[Billing Code 4120-01-P]

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9149-N]
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—
April through June 2024
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 in the 3-month period,
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
I CMS Manual Instructions
II Regulation Documents Published in the Federal Register
III CMS Rulings
IV Medicare National Coverage Determinations
V FDA-Approved Category B IDEs
VI Collections of Information
VII Medicare –Approved Carotid Stent Facilities
VIII American College of Cardiology-National Cardiovascular Data Registry Sites
IX Medicare’s Active Coverage-Related Guidance Documents
X One-time Notices Regarding National Coverage Provisions
XI National Oncologic Positron Emission Tomography Registry Sites
XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities
XIII Medicare-Approved Lung Volume Reduction Surgery Facilities
XIV Medicare-Approved Bariatric Surgery Facilities
XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials
All Other Information

Contact
Ismael Torres
Terri Plumb
Tiffany Lafferty
Wanda Belle, MPA
John Manlove
William Parham
Sarah Fulton, MHS
Sarah Fulton, MHS
Lori Ashby, MA
JoAnna Baldwin, MS
David Dolan, MBA
David Dolan, MBA
Sarah Fulton, MHS
Sarah Fulton, MHS
David Dolan, MBA
Annette Brewer

Phone Number
(410) 786-1864
(410) 786-4481
(410)786-7548
(410) 786-7491
(410) 786-6877
(410) 786-4669
(410) 786-2749
(410) 786-2749
(410) 786-6322
(410) 786-7205
(410) 786-3365
(410) 786-3365
(410) 786-2749
(410) 786-2749
(410) 786-3365
(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 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 Trenesha Fultz-Mimms, who is the Federal Register
Liaison, to electronically sign this document for purposes of publication in the Federal Register.
Trenesha Fultz-Mimms,
Federal Register Liaison,
Department of Health and Human Services.

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 4, 2023 (88 FR 51814), October 26, 2023 (88 FR 73591),
January 30, 2024 (89 FR 5897) and April 29, 2024 (89 FR 33356). 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 2024)
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) are 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/libraries/
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, for use by the general

public. These libraries provide reference services and interlibrary loans;
however, they are not sales outlets. Individuals may obtain information
about the location of the nearest regional depository library from any
library. CMS publication and transmittal numbers are shown in the listing
entitled Medicare and Medicaid Manual Instructions. To help FDLs locate
the materials, use the CMS publication and transmittal numbers. For
example, to find the manual Updates for Clarification on Services Under the
Medicare Hospice Benefit for Dually Eligible Veterans (CMS-Pub. 100-02)
Transmittal No. 12589.
Addendum I lists a unique CMS transmittal number for each
instruction in our manuals or program memoranda and its subject number.
A transmittal may consist of a single or multiple instruction(s). Often, it is
necessary to use information in a transmittal in conjunction with
information currently in the manual.
Fee-For Service Transmittal Numbers
Please Note: Beginning Friday, March 20, 2020, there will be the
following change regarding the Advance Notice of Instructions due to a
CMS internal process change. Fee-For Service Transmittal Numbers will
no longer be determined by Publication. The Transmittal numbers will be
issued by a single numerical sequence beginning with Transmittal Number
10000.
For the purposes of this quarterly notice, we list only the specific
updates to the list of manual instructions that have occurred in the 3-month
period. This information is available on our website at
www.cms.gov/Manuals.
Transmittal
Number
12566
12568
12637
12638
12589
12599
12600
Manual/Subject/Publication Number
Medicare General Information (CMS-Pub. 100-01)
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Medicare Benefit Policy (CMS-Pub. 100-02)
Manual Updates for Clarification on Services Under the Medicare Hospice
Benefit for Dually Eligible Veterans
A Social Determinants of Health Risk Assessment in the Annual Wellness
Visit Policy Update in the Calendar Year 2024 Physician Fee Schedule Final
Rule
Expand Diabetes Screening and Diabetes Definitions Policy Update in the
Calendar Year 2024 Physician Fee Schedule Final Rule
Medicare National Coverage Determination (CMS-Pub. 100-03)
National Coverage Determination (NCD) 20.7 Percutaneous Transluminal
Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting
Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates
Below)

