80_FR_46128 80 FR 45980 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2015

80 FR 45980 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2015

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

Federal Register Volume 80, Issue 148 (August 3, 2015)

Page Range45980-45993
FR Document2015-18904

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2015, relating to the Medicare and Medicaid programs and other programs administered by CMS.

Federal Register, Volume 80 Issue 148 (Monday, August 3, 2015) 
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 45980-45993]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18904]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9092-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--April Through June 2015

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from April through June 2015, relating to 
the Medicare and Medicaid programs and other programs administered by 
CMS.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may need specific information and not be able to determine from 
the listed information whether the issuance or regulation would fulfill 
that need. Consequently, we are providing contact persons to answer 
general questions concerning each of the addenda published in this 
notice.

----------------------------------------------------------------------------------------------------------------
                  Addenda                                        Contact                           Phone No.
----------------------------------------------------------------------------------------------------------------
I CMS Manual Instructions.................  Ismael Torres....................................     (410) 786-1864
II Regulation Documents Published in the    Terri Plumb......................................     (410) 786-4481
 Federal Register.
III CMS Rulings...........................  Tiffany Lafferty.................................     (410) 786-7548
IV Medicare National Coverage               Wanda Belle......................................     (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs............  John Manlove.....................................     (410) 786-6877
VI Collections of Information.............  Mitch Bryman.....................................     (410) 786-5258
VII Medicare-Approved Carotid Stent         Lori Ashby.......................................     (410) 786-6322
 Facilities.
VIII American College of Cardiology--       Marie Casey, BSN, MPH............................     (410) 786-7861
 National Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-Related       JoAnna Baldwin...................................     (410) 786-7205
 Guidance Documents.
X One-time Notices Regarding National       JoAnna Baldwin...................................     (410) 786-7205
 Coverage Provisions.
XI National Oncologic Positron Emission     Stuart Caplan, RN, MAS...........................     (410) 786-8564
 Tomography Registry Sites.
XII Medicare-Approved Ventricular Assist    Marie Casey, BSN, MPH............................     (410) 786-7861
 Device (Destination Therapy) Facilities.
XIII Medicare-Approved Lung Volume          Marie Casey, BSN, MPH............................     (410) 786-7861
 Reduction Surgery Facilities.
XIV Medicare-Approved Bariatric Surgery     Jamie Hermansen..................................     (410) 786-2064
 Facilities.
XV Fluorodeoxyglucose Positron Emission     Stuart Caplan, RN, MAS...........................     (410) 786-8564
 Tomography for Dementia Trials.
All Other Information.....................  Annette Brewer...................................     (410) 786-6580
----------------------------------------------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION:

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.

[[Page 45981]]

III. How To Use the Notice

    This notice is organized into 15 addenda so that a reader may 
access the subjects published during the quarter covered by the notice 
to determine whether any are of particular interest. We expect this 
notice to be used in concert with previously published notices. Those 
unfamiliar with a description of our Medicare manuals should view the 
manuals at http://www.cms.gov/manuals.

    Dated July 27, 2015.
Kathleen Cantwell
Director, Office of Strategic Operations and Regulatory Affairs.

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[FR Doc. 2015-18904 Filed 7-31-15; 8:45 am]
BILLING CODE 4120-01-P

45980 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices Subsequent regulations for these collection contact Leigha Basini at 301– ACTION: Notice. programs including the final HHS 492–4380.) Notice of Benefit and Payment Dated: July 28, 2015. SUMMARY: This quarterly notice lists Parameters for 2014 and the Program William N. Parham, III, CMS manual instructions, substantive Integrity: Exchange, Premium and interpretive regulations, and other Director, Paperwork Reduction Staff, Office Stabilization Programs, and Market of Strategic Operations and Regulatory Federal Register notices that were Standards; Amendments to the HHS Affairs. published from April through June Notice of Benefit and Payment [FR Doc. 2015–18848 Filed 7–31–15; 8:45 am] 2015, relating to the Medicare and Parameters for 2014 provide further Medicaid programs and other programs BILLING CODE 4120–01–P reporting requirements. Based on administered by CMS. experience with the first three years of data collection, we request the DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: It is continuation of data collection and HUMAN SERVICES possible that an interested party may propose revisions to data elements being need specific information and not be collected and the burden estimates for Centers for Medicare & Medicaid able to determine from the listed years four, five, and six. Form Number: Services information whether the issuance or CMS–10433 (OMB Control Number: regulation would fulfill that need. 0938–1187); Frequency: Annually; [CMS–9092–N] Consequently, we are providing contact Affected Public: Private sector (Business persons to answer general questions Medicare and Medicaid Programs; or other For-profits and Not-for-profit concerning each of the addenda Quarterly Listing of Program institutions); Number of Respondents: Issuances—April Through June 2015 published in this notice. 26,951; Total Annual Responses: 26,951; Total Annual Hours: 235,153. AGENCY: Centers for Medicare & (For policy questions regarding this Medicaid Services (CMS), HHS. Addenda Contact Phone No. I CMS Manual Instructions ..................................................................................................... Ismael Torres ......................... (410) 786–1864 II Regulation Documents Published in the Federal Register ............................................... Terri Plumb ............................ (410) 786–4481 III CMS Rulings ....................................................................................................................... Tiffany Lafferty ....................... (410) 786–7548 IV Medicare National Coverage Determinations .................................................................... Wanda Belle .......................... (410) 786–7491 V FDA-Approved Category B IDEs ........................................................................................ John Manlove ........................ (410) 786–6877 VI Collections of Information .................................................................................................. Mitch Bryman ......................... (410) 786–5258 VII Medicare-Approved Carotid Stent Facilities ..................................................................... Lori Ashby .............................. (410) 786–6322 VIII American College of Cardiology—National Cardiovascular Data Registry Sites ............ Marie Casey, BSN, MPH ....... (410) 786–7861 IX Medicare’s Active Coverage-Related Guidance Documents ............................................. JoAnna Baldwin ..................... (410) 786–7205 X One-time Notices Regarding National Coverage Provisions .............................................. JoAnna Baldwin ..................... (410) 786–7205 XI National Oncologic Positron Emission Tomography Registry Sites .................................. Stuart Caplan, RN, MAS ....... (410) 786–8564 XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities .............. Marie Casey, BSN, MPH ....... (410) 786–7861 XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ..................................... Marie Casey, BSN, MPH ....... (410) 786–7861 XIV Medicare-Approved Bariatric Surgery Facilities .............................................................. Jamie Hermansen .................. (410) 786–2064 XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ...................... Stuart Caplan, RN, MAS ....... (410) 786–8564 All Other Information ................................................................................................................. Annette Brewer ...................... (410) 786–6580 SUPPLEMENTARY INFORMATION: authority granted to the Secretary of the as our resources. This is the most Department of Health and Human current up-to-date information and will I. Background Services under sections 1102, 1871, be available earlier than we publish our The Centers for Medicare & Medicaid 1902, and related provisions of the quarterly notice. We believe the Web Services (CMS) is responsible for Social Security Act (the Act) and Public site list provides more timely access for administering the Medicare and Health Service Act. We also issue beneficiaries, providers, and suppliers. Medicaid programs and coordination various manuals, memoranda, and We also believe the Web site offers a and oversight of private health statements necessary to administer and more convenient tool for the public to insurance. Administration and oversight oversee the programs efficiently. find the full list of qualified providers of these programs involves the Section 1871(c) of the Act requires for these specific services and offers following: (1) Furnishing information to that we publish a list of all Medicare more flexibility and ‘‘real time’’ Medicare and Medicaid beneficiaries, manual instructions, interpretive rules, accessibility. In addition, many of the health care providers, and the public; statements of policy, and guidelines of Web sites have listservs; that is, the and (2) maintaining effective general applicability not issued as communications with CMS regional public can subscribe and receive regulations at least every 3 months in offices, state governments, state immediate notification of any updates to the Federal Register. Medicaid agencies, state survey the Web site. These listservs avoid the II. Format for the Quarterly Issuance need to check the Web site, as mstockstill on DSK4VPTVN1PROD with NOTICES agencies, various providers of health care, all Medicare contractors that Notices notification of updates is automatic and process claims and pay bills, National This quarterly notice provides only sent to the subscriber as they occur. If Association of Insurance Commissioners the specific updates that have occurred assessing a Web site proves to be (NAIC), health insurers, and other in the 3-month period along with a difficult, the contact person listed can stakeholders. To implement the various hyperlink to the full listing that is provide information. statutes on which the programs are available on the CMS Web site or the based, we issue regulations under the appropriate data registries that are used VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1

Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 45981 III. How To Use the Notice We expect this notice to be used in Dated July 27, 2015. This notice is organized into 15 concert with previously published Kathleen Cantwell addenda so that a reader may access the notices. Those unfamiliar with a Director, Office of Strategic Operations and subjects published during the quarter description of our Medicare manuals Regulatory Affairs. covered by the notice to determine should view the manuals at http:// whether any are of particular interest. www.cms.gov/manuals. mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1

©865FP Publication Dates for the Previous Four Quarterly Notices designated libraries throughout the United States. Some FDLs may have We publish this notice at the end of each quarter reflecting arrangements to transfer material to a local library not designated as an information released by CMS during the previous quarter. The publication FDL. Contact any library to locate the nearest FDL. This information is dates of the previous four Quarterly Listing of Program Issuances notices available at http://www.gpo.gov/libraries/ are: July 25, 2014 (79 FR 43475), November 14, 2014 (79 FR 68253), In addition, individuals may contact regional depository libraries February 2, 2015 (80 FR 5537) and April 24, 2015 (80 FR 23013). For the that receive and retain at least one copy of most federal government saonoNnN/sIOZ ‘g jsngny ‘Aepuopy/8pT ‘ON ‘08 ‘TOA /4opst8ay fedapaq purposes of this quarterly notice, we are providing only the specific updates publications, either in printed or microfilm form, for use by the general that have occurred in the 3—month period along with a hyperlink to the public. These libraries provide reference services and interlibrary loans; website to access this information and a contact person for questions or however, they are not sales outlets. Individuals may obtain information additional information. about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing Addendum I:; Medicare and Medicaid Manual Instructions entitled Medicare and Medicaid Manual Instructions. To help FDLs locate (April through June 2015) the materials, use the CMS publication and transmittal numbers. For The CMS Manual System is used by CMS program components, example, to find the manual for Microvolt T—wave Alternans (MTWA), use partners, providers, contractors, Medicare Advantage organizations, and Medicare National Coverage Determination (CMS—Pub. 100—03) State Survey Agencies to administer CMS programs. It offers day—to—day Transmittal No. 182. operating instructions, policies, and procedures based on statutes and Addendum I lists a unique CMS transmittal number for each regulations, guidelines, models, and directives. In 2003, we transformed the instruction in our manuals or program memoranda and its subject number. CMS Program Manuals into a web user—friendly presentation and renamed A transmittal may consist of a single or multiple instruction(s). Often, it is it the CMS Online Manual System. necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly How to Obtain Manuals notice, we list only the specific updates to the list of manual instructions The Internet—only Manuals (IOMs) are a replica of the Agency‘s that have occurred in the 3—month period. This information is available on official record copy. Paper—based manuals are CMS manuals that were our website at www.cms.gov/Manuals. officially released in hardcopy. The majority of these manuals were transferred into the Internet—only manual (IOM) or rctired. Pub 15—1, Pub Transmittal Manual/Subject/Publication Number 15—2 and Pub 45 arc exceptions to this rule and are still active paper—based manuals. The remaining paper—based manuals are for referencee purposes 91 Manual Updates to Clarify Requirements for Physician Certification and only. If you notice policy contained in the paper—based manuals that was Recertification of Patient Eligibility for Home Health Services not transferred to the IOM, send a message via the CMS Feedback tool. Recertifications for Home Iealth Services Those wishing to subscribe to old versions of CMS manuals should Content of the Physician‘s Certification Method and Disposition of Certifications for Home Health Services contact the National Technical Information Service, Department of Certification and Recertification by Physicians for Home Health Services Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone 92 Manual Updates to Clarify Requirements for Physician Certification and (703—605—6050). You can download copies of the listed material free of Recertification of Patient Eligibility for Home Health Services charge at: http://cms.gov/manuals. Recertifications for Home Health Services Content of the Physician‘s Certification Method and Disposition of Certifications for Home Health Services How to Review Transmittals or Program Memoranda Certification and Recertification by Physicians for Home Health Services 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

