45986 Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 

and dollars, and improve Americans’ 

quality of life. CDC is mandated to 

provide ongoing administrative, 

research, and technical support for the 

operations of the CPSTF. During its 

meetings, the CPSTF considers the 

findings of systematic reviews of 

existing research and practice-based 

evidence and issues recommendations. 

CPSTF recommendations are not 

mandates for compliance or spending. 

Instead, they provide information about 

evidence-based options that decision 

makers and stakeholders can consider 

when they are determining what best 

meets the specific needs, preferences, 

available resources, and constraints of 

their jurisdictions and constituents. The 

CPSTF’s recommendations, along with 

the systematic reviews of the evidence 

on which they are based, are compiled 

in the The Community Guide. 

Matters proposed for discussion: The 

agenda will consist of deliberation on 

systematic reviews of literature and is 

open to the public. Topics will include 

Cancer Screening; HIV Prevention; 

Nutrition, Physical Activity, and 

Obesity; Social Determinants of Health, 

and Violence Prevention. Information 

regarding the start and end times for 

each day, and any updates to agenda 

topics, will be available on the 

Community Guide website 

(www.thecommunityguide.org) closer to 

the date of the meeting. 

The meeting agenda is subject to 

change without notice. 

Dated: August 11, 2021. 

Sandra Cashman, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2021–17556 Filed 8–16–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9131–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—April Through June 2021 

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 April through June 

2021, 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. 

Addenda Contact Phone No. 

I CMS Manual Instructions ......................................................................................................... Ismael Torres ..................... (410) 786–1864 

II Regulation Documents Published in the Federal Register ................................................... Terri Plumb ......................... (410) 786–4481 

III CMS Rulings .......................................................................................................................... Tiffany Lafferty ................... (410) 786–7548 

IV Medicare National Coverage Determinations ........................................................................ Wanda Belle, MPA ............. (410) 786–7491 

V FDA-Approved Category B IDEs ............................................................................................ John Manlove ..................... (410) 786–6877 

VI Collections of Information ...................................................................................................... William Parham .................. (410) 786–4669 

VII Medicare-Approved Carotid Stent Facilities ......................................................................... Sarah Fulton, MHS ............ (410) 786–2749 

VIII American College of Cardiology-National Cardiovascular Data Registry Sites .................. Sarah Fulton, MHS ............ (410) 786–2749 

IX Medicare’s Active Coverage-Related Guidance Documents ................................................ JoAnna Baldwin, MS .......... (410) 786–7205 

X One-time Notices Regarding National Coverage Provisions ................................................. JoAnna Baldwin, MS .......... (410) 786–7205 

XI National Oncologic Positron Emission Tomography Registry Sites ..................................... David Dolan, MBA .............. (410) 786–3365 

XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities .................. David Dolan, MBA .............. (410) 786–3365 

XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ......................................... Sarah Fulton, MHS ............ (410) 786–2749 

XIV Medicare-Approved Bariatric Surgery Facilities .................................................................. Sarah Fulton, MHS ............ (410) 786–2749 

XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials .......................... David Dolan, MBA .............. (410) 786–3365 

All Other Information ..................................................................................................................... Annette Brewer .................. (410) 786–6580 

SUPPLEMENTARY INFORMATION: 

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 website 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 website 

list provides more timely access for 

beneficiaries, providers, and suppliers. 

We also believe the website offers a 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 45987 

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 

websites have listservs; that is, the 

public can subscribe and receive 

immediate notification of any updates to 

the website. These listservs avoid the 

need to check the website, as 

notification of updates is automatic and 

sent to the subscriber as they occur. If 

assessing a website 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. 

The Director of the Office of Strategic 

Operations and Regulatory Affairs of the 

Centers for Medicare & Medicaid 

Services (CMS), Kathleen Cantwell, 

having reviewed and approved this 

document, authorizes Lynette Willson, 

who is the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: August 11, 2021. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

and Medicaid Services. 

BILLING CODE 4120–01–P 


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EN17AU21.000</GPH>khammond on DSKJM1Z7X2PROD 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: August 12, 2020 (85 FR 48691), November 4, 2020 (85 FR 70168), 

March 17, 2021 (86 FR 14629) and May 3, 2021 (86 FR 23373). 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 I: Medicare and Medicaid Manual Instructions 

(April through June 2021) 

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 Internet-only Manuals (IOMs) arc a replica of the Agency's 

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

officially released in hardcopy. The majority of these manuals were 

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 

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 IOM, 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, government publications are sent to approximately 1,400 

designated libraries throughout the United States. Some FDLs may have 

arrangements to transfer material to a local library not designated as an 

FDL. Contact any library to locate the nearest FDL. This information is 

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

In addition, individuals may contact regional depository libraries 

that receive and retain at least one copy of most federal government 

publications, either in printed or microfilm form

public. These libraries provide reference service

however, they are not sales outlets. Individuals 

about the location of the nearest regional deposit

library. CMS publication and transmittal numbe

entitled Medicare and Medicaid Manual Instruct

the materials, use the CMS publication and trans

example, to find the manual for 2021 Durable M

Prosthetics, Orthotics, and Supplies Healthcare C

System (HCPCS) Code Jurisdiction List, use (CM

Transmittal No. 10737. 

Addendum I lists a unique CMS transm

instruction in our manuals or program memoran

A transmittal may consist of a single or multiple 

necessary to use information in a transmittal in c

information currently in the manual. 

Fee-For Service Transmittal Numbers 

Please Note: Beginning Friday, March 

following change regarding the Advance Notice 

CMS internal process change. Fee-For Service T

no longer be determined by Publication The Tr

issued by a single numerical sequence beginning 

10000. 

For the purposes of this quarterly notice

updates to the list of manual instructions that hav

period. This information is available on our web

www.cms.gov/Manuals. 

