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

Transcription

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 July 2016 Volume 2016, Issue 7 What s Inside... Administration CMS Quarterly Provider Update... 3 Going Beyond Diagnosis...3 Get Your Medicare News Electronically... 5 Claim Status Category and Claim Status Codes Update... 7 October Quarterly Update to 2016 Annual Update of HCPCS Codes Used for Skilled Nursing Facility Consolidated Billing Enforcement... 8 Recovering Overpayments from Providers Who Share Tax Identification Numbers Drugs and Biologicals JW Modifier: Drug Amount Discarded/Not Administered to any Patient Education Educational Events Now Available Fee Schedules and Reimbursement Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July Calendar Year (CY) 2016 Update Medicine Coding Revisions to National Coverage Determinations (NCDs) Ambulatory Surgical Center (ASC July 2016 Update of the Ambulatory Surgical Center (ASC) Payment System Chiropractors Educational Resources to Assist Chiropractors with Medicare Billing 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 2015 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 2015 American Dental Association (ADA). All rights reserved.

3 End-Stage Renal Disease (ESRD) Update to Pub , Chapter 11 End-Stage Renal Disease (ESRD) for Calendar Year (CY) Etcetera Medical Director s Desk CMS e-news CallBack Assist CallBack Assist was implemented to improve the wait times during peak calling periods of the day. CallBack Assist allows providers to opt out for a same-day callback from a customer service representative (CSR). Typically, the callback occurs within one hour. This feature is a contact center best practice among the industry. Providers are encouraged to try this new option when offered to avoid long wait times for assistance. 2 7/2016

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 7/2016

5 Palmetto GBA Advanced Clinical Editing System (P-ACE) Palmetto GBA Advanced Clinical Editing System (P-ACE) is available to all direct submitters as well as those who transmit claims via clearinghouses/billing services. New CEM Smart edits will appear on claim rejection reports (277CA) as Palmetto GBA deploys P-ACE to the electronic claim submission process for professional claims. P-ACE returns pre-adjudicated claims information through claim acknowledgement transaction reports sent by your clearinghouse based on the Medicare 277CA All direct submitters will receive the Medicare 277CA report with the new smart edits Claims failing the pre-adjudication editing process are not forwarded to the claims adjudication system P-ACE will work with your current clearinghouse/billing service workflow so you can modify claims before the MCS system receives them After you have reviewed the Smart Edit, if you choose not to change the claims, you can resubmit in its original format and it will pass to the MCS claims adjudication system for processing. P-ACE is available to you at no cost! No downloads or software is required. P-ACE is incorporated in your normal EDI stream. Unsure what the P-ACE Smart Edit means? Smart Edits are not directives, but rather considerations for appropriate claims processing based upon the information submitted on the claim. Medicare will continue to require that all documentation and coverage requirements are met prior to providers making the claim change. To use the P-ACE Smart Edit Lookup tool, enter the P-ACE Smart Edit # from/for the claim. On the second screen you will see the P-ACE Smart Edit Message, description, and any additional information pertinent to your claim. Only P-ACE Smart Edit # s listed in the Advance Clinical Editing page table will display. 4 7/2016

6 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. 5 7/2016

7 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. 6 7/2016

8 Claim Status Category and Claim Status Codes Update MLN Matters Number: MM9550 Related Change Request (CR) #: CR 9550 Related CR Release Date: May 20, 2016 Effective Date: October 1, 2016 Related CR Transmittal #: R3527CP Implementation Date: October 3, 2016 Provider Types 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) 9550 informs MACs about the changes to Claim Status Category Codes and Claim Status Codes. Make sure that your billing staffs are aware of these changes. Background The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires all covered entities to use only Claim Status Category Codes and Claim Status Codes approved by the National Code Maintenance Committee in the ASC X12 276/277 Health Care Claim Status Request and Response transaction standards adopted under HIPAA for electronically submitting health care claims status requests and responses. These codes explain the status of submitted claim(s). Proprietary codes may not be used in the ASC X12 276/277 transactions to report claim status. The National Code Maintenance Committee meets at the beginning of each ASC X12 trimester meeting (January/February, June, and September/October) and makes decisions about additions of new codes, as well as modifications and retirement of existing codes. The Committee has decided to allow the industry 6 months for implementation of newly added or changed codes. The codes sets are available at and Included in the code lists are specific details, including the date when a code was added, changed, or deleted. All code changes approved during the June 2016 committee meeting will be posted on the above mentioned websites on or about July 1, The Centers for Medicare & Medicaid Services (CMS) will issue future CRs regarding the need for future updates to these codes. These code changes are to be used in editing of all ASC X transactions processed on or after the date of implementation and to be reflected in the ASC X transactions issued on and after the date of implementation of CR9550. Additional Information The official instruction, CR9550 issued to your MAC regarding this change is available at 7 7/2016

9 October Quarterly Update to 2016 Annual Update of HCPCS Codes Used for Skilled Nursing Facility Consolidated Billing Enforcement MLN Matters Number: MM9688 Related Change Request (CR) #: CR 9688 Related CR Release Date: June 17, 2016 Effective Date: October 1, 2016 Related CR Transmittal #: R3546CP Implementation Date: October 3, 2016 Provider Types Affected This MLN Matters Article is intended for physicians, providers, and suppliers submitting claims to all Medicare Administrative Contractors (MACs) for services to Medicare beneficiaries who are in a Part A Skilled Nursing Facility (SNF) stay. Provider Action Needed This article is based on Change Request (CR) 9688 updates to the lists of Healthcare Common Procedure Coding System (HCPCS) codes that are subject to the consolidated billing provision of the SNF Prospective Payment System (PPS). Changes to Current Procedure Terminology (CPT)/HCPCS codes and Medicare Physician Fee Schedule designations will be used to revise CWF edits to allow MACs to make appropriate payments in accordance with policy for SNF consolidated billing in the Medicare Claims Processing Manual, Chapter 6, Section 20.6 at Make sure your staffs are aware of these updates. Background The Centers for Medicare & Medicaid Services (CMS) periodically updates the lists of HCPCS codes that are excluded from the Consolidated Billing (CB) provision of the SNF PPS. Services excluded from SNF PPS and CB may be paid to providers, other than SNFs, for beneficiaries, even when in a SNF stay. Services not appearing on the exclusion lists submitted on claims to MACs, including Durable Medical Equipment MACs (DME MACs), will not be paid by Medicare to any providers other than a SNF. For non-therapy services, SNF CB applies only when the services are furnished to a SNF resident during a covered Part A stay; however, SNF CB applies to physical and occupational therapies and speech-language pathology services whenever they are furnished to a SNF resident, regardless of whether Part A covers the stay. In order to assure proper payment in all settings, Medicare systems must edit for services provided to SNF beneficiaries both included and excluded from SNF CB. The updated lists for institutional and professional billing are available at Section 1888 of the Social Security Act codifies SNF PPS and CB. The new coding identified in each update describes the same services that are subject to SNF PPS payment by law. No additional services will be added 8 7/2016

10 by these routine updates; that is, new updates are required by changes to the coding system, not because the services subject to SNF CB are being redefined. Other regulatory changes beyond code list updates will be noted when and if they occur. Your MAC will re-open and re-process claims which you bring to their attention, for claims with dates of service on or after January 1, 2016, that have previously been denied/rejected incorrectly prior to the implementation of CR9688. Additional Information The official instruction, CR9688, issued to your MAC regarding this change, is available at 9 7/2016

11 Recovering Overpayments from Providers Who Share Tax Identification Numbers MLN Matters Number: SE1612 Related Change Request (CR) #: N/A Related CR Release Date: N/A Effective Date: N/A Related CR Transmittal #: N/A Implementation Date: N/A Provider Types Affected This MLN Matters Article is intended for providers of services and suppliers who share the same Tax Identification Number (TIN) even though they may have different National Provider Identifiers or other billing numbers used to bill Medicare. What You Need to Know Section 1866j(6) of the Social Security Act ( the Secretary to make any necessary adjustments to the payments of a provider of services or supplier who shares a TIN with a provider of services or supplier that has an outstanding Medicare overpayment. The Secretary of Health and Human Services is authorized to adjust the payments of such a provider of services or supplier regardless of whether it has been assigned a different billing number or NPI from that of the provider of services or supplier with the outstanding Medicare overpayment. In January 2016, the Centers for Medicare & Medicaid Services (CMS) enhanced its financial accounting system to include a function that allows CMS to recover payments made to a provider of services or supplier that shares the same TIN with a provider of services or supplier that has an outstanding Medicare overpayment across multiple states within a Medicare Administrative Contractor (MAC) jurisdiction. Additional Information You may review section 1866j(6) at /2016

12 JW Modifier: Drug Amount Discarded/Not Administered to any Patient MLN Matters Number: MM9603 Revised Related Change Request (CR) #: CR 9603 Related CR Release Date: June 9, 2016 Effective Date: January 1, 2017 Related CR Transmittal #: R3539CP Implementation Date: January 3, 2017 Note: This article was revised on June 10, 2016, to reflect the revised CR9603 issued on June 9. The CR was revised to change the effective and implementation dates. The article is revised accordingly. In the article, the CR release date, transmittal number and link to the CR were also 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 drugs or biologicals administered to Medicare beneficiaries. Provider Action Needed The Centers for Medicare & Medicaid Services (CMS) issued CR 9603 to alert MACs and providers of the change in policy regarding the use of the JW modifier for discarded Part B drugs and biologicals. Effective January 1, 2017, providers are required to: 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 Make sure that your billing staffs are aware of these changes. Remember that the JW modifier is not used on claims for CAP drugs and biologicals. Background The Medicare Claims Processing Manual, Chapter 17, Section 40 provides policy detailing the use of the JW modifier for discarded Part B drugs and biologicals. The current policy allows MACs the discretion to determine whether to require the JW modifier for any claims with discarded drugs or biologicals, and the specific details regarding how the discarded drug or biological information should be documented. Be aware in order to more effectively identify and monitor billing and payment for discarded drugs and biologicals, CMS is revising this policy to require the uniform use of the JW modifier for all claims with discarded Part B drugs and biologicals. 11 7/2016

