Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49819 

crosswalk to include comparable 

standards to require disclosure of the 

names and addresses of the facility’s 

owners, or those with a controlling 

interest in the CAH or in any 

subcontractor in which the CAH 

directly or indirectly has a 5 percent or 

more ownership interest. 

• Section 485.645(a)(2): Updated its 

crosswalk to include the correct 

regulatory language to require that the 

facility limits inpatient beds to no more 

than 25 and is verified on all surveys. 

• Section 488.5(a)(4)(vii): Updated its 

policies and review process to ensure 

that approved plans of correction fully 

address all non-compliant practices 

identified during the survey; that 

appropriate policy changes have been 

made to ensure compliance; and that 

plans of correction identify the 

responsible party for ensuring corrective 

actions are implemented within the 

CAH and contain a description of how 

the CAH will monitor and evaluate the 

effectiveness of the corrective actions, 

analyze the data, and report findings to 

the senior leadership and governing 

body to ensure continued regulatory 

compliance. 

• Section 488.5(a)(12): Provided CMS 

with assurance that its procedures for 

responding to, and investigating 

complaints against accredited facilities 

are fully implemented and followed. 

• Section 488.26(b): Revised surveyor 

documentation to include appropriately 

detailed deficiency statements that 

clearly support the determination of 

noncompliance and appropriate level of 

deficiency. 

TJC revised its survey policy and 

procedure to clearly delineate that a 

survey will not occur until after the 

applicable Regional Office has made a 

determination of the CAH’s compliance 

with location and distance 

requirements. 

B. Term of Approval 

Based on our review and observations 

described in section III of this final 

notice, we have determined that TJC’s 

CAH program requirements meet or 

exceed our requirements, and its survey 

processes are comparable to ours. 

Therefore, we approve TJC as a national 

accreditation organization for critical 

access hospitals that request 

participation in the Medicare program, 

effective November 21, 2017 through 

November 21, 2023. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

Dated: October 16, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2017–23449 Filed 10–26–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9105–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—July Through September 

2017 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This quarterly notice lists 

CMS manual instructions, substantive 

and interpretive regulations, and other 

Federal Register notices that were 

published from July through September 

2017, relating to the Medicare and 

Medicaid programs and other programs 

administered by CMS. 

FOR FURTHER INFORMATION CONTACT: It is 

possible that an interested party may 

need specific information and not be 

able to determine from the listed 

information whether the issuance or 

regulation would fulfill that need. 

Consequently, we are providing contact 

persons to answer general questions 

concerning each of the addenda 

published in this notice. 

BILLING CODE 4120–01–P 

BILLING CODE 4120–01–C 

I. Background 

The Centers for Medicare & Medicaid 

Services (CMS) is responsible for 

administering the Medicare and 

Medicaid programs and coordination 

and oversight of private health 

insurance. Administration and oversight 

of these programs involves the 

following: (1) Furnishing information to 

Medicare and Medicaid beneficiaries, 

health care providers, and the public; 

and (2) maintaining effective 

communications with CMS regional 

offices, state governments, state 

Medicaid agencies, state survey 

agencies, various providers of health 

care, all Medicare contractors that 

process claims and pay bills, National 

Association of Insurance Commissioners 

(NAIC), health insurers, and other 


asabaliauskas on DSKBBXCHB2PROD with NOTICESEN27OC17.002</GPH>
49820 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

stakeholders. To implement the various 

statutes on which the programs are 

based, we issue regulations under the 

authority granted to the Secretary of the 

Department of Health and Human 

Services under sections 1102, 1871, 

1902, and related provisions of the 

Social Security Act (the Act) and Public 

Health Service Act. We also issue 

various manuals, memoranda, and 

statements necessary to administer and 

oversee the programs efficiently. 

Section 1871(c) of the Act requires 

that we publish a list of all Medicare 

manual instructions, interpretive rules, 

statements of policy, and guidelines of 

general applicability not issued as 

regulations at least every 3 months in 

the Federal Register. 

II. Format for the Quarterly Issuance 

Notices 

This quarterly notice provides only 

the specific updates that have occurred 

in the 3-month period along with a 

hyperlink to the full listing that is 

available on the CMS Web site or the 

appropriate data registries that are used 

as our resources. This is the most 

current up-to-date information and will 

be available earlier than we publish our 

quarterly notice. We believe the Web 

site list provides more timely access for 

beneficiaries, providers, and suppliers. 

We also believe the Web site offers a 

more convenient tool for the public to 

find the full list of qualified providers 

for these specific services and offers 

more flexibility and ‘‘real time’’ 

accessibility. In addition, many of the 

Web sites have listservs; that is, the 

public can subscribe and receive 

immediate notification of any updates to 

the Web site. These listservs avoid the 

need to check the Web site, as 

notification of updates is automatic and 

sent to the subscriber as they occur. If 

assessing a Web site proves to be 

difficult, the contact person listed can 

provide information. 

III. How To Use the Notice 

This notice is organized into 15 

addenda so that a reader may access the 

subjects published during the quarter 

covered by the notice to determine 

whether any are of particular interest. 

We expect this notice to be used in 

concert with previously published 

notices. Those unfamiliar with a 

description of our Medicare manuals 

should view the manuals at http://

www.cms.gov/manuals. 

Dated: October 20, 2017. 

Kathleen Cantwell, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 

BILLING CODE 4120–01–P 


asabaliauskas on DSKBBXCHB2PROD with NOTICES

EN27OC17.003</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

Publication Dates for the Previous Four Quarterly Notices 

We publish this notice at the end of each quarter reflecting 

information released by CMS during the previous quarter. The publication 

dates of the previous four Quarterly Listing of Program Issuances notices 

are: November 2016 (81 FR 79489, February 23, 2017 (82 FR 11456), 

May 5, 2017 (82 FR 21241) and August 4, 2017 (82 FR 36404). We are 

providing only the specific updates that have occurred in the 3-month 

period along with a hyperlink to the website to access this information and a 

contact person for questions or additional information. 

