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

2 PART B MEDICARE ADVISORY Latest Medicare News for Part B September 2016 Volume 2016, Issue 9 What s Inside... Administration CMS Quarterly Provider Update...3 Going Beyond Diagnosis...3 Get Your Medicare News Electronically...5 Reopenings Update Changes to Chapter Timely Reporting of Provider Enrollment Information Changes...9 Next Generation Accountable Care Organization - Implementation...11 Educational Events Now Available...16 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - October CY 2016 Update...17 Medicare Part B Clinical Laboratory Fee Schedule: Guidance to Laboratories for Collecting and Reporting Data for the Private Payor Rate-Based Payment System...19 Multiple Procedure Payment Reduction (MPPR) on the Professional Component (PC) of Certain Diagnostic Imaging Procedures...30 Medical Director s Desk...34 CMS e-news...38 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 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. CMS Provider Minute Videos The Medicare Learning Network has a series of CMS Provider Minute Videos ( Learning-Network-MLN/MLNProducts/MLN-Multimedia.html) on a variety of topics, such as psychiatry, preventive services, lumbar spinal infusion, and much more. The videos offer tips and guidelines to help you properly submit claims and maintain sufficient supporting documentation. Check the site often as CMS adds new videos periodically to further help you navigate the Medicare program. 2 9/2016

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 9/2016

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 9/2016

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. 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. 5 9/2016

7 Now You Can Access Your Personal Data to See Who Has Been Using Your NPI Electronic Utilization (eutilization) reports are now available in the eservices online provider portal. eutilization reports provide rendering providers and ordering and referring providers access to their personal data. This data can be reviewed to ensure providers are aware of when and by whom their NPI is being used for billing Medicare services and when their NPI is entered on a Medicare claim as the ordering referring physician. This will provide providers with the ability to identify possible misuse of their NPI. Providers will be able to select a period from 1-12 months for the previous 12 months of data. This data will be updated monthly so that providers can trend their data over time. Ordering and Referring This function enables an individual physician to view all Medicare claims billed where their NPI was entered as the ordering and referring provider for a beneficiary. The report will also allow providers to click and see a summary by the type of code for the services billed. Rendering This will allow an individual provider who is part of a group practice or multiple groups to pull a data report for their NPI, which will enable them to view their utilization for each associated provider ID for a specified time period. How to Sign Up to Receive This Data: In order to access your data, you will need to have an eservices account. You can sign up at edelivery Reminder: Are You Getting Your Greenmail? Palmetto GBA would like to remind providers that you have the option to receive letters electronically through eservices. Gaining access to these letters is a simple process! To start receiving your Medicare letters, such as prior authorization or first level redeterminations decision letters electronically, you must be signed up for our eservices online provider portal. Once you have signed into eservices, select the Admin tab, next you can choose your edelivery preferences. Just click the drop down box to choose edelivery of the letters you would like to receive via greenmail. You can also select User Notification to start receiving s when your letters are available in eservices for you. Selecting this choice is so easy and allows you to receive your letters faster! Once you have chosen the edelivery option, all of the letters you selected will come to you electronically, even if you sent in your request via fax or mail. 6 9/2016

8 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. 7 9/2016

9 Reopenings Update Changes to Chapter 34 MLN Matters Number: MM9639 Related Change Request (CR) #: CR 9639 Related CR Release Date: July 29, 2016 Effective Date: September 30, 2016 Related CR Transmittal #: R3568CP Implementation Date: September 30, 2016 Provider Types Affected This MLN Matters Article is intended for pr oviders, including home health and hospice providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs) and Durable Medicare Equipment MACs (DME MACS) for services provided to Medicare beneficiaries. Provider Action Needed Change Request (CR) 9639 provides updates to Chapter 34, Section 10 of the Medicare Claims Processing Manual to remove outdated contractor terminology, clarify remittance advice code reference and to add hyperlinks for regulation and statutory obligations. The updates enhance and clarify operating instructions and language in accordance with regulation and statute. CR9639 includes no policy changes. Make sure that your billing staffs are aware of these updates. Background A reopening is a remedial action taken to change a binding determination or decision that resulted in either an overpayment or an underpayment, even though the determination or decision was correct based on the evidence of record. Reopenings are different from adjustment bills in that adjustment bills are subject to normal claims processing timely filing requirements (that is, filed within 1 year of the date of service), while reopenings are subject to timeframes associated with administrative finality and are intended to fix an error on a claim for services previously billed (for example, claim determinations may be reopened within 1 year of the date of the initial determination for any reason, or within 1 to 4 years of the date of the initial determination upon a showing of good cause). The main clarification in CR9639 is to note that where Medicare medical review staff request documentation from a provider/supplier for a claim, but did not receive it, and issued a denial based on no documentation, the codes used for the denial are as follows: Group Code: CO Contractual Obligation Claim Adjustment Reason Code (CARC) 50 these are non-covered services because this is not deemed a medical necessity by the payer Remittance Advice Remark Code (RARC) M127 Missing patient medical record for this service). Additional Information The official instruction, CR9639 issued to your MAC regarding this change is available at 8 9/2016

10 Timely Reporting of Provider Enrollment Information Changes MLN Matters Number: SE1617 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 all providers and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services to Medicare beneficiaries. Provider Action Needed: Impact to You Failure to comply with the requirements to report changes in your Medicare enrollment information could result in the revocation of your Medicare billing privileges. This article does not establish any new or revised policy, but serves as a reminder to comply with existing policy. What You Need to Know MLN Matters Article SE1617 reinforces the importance of the timely reporting of changes in your Medicare enrollment information. What You Need to Do Comply with the reporting requirements for changes in your enrollment information and avoid disruption of your Medicare claims payments. Background In accordance with 42 Code of Federal Regulations (CFR) Section (d), all physicians, non-physician practitioners (for example, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, certified nurse-midwives, clinical social workers, clinical psychologists, registered dietitians or nutrition professionals) and physician and non-physician practitioner organizations must report the following changes in their enrollment information to your MAC via the Internet-based Provider Enrollment, Chain and Ownership System (PECOS) or the CMS 855 paper enrollment application within 30 days of the change: A change in ownership An adverse legal action, or A change in practice location. You must report all other changes to your MAC within 90 days of the change. If you are a supplier of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS), you must report any changes in information supplied on the enrollment application within 30 days of the change to the National Supplier Clearinghouse (NSC) (42 CFR (c)(2)). Continued >> 9 9/2016

11 Independent Diagnostic Testing Facilities must report changes in ownership, location, general supervision, and adverse legal actions to your MAC either online, or via the appropriate CMS-855 form, within 30 calendar days of the change. You must report all other changes to your enrollment information within 90 days of the change (42 CFR (g)(2). All providers and suppliers not previously identified must report any changes of ownership, including a change in an authorized or delegated official, within 30 days; and all other informational changes within 90 days (42 CFR (e)). It is very important that you comply with these reporting requirements. Failure to do so could result in the revocation of your Medicare billing privileges. 10 9/2016

