NOTE: Should you have landed here as a result of a search engine (or other) link, be advised that these files contain material that is copyrighted by

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1 NOTE: Should you have landed here as a result of a search engine (or other) link, be advised that these files contain material that is copyrighted by the American Medical Association. You are forbidden to download the files unless you read, agree to, and abide by the provisions of the copyright statement. Read the copyright statement now and you will be linked back to here.

2 JM PART B MEDICARE ADVISORY Latest Medicare News for JM Part B June 2018 Volume 2018, Issue 6 What s Inside... Administration Get Your Medicare News Electronically...3 CMS Quarterly Provider Update...5 Going Beyond Diagnosis...5 Medicare Beneficiary Identifier (MBI) Look-up Tool...7 New Physician Specialty Code for Medical Genetics and Genomics...9 Comprehensive ESRD Care (CEC) Model Telehealth - Implementation...10 Updates to Publication , Chapters 1 and 27, to Replace Remittance Advice Remark Code (RARC) MA61 with N Drugs and Biologicals Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes July 2018 Update...16 Education Educational Events Where You Can Ask Questions and Get Answers from Palmetto GBA...18 Save the Date for MACtoberfest : October 23-24, Electronic Data Interchange (EDI) Processing Instructions to Update the Identification Code Qualifier Being Used in the NM108 Data Element at the 2100 Loop, NM1- Patient Name Segment in the 835 Guide...21 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...22 Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update...24 palmettogba.com/jmb The JM Part B Medicare Advisory contains coverage, billing and other information for Part B. This information is not intended to constitute legal advice. It is our official notice to those we serve concerning their responsibilities and obligations as mandated by Medicare regulations and guidelines. This information is readily available at no cost on the Palmetto GBA website. It is the responsibility of each facility to obtain this information and to follow the guidelines. The JM Part B Medicare Advisory includes information provided by the Centers for Medicare & Medicaid Services (CMS) and is current at the time of publication. The information is subject to change at any time. This bulletin should be shared with all health care practitioners and managerial members of the provider staff. Bulletins are available at no-cost from our website at CPT only copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, and are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature is published in Current Dental Terminology (CDT), Copyright 2017 American Dental Association (ADA). All rights reserved.

3 Fee Schedules and Reimbursement Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2018 Update...26 Medicine International Classification of Diseases, Tenth Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) Laboratory Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment Therapy Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)...34 Etcetera Medical Director s Desk Special Edition - Friday, April 27, MLN ConnectsTM CMS Provider Minute Videos The Medicare Learning Network has a series of CMS Provider Minute Videos ( on a variety of topics, such as psychiatry, preventive services, lumbar spinal fusion, and much more. The videos offer tips and guidelines to help you properly submit claims and maintain sufficient supporting documentation. Check the site often as CMS adds new videos periodically to further help you navigate the Medicare program. 2 6/2018

4 Get Your Medicare News Electronically The Palmetto GBA Medicare listserv is a wonderful communication tool that offers its members the opportunity to stay informed about: Medicare incentive programs Fee Schedule changes New legislation concerning Medicare And so much more! How to register to receive the Palmetto GBA Medicare Listserv: Go to and select Register Now. Complete and submit the online form. Be sure to select the specialties that interest you so information can be sent. Note: Once the registration information is entered, you will receive a confirmation/welcome message informing you that you ve been successfully added to our listserv. You must acknowledge this confirmation within 3 days of your registration. eservices Makes Asking a Medicare Question Easier! The eservices Secure echat option allows providers to interact with designated Palmetto GBA staff so they can receive real-time assistance locating information on any topics or specialties they are searching for on the Palmetto GBA website or within the eservices online portal. The Secure echat feature also allows users to dialogue with an online operator who can assist with patient or provider specific inquires or address questions that require the sharing of PHI information! Using Secure echat is simple! This free portal is available to all Medicare providers as long as you have a signed Electronic Data Interchange (EDI) Enrollment Agreement and a processed claim history. Once in the eservices portal, from the bottom right corner select either Medicare Inquiries or eservices Help. If you do not have an eservices account, you can get started by clicking this eservices link Secure echat feature is available during business hours to assist providers. 3 6/2018

5 Medicare Learning Network (MLN) Want to stay informed about the latest changes to the Medicare Program? Get connected with the Medicare Learning Network (MLN) the home for education, information, and resources for health care professionals. The Medicare Learning Network is a registered trademark of the Centers for Medicare & Medicaid Services (CMS) and the brand name for official CMS education and information for health care professionals. It provides educational products on Medicare-related topics, such as provider enrollment, preventive services, claims processing, provider compliance, and Medicare payment policies. MLN products are offered in a variety of formats, including training guides, articles, educational tools, booklets, fact sheets, webbased training courses (many of which offer continuing education credits) all available to you free of charge! The following items may be found on the CMS web page at: MLN Catalog: is a free interactive downloadable document that lists all MLN products by media format. To access the catalog, scroll to the Downloads section and select MLN Catalog. Once you have opened the catalog, you may either click on the title of a product or you can click on the type of Formats Available. This will link you to an online version of the product or the Product Ordering Page. MLN Product Ordering Page: allows you to order hard copy versions of various products. These products are available to you for free. To access the MLN Product Ordering Page, scroll to the Related Links and select MLN Product Ordering Page. MLN Product of the Month: highlights a Medicare provider education product or set of products each month along with some teaching aids, such as crossword puzzles, to help you learn more while having fun! Other resources: MLN Publications List: contains the electronic versions of the downloadable publications. These products are available to you for free. To access the MLN Publications go to: Education/Medicare-Learning-Network-MLN/MLNProducts/MLN-Publications.html. You will then be able to use the Filter On feature to search by topic or key word or you can sort by date, topic, title, or format. MLN Educational Products Electronic Mailing List To stay up-to-date on the latest news about new and revised MLN products and services, subscribe to the MLN Educational Products electronic mailing list! This service is free of charge. Once you subscribe, you will receive an when new and revised MLN products are released. To subscribe to the service: 1. Go to and select the Subscribe or Unsubscribe link under the Options tab on the right side of the page. 2. Follow the instructions to set up an account and start receiving updates immediately it s that easy! If you would like to contact the MLN, please CMS at MLN@cms.hhs.gov. 4 6/2018

6 CMS Quarterly Provider Update The Quarterly Provider Update is a comprehensive resource published by the Centers for Medicare & Medicaid Services (CMS) on the first business day of each quarter. It is a listing of all non-regulatory changes to Medicare including program memoranda, 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 Communicate the specific days that CMS business will be published in the Federal Register To receive notification when regulations and program instructions are added throughout the quarter, sign up for the Quarterly Provider Update listserv (electronic mailing list) at We encourage you to bookmark the Quarterly Provider Update Web site at html and visit it often for this valuable information. Going Beyond Diagnosis Preventing Payment Errors by Improving Provider-Payer Communication A failure to communicate is the number one cause of Medicare claims denials. Palmetto GBA s Going Beyond Diagnosis (GBD) process helps reduce Medicare denials by supporting the dissemination of best practices and process improvements. The GBD Blog was established to provide a platform for discussing the challenges and complexities of communicating health care encounters and to provide potential solutions to identify the root causes for specific communication errors. The GBD Blog and Twitter are part of Palmetto GBA s innovative strategy for increasing the capacity of Medicare providers to improve the quality of healthcare records and effectively decrease the claims payment error rate. The success of this social media approach to communicating with healthcare stakeholders depends on your active participation. True innovation requires collaboration. Please join the on-line GBD community by visiting the GBD Blog at or signing-up to follow us on 5 6/2018

7 We d Love Your Feedback! Palmetto GBA is committed to continuously improve your customer experience. We welcome your feedback on your experiences with the PalmettoGBA.com website and the eservices portal. As a visitor to the Palmetto GBA's website, you may be presented with an opportunity to take the website satisfaction survey. The next time the survey is offered to you, please agree to participate and provide us with your feedback. You have the opportunity to explain your comments, share your honest opinions, and tell us what you like and what you would like to see us improve. If you find a feature or tool specifically helpful, let us know including any suggestions for making them simpler to use. We continuously analyze your feedback and develop enhancements plans to better assist you with your experience. We value your opinion and look forward to hearing from you. 6 6/2018

8 Medicare Beneficiary Identifier (MBI) Look-up Tool Palmetto GBA is excited to announce that the Medicare Beneficiary Identifier (MBI) Look-up tool is now available in eservices! This tool allows providers to use our secure online portal to obtain the new MBI number when patients do not present their Medicare card. The New Medicare Card Project, which was established in the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 mandates the removal of the Social Security Number (SSN)-based Health Insurance Claim Number (HICN) from Medicare cards by April CMS began mailing new Medicare cards with the MBI on April 2, From April 1, 2018 to December 31, 2019, CMS will offer a transition period during which the system will accept both HICNs and MBIs on Medicare transactions (including eligibility requests and claims) for beneficiaries in the Medicare program prior to April 1, 2018 (i.e., those who received a HICN on their Medicare card). Note: Providers should not submit both numbers on the same transaction. Beginning in January 2020, physicians may only use MBIs, with limited exceptions. When the new Medicare card is mailed to people with Medicare, you will be able to use the eservices MBI Look-Up Tool to obtain a patient s MBI. To submit an inquiry you must do the following: Once logged into eservices, click on the MBI LOOKUP tab located in the header of the portal Complete the required* fields: o Beneficiary s Last Name o First Name o Date of birth and o Social security number. NOTE: The social security number must be in the XXX-XX-XXXX format To meet our CAPTCHA requirements, you must select the I M NOT A ROBOT checkbox Click SUBMIT INQUIRY Figure 1: MBI Lookup Tab 7 6/2018

9 Look-Up Tool Status Results If the inquiry successfully returns an MBI, the screen will refresh with the data at the bottom. Figure 2: MBI Lookup Successful Response Screenshot In the event that your MBI lookup request does not result in a successful response, eservices will display error messages to assist you. If any required fields are left blank or are not in a proper format, a message will appear advising you which fields to correct. Figure 3: MBI Lookup Unsuccessful Response Screenshot Check the CMS New Medicare Card Project Outreach & Education webpage for additional information at 8 6/2018

