Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2015, 45980-45993 [2015-18904]

Download as PDF 45980 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices Subsequent regulations for these programs including the final HHS Notice of Benefit and Payment Parameters for 2014 and the Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 provide further reporting requirements. Based on experience with the first three years of data collection, we request the continuation of data collection and propose revisions to data elements being collected and the burden estimates for years four, five, and six. Form Number: CMS–10433 (OMB Control Number: 0938–1187); Frequency: Annually; Affected Public: Private sector (Business or other For-profits and Not-for-profit institutions); Number of Respondents: 26,951; Total Annual Responses: 26,951; Total Annual Hours: 235,153. (For policy questions regarding this collection contact Leigha Basini at 301– 492–4380.) ACTION: Dated: July 28, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. SUMMARY: Notice. 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. [FR Doc. 2015–18848 Filed 7–31–15; 8:45 am] BILLING CODE 4120–01–P 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. FOR FURTHER INFORMATION CONTACT: 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 Centers for Medicare & Medicaid Services (CMS), HHS. AGENCY: Addenda Contact I CMS Manual Instructions ..................................................................................................... II Regulation Documents Published in the Federal Register ............................................... III CMS Rulings ....................................................................................................................... IV Medicare National Coverage Determinations .................................................................... V FDA-Approved Category B IDEs ........................................................................................ VI Collections of Information .................................................................................................. VII Medicare-Approved Carotid Stent Facilities ..................................................................... VIII American College of Cardiology—National Cardiovascular Data Registry Sites ............ IX Medicare’s Active Coverage-Related Guidance Documents ............................................. X One-time Notices Regarding National Coverage Provisions .............................................. XI National Oncologic Positron Emission Tomography Registry Sites .................................. XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities .............. XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ..................................... XIV Medicare-Approved Bariatric Surgery Facilities .............................................................. XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ...................... All Other Information ................................................................................................................. Ismael Torres ......................... Terri Plumb ............................ Tiffany Lafferty ....................... Wanda Belle .......................... John Manlove ........................ Mitch Bryman ......................... Lori Ashby .............................. Marie Casey, BSN, MPH ....... JoAnna Baldwin ..................... JoAnna Baldwin ..................... Stuart Caplan, RN, MAS ....... Marie Casey, BSN, MPH ....... Marie Casey, BSN, MPH ....... Jamie Hermansen .................. Stuart Caplan, RN, MAS ....... Annette Brewer ...................... SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Phone No. (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–5258 786–6322 786–7861 786–7205 786–7205 786–8564 786–7861 786–7861 786–2064 786–8564 786–6580 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. E:\FR\FM\03AUN1.SGM 03AUN1 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices III. How To Use the Notice mstockstill on DSK4VPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 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. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 45981 Dated July 27, 2015. Kathleen Cantwell Director, Office of Strategic Operations and Regulatory Affairs. E:\FR\FM\03AUN1.SGM 03AUN1 mstockstill on DSK4VPTVN1PROD with NOTICES 45982 VerDate Sep<11>2014 Jkt 235001 PO 00000 Frm 00051 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (April through June 2015) The CMS Manual System is used by CMS program components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. Sfmt 4725 E:\FR\FM\03AUN1.SGM 03AUN1 How to Obtain Manuals The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (10M) or retired. Pub 15-l, Pub 15-2 and Pub 45 arc exceptions to tlris rule and arc still active paper-based manuals. The remaining paper-based manuals arc for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the 10M, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 530 l Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: =-'~~='-'=-'~'==:e· How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 EN03AU15.001</GPH> 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 ""-'-~-'-'-'l...':..!.