Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2017, 49819-49832 [2017-23447]

Download as PDF Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 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 VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 TJC revised its survey policy and procedure to clearly delineate that a survey will not occur until after the applicable Regional Office has made a determination of the CAH’s compliance with location and distance requirements. B. Term of Approval Based on our review and observations described in section III of this final notice, we have determined that TJC’s CAH program requirements meet or exceed our requirements, and its survey processes are comparable to ours. Therefore, we approve TJC as a national accreditation organization for critical access hospitals that request participation in the Medicare program, effective November 21, 2017 through November 21, 2023. V. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Dated: October 16, 2017. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. 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 Centers for Medicare & Medicaid Services (CMS), HHS. AGENCY: ACTION: Notice. 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. SUMMARY: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. FOR FURTHER INFORMATION CONTACT: BILLING CODE 4120–01–P [FR Doc. 2017–23449 Filed 10–26–17; 8:45 am] BILLING CODE 4120–01–P 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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 E:\FR\FM\27OCN1.SGM 27OCN1 EN27OC17.002</GPH> asabaliauskas on DSKBBXCHB2PROD with NOTICES crosswalk to include comparable standards to require disclosure of the names and addresses of the facility’s owners, or those with a controlling interest in the CAH or in any subcontractor in which the CAH directly or indirectly has a 5 percent or more ownership interest. • Section 485.645(a)(2): Updated its crosswalk to include the correct regulatory language to require that the facility limits inpatient beds to no more than 25 and is verified on all surveys. • Section 488.5(a)(4)(vii): Updated its policies and review process to ensure that approved plans of correction fully address all non-compliant practices identified during the survey; that appropriate policy changes have been made to ensure compliance; and that plans of correction identify the responsible party for ensuring corrective actions are implemented within the CAH and contain a description of how the CAH will monitor and evaluate the effectiveness of the corrective actions, analyze the data, and report findings to the senior leadership and governing body to ensure continued regulatory compliance. • Section 488.5(a)(12): Provided CMS with assurance that its procedures for responding to, and investigating complaints against accredited facilities are fully implemented and followed. • Section 488.26(b): Revised surveyor documentation to include appropriately detailed deficiency statements that clearly support the determination of noncompliance and appropriate level of deficiency. 49819 49820 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 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. asabaliauskas on DSKBBXCHB2PROD with NOTICES II. Format for the Quarterly Issuance Notices This quarterly notice provides only the specific updates that have occurred VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 assessing a Web site proves to be difficult, the contact person listed can provide information. III. How To Use the Notice This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at https:// www.cms.gov/manuals. Dated: October 20, 2017. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\27OCN1.SGM 27OCN1 asabaliauskas on DSKBBXCHB2PROD with NOTICES VerDate Sep<11>2014 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (July through September 2017) The CMS Manual System is used by CMS program components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System Sfmt 4725 E:\FR\FM\27OCN1.SGM 27OCN1 How to Obtain Manuals The lnlemel-only Manuals (IOMs) are a replica of lhe Agency's official record copy. Paper-based manuals are CMS manuals lhal were officially released in hardcopy. The majority of these manuals were tmnsferred into the Intemet-only manual (10M) or retired. Pub 15-1, Pub 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the 10M, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: https://cms.gov/manuals. How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, govemment publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at https://www.gpo.gov/libraries/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal govemment publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, usc the CMS publication and transmittal numbers. For example, to find the manual for Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure to Procedure (PTP) Edits, Version 23.3, Effective October 1, 2017 use (CMS-Pub. 100-04) Transmittal No. 3807. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject nmnber. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use infonnation in a transmittal in conjunction with information currently in the manual. For tl1e purposes of tllis quarterly notice, we list only the specific updates to tl1e list of manual instructions lhal have occurred in lhe 3-monlh period. This information is available on our website at www.cms.gov/Manuals. Transmittal Number ~:':.· ~r:;:.;.:J~'~iiS'·r. 106 107 r\c:;;~,;::;'r;~. Manual/Subject/Publication Number ~~!S;tJ:'ii,';{;!}i.fl;i~~ Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Affordable Care Act Bundled Payments for Care Improvement Initiative Recurring File Updates Models 2 and 4 January 2018 Updates ,;z f<'1( }'c;;[;;; ;)!,. None ~;c.l~i"~l~rc 199 200 201 1 fifull\etv~·.Y~tf6"\;'fii£':tY Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS)(Various Effective Dates Below) (Rev.) Percutaneous Image-guided I .umhar Decompression (PIT .D) for I .umhar Spinal Stenosis (LSS) Spinal Stenosis (LSS)(Various Effective Dates Below) National Coverage Determination (NCD20.8.4): Leadless Pacemakers Leadless Pacemakers Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 Publication Dates for the Previous Four Quarterly Notices We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: November 2016 (81 FR 79489, February 23, 2017 (82 FR 11456), May 5, 2017 (82 FR 21241) and August 4, 2017 (82 FR 36404). We are providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional information. 49821 EN27OC17.003</GPH> asabaliauskas on DSKBBXCHB2PROD with NOTICES 49822 VerDate Sep<11>2014 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\27OCN1.SGM 27OCN1 Updates to Pub. 100-04, Chapter 18 Preventive and Screening Services and Chapter 32 Billing Requirements for Special Services and Publication 100-03, Chapter I Coverage Determinations Part 4 . c2J:iic ~;;J~::!t£~'C~~;::z;{cf't r;;~":.Z4t!~ ~,~,;~;;; ;?;;_. 3805 Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) Claims Processing Requirements for Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) on Professional Claims Issued to a specific audience, not posted to Intemet/Intranet due to 3806 Confidentiality of Instmction 3807 Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure lo Procedure (PTP) Edils, Version 23.3, EITeclive Oclober 1, 2017 3808 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction October 2017 Quarterly Average Sales Price (ASP) Medicare Part B Dmg 3809 Pricing Files and Revisions to Prior Quarterly Pricing Files Issued to a specific audience, not posted to Intemet/Intranet due to 3810 Confidenlialily oflnslruclion 3811 Percutaneous Image-guided Lumbar Decompression (PILU) for Lumbar Spinal Stenosis (LSS) 3812 New Waived Tests 3813 Accepting Hospice Notices of Election via Electronic Data Interchange Procedures for Ilospice Election and Related Transactions Kotice of Election (NOE) J\otice of Termination/Revocation (NOTR) Change of Provider/Transfer Notice Cancellation of an Election Change of Ownership Notice Data Required on the Institutional Claim to AlB MAC (HHH) Independent Attending Physician Services 3814 Updated Editing of Always Therapy Services- MCS Claims Processing Requirements for Financial Limitations National Coverage Determination (NCD20.8.4): Leadless Pacemakers 3815 T.eadless Pacemaker Leadless Pacemaker Coding and Billing Requirements for Professional Claims Leadless Pacemaker Place of Service Reslriclions Leadless Pacemaker Modifier Leadless Pacemaker Additional Claim of Billing Information Leadless Pacemaker Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Medicare Summary Notice (MSN) Messages 3816 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction 3817 Issued to a specitlc audience, not posted to Intemet/Intranet due to Sensitivity of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to 3818 Confidentiality of Instmction 3819 3820 3821 3822 3823 3824 3825 3826 3827 3828 3829 3830 3831 Issued to a specific audience, not posted to Intemet/Intranet due to Contldentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Contldentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction July Quarterly Update for 2017 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Pee Schedule October Quarterly Update to 2017 Annual Update ofHCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Entorcement Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Fiscal Year (FY) Annual Update Quarterly Influenza Vims Vaccine Code Update- January 2018 Table of Preventive and Screening Services Healthcare Common Procedure Coding System (HCPCS) and Diagnosis Codes CWF Edits on AlB MAC (A) Claims CWF Edits on AlB MAC (B) Claims CWF Crossover Edits for AlB MAC (B) Claims Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY 2017 Revisions to the Home Health Pricer to Support Value-Based Purchasing and Payment Standardization Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Screening for Hepatitis B Vims (HBV) Inslilulional Billing Requiremenls Professional Billing Requirements Diagnosis Code Reporting Requirements Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Crt"oup Codes, and Medicare Summary Notice (MS"\1) Messages 3832 3833 1814 3835 Fiscal Year (FY) 2017 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes Quarterly Update to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Issued