81_FR_6032 81 FR 6009 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2015

81 FR 6009 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2015

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 23 (February 4, 2016)

Page Range6009-6021
FR Document2016-02108

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2015, relating to the Medicare and Medicaid programs and other programs administered by CMS.

Federal Register, Volume 81 Issue 23 (Thursday, February 4, 2016) 
[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Pages 6009-6021]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02108]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9094-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October Through December 2015

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from July through September 2015, relating 
to the Medicare and Medicaid programs and other programs administered 
by CMS.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may need specific information and not be able to determine from 
the listed information whether the issuance or regulation would fulfill 
that need. Consequently, we are providing contact persons to answer 
general questions concerning each of the addenda published in this 
notice.
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I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) Furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners (NAIC), health insurers, and other stakeholders. To 
implement the various statutes on which the programs are based, we 
issue regulations under the authority granted to the Secretary of the 
Department of Health and Human Services under sections 1102, 1871, 
1902, and related provisions of the Social Security Act (the Act) and 
Public Health Service Act. We also issue various manuals, memoranda, 
and statements necessary to administer and oversee the programs 
efficiently.
    Section 1871(c) of the Act requires that we publish a list of all 
Medicare manual instructions, interpretive rules, statements of policy, 
and guidelines of general applicability not issued as regulations at 
least every 3 months in the Federal Register.

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II. Format for the Quarterly Issuance Notices

    This quarterly notice provides only the specific updates that have 
occurred in the 3-month period along with a hyperlink to the full 
listing that is available on the CMS Web site or the appropriate data 
registries that are used as our resources. This is the most current up-
to-date information and will be available earlier than we publish our 
quarterly notice. We believe the Web site list provides more timely 
access for beneficiaries, providers, and suppliers. We also believe the 
Web site offers a more convenient tool for the public to find the full 
list of qualified providers for these specific services and offers more 
flexibility and ``real time'' accessibility. In addition, many of the 
Web sites have listservs; that is, the public can subscribe and receive 
immediate notification of any updates to the Web site. These listservs 
avoid the need to check the Web site, as notification of updates is 
automatic and sent to the subscriber as they occur. If assessing a Web 
site proves to be difficult, the contact person listed can provide 
information.

III. How To Use the Notice

    This notice is organized into 15 addenda so that a reader may 
access the subjects published during the quarter covered by the notice 
to determine whether any are of particular interest. We expect this 
notice to be used in concert with previously published notices. Those 
unfamiliar with a description of our Medicare manuals should view the 
manuals at http://www.cms.gov/manuals.

    Dated January 28, 2016.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
 BILLING CODE 4120-01-P

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[FR Doc. 2016-02108 Filed 2-3-16; 8:45 am]
BILLING CODE 4120-01-C

Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices 6009 Services policy stipulates that facsimile submissions cannot be ACTION: Notice. committee membership shall be accepted. balanced in terms of professional The Director, Management Analysis SUMMARY: This quarterly notice lists training and background, points of view and Services Office, has been delegated CMS manual instructions, substantive represented, and the committee’s the authority to sign Federal Register and interpretive regulations, and other function. In addition to a broad range of notices pertaining to announcements of Federal Register notices that were expertise, consideration is given to a meetings and other committee published from July through September broad representation of geographic areas management activities for both the 2015, relating to the Medicare and within the U.S., with diverse Centers for Disease Control and Medicaid programs and other programs representation of both genders, ethnic Prevention and the Agency for Toxic administered by CMS. and racial minorities, and persons with Substances and Disease Registry. disabilities. Nominees must be U.S. FOR FURTHER INFORMATION CONTACT: It is citizens, and cannot be full-time Elaine L. Baker, possible that an interested party may employees of the U.S. Government. Director, Management Analysis and Services need specific information and not be Candidates should submit the Office, Centers for Disease Control and Prevention. able to determine from the listed following items: information whether the issuance or • Current curriculum vitae, including [FR Doc. 2016–02082 Filed 2–3–16; 8:45 am] regulation would fulfill that need. complete contact information (name, BILLING CODE 4163–18–P Consequently, we are providing contact affiliation, mailing address, telephone persons to answer general questions number, email address). • A letter of recommendation from DEPARTMENT OF HEALTH AND concerning each of the addenda person(s) not employed by the U.S. HUMAN SERVICES published in this notice. Department of Health and Human Services. Centers for Medicare & Medicaid • A statement indicating the Services nominee’s willingness to potentially [CMS–9094–N] serve as a member of the Committee. Nominations should be submitted Medicare and Medicaid Programs; electronically or in writing, and must be Quarterly Listing of Program postmarked by February 19, 2016 and Issuances—October Through sent to: Ms. Monica Swann, NCCDPHP, December 2015 CDC, 395 E. Street SW., Room 9167, MS P06, Washington, DC 20024. (Email AGENCY: Centers for Medicare & address: zqe0@cdc.gov). Telephone and Medicaid Services (CMS), HHS. I. Background Medicaid agencies, state survey Health Service Act. We also issue agencies, various providers of health various manuals, memoranda, and The Centers for Medicare & Medicaid care, all Medicare contractors that statements necessary to administer and Services (CMS) is responsible for process claims and pay bills, National oversee the programs efficiently. administering the Medicare and Association of Insurance Commissioners Section 1871(c) of the Act requires Medicaid programs and coordination and oversight of private health (NAIC), health insurers, and other that we publish a list of all Medicare asabaliauskas on DSK5VPTVN1PROD with NOTICES insurance. Administration and oversight stakeholders. To implement the various manual instructions, interpretive rules, of these programs involves the statutes on which the programs are statements of policy, and guidelines of following: (1) Furnishing information to based, we issue regulations under the general applicability not issued as Medicare and Medicaid beneficiaries, authority granted to the Secretary of the regulations at least every 3 months in health care providers, and the public; Department of Health and Human the Federal Register. and (2) maintaining effective Services under sections 1102, 1871, communications with CMS regional 1902, and related provisions of the Social Security Act (the Act) and Public EN04FE16.020</GPH> offices, state governments, state VerDate Sep<11>2014 17:21 Feb 03, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\04FEN1.SGM 04FEN1

6010 Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices II. Format for the Quarterly Issuance for these specific services and offers subjects published during the quarter Notices more flexibility and ‘‘real time’’ covered by the notice to determine This quarterly notice provides only accessibility. In addition, many of the whether any are of particular interest. the specific updates that have occurred Web sites have listservs; that is, the We expect this notice to be used in in the 3-month period along with a public can subscribe and receive concert with previously published hyperlink to the full listing that is immediate notification of any updates to notices. Those unfamiliar with a available on the CMS Web site or the the Web site. These listservs avoid the description of our Medicare manuals appropriate data registries that are used need to check the Web site, as should view the manuals at http:// as our resources. This is the most notification of updates is automatic and www.cms.gov/manuals. current up-to-date information and will sent to the subscriber as they occur. If assessing a Web site proves to be Dated January 28, 2016. be available earlier than we publish our quarterly notice. We believe the Web difficult, the contact person listed can Kathleen Cantwell, site list provides more timely access for provide information. Director, Office of Strategic Operations and beneficiaries, providers, and suppliers. Regulatory Affairs. III. How To Use the Notice We also believe the Web site offers a BILLING CODE 4120–01–P more convenient tool for the public to This notice is organized into 15 find the full list of qualified providers addenda so that a reader may access the asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 17:21 Feb 03, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\04FEN1.SGM 04FEN1

