specified Cancer Indications, and All Other Cancer
Indications Not Previously Specified
Billing and Coverage Changes for PET Scans
Medicare Claims Processing Pub. 100-04 Chapter 25 Update
Form Locators 43-81
l;niform Billing with Form CMS-1450
Disposition of Copies of Completed Forms
General Instructions for Completion of Form CMS-1450 for Billing Form
Locators 1-15
Form Locators 31-41
Uniform Bi11- Form CMS-1450
Issued to a specific audience, not posted to Internet/Intranet due to
Contidentiality of Instruction
Update to Pub 100-04, Claims Processing Manual, Chapter One Section
20.3/CMS No Longer Accepts Provider Requests For A Change of Fiscal
Intermediary
Solicitation of a Provider to Secure a Change of Fiscal Intermediary
Communications
CMS No Longer Accepts Provider Requests to Change Their Fiscal
Intermediary
Implementing the Part B Inpatient Payment Policies from CMS-1599-F
Payment of Part B Services in the Payment Window for Outpatient Services
Treated as Inpatient Services when Part A Payment Cannot Be Made
Inpatient Part B Hospital Services
Editing Of Hospital Part B Inpatient Services: Reasonable and Necessary
P31i A Ilospitallnpatient Denials
Editing Of Hospital Part B Inpatient Services: Other Circumstances in
Whieh Payment Cannot Be Made under Part A
Implantable Prosthetic Devices
Indian Health Service/Tribal Hospital Inpatient Social Admits Payment
Window for Outpatient Services Treated as Inpatient Services
Correction CR - Advance Beneficiary Notice of None overage (ABN), Form
CMS-R-131
ABN Scope
flome Health Agency Use ofthe ABN
General Notice Preparation Requirements
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 InternellIntranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Aprepitant for Chemotherapy Induced Emesis
Aprepitant for Chemotherapy Induced Emesis
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2901
2902
2903
2904
2905
2906
Beginning January 1,2008
Drugs, Biologicals, and Radiopharmaceuticals Reporting and Charging
Requirements When a Device is Furnished Without Cost to the Hospital Prior
to January I, 2014
Update to Pub. 100-04, Chapter 16 to Provide Language-Only Changes for
Updating ICD-IO and ASC XI2
Update to Pub. 100-04, Chapters 7 and 8 to Provide Language-Only Changes
for Updating ICD-I0 and ASC XI2
Hilling Formats
Data Elements Required on Claim for Monthly Capitation Payment Billing
Billing for Enteral and Parenteral Nutritional Therapy as a Prosthetic Device
Mammography Screening
Hospital Services
Calculation of the Basic Case-Mix Adjusted Composite Rate and the ESRD
Prospt:ctive Payment System Rale
In-Facility Dialysis Bill Processing Procedures
Required Information tor In-Facility Claims Paid Under the Composite Rate
and the ESRD PPS
Payment for lIemodialysis Sessions
Ultrafiltration
Lab Services
Separately Billable ESRD Drugs
Physician Billing Requirements to the Carrier
Other Information Required on the Form CMS-ISOO for Epoetin Alfa (EPO)
Other Infonnation Required on the Form CMS-1500 for Darbepoetin Alfa
(Aranesp)
(Jeneral Intermediary Rill Processing Procedures for Method I Home
Dialysis Services
Physician'S Services Furnished to a Dialysis Patient Away From Home or
Usual Facility Physicians and Supplier (Nonfacility) Billing for ESRD
Services/General
Hilling tor Durable Medical Equipment (DME), OrthoticiProsthetic Devices,
and Supplies (including Surgical Dressings)
Pub 100-04, Chapter 28 language-only update for ASC XI2 version 5010.
implementation ofMACs, and MAC coordination with Medigap, \1edicaid
and Other Complementary Insurers.
