Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July through September 2015, 70218-70231 [2015-28870]

Download as PDF Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices • Regulations.gov: https:// www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link ‘‘Submit a Comment’’ that corresponds with ‘‘Information Collection 9000– 0053, Permits, Authorities, or Franchises’’. Follow the instructions provided at the ‘‘Submit a Comment’’ screen. Please include your name, company name (if any), and ‘‘Information Collection 9000–0053, Permits, Authorities, or Franchises’’ on your attached document. • Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000–0053, Permits, Authorities, or Franchises. Instructions: Please submit comments only and cite ‘‘Information Collection 9000–0053, Permits, Authorities, or Franchises,’’ in all correspondence related to this collection. Comments received generally will be posted without change to https:// www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail). FOR FURTHER INFORMATION CONTACT: Mr. Michael O. Jackson, Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA 202–208–4949 or email michaelo.jackson@gsa.gov. SUPPLEMENTARY INFORMATION: jstallworth on DSK7TPTVN1PROD with NOTICES A. Purpose The FAR requires insertion of clause 52.247–2, Permits, Authorities, or Franchises, when regulated transportation is involved. The clause VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 requires the contractor to indicate whether it has the proper authorization from the Federal Highway Administration (or other cognizant regulatory body) to move material. The contractor may be required to provide copies of the authorization before moving material under the contract. The clause also requires the contractor, at its expense, to obtain and maintain any permits, franchises, licenses, and other authorities issued by State and local governments. The Government may request to review the documents to ensure that the contractor has complied with all regulatory requirements. B. Annual Reporting Burden Respondents: 255. Responses per Respondent: 1. Annual Responses: 255. Hours per Response: 0.5. Total Burden Hours: 128. C. Public Comments Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), PO 00000 Frm 00035 Fmt 4703 Sfmt 4725 1800 F Street NW., Washington, DC 20405 telephone 202–501–4755. Please cite OMB Control No. 9000– 0053, Permits, Authorities, or Franchises, in all correspondence. Edward Loeb, Acting Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2015–28802 Filed 11–12–15; 8:45 am] BILLING CODE 6820–EP–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9093–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July through September 2015 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 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. SUMMARY: E:\FR\FM\13NON1.SGM 13NON1 EN13NO15.002</GPH> 70218 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices I. Background jstallworth on DSK7TPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 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’’ PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 70219 accessibility. In addition, many of the Web sites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the Web site. These listservs avoid the need to check the Web site, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a Web site proves to be difficult, the contact person listed can provide information. III. How to Use the Notice This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at https:// www.cms.gov/manuals. Dated: November 6, 2015. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\13NON1.SGM 13NON1 jstallworth on DSK7TPTVN1PROD with NOTICES 70220 VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (July through September 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 transfmmed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 How to Obtain Manuals The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the 10M, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: https://cms.gov/manuals. How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 EN13NO15.003</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 https://www.gpo.gov/libraries/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they arc 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 Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes- October 2015 Update, use Medicare Claims Processing (CMS-Pub. 100-04)Transmittal No. 3304. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at www.cms.gov/Manuals. Transmittal Number Manual/Subject/Publication Number .. ' '0····•·::;•:;<\':<;:'; ;.: 93 ~.i:C)\t•\,.;!•:i;ii;i •;\i~:~;.~.· Internet Only Manual (IOM) Publication 100-01- General Information, Eligibility, and Entitlement, Chapter 7 - Contract Administrative Requirements, Section 40 -Shared System Maintainer Responsibilities for Systems Releases Shared System Maintainer and Part NPart B (NB)/Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) and the Shared System Maintainer and Part A/Part B (A/B)/Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) and the Single Testing Contractor (STC) Responsibilities for Systems Releases Standardized Tenninology for Claims Processing Systems Standard Terminology Chart Release Software Implementing Validated Workarounds for Shared System Claims Processing by All Medicare DME MACs Next Generation Desktop (NGD) Requirements Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 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: November 14, 2014 (79 FR 68253), February 2, 2015 (80 FR 5537), April24, 2015 (80 FR 23013) and August 3, 2015 (80 FR 45980). 