Publication Dates for the Previous Four Quarterly Notices designated libraries throughout the United States. Some FDLs may have We publish this notice at the end of each quarter reflecting arrangements to transfer material to a local library not designated as an information released by CMS during the previous quarter. The publication FDL. Contact any library to locate the nearest FDL. This information is dates of the previous four Quarterly Listing of Program Issuances notices available at http://www.gpo.gov/libraries/ are: February 2, 2015 (80 FR 5537), April 24, 2015 (80 FR 23013) In addition, individuals may contact regional depository libraries August 3, 2015 (80 FR 45980) and November 13, 2015 (80 FR 70218). For that receive and retain at least one copy of most federal government sqonOoN/9I0Z ‘p Lrenigag ‘AKepsimnuL/gEZ ‘ON ‘I8 ‘TOA /JoipstSay jedapaq the purposes of this quarterly notice, we are providing only the specific publications, either in printed or microfilm form, for use by the general updates that have occurred in the 3—month period along with a hyperlink to public. These libraries provide reference services and interlibrary loans; the website to access this information and a contact person for questions or however, they are not sales outlets. Individuals may obtain information additional information. about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shownin the listing Addendum I: Medicare and Medicaid Manual Instructions entitled Medicare and Medicaid Manual Instructions. To help FDLs locate (October through December 2015) the materials, use the CMS publication and transmittal numbers. For The CMS Manual Systemis used by CMS program components, example, to find the manual for Quarterly Update for the Durable Medical partners, providers, contractors, Medicare Advantage organizations, and Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive State Survey Agencies to administer CMS programs. It offers day—to—day Bidding Program (CBP) — January 2016 operating instructions, policies, and procedures based on statutes and (CMS—Pub. 100—04)Transmittal No. 3377. regulations, guidelines, models, and directives. In 2003, we transformed the Addendum I lists a unique CMS transmittal number for each CMS Program Manuals into a web user—friendly presentation and renamed instruction in our manuals or program memoranda and its subject number. it the CMS Online Manual System. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with Howto Obtain Manuals information currently in the manual. For the purposes of this quarterly The Internet—only Manuals (IOMs) are a replica of the Agency‘s notice, we list only the specific updates to the list of manual instructions official record copy. Paper—based manuals are CMS manuals that were that have occurred in the 3—month period. This information is available on officially released in hardcopy. The majority of these manuals were our website at www .cms.gov/Manuals. transferred into the Internet—only manual (IOM) or retired. Pub 15—1, Pub 15—2 and Pub 45 are exceptions to this rule and are still active paper—based Transmittal Manual/Subject/Publication Number manuals. The remaining paper—based manuals are for reference purposes _ Number _MedicareGeneral Information(CMS—Pub. only. If you notice policy contained in the paper—based manuals that was 93 Internet Only Manual (IOM) Publication 100—01 — General Informaflon not transferred to the IOM, send a message via the CMS Feedback tool. Eligibility, and Entitlement, Chapter 7 — Contract Administrative Those wishing to subscribe to old versions of CMS manuals should Requirements, Section 40 — Shared System Maintainer Responsibilities for contact the National Technical Information Service, Department of Systems Releases 94 Internet Only Manual Updates to Pub. 100—01, 100—02 and 100—04 to Correct Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone Errors and Omissions (2015) (703—605—6050). You can download copies of the listed material free of 95 Internet Only Manual (IOM) Publication 100—01 — General Information, charge at: http:/cms.gov/manuals. Eligibility, and Entitlement, Chapter 7 — Contract Administrative Requirements, Section 40 — Shared System Maintainer Responsibilities for Next Generation Desktop (NGD) Requirements How to Review Transmittals or Program Memoranda Standardized Terminology for Claims Processing Systems Those wishing to review transmittals and program memoranda can Standard Terminology Chart Release Software access this information at a local Federal Depository Library (FDL). Under Implementing Validated Workarounds for Shared System Claims Processing the FDL program, government publications are sent to approximately 1,400 by All Medicare DME MACs Shared System Testing Requirements for Shared System Maintainers, Single IL09