Addendum 1: Medicare and Medicaid Manual Instructions 

(July through September 2017) 

The CMS Manual System is used by CMS program components, 

partners, providers, contractors, Medicare Advantage organizations, and 

State Survey Agencies to administer CMS programs. It offers day-to-day 

operating instructions, policies, and procedures based on statutes and 

regulations, guidelines, models, and directives. In 2003, we transformed the 

CMS Program Manuals into a web user-friendly presentation and renamed 

it the CMS Online Manual System 

How to Obtain Manuals 

The lnlemel-only Manuals (I OMs) are a replica of lhe Agency's 

official record copy. Paper-based manuals are CMS manuals lhal were 

officially released in hardcopy. The majority of these manuals were 

tmnsferred into the Intemet-only manual (10M) or retired. Pub 15-1, Pub 

15-2 and Pub 45 are exceptions to this rule and are still active paper-based 

manuals. The remaining paper-based manuals are for reference purposes 

only. If you notice policy contained in the paper-based manuals that was 

not transferred to the 10M, send a message via the CMS Feedback tool. 

Those wishing to subscribe to old versions of CMS manuals should 

contact the National Technical Information Service, Department of 

Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone 

(703-605-6050). You can download copies of the listed material free of 

charge at: http://cms.gov/manuals. 

How to Review Transmittals or Program Memoranda 

Those wishing to review transmittals and program memoranda can 

access this information at a local Federal Depository Library (FDL). Under 

the FDL program, govemment publications are sent to approximately 1,400 

designated libraries throughout the United States. Some FDLs may have 

arrangements to transfer material to a local libr

FDL. Contact any library to locate the nearest 

available at http://www.gpo.gov/libraries/ 

In addition, individuals may contact re

that receive and retain at least one copy of mos

publications, either in printed or microfilm formpublic. These libraries provide reference servic

however, they are not sales outlets. Individuals 

about the location of the nearest regional depos

library. CMS publication and transmittal numb

entitled Medicare and Medicaid Manual Instruc

the materials, usc the CMS publication and tran

example, to find the manual for Quarterly Upda

Coding Initiative (NCCI) Procedure to Procedu

23.3, Effective October 1, 2017 use (CMS-Pub

Transmittal No. 3807. 

Addendum I lists a unique CMS transm

instruction in our manuals or program memoran

A transmittal may consist of a single or multipl

necessary to use infonnation in a transmittal in 

information currently in the manual. For tl1e pu

notice, we list only the specific updates to tl1e l

lhal have occurred in lhe 3-monlh period. This 

our website at www.cms.gov/Manuals. 

Transmittal Manual/Subject/Publ

Number 

.. 

106 Issued to a specific audience, not posted to 

Confidentiality of Instruction 

107 Affordable Care Act Bundled Payments fo

Recurring File Updates Models 2 and 4 Ja

,;z f<'1( 

None 

199 Percutaneous Image-guided Lumbar Deco

Spinal Stenosis (LSS) 

Percutaneous Image-guided Lumbar Dec

Spinal Stenosis (LSS)(Various Effective D

200 Percutaneous Image-guided I .umhar Deco

Spinal Stenosis (LSS) 

Spinal Stenosis (LSS)(Various Effective 

201 National Coverage Determination (NCD2

Leadless Pacemakers 

EN27OC17.004</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

202 Updates to Pub. 100-04, Chapter 18 Preventive and Screening Services and 3819 Issued to a specific audience, not posted t

Chapter 32 Billing Requirements for Special Services and Publication 100-03, Contldentiality of Instmction 

Chapter I Coverage Determinations Part 4 3820 Issued to a specific audience, not posted t

;?;;_. . c2J:iic of Instmction 

3805 Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar 3821 Issued to a specific audience, not posted t

Spinal Stenosis (LSS) Confidentiality of Instmction 

Claims Processing Requirements for Percutaneous Image-guided Lumbar 3822 Issued to a specific audience, not posted t

Decompression (PILD) for Lumbar Spinal Stenosis (LSS) on Professional Contldentiality of Instmction 

Claims 3823 Issued to a specific audience, not posted t

3806 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction 

Confidentiality of Instmction 3824 July Quarterly Update for 2017 Durable M

3807 Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure Orthotics, and Supplies (DMEPOS) Pee S

lo Procedure (PTP) Edils, Version 23.3, EITeclive Oclober 1, 2017 3825 October Quarterly Update to 2017 Annua

3808 Issued to a specific audience, not posted to Intemet/Intranet due to Skilled Nursing Facility (SNF) Consolida

Confidentiality of Instmction 3826 Inpatient Psychiatric Facilities Prospectiv

3809 October 2017 Quarterly Average Sales Price (ASP) Medicare Part B Dmg Year (FY) Annual Update 

Pricing Files and Revisions to Prior Quarterly Pricing Files 3827 Quarterly Influenza Vims Vaccine Code U

3810 Issued to a specific audience, not posted to Intemet/Intranet due to Table of Preventive and Screening Servi

Confidenlialily oflnslruclion Healthcare Common Procedure Coding 

3811 Percutaneous Image-guided Lumbar Decompression (PILU) for Lumbar Codes 

Spinal Stenosis (LSS) CWF Edits on AlB MAC (A) Claims 

3812 New Waived Tests CWF Edits on AlB MAC (B) Claims 3813 Accepting Hospice Notices of Election via Electronic Data Interchange CWF Crossover Edits for AlB MAC (B) 

Procedures for Ilospice Election and Related Transactions 3828 Update to Hospice Payment Rates, Hospi

Kotice of Election (NOE) Hospice Pricer for FY 2017 

J\otice of Termination/Revocation (NOTR) 3829 Revisions to the Home Health Pricer to S

Change of Provider/Transfer Notice Payment Standardization 

Cancellation of an Election 3830 Issued to a specific audience, not posted t

Change of Ownership Notice Confidentiality of Instmction 

Data Required on the Institutional Claim to AlB MAC (HHH) 3831 Screening for Hepatitis B Vims (HBV) 