Transmittal Manual/Subject/Pub

Number 

10757 Physician Certification and Recertificatio

Incorporate Allowed Practitioners into Ho

Recertification by Physicians and Allowe

Services Content of the Phvsician's or All

10783 Issued to a specific audience, not posted t

Confidentiality of Instructions 

10784 Issued to a specific audience, not posted t

Confidentiality of Instructions 

10729 Updates to Medicare Benefit Policy Manu

and Federally Qualified Health Center (F

Only) of Acronyms 

Care Management Services General Care Management Services - Chronic C

10738 Home Health Manual Update to hupleme

Anticipated Pavment Policies and Correct

EN17AU21.001</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

Percentage Payment Approach to the 30-Day Period Unit of Payment and Neonatal Intensive Care (Codes 9929

Requirements for Submission of"No-Pay" RAPs 10756 Issued to a specific audience, not posted t

Who May Sign the Certification or Recertification? Confidentialitv of Instruction 

Recertification for Home Health Beneficiaries 10758 Replacing Home Health Request~ for Ant

Notice of Admission (NOA) -- Manual In

10796 National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor 10760 Issued to a specific audience, not posted t

(CAR) T-cell Therapy - This CR Rescinds and Fully Replaces CR 11783. Confidentiality of Instruction 

Chimeric Antigen Receptor (CAR) T-cell theraov 10762 Issued to a specific audience, not posted t

10797 National Coverage Determination (NCD) Removal Confidentiality of Instruction 

Extracorporeal Immunoadsorption (ECI) Using Protein A Columns 10766 Issued to a specific audience, not posted t

Electrosleep Therapy Confidentialitv of Instruction 

Implantation of Gastrointestinal Reflux Devices 10768 Issued to a specific audience, not posted t

Abarclix for the Treatment of Prostate Cancer Confidentialitv of Instruction 

Magnetic Resonance Spectroscopy 

Positron Emission Tomography (PET) Scans 

10771 Issued to a specific audience, not posted t

Confidentialitv of Instruction 

FDG PET for Inflammation and Infection 

10818 National Coverage Determination (NCD) 210.3 - Screening for Colorectal 

10773. Issued to a specific audience, not posted t

Confidentialitv of Instruction 

Cancer (CRC)-Rlood-Ra~ed Riomarker Test~ 

Colorectal Cancer Screening Tests 

10775 Issued to a specific audience, not posted t

Confidentialitv of Instruction 

10838 National Coverage Determination (NCD) Removal 

Extracorporeal Immunoadsorption (ECI) Using Protein A Columns Electrosleep Therapy 

Implantation of Gastrointestinal Reflux Devices 

Abarelix for the Treatment of Prostate Cancer 

Magnetic Resonance Spectroscopy Positron Emission Tomography (PET) Scans FDG PET for Inflammation and Infection 

10782 Issued to a specific audience, not posted t

Confidentiality of Instruction 

10788 Issued to a specific audience, not posted t

Confidentiality of Instruction 

10793 Quarterly Update to the Medicare Physici

(MPFSDB) - July 2021 Update 

10794 Issued to a specific audience, not posted t

Confidentiality of Instruction 

10702 April 2021 Update of the Ambulatory Surgical Center (ASC) Payment 

System 

10703 Issued to a specific audience, not posted to Internet/Intranet due to a 

Sensitivity of Instruction 

10704 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instructions 

10796 National Coverage Determination (NCD 

(CAR) T-cell Therapy- This CR Rescind

Chimeric Antigen Receptor (CAR) T-ce

Coverage Requirements 

Billing Requirements Medicare Administrative Contractor (M

Revenue Codes 

10713 Issued to a specific audience, not posted to Internet/Intranet due to 

Confidentiality of Instructions Billing Healthcare Common Procedural 

Diagnosis Requirements 

10716 Common Working File (CWF) Edits for Medicare Telehealth Services and Payment Requirements 

Manual Update 

Telehealth Consultation Services, Emergency Department or Initial Inpatient 

Claim Adjustment Reason Codes (CARC

Codes (RARCs), Group Codes, and Medi

versus Inpatient Evaluation and Management (E/M) Visits Messages 

Payment for Subsequent Hospital Care Services and Subsequent Nursing Claims Editing 

Facilitv Care Services as Telehealth Services 10803 Issued to a specific audience, not posted t

10721 New Waived Tests Confidentiality of Instruction 

10722 Issued to a specific audience, not posted to Internet/Intranet due to a 10809 Annual Updates to the Prior Authorizatio

Confidentialitv of Instruction Holiday Schedule Tables for Generating R

10724 Issued to a specific audience, not posted to Internet/Intranet due to a 10810 Quarterly Update for Clinical Laboratory 

Confidentialitv of Instruction Laboratorv Services Subiect to Reasonabl

10725 File Conversions Related to the Spanish Translation of the Healthcare 10811 October 2021 Healthcare Common Proce

Common Procedure Codine: Svstem (HCPCS) Descriotions Ouarterly Update Reminder 

10728 Issued to a specific audience, not posted to Internet/Intranet due to a 10812 Issued to a specific audience, not posted t

Confidentiality of Instruction Sensitivitv of Instruction 

10737 2021 Durable Medical Equipment Prosthetics, Orthotics, and Supplies 10814 Remittance Advice Remark Code (RARC

Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction (CARC), Medicare Remit Easy Print fMR

List 10815 Issued to a specific audience, not posted t

10742 Revisions of Sections 30.6. l(B), 30.6.12, and 30.6.13(H) of Chapter 12 of Confidentialitv of Instruction 

Selection of Level of Evaluation and Manae:ement Service Critical Care Visits 10816 Issued to a specific audience, not posted t

EN17AU21.002</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

Confidentiality of Instruction Claim Submission and Processing 

10818 National Coverage Determination (NCD) 210.3 - Screening for Colorectal Payment, Claim Adjustments and Cancell

Cancer (CRC)-Blood-Based Biomarker Tests RESERVED 

Preventive and Screening Services Transfer Situation - Payment Effects 

Colorectal Cancer (CRC) Screening Payment Deductible and Coinsurance Discharge and Readmission Situation Und

HCPCS Codes, Frequency Requirements, and Age Requirements Payment Adjustments - Partial Period Pay

CWF Edits Payment When Death Occurs During an H

Ambulatory Surgical Center (ASC) Facility Fee Payment Adjustments - Low Utilization P

Determining High Risk for Developing CRC Non-Covered Services RESERVED 

Billing Requirements for Claims Submitted to A/B MACs (A Medicare Payment Adjustments -Applying OASIS 

Summary Notice (MSN) Messages HIPPS Codes 

Remittance Advice Codes Payment Adjustments - Outlier Payments 

10819 Issued to a specific audience, not posted to Internet/Intranet due to a RESERVED 

Confidentialitv of Instruction Changes in a Beneficiary's Payment Sour

10822 Issued to a specific audience, not posted to Internet/Intranet due to a Glossary and Acronym List 

Sensitivity of Instruction Home Health Prospective Payment System 

10823 Combined Common Edits/Enhancements Modules (CCEM) Code Set Uodate Responsibilities of Home Health Agencie

10824 July 2021 Integrated Outpatient Code Editor (1/OCE) Specifications Version 

22.2 

Responsibilities of Providers/Suppliers of 

Billing 

10825 July 2021 Update of the Hospital Outpatient Prospective Payment System 

(OPPS) Clinic Visits 

10826 Shared Svstem Suooort Hours for Aoolication Programming Interfaces ( APis) 

10831 Healthcare Common Procedure Coding System (HCPCS) Codes Subject to 

and Excluded from Clinical Laboratory Improvement Amendments (CUA) 

Edits 

10833 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics, 

and Supplies (DMEPOS) Competitive Bidding Program (CBP) - October 

2021 

10834 Quarterlv Update to Home Health (HH) Grouper 

108% July 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing 

Files and Revisions to Prior Ouarterlv Pricing Files 

Home health Consolidated Billing Edit~ in 

Therapy Editing 

Other Editing Related to Home Health Co

Only Notice of Admission (NOA) Receiv

Admission Period 

No NOA Received and Therapy Services 

Eligibility Query to Determine Status 

CWF Response to Inquiry 

Timeliness and Limitations of CWF Resp

National Home Health Prospective Payme

Opening and Length ofHH PPS Periods o

RESERVED RESERVED 

10837 National Coverage Determination (NCD) 20.9.1 Ventricular Assist Devices 

(VADs) 

Artificial Hearts and Related Devices 

Ventricular Assist Devices (V ADs 

Exhibit: Chart Summarizing the Effects o

PPS Episode File 

Notice of Admission (NOA 

HH PPS Claims 

Post-Cardiotomy 

V ADs for Short-term or Long-term Mechanical Circulatory Support 

Other Replacement Accessories and Supplies for External V ADs or Any 

Beneficiary-Driven Demand Billing Unde

No Payment Billing 

General 

VAD 

10839 Replacing Home Health Requests for Anticipated Payment (RAPs) with a Input/Output Record Layout RESERVED 

Notice of Admission (NOA) -- Manual Instructions 

Creation of HH PPS and Subsequent Refinements 

RESERVED 

The HH PPS Unit of Payment 

Number, Duration, and Claims SubmissionofHH PPS Periods of Care 

Decision Logic Used by the Pricer on Cla

Annual Updates to the HH Pricer 

Medical and Other Health Services Subm

Temporary Suspension of Home Health S

Pavment Procedures for Terminated HHA

More Than One Agency Furnished Home Health Services 

EITect of Eledion of Medicare Advantage (MA) Organization and Eligibility 

Changes on HH PPS 

RESERVED 

10840 Updates to the Internet Only Publication 

Chapter 20, Section 10 

A/B MACs [Part BJ and DME MACs Ju

Where to Bill DMEPOS and PEN Items 

Basis of Medicare Prospective Payment Systems and Case-Mix 

Coding of HH PPS Case-Mix Groups on HH PPS Claims: HHRGs and 

HIPPS Cod 

10844 Issued to a specific audience, not posted t

Confidentiality of Instruction 

Composition of HIPPS Codes for HH PPS 

Grouper Links Assessment and Payment 

RESERVED 

Submission of the Notice of Admission (NOA) 

10730 Electronic Correspondence Referral Syste

Remote Identity Proofmg, Implementatio

and Multi-Factor Authentication (MF A) P

Transition from Connect Direct to the 

EN17AU21.003</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

Attachment 2 - ECRS Web Quick Reference Card, Version 2021/5 April 10723 Implementation of Provider Enrollment P

Attachment 1 - ECRS Web User Guide, Version 6.6 CMS Electronic File 1 - Continued Removal/Moving of Instru

Transfer (EFT) System Publication (Pub.) 100-08 to Chapter IO o

10753 Update the Common Working File (CWF) to Accept a Group Health Plan Medicare Enrollment: Contractor Proces

(GHP) and non-GHP (NGHP) Medicare Secondary Payer (MSP) Effective Other Medicare Contractor Duties 

Date 3 Months from the Current Date for Medicare Enrolled and Medicare Develooment Letters 

Entitled Beneficiaries 10727 Chapter 15 of Publication (Pub.) 100-08 M

10786 Issued to a specific audience, not posted to lntemeV!ntranet due to a Release of Chapter 10 of Pub. 100-08, Mo

Confidentiality of Instruction Standards 

10807 Update the International Classification of Diseases, Tenth Revision (ICD-10) 10733 Issued to a specific audience, not posted t

2022 Tables in the Common Working File (CWF) for Purposes of Processing Confidentiality oflnstructions 

Non-Group Health Plan (NGHP) Medicare Secondary Payer (MSP) Records 10735 Updates to Medicare Administrative Cont

and Claims Rebuttals Reporting 

10736 Issued to a specific audience, not posted t

10710 The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files Confidentiality of Instructions 

to the Provider and Statistical Reimbursement (PS&R) Svstem 10740 Voluntary Terminations of Enrollment In

10731 Notice of New Interest Rate for Medicare Overpayments and Underpayments Certified Suppliers 

-3rd Otr Notification for FY 2021 Voluntary Terminations 

10790 Issued to a specific audience, not posted to lntemeV!ntranet due to a Model Letters for Voluntary Terminatio

Confidentialitv of Instruction Certified Suooliers 

10806 The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files 10741 Issued to a specific audience, not posted t

to the Provider and Statistical Reimbursement (PS&R) Svstem Confidentiality of Instructions 

10821 Pub. 100-06, Chapter 4, Section 10 Revision (New Accounts Receivable (AR) 10743 Issued to a specific audience, not posted t

Status Codes for Undeliverable Initial Demand Lottcrs and TcrminatcdiOut of Confidentiality of Instructions 

Business Providers) Requirements for Collecting Part A and B Provider Kon- 10744 Issued to a specific audience, not posted t

MSP Overpayments Confidentiality of Instructions 

10835 Issued to a specific audience, not posted to IntemeV!ntranet due to a 10745 Issued to a specific audience, not posted t

Confidentialitv of Instruction Confidentialitv of Instructions 

10749 Updates to Chapter 4 and Chapter 5 of Pu

204 Revisions to the State Operations Manual (SOM) Appendix Z - Emergency Identity Theft Investigations and Victim

Preparedness Certificates of Medical Necessity (CMN

(DIFs) 

10709 Update to Chapter 12 (The Comprehensive Error Rate Testing (CERT) 

Program) of Publication (Puh.) 100-08 Handling Overpaymentq and 

Underoavments Resulting from the CERT Findings 

Completing a CMN or UIF 

Cover Letters for CMNs 

DME MACs and UPICs Authority to Ini

10711 Updates to Chapter 4 of Publication (Pub.) 100-08 Organizational 

Requirements 

Procedural Requirements Program Integrity Security Requirements 

Requests for Information From Outside Organizations Screening Leads 

Vetting Leads with CMS 

Conducting Investigations 

Reversed Denials by Administrative Law Judges on Open Cases 

Production of Medical Records and Documentation for an Appeals Case File 

Guidelines for Incentive Reward Program Complaint Tracking Fraud Alerts 

Administrative Relief from Program Integrity Review in the Presence ofa 

Disaster 

Monetary Penalty (CMP) When Invalid 

Documentation in the Patient's Medical 

Supplier Documentation 

Evidence of Medical c'<ecessity for the O

Period of Medical Necessity- Home Dia

Safeguards in Making Monthly Payment

Pick-up Slips 

Advance Determination of Medicare Co

DMEPOS 

10750 Issued to a specific audience, not posted t

Confidentiality of Instructions 

10751 Issued to a specific audience, not posted t

CPIC Hospice Cap Liability Process - Coordination with the MAC Confidentiality of Instructions 

Referral of Cases to the OIG/OI 10752 Issued to a specific audience, not posted t

Immediate Advisements to the OIG/01 Confidentiality of Instructions 

Referral to Other Law Enforcement Agencies 10776 Issued to a specific audience, not posted t

Reserved for Future Use Confidentialitv of Instructions 

Referral to State Agencies or Other Organizations UPICs and QIOs 10777 Issued to a specific audience, not posted t

Discounts, Rebates, and Other Reductions in Price Identity Theft Confidentialitv of Instructions 

Investigations and Victimized Provider Waiver of Liability Procedure 10779 Issued to a specific audience, not posted t

Confidentialitv of Instructions 

EN17AU21.004</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

10799 Issued to a specific audience, not posted to InterneV!ntranet due to 10829 Issued to a specific audience, not posted t

Confidentialitv of Instructions Confidentialitv of Instructions 

10800 Second General Cpdate to Chapter 10 of Publication (Pub.) 100-08, Program 10830 Issued to a specific audience, not posted t

Integrity Manual Confidentialitv of Instructions 

Suppliers That Enroll Via the Form CMS-855B 10841 Issued to a specific audience, not posted t

Ambulatory Surgical Centers (ASCs Confidentiality of Instructions 

Ilome Infusion Therapy Suppliers 10843 Issued to a specific audience, not posted t

Independent Clinical Laboratory Improvement Act Labs Confidentiality of Instructions 

Independent Uiagnostic Testing Facilities (IDTFs) 

Intensive Cardiac Rehabilitation (!CR) 

Mammography Screening Centers (MSCs) 

10705 Issued to a specific audience, not posted t

Confidentialitv of Instructions 

Phamiacies Portable X-Ray Suppliers (PXRSs) 

Radiation Therapy Centers (RTCs 

Suppliers of Ambulance Services 

Individual Practitioners Who Enroll Via the Form CMS-8551 

Anesthesiology Assistants Audiologists 

Certified Nurse-Midwives Certified Registered Nurse Anesthetists (CR.."As) 

Clinical Nurse Specialists 

Clinical Psychologists Clinical Social Workers 

l\urse Practitioners 

Occupational Therapists in Private Practice 

Physical Therapists in Private Practice Physician Physician Assistants Psychologists Practicing Independently 

11772 Updates to Pub. 100-09, Chapter 6 Benef

Manual, Chapwr 6, Provider Customer Se

Quality Assurance Monitoring (QAM) 

Remote Monitoring Disaster Recovery 

Guidelines for High Quality Responses 

Telephone Response Quality Monitorin

Telephone Responses to Provider Inqui

Requirements 

Recording Calls 

QCM Calibration 

Provider Written Inquiries 

Controlling Provider Written Inquiries 

Provider Written Inquiry Storage 

Duplicate Inquiries 

Telephone Responses to Provider Writt

Electronic Responses lo Provider Writt

Check Off Letters 

Registered DietitianstNutrition Professionals 

Speech Language Pathologists in Private Practice 

Manufacturers of Replacement PartsiSupplies for Prosthetic Implants or 

Implantable Durable Medical Equipment (DME) Surgically Inserted at an 

Ambulatory Surgical Center (ASC) 

Enrollment Form: Infomiation and Processing 

CMS-20134 (Section 1 - Basic Information) 

CMS-20134 (Section 2 - Identifying Information) 

CMS-20134 (Section 3 - Final Adverse Legal Actions/Convictions) 

Guidelines for High Quality Responses 

Stock Language/Form Letters 

Provider Written Response Quality Mo

Written Responses to Provider Inquirie

Requirements 

QWCM Calibration 

Replying to Correspondence from Mem

Provider Walk-In Inquiries 

Guidelines for Provider Walk-In Servic

CMS-20134 (Section 4- MDPP Location Information) 

CMS-20134 (Sections 5 & 6 - Owning and Managing Organizations and 

Individuals) 

Reserved for Future Use 

CMS-20134 (Section 7 - Coach Roster) CMS-20134 (Section 8 - Billing Agency Information) 

CMS-20134 (Section 13 - Contact Person) 

PRRS Operations 

Complex Provider Inquiries Complex Beneficiary Inquiries 

Provider Inquiry Tracking 

Updates to the CMS Standardized Prov

MAC Inquiry Tracking Self-Data Revie

Fraud and Abuse 

CMS-20134 (Section 14-Penalties for Falsifying Information) 

CMS-20134 (Section 15 -Certification Statement and Authorized 

Officials) CMS-20134 (Section 16 - Delegated Officials) CMS-20134 (Section 17-Supporting Documents) 

Additional Form CMS-20134 Processin11: Information and Alternatives 

10805 Issued to a specific audience, not posted to InterneV!ntranet due to 

Confidentiality oflnslruclions 

Provider Education Website Satisfactio

Staff Development and Education 

PCC Staffl)evelopment and Training 

Required Training for PCC Staff 

Provider Kotifications of PCC Training 

PCC Training Documentation 

Provider Self-Service Technology 

Interactive Voice Response System 

10808 Issued to a specific audience, not posted to InterneV!ntranet due to Provider Education Website 

Confidentiality of Instructions General Requirements 

10828 Provider Enrollment Rebuttal Process - Additional Instructions for Returning Webrnaster and Attestation 

Applications and Deactivations Website Governance 

EN17AU21.005</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

CMS Feedback Contents 

Dissemination of Information from CMS to Providers 

Frequently Asked Questions 

Internet-based Provider Educational Offerings 

Provider Education Website Promotion 

Electronic Mailing Llst (Listserv) 

Targeted Electronic Mailing Lists (Listservs) 

Electronic Mailing Llst (Listserv) Promotion 

Social Media 

Internet-based Provider Portal Service Interruptions Survey 

Provider Satisfaction Survey MAC Survey Participation Requirements 

Continuous Improvement Closed-Loop Ticketing 

Survey Response Prohibition 

MCE User Guide 

Third-Party Contractor Platform System Users 

MAC Satisfaction Score 

PCSP Performance Management 

POE - Electronic Mailing List (Listscrv) Subscribcrship 

Telephone Standards 

Call Completion Call Acknowledgment 

Average Speed of Answer (ASA) Callback 

QCM Performance Standards QAM (Telephone) Performance Standard 

Standards for Written Responses to Provider Inquiries 

QWCM Performance Standards 

Timeliness of Responses to Written Provider Inquiries Timeliness of Responses to General Provider Inquiries Timeliness of Responses to Complex Provider Inquiries (PRRS) Timeliness of Responses to Complex Beneficiary Inquiries Timeliness of Responses to Congressional Inquiries 

PCSP Data Reporting 

PIE 

Access to PIES 

Due Date for Data Submission to PIES Data to be Reported Monthly in PIES 

PCID 

Access to PCID 

MAC Contract and PCSP Data to be Reported in PCID 

Additional Data to be Reported Monthly in PCID and Reporting Due Dates 

Inyuiry Tracking Data to be Reported in PCID 

PCC Training Closure Information to be Reported in PCID 

POE Data to be Reported in PCID Provider Electronic Mailing List (Listserv) Subscriber Data to be Reported 

in PCID 

Special Initiatives Activities to be Reported in PCID 

Special Initiatives Activities to be Reported in PCID 

Emergency and Similar PCC Closure Data to be Reported in PCID 

Telecommunications Service Interruptions to be Reported in PCID 

Provider Internet-based Portal Service Interruptions to be Reported in PCID 

Provider Internet-based Portal Functionality to be Reported in PCID Provider Education Website Analytic Data to be Reported in PCID Direct Mailing Information to be Reported in PCID 

QCM 

Access to QCM 

QWCM 

Access to QWCM 

Disclosure of Information 

10813 Issued to a specific audience, not posted t

Confidcntialitv of Instructions 

None 

None None None None None 

10704 Issued to a specific audience, not posted t

of Instructions 

10715 Issued to a specific audience, not posted t

of Instructions 

10726 Issued to a specific audience, not posted t

Confidentialitv of Instructions 

10746 Primary Care First (PCF) and Serious Illn

IURs and Edits for Non-Seauential Claim

10747 Issued to a specific audience, not posted t

of Instructions 

10774 Issued to a specific audience, not posted t

Confidentialitv of Instructions 

10787 Issued to a specific audience, not posted t

of Instructions 

10791 Issued to a specific audience, not posted t

Confidentiality of Instructions 

10802 Direct Contracting (DC) Model - Professi

Capitation (TCC), Primary Care CapitatioOption (APO), Telehealth Expansion, 3-d

Disch~roe and Care-Manaeement Home V

10820 Primary Care First (PCF) and Serious Illn

IURs and Edits for Non-Sequential Claim

10712 Issued to a specific audience, not posted t

Confidentialitv oflnstructions 

10717 MAC Participation in Change Requests D

Methodology 

10718 CoPnitive Assessment & Care Plan Servic

10732 Addition of the QW Modifier to Healthca

Svstem CHCPCS) Code 87636 

10734 Issued to a specific audience, not posted t

Confidentiality of Instructions 

10739 Issued to a specific audience, not posted t

of Instructions 

10748 Issued to a specific audience, not posted t

Confidentiality of Instructions 

EN17AU21.006</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

10780 Update to Rural Health Clinic (RHC) Pavment Limits 

10781 Initiative to Reduce Avoidable Hospitalizations among Nursing Facility 

Residents (NFI) - Uodates and Clarifications 

10785 Issued to a specific audience, not posted to Internetilntranet due to Sensitivity 

oflnstructions 

10789 The Fiscal Intermediary Shared System (PISS) Business Requirement for 

Rejected Claims Throwing Off the Provider and Statistical Reimbursement 

(PS&R) Svstem Managed Care Davs 

10792 Mobile Personal Identity Verification (PIV) Station Installation 

10795 Replacing Home Health Requests for Anticipated Payment (RAPs) with a 

Notice of Admission (NOA) - Imolementation 

10801 Additional Payment Edits for DMEPOS Suppliers of Custom Fabricated and 

Prefabricated (Custom Fitted) Orthotics. Update to Change Request (CR) 