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. jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00038 ,b+~,~~~:?! r;L':•y;c;~;.,;,;;''· 183 Fmt 4703 184 Sfmt 4725 185 ;i't;i;,>;~\~\~?:;l, 3288 E:\FR\FM\13NON1.SGM 13NON1 3289 ,,, National Coverage Determination (NCD) for Screening for Colorectal Cancer Using Colo guard™- A Multitarget Stool DNA Test Kational Coverage Determination (NCD) for Screening for Colorectal Cancer Using Cologuard™- A Multitarget Stool DNA Test Update to Pub. 100-03, National Coverage Determination .\i!anual, Chapter 1, Part 1, Section 50.1 Speech Generating Device Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction \{ 1 ' •. , s':c,,\i''":.:·~. ~'>'?: '~;jiif;'· t''i3':; Medicare Internet Only Manual Publication 100-04 Chapter 22 Remittance Advice Background Remittance Balancing Electronic Remittance Advice- ERA or ASC X12 835 ASC X12 835 Medicare Standard Electronic PC-Print Software for Institutional Providers Medicare Remit Easy Print Software for Professional Providers and Suppliers Standard Paper Remittance Advice Claim Adjustment Reason Codes Remittance Advice Remark Codes Requests for Additional Codes The Council for Affordable Quality Healthcare (CAQH) Committee on Operating Rules for Information Exchange (CORE) Mandated Operating Rules Health Care Claim Payment/Advice (835) Infrastructure Rule Lniform Use ofCARCs and RARCs Rule EFT Enrollment Data Rule ERA Enrollment Form Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2016 3290 3291 3292 3293 3294 3295 3296 3297 3298 3299 3300 3301 3302 3303 3304 3305 3306 3307 3308 3309 October 2015 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2015 Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes- July 2015 Update Average Sales Price (ASP) Payment Methodology Issued to a specific audience, not posted to Intemel/Intrantl due to a Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/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 specitic audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction 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 Sensitivity oflnstruclion Issued to a specitlc audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Claims Processing Instructions for Diagnostic Digital Breast Tomosynthesis Digital Breast Tomosynthesis Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MS"\1) Messages Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes- October 2015 Update Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (UMEPOS) Competitive Bidding Program (CBP)- October 2015 Applying Therapy Caps to Maryland Hospitals Determining Payment Amounts- Institutional Claims Application of Financial Limitations Exceptions to Therapy Caps - General Exceptions Process Cse of the KX Modifier for Therapy Cap Exceptions Therapy Cap Manual Review Threshold Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 Shared System Testing Requirements for Shared System Maintainers Single Testing Contractor (STC), and UME MACs Minimum Testing Standards for Shared System Maintainers and the Single Testing Contractor (STC)/Beta Testers Testing Standards Applicable to all Beta Testers Part A/Part B (AlB) Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) (User) Testing Requirements Testing Requirements Applicable to all CWF Data Centers (Hosts) Timeframe Requirements for all Testing Entities Testing Documentation Requirements Definitions Test Case Specification Standard Shared System Testing Requirements for Shared System Maintainers, Single Testing Contractor (STC)/Beta Testers, and Part A/Part B (AlB) Durable Medical Equipment (DME) Medicare Administrative Contractors (MACs) lst.,cz,w.~.il;;;~''8~;~; ~.i£~I\,~i\'~)'. ' ;:~*'''~'.,~·'\; ' 'Z}<~X '~J~; 210 Issued to a specitlc audience, not posted to Intemet/Intranet due to Sensitivity of Instruction 70221 EN13NO15.004</GPH> jstallworth on DSK7TPTVN1PROD with NOTICES 70222 VerDate Sep<11>2014 3311 Jkt 238001 3312 3313 3314 PO 00000 3315 Frm 00039 Fmt 4703 Sfmt 4725 3316 E:\FR\FM\13NON1.SGM 3318 3317 3319 3320 3321 13NON1 3322 3323 3324 3325 3326 EN13NO15.005</GPH> 3327 3328 1129 New Waived Tests October 2015 Integrated Outpatient Code Editor (I!OCE) Specifications Version 16.3 Update to Puh. 100-04, Chapter 1S to Provide T,anguage-Only Changes for Updating ICD-10, the 02/12 version of the Form CMS-1500, and ASC X12 Hcalthcare Common Procedure Coding System (HCPCS) and Diagnosis Codes Roster Claims Submitted to AlB MACs (B) for Mass Immunization Centralized Billing for Influenza Vims and Pneumococcal Vaccines to Medicare AlB MACs (B) Claims Submitted to AlB MACs (A) for Mass Immunizations of Influenza Vims and Pneumococcal Vaccinations HCPCS and Diagnosis Codes for Mammography Services Billing Requirements -AlB MAC (B) Claims Remittance Advice Messages Pap Smears On and After July 1, 2001 HCPCS Codes for Billing Diagnoses Codes Remittance Advice Codes Screening Pelvic Examinations on and After July 1, 2001 Diagnoses Codes Revenue Code and HCPCS Codes for Billing Remittance Advice Codes Diagnosis Coding Remittance Advice Notices Payment Determining High Risk for Developing Colorectal Cancer Billing Requirements for Claims Submitted to AlB MACs Remittance Advice Notices Claims Submission Requirements and Applicable HCPCS Codes HCPCS and Diagnosis Coding Remittance Advice Notices AlB Medicare Administrative Contractor (MAC) (B) and Contractor Billing Requirements AlB MAC (B) Billing Requirements Modifier Requirements for Pre-diabetes AID MAC (A) Dilling Requirements Modifier Requirements for Pre-diabetes Diagnosis Code Reporting Medicare Summary Kotices AlB MAC (B) Billing Requirements AlB MAC (A) Billing Requirements Diagnosis Code Reporting Medicare Summary Kotice Billing Requirements Diagnosis Code Reporting Medicare Summary Kotice (MSN) and Claim Adjustment Reason Codes (CARCs) Medicare Summary Kotices (MSNs), Remittance Advice Remark Codes (RARCs), Claims