80_FR_70437 80 FR 70218 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July through September 2015

80 FR 70218 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July through September 2015

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

Federal Register Volume 80, Issue 219 (November 13, 2015)

Page Range70218-70231
FR Document2015-28870

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2015, relating to the Medicare and Medicaid programs and other programs administered by CMS.

Federal Register, Volume 80 Issue 219 (Friday, November 13, 2015) 
[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70218-70231]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9093-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July through September 2015

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

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from July through September 2015, 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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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 6, 2015.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2015-28870 Filed 11-12-15; 8:45 am]
 BILLING CODE 4120-01-C

70218 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices • Regulations.gov: http:// requires the contractor to indicate 1800 F Street NW., Washington, DC www.regulations.gov. whether it has the proper authorization 20405 telephone 202–501–4755. Submit comments via the Federal from the Federal Highway Please cite OMB Control No. 9000– eRulemaking portal by searching the Administration (or other cognizant 0053, Permits, Authorities, or OMB control number. Select the link regulatory body) to move material. The Franchises, in all correspondence. ‘‘Submit a Comment’’ that corresponds contractor may be required to provide with ‘‘Information Collection 9000– Edward Loeb, copies of the authorization before 0053, Permits, Authorities, or moving material under the contract. The Acting Director, Federal Acquisition Policy Franchises’’. Follow the instructions Division, Office of Governmentwide clause also requires the contractor, at its Acquisition Policy, Office of Acquisition provided at the ‘‘Submit a Comment’’ expense, to obtain and maintain any Policy, Office of Governmentwide Policy. screen. Please include your name, permits, franchises, licenses, and other [FR Doc. 2015–28802 Filed 11–12–15; 8:45 am] company name (if any), and authorities issued by State and local BILLING CODE 6820–EP–P ‘‘Information Collection 9000–0053, governments. The Government may Permits, Authorities, or Franchises’’ on request to review the documents to your attached document. ensure that the contractor has complied • Mail: General Services with all regulatory requirements. DEPARTMENT OF HEALTH AND Administration, Regulatory Secretariat HUMAN SERVICES Division (MVCB), 1800 F Street NW., B. Annual Reporting Burden Washington, DC 20405. ATTN: Ms. Centers for Medicare & Medicaid Respondents: 255. Flowers/IC 9000–0053, Permits, Services Responses per Respondent: 1. Authorities, or Franchises. [CMS–9093–N] Instructions: Please submit comments Annual Responses: 255. only and cite ‘‘Information Collection Hours per Response: 0.5. Medicare and Medicaid Programs; 9000–0053, Permits, Authorities, or Total Burden Hours: 128. Quarterly Listing of Program Franchises,’’ in all correspondence C. Public Comments Issuances—July through September related to this collection. Comments 2015 received generally will be posted Public comments are particularly without change to http:// invited on: Whether this collection of AGENCY: Centers for Medicare & www.regulations.gov, including any information is necessary for the proper Medicaid Services (CMS), HHS. personal and/or business confidential performance of functions of the Federal ACTION: Notice. information provided. To confirm Acquisition Regulations (FAR), and receipt of your comment(s), please whether it will have practical utility; SUMMARY: This quarterly notice lists check www.regulations.gov, whether our estimate of the public CMS manual instructions, substantive approximately two to three days after burden of this collection of information and interpretive regulations, and other submission to verify posting (except is accurate, and based on valid Federal Register notices that were allow 30 days for posting of comments assumptions and methodology; ways to published from July through September submitted by mail). enhance the quality, utility, and clarity 2015, relating to the Medicare and FOR FURTHER INFORMATION CONTACT: Mr. of the information to be collected; and Medicaid programs and other programs Michael O. Jackson, Procurement ways in which we can minimize the administered by CMS. Analyst, Office of Governmentwide burden of the collection of information FOR FURTHER INFORMATION CONTACT: It is Acquisition Policy, GSA 202–208–4949 on those who are to respond, through possible that an interested party may or email michaelo.jackson@gsa.gov. the use of appropriate technological need specific information and not be SUPPLEMENTARY INFORMATION: collection techniques or other forms of able to determine from the listed information technology. information whether the issuance or A. Purpose Obtaining Copies of Proposals: regulation would fulfill that need. The FAR requires insertion of clause Requesters may obtain a copy of the Consequently, we are providing contact 52.247–2, Permits, Authorities, or information collection documents from persons to answer general questions Franchises, when regulated the General Services Administration, concerning each of the addenda transportation is involved. The clause Regulatory Secretariat Division (MVCB), published in this notice. jstallworth on DSK7TPTVN1PROD with NOTICES EN13NO15.002</GPH> VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4725 E:\FR\FM\13NON1.SGM 13NON1

Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 70219 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 6, 2015. 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 jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\13NON1.SGM 13NON1

