82_FR_50026 82 FR 49819 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2017

82 FR 49819 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2017

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

Federal Register Volume 82, Issue 207 (October 27, 2017)

Page Range49819-49832
FR Document2017-23447

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2017, relating to the Medicare and Medicaid programs and other programs administered by CMS.

Federal Register, Volume 82 Issue 207 (Friday, October 27, 2017) 
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49819-49832]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23447]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9105-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July Through September 2017

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

ACTION: Notice.

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

SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from July through September 2017, 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.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TN27OC17.002

BILLING CODE 4120-01-C

I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) Furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners (NAIC), health insurers, and other

[[Page 49820]]

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: October 20, 2017.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

[[Page 49821]]

[GRAPHIC] [TIFF OMITTED] TN27OC17.003


[[Page 49822]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.004


[[Page 49823]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.005


[[Page 49824]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.006


[[Page 49825]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.007


[[Page 49826]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.008


[[Page 49827]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.009


[[Page 49828]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.010


[[Page 49829]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.011


[[Page 49830]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.012


[[Page 49831]]


[GRAPHIC] [TIFF OMITTED] TN27OC17.013


[[Page 49832]]


[FR Doc. 2017-23447 Filed 10-26-17; 8:45 am]
 BILLING CODE 4120-01-C

Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49819 crosswalk to include comparable TJC revised its survey policy and DEPARTMENT OF HEALTH AND standards to require disclosure of the procedure to clearly delineate that a HUMAN SERVICES names and addresses of the facility’s survey will not occur until after the owners, or those with a controlling applicable Regional Office has made a Centers for Medicare & Medicaid interest in the CAH or in any determination of the CAH’s compliance Services subcontractor in which the CAH with location and distance directly or indirectly has a 5 percent or requirements. [CMS–9105–N] more ownership interest. • Section 485.645(a)(2): Updated its B. Term of Approval Medicare and Medicaid Programs; crosswalk to include the correct Based on our review and observations Quarterly Listing of Program regulatory language to require that the described in section III of this final Issuances—July Through September facility limits inpatient beds to no more notice, we have determined that TJC’s 2017 than 25 and is verified on all surveys. CAH program requirements meet or • Section 488.5(a)(4)(vii): Updated its exceed our requirements, and its survey AGENCY: Centers for Medicare & policies and review process to ensure processes are comparable to ours. Medicaid Services (CMS), HHS. that approved plans of correction fully address all non-compliant practices Therefore, we approve TJC as a national ACTION: Notice. identified during the survey; that accreditation organization for critical appropriate policy changes have been access hospitals that request participation in the Medicare program, SUMMARY: This quarterly notice lists made to ensure compliance; and that CMS manual instructions, substantive plans of correction identify the effective November 21, 2017 through November 21, 2023. and interpretive regulations, and other responsible party for ensuring corrective Federal Register notices that were actions are implemented within the V. Collection of Information published from July through September CAH and contain a description of how Requirements 2017, relating to the Medicare and the CAH will monitor and evaluate the This document does not impose Medicaid programs and other programs effectiveness of the corrective actions, analyze the data, and report findings to information collection requirements, administered by CMS. the senior leadership and governing that is, reporting, recordkeeping or FOR FURTHER INFORMATION CONTACT: It is body to ensure continued regulatory third-party disclosure requirements. possible that an interested party may compliance. Consequently, there is no need for need specific information and not be • Section 488.5(a)(12): Provided CMS review by the Office of Management and able to determine from the listed with assurance that its procedures for Budget under the authority of the information whether the issuance or responding to, and investigating Paperwork Reduction Act of 1995 (44 regulation would fulfill that need. complaints against accredited facilities U.S.C. 3501 et seq.). Consequently, we are providing contact are fully implemented and followed. • Section 488.26(b): Revised surveyor Dated: October 16, 2017. persons to answer general questions documentation to include appropriately Seema Verma, concerning each of the addenda detailed deficiency statements that Administrator, Centers for Medicare & published in this notice. clearly support the determination of Medicaid Services. BILLING CODE 4120–01–P noncompliance and appropriate level of [FR Doc. 2017–23449 Filed 10–26–17; 8:45 am] deficiency. BILLING CODE 4120–01–P asabaliauskas on DSKBBXCHB2PROD with NOTICES BILLING CODE 4120–01–C insurance. Administration and oversight offices, state governments, state I. Background of these programs involves the Medicaid agencies, state survey following: (1) Furnishing information to agencies, various providers of health The Centers for Medicare & Medicaid Medicare and Medicaid beneficiaries, care, all Medicare contractors that Services (CMS) is responsible for health care providers, and the public; process claims and pay bills, National administering the Medicare and Medicaid programs and coordination and (2) maintaining effective Association of Insurance Commissioners communications with CMS regional (NAIC), health insurers, and other EN27OC17.002</GPH> and oversight of private health VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1

49820 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices stakeholders. To implement the various in the 3-month period along with a assessing a Web site proves to be statutes on which the programs are hyperlink to the full listing that is difficult, the contact person listed can based, we issue regulations under the available on the CMS Web site or the provide information. authority granted to the Secretary of the appropriate data registries that are used Department of Health and Human III. How To Use the Notice as our resources. This is the most Services under sections 1102, 1871, current up-to-date information and will This notice is organized into 15 1902, and related provisions of the be available earlier than we publish our addenda so that a reader may access the Social Security Act (the Act) and Public quarterly notice. We believe the Web subjects published during the quarter Health Service Act. We also issue site list provides more timely access for various manuals, memoranda, and covered by the notice to determine beneficiaries, providers, and suppliers. whether any are of particular interest. statements necessary to administer and We also believe the Web site offers a oversee the programs efficiently. We expect this notice to be used in more convenient tool for the public to concert with previously published Section 1871(c) of the Act requires find the full list of qualified providers notices. Those unfamiliar with a that we publish a list of all Medicare manual instructions, interpretive rules, for these specific services and offers description of our Medicare manuals statements of policy, and guidelines of more flexibility and ‘‘real time’’ should view the manuals at http:// general applicability not issued as accessibility. In addition, many of the www.cms.gov/manuals. regulations at least every 3 months in Web sites have listservs; that is, the public can subscribe and receive Dated: October 20, 2017. the Federal Register. immediate notification of any updates to Kathleen Cantwell, II. Format for the Quarterly Issuance the Web site. These listservs avoid the Director, Office of Strategic Operations and Notices need to check the Web site, as Regulatory Affairs. This quarterly notice provides only notification of updates is automatic and BILLING CODE 4120–01–P the specific updates that have occurred sent to the subscriber as they occur. If asabaliauskas on DSKBBXCHB2PROD with NOTICES VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1

