Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2016, 11456-11470 [2017-03559]

Download as PDF 11456 Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices Dated: February 21, 2017. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. [FR Doc. 2017–03604 Filed 2–21–17; 4:15 pm] BILLING CODE P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies rmajette on DSK2TPTVN1PROD with NOTICES The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or I. Background The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination VerDate Sep<11>2014 14:10 Feb 22, 2017 Jkt 241001 bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than March 20, 2017. A. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166–2034. Comments can also be sent electronically to Comments.applications@stls.frb.org: 1. Connections Bancshares, Inc., Ashland, Missouri; to acquire 80 percent of the voting shares of Kirksville Bancorp, Inc., Kirksville, Missouri, and thereby indirectly acquire shares of American Trust Bank, Kirksville, Missouri. Board of Governors of the Federal Reserve System, February 17, 2017. Yao-Chin Chao, Assistant Secretary of the Board. 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 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 [FR Doc. 2017–03500 Filed 2–22–17; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9100–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2016 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2016, 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\23FEN1.SGM 23FEN1 EN23FE17.000</GPH> concurred in by Director Richard Cordray (Director, Consumer Financial Protection Bureau), and Chairman Martin J. Gruenberg, that Corporation business required its consideration of the matters which were to be the subject of this meeting on less than seven days’ notice to the public; that no earlier notice of the meeting was practicable; that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10) of the ‘‘Government in the Sunshine Act’’ (5 U.S.C. 552b(c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10). Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices rmajette on DSK2TPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 14:10 Feb 22, 2017 Jkt 241001 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 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 11457 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 http:// www.cms.gov/manuals. Dated: February 16, 2017. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\23FEN1.SGM 23FEN1 rmajette on DSK2TPTVN1PROD with NOTICES 11458 VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (October through December 2016) 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\23FEN1.SGM 23FEN1 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 tlris 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: http://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 designated libraries throughout the United States. Some FDLs may have EN23FE17.001</GPH> 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 http://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 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 Medicare Internet Only Manual Publication Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 22.3, Effective October 1, 2016 use (CMS-Pub. 100-04) Transmittal No. 3561. 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 Manual/Subject/Publication Number Dasis for Determining the Part A Coinsurance Amounts Part B Annual Deductible Part B Premium Internet Only Manual Updates to Pub. 100-01, 100-02 and 100-04 to Correct Errors and Omissions (SNF) Requirements - General Medicare SNF PPS Overview Medicare SNF Coverage Guidelines Under PPS Hospital Providers of Extended Care Services Three-Day Prior Hospitalization Three-Day Prior Hospitalization - Foreign Hospital Effect on Spell of Illness Medical Service of an Intern or Resident-in-Training Medical and Other Health Services Furnished to SNF Patients Services Furnished Under Arrangements With Providers Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 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: February 4, 2016 (81 FR 6009), May 9, 2016 (81 FR 28072), August 5, 2016 (81 FR 51901) and November 2016 (81 FR 79489. 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. rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 230 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4725 E:\FR\FM\23FEN1.SGM 23FEN1 Definition of Durable Medical Equipment Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2017 Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Updates Index of Acronyms RHC General Information FQHC General Information RHC Staffing Requirements RHC Temporary Staffing Waivers RHC and FQHC Visits Multiple Visits on Same Day Day Payment Window RHC Services FQHC Services Emergency Services Non RHC/FQHC Services Description of Non RHC/FQHC Services RHC Payment Rate Payment Codes for FQHCs Billing Under the PPS FQHC PPS Payment Rate and Adjustments FQHC Payment Codes RHC and FQHC Cost Report Requirements RHC and FQHC Cost Report Forms RHC and FQHC Charges, Coinsurance, Deductible, and Waivers Commingling Dental, Podiatry, Optometry, and Chiropractic Services Graduate Medical Education Transitional Care Management (TCM) Services Chronic Care Management (CCM) Services Services and Supplies Furnished "Incident to" Physician's Services Provision oflncident to Services and Supplies Incident to Services and Supplies Furnished in the Patient's Home or Location Other than the RHC or FQHC Payment to Physician Assistants Services and Supplies Furnished Incident to NP, P A, and CNM Services Services and Supplies Incident to CP Services Mental Health Visits Physical Therapy, Occupational Therapy, and Speech Language Pathology Services Requirements for Visiting l\ursing Services Treatment Plans 231 l;~.'l.)'S,>' :t•s;.:;.::·.