13 Additional Information The official instruction, CR9603, issued to your MAC regarding this change is available at Document History Document Description History June 10, 2016 The article was revised to reflect a revised CR9603. The CR revision changed the effective and implementation dates. In the article, the CR release date, transmittal number and link to the CR were also changed. All other information remains the same. May 25, 2016 The article was revised to reflect an updated CR. That CR updated the X-Ref Requirement number in the CR s Supporting Information Section. In the article, the CR release date, transmittal number and link to the CR was changed. All other information remains the same. Denial Resolution Tool The Palmetto GBA Denial Resolution tool, located on the home page under Forms/Tools, includes resources for resolving the top claim rejections and denial reasons. Save time and resources by looking here before you pick up the phone. Access denial reasons in plain language Scroll through the titles to locate your procedure Use the Palmetto GBA search engine to search by remark code 12 7/2016

14 Educational Events Now Available Don t Miss this Wonderful Opportunity! Join the Provider Outreach and Education event listed below to learn about the Medicare program. Event Title Ask the Contractor Teleconference Topic: to be determined Medicare Updates, Changes and Reminders Webcast Date/Time August 11, a.m. ET September 15, a.m. ET Access Teleconference Phone Number: Pass code: A391FE4BEBC539944AB7A594A5E0C67E 13 7/2016

15 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July Calendar Year (CY) 2016 Update MLN Matters Number: MM9633 Related Change Request (CR) #: CR 9633 Related CR Release Date: May 20, 2016 Effective Date: January 1, 2016 Related CR Transmittal #: R3528CP Implementation Date: July 5, 2016 Provider Types Affected This MLN Matters Article is intended for physicians, other providers, and suppliers who submit claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. Provider Action Needed Change Request (CR) 9633 amends payment files that were issued to your MAC based upon the CY 2016 MPFS Final Rule published in the Federal Register on November 16, These payment files are to be effective for services furnished between January 1, 2016, and December 31, Make sure your billing staff is aware of these changes. Background Section 1848(c)(4) of the Social Security Act authorizes the Secretary to establish ancillary policies necessary to implement relative values for physicians services. Key Changes in CR9633 Unless otherwise stated, the changes included in the July update to the 2016 MPFSDB are effective for dates of service on and after January 1, The key changes for the July update, effective as of January 1, 2016, are as follows. CPT/HCPCS Action G0296 Multiple Surgery = 0; Diagnostic Imaging Family Indicator = 99 G9678 Procedure Status = C (Effective for services on or after ) Multiple Surgery Indicator = Multiple Surgery Indicator = Endo Base Code = Multiple Surgery Indicator = Bilateral Indicator = PC/TC indicator = /2016

16 The following new codes in CR9636 have also been added to the MPFSDB. CPT/ Short Descriptor Procedure RVU Effective Date HCPCS Code Status Q5102 Inj., infliximab biosimilar E no RVUs Q9981 rolapitant, oral, 1mg E no RVUs Q9982 flutemetamol f18 diagnostic E no RVUs Q9983 florbetaben f18 diagnostic E no RVUs For more information on the codes in CR9636, you may want to review the related MLN Matters Article MM9636 at Downloads/MM9636.pdf. CPT Codes effective on or after July 1, 2016 The new CPT Category III codes listed below have been added to the MPFSDB effective for dates of service on and after July 1, There are no RVUs for these codes, and the following payment policy indicators are the same for each code: Procedure Status = C, Multiple Surgery = 0, Bilateral Surgery = 0, Assistant at Surgery = 0, Co-Surgeons = 0, Team Surgeons = 0, PC/TC = 0, Physician Supervision of Diagnostic Procedures = 09, and Diagnostic Imaging Family = 99. The Global Surgery Days for 0437T, 0439T, and 0443T = ZZZ; the rest are YYY. CPT Code Short Descriptor Long Descriptor 0437T 0438T 0439T 0440T 0441T 0442T 0443T 0444T 0445T Impltj synth rnfcmt abdl wal Tprnl plmt biodegrdabl matrl Myocrd contrast prfuj echo Abltj perc uxtr/ perph nrv Abltj perc lxtr/ perph nrv Abltj perc plex/ trncl nrv R-t spctrl alys prst8 tiss 1st plmt drug elut oc ins Sbsqt plmt drug elut oc ins Implantation of non-biologic or synthetic implant (eg, polypropylene) for fascial reinforcement of the abdominal wall (List separately in addition to code for primary procedure) Transperineal placement of biodegradable material, peri-prostatic (via needle), single or multiple, includes image guidance Myocardial contrast perfusion echocardiography; at rest or with stress, for assessment of myocardial ischemia or viability (List separately in addition to code for primary procedure) Ablation, percutaneous, cryoablation, includes imaging guidance; upper extremity distal/peripheral nerve Ablation, percutaneous, cryoablation, includes imaging guidance; lower extremity distal/peripheral nerve Ablation, percutaneous, cryoablation, includes imaging guidance; nerve plexus or other truncal nerve (eg, brachial plexus, pudendal nerve) Real time spectral analysis of prostate tissue by fluorescence spectroscopy Initial placement of a drug-eluting ocular insert under one or more eyelids, including fitting, training, and insertion, unilateral or bilateral Subsequent placement of a drug-eluting ocular insert under one or more eyelids, including re-training, and removal of existing insert, unilateral or bilateral 15 7/2016

17 Note: MACs will not search their files to either retract payment for claims already paid or to retroactively pay claims. However, they will adjust claims brought to their attention. Additional Information The official instruction, CR9633 issued to your MAC regarding this change is available at Medicare Physician Fees Lookup Tool Use the Medicare Physician Fee Lookup Tool, located on our home page. The Physician Fee Schedule tool saves our customers time and money by providing a one stop shop! Customers can locate fees for the 2013 through 2016 throughout the United States. The tool can search up to five codes and each code shows the allowance, all of the indicator rules such as the Global Surgery modifiers and Multiple Surgery rules. This tool helps customers research more than a fee; they can determine if the wrong modifier was appended to a service, or if the service was subject to multiple surgery rules. The fees and indicator files are downloadable and customers can easily save the data to their systems for future use. Secure echat This secure, innovative feature allows providers to interact with designated Palmetto GBA staffers so they can receive real-time assistance with inquiries they are searching for on the website. Users can dialogue with an online operator who will provide help locating information on any topics or specialties on the Palmetto GBA website. The echat button will appear at the bottom, right side of the browser screen, when echat is available. Concierge Service for Large Provider Practices and Institutions We now offer concierge service for large provider practices and institutions. Concierge service is intended to assist providers with a large number of claims questions. Providers will need to supply Palmetto GBA with a detailed list of the claims questions at a minimum of one week in advance of the scheduled conference call in order to provide ample opportunity for research prior to the call. During the scheduled teleconference, a CSR will be prepared to respond to the submitted claims questions or will seek additional information if needed to aid us in our research. To request concierge service, providers simply contact the Provider Contact Center at and a CSR will assist in scheduling the teleconference. 16 7/2016

18 Coding Revisions to National Coverage Determinations (NCDs) MLN Matters Number: MM9631 Revised Related Change Request (CR) #: CR 9631 Effective Date: October 1, unless noted differently in CR9631 Related CR Release Date: June 3, 2016 Related CR Transmittal #: R1672OTN Implementation Date: October 3, 2016 Note: This article was revised on June 6, 2016, to reflect the revised CR9631 issued on June 3, In the article, the CR release date, transmittal number, and the Web address for accessing the CR are revised. All other information remains the same. Provider Types Affected This MLN Matters Article is intended for physicians and other providers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. Provider Action Needed CR9631 is the 8th maintenance update of International Classification of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs inclu ded are a result of feedback received from previous ICD-10 NCD CRs, specifically CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, and CR9540, while others are the result of revisions required to other NCD-related CRs released separately. Review MLN Matters Articles MM7818 ( cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/ MM7818.pdf), MM8109 ( MLNMattersArticles/downloads/MM8109.pdf), MM8197 ( Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM8197.pdf), MM8691 ( cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/ MM8691.pdf), MM9087 ( MLNMattersArticles/downloads/MM9087.pdf), MM9252 ( Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM9252.pdf), and MM9540 ( MM9540.pdf) for information pertaining to these CR s. Background The translations from ICD-9 to ICD-10 are not consistent one-to-one matches, nor are all ICD-10 codes appearing in a complete General Equivalence Mappings (GEMS) guide or other mapping guides appropriate when reviewed against individual NCD policies. In addition, for those policies that expressly allow MAC discretion, there may be changes to those NCDs based on current review of those NCDs against ICD-10 coding. For these reasons, there may be certain ICD-9 codes that were once considered appropriate prior to ICD-10 implementation that are no longer considered acceptable. 17 7/2016

19 No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. Updated NCD coding spreadsheets related to CR9631 are available at Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. To be specific, CR9631 makes adjustments to the following NCDs: NCD Implantable Automatic Defibrillators NCD Percutaneous Transluminal Angioplasty (PTA) NCD Artificial Hearts NCD Hyperbaric Oxygen Therapy NCD Cochlear Implants NCD Aprepitant NCD Colorectal Cancer Screening NCD Mammography NCD Cryosurgery of Prostate NCD Heart Transplants NCD Smoking/Tobacco-Use Cessation Counseling NCD Counseling to Prevent Tobacco Use Additional Information The official instruction, CR 9631, issued to your MAC regarding this change is available at Document History June 6, revised due to revised CR - no substantive change to the article. May 17, initial issuance. 18 7/2016