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 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: November 2016 (81 FR 79489, February 23, 2017 (82 FR 11456), that receive and retain at least one copy of most federal government May 5, 2017 (82 FR 21241) and August 4, 2017 (82 FR 36404). We are publications, either in printed or microfilm form, for use by the general samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq 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 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 I:; Medicare and Medicaid Manual Instructions entitled Medicare and Medicaid Manual Instructions. To help FDLs locate (July through September 2017) the matcrials, use the CMS publication and transmittal numbers. For The CMS Manual System is used by CMS program components, cxample, to find the manual for Quarterly Update to the National Correcet partners, providers, contractors, Medicare Advantage organizations, and Coding Initiative (NCCT) Procedure to Procedure (PTP) Edits, Version State Survey Agencies to administer CMS programs. It offers day—to—day 23.3, Effective October 1, 2017 use (CMS—Pub. 100—04) operating instructions, policies, and procedures based on statutes and Transmittal No. 3807. regulations, guidelines, models, and directives. In 2003, we transformed the Addendum I lists a unique CMS transmittal number for each CMS Program Manuals into a web user—friendly presentation and renamed instruction in our manuals or program memoranda and its subject number. it the CMS Online Manual System. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with How to Obtain Manuals information currently in the manual. For the purposes of this quarterly The Internet—only Manuals (IOMs) are a replica of the Agency‘s notice, we list only the specific updates to the list of manual instructions official record copy. Paper—based manuals are CMS manuals that were that have occurred in the 3—month period. This informationis available on officially released in hardcopy. The majority of these manuals were our website at www.cms. gov/Manuals. transferred into the Internet—only manual (IOM) or retired. Pub 15—1, Pub 15—2 and Pub 45 are exceptions to this rule and are still active paper—based Transmittal Manual/Subject/Publication Number Number manuals. The remaining paper—based manuals are for reference purposes only. If you notice policy contained in the paper—based manuals that was 106 Issued to a specific'au ience, not péste to Internet/Intranet due to not transferred to the IOM, send a message via the CMS Feedback tool. Confidentiality of Instruction Those wishing to subscribe to old versions of CMS manuals should 107 Affordable Care Act Bundled Payments for Care Improvement Initiative — contact the National Technical Information Service, Department of Recurring o File U pdates Models 2 and 4 January 2018 Updates Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703—605—6050). You can download copies of the listed material free of rel charge at: http://cms.gov/manuals. 199 Percutaneous Image—guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) How to Review Transmittals or Program Memoranda Percutancous Image—guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)(Various Effective Dates Below) (Rev.) Those wishing to review transmittals and program memoranda can 200 Percutaneous Image—guided I.umbar Decompression (PIL1) for T ambar access this information at a local Federal Depository Library (FDL). Under Spinal Stenosis (LSS) the FDL program, government publications are sent to approximately 1,400 Spinal Stenosis (LSS)(Various Effective Dates Below) designated libraries throughout the United States. Some FDLs may have 201 National Coverage Determination (NCD20.8.4): Leadless Pacemakers Leadless Pacemakers I286F

CoB6F 202 Updates to Pub. 100—04, Chapter 18 Preventive and Screening Services and 3819 Issued to a specific audience, not posted to Internet/Intranet due to Chapter 32 Billing Requirements for Special Services and Publication 100—03, Confidentiality of Instruction Chapter 1 C Determinations Part 4 3820 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction 3805 Percutaneous Image—guided Lumbar Decompression (PILD) for Lumbar 3821 Issued to a specific audience, not posted to Internet/Intranet due to Spinal Stenosis (LSS) Confidentiality of Instruction Claims Processing Requirements for Percutaneous Image—guided Lumbar 3822 Issued to a specific audience, not posted to Internet/Intranet due to samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq Decompression (PILD) for Lumbar Spinal Stenosis (LSS) on Professional Confidentiality of Instruction Claims 3823 Issued to a specific audience, not posted to Internet/Intranet due to 3806 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Confidentiality of Instruction 3824 July Quarterly Update for 2017 Durable Medical Equipment, Prosthetics, 3807 Quarterly Update to the National Correct Coding Initiative (NCCT) Procedure Orthotics, and Supplies (DMEPOS) Fee Schedule to Procedure (PTP) Edits, Version 23.3, Effective October 1. 2017 3825 October Quarterly Update to 2017 Annual Update of HCPCS Codes Used for 3808 Issued to a specific audience, not posted to Internet/Intranet due to Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement Confidentiality of Instruction 3826 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Fiscal 3809 October 2017 Quarterly Average Sales Price (ASP) Medicare Part B Drug Year (FY) Annual Update Pricing Files and Revisions to Prior Quarterly Pricing Files 3827 Quarterly Influenza Virus Vaccine Code Update — January 2018 3810 Issued to a specific audience, not posted to Internet/Intranet due to Table of Preventive and Screening Services Confidentiality of Instruction Healthcare Common Procedure Coding System (HCPCS) and Diagnosis 3811 Percutancous Image—guided Lumbar Decompression (PILD) for Lumbar Codes Spinal Stenosis (LSS) CWEF Edits on A/B MAC (A) Claims 3812 New Waived Tests CWEF Edits on A/B MAC (B) Claims 3813 Accepting Hospice Notices of Election via Electronic Data Interchange CWEF Crossover Edits for A/B MAC (B) Claims Procedures for Hospice Election and Related Transactions 3828 Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Notice of Election (NOE) Hospice Pricerfor FY 2017 Notice of Termination/Revocation (NOTR) 3829 Revisions to the Home Health Pricer to Support Value—Based Purchasing and Change of Provider/Transfer Notice Payment Standardization Cancellation of an Election 3830 Issued to a specific audience, not posted to Internet/Intranet due to Change of Ownership Notice Confidentiality of Instruction Data Required on the Institutional Claim to A/B MAC (HHH) 3831 Sercening for Hepatitis B Virus (HBV) Independent Attending Physician Services Institutional Billing Requirements 3814 Updated Editing of Always Therapy Services — MCS Claims Processing Professional Billing Requirements Requirements for Financial Limitations Diagnosis Code Reporting Requirements 3815 National Coverage Determination (NCD20.8.4): Leadless Pacemakers Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Leadless Pacemaker Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) Leadless Pacemaker Coding and Billing Requirements for Professional Messages Claims 3832 Fiscal Year (FY) 2017 Inpatient Prospective Payment System (IPPS) and Leadless Pacemaker Place of Service Restrictions Long Term Care Hospital (LTCH) PPS Changes Leadless Pacemaker Modifier 3833 Quarterly Update to the End—Stage Renal Disease (ESRD) Prospective Leadless Pacemaker Additional Claim of Billing Information Payment System (PPS) Leadless Pacemaker Claim Adjustment Reason Codes (CARC), Remittance 3834 Issued to a specific audience, not posted to Internet/Intranet due to Advice Remark Codes (RARC) and Medicare Summary Notice (MSN) Confidentiality of Instruction Messages 3835 Screening for the Human Immunodeficiency Virus (HIV) Infection 3816 Issued to a specific audience, not posted to Internet/Intranet due to Healthcare Common Procedure Coding System (HCPCS) for HIV Screening Confidentiality of Instruction Tests 3817 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Billing Requirements of Instruction Payment Method 3818 Issued to a specific audience, not posted to Internet/Intranet due to Types of Bill (TOBs) and Revenue Codes Confidentiality of Instruction Diagnosis Code Reporting

