Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2022, 68161-68173 [2022-24670]

Download as PDF 68161 Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices there has been any change in a hospital’s designated OPO due to the changes made in definitions for metropolitan statistical areas; and (4) the length and continuity of a hospital’s relationship with an OPO other than the hospital’s designated OPO. Under section 1138(a)(2)(D) of the Act, the Secretary is required to publish a notice of any waiver application received from a hospital within 30 days of receiving the application, and to offer interested parties an opportunity to submit comments during the 60-day comment period beginning on the publication date in the Federal Register. The criteria that the Secretary uses to evaluate the waiver in these cases are the same as those described above under section 1138(a)(2)(A) and (B) of the Act and have been incorporated into the regulations at § 486.308(e) and (f). khammond on DSKJM1Z7X2PROD with NOTICES II. Waiver Request Procedures In October 1995, we issued a Program Memorandum (Transmittal No. A–95– 11) detailing the waiver process and discussing the information hospitals must provide in requesting a waiver. We indicated that upon receipt of a waiver request, we would publish a Federal Register notice to solicit public comments, as required by section 1138(a)(2)(D) of the Act. According to these requirements, we will review the comments received. During the review process, we may consult on an as-needed basis with the Health Resources and Services Administration’s Division of Transplantation, the United Network for Organ Sharing, and our regional offices. If necessary, we may request additional clarifying information from the applying hospital or others. We will then make a final determination on the waiver request and notify the hospital and the designated and requested OPOs. III. Hospital Waiver Request As permitted by § 486.308(e), the following hospital has requested a waiver to enter into an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located: North Carolina Baptist Hospital, Winston-Salem, North Carolina, is requesting a waiver to work with: LifeShare Carolinas, 5000 D Airport Center Parkway, Charlotte, North Carolina 28208. The Hospital’s Designated OPO is: HonorBridge, 1430 WestBrook Plaza Drive, Winston-Salem, North Carolina 27103. IV. Collection of Information Requirements purposes of publication in the Federal Register. Dated: November 8, 2022. Lynette Wilson, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2022–24715 Filed 11–10–22; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9138–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July Through September 2022 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). V. Response to Comments We will consider all comments we receive by the date specified in the DATES section of this preamble. The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2022, 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. SUMMARY: Addenda Contact 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 ............................................................................................................................ Ismael Torres ................ Terri Plumb ................... Tiffany Lafferty .............. Wanda Belle, MPA ....... John Manlove ............... William Parham ............. Sarah Fulton, MHS ....... Sarah Fulton, MHS ....... JoAnna Baldwin, MS ..... JoAnna Baldwin, MS .... David Dolan, MBA ........ David Dolan, MBA ........ Sarah Fulton, MHS ....... Sarah Fulton, MHS ....... David Dolan, MBA ........ Annette Brewer ............. SUPPLEMENTARY INFORMATION: I. Background The Centers for Medicare & Medicaid Services (CMS) is responsible for VerDate Sep<11>2014 17:30 Nov 10, 2022 Jkt 259001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Phone number (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749 786–7205 786–7205 786–3365 786–3365 786–2749 786–2749 786–3365 786–6580 administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight E:\FR\FM\14NON1.SGM 14NON1 68162 Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 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. khammond on DSKJM1Z7X2PROD with NOTICES 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 VerDate Sep<11>2014 18:19 Nov 10, 2022 Jkt 259001 regulations at least every 3 months in the Federal Register. difficult, the contact person listed can provide information. II. Format for the Quarterly Issuance Notices III. How To Use the Notice 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 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 https:// 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 FultzMimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: November 4, 2022. Trenesha Fultz-Mimms, Federal Register Liaison, Department of Health and Human Services. BILLING CODE 4120–01–P E:\FR\FM\14NON1.SGM 14NON1 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: November 18, 2021 (86 FR 64492), February 9, 2022 (87 FR 7458), May 13, 2022 (87 FR 29327) and August 4, 2022 (87 FR 47751). 