Medigap! Definition and Scope
Assignment of Claims and Transfer Policy
Requirements as of.luly 2012
Completion of the Claim Form
Form CMS-ISOO/ ASC X 12 837 Professional COB
Form CMS-1450/ASC XI2 837 Institutional COB
MSN Messages
Remittance Notice Mcssages
Returned Mcdigap Notices
Coordination of Medicare With Medigap and Other Complementary Health
Insurance Policies
Requests for Additional Information
Release of Title XVIII Claims Information for \1edigap Insurance Purposes
by Providers
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
2899
february 26,20 10
EMC Formats
Payment Methodology and HCPCS Coding
fI Payment for Low Osmolar Contrast \1aterial (LOCM) (Radiology)
Pub 100-04, Language Only Update for Chapters Five and Six for Conversion
toICD-IO
Other Billing Situations
Appli~ation of Financial Limitations
Multiple Procedure Payment Reductions for Outpatient Rehabilitation
Services
Reporting of Service Units With HCPCS
Coding Guidance for Certain CPT Codes - All Claims
General
Off-Site CORf Services
Notifying Patient of Service Denial
Billing for DME, Prosthetic and Orthotic Devices, and Surgical Dressings
Addendum A - Chapter 5, Section 20.4 - Coding Guidance for Certain CPT
Codes - All Claims
Consolidated Billing Requirement for SNFs
Billing SNF PPS Services
Billing Procedures for Periodic Interim Payment (PIP) Method of Payment
Total and 1'oncovered Charges
Services in Excess of Covered Services
Reporting Accommodations on Claims
Bills with Covered and Noncovered Days
Billing in Benefits Exhaust and No-Payment Situations
Part B Outpatient Rehabilitation and Comprehensive Outpatient
Rehabilitation Facility (CORF) Services ~ General
April 2014 Integrated Outpatient Code Editor (VOCE) Specifications Version
15.1
April 2014 Update of the Ambulatory Surgical Center (ASC) Payment
System
April 20 14 Update of the Ambulatory Surgical Center (ASC) Payment
System
April 2014 Update of the Hospital Outpatient Prospective Payment System
(OPPS)
Composite APCs
HCPCS Codes Replacements
Reporting and Charging Requirements When the Hospital Receives Full
Credit lor the Replaced Device against the Cost of a More Expensive
Replacement Device Prior to January I, 2014
Reporting Requirements When the Hospital Receives Partial Credit for the
Replacement Device Prior to January I, 2014
Medicare Payment Adjustment Prior to January 1,2014
Reporting and Charging Requirements When a Device is furnished Without
Cost to the Hospital or When the Hospital Receives a Full or Partial Credit tor
the Replacement Device Beginning January I, 2014
Medicare Payment Adjustment Beginning January I, 2014
Billing and Payment for Observation Services Beginning January I. 2008
Billing and Payment for Direct Referral for Observation Care Furnished
mstockstill on DSK4VPTVN1PROD with NOTICES
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2908
25APN1
2909
Summary of the ASC XI2 276/277 Claim Status Request and Response
Process for A/I3 Medicare Administrative Contractors, DME MACs, CEDI
Flat File
Translation Requirements
Transmission Mode
Health Care Eligibility Benefit Inquiry and Response Implementation
2910
Update to Pub. 100-04. Medicare Claims Processing Manual, Chapter 11 to
Provide Language-Only Changes for Updating lCD-to and ASC X12
Completing the Uniform \Institutional Provider) Bill (Form CMS 1450) for
Hospice Election
Data Required on the Institutional Claim to Medicare Contractor
Medicare Summary Notice (MSN) Messages/ ASC X12 Remittance Advice
Adjustment Reason and Remark Codes
2911
Manual Updates to Clarify Skilled Nursing Facility Advanced 13cneiiciary
Notice (SNF ABN) Requirements Pursuant to Jimmo vs. Scbelius
Proper Denial Paragraphs
2912
April Update to the CY 2014 Medicare Physician Fee Schedule Database
(MPFSDB)
2913
Issued to a specitic audience, not posted to Internet/Intranet due to
Confidentiality oflnstruction
2914
Health Professional Shortage Area (I IPSA) Post-payment Review Process
Post-payment Review
2915
Medicare National Coverage Determination (NCD'! for Beta Amyloid
Positron Emission Tomography (PET) in Dementia and Neurodegencrative
Disease
Coverage for PET Scans for Dementia and Neurodegenerative Diseases
Calendar Year (CY) 2014 Annual Update for Clinical Laboratory Fee
2916
Schedule and Laboratory Services Subject to Reasonable Charge PaymentREVISION
2917
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
,\:
ii' '\;\,;;\'ls'
;~£~:'li~~';0~\ ::\1~\\l>0 ;:,11:<
99
Apply Front-End Edits to Electronic Correspondence Referral System
(ECRS) Files Submitted Via ECRS Web and PDR Assistance Request Action
Code J3N
COBC Electronic Correspondence Referral System (ECRS)
100
The Medicare Contractors and the Shared Systems Shall Send the Correct
Cost Avoided Indicator and Special Project Type to the Common Working
File (CWF) so the Correct Savings is applied both to the Medicare Secondary
Payer (MSP) Savings Report and the Originating Contractor
,;~:~t::(,\jf::\::~);;;i;i,; '~
230
231
232
'\:,"
99
:T\;;,\;~,;,,~k;'jl:;\i'i' 0~i,
Notice of :--Jew Interest Rate for Medicare Overpayments and
Underpayments-2nd qtr Notification for FY 2014
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
{i;!C~