Medicare Summary Notice (MSN) and Claim Adjustment Reason Codes 3858 Fiscal Year (FY) 2018 Inpatient Prospective Payment System (IPPS) and (CARCs) Long Term Care Hospital (LTCH) PPS Changes 3836 Home Health Value—Based Purchasing Implementation 3859 October Quarterly Update for 2017 Durable Medical Equipment, Prosthetics, 3837 Influenza Vaccine Payment Allowances — Annual Update for 2017—2018 Orthotics. and Supplies (DMEPOS) Fee Schedule Season 3860 Instructions for Downloading the Medicare ZIP Code File for January 2018 3838 Quarterly Update to the Medicare Physician Fee Schedule Database 3861 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics (MPFSDB) — October 2017 Update and Supplies (DMEPOS) Competitive Bidding Program (CBP) — January samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq 3839 Claim Status Category and Claim Status Codes Update 2018 3840 Common Edits and Enhancements Modules (CEM) Code Set Update 3862 Annual Clotting Factor Furnishing Fee Update 2018 Clotting Factor 3841 Implement Operating Rules — Phase III Electronic Remittance Advice (ERA) Furnishing Fee (Chapter 17 — Drugs and Biologicals 80.4.1) Electronic Funds Transfer (EFT): CORE 360 Uniform Use of Claim 3863 Updated Editing of Always Therapy Services — MCS Claims Processing Adjustment Reason Codes (CARC), Remittance Advice Remark Codes Requirements for Financial Limitations (RARC) and Claim Adjustment Group Code (CAGC) Rule — Update from 3864 October 2017 Update of the Hospital Oulpatient Prospective Payment System Council for Affordable Quality Healthcare (CAQH) Committee on Operating (OPPS) Rules for Information Exchange (CORE) 3865 Instructions for Retrieving the 2018 Pricing and HCPCS Data Files through 3842 Healthcare Provider Taxonomy Codes (HPTCs) October 2017 Code Set CMS‘ Mainframe Telecommunications Systems Update 3866 Accepting Hospice Notices of Election via Electronic Data Interchange 3843 2018 Healthcare Common Procedure Coding System (HCPCS) Annual Procedures for Hospice Election and Related Transactions Update Reminder Notice of Election (NOE) 3844 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Notice of Termination/Revocation (NOTR) of Instruction Change of Provider/Iransfer Notice 3845 Issued to a specific audience, not posted to Internet/Intranet due to Cancellation of an Election Confidentiality of Instruction Change of Ownership Notice 3846 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Data Required on the Institutional Claim to A/B MAC (HHH of Instruction Independent Attending Physician Services 3847 Issued to a specific audience, not posted to Internet/Intranet due to 3867 New Waived Tests Confidentiality ofInstruction 3868 Issued to a specific audience, not posted to Internet/Intranet due to 3848 Updates to Pub. 100—04, Chapter 18 Preventive and Screening Services and Confidentiality of Instruction Chapter 32 Billing Requirements for Special Services and Publication 100—03, 3869 Quarterly Update to the National Correct Coding Initiative (NCCT) Chapter 1 Coverage Determinations Part 4 Procedure—to—Procedure (PTP) Edits, Version 24.0. Effective January1, 2018 3849 Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment 3870 Annual Update for the Health Professional Shortage Area (HPSA) Bonus System (PPS) Pricer Changes for FY 2018 Payments 3850 Quarterly Healthcare Common Procedure Coding System (HCPCS) 3871 Revisions to Medicare Claims Processing Manual for Foreign, Emergency Drug/Biological Code Changes — October 2017 Update and Shipboard Claims 3851 File Conversions Related to the Spanish Translation of the Healthcare di U Common Procedure Coding System (HCPCS) Descriptions 120 Electronic Correspondence Referral System (ECRS) User Guide 3852 October 2017 Integrated Outpatient Code Editor (LOCE) Specifications Medicare Beneficiary Identifier (MBI) Version 18.3 Modifications including Updated Enterprise Identity Management (EIDM) 3853 October 2017 Update of the Hospital Outpatient Prospective Payment System Multi—Factor Authentication (MFA)/Remote Identity Proofing (RIDP) Screen (OPPS) Shots 3854 October 2017 Update of the Ambulatory Surgical Center (ASC) Payment ECRS Web User Guide System ECRS Quick Reference Card 3855 Internet Only Manual (IOM) Update to Pub. 100—04, Chapter 15 — Ambulance, to Restore Multiple Patients on One Trip Instructions 288 Pub. 100—6, Chapter 3 and 4 Revisions 3856 Clarification of the Billing of Immunosuppressive Drugs Billing for Determining Liability and Waiver of Recovery for Overpayments Immunosuppressive Drugs Determination — Limitation of Liability Determination 3857 2018 Annual Update of Healthcare Common Procedure Coding System Determination — Waiver of Recovery of an Overpayment (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing Overpayments Discovered Subsequent to the Third Year (CB) Update How to Determine the Third Calendar Year After the Payment was €TB6FP