20 July 2016 Update of the Ambulatory Surgical Center (ASC) Payment System MLN Matters Number: MM9668 Related Change Request (CR) #: CR 9668 Related CR Release Date: May 27, 2016 Effective Date: July 1, 2016 Related CR Transmittal #: R3531CP Implementation Date: July 5, 2016 Provider Types 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 Request (CR) 9668 informs MACs about changes to and billing instructions for various payment policies implemented in the July 2016 ASC payment system update. As appropriate, this notification also includes updates to the Healthcare Common Procedure Coding System (HCPCS). Make sure that your billing staffs are aware of these changes. Background Included in CR9668 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), ASC billing edits, and the CY 2016 ASC payment rates for covered surgical and ancillary services (ASCFS file). There is also an update to Chapter 14, Section 10 of the Medicare Claims Processing Manual, which is attached to CR9668. Key Changes in CR Billing Instructions for Intensity Modulated Radiation Therapy (IMRT) Planning Payment for the services identified by Current Procedural Terminology (CPT) codes 77280, 77285, 77290, 77295, through 77321, 77331, and are already included in the ASC payment for CPT code (IMRT planning). Effective, July 1, 2016, these codes should not be reported by ASCs in addition to CPT code when provided as part of the development of the IMRT plan. 2. Upper Eyelid Blepharoplasty and Blepharoptosis Repair The Centers for Medicare & Medicaid Services (CMS) payment policy does not allow ASCs to bill for separate payment for a blepharoplasty procedure (CPT codes 15822, 15823) in addition to a blepharoptosis procedure (CPT codes ) on the ipsilateral upper eyelid. Any removal of upper eyelid skin in the context of an upper eyelid blepharoptosis surgery is considered a part of the blepharoptosis surgery and is already be included in the payment rate. Also ASCs cannot bill a blepharoplasty to Medicare and the beneficiary cannot be separately charged for a cosmetic surgery regardless of the amount of upper eyelid skin that is removed on a patient receiving a blepharoptosis repair because removal of (any amount) of upper eyelid skin is part of the blepharoptosis repair. In addition, the following are not permitted: Operating on the left and right eyes on different days when the standard of care is bilateral eyelid surgery 19 7/2016

21 Charging the beneficiary an additional amount for a cosmetic blepharoplasty when a blepharoptosis repair is performed Charging the beneficiary an additional amount for removing orbital fat when a blepharoplasty or a blepharoptosis repair is performed Performing a blepharoplasty on a different date of service than the blepharoptosis procedure for the purpose of u nbundling the blepharoplasty or charging the beneficiary for a cosmetic surgery 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 blepharoplasty performed with a blepharoptosis repair Using modifier 59 to unbundle the 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 Using an Advance Beneficiary Notice of Noncoverage for a service that would be bundled into another service if billed to Medicare. 3. Category III CPT Codes Effective July 1, 2016 The American Medical Association (AMA) releases Category III CPT codes twice per year: in January, for implementation beginning the following July, and in July, for implementation beginning the following January. For the July 2016 update, CMS is implementing in the ASC Payment System five Category III CPT codes that the AMA released in January 2016 for implementation on July 1, The long and short descriptors, and ASC Payment Indicators (PIs) for these codes are shown in Table 1. Table 1 - Category III CPT Codes Effective July 1, 2016 CPT Code Long Descriptor Short Descriptor ASC PI 0438T Transperineal placement of biodegradable material, Tprnl plmt biodegrdabl G2 peri-prostatic (via needle), single or multiple, includes image guidance matrl 0440T Ablation, percutaneous, cryoablation, includes Abltj perc uxtr/perph nrv G2 imaging guidance; upper extremity distal/peripheral nerve 0441T Ablation, percutaneous, cryoablation, includes Abltj perc lxtr/perph nrv G2 imaging guidance; lower extremity distal/peripheral nerve 0442T Ablation, percutaneous, cryoablation, includes Abltj perc plex/trncl nrv G2 imaging guidance; nerve plexus or other truncal nerve (eg, brachial plexus, pudendal nerve) 0443T Real time spectral analysis of prostate tissue by fluorescence spectroscopy R-t spctrl alys prst8 tiss G2 Payment rates for these services are in Addendum AA of the July 2016 ASC Update that is posted at /2016

22 HCPCS code C9743 will be deleted June 30, 2016 since it will be replaced with Category III CPT code 0438T effective July 1, Drugs, Biologicals, and Radiopharmaceuticals a. Drugs and Biologicals with Payments Based on Average Sales Price (ASP) Effective July 1, 2016 For CY 2016, payment for nonpass-through drugs, biologicals and therapeutic radiopharmaceuticals is made at a single rate of ASP + 6 percent, which provides payment for both the acquisition cost and pharmacy overhead costs associated with the drug, biological or therapeutic radiopharmaceutical. In CY 2016, a single payment of ASP + 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 ASPs will be updated on a quarterly basis as later quarter ASP submissions become available. Updated payment rates effective July 1, 2016 are in the July 2016 ASC Addendum BB at b. Drugs and Biologicals Based on ASP Methodology with Restated Payment Rates Some drugs and biologicals 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 at on the first date of the quarter. Suppliers who think they may have received an incorrect payment for drugs and biologicals impacted by these corrections may request MAC adjustment of the previously processed claims. c. New CY 2016 HCPCS Codes and Dosage Descriptors for Certain Drugs, Biologicals, and Radiopharmaceuticals Seven new HCPCS codes have been created for reporting drugs and biologicals in the ASC setting. These new codes, their descriptors, PIs, and their effective dates are listed in Table 2. Table 2 New CY 2016 HCPCS Codes and Dosage Descriptors for Certain Drugs, Biologicals, and Radiopharmaceuticals HCPCS Code Long Descriptor Short Descriptor ASC PI Effective Date C9476 Injection, Injection, daratumumab K2 7/1/2016 daratumumab, 10 mg C9477 Injection, elotuzumab, Injection, elotuzumab K2 7/1/ mg C9478 Injection, sebelipase Injection, sebelipase alfa K2 7/1/2016 alfa, 1 mg C9479* Instillation, Instill, ciprofloxacin otic K2 7/1/2016 ciprofloxacin otic suspension, 6 mg C9480 Injection, trabectedin, Injection, trabectedin K2 7/1/ mg Q9981 Rolapitant, oral, 1 mg Rolapitant, oral, 1mg K2 7/1/2016 Q5102** Injection, infliximab, biosimilar, 10 mg Inj., infliximab biosimilar K2 4/5/ /2016

23 *Note on reporting C9479: Each vial of C9479 contains 60 mg, or 10 doses. If one single use vial is used for both patient s ears with the remainder of the drug in the vial unused, then two units of C9479 should be reported as administered to the patient; any discarded amount should be reported with the JW modifier according to the Medicare Claims Processing Manual, Chapter 17 - Drugs and Biologicals, Section 40 - Discarded Drugs and Biologicals. **Note on Q5102: the effective date of Q5102 is 4/5/2016. d. Biosimilar Biological Product Payment and Required Modifiers ASC claims for separately paid biosimilar biological products are now required to include a modifier that identifies the manufacturer of the specific product. The modifier does not affect payment determination, but is used to distinguish between biosimilar products that appear in the same HCPCS code but are made by different manufacturers. Q5101: This is a reminder that for claims with dates of service January 1, 2016 and later, Q5101 must be submitted with a modifier to identify the manufacturer of the biosimilar product. Currently, the ZA modifier is the only manufacturer/modifier that may be submitted with Q5101. Claims submitted without the modifier cannot be processed. Q5102: Effective April 5, 2016, Q5102 (Inj., infliximab biosimilar) is payable in the ASC setting, where there has not previously been a specific code available. Q5102 must be submitted with a modifier to identify the manufacturer of the biosimilar product. Currently, the ZB modifier is the only manufacturer/ modifier that may be submitted with this HCPCS. Claims submitted without the modifier will be returned as unprocessable. When these claims are returned, MACs will use the following messages when returning these claims: Claim Adjustment Reason Code (CARC) 4 The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. Remittance Advice Remark Code (RARC) MA-130- Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. Group Code: CO (Contractual Obligation) The biosimilar HCPCS codes and required modifiers are listed in Table 3. Table 3 Biosimilar Biological Product Payment and Required Modifiers HCPCS Code Short Descriptor ASC PI FDA Approval Date Modifier Q5101 Inj filgrastim g-csf K2 03/06/2015 ZA-Novartis/ biosim Sandoz Q5102 Inj., infliximab K2 04/05/2016 ZB Pfizer/ biosimilar Hospira Modifier Effective Date 01/01/ /05/2016 e. Other Changes to CY 2016 HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals Effective July 1, 2016, HCPCS code Q9982, flutemetamol f18 diagnostic, will replace HCPCS code C9459, Flutemetamol f18. The ASC payment indicator will remain K2. Pass-Through Drugs and Biologicals. 22 7/2016

24 Effective July 1, 2016, HCPCS code Q9983, florbetaben f18 diagnostic, will replace HCPCS code C9458, Florbetaben f18. The ASC payment will remain K2, Pass-Through Drugs and Biologicals. Both C9458 and C9459 have a termination date of 6/30/2016. Other Changes to CY 2016 HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals Effective July 1, 2016 are listed in Table 4. Table 4 Other Changes to CY 2016 HCPCS Codes for Certain Drugs, Biologicals, and Radiopharmaceuticals Effective July 1, 2016 HCPCS Code Short Descriptor Long Descriptor ASC PI Added Date Termination Date C9459 Flutemetamol Flutemetamol f18, diagnostic, per K2 01/01/ /30/2016 f18 study dose, up to 5 millicuries Q9982 flutemetamol Flutemetamol F18, diagnostic, per K2 07/01/2016 f18 diagnostic study dose, up to 5 millicuries C9458 Florbetaben Florbetaben f18, diagnostic, per K2 01/01/ /30/2016 f18 study dose, up to 8.1 millicuries Q9983 florbetaben Florbetaben f18, diagnostic, per K2 07/01/2016 f18 diagnostic study dose, up to 8.1 millicuries C9743 Bulking/ spacer material impl Injection/implantation of bulking or spacer material (any type) with or without image guidance (not to be used if a more specific code applies) G2 06/30/ Coverage Determinations The 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, CR9668 issued to your MAC regarding this change is available at /2016

25 eservices: Claim Status To check on a particular claim status, please enter the HICN and other required beneficiary information, as well as the date(s) of service. Should you not know the exact date of service, you are able to enter a span or range of up to 45 days. Please keep in mind, retrieving claims older than six months takes a little longer than something more current. Claims older than three years may not be searchable. For more information about eservices and the many services it offers, please visit our website at Review and Print Electronic Remittances via eremits Palmetto GBA is pleased to offer eremits through our eservices, a free, webbased, provider self-service tool. You can view or print remittances, which are available for approximately one year. In addition, eservices will let you store remittances and utilize search features to find specific information on the notices. eremits are available to be accessed every day between the hours of 8 a.m. and 7 p.m. ET. To use eservices, you must have an Electronic Data Interchange (EDI) Agreement on file with Palmetto GBA. If you are already submitting claims electronically, you do not have to submit a new EDI Enrollment Agreement. For more information on EDI, please visit our website at A list of current system-related claims payment issues is available on our website. These issues were reported to the Centers for Medicare & Medicaid Services (CMS) and/or the Multi-Carrier System (MCS). Please check often for updates before contacting the provider contact center. The issues are identified by stand alone articles and will be updated as needed. Be sure to sign-up to receive updates using the Article Update Notification feature. 24 7/2016