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
2907
Standard Medicare Charges for COB Records
General Guidelines for A/13 MAC (A, 13, or HH) or DME MAC Transfer of
Claims Information to Mcdigap Insurers
Consolidation of the Claims Crossover Process
Coordination of Benefits Agreement (COBA) Detailed Error Report
Notification Process
Coordination of Benetits Agreement (COBA) ASC X12 837 5010
Coordination of Benefits (COB) Flat File Errors
Coordination of Bcncfits Agreement (COBA) Full Claim File Repair
Process
Coordination of Benefits Agreement (COBA) Eligibility File Claims
Recovery Process
Coordination of Benefits Agreement (COB A) Medigap Claim-Based
Crossover Process
Coordination ofI3enefits Agreement (COI3A) ASC Xl2 837 Coordination of
Benefits (COB) Mapping
National Council for Prescription Drug Programs (NCPDP) Version D.O
Coordination of Benefits (COB) Mapping Requirements
Electronic Transmission/ General Requirements
Reserved
Reserved
Bencficiary Insurance Assignment Selection
AlB MAC (A) Crossover Claim Requirements
B MAC/DME MAC Crossover Claim Requirements
Reserved
Medigap Insurers Fraud Refen'al
Outline of Complaint Referral Process
Medigap Electronic Claims Transfer Agreements
Clinical Laboratory Fee Schedule - Medicare Travel Allowance Fees for
Collection of Specimens Travel Allowance
Update to Pub. 100-04. Chapter 15 to Provide Language-Only Changes for
Updating [CD-IO and ASC XI2
Medical Conditions List and Instructions
General Billing Guidelines
Coding Instructions for Paper and Electronic Claim Forms
Fiscal Intermediary Shared System (FISS) Guidelines
A/MAC Bill Processing Guidelines Effective April 1,2002, as a Result of
Fee Schedule Implementation Detinition
Medicare Claims Processing Pub. 100-04 Chapter 31 Update
Health Care Claim Status Category Codes and Health Care Claim Status
Codes for Use with the Health Care Claim Status Request and Response ASC
X12
Claim Status Request and Response
Background
Eligihility Connectivity Workflow
Claim Status Request/Response Transaction Standard
Transmission Requirements
Batch Transactions
Online Direct Data Entry
Interactive/Online (Non-DDE)
~,::;S\i:L:: "::::: ;\,i i'"
Revised State Operations Manual (SOM) Appendices A, T, L, and W
22983
EN25AP14.006
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00
Disputing/Disagreeing With a CERT Decision
Voluntary Refunds
Handling Appeals Resulting From CERT Initiated Denials
CERT Appeal Results
Disseminating CERT Information
Error Rate Reduction Plans (ERRPs)
Contacting Non-Responders & Documentation Requests
Late Documentation Received by the CERT Review Contractor Handling
Overpayments and Underpayments Resulting From the CERT
Removing Prohibition Requesting Additional Documentation During
Prepayment and Postpayment Review
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality oflnstruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Supplemental Medical Review Contractor
Overview of Program Integrity and Provider Compliance
Medicare Improper Payment Reduction Efforts - Provider Compliance
Types of Contractors
Improper Payment Prevention Goals
Applicable Program Integrity Manual Sections
Performance Metrics
Types of Claims for Which Contractors Are Responsible
Quality of(~are Issues and Potential Fraud Issues
The MAC and SMRC Medical Review Program
Goal of MAC and SMRC MR Program
Provider Self Audits
Coordination Among Contractors
Maintaining the Confidentiality of MR Medical Records and Documents
Medical Review Manager
Contractor Medical Director (CMD)
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
oflnstruction
None
'l;;I,;,.,;
i~':;2;{'ii<
00
:\Y
25APN1
116
None
i.•'; ,sj;i;.;i~)
r,1';i;::·.:>:\s:~:.1~~~;Ci';i'B\i;Z;:ili~
Conversion from ICD-9 to ICD-IO and from ASC XI2 Version 4010 to 5010
Expanded Alternative Verification Methodology
Calibration ofthe CMS-HCC Risk Adjustment Models
Model Similarities
Operations
Sources of Data
Format
Diagnosis Cluster
Valid Diagnosis Codes
Health Insurance Portability and Accountability Act (HIPAA)
Glossary of Terms
Rules for Payment of"Signific3nt Cost" NCDs and LCBs
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
EN25AP14.007
State Operations Manual (SOM) Appendix AA revisions for Intermediate
Care Facilities for Individuals with Intellectual Disabilities (lCFIIIDJ.
Psychiatric Hospitals-Interpretive Guidelines and Survey Procedures/Title
AA-Psychiatric Hospitals-Interpretive Guidelines and Survey
Procedures/BI12/§482.61(b)(2) Include a Medical History
101
State Operations Manual (SOM) Appendix I revisions for Intermediate Care
Facilities tor Individuals with Intellectual Disabilities (ICFIlID)
II-Survey Procedures and Interpretive Guidelines for Life Safety Code
Surveys/Part [I-Interpretive Guidelines/ll. The Survey Tasks/Task 4Infonnation Gathering
I-Survey Procedures and Interpretive Guidelines for Life Safety Code
Surveys/Part II-Interpretive Guidelines/II. The Survey Tasks/Task 2Entrance Conference/On site Preparatory Activities
I-Survey Procedures and Interpretive Guidelines for Life Safety Code
102
State Operations Manual (SOM) Appendix Q revisions for Intermediate Care
Facilities lor Individuals with Intellectual Disabilities (ICF/IID).