3959 CR 8390 and CR 873 

10804 International Classification of Diseases, 10th Revision (ICD-10) and Other 

Coding Revisions to National Coverage Determination (NCDs)--Julv 2021 

10817 International Classification of Diseases, 10th Revision (ICD-10) and Other 

Coding Revisions to National Coverage Determination (NCDs)--October 

2021 

10827 Addition ofthe QW Modifier to Healthcare Common Procedure Coding 

System (HCPCS) Codes 0240U, 0241U, 87637 

10832 International Classification of Diseases, 10th Revision (ICD-10) and Other 

Coding Revisions to National Coverage Determination (NCDs)--Julv 2021 

10842 Implementation of the Hospital Outpatient Department (HOPD) Prior 

Authorization (PA) Paired Items of Service for the X12 278 PA Transactions 

None None None 

Addendum II: Regulation Documents Published 

in the Federal Register (April through June 2021) 

Regulations and Notices 

Regulations and notices are published in the daily Federal 

Register. To purchase individual copies or subscribe to the Federal 

Register, contact GPO at www.gpo.gov/fdsys. When ordering individual 

copies, it is necessary to cite either the date of publication or the volume 

number and page number. 

The Federal Register is available as an online database through 

GPO Access. The online database is updated by 6 a.m. each day the 

Federal Register is published. The database includes both text and 

graphics from Volume 59, Number 1 (January 2, 1994) through the present 

date and can be accessed at http://www.gpoaccess.gov/fr/index.html. The 

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: 

https://www.cms.gov/files/document/regs2q2lqpu.pdf 

For questions or additional informatio

(410-786-4481). 

Addendum ill: CMS 

(April through June 

CMS Rulings are decisions of the Ad

precedent final opinions and orders and statem

interpretation They provide clarification and 

ambiguous provisions of the law or regulation

Medicaid, Utilization and Quality Control Pee

insurance, and related matters. 

The rulings can be accessed at http://

and-Guidance/Guidance/Rulings. For questio

contact Tiffany Lafferty (410-786-7548). 

Addendum IV: Medicare National Co

(April through June 

Addendum IV includes completed na

determinations (NCDs), or reconsiderations o

quarter covered by this notice. Completed dec

section of the NCD Manual (NCDM) in which 

title, the date the publication was issued, and t

decision. An NCD is a determination by the S

particular item or service is covered nationally 

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

any, that is assigned to a particular covered ite

determination for a particular covered item or include information concerning completed dec

program and decision memoranda, which also 

some cases, explain why it was not appropriat

Information on completed decisions as well as 

been posted on the CMS website. For the purp

we are providing only the specific updates to n

determinations (NCDs), or reconsiderations o

in the 3-month period. This information is ava

www.cms.gov/medicare-coverage-database/. 

information, contact Wanda Belle, MFA (410-

Title NCDM Trans

Section Numb

Chimeric Antigen Receptor NCD (CAR) T-cell Therapy for 110.24 121Cancers 

EN17AU21.007</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

Artificial Hearts/ Related 

Devices & V ADs for Bridge NCD20.9- 10837 06/22/2021 12/01/2020 

to Transplant/Destination 20.9.1 

Therapy 

Screening for Colorectal 

Cancer - Blood-Based NCD210.3 10818 05/21/2021 01/19/2021 

Biomarker Tests 

Addendum V: FDA-Approved Category B Investigational Device 

Exemptions (IDEs) (April through June 2021) 

(Inclusion of this addenda is under discussion internally.) 

Addendum VI: Approval Numbers for Collections of Information 

(April through June 2021) 

All approval numbers are available to the public at Reginfo.gov. 

Under the review process, approved information collection requests are 

assigned 0MB control numbers. A single control number may apply to 

several related information collections. This information is available at 

www.reginfo.gov/public/do/PRAMain. For questions or additional 

information, contact William Parham (410-786-4669). 

Addendum VII: Medicare-Approved Carotid Stent Facilities 

(April through June 2021) 

Addendum VII includes listings of Medicare-approved carotid 

stent facilities. All facilities listed meet CMS standards for performing 

carotid artery stenting for high risk patients. On March 17, 2005, we issued 

our decision memorandum on carotid artery stenting. We determined that 

carotid artery stenting with embolic protection is reasonable and necessary 

only if performed in facilities that have been determined to be competent in 

performing the evaluation, procedure, and follow-up necessary to ensure 

optimal patient outcomes. We have created a list of minimum standards for 

facilities modeled in part on professional society statements on competency. 

All facilities must at least meet our standards in order to receive coverage 

for carotid artery stenting for high risk patients. For the purposes of this 

quarterly notice, we are providing only the specific updates that have 

occurred in the 3-month period. This information is available at: 

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

For questions or additional information, contact Sarah Fulton, MHS 

(410-786-2749). 