Independent Attending Physician Services Inslilulional Billing Requiremenls 

3814 Updated Editing of Always Therapy Services- MCS Claims Processing Professional Billing Requirements 

Requirements for Financial Limitations Diagnosis Code Reporting Requirement

3815 National Coverage Determination (NCD20.8.4): Leadless Pacemakers Claim Adjustment Reason Codes (CARC

T .eadless Pacemaker Codes (RARCs), Crt"oup Codes, and Medi

Leadless Pacemaker Coding and Billing Requirements for Professional Messages 

Claims 3832 Fiscal Year (FY) 2017 Inpatient Prospect

Leadless Pacemaker Place of Service Reslriclions Long Term Care Hospital (LTCH) PPS C

Leadless Pacemaker Modifier 3833 Quarterly Update to the End-Stage Renal 

Leadless Pacemaker Additional Claim of Billing Information Payment System (PPS) 

Leadless Pacemaker Claim Adjustment Reason Codes (CARC), Remittance 1814 Issued to a specific audience, not posted t

Advice Remark Codes (RARC) and Medicare Summary Notice (MSN) Confidentiality of Instmction 

Messages 3835 Screening for the Human Immunodeficien

3816 Issued to a specific audience, not posted to Intemet/Intranet due to Healthcare Common Procedure Coding 

Confidentiality of Instmction Tests 

3817 Issued to a specitlc audience, not posted to Intemet/Intranet due to Sensitivity Billing Requirements 

of Instmction Payment Method 

3818 Issued to a specific audience, not posted to Intemet/Intranet due to Types of Bill (TOEs) and Revenue Code

Confidentiality of Instmction Diagnosis Code Reporting 

EN27OC17.005</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

Medicare Summary Notice (MSN) and Claim Adjustment Reason Codes 3858 Fiscal Year (FY) 2018 Inpatient Prospect

(CARCs) Long Term Care Hospital (LTCH) PPS C

3836 Home Health Value-Based Purchasing Implementation 3859 October Quarterly Update for 2017 Durab

1817 Influenza Vaccine Payment Allowances- Annual Update for 2017-2018 Orthotics, and Supplies (DMEPOS) Fee S

Season 3860 Instructions for Downloading the Medica

3838 Quarterly Update to the Medicare Physician Fee Schedule Database 3861 Quarterly Update for the Durable Medica

(MPFSDB) - October 2017 Update and Supplies (DMEPOS) Competitive Bi

3839 Claim Status Category and Claim Status Codes Update 2018 

3840 Common Edits and Enhancements Modules (CEM) Code Set Update 3862 Annual Clotting Factor Furnishing Fee U

3841 Implement Operating Rules- Phase III Electronic Remittance Advice (ERA) Furnishing Fee (Chapter 17- Drugs and B

Electronic Funds Transfer (EFT): CORE 360 Uniform Use of Claim 3863 Updated Editing of Always Therapy Serv

Adjustment Reason Codes (CARC), Remittance Advice Remark Codes Requirements for Financial Limitations 

(RARC) and Claim Adjustment Group Code (CAGC) Rule- Update from 3864 October 2017 Update of the Hospital Out

Council for Affordable Quality Healthcare (CAQH) Committee on Operating (OPPS) 

Rules for Information Exchange (CORE) 3865 Instructions for Retrieving the 2018 Pricin

3842 Health care Provider Taxonomy Codes (HPTCs) October 2017 Code Set CMS' Mainframe Telecommunications Sy

Update 3866 Accepting Hospice Notices of Election vi

3843 2018 Healthcare Common Procedure Coding System (HCPCS) Annual Procedures for Hospice Election and Re

Update Reminder Kotice of Election (NO I:) 

3844 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Kotice of Termination/Revocation (NOT

of Instruction Change of Provider/Transfer Notice 

3845 Issued to a specific audience, not posted to Internet/Intranet due to Cancellation of an Election 

Confidentiality of Instruction Change of Ownership Notice 

3846 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Data Required on the Institutional Claim 

of Instruction Independent Attending Physician Servic

3847 Issued to a specific audience, not posted to Internet/Intranet due to 3867 New Waived Tests 

Confidentiality of Instruction 3868 Issued to a specific audience, not posted t

3848 Updates to Pub. I 00-04, Chapter 18 Preventive and Screening Services and Confidentiality of Instruction 

Chapter 32 Billing Requirements for Special Services and Publication 100-03, 3869 Quarterly Update to the National Correct 

Chapter I Coverage Determinations Part 4 Procedure-to-Procedure (PTP) Edits, Ver

3849 Inpatient Rehabilitation facility (IRI') Annual Update: Prospective Payment 3870 Annual Update for the Health Professiona

System (PPS) Pricer Changes for FY 2018 Payments 

3850 Quarterly Healthcare Common Procedure Coding System (HCPCS) 3871 Revisions to Medicare Claims Processing 

Drug/Biological Code Changes - October 2017 Update and Shipboard Claims 

3851 File Conversions Related to the Spanish Translation of the Healthcare .• i''if;;!f. 

Common Procedure Coding System (HCPCS) Descriptions 120 Electronic Correspondence Referral Syste

3852 October 2017 Integrated Outpatient Code Editor (I!OCE) Specifications Medicare Beneficiary Identifier (MBI) 

Version 18.3 Modifications including Updated Enterp

3853 October 2017 Update of the Hospital Outpatient Prospective Payment System Multi-Factor Authentication (MFA)/Rem

(OPPS) Shots 

3854 October 2017 Update of the Ambulatory Surgical Center (ASC) Payment 

System 

ECRS Web User Guide ECRS Quick Reference Card 

3855 Internet Only Manual (!OM) Update to Pub. 100-04, Chapter 15- ;;; ;;.?;}3'::? .. ;iq 

Ambulance, to Restore Multiple Patients on One Trip Instmctions 288 Pub. I 00-6, Chapter 3 and 4 Revisions 

3856 Clarification of the Billing of Immunosuppressive Drugs Billing for 

Immunosuppressive Dmgs 

3857 2018 Annual Update ofHealthcare Common Procedure Coding System 

(HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing 

(CB) Update 

Detern1ining Liability and Waiver of Re

Determination- Limitation of Liability Determination- Waiver of Recovery of 

Overpayments Discovered Subsequent t

How to Determine the Third Calendar Y

EN27OC17.006</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

Approved Confidentiality of Instruction 

Recovery of Overpayment Due to Cost Report 737 Credentials of Reviewers 

Termination of Collection Action Complex Medical Review 

Termination of Collection Action- Provider Overpayments 738 Provider Error Rate Formula 

Termination of Collection Action- Beneficiary Overpayments Provider Error Rate 

Requirements for Collecting Part A and B Provider Non-MSP 739 Issued to a specific audience, not posted t

Overpayments Confidentiality of Instruction 

Debt Ineligible for Referral 

Intent to Refer Letter 

Response to Intent to Refer Letter 

Intermediary Claims Accounts Receivable ( 

Debts RTA by Treasury as Dispute Response not Received Timely (RX) 

Debts RTA by Treasury as a Miscellaneous Dispute, a Manual RTA, 

Complaint or as Recall Approved (RD 

Intent to Refer Letter 

740 Issued to a specific audience, not posted t

Confidentiality of Instruction 

741 Issued to a specific audience, not posted t

Confidentiality of Instruction 

742 Issued to a specific audience, not posted t

Confidentiality of Instruction 

743 Issued to a specific audience, not posted t

of Instruction 

289 Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments 

-4th Qtr Notification for FY 2017 

290 New Specialty Code for Pharmacy Non-Physician Practitioner/Supplier 

Specialty Codes 

291 Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments 

-4th Qtr Notification for FY 2017 

292 Revision to Publication I 00-06, Chapter 3, Medicare Overpayment Manual, 

Section 200, Limitation on Recoupment 

Section 935 of the Medicare Modernization Act (MMA)- Limitation on 

Recoupment Overpayments 

Limitation on Recoupment Section 935(f)(2) Eligibility 

Overpayments Subject to Limitation on Recoupment 

Overpayments Not Subject to Limitation on Recoupment Adjustment of the 

Fee-For-Service Claims 

The Rebuttal Process and the Limitation on Recoupment Extrapolated 935 

Overpayments 

Medicare Secondary Payer (MSP) Provider Duplicate Primary Payment 

(DPP) 

744 Issued to a specific audience, not posted t

Confidentiality of Instruction 

745 Issued to a specific audience, not posted t

Confidentiality of Instruction 

746 Issued to a specific audience, not posted t

Confidentiality of Instruction 

i7ik. 

37 Issued to a specific audience, not posted t

Confidentiality of Instruction 

38 Issued to a specific audience, not posted t

Confidentiality of Instruction 

39 Updates to Pub. 100-09, Chapter 6 Benef

Manual, Chapter 6, Provider Customer Se

Payment Alerts 

None 

; 

Immediate Recoupment Requirements for 935 Overpayments 

Requirements for All Initial Demand Letters (Manual or Electronic) Initial 

None 

f;;'fi' 

Demand None 

293 Revision to Publication I 00-06, Chapter 3, Medicare Overpayment Manual, ·"2 •;!,£.;! 

Section 200, Limitation on Recoupment None 

Vi?:;f!,;Cc'iiffGfi ··. 

170 Revisions to the State Operations Manual (SOM) Appendix A- Survey 

Protocol, R Panl"tion' and TntPmrPtivP Guidelines for Hospitals 

v;.::;: i''" :K';5 ,,:;;z&'Jc';lf::,r:?;,'fi7f/!c 

733 Clarification of Certificate of Medical Necessity (CMN) and Durable Medical 

Equipment Information Forms (DIFs) 

734 Update to Reporting Requirements 

Reconsideration Requests- Non-certified Providers/Suppliers 

External Reporting Requirements 

735 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instruction 

736 Issued to a specific audience, not posted to Intemet/Intranet due to 

EN27OC17.007</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

VC?Y: 1869 Issued to a specific audience, not posted t

13 !OM 100-17 Update of Instruction 

Additional Requirements for MACs 1870 Correcting Payment oflnpatient Prospect

CMS Contracting Officer's Representative (COR) Claims Assigned to 'v!edicare Severity-D

Principal Systems Security Officer (SSO 385 and Allowing Part A Deductible on M

CMS Business Owners Same Day Transfer Inpatient Claims 

CMS System Maintainers/Developers 1871 FIS S Process Enhancements - Analysis O

Personnel Security/Suitability 1872 Common Working File (CWF) to Add Us

Control Components CWF Provider Queries Audit File(s) 

Reporting Requirements 1873 Line Level versus Claim Level Reportin

System Security Plan (SSP) 

Risk Assessment (RA) 

1874 Implementation CR: Integrating NLR into 1875 ICD-10 Coding Revisions to National Co

Contingency Planning Compliance 

1876 Modifications to the National Coordinatio

Crossover Process 

Annual FISMA Assessment (FA) 

Plan of Action and Milestones (POA&M) 

Background POA&M Package Components/Submission Format 

Security Incident Reporting and Response 

Authorization To Operate 

Patch Management 

Security Configuration Management Security Technical Implementation Guides (STIG 

End of Life Technology Components 

Cloud Computing 

Minimum System Security Requirements-HIGH 

Encryption Requirements for Data Leaving Data Centers 

Intemet Security 

!Jf;; Ci4i ;;; ;[ff& '!.('!?' 

1877 Common Working File (CWF) to Modify 

Accept National Provider Identifier (NPI) 

1878 Issued to a specific audience, not posted t

Instruction 

1879 Conunon Working File (CWF) to Increas

Occurrences for Preventive Services to 99 

1880 Shared Savings Program (SSP) Demonstr

1881 Issued to a specific audience, not posted t

ofTnstruction 

1882 Issued to a specific audience, not posted t

of Instruction 

1883 Issued to a specific audience, not posted t

of Instruction 

1884 Analysis Only- Medicare Reporting on th

176 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 

of Instruction 

Overpayments 

1885 Shared System Maintainers (SSMs) Stand

177 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity 

of Instruction 

Format Analysis and Design 

1886 Issued to a specific audience, not posted t

17S Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity 

of Instruction 

of Instruction 

1887 Shared System Enhancement 2015: Ident

179 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity 

of Instruction 

Projects Within the Collllllon Working Fi

1888 Issued to a specific audience, not posted t

· 

1864 Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity 

of Instruction 

of Instruction 

1889 Implementation of the Transitional Drug 

1890 CICS Region Merge(s) for AlB MACs- A

1865 Health Insurance Portability and Accountability Act (HIP AA) Electronic Data 

Interchange (EDI) Front End Updates for January 2018 

1866 National Provider Identification Crosswalk System (NPICS) Retirement 

Analysis Only- Engage Shared Systems Maintainers (SSMs) and Medicare 

Administrative Contractors (MACs) in Meetings and Correspondence Related 

1891 Automating the HCPCS Load Process 

1S92 Shared System Enhancement 2015: Ident

Projects within the Fiscal Intermediary Sh

1893 Combined Common Edits/Enhancements 

Business and Holiday Tables 

to the NPICS Retirement with the Integrated Data Repository (!DR) Team 1894 Issued to a specitlc audience, not posted t

1867 Renovate MCS Correspondence Entry Driver Program H99PlCOO of Instruction 

1868 Fee For Service (FFS) Applications Upgrade Customer Information Control 

System (CICS) to Transaction Server (TS) v5.2 

1895 System Changes to Implement Section 15

Temporary Exception for Certain Severe 

Long-Term Care Hospitals (L TCHs) 

EN27OC17.008</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

1896 Shared System Enhancement 2015: Identify Inactive Medicare Demonstration 

Projects within the Fiscal Intermediary Shared System -

(Removing/ Archiving demonstration codes 03, 04 and 15) 

1897 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instmction 

1898 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instmction 

1899 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instmction 

1900 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

ofTnstmction 

1901 Automating the HCPCS Load Process 1902 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instruction 

1903 Implement Changes to Effect the Functionality of Combination Force Codes 

in the YiPS Medicare System (VMS) 

1904 Multi-Carrier System (MCS), Fiscal Intermediary Shared System (FISS) and 

VIPS Medicare Shared System (VMS) 

Automation of Prior Authorization (PA) Requests/Pre-Claim Reviews (PCR) 

and their Responses with Multiple Services (for programs like Home Health 

(HH)) via the Electronic Submission of Medical Documentation (esMD) 

System 

1905 Modify VMS Accreditation Logic to Accept Additional Modifiers 

1906 Out-of-Jurisdiction Providers (OJP) and Qualified Chain Providers (QCP) 

Move to Correct AlB MAC Jurisdiction - Analysis CR Only 

1907 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instruction 

1908 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instruction 

1909 Implementation of Section 1557 for Medicare Redetermination Notices 

(MRNs) by Adding a Notice and Tagline Sheet 

1910 Guidance on Implementing System Edits for Certain Durable Medical 

Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) 

1911 Part B Detail Line Expansion- Common Working File (CWF) 

1912 HIGLAS Enhancement Required for Implementation of Overpayment based 

Denials 

1913 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instmction 

1914 Shared System Enhancement 2014- Identification of Fiscal Intermediary 

Shared System (FISS) Obsolete On-Request Jobs- Analysis Only 

1915 Medicare Administrative Contractor (MAC) and Pricing, Data Analysis and 

Coding (PDAC) Contractor Implementation of the New Medicare Card 

Project 

1916 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity 

of Instruction 

1917 Shared System Enhancement 2014- Identification of Fiscal Intermediary 

Standard System (FISS) Obsolete Reports - Analysis Only 

1918 Correcting Payment of Inpatient Prospect

Claims Assigned to .\i!edicare Severity-D

385 and Allowing Part A Deductible on M

Same Day Transfer Inpatient Claims 

1919 Targeted Probe and Educate 

1920 Issued to a specific audience, not posted t

of Instmction 

1921 Implementation of Section 1557 for Medi

(MRNs) by Adding a Notice and Tagline 

1922 Shared System Enhancement 2014: Imple

Shared System (FTSS) Obsolete Financial System (ECPS) Reports 

1923 Calculating Interim Rates for Graduate M

to New Teaching Hospitals 

1924 Issued to a specific audience, not posted t

of Instruction 

1925 Guidance on Implementing System Edits 

Equipment, Prosthetics, Orthotics and Su

1926 Issued to a specific audience, not posted t

oflnstruclion 

1927 Shared System Enhancement 2014: Imple

Shared System (FISS) Obsolete Core Rep

;;;, 

367 Fiscal Year 2018 and After Payments to S

That Do Kot Submit Required Quality Da

368 Issued to a specific audience, not posted t

Confidentiality of Instruction 

369 Issued to a specific audience, not posted t

Confidentiality of Instruction 

'"ih'"'/;;:;;': 

3 Issued to a specific audience, not posted t

Confidentiality of Instruction 

Addendum II: Regulation Doc

in the Federal Register (July throu

Regulations and Notices 

Regulations and notices are published 

Register. To purchase individual copies or sub

Register, contact GPO at www.gpo.gov/fdsys. 

copies, it is necessary to cite either the date of p

number and page number. 

The Federal Register is available as a

GPO Access. The online database is updated b

Federal Register is published. The database i

graphics from Volume 59, Number 1 (January 

date and can be accessed at http://www.gpoacc

EN27OC17.009</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

following website http:/ /www.archives.gov/federal-register/ provides 

information on how to access electronic editions, printed editions, and 

reference copies. 

This information is available on our website at: 

http://www. ems. gov I quarterlyproviderupdates/downloads/Regs3Q17QPU.pdf 

For questions or additional information, contact Terri Plumb 

( 410-786-4481 ). 

Addendum III: CMS Rulings 

(July through September 2017) 

CMS Rulings are decisions of the Administrator that serve as 

precedent final opinions and orders and statements of policy and 

interpretation. They provide clarification and interpretation of complex or 

ambiguous provisions of the law or regulations relating to Medicare, 

Medicaid, Utilization and Quality Control Peer Review, private health 

insurance, and related matters. 

The rulings can be accessed at http://>vww.cms.govtKegmauonsFor questions or additional information, 

contact Tiffany Lafferty (410-786-7548). 

Addendum IV: Medicare National Coverage Determinations 

(July through September 2017) 

Addendum IV includes completed national coverage 

determinations (NCDs), or reconsiderations of completed NCDs, from the 

quarter covered by this notice. Completed decisions are identified by the 

section of the NCD Manual (NCDM) in which the decision appears, the 

title, the date the publication was issued, and the effective date of the 

decision. An NCD is a determination by the Secretary for whether or not a 

particular item or service is covered nationally under the Medicare Program 

(title XVIII of the Act), but does not include a determination of the code, if 

any, that is assigned to a particular covered item or service, or payment 

determination for a particular covered item or service. The entries below 

include information concerning completed decisions, as well as sections on 

program and decision memoranda, which also announce decisions or, in 

some cases, explain why it was not appropriate to issue an NCD. 

Information on completed decisions as well as pending decisions has also 

been posted on the CMS website. For the purposes of this quarterly notice, 

we are providing only the specific updates that have occurred in the 3-

month period. This information is available at: www.cms.gov/medicareTitle NCDM Transmitt

Section Number 

National Coverage Determination 20.8.4 201 

(NCD20.8.4): Leadless Pacemakers Addendum V: FDA-Approved Categor

Exemptions (IDEs) (July throug

Addendum V includes listings of the 

investigational device exemption (IDE) numb

listings are organized according to the categor

assigned (that is, Category A or Category B), 

number. For the purposes of this quarterly no

updates to the Category BIDEs as of the endi

by this notice and a contact person for questio

For questions or additional information, conta

6877). Under the Food, Drug, and Cosmetic 

fall into one of three classes. To assist CMS u

process, the FDA assigns one of two categorie

investigational device exemption (IDE). Cate

IDEs, and Category B refers to non-experime

information about the classes or categories, pl

published in the April21, 1997 Federal Regi

IDE Device 

BB17544 Magnetic-Activated Cell Sorter (CliniMAC

alpha/beta and CD19 T-cell depletion PBSC

BB17595 CliniMACS® TCRaB/CD19 Combined De

BB17601 Hemanext Red Blood Cell Processing SystBB17615 The Tissue Genesis Icellator Cell Isolation 

G140210 LABS ADHESION BARRIER G170039 Vas Q Device 

Gl70063 V ercise PC Deep Brain Stimulation System 

G170080 ZOLL Proteus Intravascular Temperature M

(IVTM) System G170086 AGNES 

G170104 Eximo Medical B-Laser Hybrid Atherectom

Gl70106 En do Rotor 

G170113 Coherex WaveCrest Left Atrial Appendage 

EN27OC17.010</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

IDE Device Start Date 

Gl70122 DCB Drug Coated Balloon Catheter 08/24/2017 Gl70123 Medrobotics Flex System 07/28/2017 

G170136 The Sprinter Over-the-Wire Semicompliant Balloon 08/22/2017 

Dilatation Catheter 

Gl70145 novottf-200A 08111/2017 Gl70149 SPRIJ\T PNS System 07/03/2017 

G170151 Bovie Ultimate Electrosurgical Generator; Bovie Ultimate 07/13/2017 

Electrosurgical Generator; Rovie .T-Plasma Precise Open 

handpieces; Bovie J-Plasma Precise Open handpieces 

Gl70153 WVEDERM VOLUMA XC with cannula 07/12/2017 Gl70154 Randomized Trial of Ilybrid Coronary Revascularization 07/14/2017 

versus Percutaneous Coronary Intervention 

Gl70157 Theranova 400 Dialyzer 07/14/2017 Gl70160 Exablate Model4000 Type-2 for Blood-Brain Barrier 09/29/2017 

Disruption (BBBD) 

Gl70161 Chronic Venous Thrombosis: Reliefwith Adjunctive 07/21/2017 

Catheter-Directed Therapy (C-TRACT) Trial 

Gl70162 Clotbust ER (Sonolysis Headframe System) Model3.0C 09/17/2017 Gl70164 BOND MSLN (5B2) assay 07/20/2017 Gl70166 PASCAL Transcatheter Mitral Valve Repair System 07/25/2017 Gl70169 DISCSS Spinal Cord SCS System 07/28/2017 Gl70172 AcrySofiQ PanOptix Intraocular Lens 07/28/2017 Gl70173 LUM Imaging System 07/28/2017 Gl70174 Cartiva Synthetic Cartilage Implant for CMC 08/03/2017 Gl70175 AcrySofiQ Extended Depth of Focus (EDF) Intraocular Lens 08/02/2017 

(IOL) 

Gl70184 Orion Visual Cortical Prothesis System 08/16/2017 Gl70185 NeuroStar TMS System 08/24/2017 Gl70191 LFP Beta aDBS System 08/24/2017 Gl70192 BabyGentleStick 08/30/2017 Gl70193 TULASystem 08/30/2017 

Gl70194 Model1000C Generator; Model3000C Programmer 09/01/2017 

Gl70195 Oxiplex 08/31/2017 Gl70196 Valiant PS-IDE Stent Graft System with Captiva Delivery 08/31/2017 

System 

Gl70197 LC Bead LUMI (BTG-004387) 08/31/2017 

Gl70198 Exatherm TBH 08/23/2017 Gl70200 The Bidirectional Neural Bypass System 08/31/2017 Gl70202 ProSpace System 09/07/2017 Gl70208 ExAblate Model4000 Type-1 ("ExAblate Neuro") System 09/15/2017 