Q-Guidelines for Determining Immediate Jeopardy/Attachment C-Overview
Recommended Key Components of Systemic Approach to Prevent Abuse
and Neglect
Q-Guidelines for Determining Immediate Jeopardy/Attachment A
Q-Guidelines f1.Jr Determining Immediate JeopardyIVIII-Enforcement! ATermination for Title XIX-Only NFs, ICFs!lID
Revised State Operations Manllal (SOM) Hospital Appendix A
103
Facilities, supplies, and equipment must be maintained to ensure an
acceptable level of safety and quality.
104
State Operations Manual (SOM) Appendix M revisions for Intermediate Care
Facilities tor Individuals with Intellectual Disabilities (lCFIIID)
Revised Annpnri;y A, Interpretive Guidelines lor Hospitals, Condition of
105
Participatioll: Quality Assessment and Performance
it!;(\ i.Vi ·,;1, \;~;i ':,;,;: \R';C':"
'}{':\';~~;;;i,\~:1':;@;;\':~1~~;\
501
Complex Medical Review
Registration o[Entities Using the Indired Payment Procedure (lPP)
502
Registration Letters
Indirect Payment Procedure Background
Submission of Registration Applications
Processing of Registration Applications
Disposition of Registration Applications
Revocation of Registration
Changes of Information and Other Registration Transactions
Indirect Payment Procedure
Inter-Jurisdictional Reassignments
503
Revision to Chapter 12 of the Medicare Program Integrity Manual- The
504
Comprehensive Error Rate Testing Program.
The Comprehensive Error Rate Testing (CERT) Program
MAC Communication with the CERT Program
Overview of the CERT Process
Providing Sample Information to the CERT Review Contractor
Providing Review Information to the CERT Review Contractor
MAC Responsibility After Workload Transition Providing Feedback
Information to the CERT Review Contractor
100
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94
Affordable Care Act Bundled Payments for Care Improvement Initiative Recurring File Updates Models 2 and 4 April 2014 Update
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
95
oflnstruction
96
Issued to a speciJic audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
MAPCP Demonstration - Update for ICD-IO
97
1352
00
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1332
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1343
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[345
1346
1347
1348
None
',.'
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.' ,.,{./jiL.!l'll¥ < ·,i,~i;;;::".
1353
1354
1355
:i:;\\);.\';'0:',i\\lij\;;,~\.~••"::
Rescind and Replace of CR 8409: Reclassification of Certain Durable
Medical Equipment from the Inexpensive and Routinely Purchased Payment
Category to the Capped Rental Payment Category
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Occurrence Span Code 72; Identification of Outpatient Time Associated with
an Inpatient Hospital Admission lmd Inpatient Claim for Payment
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Modifying the Daily Common Working File (CWF) to Medicare Beneficimy
Database (MBD) File to Include Diagnosis Codes 011 the Health Insurance
Portability and Accountabi[ity Act Eligibility Transaction System (HErS)
270/271 Transactions
Encounter Data System Payer 10: Payer ID Creation for the Financial
Alignment Demonstration for Medicare Medicaid Plans (MMPsJ
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
CWF Editing for Vaccines Furnished at Hospice - Correction
Health lllsurance Portability and Accountability Act (HIPAA) EDI Front End
Updates for July 2014
Changing Fiscal Intennediary Shared System (FfSS) Action on Informational
Unsolicited Responses (I U Rs) From Canceled Claims to Adjustments
Reporting principal and inkrest amounts when refunding previously recouped
money on the Remittance Advice (RAJ
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Fee for Service Beneficiary Data Streamlining (FFS BDS)
Implementing Operating Rule (OR)-Phase 1Il ERA Or Dual Delivery of ERA
and Paper Remittance
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
Handling Bankrupt Suppliers within VMS
1356
1357
1358
1359
13()O
1361
1362
1363
Implementation ofNACHA Operating Rules [or Health Care Electronic
Funds Transfers (EFT)
Clarification of Remittance Advice Code Combination Reports Generated by
Shared Systems
[mplementation ofHIPAA Standards and Operating Rules for Health Care
Electronic Funds Transfers
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
ofInstruction
Interuational Classification of Diseases, lOth Revision (ICD-IO) Testing with
Providers through the Common Edits and Enhancements Module (CEM) and
Common Electronic Data Interchange (CEDI),
Issued to a speciJic audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
oflnstruction
ModifYing the Daily Common Working File (CWF) to Medicare Beneficiary
Database (MBD) File to Include Diagnosis Codes on the Health Insurance
Portability and Accountability Act Eligibility Transaction System (HETS)
270/271 Transaction
[nternational Classification of Diseases, 10th Revision (ICD-10) Testing with
Providers through the Common Edits and Enhancements Module (CEM) and
Common Electronic Data Interchange (CEDI)
Implement Operating Rules-Phase !II ERA EFT: CORE 360 Uniform Use of
Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark
Codes (RARC) Rule-Update from CAQH CORE-Oct. 1,2013 version 3.0.3
The Coordination of Benefits Contractor (COBC) to Remove and No Longer
Apply Federal Tax Information (FTf) Received through the Internal Revenue
Service (IRS), Social Security Administration (SSA), Centers for Medicare
and Medicaid Services (eMS) Medicare Secondary Payer (MSP) Data Match
Program 011 the Common Working File (CWF).