26 Educational Resources to Assist Chiropractors with Medicare Billing MLN Matters Number: SE1603 Revised Related Change Request (CR) #: N/A Related CR Release Date: N/A Effective Date: N/A Related CR Transmittal #: N/A Implementation Date: N/A Note: This article was revised on June 21, 2016, to add a reference and link to an educational video on Improving the Documentation of Chiropractic Services ( that gives a thorough presentation on medical necessity and proper documentation. All other information is unchanged Provider Types Affected This Special Edition (SE) MLN Matters article is intended for Chiropractors submitting claims to Medicare Administrative Contractors (MACs) for chiropractic services provided to Medicare beneficiaries. This article is part of a series of SE articles prepared for Chiropractors by CMS in response to the request for educational materials at the September 24, 2015 Special Open Door Forum titled: Improving Documentation of Chiropractic Services. Provider Action Needed The Centers for Medicare & Medicaid Services (CMS) is providing this article in order to provide education for chiropractic billers on accessing the correct resources for proper billing. This article is intended to be a comprehensive resource for chiropractic documentation and billing. Be aware of these policies along with any local coverage determinations (LCDs) for these services in your area that might limit circumstances under which active/corrective chiropractic services are paid. Background In 2014, the Comprehensive Error Testing Program (CERT) that measures improper payments in the Medicare Fee-for-Service program reported a 54 percent error rate for Chiropractic services. The majority of those errors were due to insufficient documentation/documentation errors. This article provides a detailed list of informational/educational resources that can help chiropractors avoid these errors. Those resources are as follows: Enrollment Information The Medicare General Information, Eligibility, and Entitlement Manual, Chapter 5, includes Section 70.6, Chiropractors ( This section outlines the definition of a chiropractor, licensure and authorization to practice, and minimum standards. The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, includes Section 40.4, Definition of Physician/Practitioner 25 7/2016

27 ( This section explains that the opt out law does not define physician to include a chiropractor; therefore, a chiropractor may not opt out of Medicare and provide services under a private contract. The Medicare Program Integrity Manual, Chapter 15 Medicare Enrollment, includes Section , Physicians ( This section explains that a physician must be legally authorized to practice medicine by the State in which he/ she performs such services in order to enroll in the Medicare Program and to retain Medicare billing privileges. A chiropractor who meets Medicare qualifications may enroll in the Medicare Program. Coverage, Documentation, and Billing The other articles in this series of articles on chiropractic services are SE1601 ( which discusses Medicare s medical record documentation requirements for chiropractic services, and SE1602 ( SE1602.pdf), which discusses the importance of using the AT modifier on claims for chiropractic services. MLN Matters Article MM3449 ( MLN/MLNMattersArticles/downloads/mm3449.pdf), discusses Revised Requirements for Chiropractic Billing of Active/Corrective Treatment and Maintenance Therapy, Full Replacement of CR3063. The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services ( includes the following sections explaining coverage for a chiropractor s services: 30.5: Chiropractor s Services; : Certification and Recertification of Need for Treatment and Therapy Plans of Care; 240: Chiropractic Services General; This section establishes that payment for chiropractic services is based on the Medicare Physician Fee Schedule (MPFS) and that payment is made to the beneficiary or, on assignment, to the chiropractor : Manual Manipulation; : Subluxation May Be Demonstrated by X-Ray or Physician s Exam; : Necessity for Treatment; : Location of Subluxation; and : Treatment Parameters. The Chiropractic Local Coverage Determinations (LCDs) for MACs include ICD-10 Coding Information for ICD-10 Codes that support the medical necessity for Chiropractor services. Each contractor has an LCD for Chiropractors. There may be additional documentation information in your LCD. There are links to the chiropractic LCDs in the additional information section of this article. Some of those LCDs are as follows: National Government Services (LCD L33613); First Coast Options, Inc (LCD L33840); CGS Administrators, LLC (LCD L33982); Noridian Healthcare Solutions, LLC (Jurisdiction F) (LCD L34009); Noridian Healthcare Solutions, LLC (Jurisdiction E) (LCD 34242); Wisconsin Physicians Service Insurance Corporation (LCD L34585); and Novitas Solutions, Inc (LCD L35424). 26 7/2016

28 The Fact Sheet Misinformation on Chiropractic Services ( Medicare-Learning-Network-MLN/MLNProducts/downloads/Chiropractors_fact_sheet.pdf) is designed to provide education on Medicare regulations and policies on chiropractic services to Medicare providers. It includes information on the documentation needed to support a claim submitted to Medicare for medical services. The MLN Matters Article SE (Special Edition) 1101 Revised Overview of Medicare Policy Regarding Chiropractic Services ( MLNMattersArticles/downloads/SE1101.pdf) highlights Medicare policy regarding coverage of chiropractic services for Medicare beneficiaries. The MLN Matters Article SE1305 Revised Full Implementation of Edits on the Ordering/Referring Providers in Medicare Part B, DME, and Part A Home Health Agency (HHA) Claims (Change Requests 6417, 6421, 6696, and 6856) ( MLNMattersArticles/Downloads/SE1305.pdf) explains that chiropractors are not eligible to order or refer supplies or services. The Medicare Claims Processing Manual, Chapter 1 General Billing Requirements ( includes the following sections which apply to billing for a chiropractor s services: : Carrier Annual Participation Program; : Annual Open Participation Enrollment Process; : Annual Medicare Physician Fee Schedule File Information; and : A/B MAC (B) Specific Requirements for Certain Specialties/Services. The Medicare Claims Processing Manual, Chapter 12 Physicians/Nonphysician Practitioners, includes Section 220, Chiropractic Services ( This section explains the documentation requirements when billing for a chiropractor s services. Also the claims processing edits related to payment for a chiropractor s services are explained. The Medicare Claims Processing Manual, Chapter 26 Completing and Processing Form CMS-1500 Data Set, includes Section 10.4, Items Provider of Service or Supplier Information ( This section includes specific instructions for chiropractic services for items 14, 17, and 19. The NCCI Policy Manual for Medicare Services ( under the Downloads section. Chapter XI, Medicine, Evaluation and Management Services (CPT Codes ), includes information on chiropractic manipulative treatment. More Resources: A chiropractor is eligible to receive incentive payments under the Physician Quality Reporting System (PQRS), Electronic Prescribing (erx) Incentive Program, and Electronic Health Record (EHR) Incentive Program. Information on reporting these measures is available in the Physician and Other Enrolled Health Care Professionals pathway. 27 7/2016

29 The Medicare Claims Processing Manual, Chapter 23 Fee Schedule Administration and Coding Requirements, includes Section 30, Services Paid Under the Medicare Physician s Fee Schedule ( This section explains that a chiropractor is paid under the MPFS. The booklet MLN Guided Pathways - Provider Specific Medicare Resources, pages 25-28, contains many resources useful for chiropractic billing at Network-MLN/MLNEdWebGuide/Downloads/Guided_Pathways_Provider_Specific_Booklet.pdf. Advance Beneficiary Notice (ABN) Information The Medicare Benefit Policy Manual, Chapter 15 Covered Medical and Other Health Services, includes reference to Advance Beneficiary Notices (ABNs) in Section , Necessity for Treatment ( The Medicare Claims Processing Manual, Chapter 23 Fee Schedule Administration and Coding Requirements, includes Section , Instructions for Codes With Modifiers (Carriers Only) ( This section outlines the modifiers that may be used when a chiropractor notifies a beneficiary the item or service may not be covered. The Medicare Claims Processing Manual, Chapter 30, Financial Liability Protections, ( includes detailed instructions on completing the ABN and use of the GA modifier. Information about the ABN, including downloadable forms is available at on the CMS website. Additional Information You may want to review the educational video on Improving the Documentation of Chiropractic Services ( which gives a thorough presentation on medical necessity and proper documentation. Document History Date of Change Description June 21, 2016 The article was revised to add a reference and link to an educational video on Improving the Documentation of Chiropractic Services that gives a thorough presentation on medical necessity and proper documentation. March 16, 2016 Initial article post 28 7/2016

30 Update to Pub , Chapter 11 End-Stage Renal Disease (ESRD) for Calendar Year (CY) 2016 MLN Matters Number: MM9541 Related Change Request (CR) #: CR 9541 Related CR Release Date: June 3, 2016 Effective Date: January 1, 2016 Related CR Transmittal #: R224BP Implementation Date: September 6, 2016 Provider Types Affected This MLN Matters Article is intended for End-Stage Renal Disease (ESRD) facilities that submit claims to Medicare Administrative Contractors (MACs) for ESRD services provided to Medicare beneficiaries. What You Need to Know Change Request (CR) 9541 updates Chapter 11 of the Medicare Benefit Policy Manual to reflect the provisions in the Calendar Year (CY) 2016 ESRD Prospective Payment System (PPS) final rule. There are no new coverage policies, payment policies, or codes introduced in CR9541. Specific policy changes and related business requirements were addressed in CR9367, as discussed in MLN Matters article MM9367 at MM9367.pdf. Background The End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) provides a single payment to ESRD facilities, that is, hospital-based and freestanding facilities, that cover all the resources used in providing an outpatient dialysis treatment. This includes supplies and equipment used to administer dialysis in the ESRD facility or at a patient s home, drugs, biologicals, laboratory tests, training, and support services. The ESRD PPS base rate is adjusted for patient-level case mix and facility-level characteristics. For CY 2016, in accordance with the American Taxpayers Relief Act of 2012 (ATRA; Section 632(c)), The Centers for Medicare & Medicaid Services (CMS) analyzed the case-mix payment adjustments using more recent data. CMS revised the adjustments by changing the adjustment payment amounts based on an updated regression analysis using Calendar Years (CYs) 2012 and 2013 ESRD claims and cost report data. CMS also removed two comorbidity payment adjustments (bacterial pneumonia and monoclonal gammopathy). Because the updated regression analysis conducted enabled CMS to analyze and revise the case-mix payment adjustments, CMS also revised the low-volume payment adjustment and implemented a payment adjustment for rural ESRD facilities. For CY 2016, in accordance with the Protecting Access to Medicare Act of 2014 (PAMA) (Section 217(c)), CMS finalized a drug designation process for: 1. Determining when a product would no longer be considered an oral-only drug; and 2. Including new injectable and intravenous products into the bundled payment under the ESRD PPS. 29 7/2016