Po8g6bP Approved Confidentiality of Instruction Recovery of Overpayment Due to Cost Report 737 Credentials of Reviewers Termination of Collection Action Complex Medical Review Termination of Collection Action — Provider Overpayments 738 Provider Error Rate Formula Termination of Collection Action— Beneficiary Overpayments Provider Error Rate Requirements for Collecting Part A and B Provider Non—MSP 739 Issued to a specific audience, not posted to Internet/Intranet due to Overpayments Confidentiality of Instruction samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq Debt Incligible for Referral 740 Issued to a specific audience, not posted to Internet/Intranet due to Intent to Refer Letter Confidentiality of Instruction Response to Intent to Refer Letter 741 Issued to a specific audience, not posted to Internet/Intranet due to Intermediary Claims Accounts Receivable ( Confidentiality of Instruction Debts RTA by Treasury as Dispute Response not Received Timely (RX) 742 Issued to a specific audience, not posted to Internet/Intranet due to Debts RTA by Treasury as a Miscellaneous Dispute, a Manual RTA, Confidentiality of Instruction Complaint or as Recall Approved (RD 743 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Intent to Refer Letter of Instruction 289 Notice of New Interest Rate for Medicare Overpayments and Underpayments 744 Issued to a specific audience, not posted to Internet/Intranet due to —4th Qtr Notification for FY 2017 Confidentiality of Instruction 290 New Specialty Code for Pharmacy Non—Physician Practitioner/Supplier 745 Issued to a specific audience, not posted to Internet/Intranet due to Specialty Codes Confidentiality of Instruction 291 Notice of New Interest Rate for Medicare Overpayments and Underpayments 746 Issued to a specific audience, not posted to Internet/Intranet due to —4th Qtr Notification for FY 2017 Confidentiality of Instruction 292 Revision to Publication 100—06, Chapter 3, Medicare Overpayment Manual, Section 200, Limitation on Recoupment 37 Issued to a specific audience, not posted to Internet/Intranet due to Section 935 of the Medicare Modernization Act (MMA) — Limitation on Confidentiality of Instruction Recoupment Overpayments 38 Issued to a specific audience, not posted to Internet/Intranet due to Limitation on Recoupment Section 935(f)(2) Eligibility Confidentiality of Instruction Overpayments Subject to Limitation on Recoupment 39 Updates to Pub. 100—09, Chapter 6 Beneficiary and Provider Communications Overpayments Not Subject to Limitation on Recoupment Adjustment of the Manual, Chapter 6, Provider Customer Service Program Provider Claims Fee—For—Service Claims Payment Alerts The Rebuttal Process and the Limitation on Recoupment Extrapolated 935 Overpayments Medicare Secondary Payer (MSP) Provider Duplicate Primary Payment (DPP) Immediate Recoupment Requirements for 935 Overpayments Requirements for All Initial Demand Letters (Manual or Electronic) Initial Demand 293 Revision to Publication 100—06, Chapter 3. Medicare Overpayment Manual, Section 200, Limitation on Recoupment Revisions to the State Operations Manual (SOM) Appendix A — Survey Protocol, Regulations and Interpretive Guidelines for Hospitals 733 CIarlflcéfion of Certificate of Medical Necessity (CMN) and Durable Medical Equipment Information Forms (DIFs) 734 Update to Reporting Requirements Reconsideration Requests — Non—certified Providers/Suppliers External Reporting Requirements 735 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 736 Issued to a specific audience, not posted to Internet/Intranet due to

1869 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 13 IOM 100—17 Update of Instruction Additional Requirements for MACs 1870 Correcting Payment of Inpatient Prospective Payment System (IPPS) Transfer CMS Contracting Officer‘s Representative (COR) Claims Assigned to Medicare Severity—Diagnosis Related Group (MS DRG) Principal Systems Security Officer (SSO 385 and Allowing Part A Deductible on Medicare Secondary Payer (MSP) CMS Business Owners Same Day Transfer Inpatient Claims CMS System Maintainers/Developers 1871 FISS Process Enhancements — Analysis Only samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq Personnel Security/Suilability 1872 Common Working File (CWF) to Add User Identification (ID) Information to Control Components CWF Provider Queries Audit File(s) Reporting Requirements 1873 Line Level versus Claim Level Reporting — Analysis Only System Security Plan (SSP) 1874 Implementation CR: Integrating NLR into the HQR system Risk Assessment (RA) 1875 ICD—10 Coding Revisions to National Coverage Determinations (NCDs) Contingency Planning 1876 Modifications to the National Coordination of Benefits Agreement (COBA) Compliance Crossover Process Annual FISMA Assessment (FA) 1877 Common Working File (CWEF) to Modify CWF Provider Queries to Only Plan of Action and Milestones (POA&M) Accept National Provider Identifier (NPI) as valid Provider Number Background 1878 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity POA&M Package Components/Submission Format Instruction Security Incident Reporting and Response 1879 Common Working File (CWF) to Increase the Next Eligible Date Authorization To Operate Occurrences for Preventive Services to 99 Occurrences — Analysis Patch Management 1880 Shared Savings Program (SSP) Demonstration Code 77 Modification Security Configuration Management 1881 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Security Technical Implementation Guides (STIG of Instruction End of Life Technology Components Cloud Computing 1882 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Minimum System Security Requirements—HIGH of Instruction Encryption Requirements for Data Leaving Data Centers 1883 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Internet Security ofInstruction 1884 Analysis Only— Medicare Reporting on the Return of Self—Identified 176 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Overpayments of Instruction 1885 Shared System Maintainers (SSMs) Standardized Release Identification (ID) 177 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Format Analysis and Design of Instruction 1886 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 178 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction of Instruction 1887 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration 179 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Projects Within the Common Working File (CWEF) of Instruction 1888 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction 1864 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1889 Implementation of the Transitional Drug Add—On Payment Adjustment of Instruction 1890 CICS Region Merge(s) for A/B MACs — Analysis Only 1865 Health Insurance Portability and Accountability Act (HIPAA) Electronic Data 1891 Automating the HCPCS Load Process Interchange (EDI) Front End Updates for January 2018 1892 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration 1866 National Provider Identification Crosswalk System (NPICS) Retirement Projects within the Fiscal Intermediary Shared System Analysis Only — Engage Shared Systems Maintainers (SSMs) and Medicare 1893 Combined Common Edits/Enhancements Module (CCEM) Updates to Administrative Contractors (MACs) in Meetings and Correspondence Related Business and Holiday Tables to the NPICS Retirement with the Integrated Data Repository (IDR) Team 1894 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1867 Renovate MCS Correspondence Entry Driver Program H99P1COO of Instruction 1868 Fee For Service (FFS) Applications Upgrade Customer Information Control 1895 System Changes to Implement Section 15010 of the 21st Century Cures Act, System (CICS) to Transaction Server (TS) v5.2 Temporary Exception for Certain Severe Wound Discharges from Certain Long—Term Care Hospitals (LTCHs) STB6FP