Implement Operating Rules-Phase 1II ERA EFT: CORE 360 I lniform IJse of
Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark
Codes (RARC) Rule-Update from CAQH CORE-Oct. 1,2013 version 3.0.3
Implementation ofNACHA Operating Rules for Health Care Electronic
Funds Transfers (EfT)
Rescind and Replace ofCR 8409: Reclassitication of Certain Durable
Medical Equipment from the Inexpensive and Routinely Purchased Payment
Category to the Capped Renla I Payment Catego
Implement Operating Rules-Phase III ERA EFT: CORE 360 Uniform Use of
Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark
Codes (RARC) Rule-Update from CAQH CORE-Feb. 1,2014 version 3.0.4
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
Special Rules for the September 2000 NCD on Clinical Trials
Category B Investigational Device Exemption (IDE) Trials Adjustment to
MA Payments Under the CMS-HCC Risk Adjustment Models
Role and Responsibilities of Plan Sponsors
Issued to a specitic audience, not posted to Internet/Intranet due to Sensitivity
ofInstruction
22985
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For questions or additional information, contact Terri Plumb
(410-786-4481).
E:\FR\FM\25APN1.SGM
25APN1
Addendum III: CMS Rulings
CMS Rulings are decisions of the Administrator that serve as
precedent tinal 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 Ull/J.IIWWW'\';"''''!:fUV;r\.''!bUIdUUU:SFor questions or additional information,
contact Tiffany Lafferty (410-786-7548).
Addendum IV: Medicare National Coverage Determinations
(January through March 2014)
Addendum IV includes completed national coverage
dctcrminations (NCDs), or rcconsidcrations of completcd NCDs, from thc
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
EN25AP14.009
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 ofthe 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
somc cascs, cxplain why it was not appropriatc to issuc an NCD.
Infornlation 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: ~~~~~~!m:~~~~~1!g!"c
For questions or additional information, contact Wanda Belle
(4lO-786-7491).
Title
PET (FOG) for Solid
Tumors
Beta Amyloid PET in
Dementia! Neurodenerative
Disease
Single-Chamber/DualChamber Permanent
Cardiac Pacemakers
Aprepitant tor
Chemotherapy-Induced
Emesis
NCDM
Section
NCD220.6.17
Transmittal
Number
Issue Date
Effective
Date
TRI62
02/06/2014
0611112013
NCO
220.6.18
TN160
02/06/2014
09/27/2013
NCD20.8
TN 161
02/06/2014
08113/2013
02/21/2014
0512912013
NCDllO.18
TNI63
,
,
Addendum V: FDA-Approved Category B Investigational Device
Exemptions (IDEs) (January through March 2014)
Addendum V includes listings ofthe 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 ofthis quarterly notice, we list only the specific
updates to the Category B IDEs as of the ending date of the period covered
by this notice and a contact person for questions or additional infornlation.
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
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
Addendum II: Regulation Documents Published
in the Federal Register (January through March 2014)
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
When ordering individual
copies, it is necessary to cite either the date of publication or the volume
numbcr and pagc numbcr.