Adjustment Reason Codes (CARCs), and Advance Beneficiary Notices ( ABN s) Healthcare Common Procedure Coding Svstem (HCPCS) and Diagnosis Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 3310 Identifying the Certifying Physician lv!SN Messages Regarding the Therapy Cap Part B Outpatient Rehabilitation and Comprehensive Outpatient Rehabilitation Facility (CORF) Services- General Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction End Stage Renal Disease (ESRD) Home Dialysis Policy Guidelines for Physician or Practitioner Billing-- (Per Diem) None Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Procedure for Medicare Contractors to Perfonn and Record Outlier Reconciliation Adjustments New and Revised Place of Service Codes (POS) for Outpatient Hospital Part B Medicare Administrative Contractor (MAC) Instructions for Place of Service (POS) Codes Selection ofT .evel of Evaluation and Management Service Payment for Office or Other Outpatient Evaluation and Management (E/M) Visits (Codes 99201- 99215) Place of Service (POS) Instructions for the Professional Component (PC or Interpretation) and the Technical Component (TC) of Diagnostic Tests Professional Billing Requirements Items 14-33 - Provider of Service or Supplier Information Place of Service Codes (POS) and Definitions Site of Service Payment Differential Issued to a specific audience, not posted to Intcmct/Intranct due to Sensitivity of Instruction Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB)- October CY 2015 Update Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instmction National Coverage Determination (NCD) for Screening for Colorcctal Cancer Using Colo guard™- A Multitarget Stool DNA Test Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instmction Issued to a specific audience, not posted to Intcmct/Intranct due to a Confidentiality of Instruction October Quarterly Update for 2015 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule Clarification of the Policy for Competitively-Bid Wheelchair Accessories Furnished with Non-Competitively Bid Wheelchair Base Equipment Exception for Wheelchair Accessories Furnished with !\on-Competitively Bid Wheelchair Base Equipment Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instmction jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 Jkt 238001 3331 PO 00000 3332 3333 Frm 00040 3334 3335 Fmt 4703 3336 Sfmt 4725 3337 3338 3339 E:\FR\FM\13NON1.SGM 3340 3341 3342 3343 13NON1 3344 3345 3346 3347 3348 3349 3350 3351 3352 3353 3354 3355 3356 3357 3358 3359 3360 3361 3362 3363 3364 3365 3366 i;';::c;J; 113 114 of Instmction Additional Fields Added to the Outlier Reconciliation Lump Sum Utility October 2015 Update of the Hospital Outpatient Prospective Payment System (OPPS) Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 22.0, Effective January I, 2016 January 2016 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Annual Medicare Physician Fee Schedule (MPFS) Files Delivery and Implementation Maintenance and Update of the Temporary Hook Created to Hold OPPS Claims that Include Certain Drug HCPCS Codes Maintenance and Update of the Temporary Hook Created to Hold OPPS Claims that Include Certain Drug HCPCS Codes Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instmction Claims Processing Medicare Secondary Payer (MSP) Policy and Procedures Regarding Ongoing Responsibility for Medicals (ORM) October 2015 Integrated Outpatient Code Editor (IIOCE) Specifications Version 16.3 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instmction October 2015 Update of the Ambulatory Surgical Center (ASC) Payment System Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB)- October CY 2015 Update 2016 Healthcare Common Procedure Coding System (HCPCS) Almual Update Reminder Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2016 ,.Dia"J.• ,, •• ,);€.·'•'\•"' •i.~.•;~,;c;,'(;i Instmctions for the Shared Systems and Medicare Administrative Contractors (MACs) to follow when a Medicare Residual Payment must be Paid on Workers' Compensation Medicare Set-aside Arrangement (WCMSA) or for Ongoing Responsibility of Medicals (ORM) Non-Group Health Plan (NGHP) Medicare TOC Secondary Payer (MSP) Claims. MSP "W' Record and Accompanying Processes Medicare Residual Payments Due When On-going Responsibility for Medicals (ORM) Benefits Terminate, or Deplete, During a Beneficiary's Provider Facility Stay or Upon a Physician, or Supplier, Vis it. Workers' Compensation (WC) Claims Processing Medicare Secondary Payer (MSP) Policy and Procedures Regarding Ongoing Responsibility for Medicals CORM) Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 3330 Coding Common Working File (CWF) Edits Diagnosis Code Reporting Billing Requirements Policy ProfeS<ional Billing Requirements Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MS"\1) Messages Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), Claims Adjustment Reason Codes (CARCs), and Group Codes Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instmction Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment Svstem (PPS) Pricer Changes for FY 2016 Update-Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Fiscal Year (FY) 2016 Annual Cpdate October 2015 Update of the Hospital Outpatient Prospective Payment System (OPPS) Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Implement Operating Rules- Phase III ERA EFT: CORE 360 Uniform Use of Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Codes (RARC) Rule- Update from CAQH CORE Healthcare Provider Taxonomy Codes (HPTCs) October 2015 Code Set Update Instructions for Downloading the Medicare ZIP Code Pile for January 2016 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality ofTnstruction Annual Clotting Factor Furnishing Fee Update 2016 Influenza Vaccine Payment Allowances - Annual