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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 PART B MEDICARE ADVISORY Latest Medicare News for Part B October 2017 Volume 2017, Issue 10 What s Inside... Administration CMS Quarterly Provider Update... 3 Going Beyond Diagnosis... 3 Get Your Medicare News Electronically...4 Hurricane Irma and Medicare Disaster Related South Carolina and Georgia Claims...6 Revision to Publication , Chapter 3, Medicare Overpayment Manual, Section 200, Limitation on Recoupment...9 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) October Quarterly Update for 2017 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule Education MACtoberfest Workshop Conference: Innovation Today for Success Tomorrow...13 Educational Events Where You Can Ask Questions and Get Answers from Palmetto GBA...15 Fee Schedules and Reimbursement Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) October 2017 Update...17 Annual Clotting Factor Furnishing Fee Update Medicine Screening for Hepatitis B Virus (HBV) Infection...21 Ambulance Internet Only Manual (IOM) Update to Pub , Chapter 15 - Ambulance, to Restore Multiple Patients on One Trip Instructions...29 palmettogba.com/jmb The 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 ofϐicial 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 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 2016 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 2016 American Dental Association (ADA). All rights reserved.

3 Ambulatory Surgical Center (ASC) October 2017 Update of the Ambulatory Surgical Center (ASC) Payment System Skilled Nursing Facility (SNF) 2018 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Update Therapy Updated Editing of Always Therapy Services - MCS Etcetera Medical Director s Desk MLN ConnectsTM CMS Provider Minute Videos The Medicare Learning Network has a series of CMS Provider Minute Videos ( Learning-Network-MLN/MLNProducts/MLN-Multimedia.html) 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 10/2017

4 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 3 10/2017

5 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. 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. 4 10/2017

6 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, web-based 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. 5 10/2017

7 Hurricane Irma and Medicare Disaster Related South Carolina and Georgia Claims MLN Matters Number: SE17024 Article Release Date: September 11, 2017 Related CR Transmittal Number: N/A Related Change Request (CR) Number: N/A Effective Date: N/A Implementation Date: N/A PROVIDER TYPES AFFECTED This MLN Matters Special Edition Article is intended for providers and suppliers who submit claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries in the States of South Carolina and Georgia who were affected by Hurricane Irma. PROVIDER INFORMATION AVAILABLE On September 7, 2017, pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act, President Trump declared that, as a result of the effects of Hurricane Irma, an emergency exists in the State of South Carolina. On September 8, 2017, pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act, President Trump declared that, as a result of the effects of Hurricane Irma, an emergency exists in the State of Georgia. Also on September 8, 2017, Secretary Price of the Department of Health & Human Services declared that a public health emergency exists in the States of South Carolina and Georgia and authorized waivers and modifications under Section 1135 of the Social Security Act (the Act), retroactive to September 6, 2017, for the State of South Carolina and retroactive to September 7, 2017, for the State of Georgia. On September 8, 2017, the Administrator of the Centers for Medicare & Medicaid Services (CMS) authorized waivers under Section 1812(f) of the Social Security Act for the States of South Carolina and Georgia, for those people who are evacuated, transferred, or otherwise dislocated as a result of the effect of Hurricane Irma in Under Section 1135 or 1812(f) of the Social Security Act, the CMS has issued several blanket waivers in the impacted counties and geographical areas of the States of South Carolina and Georgia. These waivers will prevent gaps in access to care for beneficiaries impacted by the emergency. Providers do not need to apply for an individual waiver if a blanket waiver has been issued. Providers can request an individual Section 1135 waiver, if there is no blanket waiver, by following the instructions available at CMS/Agency-Information/Emergency/Downloads/Requesting-an-1135-Waiver-Updated pdf. The most current waiver information can be found under Administrative Actions at See the Background section of this article for more details. BACKGROUND Section 1135 and Section 1812(f) Waivers As a result of the aforementioned declaration, CMS has instructed the MACs as follows: 1. Change Request (CR) 6451 (Transmittal 1784, Publication ) issued on July 31, 2009, applies to items and services furnished to Medicare beneficiaries within the State of South Carolina from September 6 10/2017

8 6, 2017, and the State of Georgia from September 7, 2017, for the duration of the emergency. In accordance with CR6451, use of the DR condition code and the CR modifier are mandatory on claims for items and services for which Medicare payment is conditioned on the presence of a formal waiver including, but not necessarily limited to, waivers granted under either Section 1135 or Section 1812(f) of the Act. 2. The most current information can be found at Medicare FFS Questions & Answers (Q&As) posted in the downloads section at the bottom of the Emergency Response and Recovery webpage and also referenced below are applicable for items and services furnished to Medicare beneficiaries within the States of South Carolina and Georgia. These Q&As are displayed in two files: The first listed file addresses policies and procedures that are applicable without any Section 1135 or other formal waiver. These policies are always applicable in any kind of emergency or disaster, including the current emergency in the States of South Carolina and Georgia. The second file addresses policies and procedures that are applicable only with approved Section 1135 waivers or, when applicable, approved Section 1812(f) waivers. These Q&As are applicable for approved Section 1135 blanket waivers and approved individual 1135 waivers requested by providers and are effective September 6, 2017, for the State South Carolina and September 7, 2017, for the State of Georgia. In both cases, the links below will open the most current document. The date included in the document filename will change as new information is added, or existing information is revised. a) Q&As applicable without any Section 1135 or other formal waiver are available at About-CMS/Agency-Information/Emergency/Downloads/Consolidated_Medicare_FFS_Emergency_QsAs.pdf. b) Q&As applicable only with a Section 1135 waiver or, when applicable, a Section 1812(f) waiver, are available at EmergencyQsAs1135Waiver.pdf. Blanket Waivers Issued by CMS Under the authority of Section 1135 (or, as noted below, Section 1812(f)), CMS has issued blanket waivers in the affected area of the States of South Carolina and Georgia. Individual facilities do not need to apply for the following approved blanket waivers: Skilled Nursing Facilities Section 1812(f): Waiver of the requirement for a 3-day prior hospitalization for coverage of a skilled nursing facility (SNF) stay provides temporary emergency coverage of SNF services without a qualifying hospital stay, for those people who are evacuated, transferred, or otherwise dislocated as a result of the effect of Hurricane Irma in the States of South Carolina and Georgia in In addition, for certain beneficiaries who recently exhausted their SNF benefits, it authorizes renewed SNF coverage without first having to start a new benefit period. (Blanket waiver for all impacted facilities) 42 CFR : Waiver provides relief to Skilled Nursing Facilities on the timeframe requirements for Minimum Data Set assessments and transmission. (Blanket waiver for all impacted facilities) Home Health Agencies 42 CFR (c)(1): This waiver provides relief to Home Health Agencies on the timeframes related to OASIS Transmission. (Blanket waiver for all impacted agencies) 7 10/2017

9 Critical Access Hospitals This action waives the requirements that Critical Access Hospitals limit the number of beds to 25, and that the length of stay be limited to 96 hours. (Blanket waiver for all impacted hospitals) Housing Acute Care Patients In Excluded Distinct Part Units CMS has determined it is appropriate to issue a blanket waiver to IPPS hospitals that, as a result of Hurricane Irma, need to house acute care inpatients in excluded distinct part units, where the distinct part unit s beds are appropriate for acute care inpatient. The IPPS hospital should bill for the care and annotate the patient s medical record to indicate the patient is an acute care inpatient being housed in the excluded unit because of capacity issues related to Hurricane Irma. (Blanket waiver for all IPPS hospitals located in the affected areas that need to use distinct part beds for acute care patients as a result of the hurricane.) Durable Medical Equipment, Prosthetics, Orthotics, and Supplies for Medicare Beneficiaries Impacted by an Emergency or Disaster As a result of Hurricane Irma, CMS has determined it is appropriate to issue a blanket waiver to suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) where DMEPOS is lost, destroyed, irreparably damaged, or otherwise rendered unusable. Under this waiver, the face-to-face requirement, a new physician s order, and new medical necessity documentation are not required for replacement. Suppliers must still include a narrative description on the claim explaining the reason why the equipment must be replaced and are reminded to maintain documentation indicating that the DMEPOS was lost, destroyed, irreparably damaged or otherwise rendered unusable as a result of the hurricane. For more information refer to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies for Medicare Beneficiaries Impacted by an Emergency or Disaster fact sheet at Information/Emergency/Downloads/Emergency-DME-Beneficiaries-Hurricanes.pdf. Appeal Administrative Relief for Areas Affected by Hurricane Irma If you were affected by Hurricane Irma and are unable to file an appeal within 120 days from the date of receipt of the Remittance Advice (RA) that lists the initial determination or will have an extended period of non-receipt of remittance advices that will impact your ability to file an appeal, please contact your Medicare Administrative Contractor. Requesting an 1135 Waiver Information for requesting an 1135 waiver, when a blanket waiver hasn t been approved, can be found at Updated pdf. ADDITIONAL INFORMATION The Centers for Disease Control and Prevention released ICD-10-CM coding advice ( to report healthcare encounters in the hurricane aftermath. DOCUMENT HISTORY Date of Change Description September 11, 2017 Initial article released. 8 10/2017

10 Revision to Publication , Chapter 3, Medicare Overpayment Manual, Section 200, Limitation on Recoupment MLN Matters Number: MM9815 Related Change Request (CR) #: CR 9815 Related CR Release Date: September 14, 2017 Effective Date: April 2, 2018 Related CR Transmittal #: R293FM Implementation Date: April 2, 2018 Revised: This article was revised on September 15, 2017, to reflect an updated Change Request that corrected format errors in the manual instructions. In the article, the CR release date, transmittal number, and link to the transmittal changed. All other information remains the same. 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) 9815 updates the Centers for Medicare & Medicaid Services (CMS) Medicare Financial Management Manual, Chapter 3, Sections , Limitation on Recoupment Overpayments. CR9815 is the first of four CRs that are forthcoming and incorporated into this manual. Make sure your billing staffs are aware of these updates that relate to the limitation on recovery of certain overpayments. Background Section 1893(f)(2)(a) of the Social Security Act and the provision in the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) prohibits recouping Medicare overpayments from a provider or supplier that seeks a reconsideration from a Qualified Independent Contractor (QIC). This provision cha nged how interest is to be paid to a provider or supplier whose overpayment is reversed at subsequent administrative or judicial levels of appeal. The final rule defines the overpayments to which the limitation applies, how the limitation works in concert with the appeals process, and the change in our obligation to pay interest to a provider or supplier whose appeal is successful at levels above the QIC. This section also limits recoupment of Medicare overpayments when a provider or supplier seeks a redetermination until a redetermination decision is rendered. The MAC will cease recoupment or not begin recoupment when the MAC receives a valid redetermination or reconsideration request timely on an overpayment subject to these limitations The provider has until the appeal deadline to file an appeal (refer to the Medicare Claims Processing Manual, Chapter 29 at If a provider wants to delay recoupment, it must submit the redetermination appeal request within 30 days of the demand letter date. To continue the delayed recoupment, the provider will have 60 days from the redetermination decision to submit a reconsideration request. If the request is received before the appeal deadline but after recoupment has started, the MAC will stop the recoupment. The MAC shall not refund any monies collected back to the provider, unless otherwise directed by the Centers for Medicare & Medicaid Services (CMS). The MAC will be accountable to ensure the debts continue to age and accrue interest until the debt is paid in full. 9 10/2017