10 New Physician Specialty Code for Medical Genetics and Genomics MLN Matters Number: MM10457 Related CR Release Date: April 27, 2018 Related CR Transmittal Number: R304FM and R4039CP Related Change Request (CR) Number: Effective Date: October 1, 2018 Implementation Date: October 1, 2018 PROVIDER TYPE AFFECTED This MLN Matters Article is intended for physicians, other providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services to Medicare beneficiaries. PROVIDER ACTION NEEDED This article is based on Change Request (CR) which informs MACs that CMS has established a new physician specialty code for Medical Genetics and Genomics (D3). Make sure that your billing staffs are aware of these changes. BACKGROUND Physicians self-designate their Medicare physician specialty on the Medicare enrollment application (CMS 855I or CMS-855O) or Internet-based Provider Enrollment, Chain and Ownership System (PECOS) when they enroll in the Medicare program. Medicare physician specialty codes describe the specific/unique types of medicine that physicians (and certain other suppliers) practice. The Centers for Medicare & Medicaid Services (CMS) uses specialty codes for programmatic and claims processing purpos es. CMS has established a new physician specialty code for Medical Genetics and Genomics. The new code is D3. MACs will accept and recognize the new code of D3. ADDITIONAL INFORMATION CR10457 revises The Medicare Financial Management Manual, Chapter 6, and the Medicare Claims Processing Manual, Chapter 26, to reflect this new specialty code. The revised manual sections are attached to CR The official instruction, CR10457, issued to your MAC regarding this change via two transmittals. The first updates the Medicare Financial Management Manual and it is available at The second updates the Medicare Claims Processing Manual and it is available at DOCUMENT HISTORY Date of Change Description April 27, 2018 Initial article released. 9 6/2018

11 Comprehensive ESRD Care (CEC) Model Telehealth - Implementation MLN Matters Number: MM10314 Related CR Release Date: April 27,.2018 Related CR Transmitt al Number: R196DEMO Related Change Request (CR) Number: Effective Date: October 1, 2018 Implementation Date: October 1, 2018 PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians, providers, and suppliers billing Medicare Administrative Contractors (MACs) and participating in the Comprehensive ESRD Care (CEC) Model for telehealth services provided to Medicare End-Stage Renal Disease (ESRD) beneficiaries associated with the CEC Model. PROVIDER ACTION NEEDED Change Request (CR) details the CEC Model telehealth program and how it will be implemented. Make sure your billing staffs are aware of this initiative. BACKGROUND Section 1115A) of the Social Security Act (the Act) (added by Section 3021 of the Affordable Care Act (ACA) (42 USC 1315a) authorizes the Center for Medicare and Medicaid Innovation (CMMI) to test innovate health care payment and service-delivery models that have the potential to lower Medicare, Medicaid, and the Child Health Insurance Program (CHIP) spending while maintaining or improving the quality of beneficiaries care. The CEC Model is designed to identify, test, and evaluate new ways to improve care for Medicare beneficiaries with ESRD. Through the CEC Model, the Centers for Medicare & Medicaid Services (CMS) will partner with health care providers and suppliers to test the effectiveness of a new payment and service delivery model in providing beneficiaries with person-centered, high-quality care. The Model builds on Accountable Care Organization (ACO) experience from the Pioneer ACO Model, Next Generation ACO Model, and the Medicare Shared Savings Program to test Accountable Care Organizations for ESRD beneficiaries. More than 600,000 Americans have ESRD and require life-sustaining dialysis treatments several times per week. Many beneficiaries with ESRD suffer from poorer health outcomes, often the result of underlying disease complications and multiple co-morbidities. These can lead to high rates of hospital admission and readmissions, as well as a mortality rate that is higher than that of the general Medicare population. According to United States Renal Data System, in 2014, ESRD beneficiaries comprised less than 1 percent of the Medicare population, but accounted for an estimated 7.2 percent of total Medicare Fee-For-Service (FFS) spending, totaling more than $32.8 billion. Because of their complex health needs, beneficiaries often require visits to multiple providers and follow multiple care plans, all of which can be challenging for beneficiaries if care is not coordinated. The CEC Model seeks 10 6/2018

12 to create incentives to enhance care coordination and to create a person-centered, coordinated care experience, and to ultimately improve health outcomes for this population. In the CEC Model, dialysis clinics, nephrologists and other providers collaborate to create an ESRD Seamless Care Organization (ESCO) to coordinate care for matched beneficiaries. ESCOs are accountable for clinical quality outcomes and financial outcomes measured by Medicare Part A and B spending, including all spending on dialysis services for their aligned ESRD beneficiaries. This model encourages dialysis providers to think beyond their traditional roles in care delivery and supports them as they provide patient-centered care that will address beneficiaries health needs, both in and outside of the dialysis clinic. The CEC Model includes separate financial arrangements for larger and smaller dialysis organizations. Large Dialysis Organizations (LDOs), defined as having 200 or more dialysis facilities, will be eligible to receive shared savings payments. These LDOs will also be liable for shared losses and will have higher overall levels of risk compared with their smaller counterparts. Non-Large Dialysis Organizations (Non-LDOs) include chains with fewer than 200 dialysis facilities, independent dialysis facilities, and hospital-based dialysis facilities. Non-LDOs will have the option of participating in a one-sided track where they will be able to receive shared savings payments, but will not be liable for payment of shared losses, or participating in a track with higher risk and the potential for shared losses. The one-sided track is offered in recognition of the Non-LDOs more limited resources. The CEC Model began on October 1, 2015, and will run until December 31, The CEC Model conducted a solicitation in 2016 to add more ESCOs for Performance Year 2 of the model, beginning on January 1, The CEC Model has no current plans for another round of solicitations. The CEC Model LDO payment track and Non-LDO two-sided payment track are considered Advance Payment Models (APMs) regarding the Quality Payment Program. The CEC Model will implement design elements with implications for the FFS system for its third performance year that includes benefit enhancements to give ACOs the tools to direct care and engage beneficiaries in their own care. The model also offers increased monitoring to account for different financial incentives and the provision of enhanced benefits. The model s quality requirements are similar to Shared Savings Program (SSP) and Pioneer, modified as needed to take into account unique aspects of dialysis care, in keeping with the agencies initiatives to unify and streamline quality measurement and requirements. Telehealth Waiver In order to emphasize high-value services and support the ability of ESCOs to manage the care of beneficiaries, CMS plans to design policies and use the authority under Section 1115A of the Social Security Act (Section 3021 of the Affordable Care Act) to conditionally waive certain Medicare payment requirements as part of the CEC Model. CMS will make available to qualified ESCOs a waiver of the originating site requirement for services provided via telehealth. This benefit enhancement will allow beneficiaries to receive qualified telehealth services in non- 11 6/2018

13 rural locations and locations that are not specified by statute, such as homes and dialysis facilities. The waiver will apply only to eligible aligned beneficiaries receiving services from ESCO providers. An aligned beneficiary will be eligible to receive telehealth services through this waiver if the services are otherwise qualified with respect to: 1) The service provided, as designated by Current Procedural Terminology (CPT) or Healthcare Common Procedure Coding System (HCPCS) codes, and 2) The remote site. MACs will apply claims processing edit logic, audit, medical review, Medicare Secondary Payor, and fraud and abuse activities, appeals and overpayment processes for CEC claims in the same manner as normal FFS claims. Notwithstanding these waivers, all telehealth services must be furnished in accordance with all other Medicare coverage and payment criteria, and no additional reimbursement will be made to cover set-up costs, technology purchases, training and education, or other related costs. In particular, the services allowed through telehealth are limited to those described under Section 1834(m)(4)(F) of the Act, and subsequent additional services specified through regulation with the exception that claims will not be allowed for the following telehealth services rendered to aligned beneficiaries located at their residence: Follow-up inpatient telehealth consultations furnished to beneficiaries in hospitals or Skilled Nursing Facilities (SNFs) - HCPCS codes G0406-G0408. Subsequent hospital care services, with the limitation of 1 telehealth visit every 3 days - CPT codes Subsequent nursing facility care services, with the limitation of 1 telehealth visit every 30 days - CPT codes Telehealth consultations, emergency department or initial inpatient - HCPCS codes G0425-G0427. Telehealth Consultation, Critical Care, initial - HCPCS code G0508. Telehealth Consultation, Critical Care, subsequent - HCPCS code G0509. Prolonged service in the inpatient or observation setting requiring unit/floor time beyond the usual service - CPT codes MACs will be ready to process Part B CEC claims for dates of service on or after October 1, MACs will process CEC telehealth claims (Place of Service (POS) 02) when providers are ESCO providers and beneficiaries are aligned to the same ESCO for the Date of Service (DOS) on the claims and contains the demo code 85 and one of the following CPT or HCPCS codes: 90785, 90791, 90792, 90832, 90833, 90834, 90836, 90837, 90838, 90839, 90840, 90845, 90846, 90847, 90951, 90952, 90954, 90955, 90957, 90958, 90960, 90961, 90963, 90964, 90965, 90966, 90967, 90968, 90969, 90970, 96116, 96150, 96151, 96152, 96153, 96154, 96160, 96161, 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99354, 99355, 99406, 99407, 99495, 99496, 99497, 99498, G0108, G0109, G0270, G0396, G0397, G0420, G0421, G0438, G0439, G0442, G0443, G0444, G0445, G0446, G0447, G0459, G0506, G9481, G9482, G9483, G9484, G9485, G9486, G9487, G9488, G /2018

14 For Part A CEC claims when providers are ESCO providers and beneficiaries are aligned to the same ESCO for the Date of Service (DOS) on the claims submitted on Type of Bill (TOB) 12X, 13X, 22X, 23X, 71X, 72X, 76X, 77X, or 85X and contains the demo code 85 and one of the following CPT or HCPCS codes: 90785, 90791, 90792, 90832, 90833, 90834, 90836, 90837, 90838, 90839, 90840, 90845, 90846, 90847, 90951, 90952, 90954, 90955, 90957, 90958, 90960, 90961, 90963, 90964, 90965, 90966, 90967, 90968, 90969, 90970, 96116, 96150, 96151, 96152, 96153, 96154, 96160, 96161, 97802, 97803, 97804, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99354, 99355, 99406, 99407, 99495, 99496, 99497, 99498, G0108, G0109, G0270, G0396, G0397, G0420, G0421, G0438, G0439, G0442, G0443, G0444, G0445, G0446, G0447, G0459, G0506, G9481, G9482, G9483, G9484, G9485, G9486, G9487, G9488, G9489 MACs will not process as CEC telehealth claims that contain the following codes. Claims that contain these codes these codes can be processed following existing claims processing logic: HCPCS codes G0406 G0408. CPT codes CPT codes HCPCS codes G0425-G0427 HCPCS code G0508 HCPCS code G0509 CPT codes MACs will treat CEC payments the same as Medicare patients for cost reporting purposes. Providers submitting electronic 837 claims should enter DEMO 85 in the REF segment 2300 Loop Demonstration Project Identifiers and providers will include Qualifier P4. Providers submitting a paper claim should enter demo 85 in the treatment authorization field. Providers should be aware that MACs will return claims if you append demo code 85, and: You are not on the CEC participant provider list with a telehealth record type; or DOS from date is prior to your telehealth effective date, or DOS from date is after your telehealth termination date, or The DOS from date is prior to the beneficiary s effective date; or The DOS from date is after the beneficiary s termination date, or The DOS from date is more than 90 days after the beneficiary s termination date; or The beneficiary was not aligned to the same ESCO with which you are participating, as identified by ESCO ID; or The claim is for Part A and the TOB is other than 12X, 13X, 22X, 23X, 71X, 72X, 76X, 77X, and 85X, Other, non-telehealth services are billed on the same claim. In these cases, none of the services on the claim are processed. In returning Part B claims, your MAC will use the following messaging: Claims Adjustment Reason Code (CARC) 16: (Claim/service lacks information or has submission/billing error(s) which is needed for adjudication) and Remittance Advice Remark Code (RARC) N763 (The demonstration code is not appropriate for this claim; resubmit without a demonstration code.) Group Code: CO (Contractual Obligation) 13 6/2018