Update for 20 I 5-20 I G Season Common Edits and Enhancements Modules (CEM) Code Set Update Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instmction Claim Status Category and Claim Status Codes Update Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY 2016 Removing References to Network Service Vendors from Chapter 24 of the Medicare Claims Processing Manual, Pub. 100-04 Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Intemel/Intranel due to a Confidentiality of Instruction 2016 Annual Update ofHealthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CR) Update Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity 70223 EN13NO15.006</GPH> jstallworth on DSK7TPTVN1PROD with NOTICES 70224 VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 EN13NO15.007</GPH> ),'l:ti'fi?'f :;''''!i'iiMt/'Ii!f'gt; ~'f'~c'f)~h~';f'c,:i'c::r: 251 Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments -4th Qtr. Notification for FY 20 15 252 Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction 253 Update the Contractor Reporting of Operational and Workload Data (CROWD) CMS-2592 Report to Indicate Requests Received in Claims and Requests Received That Are Recovery Audit Related i'( ;:'(,;;:~fi i;~;;i*~~}Y;&if, ',;;;iit:i;<:; 141 Revisions to the State Operations Manual (SOM), Appendix A- Survey Protocol, Regulations and Interpretive Guidelines for Hospitals 142 Revisions to State Operations Manual (SOM) Chapter 9 Exhibits 143 Revisions to State Operations Manual (SOM) Chapter 2, The Certification Process and Appendix W, Survey Protocol, Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs) and Swing-Beds in CAHs Revisions to State Operations Manual (SOM) Appendix J, Part II144 Interpretive Guidelines- Responsibilities of Intermediate Care Facilities for Individuals with Intellectual Disabilities Revisions to Medicare State Operations Manual (SOM), Chapter 9- Exhibits 145 146 State Operations Manual (SOM), Section 2185- Home Health Agencies (HHAs), Change of Address to a Medical Administrative Contractor (MAC) within 90 Days Home Health Agencies (HHAs)/2185-HHA Change of Address (;;? i'\2:;, ;;:;,;;{(;f,;i;it'' rr,?:Jp,;;;~;r,~;;;~';,~x~ ''"'!,?~: 600 601 602 Workload Reporting Prepay Complex Service Specific Review Prepay Complex Provider Specific Review Review of Home Health Claims Home Health Medical Review of Home Health Services Table of Contents Medical Review of Home Health Services Physician Certification of Patient Eligibility for the Medicare Home Health Benefit Certification Requirements Physician Recertification Recertification Elements The Usc of the Patient's Medical Record Documentation to Support the 603 604 605 606 607 608 609 610 611 612 613 Home Health Certification Coding Medical Necessity of Services Provided Examples of Sufficient Documentation Incorporated Into a Physician's Medical Record Medical Review of Home Health Demand Bills Medical Review of Home Health Services Table of Contents Medical Review of Home Health Services Physician Certification of Patient Eligibility for the Medicare Home Health Benefit Certification Requirements Physician Recertification Recertification Elements The Use ofthe Patient's Medical Record Documentation to Support the Home Health Certification Coding Medical Necessity of Services Provided Examples of Sufficient Documentation Incorporated Into a Physician's Medical Record Medical Review of Home Health Demand Bills Signature Requirements Clarification Regarding the Processing of Certain Provider EnrollmentRelated Transactions Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Workload Reporting Prepay Complex Provider Specific Review Update to Pub. 100-08 to Provide Language-Only Changes for Updating lCD10 and ASC X12 Clarification Regarding the Processing of Certain Provider EnrollmentRelated Transactions Denials Licenses and Certifications Final Adverse Action Supporting Documents Special Processing Guidelines for Form CMS-855A, Form CMS-855B, Form CMS-8551 and Form CMS-855R Applications Sole Proprietorships CMHC 40 Percent Rule Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction Changes to Supplier Documentation and Evidence of Medical Necessity for 3 Oxygen Claims Supplier Documentation Evidence of Medical Necessity for the Ox')'gen Claims Changes to Supplier Documentation and Evidence of Medical Necessity for Oxygen Claims Evidence of Medical Necessity for the Oxygen Claims Postpayment Review Requirements Complex Medical Review Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 MSP Utilization Edits and Resolutions for Claims Submitted to CWF Identification of Liability and No-Fault Situations Identify Claims with Possible WC Coverage Identification of On-Going Responsibility for Medicals (ORM) in Liability, No-Fault, and Workers' Compensation Situations Background Regarding ORM for Contractors Policy Regarding OR.\1 Operationalizing ORM for Liability, No-Fault, and Workers' Compensation Situations MSP Auxiliary File Errors Sources That May Identify Other Insurance Coverage jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 614 Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction 1531 ,,;~: 1532 :,1;j~f''~~~~ 1533 1534 None It'~:: None 'I:D;;: ;t',?l/:1\, 1535 None liL,;,\scl'' 'I; I;"\ Jkt 238001 1.'!, l?'~\~'i11i:;li ;~~;\;' (1;1/.;;\":< PO 00000 fz?~:if 1 11' '>1111111·'(; ~~i, £y.;~i~''l~~~ 1 1<· 1536 None 11 lJ1 1;11~( \' {;1.1;;,1 1,~:\t'i1 1537 None [;&(~ i€~:,,{Z2~ 'il ;; i:!'!';Q;'~~I:Ii~,~~· None 121 Frm 00042 1515 Fmt 4703 1516 1517 Sfmt 4725 1518 E:\FR\FM\13NON1.SGM 1519 1520 1521 1522 1523 13NON1 1524 1525 1526 1527 1528 1529 1530 1 i;'~,il~:<;: 1538 s);l;(j Medicare Care Choices Model (MCCM)- Per Beneficiary per Month Payment (PBPM) - Implementation '1<\:t,,\,l\:1·,;\1,\::1 ~\:,'i~±l 1514 ti,t;f; 1), 1~1\*zciJ\ 1539 ·'>,,+,:?