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. Jkt 259001 Addendum I: Medicare and Medicaid Manual Instructions (July through September 2022) PO 00000 Frm 00044 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. Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 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: https://cms.gov/rnanuals. Fee-For Senrice 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 11520 11438 11501 11520 Manual/Subject/Pnblication Number Issued to a specific audience, not posted to hrternet/hrtranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to hrternet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions 11587 11484 11486 Issued to a specific audience, not posted to hrternet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidcntialitv of Instruction 68163 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 https://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 fonn, 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 for Revision to National Coverage Detennination (NCD) 240.2 (Home Use of Oxygen) to Align to 1834(a)(5)(E) of the Social Security Act (CMS-Pub. 100-03) Transmittal No. 11587. 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. Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 EN14NO22.003</GPH> Publication Dates for the Previous Four Quarterly Notices khammond on DSKJM1Z7X2PROD with NOTICES 11490 11496 11497 11498 Jkt 259001 11500 11502 PO 00000 11504 11507 Frm 00045 11508 Fmt 4703 11509 11510 11511 Sfmt 4725 11514 11518 E:\FR\FM\14NON1.SGM 11519 11520 11523 11527 11531 14NON1 11532 11540 11541 11542 11543 11544 11547 EN14NO22.004</GPH> 11548 11549 11551 11552 11555 11558 11559 11560 11561 11564 11565 11566 11567 11571 11572 11573 11581 11583 11589 11590 11591 11592 11593 11594 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratorv Services Subiect to Reasonable Charge Payment Claim Status Category and Claim Status Codes Update Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Combined Common Edits/Enhancements Modules (CCEM) Code Set Update Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions 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 Influenza Vaccine Payment Allowances - Annual Update for 2022-2023 Season 2023 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Pavments January 2023 Healthcare Common Procedure Coding System (HCPCS) Ouarterly Update Reminder Annual Clotting Factor Furnishing Fee Update 2023 Updates are Being Made to Chapter I of the Medicare Claims Processing Manual to Include Newly Created and Utilized Paver Onlv Codes Updates are Being Made to Chapter 1 of the Medicare Claims Processing Manual to Include Newlv Created and Utilized Paver Onlv Codes Exceptions to Average Sales Price (ASP) Payment Methodology - Claims Processing Manual Changes 2023 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB)Update Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Changes to the Laboratory ~ational Coverage Determination (NCD) Edit Software for Januarv 2023 Billing for Hospital Part B Inpatient Services Editing Of Hospital Part B Inpatient Services: Reasonable and Necessary Part A Hospital Inpatient Denials Editing Of Hospital Part B Inpatient Services: Other Circumstances in Which Pavment Cannot Be Made under Part A Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 3, Section 20.l.2.7to Correct the Device Reductions Data Element in the FISS Extract File Procedure for Medicare Contractors to Perform and Record Outlier Instructions for Retrieving the January 2023 Medicare Physician Fee Schedule Database (MPFSDB) Files Through the CMS Mainframe Telecommunications System Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction October 2022 Integrated Outpatient Code Editor (I/OCE) Specifications Version 23 .3 October 2022 Update of the Hospital Outpatient Prospective Payment System Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 11493 11494 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Claim Status Category and Claim Statns Codes Update Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstructions October 2022 Quarterly Average Sales Price (ASP) Medicare Part Il Drug Pricing Files and Revisions to Prior Ouarterly Pricing Files Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality ofTnstmction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstructions Modification of Existing Common Working File (CWF) Editing for Preventive Services Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality ofTnstmction Cessation ofCse ofMvMedicare.gov Web Address Masking the Medicare Beneficiary Identifier (MBI) on the Medicare Summary Notice (MSN) Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstructions Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instrnctions Issued to a specific audience, not posted to Internet/Intranet due to a Conlidenlialilv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2023 Medicare Prut A Skilled Nursing Facility (SKF) Prospective Payment System (PPS) Pricer Cpdate Fiscal Year (FY) 2023 Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for Fiscal Year (FY) 2023 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Y car (FY) 2023 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - October 2022 Update New Waived Tests 68164 VerDate Sep<11>2014 11487 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 11596 11599 11600 llG0l 11G02 Jkt 259001 11603 11604 PO 00000 11605 11610 Frm 00046 11611 11612 Fmt 4703 11617 Sfmt 4725 11618 11619 E:\FR\FM\14NON1.SGM 11620 11621 14NON1 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Significant Updates to Internet Only Manual (IOM) Publication (Pub.) 100-05 Medicare Secondarv Paver (MSP) Manual. Chaoter 5 Automation of the Medicare Duolicate Primarv Payment (DPP) Process 11512 11513 11550 11557 11483 11528 11529 11530 11536 11537 11556 11563 11574 11575 11576 11580 11588 11597 11598 11606 11608 11609 11613 11579 11616 Automation of the Duolicatc Primary Paver (DPP) Process The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) System The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) System 11495 11499 11562 EN14NO22.005</GPH> None Revisions to State Operation Manual (SOM), Appendix PP Guidance to Surveyors for Long Term Care Facilities None Issued to a soccific audience, not oostcd to Inlcrnct/Inlranct due to a None 68165 11480 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Years (FYs) 2019 and 2020 for Inpatient Prospective Payment System (IPPS) Hosoitals with Uodated Data for Hosoitals in the 9th Circuit None I 207 Confidenlialilv of Instruction Issued lo a specific audience, nol posted lo lnlernet/Inlranel due lo a Confidenlialilv of Instruction Issued lo a specific audience, nol posted lo Inlernet/Inlranel due lo a Confidentialitv of Instruction Update of Chapter 3 in Publication (Pub.) 100-08, Including Update lo Medicare Program Integrity Contractor Post-Payment Review Process, and Update of Chapter 8 Pub. 100-08, Including Revision to When Contractor Suspects Additional Improper Claims Medical Record Review Contractor Susoects Additional ImorOPer Claims Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Providcr/Suoolicr Enrollment Adverse Legal Actions Issued to a specific audience, not posted to Internet/Intranet due to Confidcntialitv of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Sixth General Update to Provider Enrollment Instructions in Chapter 10 of Publication (Pub.) 100-08, Program Integrity Manual (PIM) Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Final Round of Transition of Enrollment and Certification Activities for Various Certified Provider and Supplier Types and Transactions Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Final Round of Transition of Enrollment and Certification Activities for Various Certified Provider and Suoolier Tvoes and Transactions Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 (OPPS) Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboralorv Services Subiecl lo Reasonable Charge Pavmenl Annual Clotting Factor Furnishing Fee Update 2023 Quarterly Update lo lhe National Correct Coding Initiative (NCCI) Procedure-lo-Procedure (PTP) Edits, Version 29.0, EITeclive Januarv 2023 Instrudions for Retrieving lhe January 2023 Opioid Trealmenl Program (OTP) Payment Rates Through lhe CMS Mainframe Telecommunications System Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes Used for Home Health Consolidated Billine: Enforcement Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction 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 a Confidentiality of Instruction October 2022 Update of the Ambulatory Surgical Center (A.SC) Payment System January 2023 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Ouartcrlv Pricing Files Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) - January 2023 Instructions for Retrieving the January 2023 Home Infusion Therapy (HIT) Services Payment Rates Through the CMS Mainframe Telecommunications System Instructions for Downloading the Medicare ZIP Code File for Januarv 2023 October Quarterly Update for 2022 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction 11595 khammond on DSKJM1Z7X2PROD with NOTICES ,. < •t::<,•;; l)ii?'fft:.:;, None 11489 11506 Jkt 259001 11515 11516 PO 00000 Frm 00047 11534 11554 Fmt 4703 11482 Sfmt 4725 11485 E:\FR\FM\14NON1.SGM 11488 11491 11492 11503 11521 14NON1 11522 11524 11525 11526 11533 - 11539 ESRD Treatment Choices (ETC) Model Performance Payment Adjustment (PPA) - Facility Component (Implementation CR) Concatenation of Multiple Separate Comma-Separated Values Files to One File - Update to CR 12492 - Implementation Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Federally Qualified Health Center (FQHC) Participation in and Payment Under the Maryland Primary Care Program (MDPCP) - Implementation Change Request (CR) to correct Business Requirement (BR) 12326. 7.2. Monthly Report of Performance Payment Adjustment (PPA) Claims Addition to Change Request (CR) 12404 - Imnlementation CR Remove Beneficiaries Below 18 Years Old From Model Adjustments Correction for CRl 1390 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Automatic Reprocessing of Claims for Kidney Care Choices (KCC) ModelImplementation Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction 11505 j'.}";/Y(:f' '(;{;'f. 11481 11538 Vh,,,: 05:,;t•i1Fii1 - Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Instrnctions to the Fiscal Intermediary Shared System [FISS] Edit to Expand the Existing MA Bypass Reusable Solution P ARMCC78 and Modify the Existing Logic to Read the New PARMs New Edit for Prospective Payment System (PPS) Outpatient and Inpatient Bill Types Receiving an Outlier Pavment When a Device Credit is Reported Interns and Residents Information System (IRIS) XML Format User CR: .v!CS - HIMR Functions Menu Additional Fields Corrections to Processing of Canceled Home Health Notices of Admission and of Period Sequence Edits Multi-Carrier System (MCS) Removal of the Physician Pay for Reporting (P4R), Physician Quality Reporting System (PQRS) and Electronic Prescribing (ERx) Incentive Payments Financial Logic from the Claims Processing System Remove Hard Coded Logic for Edits 004H and 005H - Remove the Edits from Displaying on the H99RBEAI and H99RBEA2 Reports Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions User Enhancement Change Request (CR) - Update the Multi-Carrier System (MCS) Desk Top Tool (MCSDn Editing for Same Dav Adjustments User Enhancement Change Request (CR)- Update the Model Participant Provider (.vi I) Screen and Model Participant Provider Report (H99RVMPP) in the Multi-Carrier Svstem (MCS) Implementation of the Capital Related Assets Adjustment (CRA) for the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) Under the End Stage Renal Disease Prospective Payment System (ESRD PPS) 11545 11546 11568 11569 11577 11578 11582 11584 11585 11586 11607 11614 11622 11623 Health Insurance Portability and Accountability Act (HIPAA) Electronic Data Interchange (EDI) Front-End Updates for Januarv 2023 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Implementation of the Award for the Jurisdiction N (J-N) Part A and Part B Medicare Administrative Contractor (JN A!B MAC) International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--January 2023 Update The purpose ofthis Change Request (CR) is to provide a maintenance update ofICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. Previous "<CD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGeninfo/ICD 1O.html, along with other CRs implementing new policy "<CDs User CR: .v!CS - HIMR Functions Menu Additional Fields Medicare Summary Notice (MSN) Created with Wrong Beneficiary Data Update Beneficiary Data Streamlining Logic Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Updated Merit-based Incentive Payment System (MIPS)/1HPS Value Pathways (MVP) Healthcare Common Procedure Coding System (HCPCS) Codes Mobile Personal Identity Verification (PIV) Station International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--January 2023 Update User Enhancement Change Request (CR) - Update the Multi-Carrier System CMCS) Desk Top Tool CMCSDn Editing for Same Dav Adiustments Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter As Certain Colorectal Cancer Screening Tests Updates to the Common Working File (CWF) for Editing and Claims Processing to Allow Medicare Fee-For-Service (FFS) Coverage of Kidney Acquisition Costs for Medicare Advantage (MA) Beneficiaries Provided by Marvland Waiver (MW) Hospitals None None None Addendum II: Regulation Documents Published in the Federal Register (July through September 2022) Regy!ations and Notices Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 ~'if ~'tdt ;;;:,,.c,;i" C/.c~!;/'.i:S{t)t'. 11553 11535 68166 VerDate Sep<11>2014 ,. Pub 100-17 Medicare Business Partners Systems Security Manual Update 11570 11517 EN14NO22.006</GPH> .. ;;;,,;s";;f3:.•/,t: khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Jkt 259001 PO 00000 Frm 00048 For questions or additional information, contact Terri Plumb (410-786-4481). Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM Addendum ID: CMS Rulings (July through September 2022) 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 https://www.cms.gov/Regulationsand-Guidance/Guidance/Rulings. For questions or additional information, contact Tiffany Lafferty (410-786-7548). 14NON1 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (July through September 2022) (Inclusion of this addenda is under discussion internally.) Addendum VI: Approval Numbers for Collections of Information (July through September 2022) 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 (July through September 2022) 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: https://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#Top01Page For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Facility Provider Number Date Approved State Medical City Alliance 3101 N. Tarrant Parkwa· 670103 05/0li2022 TX 68167 Addendum IV: Medicare National Coverage Determinations (July through September 2022) 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 seivice 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 seivice. 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. There are no 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-coverage-database/. For questions or additional information, contact Wanda Belle, MP A (410-786-7491 ). Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 EN14NO22.007</GPH> 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 https://www.gpoaccess.gov/fr/. The following website https://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.ems.gov/files/document/regs3q22qpu.pdf khammond on DSKJM1Z7X2PROD with NOTICES Jkt 259001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 FROM: Blake Medical Center TO: HCA Florida Blake Hospital 2020 59th Street W Bradenton, FL 34209 FROM: Orlando Health TO: OH Orlando Regional Medical Center 1414 Kuhl A venue Orlando FL 32806 FROM: St. Francis Hospital and Health Centers - Indianapolis TO: Franciscan Health Indianapolis 8111 South Emerson Avenue Indianaoolis. IN 46237 Date Approved State 010083 07/07/2022 AL 1720031636 07/15/2022 UT 100044 07/26/2022 FL 100044 07/26/2022 PL 520138 07/09/2022 WI 1548392475 08/16/2022 FL 010085 09/20/2022 AL 290054 09/27/2022 NV 390173 10/25/2022 PA 370049 10/25/2022 OK 1295788735 10/25/2022 TX 120005 10/25/2022 HI 114964244 11/06/2008 FL 100006 05/23/2005 FL 150162 08/28/2006 IN Facility FROM: Great River Medical Center TO: Southeast Iowa Regional Medical Center 1221 S. Gear Avenue West Burlington, IA 52655-1681 Franciscan St. Francis Health Indianapolis 1600 Albany Street Beech Grove, IN 46107 Provider Number 420680407 Date Approved 04/16/2010 State IA 150033 04/01/2005 IN Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (July through September 2022) 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 I CDs in certain Medicare beneficiaries. The data collection requirement ended with the posting of the final decision memo for Implantable CardioverterDefibrillators on February 15, 2018. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum IX: Active CMS Coverage-Related Guidance Documents (July through September 2022) 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 https://www.ems.gov/medicare-coverage-database/details/medicarecoverage-document-details. aspx?MCD Id=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). AddendumX: List of Special One-Time Notices Regarding National Coverage Provisions (July through September 2022) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 Fort Worth. TX76177 South Baldwin Regional Medical 1613 N. McKenzie Street Folev, AL 36535 Ogden Regional Medical Center 5475 South 500 Ogden, UT 844505 Cleveland Clinic Tradition Hospital 10000 SW Innovation Way Port St. Lucie, FL 34987 Cleveland Clinic Martin North Hospital 200 SE Hospital Avenue Stuart, FL 34994 Aurora St. Luke's Medical Center 2900 West Oklahoma Avenue Milwaukee, WI 53215 HCA Florida Gulf Coast Hospital 449 W. 23rd Street Panama Citv. FL 32405 Decatur Morgan Hospital 1201 7th Street Decatur, AL 35601 Centennial Hills Hospital Medical Center 6900 N. Durango Drive Las Veeas NV 89149 Indiana Regional Medical Center 835 Hospital Road Indiana. PA 15701 Stillwater Medical Center Authority 1323 W. 6th Avenue Stillwater, OK 74074 Memorial Hermann Sugar Land Hospital 17500 W Grand Parkway S Sugar T.and, TX 77479 Hilo Medical Center 1190 Waianuenue Avenue Hilo, HI 96720 Provider Number 68168 VerDate Sep<11>2014 EN14NO22.008</GPH> Facility khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Addendum XI: National Oncologic PET Registry (NOPR) (July through September 2022) Jkt 259001 PO 00000 Frm 00050 Fmt 4703 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 https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410786-3365). Sfmt 4725 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (July through September 2022) E:\FR\FM\14NON1.SGM 14NON1 Provider Number Date of Initial Certification DateofRccertification State Westchester Health Care Corporation 100 Woods Road Valhalla, NY 10595 330234 11/29/2009 06/30/2022 NY 050262 02/06/2009 04/09/2022 CA 040007 11/21/2017 05/04/2022 AR 390100 05/19/2009 05/04/2022 PA 180067 02/10/2009 05/12/2022 KY Other information: Joint Commission ID# 2518 Previous Re-certification Dates: 11/19/2009; 11/15/2011; 12/03/2013; 12/08/2015; 12/19/2017; 03/07/2020 Ronald Reagan UCLA Medical Center 757 Westwood Plaza Los Angeles, CA 90095 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 St. Vincent Infirmary Medical Center dba CHI St. Vincent 2 St. Vincent Circle Little Rock, AR 72205 Other information: Joint Commission ID # 8661 Previous Re-certification Dates: 11/21/2017; 02/05/2020 Lancaster General Hospital 555 North Duke Street Lancaster, PA 17602 Other information: Joint Commission ID # 6086 Previous Re-certification Dates: 05/19/2009; 09/23/2011; 09/06/2013; 09/22/2015; 10/03/2017; 02/05/2020 University of Kentucky HospitaL' UK Albert B. Chandler Hospital 800 Rose Street Lexington, KY 40536-0293 68169 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 V ADs 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 arc 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 https://www.cms.gov/MedicareApprovedFacilitieNAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA, (410-786-3365). Facility Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 EN14NO22.009</GPH> available at https://www.cms.gov. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). khammond on DSKJM1Z7X2PROD with NOTICES lQ/29/2013 05/28/2022 PA Jkt 259001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 Previous Re-certification Dates: 03/27/2008; 03/18/2010; 03/07/2012; 02/04/2014; 03/15/2016; 04/24/2018; 12/03/2020 AR Previous Re-certification Dates: 11/10/2009; 11/08/2011; 12/11/2013; 01/12/2016; 12/15/2017; 02/12/2020 Sutter Medical Center 2825 Capitol Ave Sacramento, CA 95816 050108 10/20/2009 06/16/2022 CA 390046 11/19/2012 06/18/2022 PA 390164 06/10/2008 06/03/2022 PA 330214 02/14/2012 07/27/2022 :-.y Other information: Joint Commission ID # 2902 450686 06/17/2017 07/26/2022 TX 390050 03/07/2008 07/27/2022 PA Previous Re-certification Dates: 10/20/2009; 09/22/2011; 10/17/2013; 10/27/2015; 11/07/2017; 03/04/2020 \VellSpan York Hospital 1001 South George Street York, PA 17405 Other information: Joint Commission ID # 6228 Previous Re-certification Dates: 11/19/2013; 12/15/2015; 01/23/2018; 03/14/2020 UPMC Presbyterian Shadyside 200 Lothrop Street Pittsburgh, PA 15213 Other information: Joint Commission ID# 6158 Previous Re-certification Dates: 03/07/2008; 04/02/2010; 03/13/2012; 02/U:2014; 03/15/2016; 03/30/2018; 01/09/2021 University of Michigan Health System 1500 E Medical Center Drive, SPC 5474 Ann Arbor, MI 48109 05/07/2022 Other information: Joint Commission ID# 6169 230046 03/27/2008 06/03/2022 MI Previous Re-certification Dates: 06/10/2008; 05/21/2010; 04/12/2012; 03/25/2014; 04/13/2016; 03/20/2018; 12/09/2020 NYU Langone Hospitals 550 First Avenue New York, NY 10016 Other information: Joint Commission ID# 5820 Previous Re-certification Dates: 02/14/2012; Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 390133 DNV Healthcare Certificate #: C558801 Previous Re-certification Dates: OG/17/2017; 06/09/2019 West Penn Allegheny Health System, Inc. 320 East North Avenue Pittsburgh, PA 15212 11/10/2009 Other information: Joint Commission ID # 8656 Other information: Joint Commission ID # 4880 Previous Re-certification Dates: 10/29/2013; ll/10i2015; 12/12/2017; 03/04:2020 UMC Health System 602 Indiana Avenue Lubbock, TX 79415 040114 68170 VerDate Sep<11>2014 Previous Re-certification Dates: 02/10/2009; 09/20:2011; 09/18/2013; 11/03/2015; 12/05/2017; 02/26/2020 Lehigh Valley Hospital 1200 S. Cedar Crest Boulevard Allentown, PA 18105 Other information: Joint Commission TD# 7457 EN14NO22.010</GPH> Baptist Health Medical Center - Little Rock 9601 Baptist Health Drive Little Rock, AR 72205-7299 Other information: Joint Commission ID H 7760 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 01/14/2014; 03/08/2016; 03/27/2018; 8/26/2020 The Johns Hopkins Hospital 600 N. Wolfe Street Baltimore. MD 21287 Jkt 259001 100022 12/11/2007 10/22/2009 06/15/2022 06/22/2022 MD FL PO 00000 Frm 00052 Other information: Joint Commission ID # 6850 Fmt 4703 Sfmt 4725 Previous Re-certification Dates: 10/22/2009; 10/21/2011; 11/06/2013; 12/08/2015; 12/08/2017· 3/3/2020 Christ Hospital 2139 Auburn Avenue Cincinnati, OH 45219 360163 02/17/2012 07/09/2022 OH E:\FR\FM\14NON1.SGM 14NON1 090011 04/22/2008 07/08/2022 DC 06/08/2022 TX 390231 06/28/2012 07/16/2022 PA 510001 07/26/2018 08/17/2022 WV Other information: Joint Commission ID # 6444 Previous Re-certification Dates: 07-26-2018· 