Gl70211 Belotero Balance Dermal Filler 09/15/2017 

Gl70212 NeuroStar Transcranial Magnetic Stimulation (TMS) Therapy 09/16/2017 

System 

Gl70221 FLExAbility Sensor Enabled Substrate Targeted Ablation for 09/29/2017 

Reduction of VT (LESS-VT) Study 

Gl70222 Therasphere 09/27/2017 Gl70224 VENT ANA HER2neu ( 4B5) IUO Assay; INFORM HER2 09/29/2017 

Device Dual ISH DNA Probe Cocktail IUO Assa·· 

Addendum VI: Approval Numbers for 

(July through Septemb

All approval numbers are available t

Under the review process, approved informat

assigned Ol'v!B control numbers. A single con

several related information collections. This 

www.reginfo.gov/public/do/PRAMain. For q

information, contact William Parham (410-78

Addendum VII: Medicare-Approved 

(July through Septemb

Addendum VII includes listings of M

stent facilities. All facilities listed meet CMS 

carotid artery stenting for high risk patients. 

our decision memorandum on carotid artery s

carotid artery stenting with embolic protectio

only if performed in facilities that have been d

performing the evaluation, procedure, and fol

optimal patient outcomes. We have created a 

facilities modeled in part on professional soci

All facilities must at least meet our standards 

for carotid artery stenting for high risk patient

quarterly notice, we are providing only the spoccurred in the 3-month period. This informa

http://www. ems. gov /MedicareApprovedFacil

For questions or additional information, conta

(410-786-2749). 

Facility Pr

N

r£:,:f;}; )7;; ;;:Is< 

Good Samaritan Hospital Multi Care Health 18

System 401 15th Ave SE Puyallup, WA 98372 

UPMC Altoona 16

620 Howard Avenue Altoona, PA 16601-4899 

Chippenham and Johnston Willis Medical Center 49

7101 Jahnke Road Richmond, VA 23225 

St. Helena Hospital- Napa Valley 05

10 Woodland Road St. Helena, CA 94574 

Glens Falls Hospital 18

EN27OC17.011</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

Facility Provider Effective State 

Number Date 

100 Park Street Glens Falls, NY 12801 

Memorial Hospital West 100281 08115/2017 FL 

703 North Flamingo Road 

Pembroke Pines, I'L 33028 

r ; 

FROM: Shands Hospital at the University of 100113 06/29/2005 FL Florida 

TO: UF Health Shands Hospital 

1600 SW Archer Road 

Gainesville, FL 32610 

Poplar Bluff Regional Medical Center 260119 08/23/2005 MO 

3100 Oak Grove Road 

Poplar Bluff, MO 63901 

Mercy Hospital Joplin 260001 04/19/2005 MO 

100 Mercy Way 

Joplin, MO 64804-4524 

Addendum VIII: 

American College of Cardiology's National Cardiovascular Data 

Registry Sites (July through September 2017) 

Addendum VIII includes a list of the American College of 

Cardiology's National Cardiovascular Data Registry Sites. We cover 

implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as infom1ation about the procedures is reported to a 

central registry. Detailed descriptions of the covered indications are 

available in the NCD. In January 2005, CMS established the lCD 

Abstraction Tool through the Quality Network Exchange (QNet) as a 

temporary data collection mechanism. On October 27, 2005, CMS 

announced that the American College of Cardiology's National 

Cardiovascular Data Registry (ACC-NCDR) lCD Registry satisfies the data 

reporting requirements in the NCD. Hospitals needed to transition to the 

ACC-NCDR lCD Registry by April2006. 

Effective January 27, 2005, to obtain reimbursement, Medicare 

NCD policy requires that providers implanting ICDs for primary prevention 

clinical indications (that is, patients without a history of cardiac arrest or 

spontaneous arrhythmia) report data on each primary prevention lCD 

procedure. Details of the clinical indications that are covered by Medicare 

and their respective data reporting requirements are available in the 

Medicare NCD Manual, which is on the CMS website at 

A provider can use either of two mec

reporting requirement. Patients may be enroll

Device Exemption trial studying ICDs as iden

ACC-NCDR lCD registry. Therefore, for a be

Medicare-covered lCD implantation for prima

must receive the scan in a facility that particip

registry. The entire list of facilities that partic

registry can be found at www.ncdr.com/webn

For the purposes of this quarterly not

specific updates that have occurred in the 3-m

is available by accessing our website and click

American College of Cardiology's N

Registry at: www.ncdr.com/webncdr/common

information, contact Sarah Fulton, MHS ( 410

Facility Ci

Gulf Pointe Surgery Center Po

Termination date: 9/22/17. See case 00368616. They no longer perform these procedures. 

Lake Area Medical Center La

Termination date: 9/28/17. Please see case 

00363080. TI1ey would like to tenninate CathPCI 

and ICD because cardiology services at their 

facility were discontinued effective 7/1117. 

Doctor's Same Day Surgery Center Sa

Termination date: 9/20/17. See case 00368426. 

Providers no longer perform procedures. 

Addendum IX: Active CMS Coverage-Re

(July through Septemb

CMS issued a guidance document on 

"Guidance for the Public, Industry, and CMS 

Evidence Development Document". Althoug

vehicles relating to evidence development acti

investigational device exemption (IDE), the cl

coverage determinations and local coverage ddocument is principally intended to help the p

implementation of coverage with evidence de

national coverage determination process. The 

EN27OC17.012</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

http://www. ems. gov /medicare-coverage-database/ details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional 

Active CMS Coverage-Related Guidance Documents for the 3-month 

period. For questions or additional information, contact 

JoAnna Baldwin, MS (410-786-7205). 

Addendum X: 

List of Special One-Time Notices Regarding National Coverage 

Provisions (July through September 2017) 

There were no special one-time notices regarding national 

coverage provisions published in the 3-month period. This information is available at www.cms.hhs.gov/coverage. For questions or additional 

information, contact JoAnna Baldwin, MS (410-786 7205). 