11 After the first two levels of appeal are completed, the MAC shall resume recoupment and normal debt collection processes. Whether or not the provider subsequently appeals the overpayment to the Administrative Law Judge (ALJ), or subsequent levels (Department Appeals Board (DAB), or Federal court), the MAC shall initiate recoupment at 100% until the debt is satisfied in full, unless an Extended Repayment Schedule (ERS) is established. If the debt was referred to Treasury and the provider files for an appeal, the MAC shall recall the debt from Treasury while in an appeal status. If the appeal decision is unfavorable to the provider, any outstanding debt will be referred back to Treasury, unless an approved Extended Repayment Schedule (ERS) is established or the provider pays the debt in full. Additional Information The official instruction, CR9815, issued to your MAC regarding this change is available at Chapter 29 of the Medicare Claims Processing Manual is available at Document History Date of Change September 15, 2017 September 1, 2017 Description The article was revised to reflect an updated CR that corrected format errors in the manual instructions. In the article, the CR release date, transmittal number, and link to the transmittal changed. Initial article issued Global Surgery Calculator Self-Service Tool This tool will allow you to calculate both 10 and 90 day global surgery periods. You can also look up your 2017 procedure code global days requirement by using this tool. Just enter the procedure code in the tool and the global surgery indicator information will appear. Access the Global Surgery Calculator tool under Forms/Tools on the home page /2017

12 October Quarterly Update for 2017 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule MLN Matters Number: MM10248 Related CR Release Date: September 8, 2017 Related CR Transmittal Number: R3859CP Related Change Request (CR) Number: CR Effective Date: October 1, 2017 Implementation Date: October 2, 2017 PROVIDER TYPE AFFECTED This MLN Matters Article is intended for providers and suppliers submitting claims to Medicare Administrative Contractors (MACs) for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items or services paid under the DMEPOS fee schedule. PROVIDER ACTION NEEDED Change Request (CR) provides instructions regarding the October quarterly update for the 2017 DMEPOS and parenteral and enteral nutrition (PEN) fee schedules and the October 2017 DMEPOS Rural ZIP code file containing the Quarter 4, 2017 Rural ZIP code changes. It includes information, when necessary, to implement fee schedule amounts for new codes and correct any fee schedule amounts for existing codes. BACKGROUND The DMEPOS fee schedule is updated on a quarterly basis, when necessary, to implement fee schedule amounts for new codes and correct any fee schedule amounts for existing codes, and the quarterly update process for the DMEPOS fee schedule is covered in the Medicare Claims Processing Manual, Chapter 23, Section 60 at Payment on a fee schedule basis is required for DMEPOS and surgical dressings by the Social Security Act, Section 1834(a), (h), and (i) at Also, payment on a fee schedule basis is a regulatory requirement at 42 CFR for PEN, splints and casts, and intraocular lenses (IOLs) inserted in a physician s office. Additionally, the Social Security Act (Section 1834(a)(1)(F)(ii)) mandates adjustments to the fee schedule amounts for certain items furnished on or after January 1, 2016, in areas that are not competitive bid areas, based on information from competitive bidding programs (CBPs) for DME. The Social Security Act (Section 1842(s)(3)(B)) provides authority for making adjustments to the fee schedule amount for enteral nutrients, equipment and supplies (enteral nutrition) based on information from CBPs. Also, the adjusted fees apply a rural payment rule. The DMEPOS and PEN fee schedule files contain HCPCS codes that are subject to the adjustments as well as codes that are not subject to the fee schedule adjustments. Additional information on adjustments to the fee schedule amounts based on information from CBPs is available at Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9642.pdf, Transmittal 3551, dated June 23, /2017

13 The ZIP code associated with the address used for pricing a DMEPOS claim determines the rural fee schedule payment applicability for codes with rural and non-rural adjusted fee schedule amounts. ZIP codes for noncontinental Metropolitan Statistical Areas (MSA) are not included in the DMEPOS Rural ZIP code file. The DMEPOS Rural ZIP code file is updated on a quarterly basis as necessary. Effective with the October update, code K0861 RR KF is removed from the fee schedule file. The October 2017 DMEPOS Rural ZIP code file public use files (PUFs) will be available for State Medicaid Agencies, managed care organizations, and other interested parties shortly after the release of the data files at ADDITIONAL INFORMATION The official instruction, CR10248, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change Description September 12, 2017 Initial article released 12 10/2017

14 MACtoberfest Workshop Conference: Innovation Today for Success Tomorrow Date: October 11, 2017 Audience: Part B Location: Palmetto GBA Government Programs Complex (GPC), Columbia, South Carolina Schedule: 8-8:30 a.m. Registration 8:30 a.m. - 4:30 p.m. Workshop Palmetto GBA, the JM A/B MAC, is presenting an informative workshop in Columbia, South Carolina that will provide information related to the most common errors identified through a variety of data analysis and tips to avoid them. This workshop is intended to keep providers apprised of Medicare guidelines as well as using technology for better results. The recommended participants are Part B administrators, billers, nurses and other healthcare professionals that submit claims to Medicare. Topics include: Electronic Data Interchange (EDI) Medicare Part B Updates Appeals Medical Affairs Medical Review eservices Online Secure Portal Provider Enrollment Revalidations This is a FREE event! To reserve your seat and/or schedule an appointment with a representative, make sure you: Create a profile in the Event Registration Portal if you do not already have one Register yourself as well as others at your facility or provider practice Be sure to select Registration and All Day Workshop In addition to registering for this workshop, you may also choose to sign up for a 30-minute appointment to: Discuss specific issues with a Provider Contact Center representative Attend an e-services session with a Palmetto GBA employee. An active user ID and password are required for this session. Each facility/office may have multiple staff members in each session. Note that if you sign up for multiple time slots for the same workshop, you will be attending the first time slot selected. Palmetto GBA reserves the right to limit the number of attendees from one facility or provider practice to assure as many providers are able to attend as possible /2017

15 Due to the limited availability of appointment slots providers are asked to sign up for no more than one of each type per facility/office in order to allow other providers to have the opportunity for an appointment. Providers are reminded: Registration is required Handouts will be ed to each registrant prior to the event Sign in the day of the event begins no earlier than 30 minutes prior to the event start time Please bring your Provider Transaction Access Number (PTAN) and National Provider Identifier (NPI) Bringing a light jacket or sweater may help to assure your comfort Palmetto GBA will not provide refreshments but vending machines and a cafeteria are onsite for your convenience 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 /2017

16 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: A/B MACs Team Up with DME MACs for External Breast Prostheses and Related Mastectomy Supplies Webinar: October 18 A/B MACs Team Up with DME MACs for External Breast Prostheses and Related Mastectomy Supplies Webinar on October 18, 2017! Local A/B MACs and the DME MACs are excited to announce two collaboration webinars coming October 18, The event will be offered twice in the same day to accommodate national attendees. This webinar will focus on Medicare s coverage of External Breast Prostheses and related supplies following surgical intervention. The educational representatives hosting the webinar will also spend time reviewing documentation requirements (such as detailed written orders and medical records). There will be plenty of time for questions after the presentation portion of the webinar. Please register today for the one that works for you! Date Registration Oct 18 Oct 18 Time 11 AM 4 PM 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 15 10/2017

17 Quarterly Updates Webcasts Event Registration Portal 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. 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 /2017

18 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) October 2017 Update MLN Matters Number: MM10222 Related CR Release Date: August 25, 2017 Related CR Transmittal Number: R3838CP Related Change Request (CR) Number: Effective Date: January 1, 2017 Implementation Date: October 2, 2017 PROVIDER TYPE AFFECTED This MLN Matters Article is intended for physicians, other 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 that were issued to the MACs based upon the Calendar Year (CY) 2017 Medicare Physician Fee Schedule (MPFS) Final Rule. Please make sure your billing staffs are aware of these changes. BACKGROUND Payment files are issued to the MACs based upon the CY 2017 MPFS Final Rule, published in the Federal Register on November 15, 2016, to be effective for services furnished between January 1, 2017, and December 31, Section 1848(c)(4) of the Social Security Act authorizes the Secretary of the Department of Health & Human Services (HHS) to establish ancillary policies necessary to implement relative values for physicians services. This article presents a summary of the changes for the October update to the 2017 MPFSDB. Unless otherwise stated, these changes are effective for dates of service on and after January 1, CPT/HCPCS & Mod Action Pre Op = 0, Intra Op = 0, Post Op = Bilateral Surg = Post Op = Status Indicator = C for dates of service 1/1/17 or after A4575 Status Indicator = X for dates of service 4/3/17 or after The following new codes have been added to the HCPCS file, effective August 1, The HCPCS file coverage code is C (carrier judgment) for these new codes. Coverage and payment will be determined by your MAC (they are not part of the MPFS) /2017

19 CPT Code Short Descriptor 0006U RX MNTR 120+ DRUGS & SBSTS 0007U 0008U 0009U 0010U 0011U 0012U 0013U 0014U 0015U RX TEST PRSMV UR W/DEF CONF HPYLORI DETCJ ABX RSTNC DNA ONC BRST CA ERBB2 AMP/NONAMP NFCT DS STRN TYP WHL GEN SEQ RX MNTR LC-MS/MS ORAL FLUID GERMLN DO GENE REARGMT DETCJ ONC SLD ORG NEO GENE REARGMT HEM HMTLMF NEO GENE REARGMT RX METAB ADVRS RX RXN DNA Long Descriptor Prescription drug monitoring, 120 or more drugs and substances, definitive tandem mass spectrometry with chromatography, urine, qualitative report of presence (including quantitative levels, when detected) or absence of each drug or substance with description and severity of potential interactions, with identified substances, per date of service Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, includes specimen verification including DNA authentication in comparison to buccal DNA, per date of service Helicobacter pylori detection and antibiotic resistance, DNA, 16S and 23S rrna, gyra, pbp1, rdxa and rpob, next generation sequencing, formalin-fixed paraffin embedded or fresh tissue, predictive, reported as positive or negative for resistance to clarithromycin, fluoroquinolones, metronidazole, amoxicillin, tetracycline and rifabutin Oncology (breast cancer), ERBB2 (HER2) copy number by FISH, tumor cells from formalin fixed paraffin embedded tissue isolated using image-based dielectrophoresis (DEP) sorting, reported as ERBB2 gene amplified or non-amplified Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, using oral fluid, reported as a comparison to an estimated steady-state range, per date of service including all drug compounds and metabolites Germline disorders, gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood, report of specific gene rearrangement(s) Oncology (solid organ neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, fresh or frozen tissue or cells, report of specific gene rearrangement(s) Hematology (hematolymphoid neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood or bone marrow, report of specific gene rearrangement(s) Drug metabolism (adverse drug reactions), DNA, 22 drug metabolism and transporter genes, real-time PCR, blood or buccal swab, genotype and metabolizer status for therapeutic decision support 18 10/2017

20 0016U 0017U ONC HMTLMF NEO RNA BCR/ABL1 ONC HMTLMF NEO JAK2 MUT DNA Oncology (hematolymphoid neoplasia), RNA, BCR/ABL1 major and minor breakpoint fusion transcripts, quantitative PCR amplification, blood or bone marrow, report of fusion not detected or detected with quantitation Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of exons and sequence analysis, blood or bone marrow, report of JAK2 mutation not detected or detected The short descriptors for the technical and professional components of the following codes were not displaying properly on the MPFS and did not match the HCPCS file. The global procedure accurately reflects the short descriptor from the HCPCS file. This display issue has been corrected and the short descriptors for the technical and professional components now read as follows on the MPFS: TC Endoluminl ivus oct c 1st Endoluminl ivus oct c 1st TC Endoluminl ivus oct c ea Endoluminl ivus oct c ea G0202 TC Scr mammo bi incl cad G Scr mammo bi incl cad G0204 TC Dx mammo incl cad bi G Dx mammo incl cad bi G0206 TC Dx mammo incl cad uni G Dx mammo incl cad uni Providers should be aware that MACs do not need to search their files to either retract payment for claims already paid or to retroactively pay claims. However, MACs will adjust claims that you bring to their attention. ADDITIONAL INFORMATION The official instruction, CR10222, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change August 29, 2017 Description Initial article released /2017