<109 Testing Contractor (STC)/Beta Testers, and Part A/Part B (A/B) Durable MSN Messages Regarding the Therapy Cap Medical Equipment (DME) Medicare Administrative Contractors (MACs) Application of Financial Limitations Shared System Testing Requirements for Shared System Maintainers, Single 3368 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Testing Contractor (STC), and DME MACs of Instruction Definitions 3369 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Test Case Specification Standard of Instruction Shared System Maintainer and Part A/Part B (A/B)/Durable Medical 3370 2016 Annual Update for the Health Professional Shortage Area (HPSA) sqonOoN/9I0Z ‘p Lrenigag ‘AKepsimnuL/gEZ ‘ON ‘I8 ‘TOA /JoipstSay jedapaq Equipment (DME) Medicare Administrative Contractor (MAC) and the Bonus Payments Single Testing Contractor (STC) Responsibilities for Systems Releases 3371 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Systems Releases of Instruction Medicare Benefit Policy (CMS—Pub. 100—02 3372 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 211 Internet Only Manual Updates to Pub. 100—01, 100—02 and 100—04 to Correct of Instruction Errors and Omissions (2015) 3373 Fiscal Year (FY) 2016 Inpatient Prospective Payment System (IPPS) and Three—Day Prior Hospitalization Long Term Care Hospital (LTCH) PPS Changes 212 Update to the List of Compendia as Authoritative Sources for Use in the Provider—Specific File Determination of a "Medically— Accepted Indication" of Drugs and IPPS Transfers Between Hospitals Biologicals Used Off—label in an Anti—Cancer Chemotherapeutic Regimen Addendum A/Provider Specific File Update to the List of Compendia as Authoritative Sources for Use in the Prospective Payment Changes for Fiscal Year (FY) 2004 and Beyond Determination of a "Medically— Accepted Indication" of Drugs and 3374 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Biologicals Used Off—label in an Anti—Cancer Chemotherapeutic Regimen of Instruction 213 Implementation of Changes in the End—Stage Renal Disease (ESRD) 3375 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Prospective Payment System (PPS) for Calendar Year (CY) 2016 of Instruction . Medicare National Coverage Determination (CMS—Pub. 100—0 3376 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction of Instruction 3377 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics National Coverage Determination (NCD) [or Single Chamber and Dual and Supplies (DMEPOS) Competitive Bidding Program (CBP) — January Chamber Permanent Cardiac Pacemakers — This CR rescinds and fully 2016 replaces CR 8525 Single Chamber and Dual Chamber Permanent Cardiac 3378 Additional G—Codes Differentiating RNs and LPNs in the Home Health and Pacemakers Hospice Settings 187 National Coverage Determination (NCD) for Single Chamber and Dual 3379 Internet Only Manual Updates to Pub. 100—01, 100—02 and 100—04 to Correct Chamber Permanent Cardiac Pacemakers Errors and Omissions (2015) Single Chamber and Dual Chamber Permanent Cardiac Pacemakers Decision Logic Used by the Pricer on Claims Medicare Clains Processing (CMS—Pub., 100—04) _________ Outpatient Surgery and Related Procedures — INCLUSION 3363 Issued to a specific audience, not posted to Internet/Intranet due to a Dialysis and Dialysis Related Services to a Beneficiary With ESRD Confidentiality of Instruction Uniform Use of CARCs and RARCs Rule Screening and Preventive Services 3364 Quarterly Update to the Medicare Physician Fee Schedule Database Other Excluded Services Beyond the Scope of a SNF Part A Benefit (MPFSDB) — October CY 2015 Update 3380 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 3365 2016 Healthcare Common Procedure Coding System (HCPCS) Annual of Instruction Update Reminder 3381 Instructions for Retrieving the 2016 Pricing and HCPCS Data Files through 3366 Changes to the Laboratory National Coverage Determination (NCD) Edit CMS‘ Mainframe Telecommunications Systems Software for January 2016 3382 Instructions for Retrieving the 2016 Pricing and HCPCS Data Files through 3367 Applying Therapy Caps to Maryland Hospitals CMS‘ Mainframe Telecommunications Systems Part B Outpatient Rehabilitation and Comprehensive Outpatient 3383 ITome Iealth Prospective Payment System (IIII PPS) Rate Update for Rehabilitation Facility (CORF) Services — General Calendar Year (CY) 2016 Determining Payment Amounts — Institutional Claims 3384 National Coverage Determination (NCD) for Single Chamber and Dual Exceptions to Therapy Caps — General Chamber Permanent Cardiac Pacemakers — This CR rescinds and fully Exceptions Process replaces CR 8525. Use of the KX Modifier for Therapy Cap Exceptions 3385 Issued to a specific audience, not posted to Internet/Intranet due to Therapy Cap Manual Review Threshold Confidentiality of Instruction Identifying the Certifying Physician

asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 3386 Medicare Internet Only Manual (!OM) Publication 100-04 Chapter 27 Table of Preventive and Screening Services Contractor Instructions for CWF 3404 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity 17:21 Feb 03, 2016 3387 Billing of the Transportation Fee by Portable X-ray Suppliers Transportation of Instmction Component (HCPCS Codes R0070 - R0076) 1405 Issued to a specific audience, not posted to lntemet/lntranet due to 3388 Manual Updates to Clarify IRF Claims Processing Verification Process Used Confidentiality of Instmction To Determine If The Inpatient Rehabilitation Facility Met The Classification 3406 New Waived Tests Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices Criteria 3407 Quarterly Update to the Medicare Physician Fee Schedule Database 3389 Outpatient Mental Health Treatment Limitation Split Claims Fix Splitting (MPFSDB)- October CY 2015 Update Claims for Processing Quarterly Cpdate to the Correct Coding Initiative (CCI) Edits Jkt 238001 3390 Off-Cycle Update to the Inpatient Prospective Payment System (IPPS) Fiscal 140g Version 22.1, Effective April 1, 2016 Year (FY) 2016 Pricer 3409 Instmctions for Downloading the Medicare ZIP Code File for April2016 3391 Issued to a specific audience, not posted to Intemet/Intranet due to 3410 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instmction Confidentiality of Instmction PO 00000 3392 Issued to a specific audience, not posted to Intemet/Intranet due to 3411 Implement Operating Rules- Phase III ERA EFT: CORE 360 Uniform Use of Confidentiality of Instruction Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark 3393 Reporting of Type of Bill (TOB) 014x for Billing Screening of Hepatitis Codes (RARC) Rule - Update from CAQH CORE Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark 3412 Common Edits and Enhancements Modules (CEM) Code Set Update Frm 00033 Codes (RARCs), Group Codes, and Medicare Summary Notice (MS"\1) 3413 Claim Status Category and Claim Status Codes Update Messages 3414 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Institutional Billing Requirements of Instmction C Virus (HCV) in Adults 3415 Payment for Grandfathered Tribal Federally Qualified Health Centers 3394 Implementation Instructions to Operationally Process the Claims of a (FQHCs) that were Provider-Rased Clinics on or Before April 7, 2000 Payer Fmt 4703 Subclause (II) Long Term Care Hospital (LTCH) in a Manner that is Only Codes Utilized by Medicare Generally Consistent with the Claims Processing of Non-Prospective Payment 3416 CY 2016 Update for Durable Medical Equipment, Prosthetics, Orthotics and System (PPS) Hospitals Supplies (DMEPOS) Fee Schedule 3395 Issued to a specific audience, not posted to Intemet/Intranet due to Sfmt 4725 Gap-Filling DMEPOS Fees Confidentiality of Instruction Intermediary Format for Durable Medical Equipment, Prosthetic, Orthotic, 3396 Changes to the Laboratory National Coverage Determination (NCD) Edit Supply Fee Schedule Software for January 2016 3417 Therapy Cap Values for Calendar Year (CY) 2016 1197 Calendar Year (CY) 2016 Participation Enrollment and Medicare E:\FR\FM\04FEN1.SGM 3418 Remittance Advice Remark and Claims Adjustment Reason Code and Participating Physicians and Suppliers Directory (MEDP ARD) Procedures Medicare Remit Easy Print and PC Print Update 3398 Processing Hospice Denials When Face-to-Face Encounter is Not Received 3419 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Timely of Instmction 3399 Issued to a specitlc audience, not posted to Intemet/Intranet due to 3420 Calendar Year (CY) 2016 Annual Update for Clinical Laboratory Fee Confidentiality of Instruction Schedule and Laboratory Services Subject to Reasonable Charge Payment 3400 Issued to a specific audience, not posted to Intemet/Intranet due to 3421 National Coverage Determination (NCD) for Single Chamber and Dual Confidentiality of Instmction Chamber Permanent Cardiac Pacemakers 3401 Issued to a specific audience, not posted to Intemet/Intranet due to 3422 Issued to a specific audience, not posted to Intemet/Intranet due to 04FEN1 Confidentiality oflnstruclion Contidentiality of Instmction 3402 Payment Reduction for Computed Tomography (CT) Diagnostic Imaging 3423 Summary of Policies in the Calendar Year (CY) 2016 Medicare Physician Fee Services Schedule (MPFS) Final Rule and Telehealth Originating Site Facility Fee Services That Do Not Meet the National Electrical Manufacturers Payment Amount Association (NEMA) Standard XR-29-2011 3424 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics 3403 New Influenza Virus Vaccine Code and Supplies (DMEPOS) Competitive Bidding Program (CBP)-April2016 CW!' Crossover Edits for AID MAC (D) Claims 3425 January 2016 Update of the Hospital Outpatient Prospective Payment System Healthcare Common Procedure Coding System (HCPCS) and Diagnosis (OPPS) Codes Comprehensive APCs CWF Edits on AB MAC (A) Claims Packaging CWF Edits on AB MAC (B) Claims C se of Modifiers for Discontinued Services 6013 EN04FE16.023</GPH>