15 For Part A claims, your MAC will just return the claim to the provider (RTP). ADDITIONAL INFORMATION The official instruction, CR10314, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change Description April 27, 2018 Initial article released. EDI Enrollment Instructions Guide Module Do you need help completing your EDI Enrollment packet? This interactive guide will give you all the information you need to get started, including which forms to complete, and the fields that must be completed on each form. Access the EDI Enrollment Instructions Guide Module under Forms/Tools on the home page. 14 6/2018

16 Updates to Publication , Chapters 1 and 27, to Replace Remittance Advice Remark Code (RARC) MA61 with N382 MLN Matters Number: MM10619 Related CR Release Date: May 11, 2018 Related CR Transmittal Number: R4047CP Related Change Request (CR) Number: Effective Date: August 13, 2018 Implementation Date: August 13, 2018 PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians, providers, and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. WHAT YOU NEED TO KNOW Change Request (CR) initiates both Medicare manual changes and operational changes related to the New Medicare Card. Medicare will replace the use of Remittance Advice Remark Code (RARC) MA61, referenced in the Medicare Claims Processing Manual, Chapters 1 and 27, with RARC N382 - missing/inco mplete/invalid patient identifier (HICN or MBI). Effective for claims processed on or after the effective date of CR10619, MACs will use N382 in place of MA61 to communicate reject/denials for patient identifiers (HICN or MBI) in all remittance advices and 835 transactions. However, MACs will continue to use RARC MA61 only when/ if communicating rejections/denials related to a missing/incomplete/invalid social security number. Make sure your billing staffs are aware of these updates. BACKGROUND With the implementation of the Medicare Beneficiary Identifier (MBI), references to the Health Insurance Claim Number (HICN) will be replaced with a more generic reference (Patient Identifier). CR initiates the manual changes and operational changes to accomplish this task. ADDITIONAL INFORMATION The official instruction, CR 10619, issued to your MAC regarding this change, is available at DOCUMENT HISTORY Date of Change Description May 14, 2018 Initial article released. 15 6/2018

17 Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes July 2018 Update MLN Matters Number: MM10624 Revised Related CR Release Date: May 11, 2018 Related CR Transmittal Number: R4048CP Related Change Request (CR) Number: Effective Date: July 1, 2018 Implementation Date: July 2, 2018 Note: This article was revised on May 14, 2018, to reflect a revised CR issued on May 11. In the article, a sentence is added to show that Part B payment for Q9995 includes the clotting factor furnishing fee. Also, the CR release date, transmittal number, and the Web address of the CR are revised. All other information is the same. PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians, providers and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) informs MACs of updated drug/biological HCPCS codes. The HCPCS code set is updated on a quarterly basis. The July 2018 HCPCS file includes 4 new HCPCS codes: Q9991, Q9992, Q9993 and Q9995. Please make sure your billing staffs are aware of these updates. BACKGROUND The July 2018 HCPCS file includes four new HCPCS codes, which are payable by Medicare, effective for claims with dates of service on or after July 1, Part B payment for HCPCS code Q9995 will include the clotting factor furnishing fee. These codes are: Q9991 Short Description: Buprenorph xr 100 mg or less Long Description: Injection, buprenorphine extended-release (sublocade), less than or equal to 100 mg Type of Service (TOS) Code: 1 Medicare Physician Fee Schedule Data Base (MPFSDB) Status Indicator: E Q9992 Short Description: Buprenorphine xr over 100 mg Long Description: Injection, buprenorphine extended-release (sublocade), greater than 100 mg TOS Code: 1 MPFSDB Status Indicator: E Q9993 Short Description: Inj., triamcinolone ext rel Long Description: Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg TOS Code: 1,P MPFSDB Status Indicator: E 16 6/2018

18 Q9995 Short Description: Inj. emicizumab-kxwh, 0.5 mg Long Description: Injection, emicizumab-kxwh, 0.5 mg TOS Code: 1 MPFSDB Status Indicator: E ADDITIONAL INFORMATION The official instruction, CR 10624, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change Description May 14, 2018 This article was revised to reflect a revised CR issued on May 11. In the article, a sentence is added to show that Part B payment for Q9995 includes the clotting factor furnishing fee. Also, the CR release date, transmittal number, and the Web address of the CR are revised. All other information is the same. April 20, 2018 Initial article released. 17 6/2018

19 Educational Events Where You Can Ask Questions and Get Answers from Palmetto GBA Don t Miss this Wonderful Opportunity! If you are in search of an opportunity to interact with and get answers to your Medicare billing, coverage and documentation questions from Palmetto GBA s Provider Outreach and Education (POE) department, please see these educational offerings which have a question and answer session: Event Title Date/Time Address (or link if Webinar) JJ/JM June Medicare Part B Updates, Changes and Reminders JJ/JM Part B Ask the Contractor Teleconference: Topic TBD June 6, 2018, 10 am, ET June 12, 2018, 11 am, ET C35C73FBCA519D39FDE01D8FAE4C326A Dial in Number: Access Code: Check out these resources Quarterly Ask the Contractor Teleconferences (ACTs) ACTs are intended to open the communication channels between providers and Palmetto GBA, which allows for timely identification of problems and information-sharing in an informal and interactive atmosphere. These teleconferences will be held at least quarterly via teleconference. Proceding the presentation, providers are given an opportunity to ask questions both on the topics discussed as well as any other question they may have. While we encourage providers to submit questions prior to the call, this is not required. Just fill out the Ask the Contractor Teleconference (ACT): Submit A Question form ( Once the form is completed, please fax it to (803) , Attention: Ask-the- Contractor Teleconference Quarterly Updates Webcasts The Quarterly Update Webcasts are intended to provide ongoing, scheduled opportunities for providers to stay up to date on Medicare requirements. Providers are able to type a question and have it responded to by the POE department throughout the webcast. At the end of the presentation the moderator will also read and respond to questions submitted by attendees in order to share the responses with the group at large. 18 6/2018

20 Event Registration Portal Visit our Event Registration Portal to find information on upcoming educational events and seminars. This is a complete listing of both our face-to-face outreach opportunities as well as our teleconference and webcast listings. Providers are able to dialogue with POE and get answers to their questions at all of these educational events. If you have a question that you need an answer to today or a claims specific question which requires the disclosure of PII or PHI for response, please contact the Provider Contact Center (PCC) at for Jurisdiction M or for Jurisdiction J. 19 6/2018

21 Palmetto GBA Jurisdiction M (JM) MACtoberfest Conference Save the Date for the Palmetto GBA Jurisdiction M (JM) MACtoberfest, a two-day conference in Myrtle Beach, South Carolina on October 23 and 24, 2018, that will provide information related to various aspects of the Medicare program. This conference is intended to keep providers apprised of Medicare guidelines as well as using technology for better results. The recommended participants are administrators, billers, nurses and other healthcare professionals that submit claims to Medicare. 20 6/2018

22 Processing Instructions to Update the Identification Code Qualifier Being Used in the NM108 Data Element at the 2100 Loop, NM1- Patient Name Segment in the 835 Guide MLN Matters Number: MM10565 Related Change Request (CR) Number: Related CR Release Date: April 27, 2018 Effective Date: October 1, 2018 Not based on Date of Service Related CR Transmittal Number: R2063OTN Implementation Date: October 1, 2018 PROVIDER TYPE AFFECTED This MLN Matters Article is intended for physicians, providers and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) provides instructions to the MACs to update the Identification Code Qualifier in Data Element NM108 currently being used in the 2100 Loop, NM1- Patient Name Segment of the 835 guide. This will synchronize the usage of the same qualifier as used/submitted on the claim. Make sure your billing staffs are aware of these instructions. BACKGROUND With the removal of the Social Security Number (SSN)-based Health Insurance Claim Number (HICN) from Medicare cards and in an effort to synchronize the usage of the same Identification Code Qualifier in the Health Care Claim Payment/Advice (835) and the Professional and Institutional (837) Health Care Claim as required by the 835 guide, CR10565 modifies the Identification Code Qualifier being used in the 835 Ele ctronic Remit from HN to MI. ADDITIONAL INFORMATION The official instruction, CR10565, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change April 27, 2018 Description Initial article released. 21 6/2018

23 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 MLN Matters Number: MM10566 Related CR Release Date: May 18, 2018 Related CR Transmittal Number: R4054CP Related Change Request (CR) Number: Effective Date: October 1, 2018 Implementation Date: October 1, 2018 PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians, providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs), including Home Health & Hospice MACs and Durable Medical Equipment MACs (DME/MACs) for services to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) informs MACs to update their systems based on the CORE 360 Uniform use of Claims Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) rule publication. These system updates are based on the Committee on Operating Rules for Information Exchange (CORE) Code Combination List to be published on or about June 4, CR10566 applies to the Medicare Claims Processing Manual, Chapter 22, Section Make sure that your billing staffs are aware of these changes. BACKGROUND The Department of Health and Human Services (DHHS) adopted the Phase III Council for Affordable Quality Healthcare (CAQH) CORE, Electronic Funds Transfer (EFT) and Electronic Remittance Advice (ERA) Operating Rule Set that was implemented on January 1, 2014, under the Affordable Care Act. The Health Insurance Portability and Accountability Act (HIPAA) amended the Act by adding Part C-Administrative Simplification-to Title XI of the Social Security Act, requiring the Secretary of DHHS (the Secretary) to adopt standards for certain transactions to enable health information to be exchanged more efficiently and to achieve greater uniformity in the transmission of health information. Through the Affordable Care Act, Congress sought to promote implementation of electronic transactions and achieve cost reduction and efficiency improvements by creating more uniformity in the implementation of standard transactions. This was done by mandating the adoption of a set of operating rules for each of the HIPAA transactions. 22 6/2018

