82_FR_11491 82 FR 11456 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2016

82 FR 11456 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2016

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

Federal Register Volume 82, Issue 35 (February 23, 2017)

Page Range11456-11470
FR Document2017-03559

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.

Federal Register, Volume 82 Issue 35 (Thursday, February 23, 2017) 
[Federal Register Volume 82, Number 35 (Thursday, February 23, 2017)]
[Notices]
[Pages 11456-11470]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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

11456 Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices concurred in by Director Richard bank holding company and all of the Board of Governors of the Federal Reserve Cordray (Director, Consumer Financial banks and nonbanking companies System, February 17, 2017. Protection Bureau), and Chairman owned by the bank holding company, Yao-Chin Chao, Martin J. Gruenberg, that Corporation including the companies listed below. Assistant Secretary of the Board. business required its consideration of The applications listed below, as well [FR Doc. 2017–03500 Filed 2–22–17; 8:45 am] the matters which were to be the subject as other related filings required by the BILLING CODE 6210–01–P of this meeting on less than seven days’ Board, are available for immediate notice to the public; that no earlier inspection at the Federal Reserve Bank notice of the meeting was practicable; indicated. The applications will also be DEPARTMENT OF HEALTH AND that the public interest did not require available for inspection at the offices of HUMAN SERVICES consideration of the matters in a the Board of Governors. Interested meeting open to public observation; and persons may express their views in Centers for Medicare & Medicaid that the matters could be considered in writing on the standards enumerated in Services a closed meeting by authority of the BHC Act (12 U.S.C. 1842(c)). If the subsections (c)(4), (c)(6), (c)(8), [CMS–9100–N] proposal also involves the acquisition of (c)(9)(A)(ii), (c)(9)(B), and (c)(10) of the a nonbanking company, the review also ‘‘Government in the Sunshine Act’’ (5 Medicare and Medicaid Programs; includes whether the acquisition of the Quarterly Listing of Program U.S.C. 552b(c)(4), (c)(6), (c)(8), nonbanking company complies with the (c)(9)(A)(ii), (c)(9)(B), and (c)(10). Issuances—October Through standards in section 4 of the BHC Act December 2016 Dated: February 21, 2017. (12 U.S.C. 1843). Unless otherwise Federal Deposit Insurance Corporation. noted, nonbanking activities will be AGENCY: Centers for Medicare & Robert E. Feldman, conducted throughout the United States. Medicaid Services (CMS), HHS. Executive Secretary. Unless otherwise noted, comments ACTION: Notice. [FR Doc. 2017–03604 Filed 2–21–17; 4:15 pm] regarding each of these applications SUMMARY: This quarterly notice lists BILLING CODE P must be received at the Reserve Bank CMS manual instructions, substantive indicated or the offices of the Board of and interpretive regulations, and other Governors not later than March 20, Federal Register notices that were FEDERAL RESERVE SYSTEM 2017. published from October through A. Federal Reserve Bank of St. Louis December 2016, relating to the Medicare Formations of, Acquisitions by, and (David L. Hubbard, Senior Manager) and Medicaid programs and other Mergers of Bank Holding Companies P.O. Box 442, St. Louis, Missouri programs administered by CMS. The companies listed in this notice 63166–2034. Comments can also be sent FOR FURTHER INFORMATION CONTACT: It is have applied to the Board for approval, electronically to possible that an interested party may pursuant to the Bank Holding Company Comments.applications@stls.frb.org: need specific information and not be Act of 1956 (12 U.S.C. 1841 et seq.) 1. Connections Bancshares, Inc., able to determine from the listed (BHC Act), Regulation Y (12 CFR part Ashland, Missouri; to acquire 80 percent information whether the issuance or 225), and all other applicable statutes of the voting shares of Kirksville regulation would fulfill that need. and regulations to become a bank Bancorp, Inc., Kirksville, Missouri, and Consequently, we are providing contact holding company and/or to acquire the thereby indirectly acquire shares of persons to answer general questions assets or the ownership of, control of, or American Trust Bank, Kirksville, concerning each of the addenda the power to vote shares of a bank or Missouri. published in this notice. rmajette on DSK2TPTVN1PROD with NOTICES I. Background and oversight of private health health care providers, and the public; insurance. Administration and oversight and (2) maintaining effective The Centers for Medicare & Medicaid of these programs involves the communications with CMS regional Services (CMS) is responsible for following: (1) Furnishing information to offices, state governments, state administering the Medicare and Medicare and Medicaid beneficiaries, Medicaid agencies, state survey EN23FE17.000</GPH> Medicaid programs and coordination VerDate Sep<11>2014 14:10 Feb 22, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1

Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 11457 agencies, various providers of health II. Format for the Quarterly Issuance need to check the Web site, as care, all Medicare contractors that Notices notification of updates is automatic and process claims and pay bills, National This quarterly notice provides only sent to the subscriber as they occur. If Association of Insurance Commissioners the specific updates that have occurred assessing a Web site proves to be (NAIC), health insurers, and other in the 3-month period along with a difficult, the contact person listed can stakeholders. To implement the various hyperlink to the full listing that is provide information. statutes on which the programs are available on the CMS Web site or the III. How To Use the Notice based, we issue regulations under the appropriate data registries that are used authority granted to the Secretary of the This notice is organized into 15 as our resources. This is the most Department of Health and Human addenda so that a reader may access the current up-to-date information and will Services under sections 1102, 1871, subjects published during the quarter be available earlier than we publish our 1902, and related provisions of the covered by the notice to determine quarterly notice. We believe the Web Social Security Act (the Act) and Public whether any are of particular interest. site list provides more timely access for Health Service Act. We also issue We expect this notice to be used in beneficiaries, providers, and suppliers. various manuals, memoranda, and concert with previously published We also believe the Web site offers a statements necessary to administer and notices. Those unfamiliar with a more convenient tool for the public to oversee the programs efficiently. description of our Medicare manuals find the full list of qualified providers should view the manuals at http:// Section 1871(c) of the Act requires for these specific services and offers www.cms.gov/manuals. that we publish a list of all Medicare more flexibility and ‘‘real time’’ manual instructions, interpretive rules, accessibility. In addition, many of the Dated: February 16, 2017. statements of policy, and guidelines of Web sites have listservs; that is, the Kathleen Cantwell, general applicability not issued as public can subscribe and receive Director, Office of Strategic Operations and regulations at least every 3 months in immediate notification of any updates to Regulatory Affairs. the Federal Register. the Web site. These listservs avoid the BILLING CODE 4120–01–P rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 14:10 Feb 22, 2017 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1

rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 11458 Publication Dates for the Previous Four Quarterly Notices arrangements to transfer material to a local library not designated as an We publish this notice at the end of each quarter reflecting FDL. Contact any library to locate the nearest FDL. This information is 14:10 Feb 22, 2017 information released by CMS during the previous quarter. The publication available at http://www.gpo.gov/libraries/ dates of the previous four Quarterly Listing of Program Issuances notices In addition, individuals may contact regional depository libraries are: February 4, 2016 (81 FR 6009), May 9, 2016 (81 FR 28072), that receive and retain at least one copy of most federal government Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices August 5, 2016 (81 FR 51901) and November 2016 (81 FR 79489. We are publications, either in printed or microfilm form, for use by the general providing only the specific updates that have occurred in the 3-month public. These libraries provide reference services and interlibrary loans; period along with a hyperlink to the website to access this information and a however, they are not sales outlets. Individuals may obtain information Jkt 241001 contact person for questions or additional information. about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing Addendum 1: Medicare and Medicaid Manual Instructions entitled Medicare and Medicaid Manual Instructions. To help FDLs locate PO 00000 (October through December 2016) the materials, use the CMS publication and transmittal numbers. For The CMS Manual System is used by CMS program components, example, to find the manual for Medicare Internet Only Manual Publication partners, providers, contractors, Medicare Advantage organizations, and Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 22.3, State Survey Agencies to administer CMS programs. It offers day-to-day Effective October 1, 2016 use (CMS-Pub. 100-04) Transmittal No. 3561. Frm 00033 operating instructions, policies, and procedures based on statutes and Addendum I lists a unique CMS transmittal number for each regulations, guidelines, models, and directives. In 2003, we transformed the instruction in our manuals or program memoranda and its subject number. CMS Program Manuals into a web user-friendly presentation and renamed A transmittal may consist of a single or multiple instruction(s). Often, it is Fmt 4703 it the CMS Online Manual System. necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly How to Obtain Manuals notice, we list only the specific updates to the list of manual instructions Sfmt 4725 The Internet-only Manuals (IOMs) are a replica of the Agency's that have occurred in the 3-month period. This information is available on official record copy. Paper-based manuals are CMS manuals that were our website at www.cms.gov/Manuals. officially released in hardcopy. The majority of these manuals were E:\FR\FM\23FEN1.SGM transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub Transmittal Manual/Subject/Publication Number 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 Dasis for Determining the Part A Coinsurance Amounts not transferred to the 10M, send a message via the CMS Feedback tool. Part B Annual Deductible Those wishing to subscribe to old versions of CMS manuals should Part B Premium contact the National Technical Information Service, Department of Internet Only Manual Updates to Pub. 100-01, 100-02 and 100-04 to Correct 23FEN1 Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone Errors and Omissions (SNF) (703-605-6050). You can download copies of the listed material free of Requirements - General charge at: http://cms.gov/manuals. Medicare SNF PPS Overview Medicare SNF Coverage Guidelines Under PPS Hospital Providers of Extended Care Services How to Review Transmittals or Program Memoranda Three-Day Prior Hospitalization Those wishing to review transmittals and program memoranda can Three-Day Prior Hospitalization - Foreign Hospital access this information at a local Federal Depository Library (FDL). Under Effect on Spell of Illness Medical Service of an Intern or Resident-in-Training the FDL program, government publications are sent to approximately 1,400 Medical and Other Health Services Furnished to SNF Patients designated libraries throughout the United States. Some FDLs may have Services Furnished Under Arrangements With Providers EN23FE17.001</GPH>

Definition of Durable Medical Equipment 231 Implementation of Changes in the End—Stage Renal Disease (ESRD) 229 Implementation of Changes in the End—Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKT) in ESRD Facilities for Calendar Year (CY) 2017 Acute Kidney Injury (AKT) in ESRD Facilities for Calendar Year (CY) 2017 230 Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Updates saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq Index of Acronyms 3618 Annual Update of HCPCS Codes Used for Home Health Consolidated Billing RHC General Information Enforcement FQHC General Information 3619 Table of Chemistry Panels RHC Staffing Requirements Organ or Disease Oriented Panels RHC Temporary Staffing Waivers 3620 Update to Pub 100—04, Medicare Claims Processing Manual, Chapter 15: RHC and FQHC Visits Ambulance Multiple Visits on Same Day SNF Billing Day Payment Window 3621 Billing of Vaceine Services on Hospice Claims RHC Services Hospice Claims for Vaceine Services FQHC Services Billing Requirements Emergency Services Claims Submitted to MAC‘s Using Institutional Formats Non RHC/FQHC Services Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis Description of Non RHC/FQHC Services B Virus Vaceines and Their Administration on Institutional Claims RHC Payment Rate Institutional Claims Submitted by Home Health Agencies and Hospices Payment Codes for FQHCs Billing Under the PPS Payment Procedures for Renal Dialysis Facilities (RDF) FQHC PPS Payment Rate and Adjustments 3622 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of FQHC Payment Codes Instruction RHC and FQHC Cost Report Requirements 3623 Issued to a specific audience, not posted to Internet/ Intranet to RHC and FQHC Cost Report Forms Confidentiality of Instruction RHC and FQHC Charges, Coinsurance, Deductible, and Waivers 3624 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of Commingling Instruction Dental, Podiatry, Optometry, and Chiropractic Services 3625 Ambulance Inflation Factor for CY 2017 and Productivity Adjustment Graduate Medical Education Ambulance Inflation Factor (AIF) Transitional Care Management (TCM) Services 3626 Fiscal Year (FY) 2017 Inpatient Prospective Payment System (IPPS) and Chronic Care Management (CCM) Services Long Term Care Hospital (LTCH) PPS Changes Services and Supplies Furnished "Incident to" Physician‘s Services 3627 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of Provision of Incident to Services and Supplies Incident to Services and Instruction Supplies Furnished in the Patient‘s Home or Location Other than the RHC or FQHC 3628 Changes to the Laboratory National Coverage Determination (NCD) Edit Payment to Physician Assistants Software for January 2017 Services and Supplies Furnished Incident to NP, PA, and CNM Services 3629 Denial of Home Health Payments When Required Patient Assessment Is Not Services and Supplies Incident to CP Services Received Mental Health Visits 3630 Correcting Editing for Condition Code 54 and Updating Remittance Advice Physical Therapy, Occupational Therapy, and Speech Language Pathology Messages on Home Health Claims Services 3631 Issued to a specific audience, not posted to Internet/Intranet due to Requirements for Visiting Nursing Services Confidentiality of Instruction Treatment Plans 3632 Issued to a specific audience, not posted to Internet/Intranet due to Hospice Services Confidentiality of Instruction Hospice Attending Practitioner 3633 Issued to a specific audience, not posted to Internet/Intranet due to Provision of Services to Hospice Patients in a RHC or FQHC Confidentiality of Instruction Preventive Health Services 3634 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Preventive Health Services in RHCs of Instruction Preventive Health Services in FQHCs 3635 Instructions to Process Services Not Authorized by the Veterans Copayment for FQHC Preventive Health Services Administration (VA) in a Non—VA Facility Reported With Value Code (VC) G6SPLL

rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 11460 42 Applicable Messages for ASC 2008 Payment Changes Effective January 1, Requirements for Processing Non Veterans Administration (VA) Authorized 2008 14:10 Feb 22, 2017 Inpatient Claims Applicable ASC Messages for Certain Payment Indicators Effective for 3636 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics Services Performed on or after January I, 2009 and Supplies (DMEPOS) Competitive Bidding Program (CBP) - January 3651 Issued to a specific audience, not posted to Intemet/Intranet due to 2017 Confidentiality of Instruction Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices 3637 New Physician Specialty Code for Hospitalist Physician Specialty Codes 3652 Issued to a specific audience, not posted to Intemet/Intranet due to 3638 Update to the Federally Qualified Health Centers (FQHC) Prospective Confidentiality of Instmction Payment System (PPS)- Recurring File Updates 3653 Implementation of the Restmctured Clinical Lab Fee Schedule Jkt 241001 3639 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity 3654 2017 Annual Update to the Therapy Code List Instruction 3655 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) 3640 January 2017 Quarterly Average Sales Price (ASP) Medicare Part D Drug Competitive Didding Implementation of Policy Changes for the CY 2017 Pricing Files and Revisions to Prior Quarterly Pricing Files Home Health Prospective PO 00000 3641 Issued to a specific audience, not posted to Intemet/Intranet due to Adjustments of Episode Payment- Outlier Payments Confidentiality of Instruction Therapy Editing 3642 Issued to a specific audience, not posted to Intemet/Intranet due to HH PPS Claims Confidentiality of Instruction Beneficiary-Driven Demand Billing Under HH PPS Frm 00035 3643 Instructions for Retrieving the 2017 Pricing and HCPCS Data Files through Input/Output Record Layout CMS's Mainframe Telecommunications Systems Decision Logic Used by the Pricer on Claims 3644 Therapy Cap Values for Calendar Year (CY) 2017 Annual Updates to the HH Pricer 3645 Issued to a specific audience, not posted to Intemet/Intranet due to Medical and Other Health Services Submitted Using Type of Bill 034x Billing Instmctions for Disposable Negative Pressure Wound Therapy Fmt 4703 Confidentiality of Instmction 3646 Quarterly Update to the Correct Coding Initiative (CCI) Edits, Vcrsion 23,0, Services Payment System EITeclive January 1, 2017 3656 Changes to the Laboratory National Coverage Determination (NCD) Edit 3647 Issued to a specific audience, not posted to Intemet/Intranet due to Software for January 2017 Sfmt 4725 Confidentiality of Instmction 3657 Issued to a specific audience, not posted to Intemet/Intranet due to 3648 Calendar Year (CY) 2017 Participation Enrollment and Medicare Confidentiality of Instmction Participating Physicians and Suppliers Directory (MEDP ARD) Procedures 3658 Issued to a specific audience, not posted to Intemet/Intranet due to 3649 Payment for Ox')'gen Volume Adjustments and Portable Oxygen Equipment Confidentiality of Instmction E:\FR\FM\23FEN1.SGM Billing for Oxygen and Oxygen Equipment 3659 Issued to a specific audience, not posted to Intemet/Intranet due to 3650 Updates to Pub. 100-04, Chapters S, l3 and 14 to Correct Remittance Advice Confidentiality of Instruction Messages 3660 Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code Physician Billing Requirements to the AlB MAC (B) (CARC), Medicare Remit Easy Print (MREP) and PC Print Update l\oninvasive Studies for ESRD Patients- Facility and Physician Services 3661 Claim Status Category and Claim Status Codes Update Medicare Summary Notices (MSN), Reason Codes, and Remark Codes 1662 lnstmctions for Downloading the Medicare ZIP Code File for April 2017 Messages for Noncovered PET Services 3663 Common Edits and Enhancements Modules (CEM) Code Set Update Coverage for PET Scans for Dementia and Neurodegenerative Diseases 3664 Issued to a specific audience, not posted to Intemel/Intrantl due to Billing and Coverage Changes for PET Scans Effective for Services on or Confidentiality of Instmction 23FEN1 After April 3, 2009 3665 Implement Operating Rules- Phase III Electronic Remittance Advice (ERA) Billing and Coverage Changes for PET Scans for Cervical Cancer Effective Electronic Funds Transfer (EFT): Committee on Operating Rules for for Services on or After November 10, 2009 Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Metastasis of Cancer Effective for Claims With Dates of Services on or Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and After February 26, 2010 Claim Adjustment Group Code (CAGC) Rule- Update from Council for Local Coverage Determination for PET Using New, Proprietary Affordable Quality Healthcare (CAQH) CORE Radiopharmaceuticals for their FDA-Approved Labeled Indications for 3666 New Waived Tests Oncologic Imaging Only 3667 Issued to a specific audience, not posted to Intemet/Intranet due to Denial Messages for Noncovered Bone Mass Measurements Confidentiality of Instmction Ambulatory Surgical Center Services on ASC List Applicable Messages for NTIOLs EN23FE17.003</GPH>

3668 Quarterly Update for the Durable Medical Equipment, Prosthetics. Orthotics —1"* Qir Notfication for FY 2017 and Supplies (DMEPOS) Competitive Bidding Program (CBP) — January 274 New Physician Specialty Code for Hospitalist 2017 275 Pub. 100—06, Chapter 3, Section 90 (Provider Liability) Revision 3669 HCPCS Code Update for Preventive Services Claims Processing Timeliness — All Claims Table of Preventive and Screening Services Part E — Interest Payment Data Rural Health Clinic (RHC)/Federally Qualified Health Center (FQHC) Classification of Claims for Counting Special Billing Instructions Physician/Limited License Physician Specialty Codes saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq Deductible and Coinsurance 276 New Physician Specialty Code for Hospitalist HCPCS Code Part D(1) — Claims Processing Timeliness — All Claims Advance Beneficiary Notice Part E — Interest Payment Data RHCs/FQHCs Special Billing Instructions Classification of Claims for Counting RHCs/FQHCs Special Billing Instructions Physician/Limited License Physician Specialty Codes 3670 Update to Editing of Therapy Services to Reflect Coding Changes 277 Issued to a specific audience, not posted to Internet/Intranet due to 3671 CY 2017 Update for Durable Medical Equipment, Prosthetics, Orthotics and Confidentiality of Instruction Supplies (DMEPOS) Fee Schedule 278 Medicare Financial Management Manual, Chapter 7, Internal Control Gap—filling DMEPOS Fees Requirements 3672 Issued to a specific audience, not posted to Internet/Intranet due to OMB Circular A—123 Confidentiality of Instruction GAO Standards for Internal Controls in the Federal Government 3673 Issued to a specific audience, not posted to Internet/Intranet due to Definition and Objectives Confidentiality of Instruction Contractor Internal Control Review Process and Timeline 3674 January 2017 Integrated Outpatient Code Editor (LOCE) Specifications Risk Assessment Version 18.0 Risk Analysis Chart 3675 2017 Healthcare Common Procedure Coding System (HCPCS) Annual Certification Package for Internal Controls (CPIC) Requirements Update Reminder OMB Circular A—123, Appendix A: Internal Controls Over Financial 3676 Summary of Policies in the Calendar Year (CY) 2017 Medicare Physician Fee Reporting (ICOFR) Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Certification Statement Payment Amount and Telehealth Services List, and CT Modifier Reduction CPIC— Report of Material Weaknesses List CPIC— Report of Internal Control Deficiencies 3677 Issued to a specific audience, not posted to Internet/Intranet due to Statement on Standards for Attestation Engagements (SSAE) Number 18 Confidentiality of Instruction (SSAE 18), Reporting on Controls at Service Providers 3678 Prolonged Services Without Direct Face—to—Face Patient Contact Separately Corrective Action Plans Payable Under the Physician Fee Schedule (Manual Update) Submission, Review, and Approval of Corrective Action Plans Prolonged Services Without Direct Face—to—Face Patient Contact Service Corrective Action Plan (CAP) Reports (Codes 99358 — 99359) CMS Finding Numbers 3679 Payment for Oxygen Volume Adjustments and Portable Oxygen Equipment Initial CAP Report Billing for Oxygen and Oxygen Equipment Quarterly CAP Report 3780 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity CMS CAP Report Template of Instruction List of CMS Contractor Control Objectives 3681 Issued to a specific audience, not posted to Internet/Intranet due to 279 Instructions to Hospitals on the Election of a Medicare—Supplemental Security Confidentiality of Instruction 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 SSI Ratios for Hospital Cost—Reporting Periods for 115 Electronic Correspondence Referral System (ECRS) Web Updates to Claims i isch i fe b Processing Medicare Secondary Payer (MSP) Policy and Procedures Regarding Ongoing Responsibility for Medicals (ORM) evisions to State Operations Manual ( ppendix J, Pai 116 Instructions on Using the Claim Adjustment Segment (CAS) for Medicare Interpretive Guidelines — Responsibilities of Intermediate Care Facilities for Secondary Payer (MSP) Part A CMS—1450 Paper Claims, Direct Data Entry Individuals with Intellectual Disabilities DDE), and $37 Institutional Claims Transactions 163 Revisions to State Operations Manual (SOM) Appendix W — Survey Protocol, Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs) 273 Notice of New Interest Rate for Medicare Overpayments and Underpayments and Swing—Beds in CAHs I9PLL