9286F 1896 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration 1918 Correcting Payment of Inpatient Prospective Payment System (IPPS) Transfer Projects within the Fiscal Intermediary Shared System — Claims Assigned to Medicare Severity—Diagnosis Related Group (MS DRG) (Removing/Archiving demonstration codes 03, 04 and 15) 385 and Allowing Part A Deductible on Medicare Secondary Payer (MSP) 1897 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Same Day Transfer Inpatient Claims of Instruction 1919 Targeted Probe and Educate 1898 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1920 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction of Instruction samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq 1899 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1921 Implementation of Section 1557 for Medicare Redetermination Notices of Instruction (MRNs) by Adding a Notice and Tagline Sheet 1900 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 1922 Shared System Enhancement 2014: Implementation of Fiscal Intermediary of Instruction Shared System (FISS) Obsolete Financial and Expert Claims Processing 1901 Automating the HCPCS Load Process System (ECPS) Reports 1902 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivily 1923 Calculating Interim Rates for Graduate Medical Education (GME) Payments of Instruction to New Teaching Hospitals 1903 Implement Changes to Effect the Functionality of Combination Force Codes 1924 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity in the ViPS Medicare System (VMS) of Instruction 1904 Multi—Carrier System (MCS), Fiscal Intermediary Shared System (FISS) and 1925 Guidance on Implementing System Edits for Certain Durable Medical VIPS Medicare Shared System (VMS) Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Automation of Prior Authorization (PA) Requests/Pre—Claim Reviews (PCR) 1926 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity and their Responses with Multiple Services (for programs like Home Health of Instruction (HH)) via the Electronic Submission of Medical Documentation (esMD) 1927 Shared System Enhancement 2014; Implementation of Fiscal Intermediary System Shared System (FISS) Obsolete Core Reports 1905 Modify VMS Accreditation Logic to Accept Additional Modifiers t 1906 Out—of—Jurisdiction Providers (OJP) and Qualified Chain Providers (QCP) 367 Fiscal Year 2018 and After Payments to Skilled Nursing Facilities (SNFs) Move to Correct A/B MAC Jurisdiction — Analysis CR Only That Do Not Submit Required Quality Data 1907 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivily 368 Issued to a specific audience, not posted to Internet/Intranet due to of Instruction Confidentiality of Instruction 1908 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 369 Issued to a specific audience, not posted to Internet/Intranet due to of Instruction Confidentiality of Instruction 1909 Implementation of Section 1557 for Medicare Redetermination Notices (MRNs) by Adding a Notice and Tagline Sheet 3 Issued to a specific audience, not posted to Internet/Intranet due to 1910 Guidance on Implementing System Edits for Certain Durable Medical Confidentiality of Instruction Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) }gi ; ESIE}LBgeE;LL‘ne Expansion— Common Working File (CWE) ancement Required for Implementation of Overpayment based . Addendum II: Regulation . Documents Published Denials in the Federal Register (July through September 2017) 1913 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Regulations and Notices of Instruction Regulations and notices are published in the daily Federal 1914 Shared System Enhancement 2014 — Identification of F1scz_11 Intermediary Register. To purchase individual copies or subscribe to the Federal Shared System (FISS) Obsolete On—Request Jobs — Analysis Only . ho nlgig 1915 Medicare Administrative Contractor (MAC) and Pricing, Data Analysis and RegISte.r’ .contact GPO at WWngo.gov/fdsys. WhCIl Qrdcnng individual Coding (PDAC) Contractor Implementation of the New Medicare Card copies, it is necessary to cite either the date of publication or the volume Project number and page number. 1916 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity The Federal Register is available as an online database thI'Ollgh of Instruction s s 1917 Shared System Enhancement 2014 — Identification ofFiscal Intermediary Access. The online database is updated by 6 a.m. each day the Standard System (FISS) Obsolete Reports — Analysis Only 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

asabaliauskas on DSKBBXCHB2PROD with NOTICES VerDate Sep<11>2014 following website http://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. 17:54 Oct 26, 2017 This information is available on our website at: Title NCDM Transmittal Issue Date Effective http://www. ems. govI quarterlyproviderupdates/downloads/Regs- Section Number Date National Coverage 3Q17QPU.pdf Determination Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices For questions or additional information, contact Terri Plumb 20.8.4 201 07/28/2017 01/18/2017 (NCD20.8.4): Leadless (410-786-4481 ). Pacemakers Jkt 244001 Addendum III: CMS Rulings Addendum V: FDA-Approved Category B Investigational Device (July through September 2017) Exemptions (IDEs) (July through September 2017) CMS Rulings are decisions of the Administrator that serve as Addendum V includes listings of the FDA-approved PO 00000 precedent final opinions and orders and statements of policy and investigational device exemption (IDE) numbers that the FDA assigns. The interpretation. They provide clarification and interpretation of complex or listings are organized according to the categories to which the devices are ambiguous provisions of the law or regulations relating to Medicare, assigned (that is, Category A or Category B), and identified by the IDE Frm 00047 Medicaid, Utilization and Quality Control Peer Review, private health number. For the purposes of this quarterly notice, we list only the specific insurance, and related matters. updates to the Category BIDEs as of the ending date of the period covered The rulings can be accessed at http://>vww.cms.govtKegmauons- by this notice and a contact person for questions or additional information. For questions or additional information, Fmt 4703 For questions or additional information, contact John Manlove (410-786- contact Tiffany Lafferty (410-786-7548). 6877). Under the Food, Drug, and Cosmetic Act (21 U.S. C. 360c) devices Addendum IV: Medicare National Coverage Determinations Sfmt 4725 fall into one of three classes. To assist CMS under this categorization (July through September 2017) process, the FDA assigns one of two categories to each FDA-approved Addendum IV includes completed national coverage investigational device exemption (IDE). Category A refers to experimental determinations (NCDs), or reconsiderations of completed NCDs, from the E:\FR\FM\27OCN1.SGM IDEs, and Category B refers to non-experimental IDEs. To obtain more quarter covered by this notice. Completed decisions are identified by the information about the classes or categories, please refer to the notice section of the NCD Manual (NCDM) in which the decision appears, the published in the April21, 1997 Federal Register (62 FR 19328). 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 IDE Device Start Date particular item or service is covered nationally under the Medicare Program BB17544 Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) TCR 07/03/2017 (title XVIII of the Act), but does not include a determination of the code, if alpha/beta and CD19 T-cell depletion PBSC; conditioning any, that is assigned to a particular covered item or service, or payment BB17595 CliniMACS® TCRaB/CD19 Combined Depletion System 08/09/2017 27OCN1 determination for a particular covered item or service. The entries below BB17601 Hemanext Red Blood Cell Processing System 08/16/2017 BB17615 The Tissue Genesis Icellator Cell Isolation System (Icellator) 08/17/2017 include information concerning completed decisions, as well as sections on G140210 LABS ADHESION BARRIER 09/01/2017 program and decision memoranda, which also announce decisions or, in G170039 Vas Q Device 08/01/2017 some cases, explain why it was not appropriate to issue an NCD. Gl70063 V ercise PC Deep Brain Stimulation System 07/21/2017 Information on completed decisions as well as pending decisions has also G170080 ZOLL Proteus Intravascular Temperature Management 07/20/2017 been posted on the CMS website. For the purposes of this quarterly notice, (IVTM) System G170086 AGNES 07/21/2017 we are providing only the specific updates that have occurred in the 3- G170104 Eximo Medical B-Laser Hybrid Atherectomy System 07/1112017 month period. This information is available at: www.cms.gov/medicare- Gl70106 En do Rotor 08/25/2017 G170113 Coherex WaveCrest Left Atrial Appendage Occlusion System 09/08/2017 49827 EN27OC17.009</GPH>

