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Reaching Out to the Medicare Community KENTUCKY & OHIO PART B Medicare Bulletin Jurisdiction 15 SEPTEMBER 2019 WWW.CGSMEDICARE.COM © 2019 Copyright, CGS Administrators, LLC.

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Page 1: SEPTEMBER 2019 • Medicare Bulletin · MM11230 Revised: Medicare Summary Notice (MSN) Changes to Assist Beneficiaries Enrolled in the Qualified Medicare Beneficiary (QMB) Program

Reaching Out to the Medicare

Community

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BMedicare BulletinJurisdiction 15

SEPTEMBER 2019 • WWW.CGSMEDICARE.COM

© 2019 Copyright, CGS Administrators, LLC.

Page 2: SEPTEMBER 2019 • Medicare Bulletin · MM11230 Revised: Medicare Summary Notice (MSN) Changes to Assist Beneficiaries Enrolled in the Qualified Medicare Beneficiary (QMB) Program

Medicare BulletinJurisdiction 15

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Bold, italicized material is excerpted from the American Medical Association Current Procedural Terminology CPT codes. Descriptions and other data only are copyrighted 2018 American Medical Association. All rights reserved. Applicable FARS/DFARS apply.

MEDICARE BULLETIN GR 2019-09 SEPTEMBER 2019 2

Articles contained in this edition are current as of July 31, 2019.

KENTUCKY & OHIOAdministrationProvider Contact Center (PCC) Training 3

Contact Information for CGS Medicare Part B 3

Upcoming Educational Events 4

Is Your Vendor/Clearinghouse Submitting Your Claims with the MBI? 4

MM11230 Revised: Medicare Summary Notice (MSN) Changes to Assist Beneficiaries Enrolled in the Qualified Medicare Beneficiary (QMB) Program 4

SE19012: Emergency Medical Treatment and Labor Act (EMTALA) and the Born-Alive Infant Protection Act 38

SE19014: Tropical Storm Barry and Medicare Disaster Related Louisiana Claims 40

Ambulatory Surgery CenterMM11328: July 2019 Update of the Ambulatory Surgical Center (ASC) Payment System 20

CodingMM11295: Update to Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home 17

MM11357: Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to- Procedure (PTP) Edits, Version 25.3 Effective October 1, 2019 29

DMEPOSMM11334 Revised: July Quarterly Update for 2019 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule 23

Drugs & BiologicalsMM11296 Revised: Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes – July 2019 Update 18

MM11343: October 2019 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files 26

SE19011: Reduce Risk of Opioid Overdose Deaths by Avoiding and Reducing Co-Prescribing Benzodiazepines 33

Evaluation & ManagementMM11273 Revised: Documentation of Medical Necessity of the Home Visit; and Physician Management Associated with Superficial Radiation Treatment 11

IDTFIndependent Diagnostic Testing Facility (IDTF) Web Page Update 4

LaboratoryMM11280: Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment 12

MM11344: Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2019 27

MM11354: New Waived Tests 28

PreventiveSE19001: Pre-Diabetes Services: Referring Patients to the Medicare Diabetes Prevention Program 30

RadiologyMM11268: Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging – Educational and Operations Testing Period -Claims Processing Requirements 7

NEW MEDICARE BENEFICIARY IDENTIFIER (MBI) GET IT! USE IT! #NewCardNewNumberLEARN MORE BY VISTING: https://www.cms.gov/Medicare/New-Medicare-Card/index.html

Page 3: SEPTEMBER 2019 • Medicare Bulletin · MM11230 Revised: Medicare Summary Notice (MSN) Changes to Assist Beneficiaries Enrolled in the Qualified Medicare Beneficiary (QMB) Program

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after February 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2019 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN GR 2019-09 SEPTEMBER 2019

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Kentucky & Ohio

Provider Contact Center (PCC) Training

Medicare is a continuously changing program, and it is important that we provide correct and accurate answers to your questions. To better serve the provider community, the Centers for Medicare & Medicaid Services (CMS) allows the Provider Contact Center the opportunity to offer training to our customer service representatives (CSRs). The list below indicates when the CGS Part B PCC (1.866.276.9558) will be closed for CSR training and staff development.

Date PCC Training/ClosuresThursday, September 12, 2019 PCC Closed 9:00 – 11:00 a.m. Eastern TimeThursday, September 26, 2019 PCC Closed 9:00 – 11:00 a.m. Eastern Time

The Interactive Voice Response (IVR) (1.866.290.9481) is available for assistance in obtaining patient eligibility information, claim and deductible information, and general information. For information about the IVR, access the IVR User Guide at https://www.cgsmedicare.com/partb/cs/partb_ivr_user_guide.pdf on the CGS website. In addition, CGS’ Internet portal, myCGS, is available to access eligibility information through the Internet. For additional information, go to https://www.cgsmedicare.com/partb/index.html and click the “myCGS” button on the left side of the Web page.

For your reference, access the “Kentucky/Ohio Part B 2019 Holiday/Training Closure Schedule” at https://www.cgsmedicare.com/partb/cs/2019_holiday_schedule.pdf for a complete list of PCC closures.

Kentucky & Ohio

Contact Information for CGS Medicare Part B

To contact a CGS customer service representative, call the CGS Provider Contact Center at 1.866.276.9558 and choose Option 1. Access the Kentucky & Ohio Part B “Contact Information” Web page at https://www.cgsmedicare.com/partb/cs/index.html for information about the Interactive Voice Response (IVR) system, as well as telephone numbers, fax numbers, and mailing addresses for other CGS departments.

Before You CallAccess the new “How Do I…?” icon (https://www.cgsmedicare.com/partb/cs/howdoi.html) and the “Education & Events” icon (https://www.cgsmedicare.com/partb/education/index.html) to access resources that may be able to answer your question.

The Medicare Learning Network® (MLN), offered by the Centers for Medicare & Medicaid Services (CMS), includes a variety of educational resources for health care providers. Access Web-based training courses, national provider conference calls, materials from past conference calls, MLN articles, and much more.

Learn more about what the CMS MLN offers at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNGenInfo/ index.html on the CMS website.

LEARNING NETWORK®

A Valuable Educational Resource!

Page 4: SEPTEMBER 2019 • Medicare Bulletin · MM11230 Revised: Medicare Summary Notice (MSN) Changes to Assist Beneficiaries Enrolled in the Qualified Medicare Beneficiary (QMB) Program

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after February 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2019 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN GR 2019-09 SEPTEMBER 2019

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Kentucky & Ohio

Upcoming Educational Events

The CGS Provider Outreach and Education (POE) department offers educational events through webinars and teleconferences throughout the year. Registration for these events is required. For upcoming events, please refer to the Part B Calendar of Events home page at https://www.cgsmedicare.com/medicare_dynamic/wrkshp/pr/partb_report/partb_ report.aspx. CGS suggests that you bookmark this page and visit it often for the latest educational opportunities.

If you have a topic that you would like the CGS POE department to present, send us your suggestion to [email protected].

Kentucky & Ohio

Independent Diagnostic Testing Facility (IDTF) Web Page Update

CGS has recently made updates to the Independent Diagnostic Testing Facility (IDTF) Performance Standards (V9) Web page at https://www.cgsmedicare.com/partb/enrollment/idtf.html. Specifically, under the Technician Certification/State License column, the “Certified Radiology Tech” was clarified that the certification should be in the modality they are performing.

Please share this information with your appropriate staff.

Kentucky & Ohio

Is Your Vendor/Clearinghouse Submitting Your Claims with the MBI?

This article was previously published in the July 18, 2019 edition of the MLN Connects® https://www.cms.gov/Outreach-and-Education/Outreach/FFSProvPartProg/Downloads/2019-07-18-eNews.pdf

If you send the Medicare Beneficiary Identifier (MBI) to your vendor/clearinghouse on your Medicare claim for payment, but you see both the Health Insurance Claim Number (HICN) and the MBI on your remittance advice, your vendor/clearinghouse is not using the MBI to submit your claims. Contact your vendor/clearinghouse today and ask about their process to submit Medicare claims.

Starting January 1, 2020, Medicare will reject claims with the HICN, with a few exceptions (https://www.cms.gov/Medicare/New-Medicare-Card/index.html). Make sure your vendor/clearinghouse is submitting your claims with the MBI, or they will be rejected.

For more information, see the MLN Matters Article (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE18006.pdf).

Kentucky & Ohio

MM11230 Revised: Medicare Summary Notice (MSN) Changes to Assist Beneficiaries Enrolled in the Qualified Medicare Beneficiary (QMB) Program

MLN Matters Number: MM11230 Revised Related CR Release Date: July 3, 2019 Related CR Transmittal Number: R4332CP Related Change Request (CR) Number: 11230 Effective Date: October 1, 2019 Implementation Date: October 7, 2019 for claims processed on or after this date

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after February 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2019 Copyright, CGS Administrators, LLC.

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Note: We revised this article on July 9, 2019, to reflect the revised CR 11230 issued on July 3. In the article, we deleted a reference to FISS rejections that was on page 3. Also, we revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

Provider Type AffectedThis MLN Matters Article is for providers and suppliers who serve Qualified Medicare Beneficiaries (QMBs).

What You Need to KnowCR 11230 alerts providers of further modifications to Medicare’s claims processing systems to ensure that the Medicare Summary Notice (MSN) appropriately differentiates between QMB claims that are paid and denied and to show accurate patient payment liability amounts for beneficiaries enrolled in QMB. Please make sure your billing staffs are aware of these modifications.

BackgroundThrough CRs 9911 and 10433, the Centers for Medicare & Medicaid Services (CMS) modified its claims processing systems to identify the QMB status of beneficiaries and exemption from Medicare Parts A and B cost-sharing charges. Articles related to CRs 9911 and 10433 are available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9911.pdf and https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10433.pdf, respectively.

The QMB program is a State Medicaid benefit that assists low-income Medicare beneficiaries with Medicare premiums and cost sharing, including deductibles, coinsurance, and copays. In 2016, there were 7.5 million individuals (more than one out of eight beneficiaries) enrolled in the QMB program. Some QMBs (22 percent) get state Medicaid assistance with Medicare premiums and cost sharing alone, but most (78 percent) simultaneously have full Medicaid coverage, which may cover care for services that Medicare does not cover.

Federal law bars Medicare providers and suppliers from billing an individual enrolled in the QMB program for Medicare Part A and Part B cost sharing for covered items and services. (See Sections 1902(n)(3)(B), 1902(n)(3)(C), 1905(p)(3), 1866(a)(1)(A), and 1848(g)(3)(A) of the

Social Security Act [the Act]). The QMB system updates are part of CMS’ ongoing efforts to help providers comply with QMB billing prohibitions. The updates also educate QMBs that they cannot be billed for Medicare deductibles and coinsurance.

As implemented through CRs 9911 and 10433, the Common Working File (CWF) identifies that a beneficiary has active QMB status, which results in Remittance Advice (RA) and Medicare Summary Notice (MSN) messages for QMB claims.

The RA includes two (2) Alert Remittance Advice Remark Codes (RARCs) that identify an individual currently enrolled in QMB and tells providers they may not collect deductible and coinsurance amounts from these beneficiaries. The RAs contain the QMB RARCs only in conjunction with paid claims generating Claim Adjustment Group Code Patient Responsibility (PR) and Claim Adjustment Reason Codes (CARC) 1, 2, and 66, and report Medicare deductible and coinsurance amounts so that coordination of benefits activities may result using copies of RAs if necessary.

The MSN generated for all QMB individuals includes information regarding their QMB status and lack of liability for Medicare cost-sharing amounts for covered Parts A and B items and services However, CMS has recently learned that the claims processing systems do not differentiate between paid and fully denied claims or denied service lines, and initiate the changes whenever an individual is enrolled in QMB.

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after February 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2019 Copyright, CGS Administrators, LLC.

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CR 11230 includes the following modifications to the claims processing systems to ensure that the MSNs appropriately differentiate between QMB claims that are paid and denied:

MSNs with QMB claims that are paid

yy If an MSN includes at least one detail line for a QMB that contains an allowed amount greater than zero, page one (the summary page), will use MSN Message 62.0 to briefly explain the QMB billing protections (in the “Be Informed!” section).

yy Also, on page one, the patient’s total liability amount (in the “Total You May Be billed” field) will omit the deductible and coinsurance amounts for details lines that are for a QMB and include an allowed amount greater than zero.

yy Further, in the claims detail section of the MSN, if the detail line is for a QMB and includes an allowed amount greater than zero, such detail line will reflect $0 (in the “Maximum You May Be Billed” field) and include message 62.1 that informs the beneficiary of her/his QMB status and billing protections.

MSNs with QMB claims that are denied

yy In the claim detail pages of the MSN, if a detail line is for a QMB and contains an allowed amount of zero, the MSN:

y� Will reflect the beneficiary’s total liability amount in the “Maximum You May Be Billed” field and

y� Include new MSN 11.21 message to inform the beneficiary that even though Medicare has denied the claim, Medicaid may pay for the care.

yy Since most QMBs also have full Medicaid coverage, it’s important to convey that their full Medicaid coverage may cover care that Medicare has denied.