31 Updates to the Medicare Benefit Policy Manual The key clarifications/updates to the Medicare Benefit Policy Manual are as follows: Section 20.2 To the extent a laboratory test is performed to monitor the levels or effects of any of the drugs that were specifically excluded from the ESRD PPS, these tests would be separately billable. The following table lists the drug categories that were excluded from the ESRD PPS and the rationale for their exclusion. Laboratory services furnished to monitor the medication levels or effects of drugs and biologicals that fall in those categories would not be considered to be furnished for the treatment of ESRD. DRUG CATEGORIES EXCLUDED FROM THE ESRD PPS BASE RATE FOR THE PURPOSE OF REPORTING LABS Drug Category Rationale for Exclusion Anticoagulant Drugs labeled for non-renal dialysis conditions and not for vascular access. Antidiuretic Used to prevent fluid loss. Antiepileptic Used to prevent seizures. Anti-inflammatory May be used to treat kidney disease (glomerulonephritis) and other inflammatory conditions. Antipsychotic Used to treat psychosis. Antiviral Used to treat viral conditions such as shingles. Cancer management Includes oral, parenteral and infusions. Cancer drugs are covered under a separate benefit category. Cardiac management Drugs that manage blood pressure and cardiac conditions. Cartilage Used to replace synovial fluid in a joint space. Coagulants Drugs that cause blood to clot after anti-coagulant overdose or factor VII deficiency Cytoprotective agents Used after chemotherapy treatment Endocrine/metabolic management Used for endocrine/metabolic disorders such as thyroid or endocrine deficiency, hypoglycemia, and hyperglycemia Erectile dysfunction management Androgens were used prior to the development of ESAs for anemia management and currently are not recommended practice. Also used for hypogonadism and erectile dysfunction. Gastrointestinal Used to treat gastrointestinal conditions such as ulcers and gallbladder disease management Immune system Anti-rejection drugs covered under a separate benefit category. management Migraine management Used to treat migraine headaches and symptoms Musculoskeletal management Used to treat muscular disorders such as prevent muscle spasms, relax muscles, improve muscle tone as in myasthenia gravis, relax muscles for intubation and induce uterine contractions 30 7/2016

32 Pharmacy handling for oral anti-cancer, anti-emetics and immunosuppressant drugs Pulmonary system management Radiopharmaceutical procedures Unclassified drugs Vaccines Not a function performed by an ESRD facility Used for respiratory/lung conditions such as opening airways and newborn apnea Includes contrasts and procedure preparation Should only be used for drugs that do not have a HCPCS code and therefore cannot be identified Covered under a separate benefit category Also, effective January 1, 2016, the lipid panel is no longer considered to be a renal dialysis service. However, if the panel is furnished for the treatment of ESRD it is the responsibility of the ESRD facility and should be reported on the facility s claim. Section 20.3 The ESRD PPS functional category is a distinct grouping of drugs and biologicals, as determined by CMS, whose end action effect is the treatment or management of a condition or conditions associated with ESRD. The Drug Designation Process is dependent on the functional categories, as discussed in Section , below in this article. Drugs and biologicals always considered to be renal dialysis services are those used for access management, anemia management, bone and mineral metabolism management, and cellular management. ESRD facilities are responsible for furnishing these drugs directly or under arrangement. This includes any drug or biological that is furnished in the ESRD facility or taken by the patient outside of the ESRD facility. Erythropoiesis Stimulating Agents (ESAs), such as epoetin alfa (EPOGEN ) and darbepoetin alfa (ARANESP ) when furnished to Medicare ESRD patients are always considered to be renal dialysis services and included in the ESRD PPS. Monthly dosages of these ESAs are subject to Medicare s ESA claims monitoring policy. See the Medicare Claims Processing Manual, Chapter 8, Section for more information on the ESA monitoring policy at NOTE: ESA dose edits are applied prior to pricing so that ESAs are not overvalued in determining eligibility for outlier payments. Drugs and biologicals included in the ESRD PPS base rate that may be used for both the treatment of ESRD and for reasons other than the treatment of ESRD are those used as antiemetics, anti-infectives, antipruritics, anxiolytics, excess fluid management, fluid and electrolyte management including volume expanders, and pain management. ESRD facilities are responsible for furnishing these drugs directly or under arrangement when they are prescribed for the treatment of ESRD. This includes any drug or biological that is furnished in the ESRD facility or taken by the patient outside of the ESRD facility. 31 7/2016

33 ESRD facilities are responsible for furnishing antibiotics for access site infections directly or under arrangement. When antibiotics are used at home by a patient to treat an infection of the catheter site or peritonitis associated with peritoneal dialysis, the antibiotics are included in the ESRD PPS and may not be paid separately. This includes antibiotics that may be added to a patient s dialysate solution for the purposes of vascular accessrelated and peritonitis infections. Any other drugs (other than those categories described above and below) when used for the treatment of ESRD are also included in the ESRD PPS. For example, Patient A experiences nausea or pain during a hemodialysis dialysis treatment and requires medications. Any medication furnished during the dialysis treatment or after the treatment is considered a renal dialysis service and may not be billed separately. Patient B experiences anxiety with dialysis treatments and is prescribed anti-anxiety medication during and between the dialysis treatments. Any medications furnished in preparation for the dialysis treatment, during the dialysis treatment or after the dialysis treatment, is considered a renal dialysis service and may not be billed separately. Any drug or biological added to patient dialysate solutions. Functional Categories Included in the ESRD Base Rate but May be Used for Dialysis and Non-Dialysis Purposes Category Rationale for Association Antiemetic Used to prevent or treat nausea and vomiting related to dialysis. Excludes antiemetics used for purposes unrelated to dialysis, such as those used in conjunction with chemotherapy as these are covered under a separate benefit category. Anti-infectives Used to treat vascular access-related and peritonitis infections. May include antibacterial and antifungal drugs. Antipruritic Drugs in this classification have multiple clinical indications. Use within an ESRD functional category includes treatment for itching related to dialysis. Anxiolytic Drugs in this classification have multiple actions. Use within an ESRD functional category includes treatment of restless leg syndrome related to dialysis. Excess Fluid Management Drug/fluids used to treat fluid excess/overload. Fluid and Electrolyte Intravenous drugs/fluids used to treat fluid and electrolyte needs. Management Including Volume Expanders Pain Management Drugs used to treat vascular access site pain and to treat pain medication overdose, when the overdose is related to medication provided to treat vascular access site pain. Oral-only forms of renal dialysis drugs and biologicals that have no other form of administration will be included in the ESRD PPS as a Part B renal dialysis service. Implementation of renal dialysis oral-only drugs has been delayed until January 1, /2016

34 Section Drug Designation Process A. Definition of a New Injectable or Intravenous Product A new injectable or intravenous product is an injectable or intravenous product that is approved by the Food and Drug Administration (FDA) under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, commercially available, assigned a Healthcare Common Procedure Coding System (HCPCS) code, and designated by CMS as a renal dialysis service. B. Determination To make the determination as to whether a product is a new injectable or intravenous drug or biological; whether the new injectable or intravenous drug or biological is a renal dialysis service; and whether the new injectable or intravenous drug or biological fits into an existing functional category CMS will: 1. Review the new product s FDA labeling data and information; 2. Review the new product s information presented for obtaining a HCPCS code; and 3. Conduct an internal medical review following the announcement of the new product s FDA and HCPCS decision. If a new injectable or intravenous drug is used to treat or manage a condition for which there is an ESRD PPS functional category, the new drug would be considered included in the ESRD PPS bundled payment and no separate payment is available. If the new injectable or intravenous drug is used to treat or manage a condition for which there is not an ESRD PPS functional category, the following steps occur: 1. The new injectable or intravenous drug or biological would be paid for using a transitional drug add-on payment adjustment; 2. At the next rulemaking opportunity, CMS would add a new functional category applicable to the new injectable or intravenous drug or biological being used in the treatment of ESRD; 3. The new injectable or intravenous product would be added to the ESRD PPS bundled payment following payment of the transitional drug add-on payment adjustment. C. Transitional Drug Add-On Payment Adjustment If the new injectable or intravenous drug or biological is used to treat or manage a condition for which there is not an ESRD PPS functional category, CMS will pay for the drug or biological using a transitional drug add-on payment adjustment. The transitional drug add-on payment is based on payment methodologies under Section 1847A and would continue for a period of 2 years. During the time that injectable or intravenous drugs and biologicals are paid the transitional drug add-on payment adjustment, the drug or biological is not considered an outlier service. D. Determination of When an Oral-Only Renal Dialysis Service Drug or Biological is No Longer Oral-Only An oral-only renal dialysis service drug or biological is a drug or biological with no injectable equivalent or other form of administration other than an oral form. An oral-only renal dialysis service drug or biological is no longer considered oral-only when a non-oral version of the oral-only drug or biological is approved by the FDA. Section 60 Based on the refinement of the ESRD PPS, effective January 1, 2016, adult case-mix payment adjustments are made for four comorbidity categories (two acute and two chronic) as discussed in detail in the revised section 60, which also includes detailed examples. The revised Section 60 is included as part of CR9541 and the Web address for accessing the CR is in the Additional Information section of this article. 33 7/2016

35 In addition, the revised Section 60 shows that beginning January 1, 2016, the ESRD PPS provides a percent payment adjustment for ESRD facilities located in a rural Core Based Statistical Area. Additional Information The official instruction, CR9541, issued to your MAC regarding this change is available at Related MLN Matters Article MM9367 is available at Learning-Network-MLN/MLNMattersArticles/Downloads/MM9367.pdf. Chapter 8, Section of the Medicare Claims Processing Manual is available at 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 /2016