24 CR10566 deals with the regular update in CAQH CORE defined code combinations per Operating Rule Uniform Use of CARC and RARC (835) Rule. CAQH CORE will publish the next version of the Code Combination List on or about June 4, This update is based on the CARC and RARC updates as posted at the Washington Publishing Company (WPC) website on or about March 1, This will also include updates based on market based review that CAQH CORE conducts once a year to accommodate code combinations that are currently being used by health plans including Medicare, as the industry needs them. See for CARC and RARC updates and for CAQH CORE defined code combination updates. NOTE: As the Affordable Care Act requires, all health plans including Medicare must comply with CORE 360 Uniform Use of CARCs and RARCs (835) rule or CORE developed maximum set of CARC/RARC and CAGC combinations for a minimum set of four (4) business scenarios. Medicare can use any code combination if the business scenario is not one of the four (4) CORE defined business scenarios. With the four (4) CORE defined business scenarios, Medicare must use the code combinations from the lists published by CAQH CORE. ADDITIONAL INFORMATION The official instruction, CR10566, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change Description May 18, 2018 Initial article released. 23 6/2018

25 Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update MLN Matters Number: MM10620 Related CR Release Date: May 18, 2018 Related CR Transmittal Number: R4057CP Related Change Request (CR) Number: Effective Date: October 1, 2018 Implementation Date: October 1, 2018 PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians, providers and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) updates the Remittance Advice Remark Code (RARC) and Claims Adjustment Reason Code (CARC) lists and instructs Medicare Shared System Maintainers (SSMs) to update Medicare Remit Easy Print (MREP) and PC Print. Be sure your staff are aware of these changes and obtain the updated MREP and PC Print software if they use that software. BACKGROUND The Health Insurance Portability and Accountability Act of 1996 (HIPAA) instructs health plans to conduct standard electronic transactions adopted under HIPAA using valid standard codes. Medicare policy states that CARCs and RARCs, as appropriate, which provide either supplemental explanation for a monetary adjustment or policy information that generally applies to the monetary adjustment, are required in the remittance advice and coordination of benefits transactions. The Centers for Medicare & Medicaid Services (CMS) instructs MACs to conduct updates based on the code update schedule that occurs three times per year around March 1, July 1, and November 1. CMS provides CR10620 as a code update notification indicating when updates to CARC and RARC lists are made available on the Washington Publishing Company (WPC) website. Medicare s SSMs have the responsibility to implement code deactivation, making sure that any deactivated code is not used in original business messages and allowing the deactivated code in derivative messages. SSMs must make sure that Medicare does not report any deactivated code on or after the effective date for deactivation as posted on the WPC website. If any new or modified code has an effective date past the implementation date specified in CR 10620, MACs must implement on the date specified on the WPC website available at A discrepancy between the dates may arise because the WPC website is only updated three times per year and may not match the CMS release schedule. For CR 10620, MACs and SSMs must get the complete list for both CARC and RARC from the WPC website to obtain the comprehensive lists for both code sets and determine the changes that are included on the code list since the last code update referenced in CR /2018

26 ADDITIONAL INFORMATION The official instruction, CR10620, issued to your MAC regarding this change is available at Guidance/Guidance/Transmittals/2018Downloads/R4057CP.pdf. DOCUMENT HISTORY Date of Change Description May 18, 2018 Initial article released. 25 6/2018

27 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2018 Update MLN Matters Number: MM10644 Related CR Release Date: May 18, 2018 Related CR Transmittal Number: R4053CP Related Change Request (CR) Number: Effective Date: January 1, 2018 Implementation Date: July 2, 2018 PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians, providers and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) amends payment files issued to MACs based upon 2018 Medicare Physician Fee Schedule (MPFS) Final Rule. Make sure your billings staffs are aware of these changes. BACKGROUND The Centers for Medicare & Medicaid Services (CMS) issued payment files to the MACs based upon the 2018 Medicare Physician Fee Schedule (MPFS) Final Rule, published in the Federal Register on November 15, 2017, to be effective for services furnished between January 1, 2018 and December 31, CR presents a summary of the changes for the July update to the 2018 MPFSDB. Unless otherwise stated, these changes are effective for dates of service on and after January 1, The following tables show those changes. CPT/HCPCS Action G0511 Change PC/TC indicator to 0 G0512 Change PC/TC indicator to 0 G0460* Change Status = A, Work RVU = 2.25, Non-Facility PE RVU = 2.89, Facility PE RVU =.94, Malpractice RVU =.34, Mult Proc = 2, Bilat Surg = 0, Asst Surg = 1, Co-Surg = 0, Team Surge = 0, Global Days = Facility and Non-Facility PE RVU changed to TC Facility and Non-Facility PE RVU changed to 0.35 * The work RVU of G0460 was valued at the work RVU of one billing of Current Procedural Terminology (CPT) code (1.01) plus two billings of CPT code (0.50), along with a single billing of CPT codes (0.00) and (0.24) to cover the lab portion of the work. The direct PE inputs were crosswalked from CPT code along with the inclusion of additional clinical labor, supplies, and equipment based on CMS determination of what would be typical and medically necessary for the procedure. 26 6/2018

28 The following Q codes are effective for services performed on or after July 1, 2018 (see MM10624 ( MM10624.pdf) for additional information). Code Q9991 Q9992 Q9993 Q9995 Action Procedure Status = E; there are no RVUs, payment policy indicators do not apply Procedure Status = E; there are no RVUs, payment policy indicators do not apply Procedure Status = E; there are no RVUs, payment policy indicators do not apply Procedure Status = E; there are no RVUs, payment policy indicators do not apply The following new CPT Category III codes have been added for dates of service July 1, 2018, and after: Code Short Descriptor Long Descriptor 0505T Ev fempop artl revsc Endovenous femoral-popliteal arterial revascularization, with transcatheter placement of intravascular stent graft(s) and closure by any method, including percutaneous or open vascular access, ultrasound guidance for vascular access when performed, all catheterization(s) and intraprocedural roadmapping and imaging guidance necessary to complete the intervention, all associated radiological supervision and interpretation, when performed, with crossing of the occlusive lesion in an extraluminal fashion 0506T 0507T 0508T Mac pgmt opt dns meas hfp Near ifr 2img mibmn glnd i&r Pls echo us b1 dns meas tib Macular pigment optical density measurement by heterochromatic flicker photometry, unilateral or bilateral, with interpretation and report Near-infrared dual imaging (ie, simultaneous reflective and transilluminated light) of meibomian glands, unilateral or bilateral, with interpretation and report Pulse-echo ultrasound bone density measurement resulting in indicator of axial bone mineral density, tibia Note: MACs will not search their files to retract payment for claims already paid or to retroactively pay claims. However, MACs will adjust claims brought to their attention. HCPCS/ Mod 0505T 0506T 0506T T TC 0507T 0507T T TC 0508T 0508T T TC Status C C C C C C C C C C Muti Bilat Asst Surg Co-Surg Team Surg PC/TC /2018

29 Global YYY XXX XXX XXX XXX XXX XXX XXX XXX XXX Diag Supv Diag Imag Note: Pre, intra and post-operative percentages for CPT codes 0505T-0508T are all ADDITIONAL INFORMATION The official instruction, CR10644, issued to your MAC regarding this change is available at gov/regulations-and-guidance/guidance/transmittals/2018downloads/r4053cp.pdf. DOCUMENT HISTORY Date of Change Description May 21, 2018 Initial article released. 28 6/2018

30 International Classification of Diseases, Tenth Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) MLN Matters Number: MM10622 Related CR Release Date: May 4, 2018 Related CR Transmittal Number: R2076OTN Related Change Request (CR) Number: Effective Date: October 1, 2018 Implementation Date: October 1, 2018 PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians and other providers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) constitutes a maintenance update of International Classification of Diseases, 10th Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. Please follow the link below for the NCD spreadsheets included with this CR: BACKGROUND Previous NCD coding changes appear in ICD-10 quarterly updates that are available at along with other CRs implementing new policy NCDs. Edits to ICD-10, and other coding updates specific to NCDs, will be included in subsequent quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. Coding (as well as payment) is a separate and distinct area of the Medicare Program from coverage policy/ criteria. Revisions to codes within an NCD are carefully and thoroughly reviewed and vetted by the Centers for Medicare & Medicaid Services (CMS) and are not intended to change the original intent of the NCD. The exception to this is when coding revisions are released as official implementation of new or reconsidered NCD policy following a formal national coverage analysis. Note: The translations from ICD-9 to ICD-10 are not consistent one-to-one matches, nor are all ICD-10 codes appearing in a complete General Equivalence Mappings (GEMs) mapping guide or other mapping guides appropriate when reviewed against individual NCD policies. In addition, for those policies that expressly allow MAC discretion, there may be changes to those NCDs based on current review of those NCDs against ICD-10 coding. For these reasons, there may be certain ICD-9 codes that were once considered appropriate prior to ICD-10 implementation that are no longer considered acceptable. 29 6/2018

31 CR10622 makes coding and clarifying adjustments to the following NCDs: NCD Aprepitant NCD Bone Mineral Density Studies NCD Prothrombin Time/International Normalized Ratio (PT/INR) NCD Positron Emission Tomography (PET) for Infection/Inflammation NCD PET for Solid Tumors NCD Percutaneous Image-Guided Breast Biopsy When denying claims associated with the attached NCDs, except where otherwise indicated. A/B MACs will use: Group Code PR (Patient Responsibility) assigning financial responsibility to the beneficiary (if a claim is received with occurrence code 32, or with occurrence code 32 and a GA modifier, indicating a signed Advance Beneficiary Notice (ABN) is on file). Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file). For modifier GZ, use CARC 50 and Medicare Summary Notice (MSN) 8.81 per instructions in CR 7228/TR ADDITIONAL INFORMATION The official instruction, CR 10622, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change Description May 9, 2018 Initial article released. Receive ADRs Electronically: Go Green via eservices Providers can opt to receive Additional Documentation Requests (ADRs) through eservices. If your claim is selected for review, you can receive your request as it is generated instead of by mail (which decreases the amount of time you have to respond). This process is free, secure and easy to use. Our messaging function in eservices will send an inbox message to let users know that an eletter is now available. This new process delivers the electronic document as a link within the secure message once you sign into eservices. For more information about eservices and the many services it offers, please visit our website at /2018