12 Next Generation Accountable Care Organization - Implementation MLN Matters Number: SE1613 Related Change Request (CR) #: N/A Related CR Release Date: N/A Effective Date: January 1, 2016 Related CR Transmittal #: N/A Implementation Date: January 1, 2016 Provider Types Affected This MLN Matters Article is intended for providers who are participating in Next Generation Accountable Care Organizations (NGACOs) and submitting claims to Medicare Administrative Contractors (MACs ) for certain skilled nursing facility, telehealth, and post-discharge home visit services to Medicare beneficiaries that would not otherwise be covered by Original fee-for-service (FFS) Medicare. Provider Action Needed This MLN Matters Special Edition Article provides information on the NGACO Model s benefit enhancement waiver initiatives and supplemental claims processing direction. Make sure that your billing staffs are aware of these changes. Background The Centers for Medicare & Medicaid Services (CMS) implemented the Next Generation ACO Model (NGACO or the Model) on January 1, The Model is the first in the next generation of ACO provider-based models that will test opportunities for increased innovation around care coordination and management through greater accountability for the total cost of care. The aim of the Model is to improve the quality of care, population health outcomes, and patient experience for the beneficiaries who choose traditional Medicare FFS through greater alignment of financial incentives and greater access to tools that may aid beneficiaries and providers in achieving better health at lower costs. Core principles of the Model are: Protecting Medicare FFS beneficiaries freedom to seek the services and providers of their choice Creating a financial model with long-term sustainability Utilizing a prospectively set benchmark that: Rewards quality Rewards both attainment of and improvement in efficiency, and Ultimately transitions away from updating benchmarks based on the ACO s recent expenditures Engaging beneficiaries in their care through benefit enhancements that directly improve the patient experience and incentivize coordinated care from ACOs Mitigating fluctuations in aligned beneficiary populations and respecting beneficiary preferences through supplementing a prospective claims-based alignment process with a voluntary process, and Smoothing ACO cash flow and improving investment capabilities through alternative payment mechanisms. Continued >> 11 9/2016

13 Additional information on NGACO is available at Participants and Preferred Providers NGACO defines two categories of providers/suppliers and their respective relationships to the ACO entity: Next Generation Participants and Next Generation Preferred Providers. Next Generation Participants are the core providers/suppliers in the Model. Beneficiaries are aligned to the ACO through the Next Generation Participants and these providers/suppliers are responsible for, among other things, reporting quality through the ACO and committing to beneficiary care improvement. Preferred Providers contribute to ACO goals by extending and facilitating valuable care relationships beyond the ACO. For example, Preferred Providers may participate in certain benefit enhancements. Services furnished by Preferred Providers will not be considered in alignment and Preferred Providers are not responsible for reporting quality through the ACO. Table 5.1 Types of Providers/Suppliers and Associated Functions 1 Provider Alignment Type Next Generation Participant Preferred Provider Quality Reporting Through ACO Eligible for ACO Shared Savings PBP All- Inclusive PBP Coordinated Care Reward 3-Day SNF Rule X X X X X X X X X X X X X X X X Telehealth Post- Discharge Home Visit 1 This table is a simplified depiction of key design elements with respect to Next Generation Participant and Preferred Provider roles. It does not necessarily imply that this list is exhaustive with regards to possible ACO relationships and activities. Three Benefit Enhancements In order to emphasize high-value services and support the ability of ACOs to manage the care of beneficiaries, CMS uses the authority under section 1115A of the Social Security Act (section 3021 of the Affordable Care Act) to conditionally waive certain Medicare payment requirements as part of the NGACO Model. An ACO may choose not to implement all or any of these benefit enhancements Day SNF Rule Waiver CMS makes available to qualified NGACOs a waiver of the 3-day inpatient stay requirement prior to admission to a SNF or acute-care hospital or Critical Access Hospital (CAH) with swing-bed approval for SNF services ( swing-bed hospital ). This benefit enhancement allows beneficiaries to be admitted to qualified Next Generation ACO SNF Participants and Preferred Providers either directly or with an inpatient stay of fewer than three days. The waiver will apply only to eligible aligned beneficiaries admitted to Next Generation ACO SNF Participants and Preferred Providers. An aligned beneficiary will be eligible for admission in accordance with this waiver if: Continued >> 12 9/2016

14 1) The beneficiary does not reside in a nursing home, SNF, or long-term nursing facility and receiving Medicaid at the time of the decision to admit to an SNF, and 2) The beneficiary meets all other CMS criteria for SNF admission, including that the beneficiary must: a. Be medically stable b. Have confirmed diagnoses (for example, does not have conditions that require further testing for proper diagnosis) c. Not require inpatient hospital evaluation or treatment; and d. Have an identical skilled nursing or rehabilitation need that cannot be provided on an outpatient basis or through home health services. NGACOs identify the SNF Participant and Preferred Providers with which they will partner in this waiver through the annual submission of Next Generation Participant and Preferred Provider lists. Claims Next Generation Model 3-day SNF rule waiver claims do not require a demo code to be manually affixed to the claim. When a qualifying stay does not exist, the Fiscal Intermediary Standard System (FISS) checks whether 1) the beneficiary is aligned to an NGACO approved to use the SNF 3-day rule waiver; 2) the SNF provider is also approved to use the waiver; and 3) the SNF is a provider for the same NGACO for which the beneficiary is aligned. Once eligibility is confirmed, demo code 74 (for the NGACO Model) and indicator value 4 (for the 3-day SNF rule waiver) is placed on the claim. If an eligible NGACO SNF 3-day waiver claim includes demo code 62 (for the BPCI Model 2 SNF 3-day rule waiver), for example, the FISS will not check to validate whether the claim is a valid NGACO SNF 3-day rule waiver. CMS has instructed that FISS only validate when no demo code has been affixed and no qualifying 3-day inpatient hospital stay has been met. To assist MACs in troubleshooting provider SNF 3-day rule waiver claim questions, CMS instructed the FISS and the Multi Carrier System (MCS) maintainers to create screens. The FISS maintainer created a Sub-menu of the 6Q CMS Demonstrations Screen to allow for inquiry of both the NGACO Provider File Data and the NGACO Beneficiary File Data. The screen shows the following data value for this waiver: 3 Day SNF Waiver = Value 4. The MCS maintainer created two screens to allow for SNF 3-day rule waiver validation inquiry as listed: MCS created screen PROVIDER ACCOUNTABLE CARE ORGANIZATION (ACO) so that MACs would be able to see which ACO a provider is aligned with. MCS created screen BENEFICIARY ACCOUNTABLE CARE ORGANIZATION (ACO) so that MACs would be able to see which ACO a beneficiary is aligned with. 2. Telehealth Expansion CMS makes available to qualified NGACOs a waiver of the requirement that beneficiaries be located in a rural area and at a specified type of originating site in order to be eligible to receive telehealth services. This benefit enhancement will allow payment of claims for telehealth services delivered by Next Generation ACO Participants or Preferred Providers to aligned beneficiaries in specified facilities or at their residence regardless of the geographic location of the beneficiary. Continued >> 13 9/2016