36 Appeals Calculator Self-Service Tool Providers may appeal claims that are partially or fully denied, as long as the claim has appeal rights. Different levels of appeals have different timelines in which the appeal rights are valid. Access the Appeals Calculator tool under Forms/Tools on the home page to calculate the your claims appeal deadlines. Global Surgery Denial Tool If the procedure code was denied with remittance message CO-B15/CO-97 (claim/service denied/reduced because this procedure/service is not paid separately OR payment is included in the allowance for another service/procedure), then use the following worksheet to see what, if any, corrections you can make to your claim. Just answer a few questions, and the tool will provide you with information to help you with your service. Access the Global Surgery Denial tool under Forms/Tools on the home page. 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 2016 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. 35 7/2016

37 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 36 7/2016

38 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 /2016

39 Part B Local Coverage Determinations Policy Title Response to Comments Effective Date Implantable Infusion Pump L33461 Rev #7 The comment period began on 2/8/16 and ended on 3/24/16. Comments were received from the provider community and are listed below: Comment: The commenter requested that list of covered drugs for intrathecal infusion be expanded to include sufentanil, clonidine, ropivicaine, fentanyl, gabapentin, and droperidol due to the fact that a large number of chronic pain patients do not maintain a long term sustained response to intrathecal morphine. Response: In consideration of this request the medical director performed a literature review regarding the intrathecal use of these drugs for long term pain management. The medical director also consulted a former Palmetto GBA CAC member who is a nationally recognized expert on chronic pain management. Based upon available peer reviewed literature, input from the expert, and the current recommendations of the Polyanalgesic Consensus Conference, the coverage will be expanded to include sufentanil and clonidine. There is sufficient data to support the safety and efficacy of these drugs for intrathecal use. There is limited or no data to support the use of ropivicaine, gabapentin, or droperidol. Fentanyl is already a covered drug in the LCD that is currently in effect. The notice period begins on 6/9/16 and the LCD becomes final on 7/25/16. 7/25/16 The following revisions were made to the final LCD: Under CPT/HCPCS Codes Group 1: Paragraph removed fluxuride and added sufentanil and clonidine. 38 7/2016

40 Allergy Skin Testing The comment period began on 2/8/16 and ended on 3/24/16. Comments were received 7/25/16 L33417 from the provider community and are listed below: Rev #3 Comment: Food allergen testing for patients who present with gastrointestinal symptoms suggestive of food Intolerance, is non-covered by Medicare. As a result, this would exclude testing for eosinophilic esophagitis, and for anaphlaxis that presents with GI symptoms alone. Response: Eosinophilic esophagitis and anaphylaxis due to unspecified foods, as well as anaphylaxis due to specific foods (i.e. peanuts), are covered diagnoses under this LCD. An anaphylactic reaction to a food that is manifested by GI symptoms alone without any of the more serious components of anaphylaxis such as cardiovascular and respiratory compromise would be far less common than isolated GI symptoms due solely to food intolerance, thus routine diagnostic testing for food allergy in light of isolated GI symptoms suggestive of food intolerance would not be of diagnostic value in most cases. However, if the treating physician has reason to suspect that the isolated gastrointestinal symptoms are manifestations of the much more serious issues of eosinophilic esophagitis or a true anaphylactic reaction, he or she should use their professional judgment in performing such testing. Documentation of such a circumstance in the medical record can be presented on appeal and would be considered in the determination as to whether this testing in those cases is medically reasonable and necessary. Comment: We further respectfully request clarification regarding the first two bullets on page five of the draft policy. The first bullet states, Medicare would not expect that more than 30 tests per year are medically necessary, for code 95017, for the management of an individual patient. More than 20 tests per year may be allowed upon review when the clinical circumstances documented in the patient s medical record substantiate the need for additional tests. For 95017, it is first indicated a maximum of 30 tests per year would be permitted, but then indicates that more than 20 tests would require an exception which is inconsistent. The second bullet states, Medicare would not expect that more than 12 tests per year are medically necessary, for code 95018, for the management of an individual patient. More than 20 tests per year may be allowed upon review when the clinical circumstances documented in the patient s medical record substantiate the need for additional tests. This statement seems contradicatory in that for 95018, 12 tests are permitted per year, but more than 20 tests per year would require approval. Response: Palmetto GBA acknowledges that these statements under the Utilization Guidelines section of the LCD are contradictory. They will be revised accordingly. The notice period begins on 6/9/16 and the LCD becomes final on 7/25/16. The following revisions were made to the final LCD: Under Associated Information- Utilization Guidelines changed 20 to 30 tests per year under the 5th bullet and changed 10 to 12 tests per year under the 6th bullet. 39 7/2016

41 Special The comment period began on 2/8/16 and ended on 3/24/16. Comments were received 7/25/16 Electroencephalography from the provider community and are listed below: L33447 Rev #5 Comment 1: Change the language from resting to routine for the description of a baseline EEG. Response 1: This change was made to the LCD. Comment 2: CPT is seldom used and is not a code for an ambulatory EEG. This CPT code should be removed from an ambulatory EEG policy. Response 2: CPT code was removed from the LCD. Comment 3: Remove the reference to video in the description of ambulatory EEG. Video is seldom used in that setting. Response 3: These references were removed from the LCD. Comment 4: Most often (ambulatory EEG) is done for spell characterization. Rarely is it done for surgical evaluation of epilepsy. The latter is done in the hospital and we use code for that. Response 4: CPT code was removed from the LCD. Comment 5: When doing ambulatory EEG for 72 hours, the last 24 hours of data are not very good. The electrodes are no longer making good contact and some may have come off as the patient has had them on for a long time. We will sometimes do two rounds of 48 hours of monitoring and get better data that way. Response 5: Policy language was changed to reflect this time frame. Comment 6: Sometimes the diagnosis is not established with one round of monitoring with and may need to be repeated at a later date. Response 6: Accommodation for this contingency was added to the policy language. Comment 7: Under Utilization Guidelines: Consider change of language It is anticipated that once the diagnosis has been established, this study will not be repeated for the same diagnosis, nor.. The reason I think this modification would be good, it s that occasionally I see patients with epilepsy who develop new spells that are different from their past spells. It can be very difficult to determine if these are epileptic or non-epileptic spells. I recognize that (although low yield), a repeat EEG might be helpful. Often these patients will need EMU evaluation to more definitely sort out the basis of these spells. 40 7/2016

42 Special Response 7: 7/25/16 Electroencephalography This language change was made to the LCD. L33447 Rev #5 continued Comment 8: Under Indication it is noted that one indication might include Adjusting anti- epileptic medication levels, but then the Utilization Guidelines say nor will it be used in the monitoring of a therapeutic regimen I cannot recall using the EEG to adjust anti-epileptic medication levels. Response 8: This conflicting language was corrected in the LCD. Comment 9: Under Indications would make small change. Differentiating between neurological, cardiac, and psychiatric related problems. I added psychiatry since this is often one the main reasons why we obtain a prolonged EEG the hope that we can catch a spell to determine if the patient his having epileptic or non-epileptic events. Response 9: This language was added to the LCD. Comment 10: Under documentation requirements: I agree that one should be done before a prolonged ambulatory EEG. My only concern is the one year limitation. I wonder if there might not be the opportunity to waive the one-year timeframe in patients who have a longer history of epilepsy, or who have had routine EEG testing in the somewhat more distant past. Response 10: This is a reasonable request, but is not feasible in this context as there are two issues that would be problematic: A. How would one determine how far back would such a study still be valid in the context of current patient symptomatology? B. Medicare claims systems cannot reliably locate a prior claim to validate this requirement further than a 1 year look back. This language was not changed in the LCD. The notice period begins on 6/9/16 and the LCD becomes final on 7/25/16. The following revisions were made to the final LCD: Under Coverage Indications, Limitations and/or Medical Necessity removed resting from the description of a baseline EEG, added psychiatric related problems, removed adjusting anti epileptic medication levels, changed the time frame for ambulatory EEGs and added that the study will not be repeated for the same diagnosis. Under Associated Information- Documentation Requirements removed CPT codes and 95951, resting, and changed 72 hours to 48 hours. Under Associated Information- Utilization Guidelines added that the study will not be repeated for the same diagnosis. Under CPT/HCPCS Codes Group 1: Paragraph removed CPT codes and and resting. Under CPT/HCPCS Codes Group 1: Codes removed CPT codes and /2016

43 Policy Title LCD Revisions Effective Date Mohs Micrographic Surgery (MMS) L33436 Rev #3 Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes C and C as requested. 7/07/16 Blepharoplasty, Eyelid Surgery, and Brow Lift L33765 Rev #3 HbA1c L33431 Rev #6 Virtual Colonoscopy (CT Colonography) L33452 Rev #3 Vertebroplasty/Vertebral Augmentation L33473 Rev#5 Under CMS National Coverage Policy deleted sections 50 Form CMS-R-131 Advance Beneficiary Notice of Noncoverage (ABN) and 50.1 Introduction-General Information from the CMS Internet Only Manual, Pub , Medicare Claims Processing Manual, Chapter 30, citation. Under Coverage Guidance the first paragraph was rewritten. Under Limitations and/or Medical Necessity Lower Eyelid Surgery in the second paragraph would was changed to could. Under General Information Documentation Requirements in the second paragraph a statement was deleted. Under Associated Information Section A. Patient Complaints and Physical Signs added the section titled For Reconstructive Surgery. Under Associated Information Section B. added COLOR in the first sentence. The last section titled, For Reconstructive Surgery was added. Under Sources of Information and Basis for Decision updated the URLs for Standards of Medical Care in Diabetes for Prevention or delay of type 2 diabetes and Older adults. Under CMS National Coverage Policy SSA was removed from the first reference. The second reference was corrected from the Social Security Act 1862(a)(1)(H) to the Social Security Act 1861(pp). Part 4 was added to the sixth reference. The abbreviation for chapter was replaced with the full word in references seven and eight. The s was removed from the word Manuals in the eighth reference. Under Sources of Information and Basis for Decision, the citations were corrected to conform to the American Medical Association citation style. In citation number 2: the letter B was added to Pineau to complete the author s name. In citation number 9, the initial M was added to the first name of Morrin to complete the author s name. In reference number 11, the author Goisto, was corrected to Giusti. The spelling of Endoluminal was corrected in citation number 13. Under CMS National Coverage Policy Title XVIII of Social Security Act 1862(a)(1) (A) added verbiage for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member and revised the title for 42 CFR (k)(1). Under Coverage Guidance Coverage Indications, Limitations and/or Medical Necessity the word It was deleted twice and replaced with Vertebroplasty augmentation. Under Sources of Information and Basis for Decision deleted et al and added author names to reference #2 and corrected the journal title for reference #3. The publication number was corrected for reference #16. Throughout the LCD capitalization, spelling and punctuation were corrected. 06/09/16 06/3/16 06/3/16 06/3/ /2016