21 Annual Clotting Factor Furnishing Fee Update 2018 MLN Matters Number: MM10254 Related Change Request (CR) Number: CR10254 Related CR Release Date: September 15, 2017 Effective Date: January 1, 2018 Related CR Transmittal Number: R3862CP Implementation Date: January 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 related to the administration of clotting factors provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) announces the clotting factor furnishing fee for 2018 is $0.215 per unit. Make sure that your billing staffs are aware of this update to the annual clotting factor furnishing fee for BACKGROUND The Centers for Medicare and Medicaid Services (CMS) includes the clotting factor furnishing fee in the published national payment limits for clotting factor billing codes. When the national payment limit for a clotting factor is not included on the Average Sales Price (ASP) Medicare Part B Drug Pricing File or the Not Otherwise Classified (NOC) Pricing File, the MACs make payment for the clotting factor as well as payment for the furnishing fee. For dates of service from January 1, 2018, through December 31, 2018, the clotting factor furnishing fee of $0.215 per unit is added to the payment limit for the clotting factor. ADDITIONAL INFORMATION The official instruction, CR10254, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change Description September 15, 2017 Initial article released /2017

22 Screening for Hepatitis B Virus (HBV) Infection MLN Matters Number: MM9859 Revised Related Change Request (CR) #: CR 9859 Related CR Release Date: August 4, 2017 Effective Date: September 28, 2016 Related CR Transmittal #: R3831CP and R198NCD Implementation Date: January 2, 2018 Note: This article was revised on August 8, 2017, to reflect an updated Change Request (CR) In the article, the CR release date, transmittal numbers, and the Web address of the CR are revised. Also, a clarification was made on page 3 to denote that HBV is not separately payable for ESRD TOB 72X unless reported with modifier AY. Another bullet point was added on page 3 to show that contractor pricing applies to G0499 with dates of service September 28, 2016 through December 31, All other information is unchanged. Provider Types Affected This MLN Matters Article is intended for physicians and other providers submitting claims to Medicare Administrative Contractors (MACs) for services to Medicare beneficiaries. Provider Action Needed CR 9859 provides that the Centers for Medicare & Medicaid Services (CMS) has determined that, effective September 28, 2016, Medicare will cover screening for Hepatitis B Virus (HBV) infection when performed with the appropriate U.S. Food and Drug Administration (FDA) approved/cleared laboratory tests, used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations. Medicare coinsurance and the Part B deductible are waived for this additional preventive service. You should ensure that your billing staffs are aware of this coverage change. Background Pursuant to Section 1861(ddd) of the Social Security Act (the Act), CMS may add coverage of additional preventive services through the National Coverage Determination (NCD) process. The preventive services must meet all of the following criteria: 1. Reasonable and necessary for the prevention or early detection of illness or disability. 2. Recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF). 3. Appropriate for individuals entitled to benefits under Part A or enrolled under Part B. The USPSTF has updated its recommendations for HBV screening, and CMS has reviewed these recommendations and supporting evidence; and has determined that the evidence is adequate to conclude that screening for HBV infection is reasonable and necessary for individuals entitled to benefits under Part A or enrolled under Part B, as described below. Effective for services performed on or after September 28, 2016, Medicare will cover screening for HBV infection, when ordered by the beneficiary s primary care physician or practitioner within the context of a primary care setting, and performed by an eligible Medicare provider for these services, within the context of a primary care setting with the appropriate U.S. Food and Drug Administration (FDA) approved/cleared 21 10/2017

23 laboratory tests, used consistent with FDA-approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, for beneficiaries who meet either of the following conditions: 1. Asymptomatic, non-pregnant adolescents and adults at high risk for HBV infection. High risk is defined as persons born in countries and regions with a high prevalence of HBV infection (that is, 2%), US-born persons not vaccinated as infants whose parents were born in regions with a very high prevalence of HBV infection ( 8%), HIV positive persons, men who have sex with men, injection drug users, household contacts or sexual partners of persons with HBV infection. In addition, CMS has determined that repeated screening would be appropriate annually for beneficiaries with continued high risk persons. Testing is covered annually only for persons who have continued high risk(men who have sex with men, injection drug users, household contacts or sexual partners of persons with HBV infection) who have not received hepatitis B vaccination. 2. A screening test at the first prenatal visit is covered for pregnant women and then rescreening at time of delivery for those with new or continuing risk factors. In addition, CMS has determined that screening during the first prenatal visit would be appropriate for each pregnancy, regardless of previous hepatitis B vaccination or previous negative hepatitis B surface antigen (HBsAg) test results. For the purposes of CR9859: The determination of high risk for HBV is identified by the primary care physician or practitioner who assesses the patient s history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided. A primary care setting is defined by the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services, and hospice are examples of settings not considered primary care settings under this definition. Key Points of CR9859 Applicable Healthcare Common Procedure Coding System (HCPCS) Code Effective for claims with dates of service on or after September 28, 2016, the claims processing instructions for payment of screening for hepatitis B virus will apply to the following HCPCS and CPT codes: HBV screening for asymptomatic, non-pregnant adolescents and adults at high risk - code G0499 HBV screening for pregnant women - CPT codes 86704, 86706, 87340, and Types of Bills (TOB) for Institutional Claims Effective for claims with dates of service on or after September 28, 2016, you should use the following TOBs when submitting claims with G0499, 87340, 87341, 86704, or for HBV screening: Outpatient hospitals - TOB 13X (payment based on Outpatient Prospective Payment System) Non-patient laboratory specimen - TOB 14X (payment based on laboratory fee schedule) Critical Access Hospitals (CAHs) - TOB 85X, (payment based on reasonable cost when the revenue code is not 096X, 097X, and 098X) End Stage Renal Disease (ESRD) - TOB 72X (payment based on ESRD Prospective Payment System 22 10/2017

24 when submitting code G0499 with diagnosis code N18.6. HBV is not separately payable for ESRD TOB 72X unless reported with modifier AY.) Contractor pricing applies to G0499 with dates of service September 28, 2016 through December 31, Professional Billing Requirements For claims with dates of service on or after September 28, 2016, CMS will allow coverage for HBV screening only when services are submitted by the following provider specialties found on the provider s enrollment record: 01 - General Practice 08 - Family Practice 11 - Internal Medicine 16 - Obstetrics/Gynecology 37 - Pediatric Medicine 38 - Geriatric Medicine 42 - Certified Nurse Midwife 50 - Nurse Practitioner 89 - Certified Clinical Nurse Specialist 97 - Physician Assistant Claims submitted by providers other than the specialty types noted above will be denied. Additionally, for claims with dates of service on or after September 28, 2016, CMS will allow coverage for HBV screening only when submitted with one of the following Place of Service (POS) codes: 11 - Physician s Office 19 - Off Campus Outpatient Hospital 22 - On Campus Outpatient Hospital 49 - Independent Clinic 71 - State or Local Public Health Clinic 81 - Independent Laboratory Claims submitted without one of the POS codes noted above will be denied. Diagnosis Code Reporting Requirements For claims with dates of service on or after September 28, 2016, CMS will allow coverage for G0499 for HBV screening only when services are reported with both of the following diagnosis codes denoting high risk: Z Encounter for screening for other viral disease Z Other Problems related to life style. For claims with dates of service on or after September 28, 2016, CMS will allow coverage for G0499 for subsequent visits, only when services are reported with the following diagnosis codes: Z11.59 and one of the high risk codes below - F11.10-F F13.10-F F14.10-F F15.10-F Z /2017

25 - Z Z Z72.53 For claims with dates of service on or after September 28, 2016, CMS will allow coverage for HBV screening (CPT codes 86704, 86706, and 87341) in pregnant women only when services are reported with one of the following diagnosis codes: Z Encounter for screening for other viral diseases, and one of the following Z Encounter for supervision of normal first pregnancy, unspecified trimester Z Encounter for supervision of other normal pregnancy, unspecified trimester Z Encounter for supervision of normal pregnancy, unspecified, unspecified trimester O Supervision of high risk pregnancy, unspecified, unspecified trimester For claims with dates of service on or after September 28, 2016, CMS will allow coverage for HBV screening (CPT codes 86704, 86706, 87340, and 87341) in pregnant women at high risk only when services are reported with one of the following diagnosis codes: Z Encounter for screening for other viral diseases; and Z Other problems related to lifestyle, and also one of the following: Code Description Z34.00 Encounter for supervision of normal first pregnancy, unspecified trimester Z34.01 Encounter for supervision of normal first pregnancy, first trimester Z34.02 Encounter for supervision of normal first pregnancy, second trimester Z34.03 Encounter for supervision of normal first pregnancy, third trimester Z34.80 Encounter for supervision of other normal pregnancy, unspecified trimester Z34.81 Encounter for supervision of other normal pregnancy, first trimester Z34.82 Encounter for supervision of other normal pregnancy, second trimester Z34.83 Encounter for supervision of other normal pregnancy, third trimester Z34.90 Encounter for supervision of normal pregnancy, unspecified, unspecified trimester Z34.91 Encounter for supervision of normal pregnancy, unspecified, first trimester Z34.92 Encounter for supervision of normal pregnancy, unspecified, second trimester Z34.93 Encounter for supervision of normal pregnancy, unspecified, third trimester O09.90 Supervision of high risk pregnancy, unspecified, unspecified trimester O09.91 Supervision of high risk pregnancy, unspecified, first trimester O09.92 Supervision of high risk pregnancy, unspecified, second trimester O09.93 Supervision of high risk pregnancy, unspecified, third trimester Claim/Service Denial When denying payment for HBV screening use, your MAC will use the appropriate Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), or group codes. When denying services submitted on a TOB other than 13X, 14X, or 85X, they will use: 24 10/2017

26 CARC Payment is denied when performed/billed by this type of provider.note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present RARC N95 - This provider type/provider specialty may not bill this service Group Code CO (Contractual Obligation) - Assigning financial liability to the provider When denying services when HCPCS G0499 is paid in history for claims with dates of service on and after September 28, 2016, or if the beneficiary s claim history shows claim lines containing CPT codes 86704, 86706, 87340, and submitted in the previous 11 full months they will use the following messages: CARC 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 PR (Patient Responsibility) - Assigning financial responsibility to the beneficiary (if a claim is received with occurrence code 32 with or without GA modifier or a claim line is received with a GA modifier indicating a signed 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). When denying services for G0499, when ICD-10 diagnosis code Z72.89 and Z11.59 are not present on the claim, MACs will use: CARC 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. 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 Denying services for HBV screening, HCPCS G0499, when ICD-10 diagnosis code Z34.00, Z34.01, Z34.02, Z34.03, Z34.80, Z34.81, Z34.82, Z34.83, Z34.90, Z34.91, Z34.92, Z34.93, O09.90, O09.91, O09.92, or O09.93 is present on the claim: CARC 167 This (these) diagnosis(es) is (are) not covered. Note: Refer to the 835Healthcare 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) When denying services for G0499 for subsequent visits, when ICD-10 diagnosis code Z11.59 and one of the following high risk diagnosis codes: F F11.19, F F13.99, F F14.99, F F15.99, Z20.2, Z20.5, Z72.52, or Z72.53 are not present on the claim, MACs will use: CARC This (these) diagnosis(es) is (are) not covered. Note: Refer to the 835 Healthcare Policy 25 10/2017

27 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 When denying claim lines for G0499 without the appropriate POS code, MACs will use: CARC Payment is denied when performed by this type of provider on this type offacility. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N428 - Not covered when performed in certain settings. Group Code CO When denying claim lines for G0499 that are not submitted from the appropriate provider specialties, MACs will use: CARC The prescribing/ordering provider is not eligible to prescribe/order the service billed. NOTE: Refer to the 835 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 PR (Patient Responsibility) - Assigning financial responsibility to the beneficiary (if a claim is received with a GA modifier indicating a signed ABN is on file). Group Code CO (Contractual Obligation) - Assigning financial liability to the provider (if a claim line-item is received with a GZ modifier indicating no signed ABN is on file). When denying services where previous HBV screening, HCPCS 86704, 86706, 87340, or 87341, is paid during the same pregnancy period or more than two screenings are paid to women that are at high risk, they will use: CARC Benefit maximum for this time period or occurrence has been reached. RARC N362 - The number of days or units of service exceeds our acceptable maximum. 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 PR (Patient Responsibility) - Assigning financial responsibility to the beneficiary (if a claim is received with a GA modifier indicating a signed 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). When denying claim lines for HBV screening, HCPCS G0499 for a subsequent HBV screening test for nonpregnant, high risk beneficiary when a claim line for an initial HBV screening has not yet been posted in history, use the following messages: 26 10/2017