8286F IDE Device Start Date IDE Device Start Date 6170122 DCB Drug Coated Balloon Catheter 08/24/2017 Dual ISH DNA Probe Cocktail IUO Assay 6170123 Medrobotics Flex System 07/28/2017 G170136 The Sprinter Over—the—Wire Semicompliant Balloon 08/22/2017 Addendum VI; Approval Numbers for Collections of Information Dilatation Catheter 6170145 novottf—200A 08/11/2017 (July through September 2017) 6170149 SPRINT PNS System 07/03/2017 All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq G170151 Bovie Ultimate Electrosurgical Generator; Bovie Ultimate 07/13/2017 Electrosurgical Generator; Bovie J—Plasma Precise Open assigned OMB control numbers. A single control number may apply to handpieces; Bovie J—Plasma Precise Open handpieces several related information collections. This information is available at 6170153 JUVEDERM YOLUMA XC with cannula 07/12/2017 6170154 Randomized Trial of ITybrid Coronary Revascularization 07/14/2017 www.reginfo. gov/public/do/PRAMain. For questions or additional versus Percutaneous Coronary Intervention information, contact William Parham (410—786—4669). 6170157 Theranova 400 Dialyzer 07/14/2017 G170160 Exablate Model 4000 Type—2 for Blood—Brain Barrier 09/29/2017 Addendum VII; Medicare—Approved Carotid Stent Facilities, Disruption (BBBD) (July through September 2017) G170161 Chronic Venous Thrombosis: Relief with Adjunctive 07/21/2017 Catheter—Directed Therapy (C—TRACT) Trial Addendum VII includes listings of Medicare—approved carotid G170162 Clotbust ER (Sonolysis Headframe System) Model 3.0C 09/17/2017 stent facilities. All facilities listed meet CMS standards for performing 6170164 BOND MSLN (5B2) assay 07/20/2017 carotid artery stenting for high risk patients. On March 17, 2005, we issued 6170166 PASCAL Transcatheter Mitral Valve Repair System 07/25/2017 our decision memorandum on carotid artery stenting. We determined that 6170169 DISCSS Spinal Cord SCS System 07/28/2017 carotid artery stenting with embolic protection is reasonable and necessary G170172 AcrySof IQ PanOptix Intraocular Lens 07/28/2017 6170173 LUM Imaging System 07/28/2017 only if performed in facilities that have been determined to be competent in 6170174 Cartiva Synthetic Cartilage Implant for CMC 08/03/2017 performing the evaluation, procedure, and follow—up necessary to ensure 6170175 AcrySof IQ Extended Depth of Focus (EDF) Intraocular Lens 08/02/2017 optimal patient outcomes. We have created a list of minimum standards for (IOL) facilities modeled in part on professional society statements on competency. 6170184 Orion Visual Cortical Prothesis System 08/16/2017 All facilities must at least meet our standards in order to receive coverage 6170185 NeuroStar TMS System 08/24/2017 G170191 LEFP Beta aDBS System 08/24/2017 for carotid artery stenting for high risk patients. For the purposes of this 6170192 BabyGentleStick 08/30/2017 quarterly notice, we are providing only the specific updates that have 6170193 TULA System 08/30/2017 occurred in the 3—month period. This information is available at: 6170194 Model 1000C Generator; Model 3000C Programmer 09/01/2017 http://www.cms. gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage 6170195 Oxiplex 08/31/2017 For questions or additional information, contact Sarah Fulton, MHS 6170196 Valiant PS—IDE Stent Graft System with Captiva Delivery 08/31/2017 System (410—786—2749). 6170197 LC Bead LUMI (BTG—004387) 08/31/2017 6170198 Exatherm TBH 08/23/2017 Facility Provider Effective State 6170200 The Bidirectional Neural Bypass System 08/31/2017 6170202 ProSpace System 09/07/2017 G170208 ExAblate Model 4000 Type—1 ("ExAblate Neuro") System 09/1 52017 | 1841231461 07/13/20 G170211 Belotero Balance Dermal Filler 09/15/2017 System 401 15th Ave SE Puyallup, WA 98372 6170212 NeuroStar Transcranial Magnetic Stimulation (TMS) Therapy 09/16/2017 UPMC Altoona 1649278730 07/18/2017 PA System 620 Howard Avenue Altoona, PA 16601—4899 G170221 FLExAbility Sensor Enabled Substrate Targeted Ablation for 09/29/2017 Chippenham and Johnston Willis Medical Center 490112 0§/15/2017 VA Reduction of VT (LESS—VT) Study 7101 Jahnke Road Richmond, VA 23225 6170222 Therasphere 09/27/2017 St. Helena Hospital — Napa Valley 050013 08/15/2017 CA 6170224 VENTANA HER2neu (4B5) IUO Assay; INFORM HER2 09/29/2017 10 Woodland Road St. Helena, CA 94574 Glens Falls Hospital 1871606764 08/15/2017 NY