12590
12565
12570
12571
12573
12575
12576
12577
12578
12584
12587
12594
12596
12599
12600
12601
12604
12606
12607
12608
12609
Technical Revision Only to the National Coverage Determination (NCD)
Manual, Publication (Pub) 100-03, Chapter 1, Part 4, section 310.1
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for
Myelodysplastic Syndromes (MDS) National Coverage Determination (NCD)
110.23
Medicare Claims Processing (CMS-Pub. 100-04)
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
CY 2024 Home Infusion Therapy (HIT) Payment Rates and Instructions for
Retrieving the January 2024 Home Infusion Therapy (HIT) Services Payment
Rates Through the CMS Mainframe Telecommunications System
National Coverage Determination (NCD) 20.7 Percutaneous Transluminal
Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting
Manual Update to Section 20.7 in Chapter 23 of Publication (Pub) 100-04
Internet Only Manual Updates to Publication 100-04 to Implement Updates to
Policy (Inpatient Rehabilitation Facility (IRF))
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Additional Enforcement of Required County Codes on Home Health Claims
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
April Quarterly Update for 2024 Durable Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS) Fee Schedule
Additional Implementation Edits on Hospice Claims for Hospice
Certifying Physician Medicare Enrollment
Notice of Election (NOE) Remove Modify
Notice of Termination/Revocation (NOTR)
Change of Provider/Transfer Notice
Cancellation of an Election
Change of Ownership Notice
Data Required on the Institutional Claim to A/B MAC (HHH)
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Outlier Reconciliation and Cost-to-Charge Ratio (CCR) Updates for the
Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital
(LTCH) PPS
File Conversions Related to the Spanish Translation of the Healthcare
Common Procedure Coding System (HCPCS) Descriptions
A Social Determinants of Health Risk Assessment in the Annual Wellness
Visit Policy Update in the Calendar Year 2024 Physician Fee Schedule Final
Rule
Expand Diabetes Screening and Diabetes Definitions Policy Update in the
Calendar Year 2024 Physician Fee Schedule Final Rule
Update to Several Sections of the Internet-only Manual (IOM) Publication
(Pub.) 100-04, Medicare Claims Processing Manual, Chapter 23 - Fee
Schedule Administration and Coding Requirements
Internet-Only Manual (IOM) Updates for Split (or Shared) Evaluation and
Management Visits
Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and
Laboratory Services Subject to Reasonable Charge Payment
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Enhancements to Home Health Consolidated Billing Edits
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction

12611
12612
12614
12615
12621
12627
12628
12629
12635
12644
12646
12649
12650
12652
12653
12654
12655
12657
12659
12660
12661
12664
12665
12666
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for
Myelodysplastic Syndromes (MDS) National Coverage Determination (NCD)
110.23
Quarterly Update to the End-Stage Renal Disease Prospective Payment
System (ESRD PPS)
Quarterly Update to the Medicare Physician Fee Schedule Database
(MPFSDB) - July 2024 Update
Additional Implementation Edits on Hospice Claims for Hospice Certifying
Physician Medicare Enrollment
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
National Coverage Determination (NCD) 200.3 - Monoclonal Antibodies
Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD)1
Annual Updates to the Prior Authorization/Pre-Claim Review Federal
Holiday Schedule Tables for Generating Reports
October 2024 (2025 File) Update of the International Classification of
Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)
Healthcare Common Procedure Coding System (HCPCS) Codes Subject to
and Excluded from Clinical Laboratory Improvement Amendments (CLIA)
Edits
Quarterly Update to Home Health (HH) Grouper
October 2024 Healthcare Common Procedure Coding System (HCPCS)
Quarterly Update Reminder
Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and
Laboratory Services Subject to Reasonable Charge Payment
Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code
(CARC), Medicare Remit Easy Print (MREP) and PC Print Update
Combined Common Edits/Enhancements Modules (CCEM) Code Set Update
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Implement Operating Rules – Phase III Electronic Remittance Advice (ERA)
Electronic Funds Transfer (EFT):
Committee on Operating Rules for Information Exchange (CORE) 360
Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance
Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC)
Rule - Update from Council for Affordable Quality Healthcare (CAQH)
CORE
Changing the Frequency of No-Pay Medicare Summary Notice (MSN)
Mailings from Every 90 Days to Every 120 Days
July 2024 Update of the Hospital Outpatient Prospective Payment System
(OPPS)
July 2024 Integrated Outpatient Code Editor (I/OCE) Specifications Version
25.2
July 2024 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing
Files and Revisions to Prior Quarterly Pricing Files