28 CARC B15 - This service/procedure requires that a qualifying service/procedure be received and covered. The qualifying other service/procedure has not been received/adjudicated. Note: Refer to the 835 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). When denying services for HBV screening, HCPCS 86704, 86706, 87340, and that are billed without the appropriate diagnosis code MACs will use: CARC 50 - These are non-covered services because this is not deemed a medical necessity by the payer. Note: Refer to the 835 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 PR (Patient Responsibility) - Assigning financial responsibility to the beneficiary (if a claim is received with a GA modifier indicating a signed 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). Additional Notes HCPCS code G0499 will appear in the January 1, 2018, Clinical Laboratory Fee Schedule(CLFS), in the January 1, 2017, Integrated Outpatient Code Editor (IOCE), and in the January 1, 2017, Medicare Physician Fee Schedule (MPFS) with indicator X. HCPCS codeg0499 will be effective retroactive to September 28, 2016, in the IOCE. Your MAC will not search for claims containing HCPCS G0499 with dates of service on or after September 28, 2016, but may adjust claims that you bring to their attention. You should be aware that the revision to the Medicare National Coverage Determinations Manual is a National Coverage Determination (NCD). NCDs are binding on all carriers, fiscal intermediaries, contractors with the Federal government that review and/or adjudicate claims, determinations, and/or decisions, quality improvement organizations, qualified independent contractors, the Medicare appeals council, and Administrative Law Judges (ALJs) (see 42 CFR Section (a)(4) (2005)). An NCD that expands coverage is also binding on a Medicare advantage organization. In addition, an ALJ may not review an NCD. (See Section1869(f)(1)(A)(i) of the Social Security Act.) MACs will apply contractor pricing to claim lines with G0499 with dates of service September 28, 2016, through December 31, Deductible and coinsurance do not apply to G0499. Additional Information The official instruction, CR9859, was issued to your MAC via two transmittals. The first updates the Medicare Claims Processing Manual and it is available at The 27 10/2017

29 second transmittal updates the NCD Manual and it is available at Document History Date Description August 8, 2017 This article was revised to reflect an updated CR9859. In the article, the CR release date, transmittal numbers, and the Web address of the CR are revised. A clarification was made on page 3 to denote that HBV is not separately payable for ESRD TOB 72X unless reported with modifier AY. Another bullet point was added on page 3 to show that contractor pricing applies to G0499 with dates of service September 28, 2016 through December 31, All other information is unchanged. June 30, 2017 This article was revised to reflect an updated CR9859. In the article, the CR release date, transmittal numbers, and the Web address of the CR are revised. All other information is unchanged. June 9, 2017 The article was revised to reflect an updated CR that changed the implementation date from January 1, 2018, to January 2, May 4, 2017 Initial article released. 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 on file with Palmetto GBA. 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 The Secure echat feature is available during business hours to assist providers /2017

30 Internet Only Manual (IOM) Update to Pub , Chapter 15 - Ambulance, to Restore Multiple Patients on One Trip Instructions MLN Matters Number: MM10245 Related CR Release Date: September 1, 2017 Related CR Transmittal Number: R3855CP Related Change Request (CR) Number: Effective Date: October 2, 2017 Implementation Date: October 2, 2017 PROVIDER TYPE AFFECTED This MLN Matters Article is intended for providers and suppliers submitting claims to Medicare Administrative Contractors (MACs) for ambulance services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) alerts providers that instructions in Section of Chapter 15 Ambulance, concerning Multiple Patients on One Trip were inadvertently omitted from the current version of the Medicare Claims Pr ocessing Manual. CR10245 restores the missing instructions to Section Be aware that this CR10245 contains no policy changes but does update the manual section. BACKGROUND The omitted language that is being added back into the manual is as follows: Ambulance suppliers submitting a claim using the ASC X12 professional format or the CMS-1500 paper form for an ambulance transport with more than one Medicare patient onboard must use the GM modifier ( Multiple Patients on One Ambulance Trip ) for each service line item. In addition, suppliers are required to submit documentation to A/B MACs (Part B) to specify the particulars of a multiple patient transport. The documentation must include the total number of patients transported in the vehicle at the same time and the health insurance claim numbers (HICN) for each Medicare beneficiary. Ambulance claims submitted on or after January 1, 2011 in version 5010 of the ASC X professional claim format require the presence of a diagnosis code and the absence of diagnosis code will cause the ambulance claim to not be accepted into the claims processing system. The presence of a diagnosis code on an ambulance claim is not required as a condition of ambulance payment policy. The adjudicative process does not take into account the presence (or absence) of a diagnosis code but a diagnosis code is required on the ASC X professional claim format. ADDITIONAL INFORMATION The official instruction, CR10245, issued to your MAC regarding this change is available at gov/regulations-and-guidance/guidance/transmittals/2017downloads/r3855cp.pdf. DOCUMENT HISTORY Date of Change September 1, 2017 Description Initial article released /2017

31 October 2017 Update of the Ambulatory Surgical Center (ASC) Payment System MLN Matters Number: MM10259 Related CR Release Date: September 1, 2017 Related CR Transmittal Number: R3854CP Related Change Request (CR) Number: CR10259 Effective Date: October 1, 2017 Implementation Date: October 2, 2017 PROVIDER TYPE AFFECTED This MLN Matters Article is intended for Ambulatory Surgical Centers (ASCs) submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED Change Request (CR) informs MACs about updates to the ASC payment system for October Make sure that your billing staffs are aware of these changes. BACKGROUND Included in CR10259 are updates to the ASC payment system, payment rates for separately payable drugs and biologicals, including descriptors for newly created Level II HCPCS codes for drugs and biologicals (ASC DRUG files), the ASC PI file, the CY 2017 ASC payment rates for covered surgical and ancillary services (ASCFS file), and an ASC Code Pair file. CR10259 also includes changes to billing instructions for various payment policies implemented in the October 2017 ASC payment system update. The changes are as follows: 1. New Procedure Requiring the Insertion of a Device Since January 1, 2017, in both the hospital outpatient prospective payment system and ASC settings, all new procedures requiring the insertion of an implantable medical device will be assigned a default device offset percentage of at least 41%, and thereby assigned device intensive status, until claims data is available. In certain rare instances, the Centers for Medicare & Medicaid Services (CMS) may temporarily assign a higher offset percentage if warranted by additional information. In accordance with this current policy, the code requiring the insertion of a device listed in Table 1 will be assigned device intensive status effective October 1, CMS notes that although HCPCS code C9747 was effective in the ASC setting as of July 1, 2017, its device intensive designation is not effective until October 1, See the table below. Table 1. - New Procedure Requiring the Insertion of a Device HCPCS Code Long Descriptor ASC PI Effective ASC PI Date C9747 Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance J /2017

32 2. Drugs, Biologicals, and Radiopharmaceuticals a. Drugs and Biologicals with Payments Based on Average Sales Price (ASP) Effective Oct. 1, 2017 For CY 2017, payment for nonpass-through drugs, biologicals and therapeutic radiopharmaceuticals is made at a single rate of ASP plus 6 percent, which provides payment for both the acquisition cost and pharmacy overhead costs associated with the drug, biological or therapeutic radiopharmaceutical. In CY 2017, a single payment of ASP plus 6 percent for pass-through drugs, biologicals and radiopharmaceuticals is made to provide payment for both the acquisition cost and pharmacy overhead costs of these pass-through items. Payments for drugs and biologicals based on ASP will be updated on a quarterly basis as later quarter ASP submissions become available. Updated payment rates effective October 1, 2017 are available in the October 2017 ASC Addendum BB at b. Drugs and Biologicals with Payments Based on ASP with Restated Payment Rates Some drugs and biologicals with payments based on ASP methodology may have payment rates that are corrected retroactively. These retroactive corrections typically occur on a quarterly basis. The list of drugs and biologicals with corrected payments rates will be accessible on the first date of the quarter at Suppliers who think they may have received an incorrect payment for drugs and biologicals impacted by these corrections may request contractor adjustment of the previously processed claims. c. New CY 2017 HCPCS Codes and Dosage Descriptors for Certain Drugs, Biologicals, and Radiopharmaceuticals Effective October 1, 2017 Four new HCPCS codes have been created for reporting drugs and biologicals in the ASC setting effective October 1, These new codes, their descriptors, and ASC payment indicators are listed in Table 2. Table 2. New CY 2017 HCPCS Codes and Dosage Descriptors for Certain Drugs, Biologicals, and Radiopharmaceuticals Effective October 1, 2017 HCPCS Code Short Description Long Description ASC PI C9491 Injection, avelumab Injection, avelumab, 10 mg K2 C9492 Injection, durvalumab Injection, durvalumab, 10 mg K2 C9493 Injection, edaravone Injection, edaravone, 1 mg K2 C9494 Injection, ocrelizumab Injection, ocrelizumab, 1 mg K2 d. New Modifier for Biosimilar Biological Product HCPCS Code Q5102 can be reported with either the existing modifier ZB or new modifier ZC effective July 1, See Table 3. Table 3. Biosimilar Biological Product Payment and Required Modifiers HCPCS Short Long ASC PI HCPCS Code Modifier Modifier Code Descriptor Descriptor Effective Date Effective Date Q5102 Injection, infliximab biosimilar Injection, Infliximab, Bio similar, 10 mg K2 04/05/2016 ZB Pfizer/ Hospira 04/01/ /2017

33 Q5102 Injection, infliximab biosimila Injection, Infliximab, Biosimilar, 10 mg K2 04/05/2016 ZC Merck/ Samsung Bioepis 07/01/2017 e. New Flu Vaccine The existing influenza vaccine CPT code (Cciiv4 vaccine, no preservative, 0.5 ml, intramuscular) with trade name Flucelvax Quadrivalent was effective January 1, 2017, and is a preservative-free and antibiotic-free vaccine. A new preservative, antibiotic-free influenza vaccine CPT code with the same trade name, Flucelvax Quadrivalent, will be effective on January 1, For the period between August 1, 2017 and December 31, 2017, Flucelvax Quadrivalent Preservative should be reported as Q2039. The permanent CPT code for the Flucelvax Quadrivalent preservative influenza vaccine will be released on a later date, see Table 4 below. ASCs are reminded that ASCPI L1 vaccine codes are packaged in the ASC payment system. Table 4. Flucelvax Quadrivalent Flu Vaccine Codes Vaccine Type HCPCS Code Short Descriptor Long Descriptor Flucelvax Cciiv4 vaccine, Influenza virus vaccine, Quadrivalent no preservative, quadrivalent (cciiv4), Preservative-Free and 0.5 ml, derived from cell cultures, Antibiotic-Free Flu intramuscular subunit, preservative and Vaccine antibiotic free, 0.5 ml dosage, for intramuscular use Flucelvax Quadrivalent Preservative Flu Vaccine Q2039 Cciiv4 vaccine, nos, intramuscular Influenza virus vaccine, not otherwise specified ASC PI L1 L1 3. Upper Eyelid Blepharoplasty and Blepharoptosis Repair As indicated in Chapter VIII of the CY 2017 National Correct Coding Initiative (NCCI) Policy Manual for Medicare Services, CMS payment policy does not allow separate payments for a blepharoptosis procedure (CPT code ) and a blepharoplasty procedure (CPT codes ) on the ipsilateral upper eyelid. Under this policy, any removal of upper eyelid skin in the context of an upper eyelid blepharoptosis surgery was considered a part of the blepharoptosis surgery. CMS clarified this instruction in the July 2016 ASC Payment System Update Change Request (Transmittal 3531, Change Request 9668 dated May 27, 2016) and the July 2016 ASC MLN Matters Article MM9668 which is available at However, effective October 1, 2017, CMS is revising this policy to allow either cosmetic or medically necessary blepharoplasty to be performed in conjunction with a medically necessary upper eyelid blepharoptosis surgery. Specifically, physicians may receive payment for a medically necessary upper eyelid blepharoptosis from Medicare even when performed with (non-covered) cosmetic blepharoplasty on the same eye during the same visit. Since cosmetic procedures are not covered by Medicare, Advance Beneficiary Notice of noncoverage 32 10/2017