02204 Publication Dates for the Previous Four Quarterly Notices designated libraries throughout the United States. Some FDLs may have We publish this notice at the end of each quarter reflecting arrangements to transfer material to a local library not designated as an information released by CMS during the previous quarter. The publication FDL. Contact any library to locate the nearest FDL. This information is dates of the previous four Quarterly Listing of Program Issuances notices available at http://www.gpo.gov/libraries/ are: November 14, 2014 (79 FR 68253), February 2, 2015 (80 FR 5537), In addition, individuals may contact regional depository libraries April 24, 2015 (80 FR 23013) and August 3, 2015 (80 FR 45980). For the that receive and retain at least one copy of most federal government saonoNnN/sIOZ ‘g1 Joqwaaopn ‘AepHU4/6IZ ‘ON ‘08 ‘TOA /4opstSay fedapaq purposes of this quarterly notice, we are providing only the specific updates publications, either in printed or microfilm form, for use by the general that have occurred in the 3—month period along with a hyperlink to the public. These libraries provide reference services and interlibrary loans; website to access this information and a contact person for questions or however, they arc not sales outlets. Individuals may obtain information additional information. about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing Addendum I; Medicare and Medicaid Manual Instructions entitled Medicare and Medicaid Manual Instructions. To help FDLs locate (July through September 2015) 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 Quarterly Healthcare Common Procedure partners, providers, contractors, Medicare Advantage organizations, and Coding System (HCPCS) Drug/Biological Code Changes — October 2015 State Survey Agencies to administer CMS programs. It offers day—to—day Update, use Medicare Claims Processing operating instructions, policies, and procedures based on statutes and (CMS—Pub. 100—04)Transmitial No. 3304. regulations, guidelines, models, and directives. In 2003, we trans{formed the Addendum I lists a unique CMS transmittal number for each CMS Program Manuals into a web user—friendly presentation and renamed instruction in our manuals or program memoranda and its subject number. it the CMS Online Manual System. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with How to Obtain Manuals information currently in the manual. For the purposes of this quarterly The Internet—only Manuals (IOMs) are a replica of the Agency‘s notice, we list only the specific updates to the list of manual instructions official record copy. Paper—based manuals are CMS manuals that were that have occurred in the 3—month period. This information is available on officially released in hardcopy. The majority of these manuals were our website at www .cms.gov/Manuals. transferred into the Internet—only manual (IOM) or retired. Pub 15—1, Pub 15—2 and Pub 45 are exceptions to this rule and are still active paper—based Transmittal Manual/Subject/Publication Number manuals. The remaining paper—based manuals are for reference purposes only. If you notice policy contained in the paper—based manuals that was 93 Internet Only Manual (IOM) Publication 100—01 — General Information, not transferred to the IOM, send a message via the CMS Feedback tool. Eligibility, and Entitlement, Chapter 7 — Contract Administrative Those wishing to subscribe to old versions of CMS manuals should Requirements, Section 40 — Shared System Maintainer Responsibilities for contact the National Technical Information Service, Department of Systems Releases Shared System Maintainer and Part A/Part B (A/B)/Durable Medical Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone Equipment (DME) Medicare Administrative Contractor (MAC) and the (703—605—6050). You can download copies of the listed material free of Shared System Maintainer and Part A/Part B (A/B)/Durable Medical charge at: http://cms.gov/manuals. Equipment (DME) Medicare Administrative Contractor (MAC) and the Single Testing Contractor (STC) Responsibilities for Systems Releases Standardized Terminology for Claims Processing Systems How to Review Transmittals or Program Memoranda Standard Terminology Chart Those wishing to review transmittals and program memoranda can Release Software access this information at a local Federal Depository Library (FDL). Under Implementing Validated Workarounds for Shared System Claims Processing the FDL program, government publications are sent to approximately 1,400 by All Medicare DME MACs Next Generation Desktop (NGD) Requirements

Shared System Testing Requirements for Shared System Maintainers 3290 October 2015 Quarterly Average Sales Price (ASP) Medicare Part B Drug Single Testing Contractor (STC), and DME MACs Pricing Files and Revisions to Prior Quarterly Pricing Files Minimum Testing Standards for Shared System Maintainers and the Single 3291 Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2015 Testing Contractor (STCY/Beta Testers 3292 Quarterly Healthcare Common Procedure Coding System (HCPCS) Testing Standards Applicable to all Beta Testers Drug/Biological Code Changes — July 2015 Update Average Sales Price Part A/Part B (A/B) Durable Medical Equipment (DME) Medicare (ASP) Payment Methodology Administrative Contractor (MAC) (User) Testing Requirements 3293 Issued to a specific audience, not posted to Internet/Intranet due to a saonoNnN/sIOZ ‘g1 Joqwaaopn ‘AepHU4/6IZ ‘ON ‘08 ‘TOA /4opstSay fedapaq Testing Requirements Applicable to all CWF Data Centers (Hosts) Confidentiality of Instruction Timeframe Requirements for all Testing Entities 3294 Issued to a specific audience, not posted to Internet/Intranet due to a Testing Documentation Requirements Confidentiality of Instruction Definitions 3295 Issued to a specific audience, not posted to Internet/Intranet due to a Test Case Specification Standard Confidentiality of Instruction Shared System Testing Requirements for Shared System Maintainers, Single 3296 Issued to a specific audience, not posted to Internet/Intranet due to a Testing Contractor (STCY/Beta Testers, and Part A/Part B (A/B) Durable Confidentiality of Instruction Medical Equipment (DME) Medicare Administrative Contractors (MACs 3297 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 3298 Remittance Advice Remark and Claims Adjustment Reason Code and tructi Medicare Remit Easy Print and PC Print Update 3299 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 183 National Coverage Determination (NCD) for Screening for Colorectal Cancer of Instruction Using Cologuard"¥ — A Multitarget Stool DNA Test 3300 Issued to a specific audience, not posted to Internet/Intranet due to a National Coverage Determination (NCD) for Screening for Colorectal Confidentiality of Instruction Cancer Using Cologuard"** — A Multitarget Stool DNA Test 3301 Claims Processing Instructions for Diagnostic Digital Breast Tomosynthesis 184 Update to Pub. 100—03, National Coverage Determination Manual, Chapter 1, Digital Breast Tomosynthesis Part 1, Section 50.1 Speech Generating Device Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark 185 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) of Instruction Messages 3302 Issued to a specific audience, not posted to Internet/Intranet due to a 3288 Medicare Internet Only Manual Publication 100—04 Chapter 22 Remittance Confidentiality of Instruction Advice 3303 Issued to a specific audience, not posted to Internet/Intranet due to a Background Confidentiality of Instruction Remittance Balancing 3304 Quarterly Healthcare Common Procedure Coding System (HCPCS) Electronic Remittance Advice — ERA or ASC X12 835 Drug/Biological Code Changes — October 2015 Update ASC X12 835 3305 Issued to a specific audience, not posted to Internet/Intranet due to a Medicare Standard Electronic PC—Print Software for Institutional Providers Confidentiality of Instruction Medicare Remit Easy Print Software for Professional Providers and 3306 Issued to a specific audience, not posted to Internet/Intranet due to a Suppliers Confidentiality of Instruction Standard Paper Remittance Advice 3307 Issued to a specific audience, not posted to Internet/Intranet due to a Claim Adjustment Reason Codes Confidentiality of Instruction Remittance Advice Remark Codes 3308 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics Requests for Additional Codes and Supplies (DMEPOS) Competitive Bidding Program (CBP)— October The Council for Affordable Quality Healthcare (CAQH) Committee on 2015 Operating Rules for Information Exchange (CORE) Mandated Operating Rules 3309 Applying Therapy Caps to Maryland Hospitals Determining Payment Amounts — Institutional Claims Health Care Claim Payment/Advice (835) Infrastructure Rule Application of Financial Limitations Uniform Use of CARCs and RARCs Rule Exceptions to Therapy Caps — General EFT Enrollment Data Rule Exceptions Process ERA Enrollment Form Use of the KX Modifier for Therapy Cap Exceptions 3289 Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System Therapy Cap Manual Review Threshold (PPS) Pricer Update FY 2016 TI220L

jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 70222 Identifying the Certifying Physician 3327 New Waived Tests lv!SN Messages Regarding the Therapy Cap 3328 October 2015 Integrated Outpatient Code Editor (I!OCE) Specifications 15:03 Nov 12, 2015 Part B Outpatient Rehabilitation and Comprehensive Outpatient Version 16.3 Rehabilitation Facility (CORF) Services- General 1129 Update to Puh. 100-04, Chapter 1S to Provide T,anguage-Only Changes for 3310 Issued to a specific audience, not posted to Intemet/Intranet due to a Updating ICD-10, the 02/12 version of the Form CMS-1500, and ASC X12 Confidentiality of Instruction Hcalthcare Common Procedure Coding System (HCPCS) and Diagnosis Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 3311 End Stage Renal Disease (ESRD) Home Dialysis Policy Guidelines for Codes Physician or Practitioner Billing-- (Per Diem) Roster Claims Submitted to AlB MACs (B) for Mass Immunization 3312 None Centralized Billing for Influenza Vims and Pneumococcal Vaccines to Jkt 238001 3313 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Medicare AlB MACs (B) of Instruction Claims Submitted to AlB MACs (A) for Mass Immunizations of Influenza 3314 Procedure for Medicare Contractors to Perfonn and Record Outlier Vims and Pneumococcal Vaccinations Reconciliation Adjustments HCPCS and Diagnosis Codes for Mammography Services Billing Requirements -AlB MAC (B) Claims PO 00000 3315 New and Revised Place of Service Codes (POS) for Outpatient Hospital Part B Medicare Administrative Contractor (MAC) Instructions for Place of Remittance Advice Messages Service (POS) Codes Pap Smears On and After July 1, 2001 Selection ofT .evel of Evaluation and Management Service Payment for HCPCS Codes for Billing Office or Other Outpatient Evaluation and Management (E/M) Visits (Codes Diagnoses Codes Frm 00039 99201- 99215) Remittance Advice Codes Place of Service (POS) Instructions for the Professional Component (PC or Screening Pelvic Examinations on and After July 1, 2001 Interpretation) and the Technical Component (TC) of Diagnostic Tests Diagnoses Codes Professional Billing Requirements Revenue Code and HCPCS Codes for Billing Fmt 4703 Items 14-33 - Provider of Service or Supplier Information Remittance Advice Codes Place of Service Codes (POS) and Definitions Diagnosis Coding Site of Service Payment Differential Remittance Advice Notices Payment 3316 Issued to a specific audience, not posted to Intcmct/Intranct due to Sensitivity Determining High Risk for Developing Colorectal Cancer Sfmt 4725 of Instruction Billing Requirements for Claims Submitted to AlB MACs 3317 Quarterly Update to the Medicare Physician Fee Schedule Database Remittance Advice Notices (MPFSDB)- October CY 2015 Update Claims Submission Requirements and Applicable HCPCS Codes 3318 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity HCPCS and Diagnosis Coding E:\FR\FM\13NON1.SGM of Instmction Remittance Advice Notices 3319 National Coverage Determination (NCD) for Screening for Colorcctal Cancer AlB Medicare Administrative Contractor (MAC) (B) and Contractor Billing Using Colo guard™- A Multitarget Stool DNA Test Requirements AlB MAC (B) Billing Requirements 3320 Issued to a specific audience, not posted to Intemet/Intranet due to a Modifier Requirements for Pre-diabetes Confidentiality of Instmction AID MAC (A) Dilling Requirements 3321 Issued to a specific audience, not posted to Intemet/Intranet due to a Modifier Requirements for Pre-diabetes Confidentiality of Instmction Diagnosis Code Reporting 3322 Issued to a specific audience, not posted to Intcmct/Intranct due to a Medicare Summary Kotices 13NON1 Confidentiality of Instruction AlB MAC (B) Billing Requirements 3323 October Quarterly Update for 2015 Durable Medical Equipment, Prosthetics, AlB MAC (A) Billing Requirements Orthotics, and Supplies (DMEPOS) Fee Schedule Diagnosis Code Reporting 3324 Clarification of the Policy for Competitively-Bid Wheelchair Accessories Medicare Summary Kotice Billing Requirements Furnished with Non-Competitively Bid Wheelchair Base Equipment Diagnosis Code Reporting Exception for Wheelchair Accessories Furnished with !\on-Competitively Bid Medicare Summary Kotice (MSN) and Claim Adjustment Reason Codes Wheelchair Base Equipment (CARCs) 3325 Issued to a specific audience, not posted to Intemet/Intranet due to a Medicare Summary Kotices (MSNs), Remittance Advice Remark Codes Confidentiality of Instmction (RARCs), Claims Adjustment Reason Codes (CARCs), and Advance 3326 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Beneficiary Notices ( ABN s) of Instmction Healthcare Common Procedure Coding Svstem (HCPCS) and Diagnosis EN13NO15.005</GPH>