12671
12677
12682
12683
12685
12686
12687
12688
12690
12691
12692
12693
12564

12568
12648
12583
12597
219
220
221
222
223
224
Billing and Payment for Telehealth Services with Place of Service (POS) 10
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Quarterly Update to the National Correct Coding Initiative (NCCI)
Procedure-to-Procedure (PTP) Edits, Version 30.3, Effective October 1, 2024
Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04,
Chapter 32, Section 150.3 for Coding Revisions to the National Coverage
Determinations (NCDs)--October 2024 Change Request (CR)13596
July Quarterly Update for 2024 Durable Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS) Fee Schedule
Instructions for Downloading the Medicare ZIP Code File for October 2024
Files
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Fiscal Year (FY) 2025 Annual Update to the Medicare Code Editor (MCE)
and International Classification of Diseases, Tenth Revision, Clinical
Modification (ICD-10-CM) and Procedure Coding System (ICD-10-PCS)
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Changes to the Laboratory National Coverage Determination (NCD) Edit
Software for October 2024
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
October 2024 Quarterly Average Sales Price (ASP) Medicare Part B Drug
Pricing Files and Revisions to Prior Quarterly Pricing Files
Expand Diabetes Screening and Diabetes Definitions Policy Update in the
Calendar Year 2024 Physician Fee Schedule Final Rule - This CR Rescinds
and Fully Replaces CR 13487.
Medicare Secondary Payer (CMS-Pub. 100-05)
Changes to The Electronic Correspondence Referral System (ECRS) Web
Includes Updates to Submitting Duplicate and Overlapping Drug Records;
Addition of Action Code (DR) to Investigate Deleted Drug Records and
Updates to the Electronic Data Interchange (EDI) and Coordination of
Benefits Voluntary Agreement (COBVA) Email Addresses
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Medicare Financial Management (CMS-Pub. 100-06)
Notice of New Interest Rate for Medicare Overpayments and Underpayments
-3rd Quarter Notification for FY 2024
The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files
to the Provider and Statistical Reimbursement (PS&R) System
Medicare State Operations Manual (CMS-Pub. 100-07)
Revisions to the State Operations Manual (SOM) Appendix B – Home Health
Agencies
Revisions to State Operations Manual (SOM) Appendix A-Hospitals
Revisions to the State Operations Manual (SOM) Chapter 10 –Informal
Dispute Resolution (IDR) and Enforcement Procedures for Home Health
Agencies and Hospice Programs
Revisions to the State Operations Manual (SOM) Appendix M-Hospice
Revisions to the State Operations Manual (SOM) Appendix G – RHC
Revisions to State Operations Manual (SOM), Chapter 2, section 2779A1 –
CCN for Medicare Providers
Medicare Program Integrity (CMS-Pub. 100-08)
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction

Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12582
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12591
Stay of Enrollment
12592
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12593
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12602
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12603
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12633
Medical Review Policies for Signature Requirements
12656
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12663
Medical Review Policies for Signature Requirements
12679
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12680
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
12681
Fraud Prevention System (FPS) Edit – FPS14 – Denial of Pacemaker,
Cardioverter, and Cardiovascular Monitoring Services Frequency - This CR
Rescinds and Fully Replaces CR 11594.
12700
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Medicare Contractor Beneficiary and Provider Communications (CMS-Pub. 100-09)
None
Medicare Quality Improvement Organization (CMS- Pub. 100-10)
None
Medicare Program of All-Inclusive Care for the Elderly (CMS- Pub. 100-11)
None
Medicare End Stage Renal Disease Network Organizations (CMS Pub 100-14)
None
Medicaid Program Integrity Disease Network Organizations (CMS Pub 100-15)
None
Medicare Managed Care (CMS-Pub. 100-16)
None
Medicare Business Partners Systems Security (CMS-Pub. 100-17)
None
Medicare Prescription Drug Benefit (CMS-Pub. 100-18)
None
Demonstrations (CMS-Pub. 100-19)
12563
Guiding an Improved Dementia Experience (GUIDE) Model Implementation
12567
Making Care Primary (MCP) Model Implementation
12596
Conversions Related to the Spanish Translation of the Healthcare Common
Procedure Coding System (HCPCS) Descriptions
12598
Create APIs to Support ACO REACH Model - Full Agile Pilot
12620
Primary Care First (PCF) Model: Updated Appendix B - Prohibited
Healthcare Common Procedure Coding System (HCPCS) Codes
12622
Extension of Payment Period for Pennsylvania Rural Health Model
12643
Making Care Primary (MCP) Model Implementation
12647
Guiding an Improved Dementia Experience (GUIDE) Model Implementation
12651
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction

12605
12613
12616
12617
12619
12623
12625
12626
12630
12631
12632
12634
12636
12640
12641
12658
12667
12668
12669
12672
12675
12678
12689
12698
12701
One Time Notification (CMS-Pub. 100-20)
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Fiscal Intermediary Shared System (FISS) - User Enhancement Change
Request (UECR) - Create a Beneficiary Liable Reason Code for National
Coverage Determination (NCD) 210.14
User Enhancement Change Request (UECR) - Enhance the MCS Desktop
Tool (MCSDT) Table Manager and Customer Service Representative (CSR)
Security Table
User Enhancement Change Request (UECR) - Enhance the Multi-Carrier
System Desktop Tool (MCSDT) to Export Tables
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Fiscal Intermediary Shared System (FISS) User Enhancement Change
Request (UECR) - Expiration of a Unique Tracking Number (UTN) on the
Prior Authorization (PA) Tracking File
International Classification of Diseases, 10th Revision (ICD-10) and Other
Coding Revisions to National Coverage Determinations (NCDs)— October
2024
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Fiscal Intermediary Shared System (FISS) - New Process to Create and Use
Overridable Reason Codes
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Implement Edits on Hospice Claims
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Updates to the Recovery Audit Contractor Data Warehouse (RACDW)
Suppression Upload File Format
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Clarification of Liability for Durable Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS) Claims Overlapping Inpatient Hospital
Stays
User Enhancement Change Request (UECR) - Enhance the Multi-Carrier
System Desktop Tool (MCSDT) to Export Tables
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Replacement Wheelchair Equipment When the Manufacturer Exits
Wheelchair Business
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to
Confidentiality of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity
of Instruction
New State Codes for Arizona, California, Nevada, and Texas
Fiscal Intermediary Shared System (FISS) - User Enhancement Change
Request (UECR) - Create a Beneficiary Liable Reason Code for National
Coverage Determination (NCD) 210.14

Medicare Quality Reporting Incentive Programs (CMS- Pub. 100-22)
None
State Payment of Medicare Premiums (CMS-Pub.100-24)
None
Information Security Acceptable Risk Safeguards (CMS-Pub. 100-25)
None