34 (ABN) instructions would apply for cosmetic blepharoplasty. However, medically necessary blepharoplasty will continue to be bundled into the payment for blepharoptosis when performed with and as a part of a blepharoptosis surgery. Other aspects of the July 2016 ASC Update CR and MLN guidance on upper eyelid blepharoplasty and blepharoptosis remain unchanged. Specifically, CMS notes that Medicare does not allow separate payment for the following: Operating on the left and right eyes on different days when the standard of care is bilateral eyelid surgery. Charging the beneficiary an additional amount for removing orbital fat when a blepharoplasty or a blepharoptosis repair is performed. Performing a medically necessary blepharoplasty on a different date of service than the blepharoptosis procedure for the purpose of unbundling the medically necessary blepharoplasty. Performing blepharoplasty as a staged procedure, either by one or more surgeons (note that under certain circumstances a blepharoptosis procedure could be a staged procedure). Billing for two procedures when two surgeons divide the work of a medically necessary blepharoplasty performed with a blepharoptosis repair. Using modifier 59 to unbundle a medically necessary blepharoplasty from the ptosis repair on the claim form; this applies to both physicians and facilities. Treating medically necessary surgery as cosmetic for the purpose of charging the beneficiary for a cosmetic surgery. In the rare event that a blepharoplasty is performed on one eye and a blepharoptosis repair is performed on the other eye, the services must each be billed with the appropriate RT or LT modifier. 4. Coverage DeterminationsThe fact that a drug, device, procedure or service is assigned a HCPCS code and a payment rate under the ASC payment system does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the program. Medicare Administrative Contractors (MACs) determine whether a drug, device, procedure, or other service meets all program requirements for coverage. For example, MACs determine that it is reasonable and necessary to treat the beneficiary s condition and whether it is excluded from payment. ADDITIONAL INFORMATION The official instruction, CR10259, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change September 5, 2017 Description Initial article released /2017

35 2018 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Update MLN Matters Number: MM10262 Related CR Release Date: September 8, 2017 Related CR Transmittal Number: R3857CP Related Change Request (CR) Number: Effective Date: January 1, 2018 Implementation Date: January 2, 2018 PROVIDER TYPES AFFECTED This MLN Matters Article is intended for physicians, other providers, and suppliers submitting claims to Medicar e Administrative Contractors (MACs), including Home Health & Hospice (HH&H) MACs and Durable Medical Equipment (DME) MACs, for services provided to Medicare beneficiaries who are in a Part A covered Skilled Nursing Facility (SNF) stay. PROVIDER ACTION NEEDED Change Request (CR) makes changes to Healthcare Common Procedure Coding System (HCPCS) codes and Medicare Physician Fee Schedule designations that will be used to revise Common Working File (CWF) edits to allow A/B MACs to make appropriate payments in accordance with policy for SNF CB in Chapter 6, Section and Chapter 6, Section 20.6 in the Medicare Claims Processing Manual. BACKGROUND The Common Working File (CWF) currently has edits in place for claims received for beneficiaries in a Part A covered SNF stay as well as for beneficiaries in a non-covered stay. These edits allow only those services that are excluded from consolidated billing to be separately paid. Barring any delay in the Medicare Physician Fee Schedule, the new code files will be provided to CWF by November 1, By the first week in December 2017, new code files will be posted at The files will be applicable to claims with dates of service on or after January 1, 2018, through December 31, It is important and necessary for the provider/contractor community to view the General Explanation of the Major Categories file located at the bottom of each year s update in order to understand the Major Categories including additional exclusions not driven by HCPCS codes. ADDITIONAL INFORMATION The official instruction, CR10262, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change September 8, 2017 Description Initial article released /2017

36 Updated Editing of Always Therapy Services - MCS MLN Matters Number: MM10176 Revised Related Change Request (CR) Number: Related CR Release Date: September 15, 2017 Effective Date: January 1, 2018 Related CR Transmittal Number: R3863CP Implementation Date: January 2, 2018 This article was revised on September 15, 2017, to reflect an updated Change Request (CR). In the article, the CR release date, transmittal, number and link to the transmittal changed. All other information is unchanged. PROVIDER TYPE AFFECTED This MLN Matters Article is intended for therapists, physicians, and certain other practitioners billing Medicare Administrative Contractors (MACs) for therapy services provided to Medicare beneficiaries. PROVIDER ACTION NEEDED CR implements revised editing of Part B Always Therapy services to require the appropriate therapy modifier in order for the service to be accurately applied to the therapy cap. CR10176 contains no new policy. Instead, the guidelines presented in the CR improve the enforcement of longstanding, existing instructions. Make sure your billing staffs are aware of these revisions. BACKGROUND Services furnished under the Outpatient Therapy (OPT) services benefit including Speech-Language Pathology (SLP), Occupational Therapy (OT), and Physical Therapy (PT) are subject to the financial limitations, known as therapy caps, originally required under Section 4541 of the Balanced Budget Act (1997). There are two such caps. One cap is for PT and SLP services combined and another cap is for OT services. In order to accrue incurred expenses to the correct therapy cap; the use of one of the three therapy modifiers (GN, GO, or GP) is required on a certain set of Healthcare Common Procedure Coding System (HCPCS) codes in order to identify when each OPT service is furnished under an SLP, OT, or PT plan of care, respectively. Medicare recognizes the services furnished under the OPT services benefit as either always or sometimes therapy and publishes this list as an Annual Update on the Therapy Services Billing page at On professional claims, each code designated as always therapy : Must always be furnished under an SLP, OT, or PT plan of care, regardless of who furnishes them; and, as such, Must always be accompanied by one of the GN, GO, or GP therapy modifiers. In addition, several always therapy codes have been identified as discipline-specific requiring the GN modifier for six codes, the GO modifier for four codes, and the GP modifier for four codes, as illustrated in Tables /2017

37 Table 1: Codes Requiring the GN Therapy Modifier Code CPT Short Descriptor Therapy Modifier Required Evaluation of speech fluency GN Evaluate speech production GN Speech sound lang comprehend GN Behavral quality analys voice GN Oral speech device eval GN Ex for speech device rx 1hr GN Table 2: Codes Requiring the GO Therapy Modifier Code CPT Short Descriptor Therapy Modifier Required Ot eval low complex 30 min GO Ot eval mod complex 45 min GO Ot eval high complex 60 min GO Ot re-eval est plan care GO Table 3: Codes Requiring the GP Therapy Modifier Code CPT Short Descriptor Therapy Modifier Required Pt eval low complex 20 min GP Pt eval mod complex 30 min GP Pt eval high complex 45 min GP Pt re-eval est plan care GP The following Always Therapy HCPCS codes require a GN, GO, or GP modifier, as appropriate. Descriptors for these codes are included as an attachment to CR G0281 G0283 G0329 In addition to Therapists in Private Practice (TPPs) including physical therapists, occupational therapists, and speech-language pathologists professional claims for OPT services may be furnished by physicians and certain Non-Physician Practitioners (NPPs) specifically, physician assistants, nurse practitioners, and certified nurse specialists. All OPT services furnished by TPPs are always considered therapy services, regardless of whether they are designated as always therapy or sometimes therapy. As such, the appropriate therapy modifier must be included on the claim. However, it may be clinically appropriate for physicians and NPPs to furnish OPT services that have been designated sometimes therapy codes outside a therapy plan of care -in these cases, therapy modifiers are not required and claims may be processed without them. During analyses of Medicare claims data for OPT services, the Centers for Medicare & Medicaid Services (CMS) found that these always therapy codes and modifiers are not always used in a correct and consistent manner. CMS found OPT professional claims for always therapy codes without the required modifiers. Also, CMS found claims that reported more than one therapy modifier for the same therapy service; for example, both a GP and GO modifier, when only one modifier was allowed /2017

38 These claims represent non-compliant billing by TPPs, physicians, and NPPs, and hamper CMS ability to properly track the therapy caps and analyze claims data for purposes of Medicare program improvements. The requirements in CR10176 will create new edits for Medicare professional claims processing systems to return claims when always therapy codes and the associated therapy modifiers are improperly reported. Providers should expect the following: MACs will return/reject claims which contain an always therapy procedure code, but do not also contain the appropriate discipline-specific therapy modifier of GN, GO, or GP. MACs will also return/reject claims if any service line on the claim contains more than one occurrence of a GN, GO, or GP therapy modifier. MACs who are returning/rejecting such claims will use Group Code CO and Claim Adjustment Reason Code (CARC) 4 on the related remittance advice. ADDITIONAL INFORMATION The official instruction, CR10176, issued to your MAC regarding this change is available at DOCUMENT HISTORY Date of Change Description September 15, 2017 The article was revised to reflect an updated CR. In the article, the CR release date, transmittal, number and link to the transmittal changed. All other information is unchanged. July 31, 2017 Initial article released /2017

39 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 /2017

40 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 39 10/2017

41 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 non-physician 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: Part B Medical Affairs, AG-300 Palmetto GBA PO Box Columbia, SC /2017

42 Part B Local Coverage Determinations- October 2017 Policy Title LCD Revisions Effective Date Chemodenervation L33458 Rev #16 Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added ICD-10 codes G12.23, G12.24 and G These revisions are due to the Annual ICD-10 Updates. Implantable Infusion Pump L33461 Rev #12 Swallowing Studies for Dysphagia L33449 Rev #6 Brain Natriuretic Peptide (BNP) Level L33422 Rev #8 Special Electroencephalography L33447 Rev #10 Respiratory Therapy and Oximetry Services L33446 Rev #7 Pulmonary Stress Testing L33444 Rev #5 Wireless Gastrointestinal Motility Monitoring Systems L33455 Rev #6 Varicose Veins of the Lower Extremities L33454 Rev #10 Under ICD-10 Codes that Support Medical Necessity Group 3: Codes deleted ICD-10 codes C96.2, D47.0 and M48.06 and added C96.20, C96.21, C96.22, C96.29, M and M These revisions are due to the Annual ICD-10 Updates. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added ICD-10 codes G12.23 and G The code description was revised for ICD-10 codes I63.323, I63.333, I63.513, I63.523, I63.533, M33.00, M33.01, M33.02, M33.09, M33.10, M33.11, M33.12 and M These revisions are due to the Annual ICD-10 Updates. Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes I21.9, I21.A1, I21.A9, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89 and R The code description was revised for ICD-10 codes I50.1, I63.323, I63.333, I63.513, I and I These revisions are due to the Annual ICD-10 Updates. Under ICD-10 Codes that Support Medical Necessity deleted ICD-10 codes S06.1X7S and S06.1X8S. These revisions are due to the Annual ICD-10 Updates. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added ICD-10 codes I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89 and R06.03 and the code description was revised for J15.6. Under ICD 10 Codes that Support Medical Necessity Group 2: Codes deleted ICD-10 code I27.2, added I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89 and R06.03 and the code description was revised for I50.1. These revisions are due to the Annual ICD-10 Updates. Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.84 and I The code description was revised for M33.01 and M These revisions are due to the Annual ICD-10 Updates. Under ICD-10 Codes that Support Medical Necessity deleted ICD-10 code K This revision is due to the Annual ICD-10 Updates. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes the code description was revised for I83.811, I83.812, I and I Under ICD-10 Codes that Support Medical Necessity Group 2: Codes the code description was revised for I and I This revision is due to the Annual ICD-10 Updates /2017