Coding of Instruction Common Working File (CWF) Edits 3351 Additional Fields Added to the Outlier Reconciliation Lump Sum Utility Diagnosis Code Reporting 3352 October 2015 Update of the Hospital Outpatient Prospective Payment System Billing Requirements Policy (OPPS) Professional Billing Requirements 3353 Quarterly Update to the Correct Coding Initiative (CCT) Edits, Version 22.0, Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Effective January 1, 2016 Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) saonoNnN/sIOZ ‘g1 Joqwaaopn ‘AepHU4/6IZ ‘ON ‘08 ‘TOA /4opstSay fedapaq 3354 January 2016 Quarterly Average Sales Price (ASP) Medicare Part B Drug Messages Pricing Files and Revisions to Prior Quarterly Pricing Files Medicare Summary Notices (MSNs), Remittance Advice Remark Codes 3355 Annual Medicare Physician Fee Schedule (MPFS) Files Delivery and (RARCs), Claims Adjustment Reason Codes (CARCs), and Group Codes Implementation 3330 Issued to a specific audience, not posted to Internet/Intranet due to a Maintenance and Update of the Temporary Hook Created to Hold OPPS Confidentiality of Instruction Claims that Include Cortain Drug HCPCS Codes 3331 Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment 3356 Maintenance and Update of the Temporary Hook Created to Hold OPPS System (PPS) Pricer Changes for FY 2016 Claims that Include Certain Drug HCPCS Codes 3332 Update—Inpatient Psychiatric Facilities Prospective Payment System (IPF 3357 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity PPS) Fiscal Year (FY) 2016 Annual Update of Instruction 3333 October 2015 Update of the Hospital Outpatient Prospective Payment System 3358 Claims Processing Medicare Secondary Payer (MSP) Policy and Procedures (OPPS) Regarding Ongoing Responsibility for Medicals (ORM) 3334 Issued to a specific audience, not posted to Internet/Intranet due to a 3359 October 2015 Integrated Outpatient Code Editor (LOCE) Specifications Confidentiality of Instruction Version 16.3 3335 Implement Operating Rules — Phase III ERA EFT: CORE 360 Uniform Use of 3360 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark of Instruction Codes (RARC) Rule — Update from CAQH CORE 3361 October 2015 Update of the Ambulatory Surgical Center (ASC) Payment 3336 Healthcare Provider Taxonomy Codes (HPTCs) October 2015 Code Set System Update 3362 Issued to a specific audience, not posted to Internet/Intranet due to a 3337 Instructions for Downloading the Medicare ZIP Code File for January 2016 Confidentiality of Instruction 3338 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 3363 Issued to a specific audience, not posted to Internet/Intranet due to a ofInstruction Confidentiality of Instruction 3339 Issued to a specific audience, not posted to Internet/Intranet due to a 3364 Quarterly Update to the Medicare Physician Fee Schedule Database Confidentiality of Instruction (MPFSDB) — October CY 2015 Update 3340 Annual Clotting Factor Furnishing Fee Update 2016 3365 2016 Healthcare Common Procedure Coding System (HCPCS) Annual 3341 Influenza Vaccine Payment Allowances — Annual Update for 2015—2016 Update Reminder Season 3366 Changes to the Laboratory National Coverage Determination (NCD) Edit 3342 Common Edits and Enhancements Modules (CEM) Code Set Update Software for January 2016 3343 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction 113 Instructions for the Shared Systems and Medicare Administrative Contractors 3344 Claim Status Category and Claim Status Codes Update (MACs) to follow when a Medicare Residual Payment must be Paid on 3345 Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Workers‘ Compensation Medicare Set—aside Arrangement (WCMSA) or for Hospice Pricer for FY 2016 Ongoing Responsibility of Medicals (ORM) Non—Group Health Plan (NGHP) 3346 Removing References to Network Service Vendors from Chapter 24 of the Medicare Medicare Claims Processing Manual, Pub. 100—04 TOC Secondary Payer (MSP) Claims. 3347 Issued to a specific audience, not posted to Internet/Intranet due to a MSP "W‘ Record and Accompanying Processes Confidentiality of Instruction Medicare Residual Payments Due When On—going Responsibility for 3348 Issued to a specific audience, not posted to Internet/Intranet due to a Medicals (ORM) Benefits Terminate, or Deplete, During a Beneficiary‘s Confidentiality of Instruction Provider Facility 3349 2016 Annual Update of Healthcare Common Procedure Coding System Stay or Upon a Physician, or Supplier, Visit. (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing Workers‘ Compensation (WC) (CB) Update 114 Claims Processing Medicare Secondary Payer (MSP) Policy and Procedures 3350 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Regarding Ongoing Responsibility for Medicals (ORM) €500L

FPoc0Ll MSP Utilization Edits and Resolutions for Claims Submitted to CWF Home Health Certification Coding Identification ofLiability and No—Fault Situations Medical Necessity ofServices Provided Identify Claims with Possible WC Coverage Examples of Sufficient Documentation Incorporated Into a Physician‘s Identification of On—Going Responsibility for Medicals (ORM) in Liability, Medical Record No—Fault, and Workers‘ Compensation Situations Medical Review of Home Health Demand Bills Background Regarding ORM for Contractors 603 Medical Review of Home Health Services Policy Regarding ORM Table of Contents saonoNnN/sIOZ ‘g1 Joqwaaopn ‘AepHU4/6IZ ‘ON ‘08 ‘TOA /4opstSay fedapaq Operationalizing ORM for Liability, No—Fault, and Workers‘ Compensation Medical Review of Home Health Services Situations Physician Certification of Patient Eligibility for the Medicare Home Health MSP Auxiliary File Errors Benefit Sources That May Identify Other Insurance Coverage Certification Requirements Physician Recertification 251 Notice of New Interest Rate for Medicare Overpayments and Underpayments Recertification Elements —4th Qtr. Notification for FY 2015 The Use of the Patient‘s Medical Record Documentation to Support the 252 Issued to a specific audience, not posted to Internet/Intranet due to a Home Health Certification Coding Confidentiality of Instruction Medical Necessity of Services Provided 253 Update the Contractor Reporting of Operational and Workload Data Examples of Sufficient Documentation Incorporated Into a Physician‘s (CROWD) CMS—2592 Report to Indicate Requests Received in Claims and Medical Record Requests Received That Are Recovery Audit Related Medical Review of Home Health Demand Bills 604 Signature Requirements 141 Revisions to the State Operations Manual (SOM), Appendix A — Survey 605 Clarification Regarding the Processing of Certain Provider Enrollment— Protocol, Regulations and Interpretive Guidelines for Hospitals Related Transactions 142 Revisions to State Operations Manual (SOM) Chapter 9 Exhibits 606 Issued to a specific audience, not posted to Internet/Intranet due to a 143 Revisions to State Operations Manual (SOM) Chapter 2, The Cortification Confidentiality of Instruction Process and Appendix W, Survey Protocol, Regulations and Interpretive 607 Workload Reporting Guidelines for Critical Access Hospitals (CAHs) and Swing—Beds in CAHs Prepay Complex Provider Specific Review 144 Revisions to State Operations Manual (SOM) Appendix J, Part II — 608 Update to Pub. 100—08 to Provide Language—Only Changes for Updating ICD— Interpretive Guidelines — Responsibilities of Intermediate Care Facilities for 10 and ASC X12 Individuals with Intellectual Disabilities 609 Clarification Regarding the Processing of Certain Provider Enrollment— 145 Revisions to Medicare State Opcrations Manual (SOM), Chapter 9 — Exhibits Related Transactions 146 State Operations Manual (SOM), Section 2185— Home Health Agencies Denials (HHAs), Change of Address to a Medical Administrative Contractor (MAC) Licenses and Certifications within 90 Days Final Adverse Action H Supporting Documents Special Processing Guidelines for Form CMS—855A, Form CMS—855B, 600 Workload Reporting Form Prepay Complex Service Specific Review CMS—8551 and Form CMS—855R Applications Prepay Complex Provider Specific Review Sole Proprietorships CMHC 40 Percent Rule 601 Review of Home Health Claims Home Health 610 Issued to a specific audience, not posted to Internet/Intranet due to a 602 Medical Review of Home Health Services Confidentiality of Instruction Table of Contents 611 Changes to Supplier Documentation and Evidence of Medical Necessity for 3 Medical Review of Home Health Services Oxygen Claims Physician Certification of Patient Eligibility for the Medicare Home Health Supplier Documentation Benefit Evidence of Medical Necessity for the Oxygen Claims Certification Requirements 612 Changes to Supplier Documentation and Evidence of Medical Necessity for Physician Recertification Oxygen Claims Recertification Elements Evidence of Medical Necessity for the Oxygen Claims The Use of the Patient‘s Medical Record Documentation to Support the 613 Postpayment Review Requirements Complex Medical Review

Issued to a specific audience, not posted to Internet/Intranet due to a 1531 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Confidentiality of Instruction ofInstruction 1532 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity None of Instruction 1533 Update Hard Coded Audit 205A MSP Return Code 3925 and Edit 152D None 1534 Health Insurance Portability and Accountability Act (HIPAA) EDI Front End Updates for January 2016 saonoNnN/sIOZ ‘g1 Joqwaaopn ‘AepHU4/6IZ ‘ON ‘08 ‘TOA /4opstSay fedapaq None 1535 International Classification of Diseases, 10th Revision (ICD—10) Additional Acknowledgement Testing Reporting None 1536 Increasing Tax Withholding to 100 Percent for Internal Revenue Service (IRS) Federal Payment Levy Program (FPLP) None 1537 ICD—10 Conversion/Coding Infrastructure Revisions to National Coverage Determinations (NCDs)——3rd Maintenance CR None 1538 Medicare Prior Authorization of Power Mobility Devices (PMDs) Demonstration: Advance Determination of Medicare Coverage (ADMC) Medicare Care Choices Model (MCCM) — Per Beneficiary per Month Reviews for Beneficiaries Who Have Representative Payees PBPM) — lementation 1539 Implementing the Insertion of a Sheet of Paper Promoting the Electronic Medicare Summary Notices (eMSNs) into Mailed Medicare Summary Notices (MSNs) Award of Medicare Administrative Contractor (MAC) Contract for Jurisdiction J 1540 Modification to the Telehealth Originating Site Facility Fee Billing Requirements for Rural Health Clinics (RHCs) and Federally Qualified Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Health Centers (FQHCs) of Instruction 1541 Health Insurance Portability and Accountability Act (HIPAA) EDI Front End is and ign for Part B Detail Line Updates for October 2015 Tester Resolution Reports for International Classification of Diseases, Tenth 1542 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Revision (ICD—10) Limited End to End Testing with Submitters ofInstruction Contractor Reporting of Operational and Workload Data (CROWD) Form 5 1543 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Remittance Advice R i of Instruction Medicare 1544 Implementation of Long—Term Care Hospital (LTCH) Prospective Payment Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity System (PPS) Based on Specific Clinical Criteria of Instruction 1545 Procedures for Processing Under Tolerance Part A 935, Part A—Other, Part A CMS Information Security Acceptable Risk Safeguards Update — Multifactor and B Healthcare Professional Shortage Area (HPSA), and Part A—Provider Authentication Recovery Audit Contractor (RAC) Identified debts in the Healthcare Data Act T Referral Timeframe and — DME MAC Integrated Procedures for Processing Under Tolerance Part A 935, Part A—Other, Part A General and B Healthcare Professional Shortage Area (HPSA), and Part A—Provider 1546 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of Recovery Audit Contractor (RAC) Identified debts in the Healthcare General i GLAS Medicare Remit Print U 46 Issued to a specific audience, not posted to Internet/Intranet due to a Add Original Common Working Files (CWF) Occurrence Number to the Confidentiality of Instruction CWFEFeed to MBD 47 Issued to a specific audience, not posted to Internet/Intranet due to a Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Confidentiality of Instruction of Instruction Update for Paper Claims Processing Under the Administrative Simplification liance Act (ASCA of Anti—Cancer and Anti—Emetic 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 5200L

92004 decision. An NCD is a determination by the Secretary for whether or not a Addendum II:; Regulation Documents Published particular item or service is covered nationally under the Medicare Program in the Federal Register (July through September 2015) (title XVIII of the Act), but does not include a determination of the code, if Regulations and Notices any, that is assigned to a particular covered item or service, or payment Regulations and notices are published in the daily Federal determination for a particular covered item or service. The entries below Register. To purchase individual copies or subscribe to the Federal include information concerning completed decisions, as well as sections on saonoNnN/sIOZ ‘g1 Joqwaaopn ‘AepHU4/6IZ ‘ON ‘08 ‘TOA /4opstSay fedapaq Register, contact GPO at www.gpo.gov/fdsys. When ordering individual program and decision memoranda, which also announce decisions or, in copics, it is necessaryto cite cither the date of publication or the volume some cases, explain why it was not appropriate to issuc an NCD. number and page number. Information on completed decisions as well as pending decisions has also The Federal Register is available as an online database through been posted on the CMS website. For the purposes of this quarterly notice, GPO Access. The online database is updated by 6 a.m. each day the we list only the specific updates that have occurred in the 3—month period. Federal Register is published. The database includes both text and This information is available at: www.cms. gov/medicare—coverage— graphics from Volume 59, Number 1 (January 2, 1994) through the present database/. For questions or additional information, contact Wanda Belle date and can be accessed at http://www.gpoaccess.gov/fr/index.html. The (410—786—7491). following website http://www.archives.gov/federal—register/ provides information on how to access electronic editions, printed editions, and Title NCDM Transmittal Issue Date Effective Section Number Date reference copies. Medicare Coverage of This information is available on our website at: Screening for Lung Cancer http://www.cms. gov/quarterlyproviderupdates/downloads/Regs— NCD 210.14 R185 08/21/2015 02/05/2015 with Low Dose Computed 3Q15QPU .pdf Tomography (LDCT) For questions or additional information, contact Terri Plumb National Coverage Determination (NCD) for (410—786—4481). Screening for Colorectal NCD 210.3 R183 08/06/2015 10/09/2014 Addendum III: CMS Rulings Cancer Using Cologuard"** — A Multitarget Stool DNA CMS Rulings are decisions of the Administrator that serve as Test precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or Addendum V: FDA—Approved Category B Investigational Device ambiguous provisions of the law or regulations relating to Medicare, Exemptions (IDEs) (July through September 2015) Medicaid, Utilization and Quality Control Peer Review, private health Addendum V includes listings of the FDA—approved insurance, and related matters. investigational device exemption (IDE) numbers that the FDA assigns. The The rulings can be accessed at http://wyww.cms. gov/Regulations— listings are organized according to the categories to which the devices are and—Guidance/Guidance/Rulings. For questions or additional information, assigned (that is, Category A or Category B), and identified by the IDE contact Tiffany Lafferty (410—786—7548). 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 IV: Medicare National Coverage Determinations by this notice and a contact person for questions or additional information. (July through September 2015) For questions or additional information, contact John Manlove (410—786— Addendum IV includes completed national coverage 6877). determinations (NCDs), or reconsiderations of completed NCDs, from the Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360¢) devices quarter covered bythis notice. Completed decisions are identified by the fall into one of three classes. To assist CMS under this categorization section of the NCD Manual (NCDM) in which the decision appears, the process, the FDA assigns one of two categories to each FDA—approved title, the date the publication was issued, and the effective date of the

jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 investigational device exemption (IDE). Category A refers to experimental IDE Device Start Date IDEs, and Category B refers to non-experimental IDEs. To obtain more Silicone Gel-Filled Breast Implant, MemoryGel Breast Implant 15:03 Nov 12, 2015 UHP-L Siltex Round UHP-L Silicone Gel-Filled Breast Implant infmmation about the classes or categories, please refer to the notice Gl50174 Cutera Excel V 09/02/15 published in the April21, 1997 Federal Register (62 FR 19328). Gl50175 QUARTET MODEL 1457Q IDE STUDY 09/03/15 G150177 Cardiac Resynchronization Therapy Pacemakers 09/11115 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices IDE Device Start Date Gl50178 StimGuard Protect Chronic Tibial Nerve Stimulator (CDJS) 09/18/15 Gl30235 ACTIGAIT L\1PLANTABLE DROP FOOT STL\1ULATOR 09/18/15 System SYSTEM G150179 SCD (Selective Cytopheretic Device) 09/17115 Jkt 238001 Gl40192 Organ Care System (OCS)- Liver, Organ Care System (OCS)- 07/09/15 Gl50180 Cook Antimicrobial Hernia Repair Device 09/17/15 Liver Console, OCS Liver Perfusion Set Gl50182 VENT ANA PD-Ll (SP142) CDx Assay 09/17/15 Gl40202 AEQUALIS PYROCARBON HUMERALHEAD 08/26/15 Gl501S3 Cochlear Nucleus Cl532 Cochlear Implant 09/1S/15 Gl40221 Intergraft System 07/31115 PO 00000 Gl40243 Organox Metra System 08/21115 Addendum VI: Approval Numbers for Collections of Information Gl50029 Tack Endovascular System 08/14/15 Gl50119 Mag Venture MagProXlOO with MagOption stimulator, C-D60 07/02/15 (July through September 2015) butterfly coil and MagPro Cool Coil B65 AlP All approval numbers arc available to the public at Rcginfo.gov. Frm 00044 Gl50120 Pilot Study ofNovottf- 100A System in Conjunction with 07/15/15 Under the review process, approved information collection requests are Temozolomide Chemoradiation For Newly Diagnosed assigned OMB control numbers. A single control number may apply to Glioblastoma Gl50123 Argus II Retinal Prosthesis System 07/08/15 several related information collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional Fmt 4703 Gl50125 BreathiD MCS System C-Methacetin Breath Test 07/31115 G150127 SalnSTIM, a transcntaneous electrical nerve stimulation (TENS) 07/10/15 information, contact Mitch Bryman (410-786-5258). device Gl50131 Monovisc 07/16/15 Addendum VII: Medicare-Approved Carotid Stent Facilities, Sfmt 4725 Gl50132 University of Minnesota Medical School 08/11115 Gl50134 HiResolution Bionic Ear System 07/16/15 (July through September 2015) G150136 Percutaneous Osseointegrated Prosthesis Implant 07/22/15 Addendum VII includes listings of Medicare-approved carotid Gl50138 FLT3 Mutation Assay 07/23/15 stent facilities. All facilities listed meet CMS standards for performing E:\FR\FM\13NON1.SGM Gl50140 CP81 0 Sound Processor 07/23/15 carotid artery stenting for high risk patients. On March 17, 2005, we issued Gl50143 Juvederm Voluma XC For Chin Augmentation 07/31115 our decision memorandum on carotid artery stenting. We detemrined that Gl50145 Modulight Laser, Isotropic Probe, Cylindrical Light Diffuser, 07/31115 and Diffusing Balloon Catheter carotid artery stenting with embolic protection is reasonable and necessary Gl50147 SENTUS OTW QP L-75/ SENTUS OTW QP L-85/ SENTUS 08/05/15 only if performed in facilities that have been determined to be competent in OTW QP L-95; SENTUS OTW QP S-75/ SENTUS OTW QP S- performing the evaluation, procedure, and follow-up necessary to ensure g5; SENTUS OTW QP S-95 MODF.T .1g9 g151 1g6 g16/ 1g6 optimal patient outcomes. We have created a list of nrinimum standards for 837I 400 719/ 400 720/ 400 721 facilities modeled in part on professional society statements on competency. 13NON1 Gl50150 REPLICATE Svstem 08/07/15 G150155 Osseointegrated Prostheses for the Rehabilitation of Amputees 08/14/15 All facilities must at least meet our standards in order to receive coverage (OPRA) for carotid artery stenting for high risk patients. For the purposes of tlris Gl50161 Boston Scientific Vessix system 08/19/15 quarterly notice, we are providing only the specific updates that have Gl50167 Medtronic Restore ULTRA 37712 spinal cord stimulator, 08/28/15 occurred in the 3-month period. This information is available at: Medtronic Specify 5-6-5, 16-electrode surgical lead http://www .ems. gov/MedicareApprovedF acilitie/CASF!list. asp#TopOfPage G150169 Visualase Thermal Therapy System 08/28/15 Gl50170 Mitralign Percutaneous Tricuspid Valve Annuloplasty System OS/2S/15 For questions or additional information, contact Lori Ashby (PTVAS) (410-786-6322). Gl50171 ELUVIA Drug-Eluting Vascular Stent System 09/02/15 Gl50173 MemoryGel Breast Implant UHP-L Smooth Round UHP-L 09/03/15 70227 EN13NO15.010</GPH>

82004 Facility Provider Effective State http:/Avww.cms. hhs. gov/Manuals/{IOM/itemdetail. asp?filterType=none&filt Number Date erBy DID=99& sortByDID=1&sortOrder=ascending&itemID=CMSO14961 ical Cé‘fi\te‘ |18004 A provider can use either of two mechanisms to satisfy the data 911 Bypass Road Pikeville, KY 41501 reporting requirement. Patients may be enrolled either in an Investigational Truman Medical Center 1467595793 09/22/2015 MoO Device Exemption trial studying ICDs as identified by the FDA or in the ACC—NCDR ICD registry. Therefore, for a beneficiary to receive a saonoNnN/sIOZ ‘g1 Joqwaaopn ‘AepHU4/6IZ ‘ON ‘08 ‘TOA /4opstSay fedapaq Medicare—covered ICD implantation for primary prevention, the beneficiary FROM: University Medical Center 030064 06/01/2005 AZ TO: Banner University Medical Center Tucson must receive the scan in a facility that participates in the ACC—NCDR ICD 1501 N. Campbell Avenue Tucson, AZ 85724 registry. The entire list of facilities that participate in the ACC—NCDR ICD FROM: University Physicians Hospital 030111 06/21/2012 AZ registry can be found at www.nedr.com/webnedr/common TO: Banner University Medical Center South For the purposes of this quarterly notice, we are providing only the 2800 East Ajo Way Tucson, AZ 85713 FROM: Orlando Regional Healthcare System, 100006 04/05/2006 FL specific updates that have occurred in the 3—month period. This information Inc. is available by accessing our website and clicking on the link for the TO: Orlando Health American College of Cardiology‘s National Cardiovascular Data Registry 52 West Underwood Street Orlando, FL 32806 at: www.nedr.com/webnedr/common. For questions or additional FROM: Medcenter One 350015 05/26/2005 ND information, contact Marie Casey, BSN, MPH (410—786—7861). TO: Sanford Health Bismarck 300 North 7th Street Bismarck, ND 58506 Addendum VHI: ed American College of Cardiology‘s National Cardiovascular Data University Health Conway Monroe Registry Sites (July through September 2015) Sentara Albemarle Medical Center Elizabeth City Addendum VIII includes a list of the American College of Fort HTamilton Ilospital Hamilton Ol Piedmont Newnan Hospital Newnan GA Cardiology‘s National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical ity) aton Rouge indications, as long as information about the procedures is reported to a Unity Medical and Surgical Hospital Mishawaka IN central registry. Detailed descriptions of the covered indications are available in the NCD. In January 2005, CMS established the ICD Addendum IX: Active CMS Coverage—Related Guidance Documents Abstraction Tool through the Quality Network Exchange (QNet) as a (July through September 2015) temporary data collection mechanism. On October 27, 2005, CMS CMS issued a guidance document on November 20, 2014 titled announced that the American College of Cardiology‘s National "Guidance for the Public, Industry, and CMS Staff: Coverage with Cardiovascular Data Registry (ACC—NCDR) ICD Registry satisfies the data Evidence Development Document". Although CMS has several policy reporting requirements in the NCD. Hospitals needed to transition to the vehicles relating to evidence development activities including the ACC—NCDR ICD Registry by April 2006. investigational device exemption (IDE), the clinical trial policy, national Effective January 27, 2005, to obtain reimbursement, Medicare coverage determinations and local coverage determinations, this guidance NCD policy requires that providers implanting ICDs for primary prevention document is principally intended to help the public understand CMS‘s clinical indications (that is, patients without a history of cardiac arrest or implementation of coverage with evidence development (CED) through the spontaneous arrhythmia) report data on each primary prevention ICD national coverage determination process. The document is available at procedure. Details of the clinical indications that are covered by Medicare http://www.cms. gov/medicare—coverage—database/details/medicare— and their respective data reporting requirements are available in the coverage—document—details.aspx?MCDId=27. There arc no additional Medicare NCD Manual, which is on the CMS website at Active CMS Coverage—Related Guidance Documents for the 3—month

period. For questions or additional information, contact JoAnna Baldwin facilities that have been determined to have the experience and (410—786—7205). infrastructure to ensure optimal patient outcomes. We established facility 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 2015) saonoNnN/sIOZ ‘g1 Joqwaaopn ‘AepHU4/6IZ ‘ON ‘08 ‘TOA /4opstSay fedapaq For the purposes of this quarterly notice, we are providing only the There were no special one—time notices regarding national specific updates that have occurred to the list of Medicare—approved coverage provisions published in the 3—month period. This information is facilities that meet our standards in the 3—month period. This information is available at www.cms.hhs.gov/coverage. For questions or additional available at information, contact JoAnna Baldwin (410—786 7205). http://www.cms. gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. For questions or additional information, contact Marie Casey, BSN, MPH Addendum XI: National Oncologic PET Registry (NOPR) (410—786—7861). (July through September 2015) Addendum XI includes a listing of National Oncologic Positron F Emission Tomography Registry (NOPR) sites. We cover positron emission Riverside Methodist Hospital 360006 $/11/2015 OH tomography (PET) scans for particular oncologic indications when they are 3535 Olentangy River Road performed in a facility that participates in the NOPR. Columbus, OH 43214 In January 2005, we issued our decision memorandum on positron Delray Medical Center, Inc 100258 81272015 FL emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were TO:; Keck Hospital of USC 050696 01/09/2004 CA performed in the context of a clinical study. We have since recognized the FROM: USC University Hospital National Oncologic PET Registry as one of these clinical studies. 1500 San Pablo Street Therefore, in order for a beneficiary to recceive a Medicare—covered PET Los Angeles, CA 90033 scan, the beneficiary must reccive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the Addendum XIII: Lung Volume Reduction Surgery (LVRS) listing of National Oncologic Positron Emission Tomography Registry (July through September 2015) (NOPR) in the 3—month period. This information is available at Addendum XIII includes a listing of Medicare—approved facilities http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#T opOfPage. that are eligible to receive coverage for lung volume reduction surgery. For questions or additional information, contact Stuart Caplan, RN, MAS Until May 17, 2007, facilities that participated in the National Emphysema (410—786—8564). Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Addendum XII: Medicare—Approved Ventricular Assist Device Reduction Surgery (LVRS): (Destination Therapy) Facilities (July through September 2015) e National Emphysema Treatment Trial (NETT) approved (Beginning Addendum XII includes a listing of Medicare—approved facilities 05/07/2007, these will no longer automatically qualify and can qualify only that receive coverage for ventricular assist devices (VADs) used as with the other programs); destination therapy. All facilities were required to meet our standards in e Credentialed by the Joint Commission (formerly, the Joint order to receive coverage for VADs implanted as destination therapy. On Commision on Accreditation of Healthcare Organizations (JCAHO)) under October 1, 2003, we issued our decision memorandum on VADs for the their Discase Specific Certification Program for LVRS; and clinical indication of destination therapy. We determined that VADs used e Mcdicare approved for lung transplants. as destination therapy are reasonable and necessary onlyif performed in 622074

jstallworth on DSK7TPTVN1PROD with NOTICES VerDate Sep<11>2014 70230 15:03 Nov 12, 2015 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices Jkt 238001 Only the first two types are in the list. There were no updates to Surgery Center (program standards and requirements in effect on February the listing of facilities for lung volume reduction surgery published in the 15, 2006); or (2) certified by the American Society for Bariatric Surgery PO 00000 3-month period. This information is available at (ASBS) as a Bariatric Surgery Center of Excellence (ESCOE) (program www .cms.gov/MedicareApprovedFacilitie/L VRS/list.asp#TopOfPage. For standards and requirements in effect on February 15, 2006). questions or additional information, contact Marie Casey, BSN, MPH There were no additions, deletions, or editorial changes to Frm 00047 (410-786-7861). Medicare-approved facilities that meet CMS' s minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the Addendum XIV: Medicare-Approved Bariatric Surgery Facilities 3-month period. This information is available at Fmt 4703 (July through September 2015) www. ems. gov/MedicareApprovedF acilitie/B SF/list. asp#TopOfPage. For Addendum XIV includes a listing of Medicare-approved facilities questions or additional information, contact Jamie Hermansen that meet minimum standards for facilities modeled in part on professional (410-786-2064 ). Sfmt 9990 society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21, Addendum XV: FDG-PET for Dementia and Neurodegenerative 2006, we issued our decision memorandum on bariatric surgery procedures. Diseases Clinical Trials (July through September 2015) We determined that bariatric surgical procedures are reasonable and There were no FDG-PET for Dementia and Neurodegenerative E:\FR\FM\13NON1.SGM necessary for Medicare beneficiaries who have a body-mass index (BMI) Diseases Clinical Trials published in the 3-month period. greater than or equal to 35, have at least one co-morbidity related to obesity This information is available on our website at and have been previously unsuccessful with medical treatment for obesity. www .cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. This decision also stipulated that covered bariatric surgery procedures are For questions or additional information, contact Stuart Caplan, RN, MAS reasonable and necessary only when performed at facilities that are: (1) (410-786-8564 ). certified by the American College of Surgeons (ACS) as a Level 1 Bariatric 13NON1 EN13NO15.013</GPH>

Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 70231 [FR Doc. 2015–28870 Filed 11–12–15; 8:45 am] The FACES Core study will assess the spring 2016, including surveys with BILLING CODE 4120–01–C school readiness skills of Head Start parents, teachers, program directors, children, survey their parents, and ask and center directors. their Head Start teachers to rate AI/AN FACES spring 2016 data DEPARTMENT OF HEALTH AND children’s social and emotional skills. In collection includes site visits to 37 HUMAN SERVICES addition, FACES will include centers in 22 Head Start programs. As in observations in Head Start classrooms, fall 2015, parents of sampled children Administration for Children and and program director, center director, will complete surveys on the Web or by Families and teacher surveys. FACES Plus telephone (or in person if needed) about studies include additional survey their children, activities family Submission for OMB Review; content of policy or programmatic members engage in with their children, Comment Request interest, and may include additional and family and household background Title: Head Start Family and Child programs or respondents beyond those characteristics. Head Start teachers, Experiences Survey (FACES). participating in the Core FACES study. program directors, and center directors Previous notices provided the will complete surveys about the Head OMB No.: 0970–0151. opportunity for public comment on the Start classroom or program and their Description: The Office of Planning, proposed Head Start program own background using the Web or Research and Evaluation (OPRE), recruitment and center selection process paper-and-pencil forms. Administration for Children and (FR V.78, pg. 75569 12/12/2013; FR The purpose of the Core data Families (ACF), U.S. Department of V.79, pg. 8461 02/12/2014), the child- collection is to support the 2007 Health and Human Services (HHS), is level data collection in fall 2014 and reauthorization of the Head Start proposing to collect data for a new spring 2015(FR V. 79, pg. 11445 02/28/ program (Pub. L. 110–134), which calls round of the Head Start Family and 2014; FR V. 79; pg. 27620 5/14/2014), for periodic assessments of Head Start’s Child Experiences Survey (FACES). the program- and classroom-level spring quality and effectiveness. As additional Featuring a new ‘‘Core Plus’’ study 2015 data collection activities (FR v.79; information collection activities are design, FACES will provide data on a pg. 73077 12/09/2014), and the fully developed, in a manner consistent set of key indicators, including American Indian and Alaska Native with the description provided in the 60- information for performance measures. Head Start Family and Child day notice (79 FR 11445) and prior to The design allows for more rapid and Experiences Survey (AI/AN FACES) use, we will submit these materials for frequent data reporting (Core studies) child-level data collection activities in a 30-day public comment period under and serves as a vehicle for studying fall 2015 and spring 2016 (FR V. 80, pg. the Paperwork Reduction Act. more complex issues and topics in 30250 08/07/2015). This 30-day notice Respondents: Parents of Head Start greater detail and with increased describes the planned additional data children, Head Start teachers and Head efficiency (Plus studies). collection activities for AI/AN FACES in Start staff. ANNUAL BURDEN ESTIMATES—CURRENT INFORMATION COLLECTION REQUEST Number Average Estimated Total Annual of responses burden annual Instrument number of number of per hour per burden respondents respondents respondent response hours Head Start core parent survey for plus study (AI/AN FACES Spring 2016) ........................................................ 800 267 1 0.50 134 Head Start core teacher survey for plus study (AI/AN FACES) ............................................................................ 80 27 1 0.58 16 Head Start program director core survey for plus study (AI/AN FACES) ................................................................. 22 7 1 0.33 2 Head Start center director core survey for plus study (AI/ AN FACES) ...................................................................... 37 12 1 0.33 4 Total .............................................................................. ........................ ........................ ........................ ........................ 156 Additional Information: Copies of the Therefore, a comment is best assured of DEPARTMENT OF HEALTH AND proposed collection may be obtained by having its full effect if OMB receives it HUMAN SERVICES writing to the Administration for within 30 days of publication. Written Children and Families, Office of comments and recommendations for the Administration for Children and Planning, Research and Evaluation, 370 proposed information collection should Families L’Enfant Promenade SW., Washington, be sent directly to the following: Office DC 20447, Attn: OPRE Reports of Management and Budget, Paperwork Submission for OMB Review; Clearance Officer. All requests should Reduction Project, Fax: OIRA_ Comment Request be identified by the title of the SUBMISSION@OMB.EOP.GOV, Attn: jstallworth on DSK7TPTVN1PROD with NOTICES Title: State Self-Assessment Review information collection. Email address: Desk Officer for the Administration for and Report. OPREinfocollection@acf.hhs.gov. Children and Families. OMB No.: 0970–0223. OMB Comment: OMB is required to Description: Section 454(15)(A) of the Robert Sargis, make a decision concerning the Social Security Act, as amended by the collection of information between 30 ACF Reports Clearance Officer. Personal Responsibility and Work and 60 days after publication of this [FR Doc. 2015–28815 Filed 11–12–15; 8:45 am] Opportunity Reconciliation Act of 1996, document in the Federal Register. BILLING CODE 4184–22–P requires each State to annually assess VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\13NON1.SGM 13NON1


Document Created: 2018-03-01 11:22:38
Document Modified: 2018-03-01 11:22:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactIt is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. [GRAPHIC] [TIFF OMITTED] TN13NO15.002
FR Citation80 FR 70218 
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