>~:; 'i>;,'~>(f~ ~>l;'\~1(~{\;~~~': Award of Medicare Administrative Contractor (MAC) Contract for Jurisdiction J Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Analysis and Design for Part B Detail Line Expansion Tester Resolution Reports for International Classification of Diseases, Tenth Revision (ICD-10) Limited End to End Testing with Submitters Contractor Reporting of Operational and Worldoad Data (CROWD) Form 5 Remittance Advice Reporting Medicare Appeals System (MAS) Upgrade Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction CMS Information Security Acceptable Risk Safeguards Update - Multifactor Authentication Data Act Treasury Referral Timeframe and Reporting - DME MAC Changes Procedures for Processing Cnder Tolerance Part A 935, Part A-Other, Part A and B Healthcare Professional Shortage Area (HPSA), and Part A-Provider Recovery Audit Contractor (RAC) Identified debts in the Healthcare Integrated General Ledger Accounting System (HIGLAS) Medicare Remit Easy Print (MREP) Cpgrade Add Original Common Working Files (CWF) Occurrence Number to the CWF Feed to MBD Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Update for Paper Claims Processing Cnder the Administrative Simplification Compliance Act (ASCA) Reporting of Anti-Cancer and Anti-Emetic Drugs Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction 1540 1541 1542 1543 1544 1545 1546 i!:<l\\tc~;\':1' 11 ' 46 47 . "'lm7~] '~ ,~,~~"·':<;'~' Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality ofTnstruction Issued to a specific audience, not posted to Intemet/Intranet due to a Confidentiality of Instruction ' 5'> None i'\ Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 ,';,; Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Update Hard Coded Audit 205A MSP Return Code 3925 and Edit 152D Health Insurance Portability and Accountability Act (HIPAA) ED! Front End Updates for January 2016 International Classification of Diseases, lOth Revision (ICD-1 0) Additional Acknowledgement Testing Reporting Increasing Tax Withholding to I 00 Percent for Internal Revenue Service (IRS) Federal Payment Levy Program (FPLP) ICD-10 Conversion/Coding Infrastmcture Revisions to National Coverage Determinations (NCDs)--3rd Maintenance CR Medicare Prior Authorization of Power Mobility Devices (PMDs) Demonstration: Advance Determination of Medicare Coverage (ADMC) Reviews for Beneficiaries Who Have Representative Payees Implementing the Insertion of a Sheet of Paper Promoting the Electronic Medicare Summary Notices (eMSNs) into Mailed Medicare Summary Notices (MSNs) Modification to the Telehealth Originating Site Facility Fee Billing Requirements for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (F QHCs) Health Insurance Portability and Accountability Act (HIP AA) ED! Front End Updates for October 2015 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity ofTnstruction Implementation of Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Based on Specific Clinical Criteria Procedures for Processing Cnder Tolerance Part A 935, Part A-Other, Part A and B Healthcare Professional Shortage Area (HPSA), and Part A-Provider Recovery Audit Contractor (RAC) Identified debts in the Healthcare Integrated General Issued to a specific, audience not to Intemet/ Intranet due to a Sensitivity of Instruction 70225 EN13NO15.008</GPH> jstallworth on DSK7TPTVN1PROD with NOTICES 70226 VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 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 ""1!·11 w" w .~.u.,. 16uvi "-q,;uMuvu:>ill!~~~.!l\:.!~!.!!tlli!!~~i.!!!~· For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (July through September 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 EN13NO15.009</GPH> decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda. which also armounce decisions or, in some cases, C-"1Jlain 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: www.cms.gov/medicare-coveragedatabase/. For questions or additional information, contact Wanda Belle (410-786-7491). Title Medicare Coverage of Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) National Coverage Determination (NCD) for Screening for Colorectal Cancer Using Colo guard™ - A Multitarget Stool DNA Test NCDM Sedion Transmittal Number Issue Date Effedive Date NCD 210.14 R185 08/21/2015 02/05/2015 NCD 210.3 R183 08/06/2015 10/09/2014 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (July through September 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 this quarterly notice, we list only the specific updates to the Category BIDEs as of the ending date of the period covered by this notice and a contact person for questions or additional information. For questions or additional information, contact John Manlove (410-7866877). Under the Food, Drug, and Cosmetic Act (21 U.S. C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA -approved Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 Addendum II: Regulation Documents Published in the Federal Register (July through September 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 www.gpo.gov/fdsys. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at https://www.gpoaccess.gov/fr/index.htnli. The following website https://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: http :1/www. ems. gov/quarterlyproviderupdates/downloads/Regs3Ql5QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481). jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 IDE Gl30235 Jkt 238001 Gl40192 PO 00000 Gl40202 Gl40221 Gl40243 Gl50029 Gl50119 Frm 00044 Gl50120 Fmt 4703 Gl50123 Gl50125 G150127 Sfmt 4725 E:\FR\FM\13NON1.SGM Gl50131 Gl50132 Gl50134 G150136 Gl50138 Gl50140 Gl50143 Gl50145 Gl50147 13NON1 Gl50150 G150155 Gl50161 Gl50167 G150169 Gl50170 Gl50171 Gl50173 Device ACTIGAIT L\1PLANTABLE DROP FOOT STL\1ULATOR SYSTEM Organ Care System (OCS)- Liver, Organ Care System (OCS)Liver Console, OCS Liver Perfusion Set AEQUALIS PYROCARBON HUMERALHEAD Intergraft System Organox Metra System Tack Endovascular System Mag Venture MagProXlOO with MagOption stimulator, C-D60 butterfly coil and MagPro Cool Coil B65 AlP Pilot Study ofNovottf- 100A System in Conjunction with Temozolomide Chemoradiation For Newly Diagnosed Glioblastoma Argus II Retinal Prosthesis System BreathiD MCS System C-Methacetin Breath Test SalnSTIM, a transcntaneous electrical nerve stimulation (TENS) device Monovisc University of Minnesota Medical School HiResolution Bionic Ear System Percutaneous Osseointegrated Prosthesis Implant FLT3 Mutation Assay CP81 0 Sound Processor Juvederm Voluma XC For Chin Augmentation Modulight Laser, Isotropic Probe, Cylindrical Light Diffuser, and Diffusing Balloon Catheter SENTUS OTW QP L-75/ SENTUS OTW QP L-85/ SENTUS OTW QP L-95; SENTUS OTW QP S-75/ SENTUS OTW QP Sg5; SENTUS OTW QP S-95 MODF.T .1g9 g151 1g6 g16/ 1g6 837I 400 719/ 400 720/ 400 721 REPLICATE Svstem Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) Boston Scientific Vessix system Medtronic Restore ULTRA 37712 spinal cord stimulator, Medtronic Specify 5-6-5, 16-electrode surgical lead Visualase Thermal Therapy System Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) ELUVIA Drug-Eluting Vascular Stent System MemoryGel Breast Implant UHP-L Smooth Round UHP-L Start Date 09/18/15 07/09/15 08/26/15 07/31115 08/21115 08/14/15 07/02/15 07/15/15 07/08/15 07/31115 07/10/15 07/16/15 08/11115 07/16/15 07/22/15 07/23/15 07/23/15 07/31115 07/31115 08/05/15 08/07/15 08/14/15 08/19/15 08/28/15 08/28/15 OS/2S/15 IDE Gl50174 Gl50175 G150177 Gl50178 G150179 Gl50180 Gl50182 Gl501S3 Device Silicone Gel-Filled Breast Implant, MemoryGel Breast Implant UHP-L Siltex Round UHP-L Silicone Gel-Filled Breast Implant Cutera Excel V QUARTET MODEL 1457Q IDE STUDY Cardiac Resynchronization Therapy Pacemakers StimGuard Protect Chronic Tibial Nerve Stimulator (CDJS) System SCD (Selective Cytopheretic Device) Cook Antimicrobial Hernia Repair Device VENT ANA PD-Ll (SP142) CDx Assay Cochlear Nucleus Cl532 Cochlear Implant Start Date 09/02/15 09/03/15 09/11115 09/18/15 09/17115 09/17/15 09/17/15 09/1S/15 Addendum VI: Approval Numbers for Collections of Information (July through September 2015) All approval numbers arc available to the public at Rcginfo.gov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact Mitch Bryman (410-786-5258). Addendum VII: Medicare-Approved Carotid Stent Facilities, (July through September 2015) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We detemrined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of nrinimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of tlris quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: https://www .ems. gov/MedicareApprovedF acilitie/CASF!list. asp#TopOfPage For questions or additional information, contact Lori Ashby (410-786-6322). Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 investigational device exemption (IDE). Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more infmmation about the classes or categories, please refer to the notice published in the April21, 1997 Federal Register (62 FR 19328). 09/02/15 09/03/15 70227 EN13NO15.010</GPH> jstallworth on DSK7TPTVN1PROD with NOTICES 70228 VerDate Sep<11>2014 Provider Number ,'£':!,< ;\'{';;.:: •;;;£ 1467595793 09/22/2015 :{,::::;~~:,: Pikeville Medical Center 911 Bypass Road Pikeville, KY 41501 Truman Medical Center 2301 Holmes Street Kansas City, MO 64108 12·~~:.;,:;, 180044 Effective State Date c:·:~ci! 1 ~'~ :'}f;;\~::.~\1 09/22/2015 KY (\~;;:~:;:~~ '."f Jkt 238001 PO 00000 Frm 00045 FROM: University Medical Center TO: Banner University Medical Center Tucson 15011\. Campbell Avenue Tucson, AZ 85724 FROM: University Physicians Hospital TO: Banner University Medical Center South 2800 East Ajo Way Tucson, AZ 85713 FROM: Orlando Regional Hcalthcarc System, Inc. TO: Orlando Health 52 West Underwood Street Orlando, FL 32806 FROM: Medcenter One TO: Sanford Health Bismarck 300 North 7th Street Bismarck, ND 58506 030064 MO ;I :;~ .~~1')\: ;;:z:\1;; i~ ~,.;. 'I;<; 06/01/2005 AZ 030111 06/2112012 AZ 100006 04/05/2006 FL 350015 05/26/2005 ND A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the ACC-NCDR lCD registry. Therefore, for a beneficiary to receive a Medicare-covered ICD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR lCD registry. The entire list of facilities that participate in the ACC-NCDR lCD registry can be found at www.ncdr.com/webncdr/common For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available by accessing our website and clicking on the link for the American College of Cardiology's National Cardiovascular Data Registry at: www.ncdr.com/webncdr/common. For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861). Fmt 4703 City Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1 Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (July through September 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 lCD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collection mechanism. On October 27, 2005, CMS announced that the American College of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) lCD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR lCD Registry by April2006. Effective January 27, 2005, to obtain reimbursement, Medicare NCD policy requires that providers implanting ICDs for primary prevention clinical indications (that is, patients without a history of cardiac arrest or spontaneous arrhythmia) report data on each primary prevention lCD 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 Mountain Point Medical Center University Health Conway Sentara Albemarle Medical Center I'ort Hamilton