to a specific audience, not posted to Tntemet/Tntranet due to Confidentiality of Instmction Screening for the Human Immunodeficiency Vims (HIV) Infection Healthcare Common Procedure Coding System (HCPCS) for HIV Screening Tests Billing Requirements Payment Method Types of Bill (TOEs) and Revenue Codes Diagnosis Code Reporting Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 EN27OC17.004</GPH> 202 asabaliauskas on DSKBBXCHB2PROD with NOTICES VerDate Sep<11>2014 3838 Jkt 244001 3839 3840 3841 PO 00000 3842 Frm 00043 3843 Fmt 4703 3845 Sfmt 4725 3847 3844 3846 3848 E:\FR\FM\27OCN1.SGM 3849 3850 3851 3852 27OCN1 3853 3854 3855 3856 3857 Fiscal Year (FY) 2018 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes October Quarterly Update for 2017 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule Instructions for Downloading the Medicare ZIP Code File for January 2018 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP)- January 2018 Annual Clotting Factor Furnishing Fee Update 2018 Clotting Factor Furnishing Fee (Chapter 17- Drugs and Biologicals 80.4.1) Updated Editing of Always Therapy Services- MCS Claims Processing Requirements for Financial Limitations October 2017 Update of the Hospital Outpatient Prospective Payment System (OPPS) Instructions for Retrieving the 2018 Pricing and HCPCS Data Files through CMS' Mainframe Telecommunications Systems Accepting Hospice Notices of Election via Electronic Data Interchange Procedures for Hospice Election and Related Transactions Kotice of Election (NO I:) Kotice of Termination/Revocation (NOTR) Change of Provider/Transfer Notice Cancellation of an Election Change of Ownership Notice Data Required on the Institutional Claim to AIR MAC (HHH Independent Attending Physician Services New Waived Tests Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.0, Effective January I, 2018 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments Revisions to Medicare Claims Processing Manual for Foreign, Emergency and Shipboard Claims 3858 3859 3860 3861 3862 3863 3864 3865 3866 3867 3868 3869 3870 3871 !/t!Fi'i?c;;[;J/~t:Li! 120 :!f,;/i::·~i 288 .• i''if;;!f. c;,,{:k"f;:c;J!:{'~'''" .:;;.c.;; Electronic Correspondence Referral System (ECRS) User Guide Medicare Beneficiary Identifier (MBI) Modifications including Updated Enterprise Identity Management (EIDM) Multi-Factor Authentication (MFA)/Remote Identity Proofing (RIDP) Screen Shots ECRS Web User Guide ECRS Quick Reference Card ;;; ;;.?;}3'::?.. ;iq j .::;!i·•J%~7,;:r<r,.:~;;" ~ Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 3836 1817 Medicare Summary Notice (MSN) and Claim Adjustment Reason Codes (CARCs) Home Health Value-Based Purchasing Implementation Influenza Vaccine Payment Allowances- Annual Update for 2017-2018 Season Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - October 2017 Update Claim Status Category and Claim Status Codes Update Common Edits and Enhancements Modules (CEM) Code Set Update Implement Operating Rules- Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): CORE 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule- Update from Council for Affordable Quality Healthcare (CAQH) Committee on Operating Rules for Information Exchange (CORE) Health care Provider Taxonomy Codes (HPTCs) October 2017 Code Set Update 2018 Healthcare Common Procedure Coding System (HCPCS) Annual Update Reminder Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Updates to Pub. I 00-04, Chapter 18 Preventive and Screening Services and Chapter 32 Billing Requirements for Special Services and Publication 100-03, Chapter I Coverage Determinations Part 4 Inpatient Rehabilitation facility (IRI') Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2018 Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - October 2017 Update File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions October 2017 Integrated Outpatient Code Editor (I!OCE) Specifications Version 18.3 October 2017 Update of the Hospital Outpatient Prospective Payment System (OPPS) October 2017 Update of the Ambulatory Surgical Center (ASC) Payment System Internet Only Manual (!OM) Update to Pub. 100-04, Chapter 15Ambulance, to Restore Multiple Patients on One Trip Instmctions Clarification of the Billing of Immunosuppressive Drugs Billing for Immunosuppressive Dmgs 2018 Annual Update ofHealthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Update Pub. I 00-6, Chapter 3 and 4 Revisions Detern1ining Liability and Waiver of Recovery for Overpayments Determination- Limitation of Liability Determination Determination- Waiver of Recovery of an Overpayment Overpayments Discovered Subsequent to the Third Year How to Determine the Third Calendar Year After the Payment was 49823 EN27OC17.005</GPH> asabaliauskas on DSKBBXCHB2PROD with NOTICES 49824 VerDate Sep<11>2014 Jkt 244001 PO 00000 Frm 00044 290 291 Fmt 4703 292 Sfmt 4725 E:\FR\FM\27OCN1.SGM 293 27OCN1 Vi?:;f!,;Cc'iiffGfi 170 v;.::;: 733 734 735 736 EN27OC17.006</GPH> i''" :K';5 ,,:;;z&'Jc';lf::,r:?;,'fi7f/!c Clarification of Certificate of Medical Necessity (CMN) and Durable Medical Equipment Information Forms (DIFs) Update to Reporting Requirements Reconsideration Requests- Non-certified Providers/Suppliers External Reporting Requirements Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to 737 738 739 740 741 742 743 744 745 746 Confidentiality of Instruction Credentials of Reviewers Complex Medical Review Provider Error Rate Formula Provider Error Rate Issued to a specific audience, not posted to Confidentiality of Instruction Issued to a specific audience, not posted to Confidentiality of Instruction Issued to a specific audience, not posted to Confidentiality of Instruction Issued to a specific audience, not posted to Confidentiality of Instruction Issued to a specific audience, not posted to of Instruction Issued to a specific audience, not posted to Confidentiality of Instruction Issued to a specific audience, not posted to Confidentiality of Instruction Issued to a specific audience, not posted to Confidentiality of Instruction i7ik. Internet/Intranet due to Intemet/Intranet due to Intemet/Intranet due to Intemel/Intranel due to Intemet/Intranet due to Sensitivity Intemet/Intranet due to Intemet/Intranet due to Intemet/Intranet due to •r' 37 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Updates to Pub. 100-09, Chapter 6 Beneficiary and Provider Communications Manual, Chapter 6, Provider Customer Service Program Provider Claims Payment Alerts 38 39 ,., ,/ /Z;1i5;;; :~;!!:;~if;~;;fi&.• None ;;~;;, ~'f;;i;Y[; ; None f;;'fi' None if!~'.f.:C0:':;c(;'il'• ·"2•;!,£.;! None t 10; i"· :;, c;•/fi';i./;';t;;;~·s:,,.; Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 289 Approved Recovery of Overpayment Due to Cost Report Termination of Collection Action Termination of Collection Action- Provider Overpayments Termination of Collection Action- Beneficiary Overpayments Requirements for Collecting Part A and B Provider Non-MSP Overpayments Debt Ineligible for Referral Intent to Refer Letter Response to Intent to Refer Letter Intermediary Claims Accounts Receivable ( Debts RTA by Treasury as Dispute Response not Received Timely (RX) Debts RTA by Treasury as a Miscellaneous Dispute, a Manual RTA, Complaint or as Recall Approved (RD Intent to Refer Letter Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments -4th Qtr Notification for FY 2017 New Specialty Code for Pharmacy Non-Physician Practitioner/Supplier Specialty Codes Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments -4th Qtr Notification for FY 2017 Revision to Publication I 00-06, Chapter 3, Medicare Overpayment Manual, Section 200, Limitation on Recoupment Section 935 of the Medicare Modernization Act (MMA)- Limitation on Recoupment Overpayments Limitation on Recoupment Section 935(f)(2) Eligibility Overpayments Subject to Limitation on Recoupment Overpayments Not Subject to Limitation on Recoupment Adjustment of the Fee-For-Service Claims 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 Revision to Publication I 00-06, Chapter 3, Medicare Overpayment Manual, Section 200, Limitation on Recoupment · . ;;;c/<,:(;;~.;({ff/f;f'l;· .n..·M~~il1~-a:it:Uitt Revisions to the State Operations Manual (SOM) Appendix A- Survey Protocol, R Panl"tion' and TntPmrPtivP Guidelines for Hospitals asabaliauskas on DSKBBXCHB2PROD with NOTICES VerDate Sep<11>2014 VC?Y: 13 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\27OCN1.SGM 176 177 17S 179 ;;; ~£~ ;[ff& '!.('!?' Issued to a specific of Instruction Issued to a specific of Instruction Issued to a specific of Instruction Issued to a specific of Instruction 27OCN1 1865 1866 1867 1868 audience, not posted to Intemet/Intranet due to Sensitivity audience, not posted to Intemet/Intranet due to Sensitivity audience, not posted to Intemet/Intranet due to Sensitivity ·,;?:;:~;'Y~.;'~;';·~'t/~';';t · Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Health Insurance Portability and Accountability Act (HIP AA) Electronic Data Interchange (EDI) Front End Updates for January 2018 National Provider Identification Crosswalk System (NPICS) Retirement Analysis Only- Engage Shared Systems Maintainers (SSMs) and Medicare Administrative Contractors (MACs) in Meetings and Correspondence Related to the NPICS Retirement with the Integrated Data Repository (!DR) Team Renovate MCS Correspondence Entry Driver Program H99PlCOO Fee For Service (FFS) Applications Upgrade Customer Information Control System (CICS) to Transaction Server (TS) v5.2 t~~\if{\;f;~~;~;j'j ~; ;'i{~!;"f!i, 1864 f*1!;j{;t;f;f;;[$fgt'~;jYfJ5[J.:;;j;; ~iiE{~if, audience, not posted to Internet/Intranet due to Sensitivity 1869 1870 1871 1872 1873 1874 1875 1876 1877 1878 1879 1880 1881 1882 1883 1884 1885 1886 1887 1888 1889 1890 1891 1S92 1893 1894 1895 Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Correcting Payment oflnpatient Prospective Payment System (IPPS) Transfer Claims Assigned to 'v!edicare Severity-Diagnosis Related Group (MS DRG) 385 and Allowing Part A Deductible on Medicare Secondary Payer (MSP) Same Day Transfer Inpatient Claims FIS S Process Enhancements - Analysis Only Common Working File (CWF) to Add User Identification (!D) Information to CWF Provider Queries Audit File(s) Line Level versus Claim Level Reporting- Analysis Only Implementation CR: Integrating NLR into the HQR system ICD-10 Coding Revisions to National Coverage Determinations (NCDs) Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process Common Working File (CWF) to Modify CWF Provider Queries to Only Accept National Provider Identifier (NPI) as valid Provider Number Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity Instruction Conunon Working File (CWF) to Increase the Next Eligible Date Occurrences for Preventive Services to 99 Occurrences -Analysis Shared Savings Program (SSP) Demonstration Code 77 Modification Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity ofTnstruction Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Analysis Only- Medicare Reporting on the Retum of Self-Identified Overpayments Shared System Maintainers (SSMs) Standardized Release Identification (!D) Format Analysis and Design Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects Within the Collllllon Working File (CWF) Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction Implementation of the Transitional Drug Add-On Payment Adjustment CICS Region Merge(s) for AlB MACs- Analysis Only Automating the HCPCS Load Process Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects within the Fiscal Intermediary Shared System Combined Common Edits/Enhancements Module (CCEM) Cpdates to Business and Holiday Tables Issued to a specitlc audience, not posted to Intemet/ Intranet due to Sensitivity of Instruction System Changes to Implement Section 15010 of the 21st Century Cures Act, Temporary Exception for Certain Severe Wound Discharges from Certain Long-Term Care Hospitals (L TCHs) Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 I~',~''?;J;f;~? !Jf;;:;~·Ci4i ~~~S;;"~l;;C;j; !OM 100-17 Update Additional Requirements for MACs CMS Contracting Officer's Representative (COR) Principal Systems Security Officer (SSO CMS Business Owners CMS System Maintainers/Developers Personnel Security/Suitability Control Components Reporting Requirements System Security Plan (SSP) Risk Assessment (RA) Contingency Planning Compliance Annual FISMA Assessment (FA) Plan of Action and Milestones (POA&M) Background POA&M Package Components/Submission Format Security Incident Reporting and Response Authorization To Operate Patch Management Security Configuration Management Security Technical Implementation Guides (STIG End of Life Technology Components Cloud Computing Minimum System Security Requirements-HIGH Encryption Requirements for Data Leaving Data Centers Intemet Security 49825 EN27OC17.007</GPH> asabaliauskas on DSKBBXCHB2PROD with NOTICES 49826 VerDate Sep<11>2014 1896 1898 1899 Jkt 244001 1900 1901 1902 PO 00000 1903 1904 Frm 00046 Fmt 4703 1905 1906 Sfmt 4725 1907 E:\FR\FM\27OCN1.SGM 1909 1908 1910 1911 1912 1913 27OCN1 1914 1915 1916 1917 EN27OC17.008</GPH> 1918 1919 1920 1921 1922 1923 1924 1925 1926 1927 Correcting Payment of Inpatient Prospective Payment System (IPPS) Transfer Claims Assigned to .\i!edicare Severity-Diagnosis Related Group (MS DRG) 385 and Allowing Part A Deductible on Medicare Secondary Payer (MSP) Same Day Transfer Inpatient Claims Targeted Probe and Educate Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmction Implementation of Section 1557 for Medicare Redetermination Notices (MRNs) by Adding a Notice and Tagline Sheet Shared System Enhancement 2014: Implementation of Fiscal Intermediary Shared System (FTSS) Obsolete Financial and Expert Claims Processing System (ECPS) Reports Calculating Interim Rates for Graduate Medical Education (GME) Payments to New Teaching Hospitals Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Guidance on Implementing System Edits for Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity oflnstruclion Shared System Enhancement 2014: Implementation of Fiscal Intermediary Shared System (FISS) Obsolete Core Reports ;;;, cpiJt~L 367 368 369 ;;}J,1:3~5';; Fiscal Year 2018 and After Payments to Skilled Nursing Facilities (SNFs) That Do Kot Submit Required Quality Data Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction '~~,f~, .,,~?£::'. '"ih'"'/;;:;;': 3 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Addendum II: Regulation Documents Published in the Federal Register (July through September 2017) Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal Register, contact GPO at www.gpo.gov/fdsys. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at https://www.gpoaccess.gov/fr/. The Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 1897 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects within the Fiscal Intermediary Shared System (Removing/Archiving demonstration codes 03, 04 and 15) Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity ofTnstmction Automating the HCPCS Load Process Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Implement Changes to Effect the Functionality of Combination Force Codes in the YiPS Medicare System (VMS) Multi-Carrier System (MCS), Fiscal Intermediary Shared System (FISS) and VIPS Medicare Shared System (VMS) Automation of Prior Authorization (PA) Requests/Pre-Claim Reviews (PCR) and their Responses with Multiple Services (for programs like Home Health (HH)) via the Electronic Submission of Medical Documentation (esMD) System Modify VMS Accreditation Logic to Accept Additional Modifiers Out-of-Jurisdiction Providers (OJP) and Qualified Chain Providers (QCP) Move to Correct AlB MAC Jurisdiction - Analysis CR Only Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Implementation of Section 1557 for Medicare Redetermination Notices (MRNs) by Adding a Notice and Tagline Sheet Guidance on Implementing System Edits for Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Part B Detail Line Expansion- Common Working File (CWF) HIGLAS Enhancement Required for Implementation of Overpayment based Denials Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmction Shared System Enhancement 2014- Identification of Fiscal Intermediary Shared System (FISS) Obsolete On-Request Jobs- Analysis Only Medicare Administrative Contractor (MAC) and Pricing, Data Analysis and Coding (PDAC) Contractor Implementation of the New Medicare Card Project Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Shared System Enhancement 2014- Identification of Fiscal Intermediary Standard System (FISS) Obsolete Reports - Analysis Only asabaliauskas on DSKBBXCHB2PROD with NOTICES VerDate Sep<11>2014 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Addendum III: CMS Rulings (July through September 2017) CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. The rulings can be accessed at https://>vww.cms.govtKegmauonsFor questions or additional information, contact Tiffany Lafferty (410-786-7548). Sfmt 4725 E:\FR\FM\27OCN1.SGM 27OCN1 Addendum IV: Medicare National Coverage Determinations (July through September 2017) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda, which also announce decisions or, in some cases, explain why it was not appropriate to issue an NCD. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3month period. This information is available at: www.cms.gov/medicare- Title NCDM Section National Coverage Determination (NCD20.8.4): Leadless Pacemakers Transmittal Number Issue Date Effective Date 20.8.4 201 07/28/2017 01/18/2017 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (July through September 2017) Addendum V includes listings of the FDA-approved investigational device exemption (IDE) numbers that the FDA assigns. The listings are organized according to the categories to which the devices are assigned (that is, Category A or Category B), and identified by the IDE number. For the purposes of this quarterly notice, we list only the specific updates to the Category BIDEs as of the ending date of the period covered by this notice and a contact person for questions or additional information. For questions or additional information, contact John Manlove (410-7866877). Under the Food, Drug, and Cosmetic Act (21 U.S. C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved investigational device exemption (IDE). Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the notice published in the April21, 1997 Federal Register (62 FR 19328). IDE BB17544 BB17595 BB17601 BB17615 G140210 G170039 Gl70063 G170080 G170086 G170104 Gl70106 G170113 Device Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) TCR alpha/beta and CD19 T-cell depletion PBSC; conditioning CliniMACS® TCRaB/CD19 Combined Depletion System Hemanext Red Blood Cell Processing System The Tissue Genesis Icellator Cell Isolation System (Icellator) LABS ADHESION BARRIER Vas Q Device V ercise PC Deep Brain Stimulation System ZOLL Proteus Intravascular Temperature Management (IVTM) System AGNES Eximo Medical B-Laser Hybrid Atherectomy System En do Rotor Coherex WaveCrest Left Atrial Appendage Occlusion System Start Date 07/03/2017 08/09/2017 08/16/2017 08/17/2017 09/01/2017 08/01/2017 07/21/2017 07/20/2017 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 following website https://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: https://www. ems. govI quarterlyproviderupdates/downloads/Regs3Q17QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481 ). 07/21/2017 07/1112017 08/25/2017 09/08/2017 49827 EN27OC17.009</GPH> asabaliauskas on DSKBBXCHB2PROD with NOTICES 49828 VerDate Sep<11>2014 Gl70145 Gl70149 G170151 Jkt 244001 Gl70153 Gl70154 PO 00000 Gl70157 Gl70160 Gl70161 Frm 00048 Fmt 4703 Sfmt 4725 Gl70162 Gl70164 Gl70166 Gl70169 Gl70172 Gl70173 Gl70174 Gl70175 E:\FR\FM\27OCN1.SGM Gl70184 Gl70185 Gl70191 Gl70192 Gl70193 Gl70194 Gl70195 Gl70196 27OCN1 Gl70197 Gl70198 Gl70200 Gl70202 Gl70208 Gl70211 Gl70212 Gl70221 Gl70222 Gl70224 EN27OC17.010</GPH> Device DCB Drug Coated Balloon Catheter Medrobotics Flex System The Sprinter Over-the-Wire Semicompliant Balloon Dilatation Catheter novottf-200A SPRIJ\T PNS System Bovie Ultimate Electrosurgical Generator; Bovie Ultimate Electrosurgical Generator; Rovie .T-Plasma Precise Open handpieces; Bovie J-Plasma Precise Open handpieces WVEDERM VOLUMA XC with cannula Randomized Trial of Ilybrid Coronary Revascularization versus Percutaneous Coronary Intervention Theranova 400 Dialyzer Exablate Model4000 Type-2 for Blood-Brain Barrier Disruption (BBBD) Chronic Venous Thrombosis: Reliefwith Adjunctive Catheter-Directed Therapy (C- TRACT) Trial Clotbust ER (Sonolysis Headframe System) Model3.0C BOND MSLN (5B2) assay PASCAL Transcatheter Mitral Valve Repair System DISCSS Spinal Cord SCS System AcrySofiQ PanOptix Intraocular Lens LUM Imaging System Cartiva Synthetic Cartilage Implant for CMC AcrySofiQ Extended Depth of Focus (EDF) Intraocular Lens (IOL) Orion Visual Cortical Prothesis System NeuroStar TMS System LFP Beta aDBS System BabyGentleStick TULASystem Model1000C Generator; Model3000C Programmer Oxiplex Valiant PS-IDE Stent Graft System with Captiva Delivery System LC Bead LUMI (BTG-004387) Exatherm TBH The Bidirectional Neural Bypass System ProSpace System ExAblate Model4000 Type-1 ("ExAblate Neuro") System Belotero Balance Dermal Filler NeuroStar Transcranial Magnetic Stimulation (TMS) Therapy System FLExAbility Sensor Enabled Substrate Targeted Ablation for Reduction of VT (LESS-VT) Study Therasphere VENT ANA HER2neu ( 4B5) IUO Assay; INFORM HER2 Start Date 08/24/2017 07/28/2017 08/22/2017 08111/2017 07/03/2017 07/13/2017 07/12/2017 07/14/2017 07/14/2017 09/29/2017 07/21/2017 09/17/2017 07/20/2017 07/25/2017 07/28/2017 07/28/2017 07/28/2017 08/03/2017 08/02/2017 08/16/2017 08/24/2017 08/24/2017 08/30/2017 08/30/2017 09/01/2017 08/31/2017 08/31/2017 08/31/2017 08/23/2017 08/31/2017 09/07/2017 09/15/2017 09/15/2017 09/16/2017 09/29/2017 09/27/2017 09/29/2017 Device Dual ISH DNA Probe Cocktail IUO Assa·· Addendum VI: Approval Numbers for Collections of Information (July through September 2017) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned Ol'v!B control numbers. A single control number may apply to several related information collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact William Parham (410-786-4669). Addendum VII: Medicare-Approved Carotid Stent Facilities, (July through September 2017) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: https://www. ems. gov/MedicareApprovedFacilitie/CASF/list. asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Facility r£:,:f;}; )7;; Provider Number Effective Date 1841231461 07/13/2017 WA 1649278730 07/18/2017 PA 490112 08/15/2017 VA 050013 08/15/2017 CA 1871606764 08/15/2017 NY ;;:Is< Good Samaritan Hospital Multi Care Health System 401 15th Ave SE Puyallup, WA 98372 UPMC Altoona 620 Howard Avenue Altoona, PA 16601-4899 Chippenham and Johnston Willis Medical Center 7101 Jahnke Road Richmond, VA 23225 St. Helena Hospital- Napa Valley 10 Woodland Road St. Helena, CA 94574 Glens Falls Hospital State ~;':f;!?f:;, ~~;·;;':(~"~ Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 IDE Gl70122 Gl70123 G170136 asabaliauskas on DSKBBXCHB2PROD with NOTICES VerDate Sep<11>2014 Facility Jkt 244001 PO 00000 Effective Date State 100281 08115/2017 FL 100113 06/29/2005 FL 260119 08/23/2005 MO 260001 04/19/2005 MO rz3JC}/i!~''zY;4c ; Frm 00049 FROM: Shands Hospital at the University of Florida TO: UF Health Shands Hospital 1600 SW Archer Road Gainesville, FL 32610 Poplar Bluff Regional Medical Center 3100 Oak Grove Road Poplar Bluff, MO 63901 Mercy Hospital Joplin 100 Mercy Way Joplin, MO 64804-4524 ,;~~fi~}Ji] it·i«:);:~'~fJ Fmt 4703 Sfmt 4725 E:\FR\FM\27OCN1.SGM 27OCN1 Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (July through September 2017) Addendum VIII includes a list of the American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as infom1ation about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the lCD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collection mechanism. On October 27, 2005, CMS announced that the American College of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) lCD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR lCD Registry by April2006. Effective January 27, 2005, to obtain reimbursement, Medicare NCD policy requires that providers implanting ICDs for primary prevention clinical indications (that is, patients without a history of cardiac arrest or spontaneous arrhythmia) report data on each primary prevention lCD procedure. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements are available in the Medicare NCD Manual, which is on the CMS website at A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the ACC-NCDR lCD registry. Therefore, for a beneficiary to receive a Medicare-covered lCD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR lCD registry. The entire list of facilities that participate in the ACC-NCDR lCD registry can be found at www.ncdr.com/webncdr/common For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available by accessing our website and clicking on the link for the American College of Cardiology's National Cardiovascular Data Registry at: www.ncdr.com/webncdr/common. For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). Facility ~·~~~!~:Mi::;!:· Gulf Pointe Surgery Center City State :i.l;'; ~;'{;i?f;:,;;~;·]i':(~bJ;; Port Charlotte FL Termination date: 9/22/17. See case 00368616. They no longer perform these procedures. Lake Area Medical Center Lake Charles LA Termination date: 9/28/17. Please see case 00363080. TI1ey would like to tenninate CathPCI and ICD because cardiology services at their facility were discontinued effective 7/1117. Doctor's Same Day Surgery Center Sarasota FL Termination date: 9/20/17. See case 00368426. Providers no longer perform procedures. Addendum IX: Active CMS Coverage-Related Guidance Documents (July through September 2017) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS's implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 100 Park Street Glens Falls, NY 12801 Memorial Hospital West 703 North Flamingo Road Pembroke Pines, I'L 33028 Provider Number 49829 EN27OC17.011</GPH> asabaliauskas on DSKBBXCHB2PROD with NOTICES 49830 VerDate Sep<11>2014 Jkt 244001 PO 00000 Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (July through September 2017) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at www.cms.hhs.gov/coverage. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\27OCN1.SGM 27OCN1 Addendum XI: National Oncologic PET Registry (NOPR) (July through September 2017) Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR!list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (July through September 2017) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On EN27OC17.012</GPH> October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that V ADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates to the list of Medicare-approved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www. ems. gov/MedicareApprovedF acilitie!VAD /list.asp#TopOfPage. For questions or additional information, contact Linda Gousis, JD, (410-786-8616). Facility Provider Number Date Approved 22-0086 6/23/2107 34-0002 06/09/2016 NC 110028 08/16/2017 GA 22-0077 08/07/2017 MA ~.if1~ifi":j;J~fc:;/F:{!~ Beth Israel Deaconess Medical Center 330 Brookline Avenue Boston, MA 02215 Mission Hospital 509 Biltmore Avenue Asheville, NC 28801-4690 University Health Care System 1350 Walton Way Augusta, GA 30901 Baystate Medical Center 7 59 Chestnut Street Springfield, MA 01199 .,., State ~~·<: ·~l!f'.'~ MA Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 https://www. ems. gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). asabaliauskas on DSKBBXCHB2PROD with NOTICES VerDate Sep<11>2014 Jkt 244001 PO 00000 Frm 00051 Provider Nmnber Date Approved State Fresno Community Hospital and 'vledical Center 2823 Fresno Street Fresno, CA 93721 'vlaine Medical Center 22 Bramhall Street Portland, ME 04102 Hackensack University Medical Center 10 Prospect Avenue Hackensack, NJ 07601 FROM : Banner Good Samaritan \1edical Center TO: Banner - University Medical Center Phoenix 1111 East M~Dowell Road Phoenix, AZ 85006 50060 12/14/2016 CA 200009 09/28/2016 TX 31000 1 09/20/2017 NJ 030002 07/26/2017 AZ Fmt 4703 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (July through September 2017) Sfmt 9990 E:\FR\FM\27OCN1.SGM 27OCN1 Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (L VRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs) ; • Credentialed by the Joint Commission (formerly, the Joint Conunision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for L VRS ; and • Medicare approved for lung transplants. Only the first two types are in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/L VRS!list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (July through September 2017) Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21 , 2006, we issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006) ; or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (ESCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS ' s lninimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This infonnation is available at www.cms.gov/McdicarcApprovcdFacilitic/BSF/list.asp#TopOfPagc. For questions or additional information, contact Sarah Fulton, MHS (410-7S6-2749) . Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (July through September 2017) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. This information is available on our website at www. ems. gov/MedicareApprovedF acilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564). Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 17:54 Oct 26, 2017 Facility 49831 EN27OC17.013</GPH> 49832 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices [FR Doc. 2017–23447 Filed 10–26–17; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1076] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the guidance on ‘‘Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.’’ DATES: Submit either electronic or written comments on the collection of information by December 26, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 26, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 26, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. asabaliauskas on DSKBBXCHB2PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–N–1076 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites E:\FR\FM\27OCN1.SGM 27OCN1

Agencies

[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49819-49832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23447]


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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
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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 https://www.cms.gov/manuals.

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

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

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