Facility Provider Effective State A provider can use either of two mechanisms to satisfy the data Number Date reporting requirement. Patients may be enrolled either in an Investigational 100 Park Street Glens Falls, NY 12801 Memorial Hospital West 100281 08/15/2017 FL Device Exemption trial studying ICDs as identified by the FDA or in the 703 North Flamingo Road 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 ICD samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq FROM: Shands Hospital at the University of 100113 06/29/2005 FL registry. The entire list of facilities that participate in the ACC—NCDR ICD Florida TO:; UF Health Shands Hospital registry can be found at www.nedr.com/webnedr/common 1600 SW Archer Road For the purposes of this quarterly notice, we are providing only the Gainesville, FL 32610 specific updates that have occurred in the 3—month period. This information Poplar Bluff Regional Medical Center 260119 08/23/2005 MO is available by accessing our website and clicking on the link for the 3100 Oak Grove Road Poplar Bluff, MO 63901 American College of Cardiology‘s National Cardiovascular Data Mercy Hospital Joplin 260001 04/19/2005 MO Registry at: www.nedr.com/webnedr/common. For questions or additional 100 Merey Way information, contact Sarah Fulton, MHS (410—786—2749). Joplin, MO 64804—4524 Facilit Cit State Addendum VIII: American College of Cardiology‘s National Cardiovascular Data Gulf Pointe Surgery Center Port Charlotte FL Registry Sites (July through September 2017) Termination date: 9/22/17. See case 00368616. Addendum VIII includes a list of the American College of They no longer perform these procedures. Cardiology‘s National Cardiovascular Data Registry Sites. We cover Lake Area Medical Center Lake Charles LA implantable cardioverter defibrillators (ICDs) for certain clinical Termination date: 9/28/17. Please see case indications, as long as information about the procedures is reported to a 00363080. They would like to terminate CathPCI central registry. Detailed descriptions of the covered indications are and ICD because cardiology services at their available in the NCD. In January 2005, CMS established the ICD facility were discontinued effective 7/1/17. Abstraction Tool through the Quality Network Exchange (QNet) as a Doctor‘s Same Day Surgery Center Sarasota FL temporary data collection mechanism. On October 27, 2005, CMS Termination date: 9/20/17. See case 00368426. announced that the American College of Cardiology‘s National Providers no longer perform procedures. Cardiovascular Data Registry (ACC—NCDR) ICD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the Addendum IX: Active CMS Coverage—Related Guidance Documents ACC—NCDR ICD Registry by April 2006. (July through September 2017) Effective January 27, 2005, to obtain reimbursement, Medicare CMS issued a guidance document on November 20, 2014 titled NCD policy requires that providers implanting ICDs for primary prevention "Guidance for the Public, Industry, and CMS Staff: Coverage with clinical indications (that is, patients without a history of cardiac arrest or Evidence Development Document". Although CMS has several policy spontaneous arrhythmia) report data on each primary prevention ICD vehicles relating to evidence development activities including the procedure. Details of the clinical indications that are covered by Medicare investigational device exemption (IDE), the clinical trial policy, national and their respective data reporting requirements are available in the coverage determinations and local coverage determinations, this guidance Mcedicare NCD Manual, which is on the CMS website at document is principally intended to help the public understand CMS‘s http://www.cms. hhs. gov/Manuals/IOM/itemdetailasp"filterype=—none&filt implementation of coverage with evidence development (CED) through the erBy DID=99& sortByDID=1 & sortOrder=ascending& itemID=CMSO14961 national coverage determination process. The document is available at 6286F

OE86GFT http://www.cms.gov/medicare—coverage—database/details/medicare— October 1, 2003, we issued our decision memorandum on VADs for the coverage—document—details.aspx?MCDId=27. There are no additional clinical indication of destination therapy. We determined that VADs used Active CMS Coverage—Related Guidance Documents for the 3—month as destination therapy are reasonable and necessary only if performed in period. For questions or additional information, contact facilities that have been determined to have the experience and JoAnna Baldwin, MS (410—786—7205). infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq 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 (July through September 2017) For the purposes of this quarterly notice, we are providing only the There were no special one—time notices regarding national specific updates to the list of Medicare—approved facilities that meet our coverage provisions published in the 3—month period. This information is standards that have occurred in the 3—month period. This information is available at www.cms. hhs.gov/coverage. For questions or additional available at information, contact JoAnna Baldwin, MS (410—786 7205). http://www.cms. gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. For questions or additional information, contact Linda Gousis, JD, Addendum XI: National Oncologic PET Registry (NOPR) (410—786—8616). (July through September 2017) Addendum XI includes a listing of National Oncologic Positron Facility Provider Date Approved State Emission Tomography Registry (NOPR) sites. We cover positron emission Number tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. 330 Brookline Avenue In January 2005, we issued our decision memorandum on positron Boston, MA 02215 emission tomography (PET) scans, which stated that CMS would cover Mission Hospital 34—0002 06/09/2016 NC 509 Biltmore Avenue PET scans for particular oncologic indications, as long as they were Asheville, NC 28801—4690 performed in the context of a clinical study. We have since recognized the University Health Care System 110028 08/16/2017 GA National Oncologic PET Registry as one of these clinical studies. 1350 Walton Way Augusta, GA 30901 Therefore, in order for a beneficiary to receive a Medicare—covered PET Baystate Medical Center 22—0077 08/07/2017 MA 759 Chestnut Street scan, the beneficiary must receive the scan in a facility that participates in Springfield. MA 01199 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/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410—786—8564). Addendum XII:; Medicare—Approved Ventricular Assist Device (Destination Therapy) Facilities (July through September 2017) Addendum XI 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

Provider Date Approved Number resno Community Hospital an Medical Center Addendum XIV: Medicare—Approved Bariatric Surgery Facilities samIonN/i1I0Z ‘4Z 1990190 ‘Aepuq/z0Z ‘ON ‘ZG@ ‘TOA/JemstSay je1apaq 2823 Fresno Street (July through September 2017) Fresno, CA 93721 Addendum XIV includes a listing of Medicare—approved facilities Maine Medical Center 200009 09/28/2016 TX 22 Brambhall Street that meet minimum standards for facilities modeled in part on professional Portland, ME 04102 society statements on competency. All facilities must meet our standards in Hackensack University Medical Center 310001 09/20/2017 NJ order to receive coverage for bariatric surgery procedures. On February 21, 30 Prospect Avenue 2006, we issued our decision memorandum on bariatric surgery procedures. Hackensack, NJ 07601 We determined that bariatric surgical procedures are reasonable and FROM : Banner Good Samaritan 030002 07/26/2017 AZ Medical Center necessary for Medicare beneficiaries who have a body—mass index (BMI) TO: Banner — University Medical greater than or equal to 35, have at least one co—morbidity related to obesity Center Phoenix and have been previously unsuccessful with medical treatment for obesity. 1111 East McDowell Road This decision also stipulated that covered bariatric surgery procedures are Phoenix. AZ 85006 reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Addendum XIII:; Lung Volume Reduction Surgery (LVRS) Surgery Center (program standards and requirements in effect on February (July through September 2017) 15, 2006); or (2) certified by the American Society for Bariatric Surgery Addendum XIII includes a listing of Medicare—approved facilities (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program that are eligible to receive coverage for lung volume reduction surgery. standards and requirements in effect on February 15, 2006). Until May 17, 2007, facilities that participated in the National Emphysema There were no additions, deletions, or editorial changes to Treatment Trial were also eligible to receive coverage. The following three Medicare—approved facilities that meet CMS‘s minimum facility standards types of facilities are eligible for reimbursement for Lung Volume for bariatric surgery that have been certified by ACS and/or ASMBS in the Reduction Surgery (LVRS): 3—month period. This information is available at e National Emphysema Treatment Trial (NETT) approved (Beginning www.cms. gov/MedicarcApprovedFacilitic/BSF/list.asp#TopOfPage. For 05/07/2007, these will no longer automatically qualify and can qualify only questions or additional information, contact Sarah Fulton, MHS with the other programs); (410—786—2749). e Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation of Healthcare Organizations (JCAHO)) under Addendum XV: FDG—PET for Dementia and Neurodegenerative their Disease Specific Certification Program for LVRS; and Diseases Clinical Trials (July through September 2017) e Medicare approved for lung transplants. There were no FDG—PET for Dementia and Neurodegenerative Onlythe first two types are in the list. There were no updates to Diseases Clinical Trials published in the 3—month period. the listing of facilities for lung volume reduction surgery published in the This information is available on our website at 3—month period. This information is available at www.cms. gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. www .cms. gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage. For For questions or additional information, contact Stuart Caplan, RN, MAS questions or additional information, contact Sarah Fulton, MHS (410—786—8564). (410—786—2749). IE86GFT