02-25-2021 Medical University of South Carolina Medical Center 169 Ashley Avenue Charleston, SC 29425 420004 09/23/2010 07/21/2022 SC 450054 12/07/2011 07/02/2022 TX 390256 04/01/2008 06/30/2022 PA Other information: 68171 EN14NO22.011</GPH> Previous Re-certification Dates: 06/28/2012; 06/03/2014; 06/28/2016" 05/22/2018 West Virginia University Hospitals, Inc. One Medical Center Drive Morgantown, WV 26506 Other information: Joint Commission ID # 6584 Previous Re-certification Dates: 09/23/2010; 09/07/2012; 08/05/2014; 09/13/2016; 09/26/2018; 03/24/2021 Scott & White Memorial Hospital 2401 S 31st St Temple, TX 76508 Other information: Joint Commission ID # 6308 Previous Re-certification Dates: 04/22/2008; 04/06/2010; 03/23/2012; 03/04/2014; 05/03/2016; 05/22/2018; 12/17/2020 Penn State Milton S. Hershey Medical Center 01/31/2012 Other information: Joint commission ID #: 6013 Other information: Joint commission ID #: 6987 Previous Re-certification Dates: 02/17/2012; 02/20/2014; 04/05/2016; 03/20/2018; 2/26/21 MedStar Washington Hospital Center 110 Irving St, NW Washington, DC 20010 Other information: Joint commission ID #: 9058 Previous Re-certification Dates: 01/31/2012; 01/28/2014; 02/23/2016; 01/30/2018; 10/08/2020 Abington Memorial Hospital 1200 Old York Road Abington, PA 19001 450018 Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 Other information: Joint Connnission ID # 6252 Previous Re-certification Dates: 12/11/2007; 12/15/2009; 11/29/2011; 12/03/2013; 01/12/2016; 02/13/2018; 10/24/2020 FROM: Jackson Memorial Hospital TO: Public Health Trust of Dade County Florida dba Jackson Memorial Hospital 1611 Northwest 12th Avenue Miami, FL 33136-1094 210009 500 University Drive Hershey, PA 17033 Joint Commission ID# 6075 Previous Re-certification Dates: 04/01/2008; 03/24/2010; 03/16/2012; 04/08/2014; 06/07/2016; 05/22/2018; 9/11/2020 University of Texas Medical Branch 301 University Boulevard Galveston, TX 77555-0518 khammond on DSKJM1Z7X2PROD with NOTICES Jkt 259001 PO 00000 05/11/2010 08/03/2022 NC 260138 06/15/2010 08/05/2022 MO Frm 00053 Ohio State University Hospitals 410 West Tenth Avenue, DN 168 Columbus, OH 43210 Other information: Joint Commission ID # 8351 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM Previous Re-certification Dates: 06/15/2010; 06/06/2012; 05/06/2014; 06/21/2016; 05/08/2018· 02/06/2021 The University of Kansas Hospital Authority 4000 Cambridge Street Kansas City, KS 66160 Other information: Joint Commission ID # 7029 Recertification date: 08/28/2021 Previous Re-certification Dates: 12/15/2018 170040 03/08/2016 07/20/2022 KS Other information: Joint Commission ID # 8567 Previous Re-certification Dates: 03/08/2016; 03/06/2018 14NON1 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (July through September 2022) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgeiy. 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 Surgeiy (L VRS): EN14NO22.012</GPH> 36-0085 Tammie Hayes, Director, LVRS, 614-293-3629 Addendum XN: Medicare-Approved Bariatric Surgery Facilities (July through September 2022) 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 surgeiy procedures. On Februaiy 21, 2006, we issued our decision memorandum on bariatric surgeiy procedures. We determined that bariatric surgical procedures are reasonable and necessaiy 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 surgeiy procedures are reasonable and necessaiy only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgeiy Center (program standards and requirements in effect on Februaiy 15, 2006); or (2) certified by the American Society forBariatric Surgeiy (ASBS) as a Bariatric Surgeiy Center of Excellence (ESCOE) (prognun standards and requirements in effect on Februaiy 15, 2006). Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices 17:30 Nov 10, 2022 Other information: Joint Commission ID # 6480 Previous Re-ce1tification Dates: 05/11/2010; 05/11/2012; 04/22/2014; 04/12/2016; 04/24/2018; 12/17/2020 Saint Luke's Hospital of Kansas City 4401 Woman Road Kansas City, MO 64111 340113 • 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 L VRS; and • Medicare approved for lung transplants. Only the first two types are in the list. 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 www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). 68172 VerDate Sep<11>2014 Joint commission ID#: 9241 Previous Re-certification Dates: 12/07/2011; 12/03/2013; 01/12/2016; 12/19/2017; 03/05/2020 Carolinas Medical Center 1000 Blythe Boulevard Charlotte, NC 28232 BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–2683] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration AGENCY: FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by December 14, 2022. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:30 Nov 10, 2022 Jkt 259001 JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Data To Support Social and Behavioral Research as Used by the Food and Drug Administration OMB Control Number 0910–0847— Extension This information collection is intended to support FDA-conducted research. Understanding patients, consumers, and healthcare professionals’ perceptions and behaviors plays an important role in improving FDA’s regulatory decision- PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 making processes and communications that affect various stakeholders. FDA uses the following methods to achieve these goals: (1) individual indepth interviews, (2) general public focus group interviews, (3) intercept interviews, (4) self-administered surveys, (5) gatekeeper surveys, and (6) focus group interviews. These methods serve the narrowly defined need for direct and informal opinion on a specific topic and serve as a qualitative and quantitative research tool having two major purposes: • Obtaining useful information for the development of variables and measures for formulating the basic objectives of social and behavioral research and • successfully communicating and addressing behavioral changes with intended audiences to assess the potential effectiveness of FDA communications, behavioral interventions, and other materials. While FDA will use these methods to test and refine its ideas and help develop communication and behavioral strategies research, the Agency will generally conduct further research before making important decisions (such as adopting new policies and allocating or redirecting significant resources to support these policies). FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of the E:\FR\FM\14NON1.SGM 14NON1 EN14NO22.013</GPH> www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0847. Also include the FDA docket number found in brackets in the heading of this document. [FR Doc. 2022–24670 Filed 11–10–22; 8:45 am] 68173 Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (July through September 2022) 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 (410786-3365). 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.ems.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices

Agencies

[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68161-68173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24670]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9138-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July Through September 2022

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

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from April through June 2022, 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 number
----------------------------------------------------------------------------------------------------------------
I CMS Manual Instructions..................................  Ismael Torres....................    (410) 786-1864
II Regulation Documents Published in the Federal Register..  Terri Plumb......................    (410) 786-4481
III CMS Rulings............................................  Tiffany Lafferty.................    (410) 786-7548
IV Medicare National Coverage Determinations...............  Wanda Belle, MPA.................    (410) 786-7491
V FDA-Approved Category B IDEs.............................  John Manlove.....................    (410) 786-6877
VI Collections of Information..............................  William Parham...................    (410) 786-4669
VII Medicare-Approved Carotid Stent Facilities.............  Sarah Fulton, MHS................    (410) 786-2749
VIII American College of Cardiology-National Cardiovascular  Sarah Fulton, MHS................    (410) 786-2749
 Data Registry Sites.
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  David Dolan, MBA.................    (410) 786-3365
 Sites.
XII Medicare-Approved Ventricular Assist Device              David Dolan, MBA.................    (410) 786-3365
 (Destination Therapy) Facilities.
XIII Medicare-Approved Lung Volume Reduction Surgery         Sarah Fulton, MHS................    (410) 786-2749
 Facilities.
XIV Medicare-Approved Bariatric Surgery Facilities.........  Sarah Fulton, MHS................    (410) 786-2749
XV Fluorodeoxyglucose Positron Emission Tomography for       David Dolan, MBA.................    (410) 786-3365
 Dementia Trials.
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

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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 https://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.

    Dated: November 4, 2022.
Trenesha Fultz-Mimms,
Federal Register Liaison, Department of Health and Human Services.
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[FR Doc. 2022-24670 Filed 11-10-22; 8:45 am]
BILLING CODE 4120-01-C
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