Ilosoital b,!:~~~~~~ Hospital Baton Rouge General Medical Center (Mid City) Unity Medical and Surgical Hospital Lehi Monroe Elizabeth City Hamilton Newnan I LA I NC I Oil UT Baton Rouge Mishawaka I LA I IN Addendum IX: Active CMS Coverage-Related Guidance Documents (July through September 2015) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS 's implementation of coverage with evidence development (CED) tlrrough the national coverage determination process. The document is available at https://www. ems. gov/medicare-coverage-database/details/medicarecovcragc-documcnt-dctails.aspx?MCDid=27. There arc no additional Active CMS Coverage-Related Guidance Documents for the 3-month Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 EN13NO15.011</GPH> Facility jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 Jkt 238001 Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (July through September 2015) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at www.cms.hhs.gov/coverage. For questions or additional information, contact JoAnna Baldwin (410-786 7205). PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM Addendum XI: National Oncologic PET Registry (NOPR) (July through September 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 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). 13NON1 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (July through September 2015) 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 VADs 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 VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred to the list of Medicare-approved facilities that meet our standards in the 3-month period. This information is available at https://www. ems. gov/MedicareApprovedFacilitieNAD/list. asp#TopOfPage. For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861). Facility Provider Number C\,'''''': Riverside Methodist Hospital 3535 Olentangy River Road Columbus, OH 43214 Delrav Medical Center, Inc 5352 Linton Boulevard Delray Beach, FL :C\i:~:t;:~~': State ,:,·. ;,,\;'.,;:c(;>;;:· 360006 8111!2015 OH 100258 8/12/2015 l'L 050696 01/09/2004 ~· F~t'i'c;;~~~~' ., .<}''''\ TO: Keck Hospital of USC FROM: USC University Hospital 1500 San Pablo Street Los Angeles, CA 90033 Date Approved ···:::':' 1' (:;'' '"' ' ~t;,:';"::: CA Addendum XIII: Lung Volume Reduction Surgery (LVRS) (July through September 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 types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation ofHcalthcarc Organizations (JCAHO)) under their Disease Specific Certification Program for L VRS; and • Medicare approved for lung transplants. Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 period. For questions or additional information, contact JoAnna Baldwin (410-786-7205). 70229 EN13NO15.012</GPH> jstallworth on DSK7TPTVN1PROD with NOTICES 70230 VerDate Sep<11>2014 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 9990 E:\FR\FM\13NON1.SGM Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (July through September 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 performed 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 3-month period. This information is available at www. ems. gov/MedicareApprovedF acilitie/B SF/list. asp#TopOfPage. For questions or additional information, contact Jamie Hermansen (410-786-2064 ). Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (July through September 2015) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. This information is available on our website at www .cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). 13NON1 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 15:03 Nov 12, 2015 EN13NO15.013</GPH> Only the first two types are in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This information is available at www .cms.gov/MedicareApprovedFacilitie/L VRS/list.asp#TopOfPage. For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861). 70231 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices [FR Doc. 2015–28870 Filed 11–12–15; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Head Start Family and Child Experiences Survey (FACES). OMB No.: 0970–0151. Description: The Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new round of the Head Start Family and Child Experiences Survey (FACES). Featuring a new ‘‘Core Plus’’ study design, FACES will provide data on a set of key indicators, including information for performance measures. The design allows for more rapid and frequent data reporting (Core studies) and serves as a vehicle for studying more complex issues and topics in greater detail and with increased efficiency (Plus studies). The FACES Core study will assess the school readiness skills of Head Start children, survey their parents, and ask their Head Start teachers to rate children’s social and emotional skills. In addition, FACES will include observations in Head Start classrooms, and program director, center director, and teacher surveys. FACES Plus studies include additional survey content of policy or programmatic interest, and may include additional programs or respondents beyond those participating in the Core FACES study. Previous notices provided the opportunity for public comment on the proposed Head Start program recruitment and center selection process (FR V.78, pg. 75569 12/12/2013; FR V.79, pg. 8461 02/12/2014), the childlevel data collection in fall 2014 and spring 2015(FR V. 79, pg. 11445 02/28/ 2014; FR V. 79; pg. 27620 5/14/2014), the program- and classroom-level spring 2015 data collection activities (FR v.79; pg. 73077 12/09/2014), and the American Indian and Alaska Native Head Start Family and Child Experiences Survey (AI/AN FACES) child-level data collection activities in fall 2015 and spring 2016 (FR V. 80, pg. 30250 08/07/2015). This 30-day notice