CO9PLL 164 Revisions to the State Operations Manual (SOM) Chapter 2 Numbering Revalidating Providers Involved in a Change of Ownership (CHOW) System for CMS Certification Numbers (CCN) Large Group Revalidation Coordination CCN for Medicare Providers Finalizing the Revalidation Application 165 Revisions to State Operations Manual (SOM) Appendix W — Survey Protocol, Revalidation Reporting Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs) Revalidation Files Available Online and Swing—Beds in CAHs Revalidation Extension Requests 685 Incorporation of Cycle 2 Revalidation Policies saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq 678 Issued to a specific audience, not posted to Internet/Intranet due to Definitions Confidentiality of Instruction Timeliness and Accuracy Standards 679 Issued to a specific audience, not posted to Internet/Intranet due to Standards for Initial and Revalidation Applications Confidentiality of Instruction Form CMS—855 Applications That Require a Site Visit 680 Issued to a specific audience, not posted to Internet/Intranet due to Form CMS—855 Applications That Do Not Require a Site Visit Confidentiality of Instruction Web—Based Applications — Timeliness 681 Revision to Surety Bond Collection Procedures Web—Based Applications That Require a Site Visit Claims Against Surety Bonds Web—Based Applications That Do Not Require a Site Visit Model Letters for Claims Against Surety Bonds Paper Applications — Accuracy 682 Issued to a specific audience, not posted to Internet/Intranet due to Web—Based Applications — Accuracy Confidentiality of Instruction Returns 683 Issued to a specific audience, not posted to Internet/Intranet due to Model Revalidation Letter Confidentiality of Instruction Model Large Group Revalidation Notification Letter Model Revalidation Pend Letter 684 Incorporation of Cycle 2 Revalidation Policies Model Revalidation Deactivation Letter Definitions Model Revalidation Past—Due Group Member Letter Timeliness and Accuracy Standards Model Deactivation Letter due to Inactive Provider/Supplier Letter Standards for Initial and Revalidation Applications Model Return Revalidation Letter Form CMS—855 Applications That Require a Site Visit Revalidation Lists Form CMS—855 Applications That Do Not Require a Site Visit Mailing Revalidation Letters Web—Based Applications — Timeliness Phone Calls Web—Based Applications That Require a Site Visit Pend Status Web—Based Applications That Do Not Require a Site Visit Deactivation Actions Paper Applications — Accuracy Receipt of Revalidation Application Web—Based Applications — Accuracy Revalidation Received and Development Required Returns Revalidation Received after a Pend is Applied Model Revalidation Letter Revalidation Received after a Deactivation Occurs Model Large Group Revalidation Notification Letter Change of Information Received Prior to Revalidation Letter Mailed Model Revalidation Pend Letter Reassignment Applications Received After Revalidation Letter Mailed Model Revalidation Deactivation Letter Revalidating Providers Involved in a Change of Ownership (CHOW Model Revalidation Past—Due Group Member Letter Large Group Revalidation Coordination Model Deactivation Letter due to Inactive Provider/Supplier Letter Finalizing the Revalidation Application Model Return Revalidation Letter Revalidation Reporting Revalidation Lists Revalidation Files Available Online Mailing Revalidation Letters Revalidation Extension Requests Phone Calls Pend Status 686 Comprehensive Error Rate Testing (CERT) Program: Medicare Deactivation Actions Administrative Contractor (MAC) Certifying Official Handling Overpayments and Underpayments, MAC Feedback, and Appeals Resulting Receipt of Revalidation Application From the CERT Findings Revalidation Received and Development Required Revalidation Received after a Pend is Applied Handling Appeals Resulting From CERT Initiated Denials Revalidation Received after a Deactivation Occurs 687 Extrapolated Overpayments Change of Information Received Prior to Revalidation Letter Mailed Conduct of Expanded Review Based on Statistical Sampling for Reassignment Applications Received After Revalidation Letter Mailed Overpayment

Estimation and Recoupment of Projected Overpayment by Contractors Internet—based PECOS Applications 688 Update to Pub. 100—08, Chapter 15 Medicaid State Agencies Release ofInformation Correspondence Address and E—mail Addresses Model Letter Guidance Form CMS—855A and Form CMS—§55B Signatories Reactivations — Deactivation for Non—Submission of a Claim Delegated Officials Reactivations — Miscellaneous Policies Supporting Documents 690 Issued to a specific audience, not posted to Internet/ Intranct Confidentiality Processing Alternatives —Form CMS—855B and Form CMS—8551 of Instruction saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq Processing Alternatives — Form CMS—8550 691 Contacting Non—Responders and Documentation Requests Processing Alternatives —Form CMS—855R iciary Special Program Integrity Procedures Medicare Contractor Beneficiary and Provider Communications Manual Model Revocation Letter for Part B Suppliers and Certified Providers and Beneficiary Customer Services Pub. 100—09 Chapter 2— Update Beneficiary Suppliers Customer Services Favorable Corrective Action Plan/Reconsideration Decision —Denials Escalation of Complex Beneficiary Inquiries to the MACs by the Beneficiary Corrective Action Plans (CAPs Contact Center (BCC) Reconsideration Requests — Non—Certified Providers/Suppliers Next Generation Desktop (NGD) Training Additional Appeal Levels Disclosure of Information (Adherence to the Privacy Act and the Health Appeals Involving Certified Providers and Certified Suppliers Insurance Portability and Accountability Act (HIPAA) Privacy Rule) Corrective Action Plans (CAPs) Screening of Beneficiary Complaints Alleging Fraud or Abuse Reconsideration Requests — Certified Providers and Certified Suppliers Medicare Customer Service — Next Generation Desktop (MCSC—NGD) Client Additional Appeal Levels Installation and Configuration Requirements HHA Ownership Changes Call Center User Group (CCUG Revocations Complex Beneficiary Inquiries 689 Medicare Contractor Duties Handling Complex Beneficiary Inquiries Correspondence Address and E—mail Addresses Controlling Complex Beneficiary Inquiries Contact Persons E—mail and Fax Responses to Complex Written Beneficiary Inquiries Certification Statement Signature Requirements Telephone Responses to Complex Beneficiary Inquiries Form CMS—8551 and CMS—8550 Signatories Written Responses to Complex Beneficiary Inquiries Form CMS—855R Signatories Timeliness of Responses to Complex Beneficiary Inquiries Form CMS—855A, Form CMS—855B and Form CMS—8558 Signatories Congressional Beneficiary Inquiries Authorized Officials Surveys Delegated Officials Urgent Need Regional Offices Casework Submission of Paper and Internet—based PECOS Certification Statements Certification Statement Development 28 QIO Manual Chapicr 5 —"Quality of Care Révww Reserved for Future Use 29 QIO Manual Chapter 3 "Memoranda of Agreement for Case Review Reserved for Future Use Authority and Scope for Memoranda of Agreement (MOA) Receipt/Review of Paper Applications MEMORANDA OF AGREEMENT (MOA) WITH PROVIDERS OF Receipt/Review of Internet—Based PECOS Applications SERVICES Processing Alternatives — Form CMS—855B and Form CMS—8551 Agreements with Providers of Services Processing Alternatives —Form CMS—855A Hospital Memorandumof Agreement (MOA) Processing Alternatives —Form CMS— Home Health Agencies (HHAs) and Skilled Nursing Facilities (SNFs) Paper Applications Memoranda of Agreement (MOA) Internet—Based PECOS Applications AGREEMENTS WITH PAYERS OF HEALTHCARE SERVICES General Principles — Paper and Internet—Based PECOS Applications Medicare Administrative Contractor (MAC) Joint Operating Agreements Receiving Missing/Clarifying Data/Documentation (JOA) Paper Applications Memorandum Of Agreement (MOA) with State Agencies Responsible for Internet—Based PECOS Applications Licensi ification of Providers and Practition Special Program Integrity Procedures Rejections Changes of Information — General Procedures Electronic Fund Transfers (EFT) None E9PLL