Note: For supplier claims processed by VIPS Medicare System (VMS), if a detail line is flagged as QMB and contains an allowed amount of zero, and the beneficiary has not signed an Advance Beneficiary Notice or is subject to Waiver of Liability which has not been attached, the Medicare Administrative Contractor (MAC) will not print MSN message 11.21.

Additional InformationThe official instruction, CR11230, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4332CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

For more information, refer to the Qualified Medicare Beneficiary (QMB) Program at: https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/QMB.html.

Document History

Date DescriptionJuly 9, 2019 We revised this article to reflect the revised CR 11230 issued on July 3. In the article, we deleted a

reference to FISS rejections that was on page 3. Also, we revised the CR release date, transmittal number, and the Web address of the CR. All other information remains the same.

May 7, 2019 Initial article released.

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after February 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2019 Copyright, CGS Administrators, LLC.

MEDICARE BULLETIN GR 2019-09 SEPTEMBER 2019

RETURN TO TABLE OF CONTENTS

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Kentucky & Ohio

MM11268: Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging – Educational and Operations Testing Period -Claims Processing Requirements

MLN Matters Number: MM11268 Related CR Release Date: July 26, 2019 Related CR Transmittal Number: R2323OTN Related Change Request (CR) Number: 11268 Effective Date: January 1, 2020 Implementation Date: January 6, 2020

Provider Type AffectedThis MLN Matters Article is intended for physicians, providers and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

What You Need to KnowCR11268 informs MACs that, effective on January 1, 2020 (the start of the AUC program Educational and Operations Testing Period), they should accept the Appropriate Use Criteria (AUC) related HCPCS modifiers on claims. Please be sure your billing staff and vendors are aware of this update. Subsequent CRs will follow at a later date that will continue AUC program implementation.

BackgroundThe Protecting Access to Medicare Act (PAMA) of 2014, Section 218(b) (https://www.govinfo.gov/content/pkg/PLAW-113publ93/pdf/PLAW-113publ93.pdf), established a new program to increase the rate of appropriate advanced diagnostic imaging services furnished to Medicare beneficiaries. Examples of advanced imaging services include:

yy Computed tomography

yy Positron emission tomography

yy Nuclear medicine

yy Magnetic resonance imaging

Under this program, when an advanced imaging service is ordered for a Medicare beneficiary, the ordering professional will be required to consult a qualified Clinical Decision Support Mechanism (CDSM). A CDSM is an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient’s specific clinical condition during the patient’s workup. The CDSM will provide the ordering professional with a determination of whether that order adheres to AUC, does not adhere to AUC, or if there is no AUC applicable (for example, no AUC is available to address the patient’s clinical condition) in the CDSM consulted.

When this program is fully implemented at a future date, a consultation must take place for any applicable imaging service ordered by an ordering professional that would be furnished in an applicable setting and paid under an applicable payment system and information related to the consultation must be appended to claims.

Note: The applicable setting is where the imaging service is furnished, not the setting where the imaging service is ordered.

Applicable settings include:

yy Physician offices

yy Hospital outpatient departments (including emergency departments)

yy Ambulatory Surgical Centers (ASCs)

yy Independent diagnostic testing facilities

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after February 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2019 Copyright, CGS Administrators, LLC.

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Applicable payment systems include:

yy Physician Fee Schedule (PFS)

yy Hospital Outpatient Prospective Payment System

yy ASCs

Voluntary participation was established for this program from July 1, 2018, through December 31, 2019. CR 10481 discusses the voluntary participation period. The related MLN article may be read at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10481.pdf. This CR contains information related to the Educational and Operations Testing Period which is expected to last for one year (January 1, 2020 – December 31, 2020). Full program implementation is expected January 1, 2021. At that time, information regarding the ordering professional’s consultation with CDSM, or exception to such consultation, must be appended to the furnishing professional’s claim in order for that claim to be paid.

Exceptions to consulting CDSMs include:

yy The ordering professional having a significant hardship

yy Situations in which the patient has an emergency medical condition

yy An applicable imaging service ordered for an inpatient and for which payment is made under Part A

Ultimately, PAMA requires that the program results in prior authorization for ordering professionals that are identified as having outlier-ordering patterns. Before the prior authorization component of this program begins, there will be notice and comment rulemaking to develop the outlier methodology.

AUC PolicyRegulatory language for this program is in 42 Code of Federal Regulations (CFR), Section 414.94 (https://www.govinfo.gov/content/pkg/CFR-2016-title42-vol3/pdf/CFR-2016-title42-vol3-sec414-94.pdf), titled, “Appropriate Use Criteria for Advanced Diagnostic Imaging Services.” In the Calendar Year (CY) 2018 Physician Fee Schedule final rule (https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf), CMS stated that this program will be implemented in 2020, with an Educational and Operations Testing Period.

During this phase of the program claims will not be denied for failing to include AUC-related information or for misreporting AUC information on non-imaging claims (for example, failure to include one of the below modifiers and/or one of the below G codes or reporting modifiers on the wrong claim line or for the wrong service), but inclusion is encouraged.

Also, the claims processing systems will be prepared by January 1, 2020, to accept claims that contain a Current Procedural Terminology (CPT) or HCPCS C code, for advanced diagnostic imaging along with a line item HCPCS modifier to describe either the level of adherence to AUC or an exception to the program and a separate line item G-code to identify the qualified CDSM consulted.

During CY 2020, CMS expects ordering professionals to begin consulting qualified CDSMs and providing information to the furnishing practitioners and providers for reporting on their claims. Situations in which furnishing practitioners and providers do not receive AUC-related information from the ordering professional can be reported by modifier MH. Even though claims will not be denied during this Educational and Operations Testing Period, inclusion is encouraged.

The following HCPCS modifiers have been established for this program for placement on the same line as the CPT code for the advanced diagnostic imaging service:

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after February 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2019 Copyright, CGS Administrators, LLC.

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yy MA -Ordering professional is not required to consult a clinical decision support mechanism due to service being rendered to a patient with a suspected or confirmed emergency medical condition

yy MB -Ordering professional is not required to consult a clinical decision support mechanism due to the significant hardship exception of insufficient internet access

yy MC -Ordering professional is not required to consult a clinical decision support mechanism due to the significant hardship exception of electronic health record or clinical decision support mechanism vendor issues

yy MD -Ordering professional is not required to consult a clinical decision support mechanism due to the significant hardship exception of extreme and uncontrollable circumstances

yy ME -The order for this service adheres to the appropriate use criteria in the clinical decision support mechanism consulted by the ordering professional

yy MF -The order for this service does not adhere to the appropriate use criteria in the qualified clinical decision support mechanism consulted by the ordering professional

yy MG -The order for this service does not have appropriate use criteria in the clinical decision support mechanism consulted by the ordering professional

yy MH -Unknown if ordering professional consulted a clinical decision support mechanism for this service, related information was not provided to the furnishing professional or provider

yy QQ -Ordering professional consulted a qualified clinical decision support mechanism for this service and the related data was provided to the furnishing professional (effective date: 7/1/18)

Claims that report HCPCS modifier ME, MF, or MG on the Advanced Diagnostic Imaging Services claim line should additionally contain a G-code (on a separate claim line) to report which qualified CDSM was consulted (NOTE: Multiple G codes on a single claim is acceptable.):

yy G1000 -Clinical Decision Support Mechanism Applied Pathways, as defined by the Medicare Appropriate Use Criteria Program

yy G1001 -Clinical Decision Support Mechanism eviCore, as defined by the Medicare Appropriate Use Criteria Program

yy G1002 -Clinical Decision Support Mechanism MedCurrent, as defined by the Medicare Appropriate Use Criteria Program

yy G1003 -Clinical Decision Support Mechanism Medicalis, as defined by the Medicare Appropriate Use Criteria Program

yy G1004 -Clinical Decision Support Mechanism National Decision Support Company, as defined by the Medicare Appropriate Use Criteria Program

yy G1005 -Clinical Decision Support Mechanism National Imaging Associates, as defined by the Medicare Appropriate Use Criteria Program

yy G1006 -Clinical Decision Support Mechanism Test Appropriate, as defined by the Medicare Appropriate Use Criteria Program

yy G1007 -Clinical Decision Support Mechanism AIM Specialty Health, as defined by the Medicare Appropriate Use Criteria Program

yy G1008 -Clinical Decision Support Mechanism Cranberry Peak, as defined by the Medicare Appropriate Use Criteria Program

yy G1009 -Clinical Decision Support Mechanism Sage Health Management Solutions, as defined by the Medicare Appropriate Use Criteria Program

yy G1010 -Clinical Decision Support Mechanism Stanson, as defined by the Medicare Appropriate Use Criteria Program

yy G1011 -Clinical Decision Support Mechanism, qualified tool not otherwise specified, as defined by the Medicare Appropriate Use Criteria Program

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This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff. Newsletters issued after February 1997 are available at no cost from our website at http://www.cgsmedicare.com. © 2019 Copyright, CGS Administrators, LLC.

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Since G-codes do not have associated payment rates (e.g. they are not payable codes and are only used for reporting), it is expected that your MAC will appropriately adjudicate a no-pay G-code line-item and use the following message:

• CARC 246 -This non-payable code is for required reporting only• RARC N620 Alert -This procedure code is for quality reporting/informational purposes only

Note: Although these codes are not associated with a payment rate there may be circumstances when a nominal charge amount may be necessary for operational reasons related to claims processing. The beneficiary is not responsible for the denied charge.

Medicare Appropriate Use Criteria Program for Advanced Diagnostic Imaging – Code ListHCPCS Advanced Imaging Procedure Codes Magnetic Resonance Imaging70336, 70540, 70542, 70543, 70544, 70545, 70546, 70547, 70548, 70549, 70551, 70552, 70553, 70554, 70555, 71550, 71551, 71552, 71555, 72141, 72142, 72146, 72147, 72148, 72149, 72156, 72157, 72158, 72159, 72195, 72196, 72197, 72198, 73218, 73219, 73220, 73221, 73222, 73223, 73225, 73718, 73719, 73720, 73721, 73722, 73723, 73725, 74181, 74182, 74183, 74185, 75557, 75559, 75561, 75563, 75565, 76498, 77046, 77047, 77058, 77059

Computerized Tomography70450, 70460, 70470, 70480, 70481, 70482, 70486, 70487, 70488, 70490, 70491, 70492, 70496, 70498, 71250, 71260, 71270, 71275, 72125, 72126, 72127, 72128, 72129, 72130, 72131, 72132, 72133, 72191, 72192, 72193, 72194, 73200, 73201, 73202, 73206, 73700, 73701, 73702, 73706, 74150, 74160, 74170, 74174, 74175, 74176, 74177, 74178, 74261, 74262, 74712, 74713, 75571, 75572, 75573, 75574, 75635, 76380, 76497

Single-Photon Emission Computed Tomography76390

Nuclear Medicine78012, 78013, 78014, 78015, 78016, 78018, 78020, 78070, 78071, 78072, 78075, 78099, 78102, 78103, 78104, 78110, 78111, 78120, 78121, 78122, 78130, 78135, 78140, 78185, 78191, 78195, 78199, 78201, 78202, 78205, 78206, 78215, 78216, 78226, 78227, 78230, 78231, 78232, 78258, 78261, 78262, 78264, 78265, 78266, 78267, 78268, 78270, 78271, 78272, 78278, 78282, 78290, 78291, 78299, 78300, 78305, 78306, 78315, 78320, 78350, 78351, 78399, 78414, 78428, 78445, 78451, 78452, 78453, 78454, 78456, 78457, 78458, 78459, 78466, 78468, 78469, 78472, 78473, 78481, 78483, 78491, 78492, 78494, 78496, 78499, 78579, 78580, 78582, 78597, 78598, 78599, 78600, 78601, 78605, 78606, 78607, 78608, 78609, 78610, 78630, 78635, 78645, 78647, 78650, 78660, 78699, 78700, 78701, 78707, 78708, 78709, 78710, 78725, 78730, 78740, 78761, 78799, 78800, 78801, 78802, 78803, 78804, 78805, 78806, 78807, 78811, 78812, 78813, 78814, 78815, 78816, 78999

C-codesC8900, C8901, C8902, C8903, C8905, C8908, C8909, C8910, C8911, C8912, C8913, C8914, C8918, C8919, C8920, C8931, C8932, C8933, C8934, C8935, C8936

Additional InformationThe official instruction, CR11268, issued to your MAC regarding this change, is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R2323OTN.pdf.

Institutional claim providers do not have the capability to report line level ordering physician information on the institutional claim at this point. CMS is working with industry partners and will provide additional instructions on reporting line level ordering physician information for institutional claims at a future date.

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Additional information regarding the AUC program is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

Document History

Date DescriptionJuly 26, 2019 Initial article released.

Kentucky & Ohio

MM11273 Revised: Documentation of Medical Necessity of the Home Visit; and Physician Management Associated with Superficial Radiation Treatment

MLN Matters Number: MM11273 Revised Related CR Release Date: July 25, 2019 Related CR Transmittal Number: R4339CP Related Change Request (CR) Number: 11273 Effective Date: January 1, 2019 Implementation Date: August 27, 2019

Provider Type AffectedThis MLN Matters article is for physicians and other providers billing Medicare Administrative Contractors (MACs) for home visit services provided to Medicare beneficiaries.

Provider Action NeededCR11273 removes the requirement that the medical record show a home visit was medically necessary instead of an office or outpatient visit. Also, the Centers for Medicare & Medicaid Services (CMS) added a new section to chapter 12 of the Medicare Claims Processing Manual regarding Evaluation and Management (E/M) codes that you may bill with superficial radiation treatment. Make your billing staff aware of these changes.

BackgroundIn CR11273, CMS removes the requirement that the medical record show a home visit was medically necessary instead of an office or outpatient visit from the Medicare Claims Processing Manual, Chapter 12, Section 30.6.14.1. Also, you may bill E/M codes (99211, 99212, and 99213) for levels I through III with modifier 25 when performed for the purpose of reporting physician work associated with radiation therapy planning, radiation treatment device construction, and radiation treatment management when performed on the same date of service as superficial radiation treatment delivery.

See Chapter 13, Section 70.2, of the Medicare Claims Processing Manual for information regarding services bundled into treatment management codes.

Additional InformationThe official instruction, CR11273, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4339CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

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Document History

Date DescriptionJuly 25, 2019 We revised this article to reflect the reissued CR11273 dated July 25. In the article, we revised the

CR release date, transmittal number, and the web address of the CR. All other information remains the same.

May 29, 2019 Initial article released.

Kentucky & Ohio

MM11280: Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

MLN Matters Number: MM11280 Related CR Release Date: June 28, 2019 Related CR Transmittal Number: R4326CP Related Change Request (CR) Number: 11280 Effective Date: July 1, 2019 Implementation Date: July 1, 2019

Note: We revised this article on July 3, 2019, to reflect a revised CR that CMS posted on June 28. In the article, we added a section on page 5 regarding Advanced Diagnostic Laboratory Tests. Also, we revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

Provider Type AffectedThis MLN Matters® Article is for physicians, other providers, and suppliers submitting clinical laboratory claims to Medicare Administrative Contractors (MACs)) for services to Medicare beneficiaries.

Provider Action NeededCR 11280 informs MACS about the changes in the July 2019 quarterly update to the Clinical Laboratory Fee Schedule (CLFS). Make sure that your billing staffs are aware of these changes.

BackgroundEffective January 1, 2018, Medicare bases CLFS rates on weighted median private payor rates as the Protecting Access to Medicare Act (PAMA) of 2014 requires. For more details, visit PAMA Regulations at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html.

Note: Part B deductible and coinsurance do not apply for services paid under the CLFS.

Access to Data FileThe quarterly CLFS data file will be available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html. Other interested parties, such as the Medicaid State agencies, the Indian Health Service, the United Mine Workers, and the Railroad Retirement Board, may want to retrieve the quarterly CLFS. It will be available in multiple formats: Excel, text, and comma delimited.

Pricing InformationThe CLFS includes separately payable fees for certain specimen collection methods (codes 36415, P9612, and P9615). Section 1833(h)(4)(B) of the Social Security Act provides for establishing these fees.

New Codes Effective July 1, 2019Proprietary Laboratory Analysis (PLAs)

The following new codes may need to be manually added to the HCPCS file by the MACs with an effective date of July 1, 2019. These new codes are also contractor-priced until they appear on the January 1, 2020 CLFS as applicable.

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Note: MACs will only price PLA codes for laboratories within their jurisdiction.

yy CPT Code: 0084U

y� Long Descriptor: Red blood cell antigen typing, DNA, genotyping of 10 blood groups with phenotype prediction of 37 red blood cell antigens

y� Short descriptor: RBC DNA GNOTYP 10 BLD GROUPS

y� Laboratory: BLOODchip®ID CORE XT™, Grifols Diagnostic Solutions Inc

y� TOS: 5

yy CPT Code: 0085U

y� Long Descriptor: Cytolethal distending toxin B (CdtB) and vinculin IgG antibodies by immunoassay (ie, ELISA)

y� Short Descriptor: CDTB&VINCULIN IGG ANTB IA

y� Laboratory: Accelerate PhenoTest™ BC kit, Accelerate Diagnostics, Inc

y� TOS: 5

yy CPT Code: 0086U

y� Long Descriptor: Infectious disease (bacterial and fungal), organism identification, blood culture, using rRNA FISH, 6 or more organism targets, reported as positive or negative with phenotypic minimum inhibitory concentration (MIC)-based antimicrobial susceptibility

y� Short Descriptor: NFCT DS BACT&FNG ORG ID 6+

y� Laboratory: Accelerate PhenoTest™ BC kit, Accelerate Diagnostics, Inc

y� TOS: 5

yy CPT Code: 0087U

y� Long Descriptor: Cardiology (heart transplant), mRNA gene expression profiling by microarray of 1283 genes, transplant biopsy tissue, allograft rejection and injury algorithm reported as a probability score

y� Short Descriptor: CRD HRT TRNSPL MRNA 1283 GEN

y� Laboratory: Molecular Microscope® MMDx—Heart, Kashi Clinical Laboratories

y� TOS: 5

yy CPT Code: 0088U

y� Long Descriptor: Transplantation medicine (kidney allograft rejection), microarray gene expression profiling of 1494 genes, utilizing transplant biopsy tissue, algorithm reported as a probability score for rejection

y� Short Descriptor: TRNSPLJ KDN ALGRFT REJ 1494

y� Laboratory: Molecular Microscope® MMDx—Kidney, Kashi Clinical Laboratories

y� TOS: 5

yy CPT Code: 0089U

y� Long Descriptor: Oncology (melanoma), gene expression profiling by RTqPCR, PRAME and LINC00518, superficial collection using adhesive patch(es)

y� Short Descriptor: ONC MLNMA PRAME & LINC00518

y� Laboratory: Pigmented Lesion Assay (PLA), DermTech

y� TOS: 5

yy CPT Code: 0090U

y� Long Descriptor: Oncology (cutaneous melanoma), mRNA gene expression profiling by RT-PCR of 23 genes (14 content and 9 housekeeping), utilizing formalin-fixed paraffin-

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embedded tissue, algorithm reported as a categorical result (ie, benign, indeterminate, malignant)

y� Short Descriptor: ONC CUTAN MLNMA MRNA 23 GENE

y� Laboratory: myPath® Melanoma, Myriad Genetic Laboratories

y� TOS: 5

yy CPT Code: 0092U

y� Long Descriptor: Oncology (lung), three protein biomarkers, immunoassay using magnetic nanosensor technology, plasma, algorithm reported as risk score for likelihood of malignancy

y� Short Descriptor: ONC LNG 3 PRTN BMRK PLSM ALG

y� Laboratory: REVEAL Lung Nodule Characterization, MagArray, Inc

y� TOS: 5

yy CPT Code: 0093U

y� Long Descriptor: Prescription drug monitoring, evaluation of 65 common drugs by LC-MS/MS, urine, each drug reported detected or not detected

y� Short Descriptor: RX MNTR 65 COM DRUGS URINE

y� Laboratory: ComplyRX, Claro Labs

y� TOS: 5

yy CPT Code: 0094U

y� Long Descriptor: Genome (eg, unexplained constitutional or heritable disorder or syndrome), rapid sequence analysis

y� Short Descriptor: GENOME RAPID SEQUENCE ALYS

y� Laboratory: RCIGM Rapid Whole Genome Sequencing, Rady Children’s Institute for Genomic Medicine (RCIGM)

y� TOS: 5

yy CPT Code: 0095U

y� Long Descriptor: Inflammation (eosinophilic esophagitis), ELISA analysis of eotaxin-3 (CCL26 [C-C motif chemokine ligand 26]) and major basic protein (PRG2 [proteoglycan 2, pro eosinophil major basic protein]), specimen obtained by swallowed nylon string, algorithm reported as predictive probability index for active eosinophilic esophagitis

y� Short Descriptor: INFLM EE ELISA ALYS ALG

y� Laboratory: Esophageal String Test™ (EST), Cambridge Biomedical, Inc

y� TOS: 5

yy CPT Code: 0096U

y� Long Descriptor: Human papillomavirus (HPV), high-risk types (ie, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), male urine

y� Short Descriptor: HPV HI RISK TYPES MALE URINE

y� Laboratory: HPV, High-Risk, Male Urine, Molecular Testing Labs

y� TOS: 5

yy CPT Code: 0097U

y� Long Descriptor: Gastrointestinal pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 22 targets (Campylobacter [C. jejuni/C. coli/C. upsaliensis], Clostridium difficile [C. difficile] toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio [V. parahaemolyticus/V. vulnificus/V. cholerae], including specific identification of Vibrio cholerae, Yersinia enterocolitica, Enteroaggregative Escherichia coli [EAEC], Enteropathogenic Escherichia coli [EPEC], Enterotoxigenic

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Escherichia coli [ETEC] lt/st, Shiga-like toxin-producing Escherichia coli [STEC] stx1/stx2 [including specific identification of the E. coli O157 serogroup within STEC], Shigella/Enteroinvasive Escherichia coli [EIEC], Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia [also known as G. intestinalis and G. duodenalis], adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, sapovirus [Genogroups I, II, IV, and V])

y� Short Descriptor: GI PATHOGEN 22 TARGETS

y� Laboratory: BioFire® FilmArray® Gastrointestinal (GI) Panel, BioFire® Diagnostics

y� TOS: 5

yy CPT Code: 0098U

y� Long Descriptor: Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 14 targets (adenovirus, coronavirus, human metapneumovirus, influenza A, influenza A subtype H1, influenza A subtype H3, influenza A subtype H1-2009, influenza B, parainfluenza virus, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae);

y� Short Descriptor: RESPIR PATHOGEN 14 TARGETS

y� Laboratory: BioFire® FilmArray® Respiratory Panel (RP) EZ, BioFire® Diagnostics

y� TOS: 5

yy CPT Code: 0099U

y� Long Descriptor: Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus, coronavirus OC43, human metapneumovirus, influenza A, influenza A subtype, influenza A subtype H3, influenza A subtype H1-2009, influenza, parainfluenza virus, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumonia, Mycoplasma pneumoniae)

y� Short Descriptor: RESPIR PATHOGEN 20 TARGETS

y� Laboratory: BioFire® FilmArray® Respiratory Panel (RP), BioFire® Diagnostics

y� TOS: 5

yy CPT Code: 0100U

y� Long Descriptor: Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus, human rhinovirus/enterovirus, influenza A, including subtypes H1, H1-2009, and H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, Bordetella parapertussis [IS1001], Bordetella pertussis [ptxP], Chlamydia pneumoniae, Mycoplasma pneumoniae)

y� Short Descriptor: RESPIR PATHOGEN 20 TARGETS;

y� Laboratory: BioFire® FilmArray® Respiratory Panel 2 (RP2), BioFire® Diagnostics

y� TOS: 5

yy CPT Code: 0101U;

y� Long Descriptor: Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (15 genes [sequencing and deletion/duplication], EPCAM and GREM1 [deletion/duplication only])

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y� Short Descriptor: HERED COLON CA DO 15 GENES

y� Laboratory: ColoNext®, Ambry Genetics®, Ambry Genetics®

y� TOS: 5

yy CPT Code: 0102U

y� Long Descriptor: Hereditary breast cancer-related disorders (eg, hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (17 genes [sequencing and deletion/duplication])

y� Short Descriptor: HERED BRST CA RLTD DO 17 GEN

y� Laboratory: BreastNext®, Ambry Genetics®, Ambry Genetics®

y� TOS: 5

yy CPT Code: 0103

y� Long Descriptor: Hereditary ovarian cancer (eg, hereditary ovarian cancer, hereditary endometrial cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (24 genes [sequencing and deletion/duplication], EPCAM [deletion/duplication only])

y� Short Descriptor: HERED OVA CA PNL 24 GENES

y� Laboratory: OvaNext®, Ambry Genetics®, Ambry Genetics®

y� TOS: 5

yy CPT Code: 0104U

y� Long Descriptor: Hereditary pan cancer (eg, hereditary breast and ovarian cancer, hereditary endometrial cancer, hereditary colorectal cancer), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (32 genes [sequencing and deletion/duplication], EPCAM and GREM1 [deletion/duplication only])

y� Short Descriptor: HERED PAN CA PNL 32 GENES

y� Laboratory: CancerNext®, Ambry Genetics®, Ambry Genetics®

y� TOS: 5

Deleted Codes Effective July 1, 2019yy Existing code 0057U is being deleted.

Advanced Diagnostic Laboratory Tests (ADLTs) Effective July 1, 2019 CMS approved three ADLTs. For additional information regarding these tests, please refer to https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html#ADLT_tests

Additional InformationThe official instruction, CR11280, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4326CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

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Document History

Date DescriptionJuly 3, 2019 We revised the article to reflect a revised CR that CMS posted on June 28. In the article, we added

a section on page 6 regarding Advanced Diagnostic Laboratory Tests. Also, we revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

May 3, 2019 Initial article released.

Kentucky & Ohio

MM11295: Update to Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home

MLN Matters Number: MM11295 Related CR Release Date: July 12, 2019 Related CR Transmittal Number: R259BP Related Change Request (CR) Number: 11295 Effective Date: August 13, 2019 Implementation Date: August 13, 2019

Provider Type AffectedThis MLN Matters® Article is for physicians, other providers, and suppliers submitting claims to Medicare Administrative Contractors for Intravenous Immune Globulin (IVIG) services for Medicare beneficiaries.

Provider Action NeededCR11295 informs MACs about changes which update the list of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes for the coverage of IVIG for treatment of Primary Immune Deficiency Diseases (PIDD) in the home. Make sure that your billing staffs are aware of these changes.

BackgroundThe Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides coverage of IVIG for the treatment of PIDD in the home. The Act defines “intravenous immune globulin” as an approved pooled plasma derivative for the treatment of PIDD. IVIG is covered under this benefit when:

yy The patient has a diagnosed PIDD

yy The IVIG administration takes place in the home of a patient with a diagnosed PIDD

yy The physician determines that administration of the derivative in the patient’s home is medically appropriate.

Effective for dates of service on or after January 1, 2004, via CR3060, the appropriate ICD-9 codes were as follows: 279.04, 279.05, 279.06, 279.12, and 279.2.

Effective for dates of service on or after October 1, 2014, via CR8605, the appropriate ICD-9 codes were converted to the following ICD-10 codes: D80.0, D80.5, D81.0, D81.1, D81.2, D81.6, D81.7, D81.89, D81.9, D82.0, D83.0, D83.2, D83.8, or D83.9 if only an unspecified diagnosis is necessary.

Effective for dates of service on or after the implementation date of CR11295, the coverage for IVIG in home for the treatment of PIDDs is updated to include the following ICD-10-CM codes; G11.3, D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7, D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2, D83.8, or D83.9 if only an unspecified diagnosis is necessary.

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Additional InformationThe official instruction, CR11295, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R259BP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

Document History

Date DescriptionJuly 15, 2019 Initial article released.

Kentucky & Ohio

MM11296 Revised: Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes – July 2019 Update

MLN Matters Number: MM11296 Revised Related CR Release Date: June 12, 2019 Related CR Transmittal Number: R4320CP Related Change Request (CR) Number: 11296 Effective Date: July 1, 2019 Implementation Date: July 1, 2019

Note: We revised this article on June 19, 2019 to reflect the revised CR 11296 issued on June 12. CMS revised the CR to update the short and long descriptors of Q5115 and we revised the article accordingly. In the article, we also revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

Provider Type AffectedThis MLN Matters Article is for physicians, providers and suppliers billing Medicare Administrative Contractors (MACs) for drug and biological services.

Provider Action NeededCR 11296 updates the HCPCS code set for codes related to drugs and biologicals. Please make sure your billing staffs are aware of these updates.

BackgroundThe HCPCS code set is updated on a quarterly basis. CR 11296 informs MACs and providers of the updated specific drug/biological HCPCS codes. The April 5, 2019, HCPCS file includes 10 new HCPCS codes. Beginning on July 1, 2019, these HCPCS codes will be established and may be used in submitting claims under Medicare effective for claims with dates of service on or after July 1, 2019:

1. J1444

a. Short Descriptor: Fe pyro cit pow 0.1 mg iron

b. Long Descriptor: Injection, ferric pyrophosphate citrate powder, 0.1 mg of iron

c. Type of Service (TOS): 1, L

2. J7208

a. Short Descriptor: Inj. jivi 1 iu

b. Long Descriptor: Injection, factor viii, (antihemophilic factor, recombinant), pegylated-

aucl, (jivi), 1 i.u.

c. TOS: 1

3. J7677

a. Short Descriptor: Revefenacin inh non-com 1mcg

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b. Long Descriptor: Revefenacin inhalation solution, fda-approved final product, non-

compounded, administered through DME, 1 microgram

c. TOS: 1, P

4. J9030

a. Short Descriptor: Bcg live intravesical 1mg

b. Long Descriptor: BCG live intravesical instillation, 1 mg

c. TOS: 1, P

5. J9036

a. Short Descriptor: Inj., belrapzo/bendamustine

b. Long Descriptor: Injection, bendamustine hydrochloride, (Belrapzo/bendamustine), 1 mg

c. TOS: 1

6. J9356

a. Short Descriptor: Inj. herceptin hylecta, 10mg

b. Long Descriptor: Injection, trastuzumab, 10 mg and Hyaluronidase-oysk

c. TOS: 1

7. Q5112

a. Short Descriptor: Inj ontruzant 10 mg

b. Long Descriptor: Injection, trastuzumab-dttb, biosimilar, (Ontruzant), 10 mg

c. TOS: 1, P

8. Q5113

a. Short Descriptor: Inj herzuma 10 mg

b. Long Descriptor: Injection, trastuzumab-pkrb, biosimilar, (Herzuma), 10 mg

c. TOS: 1, P

9. Q5114

a. Short Descriptor: Inj ogivri 10 mg

b. Long Descriptor: Injection, Trastuzumab-dkst, biosimilar, (Ogivri), 10 mg

c. TOS: 1, P

10. Q5115

a. Short Descriptor: Inj truxima 10 mg

b. Long Descriptor: Injection, rituximab-abbs, biosimilar, (Truxima), 10 mg

c. TOS: 1, P

HCPCS code J9031 (Bcg (intravesical) per instillation) is being discontinued effective July 1, 2019, and may not be used in submitting claims under Medicare effective for claims with dates of service on or after July 1, 2019.

The long and short descriptors for HCPCS code J9355 will be modified, effective for claims with dates of service on or after July 1, 2019, The TOS and all other indicators will remain the same.

yy J9355 Short Descriptor: Inj trastuzumab excl biosimi

yy J9355 Long Descriptor: Injection, trastuzumab, excludes biosimilar, 10 mg

Additional InformationThe official instruction, CR 11296, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4320CP.pdf.

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If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

Document History

Date DescriptionJune 19, 2019 We revised this article to reflect the revised CR 11296 issued on June 12. CMS revised the CR to

update the short and long descriptors of Q5115 and we revised the article accordingly. In the article, we also revised the CR release date, transmittal number, and the web address of the CR. All other information remains the same.

May 20, 2019 Initial article released.

Kentucky & Ohio

MM11328: July 2019 Update of the Ambulatory Surgical Center (ASC) Payment System

MLN Matters Number: MM11328 Related CR Release Date: June 14, 2019 Related CR Transmittal Number: R4319CP Related Change Request (CR) Number: 11328 Effective Date: July 1, 2019 Implementation Date: July 1, 2019

Provider Type AffectedThis MLN Matters Article is for physicians, providers, and suppliers billing Medicare Administrative Contractors (MACs) for services subject to the Ambulatory Surgical Center (ASC) payment system and provided to Medicare beneficiaries.

Provider Action NeededCR11328 contains the changes to and billing instructions for various payment policies implemented in the July 2019 ASC payment system update. This notification also includes updates to HCPCS. Make sure your billing staffs are aware of these updates.

BackgroundCR11328 includes Calendar Year (CY) 2019 payment rates for separately payable procedures/services, drugs, and biologicals, including descriptors for newly created CPT and Level II HCPCS codes for drugs and biologicals (ASC DRUG) files. The CR also conveys a July 2019 Ambulatory Surgical Center Payment Indicator (ASC PI) File, and a July 2019 Ambulatory Surgical Center Fee Schedule (ASCFS). The Centers for Medicare & Medicaid Services (CMS) is not issuing an ASC Code Pair file with this CR.

1. New CPT Category III Codes Effective July 1, 2019

Similar to the vaccine codes, the American Medical Association (AMA) releases the CPT Category III codes twice per year: in January, for implementation beginning the following July, and in July, for implementation beginning the following January.

Effective July 1, 2019, the CMS is implementing five (5) CPT Category III codes in the ASC payment system that the AMA released in January 2019 for implementation on July 1, 2019. These codes, along with their short and long descriptors, and their ASC PIs are shown in Table 1 below. These codes are also included in the July 2019 ASC addenda, which is posted on the CMS website.

Table 1 ─ New CPT Category III Codes Effective July 1, 2019CPT Code Short Descriptor Long Descriptor ASC PI0548T* Tprnl balo cntnc dev bi Transperineal periurethral balloon continence device;

bilateral placement, including cystoscopy and fluoroscopyJ8

0549T Tprnl balo cntnc dev uni Transperineal periurethral balloon continence device; unilateral placement, including cystoscopy and fluoroscopy

J8

0550T Tprnl balo cntnc dev rmvl ea Transperineal periurethral balloon continence device; removal, each balloon

G2

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Table 1 ─ New CPT Category III Codes Effective July 1, 2019CPT Code Short Descriptor Long Descriptor ASC PI0551T Tprnl balo cntnc dev adjmt Transperineal periurethral balloon continence device;

adjustment of balloon(s) fluid volumeR2

0558T Ct scan f/biomchn ct alys Computed tomography scan taken for the purpose of biomechanical computed tomography analysis

Z2

* HCPCS code C9746 (Transperineal implantation of permanent adjustable balloon continence device, with cystourethroscopy, when performed and/or fluoroscopy, when performed), which was effective July 1, 2017, is deleted June 30, 2019, and replaced with CPT code 0548T, effective July 1, 2019.

2. Drugs and Biologicals

a. Drugs and Biologicals with Payments Based on Average Sales Price (ASP) Effective July 1, 2019

For CY 2019, payment for nonpass-through drugs and biologicals continues to be 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 or biological. Also, in CY 2019, a single payment of ASP + 6 percent continues to be made for Outpatient Prospective Payment System (OPPS) pass-through drugs, and biologicals 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, 2019, are in the July 2019 update of ASC Addendum BB at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-payment/ASCPayment/11_Addenda_Updates.html.

b. New Established HCPCS Codes for Separately Payable Drugs and Biologicals as of July 1, 2019

Ten new separately payable drug and biological HCPCS codes will be established on July 1, 2019. Eight of the products are new. J7208 will replace HCPCS code C9141. Another HCPCS code, J9030, will replace HCPCS code J9031. The new codes are listed in Table 2 below.

HCPCS codes C9141 and J9031 will be deleted effective June 30, 2019.

Table 2 ─ New Established HCPCS Codes for Separately Payable Drugs and Biologicals, as of July 1, 2019New HCPCS Codes

Old HCPCS Codes Short Descriptor Long Descriptor ASC PI

J9036 Inj., belrapzo/bendamustine Injection, bendamustine hydrochloride, (Belrapzo/bendamustine), 1 mg

K2

J7208 C9141 Inj. jivi 1 iu Injection, factor viii, (antihemophilic factor, recombinant), pegylated-aucl, (jivi), 1 i.u.

K2

J9356 Inj. herceptin hylecta, 10mg Injection, trastuzumab, 10 mg and Hyaluronidase-oysk K2J9030 J9031 Bcg live intravesical 1mg BCG live intravesical instillation, 1 mg K2C9047 Injection, caplacizumab-yhdp Injection, caplacizumab-yhdp, 1 mg K2C9048 Dexamethasone ophth insert Dexamethasone, lacrimal ophthalmic insert, 0.1 mg K2C9049 Injection, tagraxofusp-erzs Injection, tagraxofusp-erzs, 10 mcg K2C9050 Injection, emapalumab-lzsg Injection, emapalumab-lzsg, 1 mg K2C9051 Injection, omadacycline Injection, omadacycline, 1 mg K2C9052 Injection, ravulizumab-cwv Injection, ravulizumab-cwvz, 10 mg K2

c. Descriptor Change for the HCPCS code J9355, Effective July 1, 2019

Effective July 1, 2019, the descriptors for the HCPCS code J9355 are updated. Both the old and new descriptors are located in table 3 below.

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Table 3 ─ Descriptor Change for the HCPCS code J9355, Effective July 1, 2019HCPCS Code

Old Short Descriptor

New Short Descriptor Old Long Descriptor New Long Descriptor

J9355 Trastuzumab injection

Inj trastuzumab excl biosimi

Injection, trastuzumab, 10 mg Injection, trastuzumab, excludes biosimilar, 10 mg

d. Drugs and Biologicals Based on ASP Methodology with Restated Payment Rates

Some drugs and biologicals with payment rates based on the ASP methodology may have their payment rates corrected retroactively. These retroactive corrections typically occur on a quarterly basis. The list of drugs and biologicals with corrected payment rates will be accessible on the first date of the quarter at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Restated-Payment-Rates.html.

Suppliers who think they may have received an incorrect payment for drugs and biologicals impacted by these corrections may request their MAC to adjust the previously processed claims.

3. Payment Indicator Revision for Flu Vaccine CPT Code 90689

Currently, CPT code 90689 is assigned to status indicator “E1” in the OPPS to indicate that the vaccine is not paid by Medicare when submitted on outpatient claims (any outpatient bill type). This policy is also applicable to ASCs. However, as noted in Change Request 10871 (Quarterly Influenza Virus Vaccine Code Update -January 2019), Transmittal 4141, dated September 27, 2018, effective for claims with dates of service on or after January 1, 2019, CPT 90689 will be payable by Medicare.

The vaccine is packaged in the ASC payment system; therefore, CMS is revising the status indicator to “L1” (L1: Influenza vaccine; pneumococcal vaccine. Packaged item/service; no separate payment made.) for CPT code 90689 retroactive to January 1, 2019. Please note that packaged codes should not be separately billed by ASCs. Refer to Table 4 below for the code descriptors and payment indicator assignment.

Table 4 ─ Payment Indicator Revision for Flu Vaccine CPT Code 90689CPT Code Short Descriptor Long Descriptor ASC PI90689 Vacc iiv4 no prsrv

0.25ml imInfluenza virus vaccine, quadrivalent (iiv4), inactivated, adjuvanted, preservative free, 0.25 ml dosage, for intramuscular use

L1

4. 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. 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 InformationThe official instruction, CR11328, issued to your MAC regarding this change, is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4319CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

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Document History

Date DescriptionJuly 16, 2019 Initial article released.

Kentucky & Ohio

MM11334 Revised: July Quarterly Update for 2019 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule

MLN Matters Number: MM11334 Revised Related CR Release Date: June 28, 2019 Related CR Transmittal Number: R4328CP Related Change Request (CR) Number: 11334 Effective Date: July 1, 2019 Implementation Date: July 1, 2019

Note: We revised this article on July 2, 2019, to reflect the revised CR11334 issued on June 28. CMS revised the CR to include a correction to the fee schedule amounts for HCPCS codes E1353 and E1355. The article includes this correction information on page 4. Also, we revised the CR release date, transmittal number, and the web address of CR11334. All other information remains the same.

Provider Type AffectedThis MLN Matters Article is for providers and suppliers submitting claims to Durable Medical Equipment Medicare Administrative Contractors (DME MACs) for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items or services that Medicare pays for under the DMEPOS fee schedule.

Provider Action NeededCR11334 informs DME MACs about the changes to the DMEPOS fee schedule which Medicare updates on a quarterly basis, when necessary, to implement fee schedule amounts for new codes and correct any fee schedule amounts for existing codes. Make sure that your billing staffs are aware of these changes.

BackgroundSections 1834(a), (h), and (i) of the Social Security Act (the Act) requires payment on a fee schedule basis for DMEPOS and surgical dressings by. Also, payment on a fee schedule basis is a regulatory requirement at 42 Code of Federal Regulations (CFR) Section 414.102 for Parenteral and Enteral Nutrition (PEN), splints, casts, and Intraocular Lenses (IOLs) inserted in a physician’s office. The DMEPOS and PEN fee schedule files contain HCPCS codes that are subject to the adjusted fee schedule amounts under section 1834(a)(1)(F) of the Act as well as codes that are not subject to the fee schedule Competitive Bidding Program (CBP) adjustments.

Key Points for CR11334Fee Schedule Adjustment MethodologiesSection1834(a)(1)(F)(ii) of the Act mandates adjustments to the fee schedule amounts for certain items furnished on or after January 1, 2016, in areas that are not competitive bid areas, based on information from CBPs for DME. Section 1842(s)(3)(B) of the Act provides authority for making adjustments to the fee schedule amounts for enteral nutrients, equipment, and supplies (enteral nutrition) based on information from CBPs.

The methodologies for adjusting DMEPOS fee schedule amounts under this authority are at 42 CFR Section 414.210(g). Additional information on adjustments to the fee schedule amounts based on information from CBPs is available in:

1. Transmittal 3551, Change Request (CR) 9642, June 23, 2016: See related article at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/mm9642.pdf.

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2. Transmittal 3416, CR 9431, November 23, 2015: See related article at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/mm9431.pdf.

3. Transmittal 4209, CR 11064, January 18, 2019: See related article at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/mm11064.pdf. Also, CR11064 provides information on the adjusted fee payment basis for items and services furnished from January 1, 2019, through December 31, 2020, in the following three areas:

- Rural and noncontiguous non-CBAs

- Non-rural and contiguous non-CBAs and in

- Former CBAs during a temporary gap in the DMEPOS CBP

Because of a delay in announcement of the next round of the CBP, contracts will not be in effect in Round 1, Round 2, or the National Mail Order Competitive Bidding Areas (CBAs) beginning January 1, 2019, resulting in a temporary gap period in the CBP. Additional program instructions for payment of items furnished in former CBAs is available in Transmittal 4275, CR 11233, April 5, 2019. See the related article at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11233.pdf.

Fee Schedule and ZIP Code FilesCR11334 gives instructions for the July 2019 DMEPOS Rural ZIP code file containing the Quarter 3 2019 Rural ZIP code changes. Also included in the update is the Former CBA ZIP code file containing the Quarter 3 2019 Round 1 2017 and Round 2 Re-compete CBA ZIP codes.

The ZIP code associated with the address used for pricing a DMEPOS claim determines the payment applicability for the rural fee for codes with rural and non-rural adjusted fee schedule amounts. The DMEPOS Rural ZIP code file contains the ZIP codes designated as rural areas. ZIP codes for non-continental MSA are not included in the DMEPOS Rural ZIP code file. The update for the DMEPOS Rural ZIP code file occurs quarterly, or as the Centers for Medicare & Medicaid Services (CMS) deems necessary. Regulations at 42 CFR 414.202 define a rural area to be a geographical area represented by a postal ZIP code where at least 50 percent of the estimated total geographical area of the ZIP code is outside any Metropolitan Statistical Area (MSA). A rural area also includes any ZIP Code within an MSA excluded from a CBA established for that MSA.

The ZIP code associated with the permanent address of the beneficiary determines applicability of the adjusted fee schedule amounts in former CBAs. During a gap in the CBP, a former CBA ZIP code file will contain the ZIP codes for Round 1 2017 and Round 2 Re-compete CBAs and CMS updates these on a quarterly basis as necessary.

The following DMEPOS fee schedule and ZIP code Public Use Files (PUFs) are available for State Medicaid Agencies, managed care organizations, and other interested parties shortly after the release of the data files at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule.html:

1. DMEPOS Fee schedule PUF

2. DME PEN Fee schedule PUF

3. DME Rural code PUF

4. Former CBA Fee schedule PUF

5. Former CBA National Mail Order Diabetic Testing Supply (DTS) Fee schedule PUF

6. Former CBA ZIP code PUF

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Specific Coding and Pricing IssuesTherapeutic Continuous Glucose Monitors (CGMs)Beginning in 2018, therapeutic CGMs, classified by the Food and Drug Administration (FDA) as a Class II device, became available for patient use. Previously, therapeutic CGMs were Class III devices. For items classified under the DME benefit, the annual covered item update described in Section 1834(a) (14) of the Act provides for different fee schedule updates for FDA Class II and Class III devices. The current fees for codes K0553 and K0554 are for Class III therapeutic CGMs.

As part of the July fee schedule update, the fee schedule amounts for code K0553 (Supply allowance for therapeutic Continuous Glucose Monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service) and code K0554 (Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system) require changes to implement the different covered item update amounts mandated by Section 1834(a)(14) of the Act for class III DME versus other items of DME. These changes are:

1. HCPCS modifier KF is required when billing claims for Class III DME. Therefore, effective for claims with dates of service on or after January 1, 2019, that are processed on or after July 1, 2019, suppliers should include modifier KF on claims for therapeutic CGMs (code K0554) that are Class III devices as well as claims for supplies (code K0553) used with the Class III devices. Fee schedule amounts for codes K0553 and K0554 with the KF modifier added to the fee schedule, pays claims for Class III therapeutic CGMs and related supplies only, based on the mandated covered item update factors for Class III DME items.

2. Second, effective for claims with dates of service on or after January 1, 2019, that are processed on or after July 1, 2019, for therapeutic CGMs (code K0554), such as the Dexcom Mobile G6 device, and related supplies (K0553) that are not Class III devices, should be submitted without the KF modifier. Fee schedule amounts for codes K0553 and K0554 without the KF modifier are available to pay claims for therapeutic CGMs that are not Class III devices and related supplies, based on the mandated covered item update factors for DME other than Class III items. The calculation of the fee schedule amounts for code K0553 without the KF modifier does not include an allowance for calibration supplies and equipment because therapeutic CGMs that are not Class III items no longer require calibration.

Beginning July 1, 2019, suppliers should bill with the KF modifier when billing for Class III therapeutic CGM receivers under code K0554 and supplies for Class III therapeutic CGM receivers under code K0553 for dates of service on or after January 1, 2019. Suppliers should bill without the KF modifier when billing for therapeutic CGM receivers that are not Class III items under code K0554 and supplies for therapeutic CGM receivers that are not Class III items under code K0553 for dates of service on or after January 1, 2019.

As part of the July update, CMS is correcting the fee schedule amounts for HCPCS codes E1353 and E1355, effective January 1, 2019. The fee schedule amounts for these codes on the April and January 2019 fee schedule files inadvertently omitted the 2009 covered item -9.5% change required by Section 1834(a)(14)(J) of the Act.

Additional InformationThe official instruction, CR11334, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4328CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

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Document History

Date DescriptionJuly 2, 2019 We revised this article to reflect the revised CR11334 issued on June 28. CMS revised the CR to

include a correction to the fee schedule amounts for HCPCS codes E1353 and E1355. The article includes this correction information on page 4. Also, we revised the CR release date, transmittal number, and the web address of CR11334. All other information remains the same.

June 25, 2019 Initial article released.

Kentucky & Ohio

MM11343: October 2019 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

MLN Matters Number: MM11343 Related CR Release Date: July 5, 2019 Related CR Transmittal Number: R4331CP Related Change Request (CR) Number: 11343 Effective Date: October 1, 2019 Implementation Date: October 7, 2019

Provider Type AffectedThis MLN Matters Article is for physicians, providers, and suppliers billing Medicare Administrative Contractors (MACs) for Medicare Part B drugs provided to Medicare beneficiaries.

Provider Action NeededCR11343 informs MACs about new and revised Average Sales Price (ASP) and ASP Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs. The Centers for Medicare & Medicaid Services (CMS) will make files available for download on or after September 13, 2019. CMS gives MACs the ASP and NOC drug pricing files for Medicare Part B drugs on a quarterly basis. Payment allowance limits under the Outpatient Prospective Payment System (OPPS) are incorporated into the Outpatient Code Editor (OCE) through separate instructions available in Chapter 4, Section 50 of the Medicare Claims Processing Manual found at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf. Make sure that your billing staffs are aware of these changes.

BackgroundThe ASP methodology is based on quarterly data submitted to CMS by manufacturers. CR11343 instructs MACs to download and implement the October 2019 and, if released, the revised July 2019, April 2019, January 2019, and October 2018 ASP drug pricing files for Medicare Part B drugs

CR11343 addresses the following pricing files:

yy File: October 2019 ASP and ASP NOC — Effective Dates of Service: October 1, 2019, through December 31, 2019

yy File: July 2019 ASP and ASP NOC — Effective Dates of Service: July 1, 2019, through September 30, 2019

yy File: April 2019 ASP and ASP NOC — Effective Dates of Service: April 1, 2019, through June 30, 2019

yy File: January 2019 ASP and ASP NOC — Effective Dates of Service: January 1, 2019, through March 31, 2019

yy File: October 2018 ASP and ASP NOC — Effective Dates of Service: October 1, 2018, through December 31, 2018

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For any drug or biological not listed in the ASP or NOC drug pricing files, your MACs will determine the payment allowance limits in accordance with the policy in the Medicare Claims Processing Manual, Chapter 17, Section 20.1.3 at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf.

For any drug or biological not listed in the ASP or NOC drug pricing files that you bill with the KD modifier, MACs will determine the payment allowance limits in accordance with instructions for pricing and payment changes for infusion drugs furnished through an item of Durable Medical Equipment (DME) on or after January 1, 2017, associated with the passage of the 21st Century Cures Act which is available at https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf.

Note: MACs will not search and adjust claims that have already been processed unless you bring such claims to their attention.

Additional InformationThe official instruction, CR11343, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4331CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

Document History

Date DescriptionJuly 9, 2019 Initial article released.

Kentucky & Ohio

MM11344: Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2019

MLN Matters Number: MM11344 Related CR Release Date: July 5, 2019 Related CR Transmittal Number: R4330CP Related Change Request (CR) Number: 11344 Effective Date: October 1, 2019 Implementation Date: October 7, 2019

Provider Type AffectedThis MLN Matters Article is for physicians, providers and suppliers billing Medicare Administrative Contractors (MACs) for laboratory services provided to Medicare beneficiaries.

Provider Action NeededCR 11344 announces changes that will be in the October 2019 quarterly release of the edit module for clinical diagnostic laboratory services. Please make sure your billing staffs are aware of these changes.

BackgroundThe laboratory negotiated rulemaking committee developed the National Coverage Determinations (NCDs) for clinical diagnostic laboratory services. The final rule was published on November 23, 2001. Nationally uniform software was developed and incorporated into the Medicare shared systems so that laboratory claims subject to one of the 23 NCDs (sections 190.12-190.34 of the Medicare NCD Manual) process uniformly throughout the nation, effective April 1, 2003.

Per Chapter 16, Section 120.2 of the Medicare Claims Processing Manual, the laboratory edit module is updated quarterly as necessary to reflect ministerial coding updates and substantive changes to the NCDs developed through the NCD process. The changes are a result of coding analysis decisions developed under the procedures for maintenance of codes in the negotiated

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NCDs and biannual updates of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.