49832 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices [FR Doc. 2017–23447 Filed 10–26–17; 8:45 am] www.regulations.gov will be posted to the claimed confidential information, in BILLING CODE 4120–01–C the docket unchanged. Because your its consideration of comments. The comment will be made public, you are second copy, which will have the solely responsible for ensuring that your claimed confidential information DEPARTMENT OF HEALTH AND comment does not include any redacted/blacked out, will be available HUMAN SERVICES confidential information that you or a for public viewing and posted on third party may not wish to be posted, https://www.regulations.gov. Submit Food and Drug Administration such as medical information, your or both copies to the Dockets Management [Docket No. FDA–2014–N–1076] anyone else’s Social Security number, or Staff. If you do not wish your name and confidential business information, such contact information to be made publicly Agency Information Collection as a manufacturing process. Please note available, you can provide this Activities; Proposed Collection; that if you include your name, contact information on the cover sheet and not Comment Request; Guidance for information, or other information that in the body of your comments and you Industry on Formal Dispute identifies you in the body of your must identify this information as Resolution: Scientific and Technical comments, that information will be ‘‘confidential.’’ Any information marked Issues Related to Pharmaceutical posted on https://www.regulations.gov. as ‘‘confidential’’ will not be disclosed Current Good Manufacturing Practice • If you want to submit a comment except in accordance with 21 CFR 10.20 with confidential information that you and other applicable disclosure law. For AGENCY: Food and Drug Administration, do not wish to be made available to the more information about FDA’s posting HHS. public, submit the comment as a of comments to public dockets, see 80 ACTION: Notice. written/paper submission and in the FR 56469, September 18, 2015, or access manner detailed (see ‘‘Written/Paper the information at: https://www.gpo.gov/ SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’). fdsys/pkg/FR-2015-09-18/pdf/2015- Administration (FDA or Agency) is announcing an opportunity for public Written/Paper Submissions 23389.pdf. comment on the proposed collection of Docket: For access to the docket to Submit written/paper submissions as read background documents or the certain information by the Agency. follows: electronic and written/paper comments Under the Paperwork Reduction Act of • Mail/Hand delivery/Courier (for received, go to https:// 1995 (PRA), Federal Agencies are written/paper submissions): Dockets required to publish notice in the www.regulations.gov and insert the Management Staff (HFA–305), Food and docket number, found in brackets in the Federal Register concerning each Drug Administration, 5630 Fishers proposed collection of information, heading of this document, into the Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts including each proposed extension of an • For written/paper comments existing collection of information, and and/or go to the Dockets Management submitted to the Dockets Management to allow 60 days for public comment in Staff, FDA will post your comment, as Staff, 5630 Fishers Lane, Rm. 1061, response to the notice. This notice well as any attachments, except for Rockville, MD 20852. solicits comments on the information information submitted, marked and FOR FURTHER INFORMATION CONTACT: collection in the guidance on ‘‘Formal identified, as confidential, if submitted Domini Bean, Office of Operations, Dispute Resolution: Scientific and as detailed in ‘‘Instructions.’’ Food and Drug Administration, Three Technical Issues Related to Instructions: All submissions received White Flint North, 10A–12M, 11601 Pharmaceutical Current Good must include the Docket No. FDA– Landsdown St., North Bethesda, MD Manufacturing Practice.’’ 2014–N–1076 for ‘‘Agency Information 20852, 301–796–5733, PRAStaff@ DATES: Submit either electronic or Collection Activities; Proposed fda.hhs.gov. written comments on the collection of Collection; Comment Request; Guidance SUPPLEMENTARY INFORMATION: Under the information by December 26, 2017. for Industry on Formal Dispute PRA (44 U.S.C. 3501–3520), Federal ADDRESSES: You may submit comments Resolution: Scientific and Technical Agencies must obtain approval from the as follows. Please note that late, Issues Related to Pharmaceutical Office of Management and Budget untimely filed comments will not be Current Good Manufacturing Practice.’’ (OMB) for each collection of considered. Electronic comments must Received comments, those filed in a information they conduct or sponsor. be submitted on or before December 26, timely manner (see ADDRESSES), will be ‘‘Collection of information’’ is defined 2017. The https://www.regulations.gov placed in the docket and, except for in 44 U.S.C. 3502(3) and 5 CFR electronic filing system will accept those submitted as ‘‘Confidential 1320.3(c) and includes Agency requests comments until midnight Eastern Time Submissions,’’ publicly viewable at or requirements that members of the at the end of December 26, 2017. https://www.regulations.gov or at the public submit reports, keep records, or Comments received by mail/hand Dockets Management Staff between 9 provide information to a third party. delivery/courier (for written/paper a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44 submissions) will be considered timely Friday. U.S.C. 3506(c)(2)(A)) requires Federal if they are postmarked or the delivery • Confidential Submissions—To Agencies to provide a 60-day notice in service acceptance receipt is on or submit a comment with confidential the Federal Register concerning each before that date. information that you do not wish to be proposed collection of information, asabaliauskas on DSKBBXCHB2PROD with NOTICES made publicly available, submit your including each proposed extension of an Electronic Submissions comments only as a written/paper existing collection of information, Submit electronic comments in the submission. You should submit two before submitting the collection to OMB following way: copies total. One copy will include the for approval. To comply with this • Federal eRulemaking Portal: information you claim to be confidential requirement, FDA is publishing notice https://www.regulations.gov. Follow the with a heading or cover note that states of the proposed collection of instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS information set forth in this document. Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The With respect to the following including attachments, to https:// Agency will review this copy, including collection of information, FDA invites VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1


Document Created: 2017-10-27 02:06:18
Document Modified: 2017-10-27 02:06:18
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. BILLING CODE 4120-01-P [GRAPHIC] [TIFF OMITTED] TN27OC17.002
FR Citation82 FR 49819 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR