81_FR_79708 81 FR 79489 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2016

81 FR 79489 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2016

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

Federal Register Volume 81, Issue 219 (November 14, 2016)

Page Range79489-79501
FR Document2016-27315

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS.

Federal Register, Volume 81 Issue 219 (Monday, November 14, 2016) 
[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Pages 79489-79501]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9099-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July Through September 2016

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

ACTION: Notice.

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

SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from July through September 2016, relating 
to the Medicare and Medicaid programs and other programs administered 
by CMS.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may need specific information and not be able to determine from 
the listed information whether the issuance or regulation would fulfill 
that need. Consequently, we are providing contact persons to answer 
general questions concerning each of the addenda published in this 
notice.

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------------------------------------------------------------------------
             Addenda                    Contact           Phone number
------------------------------------------------------------------------
I CMS Manual Instructions.......  Ismael Torres......     (410) 786-1864
II Regulation Documents           Terri Plumb........     (410) 786-4481
 Published in the Federal
 Register.
III CMS Rulings.................  Tiffany Lafferty...     (410) 786-7548
IV Medicare National Coverage     Wanda Belle, MPA...     (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs..  John Manlove.......     (410) 786-6877
VI Collections of Information...  William Parham.....     (410) 786-4669
VII Medicare-Approved Carotid     Sarah Fulton, MHS..     (410) 786-2749
 Stent Facilities.
VIII American College of          Sarah Fulton, MHS..     (410) 786-2749
 Cardiology-National
 Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-    JoAnna Baldwin, MS.     (410) 786-7205
 Related Guidance Documents.
X One-time Notices Regarding      JoAnna Baldwin, MS.     (410) 786-7205
 National Coverage Provisions.
XI National Oncologic Positron    Stuart Caplan, RN,      (410) 786-8564
 Emission Tomography Registry      MAS.
 Sites.
XII Medicare-Approved             Linda Gousis, JD...     (410) 786-8616
 Ventricular Assist Device
 (Destination Therapy)
 Facilities.
XIII Medicare-Approved Lung       Sarah Fulton, MHS..     (410) 786-2749
 Volume Reduction Surgery
 Facilities.
XIV Medicare-Approved Bariatric   Sarah Fulton, MHS..     (410) 786-2749
 Surgery Facilities.
XV Fluorodeoxyglucose Positron    Stuart Caplan, RN,      (410) 786-8564
 Emission Tomography for           MAS.
 Dementia Trials.
All Other Information...........  Annette Brewer.....     (410) 786-6580
------------------------------------------------------------------------

I. Background

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

II. Format for the Quarterly Issuance Notices

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

III. How To Use the Notice

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

    Dated: November 7, 2016.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
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[FR Doc. 2016-27315 Filed 11-10-16; 8:45 am]
BILLING CODE 4120-01-C

Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 79489 of the functions of the agency, including Institute for Occupational Safety and intended to generate data that can be whether the information shall have Health (NIOSH)—Centers for Disease used to validate a worker well-being practical utility; (b) the accuracy of the Control and Prevention (CDC). survey instrument through testing of its agency’s estimate of the burden of the psychometric properties. The survey Background and Brief Description proposed collection of information; (c) includes questions on five domains of ways to enhance the quality, utility, and As described in the Occupational worker well-being including: worker clarity of the information to be Safety and Health Act of 1970 (PL 91– evaluation and experiences with work; collected; (d) ways to minimize the 596), the mission of NIOSH is to workplace physical environment and burden of the collection of information conduct research and investigations on work-related disease and injury and to safety climate; organizational policies on respondents, including through the disseminate information for preventing and culture; worker health status; and use of automated collection techniques identified workplace hazards (Sections experiences outside of work (external or other forms of information technology; and (e) estimates of capital 20 (a) (1) and (d), Attachment 1). NIOSH context). or start-up costs and costs of operation, is requesting a one-year approval for For this study, the survey instrument maintenance, and purchase of services this data collection. will be programmed into a web-based to provide information. Measuring worker well-being is the survey that will be administered online Burden means the total time, effort, or first step towards improving workplace to an existing nationwide survey panel financial resources expended by persons policies, programs, and practices to of employed adults (KnowledgePanel®) to generate, maintain, retain, disclose or promote prevention of disease and hosted by our vendor, GfK. De- provide information to or for a Federal injury. identified data will be transmitted agency. This includes the time needed The Total Worker Health® Program securely to RAND, and RAND to review instructions; to develop, within NIOSH has made worker well- researchers will analyze the data as a acquire, install and utilize technology being a key aspect of its mission. The Total Worker Health (TWH) Program CDC contractor. and systems for the purpose of collecting, validating and verifying encompasses policies, programs, and The survey will be fielded to information, processing and practices that integrate protection from approximately 1,025 respondents in the maintaining information, and disclosing work-related safety and health hazards GFK panel, and the expected burden per and providing information; to train with promotion of injury and illness respondent for reading the email and personnel and to be able to respond to prevention efforts to advance worker completing the survey is 15 minutes or a collection of information, to search well-being. The goal of TWH is not only 0.25 hours of their time. This will be a data sources, to complete and review to prevent disease or injury, but also to one-time survey and panelists will not the collection of information; and to promote a culture of safety and health be asked to respond to this survey again transmit or otherwise disclose the and an enhancement of overall well- in the future. The total estimated burden information. being. hours are 385 for reading the In order to promote and enhance recruitment email and responding to the Proposed Project worker well-being it is first necessary to survey. There are no costs to the Measuring Worker Well-being for Total develop and validate instruments aimed respondent other than their time. Worker Health—New—National at measuring the concept. This study is ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Respondents Form name responses per respondents response (in hrs.) respondent (in hrs.) GFK Panelists ................................... Recruitment email ............................ 1,540 1 5/60 128 GFK Panelists ................................... Worker Well-being survey ................ 1,025 1 15/60 257 Total ........................................... ........................................................... ........................ ........................ ........................ 385 Leroy A. Richardson, DEPARTMENT OF HEALTH AND and interpretive regulations, and other Chief, Information Collection Review Office, HUMAN SERVICES Federal Register notices that were Office of Scientific Integrity, Office of the published from July through September Associate Director for Science, Office of the Centers for Medicare & Medicaid 2016, relating to the Medicare and Director, Centers for Disease Control and Services Medicaid programs and other programs Prevention. administered by CMS. [CMS–9099–N] [FR Doc. 2016–27261 Filed 11–10–16; 8:45 am] BILLING CODE 4163–18–P Medicare and Medicaid Programs; FOR FURTHER INFORMATION CONTACT: It is Quarterly Listing of Program possible that an interested party may Issuances—July Through September need specific information and not be able to determine from the listed mstockstill on DSK3G9T082PROD with NOTICES 2016 information whether the issuance or AGENCY: Centers for Medicare & regulation would fulfill that need. Medicaid Services (CMS), HHS. Consequently, we are providing contact ACTION: Notice. persons to answer general questions This quarterly notice lists SUMMARY: concerning each of the addenda CMS manual instructions, substantive published in this notice. VerDate Sep<11>2014 17:26 Nov 10, 2016 Jkt 241001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM 14NON1

79490 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices Addenda Contact Phone number I CMS Manual Instructions ....................................................................................... Ismael Torres .......................................... (410) 786–1864 II Regulation Documents Published in the Federal Register ................................. Terri Plumb ............................................. (410) 786–4481 III CMS Rulings ........................................................................................................ Tiffany Lafferty ........................................ (410) 786–7548 IV Medicare National Coverage Determinations ...................................................... Wanda Belle, MPA ................................. (410) 786–7491 V FDA-Approved Category B IDEs .......................................................................... John Manlove ......................................... (410) 786–6877 VI Collections of Information .................................................................................... William Parham ...................................... (410) 786–4669 VII Medicare-Approved Carotid Stent Facilities ....................................................... Sarah Fulton, MHS ................................. (410) 786–2749 VIII American College of Cardiology-National Cardiovascular Data Registry Sites Sarah Fulton, MHS ................................. (410) 786–2749 IX Medicare’s Active Coverage-Related Guidance Documents .............................. JoAnna Baldwin, MS .............................. (410) 786–7205 X One-time Notices Regarding National Coverage Provisions ............................... JoAnna Baldwin, MS .............................. (410) 786–7205 XI National Oncologic Positron Emission Tomography Registry Sites .................... Stuart Caplan, RN, MAS ........................ (410) 786–8564 XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities Linda Gousis, JD .................................... (410) 786–8616 XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ....................... Sarah Fulton, MHS ................................. (410) 786–2749 XIV Medicare-Approved Bariatric Surgery Facilities ................................................ Sarah Fulton, MHS ................................. (410) 786–2749 XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ........ Stuart Caplan, RN, MAS ........................ (410) 786–8564 All Other Information ................................................................................................ Annette Brewer ....................................... (410) 786–6580 I. Background various manuals, memoranda, and accessibility. In addition, many of the statements necessary to administer and Web sites have listservs; that is, the The Centers for Medicare & Medicaid oversee the programs efficiently. public can subscribe and receive Services (CMS) is responsible for Section 1871(c) of the Act requires immediate notification of any updates to administering the Medicare and that we publish a list of all Medicare the Web site. These listservs avoid the Medicaid programs and coordination manual instructions, interpretive rules, need to check the Web site, as and oversight of private health statements of policy, and guidelines of notification of updates is automatic and insurance. Administration and oversight general applicability not issued as sent to the subscriber as they occur. If of these programs involves the regulations at least every 3 months in assessing a Web site proves to be following: (1) Furnishing information to the Federal Register. difficult, the contact person listed can Medicare and Medicaid beneficiaries, provide information. health care providers, and the public; II. Format for the Quarterly Issuance and (2) maintaining effective Notices III. How To Use the Notice communications with CMS regional This quarterly notice provides only This notice is organized into 15 offices, state governments, state the specific updates that have occurred addenda so that a reader may access the Medicaid agencies, state survey in the 3-month period along with a subjects published during the quarter agencies, various providers of health hyperlink to the full listing that is covered by the notice to determine care, all Medicare contractors that available on the CMS Web site or the whether any are of particular interest. process claims and pay bills, National appropriate data registries that are used We expect this notice to be used in Association of Insurance Commissioners as our resources. This is the most concert with previously published (NAIC), health insurers, and other current up-to-date information and will notices. Those unfamiliar with a stakeholders. To implement the various be available earlier than we publish our description of our Medicare manuals statutes on which the programs are quarterly notice. We believe the Web should view the manuals at http:// based, we issue regulations under the site list provides more timely access for www.cms.gov/manuals. authority granted to the Secretary of the beneficiaries, providers, and suppliers. Department of Health and Human We also believe the Web site offers a Dated: November 7, 2016. Services under sections 1102, 1871, more convenient tool for the public to Kathleen Cantwell, 1902, and related provisions of the find the full list of qualified providers Director, Office of Strategic Operations and Social Security Act (the Act) and Public for these specific services and offers Regulatory Affairs. Health Service Act. We also issue more flexibility and ‘‘real time’’ BILLING CODE 4120–01–P mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 17:26 Nov 10, 2016 Jkt 241001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM 14NON1

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 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 17:26 Nov 10, 2016 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 13, 2015 (80 FR 70218), February 4, 2016 (81 FR 6009), that receive and retain at least one copy of most federal government Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices May 9, 2016 (81 FR 28072) and August 5, 2016 (81 FR 51901). We are publications, either in printed or microfilm form, for use by the general providing only the specific updates that have occurred in the 3 -month public. These libraries provide reference services and interlibrary loans; period along with a hypcrlink to the website to access this information and a however, they arc not sales outlets. Individuals may obtain information Jkt 241001 contact person for questions or additional information. about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing Addendum 1: Medicare and Medicaid Manual Instructions entitled Medicare and Medicaid Manual Instructions. To help FDLs locate PO 00000 (July through September 2016) the materials, use the CMS publication and transmittal numbers. For The CMS Manual System is used by CMS program components, example, to find the manual for Medicare Internet Only Manual Publication partners, providers, contractors, Medicare Advantage organizations, and Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version22.3, State Survey Agencies to administer CMS programs. It offers day-to-day Effective October 1, 2016 use (CMS-Pub. 100-04) Transmittal No. 3561. Frm 00081 operating instructions, policies, and procedures based on statutes and Addendum I lists a unique CMS transmittal number for each regulations, guidelines, models, and directives. In 2003, we transformed the instruction in our manuals or program memoranda and its subject number. CMS Program Manuals into a web user-friendly presentation and renamed A transmittal may consist of a single or multiple instruction(s). Often, it is Fmt 4703 it the CMS Online Manual System. necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly How to Obtain Manuals notice, we list only the specific updates to the list of manual instructions Sfmt 4725 The Internet-only Manuals (IOMs) are a replica of the Agency's that have occurred in the 3-month period. This information is available on official record copy. Paper-based manuals are CMS manuals that were our website at www.cms.gov/Manuals. officially released in hardcopy. The majority of these manuals were E:\FR\FM\14NON1.SGM transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub Transmittal Manual/Subject/Publication Number 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes Medicare Fee-for-Service Change Request Correction and Rescind Process only. If you notice policy contained in the paper-based manuals that was Change Management Process (Electronic Change Information Management not transferred to the 10M, send a message via the CMS Feedback tool. Portal Those wishing to subscribe to old versions of CMS manuals should 101 I Internet Only Manual Updates to Pub. 100-01, 100-02 and 100-04 to Correct Enurs and Omissions (SNF) contact the National Technical Information Service, Department of Certification and Recertification by Physicians for Extended Care Services 14NON1 Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone Admission of Medicare Patients for Care and Treatment (703-605-6050). You can download copies of the listed material free of charge at: http://cms.gov/manuals. Ambulance Staffmg Requirements Vehicle Requirements for Basic Lite Support and Advanced Lite Support Definition of Ambulance Services How to Review Transmittals or Program Memoranda Ground Ambulance Services Those wishing to review transmittals and program memoranda can 226 I Ambulance Staffmg Requirements access this information at a local Federal Depository Library (FDL). Under Vehicle Requirements for Basic Life Support and Advanced Life Support the FDL program, government publications are sent to approximately 1,400 Definition of Ambulance Services 227 I Internet Only Manual Updates to Pub. 100-0 L 100-02 and 100-04 to Correct designated libraries throughout the United States. Some FDLs may have Errors and Omissions (SNF Requirements - General 79491 EN14NO16.008</GPH>

c6P6L Medicare SNF PPS Overview 3567 Issued to a specific audience, not posted to Internet/Intranet due to Medicare SNF Coverage Guidelines Under PPS Confidentiality of Instruction Hospital Providers of Extended Care Services 3568 Reopenings Update — Changes to Chapter 34 Prior Hospitalization and Transfer Requirements Reopenings and Revisions of Claim Determinations and Decisions — General Three—Day Prior Hospitalization Authority to Conduct a Reopening Three—Day Prior Hospitalization — Foreign Hospital Reopenings Based on Clerical or Minor Errors and Omissions saomION/9I0Z ‘pT Joqwoaop ‘AepUuOop/6IZ ‘ON ‘I8 ‘TOA /4JopstSay fedapaq Effect on Spell of IlIness Telephone Reopenings — Required for A/B MACs (B) Only Medical Service o( an Intern or Resident—in—Training Informing the Provider Communities About the Telephone Reopenings Medical and Other Health Services Furnished to SNF Patients Process Services Furnished Under Arrangements With Providers Conducting the Telephone Reopening Definition of Durable Medical Equipment Monitoring the Telephone Reopening Timeframes to Reopen Claim Determinations Timeframes for Contractor Initiated Reopenings Timeframes for Party Requested Reopenings \ Timeframes for Adjudicator to Reopen Disease, and Myelodysplastic Syndromes Timeframes When a Party Requests an Adjudicator Reopen Their Decision Stem Cell Transplantation Good Cause for Reopening Billing for Stem Cell Transplantation Change in Substantive Law or Interpretative Policy Billing for Autologous Stem Cell Transplants 3569 Issued to a specific audience, not posted to Internet/Intranet due to Billing for Allogensic Stem Cell Transplants Confidentiality of Instruction Stem Cell Transplantation 3570 Issued to a specific audience, not posted to Internet/Intranet due to 3557 July 2016 Update of the Hospital Outpatient Prospective Payment System Confidentiality of Instruction (OPPS) 3571 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 3558 Implement Operating Rules — Phase III ERA EFT: CORE 360 Uniform Use of of Instruction Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes 3572 Issued to a specific audience, not posted to Internet/Intranet due to (RARC) and Claim Adjustment Group Code (CAGC) Rule — Update from Confidentiality of Instruction CAQH CORE 3573 October 2016 Quarterly Average Sales Price (ASP) Medicare Part B Drug 3559 Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Pricing Files and Revisions to Prior Quarterly Pricing Files Hospice Pricer for FY 2017 3574 Issued to a specific audience, not posted to Internet/Intranet due to 3560 Correction of Remark Code Information Confidentiality of Instruction Preparation of Denial Notices 3575 Update—Inpatient Psychiatric Facilities Prospective Payment System (IPF Processing Initial Denial PPS) Fiscal Year (FY) 2016 Annual Update 3561 Quarterly Update to the Correct Coding Initiative (CCT) Edits, Version 22.3, Electroconvulsive Therapy (ECT) Payment Effective October 1, 2016 3576 Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment 3562 Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code System (PPS) Pricer Changes for FY 2017 (CARC), Medicare Remit Easy Print (MREP) and PC Print Update 3577 Issued to a specific audience, not posted to Internet/Intranet due to 3563 New Waived Tests Confidentiality of Instruction 3564 Issued to a specific audience, not posted to Internet/Intranet due to 3578 Multiple Procedure Payment Reduction (MPPR) on the Professional Confidentiality of Instruction Component (PC) of Certain Diagnostic Imaging Procedures 3565 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) 3579 Issued to a specific audience, not posted to Internet/Intranet due to Competitive Bidding Program (CBP): Additional Instructions for the Confidentiality of Instruction Implementation of Round 2 Recompete of the DMEPOS CBP and National 3580 Issued to a specific audience, not posted to Internet/Intranet due to Mail Order (NMO) Recompete Confidentiality of Instruction Payment of a Part of a DMEPOS Item 3581 Issued to a specific audience, not posted to Internet/Intranet due to Payment for Capped Rental Items Confidentiality of Instruction Items 3582 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Payment for Repair and Replacement of Beneficiary—Owned Equipment Instruction 3566 Issued to a specific audience, not posted to Internet/Intranet due to 3583 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Confidentiality of Instruction Instruction

3584 Issued to a specific audience, not posted to Internet/Intranet due to 3605 Instructions for Downloading the Medicare ZIP Code File for January 2017 Confidentiality of Instruction 3606 2017 Healthcars Common Procedure Coding System (HCPCS) Annual 3585 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Update Reminder Instruction 3607 Annual Clotting Factor Furnishing Fee Update 2017 Clotting Factor 3586 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Furnishing Fee Instruction 3608 Issued to a specific audience, not posted to Internet/Intranet due to saomION/9I0Z ‘pT Joqwoaop ‘AepUuOop/6IZ ‘ON ‘I8 ‘TOA /4JopstSay fedapaq 3587 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Confidentiality of Instruction 3609 Annual Medicare Physician Fee Schedule (MPFS) Files Delivery and 3588 Issued to a specific audience, not posted to Internet/Intranet due to Implementation Confidentiality of Instruction 3610 2017 Annual Update for the Health Professional Shortage Area (HPSA) 3589 Issued to a specific audience, not posted to Internet/Intranet due to Bonus Payments Confidentiality of Instruction 3611 Influenza Vaccine Payment Allowances — Annual Update for 2016—2017 3590 Changes to the Fiscal Intermediary Shared System (FISS) Inpatient Provider Season Specific File (PSF) for Low—Volume Hospital Payment Adjustment Factor 3612 Internet Only Manual Updates to Pub. 100—01, 100—02 and 100—04 to Correct and New Inpatient Prospective Payment System (IPPS) Pricer Output Field Errors and Omissions (SNF) for Islet Isolation Add—on Payment Furnishing Services that are Subject to SNF Consolidated Billing Under an 3591 October 2016 Integrated Outpatient Code Editor (VOCE) Specifications "Arrangement" With an Outside Entity Version 17.3 Under Arrangements" Relationships 3592 Issued to a specific audience, not posted to Internet/Intranet due to Physician‘s Services and Other Professional Services Excluded From Part A Confidentiality of Instruction PPS Payment and the Consolidated Billing Requirement 3593 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Other Excluded Services Beyond the Scope of a SNF Part A Benefit Competitive Bidding Program (CBP): Additional Instructions for the Outpatient Surgery and Related Procedures — INCLUSION Implementation of Round 2 Recompete of the DMEPOS CBP and National Decision Logic Used by the Pricer on Claims Mail Order (NMO) Recompete 3613 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 3594 Quarterly Update to the Medicare Physician Fee Schedule Database Instruction (MPFSDB) — October CY 2016 Update 3614 Changes to the Laboratory National Coverage Determination (NCD) Edit 3595 Quarterly Update to the Medicare Physician Fee Schedule Database Software for January 2017 (MPFSDB) — October CY 2016 Update 3615 Update to Hepatitis B Deductible and Coinsurance and Screening Pap Smears 3596 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Claims Processing Information Pneumococcal Preumonia, Influenza Virus, Instruction and Hepatitis R Vaceines 3597 [ealthcare Provider Taxonomy Codes (IIPTCs) October 2016 Code Set MSN Messages Updale Remittance Advice Codes 3598 October Quarterly Update for 2016 Durable Medical Equipment, Prosthetics, 3616 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Orthotics, and Supplies (DMEPOS) Fee Schedule Instruction 3599 Claim Status Category and Claim Status Codes Update 3617 Implementation of New Influenza Virus Vaceine Code 3600 Implement Operating Rules — Phase III Electronic Remittance Advice ERA) Table of Preventive and Screening Services Electronic Funds Transfer (EFT): CORLE 360 Uniform Use of Claim Healthcare Common Procedure Coding System (HCPCS) and Diagnosis Adjustment Reason Codes (CARC), Remiliance Advice Remark Codes Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule — Update from CWT Edits on A/B MAC (A) Claims Council for Affordable Quality Healthcare (CAQH) Committee on Operating CWEF Edits on A/B MAC (B) Claims Rules for Information Exchange (CORE) CWEF Crossover Edits on A/B MAC (B) Claims 3601 October 2016 Update of the Ambulatory Surgical Center (ASC) Payment System 3602 October 2016 Updats of the Hospital Outpatient Prospective Payment System (OPPS) 270 Notice of New Interest Rate for Medicare Overpayments and Underpayments 3603 2017 Annual Update of Healthcare Common Procedure Coding System —4th Qtr Notification for FY 2016 (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing 271 Issued to a specific audience, not posted to Internet/Intranet due to (CB) Update Payer Only Codes Utilized by Medicare Confidentiality of Instruction 3604 Common Edits and Enhancements Modules (CEM) Code Set Update 272 Issued to a specific audience, not posted to Internet/Intranet due to €6T6L

P6GP6L Confidentiality of Instruction 670 Update of Payment Suspension Instructions | 1: 671 Issued to a specific audience, not posted to Internet/Intranet due to 157 Revisions to the State Operations Manual (SOM) — Appendix PP — Guidance Confidentiality of Instruction to Surveyors for Long Term Care Facilities 672 Documentation for Durable Medical Equipment Prosthetics, Orthotics and 158 Revisions to the State Operations Manual (SOM) —Chapter 5 Supplies (DMEPOS) Claims for Replacement of Essential Accessories for Survey Exit Conference and Report to the Provider/Supplier Beneficiary—Owned Continuous Positive Airway Pressure (CPAP) Devices saomION/9I0Z ‘pT Joqwoaop ‘AepUuOop/6IZ ‘ON ‘I8 ‘TOA /4JopstSay fedapaq Task 7: Exit Conference Revisions to State Operations Manual (SOM) and Respiratory Assist Devices (RADs) Appendix J, Part II — Interpretive Guidelines — Responsibilities of 673 Issued to a specific audience, not posted to Internet/Intranet due to Intermediate Care Facilities for Individuals with Intellectual Disabilities and Confidentiality of Instruction Exhibit 355. Probes and Procedures for Appendix J 674 Duplicate Postpayment Claim Reviews Case Selection 159 Revisions to the State Operations Manual (SOM), Appendix I — Survey 675 Update to Chapter 4, Pub. 100—08 Procedures for Life Safety Code Surveys 676 Clarification of Certain Policies in Pub. 100—08, Chapter 15 Regarding the 160 Revisions to the State Operations Manual (SOM) Chapter 7 Processing of Form CMS—855R Applications 161 Revisions to the State Operations Manual (SOM) Chapter 7 677 Issued to a specific audience, not posted to Internet/Intranet due to Mandatory Immediate Imposition of Federal Remedies Confidentiality of Instruction Criteria for Mandatory Immediate Imposition of Federal Remedies Effective Dates for Immediate Imposition of Federal Remedies Prior to the QIO Manual Chapter 2 — Eligibility Facility‘s Correction of Deficiencies Responsibilities of the State Survey Agency and the CMS Regional Office when there is an Immediate Imposition of Federal Remedies Imposition of a Civil Money Penalty when a Facility is not allowed an Opportunity to Correct Enforcement Action That Must Be Taken 2 Facilities Given an Opportunity to Correct Deficiencies prior to the Immediate Imposition of Federal Remedies Factors That Must Be Considered When Selecting Remedies Category 2 663 Denial Codes for Missing or Insufficient Documentation No Response or Insufficient Response to Additional Documentation Reopening Claims with Additional Information or Denied Due to Late or No Submission of Requested Information 151 Shared System Enhancement 2015 Archive/Remove Inactive Medicare Notifying the Provider Demonstration Projects Prepay Complex Provider Specific Review 152 Shared System Enhancement 2015 Archive/Remove Inactive Medicare Prepay Complex Service Specific Review Demonstration Projects Postpay Complex Provider Specific Review 153 Issued to a specific audience, not posted to Intemnet/ Intranet due to Sensitivity Postpay Complex Service Specific Review Instruction 664 The Process of Prior Authorization 154 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Prior Authorization Instruction Prior Authorization of Certain Durable Medical Equipment, Prosthetics, 155 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Orthotics, and Suppliers (DMEPOS) Instruction 665 Issued to a specific audience, not posted to Internet/Intranet due to 156 Affordable Care Act Bundled Payments for Care Improvement Initiative — Confidentiality of Instruction Recurring File Updates Models and 4 January 2017 Updates 666 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction are Sa(/lngs Prégram ( SP) A(;\(fbllfifa 8 Ce{\ré‘()rgamzanon ( ) 667 Revisions to Instructions Regarding the Fraud Investigation Database (FID) Qualifying Stay Edits and Other Program Integrity Procedures 1680 Issued to a specific audience, not posted to Internet/ Intranetto Sensitivity of 668 Issued to a specific audience, not posted to Internet/Intranet due to Instruction Confidentiality of Instruction 1681 The Supplemental Security Income (SSTYMedicare Beneficiary Data for 669 Issued to a specific audience, not posted to Internet/Intranet due to Fiscal Year 2014 for Inpatient Prospective Payment System (IPPS) Hospitals, Confidentiality of Instruction Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals (LTCBH)

1682 Issued to a specific audience, not posted to Internet/ Intranet to Sensitivity of Interchange (EDI) Front End Updates for January 2017 Instruction 1707 eMSN and Alternate Format MSN Service Improvements 1683 Shared Savings Program (SSP) Accountable Care Organization (ACO) 1708 Coding Revisions to National Coverage Determination (NCDs) Qualifying Stay Edits 1709 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 1684 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction of Instruction 1710 Adding a Foreign Language Tagline Sheet to Medicare Summary Notices saomION/9I0Z ‘pT Joqwoaop ‘AepUuOop/6IZ ‘ON ‘I8 ‘TOA /4JopstSay fedapaq 1685 Update the Primary Insurer‘s Policy Number of the Insured Field to 17 Bytes (MSNs) on the Health Insurance Master Record (HIMR) Screen Found in the 1711 Medicare Appeals System (MAS) Level 1 Part A and Home, Heath, Hospice Medicare Secondary Payer (MSP) Auxiliary File. (HHH) Onboarding Effort 1686 Part B Detail Line Expansion — MCS Phase 7 1712 Shared System Enhancement 2014 — Identification of Fiscal Standard System 1687 Common Working File (CWEF) to Locate Medicare Beneficiary Record and (FISS) Obsolete Reports — Analysis Only Provide Responses to Provider Queries 1713 Editing Update for Screening for Sexually Transmitted Infections 1688 Part B Detail Line Expansion — MCS Phase 2 1714 Shared System Enhancement 2014 — Identification of Fiscal Intermediary 1689 Update Common Working File (CWEF) Editing to Not Allow Late Charge Standard System (FISS) Obsolete Reports — Analysis Only Billing by Prospective Payment System (PPS) Providers 1715 Updates to the 72X Type of Bill for Home and Self—Dialysis Training, 1690 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Retraining, and Nocturnal Hemodialysis of Instruction 1716 Affordable Care Act — Operating Rules — Requirements for Phase II and Phase 1691 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity III Compliance for Batch Processing of Instruction 1717 Section 504; Adding a Qualified Reader Preference in Alternate Formats 1692 Remove Part B Batch Eligibility Process (HELG) from the Common Working 1718 Common Working File (CWEF) to Remove Remaining Federal Tax File (CWF)1693 Information (FTI) Received through the Internal Revenue Service (IRS), 1693 Common Working File (CWEF) to Remove Remaining Federal Tax Social Security Administration (SSA), Centers for Medicare and Medicaid Information (FTT) Received through the Internal Revenue Service (IRS), Services (CMS) Medicare Secondary Payer (MSP) Data Match Program from Social Security Administration (SSA), Centers for Medicare and Medicaid CWE. Services (CMS) Medicare Secondary Payer (MSP) Data Match Program from 1719 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity CWE. of Instruction 1694 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 1720 Reporting of All Recovery Auditor—Initiated Claim Adjustments and their of Instruction Subsequent Adjustments for Periodic Interim Payment (PIP) Facilities 1695 Fiscal Intermediary Shared System (FISS) Heath Information Technology for 1721 Adding a Foreign T anguage Tagline Shest to Medicare Summary Notices Economic and Clinical Health (HITECH) Quarterly Report (MSNs) 1696 Shared System Enhancement 2014 — Additional Removal of Obsolete Reports 1722 Updating the Fiscal Intermediary Shared System (FISS) to Make Payment for and On—Request Jobs from the ViPS Medicare System (VMS) — Drugs and Biologicals Services for Outpatient Prospective Payment System Implementation (OPPS) Providers 1697 Reporting of All Recovery Auditor—Initiated Claim Adjustments and their a p icen im M Subsequent Adjustments for Periodic Interim Payment (PIP) Facilities 58 Issued to a specific audience, not posted to Internet/Intranet due to 1698 Editing Update for Sereening for Sexually Transmitted Infections Confidentiality of Instruction 1699 Appropriate Use Criteria for Advanced Imaging — Analysis and Design 59 Issued to a specific audience, not posted to Internet/Intranct duc to 1700 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Confidentiality of Instruction of Instruction t 1701 Combined Common Edits/Enhancements (CCEM) Third Party Software None Upgrades 1702 Section 504: Adding a Qualified Reader Preference in Alternate Formats & . . 1703 Recovery Auditor Mass Adjustment and Reporting Process Enhancements — . Addendum IT: _Reglflatlon Documents Published Analysis Only in the Federal Register (July through September 2016) 1704 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity &w ofInstruction Regulations and notices are published in the daily Federal 1705 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Register. To purchase individual copies or subscribe to the Federal of Instruction . ha badie: 1706 Health Insurance Portability and Accountability Act (HIPAA) Electronic Data Register, contact GPO at www.gpo.gov/fdsys. When ordering individual S6P6L

96T6L copies, it is necessary to cite either the date of publication or the volume program and decision memoranda, which also announce decisions or, in number and page number. some cases, explain why it was not appropriate to issue an NCD. The Federal Register is available as an online database through Information on completed decisions as well as pending decisions has also GPO Access. The online database is updated by 6 a.m. each day the been posted on the CMS website. There were no updates that occurred in Federal Register is published. The database includes both text and the 3—month period. This information is available at: graphics from Volume 59, Number 1 (January 2, 1994) through the present www.cms. gov/medicare—coverage—database/. For questions or additional saomION/9I0Z ‘pT Joqwoaop ‘AepUuOop/6IZ ‘ON ‘I8 ‘TOA /4JopstSay fedapaq date and can be accessed at http:/www.gpoaccess.gov/fr/index.html. The information, contact Wanda Belle, MPA (410—786—7491). following website http:/www.archives.gov/federal—register/ provides information on how to access electronic editions, printed editions, and Addendum V; FDA—Approved Category B Investigational Device reference copies. Exemptions (IDEs) (July through September 2016) This information is available on our website at: Addendum V includes listings of the FDA—approved http://www.cms. gov/quarterlyproviderupdates/downloads/Regs— investigational device exemption (IDE) numbers that the FDA assigns. The 3Q16QPU.pdf listings are organized according to the categories to which the devices are For questions or additional information, contact Terri Plumb assigned (that is, Category A or Category B), and identified by the IDE (410—786—4481). number. For the purposes of this quarterly notice, we list only the specific updates to the Category B IDEs as of the ending date of the period covered Addendum III:; CMS Rulings by this notice and a contact person for questions or additional information. (July through September 2016) For questions or additional information, contact John Manlove (410—786— CMS Rulings are decisions of the Administrator that serve as 6877). precedent final opinions and orders and statements of policy and Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360¢) devices interpretation. They provide clarification and interpretation of complex or fall into one of three classes. To assist CMS under this categorization ambiguous provisions of the law or regulations relating to Medicare, process, the FDA assigns one of two categories to each FDA—approved Medicaid, Utilization and Quality Control Peer Review, private health investigational device exemption (IDE). Category A refers to experimental insurance, and related matters. IDEs, and Category B refers to non—experimental IDEs. To obtain more The rulings can be accessed at http‘//www.cms. gov/Regulations— information about the classes or categories, please refer to the notice and—Guidance/Guidance/Rulings. For questions or additional information, published in the April 21, 1997 Federal Register (62 FR 19328). contact Tiffany Lafferty (410—786—7548). IDE Device Start Date Addendum IV: Medicare National Coverage Determinations 6160070 Plasma Delipidation System 07/06/2016 (July through September 2016) G160123 Teosyal RHA Redensity (TPRL) 07/06/2016 Addendum IV includes completed national coverage 6150157 LifeSeal Kit — LifeSeal Surgical Sealant and Delivery System 07/07/2016 (LifeSeal Applicator/LifeSeal Laparoscopic Applicator) determinations (NCDs), or reconsiderations of completed NCDs, from the G160128 SIR—Spheres microspheres brachytherapy device plus 07/08/2016 quarter covered by this notice. Completed decisions are identified by the associated delivery accessories section of the NCD Manual (NCDM) in which the decision appears, the G160129 Embozene Microspheres 07/12/2016 title, the date the publication was issued, and the effective date of the 6150266 Evoke Closed Loop Stimulator (CLS), Evoke eCLS, Evoke 07/13/2016 decision. An NCD is a determination by the Secretary for whether or not a Percutaneous 12C Leads, Evoke Pocket Console (EPC), Evoke 12C Paddle Leads particular item or service is covered nationally under the Medicare Program G160133 Trailblaze Pharos 07/13/2016 (title XVIII of the Act), but does not include a determination of the code, if G160135 NUT IHC Companion Diagnostic Assay 07/13/2016 any, that is assigned to a particular covered item or service, or payment 6160130 Biodegradable Temporizing Matrix 07/14/2016 determination for a particular covered item or service. The entries below G160139 Infuse Bone Graft/Mastergraft Strip 07/22/2016 include information concerning completed decisions, as well as sections on 6160017 X—Seal 6F Vascular Closure Device 07/26/2016

IDE Device Start Date Addendum VI; Approval Numbers for Collections of Information 6160034 Mirabilis System 07/26/2016 (July through September 2016) G160141 MAGE—A10 Immunohistochemistry (IHC) Clinical Trial 07/26/2016 Assay All approval numbers are available to the public at Reginfo.gov. G160145 JB System 07/29/2016 Under the review process, approved information collection requests are 6160150 CERAMENT G 08/03/2016 assigned OMB control numbers. A single control number may apply to saomION/9I0Z ‘pT Joqwoaop ‘AepUuOop/6IZ ‘ON ‘I8 ‘TOA /4JopstSay fedapaq 6160026 Medtronic Valiant TAAA Stent Graft System 08/04/2016 several related information collections. This information is available at G160153 Zepto 08/05/2016 www.reginfo. gov/public/do/PRAMain. For questions or additional G150186 Sir—Sphere Microspheres 08/09/2016 information, contact William Parham (410—786—4669). 6160159 Echopulse High Intensity Focused Ultrasound Device 08/12/2016 6160155 Deep Brain Stimulation Surgery for Treatment of Focal Hand 08/17/2016 Dystonia Addendum VII; Medicare—Approved Carotid Stent Facilities, 6160157 tteris Antimicrobial Skin & Wound Cleanser 08/18/2016 (July through September 2016) G160161 Cortical Stimulation 08/19/2016 Addendum VII includes listings of Medicare—approved carotid 6160162 MagVenture MagPro X100 with MagOption Magnetic 08/19/2016 Stimulator, 230V C—B60 Butterfly Coil Coil COOL—B64 A/P stent facilities. All facilities listed meet CMS standards for performing (dyamaic cooled butterfly active & sham coil) carotid artery stenting for high risk patients. On March 17, 2005, we issued 6160170 LINX Reflux Management System 08/19/2016 our decision memorandum on carotid artery stenting. We determined that G160158 6 Month Double—Blind Randomized Placebo—Controlled Trial 0§/25/2016 carotid artery stenting with embolic protection is reasonable and necessary to Evaluate the Safety and Efficacy of Small Particle only if performed in facilities that have been determined to be competent in Hyaluronic Acid to Treat Acne Scars Located on the Cheeks and Forehead performing the evaluation, procedure, and follow—up necessary to ensure G160165 BreathID MCS System "C—Methacetin Breath Test (MBT) 08/26/2016 optimal patient outcomes. We have created a list of minimum standards for G160171 WATCHMAN Left Atrial Appendage Closure (LAAC) 08/26/2016 facilities modeled in part on professional society statements on competency. Device All facilities must at least meet our standards in order to receive coverage 6130156 NEURAL ENABLED PROSTHESIS (NEP) 08/31/2016 for carotid artery stenting for high risk patients. For the purposes of this G160146 45mm Tongue Implant, 55mm Tongue Implant, 6Smm 09/01/2016 Tongue Implant, 75mm Tongue Implant, Tongue Implanter quarterly notice, we are providing only the specific updates that have Kit occurred in the 3—month period. This information is available at: G160173 Mé6—C Artificial Cervical Disc 09/02/2016 http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage G160178 Ventana DLL3 (SC16.65) IHC Assay 09/07/2016 For questions or additional information, contact Sarah Fulton, MHS 6150244 Wireless Cardiac Stimulation System, WiCS—LV System, 09/09/2016 WiCS, WiSsEM (410—786—2749). G160177 Arctic Front Advance Cardiac CryoAblation Catheter; Freezor 09/09/2016 MAX Cardiac CryoAblation Catheter Facility Provider Effective State G160101 Cerene Crvotherapy Device 09/12/2016 Number Date 6160085 Chocolate Touch Paclitaxel Coated PTA Balloon Catheter 09/16/2016 G160132 GE Datex—Ohmeda Aisys CS2 Anesthesia System with 09/16/2016 Newton—Wellesley Hospital 220101 _ 07/22/2016 MA Optional Et Control Feature 2014 Washington Street 6160184 GelrinC Cartilage Repair Device 09/22/2016 Newton, MA 02462—1607 G160182 Medtronic TAAA Debranching Stent Graft System 09/23/2016 Temecula Valley Hospital 1679816201 07/22/2016 CA G160183 INTRAVASCULAR TEMPERATURE MANAGEMENT 09/23/2016 31700 Temecula Parkway Temecula, CA 92592 (IVTM) SYSTEM QUATTRO CATHETER Great Plains Health Heart & Vascular Center 1700855533 09/07/2016 NE G1600% Therasphere microspheres 09/26/2016 601 West Leota Street PO Box 1167 North Platte, NE 69101 G160188 SUBCUTANEOUS MEDIAN NERVE 09/29/2016 NEUROMODULATION FOR DRUG—TREATMENT RESISTANT HYPERTESION FROM: Presbytenalkl'\Hospltal of ]jfi]las 450462 2005 G160185 Jarvik 2015 Ventricular Assist System 09/30/2016 TO: Texas Health Presbyterian Hospital of Dallas G160190 AMPLATZER Duct Occluder II Additional Sizes 09/30/2016 L6P6L

8G6FT6L Facility Provider Effective State temporary data collection mechanism. On October 27. 2005, CMS Number Date announced that the American College of Cardiology‘s National 18200 Walnut Hill Lane Dallas, TX 75231—4496 FROM: Presbyterian Hospital of Denton 450743 01/10/2007 Cardiovascular Data Registry (ACC—NCDR) ICD Registry satisfies the data TO: Texas Health Presbyterian Hospital reporting requirements in the NCD. Hospitals needed to transition to the Denton ACC—NCDR ICD Registry by April 2006. saomION/9I0Z ‘pT Joqwoaop ‘AepUuOop/6IZ ‘ON ‘I8 ‘TOA /4JopstSay fedapaq 3000 1—35N Denton, TX 76201 Effective January 27, 2005, to obtain reimbursement, Medicare FROM: Harris Methodist Fort Worth 450135 04/20/2005 NCD policy requires that providers implanting ICDs for primary prevention Hospital TO: Texas Health Harris Methodist Hospital clinical indications (that is, patients without a history of cardiac arrest or Fort Worth spontaneous arrhythmia) report data on each primary prevention ICD 1301 Pennsylvania Avenue procedure. Details of the clinical indications that are covered by Medicare Fort Worth, TX 76104 and their respective data reporting requirements are available in the FROM: Arlington Memorial Hospital 450064 11/04/2005 TO: Texas Health Arlington Memorial Medicare NCD Manual, which is on the CMS website at Hospital http://www.crms hhs. gov/Manuals/IOM/itemdetail. asp?{ilterType=none&filt 800 West Randol Mill Road erByDID=99&sortByDID= 1 &sortOrder—ascending&itern[D=CMSO14961 Arlington, TX 76012 A provider can use either of two mechanisms to satisfy the data FROM: Harris Methodist HEB 450639 05/16/2005 TO: Texas Health Harris Methodist Hospital reporting requirement. Patients may be enrolled either in an Investigational Hurst—Euless—Bedford Device Exemption trial studying ICDs as identified by the FDA or in the 231 Westpark Way ACC—NCDR ICD registry. Therefore, for a beneficiary to receive a Euless, TX 76040 Medicare—covered ICD implantation for primary prevention, the beneficiary Mercy Health Partners 23—0066 12/21/2005 MI 1700 Clinton Street Muskegon, MI 49442 must receive the scan in a facility that participates in the ACC—NCDR ICD Manchester Memorial Hospital 070027 03/09/2016 CT registry. The entire list of facilities that participate in the ACC—NCDR ICD 71 Haynes Street Manchester, CT 06040 registry can be found at www.nedr.com/webnedr/common FROM: Mercy Hospital 390237 04/18/2006 PA For the purposes of this quarterly notice, we are providing only the TO: Regional Hospital of Scranton specific updates that have occurred in the 3—month period. This information 746 Jefferson Avenue Scranton, PA 18501 FROM: Wyoming Valley Health Care System 390137 04/26/2005 PA is available by accessing our website and clicking on the link for the TO: Wilkes—Barre General Hospital American College of Cardiology‘s National Cardiovascular Data 575 North River Street Registry at: www.nedr.com/webnedr/common. For questions or additional Wilkes Barre, PA 18764 information, contact Sarah Fulton, MHS (410 786 2749). Mercy Hospital 10016700 08/26/2005 FL 3663 South Miami Avenue Miami, FL 33133 F: Addendum VIII: New York Comm: American College of Cardiology‘s National Cardiovascular Data Medical Center ia Registry Sites (July through September 2016) Bartow ional Medical Center Bartow Addendum VIII includes a list of the American College of Central Carolina (TifePoint Sanford CHI St. Luke‘s Health Memorial Cardiology‘s National Cardiovascular Data Registry Sites. We cover Center Torrance implantable cardioverter defibrillators (ICDs) for certain clinical Victor V Global Medical Center Victorville indications, as long as information about the procedures is reported to a Cham i Cham! central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the ICD Doctors of Manteca Manteca North Hawaii Kameula Abstraction Tool through the Quality Network Exchange (QNet) as a

Facility City State PET scans for particular oncologic indications, as long as they were St. Luke‘s Monroc Hospital Stroudsburg PA performed in the context of a clinical study. We have since recognized the Heart and Rhythm Institute of Trinity Elfers FL National Oncologic PET Registry as one of these clinical studies. Olean General Hospital Olean NY Monongahela Valley Hospital Monongahela PA Therefore, in order for a beneficiary to receive a Medicare—covered PET Kaiser Permanente Vallgo Cath Lab Vallejo CA scan, the beneficiary must receive the scan in a facility that participates in saomION/9I0Z ‘pT Joqwoaop ‘AepUuOop/6IZ ‘ON ‘I8 ‘TOA /4JopstSay fedapaq Sonora Regional Medical Center Sonora CA the registry. There were no additions, deletions, or editorial changes to the Norton Women‘s and Kosair Children‘s Hospital Louisville KY listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3—month period. This information is available at Addendum IX: Active CMS Coverage—Related Guidance Documents http://www.cms. gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. (July through September 2016) For questions or additional information, contact Stuart Caplan, RN, MAS CMS issued a guidance document on November 20, 2014 titled (410—786—8564). "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy Addendum XII: Medicare—Approved Ventricular Assist Device vehicles relating to evidence development activities including the (Destination Therapy) Facilities (July through September 2016) investigational device exemption (IDE), the clinical trial policy, national Addendum XII includes a listing of Medicare—approved facilities coverage determinations and local coverage determinations, this guidance that receive coverage for ventricular assist devices (VADs) used as document is principally intended to help the public understand CMS‘s destination therapy. All facilities were required to meet our standards in implementation of coverage with evidence development (CED) through the order to receive coverage for VADs implanted as destination therapy. On national coverage determination process. The document is available at October 1, 2003, we issued our decision memorandum on VADs for the http://www.cms.gov/medicare—coverage—database/details/medicare— clinical indication of destination therapy. We determined that VADs used coverage—document—details.aspx?MCDId=27. There are no additional as destination therapy are reasonable and necessary only if performed in Active CMS Coverage—Related Guidance Documents for the 3—month facilities that have been determined to have the experience and period. For questions or additional information, contact infrastructure to ensure optimal patient outcomes. We established facility JoAnna Baldwin, MS (410—786—7205). standards and an application process. All facilities were required to meet Addendum X: our standards in order to receive coverage for VADs implanted as List of Special One—Time Notices Regarding National Coverage destination therapy. Provisions (July through September 2016) We are providing only the specific updates to the list of Medicare— There were no special one—time notices regarding national approved facilities that meet our standards that have occurred in the coverage provisions published in the 3—month period. This information is 3—month period. This information is available at available at www.cms. hhs.gov/coverage. For questions or additional http://www.cms. gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. information, contact JoAnna Baldwin, MS (410—786 7205). For questions or additional information, contact Linda Gousis, JD, (410—786—8616). Addendum XI: National Oncologic PET Registry (NOPR) (July through September 2016) Facility Provider Date Approved State Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission University Hospitals and Health System 25—0001 08/17/2016 MS tomography (PET) scans for particular oncologic indications when they are 2500 North State Street performed in a facility that participates in the NOPR. Jackson, MS 39216 In January 2005, we issued our decision memorandum on positron Cleveland Clinic Florida 10—0289 05/27/2015 FL emission tomography (PET) scans, which stated that CMS would cover 3100 Weston Road Weston, FL 33331 66P6L

mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 79500 17:26 Nov 10, 2016 Kaiser Sunnyside Medical Center 38-0091 09/14/2016 OR Addendum XIV includes a listing of Medicare-approved facilities 10180 SE Sunnyside Road Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices that meet minimum standards for facilities modeled in part on professional Clackamas, OR 97015-9303 T11e University of Kansas Hospital 17-0040 04/06/2016 KS society statements on competency. All facilities must meet our standards in Authority order to receive coverage for bariatric surgery procedures. On February 21, Jkt 241001 390 I Rainbow Boulevard 2006, we issued our decision memorandum on bariatric surgery procedures. Kansas City, KS 66160 We determined that bariatric surgical procedures are reasonable and "'orth Shore University Hospital 33-0106 09/28/2016 NY 300 Community Drive 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 PO 00000 'v!anhasset, NY 11030 and have been previously unsuccessful with medical treatment for obesity. Addendum XIII: Lung Volume Reduction Surgery (LVRS) This decision also stipulated that covered bariatric surgery procedures are (July through September 2016) reasonable and necessary only when performed at facilities that are: (1) Frm 00090 Addendum XIII includes a listing of Medicare-approved facilities certified by the American College of Surgeons (ACS) as a Levell Bariatric that are eligible to receive coverage for lung volume reduction surgery. Surgery Center (program standards and requirements in effect on February Until May 17, 2007, facilities that participated in the National Emphysema 15, 2006); or (2) certified by the American Society for Bariatric Surgery Fmt 4703 Treatment Trial were also eligible to receive coverage. The following three (ASBS) as a Bariatric Surgery Center of Excellence (ESCOE) (program types of facilities are eligible for reimbursement for Lung Volume standards and requirements in effect on February 15, 2006). Reduction Surgery (L VRS): There were no additions, deletions, or editorial changes to Sfmt 4725 • National Emphysema Treatment Trial (NETT) approved (Beginning Medicare-approved facilities that meet CMS' s minimum facility standards 05/07/2007, these will no longer automatically qualify and can qualify only for bariatric surgery that have been certified by ACS and/or ASMBS in the with the other programs); 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For E:\FR\FM\14NON1.SGM • Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation ofHealthcare Organizations (JCAHO)) under questions or additional information, contact Sarah Fulton, MHS their Disease Specific Certification Program for L VRS; and (410-786-2749). • Medicare approved for lung transplants. Only the first two types are in the list. There were no updates to Addendum XV: FDG-PET for Dementia and Neurodegenerative the listing of facilities for lung volume reduction surgery published in the Diseases Clinical Trials (July through September 2016) 3-month period. This information is available at There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. 14NON1 www. ems. gov/MedicareApprovedF acilitie!L VRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS This information is available on our website at (410-786-2749). www.cms.gov/MedicareApprovedFacilitie/PETDT!list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (410-786-8564 ). (July through September 2016) EN14NO16.017</GPH>

Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 79501 [FR Doc. 2016–27315 Filed 11–10–16; 8:45 am] product application. FDA bases this On or about August 30, 2007, BILLING CODE 4120–01–C order on a finding that Mr. Manookian Melanocorp received a warning letter was convicted of felonies under Federal from FDA expressing concern about law for conduct relating to the Melanocorp’s marketing of MII. The DEPARTMENT OF HEALTH AND regulation of a drug product under the warning letter noted that, based on HUMAN SERVICES FD&C Act. Mr. Manookian was given information and statements on the notice of the proposed permanent Melanocorp Web site, MII constituted a Administration for Children and debarment and an opportunity to new drug under the FD&C Act that Families request a hearing within the timeframe could not be introduced or delivered for prescribed by regulation. Mr. introduction into interstate commerce Agency Information Collection: without an FDA approved application. Manookian failed to request a hearing. Comprehensive Child Welfare The warning letter concluded that the Mr. Manookian’s failure to request a Information System sale of MII without an FDA approved hearing constitutes a waiver of his right Notice to a hearing concerning this action. application violated the FD&C Act and DATES: This order is effective November instructed Mr. Manookian’s company to The Office of Management and Budget take prompt action to correct the (OMB) has assigned approval number 14, 2016. ADDRESSES: Submit applications for violations cited in the warning letter. 0970–0463 to the Comprehensive Child On or about September 17, 2007, after Welfare Information System (CCWIS) special termination of debarment to the consulting with counsel, Mr. Manookian Final Rule (81 FR 35450, published June Division of Dockets Management (HFA– sent a letter to FDA stating that 2, 2016) information collection. The 305), Food and Drug Administration, Melanocorp had stopped all promotion CCWIS Final Rule describes an optional 5630 Fishers Lane, Rm. 1061, Rockville, and sale of MII in the United States and child welfare information system. States MD 20852. had stopped taking orders for MII from and tribes electing to build a CCWIS FOR FURTHER INFORMATION CONTACT: U.S. residents. must collect and report certain Kenny Shade, Division of Enforcement, On or about November 29, 2007, FDA information to the Administration for Food and Drug Administration, 12420 sent a letter to an attorney representing Children and Families regarding their Parklawn Dr. (ELEM–4144), Rockville, Melanocorp, which reiterated that MII CCWIS plans. The information MD 20857, 301–796–4640. was considered by FDA to be an collection described in the Final Rule SUPPLEMENTARY INFORMATION: unapproved drug and warned that its includes: introduction or delivery for introduction I. Background • The automated function list (45 CFR into interstate commerce would be a 1355.52(i)(1)(ii)–(iii) and (i)(2)) Section 306(a)(2)(B) of the FD&C Act violation of the FD&C Act. The letter • The data quality plan (45 CFR (21 U.S.C. 335a(a)(2)(B)) requires specifically stated that the sale of MII 1355.52(d)(5)) debarment of an individual if FDA finds outside of the United States violated the • The Notice of Intent (45 CFR that the individual has been convicted FD&C Act. 1355.52(i)(1)) of a felony under Federal law for On or about December 14, 2007, Mr. conduct relating to the regulation of any Manookian had a letter sent to FDA The authority for the information drug product under the FD&C Act. On from his attorney confirming that collection expires on 10/31/2019 August 28, 2015, the U.S. District Court Melanocorp had stopped taking orders 12:00:00 a.m. for the Middle District of Tennessee for MII from U.S. residents. This letter Authority: 42 U.S.C. 620 et seq., 42 U.S.C. entered judgment against Mr. also stated that Melanocorp did not 670 et seq.; 42 U.S.C. 1301 and 1302. Manookian for two counts of conspiracy disagree that FDA considered MII to be Robert Sargis, to commit an offense against the United an unapproved new drug, but Mr. Reports Clearance Officer. States, in violation of 18 U.S.C. 371. Manookian’s position was that FDA’s finding that the debarment is Melanocorp could lawfully export MII, [FR Doc. 2016–27280 Filed 11–10–16; 8:45 am] appropriate is based on the felony regardless of its status as an unapproved BILLING CODE 4184–01–P convictions referenced herein. The new drug. factual basis for these convictions is as On or about December 28, 2007, FDA DEPARTMENT OF HEALTH AND follows: Mr. Manookian was the sent a letter to Mr. Manookian’s attorney HUMAN SERVICES President and owner of Melanocorp, which reiterated that unapproved new Inc. (Melanocorp), a for-profit drugs do not qualify for export. Food and Drug Administration corporation that conducted operations Following receipt of the December 28, in the Middle District of Tennessee, and 2007, correspondence from FDA, [Docket No. FDA–2015–N–4169] his duties included overseeing the Melanocorp continued to ship MII in Edward Manookian (Also Known as Ed employees and operations of interstate commerce. Melanocorp Manning): Debarment Order Melanocorp. primarily sold MII to customers located Melanotan II (MII) was a peptide, or abroad, but also shipped MII AGENCY: Food and Drug Administration, series of amino acids, that was domestically on a more limited basis. HHS. marketed, sold, and shipped by From on or about September 17, 2007, ACTION: Notice. Melanocorp to customers in the United and continuing through in or about States and abroad. Mr. Manookian’s April 2009, Mr. Manookian conspired SUMMARY: The U.S. Food and Drug company advertised MII, an unapproved with others to defraud the United States mstockstill on DSK3G9T082PROD with NOTICES Administration (FDA or Agency) is new drug, as an injectable tanning by causing Melanocorp to ship MII to issuing an order under the Federal product through an internet Web site. customers in the United States despite Food, Drug, and Cosmetic Act (the The Melanocorp Web site also telling FDA that Melanocorp would not FD&C Act) permanently debarring advertised MII as being 100 percent U.S. distribute or market MII in the United Edward Manookian from providing made, whereas in fact some of the MII States. services in any capacity to a person that sold by Melanocorp was manufactured As a result of these convictions, FDA has an approved or pending drug in and imported from China. sent Mr. Manookian by certified mail on VerDate Sep<11>2014 17:26 Nov 10, 2016 Jkt 241001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM 14NON1


Document Created: 2018-10-24 10:46:48
Document Modified: 2018-10-24 10:46:48
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.
FR Citation81 FR 79489 
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