Addendum XI: National Oncologic PET Registry (NOPR) 

(July through September 2017) 

Addendum XI includes a listing of National Oncologic Positron 

Emission Tomography Registry (NOPR) sites. We cover positron emission 

tomography (PET) scans for particular oncologic indications when they are 

performed in a facility that participates in the NOPR. 

In January 2005, we issued our decision memorandum on positron 

emission tomography (PET) scans, which stated that CMS would cover 

PET scans for particular oncologic indications, as long as they were 

performed in the context of a clinical study. We have since recognized the 

National Oncologic PET Registry as one of these clinical studies. 

Therefore, in order for a beneficiary to receive a Medicare-covered PET 

scan, the beneficiary must receive the scan in a facility that participates in 

the registry. There were no additions, deletions, or editorial changes to the 

listing of National Oncologic Positron Emission Tomography Registry 

(NOPR) in the 3-month period. This information is available at 

http://www.cms.gov/MedicareApprovedFacilitie/NOPR!list.asp#TopOfPage. 

For questions or additional information, contact Stuart Caplan, RN, MAS 

( 410-786-8564 ). 

Addendum XII: Medicare-Approved Ventricular Assist Device 

(Destination Therapy) Facilities (July through September 2017) 

Addendum XII includes a listing of Medicare-approved facilities 

that receive coverage for ventricular assist devices (V ADs) used as 

destination therapy. All facilities were required to meet our standards in 

order to receive coverage for V ADs implanted as destination therapy. On 

October 1, 2003, we issued our decision mem

clinical indication of destination therapy. We 

as destination therapy are reasonable and nece

facilities that have been determined to have th

infrastructure to ensure optimal patient outcom

standards and an application process. All faci

our standards in order to receive coverage for destination therapy. 

For the purposes of this quarterly no

specific updates to the list of Medicare-appro

standards that have occurred in the 3-month p

available at 

http://www. ems. gov /MedicareApprovedF acil

For questions or additional information, conta

(410-786-8616). 

Facility Provider 

Number 

Beth Israel Deaconess Medical Center 22-0086 

330 Brookline Avenue 

Boston, MA 02215 

Mission Hospital 34-0002 

509 Biltmore Avenue 

Asheville, NC 28801-4690 

University Health Care System 110028 

1350 Walton Way Augusta, GA 30901 

Baystate Medical Center 22-0077 

7 59 Chestnut Street 

Springfield, MA 01199 

EN27OC17.013</GPH>asabaliauskas on DSKBBXCHB2PROD with NOTICES

Facility Provider Date 

Approved State 

Nmnber 

Fresno Community Hospital and 50060 12/14/2016 CA 

'vledical Center 

2823 Fresno Street 

Fresno, CA 93721 

'vlaine Medical Center 200009 09/28/2016 TX 

22 Bramhall Street 

Portland, ME 04102 Hackensack 

University Medical Center 310001 09/20/2017 NJ 

10 Prospect 

Avenue 

Hackensack, 

NJ 07601 

FROM : Banner Good Samaritan 030002 07/26/2017 AZ 

\1edical Center 

TO: Banner - University Medical 

Center Phoenix 

1111 East Road 

Phoenix, AZ 85006 

Addendum XIII: Lung Volume Reduction Surgery (LVRS) 

(July through September 2017) 

Addendum XIII includes a listing of Medicare-approved facilities 

that are eligible to receive coverage for lung volume reduction surgery. 

Until May 17, 2007, facilities that participated in the National Emphysema 

Treatment Trial were also eligible to receive coverage. The following three 

types of facilities are eligible for reimbursement for Lung Volume 

Reduction Surgery (L VRS): 

• National Emphysema Treatment Trial (NETT) approved (Beginning 

05/07/2007, these will no longer automatically qualify and can qualify only 

with the other programs); 

• Credentialed by the Joint Commission (formerly, the Joint 

Conunision on Accreditation of Healthcare Organizations (JCAHO)) under 

their Disease Specific Certification Program for L VRS; and 

• Medicare approved for lung transplants. 

Only the first two types are in the list. There were no updates to 

the listing of facilities for lung volume reduction surgery published in the 

3-month period. This information is available at 

www.cms.gov/MedicareApprovedFacilitie/L VRS!list.asp#TopOfPage. For 

questions or additional information, contact Sarah Fulton, MHS 

(410-786-2749). 

Addendum XIV: Medicare-Approved 

(July through Septem

Addendum XIV includes a listing o

that meet minimum standards for facilities m

society statements on competency. All facil

order to receive coverage for bariatric surge

2006, we issued our decision memorandum 

We determined that bariatric surgical proced

necessary for Medicare beneficiaries who ha

greater than or equal to 35, have at least one 

and have been previously unsuccessful with 

This decision also stipulated that covered ba

reasonable and necessary only when perform

certified by the American College of Surgeo

Surgery Center (program standards and requ

15, 2006); or (2) certified by the American S

(ASBS) as a Bariatric Surgery Center of Ex

standards and requirements in effect on Feb

There were no additions, deletions

Medicare-approved facilities that meet CMS

for bariatric surgery that have been certified 

3-month period. This infonnation is availab

www.cms.gov/McdicarcApprovcdFacilitic/B

questions or additional information, contact 

(410-7S6-2749). 

Addendum XV: FDG-PET for Demen

Diseases Clinical Trials (July thro

There were no FDG-PET for Deme

Diseases Clinical Trials published in the 3-m

This information is available on ou

www. ems. gov /MedicareApprovedF acilitie/

For questions or additional information, con

(410-786-8564). 
49832 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

[FR Doc. 2017–23447 Filed 10–26–17; 8:45 am] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1076] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection in the guidance on ‘‘Formal 

Dispute Resolution: Scientific and 

Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 26, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 26, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 26, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–N–1076 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

for Industry on Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 


asabaliauskas on DSKBBXCHB2PROD with NOTICES