~~l.'i·>1 None '\C!'}.)y~~h; ~; ~.~}1'·~ 3618 3619 3620 3621 3622 3623 3624 3625 3626 3627 3628 3629 3630 3631 3632 Hospice Services Hospice Attending Practitioner Provision of Services to Hospice Patients in a RHC or FQHC Preventive Health Services Preventive Health Services in RHCs Preventive Health Services in FQHCs Copayment for FQHC Preventive Health Services Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2017 3633 3634 3635 ki>.' ~s;:,z ::1t~;•;i:'t:}'.~21\~ Annual Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement Table of Chemistry Panels Organ or Disease Oriented Panels Update to Pub 100-04, Medicare Claims Processing Manual, Chapter 15: Ambulance SNF Billing Billing of Vaccine Services on Hospice Claims Hospice Claims for Vaccine Services Billing Requirements Claims Submitted to MACs Using Institutional Formats Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis D Virus Vaccines and T11eir Administration on Institutional Claims Institutional Claims Submitted by Home Health Agencies and Hospices Payment Procedures for Renal Dialysis Facilities (RDF) Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/ Intranet to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of Instruction Ambulance Inflation Factor for CY 2017 and Productivity Adjustment Ambulance Inflation Factor (AIF) Fiscal Year (FY) 2017 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of Instruction Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2017 Denial of Home Health Payments When Required Patient Assessment Is Not Received Correcting Editing for Condition Code 54 and Updating Remittance Advice Messages on Home Health Claims 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 Intemet/Intrant! due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Instmctions to Process Services Not Authorized by the Veterans Administration (VA) in a Non-VA Facility Reported With Value Code (VC) Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 229 11459 EN23FE17.002</GPH> rmajette on DSK2TPTVN1PROD with NOTICES 11460 VerDate Sep<11>2014 3637 3638 Jkt 241001 3639 3640 PO 00000 3641 Frm 00035 3643 Fmt 4703 Sfmt 4725 E:\FR\FM\23FEN1.SGM 23FEN1 EN23FE17.003</GPH> 3642 3644 3645 3646 3647 3648 3649 3650 3651 3652 3653 3654 3655 3656 3657 3658 3659 3660 3661 1662 3663 3664 3665 3666 3667 Applicable Messages for ASC 2008 Payment Changes Effective January 1, 2008 Applicable ASC Messages for Certain Payment Indicators Effective for Services Performed on or after January I, 2009 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Implementation of the Restmctured Clinical Lab Fee Schedule 2017 Annual Update to the Therapy Code List Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Didding Implementation of Policy Changes for the CY 2017 Home Health Prospective Adjustments of Episode Payment- Outlier Payments Therapy Editing HH PPS Claims Beneficiary-Driven Demand Billing Under HH PPS Input/Output Record Layout Decision Logic Used by the Pricer on Claims Annual Updates to the HH Pricer Medical and Other Health Services Submitted Using Type of Bill 034x Billing Instmctions for Disposable Negative Pressure Wound Therapy Services Payment System Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2017 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update Claim Status Category and Claim Status Codes Update lnstmctions for Downloading the Medicare ZIP Code File for April 2017 Common Edits and Enhancements Modules (CEM) Code Set Update Issued to a specific audience, not posted to Intemel/Intrantl due to Confidentiality of Instmction Implement Operating Rules- Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule- Update from Council for Affordable Quality Healthcare (CAQH) CORE New Waived Tests Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 3636 42 Requirements for Processing Non Veterans Administration (VA) Authorized Inpatient Claims Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) - January 2017 New Physician Specialty Code for Hospitalist Physician Specialty Codes Update to the Federally Qualified Health Centers (FQHC) Prospective Payment System (PPS)- Recurring File Updates Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Instruction January 2017 Quarterly Average Sales Price (ASP) Medicare Part D Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Instructions for Retrieving the 2017 Pricing and HCPCS Data Files through CMS's Mainframe Telecommunications Systems Therapy Cap Values for Calendar Year (CY) 2017 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Quarterly Update to the Correct Coding Initiative (CCI) Edits, Vcrsion 23,0, EITeclive January 1, 2017 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Calendar Year (CY) 2017 Participation Enrollment and Medicare Participating Physicians and Suppliers Directory (MEDP ARD) Procedures Payment for Ox')'gen Volume Adjustments and Portable Oxygen Equipment Billing for Oxygen and Oxygen Equipment Updates to Pub. 100-04, Chapters S, l3 and 14 to Correct Remittance Advice Messages Physician Billing Requirements to the AlB MAC (B) l\oninvasive Studies for ESRD Patients- Facility and Physician Services Medicare Summary Notices (MSN), Reason Codes, and Remark Codes Messages for Noncovered PET Services Coverage for PET Scans for Dementia and Neurodegenerative Diseases Billing and Coverage Changes for PET Scans Effective for Services on or After April 3, 2009 Billing and Coverage Changes for PET Scans for Cervical Cancer Effective for Services on or After November 10, 2009 Metastasis of Cancer Effective for Claims With Dates of Services on or After February 26, 2010 Local Coverage Determination for PET Using New, Proprietary Radiopharmaceuticals for their FDA-Approved Labeled Indications for Oncologic Imaging Only Denial Messages for Noncovered Bone Mass Measurements Ambulatory Surgical Center Services on ASC List Applicable Messages for NTIOLs rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 3668 Jkt 241001 PO 00000 3670 3671 3672 Frm 00036 3673 3G74 Fmt 4703 1676 Sfmt 4725 3677 3675 E:\FR\FM\23FEN1.SGM 3678 3679 3780 23FEN1 3681 l!\\:;\','\i;;'~'','':}'c'''~•\; 115 116 [;c'·~~~:<';: •c; 273 ;~h'~J~~i;; ••,;i\ti; 274 275 276 277 278 279 r;•: c\t0i~;?' Electronic Correspondence Referral System (ECRS) Web Updates to Claims Processing Medicare Secondary Payer (MSP) Policy and Procedures Regarding Ongoing Responsibility for Medicals (ORM) Instructions on Using the Claim Adjustment Segment (CAS) for Medicare Secondary Payer (MSP) Part A CMS-1450 Paper Claims, Direct Data Entry (DDE), and 837 Institutional Claims Transactions .'.';,;k~~\>'\J;';~t(A;';i Notice of .\Jew Interest Rate for Medicare Overpayments and Underpayments ~:~~J)3i>} !~'~; ··;,;;iy~ 162 163 -1 ~ Qtr N otfication for FY 2017 New Physician Specialty Code for Hospitalist Pub. 100-06, Chapter 3, Section 90 (Provider Liability) Revision Claims Processing Timeliness - All Claims Part E - Interest Payment Data Classification of Claims for Counting Physician/Limited License Physician Specialty Codes New Physician Specialty Code for Hospitalist Part D(1)- Claims Processing Timeliness- All Claims Part E - Interest Payment Data Classification of Claims for Counting Physician/Limited License Physician Specialty Codes Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Medicare Financial Management Manual, Chapter 7, Internal Control Requirements OMB Circular A-123 GAO Standards for Internal Controls in the Federal Government Definition and Objectives Contractor Internal Control Review Process and Time line Risk Assessment Risk Analysis Chart Certification Package for Internal Controls (CPIC) Requirements OMB Circular A-123, Appendix A; Internal Controls Over Financial Reporting (ICOFR) Certification Statement CPIC- Report of Material Weaknesses CPIC- Report oflnternal Control Deficiencies Statement on Standards for Attestation Engagements (SSAE) Number 18 (SSAE 18), Reporting on Controls at Service Providers Corrective Action Plans Submission, Review, and Approval of Corrective Action Plans Corrective Action Plan (CAP) Reports CMS Finding Numbers Initial CAP Report Quarterly CAP Report CMS CAP Report Template List of CMS Contractor Control Objectives Instructions to Hospitals on the Election of a Medicare-Supplemental Security Income (SSI) Component of the Disproportionate Share (DSH) Payment Adjustment for Cost Reports that Involve SSI Ratios for Fiscal Year (FY) 2004 and Earlier, or SST Ratios for Hospital Cost-Reporting Periods for Patient Dischar<>es Occurrina Before October 1 2004 ..,.,,,;;;;;; '\'i''''·{¥t''i·•::vi Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 3669 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (UMEPOS) Competitive Bidding Program (CBP)- January 2017 HCPCS Code Update for Preventive Services Table of Preventive and Screening Services Rural Health Clinic (RHC)/Federally Qualified Health Center (FQHC) Special Billing Instructions Deductible and Coinsurance HCPCS Code Advance Beneficiary Notice RHCs/FQHCs Special Billing Instructions RHCs/FQHCs Special Billing Instructions Update to Editing of T11erapy Services to Reflect Coding Changes CY 2017 Update for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Gap-filling DMEPOS Fees 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 January 2017 Integrated Outpatient Code Editor (IIOCE) Specifications Version 18.0 2017 Healthcare Common Procedure Coding System (HCPCS) Annual Update Reminder Summary of Policies in the Calendar Year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, and CT Modifier Reduction List Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Prolonged Services Without Direct Face-to-Face Patient Contact Separately Payable Under the Physician Fee Schedule (Manual Update) Prolonged Services Without Direct Face-to-Face Patient Contact Service (Codes 99358- 99359) Payment for Oxygen Volume Adjustments and Portable Oxygen Equipment Billing for Oxygen and Oxygen Equipment Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Revisions to State Operations Manual (SOM) Appendix J, Part IIInterpretive Guidelines -Responsibilities of Intermediate Care Facilities for Individuals with Intellectual Disabilities Revisions to State Operations Manual (SOM) Appendix W - Survey Protocol, Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs) and Swing-Beds in CAHs 11461 EN23FE17.004</GPH> rmajette on DSK2TPTVN1PROD with NOTICES 11462 VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\23FEN1.SGM 23FEN1 Revisions to the State Operations Manual (SOM) Chapter 2 Numbering System for CMS Certification Numbers (CCN) CCN for Medicare Providers 165 Revisions to State Operations Manual (SOM) Appendix W - Survey Protocol, Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs) and Swing-Beds in CAHs tl.,c~·: tc~c1 <z~i~i~s:~,:· f :'2 ..\\'~\\\~:~~ ~~~12~'' .......... 678 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 679 Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to 680 Confidentiality of Instruction 681 Revision to Surety Bond Collection Procedures Claims Against Surety Bonds Model Letters for Claims Against Surety Bonds Issued to a specific audience, not posted to Internet/Intranet due to 682 Confidentiality of Instruction 683 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 684 Incorporation of Cycle 2 Revalidation Policies Definitions Timeliness and Accuracy Standards Standards for Initial and Revalidation Applications Form CMS-855 Applications That Require a Site Visit Form CMS-855 Applications That Do Not Require a Site Visit Web-Based Applications- Timeliness Web-Based Applications That Require a Site Visit Web-Based Applications That Do Not Require a Site Visit Paper Applications - Accuracy Web-Based Applications- Accuracy Returns Model Revalidation Letter Model Large Group Revalidation Notification Letter Model Revalidation Pend Letter Model Revalidation Deactivation Letter Model Revalidation Past-Due Group Member Letter Model Deactivation Letter due to Inactive Provider/Supplier Letter Model Return Revalidation Letter Revalidation Lists Mailing Revalidation Letters Phone Calls Pend Status Deactivation Actions Receipt of Revalidation Application Revalidation Received and Development Required Revalidation Received after a Pend is Applied Revalidation Received after a Deactivation Occurs Change of Information Received Prior to Revalidation Letter Mailed Reassignment Applications Received After Revalidation Letter Mailed ""'.'' 685 686 687 Revalidating Providers Involved in a Change of Ownership (CHOW) Large Group Revalidation Coordination Finalizing the Revalidation Application Revalidation Reporting Revalidation Files Available Online Revalidation Extension Requests Incorporation of Cycle 2 Revalidation Policies Definitions Timeliness and Accuracy Standards Standards for Initial and Revalidation Applications Form CMS-855 Applications That Require a Site Visit Form CMS-855 Applications That Do Not Require a Site Visit Web-Based Applications- Timeliness Web-Based Applications That Require a Site Visit Web-Based Applications That Do Not Require a Site Visit Paper Applications - Accuracy Web-Based Applications- Accuracy Returns Model Revalidation Letter Model Large Group Revalidation Notification Letter Model Revalidation Pend Letter Model Revalidation Deactivation Letter Model Revalidation Past-Due Group Member Letter Model Deactivation Letter due to Inactive Provider/Supplier Letter Model Return Revalidation Letter Revalidation Lists Mailing Revalidation Letters Phone Calls Pend Status Deactivation Actions Receipt of Revalidation Application Revalidation Received and Development Required Revalidation Received after a Pend is Applied Revalidation Received after a Deactivation Occurs Change of Information Received Prior to Revalidation Letter Mailed Reassignment Applications Received After Revalidation Letter Mailed Revalidating Providers Involved in a Change of Ownership (CHOW Large Group Revalidation Coordination l'inalizing the Revalidation Application Revalidation Reporting Revalidation Files Available Online Revalidation Extension Requests Comprehensive Error Rate Testing (CERT) Program: Medicare Administrative Contractor (MAC) Certifying Official Handling Overpayments and Underpayments, MAC Feedback, and Appeals Resulting From the CERT Findings Handling Appeals Resulting From CERT Initiated Denials Extrapolated Overpayments Conduct of Expanded Review Based on Statistical Sampling for Overpayment Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 EN23FE17.005</GPH> 164 rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 688 690 Jkt 241001 691 ){';; 33 Intemet-based PECOS Applications Release of Information Model Letter Guidance Reactivations -Deactivation for Non-Submission of a Claim Reactivations -Miscellaneous Policies Issued to a specific audience, not posted to Intcmct/ Intranet Confidentiality of Instmction Contacting Non-Responders and Documentation Requests >.f'i/ PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\23FEN1.SGM Medicare Contractor Beneficiary and Provider Communications Manual Beneficiary Customer Services Pub. 100-09 Chapter 2- Update Beneficiary Customer Services Escalation of Complex Beneficiary Inquiries to the MACs by the Beneficiary Contact Center ( BCC) Next Generation Desktop (NGD) Training Disclosure of Information (Adherence to the Privacy Act and the Health Insurance Portability and Accountability Act (HIP AA) Privacy Rule) Screening of Beneficiary Complaints Alleging Fraud or Abuse Medicare Customer Service- Nex-t Generation Desk-top (MCSC-NGD) Client Installation and Configuration Requirements Call Center User Group (CCUG Complex Beneficiary Inquiries Handling Complex Beneficiary Inquiries Controlling Complex Beneficiary Inquiries E-mail and Fax Responses to Complex Written Beneficiary Inquiries Telephone Responses to Complex Beneficiary Inquiries Written Responses to Complex Beneficiary Inquiries l"imeliness of Responses to Complex Benetlciary Inquiries Congressional Beneficiary Inquiries Surveys Urgent Need Regional Offices Casework ''\'' t~~~~.Yi-~!'ti ~~~¥~;;\1e 1 ~1~·~~ 28 29 23FEN1 QIO Manual Chapter 5 -"Quality of Care Review QIO Manual Chapter 3 "Memoranda of Agreement for Case Review Authority and Scope for Memoranda of Agreement (MOA) MEMORANDA OF AGREEMENT (MOA) WITH PROVIDERS OF SERVICES Agreements with Providers of Services Hospital Memorandum of Agreement (MOA) Home Health Agencies (HHAs) and Skilled Nursing Facilities (SNFs) Memoranda of Agreement (MOA) AGREEMENTS WITH PAYERS OF HEALTHCARE SERVICES Medicare Administrative Contractor (MAC) Joint Operating Agreements (JOA) Memorandum Of Agreement (MOA) with State Agencies Responsible for Licensing and Certification of Providers and Practitioners ;j;i 1 :n:•·~ Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 689 Estimation and Recoupment of Projected Overpayment by Contractors Update to Pub. 100-08, Chapter 15 Medicaid State Agencies Correspondence Address and E-mail Addresses Form CMS-855A and Form CMS-855B Signatories Delegated Officials Supporting Documents Processing Alternatives- Form CMS-855B and Form CMS-855I Processing Alternatives- Form CMS-8550 Processing Alternatives- Form CMS-855R Special Program Integrity Procedures Model Revocation T.etter for Part R Suppliers and Certified Providers and Suppliers Favorable Corrective Action Plan/Reconsideration Decision -Denials Corrective Action Plans (CAPs Reconsideration Requests -Non-Certified Providers/Suppliers Additional Appeal Levels Appeals Involving Certified Providers and Certified Suppliers Corrective Action Plans (CAPs) Reconsideration Requests -Certified Providers and Certified Suppliers Additional Appeal Levels HHA Ownership Changes Revocations Medicare Contractor Duties Correspondence Address and E-mail Addresses Contact Persons Certification Statement Signature Requirements I'om1 CMS-855I and CMS-8550 Signatories Form CMS-855R Signatories Form CMS-S55A. Form Clv!S-S55B and Form Clv!S-S55S Signatories Authorized Officials Delegated Officials Submission of Paper and Intemet-based PECOS Certification Statements Certification Statement Development Reserved for Future Use Reserved for Future Use Receipt/Review of Paper Applications Receipt/Review oflnternet-Based PECOS Applications Processing Alternatives- Form Clv!S-855B and Form CMS-855I Processing Alternatives- Form CMS-855A Processing Alternatives- Form CMSPaper Applications Intemet-Based PECOS Applications General Principles- Paper and lntemet-Based PECOS Applications Receiving Missing/Clarifying Data/Documentation Paper Applications Intemet-Based PECOS Applications Special Program Integrity Procedures Rejections Changes oflnformation - General Procedures Electronic Fund Transfers (EFT) 1\·fi None ;~~~;, i~~;.;;;] .c:. None 11463 EN23FE17.006</GPH> rmajette on DSK2TPTVN1PROD with NOTICES 11464 VerDate Sep<11>2014 tl:::(\;~~~ ;i'(S';i·c~ ~.~;t~;: 1737 :::<;~;:.,;;;,;;.•:\;;• t~?.;\;Ji;.'\' 1738 None l','tc: '::t~:; i<t:~'!\~' ."}. •.'1:~;;~"·~.~:.:· 157 Jkt 241001 158 159 160 PO 00000 161 162 Frm 00039 1G3 164 :; J~~.i.~,~·~l:\ ·0~1 f¥;;~··· \i\\ Shared System Enhancement 2015: Archive/Remove Inactive Medicare Demonstration Projects Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction IVIG Demonstration: Payment Update for 2017 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Shared System Enhancement 2015: Archive/Remove Inactive Medicare Demonstration Projects Affordable Care Act Bundled Payments for Care Improvement Initiative Recurring File Updates Models 2 and 4 January 2017 Updates Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Fmt 4703 lli:.;:::.<em ·~ ~~ ; ·':\·. ;);<•,{!. ••. ::·......•.. 1739 1740 1741 1742 1743 1744 1745 1746 1747 \•c.it 1724 Sfmt 4725 1725 E:\FR\FM\23FEN1.SGM 1726 1727 1728 1729 1730 1731 23FEN1 1732 17:B 1734 1735 1736 EN23FE17.007</GPH> Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Common Working File (CWF) Reorganization of Daily Beneficiary Extract Files Changes to the End-Stage Renal Disease (ESRD) Facility Claim (Type of Bill 72X) to Accommodate Dialysis Furnished to Beneficiaries with Acute Kidney Injury ( AKI) Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of Instruction Section 504: Adding a Qualified Reader Preference in Alternate Formats Part B Detail Line Expansion- MCS Phase 6 Analysis Only - Populate MCS PE Screens from PECOS (Phased Approach) Part B Detail Line Expansion- MCS Phase 5 Fiscal Intermediary Shared System (FISS) Heath Information Technology for Economic and Clinical Health (HITECH) Quatterly Repmt Phase Three: Changing Fiscal Intennediary Shared System (FISS) Action on Informational Unsolicited Responses (ICRs) From Canceled Claims to Adjustments Modifications to the National Coordination of Benefits Agreement (CORA) 1748 Crossover Process 1723 1758 Phase 3- Updating the fiscal Intern1ediary Shared System (l'ISS) to Make Payment for Drugs and Biologicals Services for Outpatient Prospective Payment System (OPPS) Providers System Specific Enhancement 2014: Retaining Most Recent Update for Auxiliary (Aux) File Data in Common Working File (CWF) Shared System Enhancement 2014- Identification of Fiscal Intermediary Shared System (FISS) Obsolete On-Request Jobs -Analysis Only File 1749 1750 1751 1752 1753 1754 1755 1756 1757 1759 1760 1761 (CWF)1693 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Network Fee Reduction for Acute Kidney Injury (AKI) services submitted on Type of Bill 72x Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Shared System Enhancement 2015: National Coverage Determination (NCO) Fiscal Intermediary Shared System (FISS) Implementation Issued to a specific audience, not posted to Internet/ Intranet Confidentiality of Instruction Issued to a specific audience, not posted to Internet/ Intranet Confidentiality of Instruction Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process Audit Trail for Reason Code Edit Changes Part B Detail Line Expansion - Checkpoint Discussion Meetings Medicare Electronic Health Record (EHR) Incentive Program- Analysis of Meaningful Use Hospital Transition into Hospital Quality Reporting System Issuing Compliance Letters to Specific Providers and Suppliers Regarding Inappropriate Billing of Qualified Medicare Beneficiaries (Q'v!Bs) for Medicare Cost-Sharing Adding a Foreign Language Tagline Sheet to Medicare Summary Notices (MSNs) Issued to a specific audience, not posted to Intcrnct/Intranct due to Sensitivity oflnstruclion Increasing the Number of Address Fields in MCS to Match the Address Fields in CWF in Order to Improve the Undeliverable Medicare Summary Notices (uMSNs) Situation: Phase One oflmproving FFS9372 Adding a Foreign Language Tagline Sheet to Medicare Summary Notices (MSNs) System Specific Enhancement 2014: String Testing Automation Coding Revisions to National Coverage Determination (NCDs) Common Working File and Fraud Prevention System 2.0 Predictive Modeling and Edits, Data Feed Migration ICD-1 0 Coding Revisions to National Coverage Determination (NCDs) Analysis Only - Modification of Process for Handling the Provider Enrollment Chain Ownership System (PECOS) Exiract Pile Issuing Compliance Letters to Specific Providers and Suppliers Regarding Inappropriate Billing of Qualified Medicare Beneficiaries (Q'v!Bs) for Medicare Cost-Sharing Updates for the Shared System lvlaintainers to implement the Social Security Number Removal Initiative (SSJ\Rl) Changes to the End-Stage Renal Disease (ESRD) Facility Claim (Type of Bill 72X) to Accommodate Dialysis Fumished to Beneficiaries with Acute Kidney Injury ( AKI) Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 I\> ~ ~:~ :\;Itx.