~~=-'-~~~"'In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the manual for Microvolt T -wave Alternans (MTW A), use Medicare National Coverage Determination (CMS-Pub. 100-03) Transmittal No. 182. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at -'-'-'.!..!..C=-"=="'-'-'-""''-==· Transmittal Number Manual/Subject/Publication Number l'il>il{\~•.·. :~:·~;.:\~ cij/" 91 92 •.•.k•'\'·~·.··~··:·:•t:: 1\;t•::;•:: Manual Updates to Clarify Requirements for Physician Certification and Recertification of Patient Eligibility for Home Health Services Recertifications for Home Health Services Content of the Physician's Certification Method and Disposition of Certifications for Home Health Services Certification and Recertification by Physicians for Home Health Services Manual Updates to Clarify Requirements for Physician Certification and Recertification of Patient Eligibility for Home Health Services Recertifications for Home Health Services Content of the Physician's Certification Method and Disposition of Certifications for Home Health Services Certification and Recertification by Physicians for Home Health Services Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 Publication Dates for the Previous Four Quarterly Notices We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: July 25, 2014 (79 FR 43475), November 14, 2014 (79 FR 68253), February 2, 2015 (80 FR 5537) and April24, 2015 (80 FR 23013). 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. mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 208 Jkt 235001 206 PO 00000 207 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\03AUN1.SGM 03AUN1 Updates on Hospice Election Form, Revocation, and Attending Physician Attending Physician Services Hospice Election Hospice Notice of Election Hospice Revocation Ilospice Discharge Hospice Notice of Termination or Revocation Election, Revocation and Discharge Private Contracting: Definition of Emergency Care Services and Appeals of Opt Out Determinations Appeals Definition of Emergency and Urgent Care Situations Manual Updates to Clarify Requirements for Physician Certification and Recertification of Patient Eligibility for Home Health Services Home Health Prospective Payment System (HH PPS) l\ational 60-Day Episode Rate Adjustments to the 60-Day Episode Rates Counting 60-Day Episodes Split Percentage Payment Approach to the 60-Day Episode Low Utilization Payment Adjustment (LUP A) Partial Episode Payment (PEP) Adjustment Discharge Issues Consolidated Billing Determination of Coverage Impact of Other Available Caregivers and Other Available Coverage on Medicare Coverage of Home Health Services Patient Confined to the Home Patient's Place of Residence Physician Certification for Medical and Other Health Services Furnished by Home Health Agency (HHA) Cse of Oral (Verbal) Orders Cnder the Care of a Physician Physician Certification and Recertification of Patient Eligibility for Medicare Home Health Services Physician Certification Face-to-Face Encounter Supporting Documentation Requirements Physician Recertification Who May Sign the Certification or Recertification Physician Rilling for Certification and Recertification Psychiatric Evaluation, Therapy, and Teaching Intermittent Skilled Nursing Care General Principles Governing Reasonable and Necessary Physical Therapy, Speech-Language Pathology Services, and Occupational Therapy Impact on Care Provided in Excess of "Intermittent'' or "Part-Time" Care Counting Visits Under the Hospital and Medical Plans Services Covered Under the End Stage Renal Disease (ESRD) Program Medical and Other Health Services Furnished by Home Health Agencies Content of the Plan of Care 209 Manual Updates to Clarify Requirements for Physician Certification and Recertification of Patient Eligibility for Home Health Services Updates on Hospice Election Form, Revocation, and Attending Physician Attending Physician Services Hospice Election Election, Revocation and Discharge Ilospice Revocation Hospice Discharge Notice of Termination or Revocation Hospice Notice of Election c{f.z,~.;i'i!{!";;J;~s 182 ?ifiKd~•~iJ?·;~, Microvolt T -wave Alternans (MTW A) ••':''f:.'Ctl,;{i'i~f::'"' •;;;{f.! 3231 3232 3233 3234 3235 3236 3237 3238 3239 3240 3241 ;; ····.%~~?.f!fi.£,0!,)·itif;1!;iiZ.: Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Preventive and Screening Services -Update - Intensive Behavioral Therapy for Obesity, Screening Digital Tomosynthesis Mammography, and Anesthesia Associated with Screening Colonoscopy Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction April2015 Update of the Ambulatory Surgical Center (ASC) Payment System April2015 Update of the Hospital Outpatient Prospective Payment System (OPPS) Inpatient-only Services Cse of HCPCS Modifier- PO Payment Window for Outpatient Services Treated as Inpatient Services Remittance Advice Remark and Claims Adjustment Reason Code and Medicare Remit Easy Print and PC Print Update Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction April2015 Update of the Hospital Outpatient Prospective Payment System (OPPS) Inpatient-only Services Cse of HCPCS Modifier- PO Payment Window for Outpatient Services Treated as Inpatient Services Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Medicare Claims Processing Manual- Chapter 15, Section 40, AmbulanceMedical Conditions List Medical Conditions List and Instructions Transcatheter Mitral Valve Repair (TMVR)-National Coverage Determination (NCO) Claims Processing Requirements for Tlv!VR for MR Services for Medicare Advantage (MA) Plan Participants Coding Requirements for TMVR for MR Claims Furnished on or After August 7, 2014 Claims Processing Requirements for TMVR for MR Services on Professional Claims Claims Processing Requirements for TMVR for MR Services on Inpatient Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 205 45983 EN03AU15.002</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 45984 VerDate Sep<11>2014 3243 3244 Jkt 235001 3245 3246 PO 00000 3247 3248 Frm 00053 3249 3250 3251 Fmt 4703 3252 Sfmt 4725 3253 3254 E:\FR\FM\03AUN1.SGM 3255 03AUN1 3256 3257 EN03AU15.003</GPH> 3258 3259 3260 3261 3262 3263 3264 3265 3266 3267 3268 3269 3270 3271 3272 3273 3274 3275 3276 3277 3278 3279 3280 3281 3282 July Quarterly Update for 2015 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB)- July CY 2015 Update Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstruction Collection of Specimens Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Manual Update to Pub. 100-04, Chapter I, to include Claims Submitted by Multiple DMEPOS Suppliers Exact Duplicates Inpatient Prospective Payment System (IPPS) Hospital Extensions per the Medicare Access and CHIP Reauthorization Act of2015 July 2015 Integrated Outpatient Code Editor (I/OCE) Specifications Version 16.2 NCD20.30 Microvolt T-wave Alternans (MTW A) Messaging for MTW A Coding and Claims Processing for MTW A Microvolt T-wave Alternans (MTW A) Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction New Waived Tests Corrections to the 2015 Home Health (HH) Pricer Program Decision Logic Used by the Pricer on Claims Quarterly Update ofHCPCS Codes Used for Home Health Consolidated Billing Enforcement Implement Operating Rules- Phase III ERA EFT: CORE 360 Unifotm Use of Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Codes (RARC) Rule - Update from CAQH CORE Common Edits and Enhancements Modules (CEM) Code Set Update Claim Status Category and Claim Status Codes Update Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 21.3, Effective October 1, 2015 Instructions for Downloading the Medicare ZIP Code File for October 2015 July Quarterly Update for 2015 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction July 2015 Update of the An1bulatory Surgical Center (ASC) Payment System July 2015 Update of the Hospital Outpatient Prospective Payment System (OPPS) Inpatient Prospective Payment System (IPPS) Hospital Extensions per the Medicare Access and CHIP Reauthorization Act of2015 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 3242 Hospital Claims Transcatheter Mitral Valve Repair (TMVR) Remittance Advice Remark and Claims Adjustment Reason Code and Medicare Remit Easy Print and PC Print Update Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes- July 2015 Update Avera"e Sales Price (ASP) Payment Methodology Correction to the Multi-Carrier System (MCS) Editing on the Service Location National Provider Identifier (NPI) Reported for Anti-Markup and Reference Laboratory Claims Diagnostic Tests Subject to the Anti-Markup Payment Limitation Payment to Physician or Other Supplier for Diagnostic Tests Subject to the Anti-Markup Payment Limitation- Claims Submitted to AlB MACs (B) Billing for Diagnostic Tests (Other Than Clinical Diagnostic Laboratory Tests) Subject to the Anti-Markup Payment Limitation/Claims Submitted AlB MACs(B) Conditional Data Element Requirements for AlB MACs (B) and DMEMACs AlB MAC (B) Specific Requirements for Cettain Specialties/Services Paper Claim Submission To AlB MACs (B) Electronic Claim Submission to AlB MACs (B) Items 14-33 - Provider of Service or Supplier Information Payment Jurisdiction for Services Subject to the Anti-Markup Payment Limitation Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP)- July 2015 July Quarterly Update for 2015 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 3283 3285 Jkt 235001 3286 PO 00000 3287 Current Year Full Denial- Hospital-Filed or Beneficiary-Filed Emergency Claim Full Denial- Foreign Claim- Beneficiary Filed Denial - .\i!ilitary Personnel/Eligible Dependents Full Denial - Shipboard Claim - Beneficiary filed Partial Denial- Hos ital-Filed or Beneficiarv-Filed Emer lll 112 None Issued to a specitic audience, not posted to Internet /Intranet due to Sensitivity of Instruction Inpatient Hospital Claims and Medicare Secondary Payer (MSP) Claims with Frm 00054 Fmt 4703 Sfmt 4725 250 Notice of .\Jew Interest Rate tor Medicare Overpayments and Underpayments - 3rd Qtr. 'lotification for FY 2015 137 Revisions to State Operations Manual (SOM) Appendices A, G, Land T related to Hospitals, Rural Health Clinics, Ambulatory Surgical Centers and Swing Bed Revisions to State Operations Manual (SOM), Appendix W for Critical Access Hospitals Revisions to the Medicare State Operations Manual (SOM), Chapter 2, Rural Health Clinic Certification I Revisions to Appendix C-Survcy Procedures and Interpretive Guidelines for Laboratories and Services 138 139 140 58'J E:\FR\FM\03AUN1.SGM 590 03AUN1 591 592 593 594 595 Issued to a specitic audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Update ofCMS-855A, Physician-Owned Hospital Reporting Via the CMS855POH and Indirect Payment Procedure Registration Via the CMS-855C in Chapter 15 of Pub. 100-08 Registration Letters Submission of Registration Applications Processing of Registration Applications Disposition of Registration Applications Changes of Information and Other Registration Transactions Hospitals and Hospital Units Revisions to Surety Bond Collection Policies Model Letters for Claims against Surety Bonds Claims against Surety Bonds Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Contldentiality of Instruction Comprehensive Error Rate Testing (CERT) Program Treatment of Power Mobility Device (PMD) and Repetitive Scheduled Non-Emergent Ambulance Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 3284 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSUB)- April CY 2015 Lpdate Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Screening for Hepatitis C Virus (HCV) in Adults -Implementation of Additional Common Working File (CWF) and Shared System Maintainer (SSMs) Edits Common Working File (CWF) Edits Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) Messages Institutional Billing Requirements Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2016 Revisions to Medicare Claims Processing Manual for Foreign, Emergency and Shipboard Claims Emergency and Foreign Hospital Services Services Rendered By Nonparticipating Providers Establishing an Emergency Coverage Requirements for Emergency Hospital Services in Foreign Countries Qualifications of an Emergency Services Hospital Services Furnished in a Foreign Hospital Nearest to Beneficiary's U.S. Residence Coverage of Physician and Ambulance Services Furnished Outside U.S. Claims for Services Furnished in Canada to Qualified Railroad Retirement Beneficiaries Claims from Hospital-Leased Laboratories Not Meeting Conditions of Participation l\onemergency Part B Medical and Other Health Services Elections to Bill for Services Rendered By l\onparticipating Hospitals Processing Claims Contractors Designated to Process Foreign Claims Contractor Processing Guidelines Medicare Approved Charges for Services Rendered in Canada or Mexico Accessibility Criteria Medical Necessity Time Limitation on Emergency and Foreign Claims Payment Denial for Medicare Services Furnished to Alien Beneficiaries Who Are Not Lawfully Present in the United States Appeals on Claims for Emergency and Foreign Services Payment for Services Received By Nonparticipating Providers Payment for Services from Foreign Hospitals Attending Physician's Statement and Documentation of Medicare Emergency Designated Contractors Model Letters, Nonparticipating Hospital and Emergency Claims Letter to Nonparticipating Hospital That Elected to Bill For Current Year Model Letter to Nonparticipating Hospital That Requests to Bill the Program Model Letter to Nonparticipating Hospital That Did Not Elect to Bill for 45985 EN03AU15.004</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 45986 VerDate Sep<11>2014 597 Jkt 235001 598 599 600 PO 00000 601 1489 1490 1491 1492 1493 1494 1495 1496 hh•c'f Frm 00055 None 1497 ,.,z.~g;,::;.~;·~~~· r;;'"i~'·i'(' 1498 None "li'•'''•'>{'i c•i< Fmt 4703 ·~; I"'' 1500 None K·~~;·icl'{•'< ,:;~r••. •••• , •.•.Jt .:•·~•.;;•;v••i;;~ ,i;\;,~; Sfmt 4725 None 1:\ss Crossover Process 1499 None ,·~;;~·~1 1501 .••• ,•••. ,;:;•?.~·.~ None .;\:; ~'.10 'i·~·; ;.;;;~·;:;••. :i\\(,{ ; ;•, 1';'~\ i,;~·>;• E:\FR\FM\03AUN1.SGM 117 118 119 03AUN1 ~:·~•'12''1);:;:; ;·~; 1485 1487 1488 ••••••• i'{ii~; •{~~~ ••:~.;••·;····;•i;;;¥; Affordable Care Act Bundled Payments for Care Improvement Initiative Recurring File Updates Models 2 and 4 July 2015 Updates Updates to the :v!odel 4 Bundled Payments for Care Improvement (BPCI) Initiative to Clarify tbe Payment Calculation to Include 'lew Technology Add-On Payments, Validate Only Claims with Medicare as Primary Payer, Allowing Medical Necessity Denial Claims to Process Effectively, and Correct Processing of Claims Submitted as Model 4 for Beneficiaries Determined to be Ineligible Issued to a specific, audience not to Intemetl Intranet due to a Sensitivity of Instruction ···;~·"''' ·~.\it.•,~ \{~ Continuation of Systematic Validation of Payment Group Codes for Prospective Payment Systems (PPS) Based on Patient Assessments Increasing Tax Withholding to 30% for IRS Federal Payment Levy Program (FPLP) Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Instruction The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year 2012 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs ), and Long Term Care Hospitals (LTCH) Analysis and Design for Part B Detail Line Expansion Identification of Obsolete Shared System Maintainer (SSM) Reports- FISS and VMS Identification of Obsolete Shared System Maintainer (SSM) On-Request Jobs - FISS and VMS Health Insurance Portability and Accountability Act (HIPAA) ED! Front End Updates for July 2015 Issued to a specitlc, audience not to Internet! Intranet due to a Sensitivity of Instruction Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Instmction Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Instmction Modification to the Telehealth Originating Site Facility Fee Billing Requirements for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) Health Insurance Portability and Accountability Act (HIP AA) ED! Front End Updates for October 2015 Modifications to the National Coordination of Benefits Agreement (COBA) 1502 1503 1504 1505 1506 1507 1508 ;; .~ ~r~;'~:i 1509 1510 1511 Section 504: Implement National Medicare Summary Notices (:viSNs) in Alternate Formats !DR Shared Systems Daily Claims Feeds Expansion to Accommodate Medical Review Data Elements Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Instruction Analysis -Procedures for Undeliverable Medicare Summary Notices (MSNs) Health Insurance Portability and Accountability Act (HIP AA) ED! Front End Updates for July 2015 ICD-10 Conversion/Coding Infrastmcture Revisions/ICD-9 Updates to National Coverage Determinations (NCDs)--2nd Maintenance CR Analysis for InseJting a Pre-printed Sheet of Paper in Medicare Summary Notice (MSN) Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Instmction HTGT AS Release 12 (R 12) Upgrade and Organizational Transitions for AIR MACs - R12 Upgrade The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year 2013 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals (LTCH) Analysis- Procedures for Undeliverable Medicare Summary Notices (MSNs) Award of Medicare Administrative Contractor (MAC) Contract for Jurisdiction M Issued to a specific, audience not to Intemetl Intranet due to a Sensitivity of Instmction :\'i;i'·,;";''''' 41 :'·;~,1;.:;.\tl:;%;;; Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality ofTnstruction Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 596 1486 EN03AU15.005</GPH> Transport Claims in the Prior Authorization Model CERT Program Treatment of Power Mobility Device (PMU) and Repetitive Scheduled Non-Emergent Ambulance Transport Claims in the Prior Authorization Model 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 Proof and Date of Delivery Supplier Documentation Annual Improper Payment Reduction Strategy (IPRS) Workload Reporting Prepay Complex Service Specific Review Prepay Complex Provider Specific Review Review of Home Healtb Claims Home Health mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 42 44 45 I ~~i;l~,~i· Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 E:\FR\FM\03AUN1.SGM Addendum IT: Regulation Documents Published in the Federal Register (April through June 2015) 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 number and page number. The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at The following website provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: For questions or additional infom1ation, contact Terri Plumb (410-786-4481). 03AUN1 Addendum III: CMS Rulings CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. The rulings can be accessed at"''!-'.! 1w w w .~.u1~.!?u' 1r.."!G"'<>uuu,For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (April through June 2015) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An N CD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda, which also announce decisions or, in some cases, explain why it was not appropriate to issue an NCD. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, we list only the specific updates that have occurred in the 3-month period. This information is available at: n:YDY~~?m:L.ffi~gJJ!£l;:Q!:9!f~ For questions or additional information, contact Wanda Belle (410-786-7491). Title NCD20.30 Microvolt Twave Alternans (MTW A) Screening for Hepatitis C Vims (HCV) in AdultsImplementation of Additional Common Working File (CWF) and Shared System Maintainer (SSMs) Edits NCDM Section Transmittal Number Issue Date Effective Date NCD 20.30 Rl82 05/22/2015 01/13/2015 NCD 210.3 CPM 210.1 R3285 06/09/2015 06/02/2014 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (April through June 2015) Addendum V includes listings of the FDA-approved investigational device exemption (IDE) numbers that the FDA assigns. The listings are organized according to the categories to which the devices are assigned (that is, Category A or Category B), and identified by the IDE number. For the purposes of tlris quarterly notice, we list only the specific updates to the Category BIDEs as of the ending date of the period covered Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 43 Payments to Long Term Care Hospitals that Do Not Submit Required Quality Data Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instmction Payments to Inpatient Rehabilitation Facilities That Do Not Submit Required Quality Data Payments to IRFs That Do Not Submit Required Quality Data Payments to Hospice Agencies '!hat Do Not Submit Required Quality Data .$ilcfUI!'i,:;l'-~';iS;,\ <;> nill~~""\1,2\~'' , , None 45987 EN03AU15.006</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 45988 VerDate Sep<11>2014 Jkt 235001 PO 00000 Frm 00057 IDE G150041 G150042 G150046 Gl50047 G150051 G150052 Fmt 4703 G150055 Sfmt 4725 E:\FR\FM\03AUN1.SGM Gl50016 Gl50057 Gl50060 G150054 G150059 G140133 Gl40142 G150065 Gl50066 03AUN1 G140216 G150067 G150068 Gl50070 G150072 G150034 Gl50071 Gl50073 G150076 G150079 G140182 G150080 Gl50021 Gl50082 EN03AU15.007</GPH> Device Tricuspid Transcatheter Repair System Model 9900 PIR System (Pyrocarbon Implant Replacement System) Transcatheter Mitral Valve Implantation System (TMV1) StimGuard Sacral Nerve Stimulator System PD-Ll IHC MSB0010718C PHARMDX KIT NUSURFACE Meniscus Implant Model 50035 To 50090 Lefts and Rights Oocyte Handling Medium (OHM) pre-maturation (OHMpremat) and maturation (OHMmat) media system AMPHORA Overactive Bladder System 3.0 MM (OAB Device) Gore Excluder Confom1able AAA Endoprosthesis Vysis MET CDx FISH Kit Checkpoint Surgical Nerve Stimulator/Locator MED-EL Maestro Kona Medical Sunound Sound System TransPyloric Shuttle System Normothetmic Human Liver Perfusion Machine Cardiac Implantable Electronic Device Magnetic Resonance Imaging Registry (CIED-MRI Registry) Aries Device Lutonix A V Drug Coated Balloon Catheter Model9010 iTIND System NOVOTTF-1 OOA Device Precision Spinal Cord Stimulator MECTA Spectrum 5000Q FEAST Device GORE Excluder Thoracoabdominal Brance Endoprosthesis Millar Mikro-Tip Pressure Catheter (Mikro-Cath) NovoCure/NovoTTF-100A System (Optune) Heartmate PHP (Percutaneous Heart Pump) System BioMimics 3D Stent System Medtronic ACTIV Primary Cell and Sensing (PC+S) Implantable Deep Brain Stimulation System Embozene Microspheres ReDS Wearable System _ _ - Start Date 04/0!12015 04/0!12015 04/09/2015 04/09/2015 04/16/2015 04/16/2015 04/17/2015 04/22/2015 04/23/2015 04/23/2015 04/24/2015 04/24/2015 04/24/2015 05/0!12015 05/0!12015 05/04/2015 05/06/2015 05/06/2015 05/06/2015 05/07/2015 05/08/2015 05/08/2015 05/13/2015 05/14/2015 05/15/2015 05/20/2015 05/2!12015 05/22/2015 05/27/2015 05/29/2015 IDE Gl50086 G1500087 G150089 G150100 Gl50092 G150093 G150096 G150107 Gl50106 Gl50050 G150113 G150117 G140101 G150118 Device Freedom Spinal Cord Stimulator System Model FR8A-RCV-A1, FR8A-RCV-B1; FR4A-RCV-A1; FR4A-RCV-B1; LBRD-9152A-HF Endovascular Repair of Descending Thoraco Abdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis Aquabeam Console Model REF 210101; Aquabeam Motorpack Model REF 210401; Aquabeam Foot Pedal Model REF 210701 Fibroblast Gl·owth Factor Receptor Inhibitor (FGRFI) Clinical Trial Assay SmartPatch PNS System For The Treatment of Back Pain Espiner EMP 400 GYN SIR-Spheres microspheres (Yl!rium-90 lvlicrospheres) LARIAT+ Suture Delivery System SITESEAL TM RESCUE-VT STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio for Wavefront-Guided PRK Treatment of Myopic Astigmatism Sinai Vein Stent Registry Raleve Activa PC Implantable Neurostimulation System, Activa SC Implantable Neurostimulation System, Activa RC Implantable Neurostimulation System Start Date 05/29/2015 05/29/2015 05/29/2015 06/02/2015 06/03/2015 06/03/2015 OG/05/2015 06/18/2015 06/19/2015 06/19/2015 06/25/2015 06/25/2015 06/25/2015 06/26/2015 Addendum VI: Approval Numbers for Collections of Information (April through June 2015) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. This infonnation is available at For questions or additional infonnation, contact Mitch Bryman (410-786-5258). Addendum VII: Medicare-Approved Carotid Stent Facilities, (April through June 2015) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for perfonning carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We detennined that carotid artery stenting with embolic protection is reasonable and necessary only if perfom1ed in facilities that have been detennined to be competent in perfonning the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 by this notice and a contact person for questions or additional infonnation. For questions or additional information, contact Jolm Manlove (410-7866877). Under the Food, Drug, and Cosmetic Act (21 U.S. C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved investigational device exemption (IDE). Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the notice published in the April21, 1997 Federal Register (62 FR 19328). mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 Jkt 235001 For questions or additional information, contact Lori Ashby (410-786-6322). Facility PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\03AUN1.SGM IV:: Southside Hospital -North Shore LIJ Health System 30 1 East Main Street Bayshore, NY 11706 Bristol Regional Medical Center- Wellmont CV A Heart Institute 1 Medical Park Boulevard Bristol. TN 37620 Sanford Aberdeen Medical Center 2905 3rd Avenue Southeast Aberdeen, SD 57401 Kendall Regional Medical Center 11750 Bird Road Miami, FL 33175 Mercy Fitzgerald Hospital 1500 Landsdownc Avenue Darby, PA Beaumont Health System- Royal Oak 3601 W. 13th Mile Road Royal Oak, MI 48072 Medical Center of Trinity 9330 State Road 54 Trinity, FL 34655 San Juan Regional Medical Center NM 87401 801 West Maple Street Provider Number Effective Date 1043650625 04/14/2015 NY 1124058615 04/2112015 TN 1235406455 09/03/2013 SD 1710931522 05/18/2015 FL 390156 05/29/2015 PA 1689653305 05/29/2015 MI 100191 06/15/2015 FL 1427058510 06/15/2015 NM ;""''"' f2i·l';?>i;>:>:'?;{;! ;•;;;;;;;4:f\i/;>;i. 03AUN1 FROM: University of Kansas Medical Center TO: University of Kansas Hospital 390 1 Rainbow Boulevard Kansas City, KS 66160-7200 FROM: Exempla St. Joseph Hospital TO: St. Joseph Hospital FROM: 1835 Franklin Street Denver, CO 80218-1191 TO: 1375 E 19th Avenue Denver, CO 80218 FROM: Southwest Florida Regional Medical Center TO: Gulf Coast Medical Center 13681 Doctors Way Fort Myers, FL 33912 FROM: Southern Maryland Hospital Center TO: MedStar Southern Maryland Hospital Center 7503 Surratts Road Clinton, MD 20735 FROM: Sanford Medical Center 170040 State ;)>~);?,; ~;,,::;'(il;: ,;,: ??;•;?+t.;;i ;;;:;::c.>c>~. 05/02/2006 KS 060028 05/10/2005 co 100220 02/17/2006 FL 210062 05/26/2005 MD 430027 04/19/2005 SD Facility TO: Sanford Medical Center - Sioux Falls 1305 W. 18th Street Sioux Falls, SD 57117-5039 FROM: St. Lukes Episcopal Hospital TO: Baylor St Luke's Medical Center 6720 Bertner Avenue Houston, TX 77030 FROM: Alegent Creighton Health Creighton University Medical Center TO: CHI- Creighton University Medical Center 601 North 30th Street Omaha, NE 68131-2197 WellStar Cobb 3950 Austell Road Austell, GA 30106 Well Star Kennestone 677 Church Street Marietta, GA 30060 Provider Number Effective Date State 450193 03/30/2005 TX 280030 06/27/2005 NE 110143 06/27/2005 GA 110035 06/27/2005 GA Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (April through June 2015) Addendum VIII includes a list of the American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the TCD 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 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 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 tllis quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: A provider can usc either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the 45989 EN03AU15.008</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 45990 VerDate Sep<11>2014 Jkt 235001 PO 00000 Facility r1fs~J' City YEJ'!i;:'.;z,,vjj Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\03AUN1.SGM 03AUN1 Interfaith Medical Center Auxilio Mutuo Hospital University Medical Center Brackenridge Memoria! Care Surgical Center Saddle back Memorial HIMA San Pablo Bayamon Seminole Medical Center St. Anthony Regional Hospital & Nursing Home Taylor Station Surgical Center Cleveland Clinic Abu Dhabi Samaritan Hospital Via Christi Hospital St. Teresa Florida Hospital East Orlando Florida Hospital Celebration CHI Health St. Francis John D Archbold Memorial Hospital Guthrie Corning Hospital Saint Luke's Memorial Hospital Saint Louise Regional Hospital Medical Center Alliance (HCA) Waco Cardiology Cath Lab and Surgery Center Tyler Cardiac & Endovascular Surgery Center The Heart and Vascular Surgery Center Rockdale Medical Center Westerly Hospital Westlake Hospital •~·;z>;:;5::c0~.1'~ NY PR TX CA PR OK IA OH NY KS FL FL NE GA NY PR CA TX TX TX TX GA RI IL Addendum IX: Active CMS Coverage-Related Guidance Documents (April through June 2015) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with EN03AU15.009</GPH> There are no additional Active CMS Coverage-Related Guidance Documents for the April through June 2015 quarter. For questions or additional information, contact JoAnna Baldwin (410-786-7205). State ";.£'" Brooklyn San Juan Austin Laguna Hills Bay amon Seminole Carroll Columbus Abu Dhabi Troy Wichita Orlando Orlando Grand Island Thomasville Corning Ponce Gilroy Fort Worth Waco Tyler Bryan Conyers Westerly Melrose Park Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS 's implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (April through June 2015) There were no special one-time notices regarding national coverage provisions published in the April through June 2015 quarter. This For questions or information is available at additional information, contact JoAnna Baldwin (410-786 7205). Addendum XI: National Oncologic PET Registry (NOPR) (April through June 2015) Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the April through June 2015 quarter. This information is available at Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 ACC-NCDR lCD registry. Therefore, for a beneficiary to receive a Medicare-covered lCD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR lCD registry. The entire list of facilities that participate in the ACC-NCDR lCD registry can be found at J:YYffi:.,].!gJU~l!ffi~!]glll.\;CQ!!!!J];m 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). mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564). Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for V ADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on V ADs for the clinical indication of destination therapy. We determined that V ADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for V ADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred to the list of Medicare-approved facilities that meet our standards in the 3-month period. This infonnation is available at E:\FR\FM\03AUN1.SGM For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861). 03AUN1 Facility Provider Number Date Approved State Community Heart and Vascular Hospital 8075 N Shadeland Avenue Indianapolis, IN 46250 150074 10/01/2014 IN South Broward Hospital District DBA Memorial Regional Hospital 3501 Johnson Street Hollywood, FL 33021 10-0038 08/20/2014 FL "''·''~' Addendum XIII: Lung Volume Reduction Surgery (LVRS) (April through June 2015) 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 Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (April through June 2015) Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We 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 perfonned at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (ESCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' s minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the April through June 2015 period. This infonnation is available at w;,.vw.cms.govliVJemcarei\pprovcm-acnmclt>~tlnstaspi't Iopun"age. For Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (April through June 2015) types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (L VRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (fonnerly, the Joint Commision on Accreditation ofHealthcare Organizations (JCAHO)) under their Disease Specific Certification Program for L VRS; and • Medicare approved for lung transplants. Only the first two types are in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the April through June 2015 quarter. Tllis infonnation is available at .www.cms,gov/lVteGJcareApprovcul:"acmne/L vK:o,mst.aspH Iopun•age. For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861). 45991 EN03AU15.010</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 45992 VerDate Sep<11>2014 Jkt 235001 Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (April through June 2015) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the April through June 2015 quarter. This information is available on our website at PO 00000 For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). Frm 00061 Fmt 4703 Sfmt 9990 E:\FR\FM\03AUN1.SGM 03AUN1 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 18:35 Jul 31, 2015 EN03AU15.011</GPH> questions or additional information, contact Jamie Hermansen (410-786-2064 ). Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices [FR Doc. 2015–18904 Filed 7–31–15; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Supplemental Nutrition Assistance Program (SNAP) State Agency Performance Reporting Tool. OMB No.: New Collection. Description: State agencies administering a Supplemental Nutrition Assistance Program (SNAP) are mandated to participate in a computer matching program with the federal Office of Child Support Enforcement (OCSE). The outcomes of the computerized comparisons with information maintained in the National Directory of New Hires (NDNH) provide the state SNAP agencies with information to help administer their programs and determine an individual’s eligibility. State agencies must enter into a computer matching agreement and adhere to its terms and conditions, including providing OCSE with annual performance outcomes attributable to the use of NDNH information. The Office of Management and Budget (OMB) requires OCSE to periodically report performance measurements demonstrating how NDNH information supports OCSE’s strategic mission, goals, and objectives. OCSE will provide the annual SNAP performance outcomes to OMB. The information collection activities for the SNAP performance reports are authorized by: (1) Subsection 453 (j)(10) 45993 of the Social Security Act (42 U.S.C. 653(j)(10)), which allows the Secretary of the U.S. Department of Health and Human Services to disclose information maintained in the NDNH to state agencies administering SNAP under the Nutrition Act of 2008, as amended by the Agriculture Act of 2014; (2) the Privacy Act of 1974, as amended by the Computer Matching and Privacy Protection Act of 1988 (5 U.S.C. 552a), which sets for the terms and conditions of a computer matching program; and (3) the Government Performance and Results Modernization Act of 2010 (Pub. L. 111–352), which requires agencies to report program performance outcomes to OMB and for the reports to be available to the public. Respondents: State SNAP Agencies. ANNUAL BURDEN ESTIMATES Number of respondents (SNAP agencies) Number of responses per respondent Average burden hours per response Total burden hours SNAP Agency Matching Program Performance Reporting Tool ..................... mstockstill on DSK4VPTVN1PROD with NOTICES Instrument 52 1 1.625 84 Estimated Total Annual Burden Hours: 84. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–18952 Filed 7–31–15; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0007] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2016 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2016 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Amendments of 2013 (ADUFA III), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2016. FOR FURTHER INFORMATION CONTACT: Visit FDA’s Web site at https://www.fda.gov/ ForIndustry/UserFees/ AnimalDrugUserFeeActADUFA/ default.htm or contact Lisa Kable, SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Center for Veterinary Medicine (HFV– 10), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6888. For general questions, you may also email the Center for Veterinary Medicine (CVM) at: cvmadufa@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 740 of the FD&C Act (21 U.S.C. 379j–12) establishes four different types of user fees: (1) Fees for certain types of animal drug applications and supplements; (2) annual fees for certain animal drug products; (3) annual fees for certain establishments where such products are made; and (4) annual fees for certain sponsors of animal drug applications and/or investigational animal drug submissions (21 U.S.C. 379j–12(a)). When certain conditions are met, FDA will waive or reduce fees (21 U.S.C. 379j–12(d)). For FY 2014 through FY 2018, the FD&C Act establishes aggregate yearly base revenue amounts for each fiscal year (21 U.S.C. 379j–12(b)(1)). Base revenue amounts established for years after FY 2014 are subject to adjustment for inflation and workload (21 U.S.C. 379j–12(c)). Fees for applications, establishments, products, and sponsors are to be established each year by FDA E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 45980-45993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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III. How To Use the Notice

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

    Dated 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

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