medicare a news

84
CPT codes, descriptors, and other data only are copyright 2020 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS apply. This Bulletin should be shared with all health care practitioners and managerial members of the provider/supplier staff. Bulletins are available at no-cost from our website at: http://med.noridianmedicare.com Don’t be left in the dark, sign up for the Noridian e-mail listing to receive updates that contain the latest Medicare news. Visit the Noridian website and select “Subscribe” on the bottom right-hand corner of any page. https://www.cms.gov/Outreach- and-Education/Medicare- Learning-Network- MLN/MLNGenInfo/index Noridian Healthcare Solutions, LLC Medicare A News In This Issue… FYI Noridian Part A Customer Service Contact.............................................................................. 6 MLN Matters Disclaimer Statement ........................................................................................ 6 Sources for “Medicare A News” Articles ................................................................................. 6 Quarterly Provider Update from CMS ..................................................................................... 6 Unsolicited or Voluntary Refunds Reminder ........................................................................... 7 CERT Contractor Email Addresses ........................................................................................... 7 Change to the Payment of Allogeneic Stem Cell Acquisition Services - Revised ..................... 8 Correction to Editing Update for Vaccine Services .................................................................. 8 Implement Operating Rules - Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): CORE 360 Uniform Use of CARC, RARC and CAGC Rule - Update from Council for Affordable Quality Healthcare (CAQH) CORE .................................................................... 8 Medicare Secondary Payer - Revised ...................................................................................... 9 Modify Edits in the FFS System when a Beneficiary has a Medicare Advantage (MA) Plan - Revised .................................................................................................................................... 9 New Physician Specialty Code for MDS and ACHD and a New Supplier Specialty Code for Home Infusion Therapy Services - Revised .............................................................................. 9 The Difference Between an Appeal and a Rebuttal .............................................................. 10 Update to the Model Admission Questions for Providers to Ask Medicare Beneficiaries - Revised .................................................................................................................................. 10 World Hepatitis Day July 28, 2020......................................................................................... 10 AMBULANCE Overview of the Repetitive, Scheduled Non-emergent Ambulance Prior Authorization Model - Revised ..................................................................................................................... 12 CLAIM SUBMISSION Claim Status Category and Claim Status Codes Updates....................................................... 13 Claim Status Category Codes and Claim Status Codes Update - Rescinded .......................... 13 COVERAGE Billing and Coding: Bariatric Surgery Coverage - R13 ............................................................ 14 Billing and Coding: Chemotherapy Administration - R23 ...................................................... 14 Billing and Coding: Chemotherapy Administration - R24 ...................................................... 15 Jurisdiction E October 2020

Upload: others

Post on 02-Feb-2022

1 views

Category:

Documents


0 download

TRANSCRIPT

CPT codes, descriptors, and other data only are copyright 2020 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS apply.

This Bulletin should be shared with all health care practitioners and managerial members of the provider/supplier staff. Bulletins are available at no-cost from our website at: http://med.noridianmedicare.com Don’t be left in the dark, sign up for the Noridian e-mail listing to receive updates that contain the latest Medicare news. Visit the Noridian website and select “Subscribe” on the bottom right-hand corner of any page.

https://www.cms.gov/Outreach-

and-Education/Medicare-Learning-Network-

MLN/MLNGenInfo/index

Noridian Healthcare Solutions, LLC

Medicare A News

In This Issue… FYI Noridian Part A Customer Service Contact .............................................................................. 6

MLN Matters Disclaimer Statement ........................................................................................ 6

Sources for “Medicare A News” Articles ................................................................................. 6

Quarterly Provider Update from CMS ..................................................................................... 6

Unsolicited or Voluntary Refunds Reminder ........................................................................... 7

CERT Contractor Email Addresses ........................................................................................... 7

Change to the Payment of Allogeneic Stem Cell Acquisition Services - Revised ..................... 8

Correction to Editing Update for Vaccine Services .................................................................. 8

Implement Operating Rules - Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): CORE 360 Uniform Use of CARC, RARC and CAGC Rule - Update from Council for Affordable Quality Healthcare (CAQH) CORE .................................................................... 8

Medicare Secondary Payer - Revised ...................................................................................... 9

Modify Edits in the FFS System when a Beneficiary has a Medicare Advantage (MA) Plan - Revised .................................................................................................................................... 9

New Physician Specialty Code for MDS and ACHD and a New Supplier Specialty Code for Home Infusion Therapy Services - Revised .............................................................................. 9

The Difference Between an Appeal and a Rebuttal .............................................................. 10

Update to the Model Admission Questions for Providers to Ask Medicare Beneficiaries - Revised .................................................................................................................................. 10

World Hepatitis Day July 28, 2020 ......................................................................................... 10

AMBULANCE Overview of the Repetitive, Scheduled Non-emergent Ambulance Prior Authorization Model - Revised ..................................................................................................................... 12

CLAIM SUBMISSION Claim Status Category and Claim Status Codes Updates....................................................... 13

Claim Status Category Codes and Claim Status Codes Update - Rescinded .......................... 13

COVERAGE Billing and Coding: Bariatric Surgery Coverage - R13 ............................................................ 14

Billing and Coding: Chemotherapy Administration - R23 ...................................................... 14

Billing and Coding: Chemotherapy Administration - R24 ...................................................... 15

Jurisdiction E October 2020

2

Billing and Coding: Chemotherapy Administration - R25 ............................................................................................................... 16

Billing and Coding: Flow Cytometry - R1 ........................................................................................................................................ 17

Billing and Coding: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification (NAATs) - R3............ 18

Billing and Coding: Lab: Controlled Substance Monitoring and Drugs of Abuse Testing - R8 ........................................................ 19

Billing and Coding: Lumbar MRI - R1 .............................................................................................................................................. 19

Billing and Coding: MolDX: Avise PG Assay - R8 ............................................................................................................................. 20

Billing and Coding: MolDX: BRCA1 and BRCA2 Genetic Testing - R3 .............................................................................................. 21

Billing and Coding: MolDX: Cystatin C Measurement - R1 ............................................................................................................. 21

Billing and Coding: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test - R2 ............................................... 21

Billing and Coding: MolDX: Genetic Testing for Lynch Syndrome - R5 ........................................................................................... 22

Billing and Coding: MolDX: Minimal Residual Disease Testing for Colorectal Cancer .................................................................... 22

Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels - R6 ........................................... 22

Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels - R7 ........................................... 24

Billing and Coding: MolDX: Myriad’s BRACAnalysis CDx® - R5 ....................................................................................................... 24

Billing and Coding: MolDX: Vectra™ DA - R4 .................................................................................................................................. 25

Billing and Coding: Platelet Rich Plasma......................................................................................................................................... 25

Billing and Coding: Routine Foot Care - R2 ..................................................................................................................................... 25

Jurisdiction E Part A Local Coverage Articles Converted to Billing and Coding Articles in the Medicare Coverage Database....... 26

Positron Emission Tomography Scans Coverage - R22 ................................................................................................................... 26

ELECTRONIC DATA INTERCHANGE Improving Electronic Claims Processing with Noridian Custom Edits (NCE) .................................................................................. 28

EDUCATIONAL 2021 JE Part A Quarterly Ask-the-Contractor Teleconferences ..................................................................................................... 29

Appeals Converted to Reopenings ................................................................................................................................................. 29

CMS Prior Authorization for Certain Hospital Outpatient Department (OPD) Services Resources ............................................... 29

GoToWebinar Access Issues Utilizing Internet Explorer ................................................................................................................. 30

Medicare HMO vs Fee for Service for Hospice Patients - Who Pays .............................................................................................. 30

Overlapping Claim Resolution Tips ................................................................................................................................................. 30

Part B Provider Responsibility for Prior Authorization (PA) for Certain Hospital Outpatient Department (OPD) Services ........... 30

Patient Status Codes ....................................................................................................................................................................... 31

Submission of Requests for Prior Authorization (PA) for Certain Hospital Outpatient Department (OPD) Services ..................... 31

EMERGENCIES AND DISASTERS Comprehensive Error Rate Testing (CERT) Reviews and COVID-19................................................................................................ 32

COVID-19 Diagnostic Laboratory Tests: Billing for Clinician Services ............................................................................................. 32

COVID-19 Modifiers and Condition Code ....................................................................................................................................... 32

3

Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) - Revised ............... 33

New and Expanded Flexibilities for RHCs and FQHCs During the COVID-19 PHE - Revised ........................................................... 33

New COVID-19 Policies for IPPS Hospitals, LTCHs, and IRFs due to Provisions of the CARES Act - Revised .................................. 33

New Point of Origin Code for Transfer from a Designated Disaster ACS - Revised ........................................................................ 34

New Waivers for IPPS Hospitals, LTCHs, and IRFs due to Provisions of the CARES Act .................................................................. 34

Update to the International Classification of Diseases, Tenth Revision (ICD-10) Diagnosis Codes for Vaping Related Disorder and Diagnosis and Procedure Codes for the 2019 COVID-19 - Revised ......................................................................................... 34

ENROLLMENT Do Not Forward Initiative Reminder .............................................................................................................................................. 36

Delegated Official Role Title Change to Access Manager in I&A .................................................................................................... 37

Medicare Enrollment Application Fee Refunds through EFT ......................................................................................................... 37

INPATIENT PSYCHIATRIC FACILITY IPF PPS Updates for FY 2021........................................................................................................................................................... 38

LABORATORY Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2020 ........................................ 39

MEDICAL POLICIES 2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates .................................................... 40

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates .................................................... 41

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates .................................................... 42

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates .................................................... 42

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates - Vitamin D Assay Testing .......... 44

Helicobacter Pylori Infection Testing LCD and Billing and Coding: Helicobacter Pylori Infection Testing Retirement - Effective August 01, 2020 .............................................................................................................................................................................. 45

Implantable Continuous Glucose Monitor (I-CGM) Final LCD - Effective November 2, 2020 ........................................................ 45

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to NCDs - January 2021 Update ... 45

Lab: Urine Drug Testing Proposed LCD Retirement - Effective July 15, 2020 ................................................................................. 46

MolDX: Combinatorial Pharmacogenomics Limited Coverage Proposed LCD; Billing and Coding: MolDX: Combinatorial Pharmacogenomics Limited Coverage Retirement - Effective August 16, 2020 ............................................................................ 46

MolDX: HLA-B*15:02 Genetic Testing LCD Retirement; Billing and Coding: MolDX: HLA-B*15:02 Genetic Testing Article Retirement - Effective September 16, 2020 ................................................................................................................................... 46

MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung Cancer Final LCD - Effective August 24, 2020 ......................... 47

MolDX: Molecular Microscope® Diagnostic System for the Heart Proposed LCD Retirement; Billing and Coding: MolDX: Molecular Microscope® Diagnostic System for the Heart - Effective September 09, 2020 ........................................................... 47

MolDX: Pharmacogenomics Testing Local Coverage Determination ............................................................................................. 47

MolDX: SelectMDx for Prostate Cancer Proposed LCD Retirement - Effective July 14, 2020 ........................................................ 48

MolDX: Signatera and Minimal Residual Disease Testing for Colorectal Cancer Proposed LCD Retirement - Effective August 5, 2020 ................................................................................................................................................................................................ 48

4

MolDX: Tests on Allograft Kidney Biopsy Tissue to Assess for Graft Rejection Proposed LCD Retirement; Billing and Coding: MolDX: Tests on Allograft Kidney Biopsy Tissue to Assess for Graft Rejection - Effective September 09, 2020 ........................... 48

National Coverage Determination (NCD 30.3.3): Acupuncture for cLBP - Revised ........................................................................ 49

NCD 90.2: NGS for Medicare Beneficiaries with Germline (Inherited) Cancer .............................................................................. 49

Published for Review and Comments: Facet Joint Interventions for Pain Management-Proposed LCD and Billing and Coding Article ............................................................................................................................................................................................. 49

MLN CONNECTS MLN Connects - July 2, 2020 .......................................................................................................................................................... 51

MLN Connects Special Edition - July 6, 2020 - ESRD PPS CY 2021 Proposed Rule; COVID-19: New and Expanded Flexibilities for RHCs & FQHCs ................................................................................................................................................................................ 51

MLN Connects - July 9, 2020 .......................................................................................................................................................... 52

MLN Connects - July 16, 2020 ........................................................................................................................................................ 53

MLN Connects Special Edition - July 17, 2020 - COVID-19: Nursing Home Testing, SNF Benefit Period Waiver ........................... 53

MLN Connects - July 23, 2020 ........................................................................................................................................................ 54

MLN Connects Special Edition - July 23, 2020 - Trump Administration Announces New Resources to Protect Nursing Home Residents Against COVID-19 ........................................................................................................................................................... 54

MLN Connects - July 30, 2020 ........................................................................................................................................................ 56

MLN Connects Special Edition - July 30, 2020 - Payment for COVID-19 Counseling, Reporting Hospital Therapeutics, Out-of-Pocket Drug Costs ........................................................................................................................................................................... 56

MLN Connects Special Edition - July 31, 2020 - FY 2021 Medicare Payment Policies for IPFs, SNFs, and Hospices ...................... 58

MLN Connects Special Edition - August 04, 2020 - PFS, OPPS, and IRF: FY 2021 Payment Rules .................................................. 59

MLN Connects - August 06, 2020 ................................................................................................................................................... 63

MLN Connects - August 13, 2020 ................................................................................................................................................... 64

MLN Connects - August 20, 2020 ................................................................................................................................................... 64

MLN Connects - August 27, 2020 ................................................................................................................................................... 65

MLN Connects Special Edition - August 28, 2020 - CMS Offers Comprehensive Support for Louisiana and Texas with Hurricane Laura ............................................................................................................................................................................................... 65

MLN Connects Special Edition - Wednesday, September 2, 2020 - CMS Advancing Seniors’ Access to Cutting-edge Therapies and Technology in Medicare Hospital Rule .................................................................................................................................... 67

MLN Connects - September 3, 2020 ............................................................................................................................................... 68

MLN Connects - September 10, 2020 ............................................................................................................................................. 69

MLN Connects Special Edition - September 11, 2020 - Community Health Access and Rural Transformation Model ................. 70

MLN Connects - September 17, 2020 ............................................................................................................................................. 71

MLN Connects Special Edition - September 17, 2020 - Nursing Home COVID-19 Commission Findings, Oregon Wildfires, & Flu ........................................................................................................................................................................................................ 71

MLN Connects Special Edition - September 18, 2020 - New COVID-19 Nursing Home Visitation Guidance, Kidney Disease Care Model, & Radiation Oncology Payment Model .............................................................................................................................. 73

MLN Connects - September 24, 2020 ............................................................................................................................................. 74

5

NORIDIAN MEDICARE PORTAL Pneumococcal Vaccine Codes Available in Noridian Medicare Portal ........................................................................................... 75

Prior Authorization Request Submission and Status Now Available in the Noridian Medicare Portal for Part A Users ................ 75

OUTPATIENT PROSPECTIVE PAYMENT SYSTEM October 2020 Update of the Hospital OPPS - Revised ................................................................................................................... 76

SKILLED NURSING FACILITY Medicare Part A SNF PPS Pricer Update FY 2021 - Revised ............................................................................................................ 77

SNF Patient Driven Payment Model Interrupted Stay Issue........................................................................................................... 77

TELEHEALTH Telehealth Expansion Benefit Enhancement Under the PARHM - Implementation ...................................................................... 78

UPDATES 2021 Annual Update for the HPSA Bonus Payments...................................................................................................................... 79

Annual Clotting Factor Furnishing Fee Update 2021 ...................................................................................................................... 79

FY 2021 IPPS and LTCH PPS Changes .............................................................................................................................................. 79

HCPCS Codes for SNF CB - 2021 Annual Update ............................................................................................................................ 79

Influenza Vaccine Payment Allowances - Annual Update for 2020-2021 Season - Revised .......................................................... 80

IRF Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2021 .................................................................... 80

July 2020 Update of the Hospital OPPS - Revised .......................................................................................................................... 80

October 2020 Quarterly ASP Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files - Revised ........... 81

October Quarterly Update for 2020 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule ........................................................................................................................................................................................................ 81

Quarterly HCPCS Drug/Biological Code Changes - July 2020 Update ............................................................................................. 82

Quarterly Update for CLFS and Laboratory Services Subject to Reasonable Charge Payment - Revised ...................................... 82

Quarterly Update for CLFS and Laboratory Services Subject to Reasonable Charge Payment - Revised ...................................... 82

Quarterly Update to the End-Stage Renal Disease PPS .................................................................................................................. 83

Quarterly Update to the MPFSDB - October 2020 Update ............................................................................................................ 83

Updates to Nursing and Allied Health Education Medicare Advantage Payment Policies ............................................................ 83

Update to the Medicare Claims Processing Manual ...................................................................................................................... 84

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 6

Noridian Part A Customer Service Contact General IVR Inquiries Available 24/7

Phone Number Inquiry Hours (PT) 855-609-9960 Claim Specific Monday - Friday 6 a.m. - 5 p.m.

• Interactive Voice Response (IVR) • Provider Contact Center (PCC) • Provider Enrollment • EDISS • User Security (including NMP)

Text Teletype Calls (TTY) - 855-549-9874

Monday - Friday 8 a.m. - 5 p.m. PT

MLN Matters Disclaimer Statement Below is the CMS Medicare Learning Network (MLN) Matters Disclaimer statement that applies to all MLN Matters articles in this bulletin.

“This article was prepared as a service to the public and is not intended to grant rights or impose obligations. MLN Matters articles may contain references or links to statutes, regulations or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents.”

Sources for “Medicare A News” Articles The purpose of “Medicare A News” is to educate the Noridian Medicare Part A provider community. The educational articles can be advice written by Noridian staff or directives from CMS. Whenever we publish material from CMS, we will do our best to retain the wording given to us; however, due to limited space in our bulletins, we will occasionally edit this material. Noridian includes “Source” following CMS derived articles to allow for those interested in the original material to research it at the CMS website, https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/index. The CMS Change Request (CR) and the date issued will be referenced within the “Source” portion of applicable articles.

CMS publishes a series of educational articles within their Medicare Learning Network (MLN), titled “MLN Matters.” These “MLN Matters” articles are also included in Noridian bulletins. The Medicare Learning Network is a brand name for official CMS national provider education products designed to promote national consistency of Medicare provider information developed for CMS initiatives.

Quarterly Provider Update from CMS The Quarterly Provider Update is a comprehensive resource published by CMS on the first business day of each quarter. It is a listing of all non-regulatory changes to Medicare including Change Requests (CRs), manual changes and any other instructions that could affect providers. Regulations and instructions published in the previous quarter are also included in the Update.

The purpose of the Quarterly Provider Update is to:

• Inform providers about new developments in the Medicare program; • Assist providers in understanding CMS programs and complying with Medicare regulations and instructions; • Ensure that providers have time to react and prepare for new requirements; • Announce new or changing Medicare requirements on a predictable schedule; and • Communicate the specific days that CMS business will be published in the Federal Register.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 7

Sign up for the Quarterly Provider Update listserv to receive notification when regulations and program instructions are added throughout the quarter, (electronic mailing list) at https://www.cms.gov/About-CMS/Agency-Information/Aboutwebsite/EmailUpdates. Indicate that you wish to receive the CMS-QPU Listserv on the list of available publications.

The Quarterly Provider Update can be accessed on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/QuarterlyProviderUpdates/index. We encourage you to bookmark this website and visit it often for this valuable information.

Source: PM AB-03-075, CR 2686 dated May 23, 2003

Unsolicited or Voluntary Refunds Reminder All Medicare providers need to be aware that the acceptance of a voluntary refund as repayment for the claims specified in no way affects or limits the rights of the Federal Government, or any of its agencies or agents, to pursue any appropriate criminal, civil, or administrative remedies arising from or relating to these or any other claims.

BACKGROUND

Medicare carriers and intermediaries and A/B MACs receive unsolicited or voluntary refunds from providers. These voluntary refunds are not related to any open accounts receivable. Providers billing intermediaries typically make these refunds by submitting adjustment bills, but they occasionally submit refunds via check. Providers billing carriers usually send these voluntary refunds by check.

Related Change Request (CR) 3274 is intended mainly to provide a detailed set of instructions for Medicare carriers and intermediaries regarding the handling and reporting of such refunds. The implementation and effective dates of that CR apply to the carriers and intermediaries. But, the important message for providers is that the submission of such a refund related to Medicare claims in no way limits the rights of the Federal Government, or any of its agencies or agents, to pursue any appropriate criminal, civil, or administrative remedies arising from or relating to those or any other claims.

ADDITIONAL INFORMATION

The official CMS CR3274 instruction may be viewed in the Medicare Learning Network (MLN) Matters article at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/mm3274.pdf.

Effective Date: January 1, 2005

Implementation Date: January 4, 2005

Sources: Transmittal 50, CR 3247 dated July 30, 2004; Internet Only Manual (IOM) Medicare Financial Management Manual, Publication 100-06, Chapter 5, Section 410

CERT Contractor Email Addresses Providers and suppliers are now able to submit medical records directly to the CERT contractor at [email protected]. As a best practice, providers and suppliers are encouraged to password protect their documentation. Passwords should be submitted in a separate email to the CERT contractor.

Have questions? Reach out to the CERT Contractor at [email protected]. They can assist with questions related to medical records requests, review status, and more.

Your MAC’s CERT team is also able to assist with questions you may have regarding the CERT process. Locate their contact information on your MAC’s website.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 8

Change to the Payment of Allogeneic Stem Cell Acquisition Services - Revised MLN Matters Number: MM11729 Revised Related CR Release Date: September 24, 2020 Related CR Transmittal Number: R10371CP Related Change Request (CR) Number: 11729 Effective Date: For cost reporting periods beginning on or after October 1, 2020 Implementation Date: January 4, 2021 Note: CMS revised this article to reflect the revised CR 11729 issued on September 24, 2020. The CR revision did not impact the substance of the article. In the article, CMS revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

CR 11729 provides instructions to pay inpatient hospital Allogeneic Stem Cell Acquisition services on a reasonable cost basis. Please make sure your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11729.

Correction to Editing Update for Vaccine Services MLN Matters Number: MM11867 Related CR Release Date: August 7, 2020 Related CR Transmittal Number: R10275OTN Related Change Request (CR) Number: 11867 Effective Date: January 1, 2021 * For claims received on or after this date Implementation Date: January 4, 2021 CR 11867 informs you that Medicare is changing the Common Working File (CWF) to bypass line-item dates of service for vaccines reported on inpatient Part B claims with Type of Bill (TOB) 12X and 22X when the dates of service (DOS) equal a posted outpatient TOB 73X or 77X service dates, or if present, occurrence span code visit date, regardless of the date of service. Please make sure your billing staffs are aware of these corrections.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11867.

Implement Operating Rules - Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): CORE 360 Uniform Use of CARC, RARC and CAGC Rule - Update from Council for Affordable Quality Healthcare (CAQH) CORE MLN Matters Number: MM11881 Related CR Release Date: August 28, 2020 Related CR Transmittal Number: R10324CP Related Change Request (CR) Number: 11881 Effective Date: January 1, 2021 Implementation Date: January 4, 2021 CR 11881 informs you that Medicare will update its claims processing systems based on the Committee on Operating Rules for Information Exchange (CORE) 360 Uniform use of Claim Adjustment Reason Code (CARC), Remittance Advice Remark Code (RARC), and Claim Adjustment Group Code (CAGC) rule publication. These system updates are based on the CORE, Code Combination List, which will be published on or about October 1, 2020. Make sure that your billing staffs are aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11881.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 9

Medicare Secondary Payer - Revised A revised Medicare Secondary Payer Medicare Learning Network Booklet is available. Learn about:

• When Medicare pays first • Exceptions • How to gather accurate data from the beneficiary • What happens if you fail to file correct and accurate claims

Source: MLN Connects for Thursday June 4, 2020

Modify Edits in the FFS System when a Beneficiary has a Medicare Advantage (MA) Plan - Revised MLN Matters Number: MM11580 Revised Related CR Release Date: July 21, 2020 Related CR Transmittal Number: R10229CP Related Change Request (CR) Number: 11580 Effective Date: Claims received on or after October 1, 2020 Implementation Date: October 5, 2020 Note: We revised this article to reflect a revised CR 11850, issued on July 21, 2020. In the article, CMS revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

CR 11580 modifies Medicare system edits on inpatient claims when a beneficiary’s MA plan becomes effective during the inpatient admission. Also, the Centers for Medicare & Medicaid Services (CMS) is streamlining the editing for MA plans’ claims when it is determined that certain services are being disallowed on MA plans that are considered a significant cost under Section 422.109(a)(2) of title 42 of the Code of Federal Regulations (CFR). Original Fee- For-Service (FFS) Medicare will pay for services obtained by beneficiaries enrolled in MA plans in this circumstance.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11580.

New Physician Specialty Code for MDS and ACHD and a New Supplier Specialty Code for Home Infusion Therapy Services - Revised MLN Matters Number: MM11750 Revised Related CR Release Date: September 25, 2020 Related CR Transmittal Numbers: R10374CP and R10374FM Related Change Request (CR) Number: 11750 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 Note: CMS revised this article to reflect the revised CR 11750, issued on September 25, 2020. In the article, CMS revised the CR release date, transmittal numbers, and the web addresses of the transmittals. All other information remains the same.

CR 11750 informs you of new physician specialty codes for Micrographic Dermatologic Surgery (MDS) (D7), and Adult Congenital Heart Disease (ACHD) (D8), and a new supplier specialty code for Home Infusion Therapy Services (D6). Make sure that your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11750.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 10

The Difference Between an Appeal and a Rebuttal When a provider does not agree with an overpayment determination, they may appeal the decision. An appeal disputes the overpayment and provides documentation to show medical necessity for the procedures in question. The limitation on recoupment provision mandates that no recoupment begins when a valid and timely request for a first level or second level appeal is received.

A rebuttal does not dispute the amount of the overpayment, nor does it dispute the overpayment determination. A rebuttal permits the provider a vehicle to indicate why the proposed recoupment should not be taken at the designated time. This allows providers to submit a statement advising if the recoupment occurs, it will cause financial hardship for their facility. The contractor, based on the rebuttal statement, determines whether to delay or begin recoupment. The rebuttal process is not an appeal and does not change anything regarding the debt owed.

Internet Only Manual,(IOM), Publication 100-06, Chapter 3, Section 200.1.4: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/fin106c03.pdf

Update to the Model Admission Questions for Providers to Ask Medicare Beneficiaries - Revised MLN Matters Number: MM11945 Revised Related CR Release Date: September 15, 2020 Related CR Transmittal Number: R10359MSP Related Change Request (CR) Number: 11945 Effective Date: December 7, 2020 Implementation Date: December 7, 2020 Note: CMS revised this article to reflect an updated CR 11945. The CR revision added part of a sentence that had been left out of manual Section 20.2.2 of the Medicare Secondary Payer Manual, which is part of the CR. The correction of the CR had no impact on the substance of the article. In the article, CMS revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

CR 11945 informs you that the Centers for Medicare & Medicaid Services (CMS) is modifying and streamlining the model admission questions for providers to ask Medicare beneficiaries or authorized representatives upon admission or start of care. No other updates have been made to the hospital admissions or billing process.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11945.

World Hepatitis Day July 28, 2020 For World Hepatitis Day on July 28, 2020, learn more about the different types of viral hepatitis and how to act. Worldwide, 300 million people are living with viral hepatitis unaware. Most people with chronic hepatitis virus do not have symptoms until the later stages of the infection, putting them at risk for serious liver disease, liver cancer, and even death. Let us take action to increase awareness and understanding of viral hepatitis.

Medicare covers the following viral hepatitis immunization and screening services:

• Hepatitis B Virus (HBV) vaccine and administration: o Available to Medicare beneficiaries who are at high or intermediate risk of contracting hepatitis B

• Hepatitis C Virus (HCV) screening: o Available for beneficiaries who fall into at least one of the following categories:

High risk for HCV infection Born between 1945 and 1965 Had a blood transfusion before 1992

• Screening for Sexually Transmitted Infections (STIs) and High Intensity Behavioral Counseling (HIBC) to prevent STIs:

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 11

o Payment subject to certain coverage, frequency, and payment limitation for sexually active adolescents and adults at increased risk for STIs

o Screening tests include Chlamydia, Gonorrhea, Syphilis, and Hepatitis B (Hepatitis B Surface Antigen)

Counseling includes face-to-face, individual semi-annual visits to include education, skills training, and guidance on how to change sexual behavior

Medicare waives the deductible and coinsurance for beneficiaries for these services.

For more information on World Hepatitis Day, visit the Centers for Disease Control and Prevention websites: World Hepatitis Day and Viral Hepatitis.

References:

Preventive Services Educational Tool

National Coverage Determination (NCD) for Screening for Hepatitis B Virus (HBV) Infection (210.6)

NCD for Screening for Hepatitis C Virus (HCV) in Adults (210.13)

NCD for Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to Prevent STIs (210.10)

The A/B Medicare Administrative Contractor (MAC) Provider Outreach & Education (POE) developed this document to ensure consistent communication and education throughout the nation on a variety of topics and assist the provider and physician community with information necessary to submit claims appropriately and receive proper payment in a timely manner.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 12

Overview of the Repetitive, Scheduled Non-emergent Ambulance Prior Authorization Model - Revised MLN Matters® Number: SE1514 Revised Article Release Date: July 24, 2020 Note: This article was revised to provide information on transportation information for beneficiaries in the Additional Information section of this article. All other information is unchanged.

The Centers for Medicare & Medicaid Services (CMS) began a 3-year prior authorization model for repetitive, scheduled non-emergent ambulance transports in the states of New Jersey, Pennsylvania, and South Carolina on December 1, 2014, for transports on or after December 15, 2014, regardless of the origin or destination of the transport. Six additional areas were included in the model - Delaware, the District of Columbia, Maryland, North Carolina, Virginia, and West Virginia - on December 15, 2015, for transports on or after January 1, 2016.

View the complete CMS Medicare Learning Network (MLN) Matters (SE)1514.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 13

Claim Status Category and Claim Status Codes Updates MLN Matters Number: MM11796 Related CR Release Date: August 28, 2020 Related CR Transmittal Number: R10322CP Related Change Request (CR) Number: 11796 Effective Date: January 1, 2021 Implementation Date: January 4, 2021 CR 11796 informs you of updates to the Claim Status and Claim Status Category Codes used for the Accredited Standards Committee (ASC) X12 276/277 Health Care Claim Status Request and Response and ASC X12 277 Health Care Claim Acknowledgement transactions. Please make sure your billing staffs are aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11796.

Claim Status Category Codes and Claim Status Codes Update - Rescinded MLN Matters Number: MM11699 Related CR Release Date: May 22, 2020 Related CR Transmittal Number: R10148CP Related Change Request (CR) Number: 11699 This article was rescinded on July 9, 2020, as the related Change Request (CR) 11699, Transmittal R10148CP, dated May 22, 2020, was rescinded and will not be replaced.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 14

Billing and Coding: Bariatric Surgery Coverage - R13 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 01, 2020 Summary of Article Changes: Revisions are due to the Annual ICD-10 Updates. Addition of coding to Group 1: M19.09: Primary osteoarthritis, other specified site M19.19: Post-traumatic osteoarthritis, other specified site M19.29: Secondary osteoarthritis, other specified site M24.19: Other articular cartilage disorders, other specified site

Deleted Code in Group I: K21.0: Gastro-esophageal reflux disease with esophagitis

Descriptor Changes in Group II: Z68.35: Body mass index [BMI] 35.0-35.9, adult Z68.36: Body mass index [BMI] 36.0-36.9, adult Z68.37: Body mass index [BMI] 37.0-37.9, adult Z68.38: Body mass index [BMI] 38.0-38.9, adult Z68.39: Body mass index [BMI] 39.0-39.9, adult Z68.41: Body mass index [BMI]40.0-44.9, adult Z68.42: Body mass index [BMI] 45.0-49.9, adult Z68.43: Body mass index [BMI] 50.0-59.9, adult Z68.44: Body mass index [BMI] 60.0-69.9, adult Z68.45: Body mass index [BMI] 70 or greater, adult

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: Chemotherapy Administration - R23 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: July 1, 2020 Summary of Article Changes: The following updates were made with multiple effective dates.

1. Effective January 1, 2019: • Added J0517 - benralizumab (Fasenra®) and deleted C9016 - triptorelin (Triptodur™) and C9466 -

benralizumab (Fasenra®) in Group 1 of the CPT/HCPCS Codes section. 2. Effective October 21, 2019:

• Added the diagnosis codes for Ulcerative Colitis as payable with IV Stelara® in the Group 1 of the ICD-10 Codes that Support Medical Necessity section.

3. Effective January 1, 2020: • Converted this article to Billing and Coding: Chemotherapy Administration. • Added information regarding how to bill for drugs that have a Not Otherwise Classified (NOC) HCPCS code

and the mandatory use of the JW modifier when billing for the quantity of drug wasted per CMS CR 9603 to the Article Text section.

• Combined and added the following information for Groups 1 and 2 Paragraphs in the CPT/HCPCS Codes section:

• Combined Group 1 and 2 Paragraph into one group titled; Intramuscular, Subcutaneous and Intravenous Non-Chemotherapy Injections/Infusions and added all the associated J codes to the Group 1 Codes.

• Added Group 2 Paragraph statement and listed all the administration codes associated with the

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 15

Group 1 codes to the Group 2 list of codes. • Deleted J3590 for Orencia®, Simponi® and J1628 - Tremfya™ from all of Group 1 since these drugs

are self-administered and in the current SAD article. • Added Coding Guidelines in the Group 3 Paragraph under the CPT/HCPCS Codes section. Some of these

include: • Added Q5115 - rituximab-abbs (Truxima®) and Q5116 - trastuzumab-qyyp), Herceptin biosimilar

(Trazimera) to the table • Added instructions for Part A enrolled independent or provider-based facilities and Part B enrolled as

provider-based multispecialty clinics or independent physician clinics on how to bill both the drug and administration codes for chemotherapy administration codes 96401-96425 and 96440, 96446, 96450 and 96542.

• Added instruction for billing intravesical chemotherapy using 51720 - Bladder instillation of anticarcinogenic agent (including retention time) or 52224, 52234, 52235 or 52240 when the intravesical chemotherapy drug was administered with a fulguration procedure.

• HCPCS code G0498, is to be bill for the drugs that are infused greater than 8 hours even if the pump is not supplied by the facility or the physician’s office.

• Added instructions to bill 96416 instead of G0498 when the beneficiary goes to a facility or physician not associated with the billing facility or physician for the removal of the external pump.

• Instructed providers to report 96416 as the administration code with one of the drugs approved for prolonged infusion time (greater than 8 hours) listed in the article only if the patient has an infusaport catheter with implantable pump within the catheter itself.

• Added a list of approved chemotherapy drug HCPCS codes in Group 3 CPT/HCPCS Codes section. • Added a table for all the approved chemotherapy drugs and the appropriate administration code(s), provided

instructions for providers and facilities to appeal claims denied for the wrong admin code or if 96413 is billed when the appropriate administration code in the table is 96409 because the drug was infused greater than 15 minutes and what to include with the Appeal and instructed providers to add diagnosis code T45.1XA - Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter when a drug requiring more than 15 minutes is billed and the patient had an adverse reaction to the drug to the Group 4 Paragraph.

• Added the approved chemotherapy administration codes to the Group 4 CPT/HCPCS Codes section. 4. Effective May 1, 2020 added J9999 for daratumumab and hyaluronidase-fihj (Darzalex FasPro™). 5. Effective July 1, 2020 added HCPCS codes J9177 - enfortumab vedotin ejfv (Padcev™),

J9198 - gemcitabine hydrochloride (Infugem™), J9246 - melphalan HCL (Evomela), J9358 - fam-trastuzumab deruxtecan-nxki, (Enhertu®) , Q5119 - rituximab-pvvr (Ruxience™) and Q5121 - infliximab-axxq, biosimilar, (Avsola), deleted J9199 - gemcitabine hydrochloride (Infugem™) and the code description for J9245 changed from melphalan HCL (Evomela), 50mg to melphalan HCL, NOS, 50mg.

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: Chemotherapy Administration - R24 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 19, 2020 Summary of Article Changes: The following updates were made with multiple effective dates.

1. Added J0896-Reblozyl® to the Group 1 list of drugs and Code list and administration code to the Group 2 Paragraph effective 04/03/2020.

2. Added J9999 (OPPS: C9399) for sacituzumab govitecan-hziy (Trodelvey™), mitomycin (JelMyto™), tafasitamab-cxix (Monjuvi®, romidepsin, non-lypohilized (romidepsin), isatuximab-irfc (Sarclisa®), pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo™) and brexucabtagene autoleucel (Tecartus™) with effective dates and associated administration codes to Group 3 and 4.

3. Effective for dates of service on or after 10/01/2019, updated the effective date of service for some drugs that

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 16

erroneously had 01/01/2020. 4. Effective 10/21/2019 add the following Ulcerative Colitis diagnosis codes for IV Stelara to the Group 1 ICD-10 Codes

That Support Medical Necessity that were missed with the last update. a. K51.30 Ulcerative (chronic) rectosigmoiditis without complications b. K51.311 Ulcerative (chronic) rectosigmoiditis with rectal bleeding c. K51.312 Ulcerative (chronic) rectosigmoiditis with intestinal obstruction d. K51.313 Ulcerative (chronic) rectosigmoiditis with fistula e. K51.314 Ulcerative (chronic) rectosigmoiditis with abscess f. K51.318 Ulcerative (chronic) rectosigmoiditis with other complication g. K51.319 Ulcerative (chronic) rectosigmoiditis with unspecified complications h. K51.50 Left sided colitis without complications i. K51.511 Left sided colitis with rectal bleeding j. K51.512 Left sided colitis with intestinal obstruction k. K51.513 Left sided colitis with fistula l. K51.514 Left sided colitis with abscess m. K51.518 Left sided colitis with other complication n. K51.519 Left sided colitis with unspecified complications o. K51.80 Other ulcerative colitis without complications p. K51.811 Other ulcerative colitis with rectal bleeding q. K51.812 Other ulcerative colitis with intestinal obstruction r. K51.813 Other ulcerative colitis with fistula s. K51.814 Other ulcerative colitis with abscess t. K51.818 Other ulcerative colitis with other complication u. K51.819 Other ulcerative colitis with unspecified complications

5. Effective 01/01/2020, clarified all chemotherapy approved drugs listed in Group 3 and 4 require a chemotherapy administration code to be billed in Group 3 and clarified J9280 is not to be billed for ophthalmological procedures because the dose associated with this J-code is much higher than what is actually administered into the eye in Group 3. In the ICD-10 Codes That Support Medical Necessity Paragraph 1, clarified the IV push codes 96374 or 96375 should not be billed for the initial infusion of IV Stelara since the FDA label indicates it needs to be administered over at least one hour. Added missed approved drug codes to the Group 4 Codes section.

6. Effective 07/01/2020, added 96446 for Paclitaxel (J9267), 96450 for topotecan (J9351) and 96542 for Herceptin J9355) as an approved off-label administration codes to Group 5 Paragraph section.

7. Effective 10/01/2020 add J9304 - pemetrexed (Pemfexy™) 10 mg to Group Codes section and added 9409 & 96411 as the administration codes to Group 5 Paragraph section.

8. Effective 10/19/2020, added the DX codes required to bill with Reblozyl® (J0896) to Group 2 of the ICD-10 Codes That Support Medical Necessity section.

Visit the Noridian Medicare Coverage Articles webpage to access the Future, articles available in the CMS MCD.

Billing and Coding: Chemotherapy Administration - R25 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date of Article: October 19, 2020 Summary of Article Changes: The following updates were made to remove outdated coding information from July and October 2019 in the Group 3 Paragraph table. Added the new and revised HCPCS codes payable in the Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center (ASC) setting to the Group 3 and 4 Paragraph tables effective on 10/01/2020 and are listed below.

1. Revised: a. J9305 from Pemetrexed, 10 mg to Pemetrexed, not otherwise classified, 10 mg.

2. Added:

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 17

a. C9062 for daratumumab and hyaluronidase-fihj (Darzalex FasPro), b. C9064 for Mitomycin pyelocalyceal (Jelmyto™) instillation, 1mg, c. C9065 for romidepsin, non-lypoilized (romidepsin) (e.g. liquid), 1mg, d. C9066 for sacituzumab govitecan-hziy (Trodelvey™), 180 mg all in the OPPS setting, and e. J9227 for isatuximab-irfc (Sarclisa®), 10mg.

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: Flow Cytometry - R1 This Local Coverage Article (LCA) has been revised under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

LCD Medicare Coverage Database (MCD) Number: L34215 LCA Medicare Coverage Database Number: A57689 Effective Date: March 17, 2020 Summary of Changes: The Billing and Coding Article has been updated to add and confirm the following diagnosis codes effective on the dates of service (DOS) specified.

• Added the following diagnosis codes as they were erroneously deleted with the update effective DOS 12/01/2019. o A18.01, C21.2, C22.3-C22.4, C34.01-C34.02, C34.11-C34.1, 2C34.31-C34.32, C34.81-C34.82, C40.01-C40.02,

C40.11-C40.12, C40.21-C40.22, C40.31-C40.32, C40.81-C40.82, C44.212-C44.219, C44.222-C44.229, C44.292-C44.299, C44.612-C44.619, C44.622- C44.629, C44.692-C44.699, C44.712-C44.719, C44.722-C44.729, C44.792-C44.799, C45.0-C45.1, C45.7, C47.0, C47.11-C47.12, C47.21-C47.5, C49.11-C49.12, C49.21- C49.22, C49.A0-C49.A9, C50.011-C50.012, C50.021-C50.022, C50.111- C50.112,C50.121-C50.122, C50.211-C50.212, C50.221-C50.222, C50.311-C50.312, C50.321-C50.322, C50.411-C50.412, C50.421-C50.422, C50.511-C50.512, C50.521- C50.522, C50.611-C50.612, C50.621-C50.622, C50.811-C50.812, C50.821-C50.822, C51.8, C56.1-C56.2, C62.01-C62.02, C62.11-C62.1, C63.01-C63.02,C63.11-C63.12, C64.1-C64.2, C65.1-C65.2, C66.1-C66.2, C69.01-C69.02, C69.11-C69.12, C69.21- C69.22, C69.31-C69.32, C69.41-C69.42, C69.51-C69.52, C69.61-C69.62, C69.81-C69.82, C72.21-C72.22, C72.31-C72.32, C72.41-C72.42, C72.59, C74.01-C74.02, C74.11-C74.12, D05.01-D05.02, D05.11-D05.12, D05.81-D05.82, D35.01-D35.02, D37.09, D37.3, D39.11-D39.12, D40.11-D40.12, D48.2, D48.61-D48.62, D57.01, D57.211, D57.811-D57.812, D73.0, D82.2-D82.8, D84.0, D84.8, D89.40-D89.49, K50.011-K50.018, K50.111-K50.118, K50.811-K50.818, K51.011-K51.018, K51.211-K51.218, K51.311-K51.318, K51.411-K51.418, K51.511-K51.518, L40.51-L40.53, M02.311-M02.312, M02.321-M02.322, M02.331-M02.332, M02.341-M02.342, M02.351-M02.352, M02.361-M02.362, M02.371-M02.372, M02.38-M02.39, M08.1, M08.211-M08.212, M08.221-M08.222, M08.231-M08.232, M08.241-M08.242, M08.251-M08.252, M08.261-M08.262, M08.271-M08.272, M08.28-M08.3, M08.811-M08.812, M08.821-M08.822, M08.831-M08.832, M08.841-M08.842, M08.851-M08.852, M08.861-M08.862, M08.871-M08.872, M08.88-M08.89, M45.0-M45.8, M46.01-M46.09, M46.51-M46.59, M46.81-M46.89, M48.8X1-M48.8X8, M49.81-M49.89, N42.30-N42.39, O01.0-O01.1, R87.618, T86.830-T86.838 and Z95.4.

• Confirmed the addition of the following diagnosis codes as they were erroneously added with the update effective DOS 12/01/2019.

o C15.9, C16.5, C16.6, C16.9, C17.9, C18.9, C21.0, C22.8, C25.9, C26.0, C31.9, C32.9, C34.00, C34.10, C34.30, C34.80C34.90, C38.3, C39.0, C39.9, C40.00, C40.10, C40.20, C40.30, C41.9, C44.00, C44.101, C44.1021, C44.1022, C44.1091, C44.1092, C44.111, C44.121, C44.191, C44.201, C44.211, C44.221, C44.291, C44.300, C44.301, C44.309, C44.310, C44.320, C44.390, C44.40, C44.500, C44.501, C44.509, C44.601, C44.611, C44.621, C44.691, C44.701, C44.711, C44.721, C44.791, C44.80, C44.90, C44.91, C44.92, C44.99, C46.50, C46.9, C48.2, C49.10, C49.20, C49.6, C49.9, C50.019, C50.029, C50.119, C50.219, C50.319, C50.419, C50.519, C50.619, C50.819, C50.919, C50.929, C51.9, C53.9, C54.9, C55, C56.9, C57.4, C57.9, C60.9, C62.00, C62.10, C62.90, C63.00, C63.10, C63.9, C64.9, C65.9, C66.9, C67.9, C68.9, C69.00, C69.10, C69.20, C69.30, C69.40, C69.50, C69.60, C69.80, C69.90, C70.9, C71.9, C72.50, C72.9, C74.90, C75.8, C75.9, C76.40, C76.50, C77.0, C77.1, C77.2, C77.3, C77.4, C77.5, C77.8, C77.9, C78.00, C79.00, C79.60, C79.70, C79.89, C80.0, C80.1, C81.00, C81.10, C81.20, C81.30, C81.40, C81.70, C81.90, C81.91, C81.92, C81.93, C81.94, C81.95, C81.96, C81.97,

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 18

C81.98, C81.99, C82.00, C82.10, C82.20, C82.21, C82.22, C82.23, C82.24, C82.25, C82.26, C82.27, C82.28, C82.29, C82.30, C82.40, C82.50, C82.60, C82.80, C82.90, C82.91, C82.92, C82.93, C82.94, C82.95, C82.96, C82.97, C82.98, C82.99, C83.00, C83.10, C83.30, C83.50, C83.70, C83.80, C83.90, C83.91, C83.92, C83.93, C83.94, C83.95, C83.96, C83.97, C83.98, C83.99, C84.00, C84.10, C84.40, C84.60, C84.70, C84.90, C84.91, C84.92, C84.93, C84.94, C84.95, C84.96, C84.97, C84.98, C84.99, C84.A0, C84.A1, C84.A2, C84.A3, C84.A4, C84.A5, C84.A6, C84.A7, C84.A8, C84.A9, C84.Z0, C85.10, C85.20, C85.80, C85.90, C88.9, C91.90,, C91.91, C91.92, C92.90, C92.91, C92.92, C93.90, C93.91, C93.92, C95.00, C95.01, C95.02, C95.10, C95.11, C95.12, C95.90, C95.91, C95.92, C96.9, D05.90, D35.00, D37.039, D37.9, D38.6, D39.10, D39.9, D40.10, D40.9, D46.20, D47.9, D48.60, D56.9, D57.00, D57.219, D57.819, D59.9, D60.9, D61.9, D72.9, D73.9, D81.9, D83.9, D84.9, D89.813, D89.9, H20.9, I82.91, K50.90, K51.90, M02.30, M08.00, M35.9, M45.9, M46.00, M46.80, M46.90, M49.80, O01.9, R19.00, R59.9, R80.1, R80.9, T86.00, T86.10, T86.20, T86.30, T86.40, T86.819, T86.859, T86.899, T86.90, T86.91, T86.92, T86.93, T86.99, Z03.89 and Z94.9

• Added the following diagnosis codes effective DOS 03/17/2020. o L53.9 - Erythematous condition, unspecified; o L98.9 - Disorder of the skin and subcutaneous tissue, unspecified; o R83.6 - Abnormal cytological findings in cerebrospinal fluid; o R84.6 - Abnormal cytological findings in specimens from respiratory organs and thorax; o R90.0 -Intracranial space-occupying lesion found on diagnostic imaging of central nervous system; and o R90.89 - Other abnormal findings on diagnostic imaging of central nervous system.

Visit the Medicare Coverage Articles webpage to view the locally hosted Active LCA or access it via the CMS MCD.

Billing and Coding: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification (NAATs) - R3 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 01, 2020 Summary of Article Changes: Revisions are due to the annual ICD-10 updates and become effective on 10/1/2020

ICD-10 Codes that Support Medical Necessity Group I: Added: D84.89: Other immunodeficiencies D89.831: Cytokine release syndrome, grade 1 D89.832: Cytokine release syndrome, grade 2 D89.833: Cytokine release syndrome, grade 3 D89.834: Cytokine release syndrome, grade 4 D89.835: Cytokine release syndrome, grade 5 D89.839: Cytokine release syndrome, unspecified

ICD-10 Codes that Support Medical Necessity Group II: D84.89: Other immunodeficiencies D89.831: Cytokine release syndrome, grade 1 D89.832: Cytokine release syndrome, grade 2 D89.833: Cytokine release syndrome, grade 3 D89.834: Cytokine release syndrome, grade 4 D89.835: Cytokine release syndrome, grade 5 D89.839: Cytokine release syndrome, unspecified

Deleted Code from Group I and Group II: D84.8: Other specified immunodeficiencies

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 19

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Billing and Coding: Lab: Controlled Substance Monitoring and Drugs of Abuse Testing - R8 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 1, 2020 Summary of Article Changes: Under ICD-10 Codes that Support Medical Necessity - Group 1: Codes - added codes: F10.130, F10.131, F10.132, F11.13, F12.13, F13.130, F13.131, F13.132, F14.13, F14.93, F15.13, F19.130, F19.131, F19.132, G40.42, T40.411A, T40.411D, T40.411S, T40.412A, T40.412D, T40.412S, T40.413A, T40.413D, T40.413S, T40.414A, T40.414D, T40.414S, T40.421A, T40.421D, T40.421S, T40.422A, T40.422D, T40.422S, T40.423A, T40.423D, T40.423S, T40.424A, T40.424D, T40.424S, T40.491A, T40.491D, T40.491S, T40.492A, T40.492D, T40.492S, T40.493A, T40.493D, T40.493S, T40.494A, T40.494D, T40.494S, Z03.821, Z03.822, Z03.823

Under ICD-10 Codes that Support Medical Necessity - Group 1: Codes - deleted codes: F11.229, F11.259, F11.29, G40.901, G40.909, G40.911, G40.919, M25.50, M60.9 and R40.20

This revision is due to the annual ICD-10 Code update and is effective on October 1, 2020.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Billing and Coding: Lumbar MRI - R1 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 01, 2020 Summary of Article Changes: Revisions are due to the annual ICD-10 updates. Addition of coding to Group 1: A84.9: Tick-borne viral encephalitis, unspecified G96.01: Cranial cerebrospinal fluid leak, spontaneous G96.02: Spinal cerebrospinal fluid leak, spontaneous G96.08: Other cranial cerebrospinal fluid leak G96.09: Other spinal cerebrospinal fluid leak G96.198: Other disorders of meninges, not elsewhere classified G96.810: Intracranial hypotension, unspecified G96.811: Intracranial hypotension, spontaneous G96.819: Other intracranial hypotension G96.89: Other specified disorders of central nervous system G97.83: Intracranial hypotension following lumbar cerebrospinal fluid shunting G97.84: Intracranial hypotension following other procedure M05.7A: Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement M05.8A: Other rheumatoid arthritis with rheumatoid factor of other specified site M06.0A: Rheumatoid arthritis without rheumatoid factor, other specified site M06.8A: Other specified rheumatoid arthritis, other specified site M08.2A: Juvenile rheumatoid arthritis with systemic onset, other specified site M08.4A: Pauciarticular juvenile rheumatoid arthritis, other specified site M80.8AXA: Other osteoporosis with current pathological fracture, other site, initial encounter for fracture

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 20

M80.8AXD: Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with routine healing M80.8AXG: Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with delayed healing M80.8AXK: Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with nonunion M80.8AXP: Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with malunion M80.8AXS: Other osteoporosis with current pathological fracture, other site, sequela

Addition of coding to Group II: M25.59: Pain in other specified joint M80.8AXA: Other osteoporosis with current pathological fracture, other site, initial encounter for fracture M80.8AXD: Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with routine healing M80.8AXG: Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with delayed healing M80.8AXK: Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with nonunion M80.8AXP: Other osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with malunion M80.8AXS: Other osteoporosis with current pathological fracture, other site, sequela

Deleted Code in Group I: A84.8: Other tick-borne viral encephalitis G96.0: Cerebrospinal fluid leak G96.19: Other disorders of meninges, not elsewhere classified G96.8: Other specified disorders of central nervous system

Deleted Code in Group II: T86.848: Other complications of corneal transplant

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: MolDX: Avise PG Assay - R8 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 1, 2020 Summary of Article Changes: Under ICD-10 Codes that Support Medical Necessity - Group 1: Codes - added codes: M05.7A: Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement M05.8A: Other rheumatoid arthritis with rheumatoid factor of other specified site M06.0A: Rheumatoid arthritis without rheumatoid factor, other specified site M06.8A: Other specified rheumatoid arthritis, other specified site

This revision is due to the annual ICD-10 code update and is effective on October 1, 2020.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 21

Billing and Coding: MolDX: BRCA1 and BRCA2 Genetic Testing - R3 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: July 31, 2020 Summary of Article Changes: Addition of coding to Group 1: C54.1 - Malignant neoplasm of endometrium Z15.04 - Genetic susceptibility to malignant neoplasm of endometrium

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: MolDX: Cystatin C Measurement - R1 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 1, 2020 Summary of Article Changes: Under ICD-10 Codes that Support Medical Necessity - Group 1: Codes - added codes: N18.30: Chronic kidney disease, stage 3 unspecified N18.31: Chronic kidney disease, stage 3a N18.32 Chronic kidney disease, stage 3b

Under ICD-10 Codes that Support Medical Necessity - Group 1: Codes - deleted codes: N18.3: Chronic kidney disease, stage 3 (moderate)

This revision is due to the annual ICD-10 Code update and is effective on October 1, 2020.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Billing and Coding: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test - R2 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 01, 2020 Summary of Article Changes: Revisions are due to the annual ICD-10 updates and become effective on 10/1/2020 Added to ICD-10 Codes that Support Medical Necessity Group I: J84.170: Interstitial lung disease with progressive fibrotic phenotype in diseases classified elsewhere J84.178: Other interstitial pulmonary diseases with fibrosis in diseases classified elsewhere

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 22

Billing and Coding: MolDX: Genetic Testing for Lynch Syndrome - R5 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Dates: 01/01/2020 and 07/31/2020 Summary of Article Changes: Addition of coding to Group 1, effective 07/31/2020:

• 81432, hereditary breast cancer-related disorders (e.g., hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel, must include sequencing of at least 10 genes, always including BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, AND TP53

• 81433, hereditary breast cancer-related disorders (e.g., hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); duplication/deletion analysis panel, must include analyses for BRCA1, BRCA2, MLH1, MSH2, AND STK11

Addition of coding to Group 2, effective 01/01/2020:

• 0157U, APC (APC regulator of WNT signaling pathway) (e.g., familial adenomatosis polyposis [FAP]) MRNA sequence analysis (list separately in addition to code for primary procedure)

• 0158U, MLH1 (MUTL homolog 1) (e.g., hereditary non-polyposis colorectal cancer, lynch syndrome) MRNA sequence analysis (list separately in addition to code for primary procedure)

• 0159U, MSH2 (MUTS homolog 2) (e.g., hereditary colon cancer, lynch syndrome) MRNA sequence analysis (list separately in addition to code for primary procedure)

• 0160U, MSH6 (MUTS homolog 6) (e.g., hereditary colon cancer, lynch syndrome) MRNA sequence analysis (list separately in addition to code for primary procedure)

• 0161U, PMS2 (PMS1 homolog 2, mismatch repair system component) (e.g., hereditary nonpolyposis colorectal cancer, lynch syndrome) MRNA sequence analysis (list separately in addition to code for primary procedure)

• 0162U, hereditary colon cancer (lynch syndrome), targeted MRNA sequence analysis panel (MLH1, MSH2, MSH6, PMS2) (list separately in addition to code for primary procedure)

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: MolDX: Minimal Residual Disease Testing for Colorectal Cancer This coverage article has been created and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 18, 2020 Summary of Article: This Medicare contractor will provide limited coverage for ctDNA tests that detect minimum residual disease (MRD) in patients with a personal history of colorectal cancer.

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels - R6 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: April 01, 2020 Summary of Article Changes:

• Under Article Guidance in second bullet: Added verbiage: Per the LCD this code is non - covered after BioFire®

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 23

Diagnostics should report 0100U. Added 0115U, 0202U and 0223U to Paragraph: While each of these panels are able to report results for a specific number of pathogens, this contractor will interpret the use of 0098U, 0099U, and 0100U, 0115U, 0202U and 0223U to represent the use of a specific testing platform regardless of the number of pathogens reported by the laboratory.

• Removed from CPT/HCPC Codes that Support Medical Necessity Group I Paragraph - ICD - 10 Codes that Support Medical Necessity:

o 0098U: RESPIRATORY PATHOGEN, MULTIPLEX REVERSE TRANSCRIPTION AND MULTIPLEX AMPLIFIED PROBE TECHNIQUE, MULTIPLE TYPES OR SUBTYPES, 14 TARGETS (ADENOVIRUS, CORONAVIRUS, HUMAN METAPNEUMOVIRUS, INFLUENZA A, INFLUENZA A SUBTYPE H1, INFLUENZA A SUBTYPE H3, INFLUENZA A SUBTYPE H1 - 2009, INFLUENZA B, PARAINFLUENZA VIRUS, HUMAN RHINOVIRUS/ENTEROVIRUS, RESPIRATORY SYNCYTIAL VIRUS, BORDETELLA PERTUSSIS, CHLAMYDOPHILA PNEUMONIAE, MYCOPLASMA PNEUMONIAE)

o 0099U: RESPIRATORY PATHOGEN, MULTIPLEX REVERSE TRANSCRIPTION AND MULTIPLEX AMPLIFIED PROBE TECHNIQUE, MULTIPLE TYPES OR SUBTYPES, 20 TARGETS (ADENOVIRUS, CORONAVIRUS 229E, CORONAVIRUS HKU1, CORONAVIRUS, CORONAVIRUS OC43, HUMAN METAPNEUMOVIRUS, INFLUENZA A, INFLUENZA A SUBTYPE, INFLUENZA A SUBTYPE H3, INFLUENZA A SUBTYPE H1 - 2009, INFLUENZA, PARAINFLUENZA VIRUS, PARAINFLUENZA VIRUS 2, PARAINFLUENZA VIRUS 3, PARAINFLUENZA VIRUS 4, HUMAN RHINOVIRUS/ENTEROVIRUS, RESPIRATORY SYNCYTIAL VIRUS, BORDETELLA PERTUSSIS, CHLAMYDOPHILA PNEUMONIA, MYCOPLASMA PNEUMONIAE)

o 0100U : RESPIRATORY PATHOGEN, MULTIPLEX REVERSE TRANSCRIPTION AND MULTIPLEX AMPLIFIED PROBE TECHNIQUE, MULTIPLE TYPES OR SUBTYPES, 21 TARGETS (ADENOVIRUS, CORONAVIRUS 229E, CORONAVIRUS HKU1, CORONAVIRUS NL63, CORONAVIRUS OC43, HUMAN METAPNEUMOVIRUS, HUMAN RHINOVIRUS/ENTEROVIRUS, INFLUENZA A, INCLUDING SUBTYPES H1, H1 - 2009, AND H3, INFLUENZA B, PARAINFLUENZA VIRUS 1, PARAINFLUENZA VIRUS 2, PARAINFLUENZA VIRUS 3, PARAINFLUENZA VIRUS 4, RESPIRATORY SYNCYTIAL VIRUS, BORDETELLA PARAPERTUSSIS [IS1001], BORDETELLA PERTUSSIS [PTXP], CHLAMYDIA PNEUMONIAE, MYCOPLASMA PNEUMONIAE)

o 0115U: RESPIRATORY INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA AND RNA), 18 VIRAL TYPES AND SUBTYPES AND 2 BACTERIAL TARGETS, AMPLIFIED PROBE TECHNIQUE, INCLUDING MULTIPLEX REVERSE TRANSCRIPTION FOR RNA TARGETS, EACH ANALYTE REPORTED AS DETECTED OR NOT DETECTED

• Moved 0098U; 0099U; 0100U from Group I CPT/HCPCS Codes to Group II Codes - Noncovered, effective for dates of service on or after 7/1/2019.

• Moved 0115U Group I CPT/HCPCS Codes to Group II Codes - Noncovered, effective for dates of service on or after 10/1/2019.

• Additions to Group II CPT/HCPCS Codes per Quarterly CPT/HCPCS Code Update effective on or after 07/01/2020. o 0202U: INFECTIOUS DISEASE (BACTERIAL OR VIRAL RESPIRATORY TRACT INFECTION), PATHOGENSPECIFIC

NUCLEIC ACID (DNA OR RNA), 22 TARGETS INCLUDING SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS - COV - 2), QUALITATIVE RT - PCR, NASOPHARYNGEAL SWAB, EACH PATHOGEN REPORTED AS DETECTED OR NOT DETECTED

o 0223U: INFECTIOUS DISEASE (BACTERIAL OR VIRAL RESPIRATORY TRACT INFECTION), PATHOGEN - SPECIFIC NUCLEIC ACID (DNA OR RNA), 22 TARGETS INCLUDING SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS - COV - 2), QUALITATIVE RT - PCR, NASOPHARYNGEAL SWAB, EACH PATHOGEN REPORTED AS DETECTED OR NOT DETECTED

• Due to MCD limitations, a revision effective date may not be retroactive. Corresponding effective dates are specified within this revision history.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 24

Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels - R7 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: July 30, 2020 Summary of Article Changes: Article Text: Removed the verbiage from the second bullet point and added the verbiage “If the test does have a PLA code then submit the appropriate code.” Removed the verbiage from the third bullet point and added the verbiage “Per the MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels LCD, tests that include more than 5 viral pathogens are non-covered. Included in this are 87632, 87633, and additional PLA codes listed in the CPT/HCPCS Codes Group 2: Codes section of this Billing and Coding article.”

CPT/HCPCS Codes Group 1 paragraph: Added the word “only” and removed the verbiage “by a provider of any medical specialty for whom the ordering of this test is within the provider’s scope of practice and institutional privileges” from the second sentence.

CPT/HCPCS Codes Group 1 paragraph: Added the word “only” and removed the verbiage “by a provider of any medical specialty for whom the ordering of this test is within the provider’s scope of practice and institutional privileges” from the second sentence.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Billing and Coding: MolDX: Myriad’s BRACAnalysis CDx® - R5 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: July 17, 2020 Summary of Article Changes:

• Under Article Text removed the verbiage “Lynparza™ (olaparib) as a treatment for women with advanced ovarian cancer or women or men with metastatic breast cancer and the companion diagnostic BRACAnalysis CDx™ the laboratory test to detect mutated BRCA genes” and revised the first paragraph to state “The United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer, pancreatic cancer and prostate cancer”.

• Added the verbiage “BRACAnalysis CDx® is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR” to the second paragraph.

• Added the verbiage “Results of the test are used as an aid in identifying patients who are or may become eligible for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling” to the third paragraph.

• Added Table 1: Companion diagnostic indications. • Added the verbiage “This assay is for professional use only and is to be performed only at Myriad Genetic

Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108” to the fourth paragraph. • Added the verbiage “This article reflects the FDA-approved indications on article creation date. MolDX will allow

future FDA approved and amended indications for this test” to the fifth paragraph. • Removed the verbiage “Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor, blocks enzymes involved in

repairing damaged DNA and is intended for women with heavily pretreated ovarian cancer or HER2-negative

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 25

metastatic breast cancer associated with defective BRCA genes. BRACAnalysis CDx™ detects the presence of BRCA1 and BRCA2 gene mutations. According to the FDA, results of the test are used as an aid in identifying breast and ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza® (olaparib)” and revised the sixth paragraph to state “BRACAnalysis CDx® is only covered for individuals diagnosed with ovarian cancer, breast cancer, pancreatic cancer, or prostate cancer and who have not been previously tested for BRCA mutations”.

• Removed the word “Lynparza” and added the word “PARPi” to the second sentence in the eighth paragraph. Removed the verbiage “or other hereditary cancer syndromes” and added the verbiage “pancreatic, or prostate cancer” to the first bullet in the ninth paragraph.

• Typographical errors were corrected throughout the article. • Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added ICD-10 codes C25.0, C25.1, C25.2, C25.3,

C25.4, C25.7, C25.8, C25.9, C61, Z85.07, and Z85.46 (history of/malignant neoplasm of pancreas/prostate).

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: MolDX: Vectra™ DA - R4 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: October 01, 2020 Summary of Article Changes: Revisions are due to the annual ICD-10 updates and become effective on 10/1/2020

ICD-10 Codes that Support Medical Necessity Group 1: Codes: Added: M05.8A: Other rheumatoid arthritis with rheumatoid factor of other specified site M06.0A: Rheumatoid arthritis without rheumatoid factor, other specified site M06.8A: Other specified rheumatoid arthritis, other specified site M05.7A: Rheumatoid arthritis with rheumatoid factor of other specified site without organ or systems involvement

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

Billing and Coding: Platelet Rich Plasma This coverage article has been created and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: September 28, 2020 Summary of Article: This article explains proper coding and billing for Platelet Rich Plasma.

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Billing and Coding: Routine Foot Care - R2 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: June 29, 2020 Summary of Article: The following updates were made to this article.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 26

• Under the ICD-10 Codes that Support Medical Necessity Group 1 Paragraph, added the word 'painful' to the following statement “(For treatment of painful mycotic nails, or onychogryphosis, or onychauxis, see Group 5).”

• Clarified the timeframe the patient must have seen their treating physician for the asterisked DX code in the ICD-10 Codes that Support Medical Necessity Group 2, 3 and 4 sections.

• Added MLN Matters® Number: SE1113 and the SSA 1833(e) reference to the CMS National Coverage Policy section.

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Jurisdiction E Part A Local Coverage Articles Converted to Billing and Coding Articles in the Medicare Coverage Database The coverage articles noted below have been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

LCA Title: Billing and Coding: Modifier JW Billing Guidelines, R2 Billing and Coding: Patients Supplied Donated or Free-of-Charge Drug, R3

Summary of Article Changes: “Billing and Coding” is added to the article title. There is no change in coverage.

Visit the Noridian Medicare Coverage Articles webpage to view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD.

Positron Emission Tomography Scans Coverage - R22 This coverage article has been revised and published for notice under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 02111 (CA, HI & Territories).

Effective Date: January 01, 2019 Summary of Article Changes: The following updates were made to be consistent with NCD 220.6.17 (CR 10859).

List 1

Added: C44.01, C44.212, C44.219, C44.311, C44.319, C96.21, C96.22 Deleted: C02.3, C43.10, C43.30, C43.9, C44.300, C50.911, C50.912, C50.921, C50.922, C81.00, C81.10, C81.20, C81.30, C81.40, C81.70, C81.90, C82.00, C82.10, C82.20, C82.30, C82.40, C82.50, C82.60, C82.80, C82.90, C83.00, C83.10, C83.30, C83.50, C83.70, C83.80, C83.90, C84.00, C84.10, C84.40, C84.60, C84.70, C84.A0, C84.Z0, C84.90, C85.10, C85.20, C85.80, C85.90, C96.5, C96.6, R93.9, Z85.20, Z85.819

List II

Added: C44.510, C44.511, C44.519, C45.7, C54.0, C70.0, C70.1, Z85.43 Deleted: C26.0, C38.3, C39.0, C39.9, C44.90, C47.6, C49.6, C49.9, C55, C60.9, C62.91, C62.92, C63.9, C67.9, C68.9, C69.91, C69.92, C72.9, C7A.00, C77.9, C78.30, C78.80, C79.40, C79.9, Z85.00, Z85.40, Z85.45, Z85.50, Z85.819

List III

Deleted: C94.40, C94.41, C94.42, C94.6

List IV

Deleted: D37.039, D37.9, D38.6, D39.10, D39.9, D40.10, D40.09, D41.00, D41.10, D41.20, D41.9, D42.9, D43.2, D43.9, D44.10, D44.9, D48.60, D49.0, D49.1, D49.2, D49.3, D49.4, D49.6, D49.7, D49.81, D49.89, D49.9

List V

Deleted: D47.Z9, D47.9

Group 11

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 27

Deleted: C7A.00, C78.30, C78.80

To view a complete list of all Noridian NCD coverage articles, go to the National Coverage Determination (NCD) webpage and select the title of interest.

To view a complete list of all CMS NCDs available, go to National Coverage Determinations (NCDs) Alphabetical Index.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 28

Improving Electronic Claims Processing with Noridian Custom Edits (NCE) To decrease the provider burden associated with claim-related administrative costs, Noridian is integrating Noridian Custom Edits (NCE) into our Electronic Data Interchange (EDI) gateway for electronic claims processing. NCE enhance claims editing for both providers and payers and will integrate with existing claims acknowledgement reporting (277CA) on 837 electronic claim submissions.

NCE allow Noridian to do the following:

• Help identify problematic or “certain to deny” claims prior to Noridian claims processing • Alert providers of errors and potential claim processing issues around medical necessity, non-covered services,

missing modifiers, and other clinical editing • Deliver timely and clear notifications of how to fix claim errors • Save administrative time tied to claim resubmissions • Improve transparency of claim editing and claims processing

NCE will populate in the STC elements of the 277CA with distinct code sets that can be cross referenced to the NCE Spreadsheet. To assist submitters’ NCE review, Noridian will establish an edit spreadsheet at http://www.edissweb.com/cgp/reports/.

Rollout of NCE is slated for late September, and Noridian will continue educating on this change in the coming weeks.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 29

2021 JE Part A Quarterly Ask-the-Contractor Teleconferences Below is the listing of the 2021 Part A Quarterly Ask-the-Contractor Teleconferences (ACTs).

• January 20, 2021

ACTs are designed to open communication between providers and Noridian, which allows for timely identification of problems, and sharing information in an informal and interactive question and answer (Q&A) format. No Personal Health Information (PHI) is allowed.

Noridian representatives from various Part A departments are available to address your Medicare questions and concerns. All questions are entertained and the Q&As are posted on our website for provider convenience.

To view ACT dates, times, toll-free number, and Q&As, go to https://med.noridianmedicare.com/web/jea/education/act.

No registration is required for these calls. Please call in 10 minutes prior, all calls start promptly at the time designated in the schedule listing.

By completing and submitting the Noridian “Ask the Contractor Teleconference Question Submission Form,” providers may ask question(s), up to five (5) days prior, to be answered during the next ACT. Questions submitted with this form will be answered first. Lines will then be opened for additional questions, as time permits. Do not include any Personal Health Information (PHI) or claim specific inquiries on this form. If you have claim specific questions, contact the Provider Contact Center. Providers will need to have Version 7 or higher of Adobe Reader to use this form.

We look forward to your participation in these important calls.

Medicare Part A ACTs do not address Medicare Part B or Durable Medical Equipment (DME) inquiries. If you are interested in attending a Part B or a DME ACT, select the appropriate link below for more information.

• JE Part B - https://med.noridianmedicare.com/web/jeb/education/act • JD DME - https://med.noridianmedicare.com/web/jddme/education/act • JA DME - https://med.noridianmedicare.com/web/jadme/education/act

Appeals Converted to Reopenings Noridian receives a large number of appeal requests for corrections that should be completed through the Noridian Medicare Portal (NMP) Self-Service Reopenings function. These appeals will be processed as reopenings. Providers looking for information through the NMP on an appeal that has been converted to a reopening will find the claim information on their Remittance Advice (RA).

Providers will still have appeal rights on claims that have been processed as reopenings. The appeals timeframe of 120 days from the initial determination will remain regardless.

The Reopening process allows providers to correct clerical errors or omissions without having to request a formal appeal. Most reopenings can be initiated through Self-Service Reopenings via the NMP. Services considered too complex that cannot be completed through the NMP Self-Service Reopening function should be submitted as either a written reopening or redetermination in the NMP.

The CMS Internet Only Manual (IOM), Publication 100-09, Chapter 6, Section 50 mandates that all providers first access inquiries through self-service technology. This process change will allow Noridian to meet CMS requirements.

CMS Prior Authorization for Certain Hospital Outpatient Department (OPD) Services Resources CMS has webpages dedicated to each Prior Authorization program, including the Prior Authorization for Certain OPD Services. This page contains the program overview, recent updates, a Frequently Asked Questions (FAQs) document, and the operational guide.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 30

Everything can be viewed on the CMS Prior Authorization OPD Webpage.

GoToWebinar Access Issues Utilizing Internet Explorer Recently it has been identified that some of our users are having difficulties registering for our events when utilizing Internet Explorer (IE) as their web browser. LogMeIn (GoToWebinar) is aware of the issues and suggests that users use other browsers such as Edge, Chrome, Firefox, etc. By utilizing a different web browser, users should be able to register for all events provided by Noridian.

Medicare HMO vs Fee for Service for Hospice Patients - Who Pays Federal regulations require that Medicare fee-for-service Medicare Administrative Contracts (MAC) maintain payment responsibility for Medicare managed care enrollees who elect hospice. Health Home and Hospice MAC are responsible for all hospice related services and A/B MACs are responsible for all non-hospice related claims beginning on the date of the hospice election. Claims may be submitted by:

• The hospice provider; • Provider treating an illness not related to the terminal condition; and • Attending physician, if the physician is not employed by or under contract to the enrollee’s hospice

Medicare fee-for-service retains payment responsibility after the revocation or expiration of the hospice election until the first day of the following month. Managed care plans will assume the payment responsibility as of that date for their enrolled beneficiaries.

Reference: CMS Internet Only Manual (IOM) Publication 100-04, Medicare Claims Processing Manual, Chapter 11, Section 30.4

Overlapping Claim Resolution Tips Overlapping claim situations occur for many reasons. Is your facility having overlapping claims with other facilities? Did you know there is a resolution tool and tips webpage?

Explore tips by provider type:

• ESRD facilities • Home Health Agencies (HHAs) • Hospices • Inpatient Hospital • Outpatient Hospital • Outpatient Rehabilitation facilities • Skilled Nursing Facilities (SNFs)

Part B Provider Responsibility for Prior Authorization (PA) for Certain Hospital Outpatient Department (OPD) Services Noridian has been receiving requests for prior authorizations from Part B providers, who bill on the CMS-1500 form.

This program is for outpatient hospital services billed on a UB-04 form, with type of bill 13X. Providers who bill on a CMS-1500 form should not submit prior authorization requests for the OPD services because it is the facility’s responsibility to send in the request. A valid prior authorization request must contain the Part A Provider Transaction Access Number (PTAN), which is six digits. Requests that come from a physician’s office will be rejected.

It is the physicians’ responsibility is to assist the facility by ensuring copies of the patient’s medical records are available for the following services:

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 31

• Blepharoplasty • Botulinum Toxin Injections - use for chronic migraine treatment • Panniculectomy • Rhinoplasty • Vein Ablation

Physicians must ensure the services support medical necessity. Noridian has policies covering each of these services listed above and can be located on the Active LCDs Webpage.

Please provide the listed elements located on the Jurisdiction E Part A Prior Authorization OPD Webpage upon request.

In CMS MLN Connects for June 11, 2020, OPD services require PA as a condition of payment. The article states, “While only the hospital OPD services requires prior authorization, CMS wants to remind providers that perform services in the hospital OPD setting that claims related to or associated with these services will NOT be paid if the service requiring PA is not eligible for payment. These related services include, but are not limited to, anesthesiology services, physician services, and facility services. Only associated services performed in the OPD setting are affected. Depending on the timing of claim submission for any related services, claims may be automatically denied or denied on a postpayment basis.”

Patient Status Codes An incorrect patient status is one of the most common errors on Part A claims. For assistance with patient status codes, please visit our Quick Reference Billing Guide Patient Status Webpage. If the patient status is the only item changed on a claim, use the corresponding condition code, E0. This information can be found on our Quick Reference Billing Guide Condition Codes Webpage.

Submission of Requests for Prior Authorization (PA) for Certain Hospital Outpatient Department (OPD) Services While this prior authorization process is applicable to hospital OPDs, as specified in CMS-1717-FC, CMS allows the PA request to be sent by the physician/practitioner on behalf of the hospital OPD. If a PA request submitted by the physician/practitioner includes all necessary hospital OPD information, it is considered to be sent on behalf of the hospital OPD.

Please visit our Prior Authorization for OPD Services Webpage to learn about submitting requests.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 32

Comprehensive Error Rate Testing (CERT) Reviews and COVID-19 The CERT team at Noridian is here to help providers through their CERT review. Contact us with your provider transaction access number (PTAN) and CERT claim identifier (CID), or general education request. Services offered include:

• CERT Review Status • Provider Number Lookup for All Current CERT Reviews • Review of Medical Records • Custom PowerPoint Presentation • Provider Improper Payment Rate Analysis • Electronic Visit • Teleconference • And more

Email your inquiry to [email protected].

COVID-19 Diagnostic Laboratory Tests: Billing for Clinician Services This article provides guidance to physicians and non-physician practitioners (NPPs) regarding COVID-19 symptom and exposure assessment and specimen collection performed on and after March 1. Guidance provided addresses CPT 99211, modifier CS, and reprocessing of claims.

• Use CPT code 99211 to bill for assessment and collection provided by clinical staff (such as pharmacists) incident to your services, unless you are reporting another Evaluation and Management (E/M) code for concurrent services. This applies to all patients, not just established patients.

• Submit the CS modifier with 99211 (or other E/M code for assessment and collection). • If CS modifier was inadvertently left off the claim, providers may make the correction on the Noridian Medicare Portal

(NMP). • Noridian will automatically reprocess claims billed for 99211 that were denied due to place of service editing.

If you have other questions about reprocessing claims, contact Noridian.

Source: CMS MLN Connects June 18, 2020

COVID-19 Modifiers and Condition Code There are so many coding resources on COVID-19, and it can be overwhelming. Below are some helpful tools for physicians, providers, hospitals, and suppliers who bill Medicare Fee-For-Service (FFS) claims during the public health emergency (PHE):

• Clarification for Using the “CR” Modifier and “DR” Condition Code

Looking for the use of modifier “95”, “CS”, or “CG”? Refer to the document below for assistance with deciding which modifier to use when billing UB-04 or the CMS-1500.

• Modifiers Used during the COVID-19 Public Health Emergency (PHE)

The Provider Outreach and Education A/B Medicare Administrative Contractor Workgroup developed this material. Our joint effort ensures consistent communication and education so that providers and physicians have the information they need to submit claims appropriately and receive proper payment in a timely manner.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 33

Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) - Revised MLN Matters Number: SE20011 Revised Article Release Date: August 26, 2020 Note: CMS revised the article to add information about the HCPCS codes for OPPS, RHC, FQHC, and CAH billers in the Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section. All other information remains the same.

The Secretary of the Department of Health & Human Services declared a public health emergency (PHE) in the entire United States on January 31, 2020. On March 13, 2020 Secretary Azar authorized waivers and modifications under Section 1135 of the Social Security Act (the Act), retroactive to March 1, 2020.

View the complete CMS Medicare Learning Network (MLN) Matters (SE)20011.

New and Expanded Flexibilities for RHCs and FQHCs During the COVID-19 PHE - Revised MLN Matters Number: SE20016 Revised Article Release Date: July 6, 2020 Note: CMS revised this article to provide:

• Additional guidance on telehealth services that have cost-sharing waived and additional claim examples • An additional section on the RHC Productivity Standard

All other information remains the same.

To provide as much support as possible to Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) and their patients during the COVID-19 Public Health Emergency (PHE), both Congress and the Centers for Medicare & Medicaid Services (CMS) have made several changes to the RHC and FQHC requirements and payments. These changes are for the duration of the COVID-19 PHE, and we will make additional discretionary changes as necessary to assure that RHC and FQHC patients have access to the services they need during the pandemic. For additional information, please see the RHC/FQHC COVID-19 FAQs at https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf.

View the complete CMS Medicare Learning Network (MLN) Matters (SE)20016.

New COVID-19 Policies for IPPS Hospitals, LTCHs, and IRFs due to Provisions of the CARES Act - Revised MLN Matters Number: SE20015 Revised Article Release Date: August 17, 2020 Note: CMS revised this article on August 17, 2020, to add an update regarding the implementation of Section 3710 of the CARES Act for IPPS hospitals to address potential Medicare program integrity risks. All other information is unchanged.

SE 20015 describes certain provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act that relate to Inpatient Prospective Payment System (IPPS) hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs). These provisions are Sections 3710 and 3711 of the CARES Act.

View the complete CMS Medicare Learning Network (MLN) Matters (SE)20015.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 34

New Point of Origin Code for Transfer from a Designated Disaster ACS - Revised MLN Matters Number: MM11836 Revised Related CR Release Date: July 1, 2020 Related CR Transmittal Number: R10205OTN Related Change Request (CR) Number: 11836 Effective Date: July 1, 2020 Implementation Date: August 3, 2020 Note: CMS revised this article on July 2, 2020, to reflect an updated Change Request that changed the implementation date to August 3, 2020. The transmittal number, CR release date and link to the transmittal also changed. All other information is unchanged.

CR 11836 announces a new Point of Origin (PoO) Code “G” to indicate a “Transfer from a Designated Disaster Alternative Care Site (ACS),” due to changes relative to the COVID-19 Public Health Emergency (PHE). Make sure your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11836.

New Waivers for IPPS Hospitals, LTCHs, and IRFs due to Provisions of the CARES Act MLN Matters Number: SE20015 Article Release Date: September 11, 2020 Note: CMS revised this article to add guidance on how providers notify their MAC when there is no evidence of a positive laboratory test documented in the patient’s medical record. All other information is unchanged.

SE 20015 describes certain provisions of the Coronavirus Aid, Relief, and Economic Security (CARES) Act that relate to Inpatient Prospective Payment System (IPPS) hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs). These provisions are Sections 3710 and 3711 of the CARES Act.

View the complete CMS Medicare Learning Network (MLN) Matters (SE)20015.

Update to the International Classification of Diseases, Tenth Revision (ICD-10) Diagnosis Codes for Vaping Related Disorder and Diagnosis and Procedure Codes for the 2019 COVID-19 - Revised MLN Matters Number: MM11623 Revised Related CR Release Date: August 21, 2020 Related CR Transmittal Number: R10317OTN Related Change Request (CR): 11623 Effective Date: April 1, 2020 - For vaping-related and COVID-19 related diagnosis codes included in V37.1 of the MS-DRG Grouper and MCE.; August 1, 2020 - For new procedure codes included in V37.2 of the MS-DRG Grouper and MCE. Implementation Date: April 6, 2020 Note: CMS revised this article on August 21, 2020, to reflect an updated CR 11623. The CR revision updated the title, Background section and includes new procedure codes in Version 37.2 of the ICD-10 Medicare Severity - Diagnosis Related Groups (MS-DRG) Grouper and ICD-10 Medicare Code Editor (MCE). The CR release date, transmittal number and link to the transmittal also changed. All other information remains the same.

CR 11623 adds new ICD-10-Clinical Modification (CM) codes for vaping related disorder and 2019 Novel Coronavirus (COVID-19) and ICD-10 Procedure Coding System (PCS) codes to the Medicare Severity - Diagnosis Related Groups (MS-DRG) Grouper

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 35

and Medicare Code Editor (MCE) effective for discharges on and after April 1, 2020. Twelve new procedure codes to describe the introduction or infusion of therapeutics, including remdesivir and convalescent plasma into the ICD-10-PCS are effective for discharges on and after August 1, 2020. Make sure your billing staffs are aware of these changes related to the new code.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11623.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 36

Do Not Forward Initiative Reminder The Internet Only Manual (IOM) Medicare Claims Processing Manual, Publication 100-04 instructs Part A and Part B Medicare Administrative Contractors (A/B MACs) and carriers to use “return service requested” envelopes when mailing paper checks and remittance advices to providers.

When the post office returns a “return service requested” envelope, the A/B MAC/carrier applies a “do not forward” (DNF) flag to the provider's Medicare enrollment file. The A/B MAC/carrier will not generate any additional checks for that provider until the provider sends a properly completed change of address form back to the A/B MAC/carrier. We are not required to contact the provider to notify them that the flag has been added to their file.

Upon verifying the new address, the A/B MAC/carrier removes the DNF flag and can again generate payments for the provider. Electronic Funds Transfer (EFT) is required; therefore, when the address change update is completed, the provider will be set up to use EFT and will no longer receive paper checks.

NOTE: Because many providers get paid through EFT, there may be cases where a provider does not have a correct address on file, but the A/B MAC/carrier continues to pay the provider through EFT. It is still the provider’s responsibility to submit and address change update so that remittance notices and special checks would be sent to the proper address.

Noridian encourages providers to enroll or make changes using Internet-based Provider Enrollment, Chain and Ownership System (PECOS) for faster processing time. Applications and changes completed online currently have an average processing time of 10 days. All Medicare providers may use the new enrollment process on the CMS website https://pecos.cms.hhs.gov. To log into this internet-based PECOS, providers will use their NPI Userid and password.

POLICY

Effective October 1, 2002, A/B MACs/carriers must use “return service requested” envelopes for hardcopy remittance advices and checks, with respect to providers that have elected to receive hardcopy remittance advices. (PM B-02-023, CR 2038 dated April 12, 2002; Transmittal 1794, CR 2684 dated May 2, 2003)

IMPLEMENTATION PROCESS

1. “Return service requested” envelopes are used for all hardcopy remittance advices starting October 1, 2002. These envelopes will be used for all providers.

2. “Return service requested” envelopes will not be used for beneficiary correspondence, such as Medicare Summary Notices (MSNs) or for overpayment demand letters.

3. When the post office returns a remittance advice due to an incorrect address, A/B MACs/carriers will follow the same procedures as followed for returned checks, that is:

• Flag the provider’s file DNF. • A/B MAC/carrier staff will notify provider enrollment team. • A/B MAC/carriers will cease generating any further payments or remittance advice to that provider or

supplier until furnished with a new, verified address. 4. When the provider establishes a new, verified address, A/B MACs/carriers will remove the DNF flag and pay the

provider any funds which are still being held due to a DNF flag. A/B MAC/carriers must also reissue any remittance advices, which have been held.

5. Previously, CMS only required corrections to the “pay to” address. However, with the implementation of this initiative, CMS requires corrections to all addresses before the contractor can remove the DNF flag and begin paying the provider or supplier again. Therefore, A/B MAC/carriers cannot release any payments to DNF providers until the provider enrollment department has verified and updated all addresses for that provider's location.

IRS-1099 REPORTING

Provider or supplier checks returned and voided during the same year they were issued are not reported on the Internal Revenue Service (IRS) Form 1099 until the returned check is reissued (i.e., the DNF flag is removed and the A/B MAC/carrier reissues payment to the provider.) Checks returned and voided in the current year that were issued in prior years are not netted from the current year's IRS Form 1099.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 37

Monies withheld because a DNF flag exists on a provider or supplier record are not reported on IRS-1099s until the calendar year in which payment is made (i.e., the point at which the A/B MAC/carrier pays the provider once the DNF flag is removed.) If DNF amounts are erroneously included on IRS-1099 forms, A/B MACs/carriers will issue corrected IRS Form 1099s to affected providers.

Source: IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 22, Section 50.1

Delegated Official Role Title Change to Access Manager in I&A Starting June 8, 2020, the Identity and Access Management System (I&A) will change the title of the Delegated Official (DO) role to Access Manager (AM) throughout the I&A System.

There will not be any changes to the functions, access or privileges held by the Delegated Official role, this is simply a title change to Access Manager. The change has been made to avoid confusion between the Delegated Official in the Provider Enrollment, Chain, and Ownership System (PECOS) and the Delegated Official in the I&A System.

The change has no impact on the Delegated Officials listed in PECOS or their titles. PECOS will remain unchanged. The title, requirements and functionality for the Authorized Official (AO) role in I&A will remain the same. There is no impact to users in I&A as a result of this change except for the title change mentioned above and no additional action is required.

Medicare Enrollment Application Fee Refunds through EFT CMS is now issuing application fee refunds through Electronic Funds Transfer (EFT), rather than paper checks. We will request new information if you need an application fee refund for your CMS-855A, CMS-855B, CMS-855S, or CMS-20134 submitted via an automated clearinghouse.

Complete and return the EFT form issued by your Medicare Administrative Contractor, including your account information. This process will expedite your refund processing time.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 38

IPF PPS Updates for FY 2021 MLN Matters Number: 11949 Related CR Release Date: August 21, 2020 Related CR Transmittal Number: R10312CP Related Change Request (CR) Number: 11949 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 CR 11949 identifies changes that are required as part of the annual Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) update established in IPF Final Rule entitled “Medicare Program; Fiscal Year (FY) 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021).” These changes are applicable to discharges occurring from October 1, 2020, through September 30, 2021 (FY 2021). CR 11949 applies to the Medicare Claims Processing Manual (CLM), Chapter 3, Section 190.4.3.

Make sure that your billing staffs are aware of these changes. See the Background and Additional Information Sections of this article for further details regarding these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11949.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 39

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2020 MLN Matters Number: MM11889 Related CR Release Date: July 10, 2020 Related CR Transmittal Number: R10215NCD Related Change Request (CR) Number: 11889 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 CR 11889 announces the changes that will be included in the October 2020 quarterly release of the edit module for clinical diagnostic laboratory services. Please be sure your billing staffs are aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11889.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 40

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates The following LCA’s have been revised under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories). All LCD LCAs are titled with “Billing and Coding: LCD title”

Effective Date: October 1, 2020 Summary of Changes: The following LCA(s) have been updated to include and/or remove ICD-10 codes.

LCD Title LCD/LCA Number ICD-10 Added ICD-10 Deleted

Chest X-Ray L37547 / A57497

R51.0 - Headache, unspecified

R51.9 - Elevation of levels of liver transaminase levels

NOTE: These codes fall under ICD-10 that DO NOT Support Medical Necessity.

R51 - Headache

NOTE: These codes fall under ICD-10 that DO NOT Support Medical Necessity.

Diagnostic and Therapeutic Colonoscopy

L34213 / A57342

K59.81 - Ogilvie Syndrome

K59.89 - Other specified functional intestinal disorders

Immune Globulin Intravenous (IVIg)

L34314 / A57187

D59.11 - Warm autoimmune hemolytic anemia

D59.12 - Cold autoimmune hemolytic anemia

D59.13 - Mixed type autoimmune hemolytic anemia

D59.19 - Other autoimmune hemolytic anemia

D59.1 - Other autoimmune hemolytic anemias

Nerve Conduction Studies

L36524 / A54969

G11.11 - Friedreich ataxia

G11.19 - Other early-onset cerebellar ataxia

G71.21 - Nemaline myopathy

G71.220 - X-linked myotubular myopathy

G71.228 - Other centronuclear myopathy

G71.29 - Other congenital myopathy

G11.1 - Early-onset cerebellar ataxia

G71.2 - Congenital myopathies

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 41

LCD Title LCD/LCA Number ICD-10 Added ICD-10 Deleted

Respiratory Care (Respiratory Therapy)

L34149 / A57224

J82.81 - Chronic eosinophilic pneumonia

J82.82 - Acute eosinophilic pneumonia

J82.83 - Eosinophilic asthma

J82.89 - Other pulmonary eosinophilia, not elsewhere classified

J84.170 - Interstitial lung disease with progressive fibrotic phenotype in diseases classified elsewhere

J84.178 - Other interstitial pulmonary diseases with fibrosis phenotype in diseases classified elsewhere

D57.431 - Sickle-cell thalassemia beta zero with acute chest syndrome

D57.451 - Sickle-cell thalassemia beta plus with acute chest syndrome

J82 - Pulmonary eosinophilia, not elsewhere classified

J84.17 - Other interstitial pulmonary diseases with fibrosis in diseases classified elsewhere

Routine Footcare A57954 N18.30 - Chronic kidney disease, stage 3 unspecified

N18.31 -Chronic kidney disease, stage 3

N18.32 - Chronic kidney disease, stage 3b

N18.3 - chronic kidney disease, stage 3 (moderate)

Plastic Surgery L35163 / A57221

R51 - Headache

Visit the Noridian Website to view all LCDs and LCAs or access it via the CMS MCD.

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates This following LCA’s have been revised under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories). All LCD LCAs are titled with “Billing and Coding: LCD title”.

Medicare Coverage Database (MCD) Number: L37373 and A57204 LCD Title: MRI and CT Scans of the Head and Neck Effective Date: October 1, 2020 Summary of Changes: The following LCA has been updated to add, revise and remove the following ICD-10 codes.

• New/Revised ICD-10 codes o Revised H55.81 - Saccadic eye movements to Deficient saccadic eye movements. o Added A84.81, A84.89, B60.01, B60.02, B60.03, B60.09, D57.03, D57.09, D57.213, D57.218, D57.413, D57.42,

D57.431, D57.432, D57.433, D57.438, D57.44, D57.451, D57.452, D57.453, D57.458, D57.813, D57.818, F10.131, F10.132, F10.930, F10.931, F10.932, F11.13, F12.13, F13.131, F13.132, F14.13, F14.93, F15.13, F19.131, F19.132, G11.10, G11.11, G11.19, G40.42, G40.833, G40.834, G71.21, G71.220, G71.228, G71.29, G96.00, G96.01, G96.02, G96.08, G96.09, G96.191, G96.198, G96.810, G96.811, G96.819, G96.89, G97.83, G97.84, H55.82, M26.641, M26.642, M26.643, M26.651, M26.652, M26.653, P91.821, P91.822, P91.823, R51.0, R51.9, T86.8401, T86.8402, T86.8403, T86.8411, T86.8412, T86.8413, T86.8421, T86.8422, T86.8423, T86.8481, T86.8482, T86.8483, T86.8491, T86.8492 and T86.8493.

• Deleted ICD-10 codes

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 42

o A84.8 - Other tick-borne viral encephalitis o G11.1 - Early-onset cerebellar ataxia o G96.0 - Cerebrospinal fluid leak o G96.19 - Other disorders of meninges, not elsewhere classified o G96.8 - Other specified disorders of central nervous system o R51 - Headache

Visit the Noridian Website to view all LCDs and LCAs or access it via the CMS MCD.

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates The following LCA have been revised under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories). All LCD LCAs are titled with “Billing and Coding: LCD title”.

Medicare Coverage Database (MCD) Number: L34215 and A57689 LCD Title: Lab: Flow Cytometry Effective Date: October 1, 2020 Summary of Changes: This LCA has been updated to add three diagnosis codes missed with the last update effective on March 17, 2020.

• D48.61 - Neoplasm of uncertain behavior of right breast, • D4862 - Neoplasm of uncertain behavior of left breast, and • D84.0 - Lymphocyte function antigen-1 [LFA-1] defect

Also, this LCA has been updated to add, revise and remove the following ICD-10 codes effective for dates of service on or after October 1, 2020.

• New/Revised ICD-10 codes o Revised D57.412 - Sickle-cell thalassemia with splenic sequestration changed to Sickle-cell thalassemia,

unspecified, with splenic sequestration o Added D57.03, D57.09, D57.213, D57.218, D57.42, D57.431, D57.432, D57.433, D57.44, D57.451, D57.452,

D57.453, D57.458, D57.813, D57.818, D72.110, D72.111, D72.118, D72.12, D72.18, D72.19, D84.81, D84.821, D84.822, D84.89, D89.831, D89.832, D89.833, D89.834, D89.835, M08.0A, M08.2A, T86.8401, T86.8402, T86.8403, T86.8411, T86.8412, T86.8413, T86.8421, T86.8422, T86.8423, T86.8481, T86.8482 and T86.8483

• Deleted ICD-10 codes o D72.1 - Eosinophilia, and o D84.8 - Other specified immunodeficiencies

Visit the Noridian Website to view all LCDs and LCAs or access it via the CMS MCD.

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates The following LCA has been revised under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories). All LCD LCAs are titled with “Billing and Coding: LCD title”

Medicare Coverage Database (MCD) Number: A57326 LCA Title: Billing and Coding: Electrocardiograms Effective Date: October 1, 2020 Summary of Changes: This LCA has been updated to include/delete the following ICD-10 codes:

New/Revised ICD-10 codes

• D57.03 Hb-SS disease with cerebral vascular involvement • D57.09 Hb-SS disease with crisis with other specified complication

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 43

• D57.213 Sickle-cell/Hb-C disease with cerebral vascular involvement • D57.218 Sickle-cell/Hb-C disease with crisis with other specified complication • D57.413 Sickle-cell thalassemia, unspecified, with cerebral vascular involvement • D57.418 Sickle-cell thalassemia, unspecified, with crisis with other specified complication • D57.42 Sickle-cell thalassemia beta zero without crisis • D57.431 Sickle-cell thalassemia beta zero with acute chest syndrome • D57.432 Sickle-cell thalassemia beta zero with splenic sequestration • D57.433 Sickle-cell thalassemia beta zero with cerebral vascular involvement • D57.438 Sickle-cell thalassemia beta zero with crisis with other specified complication • D57.439 Sickle-cell thalassemia beta zero with crisis, unspecified • D57.44 Sickle-cell thalassemia beta plus without crisis • D57.451 Sickle-cell thalassemia beta plus with acute chest syndrome • D57.452 Sickle-cell thalassemia beta plus with splenic sequestration • D57.453 Sickle-cell thalassemia beta plus with cerebral vascular involvement • D57.458 Sickle-cell thalassemia beta plus with crisis with other specified complication • D57.459 Sickle-cell thalassemia beta plus with crisis, unspecified • D57.813 Other sickle-cell disorders with cerebral vascular involvement • D57.818 Other sickle-cell disorders with crisis with other specified complication • F11.13 Opioid abuse with withdrawal • F14.13 Cocaine abuse, unspecified with withdrawal • F15.13 Other stimulant abuse with withdrawal • S20.213A Contusion of bilateral front wall of thorax, initial encounter • S20.213D Contusion of bilateral front wall of thorax, subsequent encounter • S20.213S Contusion of bilateral front wall of thorax, sequela • S20.214A Contusion of middle front wall of thorax, initial encounter • S20.214D Contusion of middle front wall of thorax, subsequent encounter • S20.214S Contusion of middle front wall of thorax, sequela • S20.223A Contusion of bilateral back wall of thorax, initial encounter • S20.223D Contusion of bilateral back wall of thorax, subsequent encounter • S20.223S Contusion of bilateral back wall of thorax, sequela • S20.224A Contusion of middle back wall of thorax, initial encounter • S20.224D Contusion of middle back wall of thorax, subsequent encounter • S20.224S Contusion of middle back wall of thorax, sequela

Deleted:

• K20.8 - Other Esophagitis • K20.9 Esiogagutusm Ybsoecufued • K21.0 Gastro-esophageal reflux disease with esophagitis • R74.0 Non-Specific elevation of levels of transaminase and lactic acit dehydrogenase (LDH)

Description Changes:

• D57.411 o Old: Sickle-cell thalassemia with acute chest syndrome o New: to sickle-cell thalassemia, unspecified with acute chest syndrome

• D57.412 o Old: Sickle-cell thalassemia with splenic sequestration o New: Sickle-cell thalassemia, unspecified, with splenic sequestration

Visit the Noridian Website to view all LCDs and LCAs or access it via the CMS MCD.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 44

2020 ICD-10 Local Coverage Determinations (LCD) and Local Coverage Article (LCA) Updates - Vitamin D Assay Testing The following LCA has been revised under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories). All LCD LCAs are titled with “Billing and Coding: LCD title.”

Medicare Coverage Database (MCD) Number: L36692 and A57718 LCD Title: Billing and Coding: Vitamin D Assay Testing Effective Date: October 1, 2020 Summary of Changes: The following LCA(s) have been updated to include and/or remove ICD-10 codes.

• New/Revised ICD-10 codes Additions to Group 1:

o D89.831 - Cytokine release syndrome, grade 1 o D89.832 - Cytokine release syndrome, grade 2 o D89.833 - Cytokine release syndrome, grade 3 o D89.834 - Cytokine release syndrome, grade 4 o D89.835 - Cytokine release syndrome, grade 5 o D89.839 - Cytokine release syndrome, grade unspecified o K74.00 - Hepatic fibrosis, unspecified o K74.01 - Hepatic fibrosis, early fibrosis o K74.02 - Hepatic fibrosis, advanced fibrosis o N18.30 - Chronic kidney disease, stage 3 unspecified o N18.31 - Chronic kidney disease, stage 3a o N18.32 - Chronic kidney disease, stage 3b

Revised codes under Group 1:

o Z68.30 - Body mass index [BMI] 30.0-30.9, adult o Z68.31 - Body mass index [BMI] 31.0-31.9, adult o Z68.32 - Body mass index [BMI] 32.0-32.9, adult o Z68.33 - Body mass index [BMI] 33.0-33.9, adult o Z68.34 - Body mass index [BMI] 34.0-34.9, adult o Z68.35 - Body mass index [BMI] 35.0-35.9, adult o Z68.36 - Body mass index [BMI] 36.0-36.9, adult o Z68.37 - Body mass index [BMI] 37.0-37.9, adult o Z68.38 - Body mass index [BMI] 38.0-38.9, adult o Z68.39 - Body mass index [BMI] 39.0-39.9, adult o Z68.41 - Body mass index [BMI] 40.0-44.9, adult o Z68.42 - Body mass index [BMI] 45.0-49.9, adult o Z68.43 - Body mass index [BMI] 50.0-59.9, adult o Z68.44 - Body mass index [BMI] 60.0-69.9, adult o Z68.45 - Body mass index [BMI] 70 or greater, adult

• Deleted ICD-10 codes From Group 1:

o N18.3 - Chronic kidney disease, stage 3 (moderate)

Visit the Noridian Website to view all LCDs and LCAs or access it via the CMS MCD

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 45

Helicobacter Pylori Infection Testing LCD and Billing and Coding: Helicobacter Pylori Infection Testing Retirement - Effective August 01, 2020 This Local Coverage Determination (LCD) and coverage article has been retired under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database (MCD) Numbers: L37624/A57226 LCD Title: Helicobacter Pylori Infection Testing Article Title: Billing and Coding: Helicobacter Pylori Infection Testing Effective Date: August 01, 2020 Rationale: LCDs and coverage articles are retired due to lack of evidence of current need(s) for the education and/or edits or in some cases because the material is addressed by a National Coverage Determination (NCD), a coverage provision in a CMS interpretative manual, another LCD or an article.

The Noridian guidance in the retired article may still be helpful in assessing medical necessity. Where providers have adjusted their billing and coding practices to correspond to the guidance in a coverage article, they will want to be very careful in departing from these practices just because the article is retired. Provider offices remain responsible for correct performance, coding, billing, and medical necessity under Medicare.

Retirement does not mean that medical necessity has changed or that the LCD no longer reflects appropriate criteria. The guidance in the retired LCD and coverage article may be helpful in assessing medical necessity.

This responsibility for correct claims submission is unchanged whether or not there is a coverage article in place.

Visit the Retired LCDs webpage to access the retired LCDs.

Visit the Noridian Medicare Coverage Articles webpage to access the Retired articles in the CMS MCD.

Implantable Continuous Glucose Monitor (I-CGM) Final LCD - Effective November 2, 2020 This Local Coverage Determination (LCD) has completed the Open Public Meeting comment period and is now finalized under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories). Responses to comments received may be found as a link at the bottom of the final LCD.

Medicare Coverage Database (MCD) Number/Contractor Determination Number: L38657/A58133 LCD Title: Implantable Continuous Glucose Monitor (I-CGM) Effective Date: November 2, 2020 Summary of LCD: To provide coverage indications, limitations and/or medical necessity guidelines when billing, prescribing Implantable Continuous Glucose Monitors (I-CGM).

Visit the Future LCDs webpage to access this LCD.

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to NCDs - January 2021 Update MLN Matters Number: MM11905 Related CR Release Date: July 31, 2020 Related CR Transmittal Number: R10261OTN Change Request (CR) Number: 11905 Effective Date: January 1, 2021 Implementation Date: August 31, 2020 - A/B MACs; January 4, 2021 - Shared Systems

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 46

CR 11905 informs providers about updated International Classification of Diseases, 10th Revision (ICD-10) conversions as well as coding updates specific to National Coverage Determinations (NCDs). Please make sure your billing staffs are aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM) 11905.

Lab: Urine Drug Testing Proposed LCD Retirement - Effective July 15, 2020 This proposed Local Coverage Determination (LCD) has been retired under contractor 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database (MCD) Number: DL38625 LCD Title: Lab: Urine Drug Testing Effective Date: July 15, 2020 Rationale: Noridian has decided to retire the proposed LCD. Should Noridian decide to issue a new draft in the future, Noridian will consider the substantial feedback received. Retirement does not mean that medical necessity has changed or that the LCD no longer reflects appropriate criteria. The guidance in the retired LCD may be helpful in assessing medical necessity.

To access retired proposed LCDs, visit the CMS Medicare Coverage Database Archive.

MolDX: Combinatorial Pharmacogenomics Limited Coverage Proposed LCD; Billing and Coding: MolDX: Combinatorial Pharmacogenomics Limited Coverage Retirement - Effective August 16, 2020 This proposed Local Coverage Determination (LCD) has been retired under contractor 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database (MCD) Number: DL36323 and DA57410 LCD Title: MolDX: Combinatorial Pharmacogenomics Limited Coverage LCA Title: Billing and Coding: MolDX: Combinatorial Pharmacogenomics Limited Coverage Effective Date: August 16, 2020

LCDs are retired due to lack of evidence of current need(s) for the education and/or edits or in some cases because the material is addressed by a National Coverage Determination (NCD), a coverage provision in a CMS interpretative manual, another LCD or an article. Retirement does not mean that medical necessity has changed or that the LCD no longer reflects appropriate criteria. The guidance in the retired LCD may be helpful in assessing medical necessity.

To access retired proposed LCDs, visit the CMS Medicare Coverage Database Archive.

Visit the Noridian Medicare Coverage Articles webpage to access the Retired articles in the CMS MCD.

MolDX: HLA-B*15:02 Genetic Testing LCD Retirement; Billing and Coding: MolDX: HLA-B*15:02 Genetic Testing Article Retirement - Effective September 16, 2020 This Local Coverage Determination (LCD) has been retired under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database (MCD) Number: L361454/A57466 LCD Title: MolDX: HLA-B*15:02 Genetic Testing LCD Retirement Article Title: Billing and Coding: MolDX: HLA-B*15:02 Genetic Testing Effective Date: September 16, 2020 Rationale: The LCD is being retired because the information has been incorporated within the MolDX: Pharmacogenomics Testing LCD. The Billing and Coding Article is being retired because the information has been incorporated within the Billing and Coding: MolDX: Pharmacogenomics Testing LCD.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 47

Visit the Retired LCDs webpage to access the retired LCDs.

Visit the Articles webpage to access the retired coverage articles.

MolDX: Molecular Microscope® Diagnostic System for the Heart Proposed LCD Retirement; Billing and Coding: MolDX: Molecular Microscope® Diagnostic System for the Heart - Effective September 09, 2020 This proposed Local Coverage Determination (LCD) has been retired under contractor 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database (MCD) Number: DL38315/DA57150 LCD Title: MolDX: Molecular Microscope® Diagnostic System for the Heart LCA Title: Billing and Coding: MolDX: Molecular Microscope® Diagnostic System for the Heart Effective Date: September 09, 2020

LCDs and LCAs are retired due to lack of evidence of current need(s) for the education and/or edits or in some cases because the material is addressed by a National Coverage Determination (NCD), a coverage provision in a CMS interpretative manual, another LCD or an article. Retirement does not mean that medical necessity has changed or that the LCD no longer reflects appropriate criteria. The guidance in the retired LCD may be helpful in assessing medical necessity.

To access retired proposed LCDs, visit the CMS Medicare Coverage Database Archive.

Visit the Noridian Medicare Coverage Articles webpage to access the Retired articles in the CMS MCD.

MolDX: Pharmacogenomics Testing Local Coverage Determination This Local Coverage Determination (LCD) has completed the Open Public Meeting comment period and is now finalized under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database Number LCD Title L38335 MolDX: Pharmacogenomics Testing

Effective Date: 08/17/2020 Summary: These tests are generally covered (with a few exceptions) to improve safety in the use of specific medications by avoiding potentially harmful medications, doses and/or adverse reactions known to occur with certain genotypes. There is no billing and coding article associated with this LCD.

Visit the Future LCDs webpage to access this LCD.

MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung Cancer Final LCD - Effective August 24, 2020 This Local Coverage Determination (LCD) has completed the Open Public Meeting and Contractor Advisory Committee (CAC) comment period and is now finalized under contractor numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories). Responses to comments received may be found as a link at the bottom of the final LCD.

Medicare Coverage Database (MCD) Number/Contractor Determination Number: L38327 LCD Title: MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung Cancer Effective Date: August 24, 2020 Summary of LCD: This policy concerns the use of molecular diagnostic laboratory tests (tests of DNA, RNA, and / or proteins) as a predictive classifier for non-small cell lung cancer (NSCLC) and provides criteria for coverage.

Visit the Future LCDs webpage to access this LCD.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 48

MolDX: SelectMDx for Prostate Cancer Proposed LCD Retirement - Effective July 14, 2020 This proposed Local Coverage Determination (LCD) has been retired under contractor 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database (MCD) Number: DL38323 LCD Title: MolDX: SelectMDx for Prostate Cancer Effective Date: July 14, 2020

LCDs are retired due to lack of evidence of current need(s) for the education and/or edits or in some cases because the material is addressed by a National Coverage Determination (NCD), a coverage provision in a CMS interpretative manual, another LCD, or an article. Retirement does not mean that medical necessity has changed or that the LCD no longer reflects appropriate criteria. The guidance in the retired LCD may be helpful in assessing medical necessity.

To access retired proposed LCDs, visit the CMS Medicare Coverage Database Archive.

MolDX: Signatera and Minimal Residual Disease Testing for Colorectal Cancer Proposed LCD Retirement - Effective August 5, 2020 This proposed Local Coverage Determination (LCD) has been retired under contractor 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database (MCD) Number: DL38343 LCD Title: MolDX: Signatera and Minimal Residual Disease Testing for Colorectal Cancer Effective Date: August 5, 2020

LCDs are retired due to lack of evidence of current need(s) for the education and/or edits or in some cases because the material is addressed by a National Coverage Determination (NCD), a coverage provision in a CMS interpretative manual, another LCD, or an article. Retirement does not mean that medical necessity has changed or that the LCD no longer reflects appropriate criteria. The guidance in the retired LCD may be helpful in assessing medical necessity.

To access retired proposed LCDs, visit the CMS Medicare Coverage Database Archive.

MolDX: Tests on Allograft Kidney Biopsy Tissue to Assess for Graft Rejection Proposed LCD Retirement; Billing and Coding: MolDX: Tests on Allograft Kidney Biopsy Tissue to Assess for Graft Rejection - Effective September 09, 2020 This proposed Local Coverage Determination (LCD) has been retired under contractor 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database (MCD) Number: DL38319/DA57286 LCD Title: MolDX: Tests on Allograft Kidney Biopsy Tissue to Assess for Graft Rejection LCA Title: Billing and Coding: MolDX: Tests on Allograft Kidney Biopsy Tissue to Assess for Graft Rejection Effective Date: September 09, 2020

LCDs and LCAs are retired due to lack of evidence of current need(s) for the education and/or edits or in some cases because the material is addressed by a National Coverage Determination (NCD), a coverage provision in a CMS interpretative manual, another LCD or an article. Retirement does not mean that medical necessity has changed or that the LCD no longer reflects appropriate criteria. The guidance in the retired LCD may be helpful in assessing medical necessity.

To access retired proposed LCDs, visit the CMS Medicare Coverage Database Archive.

Visit the Noridian Medicare Coverage Articles webpage to access the Retired articles in the CMS MCD.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 49

National Coverage Determination (NCD 30.3.3): Acupuncture for cLBP - Revised MLN Matters Number: MM11755 Revised Related CR Release Date: August 27, 2020 Related CR Transmittal Numbers: R10337NCD and R10337CP Related Change Request (CR) Number: 11755 Effective Date: January 21, 2020 Implementation Date: October 5, 2020 - Medicare Shared Systems & A/B MACs, January 4, 2021 Note: CMS revised this article on August 28, 2020, to reflect an updated Change Request (CR) 11755 that provides revised messaging (page 3 in this article). It also revised the Claims Processing Manual at Section 410.4. All other information remains the same.

CR 11755 informs you that the Centers for Medicare & Medicaid Services (CMS) will cover acupuncture for chronic Low Back Pain (cLBP) effective for claims with dates of service (DOS) on and after January 21, 2020. Note that CMS still determines that acupuncture for treatment of fibromyalgia or osteoarthritis is still not considered reasonable and necessary and remain noncovered by Medicare. Make sure your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11755.

NCD 90.2: NGS for Medicare Beneficiaries with Germline (Inherited) Cancer MLN Matters Number: MM11837 Related CR Release Date: September 11, 2020 Related CR Transmittal Number: R10346NCD Related Change Request (CR) Number: 11837 Effective Date: January 27, 2020 Implementation Date: November 13, 2020 CR 11837 informs you about National Coverage Determination (NCD) 90.2, Next Generation Sequencing (NGS) for Medicare Beneficiaries with germline (inherited) cancer. Effective for dates of service on and after January 27, 2020, the Centers for Medicare & Medicaid Services (CMS) has determined that NGS, as a diagnostic laboratory test, is reasonable and necessary and covered nationally for patients with germline (inherited) cancer when performed in a CLIA-certified laboratory, when ordered by a treating physician, and when specific requirements are met. Make sure that your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11837.

Published for Review and Comments: Facet Joint Interventions for Pain Management-Proposed LCD and Billing and Coding Article The following proposed Local Coverage Determinations (LCDs) have been published for review and comments for contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Medicare Coverage Database Number LCD Title DL38801 Facet Joint Interventions for Pain Management

Medicare Coverage Database Number Billing and Coding Article Title DA58403 Billing and Coding: Facet Joint Interventions for Pain Management

Comment Period: September 24, 2020 to November 7, 2020

Visit the CMS MCD to access Proposed LCDs not released to final LCDs.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 50

Providers may address details for comment submission. When sending comments, reference the specific policy to which they are related. See the Proposed LCDs webpage for email and mail specifics.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 51

MLN Connects - July 2, 2020 Attend Nursing Home Training Series Webcasts

MLN Connects® for Thursday, July 2, 2020 View this edition as a PDF

NEWS

• CMS Proposes to Expand Coverage Policy for Transcatheter Edge-to-Edge Repair for Patients with Mitral Valve Regurgitation

• Physician Compare Preview Period Open through August 20 • ABN Form Renewal • Medicare Enrollment Application Fee Refunds through EFT

CLAIMS, PRICERS & CODES

• SNF Benefit Waiver Period: Billing Update

EVENTS

• Nursing Home Training Series Webcasts - July 2, 9, and 16 • Medicare Part A Cost Report: New Online Status Tracking Feature Call - July 9

MLN MATTERS® ARTICLES

• July 2020 Update of the Ambulatory Surgical Center (ASC) Payment System • Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 26.3,

Effective October 1, 2020 • International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage

Determination (NCDs) - July 2020 Update - Revised • National Coverage Determination (NCD) 160.18 Vagus Nerve Stimulation (VNS) - Revised • Quarterly Update to the Long Term Care Hospital (LTCH) Prospective Payment System (PPS) Fiscal Year (FY) 2020

Pricer - Revised

MLN Connects Special Edition - July 6, 2020 - ESRD PPS CY 2021 Proposed Rule; COVID-19: New and Expanded Flexibilities for RHCs & FQHCs

ESRD PPS CY 2021 PROPOSED RULE

On July 6, CMS issued a proposed rule that proposes to update payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to beneficiaries on or after January 1, 2021. This rule also proposes updates to the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI and proposes changes to the ESRD Quality Incentive Program (QIP).

In addition to the annual technical updates for the ESRD PPS, the proposed rule proposes the following:

• An addition to the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment • Changes to the eligibility criteria and determination process for the Transitional add-on Payment adjustment for New

and Innovative Equipment and Supplies (TPNIES) • Expansion of the TPNIES to include new and innovative capital-related assets that are home dialysis machines • A change to the low-volume adjustment eligibility criteria and attestation requirement to account for the COVID-19

public health emergency • An update to the ESRD PPS wage index to adopt the new Office of Management and Budget delineations with a

transition period • Information received from two manufacturers whose products, a dialyzer and a cartridge for a home dialysis machine,

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 52

are being considered for TPNIES in CY 2021

Additionally, the proposed rule proposes the following updates to the ESRD QIP:

• Scoring methodology changes to the ultrafiltration rate reporting measure • Updates to the National Healthcare Safety Network validation study

The proposed CY 2021 ESRD PPS base rate is $255.59, an increase of $16.26 to the current base rate of $239.33. This proposed amount reflects the application of the proposed wage index budget-neutrality adjustment factor (.998652), the proposed addition to the base rate of $12.06 to include calcimimetics, and a proposed productivity-adjusted market basket increase as required by section 1881(b)(14)(F)(i)(I) of the Act (1.8 percent), equaling $255.59 (($239.33 x .998652) + $12.06) x 1.018 = $255.59).

The proposed rule also includes:

• Annual update to the wage index • Update to the outlier policy • Low-volume eligibility criteria and attestation requirement • Impact analysis

For More Information:

• Proposed Rule • Press Release

See the full text of this excerpted CMS Fact Sheet (issued July 6).

COVID-19: NEW AND EXPANDED FLEXIBILITIES FOR RHCS & FQHCS DURING THE PUBLIC HEALTH EMERGENCY

On July 6, CMS updated MLN Matters Article SE20016 to clarify how Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) can apply the Cost Sharing (CS) modifier to preventive services furnished via telehealth. This update includes:

• Additional claim examples • New section on the RHC Productivity Standard

MLN Connects - July 9, 2020 ICD-10-CM Diagnosis Codes: FY 2021

MLN Connects® for Thursday, July 9, 2020 View this edition as a PDF

NEWS

• Open Payments: Program Year 2019 Data • LTCH Provider Preview Reports: Review Your Data by July 18 • IRF Provider Preview Reports: Review Your Data by July 21 • Reduce Provider Burden: Participate in Medical Documentation Interoperability Pilot • COVID-19: Alternate Care Site Toolkit, Third Edition

CLAIMS, PRICERS & CODES

• ICD-10-CM Diagnosis Codes: FY 2021 • Teaching Physicians and Residents: Expansion of CPT Codes that May Be Billed with the GE Modifier

EVENTS

• Nursing Home Training Series Webcasts - July 9 and 16

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 53

MLN MATTERS® ARTICLES

• Quarterly Update to the End-Stage Renal Disease Prospective Payment System (ESRD PPS) • Revising Chapters 3 and 5 of Publication (Pub.) 100-08, to Reflect the Recent Final Rule CMS-1713-F • New Point of Origin Code for Transfer from a Designated Disaster Alternate Care Site - Revised

PUBLICATIONS

• Hospice Quality Reporting Program: COVID-19 PHE

MLN Connects - July 16, 2020 Nursing Homes & COVID: Five Things to Know, Additional Resources, Training

MLN Connects® for Thursday, July 16, 2020 View this edition as a PDF

NEWS

• CMS Directs Additional Resources to Nursing Homes in COVID-19 Hotspot Areas • Five Things About Nursing Homes During COVID-19 • PEPPER for Short-term Acute Care Hospitals • Lower Extremity Joint Replacement: Comparative Billing Report

EVENTS

• Nursing Home Training Series Webcasts: New Topic for July 16 • COVID-19: Lessons from the Front Lines Call - July 17

MLN MATTERS® ARTICLES

• Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2020 • Influenza Vaccine Payment Allowances - Annual Update for 2020-2021 Season • Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2021 • October 2020 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly

Pricing Files • Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - July 2020 Update • July 2020 Update of the Ambulatory Surgical Center (ASC) Payment System - Revised • July 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS) - Revised • Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

- Revised • Claim Status Category Codes and Claim Status Codes Update - Rescinded

MLN Connects Special Edition - July 17, 2020 - COVID-19: Nursing Home Testing, SNF Benefit Period Waiver COVID-19: Nursing Home Testing, SNF Benefit Period Waiver

MLN Matters Special Edition Article SE20011 Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) is updated. Learn about:

• Updated Centers for Disease Control and Prevention guidelines for testing nursing home residents and patients • Update on applying the Skilled Nursing Facility (SNF) benefit period waiver

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 54

MLN Connects - July 23, 2020 Telemedicine Hack: 10-Week Learning Community for Ambulatory Providers

MLN Connects® for Thursday, July 23, 2020 View this edition as a PDF

NEWS

• Peripheral Vascular Intervention for Claudication: Comparative Billing Report • Physician Compare Preview Period Open through August 20

CLAIMS, PRICERS & CODES

• SNF Patient Driven Payment Model Interrupted Stay Issue

EVENTS

• Telemedicine Hack: A 10-Week Learning Community to Accelerate Telemedicine Implementation for Ambulatory Providers: July 22-September 23

• National CMS/CDC Nursing Home COVID-19 Training Series Webcast - July 23

MLN MATTERS® ARTICLES

• Change to the Payment of Allogeneic Stem Cell Acquisition Services • July 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS) - Revised

MULTIMEDIA

• Part A Cost Report Call: Audio Recording and Transcript

MLN Connects Special Edition - July 23, 2020 - Trump Administration Announces New Resources to Protect Nursing Home Residents Against COVID-19 As part of the unprecedented efforts taken by the Trump Administration, President Trump announced several new CMS initiatives designed to protect nursing home residents from Coronavirus Disease 2019 (COVID-19).

“From the moment the threat of this virus materialized, the Trump Administration has placed a priority on protecting nursing home residents,” said CMS Administrator Seema Verma. “Today’s multi-pronged intervention represents the latest efforts in fulfilling that unwavering commitment. As caseloads continue to increase in areas around the country, it has never been more important that nursing homes have what they need to maintain a sturdy defense against the virus. These measures will help them do exactly that.”

NEW FUNDING:

HHS will devote $5 billion of the Provider Relief Fund authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act to Medicare-certified long term care facilities and state veterans’ homes (“nursing homes”), to build nursing home skills and enhance nursing homes’ response to COVID-19, including enhanced infection control. This funding could be used to address critical needs in nursing homes including hiring additional staff, implementing infection control “mentorship” programs with subject matter experts, increasing testing, and providing additional services, such as technology so residents can connect with their families if they are not able to visit. Nursing homes must participate in the Nursing Home COVID-19 Training (described below) to be qualified to receive this funding. This new funding is in addition to the $4.9 billion previously announced to offset revenue losses and assist nursing homes with additional costs related to responding to the COVID-19 public health emergency and the shipments of personal protective equipment provided to nursing homes by the Federal Emergency Management Agency.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 55

ENHANCED TESTING:

Building on the initiative HHS announced last week, in which rapid point-of-care diagnostic testing devices will be distributed to nursing homes, and the new funding from the Provider Relief Fund, CMS will begin requiring, rather than recommending, that all nursing homes in states with a 5% positivity rate or greater test all nursing home staff each week. This new staff testing requirement will enhance efforts to keep the virus from entering and spreading through nursing homes by identifying asymptomatic carriers.

More than 15,000 testing devices will be deployed over the next few months to help support this mandate, with over 600 devices shipping this week. Funds from the Provider Relief Fund can also be used to pay for additional testing of visitors.

ADDITIONAL TECHNICAL ASSISTANCE & SUPPORT:

The Trump administration recently deployed federal Task Force Strike Teams to provide onsite technical assistance and education to nursing homes experiencing outbreaks in an effort to help reduce transmission and the risk of COVID-19 spread among residents. The first deployments took place in 18 nursing homes in Illinois, Florida, Louisiana, Ohio, Pennsylvania and Texas between July 18 and July 20. The Task Force Strike Teams are composed of clinicians and public health service officials from CMS, the Centers for Disease Control & Prevention (CDC), and the Office of the Assistant Secretary for Health.

The Task Force Strike Teams went into nursing homes based on data they reported to the CDC that indicated an increase in COVID-19 cases. The teams focused on the four key areas of support, including keeping COVID-19 out of facilities, detecting COVID-19 cases quickly, preventing virus transmission, and managing staff. The goal was to determine what immediate actions nursing homes needed to take to help reduce the spread and risk of COVID-19 among residents, and to better understand what federal, state, and local resources nursing homes need to ensure the health and safety of their residents. CMS and its partners plan to use what is learned on the ground to determine remote education and other critical needs to support nursing homes and mitigate future outbreaks.

In addition, CMS, in partnership with the CDC, is rolling out an online, self-paced, on-demand Nursing Home COVID-19 Training focused on infection control and best practices. The training being offered has 23 educational modules and a scenario-based learning modules that include materials on cohorting strategies and using telehealth in nursing homes to assist facilities as they continue to work to mitigate the virus spread in their facilities. This program supplements training already underway to better equip nursing homes to contain and stop the spread of COVID-19. The training is a requirement for nursing homes to receive the additional funding from the Provider Relief Fund Program.

The training will be available to all 15,400 nursing homes nationwide along with specialized technical assistance to nursing homes who have been found to have infection prevention deficiencies in their most recent CMS inspection and had recent COVID-19 cases based upon their data submissions to CDC. A certificate of completion is offered and recognition badges can be downloaded for nursing homes to display on their website.

WEEKLY DATA ON HIGH RISK NURSING HOMES:

Early on during this pandemic, CMS required nursing homes to inform residents, their families and representatives of COVID-19 cases in their nursing homes. Starting in May, CMS and CDC began collecting weekly data on each nursing home including their number of COVID-19 cases. Now that this data collection process has matured, the White House and CMS will release a list of nursing homes with an increase in cases that will be sent to states each week as part of the weekly Governor’s report to ensure states have the information needed to target their support to the highest risk nursing homes.

This announcement builds on the unprecedented and aggressive actions CMS has taken to address the impact of COVID-19 in nursing homes.

See the full text of this excerpted CMS Press Release (issued July 22), including a list of actions CMS took to address the impact of COVID-19 in nursing homes.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 56

MLN Connects - July 30, 2020 COVID-19 Impacts on Medicare Beneficiaries - Updated Data

MLN Connects® for Thursday, July 30, 2020 View this edition as a PDF

NEWS

• CMS Updates Data on COVID-19 Impacts on Medicare Beneficiaries • Short-Term Acute Care Hospitals: Submit Occupational Mix Surveys by September 3 • PEPPERs for SNFs, Hospices, IRFs, IPFs, CAHs, and LTCHs • Hospice Quality Reporting Program: HART v1.6.0 • Medicare Diabetes Prevention Program: Become a Medicare Enrolled Supplier

CLAIMS, PRICERS & CODES

• COVID-19: Laboratory Claims Requiring the NPI of the Ordering/Referring Professional - Update • Medicare Diabetes Prevention Program: Valid Claims

EVENTS

• National CMS/CDC Nursing Home COVID-19 Training Series Webcast - July 30

MLN MATTERS® ARTICLES

• Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code 87426 • Overview of the Repetitive, Scheduled Non-Emergent Ambulance Prior Authorization Model - Revised • Modify Edits in the Fee for Service (FFS) System when a Beneficiary has a Medicare Advantage (MA) Plan - Revised

PUBLICATIONS

• Medicare Quarterly Provider Compliance Newsletter, Volume 10, Issue 4 • Home Health, IRF, LTCH, and SNF Quality Reporting Programs: COVID-19 PHE

MLN Connects Special Edition - July 30, 2020 - Payment for COVID-19 Counseling, Reporting Hospital Therapeutics, Out-of-Pocket Drug Costs

CMS AND CDC ANNOUNCE PROVIDER REIMBURSEMENT AVAILABLE FOR COUNSELING PATIENTS TO SELF-ISOLATE AT TIME OF COVID-19 TESTING

On July 30, CMS and the Centers for Disease Control and Prevention (CDC) are announcing that payment is available to physicians and health care providers to counsel patients, at the time of Coronavirus Disease 2019 (COVID-19) testing, about the importance of self-isolation after they are tested and prior to the onset of symptoms.

The transmission of COVID-19 occurs from both symptomatic, pre-symptomatic, and asymptomatic individuals emphasizing the importance of education on self-isolation as the spread of the virus can be reduced significantly by having patients isolated earlier, while waiting for test results or symptom onset. The CDC models show that when individuals who are tested for the virus are separated from others and placed in quarantine, there can be up to an 86 percent reduction in the transmission of the virus compared to a 40 percent decrease in viral transmission if the person isolates after symptoms arise.

Provider counseling to patients, at the time of their COVID-19 testing, will include the discussion of immediate need for isolation, even before results are available, the importance to inform their immediate household that they too should be tested for COVID-19, and the review of signs and symptoms and services available to them to aid in isolating at home. In addition, they will be counseled that if they test positive, to wear a mask at all times, and they will be contacted by public health authorities and asked to provide information for contact tracing and to tell their immediate household and recent contacts in case it is appropriate for these individuals to be tested for the virus and to self-isolate as well.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 57

CMS will use existing evaluation and management payment codes to reimburse providers who are eligible to bill CMS for counseling services no matter where a test is administered, including doctor’s offices, urgent care clinics, hospitals, and community drive-thru or pharmacy testing sites.

For More Information:

• Medicare Fee-For-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) MLN Matters Special Edition Article SE20011

• Counseling Check List, including resource links

CMS ANNOUNCES NEW HOSPITAL PROCEDURE CODES FOR THERAPEUTICS IN RESPONSE TO THE COVID-19 PUBLIC HEALTH EMERGENCY

With the emergence of Coronavirus Disease 2019 (COVID-19) and the new treatments that have followed, it is critical to be able to track the use of these treatments and their effectiveness in real-time. CMS responded to this need, and in record time is implementing new procedure codes to allow Medicare and other insurers to identify the use of the therapeutics remdesivir and convalescent plasma for treating hospital in-patients with COVID-19. These new codes, which go into effect August 1, will enable CMS to conduct real-time surveillance and obtain real-world evidence in how these drugs are working and provide critical information on their effectiveness and how they can protect patients. These codes can be reported to Medicare and other insurers may also use the codes to identify the use of COVID-19 therapies and help facilitate monitoring and data collection on their use.

These new codes are being implemented into the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS). ICD-10-PCS is the Health Insurance Portability and Accountability Act (HIPAA) designated code set for reporting hospital inpatient procedures, which is developed and maintained by CMS and can be used by other health insurers.

The implementation of these new procedure codes is part of the Trump Administration’s ongoing efforts to protect the health and safety of COVID-19 patients across the country during the public health emergency.

For more information, see ICD-10 MS-DRGs Version 37.2 Effective August 1.

TRUMP ADMINISTRATION CONTINUES TO KEEP OUT-OF-POCKET DRUG COSTS LOW FOR SENIORS

On July 29, CMS announced the average basic premium for Medicare Part D prescription drug plans, which cover prescription drugs that beneficiaries pick up at a pharmacy. Under the leadership of President Trump, for the first time seniors that use insulin will be able to choose a prescription drug plan in their area that offers a broad set of insulins for no more than $35 per month per prescription.

The average basic Part D premium will be $30.50 in 2021. The 2021 and 2020 average basic premiums are the second lowest and lowest, respectively, average basic premiums in Part D since 2013. This trend of lower Part D premiums, which have decreased by 12 percent since 2017, means that beneficiaries have saved nearly $1.9 billion in premium costs over that time. Further, Part D continues to be an extremely popular program, with enrollment increasing by 16.7 percent since 2017.

“At every turn, the Trump Administration has prioritized policies that introduce choice and competition in Part D,” said CMS Administrator Seema Verma. “The result is lower prices for life-saving drugs like insulin, which will be available to Medicare beneficiaries at this fall’s Open Enrollment for no more than $35 a month. In short, Part D premiums continue to stay at their lowest levels in years even as beneficiaries enjoy a more robust set of options from which to choose a plan that meets their needs.”

In addition to the $1.9 billion in premium savings for beneficiaries since 2017, the Trump Administration has produced substantial Part D program savings for taxpayers. With about 200 additional standalone prescription drug plans and 1,500 additional Medicare Advantage plans with prescription drug coverage joining the program between 2017 and 2020, and that trend expected to continue in 2021, increased market competition has led to lower costs and lower Medicare premium subsidies, which has saved taxpayers approximately $8.5 billion over the past four years.

Earlier this year, CMS launched the Part D Senior Savings Model, which will allow Medicare beneficiaries to choose a plan that provides access to a broad set of insulins at a maximum $35 copay for a month’s supply. Starting January 1, 2021, beneficiaries who select these plans will save, on average, $446 per year, or 66 percent, on their out-of-pocket costs for insulin. Beneficiaries will be able to choose from more than 1,600 participating standalone Medicare Part D prescription drug plans

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 58

and Medicare Advantage plans with prescription drug coverage, all across the country this open enrollment period, which runs from October 15 through December 7. And because the majority of participating Medicare Advantage plans with prescription drug coverage do not charge a Part D premium, beneficiaries who enroll in those plans will save on insulin and not pay any extra premiums.

In January 2020, CMS, through the Part D Payment Modernization Model, offered an innovative new opportunity for Part D plan sponsors to lower costs for beneficiaries, while improving care quality. Under this model, Part D sponsors can better manage prescription drug costs through all phases of the Part D benefit, including the catastrophic phase. Through the use of better tools and program flexibilities, sponsors are better able to negotiate on high cost drugs and design plans that increase access and lower out-of-pocket costs for beneficiaries. For CY 2021, there will be nine plan options in Utah, New Mexico, Idaho and Pennsylvania that participate in this model.

In Medicare Part D, beneficiaries choose the prescription drug plan that best meets their needs, and plans have to improve quality and lower costs to attract beneficiaries. This competitive dynamic sets up clear incentives that drive towards value. CMS has taken steps to modernize the Part D program by providing beneficiaries the opportunity to choose among plans with greater negotiating tools that have been developed in the private market and by providing patients with more transparency on drug prices. Improvements to the Medicare Part D program that CMS has made to date include:

• Beginning in 2021, providing more information on out-of-pocket costs for prescription drugs to beneficiaries by requiring Part D plans to provide a real time benefit tool to clinicians with information that they can discuss with patients on out-of-pocket drug costs at the time a prescription is written

• Implementing Part D legislation signed by President Trump to prohibit “gag clauses,” which keep pharmacists from telling patients about lower-cost ways to obtain prescription drugs

• Beginning in 2021, requiring the Explanation of Benefits document that Part D beneficiaries receive each month to include information on drug price increases and lower-cost therapeutic alternatives

• Providing beneficiaries with more drug choices and empowering beneficiaries to select a plan that meets their needs by allowing plans to cover different prescription drugs for different indications, an approach used in the private sector

• Reducing the maximum amount that low-income beneficiaries pay for certain innovative medicines known as “biosimilars,” which will lower the out-of-pocket cost of these innovative medicines for these beneficiaries

• Empowering Medicare Advantage to negotiate lower costs for physician-administered prescription drugs for seniors for the first time, as well allowing Part D plans to substitute certain generic drugs on plan formularies more quickly during the year, so beneficiaries immediately have access to the generic, which typically has lower cost sharing than the brand

• Increasing competition among plans by removing the requirement that certain Part D plans have to “meaningfully differ” from each other, making more plan options available for beneficiaries

For More Information:

• Part D Senior Savings Model webpage • Ratebooks & Supporting Data webpage: View the 2021 Part D base beneficiary premium, the Part D national average

monthly bid amount, the Part D regional low-income premium subsidy amounts, the de minimis amount, the Medicare Advantage employer group waiver plan regional payment rates, and the Medicare Advantage regional PPO benchmarks

MLN Connects Special Edition - July 31, 2020 - FY 2021 Medicare Payment Policies for IPFs, SNFs, and Hospices FY 2021 Medicare Payment Policies for IPFs, SNFs, and Hospices

CMS UPDATES MEDICARE PAYMENT POLICIES FOR IPFS, SNFS, AND HOSPICES

Inpatient Psychiatric Facilities:

The final rule updates Medicare payment policies and rates for the IPF Prospective Payment System (PPS) for FY 2021. In this final rule, CMS is finalizing a 2.2 percent payment rate update and finalizing its proposal to adopt revised Office of

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 59

Management and Budget (OMB) statistical area delineations resulting in wage index values being more representative of the actual costs of labor in a given area. CMS is finalizing updates to allow advanced practice providers, including physician assistants, nurse practitioners, psychologists, and clinical nurse specialists to operate within the scope of practice allowed by state law by documenting progress notes in the medical record of patients for whom they are responsible, receiving services in psychiatric hospitals.

Skilled Nursing Facilities:

The final rule updates the Medicare payment rates and the quality programs for SNFs. These updates include routine technical rate-setting updates to the SNF PPS payment rates, as well as finalizes adoption of the most recent OMB statistical area delineations and applies a 5 percent cap on wage index decreases from FY 2020 to FY 2021. CMS is also finalizing changes to the ICD-10 code mappings that would be effective beginning in FY 2021 in response to stakeholder feedback. CMS projects aggregate payments to SNFs will increase by $750 million, or 2.2 percent, for FY 2021, compared to FY 2020.

Hospices:

For FY 2021, hospice payment rates are updated by the market basket percentage increase of 2.4 percent ($540 million). Hospices that fail to meet quality reporting requirements receive a 2 percentage point reduction to the annual market basket percentage increase for the year. The hospice payment system includes a statutory aggregate cap. The aggregate cap limits the overall payments made to a hospice annually. The final hospice cap amount for the FY 2021 cap year is $30,683.93, which is equal to the FY 2020 cap amount ($29,964.78) updated by the final FY 2021 hospice payment update percentage of 2.4 percent.

For More Information:

• IPF Final Rule and Fact Sheet • SNF Final Rule and Fact Sheet • Hospice Final Rule and Fact Sheet

COVID-19: COVERAGE OF PHYSICIAN TELEHEALTH SERVICES PROVIDED TO SNF RESIDENTS

The current COVID-19 Public Health Emergency (PHE) does not waive any requirements related to Skilled Nursing Facility (SNF) Consolidated Billing (CB); however, CMS added CPT codes 99441, 99442, and 99443, to the list of telehealth codes coverable under the waiver during the COVID-19 PHE. These codes designate three different time increments of telephone evaluation and management service provided by a physician. You can bill for these physician services separately under Part B when furnished to a SNF's Part A resident.

Medicare Administrative Contractors (MACs) will reprocess claims for CPT codes 99441, 99442, and 99443 with dates of service on or after March 1, 2020, that were denied due to SNF CB edits. You do not have to do anything. If you already received payment from the SNF for these physician services, return that payment to the SNF once the MAC reprocesses your claim.

MLN Connects Special Edition - August 04, 2020 - PFS, OPPS, and IRF: FY 2021 Payment Rules

TRUMP ADMINISTRATION PROPOSES TO EXPAND TELEHEALTH BENEFITS PERMANENTLY FOR MEDICARE BENEFICIARIES BEYOND THE COVID-19 PUBLIC HEALTH EMERGENCY AND ADVANCES ACCESS TO CARE IN RURAL AREAS

CMS is proposing changes to expand telehealth permanently, consistent with the Executive Order on Improving Rural and Telehealth Access that President Trump signed. The Executive Order and proposed rule advance our efforts to improve access and convenience of care for Medicare beneficiaries, particularly those living in rural areas. Additionally, the proposed rule implements a multi-year effort to reduce clinician burden under our Patients Over Paperwork initiative and to ensure appropriate reimbursement for time spent with patients. This proposed rule also takes steps to implement President Trump’s Executive Order on Protecting and Improving Medicare for our Nation’s Seniors and continues our commitment to ensure that the Medicare program is sustainable for future generations.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 60

Expanding Beneficiary Access to Care through Telehealth:

Over the last three years, as part of the Fostering Innovation and Rethinking Rural Health strategic initiatives, CMS has been working to modernize Medicare by unleashing private sector innovations and improve beneficiary access to services furnished via telecommunications technology. Starting in 2019, Medicare began paying for virtual check-ins, meaning patients across the country can briefly connect with doctors by phone or video chat to see whether they need to come in for a visit. In response to the COVID-19 pandemic, CMS moved swiftly to significantly expand payment for telehealth services and implement other flexibilities so that Medicare beneficiaries living in all areas of the country can get convenient and high-quality care from the comfort of their home while avoiding unnecessary exposure to the virus. Before the Public Health Emergency (PHE), only 14,000 beneficiaries received a Medicare telehealth service in a week, while over 10.1 million beneficiaries have received a Medicare telehealth service during the PHE from mid-March through early-July. For more information on Medicare’s unprecedented increases in telemedicine and its impact on the health care delivery system, visit the CMS Health Affairs blog.

As directed by President Trump’s Executive Order on Improving Rural and Telehealth Access, through this rule, CMS is taking steps to extend the availability of certain telemedicine services after the PHE ends, giving Medicare beneficiaries more convenient ways to access health care particularly in rural areas where access to health care providers may otherwise be limited.

“Telemedicine can never fully replace in-person care, but it can complement and enhance in-person care by furnishing one more powerful clinical tool to increase access and choices for Americas seniors,” said CMS Administrator Seema Verma. “The Trump Administration’s unprecedented expansion of telemedicine during the pandemic represents a revolution in health care delivery, one to which the health care system has adapted quickly and effectively. Never one merely to tinker around the edges when it comes to patient-centered care, President Trump will not let this opportunity slip through our fingers.”

During the PHE, CMS added 135 services such as emergency department visits, initial inpatient and nursing facility visits, and discharge day management services that could be paid when delivered by telehealth. CMS is proposing to permanently allow some of those services to be done by telehealth, including home visits for the evaluation and management of a patient (in the case where the law allows telehealth services in the patient’s home) and certain types of visits for patients with cognitive impairments. CMS is seeking public input on other services to permanently add to the telehealth list beyond the PHE in order to give clinicians and patients time as they get ready to provide in-person care again. CMS is also proposing to temporarily extend payment for other telehealth services, such as emergency department visits for a specific time period, through the calendar year in which the PHE ends. This will also give the community time to consider whether these services should be delivered permanently through telehealth outside of the PHE.

Prioritizing Investment in Preventive Care and Chronic Disease Management:

Under our Patients Over Paperwork initiative, the Trump Administration has taken steps to eliminate burdensome billing and coding requirements for Evaluation and Management (E/M) (for office/outpatient visits) that make up 20 percent of the spending under the Physician Fee Schedule. These billing and documentation requirements for E/M codes were established 20 years ago and have been subject to longstanding criticism from clinicians that they do not reflect current care practices and needs. After extensive stakeholder collaboration with the American Medical Association and others, simplified coding and billing requirements for E/M visits will go into effect January 1, 2021, saving clinicians 2.3 million hours per year in burden reduction. As a result of this change, clinicians will be able to make better use of their time and restore the doctor-patient relationship by spending less time on documenting visits and more time on treating their patients.

Additionally, last year, the Trump Administration finalized historic changes to increase payment rates for office/outpatient E/M visits beginning in 2021. The higher payment for E/M visits takes into account the changes in the practice of medicine, recognizing that additional resources are required of clinicians to take care of their Medicare patients, of which two-thirds have multiple chronic conditions. The prevalence of certain chronic conditions in the Medicare population is growing. For example, as of 2018, 68.9% of beneficiaries have 2 or more chronic conditions. In addition, between 2014 and 2018, the percent of beneficiaries with 6 or more chronic conditions has grown from 14.3% to 17.7%.

In this rule, CMS is proposing to similarly increase the value of many services that are comparable to or include office/outpatient E/M visits, such as maternity care bundles, emergency department visits, end-stage renal disease capitated payment bundles, physical and occupational therapy evaluation services, and others. The proposed adjustments, which implement recommendations from the American Medical Association, help to ensure that CMS is appropriately recognizing the kind of care where clinicians need to spend more face-to-face time with patients, like primary care and complex or chronic disease management.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 61

Bolstering the Health Care Workforce/Patients Over Paperwork:

CMS is also taking steps to ensure that health care professionals can practice at the top of their professional training. During the COVID-19 public health emergency, CMS announced several temporary changes to expand workforce capacity and reduce clinician burden so that staffing levels remain high in response to the pandemic. As part of its Patients over Paperwork initiative to reduce regulatory burden for providers, CMS is proposing to make some of these temporary changes permanent following the PHE. Such proposed changes include:

• Nurse practitioners, clinical nurse specialists, physician assistants, and certified nurse-midwives (instead of only physicians) to supervise others performing diagnostic tests consistent with state law and licensure, providing that they maintain the required relationships with supervising/collaborating physicians as required by state law

• Clarifying that pharmacists can provide services as part of the professional services of a practitioner who bills Medicare

• Allowing physical and occupational therapy assistants (instead of only physical and occupational therapists) to provide maintenance therapy in outpatient settings

• Allowing physical or occupational therapists, speech-language pathologists, and other clinicians who directly bill Medicare to review and verify (sign and date), rather than re-document, information already entered by other members of the clinical team into a patient’s medical record

For More Information:

• CY 2021 Physician Fee Schedule and Quality Payment Program Proposed Rule: Public comments are due by October 5, 2020.

• CY 2021 Physician Fee Schedule Proposed Rule Fact Sheet • CY 2021 Quality Payment Program Proposed Rule Fact Sheet • Medicare Diabetes Prevention Program Fact Sheet

TRUMP ADMINISTRATION PROPOSES POLICIES TO PROVIDE SENIORS WITH MORE CHOICES AND LOWER COSTS FOR SURGERIES

Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) proposed rule advances CMS’ commitment to increasing competition

As directed by President Trump’s Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors, CMS is proposing several policies that would give Medicare beneficiaries more choices in where they seek care and lower their out-of-pocket costs for surgeries. The proposed rule takes steps that would allow hospitals and ambulatory surgical centers to operate with better flexibility and patients to have what they need to make informed decisions on where they receive care.

“President Trump’s mandate is to put patients and doctors back in charge of health care,” said CMS Administrator Seema Verma. “Following through on that mandate entails loosening the stranglehold of government control that has accumulated over decades. Surgeries can be expensive. Patients should have as many options as possible for lowering their costs while getting quality care. These proposed changes, if finalized, would do exactly that, help put patients and doctors back in the driver’s seat and in a position to make decisions about their own care."

For patients having surgery, hospital outpatient departments are subject to the same quality and safety standards as inpatient settings under Medicare rules. With this in mind, for 2021, CMS proposes to expand the number of procedures that Medicare would pay for in the hospital outpatient setting by eliminating the “Inpatient Only list,” which includes procedures for which Medicare will only make payment when performed in the hospital inpatient setting. This proposed change would remove regulatory barriers to give beneficiaries the choice to receive these services in a lower cost setting and convenience to go home as early as the same day after a procedure, when their clinician decides such a setting is appropriate. CMS would phase-in this proposal over three years and would gradually allow over 1,700 additional services to be paid when furnished in the hospital outpatient setting. In 2021, approximately 300 musculoskeletal services (such as certain joint replacement procedures) would be newly payable in the hospital outpatient setting. The proposed change would be the largest one-time reduction to the Inpatient Only list by far; from 2017 through 2020, approximately 30 services total were removed from the Inpatient Only list.

Medicare pays for most services furnished in ASCs at a lower rate than hospital outpatient departments. As a result, when receiving care in an ASC rather than a hospital outpatient department, patients can potentially lower their out-of-pocket costs

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 62

for certain services. For example, for one of the most common cataract surgeries, currently, on average, a Medicare beneficiary pays $101 if the procedure is done in a hospital outpatient department compared to $51 if done in a surgery center.

CMS proposes to expand the number of procedures that Medicare would pay for when performed in an ASC, which would give patients more choices in where they receive care and ensure CMS does not favor one type of care setting over another. For CY 2021, we propose to add eleven procedures that Medicare would pay for when provided in an ASC, including total hip arthroplasty. Since 2018, CMS has added 28 procedures to the list of surgical services that can be paid under Medicare when performed in ASCs.

Additionally, we propose two alternatives that would further expand our goals of increasing access to care at a lower cost. Under the first alternative, CMS would establish a process where the public could nominate additional services that could be performed in ASCs based on certain quality and safety parameters. Under the other proposed alternative, we would revise the criteria used to determine the procedures that Medicare would pay for in an ASC, potentially adding approximately 270 procedures that are already payable when performed in the hospital outpatient setting to the ASC list. Under this alternative, we solicit comment on whether the ASC conditions for coverage (the baseline health and safety requirements for Medicare-participating ASCs) should be revised given the potential for a significant expansion in the nature of services that would be added under this alternative proposal.

As part of the Trump Administration’s commitment to lowering drug prices, CMS is proposing a change that would lower beneficiaries’ out-of-pocket drug costs for certain hospital outpatient drugs. In 2018 and 2019, CMS implemented a payment policy to help beneficiaries save on coinsurance for drugs that were administered at hospital outpatient departments and acquired through the 340B program, which allows certain hospitals to buy outpatient drugs at lower costs. Due to CMS’ policy change, which was recently upheld by the United States Court of Appeals for the D.C Circuit, Medicare beneficiaries now benefit from the steep discounts that 340B-enrolled hospitals receive when they purchase drugs through the 340B program.

For 2021, CMS would provide even larger discounts for beneficiaries by proposing to further reduce the payment rate for drugs purchased through the 340B Program based on hospital survey data on drug acquisition costs. CMS is proposing to pay for 340B acquired drugs at average sales price minus 28.7 percent. With this proposed change, CMS estimates that, in 2021, Medicare beneficiaries would save an additional $85 million on out-of-pocket payments for these drugs and that OPPS payments for 340B drugs would be reduced by approximately $427 million. The savings from this change would be reallocated on an equal percentage basis to all hospitals paid under the OPPS. We propose that children’s hospitals, certain cancer hospitals, and rural sole community hospitals would continue be excepted from these drug payment reductions. In the alternative, and in light of the court’s recent decision, we propose to continue our current policy of paying ASP minus 22.5% for 340B drugs.

In continuing the agency’s Patients Over Paperwork Initiative to reduce burden for health care providers, CMS is proposing to establish, update, and simplify the methodology to calculate the Overall Hospital Quality Star Rating (Overall Star Rating) beginning with CY 2021. The Overall Star Rating summarizes a variety of quality measures published on the Medicare.gov Hospital Compare tool for common conditions that hospitals treat, such as heart attacks or pneumonia. Along with publicly reported data on Hospital Compare, the Overall Star Rating helps patients make better informed health care decisions.

Responding to stakeholder feedback about the current methodology used to calculate the Overall Star Rating, CMS is proposing revisions on how to calculate the ratings and grouping hospitals in the Readmission measure group by the hospital’s percentage of patients who are dually enrolled in Medicare and Medicaid, which would help provide better insight on health disparities. These and other proposed changes are intended to reduce provider burden, improve the predictability of the star ratings, and make it easier to compare ratings between similar hospitals.

As part of the agency’s Rethinking Rural Health Initiative, in the FY 2020 Inpatient Prospective Payment System (IPPS) final rule, CMS increased the wage index for certain low wage index hospitals for at least four years, beginning in FY 2020. In the CY 2020 OPPS/ASC Payment System final rule, CMS adopted changes to the wage index for outpatient hospitals as were finalized in the FY 2020 IPPS final rule, including the increase in wage index for certain low wage index hospitals. The OPPS wage index adjusts hospital outpatient payment rates to account for local differences in wages that hospitals face in their respective labor markets. For 2021, under the OPPS, CMS proposes to continue to adopt the IPPS post-reclassified wage index, including the wage index increase for certain low wage index hospitals. The increase would address a common concern that the current wage index system contributes to disparities between high and low wage index hospitals. Overall, CMS estimates that

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 63

payment for outpatient services in rural hospitals across the country would increase by 3 percent, which is 0.5 percent higher than the national average increase of 2.5 percent.

For More Information:

• Proposed Rule • Fact Sheet

CMS UPDATES MEDICARE PAYMENT POLICIES FOR IRFS

On August 4, CMS finalized a Medicare payment rule that further advances our efforts to strengthen the Medicare program by better aligning payments for Inpatient Rehabilitation Facilities (IRFs). The final rule updates Medicare payment policies and rates for facilities under the IRF Prospective Payment System (PPS) for FY 2021. This final rule also includes making permanent the regulatory change to eliminate the requirement for physicians to conduct a post admission visit since much of the information is included in the pre-admission visit. This flexibility was offered during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE), and the rule would make this flexibility permanent beyond the expiration of the PHE. In recognition of the interdisciplinary role that non-physician practitioners are currently performing with patients in the IRF, CMS is also finalizing that a non-physician practitioner may perform one of the three required visits in lieu of the physician in the second and later weeks of a patient’s care when consistent with the non-physician practitioner’s state scope of practice. Additionally, for FY 2021, CMS is updating the IRF PPS payment rates by 2.4 percent.

For More Information:

• Final Rule • Fact Sheet

MLN Connects - August 06, 2020 Physician Fee Schedule Proposed Rule Listening Session: Register Now

MLN Connects® for Thursday, August 6, 2020 View this edition as a PDF

NEWS

• Electronic Prescribing of Controlled Substances in Medicare Part D: Request for Information • Release of the IRF Web Pricer • Subsequent Nursing Facility E/M Services: Comparative Billing Report • Nursing Home Compare Refresh • Medicare Ground Ambulance Data Collection System: Updated Documents • MACs Resume Medical Review on a Post-Payment Basis • Renewed ABN: Deadline Extended to January 1 • COVID-19: Telemedicine, Clinical Experiences, Resources for Hospitals and Urgent Care Centers • Protect Your Patients Against Vaccine-Preventable Diseases

EVENTS

• National CMS/CDC Nursing Home COVID-19 Training Series Webcast - August 6 • COVID-19: Lessons from the Front Lines Call - August 7 • Physician Fee Schedule Proposed Rule: Understanding 4 Key Topics Listening Session - August 13 • Dr. Todd Graham Pain Management Study Listening Session - August 27

MLN MATTERS® ARTICLES

• New Waived Tests • Penalty for Delayed Request for Anticipated Payment (RAP) Submission - Implementation

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 64

MLN Connects - August 13, 2020 COVID-19: CMS/CDC Nursing Home Training Series Webcast - August 13

MLN Connects® for Thursday, August 13, 2020 View this edition as a PDF

NEWS

• Trump Administration Announces Initiative to Transform Rural Health • Physician Compare Preview Period Open through August 20 • Management of Acute and Chronic Pain - Stakeholder Engagement Opportunity: Reply by August 21 • SNF Provider Preview Reports: Review Your Data by August 30 • PEPPERs for HHAs and PHPs • Hospitals: Three Year Geographic Reclassification Data for FY 2022 MGCRB Applications • Opioids: Co-Prescribing Naloxone

EVENTS

• National CMS/CDC Nursing Home COVID-19 Training Series Webcast - August 13 • Dr. Todd Graham Pain Management Study Listening Session - August 27

MLN MATTERS® ARTICLES

• Billing for Home Infusion Therapy Services On or After January 1, 2021 • Correction to Editing Update for Vaccine Services • International Classification of Diseases, 10th Revision (ICD10) and Other Coding Revisions to National Coverage

Determination (NCDs) - January 2021 Update • Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment • Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - October 2020 Update • Update to Osteoporosis Drug Codes Billable on Home Health Claims • Influenza Vaccine Payment Allowances - Annual Update for 2020-2021 Season - Revised

MULTIMEDIA

• HQRP Training Resources Web-Based Training Course

MLN Connects - August 20, 2020 Routine Provider Inspections Resume

MLN Connects® for Thursday, August 20, 2020 View this edition as a PDF

NEWS

• CMS Announces Resumption of Routine Inspections of All Provider and Suppliers, Issues Updated Enforcement Guidance to States, and Posts Toolkit to Assist Nursing Homes

• Reduce Provider Burden: Electronic Medical Documentation Interoperability Pilot Program

EVENTS

• CMS-CDC Fundamentals of COVID-19 Prevention for Nursing Homes: New Format

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 65

MLN MATTERS® ARTICLES

• New COVID-19 Policies for Inpatient Prospective Payment System (IPPS) Hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Act - Revised

PUBLICATIONS

• Enhancing RN Supervision of Hospice Aide Services

MULTIMEDIA

• Medicare Secondary Payer (MSP) Provision (June 2020)

MLN Connects - August 27, 2020 COVID-19: Training to Strengthen Nursing Home Infection Control Practices

MLN Connects® for Thursday, August 27, 2020 View this edition as a PDF

NEWS

• Trump Administration Launches National Training Program to Strengthen Nursing Home Infection Control Practices • SNF Provider Preview Reports: Review Your Data by August 30 • COVID: Nursing Home Toolkit • Medicare Diabetes Prevention Program: Become a Medicare Enrolled Supplier

CLAIMS, PRICERS & CODES

• COVID-19: Waive Cost Sharing for These HCPCS Codes

MLN MATTERS® ARTICLES

• Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2021 - Revised • October 2020 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly

Pricing Files - Revised

PUBLICATIONS

• Creating an Effective Hospice Plan of Care

MULTIMEDIA

• Physician Fee Schedule Listening Session: Audio Recording and Transcript

MLN Connects Special Edition - August 28, 2020 - CMS Offers Comprehensive Support for Louisiana and Texas with Hurricane Laura On August 27, CMS announced efforts underway to support Louisiana and Texas in response to Hurricane Laura. On August 26, 2020, Department of Health and Human Services (HHS) Secretary Alex Azar declared public health emergencies (PHEs) in these states, retroactive to August 22, 2020 for the state of Louisiana and to August 23, 2020 for the state of Texas. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of Hurricane Laura.

CMS provided numerous waivers to health care providers during the current coronavirus disease 2019 (COVID-19) pandemic to meet the needs of beneficiaries and providers. The waivers already in place will be available to health care providers to use during the duration of the COVID-19 PHE determination timeframe and for the Hurricane Laura PHE. CMS may waive certain

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 66

additional Medicare, Medicaid, and Children's Health Insurance Program (CHIP) requirements, create special enrollment opportunities for individuals to access healthcare quickly, and take steps to ensure dialysis patients obtain critical life-saving services.

"Our thoughts are with everyone who is in the path of this powerful and dangerous hurricane and CMS is doing everything within its authority to provide assistance and relief to all who are affected," said CMS Administrator Seema Verma. "We will partner and coordinate with state, federal, and local officials to make sure that in the midst of all of the uncertainty a natural disaster can bring, our beneficiaries will not have to worry about access to healthcare and other crucial life-saving and sustaining services they may need."

Below are key administrative actions CMS will be taking in response to the PHEs declared in Louisiana and Texas:

Waivers and Flexibilities for Hospitals and Other Healthcare Facilities: CMS has already waived many Medicare, Medicaid, and CHIP requirements for facilities. The CMS Dallas Survey & Enforcement Division, under the Survey Operations Group, will grant other provider-specific requests for specific types of hospitals and other facilities in Louisiana and Texas. These waivers, once issued, will help provide continued access to care for beneficiaries. For more information on the waivers CMS has granted, visit http://www.cms.gov/emergency.

Special Enrollment Opportunities for Hurricane Victims: CMS will make available special enrollment periods for certain Medicare beneficiaries and certain individuals seeking health plans offered through the Federal Health Insurance Exchange. This gives people impacted by the hurricane the opportunity to change their Medicare health and prescription drug plans and gain access to health coverage on the Exchange if eligible for the special enrollment period. For more information, please visit:

• https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/8-9-natural-disaster-SEP.pdf • https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Past-Emergencies/Hurricanes-and-tropical-

storms.html

Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. For more information and to access the toolkit, visit: https://www.medicaid.gov/resources-for-states/disaster-response-toolkit/index.html.

Dialysis Care: CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated and is working with the End Stage Renal Disease (ESRD) Network, Network 13 - Louisiana, and Network 14 - Texas, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients and more.

The KCER is also assisting patients who evacuated ahead of the storm to receive dialysis services in the location to which they evacuated. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility, the ESRD Network hotline number, and contact information of those with whom they may stay or for out-of-state contacts in a waterproof bag. They have also been instructed to have supplies on hand to follow a three-day emergency diet. The ESRD Network 8 - Mississippi hotline is 1-800-638-8299, Network 13 - Louisiana hotline is 800-472-7139, the ESRD Network 14 - Texas hotline is 877-886-4435, and the KCER hotline is 866-901-3773. Additional information is available on the KCER website https://www.kcercoalition.com/.

During the 2017 and 2018 hurricane seasons, CMS approved special purpose renal dialysis facilities in several states to furnish dialysis on a short-term basis at designated locations to serve ESRD patients under emergency circumstances in which there were limited dialysis resources or access-to-care problems due to the emergency circumstances.

Medical equipment and supplies replacements: Under the COVD-19 waivers, CMS suspended certain requirements necessary for Medicare beneficiaries who have lost or realized damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the PHE. This will help to make sure that beneficiaries can continue to access the needed medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.

Ensuring Access to Care in Medicare Advantage and Part D: During a public health emergency, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 67

Emergency Preparedness Requirements: Providers and suppliers are expected to have emergency preparedness programs based on an all-hazards approach. To assist in the understanding of the emergency preparedness requirements, CMS Central Office and the Regional Offices hosted two webinars in 2018 regarding Emergency Preparedness requirements and provider expectations. One was an all provider training on June 19, 2018 with more than 3,000 provider participants and the other an all-surveyor training on August 8, 2018. Both presentations covered the emergency preparedness final rule which included emergency power supply; 1135 waiver process; best practices and lessons learned from past disasters; and helpful resources and more. Both webinars are available at https://qsep.cms.gov/welcome.aspx.

CMS also compiled a list of Frequently Asked Questions (FAQs) and useful national emergency preparedness resources to assist state Survey Agencies (SAs), their state, tribal, regional, local emergency management partners and health care providers to develop effective and robust emergency plans and tool kits to assure compliance with the emergency preparedness rules. The tools can be located at:

• https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Emergency-Prep-Rule.html

• https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Templates-Checklists.html

CMS Regional Offices have provided specific emergency preparedness information to Medicare providers and suppliers through meetings, dialogue, and presentations. The regional offices also provide regular technical assistance in emergency preparedness to state agencies and staff, who, since November 2017, have been regularly surveying providers and suppliers for compliance with emergency preparedness regulations.

Additional information on the emergency preparedness requirements can be found here: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_z_emergprep.pdf

CMS will continue to work with all geographic areas impacted by Hurricane Laura. We encourage beneficiaries and providers of healthcare services that have been impacted to seek help by visiting CMS' emergency webpage (http://www.cms.gov/emergency).

For more information about the HHS PHE, please visit: https://www.hhs.gov/about/news/2020/08/26/hhs-secretary-azar-declares-public-health-emergencies-in-louisiana-and-texas-due-to-hurricane-laura.html.

MLN Connects Special Edition - Wednesday, September 2, 2020 - CMS Advancing Seniors’ Access to Cutting-edge Therapies and Technology in Medicare Hospital Rule Finalized policy changes expand new technology add-on payment pathway for certain antimicrobials

On September 2, CMS issued the FY 2021 Medicare Hospital Inpatient Prospective Payment System and Long Term Acute Care Hospital (LTCH) final rule, which includes important provisions designed to ensure access to potentially life-saving diagnostics and therapies for hospitalized Medicare beneficiaries. The changes will affect approximately 3,200 acute care hospitals and approximately 360 LTCHs. CMS estimates that total Medicare spending on acute care inpatient hospital services will increase by about $3.5 billion in FY 2021, or 2.7 percent.

“President Trump is committed to ensuring that seniors on Medicare have access to the latest life-saving diagnostics and therapies,” said CMS Administrator Seema Verma. “This rule is another critical step in our effort to modernize the program and strip away bureaucratic barriers between our seniors and the latest innovative treatments.”

CMS’ rule creates a new Medicare Severity Diagnostic Related Group (MS-DRG) that provides a predictable payment to help adequately compensate hospitals for administering Chimeric Antigen Receptor (CAR) T-cell therapies. The current FDA-approved CAR-T-cell cancer therapies use a patient’s genetically modified immune cells to treat specific types of cancer.

Also in the final rule, CMS approved a record number of 24 New Technology Add-on Payments (NTAPs), which is an additional payment to hospitals for cases involving eligible new and relatively high cost technologies. Last year, to remove barriers to innovation, CMS established alternative streamlined pathways for FDA Breakthrough Devices and FDA Qualified Infectious Disease Products (QIDPs) to qualify for NTAPs. Among CMS’ approval of these 24 additional NTAPs are two technologies for new medical devices that are part of the FDA’s Breakthrough Devices Program and six technologies that received FDA QIDP

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 68

designation. This will provide additional Medicare payment for these technologies while real-world evidence is emerging, giving Medicare beneficiaries timely access to the latest innovations.

CMS is also expanding the add-on payment alternative pathway for antimicrobial products approved under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway), which encourages the development of safe and effective drug products that address unmet needs of patients with serious bacterial and fungal infections. Specifically, an antibacterial or antifungal drug approved under the LPAD pathway is used to treat a serious or life-threatening infection in a limited population of patients with unmet needs.

CMS is also taking steps to ensure that the Medicare Fee-for-Service (FFS) program adopts pricing strategies based on real world market forces. Medicare generally pays hospitals a rate that is weighted by the relative cost of providing certain services based on a patient's diagnosis. These weights are currently based in large part on the charges that hospitals report to the federal government, which often have little relevancy to the actual rates paid by insurance companies. Hospitals are already required to report these negotiated rates as part of the Trump Administration’s efforts to promote price transparency, and CMS is now finalizing a requirement for hospitals to report to CMS the median rate negotiated with Medicare Advantage Organizations for inpatient services to use instead of the charge based data. CMS will begin to collect this data in 2021 and will use it in the methodology for calculating inpatient hospital payments beginning in 2024. These provisions will introduce the influences of market competition into hospital payment and help advance CMS's goal of utilizing market- based pricing strategies in the Medicare FFS program.

For More Information:

• Final Rule • Fact Sheet

MLN Connects - September 3, 2020 CMS Acts to Spur Innovation for America’s Seniors

MLN Connects® for Thursday, September 3, 2020 View this edition as a PDF

NEWS

• CMS Acts to Spur Innovation for America’s Seniors • Hospital Opioid Toolkit • CMS Offers Comprehensive Support for California due to Wildfires • PEPPERs for Short-term Acute Care Hospitals • Office Visits by Nurse Practitioners: Comparative Billing Report

EVENTS

• Dementia Care Call - September 22

MLN MATTERS® ARTICLES

• 2021 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments • Annual Clotting Factor Furnishing Fee Update 2021 • Claim Status Category and Claim Status Codes Update • 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

• Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2021 • The Intravenous Immune Globulin (IVIG) Demonstration: Demonstration is ending on December 31, 2020 • October 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.3

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 69

• October Quarterly Update for 2020 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

• Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment - Revised

• Update to the International Classification of Diseases, Tenth Revision (ICD-10) Diagnosis Codes for Vaping Related Disorder and Diagnosis and Procedure Codes for the 2019 Novel Coronavirus (COVID-19) - Revised

PUBLICATIONS

• Medicare Preventive Services - Revised • Medicare Preventive Services Poster - Revised

MLN Connects - September 10, 2020 CMS Care Compare Empowers Patients

MLN Connects® for Thursday, September 10, 2020 View this edition as a PDF

NEWS

• CMS Care Compare Empowers Patients When Making Important Health Care Decisions • Open Payments: Adding 5 Provider Types in 2021 • Breast Re-Excision: Comparative Billing Report in September

EVENTS

• CMS-CDC Fundamentals of COVID-19 Prevention for Nursing Home Management Call - September 10 • Dementia Care Call - September 22

MLN MATTERS® ARTICLES

• October 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS) • Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY 2021 • Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2021 • Internet Only Manual Update to Pub. 100-04, Chapter 16, Section 60.1.2 and Pub. 100-04, Chapter 26, Section 10.4,

Item 19 • Update to the Model Admission Questions for Providers to Ask Medicare Beneficiaries • National Coverage Determination (NCD 30.3.3): Acupuncture for Chronic Low Back Pain (cLBP) - Revised

PUBLICATIONS

• Understanding Your Remittance Advice Reports • Home Health, Hospice, IRF, LTCH, & SNF Quality Reporting Programs: COVID-19 Public Reporting

MULTIMEDIA

• Pain Management Listening Session: Audio Recording & Transcript • Introduction to the LTCH Quality Reporting Program Web-Based Training • Introduction to the Home Health Quality Reporting Program Web-Based Training

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 70

MLN Connects Special Edition - September 11, 2020 - Community Health Access and Rural Transformation Model

COMMUNITY HEALTH ACCESS AND RURAL TRANSFORMATION MODEL

The CMS Innovation Center announced the Community Health Access and Rural Transformation (CHART) Model.

The approximately 57 million Americans living in rural communities, including millions of Medicare and Medicaid beneficiaries, face unique challenges when seeking health care services, such as limited transportation options, shortages of health care services, and an inability to fully benefit from technological and care-delivery innovations.

Current regulations and volume-based payment structures perpetuate these challenges, with unsustainable financial models leading to over 130 rural hospitals closing since 2010. The constellation of reduced access to care and patients not seeking or delaying care leads to rural Americans facing worse health outcomes and having higher rates of preventable diseases than those living in urban areas.

CMS remains focused on the transformation of rural health care delivery and enabling local community collaboration to redesign their systems of care and align across providers and payers based on their unique needs. As part of that rural transformation, including transforming a system built on fee-for-service and volume to one based on value, CMS is testing the CHART Model.

Through the Model, CMS is directly providing a pool of $75M in upfront, seed funding, with 15 rural communities applying for up to $5M to develop local transformation plans. With this upfront seed funding, CMS is also providing regulatory and operational flexibility for updated service delivery models as well as changing how participating hospitals in these communities are paid, from a system based on volume to stable, monthly payments. In additional to supporting these 15 rural communities, CMS is also looking for 20 rural Accountable Care Organizations (ACOs) to participate in the model, paying shared savings upfront so that ACOs have infrastructure funding to be successful on the move towards achieving better outcomes. Taken together, these are substantial and tangible actions to support health care in our rural communities.

Specifically, the CHART Model will:

• Increase financial stability for rural health care providers through multiple new funding approaches, including the use of up-front investments and predictable, capitated payments that pay for quality and patient outcomes over volume

• Provide the necessary operational and regulatory flexibilities to allow health care providers and CMS to test the Model in their local communities and successfully transform themselves

• Support local rural communities’ transformation efforts by being directly engaged at CMS, offering real-time technical expertise and other learning when needed to foster success

If successful, beneficiaries’ access to health care services should be improved, rural provider’s financial sustainability should increase for years to come, and communities can align with payers and other stakeholders to address both their health care service delivery ecosystem and the necessary social support structures, such as food and housing, to deliver improved health. Ultimately, the CHART Model aims to improve quality and health, while reducing Medicare and Medicaid expenditures, in rural communities over the long-term.

CMS is providing funding, regulatory and operational flexibilities, and technical assistance for rural communities to transform their systems of care through a Community Transformation Track. Further, CMS is enabling providers to participate in value-based payment models where they are paid for quality and outcomes, instead of volume, through an ACO Transformation Track.

CMS anticipates the Notice of Funding Opportunity for the Community Transformation Track will be available in September on the Model website. The Request for Application for the ACO Transformation Track will be available in early 2021 on the CHART Model website.

See the full text of this excerpted CMS Fact Sheet (issued August 11).

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 71

MLN Connects - September 17, 2020 Participate in Medical Documentation Interoperability Pilot

MLN Connects® for Thursday, September 17, 2020 View this edition as a PDF

NEWS

• SNF Healthcare-Associated Infections Measure: Submit Comments by October 14 • Participate in Medical Documentation Interoperability Pilot • COVID-19 Lessons Learned & Infectious Disease Surge Annex Template • Healthy Aging® Month: Discuss Preventive Services with Your Patients • Prostate Cancer Awareness Month

EVENTS

• Dementia Care Call - September 22

MLN MATTERS® ARTICLES

• October 2020 Update of the Ambulatory Surgical Center (ASC) Payment System • New Waivers for Inpatient Prospective Payment System (IPPS) Hospitals, Long-Term Care Hospitals (LTCHs), and

Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Act - Revised • Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index, and Hospice Pricer for FY 2021 - Revised

MLN Connects Special Edition - September 17, 2020 - Nursing Home COVID-19 Commission Findings, Oregon Wildfires, & Flu

INDEPENDENT NURSING HOME COVID-19 COMMISSION FINDINGS VALIDATE UNPRECEDENTED FEDERAL RESPONSE

On September 16, CMS received the final report from the independent Coronavirus Commission for Safety and Quality in Nursing Homes (Commission), which was facilitated by MITRE. CMS also released an overview of the robust public health actions the agency has taken to date to combat the spread of the Coronavirus Disease 2019 (COVID-19) in nursing homes. The Commission’s findings align with the actions the Trump Administration and CMS have taken to contain the spread of the virus and to safeguard nursing home residents from the ongoing threat of the COVID-19 pandemic. This announcement delivers on the Administration’s commitments to keeping nursing home residents safe and to transparency for the American people in the face of this unprecedented pandemic.

“The Trump Administration’s effort to protect the uniquely vulnerable residents of nursing homes from COVID-19 is nothing short of unprecedented,” said CMS Administrator Seema Verma. “In tasking a contractor to convene this independent Commission comprised of a broad range of experts and stakeholders, President Trump sought to refine our approach still further as we continue to battle the virus in the months to come. Its findings represent both an invaluable action plan for the future and a resounding vindication of our overall approach to date. We are grateful for the Commission’s important contribution.”

As the capstone to the Commission’s extensive report, on September 17, Administrator Verma will join Vice President Mike Pence and CDC Director Dr. Robert R. Redfield, some members of the Commission, and other public health and elder care experts at the White House. The Vice President, Dr. Redfield, and Administrator Verma will lead the group in a discussion regarding the Commission’s findings and general issues facing the nation’s elder care system.

Nursing homes and other shared or congregate living facilities have been severely affected by COVID-19, as these facilities often house older individuals who suffer from multiple medical conditions, making them particularly susceptible to complications from the virus. To help CMS inform immediate and future actions as well as identify opportunities for improvement, the Commission was created to conduct an independent review and comprehensive assessments of

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 72

confronting COVID-19. The Commission’s report contains best practices that emphasize and reinforce CMS strategies and initiatives to ensure nursing home residents are protected from COVID-19.

As outlined in the overview released on September 16, the Trump Administration has already taken significant steps to implement many of the Commission’s findings. The Administration has worked to support nursing homes financially during this challenging time, distributing over $21 billion to America’s nursing homes - more than $1.5 million each on average. To ensure nursing homes had access to supplies, the Trump Administration shipped a 14-day supply of personal protective equipment to more than 15,000 nursing homes across the Nation in May.

The Administration has also required facilities to report data about COVID-19 cases, deaths, and supply levels, with 99.3 percent of facilities currently reporting. CMS took action to keep COVID-19 out of nursing homes by requiring them to test staff, a requirement that was paired with the Administration’s distribution of 13,850 point-of-care testing devices to America’s nursing homes. The Administration has also deployed federal Task Force Strike Teams in six waves, in 18 states so far, to 61 facilities particularly affected by COVID-19 to share best practices and gain a deeper understanding of how the virus spreads. CMS also required states to conduct focused infection control inspections at their nursing homes; between June and July, states completed these inspections at 99.8 percent of Medicare and Medicaid certified nursing homes.

Additionally, since March, CMS has conducted weekly calls with nursing homes, issued over 22 guidance documents and established a National Nursing Home COVID-19 Training program focused on infection control and best practices. CMS is also using COVID-19 data to target support to the highest risk nursing homes. In May, CMS released a new toolkit developed to aid nursing homes, Governors, states, departments of health, and other agencies who provide oversight and assistance to nursing homes. The toolkit is a catalogue of resources dedicated to addressing the specific challenges facing nursing homes as they combat COVID-19. CMS updates the toolkit on a biweekly basis.

For More Information:

• Coronavirus Commission for Safety and Quality in Nursing Homes Report • Trump Administration Response to Commission findings • COVID-19 Guidance and Updates for Nursing Homes during COVID-19

See the full text of this excerpted CMS Press Release (issued September 16), including a list of CMS public health actions for nursing homes on COVID-19 to date.

CMS OFFERS COMPREHENSIVE SUPPORT FOR OREGON DUE TO WILDFIRES

On September 17, CMS announced efforts underway to support Oregon in response to wildfires across the state. On September 16, HHS Secretary Alex Azar declared a Public Health Emergency (PHE) in Oregon, retroactive to September 8. CMS is working to ensure hospitals and other facilities can continue operations and provide access to care despite the effects of the wildfires. CMS provided numerous waivers to health care providers during the current Coronavirus Disease 2019 (COVID-19) pandemic to meet the needs of beneficiaries and providers. These waivers will continue be available to health care providers to use for the duration of the COVID-19 PHE and for the wildfires PHEs. CMS will be waiving certain Medicare, Medicaid, and Children’s Health Insurance Program requirements; creating special enrollment opportunities for individuals to access health care quickly; and taking steps to ensure dialysis patients obtain critical life-saving services.

For More Information, visit https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/EPRO-Home. See the full text of this excerpted CMS Press Release (issued September 17).

PROTECT YOURSELF & YOUR PATIENTS FROM FLU THIS SEASON

Do your part to prevent the spread of seasonal flu. The CDC published flu vaccine recommendations for the 2020-2021 season. Because of the COVID-19 pandemic, reducing the spread of respiratory illness, like flu, this fall and winter is more important than ever.

Frequency and Coverage:

• Medicare Part B covers one flu shot per flu season and additional flu shots if medically necessary • Flu shots are free for your Medicare patients if you accept assignment

You can give pneumonia and flu shots during the same office visit; see CDC recommendations.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 73

The CDC, the Advisory Committee on Immunization Practices, and the Healthcare Infection Control Practices Advisory Committee recommend that all U.S. health care workers get annual flu shots.

For More Information:

• CMS Flu Shot webpage • CDC Flu website • CDC Information for Health Professionals webpage • CDC Fight Flu Toolkit webpage • Vaccines.gov

MLN Connects Special Edition - September 18, 2020 - New COVID-19 Nursing Home Visitation Guidance, Kidney Disease Care Model, & Radiation Oncology Payment Model

CMS ANNOUNCES NEW GUIDANCE FOR SAFE VISITATION IN NURSING HOMES DURING COVID-19 PUBLIC HEALTH EMERGENCY

On September 17, CMS issued revised guidance providing detailed recommendations on ways nursing homes can safely facilitate visitation during the coronavirus disease 2019 (COVID-19) pandemic. After several months of visitor restrictions designed to slow the spread of COVID-19, CMS recognizes that physical separation from family and other loved ones has taken a significant toll on nursing home residents. In light of this, and in combination with increasingly available data to guide policy development, CMS is issuing revised guidance to help nursing homes facilitate visitation in both indoor and outdoor settings and in compassionate care situations. The guidance also outlines certain core principles and best practices to reduce the risk of COVID-19 transmission to adhere to during visitations.

See the full text of this excerpted CMS Press Release (issued September 17).

CMS ANNOUNCES TRANSFORMATIVE NEW MODEL OF CARE FOR MEDICARE BENEFICIARIES WITH CHRONIC KIDNEY DISEASE

Model focuses on reducing costs and improving quality of care for patients

On September 18, CMS announced it has finalized the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model, to improve or maintain the quality of care and reduce Medicare expenditures for patients with chronic kidney disease. The ETC Model delivers on President Trump’s Advancing Kidney Health Executive Order and encourages an increased use of home dialysis and kidney transplants to help improve the quality of life of Medicare beneficiaries with ESRD. The ETC Model will impact approximately 30 percent of kidney care providers and will be implemented on January 1, 2021 at an estimated savings of $23 million over five and a half years.

“Over the past year, the Trump Administration has taken more action to advance American kidney health than we’ve seen in decades,” said HHS Secretary Alex Azar. “This new payment model helps address a broken set of incentives that have prevented far too many Americans from benefiting from enjoying the better lives that could come with more convenient dialysis options or the possibility of a transplant.”

For More Information:

• Full Press Release • Fact Sheet

CMS ANNOUNCES INNOVATIVE PAYMENT MODEL TO IMPROVE CARE, LOWER COSTS FOR CANCER PATIENTS

Radiation Oncology Model will modernize Medicare payments for radiotherapy services

On September 18, CMS finalized a new Innovation Center model expected to improve the quality of care for cancer patients receiving radiotherapy and reduce Medicare expenditures through bundled payments that allow providers to focus on delivering high-quality treatments. The new Radiation Oncology (RO) Model allows this focus on value-based care by creating

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 74

simpler, more predictable payments that incentivize cost-efficient and clinically effective treatments to improve quality and outcomes. The RO Model, part of a final rule on specialty care models issued by CMS, will begin on January 1, 2021 and is estimated to save Medicare $230 million over 5 years.

“President Trump knows that, for cancer patients, what matters is their quality of life and beating their cancer. But today, Medicare payment for radiotherapy is based on the number of treatments a patient receives and where they receive it, which can lead to spending more time traveling for treatment with little clinical value,” said CMS Administrator Seema Verma. “That’s why the Trump administration has developed a new innovative model that allows patients and providers to focus on better outcomes for patients.”

For More information:

• Full Press Release • Fact Sheet • Radiation Oncology Model webpage

These Models are a part of a CMS final rule on Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures (CMS-5527-F).

MLN Connects - September 24, 2020 Need Help Checking Medicare Eligibility?

MLN Connects® for Thursday, September 24, 2020 View this edition as a PDF

NEWS

• CMS to Expand Successful Ambulance Program Integrity Payment Model Nationwide • Medicare Diabetes Prevention Program: Become a Medicare Enrolled Supplier • COVID-19: Maintaining Safety, Critical Care Load-Balancing, & Behavioral Health • National Cholesterol Education Month & World Heart Day

CLAIMS, PRICERS & CODES

• Medicare Diabetes Prevention Program: Valid Claims

EVENTS

• CMS-CDC Fundamentals of COVID-19 Prevention for Nursing Home Management Call - September 24

MLN MATTERS® ARTICLES

• 2021 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Update

• National Coverage Determination (NCD 90.2): Next Generation Sequencing (NGS) for Medicare Beneficiaries with Germline (Inherited) Cancer

• Update to the Medicare Claims Processing Manual • Update to the Model Admission Questions for Providers to Ask Medicare Beneficiaries - Revised

PUBLICATIONS

• Checking Medicare Eligibility

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 75

Pneumococcal Vaccine Codes Available in Noridian Medicare Portal The Noridian Medicare Portal (NMP) provides the previous service history for Pneumococcal Vaccine (PPV) HCPCS codes 90670 and 90732 in the “Preventive” section of the Eligibility inquiry response. The service history will display up to 10 previous dates of service and provide the rendering NPI.

If no PPV information is available, the HCPCS codes will not be viewable in the “Preventive” section of the Eligibility inquiry response.

Prior Authorization Request Submission and Status Now Available in the Noridian Medicare Portal for Part A Users The Noridian Medicare Portal (NMP) now allows Part A users to submit Prior Authorization Requests (PAR) and view the decision letter following review. At this time, PAR submissions are only required for certain Hospital Outpatient Department (OPD) services.

Part A users will need to request access to the Prior Authorization function in NMP by going to Manage Account and then the Provider/Supplier Combinations tab of your NMP account.

Currently, PAR submissions are submitted by completing and uploading the PAR coversheet. An electronic form within the portal will become available within the coming months.

To begin submitting PARs, view the Prior Authorization Request Status and Submit New Prior Authorization section of the NMP Inquiry Guide below or view the Prior Authorizations for Part A Users tutorial on the Noridian YouTube Channel.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 76

October 2020 Update of the Hospital OPPS - Revised MLN Matters Number: MM11960 Revised Related CR Release Date: September 24, 2020 Related CR Transmittal Number: R10373CP Related Change Request (CR) Number: 11960 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 Note: CMS revised this article to reflect an updated CR 11960 that made a number of changes including:

1. Added a new COVID-19 CPT code, 86413, to Table 1 2. Added new Section 2: "New Category I CPT code 99072 for Reporting of Additional Practice Expenses Incurred During

a Public Health Emergency (PHE), Including Supplies and Additional Clinical Staff Time.” 3. Added new Table 2, with the new 99072 CPT code. 4. Re-numbered all sections after Section 2 and all the tables following Table 2. 5. Added a new Sub-section e. to Section 8: "Drugs, Biologicals, and Radiopharmaceuticals.” 6. Added New Table 12 to describe these changes. All sub-sections following new Sub-section e. were re-numbered. 7. Updated Sub-section g. and Table 14 to reflect the change to the long descriptor for HCPCS, C9066. 8. Updated Tables 8 and 13 to reflect the correct long descriptor for C9066.

The CR release date, transmittal number and link to the transmittal was also changed. All other information remains the same.

CR 11960 informs you about the changes to and billing instructions for various payment policies implemented in the October 2020 Outpatient Prospective Payment System (OPPS) update. The October 2020 Integrated Outpatient Code Editor (I/OCE) will reflect the HCPCS, Ambulatory Payment Classification (APC), HCPCS Modifier, and Revenue Code additions, changes, and deletions identified in CR 11960. The October 2020 revisions to I/OCE data files, instructions, and specifications are provided in the forthcoming October 2020 I/OCE CR. Make sure that your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11960.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 77

Medicare Part A SNF PPS Pricer Update FY 2021 - Revised MLN Matters Number: MM11859 Revised Related CR Release Date: August 19, 2020 Related CR Transmittal Number: R10314CP Related Change Request (CR) Number: 11859 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 Note: CMS revised this article to reflect a revised CR 11859, issued on August 19, 2020. The CR revision shows that effective for Fiscal Year (FY) 2021, a 5 percent cap will be adopted and applied to all Skilled Nursing Facility providers on any decrease to a provider’s FY 2021 final wage index from that provider’s final wage index of the prior fiscal year (FY 2020). CMS added that language to the article. Also, CMS revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same

CR 11859 provides information on the Fiscal Year (FY) 2021 updates to the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) payment rates, as required by statute. Make sure your billing staffs are aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11859.

SNF Patient Driven Payment Model Interrupted Stay Issue A new issue is affecting some inpatient hospital and Skilled Nursing Facility (SNF) claims when an interrupted stay is billed at the end of the month. The system incorrectly assigns edits U5601-U5608 (overlapping a hospital claim). If you billed the interrupted stay correctly, and your claim is rejected, modify your billing so the claim spans past the last day of the interrupted stay:

• Bill two months at a time, or • Bill a month plus the days in the following month that span the interrupted stay plus 1 day

Adjusting the statement covered from and through dates to encompass the entire interrupted stay will allow your claim to process and pay correctly. Medicare Administrative Contractors will finalize any suspended claims that meet the criteria, so you can make corrections and resubmit your claim.

If we rejected an inpatient hospital claim, the hospital should ask the SNF to modify their claim. Until October 5, a SNF cannot submit an adjustment to a paid claim; they must cancel the paid claim and all subsequent claims in the same stay and resubmit them in sequential order.

CMS will correct the system in the future.

Source: MLN Connects® for Thursday, July 23, 2020

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 78

Telehealth Expansion Benefit Enhancement Under the PARHM - Implementation MLN Matters Number: MM11870 Related CR Release Date: August 7, 2020 Related CR Transmittal Number: R10282DEMO Related Change Request (CR) Number: 11870 Effective Date: January 1, 2021 Implementation Date: January 4, 2021 This article informs you about information related to the Pennsylvania Rural Health Model (PARHM) and the “Transformation Plans” for participating hospitals. CR 11870 expands the allowable telehealth services for Model-participant hospitals. Without this CR, some hospitals may fail to meet healthcare transformation goals set by the Model. Make sure your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11870.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 79

2021 Annual Update for the HPSA Bonus Payments MLN Matters Number: MM11852 Related CR Release Date: August 28, 2020 Related CR Transmittal Number: R10323CP Related Change Request (CR) Number: 11852 Effective Date: January 1, 2021 Implementation Date: January 4, 2021 CR 11852 informs you that the Centers for Medicare & Medicaid Services (CMS) will provide MACs with files for the automated payments of Health Professional Shortage Area (HPSA) bonuses for dates of service January 1, 2021, through December 31, 2021. Make sure that your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11852.

Annual Clotting Factor Furnishing Fee Update 2021 MLN Matters Number: MM11932 Related CR Release Date: August 28, 2020 Related CR Transmittal Number: R10329CP Related Change Request (CR) Number: 11932 Effective Date: January 1, 2021 Implementation Date: January 4, 2021 CR 11932 informs you that the clotting factor furnishing fee for 2021 is $0.238 per unit. Make sure your billing staffs are aware of the update to the annual clotting factor furnishing fee for 2021, which pertains to Chapter 17, Section 80.4.1 of the Medicare Claims Processing Manual.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11932.

FY 2021 IPPS and LTCH PPS Changes MLN Matters Number: MM11879 Related CR Release Date: September 18, 2020 Related CR Transmittal Number: R10360CP Related Change Request (CR) Number:11879 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 CR 11879 provides the Fiscal Year (FY) 2021 update to the Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS). Please make sure your billing staffs are aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11879.

HCPCS Codes for SNF CB - 2021 Annual Update MLN Matters Number: MM11968 Related CR Release Date: September 11, 2020 Related CR Transmittal Number: R10349CP Related Change Request (CR) Number: 11968

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 80

Effective Date: January 1, 2021 Implementation Date: January 4, 2021 CR 11968 makes changes to Healthcare Common Procedure Coding System (HCPCS) codes and Medicare Physician Fee Schedule (MPFS) designations that Medicare uses to revise its Common Working File (CWF) edits to allow MACs to make appropriate payments in accordance with policy for Skilled Nursing Facility (SNF) Consolidated Billing (CB) in Chapter 6, Section 110.4.1 and Chapter 6, Section 20.6 in the Medicare Claims Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c06.pdf). Make sure your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11968.

Influenza Vaccine Payment Allowances - Annual Update for 2020-2021 Season - Revised MLN Matters Number: MM11882 Revised Related CR Release Date: July 31, 2020 Related CR Transmittal Number: R10263CP Related Change Request (CR) 11882 Effective Date: August 1, 2020 Implementation Date: No later than October 1, 2020; for mass adjustments, November 1, 2020. Note: CMS revised this article on July 31, 2020, to reflect an updated Change Request (CR) 11882 that extended the implementation date. All other information remains the same.

CR 11882 informs you of the availability of payment allowances for the seasonal influenza virus vaccines as updated on an annual basis, effective August 1 of each year. Please make sure your billing staffs are aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11882.

IRF Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2021 MLN Matters Number: MM11858 Related CR Release Date: August 28, 2020 Related CR Transmittal Number: R10321CP Related Change Request (CR) Number: 11858 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 CR 11858 notifies Inpatient Rehabilitation Facilities (IRFs) that Medicare will release a new IRF PRICER software package prior to October 1, 2020. It will contain updated rates that are effective for IRF claims with discharges that fall within October 1, 2020, through September 30, 2021. Make sure your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11858.

July 2020 Update of the Hospital OPPS - Revised MLN Matters Number: MM11814 Revised Related CR Release Date: July 15, 2020 Related CR Transmittal Number: R10224CP Related Change Request (CR) Number: 11814

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 81

Effective Date: July 1, 2020 Implementation Date: July 6, 2020 Note: CMS revised this article on July 16. 2020, to reflect a revised CR 11814. In the article:

• CMS updated the section on "Covid-19 Laboratory Tests and Services and Other Laboratory Tests Coding Update". • Table 1 has also been updated to add 3 new COVID-19 codes: 87426, 0223U, and 0224U. • CMS is also changing payment status indicator for HCPCS code Q5112 from SI=E2 to SI=K, effective April 15, 2020

through September 30, 2020 and are updating section 9 “Drugs, Biologicals, and Radiopharmaceuticals” by adding new subsections j and k to reflect this change.

• Therefore, CMS is re-numbering all other subsequent sub-sections, and Tables 19 and 20 have been added to reflect payment status indicator change for Q5112. All other subsequent tables have been re-numbered.

• CMS also revised the CR release date, transmittal number and the web address of the CR. All other information remains the same.

CR 11814 informs you about the changes to and billing instructions for various payment policies implemented in the July 2020 Outpatient Prospective Payment System (OPPS) update. The July 2020 Integrated Outpatient Code Editor (I/OCE) will reflect the HCPCS, Ambulatory Payment Classification (APC), HCPCS Modifier, and Revenue Code additions, changes and deletions identified in CR 11814. The July 2020 revisions to I/OCE data files, instructions, and specifications are provided in CR 11792. The article related to that CR, MM11792, is available at https://www.cms.gov/files/document/mm11792.pdf.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11814.

October 2020 Quarterly ASP Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files - Revised MLN Matters Number: MM11854 Revised Related CR Release Date: August 14, 2020 Related CR Transmittal Number: R10306CP Related Change Request (CR) Number: 11854 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 Note: CMS revised this article to reflect a revised CR 11854 issued on August 14, 2020. The revised CR did not change the substance of the article. In the article, CMS revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

CR 11854 updates the Quarterly Average Sales Price (ASP) Medicare Part B Pricing Files and informs providers of revisions to prior quarterly pricing files. Please make sure your billing staffs are aware of these updates and revisions.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11854.

October Quarterly Update for 2020 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule MLN Matters Number: MM11956 Related CR Release Date: August 28, 2020 Related CR Transmittal Number: R10334CP Related Change Request (CR) Number: 11956 Effective Date: October 1, 2020 Implementation Date: October 5, 2020

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 82

CR 11956 informs DME MACs about the changes to the DMEPOS fee schedules that Medicare updates quarterly, when necessary, to implement fee schedule amounts for new and existing codes, as applicable, and apply changes in payment policies. Make sure your billing staffs are aware of these changes.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11956.

Quarterly HCPCS Drug/Biological Code Changes - July 2020 Update MLN Matters Number: MM11769 Related CR Release Date: June 23, 2020 Related CR Transmittal Number: R10196CP Related Change Request (CR) Number: 11769 Effective Date: July 1, 2020 Implementation Date: July 6, 2020 CR 11769 updates the Healthcare Common Procedure Coding System (HCPCS) code set for codes related to drugs and biologicals. Please alert your billing staffs of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11769.

Quarterly Update for CLFS and Laboratory Services Subject to Reasonable Charge Payment - Revised MLN Matters Number: MM11815 Revised Related CR Release Date: July 8, 2020 Related CR Transmittal Number: R10217CP Related Change Request (CR) Number: 11815 Effective Date: July 1, 2020 Implementation Date: July 6, 2020 Note: CMS revised this article to reflect a revision to CR 11815. The CR revision added information on COVID-19 codes 87426, 0223U and 0224U and CMS added the same information to this article. CMS also revised the CR release date, transmittal number and the web address of the CR. All other information remains the same.

CR 11815 informs laboratories of changes in the quarterly update to the clinical laboratory fee schedule (CLFS). Please be sure your billing staff is aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11815.

Quarterly Update for CLFS and Laboratory Services Subject to Reasonable Charge Payment - Revised MLN Matters Number: MM11937 Revised Related CR Release Date: September 24, 2020 Related CR Transmittal Number: R10367CP Related Change Request (CR) Number: 11937 Effective Date: October 1, 2020 Implementation Date: October 5, 2020 Note: CMS revised the article to add a new COVID 19 code (86413) and ADLT code (0090U). Also, CMS revised the CR release date, transmittal number, and web address of the CR. All other information remains the same.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 83

This article informs laboratories of changes resulting from the quarterly update to the clinical laboratory fee schedule (CLFS). Please be sure your billing staff is aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11937.

Quarterly Update to the End-Stage Renal Disease PPS MLN Matters Number: MM11835 Related CR Release Date: June 26, 2020 Related CR Transmittal Number: R10198CP Related Change Request (CR) Number: 11835 Effective Date: October 1,2020 Implementation Date: October 5,2020 CR 11835 informs providers about new diagnosis codes eligible for the ESRD Prospective Payment System (PPS) comorbidity payment adjustment effective October 1, 2020. Make your billing staff aware of these additions.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11835.

Quarterly Update to the MPFSDB - October 2020 Update MLN Matters Number: MM11939 Related CR Release Date: August 7, 2020 Related CR Transmittal Number: R10288CP Related Change Request (CR) Number: 11939 Effective Date: January 1, 2020 Implementation Date: October 5, 2020 CR 11939 informs you about the issuance of updated payment files in the October update of the 2020 Medicare Physician Fee Schedule Database (MPFSDB). Make sure your billing staffs are aware of these updates.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11939.

Updates to Nursing and Allied Health Education Medicare Advantage Payment Policies Release Date: August 21, 2020 CR Transmittal Number: R10315OTN Change Request (CR) Number: 11642 Effective Date: September 21. 2020 Implementation Date: November 23, 2020 Section 541 of the Balanced Budget Refinement Act (BBRA) of 1999 (P. L. 106-113), and section 512 of the Benefits Improvement and Protection Act (BIPA), (P.L. 106-554), instituted Medicare+Choice nursing and allied health payments for portions of cost reporting periods occurring on or after January 1, 2000. CMS last provided instructions to the Medicare Administrative Contractors (MACs) on May 23, 2003, in the form of Transmittal A-03-043, CR 2692, for the purpose of making the Calendar Year (CY) 2001 nursing and allied health Medicare+Choice payments. This CR provides MACs with instructions on how to compute and/or reconcile these payments for CYs 2002 through 2018, as applicable.

View the complete CMS Change Request (CR)11642.

Medicare A News | Noridian Medicare A Jurisdiction E | October 2020 84

Update to the Medicare Claims Processing Manual MLN Matters Number: MM11958 Related CR Release Date: September 18, 2020 Related CR Transmittal Number: R10356CP Related Change Request (CR) Number: 11958 Effective Date: October 19, 2020 Implementation Date: October 19, 2020 CR 11958 updates the Medicare Claims Processing Manual, Chapters 12 and 23. The list of non-facility Place of Service (POS) codes in the Medicare Claims Processing Manual, Chapter 12, Section 20.4.2, is updated to reflect previous updates to the POS list in Chapter 26, Section 10.5. Therefore, the Non-Residential Opioid Treatment Facility (POS code 58) setting is now included in Chapter 12, Section 20.4.2. Also, the Medicare Physician Fee Schedule Database (MPFSDB) file layout in the Chapter 23 Addendum is updated to show the procedure code series that are not included on the MPFSBD file.

There are no policy changes, and no changes to the function of the MPFSBD file.

View the complete CMS Medicare Learning Network (MLN) Matters (MM)11958.