Facility Provider Effective Date State 

Number 

New York Health+ Hospitals 330204 03/30/2021 NY 

462 I'' Street H-Building, Executive 

Administration 

New York, NY 10016 

!nova Fair Oaks Hospital 490101 04/26/2021 VA 

Facility Provider 

Number 

3600 Joseph Siewick Drive 

Faitfax, VA 22033 

UPMC Hanover 390233 

300 Highland Avenue 

Hanover PA 17331 

St. Joseph's Hospital - North 188163281

4211 Van Dyke Road 

Lutz, FL 33558 

Kalispell Regional Medical Center 141794562

310 Sunnyview Lane 

Kalispell, MT 59901 

Sierra Vista Regional Medical Center 050506 

1010 Murray Avenue 

San Luis Obispo, CA 93405 

Emanate Health-Queen of the Valley 050382 

Hospital 

1115 South Sunset Avenue 

WestCovina CA91790 

Carilion New River Valley Medical 129586879Center 

2900 Lamb Circle 

Christianburg, VA 24073 

Orlando Health 100006 

Old Address: 52 West Underwood 

Street Orlando, FL 32806 

New Address: 1414 Kuhl Avenue 

Orlando, FL 32806 

Previous Name: Gwinnett Medical 110087 

Center 

New Name: Northside Hospital 

Gwinnett (For 1000 Medical Center 

Boulevard Lawrenceville, GA 30045 

Previous Name: Bay Medical Center 100026 

New Name: Ascension Sacred Heart Bay 615 North Bonita Avenue Panama City, FL 32402 

Addendum VIII

American College of Cardiology's Natio

Registry Sites (April throug

The initial data collection requiremen

College of Cardiology's National Cardiovascu

NCDR) has served to develop and improve the 

I CDs in certain Medicare beneficiaries. The d

ended with the posting of the final decision m

CardioverterDefibrillators on February 15, 20

For questions or additional informatio

MHS (410-786-2749). 

Addendum IX: Active CMS Coverage-Re

EN17AU21.008</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

(April through June 2021) 

CMS issued a guidance document on November 20, 2014 titled 

"Guidance for the Public, Industty, and CMS Staff: Coverage with 

Evidence Development Document". Although CMS has several policy 

vehicles relating to evidence development activities including the 

investigational device exemption (IDE), the clinical trial policy, national 

coverage determinations and local coverage determinations, this guidance 

document is principally intended to help the public understand CMS's 

implementation of coverage with evidence development (CED) through the 

national coverage determination process. The document is available at 

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 

JoA1ma Baldwin, MS ( 410-786-7205). 

AddendumX: 

List of Special One-Time Notices Regarding National Coverage 

Provisions (April through June 2021) 

There were no special one-time notices regarding national 

coverage provisions published in the 3-month period. This information is 

available at http://www.cms.gov. For questions or additional information, 

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

Addendum XI: National Oncologic PET Registry (NOPR) 

(April through June 2021) 

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 Registty 

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

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

For questions or additional information, contact David Dolan, MBA ( 410-

786-3365). 

Addendum XII: Medicare-Approved 

(Destination Therapy) Facilities (Apri

Addendum XII includes a listing of M

that receive coverage for ventricular assist devi

destination therapy. All facilities were required 

order to receive coverage for V ADs implanted 

October 1, 2003, we issued our decision memo

clinical indication of destination therapy. We d

as destination therapy are reasonable and neces

facilities that have been determined to have the 

infrastructure to ensure optimal patient outcom

standards and an application process. All facili

our standards in order to receive coverage for V 

destination therapy. 

For the pmposes of this quarterly notic

specific updates to the list of Medicare-approve

standards that have occurred in the 3-month pe

available at 

http://www.cms.gov/MedicareApprovedFacili

For questions or additional information, contac

(410-786-3365). 

Facility Provider Date of 

Number Certific

HCA Houston Healthcare 450659 04/13/20

Medical Center 

1313 Hermann Drive 

Houston, TX 77004 

Other information: 

DNV ID # 10000432549-MSC-VAD-USA Previous Re-certification Dates: n/a Kaiser Foundation Hospital - 050071 03/25/20

Santa Clara 

700 Lawrence Expressway 

Santa Clara, CA 95051 

Other information 

Joint Commission ID H 10123 

Previous Re-certification 

Uates: n/a 

The University of Kansas 170040 03/08/2

Health System 4000 Cambridge Street 

Kansas Citv, KS 66160-7200 

EN17AU21.009</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

Facility Provider Date of Initial DateofRc- State Facility Provider Date of 

Number Certification certification Number Certific

University of North Carolina 340061 10/2612

Other information: Hospitals 

Joint Commission ID # 8567 101 Manning Drive 

Chapel Hill, NC 27514 

Previous Re-certification Dates: Other information: 

03/08/2016 03/06/2018 Joint Commission ID # 6478 

Froedtert Memorial Lutheran 520177 07/31/2012 01/07/2021 WI 

Hospital, Inc Previous Re-certification 

9200 West Wisconsin Avenue Dates: 

Milwaukee, WI 53226 10/16/2008; 10/19/2010; 

10/26/2012; 10/16/2014; 

Other information: 11/08/20 l 6- 11/28/2018 

Joint Commission ID# 7718 Mayo Clinic Hospital - 240010 02/2612

Rochester 

Previous Re-certification 1216 Second Street SW 

Dates: Rochester, MN 55902-1906 

07/31/2012; 07/08/2014; 08/09/2016 Other information: 

From: Saint Thomas West 440082 06/22/2010 01/14/2021 TN Joint Commission ID# 8181 Hospital 

To: Ascension Saint Thomas Previous Re-certification 

Ho~pital Dates: 

4220 Harding Road 02/26/2008; 02/09/2010; 

Nashville, TN 37205 02/21/2012; 02/21/2014; 

04/05/2016; 03/23/2018 

Other infonnation: St. Francis Hospital 330182 11/08/2

100 Port Washington Rlvd 

Joint Commission ID# 7891 Roslyn, NY 11576 

Previous Re-certification Other information: Dates: Joint Commission ID# 5860 

06/22/201 O; 06/22/2012; 

05/20/2014: 07/13/2016 Previous Re-certification 

University Hospitals Cleveland 360137 02/09/2010 01/21/2021 OH Dates: 

Medical Center 11/08/2016- 11/14/201 8 

11100 Euclid Avenue West Virginia University 510001 07/26/2

Cleveland, OH 44106 Hospitals, Inc. 