FPLI09 Use of HCPCS Modifier —CT 148 Revisions and Deletion to the State Operations Manual (SOM) Chapter 9 Transitional Pass—Through Payments for Designated Devices Exhibits Billing for Devices Eligible for Transitional Pass—Through Payments and 149 State Operations Manual (SOM) for All Types of Providers and Suppliers Items Classified in "New Technology" APCs Subject to Certification Categories for Use in Coding Devices Eligible for Transitional Pass Through 150 Revisions to State Operations Manual (SOM), Chapter 2, Clarification of Payments Under the Hospital OPPS Requirements for Off—Premises Activities and Approval of Extension Devices Eligible for Transitional Pass—Through Payments Locations for Providers of Outpatient Physical Therapy and Speech—Language sqonOoN/9I0Z ‘p Lrenigag ‘AKepsimnuL/gEZ ‘ON ‘I8 ‘TOA /JoipstSay jedapaq General Coding and Billing Instructions and Explanations Pathology Services Services Eligible for New Technology APC Assignment and Payments 151 Revisions to State Operations Manual (SOM), Appendix A —Survey Protocol, Edits for Claims on Which Specified Procedures are to be Reported Regulations and Interpretive Guidelines for Hospitals Device Codes and For Which Specific Devices are to be Reported With Medicare Program Integrity (CMS—Pub. 100—08 Procedure Codes 615 Signature Requirements, Amendments, Corrections and Delayed Entries in Inpatient—only Services Medical Documentation Billing for Corneal Tissue 616 Issued to a specific audience, not posted to Internet/Intranet due to a Billing Instructions for IMRT Planning Confidentiality of Instruction Separately Billable ESRD Laboratory Tests Furnished by Hospital—Based 617 Update to Chapter 3 of Pub. 100—08 Facilities 618 Written Orders Prior to Delivery (WOPD) Billing and Payment for Observation Services Furnished Between January 1. Items and Services Having Special DME Review Considerations 2008 and December 31, 2015 Refills of DMEPOS Items Provided on a Recurring Basis Billing and Payment for Direct Referral for Observation Care Furnished Detailed Written Orders Beginning January 1, 2008 Written Orders Prior to Delivery Billing and Payment for Observation Services Furnished Beginning January Face—to—Face Encounter Requirements 1, 2016 Face—to—Face Encounter Conducted by the Physician Method of Payment for Clinical Laboratory Tests — Place of Service Face—to—Face Encounter Conducted by a Nurse Practitioner, Physician Variation Assistant or Clinical Nurse Specialist Billing for Multi—Source Photon (Cobalt 60—Rased) Stereotactic Date and Timing Requirements Radiosurgery (SRS) Planning and Delivery Requirements of New Orders 3426 Issued to a specific audience, not posted to Internet/Intranet due to Billing for Refills of DMEPOS Items Provided on a Recurring Basis Confidentiality of Instruction Verbal and Preliminary Written Orders 3427 January 2016 Integrated Outpatient Code Editor (LOCE) Specifications 619 Issued to a specific audience, not posted to Internet/Intranet due to a Version 17.0 Confidentiality of Instruction 3428 Advance Care Planning (ACP) as an Optional Element of an Annual Wellness 620 Pub. 100—08 Chapter 3 Updates: Section 3.2.3.2 Timeframes for Submission Visit (AWV) and Section 3.2.3.8 — No response to Additional 140.8 Advance Care Planning (ACP) as an Optional Element of an Annual No Response or Insufficient Response to Additional Documentation Weliness Visit (AWV) Requests 3429 New Influenza Virus Vaccine Code Timeframes for Submission Medicare Secondary Payer (CMS—Pub. 100—05 Verifying Potential Errors and Taking Corrective Actions 115 Electronic Correspondence Referral System (ECRS) Web Updates to Claims Documentation Requests Processing Medicare Secondary Payer (MSP) Policy and Procedures 621 Issued to a specific audience, not posted to Internet/Intranet due to a Regarding Ongoing Responsibility for Medicals (ORM) Confidentiality of Instruction 116 Instructions on Using the Claim Adjustment Segment (CAS) for Medicare 622 Program Integrity Manual Chapter 12 Revision Secondary Payer (MSP) Part A CMS—1450 Paper Claims, Direct Data Entry The Comprehensive Error Rate Testing Program DDE), and $37 Institutional Claims Transactions Annual Improper Payment Reduction Strategy (IPRS) Medicare Kinancial Management (CMS—Pub. 100—06 623 Written Orders Prior to Delivery (WOPD) 255 Notice of New Interest Rate for Medicare Overpayments and Underpayments Items and Services Having Special DME Review Considerations — 1st Otr Notfication for FY 2016 Verbal and Preliminary Written Orders 256 Medicare Financial Management Manual, Chapter 7, Internal Controls Detailed Written Orders Medicare State Operations Manual (CMS—Pub. 100—07) _ Written Orders Prior to Delivery 147 Revisions to State Operation Manual (SOM), Appendix C—Survey Procedures Face—to—Face Encounter Conducted by the Physician and Interpretive Guidelines for Laboratories and Laboratory Services Refills of DMEPOS Items Provided on a Recurring Basis

asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 Face-to-Face Encounter Requirements (MEOS) Payment Implementation Date and Timing Requirements 128 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity 17:21 Feb 03, 2016 Requirements of New Orders of Instruction Billing for Refills of DMEPOS Items Provided on a Recurring Basis 129 Oncology Care Model (OCM) Monthly Enhanced Oncology Services Face-to-Face Encounter Conducted hy a Nurse Practitioner, Physician (MEOS) Payment Implementation Assistant or Clinical Nurse Specialist 130 Demonstration: Payment Update for 2016 624 Issued to a specific audience, not posted to Intemet/Intranet due to a Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices 131 Implementing Payment Changes for FCHIP (Frontier Community Health Confidentiality of Instruction Integration Project), Mandated by Section 123 of MIPPA ZOOS and as 625 Issued to a specitlc audience, not posted to Intemet/Intranet due to a Amended by Section 3126 of the ACA of2010 (This CR Rescinds and Jkt 238001 Confidentiality of Instruction Replaces CR 8683) 626 Update to Surety Bond Collection Requirements 132 Oncology Care Model (OCM) Monthly Enhanced Oncology Services Claims against Surety Bonds (MEOS) Payment Implementation Model Letters for Claims against Surety Bonds 133 Issued to a specific audience, not posted to Intemet/Intranet due to a 627 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction PO 00000 Confidentiality of Instruction 134 Medicare Care Choices Model (MCCM)- Per Beneticiary per Month 628 Update to CMS Publication 100-08, Chapter 3, Section 3.2.3.2 (Time Frames Payment (PBPM)- Implementation for Submission) 135 Affordable Care Act Bundled Payments for Care Improvement Initiative - 629 Issued to a specific audience, not posted to Intemet/Intranet due to a Recurring File Updates Models 2 and 4 April2016 Updates Frm 00035 Confidentiality of Instruction One Time Notification (CMS-Pub. 100-20) I 630 Medicare Program Integrity Data Analysis-Update 1546 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Medicare Contractor Beneficiary and Provider Commnnications (CMS-Pnb. 100-09) of Instruction None 1547 ICD-10 Conversion/Coding Infrastructure Revisions to National Coverage Fmt 4703 Medicare Quality Improvement Ore:anization (CMS- Pull.100-10) Determinations (NCDs)--3rd Maintenance CR I None 1548 Analysis Only: To Obtain the Level of Effort (LOE) from Medicare Medicare End Stae;e Renal Disease l'\etwork Ore;anizations (CMS Pnb 100-14) Administrative Contractors (MACs) to Implement Multifactor Authentication I None (MFA) as an Option for Non-Organization Users and to also Obtain the Level Sfmt 4725 Medicaid Proe;mm Intee:ritv Disease :Setwork Ore:anizations (CMS Pub 100-15) of Effort (LOE) from Medicare Administrative Contractors (MACs) to I None Implement lvlultifactor Authentication (MFA) as a Requirement for Non- Medicare Manae;ed Care (CMS-Pub.100-16) Organization Users I None 1549 Shared System Enhancement 2014- Removal of Railroad Board (RRB) E:\FR\FM\04FEN1.SGM Medicare Business Pal'tners Svstems Secmity (CMS-Pnb. 100-17) obsolete reports identified by Multi-Carrier System (MCS) Shared System None Maintainer (SSM) Demonstrations (CMS-Pnb. 100-19) 1550 System Specific Enhancement 2014: Process Health Maintenance 121 Medicare Care Choices Model (MCCM)- Per Beneficiary per Month Organization (HMO) edits in a single module in Common Working File Payment (PBPM) - Implementation (CWF) 122 Termination of the Rural Community Hospital Demonstration, Mandated by 1551 System Specific Enhancements 2014: Move PAP smear Risk Indicator Section 410A of the Medicare Modemization Act and Extended by Sections (P APR!) and Technical (TECH)/Professional (PROF) Dates to Screening 3123 and 10313 of the Affordable Care Act Auxiliarv file 04FEN1 123 Implementing Payment Changes for FCHIP (Frontier Community Health 1552 Medicare Remit Easy Print (MREP) Cpgrade Integration Project), Mandated by Section 123 of MIPPA 2008 and as 1553 New Stale Code for CT, MA, NJ, PR, GA, NC, SC, TN, AR, OK, CO, CA, Amended by Section 3126 of the ACA of2010 (This CR Rescinds and OR, LA, NM, TX and WA Replaces CR 8683 1554 System Specific Enhancements 2014: Retaining Most Recent Update for 124 Affordable Care Act Bundled Payments for Care Improvement Initiative - Auxiliarv (Aux) File Data in Common Working File (CWF) Recurring File Updates Models 2 and 4 January 2016 Updates 1555 Issued to a specific audience, not posted to Internet/ Intranet due to 125 Medicare Care Choices Model (MCCM) - Per Beneficiary per Month Confidentiality of Instruction Payment (PBPM)- Implementation 1556 Shared System Enhancement 2015: Eliminate Remaining Uses of AREAFILE 126 Issued to a specific audience, not posted to Intemet/Intranet due to a and CUSTCHRG Virtual Storage Access Method Files Confidentiality ofTnstruction 1557 System Specific Enhancement 2015: Archive Competitive Bidding 127 Oncology Care Model (OCM) Monthly Enhanced Oncology Services Demonstration Logic in YiPS Medicare System (VMS) 6015 EN04FE16.025</GPH>

9109 1558 Issued to a specific audience, not posted to Internet/ Intranet due to Services‘ (DHHS) Office of Medicare Hearings and Appeals (OMHA) Confidentiality of Instruction Settlement Conference Facilitation (SCF) Pilot 1559 Shared System Enhancement 2015: Modify Purged Claim History to Improve 1584 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity Efficiency of Instruction 1560 Instruction to Apply the Part A Deductible on a Medicare Secondary Payer 1585 Modifications to the National Coordination of Benefits Agreement (COBA) (MSP) Inpatient Same Day Transfer Claim Crossover Process 1561 Part B Detail Line Expansion — Trailer 08 Update 1586 Eliminate Two Case—mix Payment Adjustments (Monoclonal Gammopathy sqonOoN/9I0Z ‘p Lrenigag ‘AKepsimnuL/gEZ ‘ON ‘I8 ‘TOA /JoipstSay jedapaq 1562 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity and Bacterial Pneumonia) Available Under the End State Renal Disease of Instruction (ESRD) Prospective Payment System (PPS) in Accordance With Section 632 1563 Issued to a specific audience, not posted to Internet/ Intranet due to of the American Taxpayer Relief Act (ATRA) Confidentiality of Instruction 1587 Instruction to Apply the Part A Deductible on a Medicare Secondary Payer 1564 Health Insurance Portability and Accountability Act (HIPAA) EDI Front End (MSP) Inpatient Same Day Transfer Claim Updates for April 2016 1588 Settlement Effectuation Instructions for the Department of Health and Human 1565 System Specific Enhancement 2015: Fiscal Intermediary Standard System Services‘ (DHHS) Office of Medicare Hearings and Appeals (OMHA) (FISS) Extend Hard Segregation of Security Settlement Conference Facilitation (SCF) Pilot 1566 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction 49 Issued to a specific audience, not posted to Internet/Intranet due to a 1567 System Specific Enhancements 2014: Retaining most recent update for Confidentiality of Instruction Auxiliary (Aux) file data in Common Working File (CWEF) Analysis Only 50 Issued to a specific audience, not posted to Internet/Intranet due to a 1568 Implementation of Procedures for Undeliverable Medicare Summary Notices Confidentiality of Instruction (uMSNs) 51 Issued to a specific audience, not posted to Internet/Intranet due to a 1569 Shared System Enhancement 2015: Combined Common Edits/Enhancements Confidentiality of Instruction Module (CCEM) Claim Tracking and Logging. 52 Fiscal Year 2017 and After Payments to Hospice Agencies That Do Not 1570 Reporting Principal and Interest Amounts When Refunding Previously Submit Required Quality Data — This CR Rescinds and Fully Replaces Recouped Money on the Remittance Advice (RA) CRO91 1571 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction None 1572 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Addendum II:;: Regulation Documents Published 1573 Shared System Enhancement 2014 — Removal of Obsolete Reports and On— . . Request Jobs from the ViPS Medicare System (VMS) — Implementation . in the Fede.ral Register (October through December 2015) 1574 Shared System Enhancement 2015: Technical Improvements to the and Redesigned Medicare Summary Notice (MSN) process. Regulations and notices are published in the daily Federal 1575 f,ha_red S(yAsteril E_nhSn;:e)ment 2015: Identify Inactive Medicare Demonstration Register. To purchase individual copies or subscribe to the Federal rojects (Analysis On & & hh: 1576 Chl;lonic Care glanagerient (CCM) services for Rural Health Clinies (RHCs) Reg.ISte.r* .contact GPO at WWV.V'ng'gOV/deyS' When 9rdenng individual and Federal Qualified Health Centers (FQHCs) copies,. it is necessary to cite either the date of publication or the volume 1577 System Specific Enhancement 2015; Remove Direct Claim Updates within number and page number. the Daily Batch Cycle Analysis and Design CR The Federal Register is available as an online database through 1578 Issued to a specific, audience not to Internet/ Intranet due to a Sensitivity of GPO Access. The online database is updated by 6 a.m. each day the 157 Elzg:mon Federal Register is published. The database includes both text and 1580 ICD—10 Conversion/Coding Infrastructure Revisions to National Coverage graphlcs from Volume 59, Number 1 (January 2, 1994) thIOU»gh the present Determinations (NCDs)——3rd Maintenance CR date and can be accessed at http://www.gpoaccess.gov/fr/index.html. The 1581 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity following website http://www.archives. gov/federal—register/ provides of Instruction _ — —— information on how to access electronic editions, printed editions, and 1582 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity . of Instruction reference copices. 2o . . 1583 Settlement Effectuation Instructions for the Department of Health and Human This information is available on our website at:

http://www.cms. gov/quarterlyproviderupdates/downloads/Regs— Addendum V includes listings of the FDA—approved 3Q15QPU .pdf investigational device exemption (IDE) numbers that the FDA assigns. The For questions or additional information, contact Terri Plumb listings are organized according to the categories to which the devices are (410—786—4481). assigned (that is, Category A or Category B), and identified by the IDE number. For the purposes of this quarterly notice, we list only the specific Addendum IILI: CMS Rulings updates to the Category B IDEs as of the ending date of the period covered sqonOoN/9I0Z ‘p Lrenigag ‘AKepsimnuL/gEZ ‘ON ‘I8 ‘TOA /JoipstSay jedapaq (October through December 2015) by this notice and a contact person for questions or additional information. CMS Rulings are decisions of the Administrator that serve as For questions or additional information, contact John Manlove (410—786— precedent final opinions and orders and statements of policy and 6877). interpretation. They provide clarification and interpretation of complex or Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360¢) devices ambiguous provisions of the law or regulations relating to Medicare, fall into one of three classes. To assist CMS under this categorization Medicaid. Utilization and Quality Control Peer Review, private health process, the FDA assigns one of two categories to each FDA—approved insurance, and related matters. investigational device exemption (IDE). Category A refers to experimental The rulings can be accessed at http://www.cms. gov/Regulations— IDEs, and Category B refers to non—experimental IDEs. To obtain more and—Guidance/Guidance/Rulings. For questions or additional information, information about the classes or categories, please refer to the notice contact Tiffany Lafferty (410—786—7548). published in the April 21, 1997 Federal Register (62 FR 19328). Addendum IV: Medicare National Coverage Determinations IDE Device Start Date (October through December 2015) G150121 SurVeil Drug Coated Balloon Catheter 10/02/15 Addendum IV includes completed national coverage G150191 Restylane; Restylane — 1. Perlane; Restylane Tyft; Restylane Silk 10/02/15 determinations (NCDs), or reconsiderations of completed NCDs, from the 6150192 Prostate Embolization for Massive Benign Prostatic Hypertrophy 10/02/15 (BPH) Using Embosphere Microsperes quarter covered bythis notice. Completed decisions are identified by the 6150194 SYNERGYTM Everolimus—Eluting Platinum Chromium 10/02/15 section of the NCD Manual (NCDM) in which the decision appears, the Coronary Stent System title, the date the publication was issued, and the effective date of the G150198 Multichannel Vestibular Implant 10/09/15 decision. An NCD is a determination by the Secretary for whether or not a 6150201 VOCARE Bladder System 10/09/15 particular item or service is covered nationally under the Medicare Program 6150208 EPIFLO (Spinal Fusion) 10/16/15 (title XVIII of the Act), but does not include a determination of the code, if 6150209 EPIFLO (Colo—Rectal Surgery) 10/16/15 6150210 Corvia Medical InterAtrial Shunt Device (IASD) System II 10/22/15 any, that is assigned to a particular covered item or service, or payment 6150035 JenaValve Pericardial THV System 10/22/15 determination for a particular covered item or service. The entries below G130173 CELSTAT 10/29/15 include information concerning completed decisions, as well as sections on G150211 MET Exon 14 Deletion Test 10/29/15 program and decision memoranda, which also announce decisions or, in 6150214 HAC Coil Transcranial Magnetic Stimulation (DTMS) Device 10/29/15 some cases, explain why it was not appropriate to issue an NCD. 6150218 Halo Craniofacial Nerve Stimulator; Earpiece Wearable Antenna 11/06/15 6150220 Edwards SAPIEN 3 Transcatheter Heart Valve [sizes 20mm, 11/06/15 Information on completed decisions as well as pending decisions has also 23mm, 26mm, 22mm|], Edwards Commander Delivery System, been posted on the CMS website. For the purposes of this quarterly notice, Edwards Balloon Catheter, Crimper there were no additions in the 3—month period. This information is 6150222 Penumbra Apollo System 11/12/15 available at: www.cms. gov/medicare—coverage—database/. For questions or 6150223 High Resolution Microendoscope (HRME). Portable Screening 11/12/15 additional information, contact Wanda Belle (410—786—7491). System (PS2.1/PS3) 6150224 Thorflex Hybrid 11/13/15 6150225 Venous External Support (VEST) Device 11/13/15 6150226 BreathID MCS System °C— Methacetin Breath Test (MBT) 11/13/15 Addendum V: FDA—Approved Category B Investigational Device G150207 Lowsurgical risk transcatheter aortic valve replacement (TAVR) 11/19/15 Exemptions (IDEs) (October through December 2015) 6150228 Panpac Vaginal Pessary [distributed in the US under the 11/19/15 L109

asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 6018 IDE Device Start Date Device company name Bioteque America Inc. MED SYSTEM MODEL MED-WSl, MED-MBl 17:21 Feb 03, 2016 Gl50227 Precision Spinal Cord Stimulator 11120/15 InPress Technologies Post Pactum Hemorrhage Device Gl50232 Vessix Renal Denervation System 11120/15 Gl50212 Espiner Tissue Retrieval System 11124/15 Addendum VI: Approval Numbers for Collections of Information Gl50230 Prosigna Breast Cancer Gene Signature Assay for use on 11124/15 (October through December 2015) Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices nCounter Dx Analysis System Gl50233 Roche co bas ADCY9 Genotype Test; Roche co bas 4800 system 11124/15 All approval numbers are available to the public at Reginfo.gov. Sample Preparation Kit [240 tests. 960 tests]; Roche cohas 4SOO Under the review process, approved information collection requests are Jkt 238001 System Lysis Kit 1 f240 tests, 960 tests l; Roche assigned OMB control numbers. A single control number may apply to Gl50235 FGFR-CTA Clinical Trial Assay (FGFR-CTA) 11125/15 several related information collections. This information is available at Gl50234 Intergrated Diagnostics Driven Diuretic and Chronic Medication 12/02/15 Management for Heart Failure (INTERVEJ\E-HF) www.rcginfo.gov/public/do/PRAMain. For questions or additional PO 00000 Gl50139 CarboClear Pedicle Screw System 12/02/15 information, contact Mitch Bryman (410-786-5258). Gl50101 ROXCOUPLER 12/04/15 Gl50236 Halo Migraine System (HMS), Halo Stimulator, Earpiece 12/04/15 Addendum VII: Medicare-Approved Carotid Stent Facilities, Wearable Antenna (October through December 2015) Frm 00038 Gl50237 Vercise DBS System; MagPro R30 Magnetic Stimulator, MCF- 12/04/15 B65 coil Addendum VII includes listings of Medicare-approved carotid Gl50185 WallFlex Pancreatic RX Fully Covered Soft Stent System 12/10/15 stent facilities. All facilities listed meet CMS standards for performing Gl40249 ROADS AVER Carotid Artery Stent System and 12/11115 carotid artery stenting for high risk patients. On March 17, 2005, we issued Fmt 4703 NANOPARASOL Embolic Protection Device our decision memorandum on carotid artery stenting. We determined that Gl50238 Safety and efficacy of remote programming of Nucleus cochlear 12/11115 implants carotid artery stenting with embolic protection is reasonable and necessary Gl50200 W ATCHMA"\1 FLX Left Atrial Appendage Closure (LAAC) 12/14/15 only if performed in facilities that have been determined to be competent in Sfmt 4725 Device performing the evaluation, procedure, and follow-up necessary to ensure Gl50246 Brainsway Deep Transcranial Magnetic Stimulation (TMS) 12/16/15 optimal patient outcomes. We have created a list of minimum standards for Machine facilities modeled in part on professional society statements on competency. Gl50243 The Spanner Temporary Prostatic Stent 12/16/15 E:\FR\FM\04FEN1.SGM Gl50144 RECOR PARADISE RENAL DENERVATION SYSTEM 12/17/15 All facilities must at least meet our standards in order to receive coverage (PARADISE SYSTEM) for carotid artery stenting for high risk patients. For the purposes of this Gl50252 The Edwards SAPIEN 3 Transcatheter Heart Valve 12/17/15 quarterly notice, we are providing only the specific updates that have Gl50248 Venovo Venous Stent System 12/18/15 occurred in the 3-month period. This information is available at: Gl50251 Valiant Evo Thoratic Stent Graft System 12/18/15 http://www .ems. gov/MedicareApprovedF acilitie/CASF/list. asp#TopOfPage Gl50253 Restylane Silk 12/18/15 Gl50216 dEEG-guided rTMS for treatment of epileptic seizures 12/18/15 For questions or additional information, contact Lori Ashby Gl50260 Self-Centering Guide Catheter 12/21115 (410-786-6322). 04FEN1 Gl50264 Dexcom G5 Mobile Continuous Glucose Monitoring System 12/22/15 Gl50181 Image Ready MR Conditional Defibrillation System 12/22/15 Facility Provider Etrective State Gl50196 Neocis Guidance System (NGS) 12/22/15 Number Date G150164 Cordis Precise Pro Rx Nitinol Stent System 12/21115 The followbu! facilities are new Ustin!!s for this onarter. Gl50254 PINPOINT Endoscopic Fluorescence Imaging System 12/23/15 Valley View Hospital Association 060075 10/09/2015 co (PI'IPOINT) 1906 Blake Avenue Gl50255 Visualase Thermal Therapy System (VTTS), Visualase Cooled 12/23/15 Glenwood Springs, CO 81601 Laser Applicator System (VCLAS), Visualase Software, St. Rita's Medical Center 1Sll939SS7 11109/2015 OH PHOTEX 15 W DIODE LASER SERIES 980. 810,940, 730 West .\i!arket Street Lima, OH 45801 Peristaltic Pump White Plains Hospital 330304 11109/2015 NY Gl50262 OL-1000 12/25/15 41 East Post Road White Plains, NY 10601 EN04FE16.028</GPH>

asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 Facility City State Addendum VIII: The following facilities are new listings for this quarter. 17:21 Feb 03, 2016 The Mount Sinai Hospital of Queens Long Island NY American College of Cardiology's National Cardiovascular Data Patients' Hospital of Redding Redding CA Registry Sites (October through December 2015) Johnston Memorial Hospital Abingdon VA Addendum VIII includes a list of the American College of Saint Joseph East Lexington KY Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices Cardiology's National Cardiovascular Data Registry Sites. We cover Brownwood Hospital, LP Brownwood TX implantable cardioverter defibrillators (ICDs) for certain clinical Lucile S Packard Children's Hospital at Stanford U Palo Alto CA Jkt 238001 indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are Addendum IX: Active CMS Coverage-Related Guidance Documents available in the NCD. In January 2005, CMS established the lCD (October through December 2015) Abstraction Tool through the Quality Network Exchange (QNet) as a CMS issued a guidance document on November 20, 2014 titled PO 00000 temporary data collection mechanism. On October 27, 2005, CMS "Guidance for the Public, Industry, and CMS Staff: Coverage with armounced that the American College of Cardiology's National Evidence Development Document". Although CMS has several policy Cardiovascular Data Registry (ACC-NCDR) lCD Registry satisfies the data vehicles relating to evidence development activities including the Frm 00039 reporting requirements in the NCD. Hospitals needed to transition to the investigational device exemption (IDE), the clinical trial policy, national ACC-NCDR TCD Registry by April 2006. coverage determinations and local coverage determinations, this guidance Effective January 27, 2005, to obtain reimbursement, Medicare document is principally intended to help the public understand CMS 's Fmt 4703 NCD policy requires that providers implanting ICDs for primary prevention implementation of coverage with evidence development (CED) through the clinical indications (that is, patients without a history of cardiac arrest or national coverage determination process. The document is available at spontaneous arrhythmia) report data on each primary prevention lCD http://www. ems. gov/medicare-coverage-database/details/medicare- Sfmt 4725 procedure. Details of the clinical indications that are covered by Medicare coverage-document-details.aspx?MCDid=27. There are no additional and their respective data reporting requirements are available in the Active CMS Coverage-Related Guidance Documents for the 3-month Medicare NCD Manual, which is on the CMS website at period. For questions or additional information, contact JoAnna Baldwin (410-786-7205). E:\FR\FM\04FEN1.SGM A provider can usc either of two mechanisms to satisfy the data Addendum X: reporting requirement. Patients may be enrolled either in an Investigational List of Special One-Time Notices Regarding National Coverage Device Exemption trial studying ICDs as identified by the FDA or in the Provisions (October through December 2015) ACC-NCDR lCD registry. Therefore, for a beneficiary to receive a There were no special one-time notices regarding national Medicare-covered lCD implantation for primary prevention, the beneficiary coverage provisions published in the 3-month period. This information is 04FEN1 must receive the scan in a facility that participates in the ACC-NCDR lCD available at www.cms.hhs.gov/coverage. For questions or additional registry. The entire list of facilities that participate in the ACC-NCDR lCD information, contact JoAnna Baldwin (410-786 7205). registry can be found at www.ncdr.com/webncdr/common For the purposes of this quarterly notice, we are providing only the Addendum XI: National Oncologic PET Registry (NOPR) specific updates that have occurred in the 3-month period. This information (October through December 2015) is available by accessing our website and clicking on the link for the Addendum XI includes a listing of National Oncologic Positron American College of Cardiology's National Cardiovascular Data Registry Emission Tomography Registry (NOPR) sites. We cover positron emission at: www.ncdr.com/webncdr/common. For questions or additional tomography (PET) scans for particular oncologic indications when they are information, contact Marie Casey, BSN, MPH (410-786-7861). performed in a facility that participates in the NOPR. 6019 EN04FE16.029</GPH>

asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 6020 In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover Facility Provider Date Approved State PET scans for particular oncologic indications, as long as they were Number 17:21 Feb 03, 2016 The followine; facilities are new listine;s for this quarter. performed in the context of a clinical study. We have since recognized the Advocate Christ Medical Center 140208 9/28/2015 IL National Oncologic PET Registry as one of these clinical studies. 4440 W. 95th Street Therefore, in order for a beneficiary to receive a Medicare-covered PET Oak Lawn, IL 60505 Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices scan, the beneficiary must receive the scan in a facility that participates in Hackensack University Medical Center 31001 10/20/2015 NJ 30 Prospect Avenue the registry. There were no additions, deletions, or editorial changes to the Hackensack, NJ 07601 Jkt 238001 listing of National Oncologic Positron Emission Tomography Registry University of California, Davis Medical 050599 11125/2015 CA (NOPR) in the 3-month period. This information is available at Center (UCDMC) http•//www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. 2315 Stockton Blvd For questions or additional information, contact Stuart Caplan, RN, MAS Sacramento, CA 95817 PO 00000 (410-786-8564). Addendum XIII: Lung Volume Reduction Surgery (LVRS) Addendum XII: Medicare-Approved Ventricular Assist Device (October through December 2015) Frm 00040 (Destination Therapy) Facilities (October through December 2015) Addendum XIII includes a listing of Medicare-approved facilities Addendum XII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. that receive coverage for ventricular assist devices (VADs) used as Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three Fmt 4703 destination therapy. All facilities were required to meet our standards in order to receive coverage for V ADs implanted as destination therapy. On types of facilities are eligible for reimbursement for Lung Volume October 1, 2003, we issued our decision memorandum on VADs for the Reduction Surgery (L VRS): • National Emphysema Treatment Trial (NETT) approved (Beginning Sfmt 4725 clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in 05/07/2007, these will no longer automatically qualify and can qualify only facilities that have been determined to have the experience and with the other programs); • Credentialed by the Joint Commission (formerly, the Joint E:\FR\FM\04FEN1.SGM infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet Commision on Accreditation ofHealthcare Organizations (JCAHO)) under our standards in order to receive coverage for VADs implanted as their Disease Specific Certification Program for LVRS; and destination therapy. • Medicare approved for lung transplants. For the purposes of this quarterly notice, we are providing only the Only the first two types are in the list. There were no updates to specific updates that have occurred to the list of Medicare-approved the listing of facilities for lung volume reduction surgery published in the facilities that meet our standards in the 3-month period. This information is 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/L VRS/list.asp#TopOfPage. For 04FEN1 available at http://www. ems. gov/MedicareApprovedF acilitie/VAD/list.asp#TopOfPage. questions or additional information, contact Marie Casey, BSN, MPH For questions or additional information, contact Marie Casey, BSN, MPH (410-786-7861 ). (410-786-7861). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (October through December 2015) Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional EN04FE16.030</GPH>

asabaliauskas on DSK5VPTVN1PROD with NOTICES VerDate Sep<11>2014 BILLING CODE 4120–01–C [FR Doc. 2016–02108 Filed 2–3–16; 8:45 am] 17:21 Feb 03, 2016 Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices Jkt 238001 PO 00000 society statements on competency. All facilities must meet our standards in for bariatric surgery that have been certified by ACS and/or ASMBS in the order to receive coverage forbariatric surgery procedures. On February 21, 3-month period. This information is available at Frm 00041 2006, we issued our decision memorandum on bariatric surgery procedures. www .cms.gov/MedicareApprovedFacilitie/B SF/list.asp#TopOfPage. For We determined that bariatric surgical procedures are reasonable and questions or additional information, contact Sarah Fulton, MPH necessary for Medicare beneficiaries who have a body-mass index (BMI) (410-786-27 49). greater than or equal to 35, have at least one co-morbidity related to obesity Fmt 4703 and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are Addendum XV: FDG-PET for Dementia and Neurodegenerative reasonable and necessary only when performed at facilities that are: (1) Diseases Clinical Trials (October through December 2015) Sfmt 9990 certified by the American College of Surgeons (ACS) as a Level 1 Bariatric There were no FDG-PET for Dementia and Neurodegenerative Surgery Center (program standards and requirements in effect on February Diseases Clinical Trials published in the 3-month period. 15, 2006): or (2) certified by the American Society for Bariatric Surgery This information is available on our website at E:\FR\FM\04FEN1.SGM (ASBS) as a Bariatric Surgery Center of Excellence (ESCOE) (program www .cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. standards and requirements in effect on February 15, 2006). For questions or additional information, contact Stuart Caplan, RN, MAS There were no additions, deletions, or editorial changes to (410-786-8564 ). Medicare-approved facilities that meet CMS' s minimum facility standards 04FEN1 6021 EN04FE16.031</GPH>


Document Created: 2016-02-04 00:30:47
Document Modified: 2016-02-04 00:30:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactIt is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. [GRAPHIC] [TIFF OMITTED] TN04FE16.020
FR Citation81 FR 6009 
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