43 Repetitive Transcranial Magnetic Stimulation (rtms) in Adults with Treatment Resistant Major Depressive Disorder L34869 Rev #6 Virtual Colonoscopy (CT Colonography) L33452 Rev #6 Computerized Axial Tomography (CT), Thorax L33459 Rev #6 Lumbar Epidural Steroid Injections L35148 Rev #5 HbA1c L33431 Rev #10 MRI of a Joint L33464 Article Title Medicare Preventive Coverage for Certain Vaccines A54767 Rev #10 Under Bibliography updated the URL for #5. Under ICD-10 Codes That Support Medical Necessity deleted ICD-10 codes K56.5, K56.60 and K56.69 and added K56.50, K56.51, K56.52, K56.600, K56.601, K56.609, K56.690, K56.691, K56.699, K91.30, K91.31 and K This revision is due to the Annual ICD-10 Updates. Under ICD-10 Codes That Support Medical Necessity deleted ICD-10 codes C96.2, D47.0 and N63 and added C96.20, C96.21, C96.22, C96.29, D47.02, D47.09, E85.81, E85.82, E85.89, I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, N63.11, N63.12, N63.13, N63.14, N63.21, N63.22, N63.23, N63.24, N63.31, N63.32, N63.41, N63.42 and R The code description was revised for I50.1, J15.6, M33.01 and M This revision is due to the Annual ICD-10 Updates. Under ICD-10 Codes That Support Medical Necessity deleted ICD-10 code M48.06 and added M and M This revision is due to the Annual ICD-10 Updates. Under CMS National Coverage Policy added CMS Manual System, Pub , Medicare Claims Processing Manual, Change Request 10156, Transmittal 3797, Dated June 16, 2017, Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes E11.10 and E These codes were added due to the Annual ICD-10 Updates. Under ICD-10 Codes That Support Medical Necessity Group 2: Codes deleted ICD 10 codes E , E , E , E , E08.37X9, E , E , E , E , E09.37X9, E , E , E , E , E10.37X9, E , E , E , E , E11.37X9, E , E , E , E and E13.37X9. These codes were deleted due to CR 10156, Transmittal Retired LCDs This LCD is being retired being that a significant shift in practice guidelines has made this LCD as written no longer valid. Articles Under Covered ICD-10 Codes Group 3: Codes the descriptions were revised for ICD-10 codes S62.311B, S62.317B, S62.341B, S62.347B, S62.620B, S62.621B, S62.622B, S62.623B, S62.624B, S62.625B, S62.650B, S62.651B, S62.652B, S62.653B, S92.521B, S92.522B, S92.524B and S92.525B. These revisions are due to the Annual ICD-10 Updates. 9/7/17 8/24/17 Effective Date 42 10/2017

44 A/B MAC Local Coverage Determinations- October 2017 Policy Title LCD Revisions Effective Date Corneal Pachymetry L34512 Rev #10 Under Associated Information-Utilization Guidelines the verbiage was revised in the second paragraph. Under Related Local Coverage Documents the related article A54556 was deleted as it was retired on 8/24/17. Information in the retired article is currently included in the LCD. 8/31/17 Wireless Capsule Endoscopy L36427 Rev #5 Infliximab (Remicade ) L35677 Rev #17 Application of Skin Substitutes L36466 Rev #6 Blepharoplasty, Eyelid Surgery, and Brow Lift L34411 Rev #7 Cardiac Radionuclide Imaging L33457 Rev #10 Cardiac Rehabilitation L34412 Rev #13 Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes K56.51, K56.600, K and K This revision is due to the Annual ICD-10 Code Updates. Under CPT/HCPCS Codes Group 1: Paragraph deleted the verbiage Effective for dates of service on or after April 5, 2016 claims for Q5102 must use the ZB (Pfizer/hospira) modifier (Q5102ZB). Under ICD-10 Codes that do not Support Medical Necessity Group 1: Paragraph revised the verbiage to read Diagnosis code M31.4 (Aortic arch syndrome [Takayasu]) is not a covered diagnosis given its use has not been demonstrated to be a standard of care and claims can be denied as not medically reasonable and necessary. In rare cases consideration may be given for coverage of diagnosis code M31.4 (Aortic arch syndrome [Takayasu]) when used as a third line therapy when other immunosuppressive therapies have failed. Supporting documentation will be required. Under ICD-10 Codes That Support Medical Necessity Group 1:Codes added ICD-10 codes E11.10, L97.115, L97.116, L97.118, L97.125, L97.126, L97.128, L97.215, L97.216, L97.218, L97.225, L97.226, L97.228, L97.315, L97.316, L97.318, L97.325, L97.326, L97.328, L97.415, L97.416, L97.418, L97.425, L97.426, L97.428, L97.515, L97.516, L97.518, L97.525, L97.526, L97.528, L97.815, L97.816, L97.818, L97.825, L97.826, L97.828, L97.915, L97.916, L97.918, L97.925, L97.926, L97.928, L98.415, L98.416, and L This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes that Support Medical Necessity Group1: Codes code description changes were made to the following codes: H02.051, H02.052, H and H This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes That Support Medical Necessity Myocardial Perfusion Imaging Group 1: Codes added ICD-10 codes I21.9, I21.A1, I21.A9, I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, and I The code description was changed for I50.1. Under ICD-10 Codes That Support Medical Necessity Cardiac Blood Pool Imaging Group 2: Codes added ICD-10 codes I21.9, I21.A1, I21.A9, I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, and I ICD-10 code I27.2 was deleted. The code description was changed for I50.1. This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes that Support Medical Necessity Group1: Codes added ICD-10 codes I21.9, I21.A1, I21.A9, I50.82, I50.84, I50.89, I and I This revision is due to the Annual ICD-10 Code Updates. 10/01/17 9/04/17 10/01/ /2017

45 Cardiac Computed Tomography & Angiography (CCTA) L33423 Rev #6 Colonoscopy/ Sigmoidoscopy/ Proctosigmoidoscopy L34454 Rev #12 CT of the Abdomen and Pelvis L34415 Rev #10 CT of the Head L34417 Rev #11 Echocardiography L37379 Rev #2 Under ICD-10 Codes That Support Medical Necessity Group 1: Codes deleted ICD-10 code I27.2 and added ICD-10 codes I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, and I The code description was revised for I50.1. Under ICD-10 Codes That Support Medical Necessity Group 2: Codes deleted ICD 10 code P29.3 and added ICD-10 code P This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes that Support Medical Necessity Group1: Codes deleted ICD-10 codes A04.7, K56.5, K56.60 and K Under ICD-10 Codes that Support Medical Necessity Group1: Codes added ICD-10 codes A04.71, A04.72, K56.50, K56.51, K56.52, K56.600, K56.601, K56.609, K56.690, K56.691, K56.699, K91.30, K91.31and K This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes That Support Medical Necessity Group 1:Codes added ICD-10 codes C96.20, C96.21, C96.22, C96.29, D47.02, D47.09, E85.81, E85.82, E85.89, K56.50, K56.51, K56.52, K56.600, K56.601, K56.609, K56.690, K56.691, K56.699, K91.30, K91.31, K91.32, Q53.111, Q53.112, Q53.211, and Q Under ICD-10 Codes That Support Medical Necessity Group 1: Codes ICD-10 codes C96.2, E85.8, K56.5, K56.60, K56.69, K91.3, Q53.11, and Q53.21 were deleted. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes the code description was revised for Q This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes that Support Medical Necessity Group1: Codes deleted ICD-10 codes C96.2 and E85.8. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes E85.81, E85.82, E85.89, F10.11 and G Under ICD-10 Codes That Support Medical Necessity Group 1:Codes code description changes were made to ICD-10 codes I63.211, I63.212, I63.22, I63.323, I63.333, I63.513, I63.523, I63.533, S04.031A, S04.031D, S04.031S, S04.032A, S04.032D, S04.032S, S04.041A, S04.041D, S04.041S, S04.042A, S04.042D and S04.042S. This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes That Support Medical Necessity Group 2:Codes added ICD-10 codes E85.81, E85.82, E85.89, I21.9, I21.A1, I21.A9, I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, and R06.03 and deleted ICD-10 codes E85.8 and I27.2. The code description was revised for ICD-10 codes I50.1, I63.513, I63.523, and I Under ICD-10 Codes That Support Medical Necessity Group 3: Codes added ICD-10 codes E85.81, E85.82, E85.89, I21.9, I21.A1, I21.A9, I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, and R06.03 and deleted ICD-10 codes E85.8 and I27.2. The code description was revised for I50.1. Under ICD-10 Codes That Support Medical Necessity Group 4: Codes added E11.10, E11.11, I21.9, I21.A1, I21.A9, I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89 and R06.03 and deleted ICD-10 code I27.2. The code description was revised for I50.1. Under ICD-10 Codes That Support Medical Necessity Group 5: Codes added ICD-10 codes I21.9, I21.A1, I21.A9, I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, and R06.03 and deleted ICD-10 code I27.2. The code description was revised for I50.1, I63.211, I63.212, and I This revision is due to the Annual ICD-10 Code Updates /2017

46 Removal of Benign and Malignant Skin Lesions L33445 Rev #11 Nerve Conduction Studies and Electromyography L35048 Rev #15 Ophthalmic Angiography (Fluorescein and Indocyanine Green) L34426 Rev #13 Retroperitoneal Ultrasound L34577 Rev #16 Laparoscopic Sleeve Gastrectomy for Severe Obesity L34576 Rev #11 Somatosensory Testing L34433 Rev #7 Scanning Computerized Ophthalmic Diagnostic Imaging (SCODI) L34431 Rev #12 Rituximab (Rituxan ) L35026 Rev #14 Intravenous Immunoglobulin (IVIG) L34580 Rev #10 Ophthalmology: Extended Ophthalmoscopy and Fundus Photography L33467 Rev #9 Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes C96.29 and D This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes that Support Medical Necessity Group1: Codes deleted ICD-10 code M Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes G12.23, G12.24, G12.25, M33.03, M33.13, M33.93, M and M Under ICD-10 Codes That Support Medical Necessity Group 1:Codes code description changes were made to ICD 10 codes M33.00, M33.01, M33.02, M33.09, M33.10, M33.11, M33.12 and M This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes H44.2A1, H44.2A2, H44.2A3, H44.2B1, H44.2B2, H44.2B3, H44.2E1, H44.2E2 and H44.2E3. This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes deleted ICD-10 code E85.8. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes E85.81, E85.82, E85.89, Q53.111, Q53.112, Q and Q This revision is due to the Annual ICD-10 Code Updates Under ICD-10 Codes That Support Medical Necessity Group 3: Codes deleted ICD-10 code I27.2 and added I27.21 and I The code description was revised for I50.1, I83.811, I83.812, I and I This revision is due to the Annual ICD-10 Updates. Under ICD-10 Codes That Support Medical Necessity deleted ICD-10 code M48.06 and added M and M This revision is due to the Annual ICD-10 Updates. Under ICD-10 Codes That Support Medical Necessity Group 3: Codes added ICD-10 codes H44.2A1, H44.2A2, H44.2A3, H44.2B1, H44.2B2, H44.2B3, H44.2C1, H44.2C2, H44.2C3, H44.2D1, H44.2D2, H44.2D3, H44.2E1, H44.2E2 and H44.2E3. This revision is due to the Annual ICD-10 Updates. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes M33.00, M33.01, M33.02, M33.03, M33.09, M33.10, M33.11, M33.12, M33.13, M33.19 and M This revision is due to the Annual ICD 10 Code Updates. Under ICD-10 Codes That Support Medical Necessity added ICD-10 codes M33.03, M33.13 and M The code description was revised for M33.00, M33.01, M33.02, M33.09, M33.10, M33.11, M33.12 and M This revision is due to the Annual ICD-10 Updates. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes H44.2A1, H44.2A2, H44.2A3, H44.2B1, H44.2B2, H44.2B3, H44.2C1, H44.2C2, H44.2C3, H44.2D1, H44.2D2, H44.2D3, H44.2E1, H44.2E2 and H44.2E3. This revision is due to the Annual ICD-10 Code Updates /2017