CR 11344 communicates requirements to Medicare’s Shared System Maintainers (SSMs) and MACs to notify them of changes to the laboratory edit module to update it for changes in laboratory NCD code lists for October 2019. Please access https://www.cms.hhs.gov/Medicare/Coverage/DeterminationProcess/downloads/October2019.zip for the NCD spreadsheet included in CR 11344.

Note: MACs will not search their files to either retract payment for claims already paid or to retroactively pay claims unless you bring such claims to their attention.

Additional InformationThe official instruction, CR 11344, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4330CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

Document History

Date DescriptionJuly 12, 2019 Initial article released.

Kentucky & Ohio

MM11354: New Waived Tests

MLN Matters Number: MM11354 Related CR Release Date: July 19, 2019 Related CR Transmittal Number: R4336CP Related Change Request (CR) Number: 11354 Effective Date: October 1, 2019 Implementation Date: October 7, 2019

Provider Type AffectedThis MLN Matters article is for clinical diagnostic laboratories submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Provider Action NeededCR 11354 informs MACs of new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA). Since these tests are marketed immediately after approval, the Centers for Medicare & Medicaid Services (CMS) must notify the MACs of the new tests so that they can accurately process claims. Make sure your billing staffs are aware of these CLIA-related changes.

BackgroundCR 11354 presents the latest tests approved by the FDA as waived tests under CLIA. The Current Procedural Terminology (CPT) codes for these new tests must have the modifier “QW” to be recognized as a waived test.

Note: The tests mentioned on the first page of the list attached to CR 11354 (CPT codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651), do not require a “QW” modifier to be recognized as a waived test.

Note: The tests mentioned on the first page of the list attached to CR 11354 (CPT codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651), do not require a “QW” modifier to be recognized as a waived test.

The CPT code, effective date, and description for the latest tests approved by the FDA as waived tests under CLIA include:

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yy 80305QW, December 13, 2018, Shenzhen Bioeasy Biotechnology Co., Ltd, BIOEASY Multi-Drug Test Cup

yy 80305QW, April 18, 2019, Mercedes Scientific Inc., Platinum+ Multi-Drug Urine Test Cup

yy 80305QW, April 18, 2019, Mercedes Scientific Inc., Platinum+ Multi-Drug Urine Test Dip Card

yy 87880QW, May 9, 2019, McKesson Consult Strep A Test Cassette

yy 87502QW, May 28, 2019, Alere ID NOW Instrument {Nasal and Nasopharyngeal swabs}, for Influenza A/B

yy 87634QW, May 29, 2019, Alere ID NOW Instrument {Nasopharyngeal swabs}, for respiratory syncytial virus

CLIA regulations require a facility to be appropriately certified for each test performed. To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.

Note: MACs will not search their files to either retract payment or retroactively pay claims; however, MACs should adjust claims if you bring those claims to their attention.

Additional InformationThe official instruction, CR 11354, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4336CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

Document History

Date DescriptionJuly 23, 2019 Initial article released.

Kentucky & Ohio

MM11357: Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 25.3 Effective October 1, 2019

MLN Matters Number: MM11357 Related CR Release Date: July 12, 2019 Related CR Transmittal Number: R4334CP Related Change Request (CR) Number: 11357 Effective Date: October 1, 2019 Implementation Date: October 7, 2019

Provider Type AffectedThis MLN Matters Article is for physicians, providers, and suppliers billing Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Provider Action NeededCR11357 updates the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) edits, which relate to Chapter 23, Section 20.9 of the Medicare Claims Processing Manual.

Please make sure your billing staffs are aware of these updates.

BackgroundThe Centers for Medicare & Medicaid Services (CMS) developed the NCCI to promote national correct coding methodologies and to control improper coding that leads to inappropriate payment in Part B claims.

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Version 25.3 includes all previous versions and updates from January 1, 1996 to the present. In the past, NCCI was organized in two tables: Column 1/Column 2 Correct Coding Edits and Mutually Exclusive Code (MEC) Edits. To simplify the use of NCCI edit files (two tables), on April 1, 2012, CMS consolidated these two edit files into the Column One/Column Two Correct Coding edit file. Separate consolidations occurred for the two practitioner NCCI edit files and the two NCCI edit files used for the Outpatient Code Editor (OCE). You only have to search the Column One/Column Two Correct Coding edit file for active or previously deleted edits. CMS no longer publishes a Mutually Exclusive edit file for either practitioner or outpatient hospital services, since all active and deleted edits will appear in the single Column One/Column Two Correct Coding edit file. The edits previously available in the Mutually Exclusive edit file are NOT deleted but are moved to the Column One/Column Two Correct Coding edit file.

Refer to the CMS NCCI webpage for additional information at http://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html.

These coding policies are based on coding conventions defined in the American Medical Association’s Current Procedural Terminology manual, national and local policies and edits, coding guidelines developed by national societies, analysis of standard medical and surgical practice, and review of current coding practice.

Additional InformationThe official instruction, CR11357, issued to your MAC regarding this change is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4334CP.pdf.

If you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

Document History

Date DescriptionJuly 15, 2019 Initial article released.

Kentucky & Ohio

SE19001: Pre-Diabetes Services: Referring Patients to the Medicare Diabetes Prevention Program

MLN Matters Number: SE19001 Article Release Date: June 27, 2019 Related CR Transmittal Number: N/A Related Change Request (CR) Number: N/A Effective Date: N/A Implementation Date: N/A

Provider Type AffectedThis MLN Matters Article is for providers who may refer Medicare patients to the Medicare Diabetes Prevention Program (MDPP) for services to reduce diabetes risk.

What You Need to KnowMDPP is a Behavior Change Interventionyy An estimated half of all adults age 65 and older have pre-diabetes. The MDPP is an evidence-based, structured behavior change intervention to prevent or delay type 2 diabetes in individuals with an indication of pre-diabetes.

yy The primary goal of MDPP services is to help individuals lose at least 5 percent of their weight, which is associated with a clinically significant reduction in risk for type 2 diabetes. When studied, this intervention reduced the incidence of diabetes by 71 percent in individuals over age 60.

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MDPP is a New Medicare-Covered Serviceyy MDPP suppliers began enrolling in Medicare in January 2018 and Medicare began paying for MDPP services on April 1, 2018.

yy Both traditional health care providers and community-based organizations can enroll as MDPP suppliers (a new Medicare supplier type) to provide MDPP services.

yy Screen, test, and refer. You can screen and test your patients’ risk for pre-diabetes and refer your patients to a Medicare-enrolled MDPP supplier. Medicare doesn’t require providers’ referral for MDPP services, but your patients may want to discuss MDPP services with you.

yy There is no co-pay or deductible for MDPP services for patients who have Medicare Part B (Fee-For-Service) and meet other eligibility criteria. Patients in a Medicare Advantage plan can contact their plan for cost-sharing information.

BackgroundMDPP Services for People with MedicareEligible participants can get up to 2 years of MDPP services with the primary goal of achieving and maintaining at least 5 percent weight loss. MDPP services include:

yy Training to make realistic, lasting lifestyle changes

yy Tips on getting more exercise

yy Strategies for controlling weight

yy Support from people with similar goals

yy At least 16 “Core Sessions” in the first 6 months

yy An additional 6 months of less-intensive monthly sessions to help maintain healthy habits

yy An additional 12 months of ongoing maintenance sessions (if the patient meets certain weight loss and attendance goals)

To Start MDPP Services, People with Medicare Must Have:yy Medicare Part B coverage through Original Medicare or a Medicare Advantage (MA) plan

yy Results from one of three blood tests taken within 12 months before they started MDPP services:

y� Hemoglobin A1c test with a value of 5.7-6.4 percent

y� Fasting plasma glucose test with a value of 110-125 mg/dl

y� Oral glucose tolerance test with a value of 140-199 mg/dl

yy A Body Mass Index (BMI) of at least 25 (or 23 if the patient self-identifies as Asian)

yy No history of type 1 or type 2 diabetes with the exception of gestational diabetes

yy No End Stage Renal Disease (ESRD)

yy Never received MDPP services before

MDPP Outcomes for People with MedicareOutcomes of MDPP services for eligible patients may include:

yy Reduced or delayed risk of developing type 2 diabetes

yy Feeling healthier, greater self-confidence and more energized

yy Improved quality of life

Some MDPP participants report that they like the support and accountability of a group-based class setting. Diet and physical activity changes mean that some participants may also be able to better manage other conditions.

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MDPP SuppliersOrganizations must get recognition through the Centers for Disease Control and Prevention (CDC) Diabetes Prevention Recognition Program (DPRP), before enrolling in Medicare. Once enrolled in Medicare, MDPP suppliers may deliver MDPP services in community or health care settings. Only organizations can enroll in MDPP as suppliers, individuals cannot enroll.

Organizations must enroll as an MDPP supplier even if they’re already enrolled with Medicare as another provider or supplier type. Medicare payments to MDPP suppliers are performance-

based, meaning that Medicare pays suppliers based on their success in helping participants lose weight.

Finding Enrolled MDPP SuppliersUse the interactive MDPP Supplier Map (https://innovation.cms.gov/initiatives/medicare-diabetes-prevention-program/mdpp-map.html) to search for suppliers by ZIP code. Or, browse a list of all currently enrolled MDPP suppliers (https://data.cms.gov/Special-Programs-Initiatives/Medicare-Diabetes-Prevention-Program/vwz3-d6x2/data), including supplier location and contact information.

Your Role in the MDPP Referral ProcessScreen, Test, and Refer

yy Screen patients for their risk of pre-diabetes – do they have a BMI over 25 (or 23, if the patient self-identifies as Asian)? Do they have elevated blood glucose levels in the above-

specified ranges?

yy Order blood tests (for example, oral glucose tolerance test or fasting plasma glucose) for patients who may be at risk of diabetes and could qualify for MDPP services. (Note that the Hemoglobin A1c is not currently covered by Medicare for pre-diabetes screening).

yy Refer eligible patients. Identify if your patients meet other MDPP eligibility requirements, such as having Medicare Part B, no diagnosis of type 1 or type 2 diabetes, and no diagnosis of ESRD. While your patients don’t need a referral to get MDPP services, you can help spread the word about MDPP and answer patients’ questions.

yy Increase your patients’ awareness of new MDPP services and eligibility requirements. In the Medicare & You handbook for 2019 (https://www.medicare.gov/sites/default/files/2018-09/10050-medicare-and-you.pdf) go to the Preventive Services section for MDPP information.

yy Help your eligible patients find a local MDPP supplier by using the MDPP Supplier Map (https://innovation.cms.gov/initiatives/medicare-diabetes-prevention-program/mdpp-map.html).

Additional Informationyy MDPP overview: https://innovation.cms.gov/initiatives/medicare-diabetes-prevention-program/

yy MDPP Sessions Journey Map: https://innovation.cms.gov/Files/x/mdpp-journeymap.pdf

yy Beneficiary Eligibility Fact Sheet: https://innovation.cms.gov/Files/fact-sheet/mdpp-beneelig-fs.pdf

yy Preparing to Enroll as an MDPP Supplier Fact Sheet: https://innovation.cms.gov/Files/x/mdpp-enrollmentfs.pdf

yy Frequently Asked Questions (FAQs) about becoming an MDPP supplier: https://innovation.cms.gov/initiatives/medicare-diabetes-prevention-program/faq.html

yy Centers for Disease Control and Prevention (CDC) Diabetes prevention information: https://www.cdc.gov/diabetes/prevention/index.html

yy CDC’s Screen, Test, Refer process for diabetes prevention: https://www.cdc.gov/diabetes/prevention/lifestyle-program/deliverers/screening-referral.html

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yy MDPP Supplier Map: https://innovation.cms.gov/initiatives/medicare-diabetes-prevention-program/mdpp-map.html

yy List of current MDPP Suppliers: https://data.cms.gov/Special-Programs-Initiatives/Medicare-Diabetes-Prevention-Program/vwz3-d6x2/data

yy Sign up for the MDPP listserv

Document History

Date DescriptionJune 27, 2019 Initial article released.

Kentucky & Ohio

SE19011: Reduce Risk of Opioid Overdose Deaths by Avoiding and Reducing Co-Prescribing Benzodiazepines

MLN Matters Number: SE19011 Article Release Date: July 1, 2019 Related CR Transmittal Number: N/A Related Change Request (CR) Number: N/A Effective Date: N/A Implementation Date: N/A

Provider Type AffectedThis MLN Matters article is for physicians, non-physician practitioners (NPPs), other prescribers, and pharmacists who prescribe or dispense opioids and benzodiazepines (BZDs).

Provider Action NeededWhen you prescribe opioids and BZDs to the same patient, there are potential negative consequences, such as:

yy Higher risk of overdose deaths1

yy Higher risk of suicide2

yy Worse treatment outcomes3

yy Increased health service use4

These are significant risks regardless of whether you prescribe these medications for comorbid chronic pain, anxiety, or insomnia, or if your patients use illicit opioids (for example, fentanyl or heroin) or get BZDs through a non-prescription source.1 In 2017, 10,010 people died from overdosing with both BZDs and an opioid, which is more than a fifth of the 47,600 total opioid overdose deaths in that year.5

This MLN Matters article describes the latest key issues related to co-prescribing BZDs with opioids. It summarizes multiple strategies to reduce the impact of this potentially dangerous practice, with a focus on patient health, safety, and well-being.