·~~ ~:·z·,: i'.·\;'N:t\!2', 123 Chapter 16b, Special Needs Plans 124 Update ot Chat tel 1 of the Managed Care Manual rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 1762 .··.•:',:\:l•'"·.i.sz· ·:<:.·.'•'····"''•<::•··\ None .: •:.: ;:t\•~ ~,,~~ ('0C'\j'•c, ::•.•:· Jkt 241001 None PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\23FEN1.SGM Addendum II: Regulation Documents Published in the Federal Register (October through December 2016) 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 http://www.gpoaccess.gov/fr/index.html. The following website http://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://www.cms.gov/quarterlyproviderupdates/downloads/Regs3Ql6QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481). 23FEN1 Addendum III: CMS Rulings (October through December 2016) 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 mlp:!iWW\1 .~,;m::;.gvvl "'"'!:'lwmvu;,For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (October through December 2016) 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 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 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. There were no updates that occurred in the 3-month period. This information is available at: www.cms.gov/medicare-coverage-database/. For questions or additional information, contact Wanda Belle, MP A (410-786-7491). Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (October through December 2016) 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 (410-786 6877). 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 Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 1763 Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Shared Savings Program (SSP) Accountable Care Organization (ACO) Qualifying Stay Edits 11465 EN23FE17.008</GPH> rmajette on DSK2TPTVN1PROD with NOTICES 11466 VerDate Sep<11>2014 IDE Gl60189 Gl60131 Gl60191 Jkt 241001 PO 00000 Frm 00041 Gl60149 Gl60200 Gl60197 Gl60205 Gl60203 G160168 G040175 Gl60136 Gl60206 Gl60207 Fmt 4703 Gl60211 Sfmt 4725 Gl60212 Gl60208 Gl60213 E:\FR\FM\23FEN1.SGM G160214 Gl60216 Gl60218 Gl60219 23FEN1 Gl60223 Gl60226 Gl60229 Gl60234 Gl60233 Gl00108 Gl60238 Gl60106 G160232 Gl60243 Gl60242 EN23FE17.009</GPH> Device Exablate Model 4000 Type 1 EMBOSPHERE MICROSPHERE RETINOIC ACID RECEPTOR ALPHA- INTERFERON RESPONSE FACTOR 8(RARA-IRF8) E-QURE Bioelectrical Signal Therapy (BST) Device FE NIX Plus Continence Restoration System IMPELLA CP SYSTEM Agili-C BREATHID HP SYSTEM, BREATHID HP LAB SYSTEM TOPS Svstem Relay Thoracic Stend Graft with Transport Delivery System for treatment of thoracic aortic aneurysms. Medtronic Spinal Cord Stimulation Systems Restylane Silk Injectables Cook Zenith TX2 Proximal Component, Cook Zenith TX2 Proximal Extension, Cook Zenith TX2 Proximal Taper BEAT AML MASTER TRIAL CLINICAL TRIAL ASSAY (BEAT AML GENOMIC PROFILING ASSAY) SENSE BRAIN INWRY MONITOR (SDX1) STARS TIM ARTISSE INTRASACCULAR DEVICE, ARTISSE DETACHMENT DEVICE EMBOSPHERE MICROSPHERES Morphology Recurrence Plot Mapping The GORE Cardioform ASD Occuluder ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER Carillon Mitral Contour System Ovation Alto Abdominal Stent Graft System Custom bipolar electrode based on PermaLoc Electrode Embosphere (R) Microspheres Activa Deep Brain Stimulation Therapy System Exablate Model2100 Type 3.0 ALUVRA FemBLOC Permanent Contraceptive System; Component 1) FemBLOC Biopolymer; Component 2) FemBLOC Delivery System; Component 3) FemBLOC FemChec Tubal Occlusion Confirmation Device Zilver Vascular Stent Lynparza HRR Assay IN.PACT AV Access Paclitaxel-Coated PTA Balloon Catheter Start Date 10/0112016 10/04/2016 10/07/2016 10/14/2016 10/18/2016 10/19/2016 10/20/2016 10/2112016 10/26/2016 10/27/2016 10/28/2016 10/28/2016 10/28/2016 1110112016 11102/2016 11104/2016 11104/2016 11104/2016 11109/2016 11110/2016 11110/2016 11117/2016 11117/2016 11118/2016 1112112016 11123/2016 12/02/2016 12/06/2016 12/07/2016 12/09/2016 12/13/2016 12/14/2016 IDE Gl60250 Gl60172 Gl60180 Gl60209 Gl60247 Gl60248 Gl60249 Gl60251 G160265 Gl60253 Gl60259 Device tRISTAN 624 biOMAGNETOMETER Ranger Paclitaxel-Coated PTA Balloon Catheter OPTUKE (NovoTTF 100A System) LOTUS Edge Valve System, 23 mm; LOTUS Edge Valve System, 25 mm, LOTUS Edge Valve System, 27 mm Proclaim Elite Implantable Pulse Generator; Triple 16 Paddle Leads A Prospective Pilot Trial for PFO CLOSURE at the Time of ENDOCASCULAR Cardiac Electronic Device Implantation Hydrus Microstent da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories In Press Technologies Post Pactum Hemorrhage Device PERIODONTAL STRUCTURE REPAIR DEVICE Edwards SAPIEN 3 Transcatheter Heart Valve and Start Date 12115/2016 12116/2016 12116/2016 12116/2016 12116/2016 12116/2016 12116/2016 12116/2016 12/20/2016 12/20/2016 12/20/2016 Accessories Gl00322 Gl30034 Gl60256 Gl60263 GlG02G5 Gl60121 TheraSphere BIOFREEDOM Drug Coated Coronary Stent System NUCLEUS C1532 COCHLEAR IMPLANT EXTRACORPOREAL CPR FOR REFRACTORY OUT-OFHOSPITAL CARDIAC ARREST (EROCA) EMBOZENE MICROSPHERES Implantable Miniature Telescope (IMT) Models Wide Angle 2.2X and Wide Angle 2.7X 