describes the planned additional data collection activities for AI/AN FACES in spring 2016, including surveys with parents, teachers, program directors, and center directors. AI/AN FACES spring 2016 data collection includes site visits to 37 centers in 22 Head Start programs. As in fall 2015, parents of sampled children will complete surveys on the Web or by telephone (or in person if needed) about their children, activities family members engage in with their children, and family and household background characteristics. Head Start teachers, program directors, and center directors will complete surveys about the Head Start classroom or program and their own background using the Web or paper-and-pencil forms. The purpose of the Core data collection is to support the 2007 reauthorization of the Head Start program (Pub. L. 110–134), which calls for periodic assessments of Head Start’s quality and effectiveness. As additional information collection activities are fully developed, in a manner consistent with the description provided in the 60day notice (79 FR 11445) and prior to use, we will submit these materials for a 30-day public comment period under the Paperwork Reduction Act. Respondents: Parents of Head Start children, Head Start teachers and Head Start staff. ANNUAL BURDEN ESTIMATES—CURRENT INFORMATION COLLECTION REQUEST Total number of respondents Instrument Head Start core parent survey for plus study (AI/AN FACES Spring 2016) ........................................................ Head Start core teacher survey for plus study (AI/AN FACES) ............................................................................ Head Start program director core survey for plus study (AI/AN FACES) ................................................................. Head Start center director core survey for plus study (AI/ AN FACES) ...................................................................... jstallworth on DSK7TPTVN1PROD with NOTICES Total .............................................................................. 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: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: OPREinfocollection@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. VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 Number of responses per respondent Annual number of respondents Estimated annual burden hours 800 267 1 0.50 134 80 27 1 0.58 16 22 7 1 0.33 2 37 12 1 0.33 4 ........................ ........................ ........................ ........................ 156 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, Fax: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, ACF Reports Clearance Officer. [FR Doc. 2015–28815 Filed 11–12–15; 8:45 am] BILLING CODE 4184–22–P PO 00000 Average burden hour per response Frm 00048 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: State Self-Assessment Review and Report. OMB No.: 0970–0223. Description: Section 454(15)(A) of the Social Security Act, as amended by the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, requires each State to annually assess E:\FR\FM\13NON1.SGM 13NON1

Agencies

[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70218-70231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9093-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July through September 2015

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from July through September 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.
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[[Page 70219]]



I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) Furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners (NAIC), health insurers, and other stakeholders. To 
implement the various statutes on which the programs are based, we 
issue regulations under the authority granted to the Secretary of the 
Department of Health and Human Services under sections 1102, 1871, 
1902, and related provisions of the Social Security Act (the Act) and 
Public Health Service Act. We also issue various manuals, memoranda, 
and statements necessary to administer and oversee the programs 
efficiently.
    Section 1871(c) of the Act requires that we publish a list of all 
Medicare manual instructions, interpretive rules, statements of policy, 
and guidelines of general applicability not issued as regulations at 
least every 3 months in the Federal Register.

II. Format for the Quarterly Issuance Notices

    This quarterly notice provides only the specific updates that have 
occurred in the 3-month period along with a hyperlink to the full 
listing that is available on the CMS Web site or the appropriate data 
registries that are used as our resources. This is the most current up-
to-date information and will be available earlier than we publish our 
quarterly notice. We believe the Web site list provides more timely 
access for beneficiaries, providers, and suppliers. We also believe the 
Web site offers a more convenient tool for the public to find the full 
list of qualified providers for these specific services and offers more 
flexibility and ``real time'' accessibility. In addition, many of the 
Web sites have listservs; that is, the public can subscribe and receive 
immediate notification of any updates to the Web site. These listservs 
avoid the need to check the Web site, as notification of updates is 
automatic and sent to the subscriber as they occur. If assessing a Web 
site proves to be difficult, the contact person listed can provide 
information.

III. How to Use the Notice

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

    Dated: November 6, 2015.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2015-28870 Filed 11-12-15; 8:45 am]
 BILLING CODE 4120-01-C
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