Practices to Reduce Co-Prescribing BZDs and OpioidsConsider possible fatal overdoses when weighing the risks and benefits of co-prescribing BZDs and opioids. Most prescribers already use caution when prescribing controlled substances, and the nature of the black box warning for BZDs and opioids requires you to educate patients about the potential risks.6

There are five central principles for co-prescribing BZDs and opioids:

1. Avoid initial combination by offering alternative approaches

2. If new prescriptions are needed, limit the dose and duration

3. Taper long-standing medications gradually and, whenever possible, discontinue

4. Continue long-term co-prescribing only when necessary and monitor closely

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5. Provide rescue medication (for example, naloxone) to high-risk patients and their caregivers

Carefully discuss the risks and benefits with your patients, including legal representatives if needed, before making changes to medication regimens. This can be challenging as often patients want to continue medications that they feel help them stay stable. You are more likely to succeed when you take an individualized, person-centered approach, and create treatment plans that involve your patients’ support networks, including friends, family, and caregivers.7

1. Avoid initial combination by offering alternative approaches

Do not start BZDs as an adjunct treatment with opioids for chronic pain due to the lack of evidence and efficacy.8 Avoid prescribing BZDs along with medication-assisted treatment (MAT) for opioid use disorder (OUD).9 Even short-term BZD use, on an as needed basis, in patients with long-term opioid use, can be a problem. You should also screen people taking BZDs and prescription opioids for mental disorders, given the frequent comorbidity. Providers must carefully weigh the benefits and risk of each individual’s circumstances when making prescribing decisions.

Use caution before co-prescribing BZDs and opioids and make every effort to choose a different treatment plan. For example, use a prescription drug monitoring program (PDMP)—an electronic database that tracks controlled substance prescriptions in a state—as part of the decision-making process to help stratify risk.10 Proactively communicate with your patients’ other health care providers if you are concerned that your patients are getting prescriptions from multiple sources or are using illegal drugs. The Table below lists some alternatives to BZDs and prescription opioids; tailor treatment to each individual’s clinical status and other factors.

Table. Alternatives to Benzodiazepines and OpioidsAlternatives to Benzodiazepines Alternatives to Opioids

• Psychotherapies (for example, cognitive behavioral therapy for anxiety and sleep disorders)

• Progressive relaxation techniques• Sleep hygiene• Other medication classes (for

example, selective serotonin reuptake inhibitors, tricyclic antidepressants, and buspirone)

• Other medication classes (for example, over the counter and non-scheduled analgesics, serotonin-norepinephrine reuptake inhibitors, and gabapentin)

• Psychotherapies (for example, cognitive behavioral therapy, mindfulness, and meditation)

• Other treatments (for example, topical medications, trigger point injections, and transcutaneous electrical nerve stimulation)

• Complementary and integrative care (for example, acupuncture, physical therapy, exercise, and aquatic therapy)

Where possible, consider prescribing alternative treatments described in the Table, noting that not all treatments are available to or appropriate for all patients.

2. If new prescriptions are needed, limit the dose and duration

If you determine the benefits of co-prescribing BZDs and opioids outweigh the risks, prescribe short-term treatments (such as, 7 or fewer days’ supply and no more than 2 weeks). While prescribing medications, tell your patients about the possible adverse outcomes from combining a BZD and an opioid. Warn your patients about the additional risk when patients also drink alcohol or use other substances. Educate your patients about the black box warning for potential adverse events, including “unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, coma, and death.”6 If you prescribe BZDs and opioids, you should have a clear expectation regarding the clinical benefit and a plan for tapering the medications when appropriate.

3. Taper long-standing medications gradually and, when possible, discontinue

Your patients who are already on a BZD and an opioid are at increased risk of significant negative outcomes. According to some estimates, eliminating concurrent use of BZDs and opioids could reduce the risk of an emergency department visit or inpatient admission for opioid overdose by as much as 15 percent.11

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Review, with your patients, the risks and benefits of the current therapy and decide if tapering down either, or both, medications is appropriate based on your patient’s unique circumstances.12 Encourage patient buy-in with a person-centered approach such as motivational interviewing techniques, when possible. Consider functional assessments for your patients to optimize outcomes based on treatment goals. Consider alternatives to controlled medication outlined in the Table above.

Monitor for evidence of misuse or abuse, such as adjusting dosage or frequency in ways other than prescribed or taking medication for indications other than the intended use. For example, patients may take opioids or BZDs for their mood-altering effects. If you suspect misuse or abuse, reemphasize the treatment plan, discuss your concerns with your patient, and consider reducing one or both prescriptions through careful tapering.

You can taper your patient’s BZD in several different ways. It can take months or even years to complete a taper. One approach, shown to be effective in a primary care setting, is to convert the BZD to the dose equivalent of a longer-acting BZD then reduce the total dose by 10-25 percent every 1-2 weeks, with close monitoring.12 This may be too rapid a schedule for some patients to tolerate after using BZDs long-term. Symptom relapse may require smaller dose decreases and longer time intervals between changes. Do not immediately discontinue BZDs as it may:

- Precipitate severe withdrawal, including seizures

- Disrupt sleep

- Increase suicidal thoughts

There are multiple resources to help with tapering BZDs, including:

- VA National Center for PTSD, Effective Treatment for PTSD: Helping Patients Taper from Benzodiazepines

> https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/Academic_Det ailing_Educational_Material_Catalog/59_PTSD_NCPTSD_Provider_Helping_Patient s_Taper_BZD.pdf

You and your patient may also consider working together to taper an opioid; any reduction in opioid dose is always more successful if it is consensual. You may find these resources helpful:

- The Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (for adults in primary care settings excluding cancer, palliative care, and hospice)

> https://www.cdc.gov/drugoverdose/prescribing/guideline.html

4. Continue long-term co-prescribing only when necessary and monitor closely

If your patient has been stable and functional for a long period on both a BZD and an opioid at low or as needed doses, and there is no evidence of problematic use, then decide whether to taper based on the patient’s needs and goals, accepting the long-term risks. Discussing possible tolerance should be a foundation of education about the risks and benefits of both medications over time. Even low dose and as needed dosing can be risky.13 If your patient needs moderate to high doses of either or both medications, you should attempt to taper the dose slowly or document why you are not tapering the dose. Again, consider the approaches in the above Table to help patients concurrently using opioids and BZDs.

You may also consider “contingency prescribing practices” to maintain safety and efficacy as agreed upon with your patients, including safely discontinuing a medication if your patients do not appropriately follow the prescribed regimen.14 Adherence monitoring may increase compliance rates and reduce rates of drug misuse among people with chronic pain.15 This agreement with the patient may include:

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- Getting informed consent for treatment, including risks and benefits

- Limiting controlled substance prescribing to only one doctor or clinician and getting prescription opioids and BZDs from one pharmacy

- Giving notice to the patient that the prescriber will get the record of controlled substance prescriptions through the state PDMP

- Counseling the patient not to use illicit substances or alcohol because of potential interactions

You should employ strategies to empower patients to actively participate in their treatment and maintain responsibility for their appropriate use of prescribed BZDs and opioids. Evaluate patients who are taking opioids in person at least every 3 to 6 months. Patients who chronically use a BZD are at higher risk and may require monitoring more often, depending on their individual risk factors and comorbidities. For high-risk patients, you should complete a baseline urine test. Use point of care urine testing with lab confirmation at your discretion, including breath alcohol tests if indicated. Be aware that many tests do not screen for or often do not detect:

- Alcohol

- Certain BZDs (for example, alprazolam, clonazepam and lorazepam)

- Recently ingested medications

- Low levels of illicit drugs (for example, cannabis and cocaine)16

Familiarize yourselves with sensitivities in urine or saliva samples. Consider sending samples to outside laboratories for confirmation, particularly when the result of the drug test is different from that suggested by the medical history, clinical presentation, or self-report.17

5. Provide rescue medication (for example, naloxone) to high-risk patients and their caregivers

Given the high risk associated with taking both a BZD and an opioid, you may want to consider a naloxone prescription as a rescue medication for unintentional respiratory suppression. If it is appropriate, discuss naloxone with your patients and their family or caregiver to ensure they know the signs of overdose and how to administer naloxone. When clinically appropriate, prescribers and pharmacists can encourage patients to request naloxone when they fill an opioid prescription. Many states permit pharmacists to dispense naloxone over-the-counter without a prescription.

SummaryConcurrent use of opioids and BZDs presents multiple potential risks and challenges for prescribers and people with chronic pain. You must carefully consider how to approach co-

prescribing these medication classes. When possible, take the following steps:

1. Avoid initial combination by offering alternative approaches

- Always consider alternatives to opioids for chronic pain

- Always consider alternatives to BZDs for anxiety or insomnia

- Remember BZDs are not indicated to treat pain

- Avoid prescribing BZDs for patients on MATs

- Avoid prescribing opioids for patients taking long-term BZDs

2. If new prescriptions are needed, limit the dose and duration

3. Taper long-standing medications gradually and, whenever possible, discontinue

- Do not abruptly stop BZDs or opioids

- Taper slowly according to guidelines and adjust depending on symptoms

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- Always work collaboratively with your patients to taper or discontinue

4. Continue long-term co-prescribing BZDs and opioids only when necessary and monitor closely

- Clearly explain risks and black box warnings

- Closely monitor and consider drug testing at baseline and regularly, especially for high-risk patients

- Set clear expectations for what steps will be taken if your patients do not follow the prescribed regimen, including safely discontinuing a medication

- Monitor PDMP regularly

5. Provide rescue medication (for example, naloxone) to high-risk patients and their caregivers

Additional Informationyy Treatment Improvement Protocol (TIP) 63: Medications for Opioid Use Disorders (SMA 18-5063) https://store.samhsa.gov/product/TIP-63-Medications-for-Opioid-Use-Disorder-Pharmacotherapy-for-Opioid-Use-Disorder-Part-3-of-5-/SMA18-5063PT3

yy Opioid Overdose Prevention Toolkit (SMA 18-4742) https://store.samhsa.gov/system/files/sma18-4742.pdf

yy Federal Guidelines for Opioid Treatment Programs (SMA PEP15-FEDGUIDEOTP) https://store.samhsa.gov/product/Federal-Guidelines-for-Opioid-Treatment-Programs/PEP15-FEDGUIDEOTP

yy CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016 https://www.cdc.gov/drugoverdose/prescribing/guideline.html

yy FDA Drug Safety Communication urging caution about withholding OUD medications from people taking BZDs and concurrent prescribing: “The opioid addiction medications buprenorphine and methadone should not be withheld from people taking BZDs or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks.”

yy National Center for Complementary and Integrative Health: https://nccih.nih.gov/

REFERENCES1. Jann M, Kennedy WK, Lopez G. Benzodiazepines: A Major Component in Unintentional

Prescription Drug Overdoses With Opioid Analgesics. J Pharm Pract 2014;27(1):5–16.

2. Schepis TS, Simoni-Wastila L, McCabe SE. Prescription opioid and benzodiazepine misuse is associated with suicidal ideation in older adults. Int J Geriatr Psychiatry 2018

3. Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Key substance use and mental health indicators in the United States: Results from the 2017 National Survey on Drug Use and Health (HHS Publication No. SMA 18-5068, NSDUH Series H-53). [Internet]. Rockville, MD: 2018 [cited 2018 Oct 16]. Available from: https://www.samhsa.gov/data

4. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. The TEDS Report: Admissions Reporting Benzodiazepine and Narcotic Pain Reliever Abuse at Treatment Entry. Rockville, MD: 2012.

5. Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). Multiple Cause of Death 1999-2016 on CDC WONDER Online Database [Internet]. [cited 2018 Oct 25]; Available from: https://wonder.cdc.gov/wonder/help/mcd.html

6. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning [Internet]. 2016 [cited 2019 Feb 8];

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Available from: https://wayback.archive-it.org/7993/20170111160700/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518697.htm

7. Administration for Community Living. No Wrong Door National Key Elements [Internet]. 2017. Available from: https://acl.gov/sites/default/files/programs/2016-10/NWD-National-Elements.pdf

8. Reddy S, Patt RB. The benzodiazepines as adjuvant analgesics. J Pain Symptom Manage 1994;9(8):510–4.

9. Zhu Y, Coyle DT, Mohamoud M, et al. Concomitant use of buprenorphine for medication-assisted treatment of opioid use disorder and benzodiazepines: Using the prescription behavior surveillance system. Drug Alcohol Depend 2018;187:221–6.

10. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. What States Need to Know about PDMPs [Internet]. 2017; Available from: https://www.cdc.gov/drugoverdose/pdmp/states.html

11. Sun EC, Dixit A, Humphreys K, Darnall BD, Baker LC, Mackey S. Association between concurrent use of prescription opioids and benzodiazepines and overdose: retrospective analysis. BMJ 2017;356:j760.

12. Vicens C, Fiol F, Llobera J, et al. Withdrawal from long-term benzodiazepine use: randomized trial in family practice. Br J Gen Pract 2006;56(533):958–63.

13. Park TW, Saitz R, Ganoczy D, Ilgen MA, Bohnert ASB. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ 2015;350:h2698.

14. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain Physician 2012;15(3 Suppl):S67-116.

15. Manchikanti L, Manchukonda R, Pampati V, et al. Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids? Pain Physician 2006;9(2):123–9.

16. Owen GT, Burton AW, Schade CM, Passik S. Urine drug testing: current recommendations and best practices. Pain Physician 2012;15(3 Suppl):ES119-133.

17. Petrides AK, Melanson SEF, Kantartjis M, Le RD, Demetriou CA, Flood JG. Monitoring opioid and benzodiazepine use and abuse: Is oral fluid or urine the preferred specimen type? Clin Chim Acta 2018;481:75–82.

Document History

Date DescriptionJuly 1, 2019 Initial article released.

Kentucky & Ohio

SE19012: Emergency Medical Treatment and Labor Act (EMTALA) and the Born-Alive Infant Protection Act

MLN Matters Number: SE19012 Article Release Date: June 27, 2019 Related CR Transmittal Number: N/A Related Change Request (CR) Number: N/A Effective Date: N/A Implementation Date: N/A

Provider Type AffectedThis MLN Matters Article is for CORE defined code combination updates

Additional InformationThis MLN Matters Article is for Medicare participating hospitals (including critical access hospitals).

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What You Need to KnowEMTALA requires Medicare participating hospitals (including critical access hospitals) to perform the following:

yy Provide medical screening examinations to every individual, including women in labor, their unborn child(ren), and newly born infants protected by the Born-Alive Infant Protection Act when they present for care to dedicated emergency departments, which includes labor and delivery departments, or other locations on the hospital campus;

yy Provide stabilizing treatment within the hospital’s capabilities to any individual, including a born-alive infant, with an emergency medical condition;

yy If unable to stabilize the emergency medical condition, arrange for an appropriate transfer to another hospital with specialized services for the necessary stabilizing treatment; and,

yy Accept appropriate transfers of patients with unstable emergency medical conditions if the hospital has the capabilities and capacity to provide necessary stabilizing treatment.

EMTALA protections start for an infant at time of birth. A newly born infant is presumed to be presenting with an emergency medical condition and requires a medical screening examination to determine necessary stabilizing treatment. EMTALA requires physicians and other qualified practitioners to provide care within nationally accepted standards of practice.

As long as an infant has an unstabilized emergency medical condition in need of stabilizing treatment, EMTALA continues to apply. If the hospital has the capabilities to stabilize the emergency medical condition, it is required to do so. If not, the hospital must arrange an appropriate transfer of the infant to a hospital with specialized capabilities and capacity, while providing care until the transfer is effectuated. Once the infant is admitted in good faith to stabilize the emergency medical condition, EMTALA no longer applies. The Centers for Medicare & Medicaid Services (CMS) hospital or critical access hospital Conditions of Participation apply throughout the hospital stay.

Communication Between Healthcare Professionals and PatientsCMS encourages healthcare professionals, including obstetricians, midwives, pediatricians, family practice practitioners and others providing prenatal care to engage in thoughtful discussions with pregnant women throughout the course of their pregnancy. The discussions should reference potential emergencies and serious conditions that may occur to the pregnant woman, her unborn fetus, and born-alive infant. Discussing potential serious occurrences during the prenatal period provides an opportunity for the pregnant woman and her healthcare provider to anticipate and be prepared to respond to potentially difficult decisions during an emergency situation. Clarifying patient preferences prior to an emergency situation may assist in the decision making process for both the patient and her healthcare provider.

The CMS hospital Condition of Participation for Patient Rights states the hospital must protect and promote each patient’s rights. The patient has the right to participate in the development and implementation of her care. The patient also has the right to make informed decisions regarding her care, including being informed and being able to request or refuse treatment.

Reporting Concerns or Complaints Regarding EMTALAConcerns regarding a hospital’s compliance with EMTALA and the Medicare hospital Conditions of Participation can be reported to the State Survey Agency or the CMS Regional Office for evaluation and possible investigation. Complaints can be generated by patients, family members, healthcare professionals, and other interested parties. The enforcement of EMTALA is a complaint driven process. It is important to note that as a complaint driven process, EMTALA is not a mechanism for immediate response at the time of any occurrence, in this instance at the time of delivery of a born-alive infant.

The CMS Regional Office evaluates the complaint allegations to determine if criteria are met for onsite investigations and, if so, authorizes the State Survey Agency to investigate. While onsite,

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surveyors review compliance with all EMTALA requirements and, if applicable, the Conditions of Participation. The investigation is accomplished by reviewing medical records, patient logs including transfers in and out, on-call physician and staffing schedules, policies and procedures, and other documentation. Surveyors interview patients, family members, and hospital staff and may perform observations of patient and staff processes while onsite.

After the onsite survey the CMS Regional Office sends the EMTALA case to Quality Improvement Organization expert physician reviewers to evaluate the provision of medical, surgical, obstetric, psychiatric, or other type of care provided. The physician reviewers evaluate the care, or lack of care, provided in accordance with national standards of practice. It is outside the scope of State Survey Agency or Regional Office surveyors to determine if the care provided was appropriate; this determination is the responsibility of the Quality Improvement

Organization expert physician reviewer.

Additional Informationyy State Survey Agency Contact Information: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Complaintcontacts.pdf

yy CMS Regional Office Contact Information: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Regional_and_Central_Office_Cont acts.pdf

yy CMS State Operations Manual Chapter 5 Complaints: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c05.pdf

yy CMS State Operations Manual Appendix V EMTALA: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_v_emerg.pdf

Document History

Date DescriptionJune 27, 2019 Initial article released.

Kentucky & Ohio

SE19014: Tropical Storm Barry and Medicare Disaster Related Louisiana Claims

MLN Matters Number: SE19014 Article Release Date: July 15, 2019 Related CR Transmittal Number: N/A Related Change Request (CR) Number: N/A Effective Date: N/A Implementation Date: N/A

Provider Type AffectedThis MLN Matters® Special Edition Article is for providers and suppliers who bill Medicare Fee-

For-Service (FFS).

Provider Information AvailableThe Secretary of the Department of Health & Human Services declared a Public Health Emergency (PHE) in the state of Louisiana on July 12, 2019, and authorized waivers and modifications under Section 1135 of the Social Security Act (the Act), retroactive to July 10, 2019, and are in effect for 90 days.

The Centers for Medicare & Medicaid Services (CMS) is issuing blanket waivers consistent with those issued for past PHE declarations. These waivers prevent gaps in access to care for beneficiaries impacted by the disaster/emergency. You do not need to apply for an individual waiver if a blanket waiver is issued.

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More Information:

yy Current Emergencies (https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page.html) Web page

yy Instructions to request an individual waiver if there is no blanket waiver (https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Requesting-an-1135-Waiver-Updated-11-16-2016.pdf)

BackgroundSection 1135 and Section 1812(f) WaiversAs a result of this PHE, apply the following to claims for which Medicare payment is based on a “formal waiver” including, but not limited to, Section 1135 or Section 1812(f) of the Act:

1. The “DR” (disaster related) condition code for institutional billing, i.e., claims submitted using the ASC X12 837 institutional claims format or paper Form CMS-1450.

2. The “CR” (catastrophe/disaster related) modifier for Part B billing, both institutional and non-institutional, i.e., claims submitted using the ASC X12 837 professional claim format or paper Form CMS-1500 or, for pharmacies, in the NCPDP format.

Medicare FFS Questions & Answers (Q&As) available on the Waivers and Flexibilities webpage (https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Resources/Waivers-and-flexibilities.html) apply to items and services for Medicare beneficiaries in the current disaster or emergency. These Q&As are displayed in two files:

yy Q&As that apply without any Section 1135 (https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Consolidated_Medicare_FFS_Emergency_QsAs.pdf) or other formal waiver.

yy Q&As apply only with a Section 1135 (https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/MedicareFFS-EmergencyQsAs1135Waiver.pdf) waiver or, when applicable, a Section 1812(f) waiver.

Blanket Waivers Issued by CMSYou do not need to apply for the following approved blanket waivers:

Skilled Nursing Facilities (SNFs)

yy Section 1812(f): This waiver of the requirement for a 3-day prior hospitalization for coverage of a SNF stay provides temporary emergency coverage of SNF services without a qualifying hospital stay, for those people who are evacuated, transferred, or otherwise dislocated as a result of the effect of disaster or emergency. In addition, for certain beneficiaries who recently exhausted their SNF benefits, it authorizes renewed SNF coverage without first having to start a new benefit period (Blanket waiver for all impacted facilities).

yy 42 CFR 483.20: This waiver provides relief to SNFs on the timeframe requirements for Minimum Data Set assessments and transmission (Blanket waiver for all impacted facilities).

Home Health Agencies

yy 42 CFR 484.20(c)(1): This waiver provides relief to Home Health Agencies on the timeframes related to OASIS Transmission (Blanket waiver for all impacted agencies).

yy To ensure the correct processing of home health disaster related claims, Medicare Administrative Contractors (MACs) are allowed to extend the auto-cancellation date of Requests for Anticipated Payment (RAPs).

Critical Access Hospitals

This action waives the requirements that Critical Access Hospitals limit the number of beds to 25, and that the length of stay be limited to 96 hours. (Blanket waiver for all impacted hospitals)

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Housing Acute Care Patients In Excluded Distinct Part Units

CMS has determined it is appropriate to issue a blanket waiver to inpatient prospective payment system (IPPS) hospitals that, as a result of disaster or emergency, need to house acute care inpatients in excluded distinct part units, where the distinct part unit’s beds are appropriate for acute care inpatient. The IPPS hospital should bill for the care and annotate the patient’s medical record to indicate the patient is an acute care inpatient being housed in the excluded unit because of capacity issues related to the disaster or emergency. (Blanket waiver for all IPPS hospitals located in the affected areas that need to use distinct part beds for acute care patients.)

Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital

CMS has determined it is appropriate to issue a blanket waiver to IPPS and other acute care hospitals with excluded distinct part inpatient psychiatric units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part psychiatric unit to an acute care bed and unit. The hospital should continue to bill for inpatient psychiatric services under the inpatient psychiatric facility prospective payment system for such patients and annotate the medical record to indicate the patient is a psychiatric inpatient being cared for in an acute care bed because of capacity or other exigent circumstances related to the disaster or emergency. This waiver may be utilized where the hospital’s acute care beds are appropriate for psychiatric patients and the staff and environment are conducive to safe care. For psychiatric patients, this includes assessment of the acute care bed and unit location to ensure those patients at risk of harm to self and others are safely cared for.

Care for Excluded Inpatient Rehabilitation Unit Patients in the Acute Care Unit of a Hospital

CMS has determined it is appropriate to issue a blanket waiver to IPPS and other acute care hospitals with excluded distinct part inpatient rehabilitation units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part rehabilitation unit to an acute care bed and unit. The hospital should continue to bill for inpatient rehabilitation services under the inpatient rehabilitation facility prospective payment system for such patients and annotate the medical record to indicate the patient is a rehabilitation inpatient being cared for in an acute care bed because of capacity or other exigent circumstances related to the disaster or emergency. This waiver may be utilized where the hospital’s acute care beds are appropriate for providing care to rehabilitation patients, and such patients continue to receive intensive rehabilitation services.

Emergency Durable Medical Equipment, Prosthetics, Orthotics, and Supplies for Medicare Beneficiaries Impacted by an Emergency or Disaster

CMS has determined it is appropriate to issue a blanket waiver to suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) where DMEPOS are lost, destroyed, irreparably damaged, or otherwise rendered unusable. Under this waiver, the face-to-face requirement, a new physician’s order, and new medical necessity documentation are not required for replacement. Suppliers must still include a narrative description on the claim explaining the reason why the equipment must be replaced and are reminded to maintain documentation indicating that the DMEPOS were lost, destroyed, irreparably damaged or otherwise rendered unusable as a result of the disaster or emergency.

For more information refer to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies for Medicare Beneficiaries Impacted by an Emergency or Disaster fact sheet at https://www.cms.gov/About-CMS/Agency-Information/Emergency/Downloads/Emergency-DME-Beneficiaries-Hurricanes.pdf.

Medicare Advantage Plan or other Medicare Health Plan Beneficiaries

CMS reminds suppliers that Medicare beneficiaries enrolled in a Medicare Advantage or other Medicare Health Plans should contact their plan directly to find out how it replaces DMEPOS damaged or lost in an emergency or disaster. Beneficiaries who do not have their plan’s contact information can contact 1.800.MEDICARE (1.800.633.4227) for assistance.

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Replacement Prescription Fills

Medicare payment may be permitted for replacement prescription fills (for a quantity up to the amount originally dispensed) of covered Part B drugs in circumstances where dispensed medication has been lost or otherwise rendered unusable by damage due to the disaster or emergency.

Additional InformationIf you have questions, your MACs may have more information. Find their website at http://go.cms.gov/MAC-website-list.

The Centers for Disease Control and Prevention released ICD-10-CM coding advice to report healthcare encounters.

Providers may also want to review the CMS Emergency and Preparedness webpage at https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/EPRO-Home.html.

Providers may also want to view the Survey and Certification Frequently Asked Questions at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/index.html.

Document History

Date DescriptionJuly 15, 2019 Initial article released.