For questions or additional information, contact Ismael Torres
(410-786-1864).
Addendum II: Regulation Documents Published
in the Federal Register (April through June 2024)
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.
For questions or additional information, contact Terri Plumb
(410-786-4481).
Addendum III: CMS Rulings
(April through June 2024)
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://www.cms.gov/Regulationsand-Guidance/Guidance/Rulings.
For questions or additional information, contact Tiffany Lafferty
(410-786-7548).
Addendum IV: Medicare National Coverage Determinations
(April through June 2024)
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,
there were no specific updates to national coverage determinations (NCDs),
or reconsiderations of completed NCDs published in the 3-month period.
This information is available at: www.cms.gov/medicare-coveragedatabase/.
For questions or additional information, contact Wanda Belle,
MPA (410-786-7491).
Title
Allogeneic Hematopoietic
Stem Cell Transplantation
(HSCT) for Myelodysplastic
Syndromes (MDS) National
Coverage Determination
(NCD) 110.23

NCDM
Section
NCD
110.23

Transmittal
Number

Issue Date

Effective
Date

05/09/2024

03/06/2024

Addendum V: FDA-Approved Category B Investigational Device
Exemptions (IDEs) (April through June 2024)
(Inclusion of this addenda is under discussion internally.)
Addendum VI: Approval Numbers for Collections of Information
(April through June 2024)
All approval numbers are available to the public at Reginfo.gov.
Under the review process, approved information collection requests are
assigned OMB 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 2024)
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. There were no additions, deletions, or
editorial changes to the listing for Medicare-approved carotid stent facilities
for this 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).
Addendum VIII:
American College of Cardiology’s National Cardiovascular Data
Registry Sites (April through June 2024)
The initial data collection requirement through the American
College of Cardiology's National Cardiovascular Data Registry (ACCNCDR) has served to develop and improve the evidence base for the use of
ICDs in certain Medicare beneficiaries. The data collection requirement
ended with the posting of the final decision memo for Implantable
Cardioverter Defibrillators on February 15, 2018.
For questions or additional information, contact Sarah Fulton,
MHS (410-786-2749).
Addendum IX: Active CMS Coverage-Related Guidance Documents
(April through June 2024)
CMS issued a guidance document on November 20, 2014 titled
“Guidance for the Public, Industry, and CMS Staff: Coverage with
Evidence Development Document”. Although CMS has several policy
vehicles relating to evidence development activities including the
investigational device exemption (IDE), the clinical trial policy, national
coverage determinations and local coverage determinations, this guidance
document is principally intended to help the public understand CMS’s
implementation of coverage with evidence development (CED) through the
national coverage determination process. The document is available at
http://www.cms.gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDId=27.
CMS published three proposed guidance documents on June 22,
2023 to provide a framework for more predictable and transparent evidence
development and encourage innovation and accelerate beneficiary access to
new items and services. The documents are available at:

https://www.cms.gov/medicare-coverage-database/view/medicarecoverage-document.aspx?mcdid=35&docTypeId=1&sortBy=title&bc=16
https://www.cms.gov/medicare-coverage-database/view/medicarecoverage-document.aspx?mcdid=34&docTypeId=1&sortBy=title&bc=16
https://www.cms.gov/medicare-coverage-database/view/medicarecoverage-document.aspx?mcdid=33&docTypeId=1&sortBy=title&bc=16
For questions or additional information, contact Lori Ashby, MA
(410 786 6322).
Addendum X:
List of Special One-Time Notices Regarding National Coverage
Provisions (April through June 2024)
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 2024)
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 David Dolan,
MBA (410-786-3365).
Addendum XII: Medicare-Approved Ventricular Assist Device
(Destination Therapy) Facilities (April through June 2024)
Addendum XII includes a listing of Medicare-approved facilities
that receive coverage for ventricular assist devices (VADs) used as
destination therapy. All facilities were required to meet our standards in
order to receive coverage for VADs implanted as destination therapy. On
October 1, 2003, we issued our decision memorandum on VADs for the
clinical indication of destination therapy. We determined that VADs used
as destination therapy are reasonable and necessary only if performed in

facilities that have been determined to have the experience and
infrastructure to ensure optimal patient outcomes. We established facility
standards and an application process. All facilities were required to meet
our standards in order to receive coverage for VADs implanted as
destination therapy.
For the purposes of this quarterly notice, we are providing only the
specific updates to the list of Medicare-approved facilities that meet our
standards that have occurred in the 3-month period. This information is
available at
http://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage.
For questions or additional information, contact David Dolan,
MBA, (410-786-3365).
Facility

Provider
Date of Initial
Date of ReNumber
Certification
certification
The following facility is a new listing.
Virginia Mason Medical
50-0005
03/07/2024
n/a
Center
1100 Ninth Avenue
Seattle, WA 98101

State

WA

Other information:
DNV ID #: C667499
Previous Re-certification
Dates: n/a
The following facilities have editorial changes (in bold).
Shands Teaching Hospitals &
100113
11/26/2003
01/31/2024
Clinics, Inc.
1600 SW Archer Road
Gainesville, FL 32608

FL

Other information:
Joint Commission ID #6804
Previous Re-certification
Dates: 11/18/2008;
02/08/2011; 02/12/2013;
01/27/2015; 02/14/2017;
04/24/2019; 12/16/2021
Stanford Health Care
300 Pasteur Drive
Stanford, CA 94305
Other information:
Joint Commission ID #10010
Previous Re-certification
Dates: 11/24/2010;
12/12/2012; 12/09/2014;
03/14/2017; 08/28/2019;
12/15/2021

12/22/2003

01/31/2024

CA

Cedars-Sinai Health System
8700 Beverly Boulevard
Los Angeles, CA 90048

12/29/2003

04/12/2024

CA

Other information:
Joint Commission ID #9792
Previous Re-certification
Dates: 12/11/2008;
06/21/2011; 06/11/2013;
05/29/2015; 07/11/2017;
09/11/2019; 02/26/2022
Wellstar Kennestone Hospital
677 Church Street
Marietta, GA 30060

Northeast Georgia Medical
Center
743 Spring Street
Gainesville, GA 30501

11/07/2017

02/07/2024

GA

Previous Re-certification
Dates: 04/26/2018; 05/05/2021
Pitt County Memorial Hospital,
Inc. DBA Vidant Medical
Center
2100 Stantonsburg Road
Greenville, NC 27835-6028
Other information:
Joint Commission ID #6506

Previous Re-certification
Dates: 11/07/2017;
11/22/2019; 01/15/2022
University of Chicago Medical
Center
5841 South Maryland Avenue
Chicago, IL 60637

Previous Re-certification
Dates: 09/26/2017;
12/17/2019; 02/09/2022
Florida Health Sciences Center
Inc.
1 Tampa General Circle
Tampa, FL 33606

02/24/2009

02/07/2024

IL

Other information:
Joint Commission ID #7315

Other information:
Joint Commission ID #6934

Previous Re-certification
Dates: 02/24/2009;
08/17/2011; 09/04/2013;
09/15/2015; 10/24/2017;
12/17/2019; 01/22/2022
Emory University Hospital
1364 Clifton Road NE
Atlanta, GA 30322

Previous Re-certification
Dates: 12/19/2008;
04/05/2011; 04/09/2013;
04/21/2015; 06/06/2017;
7/24/2019; 01/20/2022
Baptist Memorial Hospital Memphis
6019 Walnut Grove Road
Memphis, TN 38120

Previous Re-certification
Dates: 08/18/2009;
09/09/2011; 08/29/2013;
08/11/2015; 09/26/2017;
11/20/2019; 02/12/2022

04/26/2018

05/05/2024

GA

09/26/2017

02/21/2024

NC

12/18/2008

02/28/2024

FL

04/07/2007

03/13/2024

TN

Other information:
DNV ID #: C690194

Other information:
Joint Commission ID #6711

Other information:
Joint Commission ID #6689

110010

08/18/2009

02/14/2024

GA

Other information:
Joint Commission ID #7869
Previous Re-certification
Dates: 01/27/2009;
05/20/2011; 04/17/2013;
06/02/2015; 07/25/2017;
09/17/2019; 02/19/2022

UT Southwestern Medical
Center/William P. Clements Jr.
University Hospital
6201 Harry Hines Boulevard
Dallas, TX 75390-9262

12/10/2003

03/13/2024

TX

Other information:
Joint Commission ID #9013
Previous Re-certification
Dates: 12/17/2008;
06/07/2011; 06/04/2013;
06/23/2015; 08/08/2017;
10/11/2019; 02/12/2022
University Hospital Cleveland
Medical Center
11100 Euclid Avenue
Cleveland, OH 44106

36-0137

02/09/2010

04/17/2024

OH

11/14/2008

03/13/2024

KY

Other information:
Joint Commission ID #: 9219

03/23/2024

OH

Previous Re-certification
Dates: 07/14/2015;
08/29/2017; 10/23/2019;
02/26/2022
Texas Heart Hospital of the
Southwest LLP
1100 Allied Drive
Plano, TX 75093-5348

06/15/2011

03/16/2024

TX

Previous Re-certification
Dates: 06/15/2011;
07/09/2013; 07/14/2015;
08/22/2017; 9/7/2019;
01/28/2022
Christiana Care Health
Services, Inc.
4755 Ogletown-Stanton Road
Newark, DE 19718

07/25/2013

04/10/2024

DE

07/09/2009

03/27/2024

PA

02/04/2009

04/04/2024

AZ

Other information:
Joint Commission ID #6237
03/13/2009

03/14/2024

CA

Other information:
Joint Commission ID #5033
Previous Re-certification
Dates: 03/13/2009;
08/16/2011; 09/10/2013;
10/06/2015; 10/20/2017;
12/4/2019; 02/02/2022
Methodist Hospital
7700 Floyd Curl Drive
San Antonio, TX 78229

07/14/2015

Other information:
Joint Commission ID #:
Other information:
Joint Commission ID #7765
Previous Re-certification
Dates: 11/14/2008;
03/22/2011; 02/26/2013;
03/24/2015; 05/23/2017;
8/6/2019; 02/23/2022
Keck Hospital of USC
1500 San Pablo Street
Los Angeles, CA 90033

Other information:
Joint Commission ID #: 7030

Other information:
DNV ID #: C669039
Previous Re-certification
Dates: 02/09/2010;
01/24/2012; 01/30/2014;
02/23/2016; 02/09/2018; 0121-2021; 08/17/2022
UofL Health - Louisville, Inc.
200 Abraham Flexner Way
Louisville, KY 40202

Previous Re-certification
Dates: 01/27/2009;
07/12/2011; 07/09/2013;
07/07/2015; 08/08/2017;
10/23/2019; 01/22/2022
Riverside Methodist Hospital
3535 Olentangy River Road
Columbus, OH 43214-3998

Previous Re-certification
Dates: 07/25/2013;
07/21/2015; 10/24/2017;
12/21/2019; 03/03/2022
Thomas Jefferson University
Hospitals, Inc.
111 South 11th Street
Philadelphia, PA 19107
Other information:
Joint Commission ID #6132

01/27/2009

03/08/2024

TX

Previous Re-certification
Dates: 07/09/2009;
09/13/2011; 10/17/2013;
09/22/2015; 09/20/2017;
11/6/2019; 02/24/2022
Banner-University Medical
Center Tucson Campus
1625 North Campbell Avenue

Tucson, AZ 85719

10/31/2017; 12/18/2019;
03/24/2022
Ochsner Medical Center
1516 Jefferson Highway
New Orleans, LA 70121