PIPLL (CWF)1693 123 Chapter 16b, Special Needs Plans 1737 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 124 Update of Chapter 1 of the Managed Care Manual Instruction 1738 Network Fee Reduction for Acute Kidney Injury (AKT) services submitted on Type of Bill 72x 1739 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq 157 Shared System Enhancement 2015: Archive/Remove Inactive Medicare Instruction Demonstration Projects 1740 Shared System Enhancement 2015: National Coverage Determination (NCD) 158 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Fiscal Intermediary Shared System (FISS) Implementation Instruction 1741 Issued to a specific audience, not posted to Internet/ Intranet Confidentiality 159 IVIG Demonstration: Payment Update for 2017 of Instruction 160 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivily 1742 Issued to a specific audience, not posted to Internet/ Intranet Confidentiality Instruction of Instruction 161 Shared System Enhancement 2015: Archive/Remove Inactive Medicare 1743 Modifications to the National Coordination of Benefits Agreement (COBA) Demonstration Projects Crossover Process 162 Affordable Care Act Bundled Payments for Care Improvement Initiative — 1744 Audit Trail for Reason Code Edit Changes Recurring File Updates Models 2 and 4 January 2017 Updates 1745 Part B Detail Line Expansion — Checkpoint Discussion Mestings 163 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1746 Medicare Electronic Health Record (EHR) Incentive Program — Analysis of Instruction Meaningful Use Hospital Transition into Hospital Quality Reporting System 164 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1747 Issuing Compliance Letters to Specific Providers and Suppliers Regarding Instruction Inappropriate Billing of Qualified Medicare Beneficiaries (QMBs) for Medicare Cost—Sharing 1723 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1748 Adding a Foreign Language Tagline Sheet to Medicare Summary Notices Instruction (MSNs) 1724 Common Working File (CWF) Reorganization of Daily Beneficiary Extract 1749 Issued to a specific audience, not posted to Internet/Intranct due to Sensitivity Files of Instruction 1725 Changes to the End—Stage Renal Disease (ESRD) Facility Claim (Type of Bill 1750 Increasing the Number of Address Fields in MCS to Match the Address Fields 72X) to Accommodate Dialysis Furnished to Beneficiaries with Acute Kidney in CWE in Order to Improve the Undeliverable Medicare Summary Notices Injury (AK1) (uMSNs) Situation: Phase One of Improving FFS9372 1726 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of 1751 Adding a Foreign Language Tagline Sheet to Medicare Summary Notices Instruction (MSNs) 1727 Section 504; Adding a Qualified Reader Preference in Alternate Formats 1752 System Specific Enhancement 2014: String Testing Automation 1728 Part B Detail Line Expansion — MCS Phase 6 1753 Coding Revisions to National Coverage Determination (NCDs) 1729 Analysis Only — Populate MCS PE Screens from PECOS (Phased Approach) 1754 Common Working File and Fraud Prevention System 2.0 Predictive Modeling 1730 Part B Detail Line Expansion — MCS Phase 5 and Edits, Data Feed Migration 1731 Fiscal Intermediary Shared System (FISS) Heath Information Technology for 1755 ICT—10 Coding Revisions to National Coverage Determination (NCDs) Economic and Clinical Health (HITECH) Quarterly Report 1756 Analysis Only — Modification of Process for Handling the Provider 1732 Phase Three: Changing Fiscal Intermediary Shared System (FISS) Action on Enrollment Chain Ownership System(PECOS) Extract File Informational Unsolicited Responses (IURs) From Canceled Claims to 1757 Issuing Compliance Letters to Specific Providers and Suppliers Regarding Adjustments Inappropriate Billing of Qualified Medicare Beneficiaries (QMBs) for 1733 Modifications to the National Coordination of Benefits Agreement (COBA) Medicare Cost—Sharing Crossover Process 1758 Updates for the Shared System Maintainers to implement the Social Security 1734 Phase 3 — Updating the Fiscal Intermediary Shared System (F‘ISS) to Make Number Removal Initiative (SSNRI) Payment for Drugs and Biologicals Services for Outpatient Prospective 1759 Changes to the End—Stage Renal Disease (ESRD) Facility Claim (Type of Bill Payment System (OPPS) Providers 72X) to Accommodate Dialysis Furnished to Beneficiaries with Acute Kidney 1735 System Specific Enhancement 2014: Retaining Most Recent Update for Injury (AKT) Auxiliary (Aux) File Data in Common Working File (CWEF) 1760 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1736 Shared System Enhancement 2014 — Identification of Fiscal Intermediary Instruction Shared System (FISS) Obsolete On—Request Jobs — Analysis Only File 1761 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity

Instruction The rulings can be accessed at http://www.cms. gov/Regulations— 1762 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity and—Guidance/Guidance/Rulings. For questions or additional information, Instruction 1763 Shared Savings Program (SSP) Accountable Care Organization (ACO) contact Tiffany Lafferty (410—786—7548). lifying Stay Edi Addendum IV: Medicare National Coverage Determinations saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq (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 Addendum II: Regulation Documents Published section of the NCD Manual (NCDM) in which the decision appears, the in the Federal Register (October through December 2016) title, the date the publication was issued. and the effective date of the Regulations and Notices decision. An NCD is a determination by the Secretary for whether or not a Regulations and notices are published in the daily Federal particular item or service is covered nationally under the Medicare Program Register. To purchase individual copies or subscribe to the Federal (title XVIII of the Act), but does not include a determination of the code, if Register, contact GPO at www.gpo.gov/fdsys. When ordering individual any, that is assigned to a particular covered item or service, or payment copies, it is necessary to cite either the date of publication or the volume determination for a particular covered item or service. The entries below number and page number. include information concerning completed decisions, as well as sections on The Federal Register is available as an online database through program and decision memoranda, which also announce decisions or, in GPO Access. The online database is updated by 6 a.m. each day the some cases, explain why it was not appropriate to issue an NCD. Federal Register is published. The database includes both text and Information on completed decisions as well as pending decisions has also graphics from Volume 59, Number 1 (January 2, 1994) through the present been posted on the CMS website. There were no updates that occurred in date and can be accessed at http://www.gpoaccess.gov/fr/index.html. The the 3—month period. This information is available at: following website http:/www.archives. gov/federal—register/ provides www.cms. gov/medicare—coverage—database/. For questions or additional information on how to access electronic editions, printed editions, and information, contact Wanda Belle, MPA (410—786—7491). reference copics. This information is available on our website at: Addendum V: FDA—Approved Category B Investigational Device http://www.cms. gov/quarterlyproviderupdates/downloads/Regs— Exemptions (IDEs) (October through December 2016) 3Q16QPU.pdf Addendum V includes listings of the FDA—approved For questions or additional information, contact Terri Plumb investigational device exemption (IDE) numbers that the FDA assigns. The (410—786—4481). listings are organized according to the categories to which the devices are Addendum III: CMS Rulings assigned (that is, Category A or Category B), and identified by the IDE (October through December 2016) number. For the purposes of this quarterly notice, we list only the specific CMS Rulings are decisions of the Administrator that serve as updates to the Category B IDEs as of the ending date of the period covered precedent final opinions and orders and statements of policy and by this notice and a contact person for questions or additional information. interpretation. They provide clarification and interpretation of complex or For questions or additional information, contact John Manlove (410—786— ambiguous provisions of the law or regulations relating to Medicare, 6877). Medicaid, Utilization and Quality Control Peer Review, private health Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360¢) devices insurance, and related matters. 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 SOPLL