208 Manual Updates to Clarify Requirements for Physician Certification and 205 Updates on Hospice Election Form, Revocation, and Attending Physician Recertification of Patient Eligibility for Home Health Services Attending Physician Services 209 Updates on Hospice Election Form, Revocation, and Attending Physician Hospice Election Attending Physician Services Hospice Notice of Election Hospice Election Hospice Revocation Election, Revocation and Discharge Iospice Discharge Iospice Revocation saonoNnN/sIOZ ‘g jsngny ‘Aepuopy/8pT ‘ON ‘08 ‘TOA /4opst8ay fedapaq Hospice Notice of Termination or Revocation Hospice Discharge Election, Revocation and Discharge Hospice Notice of Termination or Revocation 206 Private Contracting: Definition of Emergency Care Services and Appeals of Hospice Notice of Election Opt Out Determinations Appeals Microvolt T—wave Alternans (MTWA) Definition of Emergency and Urgent Care Situations 207 Manual Updates to Clarify Requirements or Physician Certification and 3231 Issued to a specific audience, not posted to Internet/Intranet due to Recertification of Patient Eligibility for Home Health Services Confidentiality of Instruction Home Health Prospective Payment System (HH PPS) 3232 Preventive and Screening Services — Update — Intensive Behavioral Therapy National 60—Day Episode Rate for Obesity, Screening Digital Tomosynthesis Mammography, and Anesthesia Adjustments to the 60—Day Episode Rates Associated with Sereening Colonoscopy Counting 60—Day Episodes 3233 Issued to a specific audience, not posted to Internet/Intranet due to Split Percentage Payment Approach to the 60—Day Episode Confidentiality of Instruction Low Utilization Payment Adjustment (LUPA) 3234 April 2015 Update of the Ambulatory Surgical Center (ASC) Payment Partial Episode Payment (PEP) Adjustment System Discharge Issues 3235 April 2015 Update of the Hospital Outpatient Prospective Payment System Consolidated Billing (OPPS) Determination of Coverage Inpatient—only Services Impact of Other Available Caregivers and Other Available Coverage on Use of HCPCS Modifier — PO Medicare Coverage of Home Health Services Payment Window for Outpatient Services Treated as Inpatient Services Pationt Confined to the Home 3236 Remittance Advice Remark and Claims Adjustment Reason Code and Patient‘s Place of Residence Medicare Remit Easy Print and PC Print Update Physician Certification for Medical and Other Health Services Furnished by 3237 Issued to a specific audience, not posted to Internet/Intranet due to a Home Health Agency (HHA) Confidentiality of Instruction Use of Oral (Verbal) Orders 3238 April 2015 Update of the ITospital Outpatient Prospective Payment System Under the Care of a Physician Physician Certification and Recertification of Patient Eligibility for (OPPS) Inpatient—only Services Medicare Home Health Services Use of HCPCS Modifier — PO Physician Certification Payment Window for Outpatient Services Treated as Inpatient Services Face—to—Face Encounter 3239 Issued to a specific audience, not posted to Internet/Intranet due to a Supporting Documentation Requirements Confidentiality of Instruction Physician Recertification 3240 Medicare Claims Processing Manual — Chapter 15, Section 40, Ambulance — Who May Sign the Certification or Recertification Medical Conditions List Physician Billing for Certification and Recertification Psychiatric Evaluation, Therapy, and Teaching Medical Conditions List and Instructions Intermittent Skilled Nursing Care 3241 Transcatheter Mitral Valve Repair (TMVR)—National Coverage General Principles Governing Reasonable and Necessary Physical Therapy, Determination (NCT) Claims Processing Requirements for TMVR for MR Speech—Language Pathology Services, and Occupational Therapy Services for Medicare Advantage (MA) Plan Participants Impact on Care Provided in Excess of"Intermittent" or "Part—Time" Care Coding Requirements for TMVR for MR Claims Furnished on or After Counting Visits Under the Hospital and Medical Plans August 7, 2014 Services Covered Under the End Stage Renal Disease (ESRD) Program Claims Processing Requirements for TMVR for MR Services on Medical and Other Health Services Furnished by Home Health Agencies Professional Claims Content of the Plan of Care Claims Processing Requirements for TMVR for MR Services on Inpatient €86GTP

mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 45984 Hospital Claims 3258 July Quarterly Update for 2015 Durable Medical Equipment, Prosthetics, Transcatheter Mitral Valve Repair (TMVR) Orthotics and Supplies (DMEPOS) Fee Schedule 18:35 Jul 31, 2015 3242 Remittance Advice Remark and Claims Adjustment Reason Code and 3259 Quarterly Update to the Medicare Physician Fee Schedule Database Medicare Remit Easy Print and PC Print Update (MPFSDB)- July CY 2015 Update 3243 Issued to a specific audience, not posted to Internet/Intranet due to a 3260 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Confidentiality of Instruction oflnstruction Collection of Specimens 3244 Issued to a specific audience, not posted to Internet/Intranet due to a 3261 Issued to a specific audience, not posted to Internet/Intranet due to a Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices Confidentiality of Instruction Confidentiality of Instruction 3245 Issued to a specific audience, not posted to Internet/Intranet due to a 3262 Manual Update to Pub. 100-04, Chapter I, to include Claims Submitted by Jkt 235001 Confidentiality of Instruction Multiple DMEPOS Suppliers 3246 Issued to a specific audience, not posted to Internet/Intranet due to a Exact Duplicates Confidentiality of Instruction 3263 Inpatient Prospective Payment System (IPPS) Hospital Extensions per the 3247 Issued to a specific audience, not posted to Internet/Intranet due to a Medicare Access and CHIP Reauthorization Act of2015 PO 00000 Confidentiality of Instruction 3264 July 2015 Integrated Outpatient Code Editor (I/OCE) Specifications Version 3248 Issued to a specific audience, not posted to Internet/Intranet due to a 16.2 Confidentiality of Instruction 3265 NCD20.30 Microvolt T-wave Alternans (MTW A) 3249 Issued to a specific audience, not posted to Internet/Intranet due to a Messaging for MTW A Frm 00053 Confidentiality of Instruction Coding and Claims Processing for MTW A 3250 Issued to a specific audience, not posted to Internet/Intranet due to a Microvolt T-wave Alternans (MTW A) Confidentiality of Instruction 3266 Issued to a specific audience, not posted to Internet/Intranet due to a 3251 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Fmt 4703 Confidentiality of Instruction 3267 New Waived Tests 3252 Issued to a specific audience, not posted to Internet/Intranet due to a 3268 Corrections to the 2015 Home Health (HH) Pricer Program Decision Logic Confidentiality of Instruction Used by the Pricer on Claims 3253 Issued to a specific audience, not posted to Internet/Intranet due to a 3269 Quarterly Update ofHCPCS Codes Used for Home Health Consolidated Sfmt 4725 Confidentiality of Instruction Billing Enforcement 3254 Quarterly Healthcare Common Procedure Coding System (HCPCS) 3270 Implement Operating Rules- Phase III ERA EFT: CORE 360 Unifotm Use of Drug/Biological Code Changes- July 2015 Update Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Avera"e Sales Price (ASP) Payment Methodology Codes (RARC) Rule - Update from CAQH CORE E:\FR\FM\03AUN1.SGM 3255 Correction to the Multi-Carrier System (MCS) Editing on the Service 3271 Common Edits and Enhancements Modules (CEM) Code Set Update Location National Provider Identifier (NPI) Reported for Anti-Markup and 3272 Claim Status Category and Claim Status Codes Update Reference Laboratory Claims 3273 Issued to a specific audience, not posted to Internet/Intranet due to a Diagnostic Tests Subject to the Anti-Markup Payment Limitation Confidentiality of Instruction Payment to Physician or Other Supplier for Diagnostic Tests Subject to the 3274 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Anti-Markup Payment Limitation- Claims Submitted to AlB MACs (B) of Instruction Billing for Diagnostic Tests (Other Than Clinical Diagnostic Laboratory 3275 Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 21.3, Tests) Subject to the Anti-Markup Payment Limitation/Claims Submitted AlB Effective October 1, 2015 MACs(B) 3276 Instructions for Downloading the Medicare ZIP Code File for October 2015 03AUN1 Conditional Data Element Requirements for AlB MACs (B) and 3277 July Quarterly Update for 2015 Durable Medical Equipment, Prosthetics, DMEMACs Orthotics and Supplies (DMEPOS) Fee Schedule AlB MAC (B) Specific Requirements for Cettain Specialties/Services Paper 3278 Issued to a specific audience, not posted to Internet/Intranet due to a Claim Submission To AlB MACs (B) Confidentiality of Instruction Electronic Claim Submission to AlB MACs (B) 3279 July 2015 Update of the An1bulatory Surgical Center (ASC) Payment System Items 14-33 - Provider of Service or Supplier Information Payment 3280 July 2015 Update of the Hospital Outpatient Prospective Payment System Jurisdiction for Services Subject to the Anti-Markup Payment Limitation (OPPS) 3256 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics 3281 Inpatient Prospective Payment System (IPPS) Hospital Extensions per the and Supplies (DMEPOS) Competitive Bidding Program (CBP)- July 2015 Medicare Access and CHIP Reauthorization Act of2015 3257 July Quarterly Update for 2015 Durable Medical Equipment, Prosthetics, 3282 Issued to a specific audience, not posted to Internet/Intranet due to a Orthotics and Supplies (DMEPOS) Fee Schedule Confidentiality of Instruction EN03AU15.003</GPH>

mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 3283 Quarterly Update to the Medicare Physician Fee Schedule Database Current Year (MPFSUB)- April CY 2015 Lpdate Full Denial- Hospital-Filed or Beneficiary-Filed Emergency Claim 18:35 Jul 31, 2015 3284 Issued to a specific audience, not posted to Internet/Intranet due to a Full Denial- Foreign Claim- Beneficiary Filed Confidentiality of Instruction Denial - .\i!ilitary Personnel/Eligible Dependents 3285 Screening for Hepatitis C Virus (HCV) in Adults -Implementation of Full Denial - Shipboard Claim - Beneficiary filed Additional Common Working File (CWF) and Shared System Maintainer Partial Denial- Hos ital-Filed or Beneficiarv-Filed Emer (SSMs) Edits Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices Common Working File (CWF) Edits lll None Issued to a specitic audience, not posted to Internet /Intranet due to Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Sensitivity of Instruction Jkt 235001 Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) 112 Inpatient Hospital Claims and Medicare Secondary Payer (MSP) Claims with Messages Institutional Billing Requirements 3286 Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System PO 00000 (PPS) Pricer Update FY 2016 3287 Revisions to Medicare Claims Processing Manual for Foreign, Emergency 250 Notice of .\Jew Interest Rate tor Medicare Overpayments and Underpayments and Shipboard Claims - 3rd Qtr. 'lotification for FY 2015 Emergency and Foreign Hospital Services Frm 00054 Services Rendered By Nonparticipating Providers Establishing an 137 Revisions to State Operations Manual (SOM) Appendices A, G, Land T Emergency related to Hospitals, Rural Health Clinics, Ambulatory Surgical Centers and Coverage Requirements for Emergency Hospital Services in Foreign Swing Bed Countries 138 Revisions to State Operations Manual (SOM), Appendix W for Critical Qualifications of an Emergency Services Hospital Fmt 4703 Access Hospitals Services Furnished in a Foreign Hospital Nearest to Beneficiary's U.S. 139 Revisions to the Medicare State Operations Manual (SOM), Chapter 2, Rural Residence Health Clinic Certification Coverage of Physician and Ambulance Services Furnished Outside U.S. 140 I Revisions to Appendix C-Survcy Procedures and Interpretive Guidelines for Sfmt 4725 Claims for Services Furnished in Canada to Qualified Railroad Retirement Laboratories and Services Beneficiaries Claims from Hospital-Leased Laboratories Not Meeting Conditions of 58'J Issued to a specitic audience, not posted to Internet/ Intranet due to Participation Confidentiality of Instruction l\onemergency Part B Medical and Other Health Services E:\FR\FM\03AUN1.SGM 590 Update ofCMS-855A, Physician-Owned Hospital Reporting Via the CMS- Elections to Bill for Services Rendered By l\onparticipating Hospitals 855POH and Indirect Payment Procedure Registration Via the CMS-855C in Processing Claims Chapter 15 of Pub. 100-08 Contractors Designated to Process Foreign Claims Registration Letters Contractor Processing Guidelines Submission of Registration Applications Medicare Approved Charges for Services Rendered in Canada or Mexico Processing of Registration Applications Accessibility Criteria Disposition of Registration Applications Medical Necessity Changes of Information and Other Registration Transactions Time Limitation on Emergency and Foreign Claims Hospitals and Hospital Units 03AUN1 Payment Denial for Medicare Services Furnished to Alien Beneficiaries 591 Revisions to Surety Bond Collection Policies Model Letters for Claims Who Are Not Lawfully Present in the United States against Surety Bonds Appeals on Claims for Emergency and Foreign Services Claims against Surety Bonds Payment for Services Received By Nonparticipating Providers Payment for Services from Foreign Hospitals 592 Issued to a specific audience, not posted to Internet/ Intranet due to Attending Physician's Statement and Documentation of Medicare Confidentiality of Instruction Emergency 593 Issued to a specific audience, not posted to Internet/ Intranet due to Designated Contractors Confidentiality of Instruction Model Letters, Nonparticipating Hospital and Emergency Claims Letter to 594 Issued to a specific audience, not posted to Internet/ Intranet due to Nonparticipating Hospital That Elected to Bill For Current Year Contldentiality of Instruction Model Letter to Nonparticipating Hospital That Requests to Bill the Program 595 Comprehensive Error Rate Testing (CERT) Program Treatment of Power Model Letter to Nonparticipating Hospital That Did Not Elect to Bill for Mobility Device (PMD) and Repetitive Scheduled Non-Emergent Ambulance 45985 EN03AU15.004</GPH>

986GTP Transport Claims in the Prior Authorization Model 1489 Analysis and Design for Part B Detail Line Expansion CERTProgram Treatment of Power Mobility Device (PMD) and Repetitive 1490 Identification of Obsolete Shared System Maintainer (SSM) Reports — FISS Scheduled Non—Emergent Ambulance Transport Claims in the Prior and VMS Authorization Model 1491 Identification of Obsolete Shared System Maintainer (SSM) On—Request Jobs 596 Issued to a specific audience, not posted to Internet/ Intranet due to —FISS and VMS Confidentiality of Instruction 1492 Health Insurance Portability and Accountability Act (HIPAA) EDI Front End 597 Issued to a specific audience, not posted to Internet/ Intranet due to Updates for July 2015 saonoNnN/sIOZ ‘g jsngny ‘Aepuopy/8pT ‘ON ‘08 ‘TOA /4opst8ay fedapaq Confidentiality of Instruction 1493 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of 598 Proof and Date of Delivery Supplier Documentation Instruction 599 Annual Improper Payment Reduction Strategy (IPRS) 1494 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of 600 Workload Reporting Instruction Prepay Complex Service Specific Review 1495 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Prepay Complex Provider Specific Review Instruction 601 Review of Home Health Claims 1496 Modification to the Telehealth Originating Site Facility Fee Billing Home Health Requirements for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) 1497 Health Insurance Portability and Accountability Act (HIPAA) EDI Front End Updates for October 2015 1498 Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process 1499 Section 504; Implement National Medicare Summary Notices (MSNs) in Alternate Formats 1500 IDR Shared Systems Daily Claims Feeds Expansion to Accommodate Medical Review Data Elements 1501 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Instruction 1502 Analysis — Procedures for Undeliverable Medicare Summary Notices (MSNs) 1503 Health Insurance Portability and Accountability Act (HIPAA) EDI Front End 117 Affordable Care Act Bundled Payments for Care Improvement Initiative — Updates for July.2015 — — Recurring File Updates Models 2 and 4 July 2015 Updates 1504 ICD-IO Conversmn/Codmg Inf.‘rastnlcture Rev1510ns/.ICD-9 Updates to 118 Updates to the Model 4 Bundled Payments for Care Improvement (BPCI) Nat1one.11 CoverageDeterminations (NCDs)—2nd Maintenance CR Initiative to Clarify the Payment Calculation to Include New Technology 1505 Ana.lyms for Inserting a Pre—printed Sheet of Paper in Medicare Summary Add—On Payments, Validate Only Claims with Medicare as Primary Payer, Notice (MSN) Allowing Medical Necessity Denial Claims to Process Effectively. and 1506 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Correct Processing of Claims Submitted as Model 4 for Beneficiaries Instruction Determined to be Incligible 1507 HIGLAS Release 12 (R12) Upgrade and Organizational Transitions for A/B 119 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of MACs — R12 Upgrade Instruction 1508 The Supplemental Security Income (SSTY/Medicare Beneficiary Data for Fiscal Year 2013 for Inpatient Prospective Payment System (IPPS) Hospilals, 1485 Continuation of Systematic Validation of Payment Group Codes for Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals Prospective Payment Systems (PPS) Based on Patient Assessments (LTCH_) — — — 1186 Increasing Tax Withholding to 30% for IRS Federal Payment Levy Program 1509 Analysis — Procedures for Undeliverable Medicare Summary Notices (MSNs) (FPLP) 1510 Award of Medicare Administrative Contractor (MAC) Contract for 1487 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Jurisdiction M Instruction 1511 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of 1488 The Supplemental Security Income (SST)/Medicare Beneficiary Data for Instruction Fiscal Year 2012 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals 41 Issued to a specific audience, not posted to Internet/Intranet due to a (LTCH) Confidentiality of Instruction