12/2112016 12/2112016 12/2112016 12/2112016 12/23/2016 12/29/2016 Addendum VI: Approval Numbers for Collections of Information (October through December 2016) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact William Parham (410-786-4669). Addendum VII: Medicare-Approved Carotid Stent Facilities, (October through December 2016) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if perfonned in facilities that have been determined to be competent in perfonning the evaluation, procedure, and follow-up necessary to ensure Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 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). rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 Jkt 241001 Facility PO 00000 Frm 00042 Fmt 4703 IY: 'i~\J~}; ~·j: . Baxter Regional Medical Center 624 Hospital Drive Mountain Home, AR 72653 Wellington Regional Medical Center 10101 Forest Hill Boulevard Wellington, FL 33414 St Mark's Hospital 1100 East 3900 South Salt Lake City, UT 84124 Sfmt 4725 E:\FR\FM\23FEN1.SGM Provider Number Effective Date 1033147921 10/26/2016 AR 1720078702 11108/2016 FL 470046 11130/2016 NE 100077 08/24/2009 FL 15-0074 08/04/2005 IN \\;.(!:i;,·\ .•,•''"'"~··>'~< . :\'li\~\~fi\-J, .';i i.''''''''"····•·;·;~'·'''' FROM: Peace River Regional Medical Center TO: Bayfront Health Port Charlotte 2500 Harbor Boulevard Port Charlotte, FL 33952 FROM: Community Heart and Vascular Hospital TO: Community Health Network, Inc 1500 N. Ritter Avenue Indianapolis, IN 46219 State 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 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 ICD procedure. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements are available in the Medicare NCD Manual, which is on the CMS website at A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the ACC-NCDR ICD registry. Therefore, for a beneficiary to receive a Medicare-covered ICD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR lCD registry. The entire list of facilities that participate in the ACC-NCDR ICD registry can be found at www.ncdr.com/webncdr/conunon 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 Sarah Fulton, MHS (410 786 2749). Facility 23FEN1 Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (October through December 2016) Addendum VIII includes a list of the American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the ICD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collection mechanism. On October 27, 2005, CMS City r ~:li~;.i '*'l;c:•'0s'·:·~r>' Sarah Bush Lincoln Health Center Kaiser Permanente - Vacaville Medical Center Jersey Community Hospital District Roane Medical Center 1:1 \'Yi•·~··.···:o'.\;i'~i~i Unity Hospital St. Mary's Medical Center Wheaton Franciscan Inc. -Wisconsin Heart Hospital Vaughan Regional Medical Center Northshore Regional Medical Center TriStar Southern Hills Medical Center St. Elizabeth Boardman Mattoon Vacaville Jerseyville Harriman Fridley West Palm Beach Milwaukee Selma Slidell Nashville Boardman State ··•····•···•· IL ..,., .. \,\';\•;': CA IL TN ;s;''!i•'0~:•':iR\ ~:\', MN FL WI Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: http://www. ems. gov/MedicareApprovedF acilitie/CASF/list.asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). AL LA TN OH 11467 EN23FE17.010</GPH> rmajette on DSK2TPTVN1PROD with NOTICES 11468 VerDate Sep<11>2014 City Dickson Lihue Tiffin Coming Livingston State TN HI OH NY TX Jkt 241001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\23FEN1.SGM Addendum IX: Active CMS Coverage-Related Guidance Documents (October through December 2016) 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) through the national coverage determination process. The document is available at http://www. ems. gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (October through December 2016) 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, contactJoAnna Baldwin, MS (410-786 7205). 23FEN1 Addendum XI: National Oncologic PET Registry (NOPR) (October through December 2016) 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 http://www.cms.gov/MedicareApprovedJ:iacilitie/NOPR!list.asp#'l'opOtPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (October through December 2016) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. We are providing only the specific updates to the list of Medicareapproved facilities that meet our standards that have occurred in the 3-month period. This information is available at http://www. ems. gov/MedicareApprovedF acilitie!VAD/list.asp#TopOfPage. For questions or additional information, contact Linda Gousis, JD, (410-786-8616). Facility .. ~~;,~: .!i NorthShore University Health System 130 1 Central Street, Suite 300 Evanston, IL 6020 1 St. Francis Hospital 100 Port Washington Boulevard Roslyn, NY 11576 Swedish Medical Center Cherry Hill 500 17th Avenue Seattle, W A 98122 Provider Number Date Approved State 14-0010 10/26/2016 IL 33-0182 11/09/2016 NY 500025 11/09/2016 WA . (,:~~E:~;;. ;·,~· :\'~~ [<:&:,~,,,,; Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 EN23FE17.011</GPH> Facility Tristar Horizon Medical Center Wilcox Memorial Hospital (Hawai'i Pacific) Mercy Tiffin Hospital Guthrie Corning Hospital CHI St. Luke's Health Memorial Livingston rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 Facility Date Approved 450044 12/10/2003 )\'~~~,:; 1'•·\~:;:: ;~1,>(', 1;', Jkt 241001 PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 FROM: UT Southwestern University Hospital TO: UT Southwestern Medical Center 6201 Harry Hines Rlvd. Dallas, TX 75390 Other information: Joint Commission certified on 2/3/09. Hospital previously listed as St. Paul Medical Center. FROM: Methodist Hospital, The TO: Houston Methodist Hospital 6565 Fatmin Street Houston, TX 77030 Other information: DNV GL certified 12/6/16; JCAHO certified 10/29/08 FROM: Community Heart and Vascular TO: Community Health Network, Inc. 8075 N Shadeland Avenue Indianapolis, IN 46250 Other information: Joint Commission Certified State '·s•\i''>i.z''' TX 450358 12/06/2016 TX 150074 10/01/2014 IN E:\FR\FM\23FEN1.SGM 23FEN1 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (October through December 2016) 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 (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 Col1llllission (formerly, the Joint Col1llllision on Accreditation of Healthcare 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 3-month period. This infonnation is available at www.cms.gov/MedicareApprovedFacilitie/L VRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (October through December 2016) 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 detennined 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 Levell Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (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 Ininimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This infonnation is available at www. ems. gov/MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For questions or additional information, contact Saral1 Fulton, MHS (410-786-2749). Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (October through December 2016) 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. ems. gov/MedicareApprovedF acilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 14:10 Feb 22, 2017 Provider Number 11469 EN23FE17.012</GPH> 11470 Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices this notice, you may make your request using one of following: 1. Access CMS’ Web site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. [FR Doc. 2017–03559 Filed 2–22–17; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10282] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by March 27, 2017. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–5806, or Email: OIRA_submission@omb.eop.gov. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in rmajette on DSK2TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:10 Feb 22, 2017 Jkt 241001 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Conditions of Participation for Comprehensive Outpatient Rehabilitation Facilities (CORFs) and Supporting Regulations; Use: The Conditions of Participation (CoPs) and accompanying requirements specified in the regulations are used by our surveyors as a basis for determining whether a comprehensive outpatient rehabilitation facility (CORF) qualifies to be awarded a Medicare provider agreement. We believe the health care industry practice demonstrates that the patient clinical records and general content of records are necessary to ensure the well-being and safety of patients and that professional treatment and accountability are a normal part of industry practice. Form Number: CMS– 10282 (OMB control number: 0938– 1091); Frequency: Yearly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of SUPPLEMENTARY INFORMATION: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Respondents: 509; Total Annual Responses: 509 Total Annual Hours: 6,815. (For policy questions regarding this collection contact Jacqueline Leach at 410–786–4282.) Dated: February 16, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017–03453 Filed 2–22–17; 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: National Survey of Child and Adolescent Well-Being-Third Cohort (NSCAW III): Data Collection. OMB No.: 0970–0202. Description: The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) intends to collect data on a third cohort of children and families for the National Survey of Child and Adolescent Well-Being (NSCAW III). NSCAW is the only source of nationally representative, longitudinal, firsthand information about the functioning and well-being, service needs, and service utilization of children and families who come to the attention of the child welfare system. Information is collected about children’s cognitive, social, emotional, behavioral, and adaptive functioning, as well as family and community factors that are likely to influence their functioning. Family service needs and service utilization also are addressed in the data collection. A previous notice provided the opportunity for public comment on the proposed Phase 1 recruitment and sampling process (FR V.81, 4/8/2016). This notice is specific to the Phase 2 data collection activities: (1) Baseline and (2) 18-month follow-up data collection. Data collection includes child interviews and direct assessments, as well as caregiver and caseworker interviews. The overall goal is to maintain the strengths and continuity of the prior surveys while better positioning the study to address changes in the child welfare population. Respondents: Children, and their associated caregivers and caseworkers. E:\FR\FM\23FEN1.SGM 23FEN1

Agencies

[Federal Register Volume 82, Number 35 (Thursday, February 23, 2017)]
[Notices]
[Pages 11456-11470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03559]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9100-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October Through December 2016

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 October through December 2016, 
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.
[GRAPHIC] [TIFF OMITTED] TN23FE17.000

I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) Furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey

[[Page 11457]]

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 http://www.cms.gov/manuals.

    Dated: February 16, 2017.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2017-03559 Filed 2-22-17; 8:45 am]
BILLING CODE 4120-01-C