The Federal Register is available as an onlinc 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:
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0130300
UI30132
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0140003
0130248
U13022~
0130127
0140006
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Device
Medtronic Activa PC+S System Cook Custom Aortic Endograft
and Zenith t-Branch Endovascular Graft
EXOGEN Ultrasound Bone Healing System
Fucused Ultrasuund Stimulatur Fur Aesthetic Use
lherapy Cool Flex Ablation Catheter
Embosphere Microspheres
Concert Implant
Essure System for Permanent Birth Control
SIR-Spere Microspheres
SIR-Spheres :viicrospheres Brachytherapy Device Plus Delivery
VIOl ICV Filter System
Medtronic Tined Leads (Models 3889 and 3093) and the
Medtronic Restoreprime Neurostimulatory (Model 37701)
LUTONIX 035 Drug Coated Balloon PTA Catheter
Nucleus 24 Auditory Brainstem Implant (ABI)
Micra Transcatheter Pacemaker System Model MCI VROI
Embozene Microspheres
BrainSonix BX Pulsar 1001 Focused Ultrasonic
Sentinel Cerebral Protection System
Embospherc
E:\FR\FM\25APN1.SGM
25APN1
0130244
GI40001
0130245
0130278
G130290
G130276
GI30205
0130172
---------- _~i~~_3'YS~~!lI________
0140014
RMY Contact Lens
0140013
FAME 3
Vascular Embolization Device
GI30190
BB15909
Emergency Use - Treatment of using Haploidcntical Parental
Adenovirus Specific I-Cells using the CliniMACS System
(Cytokine Capture Reagent, Interferon-gamma)
Vascular Sealing System
0130213
lmplany, Cochlear
GI40019
GI40020
Dako PD-L! IHC pharmDx kit
0140021
Toronto EVLP System
0140025
COST A TUS SYSTEM
G130223
Concentric Medical, Inc
0130287
Microtransponder, Inc
GI30034
BIOFREEDOM Drug Couted Coronary Sten! System
0140028
Teosyal RHA 010bal Action (TP30L), Teosyal RHA Deep Lines
(TP27L)
GI40030
Bcst-CLI
Gl40032
MolecularMD MRDX BCR-ABL TEST
Start Date
01/03/2014
01108/2014
01/22/2014
01/22/2014
01/24/2014
01/30/2014
0113112014
Oli3112014
01/3112014
02/04/2014
02/04/2014
02106/2014
02/07/2014
02110/2014
02/11/2014
02112/2014
02114/2014
02/14/2014
02/2112014
--------02/2112014
02/2112014
02/26/2014
02/27/2014
Addendum VI: Approval Numbers for Collections of Information
(January through March 2014)
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 inf0l11lation collections. This infol1nation is available at
For questions or additional
information, contact Mitch Bryman (410-786-5258).
Addendum VII: Medicare-Approved Carotid Stent Facilities,
(January through March 2014)
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
performing the evaluation, procedure, and follow-up necessary to ensure
optimal patient outcomes. We have created a list of minimum standards for
facilities modeled in part on professional society statements on competency.
All facilities must at least meet our standards in order to receive coverage
for carotid artery stenting for high risk patients. For the purposes of this
quarterly notice, we are providing only the specific updates that have
occurred in the 3-month period. This infonnation is available at:
For questions or additional information, contact Lori Ashby
(410-786-6322).
'F~cility
02/28/2014
03/05/2014
03/06/2014
03/06/2014
03/12/2014
03/20/2014
03/20/2014
03/25/2014
03/26/2014
03/27/2014
03/27/2014
b;.i~Yi!'~;:·._·,~t'~.\'k"
Provider - - Effective
Number
Date
.
Capital Regional Medical Centcr
2626 Capital Medical Boulevard
Tallahassee, FL 32308
Berwick Hospital Center
701 E. 16th Street Berwick, PA 18603
Texas Heart Health and Vascular Hospital Arlington
811 Wright Street Arlington, TX 76012
Doctors Hospital
3651 Wheeler Road Augusta, GA 30909
Baylor Medical Center at McKinney
5252 W. University Drive. Hwy 380
At Lake Forest Drive McKinney, TX 75071
State
);~0::.\~.:~!; §;~t\y;~i'
100254
02/27/2014
1316919699
02/27/2014
670071
02/27/2014
TX
110177
03/05/2014
GA
670082
03/24/2014
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
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 April 21, 1997 Federal Register (62 FR 19328).
TX
FL
--=--PA
22987
EN25AP14.010
mstockstill on DSK4VPTVN1PROD with NOTICES
22988
VerDate Mar<15>2010
Facility
Jkt 232001
Effective
Date
500050
05/26/2005
WA
230070
06/22/2006
MI
1~;\;s;;;.~
FROM: Southwest Wasbington Medical Center
TO: Peace Health Southwest Medical Center
400 N.E. Mother Joseph Place
Vancouver, WA 98668
P.O. Box 1600
Covenant Healthcare
900 Cooper Avenue
Saginaw, :\,11 48602
State
,~;%i.ii.?\
Facility
PO 00000
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25APN1
Addendum VIII:
American College of Cardiology's National Cardiovascular Data
Registry Sites (January through March 2014)
Addendum Vlll includes a list ofthe 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) ICD Registry satisfies the data
reporting requirements in the NCD. Hospitals needed to transition to the
ACC-NCDR ICD Registry by April 2006.
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 TCDs 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
EN25AP14.011
registry. The entire list offacilities that participate in the ACC-NCDR ICD
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
information, contact Marie Casey, BSN, MPH (410-786-7861).