One Medical Center Drive 

Other infonnation: Morgantown, WV 26506 

Joint Commission ID# 7017 

Other information: 

Previous Re-certification Joint Commission ID II 6444 

Dates: 

02/09/2010: 01/24/2012; Previous Re-certification 

01/30/2014; 02/23/2016; Dates: 2018-07-26 02/09/2018 Christ Hospital 360163 02/17/2

2139 Auburn Avenue 

Cincinnati, OH 45219 

Other information: 

Joint Commission ID # 6987 

Previous Re-certification Dates: 

EN17AU21.010</GPH>khammond on DSKJM1Z7X2PROD with NOTICES

Facility Provider 

Number 

02/17/2012: 02/20/2014; 04/05/2016; 03/20/2018 

Northeast Georgia Medical 110029 

Center 743 Spring Street 

Gainesville, GA 30501 Other information: 

DNV GL-CSA ID# 

10000464475-MSC-DNV GLUSA 

Previous Re-certification Dates: 04-26-2018 

University of Colorado 060024 

Hospital Authority 

12605 E 16th Ave 

Aurora, CO 80045 

Other infonnation: 

Joint Commission ID # 9384 

Previous Re-certification Dates: 

07/22/2008: 08/17/2010; 08/10/2012; 07/22/2014; 07/26/2016 

From: California Padfic 050047 Medical Center-Van Ness 

Campus 

1101 Van Ness Avenue 

San Francisco, CA 94109 

To: California Pacific 

Medical Center-Pacific 

Campus; 

Other information: 

Joint Commission ID# 5152 

Previous Re-certification 

Dates: 

12/08/2009; 11/11/2011; 

01/07/2014; 02/09/2016; 03/20/2018 

JFK Medical Center 100080 

5301 South Congress Avenue 

Allanlis, FL 33462 

Other infonnation: 

Joint Commission ID # 6836 

Previom Re-certification 

Dates: 

01/24/2017: 3/6/2019 

Mission Hospital 340002 

Date of Initial DateofRc- State 

Certification certification 

04/26/2018 05/05/2021 GA 07/22/2008 03/10/2021 co 

12/08/2009 02/20/2021 CA 

01/24/2017 03/03/2021 FL 

05/17/2016 04/14/2021 NC 

Facility Provider Date of 

Number Certific

509 Biltmore Avenue 

Asheville, NC 28801-4690 

Other information: 

Joint Commission ID # 6468 

Previous Re-certification Dates: 

05/17/2016' 6/27/2018 

Addendum XIII: Lung Volume Reduc

(April through June 2

Addendum XIII includes a listing of M

tliat are eligible to receive coverage for lung vo

Until May 17, 2007, facilities tliat participated 

Treatment Trial were also eligible to receive co

types of facilities are eligible for reimbursemen

Reduction Surgery (L VRS): 

• National Emphysenia Treatment Trial (N

05/07/2007, these will no longer autoniatically 

with the other programs); 

• Credentialed by the Joint Commission (

Commission on Accreditation of Healthcare Or

their Disease Specific Certification Program fo

• Medicare approved for lung transplants, 

Only the first two types are in the list 

the listing of facilities for lung volume reductio

3-month period, This inforniation is available 

www,cms,gov/MedicareApprovedFacilitie/L V

questions or additional inforniation, contact Sa

(410-786-2749), 

Addendum XIV: Medicare-Approved Ba

(April through June 2

Addendum XIV includes a listing of M

tliat meet minimum standards for facilities mod

society statements on competency, All facilitie

order to receive coverage for bariatric surgery p

2006, we issued our decision memorandum on 

We determined tliat bariatric surgical procedur

necessary for Medicare beneficiaries who have 

greater than or equal to 35, have at least one co

and have been previously unsuccessful with me

This decision also stipulated tliat covered baria

reasonable and necessary only when perfonned 

certified by the American College of Surgeons 
Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 45999 

[FR Doc. 2021–17602 Filed 8–16–21; 8:45 am] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 08N146B, 

Rockville, Maryland 20857; (301) 443– 

6593, or visit our website at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the United States Court of Federal 

Claims and to serve a copy of the 

petition to the Secretary of HHS, who is 

named as the respondent in each 

proceeding. The Secretary has delegated 

this responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 

manifestation of onset or of significant 

aggravation after vaccine 

administration. Compensation may also 

be awarded for conditions not listed in 

the Table and for conditions that are 

manifested outside the time periods 

specified in the Table, but only if the 

petitioner shows that the condition was 

caused by one of the listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 

under section 2111 the Secretary shall 

publish notice of such petition in the 

Federal Register.’’ Set forth below is a 

list of petitions received by HRSA on 

July 1, 2021, through July 31, 2021. This 

list provides the name of petitioner, city 

and state of vaccination (if unknown 

then city and state of person or attorney 

filing claim), and case number. In cases 

where the Court has redacted the name 

of a petitioner and/or the case number, 

the list reflects such redaction. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that 

there is not a preponderance of the 

evidence that the illness, disability, 


khammond on DSKJM1Z7X2PROD with NOTICESEN17AU21.011</GPH>

Surgery Center (program standards and requirements in effect on February 

15, 2006)~ or (2) certified by the American Society for Bariatric Surgery 

(ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program 

standards and requirements in effect on February 15, 2006). 

There were no additions, deletions, or editorial changes to 

Medicare-approved facilities that meet CMS' minimum facility standards 

for bariatric surgery that have been certified by ACS and/or ASMBS in the 

3-month period. This information is available at 

www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For 

questions or additional information, contact Sarah Fulton, MHS 

(410-786-2749). 

Addendum XV: FDG-PET for Dementia and Neurodegenerative 

Diseases Clinical Trials (April through June 2021) 

There were no FDG-PET for Dementia and Neurodegenerative 

Diseases Clinical Trials published in the 3-month period. 

This information is available on our website at 

www.ems.gov/MedicareApprovedFacilitie/PETDT /list.asp#TopOfPage. 

For questions or additional information, contact David Dolan, MBA (410-

786-3365).