47 White Cell Colony Stimulating Factors L37176 Rev #2 Upper Gastrointestinal Endoscopy and Visualization L34434 Rev #12 Article Title Billing Requirements Under Covered ICD-10 Codes deleted ICD-10 code C96.2 and added C96.20, for Cardiac Blood Pool C96.21, C96.22 and C These revisions are due to the Annual ICD-10 Imaging (Multiple Updates. Gated Acquisition Scanning- MUGA, Ventriculography) When Performed in Conjunction with Cardiotoxic Chemotherapy Article A54768 Rev #7 Single Chamber and Dual Chamber Permanent Cardiac Pacemakers Coding and Billing A54831 Rev #3 Under ICD-10 Codes That Support Medical Necessity Group 1: Codes Patients with Cancer Receiving Myelosuppressive Chemotherapy added ICD-10 codes C96.20, C96.21, C96.22, and C Under ICD-10 Codes That Support Medical Necessity Group 3: Codes Acute lymphocytic leukemia (ALL) after completion of the first few days of initial induction chemotherapy added ICD-10 codes C96.20, C96.21, C96.22, and C Under ICD-10 Codes That Support Medical Necessity Group 5: C odes Adult individuals with acute myeloid leukemia (AML) added ICD-10 codes C96.20, C96.21, C96.22, and C Under ICD-10 Codes That Support Medical Necessity Group 8: Codes Hairy Cell Leukemia added ICD-10 codes C96.20, C96.21, C96.22, and C This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes Patients with Cancer Receiving Myelosuppressive Chemotherapy and under ICD-10 Codes That Support Medical Necessity Group 6: Codes After a hematopoietic progenitor stem cell transplant (HPCT/HSCT) added ICD-10 codes C91.10 and C91.12 due to a reconsideration request. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes deleted ICD-10 code K91.3. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes K91.30, K91.31 and K This revision is due to the Annual ICD-10 Code Updates. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 code K80.30 due to a reconsideration request. Articles All ICD-9 diagnoses codes and ICD-9 verbiage were removed from this article. Effective Date 8/31/ /2017

48 Herceptin (trastuzumab): Coverage and Billing A53777 Rev #6 Corneal Pachymetry Once in a Lifetime Limit A54556 Under Article Text the first paragraph was deleted and replaced with the following verbiage: HerceptinR (trastuzumab) is a Medicare covered drug used to treat HER2-overexpressing breast cancer and HER2- overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. HerceptinR has been supplied in a multi-use vial of 440 milligrams along with a 20-milliliter vial of bacteriostatic water for reconstitution. A multi-use vial contains more than one individual dose of medication and is labeled as such by the manufacturer. When stored properly, reconstituted HerceptinR can be used for up to 28 days. For multi-use vials Medicare pays only for the amount administered to the beneficiary and does not pay for any discarded or wasted amount of drug. The 440 mg multi-use vial dosage form of Herceptin is being discontinued and will be replaced by a single use 150mg vial. Until current supplies of the multiuse 440 mg vials are depleted the above guidance will continue to apply when the drug is administered from a multi-use vial. When reporting the use of drug supplied in a 150mg single use vial use the JW modifier for claims with unused drugs or biologicals from single use vials or single use packages that are appropriately discarded (except those provided under the Competitive Acquisition Program (CAP) for Part B drugs and biologicals) and document the discarded drug or biological in the patient s medical record when submitting claims with unused Part B drugs or biologicals from single use vials or single use packages that are appropriately discarded. Retired Articles This article is being retired due to the information being included in the Corneal Pachymetry L34512 LCD. Retirement Date 8/24/ /2017

49 MolDX Local Coverage Determinations Policy Title LCD Revision Effective Date Controlled Substance Monitoring and Drugs of Abuse Testing L35724, #9 Added 3 ICD-10 codes: R41.82, R45.850, and R Corrected typographical errors in bullets and tables. 8/17/17 MolDX: APC and MUTYH Gene Testing L36827, #2 MolDX: BRCA1 and BRCA2 Genetic Testing L36082, #5 Special Histochemical Stains and Immunohistochemical Stains L35922, #3 MolDX: AlloSure Donor-Derived Cell-Free DNA Test L37266, Notice, Rev 1, Rev 2 MolDX: EndoPredict Breast Cancer Gene Expression Test L37264, Notice MolDX: Oncotype DX Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer L37262, Notice, Rev 1 Palmetto GBA corrected the first paragraph in the LCD 8/24/17 to insert sentences that were inadvertently deleted. ICD-10 code D12.2 was also added to Group 1 ICD-10 Codes. Clarified the Criteria for Testing to align with the 8/31/17 reformatted NCCN Guidelines. Reformatted the References to correct the numbering typographical errors and added the newest NCCN reference. Corrected typographical errors in bullets and references. 8/31/17 This LCD version was created as a result of DL37266 being released to a Final LCD. Corrected the Notice Start and End Dates. Original Effective date should be October 9, Notice begins 8/24/17 and end 10/08/17. Corrected contract numbers. Contract numbers were inadvertently unselected when LCD was released to Final LCD. Applicable contractor numbers from the Draft LCD, 11201, 11301, 11302, 11401, 11402, were reselected. No additional changes were made. This LCD version was created as a result of DL37264 being released to a Final LCD. This LCD version was created as a result of DL37262 being released to a Final LCD. Corrected the Notice Start and End Dates. Original Effective date should be October 9, Notice begins 8/24/17 and end 10/08/17. 10/9/ /02/ /09/17 Article Title Article Revision Effective Date MolDx: ResponseDX Tissue of Origin Coding Added ICD-10 D49.7 to Group 1. 8/24/17 and Billing Guidelines A53108, #7 MolDX: Next Generation Sequencing Coding and Billing Guidelines A54795, #3 Revised article to incorporate A MolDX: Next Generation Sequencing (NGS) and Tier 1 and Tier 2 Coding and Billing Guidelines. Added Part A contract numbers. 9/21/17 Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy A55680 The comment period for the MolDX: Prometheus IBD sgi Diagnostic Local Coverage Determination (LCD) began on 06/05/17 and ended on 07/20/17. The notice period will begin on 8/10/2017 and will end on 9/24/17. The LCD will become effective on 9/25/2017. There were no comments received from the provider community. 8/10/ /2017

50 Response to Comments: MolDX: AlloSure Donor-Derived Cell-Free DNA Test A55686 The comment period for the MolDX: AlloSure Donor-Derived Cell-Free DNA Test Local Coverage Determination (LCD) began on 06/05/17 and ended on 07/20/17. The notice period will begin on 8/17/2017 and will end on. The LCD will become effective on 10/2/2017. There were no comments received from the provider community. 8/17/17 Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test A55692 Effective Date: 8/17/17 The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression Test Local Coverage Determination (LCD) began on 06/05/17 and ended on 07/20/17. The notice period will begin on 8/17/2017 and will end on 10/01/17. The LCD will become effective on 10/02/2017. The following comments were received from the provider community: Comment 1: From Johnathan M. Lancaster, MD, PhD; Chief Medical Officer, Myriad Genetic Laboratories Myriad Genetic Laboratories, Inc. appreciates the opportunity to comment on Draft Local Coverage Determination (LCD) MolDX: EndoPredict Breast Cancer Gene Expression Test (DL37264). We are writing to express our support for the content of the Draft LCD and to reiterate the importance of the proposed coverage for women with breast cancer. As described in the Draft LCD, determining which patients with ER+/Her2- breast cancer will have a low enough risk of distant recurrence after 5 years of endocrine therapy to forgo adjuvant chemotherapy is a priority for physicians who manage these patients. The Endopredict 12 gene molecular score is combined with clinicopathologic features (tumor size and lymph node status) to produce the EndoPredict (EPclin) score, which is reported as low- or high-risk and includes a personalized risk of 10- year distant recurrence (DR) based on each patient s result. The prognostic ability of EndoPredict has been validated by prospectively designed-retrospective studies in three different cohorts from phase III trials involving more than 2,600 patients.1,2 These studies collectively demonstrate the ability of EndoPredict to predict the primary endpoint of DR in both early and late time periods, to accurately classify patients into a low or high risk group, and to identify a low risk group with excellent 10 year outcomes after treatment with 5 years of endocrine therapy only. Among patients in the validation studies: 73-78% of node-negative patients fell into the Endopredict low-risk category with 10-year risk of distant recurrence of 5-5.9%, compared to 16-20% for the high-risk patients % of node-positive patients fell into the Endopredict low-risk category with 10-year risk of distant recurrence of 5-5.2%, compared to % for the high risk patients. In summary, Endopredict is a second-generation test for highly accurate assessment of 10-year risk ofdistant recurrence. Coverage of Endopredict for Medicare beneficiaries meeting the criteria outlined in the Draft LCD provides the opportunity for physicians to identify those patients with a low-risk EPClin score, for whom the absolute benefit of adjuvant chemotherapy is unlikely to outweigh the risks. References Filipits M, Rudas M, Jakesz R, et al. A new molecular predictor of distant recurrence in ER-positive, HER2-negative breast cancer adds independent information to conventional clinical risk factors. Clin Cancer Res. 2011;17(18): Buus R, Sestak I, Kronenwett R, et al. Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst Jul 10;108(11). Print 2016 Nov. Response 1: Comment acknowledged /2017

51 Comment 2: From Jack Spicer, MD, Medical Director, Managed Care Medical Affairs, Genomic Health On behalf of Genomic Health, Inc., we are pleased to submit comments in response to the Proposed/Draft Local Coverage Determination for the Endopredict Breast Cancer Assay (DL37264). Our comments are not directed at the decision to cover the Endopredict Breast Cancer Assay or the scope of coverage, but rather, are limited to addressing the accuracy of the comparison table shown at the beginning of the LCD. Requested Change: Remove the comparison table (first table in the LCD) and the statement on page 5 that the observed change in treatment recommendations after the use of Endopredict is therefore consistent with the expected clinical utility of similar established tests. Rationale: The Endopredict Breast Cancer Assay should be assessed based on the analytical validation, clinical validation, and clinical utility data specifically generated for the Endopredict test in the targeted patient population. It is inappropriate to infer or assume clinical utility for Endopredict based on the performance of other tests with unique evidentiary portfolios. Specifically, inferring utility for Endopredict because of performance relative to Oncotype DX Recurrence Score based on one single study in post-menopausal patients is inappropriate. Importantly, the study upon which this comparison was made included women with more than three axillary nodes which is outside the intended use population of Oncotype DX. The focus on this single study fails to reflect that the Oncotype DX Recurrence Score is distinguished from Endopredict not only by its proven ability to predict chemotherapy benefit but also by the reporting of prospective outcomes from multiple datasets, including the Level IA evidence from the RS th edition of the AJCC is now exclusively utilizing the 21-gene RT-PCR assay to downstage patients with T1/T2, N0, M0, ER+, HER2-negative EBC as high as Prognostic Stage IIIA to Prognostic Stage IA if they have RS. Response 2: The commenter is absolutely correct that inferring utility for one assay because of performance relative to another assay is inappropriate. The table has been removed. Comment 3: From Alessandra Cesano, MD, PhD; Chief Medical Officer, NanoString Inc. On behalf of the NanoString Inc., I respectfully ask Palmetto GBA to consider the following comments related to the recent Draft MolDX LCD: EndoPredict Breast Cancer Gene Expression Test (DL 37264). The published draft contains a misleading cross-trial comparison with the Prosigna Breast Cancer Gene Signature Assay and other minor inaccuracies. While we respectfully acknowledge the evidence evaluation performed by Palmetto, we assert that the presentation of the information in this manner may create confusion in the interpretation of comparative information between genomic tests for hormone receptorpositive early stage breast cancer for the following reasons: 1. In the table comparing Myriad s EndoPredict test with Prosigna, the comparative information is derived from different clinical trial cohorts (TransATAC for EndoPredict and ABCSG.8 for Prosigna). This is an inappropriate comparison due to the differences in clinical and pathological characteristics of the patients within each cohort which produces differing risk group distributions and group estimates of survival. The presentation of this information in the table creates an impression that the results are representative of those that would be observed if utilizing the tests on an identical set of patients. The table could be construed as encouraging the inappropriate comparison as it includes a comparison of two tests within the same cohort (EndoPredict and OncotypeDX) with Prosigna which was tested in a separate cohort. 2. The risk score cutoff value to define the low risk group for reporting survival and percentage of patients for Prosigna in node-positive (1-3 positive nodes) patients in the table is not the same as the cutoff value utilized by the FDA-cleared product in the United States. The low risk cutoff value for node-positive patients in the United States is 40 ROR score units. The values in the table do not reflect the results that would be obtained in the United States on those same patients. We respectfully request removal of the information regarding Prosigna from the table in the Draft MolDX LCD: EndoPredict Breast Cancer Gene Expression Test (DL 37264) based on the points stated above. If Palmetto GBA determines that it is necessary to include Prosigna in the table, we would like to respectfully request the following changes be made to the table in order to provide accurate information consistent with the FDA 510(k)-cleared package insert: 1. Under the Low Risk Scores heading, the value for % of Node-pos pts with Low Risk Score should be changed to 41.4%. The draft LCD indicated a value 4.1% which is associated with the European product labeling (CE mark) 50 10/2017