32 Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment MLN Matters Number: MM10642 Related CR Release Date: May 11, 2018 Related CR Transmittal Number: R4045CP Related Change Request (CR) Number: Effective Date: July 1, 2018 Implementation Date: July 2, 2018 PROVIDER TYPE AFFECTED This MLN Matters Article is intended for clinical diagnostic laboratories submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) informs MACs about the changes in the July 2018 quarterly update to the Clinical Laboratory Fee Schedule (CLFS). Make sure that your billing staffs are aware of these changes. BACKGROUND Effective January 1, 2018, CLFS rates will be based on weighted median private payor rates as required by the Protecting Access to Medicare Act (PAMA) of For more details, visit PAMA Regulations, at Part B deductible and coinsurance do not apply for services paid under the clinical laboratory fee schedule. Access to Data File Under normal circumstances, CMS will make the updated CLFS data file available to MACs approximately 6 weeks prior to the beginning of each quarter. For example, the updated file will typically be made available for download and testing on or before approximately May 15 for the July 1 release. Internet access to the quarterly CLFS data file will be available at ClinicalLabFeeSched/index.html. Other interested parties, such as the Medicaid State agencies, the Indian Health Service, the United Mine Workers, and the Railroad Retirement Board, should use the Internet to retrieve the quarterly CLFS. It will be available in multiple formats: Excel, text, and comma delimited. Pricing Information The CLFS includes separately payable fees for certain specim en collection methods (codes 36415, P9612, and P9615). The fees are established in accordance with Section 1833(h)(4)(B) of the Social Security Act. New Codes The following new codes will be contractor priced until they are addressed at the annual Clinical Laboratory Public Meeting, which will take place in July The following U codes will have HCPCS Pricing Indicator Code - 22 = Price established by A/B MACs Part B (e.g., gap-fills, A/B MACs Part B established panels) instead of Pricing Indicator - 21 = Price Subject to National Limitation Amount. (Code, Type of Service (TOS), Short Descriptor, Long Descriptor) 31 6/2018

33 The following new codes are effective April 1, 2018: 0035U TOS 5; Short Descriptor Neuro csf prion prtn qual; Long Descriptor Neurology (prion disease), cerebrospinal fluid, detection of prion protein by quaking-induced conformational conversion, qualitative 0036U TOS 5; Short Descriptor Xome tum & nml spec seq alys; Long Descriptor Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses 0037U TOS 5; Short Descriptor Trgt gen seq dna 324 genes; Long Descriptor Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden 0038U TOS 5; Short Descriptor Vitamin d srm microsamp quan; Long Descriptor Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative 0039U TOS 5; Short Descriptor Dna antb 2strand hi avidity; Long Descriptor Deoxyribonucleic acid (DNA) antibody, double stranded, high avidity 0040U TOS 5; Short Descriptor Bcr/abl1 gene major bp quan; Long Descriptor BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis, major breakpoint, quantitative 0041U TOS 5; Short Descriptor B brgdrferi antb 5 prtn igm; Long Descriptor Borrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot, IgM 0042U TOS 5; Short Descriptor B brgdrferi antb 12 prtn igg; Long Descriptor Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG 0043U TOS 5; Short Descriptor Tbrf b grp antb 4 prtn igm; Long Descriptor Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgM 0044U TOS 5; Short Descriptor Tbrf b grp antb 4 prtn igg; Long Descriptor Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgG0024U Glycosylated acute phase proteins (GlycA), nuclear magnetic resonance spectroscopy, quantitative 0012M TOS 5; Short Descriptor Onc mrna 5 gen rsk urthl ca; Long Descriptor Oncology (urothelial), mrna, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and XCR2), utilizing urine, algorithm reported as a risk score for having urothelial carcinoma 0013M TOS 5; Short Descriptor Onc mrna 5 gen recr urthl ca; Long Descriptor Oncology (urothelial), mrna, gene expression profiling by real-time quantitative PCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and CXCR2), utilizing urine, algorithm reported as a risk score for having recurrent urothelial carcinoma The following new code is effective January 1, 2018: 0011M TOS 5; Short Descriptor Onc prst8 ca mrna 12 gen alg; Long Descriptor Oncology, prostate cancer, mrna expression assay of 12 genes (10 content and 2 housekeeping), RT-PCR test utilizing blood plasma and/or urine, algorithms to predict high-grade prostate cancer risk Notes: In instances where Medicare-covered CLFS procedure codes do not yet appear on the quarterly CLFS file or the quarterly Integrated Outpatient Code Editor (I/OCE) update, MACs will locally price the codes until they appear on the CLFS file and/or, for Part A claims, the I/OCE. MACs will not search their files to either retract payment or retroactively pay claims; however, they should adjust claims that you bring to their attention. 32 6/2018

34 ADDITIONAL INFORMATION The official instruction, CR 10642, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change Description May 14, 2018 Initial article released. eservices Eligibility eservices, by Palmetto GBA, allows you to search for patient eligibility, which is a functionality of HETS. HETS requires you to enter beneficiary last name and HICN, in addition to either the birth date or first name. See options below: HICN, Last Name, First Name, Birth Date HICN, Last Name, Birth Date HICN, Last Name, First Name For more information about eservices and the many services it offers, please visit our website at /2018

35 Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) MLN Matters Number: MM10295 Revised Related CR Release Date: May 11, 2018 Related CR Transmittal Number: R207NCD and R4049CP Related Change Request (CR) Number: Effective Date: May 25, 2017 Implementation Date: July 2, 2018 Note: The article was revised on May 15, 2018, to clarify that one of the requirements of the SET program is it must be conducted in a hospital outpatient setting or in a physician s office. All other information remains the same. PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians, providers, and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medic are beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) informs MACs that effective May 25, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) to cover Supervised Exercise Therapy (SET) for beneficiaries with Intermittent Claudication (IC) for the treatment of symptomatic Peripheral Artery Disease (PAD). Make sure your billing staffs are aware of these changes. BACKGROUND SET involves the use of intermittent walking exercise, which alternates periods of walking to moderate-tomaximum claudication, with rest. SET has been recommended as the initial treatment for patients suffering from IC, the most common symptom experienced by people with PAD. Despite years of high-quality research illustrating the effectiveness of SET, more invasive treatment options (such as, endovascular revascularization) have continued to increase. This has been partly attributed to patients having limited access to SET programs. There is currently no NCD in effect. CMS issued the NCD to cover SET for beneficiaries with IC for the treatment of symptomatic PAD. Up to 36 sessions over a 12-week period are covered if all of the following components of a SET program are met: The SET program must: Consist of sessions lasting minutes, comprising a therapeutic exercise-training program for PAD in patients with claudication Be conducted in a hospital outpatient setting or a physician s office Be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD 34 6/2018

36 Be under the direct supervision of a physician (as defined in Section 1861(r)(1)) of the Social Security Act (the Act), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in Section 1861(aa) (5) of the Act)) who must be trained in both basic and advanced life support techniques. Beneficiaries must have a face-to-face visit with the physician responsible for PAD treatment to obtain the referral for SET. At this visit, the beneficiary must receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments. MACs have the discretion to cover SET beyond 36 sessions over 12 weeks and may cover an additional 36 sessions over an extended period of time. MACs shall accept the inclusion of the KX modifier on the claim line(s) as an attestation by the provider of the services that documentation is on file verifying that further treatment beyond the 36 sessions of SET over a 12-week period meets the requirements of the medical policy. SET is non-covered for beneficiaries with absolute contraindications to exercise as determined by their primary attending physician. Coding Requirements for SET Providers should use Current Procedural Terminology (CPT) (Under Peripheral Arterial Disease Rehabilitation) to bill for these services with appropriate International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) Code as follows: I right leg I left leg I bilateral legs I other extremity I right leg I left leg I bilateral legs I other extremity I right leg I left leg I bilateral legs I other extremity I right leg I left leg I bilateral legs I other extremity Medicare will deny claim line items for SET services when they do not contain one of the above ICD-10 codes using the following messages: Claim Adjustment Reason Code (CARC) 167 This (these) diagnosis (es) is (are) not covered. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. Remittance Advice Remark Code (RARC) N386: This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at If you do not have web access, you may contact the contractor to request a copy of the NCD. 35 6/2018

37 Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. Institutional claims for SET must be submitted on Type of Bills (TOB) 13X or 85X. MACs will deny line items on institutional claims that are not submitted on TOB 13X or 85X using the following messages: CARC 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. NOTE: Refer to the 832 Healthcare Policy Identification Segment (loop 2110 Service payment Information REF), if present. RARC N386: This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. Medicare will pay claims for SET services containing CPT code on Types of Bill (TOBs) 13X under OPPS and 85X on reasonable cost, except it will pay claims for SET services containing CPT with revenue codes 096X, 097X, or 098X when billed on TOB 85X Method II Critical Access Hospitals (CAHs) based on 115% of the lesser of the fee schedule amount or the submitted charge. Medicare will reject claims with CPT which exceed 36 sessions within 84 days from the date of the first session when the KX modifier is not included on the claim line OR any SET session provided after 84 days from the date of the first session and the KX modifier is not included on the claim and use the following messages: CARC 96: Non-covered charge(s). At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N640: Exceeds number/frequency approved/allowed within time period. Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary if a claim is received with a GA modifier indicating a signed ABN is on file. MACs will deny/reject claim lines for SET exceeding 73 sessions using the following codes: CARC 119: Benefit maximum for this time period or occurrence has been reached. RARC N386: This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary if a claim is received with a GA modifier indicating a signed ABN is on file. 36 6/2018

38 Medicare s Common Working File (CWF) will display remaining SET sessions on all CWF provider query screens (HIQA, HIQH, ELGH, ELGA, and HUQA). The Multi-Carrier System Desktop Tool will also display remaining SET sessions in a format equivalent to the CWF HIMR screen(s). ADDITIONAL INFORMATION The official instruction, CR10295, was issued to your MAC via two transmittals. The first updates the Medicare Claims Processing Manual and it is available at The second updates the NCD Manual and it is available at DOCUMENT HISTORY Date of Change Description May 15, 2018 The article was revised to clarify that one of the requirements of the SET program is it must be conducted in a hospital outpatient setting or in a physician s office. All other information remains the same. May 14, 2018 The article was revised to reflect a revised CR issued on May 11. The CR was revised to remove place of service code edit requirements. The article was revised accordingly. Also, in the article, the CR release date, transmittal numbers and the Web address of the CR are revised. All other information remains the same. April 11, 2018 The article was revised to clarify that the SET program must be provided in a physician s office (Place of Service code 11). All other information remains the same. April 5, 2018 The article was revised to reflect a revised CR. The MAC implementation date, CR release date, transmittal numbers and the Web addresses of the transmittals were revised. In addition, the article and CR were revised to delete place of service codes 19 and 22 as acceptable places of service for CPT All other information remains the same. March 5, 2018 The article was revised to reflect a revised CR. The MAC implementation date, CR release date, transmittal numbers and the Web addresses of the transmittals were revised. All other information remains the same. February 6, 2018 Initial article released. 37 6/2018

39 Interactive Tools These guides provide instruction on how to complete or interpret the following forms. They are available on the home page, under Forms/Tools. Remittance Advice EDI Agreement EDI Application EDI Provider Authorization CMS 1500 Claim Form 38 6/2018