rmajette on DSK2TPTVN1PROD with NOTICES VerDate Sep<11>2014 11466 IDEs, and Category B refers to non-experimental IDEs. To obtain more IDE Device Start Date information about the classes or categories, please refer to the notice Gl60250 tRISTAN 624 biOMAGNETOMETER 12115/2016 14:10 Feb 22, 2017 Gl60172 Ranger Paclitaxel-Coated PTA Balloon Catheter 12116/2016 published in the April21, 1997 Federal Register (62 FR 19328). Gl60180 OPTUKE (NovoTTF 100A System) 12116/2016 Gl60209 LOTUS Edge Valve System, 23 mm; LOTUS Edge Valve 12116/2016 IDE Device Start Date System, 25 mm, LOTUS Edge Valve System, 27 mm Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices Gl60189 Exablate Model 4000 Type 1 10/0112016 Gl60247 Proclaim Elite Implantable Pulse Generator; Triple 16 Paddle 12116/2016 Gl60131 EMBOSPHERE MICROSPHERE 10/04/2016 Leads Gl60191 RETINOIC ACID RECEPTOR ALPHA- INTERFERON 10/07/2016 Gl60248 A Prospective Pilot Trial for PFO CLOSURE at the Time of 12116/2016 Jkt 241001 RESPONSE FACTOR 8(RARA-IRF8) ENDOCASCULAR Cardiac Electronic Device Implantation Gl60149 E-QURE Bioelectrical Signal Therapy (BST) Device 10/14/2016 Gl60249 Hydrus Microstent 12116/2016 Gl60200 FE NIX Plus Continence Restoration System 10/18/2016 Gl60251 da Vinci SP Surgical System, EndoWrist SP Instruments, and 12116/2016 Gl60197 IMPELLA CP SYSTEM 10/19/2016 Accessories PO 00000 Gl60205 Agili-C 10/20/2016 G160265 In Press Technologies Post Pactum Hemorrhage Device 12/20/2016 Gl60203 BREATHID HP SYSTEM, BREATHID HP LAB SYSTEM 10/2112016 Gl60253 PERIODONTAL STRUCTURE REPAIR DEVICE 12/20/2016 G160168 TOPS Svstem 10/26/2016 Gl60259 Edwards SAPIEN 3 Transcatheter Heart Valve and 12/20/2016 G040175 Relay Thoracic Stend Graft with Transport Delivery System 10/27/2016 Accessories Frm 00041 for treatment of thoracic aortic aneurysms. Gl00322 TheraSphere 12/2112016 Gl60136 Medtronic Spinal Cord Stimulation Systems 10/28/2016 Gl30034 BIOFREEDOM Drug Coated Coronary Stent System 12/2112016 Gl60206 Restylane Silk Injectables 10/28/2016 Gl60256 NUCLEUS C1532 COCHLEAR IMPLANT 12/2112016 Gl60207 Cook Zenith TX2 Proximal Component, Cook Zenith TX2 10/28/2016 Gl60263 EXTRACORPOREAL CPR FOR REFRACTORY OUT-OF- 12/2112016 Fmt 4703 Proximal Extension, Cook Zenith TX2 Proximal Taper HOSPITAL CARDIAC ARREST (EROCA) Gl60211 BEAT AML MASTER TRIAL CLINICAL TRIAL ASSAY 1110112016 GlG02G5 EMBOZENE MICROSPHERES 12/23/2016 (BEAT AML GENOMIC PROFILING ASSAY) Gl60121 Implantable Miniature Telescope (IMT) Models Wide Angle 12/29/2016 Gl60212 SENSE BRAIN INWRY MONITOR (SDX1) 11102/2016 2.2X and Wide Angle 2.7X Sfmt 4725 Gl60208 STARS TIM 11104/2016 Gl60213 ARTISSE INTRASACCULAR DEVICE, ARTISSE 11104/2016 DETACHMENT DEVICE Addendum VI: Approval Numbers for Collections of Information G160214 EMBOSPHERE MICROSPHERES 11104/2016 (October through December 2016) E:\FR\FM\23FEN1.SGM Gl60216 Morphology Recurrence Plot Mapping 11109/2016 All approval numbers are available to the public at Reginfo.gov. Gl60218 The GORE Cardioform ASD Occuluder 11110/2016 Under the review process, approved information collection requests are Gl60219 ARTIC FRONT ADVANCE CARDIAC CRYOABLATION 11110/2016 assigned OMB control numbers. A single control number may apply to CATHETER several related information collections. This information is available at Gl60223 Carillon Mitral Contour System 11117/2016 Gl60226 Ovation Alto Abdominal Stent Graft System 11117/2016 www.reginfo.gov/public/do/PRAMain. For questions or additional Gl60229 Custom bipolar electrode based on PermaLoc Electrode 11118/2016 information, contact William Parham (410-786-4669). Gl60234 Embosphere (R) Microspheres 1112112016 23FEN1 Gl60233 Activa Deep Brain Stimulation Therapy System 11123/2016 Addendum VII: Medicare-Approved Carotid Stent Facilities, Gl00108 Exablate Model2100 Type 3.0 12/02/2016 (October through December 2016) Gl60238 ALUVRA 12/06/2016 Gl60106 FemBLOC Permanent Contraceptive System; Component 1) 12/07/2016 Addendum VII includes listings of Medicare-approved carotid FemBLOC Biopolymer; Component 2) FemBLOC Delivery stent facilities. All facilities listed meet CMS standards for performing System; Component 3) FemBLOC FemChec Tubal Occlusion carotid artery stenting for high risk patients. On March 17, 2005, we issued Confirmation Device our decision memorandum on carotid artery stenting. We determined that G160232 Zilver Vascular Stent 12/09/2016 Gl60243 Lynparza HRR Assay 12/13/2016 carotid artery stenting with embolic protection is reasonable and necessary Gl60242 IN.PACT AV Access Paclitaxel-Coated PTA Balloon 12/14/2016 only if perfonned in facilities that have been determined to be competent in Catheter perfonning the evaluation, procedure, and follow-up necessary to ensure EN23FE17.009</GPH>

optimal patient outcomes. We have created a list of minimum standards for announced that the American College of Cardiology‘s National facilities modeled in part on professional society statements on competency. Cardiovascular Data Registry (ACC—NCDR) ICD Registry satisfies the data All facilities must at least meet our standards in order to receive coverage reporting requirements in the NCD. Hospitals needed to transition to the for carotid artery stenting for high risk patients. For the purposes of this ACC—NCDR ICD Registry by April 2006. quarterly notice, we are providing only the specific updates that have Effective January 27, 2005, to obtain reimbursement, Medicare occurred in the 3—month period. This information is available at: NCD policy requires that providers implanting ICDs for primary prevention saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq http://www.cms. gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage clinical indications (that is, patients without a history of cardiac arrest or For questions or additional information, contact Sarah Fulton, MHS spontaneous arrhythmia) report data on each primary prevention ICD (410—786—2749). procedure. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements are available in the Facility Provider Effective State Medicare NCD Manual, which is on the CMS website at Number Date http://www.cms hhs. gov/Manuals/IOM/itemdetail. aspMilterType=none&filt Baxter Regional Medical Center 1033147921 10/26/2016 AR erByDID=99&sortByDID= 1 & sortOrder=ascending& itemID=CMSO14961 624 Hospital Drive A provider can use either of two mechanisms to satisfy the data Mountain Home, AR 72653 reporting requirement. Patients may be enrolled either in an Investigational Wellington Regional Medical Center 1720078702 11/08/2016 FL Device Exemption trial studying ICDs as identified by the FDA or in the 10101 Forest Hill Boulevard Wellington, FL 33414 ACC—NCDR ICD registry. Therefore, for a beneficiary to receive a St Mark‘s Hospital 470046 11/30/2016 NE Medicare—covered ICD implantation for primary prevention, the beneficiary 1100 East 3900 South must receive the scan in a facility that participates in the ACC—NCDR ICD Salt Lake City, UT 8$4124 registry. The entire list of facilities that participate in the ACC—NCDR ICD ac than registry can be found at www.nedr.com/webnedr/common FROM: Peace River Regional Medical Center 100077 08/24/2009 FL TO: Bayfront Health Port Charlotte For the purposes of this quarterly notice, we are providing only the 2500 Harbor Boulevard specific updates that have occurred in the 3—month period. This information Port Charlotte, FL 33952 is available by accessing our website and clicking on the link for the FROM: Community Heart and Vascular 15—0074 08/04/2005 IN American College of Cardiology‘s National Cardiovascular Data Hospital TO: Community Health Network, Inc Registry at: www.nedr.com/webnedr/common. For questions or additional 1500 N. Ritter Avenue information, contact Sarah Fulton, MHS (410 786 2749). Indianapolis, IN 46219 F Addendum VIII: Sarah Bush Lincoln Health Center Mattoon American College of Cardiology‘s National Cardiovascular Data Kaiser Permanente — Vacaville Medical Center Vacaville Registry Sites (October through December 2016) Community Hospital District e Addendum VIII includes a list of the American College of Roane Medical Center Harriman Cardiology‘s National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical Hospi Fri St. s Medical Center West Palm Beach indications, as long as information about the procedures is reported to a Wheaton Franciscan Inc. — Wisconsin Heart Milwaukee central registry. Detailed descriptions of the covered indications are Ho available in the NCD. In January 2005, CMS established the ICD V i Medical Center Selma Abstraction Tool through the Quality Network Exchange (QNet) as a Northshore ional Medical Center Slidell temporary data collection mechanism. On October 27, 2005, CMS TriStar Southern Hills Medical Center Nashville St. Elizabeth Boardman Boardman LIPILL

8OPLL Facility City State National Oncologic PET Registry as one of these clinical studies. Tristar Horizon Medical Center Dickson TN Therefore, in order for a beneficiary to receive a Medicare—covered PET Wilcox Memorial Hospital (Hawai‘i Pacific) Lihue HI Mercy Tiffin Hospital Tiffin OH scan, the beneficiary must receive the scan in a facility that participates in Guthrie Corning Hospital Corning NY the registry. There were no additions, deletions, or editorial changes to the CHI St. Luke‘s Health Memorial Livingston Livingston TX listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3—month period. This information is available at saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq Addendum IX: Active CMS Coverage—Related Guidance Documents http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#T opOfPage. (October through December 2016) For questions or additional information, contact Stuart Caplan, RN, MAS CMS issued a guidance document on November 20, 2014 titled (410—786—8564). "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy Addendum XII:; Medicare—Approved Ventricular Assist Device vehicles relating to evidence development activities including the (Destination Therapy) Facilities (October through December 2016) investigational device exemption (IDE), the clinical trial policy, national Addendum XII includes a listing of Medicare—approved facilities coverage determinations and local coverage determinations, this guidance that receive coverage for ventricular assist devices (VADs) used as document is principally intended to help the public understand CMS‘s destination therapy. All facilities were required to meet our standards in implementation of coverage with evidence development (CED) through the order to receive coverage for VADs implanted as destination therapy. On national coverage determination process. The document is available at October 1, 2003, we issued our decision memorandum on VADs for the http://www.cms.gov/medicare—coverage—database/details/medicare— clinical indication of destination therapy. We determined that VADs used coverage—document—details.aspx?MCDId=27. There are no additional as destination therapy are reasonable and necessary only if performed in Active CMS Coverage—Related Guidance Documents for the 3—month facilities that have been determined to have the experience and period. For questions or additional information, contact infrastructure to ensure optimal patient outcomes. We established facility JoAnna Baldwin, MS (410—786—7205). standards and an application process. All facilities were required to meet Addendum X: our standards in order to receive coverage for VADs implanted as List of Special One—Time Notices Regarding National Coverage destination therapy. Provisions (October through December 2016) We are providing only the specific updates to the list of Medicare— There were no special one—time notices regarding national approved facilities that meet our standards that have occurred in the coverage provisions published in the 3—month period. This information is 3—month period. This information is available at available at www.cms. hhs.gov/coverage. For questions or additional http://www.cms. gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. information, contact JoAnna Baldwin, MS (410—786 7205). For questions or additional information, contact Linda Gousis, JD, (410—786—8616). Addendum XI: National Oncologic PET Registry (NOPR) (October through December 2016) Facility Provider Date Approved State Number Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission y fie tomography (PET) scans for particular oncologic indications when they are 1301 Central Street, Suite 300 performed in a facility that participates in the NOPR. Evanston, IL 60201 St. Francis Hospital 33—0182 11/09/2016 NY In January 2005, we issued our decision memorandum on positron 100 Port Washington Boulevard emission tomography (PET) scans, which stated that CMS would cover Roslyn, NY 11576 PET scans for particular oncologic indications, as long as they were Swedish Medical Center Cherry Hill 500025 11/09/2016 WA performed in the context of a clinical study. We have since recognized the 500 17th Avenue Seattle, WA 98122

Facility Provider Date Approved State 3—month period. This information is available at www.cms. gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage. For FROM: UT Southwestern University 450044 12/10/2003 questions or additional information, contact Sarah Fulton, MHS Hospital (410—786—2749). TO:; UT Southwestern Medical Center Addendum XIV: Medicare—Approved Bariatric Surgery Facilities saomIoN/LIOZ ‘gZ Arenigag ‘AKepsim.,/5g ‘ON ‘zg ‘TOA/JopstSay fedapaq 6201 Harry Hines Blvd. Dallas, TX 75390 (October through December 2016) Other information: Addendum XIV includes a listing of Medicare—approved facilities Joint Commission certified on 2/3/09. that meet minimum standards for facilities modeled in part on professional Hospital previously listed as St. Paul society statements on competency. All facilities must meet our standards in Medical Center. FROM: Methodist Hospital, The 450358 12/06/2016 TX order to receive coverage for bariatric surgery procedures. On February 21, TO: Houston Methodist Hospital 2006, we issued our decision memorandum on bariatric surgery procedures. 6565 Fannin Street We determined that bariatric surgical procedures are reasonable and Houston, TX 77030 necessary for Medicare beneficiaries who have a body—mass index (BMI) Other information: DNV GL certified 12/6/16;, JCAHO greater than or equal to 35, have at least one co—morbidity related to obesity certified 10/29/08 and have been previously unsuccessful with medical treatment for obesity. FROM: Community Heart and 150074 10/01/2014 IN This decision also stipulated that covered bariatric surgery procedures are Vascular reasonable and necessary only when performed at facilities that are: (1) TO:; Community Health Network, certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Inc. 8075 N Shadeland Avenue Surgery Center (program standards and requirements in effect on February Indianapolis, IN 46250 15, 2006); or (2) certified by the American Society for Bariatric Surgery Other information: (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program Joint Commission Certified standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Addendum XIII: Lung Volume Reduction Surgery (LVRS) Medicare—approved facilities that meet CMS‘s minimum facility standards (October through December 2016) for bariatric surgery that have been certified by ACS and/or ASMBS in the Addendum XIII includes a listing of Medicare—approved facilities 3—month period. This information is available at that are eligible to receive coverage for lung volume reduction surgery. www.cms. gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For Until May 17, 2007, facilities that participated in the National Emphysema questions or additional information, contact Sarah Fulton, MHS Treatment Trial were also eligible to receive coverage. The following three (410—786—2749). types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): Addendum XV: FDG—PET for Dementia and Neurodegenerative e National Emphysema Treatment Trial (NETT) approved (Beginning Diseases Clinical Trials (October through December 2016) 05/07/2007, these will no longer automatically qualify and can qualify only There were no FDG—PET for Dementia and Neurodegenerative with the other programs); Diseases Clinical Trials published in the 3—month period. e Credentialed by the Joint Commission (formerly, the Joint This information is available on our website at Commision on Accreditation of Healthcare Organizations (JCAHO)) under www.cms. gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. their Disease Specific Certification Program for LVRS; and For questions or additional information, contact Stuart Caplan, RN, MAS e Medicare approved for lung transplants. (410—786—8564). 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 69PLL

11470 Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 / Notices [FR Doc. 2017–03559 Filed 2–22–17; 8:45 am] this notice, you may make your request Respondents: 509; Total Annual BILLING CODE 4120–01–C using one of following: Responses: 509 Total Annual Hours: 1. Access CMS’ Web site address at 6,815. (For policy questions regarding http://www.cms.hhs.gov/ this collection contact Jacqueline Leach DEPARTMENT OF HEALTH AND PaperworkReductionActof1995. at 410–786–4282.) HUMAN SERVICES 2. Email your request, including your Dated: February 16, 2017. address, phone number, OMB number, Centers for Medicare & Medicaid William N. Parham, III, and CMS document identifier, to Services Director, Paperwork Reduction Staff, Office Paperwork@cms.hhs.gov. of Strategic Operations and Regulatory [Document Identifiers: CMS–10282] 3. Call the Reports Clearance Office at Affairs. (410) 786–1326. [FR Doc. 2017–03453 Filed 2–22–17; 8:45 am] Agency Information Collection FOR FURTHER INFORMATION CONTACT: BILLING CODE 4120–01–P Activities: Submission for OMB Reports Clearance Office at (410) 786– Review; Comment Request 1326. AGENCY: Centers for Medicare & SUPPLEMENTARY INFORMATION: Under the DEPARTMENT OF HEALTH AND Medicaid Services, Department of Paperwork Reduction Act of 1995 (PRA) HUMAN SERVICES Health and Human Services. (44 U.S.C. 3501–3520), federal agencies ACTION: Notice. must obtain approval from the Office of Administration for Children and Management and Budget (OMB) for each Families SUMMARY: The Centers for Medicare & collection of information they conduct Medicaid Services (CMS) is announcing Submission for OMB Review; or sponsor. The term ‘‘collection of an opportunity for the public to Comment Request information’’ is defined in 44 U.S.C. comment on CMS’ intention to collect 3502(3) and 5 CFR 1320.3(c) and information from the public. Under the Title: National Survey of Child and includes agency requests or Adolescent Well-Being-Third Cohort Paperwork Reduction Act of 1995 requirements that members of the public (PRA), federal agencies are required to (NSCAW III): Data Collection. submit reports, keep records, or provide OMB No.: 0970–0202. publish notice in the Federal Register information to a third party. Section concerning each proposed collection of 3506(c)(2)(A) of the PRA (44 U.S.C. Description: The Administration for information, including each proposed 3506(c)(2)(A)) requires federal agencies Children and Families (ACF) within the extension or reinstatement of an existing to publish a 30-day notice in the U.S. Department of Health and Human collection of information, and to allow Federal Register concerning each Services (HHS) intends to collect data a second opportunity for public proposed collection of information, on a third cohort of children and comment on the notice. Interested including each proposed extension or families for the National Survey of Child persons are invited to send comments reinstatement of an existing collection and Adolescent Well-Being (NSCAW regarding the burden estimate or any of information, before submitting the III). NSCAW is the only source of other aspect of this collection of collection to OMB for approval. To nationally representative, longitudinal, information, including any of the comply with this requirement, CMS is firsthand information about the following subjects: The necessity and publishing this notice that summarizes functioning and well-being, service utility of the proposed information the following proposed collection(s) of needs, and service utilization of collection for the proper performance of information for public comment: children and families who come to the the agency’s functions; the accuracy of 1. Type of Information Collection attention of the child welfare system. the estimated burden; ways to enhance Request: Revision of a currently Information is collected about children’s the quality, utility, and clarity of the approved collection; Title of cognitive, social, emotional, behavioral, information to be collected; and the use Information Collection: Conditions of and adaptive functioning, as well as of automated collection techniques or Participation for Comprehensive family and community factors that are other forms of information technology to Outpatient Rehabilitation Facilities likely to influence their functioning. minimize the information collection (CORFs) and Supporting Regulations; Family service needs and service burden. Use: The Conditions of Participation utilization also are addressed in the data DATES: Comments on the collection(s) of (CoPs) and accompanying requirements collection. information must be received by the specified in the regulations are used by A previous notice provided the OMB desk officer by March 27, 2017. our surveyors as a basis for determining opportunity for public comment on the ADDRESSES: When commenting on the whether a comprehensive outpatient proposed Phase 1 recruitment and proposed information collections, rehabilitation facility (CORF) qualifies sampling process (FR V.81, 4/8/2016). please reference the document identifier to be awarded a Medicare provider This notice is specific to the Phase 2 or OMB control number. To be assured agreement. We believe the health care data collection activities: (1) Baseline consideration, comments and industry practice demonstrates that the and (2) 18-month follow-up data recommendations must be received by patient clinical records and general collection. Data collection includes the OMB desk officer via one of the content of records are necessary to child interviews and direct assessments, following transmissions: OMB, Office of ensure the well-being and safety of as well as caregiver and caseworker Information and Regulatory Affairs, patients and that professional treatment interviews. The overall goal is to Attention: CMS Desk Officer, Fax and accountability are a normal part of maintain the strengths and continuity of rmajette on DSK2TPTVN1PROD with NOTICES Number: (202) 395–5806, or Email: industry practice. Form Number: CMS– the prior surveys while better OIRA_submission@omb.eop.gov. 10282 (OMB control number: 0938– positioning the study to address changes To obtain copies of a supporting 1091); Frequency: Yearly; Affected in the child welfare population. statement and any related forms for the Public: Business or other for-profit and Respondents: Children, and their proposed collection(s) summarized in Not-for-profit institutions; Number of associated caregivers and caseworkers. VerDate Sep<11>2014 14:10 Feb 22, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1


Document Created: 2017-02-23 02:11:04
Document Modified: 2017-02-23 02:11:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactIt is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. [GRAPHIC] [TIFF OMITTED] TN23FE17.000
FR Citation82 FR 11456 
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