City
Carolina Pines Regional Medical Center
Charlotte Regional Medical Center
~n & Country Hospital
Crossgates River Oaks Hospital
St. Cloud Regional ~cdical Center
Summit Medical Center
Saint Mary's Mercy Medical Center
Fisher-Titus Medical Center
University Medical Center
Geisinger Community Medical Center
Tulare District Hospital
Lake "lorman Regional Medical Center
Methodist Mansfield Medical Center
University of Texas Health Science Center at Tyler
Mercy Hospital Ada
Hospital total Cor
St. Luke's Warren Campus
Castle Rock Adventist
New York Presbyterian - Weill Cornell Medical Center
Santa Rosa Medical Center
Shands Lake Shore Regional Medical Center
Bayfront Health Spring Hill
Williamson Memorial Hospital
Pine Creek Medical Center
New York Presbyterian Hospital-Columbia
Central Carolina (TENET)
Saint Vincent Medical Center North
Children's Hospital of Los Angeles
Northbank Surgical Center
Children's Hospital of Philadelphia
Mary Lanning Healthcare
Mercy Tiffin Hospital
Wilson Medical Center
Signature Healthcare Brockton Hospital
Norton Brownsboro Hospital
State
::~.;~. 0:;;;i\:\1~~\\\i~lt:
}.;.,.~ii~;ii;\):~~;;'?
Hartsville
Punta Gorda
Tampa
Brandon
Saint Cloud
Van Buren
Grand Rapids
Norwalk
Lebanon
Scranton
Tulare
Mooresville
Mansfield
Tyler
Ada
Sao Paulo
Phillipsburg
Castle Rock
New York
Milton
Lake City
Spring Hill
Williamson
Dallas
New York
Sanford
Little Rock
Los Angeles
Salem
Philadelphia
Hastin"s
Tit1in
Wilson
Brockton
Louisville
SC
FL
FL
MS
FL
AR
MI
OH
TN
PA
CA
NC
TX
TX
OK
Brazil
NJ
CO
NY
FL
fL
FL
WV
TX
NY
NC
AR
CA
OR
PA
NE
OH
NC
MA
KY
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
Provider
Number
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VerDate Mar<15>2010
Facility
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State
!uum:~{!:f.;::~»)~,\):: ·"!i~:··Y¥;\\;
mstockstill on DSK4VPTVN1PROD with NOTICES
22990
VerDate Mar<15>2010
39-0270
02/26/2014
PA
190176
03/15/2013
LA
150056
11125/2003
i,1\;;i~;'
Jkt 232001
FROM: Clarian Health Partners, Inc.
(Methodist Hospital)
TO: Indiana University Health, Inc.
1701 N. Senate Boulevard
Indianapolis. IN 46206
'\',;\\,}i':
IN
PO 00000
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25APN1
Addendum XIII: Lung Volume Reduction Surgery (LVRS)
(January through March 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 offacilities 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 of Healthcare 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
January through March 2014 quarter. This information is available at
For
questions or additional information, contact Marie Casey, BSN, MPH
(410-786-7861 ).
Addendum XIV: Medicare-Approved Bariatric Surgery Facilities
(January through March 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 February 21,
2006, we issued our decision memorandum on bariatric surgery procedures.
EN25AP14.013
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 bariatric surgery procedures are
reasonable and necessary only when performed at facilities that are: (I)
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
January through March 2014 period. This information is available at
For
questions or additional information, contact Kate Tillman, RN, MAS
(410-786-9252).
Addendum XV: FDG-PET for Dementia and Neurodegenerative
Diseases Clinical Trials (January through March 2014)
There were no FOG-PET for Dementia and Neurodegenerative
Diseases Clinical Trials published in the January through March 2014
quarter.
This intormation is available on our website at
For questions or additional infonnation, contact Stuart Caplan, RN, MAS
(410-786-8564).
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
16:57 Apr 24, 2014
Geisinger Wyoming Valley
Medical Center
1000 East Mountain Drive
Wilkes Barre, PA 18711
Tulane University Hospital and Clinic
14 J 5 Tulane Avenue
New Orleans, LA 70112
Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
[FR Doc. 2014–09288 Filed 4–24–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1466–N]
Medicare Program: Notice of Two
Membership Appointments to the
Advisory Panel on Hospital Outpatient
Payment
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice announces two
new membership appointments to the
Advisory Panel on Hospital Outpatient
Payment (the Panel). The two new
appointments to the Panel will each
serve a 4-year period. The new members
will have terms that begin on February
16, 2014 and continue through February
15, 2018. The purpose of the Panel is to
advise the Secretary of the Department
of Health and Human Services and the
Administrator of the Centers for
Medicare & Medicaid Services
concerning the clinical integrity of the
Ambulatory Payment Classification
groups and their relative payment
weights. The Panel also addresses and
makes recommendations regarding
supervision of hospital outpatient
services. The advice provided by the
Panel will be considered as we prepare
the annual updates for the hospital
outpatient prospective payment system.
FOR FURTHER INFORMATION CONTACT: For
additional information on the Panel
meeting dates, agenda topics, copy of
the charter, as well as updates to the
Panel’s activities, search our Internet
Web site: https://www.cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonAmbulatory
PaymentClassificationGroups.html. For
other information regarding the Panel,
contact Carol Schwartz, the Designated
Federal Officer (DFO) at CMS, Center for
Medicare, Hospital and Ambulatory
Policy Group, Division of Outpatient
Care, 7500 Security Boulevard, Mail
Stop C4–05–17, Baltimore, MD 21244–
1850, phone (410) 786–3985.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
I. Background
The Department of Health and Human
Services (the Secretary) is required by
section 1833(t)(9)(A) of the Social
Security Act (the Act) (42 U.S.C.
1395l(t)(9)(A)) and section 222 of the
VerDate Mar<15>2010
16:57 Apr 24, 2014
Jkt 232001
Public Health Service Act (PHS Act) (42
U.S.C. 217a) to consult with an expert
outside advisory panel on the clinical
integrity of the Ambulatory Payment
Classification groups and relative
payment weights, which are major
elements of the Medicare Hospital
Outpatient Prospective Payment System
(OPPS), and the appropriate supervision
level for hospital outpatient services.
The Panel is governed by the provisions
of the Federal Advisory Committee Act
(FACA) (Pub. L. 92–463), as amended (5
U.S.C. Appendix 2), which sets forth
standards for the formation and use of
advisory panels. The Panel Charter
provides that the Panel shall meet up to
3 times annually. We consider the
technical advice provided by the Panel
as we prepare the proposed and final
rules to update the OPPS for the
following calendar year.
The Panel shall consist of a chair and
up to 19 members who are full-time
employees of hospitals, hospital
systems, or other Medicare providers.
The Secretary or a designee selects the
Panel membership based upon either
self-nominations or nominations
submitted by Medicare providers and
other interested organizations. New
appointments are made in a manner that
ensures a balanced membership under
the FACA guidelines.
The Panel presently consists of the
following members and a Chair.
• Edith Hambrick, M.D., J.D., Chair,
CMS Medical Officer.
• Karen Borman, M.D., FACS.
• Kari S. Cornicelli, C.P.A., FHFMA.
• Brian D. Kavanagh, M.D., MPH.
• Scott Manaker, M.D., Ph.D.
• John Marshall, CRA, RCC, CIRCC,
RT(R), FAHRA.
• Jim Nelson, M.B.A., C.P.A., FHFMA.
• Leah Osbahr, M.A., MPH.
• Jacqueline Phillips.
• Traci Rabine.
• Michael Rabovsky, M.D.
• Marianna V. Spanaki-Varela, MD,
Ph.D., M.B.A.
• Gale Walker.
• Kris Zimmer.
II. Provisions of the Notice
We published a notice in the Federal
Register on November 1, 2013, entitled
‘‘Medicare Program; Solicitation of Five
Nominations to the Advisory Panel on
Hospital Outpatient Payment (HOP, the
Panel)’’ (78 FR 65660). The notice
solicited nominations for five new
members to fill the vacancies on the
Panel beginning September 30, 2013. As
a result of that notice, we are
announcing two new members to the
Panel. The Panel currently consists of
15 members. The two new Panel
PO 00000
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22991
members appointments are for 4-year
terms beginning on February 16, 2014.
New Appointments to the Panel
The two new members of the Panel
with terms beginning on February 16,
2014 and continuing through February
15, 2018 are as follows:
• Wendy Resnick, FHFMA.
• Johnathan Pregler, M.D.
III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
Dated: April 17, 2014.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2014–09289 Filed 4–24–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0555]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Device Tracking
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection requirements for
the tracking of medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by June 24, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
SUMMARY:
E:\FR\FM\25APN1.SGM
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Agencies
[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Notices]
[Pages 22976-22991]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09288]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9085-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--January Through March 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 January through March 2014, relating
to the Medicare and
[[Page 22977]]
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] TN25AP14.000
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 information 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.
Authority: (Catalog of Federal Domestic Assistance Program No.
93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714,
Medical Assistance Program)
Dated: April 16, 2014.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
[[Page 22978]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.001
[[Page 22979]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.002
[[Page 22980]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.003
[[Page 22981]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.004
[[Page 22982]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.005
[[Page 22983]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.006
[[Page 22984]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.007
[[Page 22985]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.008
[[Page 22986]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.009
[[Page 22987]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.010
[[Page 22988]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.011
[[Page 22989]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.012
[[Page 22990]]
[GRAPHIC] [TIFF OMITTED] TN25AP14.013
[[Page 22991]]
[FR Doc. 2014-09288 Filed 4-24-14; 8:45 am]
BILLING CODE 4120-01-P