44 Wireless Gastrointestinal Motility Monitoring Systems L33455 Rev #3 Chemodenervation L33458 Rev #8 Article Title Bevacizumab Off-Label Ophthalmologic Use Article A53595 Rev # 6 Bevacizumab Off-Label Ophthalmologic Use Article A53595 Rev #7 Implantable Infusion Pump Coding & Billing Guidelines Article A53005 Rev #8 Implantable Infusion Pump Coding & Billing Guidelines Article A53005 Rev #9 Under CMS National Coverage Policy the acronym SSA was removed throughout the section. The word check-ups was replaced with examinations in the second citation. The spelling of diagnostic was corrected in the fourth citation. In references five through seven, the s was removed from Manuals and Publication was abbreviated to Pub.. The abbreviation for chapter was replaced with the word Chapter, in the sixth reference. The s was added to requirements in the seventh citation. Under Coverage Indications, Limitations and/or Medical Necessity SmartPill was rewritten SmartPill, to denote the trademark. The words is and approved were added and the acronyms FDA and GI were defined. Under Indications corrected Mobility to Motility and created two sentences to form the paragraph, adding s to patient in the third bullet. Under Limitations an a was added before the word pacemaker. Under Associated Information Documentation Requirements the paragraph was rephrased to more clearly define the documentation requirements. Under Sources of Information and Basis for Decision the month was removed from the first four references and the formatting corrected. The citations were corrected to conform to the American Medical Association citation style. Under CPT/HCPCS Codes Group 1: Paragraph added verbiage related to achalasia. Under CPT/HCPCS Codes Group 1: Codes deleted CPT code Under ICD-10 Codes that Support Medical Necessity deleted Group 1: Paragraph stating CPT code 43201; HCPCS codes J0585, J0586, J0587, J0588 and Group 1: Codes including ICD 10 code K22.0. Articles Under Article Guidance removed FDA indications for first or second line treatment. Replaced experts with specialists and rephrased the last sentence of the first paragraph. Moved the first sentence from Article Text to last sentence of Article Guidance. Under Article Text clarified correct billing of bevacizumab for ophthalmic use. The second paragraph was added to provide instructions in the billing of injection procedures (CPT code 67028), use of bilateral modifier (-50), and right and left eye. Added third paragraph to provide instructions in the use of ICD-10 codes. The fourth, fifth, and sixth paragraphs clarify the billing of vials from the manufacturer, discarded quantities, and single-dose syringes obtained from a compounding pharmacy. Under Revision Effective Date corrected the date to read 05/26/2016. The effective date for Revision 6 should correctly read 05/26/2016. Under Article Text the information contained in the second paragraph was transferred into the first paragraph. Billing information and an example of completing the CMS 1500 in paragraph four was merged into the third paragraph and HFCA 1500 was updated to CMS Information that Evaluation and Management codes are separately reimbursed was corrected to read that these services are not separately payable unless the practitioner provides a significant, separately identifiable service. The pharmacy compounding fee was removed from the fourth paragraph. The Medication Price list was deleted. Under Statutory Requirements URL(s) the URLs were removed. Under Rules and Regulations URL(s) the URL was removed. Under CMS Manual Explanations URL(s) the URL was removed. Under Revision Effective Date corrected the date to read 05/26/2016. The effective date for Revision 8 should correctly read 05/26/ /03/16 7/5/16 Effective Date 05/19/16 05/26/16 05/19/16 05/26/ /2016

45 Repeat or Duplicate Services on the Same Day Article A53482 Rev #2 Repeat or Duplicate Services on the Same Day Article A53482 Rev #3 Sacroiliac-Bone Implant System Article A53452 Rev #4 Percutaneous Endovenous Ablation Procedure & Varithena A54406 Under Article Guidance, added and/or and in fact to the first paragraph. Added clarification related to the refiling of claims. IVR and OPS were defined. Under Article Text instructions were provided in the first paragraph related to corrections of previously submitted claims and medical necessity denials. Subsequent paragraphs and sections detail the billing of services that may appear to be duplicate services, the use of modifiers, and units submitted on claims. Under Revision Effective Date corrected the date to read 05/26/2016. The effective date for Revision 2 should correctly read 05/26/2016. Under Article Guidance the paragraph was rephrased for clarity. Under Article Text Palmetto GBA was removed from the second sentence. Retired Articles This article is being retired effective 6/7/16 due to varithena being included in the Varicose Veins of the Lower Extremities L33454 LCD. 05/19/16 05/26/16 06/09/16 Date of Retirement 06/7/16 Part A/B Local Coverage Determination Policy Title LCD Revisions Effective Date CT of the Abdomen and Pelvis L34415 Rev #8 Debridement of Wounds L35938 Rev #7 Non-Coverage of Extracorporeal Shock Wave Lithotripsy for Musculoskeletal Conditions L35627 Rev #3 Under Indications, Limitations and/or Medical Necessity Abdominal CT the paragraph describing the requirements of the CT equipment was deleted and moved to the last paragraph under Pelvic CT. The medical necessity criteria for a CT of the abdomen was clarified. A notation was added that CT angiography is not addressed in this LCD. Under Pelvic CT the first paragraph was reworded and the last paragraph addresses the requirements of the CT equipment. A statement was added related to the use of contrast material. Under CPT/HCPCS Codes removed CPT code [Computed tomographic angiography, abdomen and pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing Computed tomographic angiography, abdomen, with contrast material(s), including noncontrast images, if performed, and image postprocessing]. Under Sources of Information and Basis for Decision the initial J was added to Lee in the fourth citation. Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes L89.111, L89.112, L and L as these codes were inadvertently omitted. The title of the LCD was changed to Non-Coverage of Extracorporeal Shock Wave Lithotripsy for Musculoskeletal Conditions. Under Coverage Indications, Limitations and/or Medical Necessity Coverage Guidance the first paragraph was rephrased for clarity. Under Coverage Indications, Limitations and/or Medical Necessity the sections Musculoskeletal Conditions, Plantar Fasciitis, Tendinitis of the Elbow (Lateral Epicondylitis) were removed. The last three sentences of the final paragraph were not changed and when used in the treatment of musculoskeletal conditions was added to the fourth sentence. Under Bill Type Codes all codes were removed. Under Sources of Information and Basis for Decision a second reference was cited. 07/03/16 6/16/16 06/09/ /2016

46 Total Joint Arthroplasty L33456 Rev #7 Application of Skin Substitutes L36466 Rev #1 Rituximab L35026 Rev #8 Under ICD-10 Codes that Support Medical Necessity- Group 1 added ICD-10 codes M05.89, M06.09, M06.89, M08.09, M08.29, M08.89, M08.99, M80.051S, M80.052S, M80.851S, M80.852S, M84.351S, M84.352S, M84.451S, M84.452S, M84.551S, M84.552S, M84.651S, M84.652S, M96.661, M96.662, S32.301S, S32.302S, S32.311S, S32.312S, S32.314S, S32.315S, S32.391S, S32.392S, S32.401S, S32.402S, S32.411S, S32.412S, S32.414S, S32.415S, S32.421S, S32.422S, S32.424S, S32.425S, S32.431S, S32.432S, S32.434S, S32.435S, S32.441S, S32.442S, S32.444S, S32.445S, S32.451S, S32.452S, S32.454S, S32.455S, S32.461S, S32.462S, S32.464S, S32.465S, S32.471S, S32.472S, S32.474S, S32.475S, S32.481S, S32.482S, S32.484S, S32.485S, S32.491S, S32.492S, S32.591S, S32.592S, S32.601S, S32.602S, S32.611S, S32.612S, S32.614S, S32.615S, S32.691S, S32.692S, S32.89XS, S72.011S, S72.012S, S72.021S, S72.022S, S72.024S, S72.025S, S72.031S, S72.032S, S72.034S, S72.035S, S72.041S, S72.042S, S72.044S, S72.045S, S72.051S, S72.052S, S72.061S, S72.062S, S72.064S, S72.065S, S72.091S, S72.092S, S72.101S, S72.102S, S72.111S, S72.112S, S72.114S, S72.115S, S72.121S, S72.122S, S72.124S, S72.125S, S72.131S, S72.132S, S72.134S, S72.135S, S72.141S, S72.142S, S72.144S, S72.145S, S72.21XS, S72.22XS, S72.24XS, S72.25XS, S72.391S, S72.392S, S72.8X1S, S72.8X2S, S79.001S, S79.002S, S79.011S, S79.012S, S79.091S and S79.092S. Under ICD-10 Codes that Support Medical Necessity- Group 2 Asterisk corrected T A to now read T84.010A. Under ICD-10 Codes that Support Medical Necessity- Group 3 added ICD-10 codes C40.21, C40.22, M05.49, M05.79, M05.89, M06.09, M06.89, M84.461S, M84.462S, M84.561S, M84.562S, M84.661S, M84.662S, M96.661, M96.662, M96.671, M96.672, S72.401S, S72.402S, S72.411S, S72.412S, S72.414S, S72.415S, S72.421S, S72.422S, S72.424S, S72.425S, S72.431S, S72.432S, S72.434S, S72.435S, S72.441S, S72.442S, S72.444S, S72.445S, S72.451S, S72.452S, S72.454S, S72.455S, S72.461S, S72.462S, S72.464S, S72.465S, S72.471S, S72.472S, S72.491S, S72.492S, S72.8X1S, S72.8X2S, S79.101S, S79.102S, S79.111S, S79.112S, S79.121S, S79.122S, S79.131S, S79.132S, S79.141S, S79.142S, S79.191S, S79.192S, S82.001S, S82.002S, S82.011S, S82.012S, S82.014S, S82.015S, S82.021S, S82.022S, S82.024S, S82.025S, S82.031S, S82.032S, S82.034S, S82.035S, S82.041S, S82.042S, S82.044S, S82.045S, S82.091S, S82.092S, S82.101S, S82.102S, S82.121S, S82.122S, S82.124S, S82.125S, S82.131S, S82.132S, S82.134S, S82.135S, S82.141S, S82.142S, S82.144S, S82.145S, S82.161S, S82.162S, S82.191S, S82.192S, S89.001S, S89.002S, S89.011S, S89.012S, S89.021S, S89.022S, S89.031S, S89.032S, S89.041S, S89.042S, S89.091S and S89.092S. Under ICD-10 Codes that Support Medical Necessity- Group 4 added ICD-10 codes T84.042S and T84.043S. Added CPT/HCPCS Codes- Group 2 for Part A services only Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes N04.0, N04.1, N04.2, and N05.2. Under Coverage Indications, Limitations and/or Medical Necessity revised the verbiage in the last sentence from Other off label uses will not be covered at this time. to read Other off label uses will be considered for coverage at the discretion of Palmetto GBA. 06/16/16 05/19/16 7/08/ /2016