42 Payments to Long Term Care Hospitals that Do Not Submit Required Quality Addendum IV: Medicare National Coverage Determinations Data (April through June 2015) 43 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Addendum IV includes completed national coverage 44 Payments to Inpatient Rehabilitation Facilitics That Do Not Submit Required determinations (NCDs), or reconsiderations of completed NCDs, from the Quality Data Payments to IRFs That Do Not Submit Required Quality Data quarter covered by this notice. Completed decisions are identified by the 45 Payments to Hospice Agencies That Do Not Submit Required Quality Data section of the NCD Manual (NCDM) in which the decision appears, the saonoNnN/sIOZ ‘g jsngny ‘Aepuopy/8pT ‘ON ‘08 ‘TOA /4opst8ay fedapaq ble Ris 25) title, the date the publication was issued, and the effective date of the None 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 Addendum II: Regulation Documents Published (title XVIII of the Act), but does not include a determination of the code, if in the Federal Register (April through June 2015) any, that is assigned to a particular covered item or service, or payment Regulations and Notices determination for a particular covered item or service. The entries below Regulations and notices are published in the daily Federal include information concerning completed decisions, as well as sections on Register. To purchase individual copies or subscribe to the Federal program and decision memoranda, which also announce decisions or, in Register, contact GPO at www.gpo.gov/fdsys. When ordering individual some cases, explain why it was not appropriate to issue an NCD. copies, it is necessary to cite either the date of publication or the volume Information on completed decisions as well as pending decisions has also number and page number. been posted on the CMS website. For the purposes of this quarterly notice, The Federal Register is available as an online database through we list only the specific updates that have occurred in the 3—month period. GPO Access. The online database is updated by 6 a.m. each day the This information is available at: wwiw.cms. gov/medicare—coverage— Federal Register is published. The database includes both text and database/. For questions or additional information, contact Wanda Belle graphics from Volume 59, Number 1 (January 2, 1994) through the present (410—786—7491). date and can be accessed at http://yww.gpoacceess.gov/fr/index.html. The following website http://www.archives. gov/federal—register/ provides Title NCDM Transmittal Issue Date Effective information on how to access electronic editions, printed editions, and Section Number Date reference copies. NCD20.30 Microvolt T— wave Alternans (MTWA) NCD 20.30 R182 05/22/2015 01/13/2015 This information is available on our website at: http://www.cms. gov/quarterlyproviderupdates/downloads/Regs— Screening for Hepatitis C Virus (HCV) in Adults — 2015Q0PU .pdf Implementation of For questions or additional information, contact Terri Plumb Additional Common g}?fi g}g? R3285 06/09/2015 06/02/2014 (410—786—4481). Working File (CWF) and ' Shared System Maintainer Addendum III: CMS Rulings (SSMs) Edits CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and Addendum V: FDA—Approved Category B Investigational Device interpretation. They provide clarification and interpretation of complex or Exemptions (IDEs) (April through June 2015) ambiguous provisions of the law or regulations relating to Medicare, Addendum V includes listings of the FDA—approved Medicaid, Utilization and Quality Control Peer Review, private health investigational device exemption (IDE) numbers that the FDA assigns. The insurance, and related matters. listings are organized according to the categories to which the devices are The rulings can be accessed at http://www.cms. gov/Regulations— assigned (that is, Category A or Category B), and identified by the IDE and—Guidance/Guidance/Rulings. For questions or additional information, number. For the purposes of this quarterly notice, we list only the specific contact Tiffany Lafferty (410—786—7548). updates to the Category B IDEs as of the ending date of the period covered L86GFP

mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 45988 by this notice and a contact person for questions or additional infonnation. IDE Device Start Date Gl50086 Freedom Spinal Cord Stimulator System Model FR8A-RCV-A1, 05/29/2015 For questions or additional information, contact Jolm Manlove (410-786- 18:35 Jul 31, 2015 FR8A-RCV-B1; FR4A-RCV-A1; FR4A-RCV-B1; LBRD-915- 6877). 2A-HF Under the Food, Drug, and Cosmetic Act (21 U.S. C. 360c) devices G1500087 Endovascular Repair of Descending Thoraco Abdominal Aortic 05/29/2015 fall into one of three classes. To assist CMS under this categorization Pathologies Using Physician Modified Endovascular Prosthesis G150089 Aquabeam Console Model REF 210101; Aquabeam Motorpack 05/29/2015 process, the FDA assigns one of two categories to each FDA-approved Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices Model REF 210401; Aquabeam Foot Pedal Model REF 210701 investigational device exemption (IDE). Category A refers to experimental G150100 Fibroblast Gl·owth Factor Receptor Inhibitor (FGRFI) Clinical 06/02/2015 Jkt 235001 IDEs, and Category B refers to non-experimental IDEs. To obtain more Trial Assay information about the classes or categories, please refer to the notice Gl50092 SmartPatch PNS System For The Treatment of Back Pain 06/03/2015 published in the April21, 1997 Federal Register (62 FR 19328). G150093 Espiner EMP 400 GYN 06/03/2015 G150096 SIR-Spheres microspheres (Yl!rium-90 lvlicrospheres) OG/05/2015 PO 00000 G150107 LARIAT+ Suture Delivery System 06/18/2015 IDE Device Start Date Gl50106 SITESEAL TM 06/19/2015 G150041 Tricuspid Transcatheter Repair System Model 9900 04/0!12015 Gl50050 RESCUE-VT 06/19/2015 G150042 PIR System (Pyrocarbon Implant Replacement System) 04/0!12015 G150113 STAR S4 IR Excimer Laser System and iDesign Advanced 06/25/2015 G150046 Transcatheter Mitral Valve Implantation System (TMV1) 04/09/2015 Frm 00057 04/09/2015 WaveScan Studio for Wavefront-Guided PRK Treatment of Gl50047 StimGuard Sacral Nerve Stimulator System Myopic Astigmatism G150051 PD-Ll IHC MSB0010718C PHARMDX KIT 04/16/2015 G150117 Sinai Vein Stent Registry 06/25/2015 G150052 NUSURFACE Meniscus Implant Model 50035 To 50090 Lefts 04/16/2015 G140101 Raleve 06/25/2015 and Rights Fmt 4703 G150118 Activa PC Implantable Neurostimulation System, Activa SC 06/26/2015 G150055 Oocyte Handling Medium (OHM) pre-maturation (OHMpremat) 04/17/2015 Implantable Neurostimulation System, Activa RC Implantable and maturation (OHMmat) media system Neurostimulation System Gl50016 AMPHORA Overactive Bladder System 3.0 MM (OAB Device) 04/22/2015 04/23/2015 Sfmt 4725 Gl50057 Gore Excluder Confom1able AAA Endoprosthesis Gl50060 Vysis MET CDx FISH Kit 04/23/2015 Addendum VI: Approval Numbers for Collections of Information G150054 Checkpoint Surgical Nerve Stimulator/Locator 04/24/2015 (April through June 2015) G150059 MED-EL Maestro 04/24/2015 All approval numbers are available to the public at Reginfo.gov. E:\FR\FM\03AUN1.SGM G140133 Kona Medical Sunound Sound System 04/24/2015 05/0!12015 Under the review process, approved information collection requests are Gl40142 TransPyloric Shuttle System G150065 Normothetmic Human Liver Perfusion Machine 05/0!12015 assigned OMB control numbers. A single control number may apply to Gl50066 Cardiac Implantable Electronic Device Magnetic Resonance 05/04/2015 several related information collections. This infonnation is available at Imaging Registry (CIED-MRI Registry) For questions or additional G140216 Aries Device 05/06/2015 infonnation, contact Mitch Bryman (410-786-5258). G150067 Lutonix A V Drug Coated Balloon Catheter Model9010 05/06/2015 G150068 iTIND System 05/06/2015 Gl50070 NOVOTTF-1 OOA Device 05/07/2015 Addendum VII: Medicare-Approved Carotid Stent Facilities, 03AUN1 G150072 Precision Spinal Cord Stimulator 05/08/2015 (April through June 2015) G150034 MECTA Spectrum 5000Q FEAST Device 05/08/2015 Addendum VII includes listings of Medicare-approved carotid Gl50071 GORE Excluder Thoracoabdominal Brance Endoprosthesis 05/13/2015 stent facilities. All facilities listed meet CMS standards for perfonning Gl50073 Millar Mikro-Tip Pressure Catheter (Mikro-Cath) 05/14/2015 carotid artery stenting for high risk patients. On March 17, 2005, we issued G150076 NovoCure/NovoTTF-100A System (Optune) 05/15/2015 G150079 Heartmate PHP (Percutaneous Heart Pump) System 05/20/2015 our decision memorandum on carotid artery stenting. We detennined that G140182 BioMimics 3D Stent System 05/2!12015 carotid artery stenting with embolic protection is reasonable and necessary G150080 Medtronic ACTIV Primary Cell and Sensing (PC+S) Implantable 05/22/2015 only if perfom1ed in facilities that have been detennined to be competent in Deep Brain Stimulation System perfonning the evaluation, procedure, and follow-up necessary to ensure Gl50021 Embozene Microspheres 05/27/2015 optimal patient outcomes. We have created a list of minimum standards for Gl50082 ReDS Wearable System _ _ - 05/29/2015 EN03AU15.007</GPH>

facilities modeled in part on professional society statements on competency. Facility Provider Effective State All facilities must at least meet our standards in order to receive coverage — — Number Date for 0 carotid artery tery stentingg for1or high mig risk P patients. _6For the purp purposes of this TO: Sanford Medical Center — Sioux Falls 1305 W. 18th Street Sioux Falls, SD 57117—5039 quarterly notice, we are providing only the specific updates that have FROM: St. Lukes Episcopal Hospital 450193 033072005 TX occurred in the 3—month period. This information is available at: TO: Baylor St Luke‘s Medical Center http://www.cms. gov/MedicareApprovedFacilitie/CASF/list. asp#TopOfPage 6720 Bertner Avenue Houston, TX 77030 — saonoNnN/sIOZ ‘g jsngny ‘Aepuopy/8pT ‘ON ‘08 ‘TOA /4opst8ay fedapaq For questions or additional information, contact Lori Ashby fjfi?figfi?fiifiiofif‘(’;fl::z;‘ Health Creighton 280030 06/27/2005 NE (410—786—6322). TO: CHI— Creighton University Medical Center 601 North 30th Street Omaha, NE 68131—2197 Facility Provider Effective State WellStar Cobb 110143 06/27/2005 GA Numb Dat 3950 Austell Road Austell, GA 30106 WellStar Kennestone 110035 06/27/2005 GA Southside Hospital North Shore LIJ Health System 1043650625 04/14/2015 NY 677 Church Street Marietta, GA 30060 301 East Main Street Bayshore, NY 11706 grislt;)lI R:%i(;nall 11\\/I/Iec(;l.icall gerlite]:; — 1Wellr;lont CVA 1124058615 04/21/2015 TN Addendum VIII: cal nsttute edical Parl oulevare « « P P Bristol, TN 37620 American College of Cardiology‘s National Cardiovascular Data Sanford Aberdeen Medical Center 1235406455 09/03/2013 SD Registry Sites (April through June 2015) 2905 3rd Avenue Southeast Aberdeen, SD 57401 Addendum VIII includes a list of the American College of Iff;‘;‘gléRzgfiomg h&?dlcélgfggeb_ 1710931522 05/18/2015 FL Cardiology‘s National Cardiovascular Data Registry Sites. We cover iC AOaC VA 2 implantable cardioverter defibrillators (ICDs) for certain clinical Mercy Fitzgerald Hospital 390156 05/29/2015 PA noarllas . . . 1500 Landsdowne Avenue Darby, PA indications, as long as information about the procedures is reported to a Beaumont Health System — Royal Oak 1689653305 05/29/2015 MI central registry. Detailed descriptions of the covered indications are 3601 W. 13th Mile Road Royal Oak, MI 48072 available in the NCD. In January 2005, CMS established the ICD Medical Center of Trinity 100191 06/15/2015 FL Abstraction Tool through the Quality Network Exchange (QNet) as a 9330 State Road 54 Trinity, FL 34655 t dat HMecti hani On October 27. 2005. CMS San Juan Regional Medical Center 1427058510 06/13/2013| NM emporary data coliection mechanism. Un UctODer /, 2005, L. 801 West Maple Street Farmington, NM 87401 announced that the American College of Cardiology‘s National Cardiovascular Data Registry (ACC—NCDR) ICD Registry satisfies the data FROM: University of Kansas Medical Center 170040 05/02/2006 KS reporting requirements in the NCD. Hospitals needed to transition to the TO: University of Kansas Hospital ACC—NCDR ICD Registry by April 2006. 3901 Rainbow Boulevard Kansas City, KS 66160—7200 Effective January 27, 2005, to obtain reimbursement, Medicare FROM: Exempla St. Joseph Iospital 060028 05/10/2005 cCO NCD policy requires that providers implanting ICDs for primary prevention TO: St. Joseph Hospital clinical indications (that is, patients without a history of cardiac arrest or FROM: 1835 Franklin Street spontaneous arrhythmia) report data on each primary prevention ICD Denver, CO 80218—1191 TO: 1375 E 19th Avenue Denver, CO 80218 procedure. Details of the clinical indications that are covered by Medicare FROM: Southwest Florida Regional Medical 100220 02/17/2006 FL and their respective data reporting requirements are available in the Center Medicare NCD Manual, which is on the CMS website at TO: Gulf Coast Medical Center http://www.cms. hhs. gov/Manuals/IOM/itemdetail. asp?filterType—none&{filt 13681 Doctors Way Fort Myers, FL 33912 05/26/2005 MD crByDID=99& sortByDID=1&sortOrdcr=asconding&itemID=CMSO14961 FROM: Southern Maryland Hospital Center TO: 210062 MedStar Southern Maryland Hospital Center A provider can use cither of two mechanisms to satisfy the data 7503 Surratts Road Clinton, MD 20735 reporting requirement. Patients may be enrolled either in an Investigational FROM: Sanford Medical Center 430027 04/19/2005 SD Device Exemption trial studying ICDs as identified by the FDA or in the 6865F