40 Medical Director s Desk Medical Affairs publishes Medicare Local Coverage Determination (LCDs) and medically related articles in this special section of the Medicare Advisory. We encourage you to help us maintain accurate LCDs. Please review LCDs and address your comments and concerns to your Carrier Advisory Committee specialty representative or contact the Medical Affairs Department. Medical articles are published in the Medicare Advisory to provide education and alert Medicare providers of billing/coding issues. Remember, physicians and nonphysician practitioners (NPPs) who bill Medicare are responsible for accurate service coding. Errors may result in overpayment requests or Recovery Auditor (RA) referrals. If you purchase a new device or need to submit claims for a new procedure, please review applicable service codes and descriptions in the current CPT and HCPCS manuals. If you question the recommended service procedures received from other sources such as manufacturers, send your inquiry and the device description to the Medical Affairs Department. To contact the Medical Affairs Department: B.Policy@PalmettoGBA.com Mail: JM Part B Medical Affairs Palmetto GBA PO Box Columbia, SC /2018

41 Part B Local Coverage Determinations Policy Title LCD Revisions Effective Date Varicose Veins of the Lower Extremities L33454 Rev #13 Virtual Colonoscopy (CT Colonography) L33452 Rev# 8 Posterior Tibial Nerve Stimulation (PTNS) for Urinary Control L33443 Rev #8 Allergy Skin Testing L33417 Rev #9 Posterior Tibial Nerve Stimulation (PTNS) for Urinary Control L33443 Rev #9 Under Coverage Indications, Limitations and/or Medical Necessity criteria #3 defined the acronym CEAP (Clinical, Etiology, Anatomy and Pathophysiology). Under criteria #4 - Endovenous Radiofrequency Ablation (ERFA) or Laser Ablation: revised the verbiage to read Endovenous radiofrequency ablation (ERFA) and laser ablation are minimally invasive alternatives to vein ligation and stripping. Endovenous radiofrequency ablation is FDA-approved for treatment of the great saphenous vein, perforators and tributary veins. Endovenous laser ablation is FDA-approved for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein. Radiofrequency/laser ablation is covered for treatment of the small saphenous or great saphenous veins and selected tributaries to improve symptoms attributable to saphenous vein reflux. Treatment of perforator and tributary veins with Radiofrequency/laser ablation may be reasonable and necessary when there is documented reflux after the saphenous system has been treated. Due to reconsideration requests, under CPT/HCPCS Codes Group 1: Paragraph added and Under CPT/HCPCS Codes Group 3: Paragraph, Pre-Operative Study Codes added NOTE: All ICD-10 codes that support medical necessity under Group 1: Codes and Group 2: Codes apply to Group 3: CPT/HCPCS Codes. Under CMS National Coverage Policy removed the verbiage due to not being reasonable and necessary from 42 CFR (k)(1) and removed all italics from this section. Under Coverage Indications, Limitations and/or Medical Necessity Indications added e.g. in front of the word fiberoptic in the first paragraph and changed the acronym COPD to chronic obstructive pulmonary disease in the third bullet. Under Coverage Indications, Limitations and/or Medical Necessity Limitations deleted the words Computed tomographic and removed the parentheses from the acronym CT in the first sentence. Under Bibliography changes were made to citations to reflect AMA citation guidelines. The first citation was deleted. The journal title and page number were corrected and the supplement number was added to first citation listed. Punctuation was corrected throughout the policy. Under Bibliography revisions were made to the sources to reflect AMA citation guidelines. Under Associated Information-Utilization Guidelines deleted bullets 3-6 due to current MUE edits being published on the Medicare Coverage Database. 5/15/18 5/3/18 5/3/18 1/1/18 Under ICD-10 Codes that Support Medical Necessity added ICD-10 code N /1/ /2018

42 Respiratory Therapy and Oximetry Services L33446 Rev #9 HbA1c L33431 Rev #13 Article Title Billing and Coding Guidance for Anti- Inhibitor Coagulant Complex (AICC) National Coverage Determination (NCD) A55947 Rev #1 Implantable Infusion Pump Coding and Billing Guidelines A53005 Rev #12 Aflibercept (EYLEA ) Coding and Billing Guidelines A53387 Rev #10 Punctuation was corrected and words were capitalized or changed to lower case as appropriate throughout the policy. CPT was inserted throughout the policy where applicable. Under CMS National Coverage Policy removed italics from the CMS Internet Only Manual regulations. Under Coverage Indications, Limitations and/or Medical Necessity added /her to the first and second sub-bullet. Under Note: added CPT code in the first and second sentence in the first paragraph and revised his to now read their in the last paragraph. Under CPT/HCPCS Codes Group 1: Paragraph added verbiage related to CPT codes 94760, 94761, and The Group 2: Paragraph and Group 2: Codes were added. Under Bibliography changes were made to citations to reflect AMA citation guidelines. The author initials were revised for Jameson in the second citation. Under CMS National Coverage Policy removed the last two sentences in the first regulation that contained verbiage related to the NCD and LCD review process. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added ICD-10 Code E Type 2 Diabetes Mellitus with other Oral Complications. Under Bibliography changes were made to citations to reflect AMA citation guidelines. The date 2012 was added at the end of the first sentence, the italics were removed from the second sentence, and the city, state, and the words various pages was removed from the third sentence in the third reference. Articles Under CPT/HCPCS Codes added HCPCS code J7186 Injection antihemophilic factor VIII/von Willebrand factor complex (human), per factor VIII i.u. to Group 2 and Group 4. Under Article Text the full description of HCPCS code J7999-KD was added in the second paragraph. The verbiage at 95 percent of AWP instead of ASP + 6 percent was replaced with the verbiage based on CMS ASP methodology in the third paragraph. The CMS 1500 section reference was changed from BOX 19/4010a to BOX 19/5010 in the fourth paragraph. Under Article Text in the fifth paragraph added the verbiage Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months). 5/10/18 6/7/18 Effective Date 6/4/18 5/10/18 5/17/18 A/B MAC Local Coverage Determinations Policy Title LCD Revisions Effective Date Cosmetic and Reconstructive Surgery L33428 Rev #16 Under ICD-10 Codes that Support Medical Necessity Group 6: Paragraph and Group 7: Paragraph added ICD-10 codes H72.01, H72.02, H72.03, H72.2X1, H72.2X2 and H72.2X3. This revision is due to a reconsideration request and is retroactive on or after 10/01/17. 5/15/ /2018

43 Colonoscopy / Sigmoidoscopy / Proctosigmoidoscopy L34454 Rev #15 Scanning Computerized Ophthalmic Diagnostic Imaging (SCODI) L34431 Rev #15 CT of the Head L34417 Rev #15 Polysomnography L36593 Rev #6 Infliximab L35677 Rev #23 Throughout the entire LCD, punctuation was corrected as necessary. Under CMS National Coverage Policy deleted the second and third sentence in the first paragraph. Under Coverage Indications, Limitations and/or Medical Necessity Indications corrected lettered bullets throughout the section. Formatting was changed in the first paragraph and the acronym (GI) was added after the word gastrointestinal in number 2. The word the was added after the word evaluate in number 4.a., the word in was deleted after the word Follow-up in number 4.b., the word after was added before the word at and the word a was added before the word large in number 4.c. The word a was added before the word patient in number 9. The word a was added before the word foreign in number 11. The word an was added before the word anorectal in number 16. Under Coverage Indications, Limitations and/ or Medical Necessity Limitations replaced the words gastrointestinal (GI) with the acronym GI in number 7. The word a was added before the word neoplasm in the last sentence. Under Coverage Indications, Limitations and/or Medical Necessity Other Comments changed the word whether to the word either before the word medical in the paragraph. Under ICD-10 Codes that Support Medical Necessity corrected the ICD-10 code descriptions. Under Associated Information Documentation Requirements deleted the word the from the fourth paragraph. Under ICD-10 Codes that Support Medical Necessity Group 4: Paragraph 92133, Group 4: Codes added H This revision is due to a reconsideration request. Under Bibliography added two authors Medeiros FA and Belghith A to the 6th cited reference to now read Bowd C, Zangwill LM, Weinreb RN, Medeiros FA and Belghith A. Estimating optical coherence tomography structural measurement floors to improve detection of progression in advanced glaucoma. Am J Ophthalmol. 2017;175: Throughout the entire LCD, punctuation was corrected as necessary. Under Coverage Indications, Limitations and/or Medical Necessity changed the C in the word Cranial to lower case and added an A at the beginning of the first and fifth sentences in the first paragraph. In the second paragraph, the words Computerized Tomographic was replaced with the acronym CT and changed the S in the word Scans to lower case. Under ICD-10 Codes That Support Medical Necessity Group 1 Codes added ICD-10 code S02.11GG as it was inadvertently omitted. Under Bibliography changes were made to citations to reflect AMA citation guidelines. In the first citation, the authors names were added and the word adult was added before the word patients. Under Coverage Indications, Limitations and/or Medical Necessity in the second sentence added the acronym PSG after the word polysomnography. Under 1. Narcolepsy added the words rapid eye movement in front of the acronym REM. Under 2. Sleep Apnea added the words home sleep study in front of the acronym HST. Under Bibliography revisions were made to the sources to reflect AMA citation guidelines. Punctuation was corrected throughout the policy. Under CPT/HCPCS Group 1: Paragraph the verbiage Claims for Q5102 must use the appropriate modifier to identify the specific biosimilar used has been removed and replaced with The new biosimilar payment policy also makes the use of modifiers that describe the manufacturer of a biosimilar product unnecessary. Therefore, modifiers ZA, ZB, and ZC will be discontinued for dates of service on or after April 1, However, please note that HCPCS code Q5102 and the requirement to use applicable biosimilar modifiers remain in effect for dates of service prior to April 1, Under CPT/HCPCS Group 1: Codes, HCPCS Q5102 has been deleted and replaced with HCPCS codes Q5103 and Q5104. This revision is due to Change Request 10515, Transmittal 3988 and Change Request 10454, Transmittal /19/18 5/16/18 5/28/18 4/26/18 4/1/ /2018