47 Once in a Lifetime Abdominal Aortic Aneurysm (AAA) Screening Article A55071 New Articles Once in a Lifetime Abdominal Aortic Aneurysm (AAA) Screening Article Once in a lifetime abdominal aortic aneurysm (AAA) screening is only covered under certain specified conditions. When billing for AAA screenings, the following ICD-10 codes should be billed: * Z13.6 for the encounter for screening of cardiovascular disorders and either ** The most appropriate code for tobacco usage: F17.210, F17.211, F17.213, F and F OR * Z84.89 for family history of other specified conditions Note: G0389 is the only ultrasound service that is payable for AAA screening under Medicare services. No other CPT/HCPCS codes are covered. 06/23/16 Per the CMS Internet-Only Manual, Publication , Medicare Claims Processing Manual, Chapter 18, Section and , Payment may be made for a one-time ultrasound screening for AAA for beneficiaries who meet the following criteria: (i) receives a referral for such an ultrasound screening from the benefi ciary s attending physician, physician assistant, nurse practitioner or clinical nurse specialist; (ii) receives such ultrasound screening from a provider or supplier who is authorized to provide covered ultrasound diagnostic services; (iii) has not been previously furnished such an ultrasound screening under the Medicare Program; and (iv) is included in at least one of the following risk categories (I) has a family history of abdominal aortic aneurysm; (II) is a man age 65 to 75 who has smoked at least 100 cigarettes in his lifetime; or (III) is a beneficiary who manifests other risk factors in a beneficiary category recommended for screening by the United States Preventive Services Task Force regarding AAA, as specified by the Secretary of Health and Human Services, through the national coverage determination process.*** *For risk category (I) note that Z84.89 is an other specified code and requires that the condition be reflected in the medical record, therefore family history of abdominal aortic aneurysm must be documented in the medical record. **For risk category (II) ***For risk category (III) USPST does not currently have any additional screening recommendations at B or above grade at this time. Effective for services furnished on or after January 1, 2007, the following code, modifi ers, and type of service (TOS) are used for AAA screening services: G0389: Ultrasound, B-scan and or real time with image documentation; for abdominal aortic aneurysm (AAA) screening Short Descriptor: Ultrasound exam AAA screen Modifiers: TC, 26 TOS: 4 Bill Types: 12x, 13x, 22x, 23x, 71x, 73x, 85x 46 7/2016

48 Screening Colonoscopy Converted to a Diagnostic and/ or Therapeutic Colonoscopy Article A55069 New If during a colonoscopy a pathology is encountered that necessitates an intervention which converts the screening colonoscopy to a diagnostic/therapeutic colonoscopy, the appropriate CPT code which includes the PT modifier for the diagnostic/therapeutic colonoscopy must be submitted with the Z80.0 diagnosis. 1) choose the correct CPT code which describes the procedure that was attempted: CPT CPT CPT CPT CPT ) append the PT modifier to the CPT code. The PT modifier indicates a screening colonoscopy has been converted to a diagnostic test or other procedure. 10/01/15 3) use an appropriate ICD-10 diagnosis code to indicate the procedure was a screening procedure. The diagnosis Z80.0- Family history of malignant neoplasm of digestive organs can be used for screening of beneficiaries at high risk. Note: Z80.0 does not appear as an ICD-10 code that supports medical necessity in Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy LCD L34454 because this LCD addresses ONLY procedures performed for diagnostic and/or therapeutic purposes. LCD L34454 does not address criteria for the performance of or coding for screening procedures or screening procedures that are converted to diagnostic/therapeutic procedures based upon unanticipated pathology encountered during the visualization of the colon. FDA Approval of Keytruda (Pembrolizumab) for Treatment of Unresectable or Metastatic Melanoma A53795 Rev #7 FDA Approval of Keytruda (Pembrolizumab) for Treatment of Unresectable or Metastatic Melanoma A53795 Rev #8 Retirement of the Current FDA Approved Indications for KEYTRUDA (Pembrolizumab) Article A53842 This article has a retroactive effective date of 10/01/2015. Under Associated Contract Numbers added 11201, 11301, 11401, and Under Article Text revised the verbiage to include the FDA indication for metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDAapproved test with disease progression on or after platinum-containing chemotherapy. For the treatment of unresectable and metastatic melanoma deleted the following verbiage,...disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Deleted the requirement for drug name and National Drug Code (NDC) number to be included for claims submission from the fourth paragraph, the fifth bullet. Under Covered ICD-10 Codes added ICD-10 codes for NSCLC. These ICD-10 codes are effective as of 10/02/2015. Under Article Title the title was revised to now read FDA Approved Indications for KEYTRUDA (Pembrolizumab). Retired Articles The article Current FDA Approved Indications for KEYTRUDA (Pembrolizumab) A53842 is being retired on 06/29/2016 as it has been incorporated into the FDA Approval of Keytruda (Pembrolizumab) for Treatment of Unresectable or Metastatic Melanoma Article A53795 effective 06/30/ /30/16 06/30/16 06/29/ /2016

49 MoDX LCD/Article Upates Draft MolDX LCDs LCDs Description Comment Period MolDX-CDD: New Draft Policy 06/13/ /29/2016 ProMark Risk Score DL36665 GlycoMark Testing New Draft Policy 06/13/ /29/2016 for Glycemic Control DL KScore Assay New Draft Policy 06/13/ /29/2016 DL36763 MolDX: Breast Cancer Assay: Prosigna *DL36125 Male breast cancer CPT codes were removed making the policy m ore restrictive; therefore the policy was placed back in draft status for June CAC. 06/13/ /29/ /2016

50 New MolDX Articles Articles Description Publish Date MolDX: Billing and As per the LCD MolDX: Genetic Testing for Lynch Syndrome (LS), 4/1/2016 Coding for Lynch laboratory providers must follow a stepped approach to meet the reasonable Syndrome Testing and necessary criteria. To progress to each subsequent step, refer to the Services indications detailed in the policy. A54987/M00131 Step 1: NEW LS screening to detect the presence of a defective mismatch pair may be performed by ONE or both of the following methods: 1. Immunohistochemistry (IHC) for MLH1, MLH2, MSH6, and PMS2 2. Microsatellite instability analysis (MSI) To bill services for this step, choose the appropriate codes for methods(s) performed: Test CPT Code UOS Method 1 IHC-initial IHC-ea.addl AND/OR Method 2 MSI If results from methods 1 or 2 are abnormal, proceed to step 2. Step2: LS definitive testing may be performed by ONE of the following methods: 1. Next generation sequencing (NGS or hotspot ) testing platforms, OR 2. Non-NGS testing platforms To bill services for this step, choose ONE method: Step 2 Method 1 Test Hereditary colon cancer disorders genomic sequence panel OR CPT Code UOS Step 2 Method 2 Non-NGS testing: Continue steps as indicated by LCD Step 3 BRAF V600E Step 4 MLH1, Promoter Methylation Step 5A MLH Step 5B MSH Step 5C MSH Step 5D PMS Step 6 EpCAM Note: For Non-NGS testing (Step 2-6, Method 2), you may ONLY progress to the subsequent genetic test IF additional information is necessary to rule out or diagnose LS. 49 7/2016

51 Retired LCD/Article LCD/Article Description Date Retired MolDX: Breast Since the drafting of this policy, additional information has been identified 5/18/2016 Cancer Biomarkers to Guide Adjuvant Chemotherapy DL36719 that we feel will significantly impact this policy and would likely result in a significant revision. As such, we are retiring this draft. Revised LCDs LCD Description Effective Date MolDX: Molecular Diagnostic Tests (MDT) L35025 Rev # 10 MolDX: Molecular Diagnostic Tests (MDT) L35025 Rev # 11 MolDX: NRAS Genetic Testing L35073 Rev # 8 MolDX: Genetic Testing for BCR ABL Negative Myeloproliferative Disease L36044 Rev # 4 MolDX: Molecular RBC Phenotyping L36074 Rev # 4 MolDX- CDD: NSCLC, Comprehensive Genomic Profile Testing L36143 Rev # 4 Updated to remove items we no longer follow: PTI are no longer an option Suspension of claims that omit Z-Code IDs- we reject codes Correct POC for MK and MolDX Typographical error. Under Coverage Guidance Coverage Indications, Limitations and/or Medical Necessity section moved Technology Assessments (TA) down and removed the following last sentence Prior to completion of this TA and published coverage determination. Replaced CPT code in the opening sentence with CPT code was the correct code in 2015 but was changed to for Clarification for NGS testing. Added verbiage to cover NGS testing Added statement regarding RBC phenotyping of MM patients eligible for daratumumab therapy (anti CD-38), Inclusion of ICD-10 codes:c90.00, C90.01, and C and added 3 additional references under sources of information. Corrected typographical error from the equal (=) symbol to the less than or equal to ( ) symbol for light smokers 4/21/2016 6/20/2016 1/01/2016 4/28/2016 5/19/ /27/ /2016

52 CMS e-news e-news 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 Provider enews MLN Connects Provider enews for May 26, MLN Connects Provider enews for June 2, MLN Connects Provider enews for June 9, MLN Connects Provider enews for June 16, MLN Connects Provider enews for June 23, 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 /2016