Other information:
Joint Commission ID #: 9514
Previous Re-certification
Dates: 02/04/2009;
04/27/2011; 03/15/2013;
02/24/2015; 04/18/2017;
7/12/2019; 03/05/2022
Baylor Scott and White All
Saints – Fort Worth
1400 8th Avenue
Fort Worth, TX 76104

5/26/2021

5/26/2024

TX

05/19/2011

04/06/2024

Other information:
Joint Commission ID #8993
Previous Re-certification
Dates: 08/21/2007;
08/27/2009; 10/07/2011;
11/20/2013; 11/10/2015;

LA

Previous Re-certification
Dates: 05/28/2009;
11/09/2011; 12/12/2013;
01/05/2016; 12/12/2017;
03/12/2020; 03/10/2022
Morristown Medical Center
100 Madison Avenue
Morristown, NJ 07960

06/16/2009

04/17/2024

NJ

AZ
Previous Re-certification
Dates: 06/16/2009;
09/28/2011; 10/31/2013;
11/17/2015; 12/12/2017;
1/25/2020; 03/23/2022

02/06/2009

05/08/2024

CA

08/21/2007

04/17/2024

TX

Other information:
Joint Commission ID #9944
Previous Re-certification
Dates: 02/06/2009;
08/09/2011; 08/13/2013;
09/15/2015; 10/06/2017;
12/04/2019; 04/09/2022
Baylor University Medical
Center
3500 Gaston Avenue
Dallas, TX 75246-2017

04/03/2024

Other information:
Joint Commission ID #5958

Other information:
Joint Commission ID #9489
Previous Re-certification
Dates: 05/19/2011;
05/07/2013; 06/09/2015;
07/25/2017; 07-10-2019;
03/03/2022
Ronald Reagan UCLA Medical
Center
757 Westwood Plaza
Los Angeles, CA 90095

05/28/2009

Other information:
Joint Commission ID #

Other information:
DNV ID #: 10000469761
Previous Re-certification
Dates: 5/26/2021
Banner - University Medical
Center Phoenix
1111 East McDowell Road
Phoenix, AZ 85006

Addendum XIII: Lung Volume Reduction Surgery (LVRS)
(April through June 2024)
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 (LVRS):
● 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
Commission on Accreditation of Healthcare Organizations (JCAHO)) under
their Disease Specific Certification Program for LVRS; and
● Medicare approved for lung transplants.
Only the first two types are in the list. For the purposes of this
quarterly notice, there are no additions and deletions to a listing of
Medicare-approved facilities that are eligible to receive coverage for lung
volume reduction surgery. This information is available at
www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage.
For questions or additional information, contact Sarah Fulton,
MHS (410-786-2749).
Addendum XIV: Medicare-Approved Bariatric Surgery Facilities

(April through June 2024)
Addendum XIV includes a listing of Medicare-approved facilities
that meet minimum standards for facilities modeled in part on professional
society statements on competency. All facilities must meet our standards in
order to receive coverage for bariatric surgery procedures. On February 21,
2006, we issued our decision memorandum on bariatric surgery procedures.
We determined that bariatric surgical procedures are reasonable and
necessary for Medicare beneficiaries who have a body-mass index (BMI)
greater than or equal to 35, have at least one co-morbidity related to obesity
and have been previously unsuccessful with medical treatment for obesity.
This decision also stipulated that covered bariatric surgery procedures are
reasonable and necessary only when performed at facilities that are: (1)
certified by the American College of Surgeons (ACS) as a Level 1 Bariatric
Surgery Center (program standards and requirements in effect on February
15, 2006); or (2) certified by the American Society for Bariatric Surgery
(ASBS) as a Bariatric Surgery Center of Excellence (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 2024)
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.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage.
For questions or additional information, contact David Dolan,
MBA (410-786-3365).

[FR Doc. 2024-16040 Filed: 7/19/2024 8:45 am; Publication Date:
7/22/2024]