44 Nerve Conduction Studies and Electromyography L35048 Rev #18 White Cell Colony Stimulating Factors L37176 Rev #6 Cosmetic and Reconstructive Surgery L33428 Rev #17 Scanning Computerized Ophthalmic Diagnostic Imaging (SCODI) L34431 Rev #16 Punctuation was corrected throughout the policy as necessary. Acronyms were inserted where appropriate throughout the policy. CPT was inserted throughout the policy where applicable. Under CMS National Coverage Policy deleted the word Medicare in the first cited regulation. A (1) was added after (r) in the second cited regulation. An a was added after 42 CFR, Section in the fifth cited regulation. The words Physical Therapists was added in front of the acronym PT, the words American Board of Physical Therapy Specialties was added in front of the acronym ABPTS, and parentheses were placed around both acronyms in the eighth cited regulation. Under Coverage Indications, Limitations and/or Medical Necessity changed the words electrodiagnostics (including both NCS and EMG) to the words such as nerve conduction studies (NCS) and electromyography (EMG) that are in the first paragraph. The word the was added in front of the word American in the second paragraph. The acronym AMA was changed to the words American Medical Association in the fourth paragraph. The words nerve conduction velocity was added in front of the acronym NCVs and parentheses were placed around the acronym in the fifth paragraph. Under Coverage Indications, Limitations and/or Medical Necessity A. Nerve Conduction Studies added the word the in the third numbered sentence after the first paragraph. The word such was added after the word structures in the fourth paragraph. The word such was added after the word neuropathies in the fifth paragraph. Verbiage was added to subtitle b. Sensory that was inadvertently omitted. The word Mixed was added to subtitle c. and verbiage was added that was inadvertently omitted. Under Coverage Indications, Limitations and/or Medical Necessity B. Electromyography added the word a before the word properly in the first paragraph. Under Coverage Indications, Limitations and/or Medical Necessity Current Perception Threshold/Sensory Nerve Conduction Threshold Test (snct) added the words Internet Only Manual, before the word Publication in the first paragraph. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Under CPT/HCPCS Codes the description was revised for HCPCS code Q5101. This revision is due to the 2018 Quarter 2 CPT/HCPCS Code Update. Under ICD-10 Codes that Support Medical Necessity Group 7: Paragraph added the verbiage Medicare is establishing the following limited coverage for facial, maxillofacial and oral reconstruction and prosthetics (refer to the CPT codes as listed in the CPT/HCPCS Group 7: Paragraph). The CPT codes and following diagnoses limit the use of reconstructive surgeries of the head and neck to the repair of injuries due to trauma or ablative surgery. Under Coverage Indications, Limitations and/or Medical Necessity Posterior Segment added the verbiage <5 mg/kg real weight and who lack other major risk factors. The presence of major risk factors or a dosage exceeding 5 mg/kg real weight may necessitate earlier and more frequent screening intervals to the last paragraph and last sentence as this verbiage was inadvertently omitted. Under Indications and Limitations - SCODI Retina added the verbiage <5 mg/kg real weight who lack other major risk factors are recommended to undergo screening beginning at the 5th year of exposure and annually thereafter. The presence of major risk factors or a dosage exceeding 5 mg/kg real weight may necessitate earlier and more frequent screening intervals to the last sentence as this verbiage was inadvertently omitted. 5/10/18 4/1/18 5/15/18 5/16/ /2018

45 CT of the Abdomen and Pelvis L34415 Rev #14 Non-Covered Category III CPT Codes L34555 Rev #24 Punctuation was corrected and words were capitalized or changed to lower case as appropriate throughout the policy. Under Coverage Indications, Limitations and/ or Medical Necessity - Pelvic CT removed the words transcatheter aortic valve implantation/replacement and the parentheses around the acronyms TAVI and TAVR in the tenth bullet. The second set of bullets were italicized. Under Bibliography changes were made to citations to reflect AMA citation guidelines. The reference date was updated from 2014 to 2016 in the second citation. A correction was made to the first author s initials, and the author Heiken JP and the publishing state was added to the fourth citation. The edition was changed and the author listing was corrected in the seventh citation. Under Coverage Indications, Limitations and/or Medical Necessity in the first sentence added the verbiage American Medical Association in front of the acronym AMA and added the verbiage Current Procedural Terminology in front of the acronym CPT. In the third sentence added the verbiage National Coverage Determination in front of the acronym NCD and added the verbiage Local Coverage Determination in front of the acronym LCD. Under the seventh bullet added the verbiage Skilled Nursing Facility in front of the acronym SNF. In the last sentence added the verbiage Investigational Device Exemption in front of the acronym IDE. 5/10/18 05/17/ /2018

46 Rituximab (Rituxan ) L35026 Rev #19 Under CMS National Coverage Policy added CMS Manual System, Pub , Medicare Claims Processing Manual, Change Request 10530, Transmittal 3996 dated March 9, Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D89.89 and G61.82 due to reconsideration requests. Under CPT/HCPCS Codes added a new Group 2: Paragraph, Group 2: Codes and added C9467 with Note: For Part A services only - effective on 04/01/2018. Under ICD-10 Codes that Support Medical Necessity added a new Group 2: Codes C81.01, C81.02, C81.00, C81.03, C81.04, C81.05, C81.06, C81.07, C81.08, C81.09, C81.10, C81.11, C81.12, C81.13, C81.14, C81.15, C81.16, C81.17, C81.18, C81.19, C81.20, C81.21, C81.22, C81.23, C81.24, C81.25, C81.26, C81.27, C81.28, C81.29, C81.30, C81.31, C81.32, C81.33, C81.34, C81.35, C81.36, C81.37, C81.38, C81.39, C81.40, C81.41, C81.42, C81.43, C81.44, C81.45, C81.46, C81.47, C81.48, C81.49, C81.70, C81.71, C81.72, C81.73, C81.74, C81.75, C81.76, C81.77, C81.78, C81.79, C81.90, C81.91, C81.92, C81.93, C81.94, C81.95, C81.96, C81.97, C81.98, C81.99, C82.00, C82.01, C82.02, C82.03, C82.04, C82.05, C82.06, C82.07, C82.08, C82.09, C82.10, C82.11, C82.12, C82.13, C82.14, C82.15, C82.16, C82.17, C82.18, C82.19, C82.20, C82.21, C82.22, C82.23, C82.24, C82.25, C82.26, C82.27, C82.28, C82.29, C82.30, C82.31, C82.32, C82.33, C82.34, C82.35, C82.36, C82.37, C82.38, C82.39,C82.40, C82.41, C82.42, C82.43, C82.44, C82.45, C82.46, C82.47, C82.48, C82.49, C82.50, C82.51, C82.52, C82.53, C82.54, C82.55, C82.56, C82.57, C82.58, C82.59, C82.60, C82.61, C82.62, C82.63, C82.64, C82.65, C82.66, C82.67, C82.68, C82.69, C82.80, C82.81, C82.82, C82.83, C82.84, C82.85, C82.86, C82.87, C82.88, C82.89, C82.90, C82.91, C82.92, C82.93, C82.94, C82.95, C82.96, C82.97, C82.98, C82.99, C83.00, C83.01, C83.02, C83.03, C83.04, C83.05, C83.06, C83.07, C83.08, C83.09, C83.10, C83.11, C83.12, C83.13, C83.14, C83.15, C83.16, C83.17, C83.18, C83.19, C83.30, C83.31, C83.32, C83.33, C83.34, C83.35, C83.36, C83.37, C83.38, C83.39, C83.50, C83.51, C83.52, C83.53, C83.54, C83.55, C83.56, C83.57, C83.58, C83.59, C83.70, C83.71, C83.72, C83.73, C83.74, C83.75, C83.76, C83.77, C83.78, C83.79, C83.80, C83.81, C83.82, C83.83, C83.84, C83.85, C83.86, C83.87, C83.88, C83.89, C83.90, C83.91, C83.92, C83.93, C83.94, C83.95, C83.96, C83.97, C83.98, C83.99, C84.60, C84.61, C84.62, C84.63, C84.64, C84.65, C84.66, C84.67, C84.68, C84.69, C84.70, C84.71, C84.72, C84.73, C84.74, C84.75, C84.76, C84.77, C84.78, C84.79, C84.A0, C84.A1, C84.A2, C84. A3, C84.A4, C84.A5, C84.A6, C84.A7, C84.A8, C84.A9, C84.Z0, C84.Z1, C84.Z2, C84.Z3, C84.Z4, C84.Z5, C84.Z6, C84.Z7, C84.Z8, C84.Z9, C84.90, C84.92, C84.93, C84.94, C84.95, C84.96, C84.97, C84.98, C84.99, C85.10, C85.11, C85.12, C85.13, C85.14, C85.15, C85.16, C85.17, C85.18, C85.19, C85.20, C85.21, C85.22, C85.23, C85.24, C85.25, C85.26, C85.27, C85.28, C85.29, C85.80, C85.81, C85.82, C85.83, C85.84, C85.85, C85.86, C85.87, C85.88, C85.89, C85.90, C85.91, C85.92, C85.93, C85.94, C85.95, C85.96, C85.97, C85.98, C85.99, C86.0, C86.1, C86.2, C86.3, C86.4, C86.5, C86.6, C88.0, C88.4, C91.00, C91.01, C91.02, C91.10, C91.11, C91.12, C91.40, C91.41, C91.42, C96.4, C96.Z, C96.9 and D47.Z1. Under Bibliography revisions were made to the sources to reflect AMA citation guidelines. 6/13/ /2018

47 Echocardiography L37379 Rev #6 Article Title Accreditation and Credentialing Requirements for Polysomnography LCD L36593 A55958 New Punctuation was corrected and words were capitalized or changed to lower case as appropriate throughout the policy. Acronyms replaced verbiage or were inserted in addition to verbiage where appropriate throughout the policy. CPT was inserted throughout the policy where applicable. Under Coverage Indications, Limitations and/or Medical Necessity added the words transthoracic echocardiogram in front of the acronym TTE in the second paragraph. Under the subheading M. Cardiac Tumors and Masses added the word a before the word cardiac in the last sentence in the paragraph. Under the subheading Indications and limitations for stress echocardiography 2. Unstable Angina added the words left ventricular in front of the acronym LV in the paragraph. Under 3. Chronic Ischemic Heart Disease added the word coronary artery bypass grafting before the acronym CABG in the first paragraph and added the word an before the word obvious in the fourth paragraph. Under the subheading W. Transesophageal Echocardiography (TEE) added the words and/or at the end of the third bullet after the second paragraph. Under Associated Information Documentation Requirements added the word the before the words A/B MAC in the first paragraph, changed the acronym from ECG to EKG in the third paragraph and added the word for before the word assessment in the fourth paragraph. Under Bibliography corrected the name of the journal in the third reference and corrected the source of information and the name of the journal in the fifth reference. Changes were made to citations to reflect AMA citation guidelines. Articles Revision effective date: For services performed on or after 07/01/2018 Accreditation and credentialing requirements: Please be aware of the following changes to accreditation and credentialing requirements: Palmetto GBA Local Coverage Determination L36593 sets forth the following standards for sleep centers that perform the technical component (TC) of polysomnography (PSG) and sleep testing (including home sleep testing): 5/10/18 Effective Date 4/5/18 1. The sleep center or laboratory must maintain documentation on file that indicates it is accredited by either: the American Academy of Sleep Medicine (AASM), or the Accreditation Commission for Health Care (ACHC), or the Ambulatory Care Accreditation Program of the Joint Commission This documentation must be available on request. The AASM, ACHC, or Joint Commission accreditation applies to the hospital and freestanding facilities (including sleep clinics that are part of a physician s office, and all other non-hospital-based facilities where sleep studies are performed. Diagnostic testing performed in an Independent Diagnostic Testing Facility (IDTF) must follow the supervision and credentialing guidelines set forth by CMS and/or Palmetto GBA. The sleep laboratory or testing facility must be affiliated with a hospital or be under the direction and control of a physician (MD/DO) who meets one of the following requirements, even though the diagnostic test may be performed in the absence of direct physician supervision. The raw data from all sleep tests must be reviewed and the tests must be interpreted by a physician who meets at least one of the following requirements: 46 6/2018