0665TF ACC—NCDR ICD registry. Therefore, for a beneficiary to receive a Evidence Development Document". Although CMS has several policy Medicare—covered ICD implantation for primary prevention, the beneficiary vehicles relating to evidence development activities including the must receive the scan in a facility that participates in the ACC—NCDR ICD investigational device exemption (IDE), the clinical trial policy, national registry. The entire list of facilities that participate in the ACC—NCDR ICD coverage determinations and local coverage determinations, this guidance registry can be found at www.ncedr.com/webnedr/common document is principally intended to help the public understand CMS‘s For the purposes of this quarterly notice, we are providing only the implementation of coverage with evidence development (CED) through the saonoNnN/sIOZ ‘g jsngny ‘Aepuopy/8pT ‘ON ‘08 ‘TOA /4opst8ay fedapaq specific updates that have occurred in the 3—month period. This information national coverage determination process. The document is available at is available by accessing our website and clicking on the link for the http://www.cms. gov/medicare—coverage—database/details/medicare— American College of Cardiology‘s National Cardiovascular Data Registry coverage—document—details.aspx"?MCDId=27. There are no additional at: ww nedr.com/webrcdr/common. For questions or additional Active CMS Coverage—Related Guidance Documents for the April through information, contact Marie Casey, BSN, MPH (410—786—7861). June 2015 quarter. For questions or additional information, contact JoAnna Baldwin (410—786—7205). Addendum X: Interfaith Medical Center Brooklyn NY Auxilio Mutuo Hospital San Juan PR List of Special One—Time Notices Regarding National Coverage University Medical Center Brackenridge Austin TX Provisions (April through June 2015) MemorialCare Surgical Center Saddleback Memorial Laguna Hills CA There were no special one—time notices regarding national HIMA San Pablo Bayamon Bayamon PR coverage provisions published in the April through June 2015 quarter. This Seminole Medical Center Seminole OK information is available at www.cms. hhs.gov/coverage. For questions or St. Anthony Regional Hospital & Nursing Home Carroll IA additional information, contact JoAnna Baldwin (410—786 7205). Taylor Station Surgical Center Columbus OH Cleveland Clinic Abu Dhabi Abu Dhabi Samaritan Hospital Troy NY Addendum XI: National Oncologic PET Registry (NOPR) Via Christi Hospital St. Teresa Wichita KS (April through June 2015) Florida Hospital East Orlando Orlando FL Addendum XI includes a listing of National Oncologic Positron Florida Hospital Celebration Orlando FL CHI Health St. Francis Grand Island NE Emission Tomography Registry (NOPR) sites. We cover positron emission John D Archbold Memorial Hospital Thomasville GA tomography (PET) scans for particular oncologic indications when they are Guthrie Corning Hospital Corning NY performed in a facility that participates in the NOPR. Saint Luke‘s Memorial Hospital Ponce PR In January 2005, we issued our decision memorandum on positron Saint Louise Regional Hospital Gilroy CA emission tomography (PET) scans, which stated that CMS would cover Medical Center Alliance (HCA) Fort Worth TX Waco Cardiology Cath Lab and Surgery Center Waco TX PET scans for particular oncologic indications, as long as they were Tyler Cardiac & Endovascular Surgery Center Tyler TX performed in the context of a clinical study. We have since recognized the The Heart and Vascular Surgery Center Bryan TX National Oncologic PET Registry as one of these clinical studies. Rockdale Medical Center Conyers GA Therefore, in order for a beneficiary to receive a Medicare—covered PET Westerly Hospital Westerly RI scan, the beneficiary must receive the scan in a facility that participates in Westlake Hospital Melrose Park IL the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry Addendum IX: Active CMS Coverage—Related Guidance Documents (NOPR) in the April through June 2015 quarter. This information is (April through June 2015) available at CMS issued a guidance document on November 20, 2014 titled http://www.cms. gov/Medicare ApprovedFacilitie/NOPR/list.asp#fT opOfPage. "Guidance for the Public, Industry, and CMS Staff: Coverage with

For questions or additional information, contact Stuart Caplan, RN, MAS types of facilities are eligible for reimbursement for Lung Volume (410—786—8564). Reduction Surgery (LVRS): e National Emphysema Treatment Trial (NETT) approved (Beginning Addendum XII: Medicare—Approved Ventricular Assist Device 05/07/2007, these will no longer automatically qualify and can qualify only (Destination Therapy) Facilities (April through June 2015) with the other programs); Addendum XII includes a listing of Medicare—approved facilities e Credentialed by the Joint Commission (formenrly, the Joint saonoNnN/sIOZ ‘g jsngny ‘Aepuopy/8pT ‘ON ‘08 ‘TOA /4opst8ay fedapaq that receive coverage for ventricular assist devices (VADs) used as Commision on Accreditation of Healthcare Organizations (JCAHO)) under destination therapy. All facilities were required to meet our standards in their Disease Specific Certification Program for LVRS; and order to receive coverage for VADs implanted as destination therapy. On e Medicare approved for lung transplants. October 1, 2003, we issued our decision memorandum on VADs for the Only the first two types are in the list. There were no updates to clinical indication of destination therapy. We determined that VADs used the listing of facilities for lung volume reduction surgery published in the as destination therapy are reasonable and necessary onlyif performed in April through June 2015 quarter. This information is available at facilities that have been determined to have the experience and www .cms. gov/Medicare ApprovedFacilitie/L VRS/list.asp#TopOfPage. For infrastructure to ensure optimal patient outcomes. We established facility questions or additional information, contact Marie Casey, BSN, MPH standards and an application process. All facilities were required to meet (410—786—7861). our standards in order to receive coverage for VADs implanted as destination therapy. Addendum XIV: Medicare—Approved Bariatric Surgery Facilities For the purposes of this quarterly notice, we are providing only the (April through June 2015) specific updates that have occurred to the list of Medicare—approved Addendum XIV includes a listing of Medicare—approved facilities facilities that meet our standards in the 3—month period. This information is that meet minimum standards for facilities modeled in part on professional available at society statements on competency. All facilities must meet our standards in http://www.cms. gov/MedicareApprovedFacilitie/VAD/list.aspffTopO{Page. order to receive coverage for bariatric surgery procedures. On February 21, For questions or additional information, contact Marie Casey, BSN, MPH 2006, we issued our decision memorandum on bariatric surgery procedures. (410—786—7861). We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body—mass index (BMT) Facilit Provider Number Date Approved 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. asc 8075 N Shadc.land Avenue This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric South Broward Hospital District DBA 10—0038 08/20/2014 Surgery Center (program standards and requirements in effect on February Memorial Regional Hospital 15, 2006); or (2) certified by the American Society for Bariatric Surgery 3501 Johnson Street Hollywood, FL 33021 (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006). Addendum XIII: Lung Volume Reduction Surgery (LVRS) There were no additions, deletions, or editorial changes to {(April through June 2015) Medicare—approved facilities that meet CMS‘s minimum facility standards Addendum XIH includes a listing of Medicare—approved facilities for bariatric surgery that have been certified by ACS and/or ASMBS in the that are eligible to receive coverage for lung volume reduction surgery. April through June 2015 period. This information is available at Until May 17, 2007, facilities that participated in the National Emphysema www.cms. gov/MedicareApprovedFacilitic/BSF/list asp#TopOfPage. For Treatment Trial were also eligible to receive coverage. The following three LI66SP

mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 45992 questions or additional information, contact Jamie Hermansen (410-786-2064 ). 18:35 Jul 31, 2015 Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (April through June 2015) There were no FDG-PET for Dementia and Neurodegenerative Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices Diseases Clinical Trials published in the April through June 2015 quarter. Jkt 235001 This information is available on our website at For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). PO 00000 Frm 00061 Fmt 4703 Sfmt 9990 E:\FR\FM\03AUN1.SGM 03AUN1 EN03AU15.011</GPH>

Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 45993 [FR Doc. 2015–18904 Filed 7–31–15; 8:45 am] computerized comparisons with of the Social Security Act (42 U.S.C. BILLING CODE 4120–01–P information maintained in the National 653(j)(10)), which allows the Secretary Directory of New Hires (NDNH) provide of the U.S. Department of Health and the state SNAP agencies with Human Services to disclose information DEPARTMENT OF HEALTH AND information to help administer their maintained in the NDNH to state HUMAN SERVICES programs and determine an individual’s agencies administering SNAP under the eligibility. State agencies must enter Nutrition Act of 2008, as amended by Administration for Children and into a computer matching agreement Families the Agriculture Act of 2014; (2) the and adhere to its terms and conditions, Privacy Act of 1974, as amended by the including providing OCSE with annual Submission for OMB Review; Computer Matching and Privacy performance outcomes attributable to Comment Request Protection Act of 1988 (5 U.S.C. 552a), the use of NDNH information. The Office of Management and Budget which sets for the terms and conditions Title: Supplemental Nutrition Assistance Program (SNAP) State (OMB) requires OCSE to periodically of a computer matching program; and Agency Performance Reporting Tool. report performance measurements (3) the Government Performance and OMB No.: New Collection. demonstrating how NDNH information Results Modernization Act of 2010 (Pub. Description: State agencies supports OCSE’s strategic mission, L. 111–352), which requires agencies to administering a Supplemental Nutrition goals, and objectives. OCSE will provide report program performance outcomes Assistance Program (SNAP) are the annual SNAP performance outcomes to OMB and for the reports to be mandated to participate in a computer to OMB. available to the public. matching program with the federal The information collection activities Respondents: State SNAP Agencies. Office of Child Support Enforcement for the SNAP performance reports are (OCSE). The outcomes of the authorized by: (1) Subsection 453 (j)(10) ANNUAL BURDEN ESTIMATES Number of Number of Average respondents Total burden Instrument responses per burden hours (SNAP hours respondent per response agencies) SNAP Agency Matching Program Performance Reporting Tool ..................... 52 1 1.625 84 Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Center for Veterinary Medicine (HFV– Hours: 84. HUMAN SERVICES 10), Food and Drug Administration, Additional Information: Copies of the 7519 Standish Pl., Rockville, MD 20855, Food and Drug Administration 240–402–6888. For general questions, proposed collection may be obtained by writing to the Administration for [Docket No. FDA–2015–N–0007] you may also email the Center for Children and Families, Office of Veterinary Medicine (CVM) at: Animal Drug User Fee Rates and cvmadufa@fda.hhs.gov. Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, Payment Procedures for Fiscal Year SUPPLEMENTARY INFORMATION: 2016 DC 20447, Attn: ACF Reports Clearance I. Background Officer. All requests should be AGENCY: Food and Drug Administration, identified by the title of the information HHS. Section 740 of the FD&C Act (21 collection. Email address: ACTION: Notice. U.S.C. 379j–12) establishes four infocollection@acf.hhs.gov. different types of user fees: (1) Fees for SUMMARY: The Food and Drug certain types of animal drug OMB Comment: OMB is required to Administration (FDA) is announcing the applications and supplements; (2) make a decision concerning the rates and payment procedures for fiscal annual fees for certain animal drug collection of information between 30 year (FY) 2016 animal drug user fees. products; (3) annual fees for certain and 60 days after publication of this The Federal Food, Drug, and Cosmetic establishments where such products are document in the Federal Register. Act (the FD&C Act), as amended by the made; and (4) annual fees for certain Therefore, a comment is best assured of Animal Drug User Fee Amendments of sponsors of animal drug applications having its full effect if OMB receives it 2013 (ADUFA III), authorizes FDA to and/or investigational animal drug within 30 days of publication. Written collect user fees for certain animal drug submissions (21 U.S.C. 379j–12(a)). comments and recommendations for the applications and supplements, for When certain conditions are met, FDA proposed information collection should certain animal drug products, for certain will waive or reduce fees (21 U.S.C. be sent directly to the following: Office establishments where such products are 379j–12(d)). of Management and Budget, Paperwork made, and for certain sponsors of such For FY 2014 through FY 2018, the Reduction Project, Email: OIRA_ animal drug applications and/or FD&C Act establishes aggregate yearly SUBMISSION@OMB.EOP.GOV, Attn: investigational animal drug mstockstill on DSK4VPTVN1PROD with NOTICES base revenue amounts for each fiscal Desk Officer for the Administration for submissions. This notice establishes the year (21 U.S.C. 379j–12(b)(1)). Base Children and Families. fee rates for FY 2016. revenue amounts established for years FOR FURTHER INFORMATION CONTACT: Visit after FY 2014 are subject to adjustment Robert Sargis, FDA’s Web site at http://www.fda.gov/ for inflation and workload (21 U.S.C. Reports Clearance Officer. ForIndustry/UserFees/ 379j–12(c)). Fees for applications, [FR Doc. 2015–18952 Filed 7–31–15; 8:45 am] AnimalDrugUserFeeActADUFA/ establishments, products, and sponsors BILLING CODE 4184–01–P default.htm or contact Lisa Kable, are to be established each year by FDA VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1


Document Created: 2018-02-23 10:51:55
Document Modified: 2018-02-23 10:51:55
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactIt is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice.
FR Citation80 FR 45980 
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