15 Claims For those telehealth services originating at the beneficiary s home (in a rural or non-rural geographic setting) place of service (POS) code 12 (home) must be added to the claim. Claims will not be allowed for the following telehealth services rendered to aligned beneficiaries located at their residence: Follow-up inpatient telehealth consultations furnished to beneficiaries in hospitals or SNFs. Healthcare Common Procedure Coding System (HCPCS) codes G0406-G0408. Subsequent hospital care services, with the limitation of one telehealth visit every 3 days. Current Procedural Terminology (CPT) codes Subsequent nursing facility care services, with the limitation of one telehealth visit every 30 days. CPT codes For those telehealth services originating in a non-rural area a provider does not need to insert a demonstration code in order for the claim to process successfully. Notwithstanding these waivers, all telehealth services must be furnished in accordance with all other Medicare coverage and payment criteria, and no additional reimbursement will be made to cover set-up costs, technology purchases, training and education, or other related costs. In particular, the services allowed through telehealth are limited to those described under section 1834(m)(4)(F) of the Social Security Act and subsequent additional services specified through regulation. 3. Post-Discharge Home Visits CMS makes available to qualified NGACOs waivers to allow incident to claims for home visits to nonhomebound aligned beneficiaries by licensed clinicians under the general supervision-instead of direct supervision-of Next Generation Participants or Preferred Providers. Licensed clinicians, as defined in 42 C.F.R (a)(1), may be any employees, leased employees, or independent contractors who are licensed under applicable state law to perform the ordered services under physician (or other practitioner) supervision. A Participant or Preferred Provider may contract with licensed clinicians to provide this service and the service is billed by the Participant or Preferred Provider. Claims for these visits will only be allowed following discharge from an inpatient facility (including, for example, inpatient prospective payment system (IPPS) hospitals, Critical Access Hospitals (CAHs), SNFs, Inpatient Rehabilitation Facilities (IRFs) and will be limited to no more than one visit in the first 10 days following discharge and no more than one visit in the subsequent 20 days. Payment of claims for these visits will be allowed as services and supplies that are incident to the service of a physician or other practitioner as described under 42 CFR This provision is not generally applicable to home visits; however, for purposes of this payment waiver, CMS intends to use the same definition of general supervision as outlined in this provision. Claims Post-discharge home visit service waiver claims must contain one of the following Evaluation and Management (E/M) Healthcare Common Procedure Coding System (HCPCS) codes: Continued >> 14 9/2016

16 Providers are not required to add a demonstration code to process these claims. Additional Information Additional information about the Next Generation ACO Model is available at: 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 15 9/2016

17 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 Medicare Updates, Changes and Reminders Webcast Date/Time September 15, a.m. ET Access Locating Local Coverage Determinations, Coverage Articles and Self-Administered Drug Exclusion Lists Webcast eservices Open House (Registration Required) September 29, a.m. ET October 4, 2016 various times Palmetto GBA 17 Technology Circle Columbia, SC /2016

18 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - October CY 2016 Update MLN Matters Number: MM9749 Related Change Request (CR) #: CR 9749 Related CR Release Date: August 19, 2016 Effective Date: January 1, 2016 Related CR Transmittal #: R3594CP Implementation Date: October 3, 2016 Provider Types Affected This MLN Matters Article is intended for physicians, provider and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries and subject to the Medicare Physician Fee Schedule (MPFS). Provider Action Needed This article is based on Change Request (CR) 9749, which informs you that payment files were issued to MACs based upon the Calendar Year (CY) MPFS Final Rule. This change request amends those payment files. Make sure that your billing staffs are 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. Unless otherwise stated, the changes included in the October update to the 2016 MPFSDB are effective for dates of service on and after January 1, The key changes for the October update are the following: CPT/ Action HCPCS Code G0436 Procedure Status = I (Effective for services on or after ) G0437 Procedure Status = I (Effective for services on or after ) Procedure Status = C; Global Surgery Days = YYY Bilateral Indicator = 1 The HCPCS codes listed below have been added to the MPFSDB effective for dates of service on and after October 1, All of these new codes were communicated through other instructions. Please consult those instructions for the description and other information. Code G0490 G9679 G9680 Action Procedure Status = X; there are no RVUs; all policy indicators = concept does not apply Procedure Status = X; there are no RVUs; all policy indicators = concept does not apply Procedure Status = X; there are no RVUs; all policy indicators = concept does not apply Continued >> 17 9/2016

19 G9681 Procedure Status = X; there are no RVUs; all policy indicators = concept does not apply G9682 Procedure Status = X; there are no RVUs; all policy indicators = concept does not apply G9683 Procedure Status = X; there are no RVUs; all policy indicators = concept does not apply G9684 Procedure Status = X; there are no RVUs; all policy indicators = concept does not apply G9685 Procedure Status = A; RVUs = Work 3.86, Non-Facility 1.55, Facility 1.55, MP 0.29 G9686 Procedure Status = A; RVUs = Work 1.50, Non-Facility 0.61, Facility 0.61, MP 0.10 The following payment policy indicators apply to G9685 and G9686: 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 = XXX. New code G0498, listed below, has been added to the MPFSDB effective for dates of service on and after January 1, The Procedure Status is C and there are no RVUs. The following payment policy indicators apply to G0498: Multiple Surgery = 0, Bilateral Surgery = 0, Assistant at Surgery = 0, Co-Surgeons = 0, Team Surgeons = 0, PC/TC = 5, Physician Supervision of Diagnostic Procedures = 09, and Diagnostic Imaging Family = 99. The Global Surgery Days = YYY. Code G0498 Short Descriptor Chemo extend iv infus w/pump Long Descriptor Chemotherapy administration, intravenous infusion technique; initiation of infusion in the office/other outpatient setting using office/other outpatient setting pump/supplies, with continuation of the infusion in the community setting (e.g., home, domiciliary, rest home or assisted living) using a portable pump provided by the office/other outpatient setting, includes follow up office/other outpatient visit at the conclusion of the infusion Additional Information The official instruction, CR9749 issued to your MAC regarding this change is available at Review and Print Electronic Remittances via eremits 8 a.m. and 7 p.m. ET. 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 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 /2016

20 Medicare Part B Clinical Laboratory Fee Schedule: Guidance to Laboratories for Collecting and Reporting Data for the Private Payor Rate-Based Payment System MLN Matters Number: SE1619 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 article is intended for Medicare Part B clinical laboratories who submit claims to Medicare Administrative Contractors (MACs) for services furnished to Medicare beneficiaries. Provider Action Needed This guidance is intended to assist the laboratory community in meeting the new requirements under Section 1834A of the Social Security Act (the Act ) for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). It includes clarifications for determining whether a laboratory meets the requirements to be an applicable laboratory, the applicable information (that is, private payor rate data) that must be collected and reported to the Centers for Medicare & Medicaid Services (CMS), the entity responsible for reporting applicable information to CMS, the data collection and reporting periods, and the schedule for implementing the new CLFS. CMS will issue additional information about the CLFS data collection system and advanced diagnostic laboratory tests (ADLTs) through separate guidance. Background The CLFS was first established in 1984 based on historical charge data. It was updated to only establish payment rates for new tests or to make statutorily-required across-the board updates. Payment for new tests established after 1984 is based on crosswalking or gapfilling methodologies. For crosswalking, an existing test or combination of tests with similar methodology and resources is used as a basis for the payment amount. Gapfilling is used when there is no other test with similar methodology and resources. In this case, MACs develop a payment amount for the test. Section 1834A of the Act, as established by Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), requires significant changes to how Medicare pays for clinical diagnostic laboratory tests under the CLFS. The CLFS final rule Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule (CMS-1621-F) ( was displayed in the Federal Register on June 17, 2016, and was published on June 23, The CLFS final rule implements Section 1834A of the Act. Under the final rule, private payor rates from applicable laboratories will be the basis for the revised CLFS beginning January 1, Based on applicable information (that is, private payor rates) from applicable laboratories, the payment amount for a test on the new CLFS will be equal to the weighted median private payor rate for each test. However, for new tests or when no data is reported for an existing test, crosswalking or gapfilling methodologies will be used to establish a payment amount for the test. Continued >> 19 9/2016

21 Applicable Laboratory Section 1834A of the Act defines an applicable laboratory as a laboratory with the majority of its Medicare revenues received under the CLFS and/or Medicare Physician Fee Schedule (PFS). It also provides the authority to establish a low volume or low expenditure threshold. Under the final policies for the new Medicare CLFS, an applicable laboratory is a laboratory as defined under the Clinical Laboratory Improvement Amendments (CLIA) that bills Medicare Part B under its own National Provider Identifier (NPI) and meets the majority of Medicare revenues threshold and the low expenditure threshold. Accordingly, there are four steps in determining whether a laboratory meets the requirements to be an applicable laboratory: (1) Is the laboratory certified under CLIA?, (2) Does the CLIA- certified laboratory bill Medicare Part B under its own NPI?, (3) Does the laboratory meet the majority of Medicare revenues threshold?, and (4) Does the laboratory meet the low expenditure threshold? Step 1: CLIA Certification he CLIA applies to all laboratories performing testing on human specimens for a health purpose. To be paid under Medicare, a laboratory must be a CLIA-certified laboratory. Therefore, the first step in identifying an applicable laboratory is to determine whether the laboratory is CLIA certified. The CLIA regulatory definition of a laboratory is codified in regulation in 42 CFR Note that a facility that receives any CLIA certificate (including a CLIA certificate of waiver) is considered a laboratory as defined at 42 CFR Step 2: NPI The second step is to determine whether the CLIA-certified laboratory bills Medicare Part B under its own NPI. The NPI is the standard unique health identifier used by health care providers for billing Medicare and other payors. The NPI is assigned by the National Plan and Provider Enumeration System in 45 CFR 162. The laboratory s own billing NPI is used as the mechanism for defining an applicable laboratory. Step 3: Majority of Medicare Revenues Threshold For a CLIA-certified laboratory that bills Medicare Part B under its own NPI to be an applicable laboratory, it must meet the majority of Medicare revenues threshold. A laboratory, by its own billing NPI, meets the majority of Medicare revenues threshold if it receives more than 50 percent of its total Medicare revenues from payments under the Medicare CLFS and/or Medicare PFS. The CLFS and PFS are included under Medicare Part B, also known as Original Medicare or Fee-For-Service (FFS) Medicare. To determine whether a laboratory meets the majority of Medicare revenues threshold, the laboratory must look to its final paid claims received by its own billing NPI during the data collection period. See the Applicable Information Section below for additional guidance on final paid claims. The three steps to determine whether a laboratory meets the majority of Medicare revenues threshold are: First, sum the CLFS and PFS payment amounts received by the laboratory s own billing NPI during the data collection period. The revenues from the CLFS include payments for all laboratory services under the CLFS. The revenues from the PFS include all payments from all services paid under the PFS (for instance, laboratory services and services that are not laboratory services such as pathology services, evaluation and management services, and radiology services). The sum of CLFS and PFS revenues is the numerator of the majority of Medicare revenues threshold equation. Next, sum the total Medicare revenues received by the laboratories own billing NPI during the data collection period. Total Medicare revenues include the sum of all FFS payments under Medicare Parts A Continued >> 20 9/2016

22 and B, Medicare Advantage payments under Medicare Part C, prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance for services furnished during the data collection period. The sum of total Medicare revenues is the denominator of the majority of Medicare revenues threshold equation. Finally, divide the sum of CLFS and PFS revenues by the sum of total Medicare revenues received during the data collection period. We provide additional information on the data collection period below. If the Medicare revenues received from the CLFS and/or PFS are greater than 50 percent of the total Medicare revenues for the laboratory s billing NPI, the laboratory meets the majority of Medicare revenues threshold. The majority of Medicare revenues threshold equation is: CLFS revenues (for billing NPI) + PFS revenues (for billing NPI)/total Medicare revenues (for billing NPI) > 50 percent Step 4: Low Expenditure Threshold An applicable laboratory must meet the low expenditure requirements. A laboratory (as defined under the CLIA regulations) meets the low expenditure threshold if, by its own billing NPI, receives at least $12,500 in Medicare revenues from the CLFS (under Medicare Part B) during the data collection period. To meet the low expenditure threshold, the laboratory must look to its final paid claims received by its own billing NPI during the data collection period. To determine whether the laboratory meets the low expenditure threshold, sum all final payments for the laboratory s own billing NPI received from Medicare CLFS services during the data collection period (completed under Step 3: Majority of Medicare Revenues Threshold). It is important to note that the low expenditure threshold applies only to CLFS services. It does not include revenues received under the PFS. In other words, to meet the low expenditure threshold, the laboratory s own billing NPI must receive at least $12,500 under only the CLFS during the data collection period. The low expenditure threshold equation is: Medicare CLFS revenues (for billing NPI) = > $12,500 These are examples on how the majority of Medicare revenues threshold and low expenditure threshold are applied to the CLIA-certified laboratory s own billing NPI for purposes of determining whether the laboratory is an applicable laboratory: Example 1: A laboratory organization includes five CLIA-certified laboratories. Each CLIA-certified laboratory has its own unique NPI and bills the Medicare Program (and other payors) for laboratory tests separately under each NPI. In this example, the majority of Medicare revenues threshold and low expenditure threshold are applied to each NPI in the laboratory organization. That is, individually determine whether each laboratory meets the majority of revenues threshold and low expenditure threshold. Even though all five laboratories may be under the same Tax Identification Number (TIN), each is considered a separate laboratory for purposes of determining an applicable laboratory because each bills Medicare Part B for laboratory tests using its own unique NPI. Continued >> 21 9/2016

23 Example 2: A laboratory organization includes five CLIA-certified laboratories. Each CLIA-certified laboratory has the same NPI and bills for laboratory tests under the same NPI for each of its CLIA-certified laboratories. In this example, the majority of Medicare revenues threshold and low expenditure threshold are applied based on the combined revenues of all CLIA-certified laboratories in the organization that use the same billing NPI. In other words, for purposes of applying the applicable laboratory thresholds, all five CLIA-certified laboratories in the laboratory organization are considered a single laboratory because they all bill Medicare Part B using the same NPI. Example 3: A laboratory organization includes five CLIA-certified laboratories. Each CLIA-certified laboratory has its own unique NPI. However, only one laboratory s NPI is used for billing all laboratory tests furnished by all five laboratories in the laboratory organization. In this example, the majority of Medicare revenues threshold and low expenditure threshold are applied to the one NPI used for billing all tests furnished by the laboratory organization. Example 4: An entity consists of five physician offices and one CLIA-certified laboratory. All five physician offices and the CLIA-certified laboratory are assigned the same NPI and bill for services under the same NPI. In this example, the majority of Medicare revenues threshold and low expenditure threshold are applied based on the combined revenues of all components of the entity that bill for services under the same NPI. In other words, since the physician offices and CLIA-certified laboratory all have the same NPI and bill Medicare Part B under the same NPI, the entity is considered a single laboratory for purposes of applying the majority of Medicare revenues threshold and low expenditure threshold. Example 5: An entity consists of five physician offices and one CLIA-certified laboratory. Each of the five physician offices and the CLIA-certified laboratory have unique NPIs. The laboratory bills for laboratory tests under its own unique NPI. In this example, the majority of Medicare revenues threshold and low expenditure threshold are only applied to the CLIA-certified laboratory s own billing NPI. Example 6: A CLIA-certified hospital outreach laboratory that performs laboratory services for non-hospital patients is assigned its own unique NPI separate from the hospital s NPI. The hospital outreach laboratory bills Medicare Part B for laboratory tests furnished to non-hospital patients using its own unique NPI. In this example, the majority of Medicare revenues threshold and low expenditure threshold are applied to the NPI of the hospital outreach laboratory and not to the hospital s NPI. Example 7: A CLIA-certified hospital laboratory that performs laboratory services primarily for its hospital inpatients and hospital outpatients has the same NPI as the hospital. Laboratory services performed for non-hospital patients are billed using the hospital s NPI. In this example, the majority of Medicare revenues threshold and low expenditure threshold are applied to the NPI of the entire hospital. In this circumstance, it is unlikely that the hospital laboratory qualifies as an applicable laboratory because the majority of Medicare revenues for the NPI are received from the Hospital Inpatient Prospective Payment System and/or Hospital Outpatient Prospective Payment System, not from the CLFS and/or PFS. Applicable Laboratory Summary An applicable laboratory is defined as a CLIA-certified laboratory (which includes a facility that receives a CLIA certificate of waiver) and, using its own billing NPI, meets the majority of Medicare revenues threshold (that is, greater than 50 percent of total Medicare revenues derived from the CLFS and/or PFS) and low expenditure Continued >> 22 9/2016

24 threshold (at least $12,500 in revenue from only the CLFS). In other words, to qualify as an applicable laboratory, the CLIA-certified laboratory must be assigned an NPI and have its services billed to Medicare Part B under that NPI. The laboratory does not qualify as an applicable laboratory if no services are billed to Medicare Part B under its own NPI because no revenues attributed to the NPI are assigned to the laboratory. Both the majority of Medicare revenues threshold and low expenditure threshold are applied to the CLIA-certified laboratory s own billing NPI based on final claims paid during a data collection period. If the laboratory s own billing NPI receives more than 50 percent of its total Medicare revenues under the CLFS and/or PFS and at least $12,500 from the CLFS during the data collection period, the laboratory is considered an applicable laboratory. Applicable information (that is, private payor rate data) from applicable laboratories must be collected during the data collection period and reported by reporting entities to CMS during the data reporting period. The applicable information reported to CMS will be used to establish payment rates under the new CLFS. All CLIA-certified laboratories (that is, both applicable laboratories and laboratories that are not applicable laboratories) are subject to the new Medicare Part B CLFS payment rates when they are established and implemented on January 1, Applicable Information The applicable laboratory along with its reporting entity (we provide more information about reporting entities below) are responsible for collecting applicable information and reporting that data to CMS. Applicable information includes three major components: (1) The specific HCPCS code associated with the test (2) The private payor rate for each test for which final payment has been made during the data collection period (3) The associated volume for each test Private Payor Defined The term private payor is defined as: (1) A health insurance issuer and a group health plan (as defined in Section 2791 of the Public Health Service Act) (2) A Medicare Advantage Plan under Part C (3) A Medicaid Managed Care Organization (MCO) (as defined in Section 1903(m) of the Act) Note: Applicable information does not include information on tests for which payment is made on a capitated basis, where payments do not reflect specific HCPCS code-level amounts (see below for additional information on payments made on a capitated basis). Therefore, private payor rates from Medicaid MCO plans are considered applicable information only to the extent that the individual HCPCS code for the test, private payor rate specific to the test, and the volume paid at the specific rate for the test can be identified. These specific private payor claims data are included as applicable information: Laboratory tests associated with the CLFS. Applicable information includes the specific HCPCS code for the test, each different private payor rate for the test, and the volume associated with each private payor rate for the test. You can find a list of laboratory tests associated with the CLFS and therefore subject to the data collection and data reporting requirements at Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html. Continued >> 23 9/2016

25 Final amount paid by a private payor for laboratory tests after all private payor price concessions are applied. Applicable laboratories should look to their paid claims data from the billing NPI for which final payment was made during the data collection period. If a private payor pays a laboratory for a test but subsequent post-payment activities during the data collection change that initial payment amount, the final payment is the private payor rate for purposes of determining applicable information. For example, if an initial claim was paid in error 3 months before a data collection period and then corrected, with final payment made by the private payor during the data collection period, the final corrected payment amount for the test is considered the private payor rate for purposes of determining applicable information. However, if an initial claim was paid in error during a data collection period and then corrected, with final payment made after the data collection period, the payment amount is not a private payor rate for purposes of applicable information and, therefore, is not reported to CMS. Payments from secondary insurance payors. Final payments from secondary insurance payors are considered in calculating private payor rates if the final payment was made during the data collection period. Any patient cost sharing amounts, if applicable. For purposes of applicable information, the private payor rate for a test should include any patient cost sharing responsibilities required by the private payor (for instance, patient deductible and/or coinsurance amounts). In other words, the private payor rate is 100 percent of the private payor s fee schedule amount for the test. Multiple payment rates for the same test. If an applicable laboratory receives more than one payment rate from the same private payor for the same test or more than one payment rate from different private payors for the same test, each unique payment rate along with the associated volume for the test code at each such rate is included as applicable information. In this case, the reporting entity must report each unique payment rate and the associated volume for the test at each such rate. Appeals resolved during the data collection period. Payment rates (and the associated volume of tests) for claims under appeal are included as applicable information if the final payment amount is determined and paid by the private payor during the data collection period. For example, if a laboratory filed an appeal for a test furnished prior to a data collection period and the appeal was resolved so that final payment for the test was made during the data collection period, the final rate paid is considered applicable information. Non-contracted amounts for out-of-network laboratories or services. Applicable information includes private payor rates for out-of-network laboratories as long as the final payment for the laboratory test was made by the private payor during the data collection period. Non-contracted amounts paid to laboratories include any patient cost sharing amounts (for example, deductible and coinsurance responsibilities, if applicable). These specific private payor claims data are excluded from applicable information: Private payor rates for laboratory test codes paid only under the PFS. If a laboratory test code is not paid under the CLFS and is paid under the PFS, the test code, private payor rate, and the test volume associated with the private payor rate is not applicable information. Price concessions applied by a laboratory. A laboratory s decision to waive a patient s deductible, copay, and/or coinsurance responsibility for a given test(s) must not be factored into the determination of the private payor rate for a test. Although laboratories may provide concessions to patients, it does not reflect the rates paid by private payors. As noted above, the private payor rate is 100 percent of the private payor s fee schedule amount for the test. Information about denied payments. When a private payor denies payment for a laboratory test, payments of $0.00 or zero dollars are not considered a private payor rate for purposes of determining applicable information under the new CLFS. Laboratories should not report zero dollars for a laboratory test code where a private payor has denied payment within a data collection period. Continued >> 24 9/2016

26 Unresolved appeals. Where a laboratory test claim is still under review by the private payor or is under appeal during a data collection period, the amount that has already been paid is not considered a final payment rate and therefore is not considered applicable information. Additionally, if the appeal was settled during the data collection period but final payment was not made by the private payor until after the data collection period, the payment amount is not considered applicable information. Payments made on a capitated basis. Generally, a capitated payment is made for health care services based on a set amount for each enrolled beneficiary in the plan for a given period of time, regardless of whether the particular beneficiary receives services during the period covered by the payment. Payment is typically made on a capitated basis under a managed care arrangement. As there is no way to determine payment specifically for a given test, it cannot be reported as applicable information. Therefore, applicable information does not include information about a test for which payment is made on a capitated basis. Payments where the associated test volume cannot be determined. As discussed above, the associated volume of tests performed corresponding to each private payor rate is a component of the definition of applicable information. Where the associated volume of tests performed corresponding to each private payor rate cannot be discerned by a laboratory from the private payor s remittance, those payment amounts are not considered applicable information and should not be reported to CMS. Remittances where the payor has grouped individual HCPCS code payments into an encounter or claim level payment. When a private payor groups payments for individual HCPCS codes into a single encounter or claim-level payment that is not represented by another HCPCS code, those payments are not applicable information. In other words, if individual HCPCS codes are billed by the laboratory and the payor bundles the individual HCPCS codes into groups not represented by other HCPCS codes, the payor s bundled payment amount is not considered applicable information. Note: In general, if a laboratory cannot correlate a private payor payment amount and the associated volume paid at that rate to a specific HCPCS code, that amount is not a private payor rate for purposes of applicable information. Estimated private payor rates and volumes are also not considered applicable information. Schedule for Data Collection and Reporting The first data collection period (the period where applicable information for an applicable laboratory is obtained from claims for which the laboratory received final payment during the period) is from January 1, 2016, through June 30, A 6-month window follows the data collection period and precedes the data reporting period (the period where applicable information must be submitted to CMS). The first data reporting period will be from January 1, 2017, through March 31, During the 6-month window between the end of the data collection period and the beginning of the data reporting period, laboratories and reporting entities should assess whether the applicable laboratory thresholds are met. That is, determine whether each billing NPI-level component of the TIN meets the majority of Medicare revenues threshold and low expenditure threshold from final paid claims during the data collection period. Applicable laboratories and their reporting entity should also use this time to review and validate applicable information before it is reported to CMS. For most clinical diagnostic laboratory tests (CDLTs) paid on the CLFS, the data collection and reporting schedule will be repeated every 3 years. For instance, the first data collection period is January 1, 2016, through June 30, The first 6-month window is July 1, 2016, through December 31, 2016, and the first data reporting period is January 1, 2017, through March 31, The first data collection and reporting cycle will be used to determine CLFS payment rates for calendar year (CY) 2018 through CY Continued >> 25 9/2016

27 The second data collection period will begin on January 1, 2019, and end on June 30, 2019, with the 6-month window starting July 1, 2019, and ending December 31, The second data reporting period is January 1, 2020, through March 31, Applicable information from the second data reporting period will be used to determine CLFS payment rates for CY 2021 through CY This data collection and reporting cycle continues every third subsequent CY. This table illustrates the data collection and reporting periods for CDLTs. Data Collection and Reporting Periods for CDLTs Data Collection Period Six Month Window Data Reporting Period Used for CLFS Rate Years 1/1/2016 6/30/2016 7/1/2016 1/1/2017 3/31/ /31/2016 1/1/2019 6/30/2019 7/1/2019 1/1/2020 3/31/ /31/2019 Continues every third subsequent calendar year New CLFS rate every third year Continues every third subsequent calendar year Continues every third subsequent calendar year While reporting is required every 3 years for CDLTs (that are not ADLTs), reporting entities must report applicable information annually for ADLTs, except for ADLTs in an initial data collection period (in which case a reporting entity will report by the end of the second quarter of the new ADLT initial period). As noted previously, we will issue additional information about ADLTs through separate guidance. Reporting Entity The mechanics of reporting applicable information to CMS is separate from the actual definition of an applicable laboratory. The TIN-level entity must report applicable information individually for all its NPI-level components that are applicable laboratories. As noted above, an applicable laboratory is a CLIA-certified laboratory and, using its billing NPI, meets the majority of Medicare revenues threshold and low expenditure threshold. These are examples of reporting entities that must report applicable information individually for all NPI-level components that are applicable laboratories: Example 1: A TIN-level entity consists of five CLIA-certified laboratories. Each laboratory bills using its own unique NPI and all five CLIA-certified laboratories individually meet both the majority of Medicare revenues threshold and low expenditure threshold. This TIN-level entity consists of five unique applicable laboratories. In this case, the reporting entity reports applicable information associated with each individual NPI that is an applicable laboratory (not collectively for all NPIs that are applicable laboratories under the TIN). The reporting entity separates the applicable information by each NPI and submits applicable information during the data reporting period for five applicable laboratories. Example 2: A TIN-level entity consists of five CLIA-certified laboratories, each billing for services under its own unique NPI. However, only three of the laboratories individually meet both the majority of Medicare revenues threshold and low expenditure threshold while the remaining two laboratories do not individually meet the low expenditure threshold. In other words, two of the five CLIA-certified laboratories receive less Continued >> 26 9/2016

28 than $12,500 of revenue under the CLFS during the data collection period. This TIN-level entity consists of three unique applicable laboratories. In such case, the reporting entity will report applicable information associated with each individual NPI that is an applicable laboratory, but will not report information on the two individual NPIs of the laboratories that are not applicable laboratories. The reporting entity separates the applicable information by each NPI and submits applicable information during the data reporting period for three applicable laboratories. Example 3: A TIN-level entity consists of five CLIA-certified laboratories and each laboratory has the same NPI and bills Medicare Part B under the same NPI. Collectively, the five CLIA-certified laboratories meet the majority of Medicare revenues threshold and low expenditure threshold. This TIN-level entity consists of one applicable laboratory. In such case, the reporting entity reports applicable information for all laboratories associated with the same NPI as a single applicable laboratory. In other words, in this example, the five CLIAcertified laboratories are considered one applicable laboratory for purposes of reporting applicable information because they all have the same NPI and all bill Medicare Part B under the same NPI. The TIN-level entity along with its applicable laboratory entities should establish their own approach for ensuring that the TIN-level entity can report applicable information to CMS. To that end, applicable laboratories and their reporting entity should determine the best approach to collect applicable information from final paid claims data and for submitting applicable information to CMS during the data reporting period. Voluntary Reporting is Not Permitted The reporting entity reports only applicable information for NPI-level components that are applicable laboratories (that is, NPIs that meet the definition of an applicable laboratory). Reporting entities do not report applicable information for NPIs that do not meet the definition of an applicable laboratory. Example: A TIN-level entity consists of four NPI-level entities. Three of the NPI-level entities meet the definition of an applicable laboratory, and one NPI-level entity does not meet the definition of an applicable laboratory. In this case, the reporting entity reports applicable information to CMS for only the three NPI-level entities that are applicable laboratories. Reporting Applicable Information is Not Discretionary Reporting entities must report all applicable information for its NPI-level components that are applicable laboratories. Reporting entities do not have the discretion to selectively omit reporting certain applicable information. Example: An applicable laboratory has various final paid claims for laboratory tests from the data collection period that are only in hard copy paper format. The reporting entity along with its applicable laboratory perceives that reporting applicable information derived from the paper claims has minimal impact on the final payment rate calculated for the tests. In such case, the reporting entity cannot selectively omit reporting applicable information due to the perception that reporting such applicable information may not influence the final weighted median private payor rate for a given test. In this example, the reporting entity must report the applicable information obtained from the paper-based claims to CMS during the data reporting period. Continued >> 27 9/2016

29 Reporting Entity Summary Applicable information, which is used to set payment amounts under the new CLFS, must be reported by the TIN-level entity for its NPI components that are applicable laboratories during the data reporting period. As discussed above, applicable information includes the specific HCPCS code for each test, the final payment rate that was paid by each private payor for the test during a data collection period, and the associated volume for each test. Voluntary reporting of applicable information derived from laboratories that are not applicable laboratories and omitting certain applicable information from laboratories that are applicable laboratories is not permissible. If the laboratory meets the definition of an applicable laboratory, the applicable information for that laboratory must be reported to CMS during the data reporting period. Implementation Schedule This is the schedule for implementing the new CLFS: First data collection period for determining CY 2018 CLFS payment rates: January 1, 2016, through June 30, First data reporting period for reporting entities to report private payor rate data to CMS for determining CY 2018 CLFS payment rates: January 1, 2017, through March 31, Annual laboratory public meeting for new tests: Mid-July CMS will use crosswalking or gapfilling to set rates for new tests for which there is no private payor data collected for the CY 2018 CLFS. CMS publishes preliminary CLFS rates for CY 2018: Early September The public will have approximately 30 days, through early October 2017, to submit comments on the preliminary CY 2018 rates. CMS makes final CY 2018 CLFS rates available on the CMS website: Early November Implementation date of new CLFS: January 1, Additional Information For more information about the new private payor rate-based payment system including the CLFS final rule, related press release and fact sheet, frequently asked questions on our final policies, and a PowerPoint slide presentation of the new CLFS, visit ClinicalLabFeeSched/PAMA-Regulations.html. If you have questions about requirements for the new CLFS, please them to the CLFS Inquiries mailbox at CLFS_Inquiries@cms.hhs.gov. 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. 28 9/2016

30 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. 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 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. 29 9/2016

31 Multiple Procedure Payment Reduction (MPPR) on the Professional Component (PC) of Certain Diagnostic Imaging Procedures MLN Matters Number: MM9647 Related Change Request (CR) #: CR 9647 Related CR Release Date: August 5, 2016 Effective Date: January 1, 2017 Related CR Transmittal #: R3578CP Implementation Date: January 3, 2017 Provider Types Affected This MLN Matters Article is intended for physicians, providers, and clinical diagnostic laboratories, submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries. Provider Action Needed Change Request (CR) 9647 informs providers that Section 502(a)(2) of the Consolidated Appropriations Act of 2016 revised the Multiple Procedure Payment Reduction (MPPR) for the Professional Component (PC) of the second and subsequent procedures from 25 percent to 5 percent of the physician fee schedule amount. Make sure that your billing staffs are aware of these changes. Background Medicare currently applies the MPPR of 25 percent to the PC of certain diagnostic imaging procedures. The reduction applies to PC-only services, and the PC portion of global services, for the procedures with a multiple surgery value of 4 in the Medicare Fee Schedule database. The Centers for Medicare & Medicaid Services (CMS) currently makes full payment for the PC of the highestpriced procedure and payment at 75 percent for the PC of each additional procedure when furnished by the same physician (or physician in the same group practice) to the same patient, in the same session on the same day. Section 502(a)(2) of the Consolidated Appropriations Act of 2016 revised the MPPR for the PC of the second and subsequent procedures from 25 percent to 5 percent of the physician fee schedule amount. The MPPR on the Technical Component (TC) of imaging remains at 50 percent. Effective January 1, 2017, MACs shall pay 95 percent of the fee schedule amount for the PC of each additional procedure furnished by the same physician (or physician in the same group practice) to the same patient, in the same session on the same day. The current payment, and the payment as of January 1, 2017, are summarized in the example table below: Table 1: Current vs. Revised Payments Procedure 1 Procedure 2 Current Total Payment Revised Total Payment PC $100 $80 $160 ($100 + (.75 x $80)) $176 ($100 +(.95 x $80)) TC $500 $400 $700 ($500 + (.50 x $400)) $700 ($500 + (.50 x $400)) Continued >> 30 9/2016

32 Procedure 1 Procedure 2 Current Total Payment Revised Total Payment Global $600 $480 $860 ($600 + (.75 x $80) + (.50 $876 ($600 + (.95 x $80) + x $400)) (.50 x $400)) Additional Information The official instruction, CR9647 issued to your MAC regarding this change is available at 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. 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

33 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. Appeals Calculator Self-Service Tool Did you know you can use the appeals calculator to determine the timely filing date of your appeals request? All you have to do is select which level of appeal you are in and enter the date you received the response to your previous appeal. After clicking Find Deadline, the timely filing limit date will appear. This tool is very helpful to assure that you are filing your appeals on time. 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. 32 9/2016

34 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 33 9/2016

35 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 Continued >> 34 9/2016

36 Part B Local Coverage Determinations Policy Title LCD Revisions Effective Date Non-Covered Category III CPT Codes L34555 Rev#13 Non-Covered Category III CPT Codes L34555 Rev#14 Article Title Revisions to the Medicare Preventive Coverage for Certain Vaccines Article A54767 Rev #5 Aflibercept (Eylea) Coding and Billing Guidelines Article A53387 Rev #7 Title Retirement of the Part B Failed Colonoscopy: Screening & Diagnostic Article A53412 Under CPT/HCPCS Codes Group 1: Codes added CPT codes 0437T, 0438T, 0439T, 0440T, 0441T, 0442T, 0443T, 0444T and 0445T. Please refer to Change Request (CR) 9658 dated June 28, These CPT codes are effective for dates of service on or after July 1, Under CPT/HCPCS Codes Group 1: Codes added CPT code 0253T due to omission. Articles Under Covered ICD-10 Codes-Group 3 for Tetanus added the following codes: S81.001A, S81.001D, S81.001S, S81.002A, S81.002D, S81.002S, S81.812A, S81.812D, S81.812S, S81.821A, S81.821D, S81.821S, S81.822A, S81.822D, S81.822S, S81.831A, S81.831D, S81.831S, S81.832A, S81.832D, S81.832S, S81.841A, S81.841D, S81.841S, S81.842A, S81.842D, S81.842S, S81.851A, S81.851D, S81.851S, S81.852A, S81.852D, and S81.852S. These codes are effective as of 01/04/2016. Under Article Text for Age-related Macular Degeneration (AMD) added the verbiage Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 12 weeks (3 months) to the end of the second sentence. For Diabetic Macular Edema (DME) added the verbiage Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 20 weeks (5 months) to the end of the fourth sentence. In the second Note: added the verbiage Intravitreal injection for the treatment of macular edema more frequently than every 4 weeks regardless of which drug is used for any given injection i.e. alternating drugs every two weeks will not be covered. The additional verbiage is effective for dates of service on or after May 26, Retired Articles The Part B Failed Colonoscopy: Screening & Diagnostic Article A53412 was retired effective 07/27/2016. A new updated A/B MAC article- Incomplete Colonoscopy/Failed Colonoscopy A55227 will become effective on 07/28/2016 8/22/16 9/06/16 Effective Date 08/22/16 8/04/16 Date of Retirement 7/27/16 Continued >> 35 9/2016

37 Part A/B Local Coverage Determinations Policy Title Response to Comments Effective Date Scanning Computerized Ophthalmic Diagnostic Imaging (SCODI) A55259 NEW Policy Title Laparoscopic Sleeve Gastrectomy for Severe Obesity L34576 Rev #8 Revisions to the Infliximab (Remicade ) L35677 Rev #11 Scanning Computerized Ophthalmic Diagnostic Imaging (SCODI) L34431 Rev #7 Total Joint Arthroplasty L33456 Rev #9 Article Title Incomplete Colonoscopy/Failed Colonoscopy Article A55227 NEW The comment period for the Scanning Computerized Ophthalmic Diagnostic Imaging (SCODI) LCD L34431 began on 06/13/2016 and ended on 07/29/2016. No comments were received from the provider community. This LCD will begin the notice period on 08/18/2016 and will become effective on 10/03/ /18/16 LCD Revisions Effective Date Under CMS National Coverage Policy the verbiage for the diagnoses and treatment of 7/28/16 illness or injury or to improve the functioning of a malformed body member was added to Title XVIII of the Social Security Act, 1862(a)(1)(A). The title Billing Requirements for Special Services was added to the CMS Internet-Only Manual, Pub The section symbol was added to the Title XVIII of the Social Security Act, 1862(a)(1)(A) and Title XVIII of the Social Security Act, 1833(e). Under Sources of Information and Basis for Decision volume, issue and page numbers were added. Sources were removed and updated. Punctuation was corrected throughout the LCD. Under CPT/HCPCS Codes Group 1: Paragraph added Note: Effective for dates of service 8/22/16 on or after April 5, 2016 claims for Q5102 must use the ZB (Pfizer/hospira) modifier (Q5102ZB). Under CPT/HCPCS Codes Group 1: Codes added HCPCS code Q5102. Please refer to Change Request (CR) 9658 dated June 28, Under Associated Contract Numbers added the contractor numbers for Part B as the Part A LCD was made an A/B MAC LCD. Under Sources of Information and Basis for Decision removed the URL for National Guideline Clearinghouse. Medical Management of Adults with Osteoarthritis. Article Revisions Under Article Text added the verbiage A covered colonoscopy that is attempted but cannot be completed because of extenuating circumstances is considered to be an incomplete colonoscopy (the inability to advance the colonoscope to the cecum or to the colon-small intestine anastomosis due to unforeseen circumstances. The failed procedure is billed and paid using CPT code 45378, HCPCS code G0105, or CPT code 44388, if attempting to perform the colonoscopy through an existing stoma. Modifier -53 (discontinued procedure) must be appended to any procedure code submitted when billing for a failed colonoscopy attempt. When a covered colonoscopy is next attempted and completed, Medicare will pay for that colonoscopy according to its payment methodology for this procedure, as long as all coverage conditions are met. This applies to both screening and diagnostic colonoscopies. 10/03/16 8/08/16 Effective Date 07/28/ /2016

38 MolDX Local Coverage Determinations Policy Title LCD Revision Effective Date MolDX: Breast Cancer Assay Prosigna L36125 The comment period began on 06/13/16 and ended on 07/29/2016. Comments were received from the provider community. The notice period begins on 09/01/2016 and ends 10/16/2016. The LCD becomes final on 10/17/ /17/2016 MolDX-CDD: ProMark Risk Score L36665 GlycoMark L36761 MolDX: Biomarkers in Cardiovascular Risk Assessment L36129 MolDX: Genetic Testing for BCR ABL Negative Myeloproliferative Disease L36044 The comment period began on 06/13/16 and ended on 07/29/2016. Comments were received from the provider community. The notice period begins on 08/25/2016 and ends 10/09/2016. The LCD becomes final on 10/10/2016. The comment period began on 06/13/16 and ended on 07/29/2016. Comments were received from the provider community. The notice period begins on 09/01/2016 and ends 10/16/2016. The LCD becomes final on 10/17/2016. The following changes were made in the summary paragraph for Highsensitivity C-reactive protein (hs-crp): Removed 1. Men must be > 50 years of age; women must be > 60 years of age; and ACCF/AHA, 2010 In the first bullet changed the age for Men from >45 to >50 and Women from >55 to >60. Typographical error correction. Replaced MPL with MPD. Changed CALF to CALR in the following sentence... CALF mutations are reported to predict a more indolent disease course than patients with JAK2 mutations. 10/10/ /17/ /28/ /28/2016 Article Title Article Revision Effective Date Definitive Drug Testing Crosswalk A53952/M00109-A Typographical error. Replaced G5054 with G6054, G84999 with 84999, and G5058 with G /28/ /2016

39 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 July 28, MLN Connects Provider enews for August 4, MLN Connects Provider enews for August 11, MLN Connects Provider enews for August 18, MLN Connects Provider enews for August 25, 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