52 2. Under the DR in Pts with Low Risk Score heading, the value for Node-pos, Low Risk Score- 10yr DR risk should be changed to 5.8% ( %). The draft LCD indicated a value of 0% (0-21.8%), which is associated with the European product labeling (CE mark). 3. Under the High/Non-Low Risk Scores heading, the value for % of Node-neg pts with High/Non-Low Risk Score should be changed to 53.5%. The draft LCD separates this field into two separate fields for Prosigna (Int and High), which is inconsistent with the reporting convention for the other tests. Removal of the Int and High values and replacement with a single value of 53.5% reflects a fair comparison between the tests. 4. Under the High/Non-Low Risk Scores heading, the value for % of Node-pos pts with Non-Low Risk Score should be changed to 58.6%. The draft LCD separates this field into two separate fields for Prosigna (Int and High), which is inconsistent with the reporting convention for the other tests. Removal of the Int and High values and replacement with a single value of 58.6% reflects a fair comparison between the tests and the appropriate risk cutoffs for US patients. 5. Under the DR in Pts with High/Non-Low Risk Score heading, the value for Node-pos, Non-Low Risk Score- 10yr DR risk should be changed to 24.2% ( %). The draft LCD separates this field into two separate fields for Prosigna (Int and High), which is inconsistent with the reporting convention for the other tests. Removal of the Int and High values and replacement with a single value of 24.2% ( %) reflects a fair comparison between the tests and the appropriate risk cutoffs for US patients. 6. Under the DR in Pts with High/Non-Low Risk Score heading, the value for % of Patients in Intermediate Risk Group should be changed to 23.4%. The draft LCD indicated a value of 33.5% which is associated with the European product labeling (CE mark). In summary, we are primarily seeking removal of Prosigna from the table in the Draft MolDX LCD: EndoPredict Breast Cancer Gene Expression Test (DL 37264) as it inappropriately compares results between trial populations with differing patient characteristics. Alternatively, at a minimum, we request an update to the Prosigna portion of the table to be consistent with the US product labeling cleared for marketing during FDA 510(k) review. Response 3: The table has been removed. Response to Comments: MolDX: Oncotype DX Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer A55694 Effective Date: 8/24/17 The comment period for the MolDX: Oncotype DX Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer Local Coverage Determination (LCD) began on 06/05/17 and ended on 07/20/17. The notice period will begin on 8/17/2017 and will end on. The LCD will become effective on 10/2/2017. The following comments were received from the provider community: Comment 1: From The Prostate Cancer Research Institute PCRI supports Palmetto/M oldx s recent coverage recommendation for the Oncotype DX Genomic Prostate Score for Favorable Intermediate risk prostate cancer patients. PCRI agrees that all patients should have access to the tools, information, and advancements which provide clarity for their prostate cancer, thereby helping them make wiser treatment decisions. Prostate cancer treatments vary, and there are many side effects and often permanent symptoms associated with more aggressive treatments. Before a man and his doctor makes treatment choices, they deserve a better understanding and clear knowledge of the cancer and its aggressiveness. The standard protocol, random biopsies, does not provide enough information about a man s cancer. And, considering the pathology report after surgery has been shown to differ from that of the Gleason grade given after the random biopsy, it s only logical and of sound mind to acknowledge the necessity for Oncotype DX GPS, based on the crucial information it provides. A patient needs to be able to make the right treatment choice; this is vital. If you can recognize the importance of this, then you must recognize Oncotype DX Genomic Prostate Score is necessary for these men. Coverage for this test should be provided to men Gleason Grade Group 2 (Gleason Sum 3+4=7), and PSA < 20 and clinical stage <T3 and Gleason Sum 6 and PSA and clinical stage T2a /2017

53 The Oncotype DX GPS is proven to change the treatment choices of men. With more information, men were able to make a treatment choice with ALL of the information, instead of just a fraction. Treatment is a man s choice, and this test should be covered for these men so they have the ability to make the best choice with all of the available information and resources. You have the studies, the statistics, and the facts. We encourage you to make the wise choice and approve coverage of Oncotype DX GPS for these men. Response 1: Comment acknowledged. Comment 2: From Jamie Bearse, President & CEO, ZERO The End of Prostate Cancer On behalf of prostate cancer patients and their families, ZERO The End of Prostate Cancer is writing to express its support for MoIDx s proposed expansion of coverage for Oncotype DX Genomic Prostate Score (GPS) to men with favorable intermediaterisk prostate cancer via the above referenced draft local coverage determination (LCD). ZERO is a national nonprofit with a mission to end prostate cancer. ZERO advances research, improves the lives of men and families, and inspires action. We believe that coverage expansion of GPS to men with favorable intermediate-risk contributes enables men to confidently choose between active surveillance and treatment with more confidence. The use of GPS for this population could be a difficult decision for a man and his care team. Use of GPS will lead to better clinical understanding of the aggressiveness of a man s prostate cancer. As a result, men will experience greater satisfaction with the decision they choose. We support utilization of the National Comprehensive Cancer Center (NCCN) guidelines as a resource for the decision to cover men with favorable intermediate-risk prostate cancer. However, to encourage both patients and their physicians to use GPS as a decision making tool, we would support MoIDX simplifying the risk stratification definition for favorable intermediate-risk population to mirror the definition recently endorsed by the American Urological Association (AUA) guidelines: Gleason Grade Group 2 (Gleason Sum 3+4=7), and PSA < 20 and clinical stage <T3 Gleason Sum 6 and PSA and clinical stage T2a As you know, the prostate specific antigen (PSA) as a screening tool has its weaknesses and the biopsy only provides limited information about a man s prostate cancer. However, genomic testing, like the GPS, bridges the gap between a screening tool, a biopsy, and a treatment or active surveillance decision. With broad coverage and utilization of GPS we can increase utilization of active surveillance in appropriate cases and increase treatment satisfaction decisions for those men whose cancer requires intervention. Response 2: The new AUA/ASTRO/SUO guidelines for intermediate risk localized prostate cancer have been adopted by the AUA and the WHO. In the new grouping, Gleason 7 disease is separated into two distinct groups, group 2 (Gleason 3+4) and group 3 (Gleason 4+3). In the new guidelines intermediate risk prostate cancer is broken in two separate categories favorable and unfavorable intermediate risk disease. Unfavorable intermediate risk is defined as any patients with group 3 prostate cancer or patients with group 2 prostate cancer presenting with ct2c disease or a PSA between ng/dl. For patients in the unfavorable group physicians should consider staging studies to rule out nodal or distant metastatic disease. The draft policy was written prior to the adoption of the new guidelines and has been changed to reflect the new AUA definition. Comment 3: The National Alliance of State Prostate Cancer Coalitions (NASPCC) is a not-forprofit organization comprised of many state prostate cancer coalitions, each of which represents thousands of prostate cancer patients. We represent both a very large critical mass of already-diagnosed prostate cancer patients and those as-yet-undiagnosed whom we are watching out for /2017

54 NASPCC wants all prostate cancer patients to have access to available tools that help them and their physicians better understand their disease. We therefore appreciate Palmetto/MolDx s recent coverage recommendation for the Oncotype DX Genomic Prostate Score (GPS) to include Favorable Intermediate Risk patients. These patients are starting to be offered (along with Low Risk and Very Low Risk patients) Active Surveillance (AS) as a viable option when appropriate, which is a good choice especially with the known risk of overtreatment of non-threatenin g disease. Better risk assessment tools are necessary so that men and their physicians can correctly choose between AS and active treatment. Broader access to genomic tools, such as the Oncotype DX Genomic Prostate Score Test will help guide patients and physicians so that the right treatment is recommended for the right patient. While NASPCC agrees with the clinical conditions as described in the draft LCD, there may be some confusion as to the exact indicia for proper use of AS in the Favorable Intermediate Risk population. We therefore recommend that Palmetto/MolDx use a simpler definition of the Intermediate Risk Population, a definition endorsed by the AUA Guidelines, which should read: *Gleason Grade Group 2 (Gleason Sum 3=4=7), PSA <20 and Clinical Stage <3; and *Gleason Sum <6 or =6 and clinical stage < or = T2a. Response 3: The new AUA/ASTRO/SUO guidelines for intermediate risk localized prostate cancer have been adopted by the AUA and the WHO. In the new grouping, Gleason 7 disease is separated into two distinct groups, group 2 (Gleason 3+4) and group 3 (Gleason 4+3). In the new guidelines intermediate risk prostate cancer is broken in two separate categories favorable and unfavorable intermediate risk disease. Unfavorable intermediate risk is defined as any patients with group 3 prostate cancer or patients with group 2 prostate cancer presenting with ct2c disease or a PSA between ng/dl. For patients in the unfavorable group physicians should consider staging studies to rule out nodal or distant metastatic disease. The draft policy was written prior to the adoption of the new guidelines and has been changed to reflect the new AUA definition. Comment 4: From Jack Spicer, MD, Medical Director, Managed Care Medical Affairs, Genomic Health Genomic Health appreciates the opportunity to comment on MolDx s draft coverage LCD for the Oncotype DX Genomic Prostate Score (GPS) in Favorable Intermediate risk patients. Both the NCCN and the AUA now recognize active surveillance as a management option for men diagnosed with Favorable Intermediate risk prostate cancer. This is an important step forward for the urology community and a significant step for newly diagnosed men. Access to the Oncotype DX GPS will provide a personalized risk assessment to help inform the decision between AS and immediate intervention in these patients. We do request consideration of simplifying the definition of favorable intermediate risk to include the AUA s current definition. Specifically, the NCCN definition, currently included in the draft LCD, is Gleason Grade Group 2 (3+4=7), percentage of biopsy cores As proposed in our Favorable Intermediate dossier, this is precisely the population for which we demonstrated the validity of GPS, and importantly, is much easier for urology practices to understand and incorporate into their respective clinics. Response 4: The new AUA/ASTRO/SUO guidelines for intermediate risk localized prostate cancer have been adopted by the AUA and the WHO. In the new grouping, Gleason 7 disease is separated into two distinct groups, group 2 (Gleason 3+4) and group 3 (Gleason 4+3). In the new guidelines intermediate risk prostate cancer is broken in two separate categories favorable and unfavorable intermediate risk disease. Unfavorable intermediate risk is defined as any patients with group 3 prostate cancer or patients with group 2 prostate cancer presenting with ct2c disease or a PSA between ng/dl. For patients in the unfavorable group physicians should consider staging studies to rule out nodal or distant metastatic disease. The draft policy was written prior to the adoption of the new guidelines and has been changed to reflect the new AUA definition /2017

55 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 August 31, MLN Connects for September 7, MLN Connects for September 14, MLN Connects for September 21, Receive ADRs Electronically: Go Green via eservices Providers can now 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 new 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 /2017