48 Accreditation and Credentialing Requirements for Polysomnography LCD L36593 A55958 New continued o Certification in Sleep Medicine by the American Board of Sleep Medicine (ABSM) or by a member board of either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA) o A completed fellowship in sleep medicine through an Accreditation Council for Graduate Medical Education (ACGME) accredited program. Following the completed fellowship, certification in sleep medicine is completed within two examination cycles through the American Board of Sleep Medicine (ABSM) or a member board of either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA) 4/5/18 Sleep centers in Jurisdiction M have been subject to these regulations since the implementation of the LCD on October 1, 2015 and similar regulations that appeared in previous versions of the Polysomnography LCD. Sleep centers in Jurisdiction J prior to February 26, 2018 were not required to meet similar standards by the previous contractor. All sleep centers in Jurisdiction J must now obtain accreditation by one of the three organizations listed above by July 1, 2018 in order to continue to render services to Medicare beneficiaries and submit claims to Palmetto GBA. Revision effective date: For services performed on or after 10/01/ As noted above in section 1, outpatient sleep centers affiliated with a hospital which is currently accredited by The Joint Commission (formerly JCAHO) through the hospital s accreditation will now be required to obtain separate ambulatory care accreditation for the sleep center if ambulatory services accreditation for the sleep center is not currently in place. This accreditation must be obtained by October 1, 2018 in order to continue to render services to Medicare beneficiaries and submit claims to Palmetto GBA. 3. There is a new physician-credentialing standard published by The Joint Commission (formerly JCAHO) for ambulatory care organizations providing sleep center services that reduces quality variation and aligns credentialing requirements for all sleep testing facilities defined by the Polysomnography LCD. Specifically, as of January 1, 2018, the Joint Commission requires that organizations verify that physicians have at least one of the following qualifications before granting initial or revised privileges to physicians responsible for interpreting sleep studies: o Certifi cation in Sleep Medicine by the American Board of Sleep Medicine (ABSM) or by a member board of either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA) OR o A completed fellowship in sleep medicine through an Accreditation Council for Graduate Medical Education (ACGME) accredited program. Following the completed fellowship, certification in sleep medicine is completed within two examination cycles through the American Board of Sleep Medicine (ABSM) or a member board of either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA). 47 6/2018

49 Accreditation and Credentialing Requirements for Polysomnography LCD L36593 A55958 New continued Durolane Coding and Billing Guidelines A55967 New The above language is not a new requirement under the Polysomnography LCD L Since its implementation on October 1, 2015, this LCD has required and continues to require, regardless of the standards put forth by any of the three listed accrediting organizations, that the sleep laboratory or testing facility be affiliated with a hospital or be under the direction and control of a physician (MD/ DO) who meets one of the above requirements. The raw data from all sleep tests must be reviewed and the tests must be interpreted by a physician who meets at least one of the above requirements. This documentation must be available upon request. Please review the entire LCD (L36593) for complete information regarding polysomnography testing and billing requirements. Durolane (hyaluronate sodium solution for injection) is indicated for adults 22 years and older for the treatment of pain in osteoarthritis of the knee when response to conservative nonpharmacologic therapy and simple analgesics (e.g., acetaminophen) has been inadequate. 4/5/18 5/3/18 Article Title Accreditation and Credentialing Requirements for Polysomnography LCD L36593 A55945 Retire Only a single injection is necessary to complete a treatment course per affected knee when indicated. If treatment is bilateral, use a separate 3 ml syringe to administer the dose to the second knee. The effectiveness of more than 1 treatment course has not been established. For Part A Services Only: Effective for dates of service 04/01/2018, to report Durolane on a claim, enter C9465- Hyaluronan or Derivative, Durolane, for Intra-Articular Injection, Per Dose. When submitting a claim, the name of the drug and the NDC number and dose must be reported in the remarks field (Field Locator 80) on the UB-04 (CMS 1450 form) or the equivalent 5010 electronic claims field. For Part B Services Only: To report Durolane on a claim, enter code as J3490 as Durolane does not have a unique HCPCS code at this time. The name of the drug and the NCD number and dose must be reported in Box 19 of the CMS 1500 form or its electronic equivalent. Retired Articles Accreditation and Credentialing Requirements for Polysomnography LCD L36593 Article A55945 is being retired effective 4/17/18 as the original effective date was entered incorrectly. The retired article is being replaced with the Accreditation and Credentialing Requirements for Polysomnography LCD L36593 Article A55958 effective 4/05/18. Date of Retirement 4/17/ /2018

50 MolDX Local Coverage Determinations Policy Title LCD Revision Effective Date MolDX: Decipher Prostate Cancer Classifier Assay L35868, #7 MolDX: Decipher Prostate Cancer Classifier Assay L35868, #8 Palmetto GBA inadvertently deleted the end of a sentence, Of the men that developed metastatic disease, only 16% of men received adjuvant XRT (43% received salvage XRT) and 57% of these men received adjuvant androgen deprivation. Despite an imbalance between the non-metastasis and metastasis groups, as would be expected in a retrospective study, the Decipher GC showed that men with a high GC score ( 0.4) had a 8 year risk of metastatic disease of > 50% where as those with a GC score of, and added it back <0.4 had a risk of metastatic disease of approximately 10%. Revision #6 verbiage Removed CDD from the title. Revised the second bullet in the Criteria for Coverage to remove undetectable PSA and change it to at or below 0.2 ng/ml within 120 days of RP surgery. is retro-active to 10/1/15. No other changes to the policy. 04/12/18 04/19/18 Article Title Article Revision Effective Date MolDX: biotheranostics Cancer TYPE ID A53101, #14 MolDX: CDH1 Genetic Testing Coding and Billing Guidelines A54835, #3 Added D49.59 to ICD-10 Codes Group 1. This ICD-10 code addition is retro-active to 10/01/ /26/18 Added MolDX to the title, no additional changes. 5/10/ /2018

51 Special Edition - Friday, April 27, 2018 Skilled Nursing Facility: Proposed FY 2019 Payment and Policy Changes CMS issued a proposed rule outlining proposed FY 2019 Medicare payment updates and proposed quality program changes for Skilled Nursing Facilities (SNFs). Proposed Rule Details: Advancing My HealthEData: Request for Information from stakeholders Modernizing the SNF Prospective Payment System (PPS) Case-mix Classification System SNF Quality Reporting Program (QRP) SNF Value-Based Purchasing Program (VBP) Payment rate changes under SNF PPS For More Information: Proposed Rule: CMS will accept comments until June 26 at documents/2017/05/04/ /medicare-program-prospective-payment-system-and-consolidatedbilling-for-skilled-nursing-facilities Press Release: Press-releases/2018-Press-releases-items/ html?dlpage=1&dlentries=10&dlsort=0&dlsortdir=descending&wb =b657716e SNF PPS website: html SNF QRP website: NursingHomeQualityInits/Skilled-Nursing-Facility-Quality-Reporting-Program/SNF-Quality Reporting-Program-IMPACT-Act-2014.html IMPACT Act of 2014 Data Standardization & Cross Setting Measures webpage: Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/ IMPACT-Act-of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting-Measures.html SNF VBP Program website: Instruments/Value-Based-Programs/Other-VBPs/SNF-VBP.html See the full text of this excerpted CMS Fact Sheet (issued April 27): ( html?dlpage=1&dlentries=10&dlsort=0&dlsortdir=descending&wb =b657716e) Inpatient Rehabilitation Facility: Prospective Payment System FY 2019 Proposed Rule On April 27, CMS proposed changes on how Medicare pays Inpatient Rehabilitation Facilities (IRFs) to make it easier for providers to spend more time with their patients and improve the use of electronic health records. Proposed Rule Details: Advancing My HealthEData: Request for Information from stakeholders Burden reduction / Patients over Paperwork Meaningful Measures 50 6/2018

52 Proposed updates to IRF payment rate s Solicitation of comments regarding additional changes to the physician supervision requirement For More Information: Proposed Rule: CMS will accept comments until June 26: documents/2018/05/08/ /medicare-program-inpatient-rehabilitation-facility-prospectivepayment-system-for-federal-fiscal Press Release: See the full text of this excerpted CMS Fact Sheet (issued April 27): gov/newsroom/mediareleasedatabase/fact-sheets/2018-fact-sheets-items/ html?dlpage=1&dlentries=10&dlsort=0&dlsortdir=descending Inpatient Psychiatric Facility: FY 2019 Payment and Quality Reporting Updates On April 27, CMS issued a rule proposing updates for FY 2019 to Medicare payment policies and rates for the Inpatient Psychiatric Facility (IPF) Prospective Payment System (PPS) and the IPF Quality Reporting Program. Proposed Rule Details: Advancing My HealthEData: Request for Information from stakeholders Meaningful Measures Proposed payment updates Proposed technical corrections to IPF regulations IPF PPS refinements comment solicitation For More Information: Proposed Rule: CMS will accept comments until June 26: documents/2018/05/08/ /medicare-program-inpatient-rehabilitation-facility-prospectivepayment-system-for-federal-fiscal Press Release: See the full text of this excerpted CMS Fact Sheet (issued April 27): gov/newsroom/mediareleasedatabase/fact-sheets/2018-fact-sheets-items/ html?dlpage=1&dlentries=10&dlsort=0&dlsortdir=descending Hospice: Proposed Updates to the Wage Index and Payment Rates for FY 2019 On April 27, CMS issued a proposed rule that would update FY 2019 Medicare payment rates and the wage index for hospices serving Medicare beneficiaries. This rule also proposes changes to the Hospice Quality Reporting Program. Proposed Rule Details: Advancing My HealthEData: Request for Information from stakeholders Burden reduction Meaningful Measures 51 6/2018

53 Routine annual rate setting changes Hospice regulations text changes due to the Bipartisan Budget Act of 2018 Improving transparency for patients For More Information: Proposed Rule: CMS will accept comments until June 26: documents/2018/05/08/ /medicare-program-fy-2019-hospice-wage-index-and-payment-rateupdate-and-hospice-quality-reporting Press Release: See the full text of this excerpted CMS Fact Sheet (issued April 27): gov/newsroom/mediareleasedatabase/fact-sheets/2018-fact-sheets-items/ html?dlpage=1&dlentries=10&dlsort=0&dlsortdir=descending&wb =ca0bcc /2018

54 MLN Connects TM MLN Connects contains a week s worth of Medicare-related messages instead of many different messages being sent to you throughout the week. This notification process ensures planned, coordinated messages are delivered timely about Medicare-related topics. MLN Connects for May 3, MLN Connects for May 10, MLN Connects for May 17, MLN Connects for May 24, /2018